Cryotherapy: Making it Safe for Patients and Providers
Cryotherapy has been getting plenty of attention of late. Over the past year, growing media coverage has featured people who swear by it for pain reduction and all kinds of other health conditions. There are distinct types of cryotherapy, from whole-body cylinders to freezing rooms to localized administration to extremities. Generally, they involve nitrogen gas or some other freezing cold source.
Like many new therapies, cryotherapy enthusiasts are making all kinds of claims about its benefits – not just pain reduction but for fibromyalgia, arthritis, weight loss, depression, osteoporosis, and a host of other treatments. Celebrities are lining up to praise its benefits.
And, like many new therapies, critics are decrying the lack of oversight. The death last month of Chelsea Ake-Salvacion, an employee who froze to death using a cryotherapy chamber in Las Vegas, has drawn nationwide attention. There have been a number of complaints of lesser injuries, such as frostbite, garnering negative attention.
So what’s the story? Is cryotherapy safe? Where are the risks for providers and patients? Some people are calling for new regulations to address it. The State of Nevada just released guidelines, including recommendations that include limiting users to one 3-minute session per day, blood pressure checks before and after use, CPR training of staff, emergency kits and defibrillators onsite, nitrogen monitors, and all kinds of risk disclosures.
While detailed regulations can’t hurt, they shouldn’t strictly be necessary. After all, existing state laws governing the practice of medicine and federal regulations offer a ready-made framework for consumers and providers alike to assess and ensure that cryotherapy is conducted safely.
- FDA and Medical Device Compliance for Cryotherapy
The first question to ask about any therapeutic treatment is its status with the United States Food and Drug Administration (FDA). The FDA is responsible for oversight of the safety, efficacy and security of medical devices throughout the United States. Under the Food, Drug, and Cosmetic Act (FDCA), the FDA regulates the approval of devices, as well as the labeling and marketing claims that can be made about the. The FDA is also responsible for ensuring that manufacturers produce consistent quality devices for consumers.
Are cryotherapy chambers and other means of administration medical device? Absolutely. The FDCA defines a medical device to include a “machine . . . or other similar or related article . . . which is: . . . intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease …” (FDCA § 201(h).) This broad definition certainly includes any device used in cryotherapy.
Through the Medical Device Amendments of 1976, the FDA categorizes medical devices in three categories: Class I devices that are low risk and require only “general controls,” which generally translates to appropriate labelling, compliance with FDA quality systems regulations, current good manufacturing practice, and adverse event reporting requirements. Class II devices are higher risk devices than Class I and require greater regulatory oversight – “special controls” to provide reasonable assurance of the device’s safety and effectiveness. Special controls can include special labeling requirements, mandatory performance standards, postmarket surveillance, and, typically, a premarket notification submission requirement known as 510(k). In a 510(k) submission, the manufacturer relates the device to one already on the market (a “predicate” device) and gets approval to make similar approved marketing claims. Finally, Class III devices are the highest risk to patients and typically require specific Pre-Market Approval (PMA) by the FDA before being marketed.
What about devices that are unclassified or unapproved? These two terms mean significantly different things. Some unclassified or not-yet-classified devices were not classified after the Medical Device Amendments of 1976, and yet remain on the market. Devices that are unapproved, by contrast, are not legal to use in the United States. They may be approved in another country, but it is against the law to bring them into the U.S., or to buy, sell, or use these devices. Recent media reports have suggested that many of the cryotherapy chambers being utilized at the present time are not yet approved, which should sound alarm bells both for cryotherapy operators who may be using unapproved devices, and for manufacturers and resellers who have sold the devices into the U.S. market. The FDA status of cryotherapy equipment is a serious issue: any business that bought or sold a cryotherapy device not approved with the FDA may be at risk of criminal liability under the FDCA.
In many instances, there is simply too much international commerce going on for the FDA to police the introduction into the United States of unapproved devices. The FDA has to be selective about where to focus its limited resources and attention. The surest way to attract FDA interest, however, is media reports of events like deaths associated with devices. Once the FDA is involved, any person who buys, sells, or utilizes an unapproved device in commerce is potentially liable of a crime known as misbranding. It is safe to assume that Ms. Ake-Salvacion’s death has set in motion FDA scrutiny.
Given the growing popularity and consumer interest in cryotherapy, it would seem that the market opportunity for cryotherapy in the United States would justify the investment by operators in seeking approval, as opposed to circumventing federal laws and regulations. While the FDA approval process is expensive and time-consuming, it will be far cheaper than the potential liability for defiance of federal law.
Even for those cryotherapy operators who are FDA compliance, the issue of marketing claims about its therapeutic benefits should be an issue of concern. While physicians make “off-label” claims about the ways in which they believe a particular therapy can be used beyond FDA-approved indications, they have a recognized right of “free speech” to do so. Manufacturers and resellers of the device, however, have to take great care not to engage in “off-label” marketing by exceeding FDA-approved labelling claims in their marketing. Off-label marketing is also potentially criminal as misbranding.
Finally, the FDA status of cryotherapy devices will also clarify who can utilize the machines. It is almost certain that any approved FDA device will be deliberately labelled by the manufacturer to be for use only under physician prescription and supervision, precisely because of the danger involved and the inability to provide adequate instruction through manuals or safety videos. With this in mind, we turn to the related subject of insufficient physician oversight of cryotherapy to dates.
- Practice of Medicine Issues
In addition to the seeming inadequate attention to FDA medical device compliance issue, the other glaring problem with weak cryotherapy oversight relates to enforcement of state laws governing the practice of medicine. In utilizing cold temperatures to treat physical health conditions, cryotherapy falls squarely within the practice of medicine, which is defined under the laws of each state. Our experience has been that many cryotherapy operators are unaware of the implications of being regulated as a form of medical practice.
First, in many states, corporate practice of medicine laws restrict ownership and control to physicians, who are better trained to take safety precautions and deal with complications and who are subject to oversight of their professional licenses by state medical boards. Adherence to these rules would limit the risk associated with therapeutic choices and control of machines by unqualified personnel.
Second, compliance with requirements of medical practice would lead to a proper informed consent process, medical recordkeeping standard, and establishment of standards of care for the field. It would also lead to clear supervision and scope of practice requirements for staff. Many cryotherapy clinics are run by “cryotherapists” who are unlicensed. In most states, however, a small handful of non-physicians, such as registered nurses and physicians’ assistants, may legally utilize complex medical devices (such as cosmetic lasers) under appropriate physician supervision and with appropriate training, while unlicensed personnel cannot do so. Even without specific cryotherapy regulations, enforcement of these existing rules related to the practice of medicine would go a long way to improving safety.
Third, federal and state laws impose marketing restrictions to prohibit excessive marketing claims about the promising but unproven healing powers of cryotherapy. Similarly, many states impose insurance requirements, such as malpractice insurance coverage, that would protect patients and staff.
Rather than wait for states to develop new regulations for cryotherapy, the simplest solution is enforcement of laws and regulations already on the books by FDA and state medical board personnel. Consumers interested in cryotherapy should ask questions, like the name and model of the device, to check it on the FDA website, www.fda.gov, and should steer clear of operators who are offering unapproved devices. Business operators who have not been paying attention to medical practice rules should not delay in speaking to lawyers and getting their business into compliance; the practice of medicine without a license is a crime. It would be far better for entrepreneurs who are unlicensed to find legitimate roles on the “business” side and to ensure that clinical administration is left to physicians and appropriate personnel under physician supervision.