Is this medical device safe to be in the chamber?: An introduction to the Medical Device Approval document

Author Bio: Kevin P Gardner serves as the Hyperbaric Safety Director at Aurora St. Luke’s Medical Center in Milwaukee, WI, overseeing the maintenance and safety of a large Fink Engineering multiplace hyperbaric chamber. He also serves as a member of the NFPA 53 technical committee, the UHMS Hyperbaric Oxygen Safety Committee (SC), Advocate Aurora’s Emergency Response and Planning Committee, and is a volunteer Firefighter.

Background

Aurora St. Luke’s Medical Center in Milwaukee has a long, storied history of contributions to the hyperbaric industry. You might even say that we were pioneers of engineering and testing medical devices to ensure their safety in the hyperbaric environment. Of note, The Kindwall HBO Handbook, “Hyperbaric Medicine Procedures,” states the following:

“There are not enough clinical hyperbaric chambers to make it financially rewarding for equipment manufacturers to make devices approved for use in or with the hyperbaric environment. As the number of facilities continues to rise there will be an increased financial incentive for equipment manufacturers to meet the demands of this neglected market. Manufacturers should be encouraged to engineer hyperbaric specific devices or design chamber compatibility into their product line. Until this happens we must continue to evaluate and modify existing medical devices to meet our needs for safely caring for patients during their hyperbaric oxygen therapy.” EP Kindwall, 1971

As you probably know, this situation has largely remained unchanged since Dr. Kindwall wrote these comments. Today, the UHMS Hyperbaric Oxygen Safety Committee regularly receives requests for advice on what can and cannot go into a hyperbaric environment. The UHMS Equipment Subcommittee spent several years developing a medical device approval form in response to the community's needs. In late 2023, the UHMS Equipment Subcommittee approved and published the medical device approval form. This document was passed to the larger Safety Committee for approval and finally was accepted by the UHMS Board for publishing. The form can be found on the UHMS website Medical Device Approval Form - Multiplace (FINAL 9-14-23).docx (uhms.org). This article aims to introduce you to the approval form and describe the sections of the approval process.

Introduction

The introduction of the Medical Device Approval Process – Class ‘A’ Multiplace Chambers states the following:

“The following Medical Device Approval Process is a generic process that has been endorsed by the Hyperbaric Oxygen Safety Committee of the Undersea and Hyperbaric Medical Society as a method that may be used to systematically document the evaluation and risk mitigation of medical devices to be connected to or used inside a Class ‘A’ Multiplace Chamber. This approval process was formatted using the current edition of the National Fire Protection Association (NFPA) 99 Health Care Facilities Code, 2021 Edition, Chapter 14, and other codes invoked by this chapter. This process is intended to serve as an aid in the selection, testing, modification, documentation, and approval of medical devices for use in the Class ‘A’ Multiplace chamber environment. The user of this document may choose to add other testing as deemed appropriate by their institution.”

It is important to note that while this process does not certify any device for global use, it does assure a measure of safety regarding flammability, pressure intolerance, oxygen incompatibility, and explosiveness. The process may allow a facility to use existing medical devices off-label after they have passed rigorous examination and testing.

The FDA’s Use of “Off-Label" and Investigational Use of Medical Devices

As Dr. Kindwall stated, few medical devices are intended to be used in the Multiplace hyperbaric environment. Thankfully, the FDA has acknowledged that there are instances where medical devices not cleared for a particular use may be deemed appropriate by the Physician delivering care.

“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 judgement. 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). However, the institution at which the product will be used may, under its own authority, require IRB review or other institutional oversight.”

Source: "Off-Label" and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices.“

(for more information on this topic, you may also wish to review this FDA.gov site: Frequently Asked Questions about Medical Devices.)

“The process starts by identifying the equipment/device to be reviewed for approval."

• Page one, “The Medical Device Approval Team” establishes the guidelines for who should be involved in the evaluation process. It is the expectation that all team members become familiar with the Medical Device Approval Form used by your facility.
• Page two calls out the resources the team needs to complete and verify code requirements successfully. It is important to remember that the document references the current code at the time of authorship. As code language is subject to change, subsequent document versions will be edited accordingly.
  
  1. NFPA 99: Health Care Facilities Code (2021)
  2. NFPA 70E: National Electrical Code
  3. ANSI Z136.3 American National Standard for Safe Use of Lasers in Health Care
  4. NFPA 101: Life Safety Code
  5. NFPA 53: Recommended Practice on Materials, Equipment, and Systems Used in Oxygen-Enriched Atmospheres
  6. CGA Compressed Gas Safety Guidelines
  7. ASME PVHO -1 and -2 NOTE: Other electrical engineering Codes and Standards may be required by your institution.
• Pages three and four are for equipment information (medical device being evaluated).
• Pages five through thirteen include the biomedical engineering visual exam & schematic review. These pages must be completed by the Bio-Medical Engineering department alongside the Hyperbaric Safety Director (HSD). Code information is necessary to complete this section.
• Pages fourteen and fifteen, “Hyperbaric Function Testing,” provide steps to guide you through functional testing of your new equipment.
• Pages sixteen and seventeen, “LETTER OF MEDICAL DEVICE APPROVAL,” contain a declaration for the HSD to fill out after the medical device is either approved or not approved.

As technology advances, hyperbaric programs will continue to face many new medical products available to our patients. Therefore, it is imperative that we remain aware of these emerging risks and continue to develop mitigation strategies to improve safety. It is also vitally important to have a consistent and thorough process to evaluate these products.

We are currently using the Medical Device Approval Form here at St Luke’s to investigate a ventilator for critical care in the multiplace.

To serve as a reminder,

***The UHMS HBO₂ Safety Committee can provide information to aid you in answering your question. Still, the ultimate responsibility for these questions rests with your facility's Hyperbaric Medical Director (HMD) and Hyperbaric Safety Director/Coordinator (HSD/C).

***This assessment is the opinion of the Hyperbaric Safety Committee and does not constitute product approval. We suggest that the HMD and HSD/C of your facility perform a risk assessment and document your conclusions before treating the patient.