Society memberships:

It is also important to remember that most pressure vessel laws are not retroactive. If a vessel was placed into service before the applicable regulation went into effect, it is most likely "grandfathered" and can legally continue to be used despite differences that may exist with the later-adopted regulations. However, vessels placed into service after the date the regulations became effective cannot normally claim this exemption.

REGULATORY ISSUES: THE ROLE OF THE FDA

Of all of the organizations that have something to say about hyperbaric equipment and the operations there are two that have very real teeth - the local Fire Marshall's office and the Food and Drug Administration (FDA). The relevance of the NFPA 99 "Standard for Health Care Facilities" to hyperbaric facilities and the role of the local Fire Marshall's office in enforcing its requirements are generally well appreciated, although not always well understood. The FDA's role is even less well understood.

The Food and Drug Administration (FDA) has what could be called a "background" role in modern clinical hyperbarics. It is generally out of sight, but ALWAYS there. With the accelerating expansion of clinical hyperbarics into mainstream medicine, the FDA's role is becoming more important. It is also becoming more visible with encouragement from both the NFPA Committee on Hyperbaric and Hyperbaric Facilities and the ASME Safety Code Committee on Pressure Vessels for Human Occupancy (PVHO). Both Committees have invited the FDA to send a representative to participate in the Committee's work.

So what is the role of the FDA?

With respect to hyperbarics, the FDA's scope of authority breaks down into two areas: Drugs: Safety, Effectiveness, Labeling
Medical Devices: Safety, Effectiveness, Labeling

OXYGEN AS A DRUG

The FDA classifies oxygen as drug. Therefore, both its application and the devices used to administer it fall under the FDA's jurisdiction. As a drug, oxygen can be administered only on the order of a physician. The classification of oxygen as a drug creates some situations that could be used to make a good political cartoon. Clearly, oxygen used under hyperbaric conditions for wound healing purposes is a "drug" in the true sense of the word. However, the same oxygen partial pressure occurring in compressed air or enriched air diving, or in oxygen breathing during decompression is not of interest to the FDA. The many facets, and there are many, of regulating the use of oxygen as a drug may be the subject of a future column. The FDA's primary interest in oxygen as a drug, as that interest affects hyperbaric facilities, is in the claims that are made for its effectiveness. At this time, the FDA recognizes the 13 indications for HBO that are defined in the UHMS document: "Hyperbaric Oxygen Therapy: A Committee Report" (UHMS HBO Report). Claims, especially in advertising, that a hyperbaric service can treat other conditions can leave it open to a visit by FDA investigators. This isn't a "black & white" issue, and the FDA doesn't normally get involved unless someone files a complaint, there is an accident or an apparently non-compliant situation somehow comes to his or her attention. The FDA typically does not try to regulate standard medical practice. However, if a facility is claiming it can treat conditions not listed in the UHMS HBO Report as accepted indications, it should be prepared to explain its reasons for doing so, if challenged.

HYPERBARIC CHAMBERS AS MEDICAL DEVICES

Hyperbaric chambers are used to administer hyperbaric oxygen, therefore, hyperbaric chambers and certain related accessories are considered by the FDA to be medical devices. Consequently, they are subject to FDA controls that apply to all medical devices entered into commercial distribution after May 28, 1976. Hyperbaric chambers and other medical devices built prior to that date or in continuous production since before that date are not subject to FDA controls.

The medical device rules apply to manufacturers and organizations that refurbish/recondition medical equipment. They do not apply to the users of medical equipment so long as those users are not modifying the equipment. The rules address the design, manufacturing, labeling and marketing of the products. Manufacturers are also required to have established procedures for tracking and responding to complaints from users.

Medical devices are divided by the FDA into three classes with differing levels of FDA involvement:

Class I: General Controls: These are simple devices where performance is not much of a concern, such as tongue depressors. The FDA's oversight controls are generally limited to labeling, manufacturing QA, records, inspections, etc. Pre-market Notification (notification of intention to market the device) to the FDA is required under Section 510(k) of the Safe Medical Device Amendments enacted in 1976. FDA clearance of the Pre-Market Notification (hence the term 510(K) clearance) is required prior to marketing the device or placing it in commercial distribution.

Class II: Special Controls: These are complex devices where performance is a concern, but at a somewhat general level. Class II devices must comply with general controls and the requirements of some applicable standard. A 510(k) Pre-market Notification to the FDA is required. FDA clearance of the Pre-Market Notification is required prior to marketing the device or placing it in commercial distribution.

Class III: Pre-market Approval: These are generally devices that are directly related to patient life support with a substantial risk of injury in the event of malfunction. An example is a cardiac pacemaker. Pre-market approval by the FDA is required. The related design and manufacturing controls are very strict.

Hyperbaric chambers are generally treated as Class II devices. The "applicable standard" requirement is taken to be the applicable industry consensus standards, primarily NFPA 99, Chapter 19 "Hyperbaric Facilities" and ASME PVHO-1, "Safety Standard for Pressure Vessels for Human Occupancy".

All Classes of medical devices are subject to the FDA's Good Manufacturing Practice (GMP) regulations. The FDA GMP rules are very similar to international quality assurance regulations (ISO 9000, ISO 9001, etc.) that have come into widespread use in recent years.

The main requirements are:

Conformance with the FDA's rules as they apply to the manufacture of hyperbaric chambers is usually not difficult in a technical sense. However, it does require a commitment to procedural controls that can be difficult to sustain, especially in small companies.

"Labeling" is interpreted by the FDA to mean just about everything the manufacturer says about what the device can be used for and how it can be used. As with oxygen itself, claims for applications outside those listed in the UHMS HBO Report can lead to unwelcome consequences.

Adultered Devices are prohibited. Adultered devices are devices:

Modifications to Existing Chambers: If you are planning a modification of a chamber owned by your facility, you should check out the regulatory implications before proceeding. Under current FDA policy guidelines, an organization does not have to be registered with the FDA as a reconditioner/rebuilder to do major repair/restoration work on a hyperbaric chamber owned by others. However, it must be registered if it is doing similar work on a chamber to which it has acquired ownership. Normal maintenance and simple repairs are not of interest to the FDA. However, any modifications that may effect function or performance are likely to be.

Avoidance of Appearance of Endorsement of Products. Manufacturers are not permitted to refer to their FDA 510(k) Pre-market Notifications nor resulting FDA Clearances in advertising or in any published literature. However, a manufacturer can respond to a request from a potential customer regarding whether or not a manufacturer has a cleared 510(k) Pre-market Notification for a specific device.

How to Find Out if a Particular Hyperbaric Chamber Has Been Cleared by the FDA. The simplest way is to ask the manufacturer. Alternatively, you can put the Internet to work for you. Hyperbaric chambers are categorized by the FDA under the general heading of anesthesiology products.
The address for FDA 510(k) information is:

www.fda.gov/cdrh/510khome.html (Changed in 1999, see below)

Once there, click on the button for "Search the releasable 510k data base" and select the category "anesthesiology". You can then search by any number of methods, including manufacturer, product type, etc. The FDA product code for hyperbaric chambers is 73 CBF. COMMUNICATIONS: Questions or comments for TechTalk should be addressed to Triage. A sincere effort will be made to respond to all correspondence. Questions and answers of general industry interest will be included in future editions of TechTalk.

It is important to remember what the FDA does. The FDA regulates what pharmaceuticals are allowed on the market and what claims of effectiveness the sellers of those pharmaceuticals are allowed to make. Similarly, the FDA regulates what medical devices are allowed on the market and what claims of effectiveness the vendors of those devices are permitted to make.

The FDA does NOT regulate the practice of medicine, per se. Any licensed physician is free, within broad limits, for any particular patient to use any combination of approved pharmaceuticals and cleared medical devices that he wishes. The physician's activities are subject to scrutiny by the appropriate state board of medicine, but not the FDA. The FDA will get involved at that level only if studies being conducted or some really outrageous advertising claims are made.

Most people that are buying uncleared chambers are likely doing so either because they just don't understand the system or they are looking to "fly cheap". Either way, it is not a good situation. The FDA can impose very severe penalties on companies and individuals that persist in selling uncleared devices. In the event of an accident, the operators of uncleared devices could find their insurance denying coverage.

Steve Reimers