Month: April 2017

UHMS Members featured in local news story about hyperbaric treatment

UHMS members Dr. Marc Robins and Associate Annette Gwilliam of Intermountain’s Utah Valley Hospital were featured in a local new story on the benefits of hyperbaric oxygen therapy.

The news feature profiled success stories from Eric Anderson and Barbara Allen, both patients of Dr. Robins, who received HBO2 therapy and demonstrated measurable healing. Both were happy to talk about their experiences.

KSL-TV, an NBC-affiliated television station located in Salt Lake City, Utah, ran the story, oddly referring to HBO2 therapy as a ‘bygone’ technology that has regained new life.

UHMS members know hyperbaric oxygen therapy is alive and well. The broadcast does end with the statement that HBO2 is approved for 14 illnesses. So, not so bygone after all.

For the story and to see Marc and Annette on camera, see:

http://www.ksl.com/?sid=43952527&nid=148&title=bygone-navy-technology-used-for-healing-wounds

The Hyperbaric Medicine Department is a UHMS-accredited facility with distinction, the Utah Valley Regional Medical Center Joint Commission-accredited and the Intermountain group a UHMS Corporate Partner.

 

 

RISK MANAGEMENT AND THE USE OF HYPERBARIC OXYGEN CHAMBERS

Special Report from the Safety Committee

TOM WORKMAN and JIM BELL, UHMS Safety Committee

Over the past four decades we have seen a geometric growth in the number of clinical hyperbaric medicine facilities. The numbers have grown, from approximately 27 facilities in the early 1970s to now more than 1,350 hospital-based programs. There is no reliable estimate of the number of non-hospital based facilities in operation. For the most part, facilities that are a part of a healthcare system are well regulated; those in non-healthcare rated occupancies, such as health spas, commercial office buildings and homes, much less so.

Areas of concern

A segment of the community that presents the highest level of concern is based on the use of portable, fabric, low-pressure hyperbaric chambers that do not meet existing safety codes such as the National Fire Protection Association (NFPA) 99, Health Care Facilities Code. These types of chambers, while cleared by the FDA as a Class II medical device,
do not comply with American Society of Mechanical Engineers, Pressure Vessels for Human Occupancy -1 (ASME PVHO-1) hyperbaric chamber design and fabrication code (as required by NFPA 99) nor with the installation and operational requirements mandated in NFPA 99.

A confounding problem is that local authorities having jurisdiction (AHJs) are not aware that these devices are being used in their jurisdiction. When a traditional hyperbaric chamber is installed, installation permits, and other paperwork are required, and accordingly, AHJs are appropriately notified. There is no comparable notification process for these low-pressure chambers, as they are delivered by a commercial carrier (such as FedEx) and require no traditional installation. Plus, they can be operational within 15-30 minutes of receipt. Because of this, there is no mechanism to notify the AHJ of their presence, and thus they routinely operate “under the radar” of the established regulatory community. There are estimated to be more than 10,000 such hyperbaric chambers in use throughout the country.

Additional examples of non-compliance . . .

Other examples of non-compliance to NFPA 99 are numerous. For example, NFPA 99 requires that the exhaust from a hyperbaric chamber be piped to the exterior of the building housing the chamber. These low-pressure chambers, however, vent to the ambient space in the room in which they are located.

Perhaps the most concerning risk is that these chambers are frequently used with oxygen concentrators to increase the concentration of oxygen that the patient breathes while in the chamber. When used in this configuration, the concentration of oxygen inside the chamber often exceeds the NFPA 99 limit of 23.5%. Operation of hyperbaric chambers with atmospheres containing more than 23.5% oxygen requires the patient to be grounded. Patients treated in these portable chambers are rarely, if ever, electrically grounded. This is exacerbated by facility operators who encourage or allow patients to take into the chamber with them their tablet, cell phone, laptop, and similar devices. The use of these types of electrical devices in a hyperbaric chamber is strictly prohibited by NAPA 99.

. . . and a recent example

The death of a young autistic boy from North Carolina (June 9, 2011) might have been avoided had these low-pressure chambers been regulated as required. As noted above, they do not comply with the well-established design and fabrication code, ASME PVHO-1, Safety Standard for Pressure Vessels for Human Occupancy. North Carolina mandates compliance to this code. NFPA 99 mandates compliance to this code. The Life Safety Code (NFPA 101) invokes compliance to the hyperbaric requirements noted in NFPA 99, which also mandates compliance through reference. Therefore, if properly regulated, hyperbaric chambers of this type would not have been allowed to operate in North Carolina.

The National Fire Protection Association recently highlighted the importance of this issue in the January/February issue of its magazine, NFPA Journal. The story, entitled “The Air In There,” provides a general overview of the hazards and challenges associated with hyperbaric chambers and informs local authorities having jurisdiction about the magnitude of the problem while offering suggestions on how to deal with it.

“This is an area of health care that a lot of AHJs may not know that much about,” said Scott Sutherland, executive editor of NFPA Journal. “With these types of facilities proliferating, though, it’s important for AHJs to understand the potential hazards. I think our story does a good job of describing those hazards and of explaining why this is an area of concern right now.”

Read the complete NFPA Journal story at http://www.nfpa.org/news-and-research/publications/nfpa-journal/2017/january-february-2017/features/hyperbaric-chambers

The Food and Drug Administration (FDA) has posted a consumer update – “Hyperbaric Oxygen Therapy: Don’t Be Misled” –  for the use hyperbaric oxygen on its website http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm364687.htm

It’s a growing concern

A casual search of the internet demonstrates the prolific use of low- pressure fabric chambers for indications that have not been proven. At the time of the posting the FDA had received 27 complaints from consumers over three years about treatment centers promoting hyperbaric chambers for uses not cleared by the agency.

Low-pressure fabric chambers are designed and have an FDA 510(K) premarket notification to be pressurized with air to treat acute mountain sickness. They are not built to ASME PVHO or NFPA 99 codes. However, they are routinely being operated outside of the FDA approval and NFPA codes and standards. The use of these chambers is sometimes referred to as mild hyperbaric oxygen therapy (mHBOT).

From a position of risk management we do not support the use of low-pressure portable fabric chambers for anything other than acute mountain sickness. Clinical hyperbaric oxygen therapy as defined by the Undersea and Hyperbaric Medical Society, Hyperbaric Oxygen Therapy Indications, 13th edition, requires that the patient breathe near 100% oxygen while inside a chamber pressurized to at least 1.5 atmospheres absolute. The low-pressure fabric chambers are not designed to provide this clinical dose of oxygen and pressure. Clinical hyperbaric oxygen chambers need to be designed, manufactured, housed and operated according to the FDA, NFPA and ASME-PVHO codes.

Jim Bell CHT/EMT/CFPS is Chair of the UHMS HBO2 Safety Committee; Tom Workman MS, CAsp, CHT, FAsM is UHMS Director of Quality Assurance and Regulatory Affairs and a dedicated committee member.

 

From the First Quarter 2017 issue of Pressure, the UHMS member newsletter. See the entire open-access document at:

https://www.uhms.org/publications/pressure-online.html

TAKE A NEW ROUTE: UHMS PROGRAM FOR ADVANCED TRAINING IN HYPERBARICS (PATH)

ENOCH HUANG MD, FUHM  •  E: enoch.huang@mac.com  •  Twitter: @POTUHMS

Let’s talk education.

There is currently a low bar to practice undersea and hyperbaric medicine (UHM). Most hospitals only require completion of a 40-hour introductory course in hyperbaric medicine (ICHM) to get hospital privileges, and some organizations are offering portions of the ICHM online, circumventing the UHMS requirement that those 40 hours be conducted in person with live, face-to-face encounters with course faculty.

On the other end of the spectrum, the UHMS considers UHM fellowship training and American Board of Medical Specialties (ABMS) UHM board certification to be the gold standard when considering education in hyperbaric medicine, and we recommend this pathway for all new graduates and anyone who has the means to do so.

However, we recognize that not every current practitioner can take a year off from work to complete this process. This is where the Program for Advanced Training in Hyperbarics (PATH) comes into play. This extensive online program allows individuals to earn recognition for the extra effort that they have put into obtaining advanced education in hyperbaric medicine. Physicians (MDs/DOs) will be able to earn a Certificate of Added Qualification (CAQ), and Advanced Practice Clinicians (NPs/PAs) will be able to earn a Certificate of Advanced Education (CAE), demonstrating that they have gone above and beyond the minimum 40-hour ICHM.

While other organizations offer a CAQ in hyperbaric medicine, the UHMS CAQ is different: The requirements are much more stringent and involve both didactic material as well as a peer-reviewed clinical management component as part of the PATH. Additionally, the UHMS PATH will be the first program to include Advanced Practice Clinicians (APCs), who will be able to earn a Certificate of Advanced Education. While the issue of whether APCs should be allowed to supervise hyperbaric oxygen (HBO2) treatment or not is still actively debated, this is an issue that is outside the control of the UHMS and is regulated by the laws of individual states. The UHMS Board of Directors voted to embrace our mission of education and raise the level of education for all providers of HBO2.

Students in PATH will be able to earn more than 100 hours of CME reviewing a carefully curated syllabus of pertinent hyperbaric literature and video lectures. They will also have to submit cases that they have seen and personally managed for peer review and feedback. There will be live online case conferences where nuances of management decisions and documentation pearls will be discussed. Finally, students will have to complete an in-person hands-on skills lab to demonstrate familiarity with chamber systems and treatment algorithms. This program is far and above what is available through other certification programs, which usually include only a written examination and a self-reported “log” of supervised treatments. Completion of the UHMS PATH will prepare the student to be a safer, smarter and superior hyperbaric practitioner.

Over a year in the making, the UHMS PATH represents an evolution of the Stellenbosch University CAQ program from several years ago. While that curriculum is still available directly through Stellenbosch University, this program was designed to meet the needs of UHMS members based on feedback received from enrollees and graduates of that program. We are continually refining the elements of PATH and will be rolling out additional modules as they are ready. As an overview, PATH will have the following components:

SELF-DIRECTED LEARNING

(9 blocks of material covering 70-plus assignments):

  • Reading assignments – Students will read selected textbook chapters, seminal articles and other publications.
  • Video presentations – Students will view selected PowerPoint presentations that have been selected from previous UHMS educational events or prepared especially for PATH.
  • Pre-test/Post-test – For each block of material, students will be given a pre-test and post-test. The pre-test will be “closed book” to assess baseline knowledge of the material prior to reading the assignments. The post-test will be “open book” and will be administered after all of the reading has been completed. Students will be given feedback on which questions were answered incorrectly on the post-test in order to research the content.
  • Final examination – After completion of all of the blocks, a final examination will be administered. Students must get 70% of answers correct on the final examination to be eligible for completion of the program. Students will be given three opportunities to pass the examination.
  • Case presentations – Students will submit case write-ups from the initial consultation to the end-of-treatment summary for peer review by a board-certified UHM faculty member. Students will have to receive a passing review of 10 cases (covering at least four distinct HBO2 indications) to be eligible for completion of the program.
  • Case conferences – Students will participate in regularly scheduled web-hosted case conferences led by board-certified UHM faculty members to discuss interesting cases and provide feedback on case workups. Students will be expected to attend six conferences to be eligible for completion of the program.
  • Skills lab – Students will have to complete the UHMS Hyperbaric Skills and Emergency Management course that will be offered periodically in a live setting. The tuition for the skills lab will be independent of PATH tuition.

IN SUMMARY

  • PATH is not a substitute for ABMS board certification in UHM, and its curriculum is certainly not a substitute for fellowship training, which is considered the gold standard for physician education in UHM.
  • There is a large knowledge gap between completion of a 40-hour ICHM and fellowship training.
  • The knowledge gained in a 40-hour ICHM is insufficient to fully prepare a clinician to practice the full breadth of undersea and hyperbaric medicine.
  • There is no formal training program other than the 40-hour ICHM available to APCs.
  • There is no means for clinicians who have undertaken additional continuing medical education in UHM to show that they possess training/education above the most basic attendee of a 40-hour ICHM.
  • There is no means for foreign medical graduates to obtain ABMS board certification, and limited opportunities for them to receive an advanced certification in UHM.
  • Hospitals have no means other than board certification to identify more highly trained providers of UHM.
  • The UHMS feels that raising the level of knowledge for all providers of UHM falls within its mission to develop and promote educational activities, symposia and workshops that improve the scientific knowledge of matters related to undersea exposures and hyperbaric oxygen therapy.
  • While this CAQ and CAE will be provided and recognized by the UHMS, it will ultimately be up to hospitals and other regulatory agencies to determine whether they will require any minimum training requirements for practice.

We have been working hard on the foundation of this program, and will continue to refine and improve it based on your feedback. I look forward to seeing you all on the UHMS PATH.

QUESTIONS/ANSWERS ABOUT PATH

Here are several questions that have already been asked about the program:

Do I need to be a member of the UHMS to enroll in PATH?
Yes. You need to be a UHMS member in good standing to enroll in PATH and to maintain your CAQ / CAE.

Why is there a difference between the CAQ (for physicians) and the CAE (for APCs)?
Distinction. While both groups of providers will complete an identical curriculum, the committee felt that we needed to maintain the distinction between provider types.

Will there be CME credits for this program?
Yes. We will provide more than 100 hours of CME for the program. This is in distinction to the previous Stellenbosch program that did not award any CME credits. You will be awarded CME credits after each post-test is completed for the self-directed learning, after each case presentation that has been passed, and after each case conference attended.

If I completed the Stellenbosch CAQ program, do I have to take the UHMS PATH?
No. The UHMS CAQ awarded through the Stellenbosch program remains a recognized CAQ.

If I deferred completion of the Stellenbosch CAQ program, do I have to register for the UHMS PATH?
No. Students who deferred completion of the Stellenbosch program are automatically registered for the UHMS PATH.

Do I have to complete the blocks in order?
No. You can complete the blocks in any order you wish. As a matter of fact, we will be releasing blocks when the review committee has completed writing and reviewing the test questions, so they may not be released in the order that they are listed.

If I do not see patients in consultation, can I enroll in the program just for the didactic portion (self-directed learning)?
That depends. This will depend on the number of people who express interest in this option.

If I do not pass the examination or do not complete the course, can I get a refund?
Unfortunately, we will not be granting refunds if you do not complete the course. You will still receive the CME credits for any modules that you do complete.

Who was involved in the creation of the UHMS PATH?
I want to thank the following contributors who have provided advice, didactic content, examination questions, and/or feedback used for the creation of the UHMS PATH.

Robert Barnes MD
Richard Baynosa MD
Michael Bennett MD
Fred Bove MD
Walter Chin RN
Paul Cianci MD
Richard Clark, CHT
Paul Claus MD*
Bruce Derrick MD
John Feldmeier DO
Jake Freiberger MD*
Lisa Gould MD*
Neil Hampson MD
Sean Hardy MD
Harriet Hopf MD
James Holm MD*
Enoch Huang MD*
Folke Lind MD
Simon Mitchell MD
Hassan Murad MD
Heather Murphy-Lavoie MD*
Neal Pollock PhD
Michael Strauss MD
Bill Tettelbach MD
Richard Vann PhD
Lindell Weaver MD
Gene Worth MD

*PATH Committee Member

From the First Quarter 2017 issue of Pressure, the UHMS member newsletter. See the entire open-access document at:

https://www.uhms.org/publications/pressure-online.html