Our office is currently representing a client who sustained what appears to be permanent scarring as a result of undergoing laser hair removal. However, the laser hair removal center involved has gone out of business to the chagrin of, as readily apparent from the internet, many former customers of the facility.
An apparent owner of the laser hair removal facility, a non-physician, has boasted on the internet that any judgment a customer might obtain in court for the facility’s breach of contract by not rendering services that had been paid for would be a useless judgment against his “defunct” corporation that would never be collected.
But an important question arises: Isn’t there supposed to be a doctor supervising the laser procedure?In August 2002, the New York State Board of Medicine passed a resolution recommending that the use of lasers and intense pulsed light for hair removal be considered the practice of medicine and thus be performed by a physician or under direct physician supervision.
A bill has been introduced in the New York State Assembly (2007 AB 8142), and a similar bill in the State Senate (SB 4173) that if passed would amend the current law in relation to the regulation of the use of laser, intense pulsed light, radio frequency and medical microwave devices. The law states only authorized persons can use any laser classified as Class IIIB or Class IV, intense pulsed light, radio frequency and medical microwave devices on human beings, and that their use on human beings is deemed to be the practice of medicine. The bill is presently pending.
Significantly, the proposed law permits physicians to delegate the use of these devices to registered nurses but only if it is done pursuant to a patient specific order and under the direct supervision of the delegating provider. Direct supervision means that the supervising provider is physically present on-site and immediately available to respond to any questions or problems that may arise while treatment is being performed.
The justification for the bill states: “Over the past several years in New York, there has been a marked increase in the use of laser and other devices to do cosmetic, esthetic and other skin enhancement procedures. Simultaneously, there has been an increase in the number of injuries caused by the proliferation and use of these devices by untrained and unskilled personnel. Entrepreneurs, without medical training, are treating people with little or no oversight or regulation. Spas and self-styled “skin clinics” advertise these high-tech procedures using medical devices.
“More and more media reports and exposes are reporting an increase in malpractice cases, a result of adverse outcomes related to inappropriately rendered treatment by clinicians in New York. The majority of cases are the result of a lack of experience, lack of training, poor judgment, and/or inappropriately selected technology for a particular procedure. The burns and other injuries which can result from the inappropriate use of these devices by unqualified persons can cause permanent scarring, disfigurement and disability.
“These laser devices are classified as prescriptive devices by the FDA. They can only be sold to professionals who can prescribe. However, it is up to each state to regulate the use of these devices by physicians and non-physician personnel. Standards of use and care are needed to deduce the risk to the public who seek out these treatments. This bill will make these devices available for use only by authorized professionals.”
In California, legislation is being sponsored by the American Society for Dermatologic Surgery, and if passed will have a monumental impact on physicians, nurses, NPs , PAs and management companies involved in the aesthetic field. Physicians who are involved in aesthetic practices on a part-time basis must be on-site, providing direct supervision of delegated procedures, and must personally provide good faith exams on all patients prior to delegation. RNs will not be allowed to perform any procedures without the physician on-site unless the treatment is performed in a physician owned office with certain restrictions.
Of great note included in this bill is the severe scrutiny of lay (non-physician), corporate owned entities, or management companies, that manage “medspas”, which would deemed to be the “owners / operators” of the practice in violation of the “corporate practice of medicine prohibition.” Entities in violation would be subjected to extreme penalties and even prison time. Physicians supervising aesthetic practices conducted in these entities would also risk penalties and loss of licenses.
The Board of Directors of the American Academy of Dermatology (AAD) approved a Position Statement on the Use of Lasers, Pulsed Light, Radiofrequency, and Medical Microwave Devices in February of 2004. This document permits a physician to delegate such procedures to nonphysicians and does not require a physician to be physically present in the room when the procedures are performed. But the supervising physician must be physically present on-site, immediately available, and able to respond promptly to any questions or problem that may occur while the procedure is being performed.
The nonphysician office personnel must have appropriate documented training and education in the physics, safety, and surgical techniques of each system, be properly licensed in their state if required, and be adequately insured for that procedure. The nonphysician office personnel should also be appropriately trained by the delegating physician in cutaneous medicine.
According to the American Society for Dermatologic Surgery (ASDS), laser hair removal is more than just “zapping” unwanted hairs. It is a medical procedure that reduces the amount of hair growth through a series of treatments, usually over a period of six to eight weeks and should be performed by a qualified physician. In an effort to educate consumers about undergoing laser hair removal procedures without complications, the ASDS created the following do’s and don’ts guidelines: do ensure the physician has experience with different skin types, don’t tan before or after a procedure, and more.
The ASDS provided, in the public portion of its web-site, a statement entitled Don’t Get Burned What You Need to Know About Laser Hair Removal, which reads in part:
• Do consult a qualified physician: Regulations for laser use have not kept up with the demand and consumers should be cautious of nonphysicians practicing these procedures in spas/salons. Only a physician who is board-certified in dermatology or another specialty with equivalent training and experience should perform this procedure or the physician can designate another trained technician to perform a procedure as long as he/she is under the direct (on-site) supervision of the physician.
• Do ask questions: What kind of lasers do they use? What kind of training or experience do they have? Can you speak with one of their clients? If the person performing the procedure can’t answer these simple questions, you should walk away.
• Do ensure the physician has experience with different skin types: People of a darker complexion may experience unusual lightening of the skin if an incorrect laser is used at an inappropriate setting.
The position of the American Society of Laser Surgery and Medicine (ASLMS) is that a properly trained and licensed medical professional may carry out specifically designed laser procedures only under physician supervision and following written procedures and/or policies established by the specific site at which the laser procedure is performed.
Since the ultimate responsibility for performing any procedure lies with the physician, the supervising physician should be immediately available and shall be able to respond within five minutes to any untoward event that may occur. Ultimate responsibility lies with the supervising physician. The American College of Surgeons believes that surgery using lasers, pulsed light, radio frequency devices, or other means is part of the practice of medicine and constitutes standard forms of surgical intervention.