Friday, July 10, 2009

How to determine whether operating laser devices falls under "practice of medicine"?

By: Bill Gillette

AUSTIN, TEXAS — The Texas State Legislature has passed a bill that would require laser hair-removal technicians to undergo training and obtain a state certificate. As of press time, the bill is under review by Gov. Rick Perry. Currently, Texas has no regulations governing who can administer laser hair removal treatments — which means that anyone can.

Texas is not unique in this regard. According to Paul M. Friedman, M.D., director of the Dermsurgery Laser Center in Houston and clinical assistant professor of dermatology at the University of Texas Houston Medical School, only a handful of states do not specifically address lasers within state law or regulation.

"To my knowledge, they are Alabama, Alaska, Massachusetts — which is considering a bill — Missouri, New York, Rhode Island, South Carolina, West Virginia and Wyoming," he tells Cosmetic Surgery Times . "However, in many of these states, the use of lasers falls under the larger category of being subject to any law which regulates the practice of medicine. The lack of regulations in Texas is due to the fact that the Texas Medical Board had to repeal its laser regulations following two lawsuits that blocked its implementation."

David J. Goldberg, M.D., director of Skin Laser & Surgery Specialists of New York and New Jersey and director of Mohs surgery and laser research at New York's Mt. Sinai School of Medicine, adds that some states do not consider the removal of unwanted hair by high-powered medical lasers as the "practice of medicine."

"It turns out that in the states of New York, Virginia and Georgia, such laser treatments are not even considered medical procedures," he says. "In theory, in those states, the procedures could be done by a high-school student."

POWER POSITION Dr. Friedman relates that several states have taken the position that laser hair removal should be treated differently than other nonablative medical procedures. "I do not agree — these lasers are just as powerful and have the same potential for harm in the wrong hands as do other nonablative lasers," he says. "Any procedure, including hair removal, which utilizes energy-based devices capable of altering or damaging living tissue, should be considered as the practice of medicine. After all, the Food and Drug Administration considers these devices to be 'prescription devices'" he says. "Furthermore, consideration of laser-and light-based hair removal as the practice of medicine is consistent with the American Medical Association's and the American College of Surgeon's definition of surgery, as well as other AMA laser-surgery policy."

"In my opinion," Dr. Friedman adds, "laser hair removal should only be performed by appropriately trained physicians or licensed allied health professional under a physician's on-site supervision."

TEXAS SPECIFICS That will not be the case if the Texas bill is enacted, says Dr. Friedman, adding, however, that protocol will have to be developed in conjunction with the consulting physician. The bill states that a person is prohibited from "operating a laser or pulsed light device with the intent to treat an illness, disease, injury or physical defect or deformity unless the person is a physician, acting under a physician's order or authorized under other law to treat the illness, disease, injury or physical defect or deformity in that manner." The proposed law also states that a person can operate a laser for hair removal without being in a physician's office, but only if the laser technician has at least 24 hours of training, has performed 100 laser hair-removal procedures and has worked under the guidance of a supervisor. Facilities using lasers must also consult with a physician to develop proper protocols for laser use. If the bill is signed into law, violators could face a $5,000 fine and loss of their license.

PATIENT RISK Dr. Friedman says Texas dermatologists have reported an increasing number of patient complications from the nonphysician practice of dermatologic surgery, and that national surveys have reported similar findings. He cites a 2007 survey of American Society for Dermatologic Surgery members, which found that laser hair removal was the number two procedure for which complications occur — second only to misdiagnosis of skin cancer. He also cites a study that appeared in the September 2005 issue of Skin and Aging, which found that "Eighty-two percent of all complications occurred in facilities that had no direct physician supervision. Of these, 57 percent were in facilities with a 'medical director' who had limited training in dermatologic procedures and laser/light-based therapy. Of all the complications, 78 percent occurred in nontraditional medical facilities, such as free-standing medical spas and laser centers in shopping malls." That same study found that laser hair removal causes more complications than any other laser medical treatment, followed by laser/light leg vein treatments and nonfacial photorejuvenation.

Dr. Friedman says he thinks the legislation is a good first step toward protecting the public and addressing this important safety issue. "I hope to see policymakers continue to ensure that providers of cosmetic medical procedures have the appropriate medical training, licensure, physician oversight and supervision to ensure patient safety," he says. "For the first time in Texas, we have requirements for training, testing, advertising, complaints and penalties for violations if the bill passes. We are optimistic and we think the Governor will sign this bill into law."

When asked what action the governor plans to take regarding the legislation, Katherine Cesinger, a spokesperson for the Governor's office, told CST , "Gov. Perry is reviewing the bill...He will either sign it into law, veto it, or it will become law without his signature. Action must be taken by June 21."

For the safety of the public or the customers, its really best to have legislations like this.

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