Medical Device Approval Process Form

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DESCRIPTION OF MEDICAL DEVICE APPROVAL PROCESS – CLASS ‘A' MULTIPLACE CHAMBERS 

PURPOSE 

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. 

SCOPE 

This document is intended to be used by Safety Directors/Coordinators and Medical Directors of Multiplace Hyperbaric Facilities, working jointly with the facility's Biomedical, Managerial and Administrative Teams. 

NOTE: The term Hyperbaric Safety Director is a title used for convenience. This individual may have a different title. 

HYPERBARIC MEDICINE MEDICAL DEVICE APPROVAL TEAM 

The establishment of a Hyperbaric Medicine Medical Device Approval Team is recommended and may consist of the following members: 

Hyperbaric Medicine Safety Director (HSD) Hyperbaric Medicine Medical Director (HMD) 

We also recommend that the following individuals are involved in the process: Hyperbaric Medicine Manager/Supervisor 

Hospital Biomedical Engineering Representative Hospital Administrative Representative 

All members of the Medical Device Approval Team are expected to review the Medical Device Approval Form for each new or modified medical device. At minimum, the HSD and HMD should indicate their approval by signing the Medical Device Approval Letter prior to use in the hyperbaric chamber. The Medical Device Approval Team may approve the device as presented or with conditions which must be specified on the Letter of Medical Device Approval. The Medical Device Approval Team must determine if each subsequent device of the same make and model must be individually tested and to what extent. 

1. No testing required on subsequent devices
2. Each subsequent device receives full functional testing
3. Each subsequent device receives abbreviated testing as determined by the HSD and theBiomedical Engineering Representative.

REFERENCE DOCUMENTS 

Access to the reference documents below are needed to complete and verify code requirements: 

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-EnrichedAtmospheres
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. 

PROCESS 

1. Requests for medical device approval should be submitted to the HSD for consideration.
2. The HSD will pass the device, manuals, and approval forms to the Biomedical Engineeringrepresentative for visual inspection and schematic review.
3. The device will be disassembled to whatever extent is necessary to complete the examination.
4. Post inspection, the HSD may pass the device approval forms directly to the medical device reviewboard if reasonable data exists from the manufacturer, other facilities, or journal documentation.
5. If inadequate data exists, the HSD will enlist the assistance of appropriate personnel to performdevice testing.
6. Upon completion of successful testing, all documentation of the testing process will be forwardedto all medical device review board members for review and approval.
7. All team members are required to sign-off on each device prior to use in the hyperbaric chamber.Any member of the medical device review board may disapprove a device or request furtherdocumented evidence or testing at any time prior to approval.
8. All paperwork will be coordinated and maintained by the HSD.

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