Item Approval

Is there a particular company or 100% cotton blanket that you could recommend for the hyperbaric chamber?

Thank you for your question. The UHMS hyperbaric oxygen safety committee (SC) can provide information but the ultimate responsibility for these types of questions is with the medical director and safety director of your facility.

Regarding blankets for the chamber:

• There are several commercial vendors that supply hyperbaric blankets. UHMS hyperbaric oxygen safety committee is not able to recommend one vendor over another. If you are in a hospital system, you may even be able to utilize hospital supplied blankets.
• The NFPA 99, 2018 edition 14.3.1.6.4 and annex note for textiles in the chamber such as, sheets, pillowcases, and blankets, directs us to conform with 14.3.1.6.4.2*, and annex note A14.3.1.6.4.2, specify that 100% cotton or a blend of cotton/polyester are permitted in the class A chambers and 100% cotton or a blend containing no more than 50% polyester for the class B chamber. We recommend that you adopt this practice for blankets, sheets and pillow cases in the hyperbaric chamber. You should have this document in your library. There is also free access to the NFPA codes (read only) at http://www.nfpa.org/
• The UHMS Ad Hoc Materials Testing Advisory Committee (MTAC) was formed to address questions related to materials in oxygen enriched environments. A presentation from the MTAC regarding material selection and risk assessment occurred during the 2017 UHMS Safety Pre-course to the UHMS ASM. These were recorded and we hope to have them as enduring materials available to the public soon.

Additionally, there are public articles related to this topic that may be of interest to you.

https://learn.hyperbaricmedicine.com/wp-content/uploads/2016/08/Burman-Chamber-Clothing-Flat.pdf

https://www.liebertpub.com/doi/pdfplus/10.1089/wound.2017.0742

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 glistening free hydrophobic acrylic material lens implants able to go into the chamber? This same pt has had bilateral knee replacements and there is no available information regarding what was used. How would you clear the pt for HBO?

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.

Regarding whether patients with glistening free hydrophobic acrylic intraocular lens implants are able to go into the hyperbaric chamber:

• We are not aware of studies on this specific topic. We have never seen complications from hyperbaric oxygen and intraocular lenses.
• Our recommendation would be to work closely with the ophthalmic surgeon.
• Each supplier may have a recommended period of time to avoid pressure changes. This time may vary from days to weeks. Your best source of information would be found by contacting the lens manufacturer and asking about hyperbaric pressure documents.
• In practice, for anterior chamber and intraocular lens implants, we see a 3-5 day waiting period before starting HBO2. This is usually a limitation of the surgical procedure and not the intraocular lens material.

Regarding bilateral knee replacements:

• Inert biological implants without a closed airspace or electrical circuits are safe, but individual consideration must be given as to the potential effects of pressure changes We are not aware of any limitations for hyperbaric oxygen and total joint operations. This would be a decision made by information from the manufacturer, the orthopedic surgeon, and the hyperbaric medical director.

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 it safe to treat a patient with titanium posts securing dentures in both the maxilla and mandible? These were placed 20 and 10 years respectively.

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.

Regarding treating a patient with titanium implants in a multiplace or monoplace chamber:

Titanium oral posts are safe for the hyperbaric chamber. The hyperbaric oxygen Safety Committee is not aware of any untoward events related to these devices and hyperbaric oxygen. Titanium in the hyperoxic environment is certainly a concern. However, the conditions required to create a titanium fire risk do not occur in treatments at clinical pressures. In the mouth particularly, where there is aqueous based saliva with a fairly high specific heat, it is even less likely to generate enough heat for combustion.

Additionally, there are public articles related to this topic that may be of interest to you.

• Dental implants in irradiated jaws: A literature review
• Osseointegrated Implants in Irradiated Bone: A Case-Controlled Study Using Adjunctive Hyperbaric Oxygen Therapy

We are in need of reference materials to come up with a no/go list for our chamber. What are the best resources for this information? ...

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.

References for this question include:

• Approved and Prohibited Items (local Go / No-Go list)
• ASTM G04 Committee: Compatibility and Sensitivity of Materials in Oxygen Enriched Atmospheres
• ASTM Safe Use of Oxygen and Oxygen Systems
• Attendance and involvement in the UHMS chapter, annual meetings and pre-courses.
• Food and Drug Administration (FDA) E-mail Alerts: Manufacturer and User Facility Device Experience Database (MAUDE)  https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
• Emergency Care Research Institute, https://www.ecri.org/Pages/default.aspx
• Hyperbaric Facility Safety: A Practical Guide, Wilbur Workman, Best Publishing
• Manufacturer’s Instructions for Use statements
• NFPA 101, 2018 edition, Life Safety Code
• NFPA 53, 2016 edition Recommend Practice on Materials, Equipment, and Systems Used in OEA
• NFPA 77, 2019 edition Recommended Practice on Static Electricity
• NFPA 99, 2018 edition, chapter 14 and annex material
• Previous questions answered on MEDFAQs
• Product Manufacturer (Tech Support)
• Safety Data Sheet (SDS) (Note: these ratings apply to air environments  at 1 ATA)
• The UHMS Web site, Safety Documents section contains an extended list of references: https://www.uhms.org/publications/safety-documents/safety-references.html
• UHMS Facility Accreditation Manual, 4^th edition
• UHMS Guidelines for Hyperbaric Facility Operations, 2nd Edition

Note: The UHMS Hyperbaric Oxygen Safety Committee sees value in developing a support network of trusted colleagues in the hyperbaric industry by which the Hyperbaric Technical and/or Safety Director can gather information related to the safe and proper administration of hyperbaric oxygen therapy. 

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, who 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 been told about the affects of titanium in the chamber - what about aluminum? Nowadays patients have aluminum eyeglasses. Are these safe in a monoplace chamber?

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 SC is not aware of any concerns regarding aluminum eyeglasses in the monoplace chamber.

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, who 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 hyperbaric oxygen therapy with a spinal stimulator?

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.

While the hyperbaric safety director has the responsibility to assess the performance and safety risks of the device, assessing the medical risk to the patient is the responsibility of the medical director of the hyperbaric clinic. In all cases, a risk assessment weighing the benefit of hyperbaric medicine versus the possible malfunction or damage to the stimulator should be completed. Following this assessment, it is important that the patient is fully aware of any risks discovered and informed consent is gained. Consider as well the possibility of the device to be turned down or off for the treatment. If this occurs, we recommend that the patients’ medical team outside of the hyperbaric practice be involved in this process.

Obtaining testing documentation from the manufacturer pertaining to the device’s exposure to increased atmospheric pressure is vital to the risk assessment. We advise that this documentation be kept within the patient’s medical record. Neuromodulators from varying companies may not carry the manufacturer’s full endorsement. Furthermore, each manufacturer may provide differing information regarding the performance of spinal stimulators in a hyperbaric environment. We would encourage you to contact the manufacturer each time you encounter a patient with this type of device, as it is necessary to access the most up to date recommendation.

The following reference document is provided for your information only, as it may be pertinent to your decision making. The reference made to this document is not an endorsement by the HBO2 Safety Committee of any particular product or process.

Article of interest: 

• Studies from Karolinska University Hospital Have Provided New Information about Hyperbaric Oxygen (Hyperbaric Oxygen Therapy as Adjuvant Treatment for
  Hardware-Related Infections in Neuromodulation)

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, who 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 polyurethane undergarments for compression therapy, an acceptable product in a monoplace chamber?

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 SC does not have enough information to answer this question. We can provide information for your consideration while you complete the due diligence required for this topic. In general unless there is a compelling medical necessity the consensus is that we would not allow this product in the class B chamber.

• NFPA 99, 2018 edition, 14.3.1.5.4.1, except where permitted by 14.3.1.5.4.1, synthetics are prohibited in class A or class B chambers.
• NFPA 99, 2018 edition, 14.3.1.5.4.3 allow for the physician or surgeon in charge, in concurrence with the safety director to allow synthetic materials.
• NFPA 99, 2018 edition, A14.3.1.5.4.3 includes a risk assessment that outlines the process where one could decide whether or not to allow a synthetic such as a polyurethane undergarment.

Questions you may wish to ask while performing the risk assessment include:

• What is the medical necessity? If there is no medical necessity then it would be a No Go.
• This product would be a fuel if ignition were to occur, how much of the material would be allowed if used?
• Does the product have a relatively low flammability rating?
• Polyurethane can be produced as an antistatic product, but most are not. There is a static risk with dissimilar materials. How do you manage the static concern?
• What information can be obtained from the manufacturer, safety data sheets, your peers, etc. regarding static producing properties and flammability?

Here are a few additional resources that may assist you in your decision-making process:

Burman, F. (2015). Risk Assessment Guide for Installation and Operation of Clinical Hyperbaric Facilities. San Antonio, TX: International ATMO, Inc.

Chimiak, J. (2010). Evaluating Equipment and Materials for Use in a Hyperbaric Oxygen Environment: Clinical Hyperbaric Evaluation and Testing (CHET) Program. (3rd ed.). Best Publishing Company.

National Fire Protection Agency (NFPA). (2016). NFPA 53: Recommended Practice on Materials, Equipment, and Systems Used in Oxygen-Enriched Atmospheres. Quincy, Massachusetts.

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 the Lap Band device with a filling port, approved for the hyperbaric chamber?

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.

Regarding:  Whether or not the lap band device with a filling port is approved for the hyperbaric chamber. 

The SC is not aware of an “approval” of this device for hyperbaric conditions. This decision would be the responsibility of the medical director in concurrence with the safety director and communications with the manufacturer. The Directions for Use (DFU) from the manufacturer of the device and the Summary of Effectiveness and Safety from the FDA should be used to help guide the decision process.  The Lap-Band AP® Adjustable Gastric Banding System with RapidPort® EZ and Omniport® Design directions for use is attached.

THE LAP-BAND® ADJUSTABLE GASTRIC BANDING SYSTEM SUMMARY OF SAFETY AND EFFECTIVENESS DATA

LAP-BAND AP® Adjustable Gastric Banding System with RapidPort® EZ and OmNifORm® Design

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 would like to use a BIS monitor in our monoplane chamber. What steps are important to clear this device for our use?

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.

Regarding: Important steps to consider before using equipment in the hyperbaric chamber.

The question of how to approve medical equipment for hyperbaric use comes up quite often.  The UHMS safety committee can provide resources and information but the responsibility for testing and evaluating equipment for use with the clinical chamber is with the medical director and safety director of the facility. There are very few medical devices that have hyperbaric medicine listed as one of the “approved” conditions. The UHMS has presented a Safety Pre-Course to the 2013 and 2015 Annual Scientific Meetings that included lectures on approval of equipment.

In regards to the question of the BIS 4 channel monitor. It sounds as though you have managed getting the patient lead through the hull. You will need a proper, pressure proof thru-hull connector, and matching plug ends for the cable. The “sensors’ appear to transmit signals out the chamber and if there is no current flow into the chamber, it appears to be safe. The manufacturer needs to be contacted to confirm that the signals pass out and are not amplified in the chamber. There is neither, sufficient evidence in the brochure, nor on the website to clarify this. 

Some thoughts to consider are:

• The National Fire Protection Association 99 Health Care Facilities Code, 2018 edition, chapter 14, lists the temperature, electrical limits, and responsibilities of the safety director regarding equipment used in the class A and class B chambers. You should have this reference in your library.
• 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 labelled 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).”

• 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.

References:

• NFPA 99, Health Care Facilities Code, 2018 edition
• Food and Drug Administration, http://www.fda.gov/default.htm
• Burman F., “Risk Assessment Guide,” Fifth Edition, 2015, (Ref. 1.6.1 - 1.6.21)
• Burman F., Sheffield R., Posey, K., “Decision process to assess medical equipment for hyperbaric use.” UHM 2009, Vol. 36, No. 2
• Richard Barry, 2013 ASM pre-course material
• William Gearhart, 2015 ASM pre-course material

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.

An external fixator is on a patient that has been referred for treatment, the doctor states the metal is a hydrocarbon, is this safe in a monoplace chamber?

Published Date:   05/2016
Review Date:       04/2019
Due Review:        04/2022

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.

Regarding:  Hydrocarbon External fixators in a monoplace chamber.

We are not aware of any Hydrocarbon external fixators and without more information we are offering a generic statement with regards to fixators. External fixators are, in general, safe in the monoplace chamber, but they should be padded to protect the chamber from damage if the patient has a seizure or if the fixator has contact with the chamber window in some manner.

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.

Have we definitively proven any tapes to be safe in the monoplace environment, and can the data be viewed?

Published Date:   5/2016
Review Date:       4/2019
Due Review:        4/2022

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.

Regarding: Proof of any tape being safe in the monoplace environment:

The UHMS Hyperbaric Oxygen Safety Committee cannot recommend a specific product or type of product to be used as adhesive tape in the Monoplace Hyperbaric Environment. The decision to allow items containing adhesive that would increase the fuel load within the hyperbaric environment should be made carefully, and made only by the Hyperbaric Safety Director and Hyperbaric Medical Director. Careful consideration with respect to the flammability, MSDS rating, amount, potential vapors released, and fuel load added to the environment must be taken. The NFPA identifies that special consideration must be given to flammable vapors.

NFPA 99 (2018) 14.3.1.6.4.4 Physician and safety director approval to use prohibited items shall be stated in writing for all prohibited materials employed. (See A.14.3.1.3.2.)

NFPA 99 (2018) 14.3.1.3.2.3 The safety director shall have the authority to

restrict or remove any potentially hazardous supply or equipment

items from the chamber.

NFPA 99 (2018) 14.3.1.6.2.3 Flammable liquids, gases, or vapors shall not be

permitted inside any Class B chamber.

If flammable vapors are not present, a risk assessment should be performed and documented; any mitigations must be applied prior to treatment. A full description of a material risk assessment can be found in NFPA 99, Chapter 14, Appendix A, A.14.3.1.6.4.3.

Additional support for this approach can be found within the references below:

References and Additional Resources:

ASTM G04 Committee: Compatibility and Sensitivity of Materials in Oxygen Enriched Atmospheres

NFPA 53, 2016 edition Recommend Practice on Materials, Equipment, and Systems Used in OEA

NFPA 99, 2018 edition, chapter 14 and annex material

Bernatchez SF, Tucker J, Chiffoleau G “Hyperbaric Oxygen Therapy and Oxygen Compatibility of Skin and Wound Care Products” Adv Wound Care (New Rochelle). 2017 Nov 1;6(11):371-381. doi: 10.1089/wound.2017.0742.

https://www.liebertpub.com/doi/pdfplus/10.1089/wound.2017.0742

Safety Data Sheet (SDS) (Note: these ratings apply to air environments at 1 ATA)

The UHMS Web site, Safety Documents section contains an extended list of references: https://www.uhms.org/publications/safety-documents/safety-references.html

UHMS Facility Accreditation Manual, 4th edition

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.

If a metered dose inhaler was to be used in a chamber would the dose delivered be the same as if given at 1 ATA?

Published Date:   7/2016
Review Date:       7/2019
Due Review:   7/2022

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.

Regarding: Use of a metered dose inhaler (MDI) in a hyperbaric chamber.

There is an article on the topic of the use of MDI in a multiplace chamber, UHM 2009, Vol. 36, No.1 Inhaler Performance under Hyperbaric Conditions. The conclusion was “We conclude that the weight change per actuation of albuterol and the sizes and numbers of aerosol particles emitted from albuterol MDI’s actuated in a hyperbaric environment varied by canister type.”

This paper can be a useful reference when evaluating asthmatic – COPD patients. The final decision needs to be made by the medical director after a thorough risk assessment & weighing other options. 

There are some additional thoughts the SC would include on this topic.

• The Mechanical Delivery, which is adequately addressed by the referenced study.
• The Pharmacological component which is also addressed by the study.
• Due to delivery variations associated with MDI’s, a random survey of facilities indicates that there are a number of approaches which often include additional “puffs”, especially when delivery is through an ETT.
• The use of a spacer or holding chamber is highly recommended for MDI delivery as it improves particle deposition in the airway.
• The Safety Data Sheet for the propellant indicates that it is non-flammable and has a flammability rating of zero.
• In personal communications, at least one manufacturer indicates that their MDI’s do deliver the prescribed dose at various barometric pressures, admittedly this has not been tested by the manufacturer at 2-3 ATA.
• This device should not be used during compression or decompression to avoid barotrauma

References

Johnson GA, Gutti VR, Loyalka SK, “Albuterol metered dose inhaler performance under hyperbaric pressures.” Undersea Hyperb Med. 2009 Jan-Feb;36(1):55-63. 

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

Can safety committee provide and update on titanium in HBO. Dr. Weaver answered a question about this at the Winter Symposium in SLC.

Published Date:   6/2016
Review Date:       6/2019
Due Review:        6/2022

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.

Regarding:  An update regarding the decision process for whether or not a piece of equipment having titanium components will be allowed in the hyperbaric chamber will be presented.

The 2018 NFPA 99 Health Care Facilities Handbook, 14.3.2.5* prohibits equipment made from cerium, magnesium and magnesium alloys in the hyperbaric chamber.  There is concern expressed within the handbook annex, A14.3.2.2 regarding the potential risk of many products. Iron alloys, aluminum, human skin, plastic tubing etc may not self-extinguish. Titanium and Titanium alloys are not specifically prohibited in the hyperbaric chamber by NFPA 99.

Oxygen compatibility testing is complicated and there is little data available for materials in clinical chambers, self-ignition temperatures are generally unknown in special atmospheres. The concern is that if a piece of titanium is broken, enough energy could be produced by the stress fracture to ignite the titanium in a high oxygen environment. 

All equipment taken into a hyperbaric chamber should be evaluated for any associated risk. 

Equipment made of titanium and titanium alloys should be evaluated before use in the hyperbaric chamber. Each product should be evaluated before use.  A common example is the titanium eyeglass frames. It is unlikely that a patient wearing eye glasses made from a titanium alloy would be able to break the frames with enough energy to initiate combustion at 30 psig and near 100% oxygen. Further, multiplace and monoplace chambers operate under the threshold temperatures for a flammability concern with solid titanium.  The loose powder or fines of titanium that are a concern are not present with this device.   Any amount of powder, or filings, should never be allowed into the chamber. Manipulation of eyeglass frames or jewelry while in the hyperbaric chamber should be prohibited.

1. Evaluate each piece of equipment containing titanium or titanium alloys before using in the chamber.
2. Document the process
3. Solid titanium is safe to use in the chamber during normal operations.

References

NFPA 99 Health Care Facilities Handbook 2018 edition

Corrosion Resistance of titanium, Titanium Materials Corporation, TIMET, pp20 figures 13 & 14

Electronics Space Products International, MSDS Sheet, Titanium, (Ti)

Safety-Related Problems in the Titanium Industry in the last 50 years, Poulsen, JOM, 52 (5) (2000), Safety Guidelines, pg 5 & 6, #5 

A study of the mechanism of the titanium – liquid oxygen explosive reaction, Technical Report ASD-TR-61-479, Directorate of Materials and Process Aeronautical Systems Command, Wright-Patterson Air Force Base, Ohio

Titanium in a Hyperbaric Oxygen Environment May Pose a Fire Risk, AviatSpace Environ Med 2003; 74:1301-2

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

Can laptop computers be safely operated inside a Class A multiplace environment? What precautions must be taken? Can the computer be operated on battery power? Can the computer be operated on 120 V power? Please explain all safety related issues and regulatory compliance issues.

Thank you for your question. The UHMS hyperbaric oxygen safety committee (SC) can provide information but the ultimate responsibility for these types of questions is with the medical director and safety director of your facility.

Regarding: Laptop computers in the multiplace

Thank you for the question, this has provided a stimulating conversation. With electronic charting being mandated in the USA it would be attractive to be able to have a laptop in the chamber for patient care purposes. We would not consider a laptop for patient or staff entertainment as this purpose would not be necessary for the treatment and therefore would be prohibited by 2015 edition of NFPA 99, 14.2.8.3.3, Only portable equipment necessary for the safe operation of the chamber and for required patient care shall be permitted in the chamber.

This question is not one that the SC can provide a definitive answer for. A careful risk assessment provided by a competent person must be completed. We are able to provide some general thoughts on the matter; we had opposing viewpoints within the committee. The USN has evaluated two commercial off the shelf “ruggedized” laptops for use in disabled submarines in hyperbaric conditions up to 5 bar. One failed, one worked, we have attached the study for your convenience. There is at least one manufacturer that provides a laptop for use in saturation diving chambers to 450 MSW or 18 msw in 25% O2 in hyperbaric chambers. Therefore, yes it can be done; and no, not all the SC members agreed that we would allow laptops in the clinical multiplace chamber. A detailed risk assessment and testing of the device would need to happen before this was considered. We are not aware of any clinical chambers that are providing laptops in the chamber. We are aware of facilities in the USA and Europe that have installed the monitor, key board and mouse inside the chamber with the CPU outside the chamber. There is at least one facility that installed the CPU inside the chamber as well. So there are alternatives to consider.

Things to consider:

• The battery pack should be removed. Lithium – cobalt is the most unstable of all the lithium – ion chemistries and Lithium batteries are currently prohibited in the NFPA 99. Please see that attached reference articles. The devise should be able to operate on the multiplace 24 volt supply without the battery pack.
• The fan helps keep the CPU cooled down.  The fan is designed to operate in a 1 atmosphere environment.  When used at elevated pressures they are trying to move dense air and the additional work load may cause the fan motor to overheat and shut down, causing the CPU to overheat. The SC had differing views on this topic; air density may in fact cause the CPU to run cooler, although we do not know if this increased density would cause the fan motor to overheat.
  NFPA-99 14.2.8.3.12 TEMPERATURE
  No electrical equipment installed or used in the chamber shall have an operating temperature in excess of 85⁰C (185⁰F)
• The battery and 120V considerations, we are not allowed to charge batteries while the chamber is in use. Many devices are designed to charge the batteries if they are plugged into a 120 V supply. Removing the batteries and providing a 12V supply may be an option for some devices
  NFPA-99 14.2.8.3.17.5 Battery-operated devices
  (4) Batteries or battery-operated equipment shall not undergo charging while located in the chamber.
  (7) Lithium and Lithium ion batteries shall be prohibited in the chamber during chamber operations, unless the product has been accepted or listed for use in hyperbaric conditions by the manufacturer or a nationally recognized agency.
• NFPA-99 14.2.8.3.10*Concern noted in meeting the requirements of Receptacles inside the chamber, specifically that interruption of power, even low voltage, could produce a spark with enough energy to ignite a flammable agent.
• Consider inert gas purging of the device.

We hope this helps and look forward to seeing your abstract at a future ASM or UHM journal article on this topic.

DanMedical Analysis System1.94 MB

DanMedical Product Information September 2014554.68 KB

Hydra Engineering D-MAS HyperSat250.33 KB

NSMRL TECHNICAL REPORT #1220965.05 KB

Flammability Assessment of Bulk-Packed, Rechargeable Lithium-Ion Cells in Transport Category Aircraft752.02 KB

DISCLAIMER

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

We currently have a new HBO patient that is requesting to have water in the chamber with "Thick-It" added as he has swallowing issues. Does anyone have experience with this or have any reason to not have this in the chamber. The only ingredients are modified food starch and maltodextrin.

Published Date:      10/2016
Review Date:         10/2019

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.

There are no issues with patients consuming “Thick-It” in the hyperbaric chamber regardless of monoplace or multiplace.

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.

Can patients be safely treated with an existing peritoneal dialysis catheter? Are there any precautions that need to be taken prior to therapy?

Published Date:   5/2016
Review Date:       5/2019
Due Review:        5/2022

This is a question for your medical director, there may be medical reasons why this patient should or should not be treated in the chamber.  The catheter in and of itself does not present a safety hazard in the chamber.

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 HBO2 in a monoplace chamber if the individual is having a BSN fiberglass cast put on biweekly?

Published Date:      11/2016
Review Date:     11/2019

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.

Regarding: BSN Fiberglass cast in a monoplace chamber.

The manufacturer of the cast states that the curing levels reach a high point after approximately 1.5 hours and suggests that hyperbaric therapy could commence soon after the cast was applied. There is also an abstract on http://archive.rubicon-foundation.org/10534 regarding a plaster surgical cast during hyperbaric oxygen therapy.

We see no reason that a patient could not be treated in a monoplace chamber when the BSN fiberglass cast is applied bi-weekly. You are encouraged to follow the manufacturer’s recommendation of 1.5 hours as a minimum prior to hyperbaric therapy. The cast should be wrapped with a soft cotton or minimum 50% cotton / poly blend blanket or towel to protect the chamber acrylic from damage in case of a seizure.

References:

BSN Medical manufacturer notice regarding the fiberglass cast and HBO2

UHMS 2012 ASM, abstract Safety of Plaster Cast Material During Hyperbaric Oxygen Therapy.

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.

Should a hair weave or extension with Keratin glue be allowed in a monoplace or multiplace hyperbaric chamber? Any precautions or information you can provide regarding this matter would be appreciated.

Q: 
Should a hair weave or extension with Keratin glue be allowed in a monoplace or multiplace hyperbaric chamber? Any precautions or information you can provide regarding this matter would be appreciated.

A: 
Thank you for your question. The UHMS HBO2 safety committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the medical director and safety director of your facility.

• Regarding the material: NFPA 99, (2021) 14.3.1.6.2 and annex material is related to textiles and wound dressings. It is not specifically written to address hair extensions.  The risk assessment process should be used to evaluate any material being introduced into the hyperbaric environment.
• Regarding any hair products:
  • NFPA 99, (2021) 14.3.1.6.5 – The use of flammable hair sprays, hair oils, and skin oils shall be prohibited for all chamber occupants/patients as well as personnel.
  • NFPA 99, (2021) 14.3.1.6.5.2 – All cosmetics, lotions and oils shall be removed from the patient’s body and hair.
• Multiplace:  If the patient can tolerate it, consider using a mask for oxygen administration
• Monoplace or hood:  Comments from the HBO2 Safety Committee that may assist you in the risk-assessment process:
  • Consider the volume of weave/hair extensions (understand there is a difference between the two!  Although some people use the two synonymously)
  • Consider the volume of real hair.
  • List all of the material(s) involved: real hair, synthetic hair, metal(s), glues, cure time of adhesive(s), etc.
  • Consider the washing history, chemical(s) used on it, etc.
  • Does your facility have the ability to humidify a hood circuit?  If so, and research data doesn’t bring up any major RED flags, consider humidifying the hood.  As always, the facility needs to determine the definition of RED flags.
  • For some types of weaves/hair extensions there is a service life (recommended to be changed out every “X” amount of time).  If non-emergent, when does the patient plan on getting them removed/changed out anyway?
• For risk assessment purposes, we recommend reviewing the Safety Data Sheet (SDS) for the Keratin glue. We are not aware of any studies of Keratin glue performed at pressure in an oxygen filled monoplace or an air filled multiplace.
• The UHMS HBO2 safety committee’s consensus is:
  • If the wig or extension is easily removed then we recommend removing the item. We recognize that not all hair extensions are glued in and some are not synthetic.
  • If the item is not easily removed, consider a tight-fitting cap to cover the extension or wrapping with a damp cloth to mitigate any static concerns. Of primary concern is the flammable vapors emitted from hair products that have been applied shortly before a hyperbaric treatment.
  • Allotting time for these flammable vapors to off-gas is important. The ultimate decision to allow or mitigate this item should be made by the Hyperbaric Safety Director and Hyperbaric Medical Director of your facility.
• We recognize that removal of a glued-in weave or hair extensions can be a financial or personal hardship for the patient, but consider encouraging the patient to have glued-in products removed. If this is not possible, consider the mitigations mentioned above.

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

I am curious what your thoughts are on the use of aerosolized anti-fungal spray directly prior to treatment in a monoplace chamber. The spray in question is generic miconazole nitrate, and the main propellants are isobutane and alcohol.

I am curious what your thoughts are on the use of aerosolized anti-fungal spray directly prior to treatment in a monoplace chamber. The spray in question is generic miconazole nitrate, and the main propellants are isobutane and alcohol. Is there any documentation to identify how long after being applied the combustible propellants would be dissipated? I\'m inclined to err on the side of caution and say that it should be applied post treatment, but am having some push back from the physicians. Am I being overly cautious? Or is there any documentation to support my position?

Published Date:      01/2017
Review Date:         01/2020

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 SC would not encourage the use of this product prior to hyperbaric oxygen therapy. The Directions for Use found on-line list this product as flammable and to avoid inhaling the vapors. We would be concerned about both the flammability of the fumes as well as inhalation of the product. The flammability of the propellants used is concerning, especially in the high concentration of oxygen in the monoplace chamber. There are no studies we are aware of specifically for this product and its use in hyperbaric conditions. Using the Risk Assessment Guide found in the NFPA 99, 2018 Edition, Annex A: A.14.3.1.6.4.3, we would recommend waiting until after the hyperbaric treatment is over to apply this product.

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.

We have a question in refrence to a neurostimulator model # 3037 from Medtronic designed to stimulate a bowel movement. The unit is internal and can be remotely shut off. How safe would this unit be to introduce into a monoplace chamber?

Published Date:      05/2017       
Review Date:         05/2020
Due Review:          05/2023

Q:
We have a question in reference to a neurostimulator model # 3037 from Medtronic designed to stimulate a bowel movement. The unit is internal and can be remotely shut off. How safe would this unit be to introduce into a monoplace chamber?

A:
Thank you for your question. The UHMS hyperbaric oxygen safety committee (SC) can provide information but the ultimate responsibility for these types of questions is with the medical director and safety director of your facility.

The Directions for Use for the External unit 3037 (attached), Precautions states: Patient device use_ Equipment is not certified for use in the presence of a flammable or anesthetic mixture with air or with oxygen or with nitrous oxide. The model 3037 appears to be an external and not internally implanted device. There are different concerns for internal versus external devices in the monoplace. Further the NFPA 99, chapter 14 prohibits any electrical device other than physiological monitoring and communications in the Class B chamber.
Without more information: eg, do we have the correct model number, can the device be turned off, are there air spaces, etc…the SC would not encourage the use of this device in the monoplace chamber.

Respectfully,

The UHMS Safety Committee

INTERSTIM ICON® Model 3037 Patient Programmer User Manual

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've been consulted to treat a patient with an Ommaya reservoir for intrathecal chemotherapy. I've contacted the companies Integra and Medtronics and have been unable to get an answer on hyperbaric compatibility. Do you know if anyone has been treated with this device?

Published Date: 04/2017
Review Date: 04/2020
Due Review: 04/2023

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 potential patient going through clearance for HBO. He has a venous port which was placed in the hospital but was not documented properly. There is no record of manufacturer or serial number on his patient card or in his medical records. Are there any documented recommendations for hyperbaric treatment with a venous port in general? I can't ask for a letter with pressure rating without the information.

If this is a venous access port there is no issue. The only theoretical risk would be if the port contains air, in which case compression in the chamber could facilitate Blood backing into the port, which could facilitate clot formation.

What the protocol is for most facilities regarding having a purell hand sanitizer unit with an HBO area

Thank you for your question. The UHMS hyperbaric oxygen safety committee (SC) can provide information but the ultimate responsibility for these types of questions is with the medical director and safety director of your facility.

Question;

I am wondering what the protocol is for most facilities regarding having a Purell hand sanitizer unit with an HBO area.  I was always taught that you cannot use hand sanitizer within the unit, due to the 60% content of alcohol.  However, if a facility has no sink in the area, and would like to do some wound care, what are the options?

Wondering if the alcohol content of the hand sanitizer would be absorbed on your hands quickly enough that it is not a hazard to a patient you are preparing to place in the chamber, just like the alcohol wipes used to test blood sugars in the units, pre-treatment?

Any information/input you can provide would be useful, as each facility seems to have their own perceptions, and I would like to know for sure.

Regarding: Hand sanitizers in the hyperbaric suite

The Safety Committee would encourage you to work with your infection prevention department to develop a procedure for hand sanitizing. Hand washing is the preferred frontline infection procedure. We would encourage the installation of a sink in an area where any wound care / patient was being done. It is recommended that you wash your hands before and after touching a patient regardless of whether or not you are doing wound care.

Hand sanitizers come in alcohol based and non-alcohol based formulas. We have attached information on two of the non-alcohol based products for your consideration. The non-alcohol based products are not as effective as the alcohol based products. Neither the alcohol nor non-alcohol based kill C-Diff.

While some hyperbaric facilities have both alcohol based and non-alcohol based hand sanitizers available. Many hyperbaric departments have adopted the non-alcohol based products for use inside the multiplace chambers and for use in the room(s) housing the hyperbaric chambers. This practice has evolved due to the flammability of the alcohol based sanitizers. It has been established that alcohol based hand sanitizers can ignite in ordinary air and that it takes tens of seconds for the hand sanitizers to be absorbed into the skin before the alcohol fumes would not be a ready fuel. The FAA looked at this extensively (attached) as well as an interesting article from Popular Science https://www.popsci.com/science/article/2013-02/fyi-could-hand-sanitizer-make-you-catch-fire.

In hospitals and clinics, we have the added risk of oxygen enriched environments around our patients and the oxygen delivery devices. NFPA 99, 2018 edition, Health Care Facilities Code, chapter 11 has a definition of “the area of intentional expulsion” that is helpful in understanding this concern. We are looking at the area around a patient or device that has oxygen present. Usually the area a foot or so away from the source is no longer considered an oxygen enriched environment. For example, while the hyperbaric suite is not an oxygen enriched environment, there is a potential for there to be an area around the patient or an oxygen delivery device that is an oxygen enriched environment.

A Health Device Alert was published by the ECRI Institute, www.ecri.org, Fire Risk from Alcohol-Based Hand Sanitizers Worsens in Oxygen-Enriched Environments (Hazard Report) Health Devices 2006, Oct, 35(10):390. A fire occurred when a nurse in a neonatal unit used an alcohol based hand sanitizer and then, while still rubbing the sanitizer into the skin, walked toward the O₂/Air proportioner to change a setting. When the control knob was touched, a static spark caught the control knob and her hands on fire. Typically, such a discharge of static would not have caused this type of hazard…in this case three things were present: 1 An ignition source (static) - 2. Fuel (the still wet alcohol based sanitizer) - and 3. The oxygen enriched environment around the device (the proportioner leak, and bleed port discharging O₂).

ECRI’s recommendations at the time were to: 1. Alert users; and 2. Direct clinicians to ensure that when they use an alcohol based hand sanitizer, to insure that it has fully evaporated before touching devices, linens, or patients. When the clinician’s hands feel dry and the cooling sensation associated with evaporation is gone, the alcohol vapors should be adequately dissipated.   

We have attached an abstract from the 2009, UHMS Annual Scientific Meeting that evaluated the non-alcohol based product as further reference on this topic.

There is another concern regarding the alcohol based hand sanitizer that should be recognized. We tend to focus on the fire concern. Alcohol products should not be used on the acrylic windows of a hyperbaric chamber. The acrylic could be damaged by someone touching the chamber while the alcohol based sanitizer is still wet.

For reference please see:

• Patient Safety Authority 2006
• Fire Testing of Ethanol-Based Hand Cleaner
• Safety Data Sheet: PURELL® SF607™ Hand Sanitizer Foam
• UHM Journal: 2009; Vol 36 #4: pg 317: 2009 ASM: E8 Abstract: An evaluation of alcohol-based products in monoplace hyperbaric chamber facilities: Introduction to safer alternatives
• CleanLife: InstantFoam Non-Alcohol Hand Sanitizer

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 would like to find out if Iodoflex medication is allowed in the Monoplace Hyperbaric Chamber. Upon reviewing the MSDS for this product sold by Smith and Nephew, there is no flammability.

The SC commends you for completing your research before asking the question. We have no specific test data on this product in the monoplace chamber. The SDS sheets are based on air environments at sea level ambient pressure. In 2016, ASTM G72/G72M, Standard Test Method for Autogenous Ignition Temperature of Liquids and Solids in a High-Pressure Oxygen-Enriched Environment, added a test procedure for testing materials in oxygen-enriched environments at pressures less than 300 psig (2068 kPa).

• Prior to 2016, no appropriate standard existed for testing materials in the low-pressure oxygen-enriched atmosphere (OEA) of a hyperbaric chamber.
• The ASTM G72/G72M standard is not a “pass/fail” test. It provides data on the autoignition temperature (AIT) of a material in a low-pressure OEA.
• Although performance limits for AIT have not been set, the data from this ASTM test are valuable in determining the relative ease of ignition of materials.
• The user is referred to ASTM G72/G72M-15, Section 8.2.3, Special Case 2, for testing at pressures less than 2.1 MPa (300 psig).

We encourage manufacturers to test their products using this new procedure.

The SC collective opinion is that, given the physical properties of this product (no flashpoint) the only possible problem (extremely remote) is the respiratory irritation.  Given the lowest ventilation rate on a class, B chamber is 80 liters per minute we find no reason why this should not be allowed in both class A & B chambers 

Safety Data Sheet: IODOFLEX™ Dressing

DISCLAIMER
Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members can provide medical diagnoses or recommendations for equipment over the internet.  The responsibility for medical diagnoses and treatments resides with the medical director; 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.

I have a question concerning the acceptability of materials for use in hyperbaric chambers. Specifically, the use of a HoverMatt transfer air mattress in a multiplace chamber?

Regarding: (1) The use of the HoverMatt  transfer air mattress in the multiplace chamber and (2) criteria for materials testing in a class a or B chamber.

(1) The HoverMatt in the multiplace chamber:

The Safety Committee would commend you on the work you have already done in compiling safety material related to the use of the HoverMatt. This is the type of information the hyperbaric safety director will need to gather in order to make an informed decision. NFPA 99, 2018 edition 14.3.1.6.4.3, places the responsibility of this decision on the physician and safety director of the facility. While the attached pdfs are information obtained in an air atmosphere at ambient pressures, they do provide some guidance in deciding whether or not to allow the HoverMatt in the multiplace. In general we would not see a problem with this device in the multiplace. This type of material would normally be on the No/Go list. For patient care and safety of staff versus a low risk of static or ignition we would consider allowing it in the multiplace.

Things to consider:

• Is it required and if so is there an alternative?
• Document the exception the process you used, why and for how long you are allowing this product, and have the medical director and safety director sign off on the approval.
• Have a check list to insure the hyperbaric staff are all doing the same procedure for this device (eg: remove the blower motor prior to compressing the chamber).
• Keep in mind the total volume of combustibles allowed in the chamber

 (2) Test for materials in a class A or B chamber.

The Material Testing Advisory Committee has been working on the development of a standardized test that could be used to evaluate materials in a low pressure oxygen environment. As of last summer, we have a test process in ASTM G72/G72M, Standard Test Method for Autogenous Ignition temperature of Liquids and Solids in a High-Pressure Oxygen –Enriched environment. The ASTM G72/G72M is not a pass fail test. It provides data on the autoignition temperature (AIT) of a material. For low pressures such as a clinical chamber, the user is referred ASTM/G72/G72M-15, Section 8.2.3, Special case 2, For testing at pressures less than 2.1 MPa (300psig). This test can be performed at a qualified testing facility, such as WHA International, in Las Cruces, New Mexico. We have been asking people to encourage our venders to use this test on their products. Please take a look at the link on the UHMS website, for a great article on this topic, https://www.uhms.org/publications/safety-documents/safety-articles.html. Hyperbaric Oxygen Therapy and Oxygen Compatibility of Skin and Wound Care Products.

Hovermatt static testing summary
Hovermatt brochure
Intertek: 16 CF 1610-97: Consumer Product Safety Commission Flammability Standards for Clothing Textiles: Test Report
Intertek: 16 CFR Part 1632.4 (1997): Flammability of Mattresses and Mattress Pads (FF 4-72, Amended): Test Results

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

What are the UHMS's thoughts/stance, if any regarding the use of hydrofera blue within the HBO2 environment? We find it versatile for broad-spectrum bacteriostatic protection. It's MSDS states that it's polyvinyl alcohol (PVA) construction is stable with a flash point above 200 Celsius. Please let me know what your thoughts are regarding it's safety or lack there of inside the chamber?

SC Response regarding Hydrofera Blue Safety in the hyperbaric chamber

We understand that the word “alcohol” may be concerning when considered for use in a hyperbaric chamber. This is a valid concern; however, the concern should consider the context in which alcohol is being utilized, and in what chemical structure.

Please see the attached letter from Hydrofera (prior to Hollister ownership).

The UHMS Material Testing Advisory Committee (MTAC) oversaw the testing of Hydrofera Blue READY™ (this product has no PVA), which determined an autogenous ignition temperature (AIT) of 259°C (498°F) at 59 psig (5 ATA).

The AIT is a determination of the temperature at which liquids and solids will spontaneously ignite when heated in an oxygen-enriched environment, without the application of spark, flame or any other positive ignition mechanism.

The test result of Hydrofera Blue READY™ cannot not be used for Hydrofera Blue, however, if you would like to consider an option, the Hydrofera Blue READY product may carry a greater assurance of safety.

It is our collective opinion that either product is appropriate for use in the hyperbaric environment as an effective disinfectant and carries no enhanced flammability concerns.

However, this product is not listed as being suitable for use with chamber acrylic windows.

Letter from Hydrofera (June 10, 2009)

DISCLAIMER
Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members can provide medical diagnoses or recommendations for equipment over the internet.  The responsibility for medical diagnoses and treatments resides with the medical director; 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.

I would greatly appreciate if you have any information on the safety and use of Ear Planes in the HBO chambers. As we had spoken I could not find any references to validate usage.

Thank you for your question. The UHMS Hyperbaric Oxygen Safety Committee (SC) can provide information but the ultimate responsibility for these types of questions is with the medical director and safety director of your facility.

Regarding: The use of EarPlanes in the hyperbaric chamber.

The EarPlanes are advertised for low flow and low-pressure use, such as in an airplane. There is a little porcelain regulator in the center of the device that could fail or be removed. This could expose the outer ear to a higher level of flow and pressure when in a hyperbaric chamber, causing pain or damage

In general, the use of pressure–equalizing earplugs or ear plugs in general is discouraged in a hyperbaric chamber. An article published in 2005 Aviation Space Environmental Medicine, Nov:78(11): 1079-82, for flight that found that such a device caused a reduction in sound levels, but provided no significant relief in equalizing pressure.

( https://www.ncbi.nlm.nih.gov/pubmed/16313146 )  The pressure changes in a hyperbaric chamber are significantly than those experienced in an aircraft.

We are aware of centers that allow patients to make their own decision to use pressure-equalizing ear plugs, but only in the multiplace environment, as there is an inside attendant to monitor and help if there is any discomfort. The majority of comments from the SC members indicated that they would not allow these to be used. The potential for injury to the patient exists, as well as the practical matter of the recommended slower than normal rate of compression than typically used in hyperbaric medicine.

Requests to the manufacturer of EarPlanes to see if they have ever been tested under hyperbaric conditions, proof of their effectiveness, or any recommendations that these devices can be used in the hyperbaric environment have not been answered. There have been reports in the past of other similar devices (no longer available) that were not supported by the manufacturer for use under hyperbaric pressure.

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.

Thank you for returning my call. I called you to ask a question about a device used to transmit blood glucose values to a free standing meter that our patient had attached to his abdomen. The device is a Dexcom G5 Continuous Monitoring System. I looked the device up on line and could not any information about it's use in hyperbaric chambers. I called the manufacturer and was told it was never tested for hyperbaric chamber use. Have you ever had any experience with this device or know someone who has any

Thank you for your question. The UHMS hyperbaric oxygen safety committee (SC) can provide information but the ultimate responsibility for these types of questions is with the medical director and safety director of your facility.

Regarding: Dexcom 5 Continuous glucose monitoring system in the hyperbaric chamber.

As far as we are aware, the Dexcom has not been evaluated for use in hyperbaric conditions. One of our SC committee member had conversations with Dexcom regarding evaluating the G4 for use in hyperbaric conditions in 2015. The conversation went as far as legal documents and stopped there.  The evaluation of this system under hyperbaric conditions is something that would good to pursue at some point. 

Consider removing the transmitter and leave the sensor in place for the hyperbaric oxygen session.  The Gen4 Instructions For Use say not to do this, but the sensors are expensive.  We are aware of at least one patient treated in the monoplace by removing the transmitter for the treatment and re-installing the transmitter back in the sensor after the treatment. In all cases the receiver would be left outside of the chamber. 

We have been made aware of a multiplace facility that has left the transmitter and sensor for the Dexcom G5, on the patient and the receiver positioned outside the chamber. We are not aware of anyone using this device in the monoplace.  Unless the manufacturer allows their device to be exposed to hyperbaric conditions, we would remove it.

Medtronic has a similar device that has been evaluated in hyperbaric and hypobaric conditions, article below.

Abbot has one as well, for sale in Canada, not the states as of yet

In summary:

Similar sensors have shown to operate within specification under hyperbaric conditions.

Similar sensors have shown no adverse effects due to hyperbaric / hypobaric exposures.

Only the transmitter and the receiver have electrical power sources.

The transmitter can removed before treatment.

The removal of the transmitter from the sensor can be done easily enough without harming the patient.

The transmitter has a built-in battery and cannot be recharged.

We have not evaluated the device to determine if there are trapped airspaces in the sensor (nor the transmitter).

Article: In-Vitro Performance of the Enlite Sensor in Various Glucose Concentrations during Hypobaric and Hyperbaric Conditions; Journal of Diabetes Science and Technology
Volume 6, Issue 6, November 2012

DEXCOM: CONTINUOUS GLUCOSE MONITORING SYSTEM Receiver with ShareTM

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 dive a patient with cochlear implants? Are there any special precautions that need to be taken.

Thank you for your question. The UHMS hyperbaric oxygen safety committee (SC) can provide information but the ultimate responsibility for these types of questions is with the medical director and safety director of your facility.

As with many medical devices considered for exposure to hyperbaric conditions, the Safety Committee recommends consultation with the device manufacturer and proceeding with caution. The UHMS Safety Committee is aware of several hyperbaric centers that would remove the external portion of the device, leaving the titanium implant in place. This is a reasonable approach, as it is possible that the external device could be damaged by changes in atmospheric pressure. Furthermore, the energy generated by the battery is a heat source that could potentially cause harm to a patient receiving hyperbaric oxygen therapy.

Additional considerations should be given to the ability to communicate with the patient during therapy. Furthermore, we would advise that any medical concerns derived from the removal of this device be bought to the attention of the patient’s Otolaryngologist.

There are resources available to the public that may be of assistance when managing the safety of patients with cochlear implants:

Cochlear ENVIRONMENTAL ISSUES CATALOGUE (JUN 2011)202813 Issue: 9.C, Page 96 of 109 (Attached)

J Oral Maxillofac Surg. 1999 May;57(5):493-9. “Osseointegrated implants in irradiated bone: a case-controlled study using adjunctive hyperbaric oxygen therapy.”

Backus D. et.al., Effects of Hyperbaric Exposure on the Integrity if the Internal Components of Commercially Available Cochlear Implant Systems, Otology&Neurotology (2002) 23:461-467

Hyperbaric Oxygen TreatmentHyperbaric Oxygen TreatmentCategory: Mechanical Impact; Pressure

DISCLAIMER

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

I am looking for any information on the laundering of hyperbaric linens. Is there a special process ? Are there only certain detergents that can be used ? Is the process and detergent different for class A or B chambers ?Are we to monitor the linen company ? Any advice and input would be greatly appreciated.

Regarding: Information on the laundering of hyperbaric linens.

The SC responded to a similar question on 11-25-2016 and that reply is attached here for your convenience. As far as a special process, we are not aware of a special process due to the hyperbaric chamber. There are Health Department requirements for hospital linen and OSHA requirements for public supply that would apply regardless of whether your chamber is located in a hospital or free standing and supplied by a contractor.

The process and detergents would be the same for class B or class A chambers. We would encourage non-scented products due to reported adverse reactions for  patients and staff. There is very little data on detergents or static reducing products for use in hyperbaric conditions. There is data on flammability of detergents, in air at 1 atm, especially with children’s clothing. All laundry cleaning products should be rated as a risk category 1 by the Safety Data Sheet.

We would encourage you to monitor the linen supply company (or linen supply in house), not only to insure that the proper, detergents,  temperatures, water quality and handling are being done, but also to insure that the linen meets NFPA 99, 2015 edition, 14.3.1.5.4 textiles.

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.

Has anyone had any experience with a Dexcom G5 transmitter for management of diabetes?. The sensor is attached to the patient and is battery operated.

Thank you for your question. The UHMS hyperbaric oxygen safety committee (SC) can provide information but the ultimate responsibility for these types of questions is with the medical director and safety director of your facility.

Regarding: Dexcom 5 Continuous glucose monitoring system in the hyperbaric chamber.

As far as we are aware, the Dexcom has not been evaluated for use in hyperbaric conditions. One of our SC committee member had conversations with Dexcom regarding evaluating the G4 for use in hyperbaric conditions in 2015. The conversation went as far as legal documents and stopped there.  The evaluation of this system under hyperbaric conditions is something that would good to pursue at some point. 

Consider removing the transmitter and leave the sensor in place for the hyperbaric oxygen session.  The Gen4 Instructions For Use say not to do this, but the sensors are expensive.  We are aware of at least one patient treated in the monoplace by removing the transmitter for the treatment and re-installing the transmitter back in the sensor after the treatment. In all cases the receiver would be left outside of the chamber. 

We have been made aware of a multiplace facility that has left the transmitter and sensor for the Dexcom G5, on the patient and the receiver positioned outside the chamber. We are not aware of anyone using this device in the monoplace.  Unless the manufacturer allows their device to be exposed to hyperbaric conditions, we would remove it.

Medtronic has a similar device that has been evaluated in hyperbaric and hypobaric conditions, article below.

Abbot has one as well, for sale in Canada, not the states as of yet

In summary:

Similar sensors have shown to operate within specification under hyperbaric conditions.

Similar sensors have shown no adverse effects due to hyperbaric / hypobaric exposures.

Only the transmitter and the receiver have electrical power sources.

The transmitter can removed before treatment.

The removal of the transmitter from the sensor can be done easily enough without harming the patient.

The transmitter has a built-in battery and cannot be recharged.

We have not evaluated the device to determine if there are trapped airspaces in the sensor (nor the transmitter).

Article: In-Vitro Performance of the Enlite Sensor in Various Glucose Concentrations during Hypobaric and Hyperbaric Conditions; Journal of Diabetes Science and Technology
Volume 6, Issue 6, November 2012

DEXCOM: CONTINUOUS GLUCOSE MONITORING SYSTEM Receiver with ShareTM

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

What is the current consensus on the safety compatibilty of various wound care creams/products in the hyperbaric oxygen environment? There are currently so many products that patients are coming with it is difficult to keep up. Are there any that are absolutely contraindicated?

Thank you for your question. The UHMS hyperbaric oxygen safety committee (SC) can provide information but the ultimate responsibility for these types of questions is with the medical director and safety director of your facility.

Regarding: Safety of various wound care products and any absolute contraindications.

Thank you for your question, and we appreciate your diligence regarding hyperbaric safety. It appears as though you are asking three questions, so we will attempt to provide a useful response to address your concerns.

Submitter’s questions:

1. What is the current consensus on the safety compatibility of various wound care creams?
2. What is the current consensus on the safety compatibility of various wound products?
3. Are there any creams/products that are absolutely contraindicated?

SC response:

Within NFPA 99-2018, Chapter 14, the authority to approve an item (creams, dressing, and devices) for use within a hyperbaric chamber is delegated to the Physician-in-Charge (Medical Director) with the concurrence of the (hyperbaric) Safety Director; meaning you need two people to agree when allowing an item.

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

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

The testing of products conducted by the UHMS Materials Testing Advisory Committee shows us that heat is our most significant concern. Therefore, the elimination of heat or static discharge sources,  is essential to every hyperbaric program.

As for the cream, it is important to understand the ingredients of the cream (ointment or gel) to know if the product has the potentially to off-gas flammable vapors. Should this be the case, you would prohibit that item or product from going inside the chamber.

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

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

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

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

Can you share information or recommendations regarding the use of a Freestyle Libre Sensor (glucose monitor) during HBOT?

Thank you for your question. The UHMS hyperbaric oxygen safety committee (SC) can provide information but the ultimate responsibility for these types of questions is with the medical director and safety director of your facility.

Recently, medical device manufacturers have marketed new, sophisticated continuous glucose monitoring (CGM) devices. These can be an effective tool for diabetic patients that can aid them in the management of their glucose. However, these devices may not be safe under hyperbaric conditions. It is important that the safety director of your facility assesses the risk of these devices.

The UHMS Safety Committee frequently receives requests to review blood glucose monitoring devices for use in hyperbaric chambers. Some manufacturers of these devices have stated the devices are not safe in a hyperbaric chamber or have not been tested under pressure. Some do not. Therefore, the first step in assessing the risk of these devices is a direct call to the manufacturer’s technical support team.

Keep in mind that some CGM devices use an oxidative process to assay for glucose. We are concerned that this reaction may be altered under hyperbaric conditions. We also realize that the dressing or patch worn by the patient is a transmitter which emits or senses an electronic impulse. This signal is then wirelessly passed to the monitor to display the result. We are not aware of any testing performed in hyperbaric environments to ensure the continuity of performance of this particular transmitter.

We are aware of facilities that have chosen to leave the sensor in place and remove the transmitter for the hyperbaric treatment. This may not be possible with some models and is not described in the directions for use from the manufacturer. The transmitter and receiver would remain outside of the chamber in all cases.

After further review, information from the manufacturer states that: “the device has not been tested under pressure, nor in a high oxygen environment. We do not support this device for use in a hyperbaric chamber”.

Based on these findings, the UHMS Safety Committee recommends the following:

• Consider other methods by which the patient’s blood glucose is monitored
• Consider managing the patient’s blood glucose as you would for a patient who did not utilize this device
• Encourage the manufacturers to have these devices evaluated for use in hyperbaric conditions

Additionally, there are public articles related to this topic that may be of interest to you.

• In-Vitro Performance of the Enlite Sensor in Various GlucoseIn-Vitro Performance of the Enlite Sensor in Various GlucoseConcentrations during Hypobaric and Hyperbaric Conditions
• Glucose Monitors, Continuous

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.

Good morning All, Currently we have been using a Oscillomate 1630 for our NIBP in our monoplace chambers. it appears that our monitor is end of life. We are having difficulty locating a suitable replacement. Does anyone here currently use a device for NIBP in monoplace? If so what monitor are you using? Thank you.

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 committee is not aware of any replacement on the market for the Oscillomate 1630 that would be compatible with the monoplace chamber.

An option for your consideration would be to measure blood pressure with the assistance of an ultrasonic Doppler device, as described in the references below. However, please note that the experience described in the two references relied on a good degree of technical expertise, did not specifically endorse that particular product, and did not address the FDA approval aspects. Considering that this example describes an alternative method of Non-Invasive Blood Pressure monitoring, we strongly recommend that the user seek the expertise of biomedical engineering experts prior to considering this option.

Whelan, H. T., & Kindwall, E. P. (2017). Hyperbaric Medicine Practice, 4th Edition, “Management of Critically Ill patients in the Monoplace chamber.”  Best Publishing Company

Weaver LK, Howe S. (1991). Non-Invasive Doppler Blood pressure Monitoring in the Monoplace Hyperbaric Chamber Journal of Clinical Monitoring 1991:7(4) 304-308

Bell JE (2011). UHMS ASM presentation, “Non-invasive Doppler blood pressure monitoring in the Monoplace Hyperbaric Chamber.”

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.

What types of pillows can be used in the Monoplace chamber? Can we utilize reusable pillows?

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.

Regarding pillows approved for use in Monoplace chambers: One should be careful not to allow just any pillow into the monoplace chamber. The National Fire Protection Association (NFPA) 99, “Health Care Facilities Code,” 2021 edition contains a section regarding textiles (14.3.1.6.4) that provides guidance on the decision process for textiles, garments and wound care products.

We suggest that a proper risk assessment be initiated by the Safety Director of the hyperbaric program. The risk assessment found in section A14.3.1.6.4.3 is written for hyperbaric wound dressings, but the process is useful for other items as well. The Safety Director should consider using this risk assessment when making decisions about pillows to be used in the hyperbaric environment. Furthermore, section 14.3.1.6.4.4 calls for written approval by the Safety Director and Medical Director for prohibitive items to be allowed. The Safety Committee suggests that this code applies to the acceptance or disapproval of pillows.

You may wish to review these safety factors that may impact your decision:

• The increased oxygen atmosphere in the chamber and the need to limit combustibles
• Silk, wool and synthetic textiles are prohibited, unless approved by the medical director and safety director and based on sound and safe reasoning
• Static producing materials should be avoided
• Closed cell materials, such as some synthetics may retain oxygen after decompression, presenting an additional risk once the treatment has been concluded.
• Infection prevention: Non-synthetic cotton or down pillows are relatively safe to be used in some chambers but are challenging when it comes to disinfection. Wipe-able covers are available and may need to be considered for those types of pillows.
• The pillows need to be able to vent with the change of pressure in the chamber to avoid the pillow expanding on decompression.

It may be beneficial to inquire of your chamber manufacturer when seeking options for pillows. The UHMS website below contains links to many chamber vendors that may offer pillows. However, the Hyperbaric Oxygen Safety Committee suggests that your own risk assessment be performed regardless of the pillow manufacturer.

https://www.uhms.org/resources/links/11-chamber-equipment-manufacturers.html

Please let us know if we can provide any additional guidance or information.

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.

We recently stated using maggots in wound care. Have you guys used these? I looked into the product and I wondered your thoughts of the Dacron screen that holds them in place? We do not currently have any HBO patients using this therapy but trying to get prepared if it comes up.

Thank you for your question. The UHMS HBO2 safety committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the medical director and safety director of your facility.

The UHMS HBO2 Safety Committee is well aware that maggot therapy is a viable and common practice in wound care. We have evaluated the Dacron screen utilized for this therapy and can find no evidence that this item poses a significant risk in the hyperbaric environment. We must reiterate that the decision to allow foreign materials into the chamber rests upon the safety director and medical director of your facility.

It was observed by members of our committee that several articles regarding maggot therapy are available for your review and may contribute to the decision-making process for your facility.

https://www.ncbi.nlm.nih.gov/m/pubmed/24224280/

http://dx.doi.org/10.1155/2014/592419

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3233395/

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 it safe to treat a patient in hyperbaric oxygen therapy when they have an indwelling peritoneal dialysis catheter that has a minicap that has a iodine impregnated sponge and titanium adapter? The minicap is not able to be substituted at all per manufacturer guidelines.

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 iodine within the minicap of this type of catheter does not pose an increased risk of fire. Since no flammable materials are otherwise identified, the remaining concern is the titanium adapter. For more information regarding this material, please refer to previously answered questions regarding titanium and peritoneal dialysis catheters.

Respectfully,

The UHMS Safety Committee

REFERENCES:

Material Safety Data Sheet – Iodine (Ratings listed are for the 1ATA environment)

http://dept.harpercollege.edu/chemistry/msds/Iodine%20Fisher.pdf  

________________________________________

MEDFAQ Published: 03 May 2016

Can patients be safely treated with an existing peritoneal dialysis catheter? Are there any precautions that need to be taken prior to therapy?

https://www.uhms.org/resources/medfaqs-frequently-asked-questions-faq/53-safety-technical.html

________________________________________

MEDFAQ Published: 20 June 2016

Can safety committee provide and update on titanium in HBO. Dr. Weaver answered a question about this at the Winter Symposium in SLC.

https://www.uhms.org/resources/medfaqs-frequently-asked-questions-faq/53-safety-technical.html

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 diapers with synthetic material (infant and adult) allowed in the Monoplace hyperbaric chamber, pressurized with 100% oxygen?”

Thank you for your question. The UHMS HBO 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 Hyperbaric Safety Director of your facility.

The UHMS Hyperbaric Safety Committee understands the advantage that absorbent diapers offer to the patient and the caregiver. Regarding the allowance of synthetic materials in Class A or Class B chambers, one must weigh the risks carefully and consider any opportunity for risk mitigation. For guidance concerning risk assessment and mitigation, we refer you to the National Fire Protection Association® (NFPA) 99, Health Care Facilities Code, 2018 Edition, which contains a section regarding textiles (14.3.1.6.4) offering guidance on the decision process for textiles, garments and wound care products.

We suggest that you know the types of materials commonly used to manufacture these products and their potential flammability. Typically, disposable diapers contain several layers of material Consisting of::

• The inner layer or top sheet rests against the skin of the wearer and can be made from polypropylene material. Some top sheets include a skin-care lotion, which can protect the skin from overhydration and reduce irritation.
• The absorbent core layer is designed to hold fluids. To enhance absorbency, most disposable diapers include a matrix of fluff material and a chemical compound known as Super Absorbent Polymer (SAP) that holds up to three hundred times its weight. This material forms into a gel as it absorbs fluids, and is known by other names, including hydrogel, sodium polyacrylate, polyacrylate absorbents, or Absorbent Gel Material (AGM).
• The fluff in the absorbent core is usually made from wood pulp and may include wheat/corn-based materials. It is designed to distribute fluid across the diaper surface, while the SAP is intended to absorb and lock liquids in its core.
• The waterproof outer shell is most often a petroleum-based plastic or polyethylene-treated material.
• Bands made of elastic Lycra® or spandex to keep the diaper close to the wearer.
• Non-woven refastening tape which holds the diaper in place and allows for adjustment.

We suggest the Hyperbaric Safety Director initiate a risk assessment. The risk assessment found in section A.14.3.1.6.4.3 is written for hyperbaric wound dressings, but the process is useful for other items as well. The Hyperbaric Safety Director should consider using this risk assessment when deciding which materials may be allowed in the hyperbaric environment. Furthermore, section 14.3.1.6.4.4 calls for written approval by the (Hyperbaric) Safety Director and Medical Director for prohibitive items to be allowed. The Safety Committee suggests that this code applies to the acceptance or disapproval of diapers.

You may wish to review these safety factors that  impact your decision:

Material Considerations

• The increased oxygen atmosphere in the chamber and the need to limit combustibles
• Silk, wool and synthetic textiles are prohibited unless approved by the Medical Director and (Hyperbaric) Safety Director based on sound and safe reasoning
• Avoid static producing materials
• Closed-cell materials, such as some synthetics may retain oxygen after decompression, presenting an additional risk once the treatment has been concluded. Patients must avoid contact with any naked flames for approximately 30 minutes after therapy.
• Although most codes regarding textiles are not written for 100% oxygen environments, garments are required to comply with UL requirements and A Guide to the Undited States Apparel and Household Textiles Compliance Requirements; NISTIR 8115, https://nvipubs.nist.gov
• The Safety Committee is aware of practices that have utilized cotton towels to fashion a cloth diaper as well.

Static Considerations

• Confirmation of the continuity of ground between the patient and the chamber before each therapy.
• Consider placing a damp cotton towel over the garment to lessen static capacity.

References

https://www.babygearlab.com/expert-advice/what-is-inside-those-disposable-diapers

https://tapes.averydennison.com/en/home/solutions/personal-care/baby-diaper.html

https://nvlpubs.nist.gov/nistpubs/ir/2016/NIST.IR.8115.pdf

Please let us know if we can provide any additional guidance or information.

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.

Does anyone know of any safety issues preventing the use of the Eagle Uni-ventilator in the multiplace chamber?

Date posted: 1/2/2020

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.

It is known to many of the Committee Members that the impact Uni-Vent® Eagle™ Model 754 Ventilator has been used successfully in the multiplace hyperbaric environment at treatment pressures up to and including 3ATA.

Notably, the U.S. Navy has tested and used this ventilator since February of 2007. However, parts for this ventilator are known to be in short supply as the current manufacturer, ZOLL (formerly IMPACT) has discontinued the sale of this ventilator as of April 23^rd, 2015. The ZOLL Company will continue to provide support, to the best of their ability, until 2022. Due to these concerns, the UHMS Safety Committee recommends that these factors are considered when deciding how best to support your equipment and provide safe care to your most critical of patients.

In this Committee’s opinion, choosing a ventilator to use in the hyperbaric environment is a critical decision that should be made jointly by the Hyperbaric Safety Director, Medical Director, Nursing Leadership, Hospital Biomedical, Respiratory Care support, and Hospital Administration.

While the UHMS Hyperbaric Safety Committee cannot endorse a specific device, many Safety Committee Members have shared their experience with this ventilator. It is specifically noted that since it is gas driven, a sufficient supply of gas is necessary to use this ventilator under hyperbaric conditions. Other comments include:

• Inaccurate readout of supply tidal volume (Vt) when operating on pneumatic power (with air and oxygen connected). When operating on DC power and with the internal air pump operating, the Vt is correct. Suggest not relying on the digital supply readout, but always confirm Vt by measuring exhaled Vt with a mechanical spirometer.
• Use a simple test lung to initially set up Vt, RR, FiO2 and PEEP and verify all settings with a spirometer, timer, O2 analyzer, and external manometer.
• Inert purge battery and electronics compartments to prevent oxygen ingress, causing a fire hazard.
• Battery power is short lived. Suggest running on pneumatic power (air and oxygen connected) without the air pump running.
• If powered using 110 VAC, it is important to keep the AC/DC adapter outside the chamber.
• It will need adjustments for Vt during compression and decompression.
• In general terms, be mindful of Boyle’s law when preparing to mechanically ventilate a patient in the hyperbaric environment. Ensure that the ET tube cuff is switched from air to saline or sterile water.

It is our recommendation that each ventilator should be individually tested to measure changes in tidal volume at varying treatment pressures. We suggest that a detailed record of the evaluation be completed and signed by the Safety Director, Medical Director, and Biomedical support specialist. Finally, it is important that all end-users receive proper training in the use of this ventilator before placing the device into service.

We would also like to provide the following references for your consideration:

Popa DA, Waterhouse L, Duchnick JJ, Witucki PJ, “Performance of the Uni-Vent Eagle™ Model 754 ventilator under hyperbaric conditions,” 2017, UHMS Annual Scientific Meeting, UHM 2017, Vol 44, No.5, pg. 470-471

Hennessey PJ, “EVALUATION OF THE UNI-VENT™ EAGLE™ MODEL 754 VENTILATOR FOR USE IN THE SURFACE RECOMPRESSION CHAMBERS (SRC) OF THE SUBMARINE RESCUE DIVING AND RECOMPRESSION SYSTEM (SRDRS),” Navy Experimental Diving Unit Publication TR 07-03, February 2007

Stanga DF, Beck G, Chimiak JM, “EVALUATION OF RESPIRATORY SUPPORT DEVICES FOR USE IN THE HYPERBARIC CHAMBER,” Navy Experimental Diving Unit Publication TR 03-18, November 2003

ZOLL Mechanical Ventilation and Airway Management Group, “754 Commercial EOL Letter,” ZOLL Medical Corporation, April 23^rd, 2015

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.

I would like to ask you regarding one of our patient’s device (Ahmed glaucoma valve implant/ glaucoma drainage implant). Is he allowed to enter the hyperbaric chamber with this device without any concern?

Posted Date:       2/5/2020

MEDFAQ Question: I would like to ask you regarding one of our patient’s device (Ahmed glaucoma valve implant/ glaucoma drainage implant). Is he allowed to enter the hyperbaric chamber with this device without any concern?

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 safety committee understands this item to be surgically attached to the sclera of the eye and free of air. Therefore it is reasonable to consider that pressure would have no effect on the functionality of the device. However, we strongly suggest that a risk assessment be performed by the hyperbaric physician aided by the patient’s ophthalmologist, as there may be the potential for intraocular changes during and after hyperbaric oxygen therapy.

Literature review reveals a handful of studies and commentary on the application of hyperbaric oxygen therapy, intraocular pressure, and glaucoma-related procedures, but there are no known studies specifically related to the Ahmed valve and hyperbaric oxygen therapy.

The following references may assist you in completing the risk assessment and determining the proper course of action for your particular case. Again, we strongly suggest consulting the patient’s ophthalmologist prior to the decision to proceed with hyperbaric oxygen therapy:

Ersanli D, Akin T, “The effect of hyperbaric oxygen on intraocular pressure,”  Vol 33: Journal of the Undersea and Hyperbaric Medical Society, 2006

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

Official site: “Ahmed Glaucoma Valve,” New World Medical, 2020

Animation: “How does the Ahmed Valve Work,” New World Medical, 2014

Animation: “(Surgical Placement of the) Ahmed Valve model PC7,” New World Medical, 2010

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.

We would like to start treatment in the monoplace chamber for a patient that currently has a Denali Vena Cava Filter in place. Called manufacturer, no hyperbaric testing has been done for this device. Does anyone have experience with these devices or know of any contraindications?

Posted Date:       2/5/2020

MEDFAQ Question: We would like to start treatment in the monoplace chamber for a patient that currently has a Denali Vena Cava Filter in place. Called manufacturer, no hyperbaric testing has been done for this device. Does anyone have experience with these devices or know of any contraindications?

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.

Several members of the committee have expressed no concerns allowing this type of device. This is mainly due to the fact that the item is solid and contains no air-filled spaces. The UHMS Safety Committee considers this device to be compatible in either the Monoplace or Multiplace hyperbaric environment.

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.

I have a patient referred by Urology to provide HBO therapy for radiation cystitis. The patient qualifies but has a bladder stimulator in place. The company states that these devices have been tested to only 2.0ATA, and our not safe beyond this pressure. This device has a battery, but is implanted in the body. Is it safe to provide HBO therapy with the bladder stimulator in place. Thanks.

Date: 8/24/2020
From: UHMS HBO2 Safety Committee

Q:
I have a patient referred by Urology to provide HBO therapy for radiation cystitis. The patient qualifies but has a bladder stimulator in place. The company states that these devices have been tested to only 2.0ATA, and our not safe beyond this pressure. This device has a battery, but is implanted in the body. Is it safe to provide HBO therapy with the bladder stimulator in place?

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.

While the hyperbaric safety director has the responsibility to assess the performance and safety risks of the device, assessing the medical risk to the patient is the responsibility of the medical director of the hyperbaric clinic. In all cases, a risk assessment weighing the benefit of hyperbaric medicine versus the possible malfunction or damage to the stimulator should be completed. We would not recommend exposing the device to pressures that exceed the manufacturer’s recommendations.

Following this assessment, it is important that the patient is fully aware of any risks discovered and informed consent is obtained. Consider as well the possibility of the device to be turned down or off for the treatment. If this occurs, we recommend that the patients’ medical team outside of the hyperbaric practice be involved in this process.

Obtaining testing documentation from the manufacturer pertaining to the model’s exposure to increased atmospheric pressure is vital to the risk assessment. We advise that this documentation be kept within the patient’s medical record. We would encourage you to contact the manufacturer each time you encounter a patient with this type of device, as it is necessary to access the most up to date recommendation. We may also wish to retain the decision process documents for reference, in the event that the same device is encountered in the future.

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.

A patient has a Loop Recorder implanted 15-20+ years ago, after researching all of his documents and physicians we do not have a manufacturer or serial number to look up. Do you have any information that could help with the pressure testing of Loop Recorders?

Posted: 8/26/2020

Q: 
A patient has a Loop Recorder implanted 15-20+ years ago, after researching all of his documents and physicians we do not have a manufacturer or serial number to look up. Do you have any information that could help with the pressure testing of Loop Recorders?

A:
Thank you for your inquiry regarding the loop recorder that you have encountered. My name is Andrew Melnyczenko, chair of the UHMS Safety Committee. Your question was recently forwarded to me by the executive director of the UHMS.

The committee would be glad to assist you in answering your question, but please realize that the ultimate responsibility for these types of questions rests with the medical director and safety director of your facility.

In cases of undocumented medical devices where little is known of the device, we cannot unequivocally recommend it’s allowance in the chamber. Without knowing the manufacturer, make or model of the device, testing the device does not seem feasible. A proper risk assessment of the device would also be difficult to accomplish. You may wish to discuss removal of the device with the patient if there is an urgent/emergent need for Hyperbaric Oxygen Therapy or the benefit of therapy is deemed to be prodigious.

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. 

Does anyone have experience with an Aircast boot in a monoplace chamber?

Posted: 8/26/2020

Q:
Does anyone have experience with an Aircast boot in a monoplace 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.

It is our understanding that these types of boots are designed to assist patients with mobility (i.e. “walking boot”) and are not a necessity during monoplace hyperbaric therapy. Therefore, these should be removed just prior to therapy once the patient is safety positioned on the sliding stretcher.

Respectfully,

The UHMS Safety Committee

DISCLAIMER

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

Posted: 10/23/2020

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

A:

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

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

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

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

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

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

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

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

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

Respectfully,

The UHMS HBO₂ Safety Committee

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

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

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

We are looking at letting our patient stay on their inpatient telemetry box during their HBO treatment. Box Model is GE, Apex Pro FH (FH = Frequency Hopping). Also attached to the outside of the tele box is a in-hospital tracker which contains a SONY CR2032 3 volt lithium battery. What are your thought about allowing device this into a multiplace hyperbaric chamber?

Date Posted: 11/20/2020

Q: We are looking at letting our patient stay on their inpatient telemetry box during their HBO treatment. Box Model is GE, Apex Pro FH (FH = Frequency Hopping). Also attached to the outside of the tele box is a in-hospital tracker which contains a SONY CR2032 3 volt lithium battery. What are your thought about allowing device this into a multiplace hyperbaric 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 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. We invite you to explore the instances of previous evaluations and key concerns as it may guide your own process. 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 telemetry (or other) equipment for the hyperbaric (multiplace – air) environment:

1. 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. There are many useful examples of published risk assessment strategies applied to medical devices in the literature. Here are a few:
   1. “A Zigbee-Based wireless system for monitoring vital signs in hyperbaric chambers: Technical Report.”
   2. “Decision process to assess medical equipment for hyperbaric use.”
   3. ”Safety of a continuous glucose monitoring device during hyperbaric exposure.”
   4. “An approach to treating a patient with a HeartMate II left ventricular assist device in a multiplace hyperbaric chamber: a case report”
   5. “Medical Equipment for Multiplace Hyperbaric Chambers Part I: Devices for Monitoring and Cardiac Support.”
   6. ”The Hyperbaric Protective Tube: A housing for a left ventricular assist device (LVAD) in a multiplace hyperbaric chamber”
2. 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.)
3. Consider reaching out to the manufacturer to learn more about the device, especially if there are limited performance details/specifications in the OEM.
   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. Regardless of the manufacturer’s response, there may be good reason for you to proceed with the evaluation, as telemetry systems offer uninterrupted monitoring of the patient and may be vital to the continuum of care to the patient.
   4. 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.
   5. Using the device in an increased atmospheric environment is not in concert with the manufacturer’s environmental specifications (GE Apex pro Service Manual, Pg. A-4, Operating Environment Specifications).
4. 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.
5. 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).”
6. 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.
7. 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. The voltage and intended power draw for this particular device is in accordance with NFPA specifications (GE Apex pro Service Manual, Appendix A, Technical specifications). Addressing the risk of the potential to generate heat, you should confirm that the telemetry device contains a low-power, non-rechargeable lithium battery. (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.
8. Pay attention to any sealed compartments 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.

References:

Bliss, C., Huang, E., & Savaser, D. (2020). Safety of a continuous glucose monitoring device during hyperbaric exposure. Undersea & hyperbaric medicine: journal of the Undersea and Hyperbaric Medical Society, Inc, 47(1), 13-19.

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.

Carmona, C., Alorda, B., Gracia, L., Perez-Vidal, C., & Salinas, A. (2017). A ZigBee-based wireless system for monitoring vital signs in hyperbaric chambers: Technical report. Undersea & Hyperbaric Medicine: Journal of the Undersea and Hyperbaric Medical Society, Inc, 44(3), 243-256.

Kot, J., Siondalski, P., & Lenkiewicz, E. (2019). The Hyperbaric Protective Tube: A housing for a left ventricular assist device (LVAD) in a multiplace hyperbaric chamber. Diving and hyperbaric medicine, 49(2), 137-140.

Kot J. Medical devices and procedures in the hyperbaric chamber. Diving and Hyperbaric Medicine. 2014 Dec;44(4):223-227.

Kot, J. (2005). Medical equipment for multiplace hyperbaric chambers. part i: Devices for monitoring and cardiac support. Eur J Underwater Hyperb Med, 6, 115-20.

Orwig D, Logue C, Hendriksen S, Westgard B, Walter J, Pullis M, et al. An approach to treating a patient with a HeartMate II left ventricular assist device in a multiplace hyperbaric chamber: a case report. Undersea Hyperb Med. 2018;45:89–93. PMID: 29571237.

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

General Electric Company, (2008). GE ApexPro [R] FH. Service Manual, Boston, Massachusetts. https://www.gehealthcare.com/

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. 

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

Posted: 1/19/2021

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

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

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

Respectfully,

The UHMS HBO2 Safety Committee

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

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

Posted: 1/19/2021

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

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

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

More Information on RFID and RFID tags (source):

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

There are two types of RFID tags:

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

References:

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

Respectfully,

The UHMS HBO2 Safety Committee

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

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

Posted: 1/22/2021

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

A: 

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

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

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

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

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

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

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

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

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

Respectfully,

The UHMS HBO2 Safety Committee

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

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

DISCLAIMER

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

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

Posted: 3/15/2021

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

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

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

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

On The NFPA:

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

On IV Caps:

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

On Infection Prevention and Control:

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

On Risk Assessment:

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

REFERENCES:

1. Burman, F. (2019). Risk Assessment Guide for Installation and Operation of Clinical Hyperbaric Facilities (6th ed.). San Antonio, TX: International ATMO, Inc. LINK
2. Gorski, L. A. (2021). A Look at 2021 Infusion Therapy Standards of Practice. Home healthcare now, 39(2), 62-71. LINK
3. Infusion Nursing Society. (2016). Infusion therapy standards of practice. J Infus Nurs., 39(s1). LINK
4. Kamboj, M., Blair, R., Bell, N., Son, C., Huang, Y. T., Dowling, M., ... & Sepkowitz, K. (2015). Use of disinfection cap to reduce central-line–associated bloodstream infection and blood culture contamination among hematology–oncology patients. Infection control and hospital epidemiology, 36(12), 1401. LINK
5. Moureau, N. L., & Flynn, J. (2015). Disinfection of needleless connector hubs: clinical evidence systematic review. Nursing Research and Practice, 2015. LINK
6. National Fire Protection Agency (NFPA). (2021). “NFPA 99 2021 Edition: Health Care Facilities Code.” Quincy, Massachusetts. LINK
7. Undersea and Hyperbaric Medical Society MEDFAQ: “Use of alcohol swabs in the multiplace hyperbaric environment,” Accessed 3/8/21 LINK
8. US Food and Drug Administration. (2014). “Off-label” and investigational use of marketed drugs, biologics, and medical devices: information sheet. Silver Spring, MD. LINK
9. Voor, A. F., Helder, O. K., Vos, M. C., Schafthuizen, L., Sülz, S., van den Hoogen, A., & Ista, E. (2017). Antiseptic barrier cap effective in reducing central line-associated bloodstream infections: a systematic review and meta-analysis. International journal of nursing studies, 69, 34-40. LINK

Respectfully,

The UHMS HBO₂ Safety Committee

DISCLAIMER

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