‘Mild hyperbaric’ facilities need to comply with standards or cease and desist until they can
The medical discipline of clinical hyperbaric medicine had its origins in the 1960s with seminal work done in both Holland and the United States. One of the early applications employed hyperbaric oxygen delivered in large chambers configured as operating theaters. By operating under pressure and delivering significantly increased oxygen doses to the patient, open-heart surgery was possible because the enhanced hyperoxemia permitted a tolerance to a longer period of asystole than would be possible for patients operated at normal surface pressures.
Once heart and lung machines became available, there was no need for surgery under pressure. The very first application of hyperbaric or recompression treatment was its application to the treatment of decompression sickness (commonly known as the bends) and other diving injuries. This treatment is still the definitive intervention for decompression sickness and injury due to rapid changes in pressure for divers, including traumatic air embolism also known as barotrauma.
In the intervening years, hyperbaric oxygen has evolved to be a studied and effective therapy for many disorders, often as an adjunct to the primary treatment (See Table 1. for the list of accepted indications). These applications are based on a large body of supporting literature and research, much of it Level 1 evidence. Some in other medical disciplines still think of hyperbaric oxygen as an “alternative medicine.”
It is certainly an unusual medical treatment: It does not come as a pill or capsule, nor is it delivered intravenously. Hyperbaric oxygen has been recognized as a medical subspecialty by both the American Board of Preventive Medicine and the American Board of Emergency Medicine both of whom offer board certification in this discipline.
Hyperbaric oxygen is most commonly employed now for non-healing wounds in the lower extremities of individuals with diabetes and delayed complications of therapeutic radiation. In both of these applications, hyperbaric oxygen can often permit avoidance of major disfiguring and disabling surgeries. Randomized controlled trials support its application in both these pathologies. One mark of its acceptance is the declaration that hyperbaric oxygen should be considered an intervention supported by Level 1 evidence published in the article laying out clinical guidelines by the American Society of Colon and Rectal Surgeons for the treatment of chronic radiation proctitis. Most third-party payers, including Medicare, will reimburse for hyperbaric oxygen treatments for the indications provided in Table 1.
Table 1
|
| Hyperbaric Treatment of Air or Gas Embolism: |
As primary treatment along with supportive measures |
| Arterial Insufficiencies including Central Retinal Artery Occlusion and Selected Problem Wounds |
As adjunct to other established treatments |
| Carbon Monoxide Poisoning |
As primary treatment along with supportive measures |
| Clostridial Myonecrosis (Gas Gangrene) |
As adjunct to surgery and antibiotics |
| Compromised Grafts and Flaps |
As adjunct to surgery and antibiotics |
| Acute Traumatic Ischemias |
As adjunct to surgery and antibiotics |
| Decompression Sickness |
Primary treatment |
| Delayed Radiation Injuries |
As adjunct to other treatments |
| Sudden Sensorineural Hearing Loss |
Along with steroids |
| Intracranial Abscess |
As adjunct to surgery and antibiotics |
| Necrotizing Soft Tissue Infections |
As adjunct to surgery and antibiotics |
| Chronic Refractory Osteomyelitis |
As adjunct to surgery and antibiotics |
| Severe Anemia |
As temporizing measure until normal hematogenesis is adequate in selected pati |
| Thermal Burns |
As adjunct to surgery and antibiotics |
The Undersea and Hyperbaric Medical Society (UHMS) has been the premier professional organization for the hyperbaric medicine community for over 50 years. This organization seeks to provide support for education, research and communication and offers a forum for continuing education and exchange of the latest updates at its national and regional meetings.
The UHMS has conducted a practice accreditation program for 20 years that seeks to promote high standards of practice within the hyperbaric medicine community. Hyperbaric oxygen is a unique treatment that offers unique benefits in certain cases but also introduces unique concerns regarding safety in this very specialized environment involving high pressures, high oxygen content and the attendant risk for both fire and explosive decompression. It is vital that the equipment involved in treatment, especially the pressure vessel itself, be designed, manufactured, installed and maintained to the highest standards.
This requires adherence to established hyperbaric design and operational standards provided by the NFPA (National Fire Protection Association) and the American Society of Mechanical Engineers Safety Standards for Pressure Vessels for Human Occupancy (ASME PVHO-1). Perhaps, most importantly the chambers should be cleared in accordance with the Pre-Market Notification Process (FDA 510k) by the FDA.
Over the past decade or so, “mild hyperbaric” facilities have proliferated in the United States and internationally. These “mild hyperbaric” centers are mostly located in spas, wellness centers, and even shopping center storefronts. They are not being operated as medical facilities or even doctors’ offices. They frequently operate with minimal or no physician involvement. Staff are often inadequately trained. Many, if not most, employ pressure vessels to deliver mild hyperbaric “treatment” that fails to meet the safety standards of the NFPA or ASME and frequently they are not FDA cleared. Many use zip-up chambers made of non-rigid material very much akin to a canvas bag (see photo).
Generic bag chamber
Some of the soft-sided chambers have FDA clearance for the treatment of acute mountain sickness but are not cleared for the range of disorders scientifically supported by the Undersea and Hyperbaric Medical Society and are not cleared when combined with oxygen.
Even more recently we have seen rigid chambers manufactured in other countries and exported to the U.S. in parts and pieces to be assembled. In this piecemeal fashion, these uncleared chambers are often not detected by inspectors and pass into the country to be used without FDA awareness. Standard, mainstream hyperbaric medicine requires treatment most often at ambient pressures of 2.0 to 3.0 ATA (atmospheres absolute), with oxygen delivery at those pressures exceeding 95% of the breathing gas mix. The “mild hyperbaric” facilities typically treat their patients – or more properly, clients – at pressures of 1.4 ATA or lower. While many “mild” centers treat with compressed air only, some “mild” facilities attempt to increase the oxygen concentration for patients in their noncleared chambers and compound safety issues by adding oxygen concentrators. The oxygen concentrators employed are themselves often imported without 510K clearance. Since both hyperbaric chambers and oxygen concentrators are classified as Class 2 medical devices, they have to be reviewed and cleared individually and in any joint usage.
In websites and promotional brochures, some of these facilities have intentionally usurped the large body of published scientific articles reporting the results of standard and properly dosed and delivered hyperbaric oxygen. These include the 14 indications listed in Table 1. The mainstream hyperbaric community, as does the FDA, considers hyperbaric oxygen to be a “drug.” As such, it must be delivered by prescription in adequate doses with proven protocols to be effective. Ineffective treatments can delay the appropriate application of hyperbaric oxygen. Just recently, in Great Britain, a diver was treated for decompression sickness (the bends) ineffectively in a “mild hyperbaric” facility. The diver did not have resolution with the “mild” treatment and subsequently required retreatment at a standard hyperbaric recompression/hyperbaric facility. Severe, improperly treated decompression sickness can result in death for the diver if treatment is inadequate or delayed.
“Mild hyperbaric medicine” centers are targeting a vulnerable population of patients with disorders for which there is no established role for hyperbaric oxygen at any pressure in any treatment protocol. Desperate parents will pay large sums of money to these centers to treat children with cerebral palsy, autism or other unproven, often neurologic indications. “Mild hyperbarics” is portrayed as an innovative new therapy. Another vulnerable group includes stroke patients who may be months or years post stroke. Although the treatment of stroke patients with hyperbaric oxygen has been and continues to be studied, this treatment is investigational and not reimbursed by health insurance carriers. Therefore, when treated in unsafe chambers and with ineffective doses, these patients accumulate a substantial debt with virtually no hope of improvement.
The delivery of hyperbaric medicine IS the practice of medicine. Non-physicians must not be permitted to deliver this very specialized medical treatment without the involvement, prescription and oversight of properly trained and licensed physicians.
Both the American Medical Association and the Bexar County Medical Society have approved resolutions calling for a cessation of “mild hyperbaric” treatments. As you may know, the Bexar County resolution was recently communicated to the Texas Medical Board. The TMB took prompt action to issue a cease-and-desist order to two “mild hyperbaric” activities in state. Each were operated by dentists. These operations were shut down based on the determination that these individuals were practicing medicine without a medical license.
In summary, “mild hyperbaric” advocates and providers offer a duplicitous presentation to their potential clients and regulators. On one hand, they claim that their chambers need not adhere to the long-established standards for safe design and operation required for clinical hyperbaric installations because of the “mild” doses delivered at pressures just slightly elevated above sea level pressure. On the other hand, they attempt to convince their potential customers that these mild pressures will be as effective as the established higher pressures combined with essentially 100% oxygen offered by mainstream hyperbaric facilities. All too often, the current “mild hyperbaric” operators promote their therapy to vulnerable populations for unproven indications.
Until and unless, these “mild hyperbaric facilities” comply with all appropriate safety regulations and select appropriate treatment pressures and protocols along with safely delivered and approved oxygen delivery systems to treat scientifically supported disorders, they should be required to cease and desist treatments.
The delivery of hyperbaric medicine IS the practice of medicine. Non-physicians must not be permitted to deliver this very specialized medical treatment without he involvement, prescription and oversight of properly trained and licensed physicians. Nurses and staff working under the direction of trained and preferably board-certified physicians must be adequately trained to understand and respond to their patients’ unique hyperbaric environment and their patients’ reactions and special needs in this environment. Physicians of the UHMS would gladly welcome new colleagues to our discipline if indeed they were committed to practice safe and effective hyperbaric oxygen treatments. As it now stands, we are a discipline which aims to police itself and seeks to support safe and effective treatments by professional and technical staff who are prepared and trained to deal with the unique complications that can occur in the hyperbaric realm and do so with greater frequency when the treatments are improperly delivered.
First published in San Antonio Medicine in January 2023 and republished with consent.
