Oxygen administered under high pressure presents unique safety and compliance concerns to clinicians and allied health providers.
Omni Oxygen Solutions believes that there is no greater concern in the realm of Hyperbaric Oxygen Therapy (HBOT) than safety. Because of this, and our commitment to education, we actively seek to inform both the medical community and the general public on the various practices and considerations necessarily to safely administer hyperbaric oxygen.
1. Risk of Fire and/or “Catastrophic Loss”
Fire is one of the most serious risks associated at facilities administering 100% oxygen under pressure. There are many safety regulations aimed at reducing the risk of fire. Among them are:
i. NFPA:
NFPA 99: Guidelines for Healthcare Facilities, which is widely used throughout North America as a building standard and regulation for hospitals. Because of their complex nature, hyperbaric facilities are the only type of facility that receive an entire chapter, reserved exclusively for the safe practice of hyperbarics.
ii. ASME:
ASME PVHO-1, which is the American Society of Mechanical Engineers’ design regulation governing the construct of all “pressure vessels” designed for “human occupancy” is an essential component of a hyperbaric facility. Hyperbaric chambers that do not meet ASME PVHO-1 standards should never be used, either with oxygen or with air if the internal pressure exceeds 2 PSI. However, many “boutique” spas and off-label practitioners use grossly inadequate chambers, including nylon zipper bags and ad-hoc converted home boilers.
iii. ASTM:
The American Society of Testing and Materials provides extensive scientific data to allow engineers and hyperbaric chamber safety coordinators/directors to practice responsible discretion.
iv. CGA:
The Compressed Gas Association provides data and regulations for pressurized oxygen that are vital to safe hyperbaric treatment.
2. Risk of Medical Complication
Although hyperbaric oxygen therapy is considered one of the safest advanced treatment modalities in modern medicine, there are various associated clinical risks that should factor into a physician’s decision to prescribe hyperbaric oxygen. Contra-indication for therapy should be considered prior to beginning treatment; however, there are other potential medical complications to be considered at every facility. Chief among them are:
i. Barotrauma
Because the body contains “gas containing” spaces, including the lung and sinuses, and because gaseous molecules (eg. air and oxygen) follow the laws of physics with regards to pressure change, it is important that physicians, chamber operators, and patients all undergo extensive education and appropriate consideration and practice relating to barotrauma.
ii. Oxygen Toxicity (Oxygen Overdosing)
At normal pressure, it is impossible to “overdose” on oxygen. However, with the increased pressure achieved in hyperbaric chambers, oxygen behaves like a drug. In such conditions, oxygen “overdosing”, or oxygen toxicity becomes possible. It is the responsibility of physicians and medical directors to mitigate the risk of oxygen toxicity, and to educate patients on reducing toxicity factors.
iii. Vision Change
Although the processes contributing to vision change are not well understood, HBO has been shown to: (a) temporarily correct farsightedness (hyperopia), and (b) temporarily worsen nearsightedness (myopia). Further, HBO can, over long periods of time, permanently worsen existing cataract conditions, and even create cataracts. Cataract formation or degradation as a result of HBO is not self-correcting.
iv. Vasocontriction
HBO treatment will temporarily increase systolic (“top number”) blood pressure. This is normal, and usually corrects within 3-5 hours after treatment.
v. Hypoglycemia (in Diabetics)
Because of complex chemical processes, hyperbaric oxygen “activates” the digestive system. The resulting energy demands of this activation deplete stored sugar in diabetic patients. It has been documented that patients may experience a decline in blood sugar of as much as 51 mg/dL over the course of a 90 minute hyperbaric oxygen treatment. Therefore, it is recommended that all patients eat prior to treatment.
3. Risk of Liability/Neglect
If a facility offers or maintains operational medical treatment for a disease, ailment, or condition, and a physician responsible for the care of a patient decides against or fails to consider the “standard of care” related to that process. If the clinician fails to treat the patient appropriately, both they and the facility are responsible for that neglect, and are held liable for medical misconduct relating to the non-conformity to the standard of care.
4. Risk of Misconduct
Hyperbaric facilities are complicated and unique operations within hospital settings because of the various skill-sets required to operate the unit. Because of this, regulatory agencies have created guidelines, accreditation and certification standards, and operational textbooks related to hyperbaric facilities. Additionally, all hyperbaric facilities should implement the practices outlined by W.T. Workman in his textbook, Hyperbaric Facility Safety: A Practical Guide.
i. UHMS:
The Undersea and Hyperbaric Medical Society exists to regulate the use, practice, and operation of hyperbaric facilities. In some U.S. states, UHMS Facility Accreditation is a requirement for CMS reimbursement. The UHMS additionally provides Facility Operation Guidelines and Standards, and are the primary entity responsible for the clinical advocacy of HBOT to the larger medical community, the FDA, and insurance providers.
ii. NBDHMT:
The National Board of Diving and Hyperbaric Medical Technology provide certification for experienced clinicians involved in hyperbaric nursing and chamber/facility operations.
iii. ABEM/ABPM Board Certification for MD/DO:
The American Board of Emergency Medicine and the American Board of Preventive Medicine both offer Specialty Board Certification for physicians after the completion of ACGME Approved Residency Programs and Exams.
iv. Hyperbaric Safety Director:
The NFPA 99 Hyperbaric Facility regulations stipulate the mandatory appointment of a hyperbaric facility safety director. The appointment of such a person is invaluable if that individual possesses the expertise necessary to provide facility medical directors with the information necessary to direct clinical administration.
v. FDA:
The U.S. Food and Drug Administration requires hyperbaric chambers to provide “label use” indications. Such label use is defined as the precise medicinal application of the device. The FDA may add or retract label indications based on the medical and scientific evidence it receives, as well as current and/or past events that otherwise shape the safe usage of device. Any indication or application where hyperbaric chambers are used outside of acceptable (label) indications are considered “off-label.” In addition to lack of reputable scientific or clinical evidence to support therapeutic benefit and reimbursement refusal by insurance providers, the F.D.A has the authority to close any operation, business, practice, or facility engaging, participating in, or allowing “off-label” treatment, including hospitals. Further, they have the authority to cease and penalize any entity engaging in the advertisement, solicitation, or allowance of advertisement for such off-label usage.
5. Risk of Reimbursement Refusal
Recently, physicians prescribing hyperbaric oxygen have encountered difficulty collecting reimbursement. Of course, standard clinical documentation verbiage plays a role in some instances, as does the particular diagnosis for which the patient is being prescribed therapy. However, there are additional reimbursement factors that will affect facilities, which include:
i. UHMS Facility Accreditation- Some third party insurers, such as CMS, are already requiring UHMS facility accredidation in order to reimburse facilities. This reimbursement qualifier ensures that facilities adhere to proper standards of safety, care, and ethics.
ii. CHRN Availbility- At least two private insurers require that at least one (1) NBDHMT CHRN, or Certified Hyperbaric Registered Nurse be available in the treatment locale for treatment to qualify as billable. This requirement is a jointly held standard by the UHMS for facility accreditation.
iii. ABEM/ABPM Board Certification- In addition to hyperbaric credentialing by a facility, third party payers are beginning to require that a billing physician for hyperbaric therapy be board certified by either the ABPM or ABEM. Alternate certification routes are not yet recognized, and physicians must conduct a 1 year residency in an ACGME-approved fellowship program before they may qualify for Board Certification by either body.
iv. Revisions to NFPA Code – If local municipalities or fire marshalls adopt newer versions of the NFPA than the ones your facility has been met to, they may choose (and have legal authority to) shut down a hyperbaric unit and/or an entire facility housing a hyperbaric chamber.
v. Joint Commission / CMS Requirements – Because of the recent boom in hyperbaric oxygen therapy and wound care centers, both the Joint Commission and the Centers for Medicare and Medicaid have begun re-evaluating qualifications at such facilities. In addition to incorporating some or all of the above mentioned qualifiers, both bodies require the immediately available presence of the unlimited license physician credentialed in hyperbaric medicine who is overseeing the treatment. Both organizations are additionally calling upon Mechanical Engineering PE/PVHO experts and local Building Inspectors to verify stringent code compliance.