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

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

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. 

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

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

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.

 

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

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.

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

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

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. 

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

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

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.

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

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?

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.

 

any information on cardiac Watchman implant from Boston Scientific? Tried calling company but have not received call back. Safe for HBO?
Published: 26 February 2020

any information on cardiac Watchman implant from Boston Scientific? Tried calling company but have not received call back. Safe for HBO?

Date:       3/11/2020


Q:
Any information on cardiac Watchman implant from Boston Scientific? Tried calling company but have not received call back. Safe for 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.

This device is similar in design and purpose to other types of cardiac stents. The particular difference is that this implant helps to reduce clotting in a specific region of the heart known as the left atrial appendage. Patients with atrial fibrillation may benefit from the use of this implant by reducing the risk of stroke due to clots that tend to form in this area of the heart.

Several members of the Safety Committee have indicated that there are no overt concerns raised that would prohibit a patient with a cardiac Watchman Implant from receiving Hyperbaric Oxygen Therapy.  One of the committee members consulted Boston Scientific and spoke with their representatives. They confirmed that “There are no issues with the Watchman and HBO therapy”. Additionally, the committee consulted a cardiovascular specialist who is familiar with this implant, who agreed with this conclusion. Therefore the UHMS Safety Committee sees no reason to withhold hyperbaric oxygen therapy from a patient due to the presence of a cardiac Watchman implant.

Respectfully,

The UHMS 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 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

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.

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.

 

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

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?

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.

 

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

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.

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.

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

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?

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.

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

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.

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.

 

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

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.

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 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

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?

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.

 

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

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?

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 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

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

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.

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

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.

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.

Are there any suspected risks involved with the use of Invisalign (orthodontic product) during hyperbaric oxygen treatment in a multi-place chamber?
Published: 03 July 2022

Are there any suspected risks involved with the use of Invisalign (orthodontic product) during hyperbaric oxygen treatment in a multi-place chamber?

Posted: 7/6/2022


Q: 
Are there any suspected risks involved with the use of Invisalign (orthodontic product) during hyperbaric oxygen treatment in a multi-place chamber?


A:
We see no concerns (UHMS SC Chair), but of course removing the retainer during treatment is recommended as there could be some trapped gas causing a “squeeze” which could occur during pressurization making the retainer more difficult to remove as well.

 
 

 

We have a patient with bilateral K Pro 1 lenses, can they go in the mono-place chamber or do they need to be removed prior to treatment. Are there any specific modifications needed for treatment?
Published: 26 May 2022

We have a patient with bilateral K Pro 1 lenses, can they go in the mono-place chamber or do they need to be removed prior to treatment. Are there any specific modifications needed for treatment?

Posted: 8/12/22


 Q:
We have a patient with bilateral K Pro 1 lenses, can they go in the mono-place chamber or do they need to be removed prior to treatment. Are there any specific modifications needed for treatment?


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.

Before we respond to this question, it is important for our readers to understand this optical device a bit more. The Safety Committee would like to provide general information on the K-Pro Type 1 and Type II implants and procedure, taken from this article(7):

The Boston Type I Keratoprosthesis (BI-KPro) is an artificial cornea device. It is implanted as a treatment for many severe, recalcitrant corneal disorders that are not amenable to traditional corneal transplantation such as penetrating ker­atoplasty (PK). Although the device was initially rejected by ophthalmologists because of its high rate of complications, modifications to the mechanical design, as well as the development of antibiotic prophylaxis regimens and large-diame­ter bandage contact lenses, have allowed the BI-KPro to become a viable option for preserving or restoring vision.

 

The BI-KPro was first developed by Claes H. Dohlman, MD, PhD, at the Massachusetts Eye and Ear Infirmary in the 1960s, but it was not approved by the U.S. Food and Drug Administra­tion until 1992.  Since its approval, the BI-KPro has become more widely adopted in the United States and glob­ally and is now considered a standard of care for the treatment of many oth­erwise blinding corneal diseases.


The Boston KPro is available in 2 variants, Type I and Type II, both of which contain an optic, as well as a front plate and a back plate, between which a donor corneal graft is placed. Type I is much more commonly used, as its implantation procedure more closely resembles PK surgery. It is avail­able in both adult and pediatric sizes.

The UHMS HBO2 Safety Committee was unable to receive feedback from the manufacturer regarding the risk to patients with this implant receiving hyperbaric oxygen therapy. We suggest that this is a local decision and recommend that a risk assessment weighing the benefit of hyperbaric medicine versus the medical risk to the patient is performed(1). It this case, the primary responsibility rests upon the HMD of the hyperbaric clinic with input from the HSD and the patient’s Ophthalmology team. Members of the UHMS HBO2 Safety Committee have reached out to diving and ophthalmology physicians to inquire about this implant and the implant procedure. Their assessment revealed several points of consideration:

  • These implants are not typically or easily removed.
  • There are no obvious air spaces that would incur a mechanical hazard.
  • Consultation between the Hyperbaric Provider and the Ophthalmology team who performed the procedure is recommended. A specific point that should be addressed by the patient's ophthalmologist is whether there are any gas bubbles in the eye. Intraocular gas bubbles are an absolute contraindication to both HBO2 therapy and diving.
  • You may wish to consider delaying the therapy several weeks if this procedure occurred recently.

We will provide several resources(2,3,4,5,6) intended to guide you in the decision-making process. Thank you for reaching out to the UHMS HBO2 Safety Committee.

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. Butler Jr, F. K. (1995). Diving and hyperbaric ophthalmology. Survey of ophthalmology, 39(5), 347-366. LINK
  3. McMonnies CW, “Hyperbaric oxygen therapy and the possibility of ocular complications or contraindications” Journal of clinical and experimental optometry, 2015, Volume 98, Issue 2, Pages 122-125. LINK
  4. Simon, D. R., & Bradley, M. E. (1978). Corneal edema in divers wearing hard contact lenses. American journal of ophthalmology85(4), 462-464. LINK
  5. Simon, D. R., & Bradley, M. E. (1980). Adverse effects of contact lens wear during decompression. JAMA, 244(11), 1213-1214. LINK
  6. Socks, J. F., Molinari, J. F., & Rowey, J. L. (1987). Rigid gas permeable contact lenses in hyperbaric environments. NAVAL SUBMARINE MEDICAL RESEARCH LAB GROTON CT. LINK
  7. Starr, C. E., Klufas, M. A., Feldman, B. H., Bunya, V. Y., & Moon, C. Boston Keratoprosthesis (KPro). eWiki (aao.org), Accessed 6/20/22 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.


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