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Recently, an brain abscess patient with halo ring fixator was referred to our center. After vertified with case physician, the halo ring fixator was made of mainly plastic & carbon fiber with titanium pin. We are aware that titanium may pose an increased fire risk. Does UHMS committee have any suggestions to make the treatment safer? Is it necessary to cover the titanium pin with wet graze? Our chamber is a multiplace chamber which the patient will be given O2 via tracheostomy tube. Thanks.
Published: 28 June 2022

Posted: 6/29/22


Q:
Recently, an brain abscess patient with halo ring fixator was referred to our center. After vertified with case physician, the halo ring fixator was made of mainly plastic & carbon fiber with titanium pin. We are aware that titanium may pose an increased fire risk. Does UHMS committee have any suggestions to make the treatment safer? Is it necessary to cover the titanium pin with wet graze? Our chamber is a multiplace chamber which the patient will be given O2 via tracheostomy tube. Thanks.


A: 
My name is Andrew Melnyczenko, Chair of the UHMS Hyperbaric Oxygen Therapy Safety Committee, and your question regarding allowance a fixator containing titanium in the multiplace environment was forward to me by John Peters, Executive Director of the UHMS. 

Ultimately, the decision to allow any item into the hyperbaric environment is the joint responsibility of the Hyperbaric Safety Director and Medical Director of your facility. I will provide you with information to assist you in answering your question. You may consider that the testing performed on titanium that is often quoted in these instances was done in 100% oxygen environment, and under greater-than-clinical levels of pressure (4.4 ATA). Based upon the description in your question, it seems that your conditions do not meet those identified in this article. For this reason, and the improbability that these materials would need to be stressed to the point of breaking, the risk of fire should be low in the multiplace environment with oxygen monitoring and ventilation present to keep oxygen levels below 23.5%. I am aware of many instances where fixation devices such as the one you describe have been allowed inside multiplace chambers in an air environment, with oxygen monitoring and ventilation present to keep oxygen levels below 23.5%.

The 2021 NFPA 99 Health Care Facilities Handbook, 14.3.2.5* prohibits equipment made from cerium, magnesium and magnesium alloys in the Class A hyperbaric chamber. There is concern expressed within the handbook annex, A.14.3.2.2 regarding the potential risk of many products. Iron alloys, aluminum, human skin, plastic tubing etc may not self-extinguishing in an oxygen-enriched environment. Titanium and Titanium alloys are not specifically prohibited in the hyperbaric chamber by NFPA 99.

I will also refer you to several questions previously answered by the committee on the subject of titanium. These are publicly available on the UHMS MEDFAQ page:

https://www.uhms.org/resources/medfaqs-frequently-asked-questions-faq/safety-technical/162-item-approval.html?faq=36

https://www.uhms.org/resources/medfaqs-frequently-asked-questions-faq/safety-technical/162-item-approval.html?faq=137

I hope this information is beneficial. Thank you for reaching out to the UHMS Safety Committee.

Sincerely,

Andrew R. Melnyczenko  
UHMS Safety Committee Chair


DISCLAIMER

Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet. If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility. Information provided on this forum is for general educational purposes only. It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.

Is hereditary spherocytosis a contraindication to hyperbaric oxygen treatments?
Published: 07 June 2022

Posted 6/7/22


Q:
Is hereditary spherocytosis a contraindication to hyperbaric oxygen treatments?


A:
Sporadically, there is mention in literature that hyperbaric oxygen may cause increased hemolysis for patients with hereditary spherocytosis. In my search, I was unable to find an original reference citing an organized study or even a case series or case report demonstrating increased hemolysis for spheroid cytosis patients treated with hyperbaric oxygen. I suspect (but cannot prove) that some where along the line, some one speculated that since hyperbaric oxygen causes vasoconstriction that abnormally shaped red blood cells and prone to hemolysis would have more mechanical stress and therefore more hemolysis. Although spherocytosis is relatively rare, I suspect that patients with spheroid cytosis have been previously treated perhaps inadvertently, and we have no reports of increased hemolysis.

I recommend that you include in your informed consent a statement to the effect that some have suggested that there may be increased hemolysis for spheroid cytosis patients undergoing hyperbaric oxygen but that there are reports of patients treated without toxicity. A weekly CBC during treatment would also be prudent, and if there are signs of increased hemolysis, HBO2 should be discontinued and the patient should see his or her hematologist.

We have a patient with the Medtronic Activa SC model 37603 brain stimulator (seizure disorder). The company states it is okay to 2ATA. Has anyone treated someone with such a device? (Monoplace
Published: 27 May 2022

Posted: 6/14/2022


Q: 
We have a patient with the Medtronic Activa SC model 37603 brain stimulator (seizure disorder). The company states it is okay to 2ATA. Has anyone treated someone with such a device? (Monoplace)


A: 
Thank you for your question. The UHMS HBO2 Safety Committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the Hyperbaric Medical Director (HMD) and Hyperbaric Safety Director (HSD) of your facility.

First of all, the Safety Committee appreciates your willingness to learn as much as you can about these devices and the potential risk they may add to the patient in your care.  As with any medical device, a risk assessment performed by your HSD in conjunction with your HMD should be your first step. In this instance, the manufacturer has given parameters, and the HBO2 SC would advise that you would follow their recommendations.

In response to your specific inquiry of the committee with this device, none of our members have had experience treating a patient with a Medtronic Activa SC model 37603 brain stimulator. One member from Europe has shared his experience. Several other members have shared that they have treated patients with several different makes and models of stimulators made to stimulate the central nervous system. I will include some of their comments below. We have also included links to several resources in the references section that may help you conduct a risk assessment.

  • I have not personally treated a patient with a deep brain stimulator; however, I know of patients that have been treated without issue.
  • I have no experience with the Medtronic brain stimulator. We’ve treated with the Medtronic spinal stimulator previously – also limited to 2.0 ATA – without apparent adverse effect.
  • We have treated some patients with those devices, and I know from our previous survey that some other hyperbaric facilities in Europe had done it as well. This includes also hyperbaric facility at the Karolinska Institute in Sweden. In my opinion:
    • First, internal electrodes do not present any additional hazard in the hyperbaric environment
    • Second, controlling device is quite similar to Implantable Cardiac Pacemakers (ICD) which means that they are all exposed to initial “unintentional” hyperbaric environment during the ISO-compatible ETO-standard sterilization process, when the pressure is from 1.7 up to 2.5 ATA (7–15 msw).
    • Third, Medtronic stated about the compatibility of their ICD to hyperbaric pressure, but - as far as I am aware - not with IBS. Therefore, patients in our center are informed about the POSSIBLE INCREASED RISK for malfunction of the device, but it does not stop us in using HBOT (up to 2.5 ATA until now) both for chronic and emergency indications.

REFERENCES:

  • Burman, F. (2019). Risk Assessment Guide for Installation and Operation of Clinical Hyperbaric Facilities (6th ed.). San Antonio, TX: International ATMO, Inc.
  • Burman F, Sheffield R, Posey K. Decision process to assess medical equipment for hyperbaric use. Undersea Hyperb Med. 2009;36:137–44. PMID: 19462753.
  • Jagadeeswaran, I., & Chandran, S. (2022). ISO 11135: Sterilization of Health-Care Products—Ethylene Oxide, Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices. In Medical Device Guidelines and Regulations Handbook (pp. 145-153). Springer, Cham. LINK
  • Medtronic, inc. (Updated March 2022). INDICATIONS, SAFETY, AND WARNINGS - Deep Brain Stimulation Therapy. Accessed 5/31/2022 LINK
  • U.S. Food and Drug Administration (2022).  Deep Brain Stimulator - Patient Manual. Accessed 5/31/2022 LINK
  • Workman, W. T., & Wood, J. S. (2020). Hyperbaric Facility Safety: A Practical Guide (2nd ed.). Best Publishing Company.

Respectfully,

The UHMS HBO2 Safety Committee


 

DISCLAIMER

Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet.  If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility.  Information provided on this forum is for general educational purposes only.  It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.

should HBOT treatment be added to debridement and IV antibiotics for soft tissue clostridium infection
Published: 18 May 2022

Posted: 5/20/22


Q:
Should HBO2 treatment be added to debridement and IV antibiotics for soft tissue clostridium infection?


A:

Hyperbaric oxygen has been a mainstay in the treatment of Clostridial necrotizing soft tissue infections since the pioneering work of Brummelkamp in Holland in the 1960’s. This work was done along with much of the early work that established hyperbaric oxygen as an appropriate adjunctive treatment for several disorders that we continue to treat. The initial rationale was Clostridial organisms are anerobic bacteria and would likely find hyperbaric oxygen lethal or at least bacteriostatic.

Liquefactive soft tissue necrotizing infections can be caused by several Clostridial species including C. perfringens (the most common) along with C. oedematiens, C. septicum, C. histolyticum, C. bifermentans, and C. fallax. More recent investigation of the Clostridial species causing gas gangrene have shown that they are not strict anerobes. Clostridial perfringens will grow freely in oxygen tensions as high as 30mmHg with some growth even up to tissue oxygen tensions of 70mmHg.

The clostridial organisms release at least 20 toxins which are largely responsible for the lethality and toxicity of the disease. The most studied and most important of these is called alpha toxin. This toxin is responsible in large part for the rapidly spreading liquefactive necrosis which is a prominent feature of the serious infections we know as gas gangrene with the local necrotizing process advancing more than one inch every hour. This toxin also plays a large part in causing systemic toxicities.

Four distinct levels of severity have been described. These include: 1) Diffuse clostridial necrosis with systemic toxicity (true gas gangrene); 2) Localized Clostridial myonecrosis; 3) Clostridial cellulitis with systemic toxicity; and Clostridial cellulitis without toxicity.

Clinical signs of gas gangrene include a mild fever (100 to 101 degrees), a tachycardia of 150 beats per minute or higher which is disproportionately elevated for the fever, and a peculiar sort of sensorium where the patient is intellectually aware of the seriousness of their infection but is emotionally unconcerned, also called “la belle indifference.” Interstitial gas is often shown on radiographic studies. Clinically crepitus may be palpated.

Hyperbaric oxygen should be part of a combined modality therapy including high dose antibiotics and surgical debridement. Hyperbaric oxygen is very useful in helping to distinguish between permanently destroyed damage versus salvageable tissues. We recommend against amputation immediately unless the limb is absolutely and certainly beyond salvage and instead recommend hyperbaric oxygen be initiated prior to any radical surgeries. The intent here is to identify and save as much viable tissue as possible.  Antibiotics typically include penicillin and/or clindamycin.

Early diagnosis is generally made by history along with a gram stain of the wound which will show large gram positive rods.

The spectrum of effects of Clostridial infections includes respiratory, cardiac, renal complications and DIC. Often these patients will require heparin therapy.

The most important effect of hyperbaric oxygen appears to be the shut down of further alpha toxin production if/when tissue oxygen tensions are increased to 250 mmHg or higher. Oxygen tensions of 2000 or more mmHg are cytotoxic but may not be achieved in vivo.

Patients with trauma or pre-existing vasculopathies including diabetes are at higher risk for gas gangrene. A common source for gas gangrene is a contaminated wound in a patient with impaired circulation. Gas gangrene can occur post operatively, but compared to trauma this occurrence is relatively rare.

In order to have the best impact of hyperbaric oxygen on the infection as part of the multi-disciplinary management, it is necessary to treat these patient at high pressures and multiple times daily typically for 3 days. Typically 3 treatments are given in the first 24 hours and then BID treatments for the next 2 days. In this writer’s experience, oxygen induced seizures are fairly common because these patients are toxic and treated at high pressures of 3.0 ATA. This usually requires a modification in treatment profile to allow continuation of treatment. Since it is important to achieve high treatment pressures and high tissue oxygen levels in the tissues, it is preferrable to shorten oxygen periods over reducing treatment pressure.

All standard textbooks of hyperbaric oxygen deal present extensive information on the treatment of gas gangrene. The treatment of gas gangrene is one of the 14 indications approved by the UHMS. The Indications Manual 14th Edition is a good reference as well as the Whelan-Kindwall textbook or the Neuman-Thom textbook.

John J. Feldmeier, D.O., FACRO, FUHM

Note: see a typical treatment profile below:

 

GG medfaq

I have a patient that has a Braun ezpump for antibiotics infusing into a picc line. It infuses 10ml/hr. Could this pump go into the chamber?
Published: 05 May 2022

Posted: 5/20/22


 Q:

I have a patient that has a Braun ezpump for antibiotics infusing into a picc line. It infuses 10ml/hr. Could this pump go into the chamber?


 A:

Thank you for your question. The UHMS HBO2 Safety Committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the Hyperbaric Medical Director (HMD) and Hyperbaric Safety Director (HSD) of your facility.

Several elastomeric-style pumps have been tested within a hyperbaric environment. However, the UHMS HBO2 Safety Committee is not aware of any performance testing of  the Braun Easypump™ Elastomeric Infusion Pump  inside of a hyperbaric chamber. We would encourage you to first determine the necessity of the item for the time duration required to complete the therapy. Oftentimes, antibiotics may be delayed or briefly interrupted without negative outcomes. If it is possible and safe to delay either the HBO Therapy or the infusion, we would recommend this approach.

It is important to note that changes in delivery rate have been noticed during air travel in another make and model (Baxter Infusor pump). It is plausible then that changes to the delivery rate of the Braun Easypump™ may also be effected under hyperbaric conditions. However, it is noted that other elastomeric pumps have been tested and shown to function well under hyperbaric conditions. For example, the On-Q elastomeric pain pump has been tested under hyperbaric conditions and demonstrated “no clinically significant change in the function of the On-Q infusion device during hyperbaric exposure for the usual clinical durations and hyperbaric pressures.”

If you are considering the option to test this device for safe use within the hyperbaric environment, we can provide you with specific resources that may assist you in your evaluation process. This information not an

endorsement by the UHMS HBO2 Safety Committee for the use of this device in the hyperbaric environment. Rather, we hope that you will consider these suggestions in your individual approach:

  • We strongly encourage a formal risk assessment of the device, with assistance from your hospital biomedical engineering group and perhaps your hospital safety or legal teams.
  • If you discover that the device has been tested previously under hyperbaric conditions, we suggest that this may be utilized as validation of your final assessment, but we do not recommend that this is the entirety of device approval. Simply put, we recommend a formal risk assessment regardless of testing methods. (Exception: Modern ICD’s and Pacemakers are commonly tested by the manufacturer for function under pressure. Therefore, use under increased atmospheric conditions does not constitute an off-label use of those devices.)
  • Consider reaching out to the manufacturer to learn more about the device, especially if there are limited performance details/specifications in the product manual.
  • Try to gain an understanding of what types of stress the device was subjected to during the manufacturing and testing phase.
  • You may wish to make the manufacturer aware of your intentions or you may remain anonymous.
  • Regardless of the manufacturer’s response, there may be good reason for you to proceed with the evaluation, as this device may be vital to the continuum of care to the patient.
  • It should be noted that any modifications to the device or use other than as recommended by the manufacturer risks voiding any warranty on the product.
  • If evaluating a medical device, it is understood that few are intended to be used in the Multiplace hyperbaric environment. Therefore, consider that such use will likely fall into the FDA category of "Off-Label" and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices “. You may also wish to review FDA.gov: Frequently Asked Questions about Medical Devices for more information.

NOTE: Regarding medical device evaluation, at least one major academic institution’s legal team with experience in medical device modification has approached the current FDA regulations in the following fashion:

“The program (modification and testing of medical devices for safe use in the hyperbaric environment) is not subject to FDA regulation. FDA regulates manufacturers and not the practice of medicine. Physicians are able to use FDA approved products other than under the labeled indications as long as the physician meets certain criteria. FDA’s statement on this off-label use is as follows:

 

“Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgment. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects. Use of a marketed product in this manner when the intent is the "practice of medicine" does not require the submission of an Investigational New Drug Application (IND), Investigational Device Exemption (IDE) or review by an Institutional Review Board (IRB).”

REFERENCES:

Burman, F. (2019). Risk Assessment Guide for Installation and Operation of Clinical Hyperbaric Facilities (6th ed.). San Antonio, TX: International ATMO, Inc.

Burman F, Sheffield R, Posey K. Decision process to assess medical equipment for hyperbaric use. Undersea Hyperb Med. 2009;36:137–44. PMID: 19462753.

Dohgomori, H., Arikawa, K., Gushiken, T., & Kanmura, Y. (2002). Accuracy of portable infusers under hyperbaric oxygenation conditions. Anaesthesia and intensive care, 30(1), 25-28.

Millar, I. L. (2015). Hyperbaric intensive care technology and equipment. Diving Hyperb Med, 45(1), 50-56.

National Fire Protection Agency (NFPA). (2021). NFPA 99 2021 Edition: Health Care Facilities Code. Quincy, Massachusetts. https://www.nfpa.org/

Perks, S., Blake, D. F., Young, D. A., Hardman, J., Brown, L. H., Lewis, I., & Pain, T. (2017). An assessment of the performance of the Baxter elastomeric (LV10) Infusor™ pump under hyperbaric conditions. Diving and Hyperbaric Medicine, 47(1), 33.

Salman, D., Barton, S., & Nabhani-Gebara, S. (2013). Effect of environmental conditions on performance of elastomeric pumps. American Journal of Health-System Pharmacy, 70(13), 1100-1100.

Tobias, J. D., Johnson, G. A., & Patel, M. (2011). Performance of the On-Q pain infusion device during hyperbaric therapy. Anesthesia & Analgesia, 113(2), 275-277.

US Food and Drug Administration. (2014). “Off-label” and investigational use of marketed drugs, biologics, and medical devices: information sheet. Silver Spring, MD. LINK

Wang, J. (2013). Effect of environmental conditions on performance of elastomeric pumps--author's reply. American Journal of Health-system Pharmacy: AJHP, 70(13), 1100-1101.

Workman, W. T., & Wood, J. S. (2020). Hyperbaric Facility Safety: A Practical Guide (2nd ed.). Best Publishing Company.

Respectfully,

The UHMS HBO2 Safety Committee


DISCLAIMER

Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet.  If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility.  Information provided on this forum is for general educational purposes only.  It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.

 

We have a patient with dentures that are firmly secured in place with denture glue, and they are refusing to remove them for treatment. Can we allow dentures and over-the-counter bonding compounds like Sea-Bond©, Poligrip©, or Fixodent© in the Monoplace / Multiplace chamber?
Published: 20 April 2022

Posted: 4/20/22


Q:

We have a patient with dentures that are firmly secured in place with denture glue, and they are refusing to remove them for treatment. Can we allow dentures and over-the-counter bonding compounds like Sea-Bond©, Poligrip©, or Fixodent© in the Monoplace / Multiplace chamber?  


A:

Thank you for your question. The UHMS HBO2 Safety Committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the Hyperbaric Medical Director (HMD) and Hyperbaric Safety Director (HSD) of your facility.

The UHMS Safety Committee agrees that removing loose dentures prior to hyperbaric therapy is a good practice. However, we do not think it is unreasonable to leave secured dentures in place. As part of your local approval process, we would recommend that the HSD should identify all known risk factors and document any potential risk mitigations (Ref 1). It is well known that many facilities will remove “loose” dentures due to the increased risk of a blocked airway in the event of a seizure. In many cases, dentures are not easily removed. If used as directed, the bonding products on the market today will hold dentures firmly in place.

The UHMS Safety Committee would advise you to consider, at minimum, the following risk factors when completing your assessment:

Ingredients within the bonding agents/compounds:

  • The bonding agents are made of several compounds that could, in theory, lead to an increase in the risk of flammable vapors. We are not aware of any published reports on this topic and we believe the impact on vapor load is nominal. Mitigating factors may be:
    • There is a limited volume of glue present.
    • The bonding compound is not fresh and has largely off-gassed by the time that treatments take place
  • The moist environment of the mouth will greatly decrease the potential for ignition.
  • You may wish to contact the manufacturer or retain SDS information as you perform your risk assessment.

Risk of a patient choking on loose dentures in the event of a seizure:

  • As described above, many bonding products on the market today will hold dentures firmly in place for many hours.
  • Consider adding a pre-therapy question related to dentures during intake screening.
  • Consider inquiring of the patient how firmly the dentures are in place (i.e., they are clattering, easily moved with the tongue, or obviously loose). If they are easily removed, this may be the safest option.
  • Consider that keeping dentures in place is likely to be helpful for emergency response teams by maintaining a more secure airway during resuscitation efforts (Ref. 2).

Communication considerations:

  • Removing dentures may make it more difficult for the patient to enunciate
  • Communication is a key factor in treating hyperbaric patients. Consider keeping secure dentures in place to avoid this barrier.

REFERENCES:

  1. Burman, F. (2019). Risk Assessment Guide for Installation and Operation of Clinical Hyperbaric Facilities (6th ed.). San Antonio, TX: International ATMO, Inc. LINK
  2. Conlon, N. P., Sullivan, R. P., Herbison, P. G., Zacharias, M., & Buggy, D. J. (2007). The effect of leaving dentures in place on bag-mask ventilation at induction of general anesthesia. Anesthesia & Analgesia, 105(2), 370-373. LINK

BIBLIOGRAPHY:

  1. National Fire Protection Agency (NFPA). (2021). “NFPA 99 2021 Edition: Health Care Facilities Code.” Quincy, Massachusetts. LINK
  2. Safety Committee MEDFAQ Response: “Hair Weave or extension with Keratin Glue,” Published 10/2015. LINK

Respectfully,

The UHMS HBO2 Safety Committee


DISCLAIMER

Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet.  If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility.  Information provided on this forum is for general educational purposes only.  It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.

 

Is there a policy for HBO treatments in single person chamber that hbo tech can monitor patients with camera monitor installed on the outside of the chambers? Can the technician leave the HBO room with the monitor?
Published: 07 March 2022

Posted: 3/7/22


Q:
Is there a policy for HBO treatments in single person chamber that hbo tech can monitor patients with camera monitor installed on the outside of the chambers? Can the technician leave the hbo room with the monitor?


A:

Thank you for your question. The UHMS HBO2 Safety Committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the Hyperbaric Medical Director (HMD) and Hyperbaric Safety Director (HSD) of your facility.

The UHMS HBO2 Safety Committee appreciates your attention to the guidelines and standards that have been established for the hyperbaric community. It is important to note that the NFPA 99 (2021), 14.2.1.4.2 gives joint authority to the HMD and HSD to determine the “minimum staff qualifications, experience, and complement based on the following:

(1)   Number and type of hyperbaric chambers in use

(2)   Maximum treatment capacity

(3)   Type of hyperbaric therapy normally provided”  

As such, the UHMS HBO2 Safety Committee recommends that a written policy is developed by the HMD and HSD that identifies the staffing levels necessary for the safe delivery of hyperbaric oxygen therapy based upon the above factors, and perhaps several other considerations that may be unique to your particular program.

The Safety Committee identifies several reasons why leaving a chamber unmanned would be deemed unsafe:

  • It is important to consider the chamber operator’s ability to respond to an emergency. Remaining outside of the chamber room watching via CCTV will severely limit your ability to respond to the patient.
  • There is likely no way for the patient to effectively communicate to the staff.
  • Be aware that screens are two-dimensional and is not an optimal way to discern visual depth. For example, it may be difficult to visualize facial twitching, a symptom of oxygen toxicity.
  • If sound is used, filtering out the noise of the ventilation system would be necessary.
  • It is also important to consider that the patient would feel totally alone and unattended. Ask yourself, is it reasonable to leave a patient alone in a room, laying inside a sealed chamber for over an hour? Would you ever leave a patient alone for this long otherwise?
  • The potential for the observer to be distracted and/or have their attention divided outside of the chamber room is highly likely (the whole purpose of being outside the chamber room is to be able to multitask), and the temptation to visit the bathroom or elsewhere hence leaving the screen unmanned is too high

Referenced Staffing Considerations:

  • The NFPA 99 Health Care Facilities Code, 2021 edition, 14.3.1.4.6 requires that:

“During chamber operations with an occupant(s) in a chamber, the operator shall be physically present and shall maintain visual or audible contact with the control panel or the chamber occupant(s).”

  • The NFPA 99 Handbook also adds this note:

“It is vitally important that a qualified chamber operator be present during chamber operations. The number of qualified chamber operators required will vary depending on the type of chamber(s), number of chambers being operated simultaneously, number and acuity of the patients, qualifications of the hyperbaric staff. and layout of the room housing the chambers. The chamber operator should always have someone available to call for help in an emergency or to provide breaks.”

Section 3, Staffing Guidelines (pg.15):

“One (1) chamber operator should not operate and/or monitor more than two (2) monoplace chambers simultaneously during patient treatments”

“At least one (1) additional hyperbaric-trained staff member should be immediately available to assist, if needed, during any patient treatment.”

The existing MEDFAQs https://www.uhms.org/resources/medfaqs-frequently-asked-questions-faq/safety-technical/160-standards-and-codes.html, refers to the UHMS Hyperbaric Facility Operations Guidelines, Section 3, Staffing Guidelines.

Specifically, Part III, Hyperbaric Technician/Chamber Operations Staff, bullet one, states a minimum of one CHT, CHRN or CHS should be on duty in the clinical area when a patient is receiving treatment. It doesn’t appear there is any exception or allowance to be monitoring by video and not in the clinical area.

In closing, we encourage administrators and program managers responsible for the safety of their hyperbaric programs to consider the standards and recommendations we have listed here and allow staffing decisions such as these to be made jointly by the HMD and HSD of the hyperbaric program. We also suggest that the HMD and HSD conduct a formal Risk Assessment that is inclusive of the factors mentioned above prior to developing a staffing policy for the program. We understand that there may be many other considerations not mentioned here that are unique to your facility and should be included within the risk assessment.

REFERENCES:

UHMS HBO2 Safety Committee response to MEDFAQ, Accessed 9/28/2020, Originally published 2/23/2017.

Workman, W. T. (2015). Guidelines for Hyperbaric Facility Operations (2nd ed.). North Palm Beach, FL: Undersea and Hyperbaric Medical Society, Inc.

National Fire Protection Agency (NFPA). (2018). NFPA 99 2018 Edition: Health Care Facilities Code. Quincy, Massachusetts.

Undersea and Hyperbaric Medical Society. (2018). Clinical Hyperbaric Facility Accreditation Manual (4th ed.). North Palm Beach, FL: Undersea and Hyperbaric Medical Society, Inc.

Respectfully,

The UHMS HBO2 Safety Committee


DISCLAIMER

Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet.  If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility.  Information provided on this forum is for general educational purposes only.  It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.

 

Hi there, I was wondering why water-only fire extinguishers are used in hyperbaric suites with monoplace chambers and not ABC fire extinguishers? It seems like anywhere that you might have an electrical fire source, it would be a good idea to have a chemical type of extinguisher. Is water-only a standard when it comes to monoplace chambers? Thank you very much.
Published: 03 March 2022

Posted: 3/3/22


Q:  
Hi there, I was wondering why water-only fire extinguishers are used in hyperbaric suites with monoplace chambers and not ABC fire extinguishers? It seems like anywhere that you might have an electrical fire source, it would be a good idea to have a chemical type of extinguisher. Is water-only a standard when it comes to monoplace chambers? Thank you very much.  


A:

Thank you for your question. The UHMS HBO2 Safety Committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the Hyperbaric Medical Director (HMD) and Hyperbaric Safety Director (HSD) of your facility. It is important for your HSD to be aware of the specific needs of your facility, and we applaud you for being thoughtful about your team’s ability to extinguish a fire, should the need ever arise.

The UHMS HBO2 Safety Committee is not aware of a specific code requirement for water-filled extinguishers near Monoplace chambers. However, there is no penalty for achieving a standard above the existing code. It is possible that this may have been added in your area intentionally - as some water-mist extinguishers have several features that may make it advantageous for the Monoplace suite. Certain types of water-mist extinguishers are suitable for both class A and C fires, leave zero residue, and use de-ionized water which can protect the user from electrical shock.

As you identified, most water-filled extinguishers are not suitable for Class C fires. The NFPA 99 Health Care Facilities Code, Chapter 14 (2018 and 2021 editions) contain the minimum standards for the room housing a Class A, Class B, or Class C chamber (14.2.1.2.2). The code calls for a ABC-type extinguisher. Specifically, a minimum of one 2-A:10B:C portable fire extinguisher.

In CFR 1910.157 – Portable Fire Extinguishers, the Occupational Safety and Health Administration (OSHA) addresses the requirements of “…placement, use, maintenance, and testing of portable fire extinguishers provided for the use of employees.” We would advise you to review this standard and assess how it applies to your area.

As you are thinking about your assessment, you may also wish to review these notable comments from our Safety Committee Members on this topic:

  • It is important to note that the chemical Monoammonium Phosphate used in the ABC extinguishers has a static affinity to monoplace chamber acrylic and is extremely abrasive. DO NOT try to even wet wipe it off - It can only be successfully flushed off with a mild detergent diluted in warm water. In addition to the ABC extinguishers, we install a 20-pound CO2 extinguisher and train staff to alarm the building and then preferentially select the water, CO2 or ABC extinguisher as appropriate. A wastepaper basket is most appropriately extinguished with water. The CO2 and ABC are overkill and can blow burning paper around the room if used too enthusiastically.  I understand this may be difficult to apply as a general policy, but a good thing for Unit Safety Directors to know.
  • Many years ago (about two generations, before there were any HBO codes) when I was working in the monoplace world, we always had at least two extinguishers in the chamber room.  One was an ABC and the other was a water handheld extinguisher.  We also had a water fire hose immediately outside the chamber room.  One of our concerns at that time was, what if there is a fire in the chamber.  We wanted to be able to spray the patient and area as we opened the door.  We didn't think an ABC was best for that purpose.
  • I suggest that one could certainly provide a water-based extinguisher (or several) in the monoplace suite. They would be useful with the type of fire we might expect inside a class B chamber...that said the code(s) requires we have at least one ABC.

In closing, we would encourage the HSD to assess the risk in your area and then work with the Facilities Management and local Fire and Life Safety representatives of your facility to make them aware of your needs. It is important to note that in accordance with the Joint Commission (TJC), many facilities adhere to an older version of the NFPA 99 (prior to 2018) which does not require an ABC extinguisher in the chamber room.

Hyperbaric facilities are unique. You may also wish to reach out to your community’s Fire Marshal to share information about your work area and to seek further guidance. It is also important to do this regularly, as the individuals in these positions change and they may not be aware of your presence. Aside from the type of extinguisher, the HSD should also ensure that extinguisher is located within an appropriate distance and that the staff is trained to use them appropriately.

REFERENCES:

  1. Burman, F. (2019). Risk Assessment Guide for Installation and Operation of Clinical Hyperbaric Facilities (6th ed.). San Antonio, TX: International ATMO, Inc.
  2. National Fire Protection Association. (2018, 2021). NFPA 99 2018 & 2021 Edition: Health Care Facilities Code. Quincy, Massachusetts.
  3. Lehtola, C. J., Brown, C. M., & Becker, W. J. (2000). Portable Fire Extinguishers: OSHA Standard 1910.157. University of Florida Cooperative Extension Service, Institute of Food and Agricultural Sciences, EDIS.
  4. Undersea and Hyperbaric Medical Society. (2018). Clinical Hyperbaric Facility Accreditation Manual (4th ed.). pg. 51 – HBOEC 3.0, North Palm Beach, FL: Undersea and Hyperbaric Medical Society, Inc.
  5. Workman, W. T. (2010). Hyperbaric Facility Safety: A Practical Guide (1st ed.). pp. 402-404, Best Publishing Company.

Respectfully,

The UHMS HBO2 Safety Committee


 

DISCLAIMER

Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet.  If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility.  Information provided on this forum is for general educational purposes only.  It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.

A woman called to ask whether we treated post covid-19 symptoms. She has had many issues including severe fatigue, brain fog, difficulty sleeping and states that she is desperate. She is apparently part of a support group; several people have evidently benefitted from HBOT. Does anyone have any experience treating these folks? The patient is willing to pay out of pocket, but I wonder if there are any institutions with ongoing research studies. We are a small monoplace operation without any capability of d
Published: 14 February 2022

Posted: 2/14/22


Q:
A woman called to ask whether we treated post covid-19 symptoms. She has had many issues including severe fatigue, brain fog, difficulty sleeping and states that she is desperate. She is apparently part of a support group; several people have evidently benefitted from HBOT. Does anyone have any experience treating these folks? The patient is willing to pay out of pocket, but I wonder if there are any institutions with ongoing research studies. We are a small monoplace operation without any capability of doing controlled studies. Any thoughts would be appreciated. Thank you.


A:
There is no central registry of hyperbaric centers that are treating patients for the persistent symptoms of COVID-19 (the so called “Long Haulers”). Through the “Grapevine” we have heard that several centers are treating these patients. The treatment pressures have varied from less than 2.0 ATA to 2.8 ATA and treatment times of 60 to 90 minutes. Typically, the number of treatments has ranged from 5 to 20 in number.

There are 2 clinical trials registered on the NIH site, clinicaltrials.gov, that are conducting studies of HBO2 for Long Haulers. One from Israel with Dr. Efrati as lead investigator and listed on this website as completed, but no results are available yet. A second study by the Karolinska Institute from Stockholm, Sweden is listed as ongoing. The lead investigator is not given on the website. No co-investigating researchers or institutions in the U.S. are mentioned on the website. On an earlier study, Dr. Pieter Lindholm at the University of California, San Diego had been listed as a co-investigator, and he may have additional information. Otherwise, we would advise that the patient in question make contact with hyperbaric facilities near her home to determine if any are doing such treatments for this patient group. Since many hyperbaric centers have popped up recently that are not treating approved indications and have inadequate medical supervision and resulting safety concerns, we recommend that she determine whether the centers she contacts are treating only approved indications or on clinical trials. A good indicator for the quality of a center’s practice is to determine whether they are treating only approved indications or patients on studies with an occasional treatment outside this guidance for compassionate purposes.  We recommend she inquire as to whether the center and its staff are members of the UHMS (Undersea and Hyperbaric Medical Society) or at least follow the recommendations of the UHMS. This recommendation is made because the Society has established high standards for the practice of Hyperbaric Medicine which can be dangerous if not properly delivered. Another good indicator of the quality and safety of the delivery of hyperbaric oxygen is to ensure that a licensed physician is always present during the treatment.

The Society cannot make a broad recommendation advocating hyperbaric oxygen for COVID long haul patients. We recognize that there are physiologic effects of Hyperbaric Oxygen which may be helpful in the treatment of COVID-19. Also, we are aware of unpublished reports that hyperbaric oxygen seems to have been successful in the treatment of some symptoms that persist after the acute infection. We do encourage participation in clinical trials whenever possible. We anxiously await the results of the pending clinical trials. We also recognize that the treating physician is ultimately the decision maker when it comes down to recommending and offering hyperbaric oxygen for a given health problem. As always, he or she needs to consider the potential benefits versus the possible side effects or complications of the therapy.

John J. Feldmeier, D.O.

 

I have a 62 y/o patient with radiation cystitis who has already received a total of 80 HBO treatments over the course of 10 months (March 2020-December 2020) for recurrent hematuria. He recently had another episode of hematuria that was treated with clot irrigation only (no cautery needed). He was referred back to me by his urologist. Is there any utility to additional treatment with HBO, given that he has already had 80 treatments within the last 2 years? I realize this is technically a new episode o
Published: 07 February 2022

Posted: 2/8/2022


Q:  
Would it be likely effective to offer more HBO2 to an 62 y/o patient who has already completed 80 HBO2 treatments over 10 months (March-December 2020) for recurrent hematuria?


A:
A few additional bits of information would be helpful. Apparently, the patient had a cessation of hematuria for a at least a short time in December 2020. When did the patient have recurrence of hematuria? What type of tumor did the patient have? Do you have any information on radiation dose or technique-specifically was there an implant or was IMRT the treatment technique? Has the patient required transfusion? Is the patient getting chemotherapy for residual or recurrent tumor?

I share your concerns that it is probably  unlikely that additional hyperbaric treatments at this point will be effective. However, I have personal experience with radiation cystitis patients who had durable response after up to 100 treatments. I have also seen patients respond to a second course of treatment after a resolution followed by recurrence.

I would recommend that the patient have a cystoscopy at this time. If the site of hematuria is focal, a local intervention with chemical or electrocautery should be considered. If it is diffuse, the instillation of formalin should be considered. If these are not appropriate or possible and the patient is willing, though unusual, additional Hyperbaric oxygen is a reasonable option. As always, especially, if the tumor was a bladder cancer to begin with, recurrent cancer should be ruled out.

John J. Feldmeier, D.O.

 

I have a 40 y/o patient with a large open lower leg wound (lower thigh/popliteal fossa) with an underlying diagnosis of mycoses fungoides. He has had radiation therapy on three separate occasions since 2016 with total dose of 7000cGy, however each treatment episode was not more than 3000cgy. Recent wound biopsies still show tumor. His family is pushing for HBO to try to heal the wound, as his oncology team is reluctant to consider stem cell transplant until the wound is healed. I have 2 questions: 1)
Published: 07 February 2022

Posted: 2/8/2022


Q: 
I have a 40 y/o patient with a large open lower leg wound (lower thigh/popliteal fossa) with an underlying diagnosis of mycoses fungoides. He has had radiation therapy on three separate occasions since 2016 with total dose of 7000cGy, however each treatment episode was not more than 3000cgy. Recent wound biopsies still show tumor. His family is pushing for HBO to try to heal the wound, as his oncology team is reluctant to consider stem cell transplant until the wound is healed. I have 2 questions: 1) his only current treatment for the tumor is Bexarotene (he has failed treatment with multiple other chemotherapy agents) and I can\'t find much info on this. Is it safe in conjunction with HBO? Does it affect wound healing? 2) In terms of possible contribution of prior radiation to poor healing, can I consider this is a possibility even though the total radiation dose was delivered in multiple treatment episodes over more than 5 years?


A:

Background:

Mycosis fungoides (MF) is a primary lymphoma of the skin due to T-Cell lymphocytes. MF is responsible for about 40% of primary skin lymphomas. As an aside T-Cell lymphocytes are responsible for cellular immune response. They directly kill the infecting organism; whereas, B-cell lymphocytes produce antibodies, and it is these antibodies that are the primary effect of B-Cell response and control of infecting organisms. Mycosis fungoides typically presents as a plaque-like, often confluent, sometimes nodular, often erythematous dermatitis. It is often very pruritic. I will attach a photo. It is not typically ulcerative though some of the lesions may demonstrate focal ulcerations. Often times the diagnosis is delayed for years (5-8 years). Survival after diagnosis is 5 to 8 years. Organ involvement is unusual early on but is present in 80% of those who die of their disease.

Oncologic treatment is often dictated by the extent of the disease. If it is localized a local radiation field is often used. If it is generalized, chemotherapies often one of the new targeted or immunologic agents are used. If lymph nodes are involved the prognosis is worse. If there is involvement of internal organs, prognosis is worse yet again. Very early mycosis is often treated with topicals including steroids and some chemo agents. Sometimes a technique of whole-body electron treatment is done for diffuse skin involvement. Ultraviolet light has been used with response in early cases in a technique termed PUVA which uses type A ultraviolet light. More recently systemic agents are used for diffuse involvement. These agents are not typically traditional cytotoxic chemotherapy but are targeted or immune therapies. Drugs used include the monoclonal antibodies Brentuximab and Mogamulizumab. Interferon has also been used for treatment as a modulator of immune response. By the way, Bexatrone is a retinoic acid (Vitamin A). it induces cell differentiation and apoptosis and prevents the development of drug resistance. Note: It also has anti-angiogenic effects and inhibits cancer metastasis. There is some experience with high dose chemotherapy and stem cell transplant but this experience is somewhat limited. Really. In almost all cases curative treatment is not possible but the course of the disease is typically long and theoretically at least it can be prolonged with intervention.

Image of Mycosis Fungoides (pdf)

Your Case:

In general, skin lesions that have tumor in them will not heal. This experience has been seen in primary skin cancers (basal and squamous cells) and lymph nodes with metastatic disease that ulcerate through the skin.

You note that the patient has had 3 prior courses of radiation with a total dose of 7000 cGy and wonder about the time interval between treatment courses and whether late radiation effects are likely to occur. Some in the radiation community believe that the radiated tissues will with time between treatment courses recover radiation tolerance. In my experience, that is certainly not always true and the late effects of the separate courses are additive. Also often, MF patients are treated with treatment fractional doses at 300 or even 500 cGy. These higher than the normal daily dose of 180 to 200 cGy are in fact more damaging for a given total dose. Therefore, I believe that this could well in part be late radiation damage.

I believe offering the patient hyperbaric oxygen is a reasonable option. A trial of therapy for perhaps 20 daily treatments is advised. If the patient is not showing expected response at that point, I believe that the presence of tumor in the lesion is the culprit. Of course the reason that transplant is being held is that the conditioning high dose chemotherapy would be very immunosuppressive and put the patient at risk for cellulitis perhaps advancing to sepsis. It is also possible that the anti-angiogenic effects of Bexatrone will work against the HBO2.

By the way, please let us know how the patient does. It will increase our knowledge. A positive outcome would make a good case presentation because of the rarity of the clinical challenges you face.

John J. Feldmeier, D.O.

 

 

I have a patient with a trach with alot of secretions. Is there some way to have suction in a monoplace chamber and/or humidified air? Thank you.
Published: 24 January 2022

Posted: 2/7/2022


Q:
I have a patient with a trach with a lot of secretions. Is there some way to have suction in a monoplace chamber and/or humidified air?


 A:
Thank you for your question. The UHMS HBO2 Safety Committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the Hyperbaric Medical Director (HMD) and Hyperbaric Safety Director (HSD) of your facility.

The UHMS HBO2 Safety Committee is aware of several hyperbaric clinics who have required this setup. Before taking this on, we recommend that the patient’s ability to self-suction is assessed by the HBO physician, proper patient education is provided, and the operational staff is trained in the setup and operation of the vacuum system. It is imperative that the vacuum regulator be pre-set and not internally manipulated during therapy, as increased vacuum well above normal can be attained with the regulator open to full vacuum. Doing so could cause great harm to the patient. That said, the setup described below could accommodate your needs and could be applied to maintain vacuum-assisted closure (VAC) therapy during their hyperbaric treatment, should the patient require it.

It is also possible to offer additional humidity for tracheostomy patients receiving hyperbaric oxygen therapy in the monoplace chamber. This is commonly done with the use of a heat moisture exchanger (HME), although this humidifying filter will have to be removed if suctioning is necessary. Again, it is important that the patient is educated well and is comfortable performing these actions alone within the monoplace chamber.

For more information on these practices, the Committee encourages you to review the work published by our hyperbaric colleagues:

Monoplace Suction System:

Excerpt from Weaver et al - Monoplace chamber safety guidelines, page 39:

A suction system for the monoplace chamber has been developed (25). (Drager also offers a suction unit with their monoplace chamber.) An Ohmeda vacuum regulator and suction canister are mounted in the chamber hatch (Fig. 13). The vacuum hose that drives the regulator is passed out of the chamber via an i.v. pass-through (no. 041-600-500, Cobe) or via a specialized port because i.v. pass­throughs are occasionally in high priority. The pressurized chamber provides the gradient of pressure necessary to operate the vacuum regulator. The regulator should NEVER he turned to "Full" but rather to the "Regulate" position. A screw serving as a stop will prevent turning the vacuum regulator to the "Full" position (Fig. 14). The degree of vacuum can be adjusted outside the chamber by carefully positioning the handle of the 3-way stopcock and reading the degree of vacuum from the regulator gauge. This system allows nasogastric, oral, wound, or pleural suction during HBO therapy. This system should not be used for endotracheal suction as there is a potential for complications (effects of auto-PEEP, reduced alveolar ventilation, or hypoxemia if inadvertently left on). Chest tubes should have a Heimlich valve or waterseal in place even with suction, in case the suction unit fails or is not turned to the "On" setting. Slow decompression rates in patients with chest tubes are recommended to allow adequate venting of any intrapleural gas that is present.

 

REFERENCES:

Neuman, T. S., & Thom, S. R. (2008). Physiology and Medicine of Hyperbaric Oxygen Therapy. Elsevier Health Sciences. Weaver LK - Technical Aspects, Chapter 2 – Monoplace Hyperbaric Chambers, pg. 30-31. LINK

Weaver LK. A functional suction apparatus within the monoplace hyperbaric chamber. J Hyperbaric Med 1988; 3:165-171. LINK

Weaver, L., & Strauss, M. B. (1997). Monoplace hyperbaric chamber safety guidelines. Bethesda, MD: Undersea and Hyperbaric Medical Society (UHMS). LINK

Raleigh, G. W., Niezgoda, J. A., & Fabus, S. V. (2002). A VACUUM REGULATION SYSTEM FOR CONTINUING VACUUM ASSISTED CLOSURE THERAPY (VAC) IN MULTIPLACE AND MONOPLACE HYPERBARIC OXYGEN CHAMBERS. LINK

Respectfully,

The UHMS HBO2 Safety Committee


DISCLAIMER

Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet.  If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility.  Information provided on this forum is for general educational purposes only.  It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.



We have an HBO candidate with a suprapubic catheter. The catheter has a silver tip for UTI prevention. Would this style of catheter be contraindicated in the HBO setting? Bard was contacted by one of our HBO nurses and they informed us that there was not testing on this catheter under hyperbaric conditions.
Published: 29 December 2021

Posted: 1/12/22


Q:
We have an HBO candidate with a suprapubic catheter. The catheter has a silver tip for UTI prevention. Would this style of catheter be contraindicated in the HBO setting? Bard was contacted by one of our HBO nurses and they informed us that there was not testing on this catheter under hyperbaric conditions.


A:

Thank you for your question. The UHMS HBO2 Safety Committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the Hyperbaric Medical Director (HMD) and Hyperbaric Safety Director (HSD) of your facility.

The UHMS HBO2 Safety Committee does not have concern with this item in either the Monoplace or Multiplace Hyperbaric environments. We do recommend the following considerations prior to the start of therapy:

  • Ensure that the catheter is patent.
  • Check that the bulb is filled with sterile water per manufacturer’s instructions.
  • Ensure that the line is free of entanglement.
  • Check that the catheter bag/reservoir is emptied prior to therapy.

We would also encourage you to examine the relevant reference materials below. Thank you for your inquiry and we hope this will assist you in the safe delivery of hyperbaric oxygen therapy.

Respectfully,

The UHMS HBO2 Safety Committee

REFERENCES:

  1. BARD MEDICAL. “A Guide for Nurses - Bard® Comprehensive Care Management of Catheters and Collection Systems,” Bard Limited, Forest House, Tilgate Forest Business Park, Brighton Road, Crawley, West Sussex, RH11 9BP, UK https://media.bardmedical.com/media/1679/a-guide-for-nurses.pdf
  2. BARD MEDICAL. “BARDEX® I.C. Foley Catheter - Product Details,” webpage accessed 1/11/2022. https://www.bardcare.uk/clinicians/view-products/foley-catheters/bardex-ic-foley-catheter/
  3. MEDFAQ Response. “Special considerations for colostomy or ileostomy bag/pouch,” Published 4/6/2021. LINK

DISCLAIMER

Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet.  If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility.  Information provided on this forum is for general educational purposes only.  It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.

 

Can an occupational therapist become a CHT?
Published: 21 November 2021

Posted: 11/22/21


Q: 
Can an occupational therapist become a CHT? 


A:

For information on becoming a CHT, please visit the NBDHMT’s website at www.nbdhmt.org and specifically here is the resource manual link - https://nbdhmt.org/forms/CHT_Resource_Manual.pdf.

The NBDHMT lists the follow qualifying pathways to be eligible to take the CHT exam.

1. Respiratory Therapist

2. Physician Assistant

3. Active Duty Military Corpsman

4. EMT/Paramedic

5. Registered Nurse or LPN

6. Nurse Practitioner

7. Physician

 

Do you know of any article of anything that gives guidelines for defibrillation in the HBO suite (monoplace)? In other words, during cardiac arrest in a monoplace chamber, are there guidelines that describe getting the patient out of the monoplace chamber and how far away from the chamber / or out of the suite to defibrillate (required distance from the chamber before defibrillation).
Published: 15 November 2021

Posted: 11/15/21


Q:
Do you know of any article of anything that gives guidelines for defibrillation in the HBO suite (monoplace)?  In other words, during cardiac arrest in a monoplace chamber, are there guidelines that describe getting the patient out of the monoplace chamber and how far away from the chamber / or out of the suite to defibrillate (required distance from the chamber before defibrillation).


A:
Thank you for your question. The UHMS HBO2 Safety Committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the Hyperbaric Medical Director (HMD) and Hyperbaric Safety Director (HSD) of your facility.

The UHMS HBO2 Safety Committee is aware of several publications that may be able to assist you in your decision-making on how to approach the defibrillation of a patient immediately following hyperbaric oxygen therapy in a monoplace chamber. For your convenience, we will provide excerpts from these publications:

  • "Hyperbaric Medicine Procedures" published by St. Luke's Medical Center, Milwaukee, WI. 1995 Edition, page 80. DEFIBRILLATION MUST NEVER BE ATTEMPTED INSIDE AN OXYGEN FILLED MONOPLACE CHAMBER. Prior to defibrillation the patient must be brought to surface and removed from the chamber and preferably from the immediate area.  When the chamber door is opened, oxygen will spill into the room making defibrillation especially hazardous for the first 30 seconds.  The fabric of patient gowns and bedclothes will remain saturated with oxygen when removed from the chamber and needs to be stripped from the patient before attempting defibrillation.
  • "Hyperbaric Medicine Procedures" published by St. Luke's Medical Center, Milwaukee, WI. 2006 Edition, page 108. DEFIBRILLATION MUST NEVER BE ATTEMPTED INSIDE AN OXYGEN FILLED MONOPLACE CHAMBER. Prior to defibrillation the patient must be brought to surface and removed from the chamber and preferably from the immediate area.   When the monoplace chamber door is opened, oxygen will spill into the room and immediately fall to the floor as it is quite cold and heavier than room air.  We have done experiments to measure oxygen in the atmosphere at various locations in the room after opening the chamber door following an emergency decompression and found that the levels return to baseline within 30 seconds.  Simply removing the sheets and blankets from the gurney will render the defibrillation safe.
  • "Hyperbaric Medicine Practice". L Weaver, page 249. I have defibrillated one patient and cardioverted another patient who were rapidly removed from the monoplace chamber for dysrhythmias, both successfully. Some hyperbaric practitioners have recommended that patients exiting the oxygen-filled chamber be moved some distance away from the chamber prior to defibrillation, because of concerns about the risk of combustion. The patient's tissues (including the brain and heart) presumably will have high concentrations of O2, so taking a few extra seconds to move the patient to an area with a lower ambient concentration of O2 should be acceptable.  In the two cases commented upon above, a few seconds elapsed following extraction of the patients from the chamber before defibrillation.  Both patients were defibrillated/cardioverted while on the gurney attached to the monoplace chamber.  There was no evidence of sparks or fire.  Provision for cardiac monitoring, defibrillation, bag-valve-mask ventilation, and intubation must be readily available if the hyperbaric unit anticipates treating critically ill patients.  (Editor's note: We have measured oxygen levels in the room after emergency decompressing and opening a monoplace chamber.  The cold oxygen falls to the floor and dissipates in about 30 seconds.  It does not measurably remain elevated at the level of the patient or rise in other parts of the room.
  • “Critical care of patients needing hyperbaric oxygen therapy” In: Physiology and Medicine of Hyperbaric Oxygen Therapy (Neuman, T.S., Thom, S.R.), page 124. Weaver, L. (2008). Defibrillation and cardioversion. For monoplace chamber patients who need defibrillation or cardioversion, these procedures must be done outside the chamber. It is advisable to switch gas supply from oxygen to air while decompressing these patients to hasten dissipation of oxygen from around the hyperbaric chamber door. Patients are cardioverted or defibrillated after opening the chamber hatch and sliding the patient out of the chamber onto the gurney. If switching the chamber gas supply to air is not possible, then 40 seconds or more needs to elapse for oxygen to dissipate before defibrillation. Also, all patient garments must be removed before defibrillation because they, too, will be oxygen enriched and thus increase the risk for fire.

Several other UHMS HBO2 Safety Committee members have offered their experience on this topic. You may find these comments helpful as you decide how to proceed:

  • “From all my discussions on this, the consensus these days is to defibrillate outside of the chamber after a rapid decompression to the surface. You would move the patient onto another bed (or remove the bedding) approximately 6 feet from the chamber door. You’d need to remove the upper clothing to reveal the chest. There is very little risk of ignition, as the spark duration is very short, even if repeated.”
  • “We do not remove the patient from the gurney or remove the sheet. We remove all other bedding and use contact gel on the pads to mitigate the risk of ignition.”
  • “I have personally attempted to ignite patient gown material, 100% cotton, that was hyperbarically oxygen saturated and the same gown material without the hyperbaric oxygen saturation. The hyperbaric oxygen saturated material ignited much easier and burned more vigorously than the cotton sample from ambient room air. This test was not quantified or published.”
  • “Our practice would be to move them from the monoplace room to an adjacent procedure room. We would remove clothing and sheets - transferring the patient to a bare cart, leaving linens behind. We’ve practiced this and the whole process takes less than a minute.”
  • “Our practice follows the regimen outlined by Dr. L Weaver in “Hyperbaric Medicine Practice".”

Respectfully,

The UHMS HBO2 Safety Committee

REFERENCES:

  1. Kindwall, E. P., & Goldmann, R. W. (1995). Hyperbaric medicine procedures. Department of Hyperbaric Medicine, St. Luke's Medical Center.
  2. Kindwall, E. P., & Niezgoda, J. A. (2006). Hyperbaric medicine procedures. Department of Hyperbaric Medicine, St. Luke's Medical Center.
  3. Weaver, L. K. (1995). Management of critically ill patients in the monoplace hyperbaric chamber, Hyperbaric Medicine Practice. Edited by Kindwall EP. Flagstaff.
  4. Weaver, L. (2008). Critical care of patients needing hyperbaric oxygen therapy. In: “Physiology and Medicine of Hyperbaric Oxygen Therapy”, Neuman, T.S., Thom, S.R., pg. 124.

 

Additional resourses: 


 DISCLAIMER

Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet.  If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility.  Information provided on this forum is for general educational purposes only.  It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.

Currently treating a cancer patient who smokes marijuana for pain control. We coached him not to smoke prior to treatments but I'm having trouble finding any studies or recommendations regarding safety.
Published: 01 November 2021

Poste: 11/01/21


Q: 
Currently treating a cancer patient who smokes marijuana for pain control. We coached him not to smoke prior to treatments but I'm having trouble finding any studies or recommendations regarding safety.


A:

Thank you for your question. The UHMS HBO2 Safety Committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the Hyperbaric Medical Director (HMD) and Hyperbaric Safety Director (HSD) of your facility.

We would advise that the HMD review the literature on cannabis use and consider the potential for adverse effects when used in conjunction with Hyperbaric Oxygen Therapy. Specifically, the Committee has viewed reports that increased risk of hemoptysis and pneumothorax to heavy users of inhaled cannabis users (see references below).

If the decision is made to treat, we would recommend that a standard pre-dive assessment by the RN/MD team is done. In the chronic or elective setting, it is important to ensure that the patient can follow commands, isn’t experiencing paranoia, confusion, or claustrophobia. It is important to make the patient aware ahead of time that for their safety and the safety of those in the chamber, the physician may determine that it isn’t safe to treat them if these conditions are present.

In the acute setting there could be cases where the mentation of the patient may be less important (e.g. carbon monoxide poisoning, AGE, etc.).

We would also recommend that an approach similar to that of cigarette use is taken. We recommend that you implement heighted precautions related to the presence of heat sources and increase the awareness of your care team. Some facilities discourage their wound care patients from smoking due to the impact of increased vasoconstriction. You may also wish to consider offering the patient other non-smoking options in order to limit some of the risk.

The UHMS HBO2 Safety Committee identifies that although there is potential for increased risk, the decision to treat rests solely on the HMD and the team providing care. The HSD should also be included in the decision-making process.

Respectfully,

The UHMS HBO2 Safety Committee

 

REFERENCES:

  1. Manasrah, N., Al Sbihi, A. F., Al Qasem, S., Naik, R., & Hettiarachchi, M. (2021). Recurrent Spontaneous Pneumothorax Associated With Marijuana Abuse: Case Report and Literature Review. Cureus, 13(2). https://doi.org/10.7759/cureus.13205
  2. Massey, M., & Barney, J. (2021). Pulmonary actinomycosis and marijuana vaping. BMJ Case Reports CP, 14(4), e240973. https://casereports.bmj.com/content/14/4/e240973.abstract
  3. McGraw, M. D., Houser, G. H., Galambos, C., Wartchow, E. P., Stillwell, P. C., & Weinman, J. P. (2018). Marijuana medusa: The many pulmonary faces of marijuana inhalation in adolescent males. Pediatric pulmonology, 53(12), 1619-1626. https://doi.org/10.1002/ppul.24171
  4. Oh, J. S., Wong, U., Bajaj, D., & Hines, S. E. (2020). Isolated pauci-immune pulmonary capillaritis associated with hydrocarbon inhalation and marijuana smoking: an unusual case of severe hypoxemia. Case reports in pulmonology, 2020. https://doi.org/10.1155/2020/1264859
  5. Singh, A., Tan, Q., Saccone, N. M., & Lindner, D. H. (2020). A case of vaping TCH oil leading to vaping associated pulmonary injury: our approach to its diagnosis, management, and recommendations. Case reports in pulmonology, 2020. https://doi:10.1155/2020/6138083
  6. Stone, T., Henkle, J., & Prakash, V. (2019). Pulmonary mucormycosis associated with medical marijuana use. Respiratory medicine case reports, 26, 176-179. https://doi:10.1016/j.rmcr.2019.01.008

7.       Tan, W. C., Bourbeau, J., Aaron, S. D., Hogg, J. C., Maltais, F., Hernandez, P., ... & Sin, D. D. (2019). The effects of marijuana smoking on lung function in older people. European Respiratory Journal, 54(6). https://doi:10.1183/13993003.00826-2019


DISCLAIMER

Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet.  If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility.  Information provided on this forum is for general educational purposes only.  It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.

I have a question pertaining to the Clear Com Belt pack communication systems that are being used in multiplace chambers. When I first started in 2007 their belt back did not have an O2 marker on them. In the present facility that I work in they have units that have the O2 marker on them and some that don’t. I have tried to reach out to Clear-com and have not received a response. Can the non O2 marked units be used in the chamber if we use Nicad / NIHM batteries?
Published: 04 October 2021

Posted: 9/24/2021


Q: 
I have a question pertaining to the Clear Com Belt pack communication systems that are being used in multiplace chambers.  When I first started in 2007 their belt back did not have an O2 marker on them.  In the present facility that I work in they have units that have the O2 marker on them and some that don’t. I have tried to reach out to Clear-com and have not received a response. Can the non O2 marked units be used in the chamber if we use Nicad / NIHM batteries? 


A:

Thank you for your question. The UHMS HBO2 Safety Committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the Hyperbaric Medical Director (HMD) and Hyperbaric Safety Director (HSD) of your facility.

Key factors to consider when evaluating equipment for the hyperbaric (multiplace – air) environment:

Communicating with the Manufacturer:

  1. Consider reaching out to the manufacturer to learn more about the device, especially if there are limited performance details/specifications in the OEM manual.
    1. Try to gain an understanding of what types of stress the device was subjected to during the manufacturing and testing phase.
    2. You may wish to make them aware of your intentions or you may remain anonymous.
    3. It should be noted that any modifications to the device or use other than as recommended by the manufacturer risks voiding any warranty on the product.
  2. If you discover that the non “O2” version has been tested previously under hyperbaric conditions, we suggest that this may be utilized as validation of your final assessment, but we do not recommend that this is the entirety of device approval. Simply put, we recommend a formal risk assessment regardless of testing methods.
  3. We strongly encourage that you seek assistance from your hospital biomedical engineering group and perhaps your hospital safety or legal teams. There are many useful examples of published risk assessment strategies applied to medical devices in the literature. Because communication devices may require the application of several safety mitigations, reviewing these strategies can provide useful guidance when considering the safety of battery-powered portable communication equipment in the multiplace (air) hyperbaric environment. There are several examples of medical device approval processes found in this MEDFAQ response.
  4. The National Fire Protection Association 99 Health Care Facilities Code, 2021 edition, chapter 14, lists the temperature, electrical limits, and responsibilities of the HSD regarding equipment used in Class A and B chambers. You should have this reference in your library.
  5. Considering the power source, we suggest ensuring that the battery remains secure within the housing and performing routine inspections. Consider involving a Biomedical Engineering representative for this process. Addressing the risk of the potential to generate heat, you should confirm the type of batteries contained within the beltpack. Along with the main battery power, the beltpack may also contain a low-power, non-rechargeable lithium battery, typically used to maintain a memory of system settings. (Disposable alkaline or silver oxide batteries are safe but are not always an option). Disposable lithium batteries are safer than rechargeable lithium battery types such as lithium-ion or lithium polymer, both of which can suffer runaway fires due to the electrolyte used in these products. Again, it is wise to involve a Biomedical Engineering representative in your risk assessment process.

REFERENCES:

  1. Burman, F. (2019). Risk Assessment Guide for Installation and Operation of Clinical Hyperbaric Facilities (6th ed.). San Antonio, TX: International ATMO, Inc.
  2. National Fire Protection Agency (NFPA). (2021). NFPA 99 2021 Edition: Health Care Facilities Code. Quincy, Massachusetts. https://www.nfpa.org/
  3. Undersea and Hyperbaric Medical Society, MEDFAQ Response, “Telemetry Box in a multiplace chamber,” Accessed 9/24/2021, LINK
  4. Workman, W. T., & Wood, J. S. (2020). Hyperbaric Facility Safety: A Practical Guide (2nd ed.). Best Publishing Company.

Respectfully,

The UHMS HBO2 Safety Committee


DISCLAIMER

Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet.  If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility.  Information provided on this forum is for general educational purposes only.  It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.

 

We are treating a patient who had a Zio XT ECG patch placed yesterday. I am unable to find any information on the patch and hyperbaric oxygen. The company is unable to provide me with any documentation of the safety of use in the hyperbaric environment. Do you know of anyone currently using the patch in the HBO(multiplace) environment?
Published: 28 September 2021

Posted: 11/15/21


Q:

We are treating a patient who had a Zio XT ECG patch placed yesterday. I am unable to find any information on the patch and hyperbaric oxygen. The company is unable to provide me with any documentation of the safety of use in the hyperbaric environment. Do you know of anyone currently using the patch in the HBO (multiplace) environment?


A:

Thank you for your question. The UHMS HBO2 Safety Committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the Hyperbaric Medical Director (HMD) and Hyperbaric Safety Director (HSD) of your facility.

The UHMS HBO2 Safety Committee cannot endorse a specific device for use in the chamber. That said, we do not endorse the use of this device in a monoplace (Class B) chamber. We can provide you with specific resources that may assist you in your evaluation process for the multiplace (Class A) in an air-filled environment. Again, this is not an endorsement by the UHMS HBO2 Safety Committee for the use of this device in the Multiplace Hyperbaric Environment. Rather, we hope that you will consider these suggestions in your individual approach:

Key factors to consider when evaluating equipment for the hyperbaric (multiplace – air) environment:

  • We strongly encourage a formal risk assessment of the device, with assistance from your hospital biomedical engineering group and perhaps your hospital safety or legal teams.
  • If you discover that the device has been tested previously under hyperbaric conditions, we suggest that this may be utilized as validation of your final assessment, but we do not recommend that this is the entirety of device approval. Simply put, we recommend a formal risk assessment regardless of testing methods. (Exception: Modern ICD’s and Pacemakers are commonly tested by the manufacturer for function under pressure. Therefore, use under increased atmospheric conditions does not constitute an off-label use of those devices.)
  • Consider reaching out to the manufacturer to learn more about the device, especially if there are limited performance details/specifications in the product manual.
  • Try to gain an understanding of what types of stress the device was subjected to during the manufacturing and testing phase.
  • You may wish to make the manufacturer aware of your intentions or you may remain anonymous.
  • Regardless of the manufacturer’s response, there may be good reason for you to proceed with the evaluation, as this device would offer uninterrupted monitoring of the patient and may be vital to the continuum of care to the patient.
  • It should be noted that any modifications to the device or use other than as recommended by the manufacturer risks voiding any warranty on the product.
  • If evaluating a medical device, it is understood that few are intended to be used in the Multiplace hyperbaric environment. Therefore, consider that such use will likely fall into the FDA category of "Off-Label" and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices “. You may also wish to review gov: Frequently Asked Questions about Medical Devices for more information.
  • At least one major academic tertiary referral institution’s legal team with experience in medical device modification across its entire complex and constantly changing needs of subspecialty patient care including hyperbaric medicine interprets current FDA regulations in the following fashion.

“The program (modification and testing of medical devices for safe use in the hyperbaric environment) is not subject to FDA regulation. FDA regulates manufacturers and not the practice of medicine. Physicians are able to use FDA approved products other than under the labeled indications as long as the physician meets certain criteria. FDA’s statement on this off-label use is as follows:

“Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgment. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects. Use of a marketed product in this manner when the intent is the "practice of medicine" does not require the submission of an Investigational New Drug Application (IND), Investigational Device Exemption (IDE) or review by an Institutional Review Board (IRB).”

  • The National Fire Protection Association 99 Health Care Facilities Code, 2021 edition, chapter 14, lists the temperature, electrical limits, and responsibilities of the HSD regarding equipment used in Class A and B chambers. You should have this reference in your library.
  • Regarding batteries, we suggest ensuring that batteries remain secure within the housing and receive routine inspections. Consider involving a Biomedical Engineering representative for this process. Disposable lithium batteries are safer than rechargeable lithium battery types such as lithium-ion or lithium polymer, both of which can suffer runaway fires due to the electrolyte used in these products. Again, it is wise to involve a Biomedical Engineering representative in your risk assessment process.
  • Pay attention to any sealed air pockets within the housing that could be affected by Boyle’s Law. Ventilation of the housing may be necessary. For tracking purposes, you might consider labeling each device so that the care of those devices can be tightly controlled.

Key factors to consider when evaluating the Zio XT ECG patch for the hyperbaric (multiplace – air) environment:

  • Using the device in an increased atmospheric environment is not in concert with the manufacturer’s environmental specifications (iRhythm Technologies, Inc. ZioXT Service Manual, Pg. 19, Environmental Specifications).
  • This device utilizes two lithium manganese dioxide coin cells. If these are secured within the housing, coin-batteries like these are unlikely to cause any issues. Power consumption appears to be miniscule, and there are unlikely to be significant air pockets. That said, pressure testing the device prior to exposure with a patient is recommended.
  • As always, check with the manufacturer prior to testing. Gaining their advice and cooperation is ideal.
  • A safety committee member contacted iRhythm Technologies, inc. and spoke to a representative who was able to provide a Clinical Reference Manual along with the following information regarding the Zio XCT ECG:
    • The patch is not sterile/sterilized during the manufacturing process
    • The device may be removed and replaced, but multiple removals will cause the adhesive to be ineffective.
    • The Product Manual states that the device should not be submerged in water (likely to protect internal circuitry).

Respectfully,

The UHMS HBO2 Safety Committee

REFERENCES:

  1. Burman, F. (2019). Risk Assessment Guide for Installation and Operation of Clinical Hyperbaric Facilities (6th ed.). San Antonio, TX: International ATMO, Inc.
  2. Burman F, Sheffield R, Posey K. Decision process to assess medical equipment for hyperbaric use. Undersea Hyperb Med. 2009;36:137–44. PMID: 19462753.
  3. National Fire Protection Agency (NFPA). (2021). NFPA 99 2021 Edition: Health Care Facilities Code. Quincy, Massachusetts. https://www.nfpa.org/
  4. US Food and Drug Administration. (2014). “Off-label” and investigational use of marketed drugs, biologics, and medical devices: information sheet. Silver Spring, MD. LINK
  5. Workman, W. T., & Wood, J. S. (2020). Hyperbaric Facility Safety: A Practical Guide (2nd ed.). Best Publishing Company.

 

DISCLAIMER

Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet.  If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility.  Information provided on this forum is for general educational purposes only.  It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.

Is PET plastic permitted in hyperbaric chamber? We have used single water bottles but infection control would like us to switch to individual use disposable wo labels.
Published: 27 September 2021

Posted: 9/27/2021
Updated: 2/7/2022


Q:
Is PET plastic permitted in hyperbaric chamber? We have used single water bottles but infection control would like us to switch to individual use disposable wo labels.


A:

Thank you for your question. The UHMS HBO2 Safety Committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the Hyperbaric Medical Director (HMD) and Hyperbaric Safety Director (HSD) of your facility.

Many of our committee members are familiar with this rather common practice (In 2018, a U.S. survey revealed that 35 of 37 Hyperbaric Facilities allow plastic water bottles in the chamber). With a few simple mitigations, this item should not pose any problems within the Monoplace or Multiplace hyperbaric environment. The material itself - Polyethylene Terephthalate (PET) is known to be flame retardant. According to sources referenced below, this material appears to melt at around 500°F. The UHMS HBO2 Safety Committee does not view this item to be a significant fire risk when combined with common patient grounding principles in place.

There are several considerations that you may wish to address before introducing the use of capped bottles. The mitigations you choose should be documented within your risk assessment, which should be completed by the Safety Director and signed by your Safety Director and Medical Director. For more guidance on performing a risk assessment, we encourage you to review NFPA 99, 14.3.1.6.4.3 (2021) annex notes on risk assessment and consider obtaining a copy of “Risk Assessment Guide for Installation and Operation of Clinical Hyperbaric Facilities” (ref 1).

It is also important to note that before introducing a new item/process, clear communication is provided to staff and any training needs are addressed. You should also ensure that any new procedural steps appear on your pre-treatment checklist and are covered during your pre-treatment safety time out/stop/pause (per NFPA 99 (2021), 14.3.1.6.1.3).

You may consider the following mitigations as you complete your risk assessment:

  • There is the potential for Boyle’s law to act upon trapped gases within the bottle during decompression. To address this, you may wish to leave the bottles uncapped, loose, or ventilate the bottles with a large-bore needle (at least 12 GA recommended).
  • We are aware of at least one facility that leaves the bottles capped. They chose to use low-mass, environmentally friendly bottles (thinner walled bottles) that will fail at lower pressures. They have found that other, more robustly made bottles have a tighter thread engagement, providing a greater potential to injure patients if they fail.
  • The Safety Committee does not endorse a particular style of drinkware. Rather, we would advise that you apply the safety principles described here to address the risk for your situation.
  • We are aware of facilities who utilize sport bottle-style pop-tops rather than bottle caps.
  • Consider the removal of paper labels (if present).

NOTE: Regarding the presence of residual glue resulting from the removal of labels, the UHMS HBO2 Safety Committee does not see this as a significant risk if no odor is present.

You may also wish to consider applying the following COVID-related mitigations:

  • Use single-use only plastic bottles
  • Clean the bottles with a surface disinfectant wipe and let air dry
  • Using new gloves, break the cap seal and close gently prior to use

REFERENCES:

  1. Burman, F. (2019). Risk Assessment Guide for Installation and Operation of Clinical Hyperbaric Facilities (6th ed.). San Antonio, TX: International ATMO, Inc. LINK
  2. Chimiak, J. (2010). Evaluating Equipment and Materials for Use in a Hyperbaric Oxygen Environment: Clinical Hyperbaric Evaluation and Testing (CHET) Program. In: Hyperbaric Facility Safety: A Practical Guide (1st ed., 3rd reprint). Best Publishing Company. LINK
  3. National Fire Protection Association (NFPA). (2021). “NFPA 99 2021 Edition: Health Care Facilities Code.” Quincy, Massachusetts. LINK
  4. Pullis, M. (2019) “National Survey of Equipment Used in Hyperbaric Facilities,” UHMS ASM Pre-Course Presentation: Hyperbaric Oxygen Safety: Clinical and Technical Issues LINK
  5. Undersea and Hyperbaric Medical Society. (2018). Clinical Hyperbaric Facility Accreditation Manual (4th ed.). North Palm Beach, FL: Undersea and Hyperbaric Medical Society, Inc. LINK, MANUAL
  6. Undersea and Hyperbaric Medical Society. (2014). Position Statement: Safety Time Out/Pause - "Stop". Undersea and Hyperbaric Medical Society, Inc. LINK
  7. Web Reference: “PET – Density, Strength, Melting Point and Thermal Conductivity,” LINK, Accessed 9/3/2021
  8. Workman, W. T., & Wood, J. S. (2020). Hyperbaric Facility Safety: A Practical Guide (2nd ed.). Best Publishing Company. LINK

Respectfully,

The UHMS HBO2 Safety Committee


DISCLAIMER

Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet.  If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility.  Information provided on this forum is for general educational purposes only.  It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.

 

Omnipod Dash for Hyperbaric use. Manufacturer says nothing about HBOT. This is what I found: The site warns that: The atmospheric pressure in an airplane cabin can change during flight, which may affect the Pod's insulin delivery. It also says Operating ATM 700hPA - 1060hPA. Powered by rechargeable Li-Ion 3.7V, 1300mAh.
Published: 20 September 2021

Posted: 11/15/21


Q:

Omnipod Dash for Hyperbaric use. Manufacturer says nothing about HBOT. This is what I found: The site warns that: The atmospheric pressure in an airplane cabin can change during flight, which may affect the Pod\'s insulin delivery. It also says Operating ATM 700hPA - 1060hPA. Powered by rechargeable Li-Ion 3.7V, 1300mAh.


A:

Thank you for your question. The UHMS HBO2 Safety Committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the Hyperbaric Medical Director (HMD) and Hyperbaric Safety Director (HSD) of your facility. Whether you ultimately allow this item or not, we recommend that a thorough risk assessment be performed by the HSD in conjunction with the HMD when evaluating items of this type.

According to public information pertaining to this product, the Omnipod Dash system consists of “a pod which is worn on the body which carries and delivers insulin, plus a wireless Personal Diabetes Manager (PDM) connected to the pod that controls insulin delivery. The Omnipod has several differentiating features from conventional continuous subcutaneous insulin infusion (CSII) therapy including a tubeless waterproof pod and automated priming and cannula insertion. The Omnipod DASH system has a touchscreen PDM interface, Bluetooth wireless technology, and wireless internet connectivity.”

Pertaining to the Monoplace hyperbaric (NFPA Class B) environment, this device contains a battery which would prohibit its use in this setting. In the Multiplace (NFPA Class A) environment, there may be several risk factors that should be considered prior to allowing a device of this type. Chief among them should be, “Does the device present a fire hazard?” and, “Does the change in atmospheric pressure impact the devices’ ability to operate normally?”

Although not specifically prohibited by NFPA 99, chapter 14 (2021), we advise you to use caution when considering any battery in the multiplace hyperbaric environment and consider the item’s potential to fail or generate more heat than usual. Venting or purging the device with Air/Nitrogen may be considered. Working with the manufacturer and/or Biomedical Engineering teams in these cases is always recommended.

Additionally, the minimum and maximum tolerable pressures provided from the manufacturer relate to the following values:

Minimum: 700hPa (millibar) or 9878. 4 feet altitude which is approximately 73 kPa absolute

Maximum: 1060 hPa (millibar) or -1200 feet which is approximately 106 kPa absolute

Further testing is needed to confirm, but these values indicate that the device may not operate as designed when exposed to increased or decreased atmospheric pressure beyond these values.

One of our Committee members reached out to a local representative for the Omnipod Dash and returned the following information:

  • It is not designed to give more than .05 units per dose
  • It contains a SMA wire that heats up to deliver the dose
  • The SMA wire is NiTinol (Nickel & Titanium)
  • It has a magnetic field, so it is not MRI compatible
  • If shorted, it will alarm and stop completely

Based upon the information reviewed, the UHMS HBO2 Safety Committee cannot recommend the use of this product in the hyperbaric environment unless it is confirmed that changes in atmospheric pressure do not affect the function of the device.

REFERENCES:

  1. Pillalamarri, S. S., Huyett, L. M., & Abdel-Malek, A. (2018). Novel bluetooth-enabled tubeless insulin pump: a user experience design approach for a connected digital diabetes management platform. Journal of diabetes science and technology, 12(6), 1132-1142. LINK
  2. Thompson, B., & Cook, C. B. (2019). Insulin pumping patches: emerging insulin delivery systems. Journal of diabetes science and technology, 13(1), 8-10. LINK

Respectfully,

The UHMS HBO2 Safety Committee


 

DISCLAIMER

Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet.  If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility.  Information provided on this forum is for general educational purposes only.  It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.

Can a podiatrist be the hyperbaric medical director?
Published: 21 August 2021

Posted: 8/23/21


Q:  Can a podiatrist be the hyperbaric medical director?


A: Please see our position on credentialing and privileging can be found in our 2019 guideline - https://www.uhms.org/images/Position-Statements/UHMS_Cred_and_Priv_Guide_-_V30_Aug_2019.pdf.

Where is it written, or is it just common practice, that if you only have ONE supervising medical practitioner on site…that they do not go in the chamber unless for an emergency?
Published: 16 July 2021

Posted: 7/16/21


Q:
Where is it written, or is it just common practice, that if you only have ONE supervising medical practitioner on site…that they do not go in the chamber unless for an emergency?


A:
Thank you for your question. The UHMS HBO2 Safety Committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the Hyperbaric Medical Director (HMD) and Hyperbaric Safety Director (HSD) of your facility.

The UHMS HBO2 Safety Committee realizes that this is a very important question for facilities with multiplace hyperbaric chambers to answer, as it will impact how your team will handle various patient emergencies and potential staffing shortages. It is important to note that the NFPA 99 (2021), 14.2.1.4.2 gives joint authority to the HMD and HSD to determine the “minimum staff qualifications, experience, and complement based on the following:

  • Number and type of hyperbaric chambers in use
  • Maximum treatment capacity
  • Type of hyperbaric therapy normally provided”

As such, the UHMS HBO2 Safety Committee recommends that a written policy is developed by the HMD and HSD that identifies the staffing levels necessary for the safe delivery of hyperbaric oxygen therapy based upon the above factors, and perhaps several other considerations that may be unique to your particular program.

Although there may be dire situations where it is necessary, the UHMS HBO2 Safety Committee strongly suggests that you consider other alternatives to the availability of the supervising Hyperbaric Provider when determining your inside attendant needs. We present to you that this individual is largely responsible for many operations within the clinic while a therapy is underway, and that the use of a provider in the chamber is necessary by exception only, as described in the USN Dive Manual and referenced in the Operating Standards for NOAA Hyperbaric Chambers:

“20-7.8.3 Use of Diving Medical Officer as Inside Tender. If only one Diving Medical Officer is on site, the Medical Officer should lock in and out as the patient's condition dictates, but should not commit to the entire treatment unless absolutely necessary. Once committed to remain in the chamber, the Diving Medical Officer effectiveness in directing the treatment is greatly diminished and consultation with other medical personnel becomes more difficult. If periods in the chamber are necessary, visits should be kept within no-decompression limits if possible.”

While some practices may vary in design, we suggest that you consider the many primary duties of the supervising Hyperbaric Provider that may exist outside of the chamber. This individual is normally relied upon to provide consultative services, complete therapy documentation, communicate with referring providers, and provide direction in the event of a facility or in-chamber emergency. It is our view that these primary supervision and management responsibilities are best performed when the provider is not encumbered by delivering direct patient care inside of the chamber.

It is also our view that the supervising Hyperbaric Provider remain aware of events occurring outside of the chamber in order to provide global direction, and must be able to do so without being exposed to the physiologic risk factors caused by hyperbaric exposure (barotrauma, nitrogen narcosis, risk of breathing oxygen during decompression, DCI). Furthermore, the UHMS Guidelines for Hyperbaric Facility Operations, 2nd edition calls for the supervising Hyperbaric Provider to be “readily available during treatments”. We suggest that if there are other chamber operations occurring within the clinic, a provider who is serving as an inside attendant will not be able to properly supervise these operations simultaneously.

Reported prevalence in the hyperbaric community:

While this practice is not considered common in the hyperbaric community, the committee is aware of a handful of hyperbaric practices that will occasionally utilize the lone provider as an attendant in the chamber for special situations. Consider these statements from members of the Hyperbaric Safety Committee:

  • Done only in extreme cases where there is no alternative attendant and there is an emergency need to treat a critical care patient.
  • Only when there is another trained hyperbaric provider on-site and standing by.
  • Only when there is a trained individual qualified by the medical director to manage the chamber in an emergency. If such a person is not available, then the physician should not enter the chamber except in a dire emergency (life-or-death event).
  • May occur in the treatment of DCS or AGE where a neurologic assessment by the physician is needed. In many cases a trained fellow is utilized instead of exposing the supervising hyperbaric provider.
  • The physician should be able to lock in, but not for any reason other than a medical emergency or complication.
  • Occurs when treating a patient using a TT6 or TT6a or COMEX, and dependent upon staffing and the time of night/day - the physician will enter the chamber when the tender goes on oxygen at the end of the table. In these cases, there are no elective treatments scheduled after this exposure.

In closing, we encourage administrators and program managers responsible for the safety of their hyperbaric programs to consider the standards and recommendations we have listed here and allow staffing decisions such as these to be made jointly by the HMD and HSD of the hyperbaric program. We also suggest that the HMD and HSD conduct a formal Risk Assessment that is inclusive of the factors mentioned above prior to developing a staffing policy for the program. We understand that there may be many other considerations not mentioned here that are unique to your facility and should be included within the risk assessment.

Respectfully,

The UHMS HBO2 Safety Committee

REFERENCES:

Burman, F. (2019). Risk Assessment Guide for Installation and Operation of Clinical Hyperbaric Facilities (6th ed.). San Antonio, TX: International ATMO, Inc.

National Fire Protection Agency (NFPA). (2021). NFPA 99 2021 Edition: Health Care Facilities Code. Quincy, Massachusetts.

National Oceanic and Atmospheric Administration (NOAA). Operating Standards for NOAA Hyperbaric Chambers (2017) NOAA.gov

Naval Sea Systems Command. (2016). US Navy Diving Manual (7th ed.). United States Navy Publication.

Workman, W. T. (2015). Guidelines for Hyperbaric Facility Operations. 2nd Ed. Best Publishing Company. Section 2: Job Descriptions and Responsibilities, I. Hyperbaric Medicine Physician and Section. 3: Staffing Guidelines, I.: Physician/NPP Staffing


DISCLAIMER

Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet.  If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility.  Information provided on this forum is for general educational purposes only.  It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.

are there any issues with antibiotic beads and hyperbaric treatments. Pt had surgery to remove the osteo bone and beads were placed in wound and sutured closed. is pt safe to treat with HBO?
Published: 14 July 2021

Posted: 8/2/21


Q: 
Are there any issues with antibiotic beads and hyperbaric treatments. Pt had surgery to remove the osteo bone and beads were placed in wound and sutured closed. is pt safe to treat with HBO?


A:

Thank you for your question. The UHMS HBO2 Safety Committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the Medical Director and Safety Director of your facility.

The UHMS HBO2 Safety Committee believes there to be a low or zero risk to the patient from the mechanical effects of pressure changes on the antibiotic beads. Typically, these beads are dissolvable and therefore have a certain degree of solubility that should not be affected by surrounding pressure changes. The beads break down over time, facilitating new bone growth once the infection is gone.

Some antibiotic beads are made of polymethyl methacrylate (PMMA). This is the same material that is found in the acrylic hulls and windows of many monoplace and multiplace chambers. This type does not dissolve and will normally be removed in a week to ten days. In some cases, this material is even left inside of the body. We would recommend that you investigate which type of product is present so that all involved can remain well informed.

Mechanical risks aside, there is a theoretical risk for increased medicinal uptake of the product, and therefore a theoretical reduction in the overall length of antibiotic therapy due to increased absorption. However, several of our committee members have witnessed good patient outcomes with no adverse effects in several patients they have treated over many years with both types of antibiotic beads. To our knowledge, no research studies exist related to the absorption rate of these products in the hyperbaric setting.

REFERENCES:

DeCoster, T. A., & Bozorgnia, S. (2008). Antibiotic beads. JAAOS-Journal of the American Academy of Orthopaedic Surgeons, 16(11), 674-678.

McPherson, E., Dipane, M., & Sherif, S. (2013). Dissolvable antibiotic beads in treatment of periprosthetic joint infection and revision arthroplasty-the use of synthetic pure calcium sulfate (Stimulan®) impregnated with vancomycin & tobramycin. Reconstructive Review, 3(1).

Respectfully,

The UHMS HBO2 Safety Committee


DISCLAIMER
Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet.  If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility.  Information provided on this forum is for general educational purposes only.  It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.

 

Dr. Feldmeier, I have a patient referred to me for treatment of soft tissue radionecrosis of oral mucosa of rt posterior maxilla and posterior rt mandible. Patient has undergone radiation and chemotherapy for carcinoma rt tonsillar fossa and tongue. He is cancer free but has ulceration in treated areas. Oncology has biopsied these areas and no recurrences. Do I have to wait 6 months from therapy to start treatment?
Published: 23 June 2021

Posted: 7/12/2021


Q:

Dr. Feldmeier, I have a patient referred to me for treatment of soft tissue radionecrosis of oral mucosa of rt posterior maxilla and posterior rt mandible. Patient has undergone radiation and chemotherapy for carcinoma rt tonsillar fossa and tongue. He is cancer free but has ulceration in treated areas. Oncology has biopsied these areas and no recurrences. Do I have to wait 6 months from therapy to start treatment?


A:

You do not mention how long ago the radiation and chemotherapy were completed or how extensive or deep the ulcerations are.

Also if these ulcerations are at the site of the tumor, it may take a period of time for the body to replace this site with normal tissues after the cancer has been eradicated.

If this is indeed radiation necrosis of the soft tissue, I know of no constraints or prohibition in initiating hyperbaric oxygen. Generally, these types of lesions are painful and interfere with eating. Hyperbaric oxygen should hasten their resolution. You may want to contact the insurance carrier ahead of time and explain the case to guarantee appropriate reimbursement.

John J. Feldmeier, D.O. 

 

EARLY HYPERBARIC OXYGEN THERAPY FOR REDUCING RADIOTHERAPY SIDE EFFECTS: EARLY RESULTS OF A RANDOMIZED TRIAL IN OROPHARYNGEAL AND
NASOPHARYNGEAL CANCER;
Int. J. Radiation Oncology Biol. Phys., Vol. 75, No. 3, pp. 711–716, 200

Is it safe to treat a patient with HBO that has Calypso Beacon Transponders implanted. He has 3 transponders implanted near his prostate due to radiation treatments he received a few years back. The company responded with: ** 2021-06-07 08:50:00 - Product Web Request Request: Are there any precautions for a patient undergoing Hyperbaric Oxygen Therapy? Or Diving? From System Operators manual: No specified indications under compatibility, contraindications, warnings and precautions or operational safety ab
Published: 08 June 2021

Posted: 7/7/21


Q:
Is it safe to treat a patient with HBO that has Calypso Beacon Transponders implanted? He has 3 transponders implanted near his prostate due to radiation treatments he received a few years back.


A:
Thank you for your question. The UHMS HBO2 Safety Committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the Medical Director and Safety Director of your facility.

The UHMS HBO2 Safety Committee recommends that a proper risk assessment be performed by the Hyperbaric Medical Director (HMD) and Hyperbaric Safety Director (HSD) of your facility, identifying the potential for this item to cause harm to the patient if hyperbaric oxygen therapy is provided. Several members of the Committee have investigated this item, contacted the manufacturer, and identified several risk factors and other details for your consideration:

  • These devices have not been tested under hyperbaric conditions by the manufacturer. Members of our committee have encouraged the company to examine the need for this further and have provided the contact information of a group that could accomplish this.
  • The Calypso Beacon Transponder is constructed with a glass outer sheath that may rupture if exposed to increased atmospheric pressure. The contents of the device could then be exposed to the surrounding tissue. It is not known if the contents could be harmful to patients.
  • The Calypso Beacon Transponder is subjected to gamma radiation during the production process to promote sterilization of the device.
  • We did not discover a safety data sheet for this device, but a 510(k) premarket clearance was discovered. LINK
  • If the patient were to require emergent hyperbaric oxygen therapy, it is the view of this committee that the therapy should not be delayed due to the presence of this item.
  • The committee located several documents related to the Calypso Beacon Transponder that may aid you in the decision-making process. (See references below)

If your risk assessment of this device concludes that the potential for harm is low and the patient would benefit from therapy, we would recommend that the patient be well-informed, and your risk assessment is fully documented by the HMD and HSD of your facility. You may also want to consider informing and receiving input from the patient’s oncology team.

REFERENCES:

  1. Burman, F. (2019). Risk Assessment Guide for Installation and Operation of Clinical Hyperbaric Facilities (6th ed.). San Antonio, TX: International ATMO, Inc. LINK
  2. FDA 510(k) resource page, US Food and Drug Administration. Accessed July 2, 2021. LINK
  3. Toufik D, PhD., “Presentation: Multivendor SBRT/IGRT The Calypso 4D Localization and Tracking System / Elekta Synergy-S,” Practical Medical Physics Symposium, AAPM 54th Annual Meeting, 2012. LINK
  4. Varian Medical Systems, Instructions – “Beacon® Care Package for Prostate,” LINK
  5. Varian Medical Systems, Product Sheet – “CALYPSO SOFT TISSUE (17G) BEACON TRANSPONDER.” LINK
  6. Varian TPS Helpdesk, email responses from web inquiries - received 6/21/2021 and 6/22/2021.

Closure Summary: “Thank you for your patience, while I have been engaged in discussions with Product Management and Engineering.

The capsule of the transponder is air-tight and there is no liquid within.

The lung beacons were tested to 2 bar pressure. However, the design for the lung beacons (which has a plastic tube around the vial for holding the legs) is very different from the prostate beacons.

No pressure testing has been done for the prostate beacons.

Recreational divers frequently go to 100 ft depth (3 atm of pressure), and certainly hyperbaric oxygen chambers reach this sort of pressure Thus, I am afraid that the integrity of neither the lung nor the prostate beacon can withstand that.

In fact, since there is no pressure testing for the prostate beacons, so it is unknown when this could fail.

Regards,

Loretta
Loretta Lewandowski, Ph.D., D.A.B.R.
Medical Physicist, North America Clinical Help Desk
Varian Medical Systems
United States”

Respectfully,

The UHMS HBO2 Safety Committee


DISCLAIMER

Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet.  If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility.  Information provided on this forum is for general educational purposes only.  It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.

I recently saw a 52-year-old male with a hx of anaplastic oligodendroglioma, referred by his neuro-oncologist for possible hyperbaric oxygen therapy treatments for brain radiation necrosis and worsening cognitive impairments. In April 2019, the patient had a left craniotomy for removal of a large frontal tumor with hemorrhage and herniation with pathology of anaplastic oligodendroglioma WHO grade 3. He had radiation therapy (5940 cGy) July-August 2019 and concurrent TMZ (Temozolomide) chemotherapy. A
Published: 17 May 2021

Posted: 5/17/2021


Q:
I recently saw a 52-year-old male with a hx of anaplastic oligodendroglioma, referred by his neuro-oncologist for possible hyperbaric oxygen therapy treatments for brain radiation necrosis and worsening cognitive impairments. In April 2019, the patient had a left craniotomy for removal of a large frontal tumor with hemorrhage and herniation with pathology of anaplastic oligodendroglioma WHO grade 3. He had radiation therapy (5940 cGy) July-August 2019 and concurrent TMZ (Temozolomide) chemotherapy. After a stereotactic brain biopsy of lesion in left splenium of the corpus callosum in November 2020, he was placed on Bevacizumab for radiation necrosis.

Patient had a stereotactic left-brain biopsy in early May 2021 for a worsening corpus callosum lesion. Pathology report: necrotic brain parenchyma with rare intermixed atypical cells, suspicious for tumor.

The next day, the pathology report shows “ …. This confirms that he does have a recurrence of oligodendroglioma, as the cause of the enlarging lesion. There is also a significant element of necrosis present, with diffuse (not nodular/necrotic) tumor.”

Patient is on a nine-day dexamethasone taper to see if it will help improve his cognition, and the patient is about to start chemotherapy: PCV (procarbazine/CCNU/vincristine) with a port being placed for the vincristine.

I am reluctant to treat the radiation necrosis while he is undergoing active cancer therapy.

I would like to get your thoughts about this situation. 


A:

These cases are always difficult because there are so many chemo agents now including targeted therapies. biologics and immune enhancing agent.

If the patient has had Bevacizumab in the past 4 months, I would not treat him with HBO. The drug is an angiogenesis inhibitor, specifically VEGF. As we know HBO works at least in part by inducing angiogenesis as one of the major growth factors. Intuitively, applying both simultaneously would have you working against yourself. Supposedly, it gives some palliation of brain necrosis by stabilizing vascular integrity and preventing or at least ameliorating interstitial edema.

The new drugs are all well-known and have been around for a while. Procarbazine is an alkylating agent. It works to inhibit DNA, RNA and protein synthesis. CCNU is also known as Lomustine. It is also an alkylator. It is known to lipid soluble and for this reason has better penetration into the brain than many other chemo agents. Vincrisine is in a class of drugs called vinca alkaloids. It inhibits microtubule formation within the cell to prevent successful mitosis. Since this patient has likely combination of tumor necrosis and persistent tumor, it makes your decision even more difficult. One of the characteristics of high-grade brain tumors is necrosis. It is possible to my reading that his problems are all due to tumor. I predict his symptoms will get worse as they taper the decadron.

With HBO2 effects on reducing edema, you may get some near immediate improvement in his brain function. With a persistent or recurrent high-grade tumor his survival is probably measured in less than 6 months. From my investigations, I have found no evidence that you will cause the tumor to be more aggressive. It is going to be aggressive whether you give him HBO2 or not. In terms of the chemo complications being worse with concurrent HBO2, it is impossible to say. Alkylators are said to be radiomimetic. In other words, they cause breaks in DNA strands mediated through free radicals. You may actually provide some sensitization of the tumor to the chemotherapy in the same fashion O2 sensitizes tumors to radiation damage.

I would wait until they have completed their taper of steroids in any case. I expect they will have to return him to the steroids. As sad as it is there is little we can do for this patient and it may be time to pull the plug on therapies.

John Feldmeier, DO

 

Is there any special considerations for treating patients that have a colostomy or ileostomy bag/pouch?
Published: 06 April 2021

Posted: 4/6/2021


Q:
Is there any special considerations for treating patients that have a colostomy or ileostomy bag/pouch?


A:
Thank you for your question. The UHMS HBO2 Safety Committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the Medical Director and Safety Director of your facility.

Ostomy devices, or an ostomy pouching system is a prosthetic medical device that provides a means for the collection of waste from a surgically diverted biological system (colon, ileum, bladder) and the creation of a stoma. Pouching systems are most commonly associated with colostomies, ileostomies, and urostomies.

The UHMS HBO2 SC recommends the creation of procedural documents specific to your practice that will accommodate your hyperbaric setting. These documents should be designed in accordance with your hospital’s nursing or gastroenterology guidelines, and approved by the Hyperbaric Safety Director and Hyperbaric Medical Director of your facility.

When considering the treatment of a patient with one of these devices in a hyperbaric chamber, the chief concern should be the effect of pressure changes on the gas that may accumulate in the bag over the course of treatment. Additionally, it is recommended that the container is emptied prior to therapy to avoid overfilling. It may be helpful for your practice to review any steps that should be accomplished during the pre-therapy safety stop, time-out, or pause.

We recommend that the following steps be applied when providing hyperbaric oxygen therapy in the Multiplace chamber to a patient with a colostomy or ileostomy bag/pouch:

  • Empty ostomy appliance and void any accumulated gas just prior to start of therapy.
  • Void excess gas in ostomy appliance prior to depressurization.

We recommend that the following steps be applied when providing hyperbaric oxygen therapy in the Monoplace chamber to a patient with a colostomy or ileostomy bag/pouch:

  • Empty the ostomy appliance and void any accumulated gas just prior to start of therapy.
  • If physically and cognitively able to perform, instruct patient to void excess gas in ostomy appliance prior to depressurization.
  • If the patient is unable to resolve this, the ostomy appliance may require voiding of excess gas immediately following patient removal from the monoplace chamber.

REFERENCES:

  1. Undersea and Hyperbaric Medical Society. (2018). Clinical Hyperbaric Facility Accreditation Manual (4th ed.). North Palm Beach, FL: Undersea and Hyperbaric Medical Society, Inc. LINK, MANUAL
  1. Undersea and Hyperbaric Medical Society. (2014). Position Statement: Safety Time Out/Pause - "Stop". Undersea and Hyperbaric Medical Society, Inc. LINK
  2. United Ostomy Associations of America. "Ostomy Information," Retrieved March 29th, 2021.

Respectfully,

The UHMS HBO2 Safety Committee


DISCLAIMER
Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet. If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility. Information provided on this forum is for general educational purposes only. It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally. 

Patient has nail powder gel that is 9 days old. Is it safe to put patient in chamber? Patient does not want to remove powder gel.
Published: 23 March 2021

Posted 4/6/2021


Q: 
Patient has nail powder gel that is 9 days old. Is it safe to put patient in chamber? Patient does not want to remove powder gel.


A:  
Thank you for your question. The UHMS HBO2 Safety Committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the Medical Director and Safety Director of your facility.

The UHMS HBO2 Safety Committee applauds you for considering very carefully the risks of flammable vapors that are produced by these types of products. The vapor given off by the nail polish is mainly due to the acetone content. However, when the polish is fully dry, the risk from the vapor emission is greatly reduced. It is highly likely that the polish has been fully cured after nine days.

That being said, it is known that Powder Gel-type nail polish does not dry immediately on its own. In some cases, a UV light curing device is utilized immediately following the application. In this instance, the polish is almost immediately dry. Cure times for non-UV light polish is 10-20 minutes (see reference below).

We recommend that hyperbaric practices develop a standardized, written approach to nail polish and other cosmetics, and that this information be shared with patients during the consultation and education process. Many facilities will include information of this nature within a patient education guide or pamphlet. It may be helpful to apply a general rule, (such as: Wait 12, 18, or 24 hours after application). It is also known that some facilities will allow nail polish so long as it is completely dry (no residue) and has no residual smell. In any case, this standardized approach should be driven from a risk assessment conducted by the Hyperbaric Safety Director and Hyperbaric Medical Director of your facility.

We encourage you to resource the references listed below which may assist you in your decision making.

REFERENCES:

  1. Burman, F. (2019). Risk Assessment Guide for Installation and Operation of Clinical Hyperbaric Facilities (6th ed.). San Antonio, TX: International ATMO, Inc.
  2. Barry, R. C. (2020). How to determine if a material is safe for use in the hyperbaric chamber. In W. T. Workman & J. S. Wood. (Eds.), Hyperbaric facility safety (2nd ed., pp. 355). Best Publishing Company.
  3. National Fire Protection Agency (NFPA). (2018). NFPA 99 2018 Edition: Health Care Facilities Code, Chapter 14 – Hyperbaric Facilities. Quincy, Massachusetts.
  4. News Article: “A fire hazard in your makeup bag,” Accessed 3/29/2021,  LINK
  5. Undersea and Hyperbaric Medical Society, “MEDFAQ: Dressings, 10/23/2020,” Accessed 3/29/2021, LINK
  6. Web Source, “How to dry gel nail polish,” Accessed 3/29/2021, LINK
  7. Workman, W. T., & Wood, J. S. (2020). Hyperbaric Facility Safety: A Practical Guide (2nd ed.). Best Publishing Company.

Respectfully,

The UHMS HBO2 Safety Committee


DISCLAIMER
Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet. If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility. Information provided on this forum is for general educational purposes only. It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.

Is it safe to allow "glass" eyes in the chamber?
Published: 17 March 2021

Posted 3/17/2021


Q:
Is it safe to allow "glass" eyes in the chamber?


A:
Thank you for your question. The UHMS HBO2 Safety Committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the Medical Director and Safety Director of your facility.

The UHMS HBO2 Safety Committee would advise that the Safety Director and Medical Director use caution when evaluating this item for risk, as there may be more risk than is obvious to you. We suggest that your admittance of this item into a hyperbaric environment be dependent upon the construction of the prosthesis (hollow, solid or porous; Integrated or non-integrated) and the patient’s level of comfort and consent with the potential risks involved. If there is any doubt about the construction of the ocular prosthesis, and the item can be easily removed, the UHMS HBO2 Safety Committee recommends removing the ocular prosthesis.

There is a single published study “Diving and Hyperbaric Ophthalmology” in the journal, “Survey of Ophthalmology” by Dr. Frank K. Butler, Jr. indicating that hollow orbital implants are contraindicated to diving:

“Diving contraindicated with hollow orbital implants," Reference pgs. 359, 361.

D. ENUCLEATION: “After the convalescent periods recommended in the previous section, diving should be possible after almost any type of eye surgery. One exception is an individual who has undergone enucleation

and who has a hollow implant. There are reports of pressure-induced collapses of hollow silicone orbital implants at depths as shallow as 10 feet.“’ A hollow glass implant was also tested and did not implode at a maximum test depth of 115 feet, but diving with hollow glass implants could not be recommended on the basis of this one test. Individuals with hollow orbital implants should not dive."

You may also consider that there are integrated implants that are more complex. We would caution that you contact the ophthalmologic surgeon prior to considering allowance in a hyperbaric environment:

The porous nature of integrated implants allows fibrovascular ingrowth throughout the implant and thus also insertion of pegs or posts. Because direct mechanical coupling is thought to improve artificial eye motility, attempts have been made to develop so-called 'integrated implants' that are directly connected to the artificial eye. Historically, implants that directly attached to the prosthesis were unsuccessful because of chronic inflammation or infection arising from the exposed nonporous implant material. This led to the development of quasi-integrated implants with a specially designed anterior surface that allegedly better transferred implant motility to the artificial eye through the closed conjunctiva and Tenon's capsule. In 1985, the problems associated with integrated implants were thought to be largely solved with the introduction of spherical implants made of porous calcium hydroxyapatite. This material allows for fibrovascular ingrowth within several months. Porous enucleation implants currently are fabricated from a variety of materials including natural and synthetic hydroxyapatite, aluminum oxide, and polyethylene.

If your risk assessment uncovers that the object is solid, is not likely to be affected by changes in pressure, and the patient consents, it may be perfectly fine to allow a solid ocular prothesis within the Multiplace or Monoplace hyperbaric environment. This allowance is wholly dependent upon your individual risk assessment performed by the Medical Director and Safety Director of your facility. We would also suggest consulting with the patient’s ophthalmologist to confirm the type of prosthesis. Several Safety Committee members have reported successful treatment of patients with solid (without air spaces) ocular prostheses left in place.

REFERENCES:

  1. Burman, F. (2019). Risk Assessment Guide for Installation and Operation of Clinical Hyperbaric Facilities (6th ed.). San Antonio, TX: International ATMO, Inc. LINK
  2. Butler Jr, F. K. (1995). Diving and hyperbaric ophthalmology. Survey of ophthalmology, 39(5), 347-366. LINK
  3. Colen, TP; Paridaens, DA; Lemij, HG; Mourits, MP; Van Den Bosch, WA (2000). "Comparison of artificial eye amplitudes with acrylic and hydroxyapatite spherical enucleation implants". Ophthalmology. 107 (10): 1889–94. LINK
  4. Custer, PL; Kennedy, RH; Woog, JJ; Kaltreider, SA; Meyer, DR (2003). "Orbital implants in enucleation surgery: a report by the American Academy of Ophthalmology". Ophthalmology. 110 (10): 2054–61. LINK

Respectfully,

The UHMS HBO2 Safety Committee


DISCLAIMER
Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet. If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility. Information provided on this forum is for general educational purposes only. It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally. 

What is the UHMS Safety Committee's view on IV port disinfection caps in the monoplace or multiplace hyperbaric environment?
Published: 15 March 2021

Posted: 3/15/2021


Q:
What is the UHMS Safety Committee's view on IV port disinfection caps in the monoplace or multiplace hyperbaric environment?


A:
Thank you for your question. The UHMS HBO2 Safety Committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the Hyperbaric Medical Director and Safety Director of your facility.

The UHMS HBO2 Safety Committee can provide guidance to assist your decision making the but cannot endorse a specific product for use. We recommend that a proper risk assessment(1) is performed by the Hyperbaric Medical Director (HMD) and Hyperbaric Safety  Director (HSD); with careful consideration given to the flammability, NFPA 704 rating of the material, amount, potential for vapor release, chamber volume, and the fuel load added to the environment (7). Disinfection caps are regularly used in hospitals and have significantly reduced central line-associated bloodstream infection rates. The risk of removing these caps and the potential for infection should also be considered in the assessment.

We would encourage you to review the following considerations and recommendations that may assist your HMD and HSD in the risk assessment and decision-making process:

On The NFPA:

  • Of note, NFPA 99 (6), section 14.3.1.6.2.3 (2021) prohibits flammable liquids, gases and vapors from the Class B (monoplace) environment. There is a formula in the annex of NFPA 99, commonly used to compute allowable quantities of isopropyl alcohol for the multiplace environment. There is no such formula for the monoplace chamber.
  • Consider NFPA 99(6), 14.3.1.6.4.3 (2021) and annex notes on risk assessment.
  • Is it possible to allow alcohol caps in the monoplace chamber and remain compliant with NFPA 99? NFPA 99(6) 14.3.1.6.4.4 (2021) allows the physician and safety director to approve an item that would normally be prohibited, but they must explain as such in writing: weighing up the benefit to the patient versus any risks to the patient or anyone else. The FDA allows off-label use of medical devices based on the physician’s decision as to what is in the best interest of the patient(8). The key here is whether the risks can be accepted and/or suitably mitigated.
  • The key word in the NFPA is “vapor.” The caps are completely sealed. The alcohol within them does not evaporate, as when they are removed after several hours, the alcohol is still present.

On IV Caps:

  • IV disinfecting port caps contain a small amount 70% isopropyl alcohol that, if exposed, could burn in the presence of an ignition source. However, if these caps remain sealed and ignition sources are removed, the risk of fire is essentially highly improbable.
  • The Baromedical Nurses Association has addressed the topic of Curos Caps, Dual Caps, Swab caps, etc. and they recommended removal prior to therapy. http://hyperbaricnurses.org/2018/04/port-caps-with-alcohol-sponges/
  • The Infusion Nurses Society (INS) publishes the “Infusion Therapy Standards of Practice”(2), (3) which Addresses roles and competencies for clinicians involved with an infusion or vascular access and provides practice recommendations.
    • o (2016) SCOPE OF PRACTICE, Standard 3.5 states: “Infusion therapy tasks are delegated by the registered nurse (RN) to unlicensed assistive personnel (UAP) in accordance with rules and regulations promulgated by the state’s Board of Nursing and within the policies and procedures of the organization. The RN and the organization are responsible and accountable for the tasks delegated to UAP and licensed practical/ vocational nurses (LPN/LVNs).” (3)
    • o Hospitals allow nurses to work with IVs as this is part of their scope of practice. Typically, RNs complete a yearly IV competency to remain IV competent.
    • o The LPN/LVN will typically receive additional IV training to become IV competent and complete an annual competency.
    • o TJC does check for IV competency when doing a survey.
    • o If caps are to be removed and replaced, a written procedure should be present and staff training should be performed and documented.

On Infection Prevention and Control:

  • The removal of these caps may increase the risk of central line-associated bloodstream infections (see references below) (4), (5), (9)
  • We would encourage you to share your risk assessment(1) with the infection prevention and control team within your institution who are responsible for setting the policies related vascular access and educate them on the unique nature of the hyperbaric environment. If your approach is other than the hospital policy on disinfection caps, we would advise you to work with your infection prevention and control team to develop a specific procedure for your practice to ensure that you are in compliance with local guidelines.

On Risk Assessment:

  • Any consideration of the presence of alcohol in a 100% oxygen-filled monoplace chamber is of concern – even if only theoretical. So, any decision to deviate from this requires a risk assessment, duly documented and endorsed. The permitted deviation from the codes would be based on a thorough evaluation and must determine that no flammable vapor can be given off, as it is the vapor that is the issue. The words ‘Flammable liquids’ is clear, but we know that it is not the liquid that burns, but the vapor.
  • One could determine the risk of flammable vapors to produce a non-compliant lower-explosive limit (LEL) with the use of a volatile organic compounds (VOC) analyzer. We are not sure, however, what happens to the LEL in the presence of 100% oxygen. On the other hand, the ventilation inside the chamber may disperse the vapor very rapidly, which may further reduce the risk of ignition. This would therefore be very much a facility-only decision, but there is certainly merit in evaluating it. Based on a suitable VOC reading, checking that pressure does not change the flammability situation, it is defendable.
  • Following a risk assessment(1), one could conclude that the risk of infection is greater than the real risk of fire. The HMD and HSD are ultimately responsible; not only for the safe operation of the chamber(s) but for the care of the patient.
  • Consider the potential for error, as patients often have multiple lines and caps. What would you do if you have a patient at pressure and someone observes one cap was left on? What is the risk to the patient if they are immediately decompressed?

REFERENCES:

  1. Burman, F. (2019). Risk Assessment Guide for Installation and Operation of Clinical Hyperbaric Facilities (6th ed.). San Antonio, TX: International ATMO, Inc. LINK
  2. Gorski, L. A. (2021). A Look at 2021 Infusion Therapy Standards of Practice. Home healthcare now39(2), 62-71. LINK
  3. Infusion Nursing Society. (2016). Infusion therapy standards of practice. J Infus Nurs., 39(s1). LINK
  4. Kamboj, M., Blair, R., Bell, N., Son, C., Huang, Y. T., Dowling, M., ... & Sepkowitz, K. (2015). Use of disinfection cap to reduce central-line–associated bloodstream infection and blood culture contamination among hematology–oncology patients. Infection control and hospital epidemiology36(12), 1401. LINK
  5. Moureau, N. L., & Flynn, J. (2015). Disinfection of needleless connector hubs: clinical evidence systematic review. Nursing Research and Practice2015. LINK
  6. National Fire Protection Agency (NFPA). (2021). “NFPA 99 2021 Edition: Health Care Facilities Code.” Quincy, Massachusetts. LINK
  7. Undersea and Hyperbaric Medical Society MEDFAQ: “Use of alcohol swabs in the multiplace hyperbaric environment,” Accessed 3/8/21 LINK
  8. US Food and Drug Administration. (2014). “Off-label” and investigational use of marketed drugs, biologics, and medical devices: information sheet. Silver Spring, MD. LINK
  9. Voor, A. F., Helder, O. K., Vos, M. C., Schafthuizen, L., Sülz, S., van den Hoogen, A., & Ista, E. (2017). Antiseptic barrier cap effective in reducing central line-associated bloodstream infections: a systematic review and meta-analysis. International journal of nursing studies69, 34-40. LINK

Respectfully,

The UHMS HBO2 Safety Committee


 

DISCLAIMER

Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet. If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility. Information provided on this forum is for general educational purposes only. It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.

I am currently the HBO safety director at the hospital where I am currently employed and also have my CHRN. My question is, does the safety director have to work specifically in the HBO department or could I work as an RN in a different department within the hospital and still function in the safety director role as long as i keep my credentials up to date. We have other RN's within my department who are HBO certified that could actually run the chambers and do so when I am on vacation or otherwise unable
Published: 09 March 2021

Posted: 3/0/2021


Q:
I am currently the HBO safety director at the hospital where I am currently employed and also have my CHRN. My question is, does the safety director have to work specifically in the HBO department or could I work as an RN in a different department within the hospital and still function in the safety director role as long as i keep my credentials up to date. We have other RN's within my department who are HBO certified that could actually run the chambers and do so when I am on vacation or otherwise unable to be here.  


A:
Thank you for your question. The UHMS HBO2 Safety Committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the Medical Director (MD) and your Hospital’s Administration as it pertains to the role of the Hyperbaric Safety Director (HSD) for your facility.

The NFPA 99, Chapter 14 (2021) places a high degree of importance in the role of the HSD. The term “Safety Director” is mentioned 26 times throughout the chapter and Appendix A. We suggest that perhaps the most relevant reference to your question is NFPA 99 14.3.1.3.2 (2021):

          “Each hyperbaric facility shall designate an on-site hyperbaric safety director to be in charge of all hyperbaric equipment and the operational safety requirements of this chapter.”

The NFPA 99 Handbook provides more insight, including this Frequently Asked Question and answer. The NFPA Handbook is a separate document containing guidance for the codebook, and the FAQ sections are intended to clarify the code for the reader. The FAQ answer is not considered part of the code.

Q:     “Does the on-site safety director have to be present during chamber operations?”

A:     “The designated on-site safety director does not have to be present during all chamber operations. The intent is that someone manages the operational responsibilities of this chapter; this does not mean that that person must be present at all times. It is recommended that there be an alternate designee trained for succession as the hyperbaric safety director.”

While the UHMS HBO2 Safety Committee cannot determine the best approach for your situation, we can offer several considerations and recommendations that may assist your MD and Hospital Administration in this decision-making process regarding the proximity or accessibility of the HSD.

  • If the HSD is working in another area, will he/she be available to respond promptly to the needs of the team if a decision is needed? What safeguards or plans exist if the Safety Director cannot be reached?
  • Has an individual been assigned to assume this role in the absence of the current HSD? If so, what is the level of experience and training that person has received? Has this assignment been made in writing?
  • What is the confidence level of your chamber operators in this approach to coverage? Are they willing to accept an increased level of responsibility if they are called upon to be the alternate designee?
  • Have you considered sending your chamber operators to HSD courses?
  • It is recommended that in a busy hyperbaric facility, an appropriately trained HSD or their designee is present in the suite and available to make day-to-day decisions. This is similar in design to the role of the supervising hyperbaric provider.
  • Many multi-center monoplace-only programs operate with a regional, more experienced remote HSD, and place designated HSDs at each satellite facility, (usually an experienced CHT or CHRN). These individuals are responsible for the day-to-day decisions. The multi-site HSD remains available to provide support to each on-site HSD and may sometimes fill-in for local personnel in their absence. All these individuals typically receive additional HSD training.
  • If the HSD is absent, on vacation, or sick, an appropriately trained alternate should be designated.
  • The individual covering for the HSD should preferably have attended an HSD training course, have knowledge and experience in hyperbaric medicine and with the equipment used at the facility.
  • As mentioned in the UHMS Guidelines for Hyperbaric Facility Operations, The Medical Director (MD) should not be the primary HSD. However, due to their appointment and level of responsibility, you may wish to consider delegating the HSD role to the MD in the absence of the HSD. In this instance we also recommend that the MD attends an HSD training course.
  • There is reason to be concerned about disengagement or drift. Over time, it is likely that an individual serving from afar may become less involved with the HBO unit. Therefore, it would be advisable to have strict guidelines for the HSD, such as:
    • The HSD should visit the HBO Unit (insert a frequency) and keep a log of the visits.
    • The HSD should be available by phone whenever the HBO Unit calls.
    • The HSD should institute a training program for chamber operators on the role and responsibilities of the HSD as outlined by the NFPA (at a minimum).

In conclusion, the UHMS HBO2 Safety Committee recommends that the Hyperbaric Medical Director, HSD and Hospital Administration examine the risks and benefits of each approach and consider the safety measures described above. We also recommend that the facility develop standardized protocols for the hyperbaric staff who will work with the HSD. There may be the need to gather recommendations from your Legal and Human Resource teams before engaging in this practice.

 

References

  1. Burman, F. (2019). Risk Assessment Guide for Installation and Operation of Clinical Hyperbaric Facilities (6th ed.). San Antonio, TX: International ATMO, Inc.
  2. National Fire Protection Agency (NFPA). (2021). “NFPA 99 2021 Edition: Health Care Facilities Code.” Quincy, Massachusetts.
  3. Undersea and Hyperbaric Medical Society MEDFAQ: “Regarding the Hyperbaric Safety Director for a hospital based hyperbaric department,” Accessed 3/8/21 Link
  4. Workman, W. T., & Wood, J. S. (2020). Hyperbaric Facility Safety: A Practical Guide (2nd ed.). Best Publishing Company.

Respectfully,

The UHMS HBO2 Safety Committee


DISCLAIMER

Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet.  If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility.  Information provided on this forum is for general educational purposes only.  It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally. 

 

 

Is the Cook Doppler wire, disconnected from the Doppler machine, safe to compress in a monoplace environment?
Published: 02 March 2021

Posted: 3/30/2021


Q: 
Is the Cook Doppler wire, disconnected from the Doppler machine, safe to compress in a monoplace environment?


A:
Thank you for your question. The UHMS HBO2 Safety Committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the Medical Director and Safety Director of your facility.

The UHMS HBO2 Safety Committee can provide guidance to assist your decision making but cannot endorse a specific product for use in the Monoplace chamber. The Cook doppler wire is also known as a Cook-Swartz Doppler Probe or Ultrasound Probe and is generally used to provide continuous monitoring of microvascular anastomoses.

From a fire safety standpoint, NFPA 99, Chapter 14 (2021) states in 14.2.9.6.1:

          “Electrical equipment inside chambers shall be restricted to communications functions and patient physiological monitoring leads.”

and in 14.2.9.6.1.3:

“Patient monitoring leads shall be part of approved electromedical apparatus meeting the requirements in 14.2.9.3.16.”

If the Cook Doppler wire is disconnected from the Doppler Blood Flow Monitoring System and the doppler unit remains outside of the chamber, one would consider the ignition source to be eliminated.

The UHMS HBO2 Safety Committee recommends that a proper risk assessment be performed by the Hyperbaric Medical Director (HMD) and Hyperbaric Safety Director (HSD) of your facility, identifying the components of the Cook Doppler Wire and any potential for harm caused by the item itself (physically) or to the patient (medically) if they are disconnected from this diagnostic device while hyperbaric oxygen therapy is provided. If your risk assessment concludes that the wire can remain in place, we would recommend that mitigations be put in place to ensure that the Doppler Blood Flow Monitoring System is removed, and that the hyperbaric team identifies this during the pre-therapy safety stop, time-out, or pause.

The following observations from Safety Committee members may assist you in the decision-making process:

  • One member has encountered several doppler wires of this type and after assessment has allowed them to remain in place in the Monoplace or Multiplace environment once they are disconnected from the doppler unit. Following multiple cycles, no damage to the ultrasound transducer assembly has been reported at this facility.
  • Another member offered the following observations regarding the Cook-Swartz Doppler and use in a hyperbaric chamber, oxygen-filled and pressurized monoplace or air pressurized multiplace, commenting only on the non-medical aspects:
    • I do not perceive an issue with the silicone cuff as it is internal and has no known gas pockets. Also, silicone is commonly utilized in hyperbaric oxygen environments.
    • I do not perceive an issue with the retention tab, braided wire, or transducer assembly as these are similar to TCOM electrodes, and when disconnected, they are passive.
    • The Doppler Blood Flow Monitoring System must be disconnected from the patient probe while the patient is inside the chamber.
    • The Doppler Blood Flow Monitoring System is not permitted inside of the chamber.

REFERENCES:

  1. Burman, F. (2019). Risk Assessment Guide for Installation and Operation of Clinical Hyperbaric Facilities (6th ed.). San Antonio, TX: International ATMO, Inc. LINK
  2. National Fire Protection Agency (NFPA). (2021). “NFPA 99 2021 Edition: Health Care Facilities Code.” Quincy, Massachusetts. LINK
  3. Cook Medical. “Cook-Swartz Doppler Probe.” Website accessed on 3/17/21. LINK
  4. Undersea and Hyperbaric Medical Society. (2018). Clinical Hyperbaric Facility Accreditation Manual (4th ed.). North Palm Beach, FL: Undersea and Hyperbaric Medical Society, Inc. LINK, MANUAL
  5. Undersea and Hyperbaric Medical Society. (2014). Position Statement: Safety Time Out/Pause - "Stop". Undersea and Hyperbaric Medical Society, Inc. LINK

Respectfully,

The UHMS HBO2 Safety Committee


DISCLAIMER

Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet.  If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility.  Information provided on this forum is for general educational purposes only.  It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.

 

We currently have a patient with RTI to head and neck. She had HBO in 2011 and 2012 for ORN of the mandible. She is now having an extraction of a tooth and surgeon is ordering 10 HBO post extraction. We follow the protocol of 20/10 HBO as stated in our LCD in Penna.from 2019. Many years ago we followed a protocol of 10 HBO post extraction if patient had HBO within 5 years of new extraction. This patient is 9 years post HBO. What is the protocol that we should be using? We do not have a new LCD to follow.
Published: 22 February 2021

Posted: 2/22/2021


Q:
We currently have a patient with RTI to head and neck. She had HBO in 2011 and 2012 for ORN of the mandible. She is now having an extraction of a tooth and surgeon is ordering 10 HBO post extraction. We follow the protocol of 20/10 HBO as stated in our LCD in Penna.from 2019. Many years ago we followed a protocol of 10 HBO post extraction if patient had HBO within 5 years of new extraction. This patient is 9 years post HBO. What is the protocol that we should be using? We do not have a new LCD to follow. 


A:
Dr. Marx who designed the protocols believes, based on transcutaneous measurements he has done on a group of patients 2 and even 3 yrs. out from HBO2, that improvement in the radiation damaged vascularity is permanent. He saw no regression in levels obtained immediately after completion of the HBO2 when compared to the 2 and 3 yr. measurements post HBO2. He does not recommend pre-extraction HBO2 for patients who have had 2 prior courses or even 1 prior course of HBO2 with either the 20/10 in association with extractions or a 30/10 course for the treatment of existent ORN. The 10 post-extraction HBO2 treatments are prudent in my judgement. If the patient were to have delayed healing with exposed bone after these ten, consideration to perhaps an additional 10 to 20 treatments could also be considered. If healing after the 10 post-extraction is progressing nicely, no additional treatments will be needed. If the oral surgeon finds more ORN at the time of the extractions, consideration should be given to a full forty treatments to treat recurrent ORN 

We currently have a patient with RTI to head and neck. She had HBO in 2011 and 2012 for ORN of the mandible. She is now having an extraction of a tooth and surgeon is ordering 10 HBO post extraction. We follow the protocol of 20/10 HBO as stated in our LCD in Penna.from 2019. Many years ago we followed a protocol of 10 HBO post extraction if patient had HBO within 5 years of new extraction. This patient is 9 years post HBO. What is the protocol that we should be using? We do not have a new LCD to follow.
Published: 19 February 2021

Posted: 2/19/2021


Q:
We currently have a patient with RTI to head and neck. She had HBO in 2011 and 2012 for ORN of the mandible. She is now having an extraction of a tooth and surgeon is ordering 10 HBO post extraction. We follow the protocol of 20/10 HBO as stated in our LCD in Penna.from 2019. Many years ago we followed a protocol of 10 HBO post extraction if patient had HBO within 5 years of new extraction. This patient is 9 years post HBO. What is the protocol that we should be using? We do not have a new LCD to follow. The doctor is questioning the 20 treatments pre extraction.


A:
Dr. Marx who designed the protocols believes, based on transcutaneous measurements he has done on a group of patients 2 and even 3 yrs out from HBO2, that improvement in the radiation damaged vascularity is permanent. He saw no regression in levels obtained immediately after completion of the HBO2 when compared to the 2 and 3 yr. measurements.. He does not recommend pre-extraction HBO for a patient like yours who has had 2 prior course of HBO2. The 10 post-extraction HBO2 treatments are prudent in my judgement. If the patient were to have delayed healing with exposed bone after these ten, consideration to perhaps an additional 10 to 20 treatments could also be considered. If healing after the 10 post-extraction is progressing nicely, no additional treatments will be needed.

 
John J. Feldmeier, D.O., FACRO, FUHM

 

I have a 45 y.o. M with hx of R sudden hearing loss and hx of posterior fossa approach for brain tumor removal, and still has a right posterior ventriculoperitoneal catheter. He needs hyperbaric tx for sudden hearing loss of now L ear. Is it safe to dive a patient with VP cathether
Published: 15 February 2021

Posted: 3/2/2021


Q: 
I have a 45 y.o. M with hx of R sudden hearing loss and hx of posterior fossa approach for brain tumor removal, and still has a right posterior ventriculoperitoneal catheter. He needs hyperbaric tx for sudden hearing loss of now L ear. Is it safe to dive a patient with VP catheter?


A:
Thank you for your question. The UHMS HBO2 Safety Committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the Medical Director and Safety Director of your facility.

For the sake of the reader who may not be familiar with this device, a ventriculoperitoneal catheter (or shunt) is used to drain excess cerebrospinal fluid (CSF) from the brain. The shunt works by moving fluid out of the brain by way of a one-way valve with reservoir connected to a short and long catheter routed to the abdomen where the fluid can be absorbed. This lowers the pressure and swelling on the brain.

The UHMS HBO2 Safety Committee observes that this device is fluid-filled and should behave similarly compared with other fluid lines and drains that are consistently allowed in chambers. One concern may be the lack of access and fluid control that the provider may have to the patient if therapy is provided in a monoplace chamber. We recommend that these and all other risks to the patient are identified in a risk assessment performed by the Safety Director and Medical Director of your facility. We also recommend reaching out to the device manufacturer, as there are programmable versions of these shunts with greater complexity.

There is at least one published article describing a successful test of a VP shunt under Hyperbaric conditions, “Ventriculo-peritoneal shunt performance under hyperbaric conditions.” The Safety Committee reached out to one of the authors of this article, who stated: “This testing was performed on a specific Medtronic VP shunt. Theoretically if the shunt is all fluid filled and had no mechanical parts, it should function as intended under hyperbaric conditions. We did the testing just to confirm that it did, but I would recommend that whomever is treating the patient should go through the same thought process (not necessarily the testing) as they would to evaluate any equipment that is to go in the chamber.”

Other considerations and observations from the UHMS HBO2 Safety Committee include:

  • I have treated a few patients with these over the years. I have approached their approval-to-dive as I would for any other fluid filled and fully implanted device.
  • Think of the VP shunt like a siphon. It is fluid filled, so generally there no worries with HBOT unless this shunt is in an inside attendant. There is an underlying reason (usually hydrocephalus) that would make me think twice about subjecting an employee to pressure routinely.
  • There might be an extra consideration depending on how the back-check valve operates for a given device, but I’ve only seen ones that open based on elevated ICP and not any biomechanical process that universally applied pressure or oxygen gradients would affect. Still always double check with the manufacturer every time, though.
  • We have treated numerous patients with a VP shunt and as the shunt is fluid filled it has not been an issue.
  • We have routinely allowed patients with the older non-programmable shunts to go into the chamber. We also let the newer programmable devices in. However, the last time we checked they were not formally pressure tested by the manufacturer. The manufacturer did have reports of their shunts in the HBO environment without issue. I haven’t contacted the company of late.

Respectfully,

The UHMS HBO2 Safety Committee

REFERENCES:

Burman, F. (2019). “Risk Assessment Guide for Installation and Operation of Clinical Hyperbaric Facilities,” (6th ed.). San Antonio, TX: International ATMO, Inc.

Huang ET, Hardy KR, Stubbs JM, Lowe RA, Thom SR. “Ventriculo-peritoneal shunt performance under hyperbaric conditions.” Undersea Hyperb Med. 2000 Winter; 27(4):191-4. https://pubmed.ncbi.nlm.nih.gov/11419359/

Memorial Sloan Kettering Cancer Center, “About Your Ventriculoperitoneal (VP) Shunt Surgery.” Accessed 02/26/2021. https://www.mskcc.org/cancer-care/patient-education/about-your-ventriculoperitoneal-vp-shunt-surgery 



DISCLAIMER

 

Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet.  If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility.  Information provided on this forum is for general educational purposes only.  It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally
Is there any reason/ caution to take in diving an 80 y/o woman s/p resection of left jaw and tongue for SCC 1982- post radiation. During her resection the vagus phrenic nerve was cut resulting in paralysis of her left diaphragm. I spoke with her pulmonologist. He states she has 47% lung capacity, mild asthma and OSA. He states he knows nothing about HBO and cannot say whether she would be safe diving or not. She runs an 88-94% O2 on room air. She is not on supplemental O2 and is asymptomatic- no SOB. The
Published: 12 February 2021

Posted: 2/12/2021



Q:
Is there any reason/ caution to take in diving an 80 y/o woman s/p resection of left jaw and tongue for SCC 1982- post radiation. During her resection the vagus phrenic nerve was cut resulting in paralysis of her left diaphragm. I spoke with her pulmonologist. He states she has 47% lung capacity, mild asthma and OSA. He states he knows nothing about HBO and cannot say whether she would be safe diving or not. She runs an 88-94% O2 on room air. She is not on supplemental O2 and is asymptomatic- no SOB. The plan is to dive her for orn with dental caries and dry mouth- in need of dental extraction with pre/post HBOT @ 2.5ATA w/ 2 air breaks x 20 up front and 10 after tx.


A:
From a safety point of view, assuming she doesn’t have bullous disease she should be fine with HBO2 unless she is a CO2 retainer (baseline hypercapnia). If her PCO2 is significantly elevated (i.e. greater than 48 mmHg) she may become more hypercapnic in the chamber, which would predispose her to CNS O2 toxicity.

However, with her baseline hypoxemia it is possible she may not achieve a therapeutic PO2 during hyperbaric therapy. If her asthma is under good control I suggest obtaining a baseline ABG on room air, from which her PO2 during HBO2 could be estimated.

Richard Moon, MD
Professor of Anesthesiology
Professor of Medicine, Division of Pulmonary, Allergy, and Critical Care Medicine
Medical Director, Center for Hyperbaric Medicine & Environmental Physiology

While we have long restricted the ascent rate to 3 psi/min to lessen the possibility of a lung bleb rupture with resultant pneumothorax, we cannot find a physiologic reason to restrict the descent rate other than to avoid barotrauma. We have used a descent time ot at least 10 minutes from surface to 2.4 ATA which has not really been a concern in the past because the compressors could not achieve depth much faster than that. However, our new compressors can easily achieve depth in 6-7 minutes. Is there
Published: 03 February 2021

Posted: 2/17/2021


Q:
While we have long restricted the ascent rate to 3 psi/min to lessen the possibility of a lung bleb rupture with resultant pneumothorax, we cannot find a physiologic reason to restrict the descent rate other than to avoid barotrauma. We have used a descent time of at least 10 minutes from surface to 2.4 ATA which has not really been a concern in the past because the compressors could not achieve depth much faster than that. However, our new compressors can easily achieve depth in 6-7 minutes. Is there a reason, other than patient comfort and barotrauma avoidance, to restrict the descent rate?


A:
Thank you for your question. The UHMS HBO2 Safety Committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the Medical Director and Safety Director of your facility.

The UHMS HBO2 Safety Committee is not aware of a uniform descent rate that should apply to all profiles and settings. Descent rates are generally considered to be part of the treatment protocol designed by the Medical Director and Safety Director of your facility. When planning treatment profiles, it is important that the Medical Director and Safety Director of your facility consider, as you stated, the risk of barotrauma to any of your patients. Keep in mind that the design of your plant (Oxygen supply for monoplace, compressor air for Multiplace) can also be a deciding factor when choosing an appropriate compression rate for your facility. Patient comfort (noise level, adiabatic heating caused by compression, and ease of ear clearing) can be a significant factor that should be considered.

It is also important that operators are aware of and follow the treatment profile; as it is an extension of written orders from the Hyperbaric Physician. Hyperbaric physicians commonly describe travel rates/times in the therapy note that supports Physician supervision. These travel rates/times may even be required by some insurance carriers.

From a broader perspective, it is noted that compression rates may vary among commonly accepted profiles. For example, the US Navy standard descent rate for all USN profiles is a very aggressive 20 fsw / min (8.82 psig / min). Even so, they note “Descent rates may have to be decreased as necessary to allow the patient to equalize.” However, one must consider the critical application of many US Navy profiles, as they are mainly designed to treat injured divers.

In 1998, the US Air Force published a paper defining the concept of non-linear (aka curvilinear) descent and reported a reduction in the incidence of barotrauma when using non-linear versus linear descent. Most chambers that utilize computer software to drive their profiles have been known to use a non-linear descent profile. Several references to this approach are listed in the references below.

It is common for clinical hyperbaric medicine practices to design their descent rates to accommodate the average patient. For your consideration we have posted responses from several members of the committee related to this question:

  • For our routine scheduled treatments of 2 ATA for 2 hours we use a descent rate of 15 minutes to treatment depth. Several years ago, our Medical Director reviewed the data and felt that we could decrease otic barotrauma rates by slowing our descent rate. It helped decrease our barotrauma some but didn’t eliminate it entirely.
  • On our emergency treatments, when we use a 2.8 for 85 min. or 2.45 for 90 min., we attempt to reach treatment depth in under 4 minutes to limit decompression obligations for the tender as much as possible.
  • We would use a 10-15min descent rate to 2.4ATA on first time divers. Then bump it to 7min or less if the group could handle it. My seasoned dive patients (after about 20 treatments) could get there in 3-5min.
  • We descend from 0 to 45 fsw in 6 minutes for the TT9. Our computers run a curved descent which starts off slow, then steadily increases as you go.
  • During the “old days” when we pressurized manually, we pressurized as fast as the pt/tender would allow; often reaching 60 fsw in 3 minutes. One thing I’ve noticed over the years is sometimes going too slow can delay ear clearing, especially on pts that aren’t familiar with the process…sometimes they need that quicker “push” to pop/clear their ears.
  • We have found patients struggle to descend faster than rate set 1.5 psi/min at this clinic location unless they have bilateral myringotomy tubes. This was not the case for my ten years in Kansas City. It causes me to wonder if there is an accustomed lower air pressure bias for those at my current altitude in Colorado. This clinic is at 4,995 feet whereas my clinic in Kansas City was at 861 feet elevation above sea level.
  • Some patients may not notice the pressure change often enough if the descent rate is slowed, and this can lead to increased risk of barotrauma.
  • We have operated at 4,500 feet of altitude for decades and our need for TM tubes is rare. The percent volume change altitude to any given chamber pressure is more than from sea level to that pressure. We generally compress at 1 to 2 psi/minute but often compress faster in patients that equalize ok.
  • I think we would all agree that making the patient’s descent pleasant and successful is critical to HBO- especially in the first compressions. It is an essential part of patient continued participation and long-term treatment compliance. Some patients claim to be fine until in excruciating pain. Slower compression rates are far more successful without a patient asking for a stop due to discomfort.
  • Adiabatic heating caused by compression is another confounding factor that distracts the patient from their ear equalization. TV or other distractions should also not be turned on during compression.
  • A combination of good patient equalization training, slow and well-ventilated compressions and eye to eye contact between technician and patient makes for a successful treatment.
  • Compress at a rate as tolerated by the patient having the most difficulty clearing their ears, but not to exceed xx psi/minute. (as determined by the medial director and safety director)
  • Equalization education should be an ongoing focus! In my experience, some people are forgetful from one day to the next. They also become complacent once they have been successful at reaching treatment pressure without issue.
  • For treatment runs with multiple patients, remember having a new patient that needs a slower descent rate can affect others who may have gotten used to a specific rate used earlier in the week.
  • Remember not all patients are successful using the same ear clearing technique, so be sure to teach different methods.
  • The chamber is a machine. We control how fast it compresses (rate, change in rate and can even ascend 2 fsw) all to provide a safe arrival at treatment pressure.
  • Assess possible barotrauma post treatment. With medical follow-up as needed.
  • Note: At our facility in Denver the standard treatment is at 2.4 ATA, and the compression rate is limited to as tolerated, but not to exceed 9 fsw/minute. We usually operate in the 4 - 7 fsw/minute range as tolerated by the slowest patient. Our barotrauma rate was 2% in 2020. We spend a lot of time on focused education from day one and continue this throughout their treatment plan.

Respectfully,

The UHMS HBO2 Safety Committee

REFERENCES

Naval Sea Systems Command. (2016). “US Navy Diving Manual (7th ed.).” United States Navy Publication.

Zwart BP. (1998). “The "smooth ride" profile: Development, implementation, and evaluation of a hyperbaric chamber descent and ascent based on a constant rate of volume change with time.” Brooks AFB, Texas.

Environmental Tectonics Corporation. (2020) “Bara-Med “Smooth-Ride.” Weblink

Peterson RE. (2008). “Alternative Pressure-Change Profiles for Hyperbaric Oxygen Therapy.” Today’s Wound Clinic, 2(4). Weblink

 


DISCLAIMER

Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet.  If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility.  Information provided on this forum is for general educational purposes only.  It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.

 

I completed an HBO consult on a patient regarding a wound in an irradiated area. He is currently on cabozantinib regarding metastatic renal cancer. My question is, the mechanism of action of this chemo medication in inhibiting VGEF resulting in decrease angiogenesis. Is this reason not to treat him? Won’t this be going against the benefit of HBO trying to promote angiogenesis? Thank you for any input.
Published: 02 February 2021

Posted: 2/3/2021


Q:
I completed an HBO consult on a patient regarding a wound in an irradiated area. He is currently on cabozantinib regarding metastatic renal cancer. My question is, the mechanism of action of this chemo medication in inhibiting VGEF resulting in decrease angiogenesis. Is this reason not to treat him? Won’t this be going against the benefit of HBO trying to promote angiogenesis? Thank you for any input. 


A:

Cabozantinib and HBO2:

As the writer has pointed out, this drug interferes with VEGFR2 (One of 3 receptors for vascular endothelial growth factor). This receptor is involved in wound healing.

I also agree that using it with hyperbaric oxygen is likely to diminish the effectiveness of HBO2 in promoting angiogenesis as an essential part of wound healing.

Another potential effect is by providing more VEGF activity, the HBO2 may diminish the effectiveness of the drug in its impact on the cancer.

We do not have any published clinical experience with the combination of the 2 modalities. However, based on an understanding of their mechanisms and common sense, I would recommend not giving HBO2 and Cabozantinib concurrently.

It has a fairly long serum half life  (120 hours) and has been shown to increase fivefold in concentration over a fifteen day administration.

See abstract below:

Clinical Pharmacokinetics and Pharmacodynamics of Cabozantinib

Steven A Lacy 1Dale R Miles 2 3Linh T Nguyen 2 4

Affiliations expand

  • PMID: 27734291

Abstract

Cabozantinib inhibits receptor tyrosine kinases involved in tumor angiogenesis and metastasis. The capsule formulation (Cometriq®) is approved for the treatment of progressive metastatic medullary thyroid cancer at a 140-mg free base equivalent dose. The tablet formulation (Cabometyx™, 60-mg free base equivalent dose) is approved for the treatment of renal cell carcinoma following anti-angiogenic therapy. Cabozantinib displays a long terminal plasma half-life (~120 h) and accumulates ~fivefold by day 15 following daily dosing based on area under the plasma concentration-time curve (AUC). Four identified inactive metabolites constitute >65 % of total cabozantinib-related AUC following a single 140-mg free base equivalent dose. Cabozantinib AUC was increased by 63-81 % or 7-30 % in subjects with mild/moderate hepatic or renal impairment, respectively; by 34-38 % with concomitant cytochrome P450 3A4 inhibitor ketoconazole; and by 57 % following a high-fat meal. Cabozantinib AUC was decreased by 76-77 % with concomitant cytochrome P450 3A4 inducer rifampin, and was unaffected following administration of proton pump inhibitor esomeprazole. Cabozantinib is a potent in vitro inhibitor of P-glycoprotein, and multidrug and toxin extrusion transporter 1 and 2-K, and is a substrate for multidrug resistance protein 2. No clinically significant covariates affecting cabozantinib pharmacokinetics were identified in a population pharmacokinetic analysis. Patients with medullary thyroid cancer with low model-predicted apparent clearance were more likely to dose hold/reduce cabozantinib early, and had a lower average dose through day 85. However, longitudinal tumor modeling suggests that cabozantinib dose reductions from 140 to 60 mg/day did not markedly reduce tumor growth inhibition in medullary thyroid cancer patients. 

Is Dermatac Dressing used in the Acelity wound vacs safe to go into HBO chambers?
Published: 22 January 2021

Posted: 1/22/2021


Q:
Is Dermatac Dressing used in the Acelity wound vacs safe to go into HBO chambers?


A: 

Thank you for your question. The UHMS HBO2 Safety Committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the Medical Director and Safety Director of your facility.

Within NFPA 99 (2021), Chapter 14, the authority to approve an item (creams, materials, and devices) for use within a hyperbaric chamber is delegated to the Physician-in-Charge (Medical Director) with the concurrence of the (hyperbaric) Safety Director; meaning you need two people to agree when allowing an item.

The authority to restrict or remove any potentially hazardous supply or equipment items from the chamber is delegated to the (hyperbaric) Safety Director.

With regards to compatibility of various wound care creams and products, the Hyperbaric Facility should institute an evaluation process to determine if an item is acceptable for use within its chamber.

The testing of products conducted by the UHMS Materials Testing Advisory Committee shows us that any source of heat or energy release are our most significant concerns when it comes to ignition of any flammable material. Therefore, the elimination of heat above the NFPA limits (185°F for a multiplace and 140°F for a monoplace chamber) or static discharge sources are essential to every hyperbaric program.

It is important to understand the ingredients of the cream (ointment or gel) to know if the product has the potential to off-gas flammable vapors. Should this be the case, you would consider prohibiting that medication product from going inside the chamber.

As for a product (or device), it is also important to consider the effect pressure will have, as well as the medical necessity of the item. Simply put, remove it if it is not necessary.

With any item you are evaluating, you should obtain the input of your Medical Director, as there are medical as well as technical considerations when considering an item for use in your chamber.

Regarding absolute contraindications, we refer you back to NFPA 99 for a list of prohibited items. Also, we recommend you take the approach of continually evaluating any item you allow or prohibited, as each patient (and treatment) presents with variables to consider; for example, what you prohibit in the Class B chamber may be acceptable a Class A chamber. Also, a large surface area or amount of a cream/oil/gel may be concerning, but the same cream/oil/gel may be acceptable in smaller quantities.

Respectfully,

The UHMS HBO2 Safety Committee

We encourage you to resource the following references, which may assist you in your decision making:

  • National Fire Protection Agency (NFPA). (2018). “NFPA 99 2018 Edition: Health Care Facilities Code, “Chapter 14 – Hyperbaric Facilities”. Quincy, Massachusetts.
  • Workman, W. T., & Wood, J. S. (2020). Hyperbaric Facility Safety: A Practical Guide (2nd ed.). Best Publishing Company.
  • Burman, F. (2019). Risk Assessment Guide for Installation and Operation of Clinical Hyperbaric Facilities (6th ed.). San Antonio, TX: International ATMO, Inc.
  • Chimiak, J. (2010). Evaluating Equipment and Materials for Use in a Hyperbaric Oxygen Environment: Clinical Hyperbaric Evaluation and Testing (CHET) Program. (3rd ed.). Best Publishing Company.


DISCLAIMER

Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet. If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility. Information provided on this forum is for general educational purposes only. It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.

I work for a charitable therapy centre in the UK providing hyperbaric oxygen therapy. We operate a small, multi place (6 person) mild dose (maximum 2atm) compression chamber where the oxygen is delivered on demand via breathing apparatus. We are looking for some expert advice on the safe decontamination/ disinfection of such a chamber using a bio fogging method. Would you have any information that you please share with us regarding the safe and appropriate bio fogging of hyperbaric chambers or know of w
Published: 19 January 2021

Posted: 1/19/2021


Q:
I work for a charitable therapy centre in the UK providing hyperbaric oxygen therapy. We operate a small, multi place (6 person) mild dose (maximum 2atm) compression chamber where the oxygen is delivered on demand via breathing apparatus. 

We are looking for some expert advice on the safe decontamination/ disinfection of such a chamber using a bio fogging method. Would you have any information that you please share with us regarding the safe and appropriate bio fogging of hyperbaric chambers or know of who may be able to help? 


A:
Good evening! We are not aware of any fogging agents that have been approved for hyperbaric applications, and we recommend you research the EUBS and UHMS recommendations for updates.

https://www.uhms.org/resources/medfaqs-frequently-asked-questions-faq/safety-technical/161-infection-prevention.html?faq=409
https://www.uhms.org/images/Safety-Articles/ECHM-position-on-HBOT-and-COVID-19-16th-March-2020_1.pdf

Our linen company approached us about adding an RFID chip to our linen. Before moving forward with our approval we wanted to ask for UHMS guidance to ensure that this is appropriate in the Monoplace chamber environment.
Published: 19 January 2021

Posted: 1/19/2021


Q:
Our linen company approached us about adding an RFID chip to our linen. Before moving forward with our approval we wanted to ask for UHMS guidance to ensure that this is appropriate in the Monoplace chamber environment.


A:
Thank you for your question. The UHMS HBO2 Safety Committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the Medical Director and Safety Director of your facility.

Based upon our knowledge of these tags, the UHMS HBO2 Safety Committee finds no reason why PASSIVE RFID tags or chips could not be allowed in monoplace chambers. We caution you against the use of ACTIVE RFID tags in the Monoplace chamber.

More Information on RFID and RFID tags (source):

Radio-frequency identification (RFID) uses electromagnetic fields to automatically identify and track tags attached to objects. An RFID system consists of a tiny radio transponder; a radio receiver and transmitter. When triggered by an electromagnetic interrogation pulse from a nearby RFID reader device, the tag transmits digital data, usually an identifying inventory number, back to the reader. This number can be used to track inventory goods.

There are two types of RFID tags:

  • Passive tags are powered by energy from the RFID reader's interrogating radio waves.
  • Active tags are powered by a battery and thus can be read at a greater range from the RFID reader; up to hundreds of meters


References:

Ajami, S., & Rajabzadeh, A. (2013). Radio Frequency Identification (RFID) technology and patient safety. Journal of research in medical sciences: the official journal of Isfahan University of Medical Sciences, 18(9), 809.

 

Respectfully,

The UHMS HBO2 Safety Committee


DISCLAIMER
Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet. If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility. Information provided on this forum is for general educational purposes only. It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally. 

Hello. There are many transesophageal prosthesis types, but are there any that are safe (or unsafe) during hyperbaric treatment? Does this change when combined with an cuffless silicone tracheostomy tube with reusable inner cannula? Thank you.
Published: 13 January 2021

Posted: 1/19/2021


Q:
There are many transesophageal prosthesis types, but are there any that are safe (or unsafe) during hyperbaric treatment? Does this change when combined with a cuffless silicone tracheostomy tube with reusable inner cannula?


A:
Thank you for your question. The UHMS HBO2 Safety Committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the Medical Director and Safety Director of your facility.

The UHMS HBO2 Safety Committee would consider this device suitable in either the monoplace or multiplace environment. We understand that this device is essentially a one-way valve that, when occluded, allows exhaled air/gas to pass through to the esophagus. There does not seem to be concern with gas trapping in the lungs, as the gas would always have an exit route either through the trachea or esophagus. The type of tracheostomy tube should not impact its functionality.

Respectfully,

The UHMS HBO2 Safety Committee


DISCLAIMER
Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet. If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility. Information provided on this forum is for general educational purposes only. It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally. 

Under UHMS and/or CMS guidelines, can HBO therapy be utilized to support artificial skin grafts? If so, are there any ways which approach to use of HBOT might differ from support of a compromised flap/graft?
Published: 11 January 2021

Posted: 1/12/2021


Q:
Under UHMS and/or CMS guidelines, can HBO therapy be utilized to support artificial skin grafts? If so, are there any ways which approach to use of HBOT might differ from support of a compromised flap/graft?


A:
These are the ICDs for compromised graft that are approved for treatment with HBO2. By definition, autograft and allograft can’t be artificial.

996.52 Mechanical complication due to graft of other tissue, not elsewhere classified T86.820 Skin graft (allograft) rejection
996.52 Mechanical complication due to graft of other tissue, not elsewhere classified T86.821 Skin graft (allograft) (autograft) failure
996.52 Mechanical complication due to graft of other tissue, not elsewhere classified T86.822 Skin graft (allograft) (autograft) infection
996.52 Mechanical complication due to graft of other tissue, not elsewhere classified T86.828 Other complications of skin graft (allograft) (autograft)

 

Is it acceptable to have a Certified Medical Assistant performing hyperbaric treatments? I have heard of it in the past but wasn't sure if it is still acceptable. I do know that they cannot certify anymore unless they have a current EMT status.
Published: 13 December 2020

Posted: 12/15/2020


Q:
Is it acceptable to have a Certified Medical Assistant performing hyperbaric treatments? I have heard of it in the past but wasn\'t sure if it is still acceptable. I do know that they cannot certify anymore unless they have a current EMT status.


A:
Thank you for your question!

I’ve included the link to the UHMS’s PS on certification - https://www.uhms.org/images/Position-Statements/position_statement_-_uhms_associates_hyperbaric_certification_recognition_v.10.05.2019_v6_1.pdf.

A CMA does qualify as a qualifying pathway for the ABWH’s CWS exam and certification but not for the NBDHMT’s CHT. Those links are listed below.

https://abwh.net/get-certified/certified-hyperbaric-specialist/

https://www.nbdhmt.org/forms/CHT_Resource_Manual.pdf - qualifying pathway page 1

  

What is the best approach of treating pediatric patients in monoplace chambers? Is it safe to allow a parent inside the chamber with the child?
Published: 29 November 2020

12/21/2020


Q:
What is the best approach of treating pediatric patients in monoplace chambers? Is it safe to allow a parent inside the chamber with the child?


A:
Thank you for your question. The UHMS HBO2 Safety Committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the Medical Director and Safety Director of your facility.

The UHMS HBO2 Safety Committee is aware of several facilities that allow this practice, provided that several risk mitigations are in place prior to therapy. While NFPA-99 classifies chambers based on occupancy, Class A (human - multiple occupancy) or Class B (human - single occupancy), the document does not prohibit this practice. The Food and Drug Administration allows the Off-Label Use of Medical Devices under the Supervision of a Physician and subject to certain, safety-based criteria. We suggest applying this principle to the scenario above.

The UHMS HBO2 Safety Committee recommends that the Hyperbaric Medical Director and Hyperbaric Safety Director examine the risks and benefits of this approach with each particular patient and consider the safety mitigations described below before proceeding with this practice. We also recommend that the facility develop standardized procedural guidance for this scenario ahead of time and discuss the approach with the hyperbaric staff. There may be the need to gather information from your legal and administrative teams before engaging in this practice, so we encourage that procedural guidance and equipment needs are ready before the consult is realized.

Please consider the following safety mitigations and recommendations pertaining to the practice of the treatment of a patient with an occupant caregiver in the monoplace chamber:

  • We recommend that the occupant caregiver be a parent, guardian or relative that is well known to the patient. If possible, try to maintain consistency with that individual throughout the treatment plan.
  • Have a plan in the event that the primary occupant caregiver is unable to be in the chamber, so as not to interrupt the treatment plan for the patient.
  • We recommend grounding both the patient and the occupant caregiver, and test the continuity of both devices prior to every therapy.
  • An individual breathing apparatus should be available for each occupant where air breaks are used.
  • Consider the use of “wye” connections for grounding and air break purposes.
  • Ensure that the air break mask is properly suited for the adult/pediatric patient, as applicable.
  • The Hyperbaric Physician should provide thorough education to the occupant caregiver and provide instruction on how to respond to the side effects of therapy
  • The Hyperbaric Physician should evaluate the occupant caregiver for the risks of hyperbaric oxygen therapy and gain consent as they would a patient.
  • The facility should have a plan to respond to an incapacitated occupant caregiver (seizure activity, cardiac arrest, etc.).
  • Consider documenting in the occupant caregiver’s chart and treating this as a separate appointment
  • Consider a nominal or ‘no-charge’ visit for the occupant caregiver
  • Avoid the use of clinical staff as occupant caregivers – the oxygen exposure creates an additional occupational risk and may be a complicated matter from the perspective of occupational health and human resources (job description/job expectations). Consult with these groups before considering this approach.
  • Anticipate the need to consult with your hospital’s Administration, Safety Management, and Legal teams. Ensure that any safety, liability, or reimbursement concerns are addressed.

Also noteworthy, the National Board of Diving and Hyperbaric Medical Technology released a statement in 2011 related to this practice:

“…the Board of Directors has posted a new Position Statement (July 2011; 2011-02). It relates to the not uncommon practice of having a pediatric patient accompanied in a monoplace chamber. The decision to require a staff or family member to join such patients is entirely that of the treating hyperbaric physician and presumably a decision based upon a risk-benefit assessment. It is not the intent of this latest Position Statement to argue the relative merits of this practice. Rather, the Board wants to ensure that should dual occupancy occur it does so with relevant safety standards considered.” Link

References:

Optimizing the pediatric hyperbaric oxygen therapy plan: Tandem therapy - Nicholas Marosek, RN, CHRN, UHMS Safety Pre-Course, June 2019

Celebi, A. R. C., Kadayifcilar, S., & Eldem, B. (2015). Hyperbaric oxygen therapy in branch retinal artery occlusion in a 15-year-old boy with methylenetetrahydrofolate reductase mutation. Case reports in ophthalmological medicine, 2015.

Fok, T. F., Shing, M. K., So, L. Y., & Leung, R. K. W. (1990). Vascular Air Embolism‐Possible Survival. Acta Pædiatrica, 79(8‐9), 856-859.

Hsieh, W. S., Yang, P. H., Chao, H. C., & Lai, J. Y. (1999). Neonatal necrotizing fasciitis: a report of three cases and review of the literature. Pediatrics, 103(4), e53-e53.

Korambayil, P. M., Ambookan, P. V., Abraham, S. V., & Ambalakat, A. (2015). A multidisciplinary approach with hyperbaric oxygen therapy improve outcome in snake bite injuries. Toxicology International, 22(1), 104. Liebelt, E. L. (1999).

Hyperbaric oxygen therapy in childhood carbon monoxide poisoning. Current opinion in pediatrics, 11(3), 259-264.

Mader, J. T., Adams, K. R., Wallace, W. R., & Calhoun, J. H. (1990). Hyperbaric oxygen as adjunctive therapy for osteomyelitis. Infectious disease clinics of North America, 4(3), 433-440.

Smith-Slatas, C. L., Bourque, M., & Salazar, J. C. (2006). Clostridium septicum infections in children: a case report and review of the literature. Pediatrics, 117(4), e796-e805.

Tsung, J. W., Chou, K. J., Martinez, C., Tyrrell, J., & Touger, M. (2005). An adolescent scuba diver with 2 episodes of diving-related injuries requiring hyperbaric oxygen recompression therapy: a case report with medical considerations for child and adolescent scuba divers. Pediatric emergency care, 21(10), 681-686.

Waisman, D., Shupak, A., Weisz, G., & Melamed, Y. (1998). Hyperbaric oxygen therapy in the pediatric patient: the experience of the Israel Naval Medical Institute. Pediatrics, 102(5), e53-e53.

Respectfully,

The UHMS HBO2 Safety Committee


DISCLAIMER
Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet. If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility. Information provided on this forum is for general educational purposes only. It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally. 

We have a simple question regarding dressings in the hyperbaric oxygen chamber. Can we safely use Mepitel (silicone-based dressing), Steri-Strips and Amnioexcel (skin substitute product) in the HBO chamber? Can you please have the safety team weigh in on the use of these 3 products in the chamber?
Published: 23 October 2020

Posted: 10/23/2020


Q:
We have a simple question regarding dressings in the hyperbaric oxygen chamber. Can we safely use Mepitel (silicone-based dressing), Steri-Strips and Amnioexcel (skin substitute product) in the HBO chamber? Can you please have the safety team weigh in on the use of these 3 products in the chamber?


A:

Thank you for your question. The UHMS HBO2 Safety Committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the Medical Director and Safety Director of your facility.

Within NFPA 99 (2021), Chapter 14, the authority to approve an item (creams, materials, and devices) for use within a hyperbaric chamber is delegated to the Physician-in-Charge (Medical Director) with the concurrence of the (hyperbaric) Safety Director; meaning you need two people to agree when allowing an item.

The authority to restrict or remove any potentially hazardous supply or equipment items from the chamber is delegated to the (hyperbaric) Safety Director.

With regards to compatibility of various wound care creams and products, the Hyperbaric Facility should institute an evaluation process to determine if an item is acceptable for use within its chamber.

The testing of products conducted by the UHMS Materials Testing Advisory Committee shows us that any source of heat or energy release are our most significant concerns when it comes to ignition of any flammable material. Therefore, the elimination of heat above the NFPA limits (185°F for a multiplace and 140°F for a monoplace chamber) or static discharge sources are essential to every hyperbaric program.

It is important to understand the ingredients of the cream (ointment or gel) to know if the product has the potential to off-gas flammable vapors. Should this be the case, you would consider prohibiting that medication product from going inside the chamber.

As for a product (or device), it is also important to consider the effect pressure will have, as well as the medical necessity of the item. Simply put, remove it if it is not necessary.

With any item you are evaluating, you should obtain the input of your Medical Director, as there are medical as well as technical considerations when considering an item for use in your chamber.

Regarding absolute contraindications, we refer you back to NFPA 99 for a list of prohibited items. Also, we recommend you take the approach of continually evaluating any item you allow or prohibited, as each patient (and treatment) presents with variables to consider; for example, what you prohibit in the Class B chamber may be acceptable a Class A chamber. Also, a large surface area or amount of a cream/oil/gel may be concerning, but the same cream/oil/gel may be acceptable in smaller quantities.

Respectfully,

The UHMS HBO2 Safety Committee

We encourage you to resource the following references, which may assist you in your decision making:

  • National Fire Protection Agency (NFPA). (2018). “NFPA 99 2018 Edition: Health Care Facilities Code, “Chapter 14 – Hyperbaric Facilities”. Quincy, Massachusetts.
  • Workman, W. T., & Wood, J. S. (2020). Hyperbaric Facility Safety: A Practical Guide (2nd ed.). Best Publishing Company.
  • Burman, F. (2019). Risk Assessment Guide for Installation and Operation of Clinical Hyperbaric Facilities (6th ed.). San Antonio, TX: International ATMO, Inc.
  • Chimiak, J. (2010). Evaluating Equipment and Materials for Use in a Hyperbaric Oxygen Environment: Clinical Hyperbaric Evaluation and Testing (CHET) Program. (3rd ed.). Best Publishing Company.

DISCLAIMER
Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet. If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility. Information provided on this forum is for general educational purposes only. It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally. 

I am asking this question because the 2018 FGI Guidelines for Design and Construction of Hospitals references the UHMS in Section A2.2-3.13.1.2 as a contact for additional information. I am an architect, and we are currently in the schematic design phase for a Wound Care Center that will house 3 Monoplace Chambers. 
Published: 14 October 2020

Posted: 10/14/2020


Your question was reviewed by the Hyperbaric Oxygen Safety Committee of the Undersea and Hyperbaric Medical Society (UHMS). Our committee can provide you with additional information to assist your decision-making, but please keep in mind that your local Authority Having Jurisdiction (AHJ) is ultimately responsible for interpreting the facilities’ classification. Neither the UHMS nor the HBO2 Safety Committee assume any responsibility in this regard as we are not a governing body. The HBO2 Safety Committee’s responses are listed below in red.

Good Morning,

Q: I am asking this question because the 2018 FGI Guidelines for Design and Construction of Hospitals references the UHMS in Section A2.2-3.13.1.2 as a contact for additional information. 

I am an architect, and we are currently in the schematic design phase for a Wound Care Center  that will house 3 Monoplace Chambers. 
A: NFPA 101 invokes the occupancy requirement of Ambulatory Healthcare whenever 4 or more patients are rendered incapable by the procedure. Although ambulatory when they arrive at the facility, hyperbaric patients in the monoplace chamber are rendered incapable of taking actions for self-preservation for the duration of the time they are in the chamber. If there is potential that the facility could expand in the future to 4 or more chambers, the facility should consider building to Ambulatory Healthcare during the initial buildout.  CMS Memo S&C-11-05-LSC has been interpreted by some AHJ’s as requiring Ambulatory Healthcare regardless of the number of monoplace chambers installed. This is the case in the state of Colorado and has led to general best practice recommendations that facilities consider Ambulatory Healthcare regardless of the number of chambers.

Although this strictly Outpatient facility will be located in a Medical Office Building (not a Hospital setting) with standard office hours of 8 a.m. – 6:00 p.m, it will be operating under the hospital umbrella as far as licensure goes.  The point to that statement is, although Hyperbaric chambers are provided for, under the above noted FGI, there are no requirements under the FGI Guidelines for the Design and Construction of Outpatient Facilities.

When designing under the “Hospital” Guidelines, the below are required. 

  • A generator with at least 24 hours of fuel, unless it’s in an area which could have extended outages. In that case, the minimum would be 96 hours.  
    A: A generator is not required unless the hyperbaric facility will treat emergent hyperbaric indications and use ancillary medical devices. The monoplace chamber is run by gas pressure versus electrical power. An exception to this rule of thumb exists in the state of Colorado. In recent years Colorado has required hyperbaric facilities to have a backup generator or a suitably sized battery UPS to provide emergency power for pneumatically operated chambers.
  • A separate electrical room for transfer switches and emergency switchgear
  • All  panelboards would need to be in rooms rather than in corridors
  • Increased receptacle counts in all patient care areas 
    A: The standard receptacle count for business occupancy should generally meet the needs for patient care areas.  Outfitting of the patient care area with computers, monitors, podiatry chairs, procedure lamps, and etc. should be taken into consideration when determining outlet count and locations.
  • HVAC equipment would likely need to be on emergency power  
    A: See response to bullet #1. The internal temperature of the monoplace chamber is primarily regulated by ambient room temperature and chamber ventilation settings. Thus, if treating emergent indications, the HVAC should be tied to the emergency power, should there be a loss of power.

REFERENCES:

Centers for Medicare and Medicaid Services (CMS). (12/17/2010 REVISED 02/18/2011). “S & C-11-05-LSC: Hospital and Critical Access Hospital (CAH) Facility Life Safety Code (LSC) Occupancy Classification Update”. Baltimore, Maryland. DEPARTMENT OF HEALTH & HUMAN SERVICES (Accessed 10/13/2020)

National Fire Protection Agency (NFPA). (2018). “NFPA 99 2018 Edition: Health Care Facilities Code, “Chapter 14 – Hyperbaric Facilities”. Quincy, Massachusetts.

National Fire Protection Agency. (2018). NFPA 101: Life Safety Code, “ 3.3.190.1, 6.1.6, A6.1.6.1”. Quincy, Massachusetts.

Undersea and Hyperbaric Medical Society. (2018). Clinical Hyperbaric Facility Accreditation Manual (4th ed.), “HBOC 1.0 – HBOC 4.0: Facility Construction”. North Palm Beach, FL: Undersea and Hyperbaric Medical Society, Inc.

Thank you for reaching out to the UHMS and please contact us if you have any further questions.

Sincerely,

The UHMS HBO2 Safety Committee


DISCLAIMER

Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet. If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility. Information provided on this forum is for general educational purposes only. It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.


 

We treated a patient recently with hemorrhagic cystitis secondary to BK virus.(40 treatments, 6/11/20-8/11/20) He has a history of CML. In the last 2-3 weeks the patient has had a recurrence of hematuria "dependent on hydration" and the team has reached out to us for more treatments. Do you think more treatments would be efficacious?
Published: 14 October 2020

Posted: 10/16/2020


Q:
We treated a patient recently with hemorrhagic cystitis secondary to BK virus.(40 treatments, 6/11/20-8/11/20) He has a history of CML. In the last 2-3 weeks the patient has had a recurrence of hematuria "dependent on hydration" and the team has reached out to us for more treatments. Do you think more treatments would be efficacious?


A:
I did a search and have seen Dr. Moon's reply. As he said there may be a role for hyperbaric oxygen in hemorrhagic cystitis  in leukemic patients who have stem cell transplants for their leukemia. In my reading up to 50% of such patients sustain cystitis and there appears to be no other effective therapies. The cystitis is viral in etiology (polyoma virus). I attach 3 abstracts of small series of cases treated with HBO2. with a good reported response. I note that they typically report response after about 10 treatments. I did not see that patients have received more than 40 treatments.  

I have 2 observations:
1. There appears to be no other effective therapy. (see the last attached abstract)
2. HBO2 has had reported good effect but 40 treatments would be well outside the previously reported courses in case reports .
 
Does this patient have any other risk factors? Is he on anticoagulants for cardiac disease or prior DVT, PE. etc. Patients with leukemia often have decreased platelet counts (and red cell counts). Does he have thrombocytopenia?
 
I would also ask what his response to the previous HBO2 has been. I agree with Dr. Moon.  Additional HBO2 is probably justified due to the absence of other effective therapies BUT I think that a durable response in this patient is unlikely since already the number of treatments far exceeds prior reported experience. I would not give more than another 20 treatments. Although not the same thing, my experience is that radiation induced hemorrhagic cystitis often requires more that 40 treatments
 
John Feldmeier, DO
 

 

I work at ***** and am often a single chamber operator (Monoplace). Our manager is trying to come up with a safety measure for if the chamber operator would go down. They have talked about placing some sort of emergency button inside chamber as a way for the security office to be notified if I were to go down. In the past, our manager would call on the telephone to check on us or security will round by the clinic. Security officers have not been able to do that due to staffing issues. Our chamber is down
Published: 13 October 2020

Posted: 10/12/2020


Q:
I work at ***** and am often a single chamber operator (Monoplace). Our manager is trying to come up with a safety measure for if the chamber operator would go down. They have talked about placing some sort of emergency button inside chamber as a way for the security office to be notified if I were to go down. In the past, our manager would call on the telephone to check on us or security will round by the clinic. Security officers have not been able to do that due to staffing issues. Our chamber is down in the basement of the main hospital and literally off the path of heavy traffic by others. I have stressed the importance of staffing but at this time extra staffing is not an option. Have you ever heard of an in chamber notification system that could be looked into? Any advice would be appreciated.


A:

Thank you for your question. The UHMS HBO2 Safety Committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the Medical Director and Safety Director of your facility.

The UHMS HBO2 Safety Committee agrees that this scenario is a legitimate concern for monoplace facilities with limited staffing. Several committee members have either encountered this question in their own experience, or have seen several worthy solutions while performing site surveys as a UHMS surveyor. The committee has previously addressed this subject in brief while answering other questions (See references below). However, we will provide a more direct and detailed answer here for your benefit.

The committee will list several options for your consideration below. Before implementing any of these solutions, it is important to note that the staffing, education, and training of personnel responsible to the monoplace hyperbaric facility are paramount to any signaling device, security system, or policy. These measures will only be successful if properly implemented into your program.

Alarm Systems:

  • The committee is aware of a facility that has utilized an emergency push button installed at the chamber operator's desk.  When pushed, an alarm would sound at the nearby nursing station and nursing staff would immediately respond. This solution could be helpful to alert staff to a variety of urgent or emergent needs.
  • While the creation of a non-electrical, pneumatically-controlled alert switch located inside the monoplace chamber is technically possible, the committee would caution you from placing the responsibility of monitoring the chamber operator in the patient’s hands. Any modification of the chamber or the creation of a switch of this nature must be either endorsed by or created and installed by the manufacturer. This committee does not endorse the use of electrically-powered, wired or wireless technology for this purpose in a monoplace hyperbaric chamber. Electrical components to include speakers (used for entertainment and communication) and physiological leads within the monoplace hyperbaric setting are intended to be designed and installed by the manufacturer, as the NFPA 99 prohibits the use of electrical components for anything other than patient physiological leads and communication functions (NFPA 99, 14.2.9.6 -  14.2.9.6.3 and annex material A.14.2.9.6.1.1)
  • For monoplace applications, this committee does not recommend the use of an automated decompression or signaling switch, which are sometimes used in multiplace systems and is usually located outside of the chamber. In this instance, the alarm is initiated and decompression begins if the timer is not reset periodically by the operator (this is commonly referred to as a “dead man’s switch”). In the monoplace setting, this could place the patient at risk for suffocation if response is delayed, as the chamber door could remain sealed at the surface without gas flowing.

Staffing Considerations:

Section 3, Staffing Guidelines (pg.15):

       “One (1) chamber operator should not operate and/or monitor more than two (2) monoplace chambers simultaneously during patient treatments”

       “At least one (1) additional hyperbaric-trained staff member should be immediately available to assist, if needed, during any patient treatment.”

Section 3, Staffing Guidelines – I. Physician/NPP Staffing Guidelines (pg.15-16):

       “Physician staffing should provide coverage of the following clinical safety provision(s): Coverage of patients for consultation and treatment supervision during published working hours in strictly outpatient facilities.”

       “Physician staffing should provide coverage of the following clinical safety provision(s): Physician or non-physician provider supervision and be readily available during treatments.”

Security Cameras and Monitors (video and in-person):

  • Perhaps a more practical solution to your concern is a closed-circuit monitoring system (CCTV) with someone positioned elsewhere (front desk or security personnel) keeping an eye on the chamber room. It is possible that motion sensor technology could also be used to ensure that the operator is present. Additionally, an alarm could be triggered if there is no movement after a period of time.
  • More than one Safety Committee member has seen CCTV used at UHMS-accredited facilities while serving as an accreditation surveyor and recommends this solution.
  • Considering the location of your chamber facility and the staffing situation you describe, we encourage you to revisit and enforce your “working alone” policy requiring your supervisors to establish a consistent means of communication with the operator. We encourage your Medical and Safety Directors to be active participants in the enforcement of these policies for the safety of every patient and chamber operator.

Respectfully,

The UHMS HBO2 Safety Committee

REFERENCES:

UHMS HBO2 Safety Committee response to MEDFAQ, Accessed 9/28/2020, Originally published 2/23/2017.

Workman, W. T. (2015). Guidelines for Hyperbaric Facility Operations (2nd ed.). North Palm Beach, FL: Undersea and Hyperbaric Medical Society, Inc.

National Fire Protection Agency (NFPA). (2018). NFPA 99 2018 Edition: Health Care Facilities Code. Quincy, Massachusetts.

Undersea and Hyperbaric Medical Society. (2018). Clinical Hyperbaric Facility Accreditation Manual (4th ed.). North Palm Beach, FL: Undersea and Hyperbaric Medical Society, Inc.


DISCLAIMER

Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet.  If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility.  Information provided on this forum is for general educational purposes only.  It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.

 

I work in a multiple facility and a patient posed a questions to one of my techs that I was not here to help discuss. The question was "why do we not use an alcohol swab when we check blood sugar levels toward the end of the treatment?" History, we do an in chamber post treatment blood sugar check on a with about 8ish minutes remaining at pressure. We use a standard 2x2 cotton swab to wipe the figure of the patient prior to the lancet. I know an alcohol swab has a low flash point, and in my prior 2 years
Published: 28 September 2020

Date:       9/28/2020
From:      UHMS HBO2 Safety Committee



Q:

I work in a multiple facility and a patient posed a questions to one of my techs that I was not here to help discuss. The question was "why do we not use an alcohol swab when we check blood sugar levels toward the end of the treatment?" History, we do an in chamber post treatment blood sugar check on a with about 8ish minutes remaining at pressure. We use a standard 2x2 cotton swab to wipe the figure of the patient prior to the lancet. I know an alcohol swab has a low flash point, and in my prior 2 years of operating in a monoplace facility, I did not use alcohol swab pre or post treatment. Just a 2x2 swab. I am curious where y'all stand on the use of alcohol swabs for an in chamber blood sugar? Any thoughts will be appreciated.


A:

Thank you for your question. The UHMS HBO2 Safety Committee can provide information to assist you in answering your question, but the ultimate decision and responsibility for these types of questions rests with the Medical Director and Safety Director of your facility.

          The UHMS HBO2 Safety Committee can provide guidance but cannot endorse a specific product for use in the multiplace hyperbaric environment to cleanse the skin before a capillary finger stick procedure for glucose scanning. The decision to allow items containing alcohol that could increase the probability of fire within the hyperbaric environment should be carefully made by the Hyperbaric Safety Director and Hyperbaric Medical Director of your particular facility. Swabs containing 70% isopropyl alcohol do emit vapors that are easily ignitable within the multiplace hyperbaric environment if in close proximity to an ignition source. However, it is plausible to consider limited and controlled amounts of this material after careful consideration of the risks and benefits involved.

  • We recommend before choosing a product that a proper risk assessment is performed by the Hyperbaric Safety Director and Hyperbaric Medical Director; with careful consideration given to the flammability, NFPA 704 rating of the material, amount, potential vapors released, chamber volume, and the fuel load added to the environment.
    • For more information related to this topic, please refer to NFPA 99 section 14.3.1.6.2 – Flammable Gases and Liquids (2018).
    • You may wish to seek an alcohol–free option like Benzalkonium Chloride wipes. It is important to work with the laboratory and infection control practices within your institution to determine the best option for your practice.
    • We strongly encourage that all hyperbaric facilities own a copy of the NFPA 99 in their library. You can find read only, free access to all the NFPA codes at http://www.nfpa.org/. You may also wish to consider the NFPA-99 Health Care Facilities Handbook, a valuable resource containing an expansive explanation of the NFPA-99.
  • We would also encourage you to share your methods with the laboratory or infection control teams within your institution who are responsible for setting the policies related to this procedure and educate them on the unique nature of the hyperbaric environment. We would advise you to work with these teams to develop a specific procedure related to glucose scanning within the hyperbaric environment of the multiplace chamber to ensure that you are in compliance with local guidelines.

Respectfully,

The UHMS HBO2 Safety Committee


 DISCLAIMER

Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet.  If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility.  Information provided on this forum is for general educational purposes only.  It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.


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