Who Was There & What Was Said
FDA & Industry Regulators Meet To Discuss Their Roles In Our Future
In the March / April issue of Pressure, the Undersea & Hyperbaric Medical Society (UHMS) President Dr. Caroline Fife reported on a December 1999 meeting that she attended with Dr. Lee Greenbaum (UHMS Executive Director), Tom Workman and the FDA. Her article covered a broad spectrum of topics that are effecting our industry, from FDA pre-market clearance of chambers, to treating the ?approved indications?, rules for advertising, and other compliance issues. After this initial meeting, Mr. Workman embarked on a challenge to raise awareness with other industry regulators. A follow up meeting date was scheduled for April of 2000. Tom Workman took it upon himself to invite the regulators that set the standards and codes for the hyperbaric community.
The meeting was held at an FDA office outside of Washington, D.C. on April 25th. The following organizations were invited and their attendance is noted:
American Society of Mechanical Engineers International www.asme.org
National Board of Pressure Vessel Inspectors www.nationalboard.org
Uniform Boiler and Pressure Vessel Law Society www.uboiler.com
National Fire Protection Association International www.nfpa.org
National Institute of Occupational Safety and Health www.cdc.gov
International Fire Marshals Association www.nfpa.org
Members of the Undersea and Hyperbaric Medical Society www.uhms.org
Associates of the UHMS www.uhms.org
American College of Hyperbaric Medicine www.hyperbaricmedicine.org
Baromedical Nurses Association www.hyperbaricnurses.org
Joint Commission for Accreditation of Healthcare Organizations www.jcaho.org
Health Care Finance Administration www.hcfa.gov
National Board of Diving and Hyperbaric Medicine Technology pbaker8065@aol.com
Association of Diving Contractors www.adc-usa.org Not present
Food and Drug Administration www.fda.gov
National Aeronautics and Space Administration www.wstf.nasa.gov Not present
Hyperbaric Oxygen Therapy Association www.hbomedtoday.com
Society of Freestanding Hyperbaric Centers of America hbot@gte.net Not present
This was an eight-hour meeting with a tremendous amount of information being presented. Tom Workman made it very clear that this was not a regulatory meeting to set down rules or guidelines but rather a meeting to help each organization understand its role in the overall hyperbaric community. This article will summarize the topics that were mentioned and expound on important issues when possible.
Dr. Caroline Fife, President of the UHMS was scheduled to speak first with opening remarks but she was not able to attend so Dr. Camporesi, the incoming UHMS President-elect, spoke on her behalf expressing his hopes for a safe and prosperous future in our industry.
Tom Workman was the facilitator of this meeting, speaking first on, ?What are the issues and what is the purpose of this meeting??
· Current and future training standards, staffing, and regulatory gaps.
· The UHMS ?approved? indications.
· New indications in research: Closed head, Acute stroke, Cerebral Palsy, and other others. It was mentioned that currently, not enough data exist for a firm decision on the efficacy of these indication being accepted.
· Types of equipment used: Multiplace and Monoplace.
· Chamber locations: freestanding, some with physician coverage some without. Tom feels that the concern is not just with freestanding clinics, but in training and safety for all centers.
Who regulates and has jurisdiction:
· ASME-PVHO covers all 50 states through the NFPA statement of complying with ASME-PVHO.
· Local fire marshals, building code inspectors, etc.
· FDA regulations: Class II Medical device. 510K premarket clearance, prescriptive device, needing a physician?s order to prescribe hyperbaric therapy.
· HCFA: Medical reimbursement mandates NFPA compliance, and requires JCAHO as well.
· JCAHO has been informed of, and may require future compliance with the following: NFPA 99 and 101, 510K, Safety director, 40 hour course for operators and physician, progress notes, procedure notes, peer review, list of fire drill training, infection control, etc. These are resources that JCAHO can use to reference existing standards.
Mr. Workman mentioned that the Association for Freestanding Centers was invited, but did not attend. You can contact the president of this association at hbot@gte.net.
Portable chambers were discussed: THERE IS NO JURISDICTION FOR HOME USE AT THIS TIME!
Regulatory gaps are things such as standards that are not mandated. Various agencies cover these issues but no single agency has the ultimate enforcement authority. Articles were read off the Internet referencing the wide availability of chambers for sale and the availability of mobile chambers that can come to you.
Mishaps were discussed:
· Japan 1996 (chemical hand warmer)
· Italy 1997 (hand warmer)
· The 1976 Hanover, Germany accident
· Cuba (friction toy)
Mr. Workman addressed concerns that this meeting with the FDA was to prohibit O2 filled chambers. He adamantly denied anything of the sort and made no mention of concerns for these types of chambers at any time throughout the day. One chamber was mentioned as being pressurized with 100% O2, but it was mentioned because of concerns that it was rated with a 5 ATA working pressure and he had heard this chamber was being used at 4 ATA on O2. Chamber door designs and other engineering specs were mentioned as well.
He discussed Internet talk of safety and chat rooms. Topical oxygen therapy (TOPOX) seems to be alive and well. Inflatable bag ?chambers? can be purchased online, treatments have actually been auctioned as well as chambers. This was mentioned to stress the ease at which this equipment can be purchased.
The major focus of the meeting was to cover staffing and training standards, facility licensing, accreditation, and what organizations seemed to have the most jurisdictions over these issues.
Dr. Leon Greebaum, Executive Director of the UHMS spoke on the past and future of the UHMS. The Society publishes the Undersea & Hyperbaric Medicine Journal and their newsletter Pressure. The current membership in the society is around 2500 members. 1100 are US Physicians, 400 non-US physicians and the associates. There are currently 12 various Committees. Dr. Greebaum highlighted the societies recent AMA board exam for hyperbaric medicine as a specialty. Sixty physicians took the exam, with the next exam being administered in November of 2000. His final words were about UHMS regulations on physicians and the society?s ability to discipline or reprimand a physician, mentioning that one physician was recently expelled.
Dr. Bozzuto, President of the American College of Hyperbaric Medicine (ACHM) talked about the efforts of the College. It was founded in 1983 to establish a unique medical association separate from the UHMS. The College was the first to discover the 1992 HCFA nonpayment to physicians and the subsequent 35-10 issues as well. He explained how the College now works closely with UHMS. Dr. Bozzuto mentioned the supposed original ?approved list? from the College and how that misunderstanding came to pass. He said the original publication of their ?approved indications? was not actually approved by the executive board of the ACHB. They support the UHMS list of approved indications. The College works on QA, outside peer review programs, training guidelines, and they produce a newsletter as well. The College created the Preferred Practice Protocols, for the approved indication list.
Future directions include supporting clinical accreditation, updating the Preferred Practice Protocols, supporting research and maintaining a close relationship with HCFA and the UHMS. They provide forms, permits (informed consent), training, videos, and other resources to their members.
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