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:
- 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:
- “A Zigbee-Based wireless system for monitoring vital signs in hyperbaric chambers: Technical Report.”
- “Decision process to assess medical equipment for hyperbaric use.”
- ”Safety of a continuous glucose monitoring device during hyperbaric exposure.”
- “An approach to treating a patient with a HeartMate II left ventricular assist device in a multiplace hyperbaric chamber: a case report”
- “Medical Equipment for Multiplace Hyperbaric Chambers Part I: Devices for Monitoring and Cardiac Support.”
- ”The Hyperbaric Protective Tube: A housing for a left ventricular assist device (LVAD) in a multiplace hyperbaric chamber”
- If you discover that the device has been tested previously under hyperbaric conditions, we suggest that this may be utilized as validation of your final assessment, but we do not recommend that this is the entirety of device approval. Simply put, we recommend a formal risk assessment regardless of testing methods. (Exception: Modern ICD’s and Pacemakers are commonly tested by the manufacturer for function under pressure. Therefore, use under increased atmospheric conditions does not constitute an off-label use of those devices.)
- Consider reaching out to the manufacturer to learn more about the device, especially if there are limited performance details/specifications in the OEM.
- Try to gain an understanding of what types of stress the device was subjected to during the manufacturing and testing phase.
- You may wish to make them aware of your intentions or you may remain anonymous.
- Regardless of the manufacturer’s response, there may be good reason for you to proceed with the evaluation, as telemetry systems offer uninterrupted monitoring of the patient and may be vital to the continuum of care to the patient.
- It should be noted that any modifications to the device or use other than as recommended by the manufacturer risks voiding any warranty on the product.
- 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).
- 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.
- At least one major academic tertiary referral institution’s legal team with experience in medical device modification across its entire complex and constantly changing needs of subspecialty patient care including hyperbaric medicine interprets current FDA regulations in the following fashion. ”The program (modification and testing of medical devices for safe use in the hyperbaric environment) is not subject to FDA regulation. FDA regulates manufacturers and not the practice of medicine. Physicians are able to use FDA approved products other than under the labeled indications as long as the physician meets certain criteria. FDA’s statement on this off-label use is as follows:
- “Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgment. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects. Use of a marketed product in this manner when the intent is the "practice of medicine" does not require the submission of an Investigational New Drug Application (IND), Investigational Device Exemption (IDE) or review by an Institutional Review Board (IRB).”
- The National Fire Protection Association 99 Health Care Facilities Code, 2021 edition, chapter 14, lists the temperature, electrical limits, and responsibilities of the HSD regarding equipment used in Class A and B chambers. You should have this reference in your library.
- 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.
- 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.
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.
The UHMS HBO2 Safety Committee
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.