Beware! New Laser Laws Could Zap You

According to statistics published by the American Society for Aesthetic Plastic Surgery, nearly 11.5 million surgical and non-surgical cosmetic procedures were performed in the United States in 2006. Among the most popular were laser hair removal (approximately 1,475,000 procedures) and laser skin resurfacing (approximately 576,000 procedures) — with Americans spending more than $1 billion on these services alone. The growing popularity of cosmetic laser procedures has, however, raised patient safety concerns. Critics argue that state regulators and licensing boards have been too slow in establishing specific guidelines on who is authorized to perform these procedures — leaving consumers, in many instances, to fend for themselves in assessing whether the person wielding a laser wand is even qualified and experienced to do so. Indeed, several medical associations have reported that their members have seen a marked increase in the number of patients seeking treatment for burns and other injuries stemming from botched laser treatments at the hands of inexperienced and/or non-physician personnel. In response to these concerns and criticisms, many states are beginning to take action to tighten their regulation and oversight of cosmetic laser procedures. For example, earlier this year the Georgia legislature passed the “Georgia Cosmetic Laser Services Act” to address unregulated cosmetic laser services being offered in that state. Signed by Gov. Sonny Perdue on May 29, 2007, the act provides for two levels of cosmetic laser practitioner licensing — an assistant laser practitioner and a senior laser practitioner. The act also establishes, among other things, new patient consent guidelines for cosmetic laser services, as well as certain practice restrictions — including that it shall be unlawful for a licensed cosmetic laser practitioner “to administer any pharmaceutical agent or other substance by injection” and “to perform cosmetic laser services within any area within one inch of the nearest part of the eye socket of any consumer.” (Note: The act does not become effective until funding is appropriated, which is anticipated in 2008.) In August 2007, the North Carolina General Assembly approved legislation to regulate laser hair removal procedures performed by “laser hair practitioners” by amending the state’s Electrolysis Practice Act. (According to a report by the North Carolina Medical Society, it lobbied for specific amendments to bring the legislation in conformity with a North Carolina Medical Board position statement on laser treatments.) Among the new requirements, laser hair practitioners in North Carolina must be appropriately licensed and “must practice laser, light source, or pulsed-light treatments under the supervision of a physician.” The new law is effective October 1, 2007. The Mississippi State Board of Medical Licensure has also recently amended its rule on the use of laser devices. The amended rule provides that “the use of lasers, pulsed light or similar devices, either for invasive or cosmetic procedures, is considered to be the practice of medicine” in the state and therefore “such use shall be limited to physicians and those directly supervised by physicians, such that a physician is on the premises and would be directly involved in the treatment if required.” Finally, on September 20, 2007, a new Alabama Board of Medical Examiners (ABME) rule went into effect concerning the use of lasers. Per the ABME, Administrative Rule 540-X-11 Guidelines for the Use of Lasers and Other Modalities Affecting Living Tissue was developed to establish reasonable guidelines in Alabama for the use of lasers outside of medical centers. (The deadline for compliance with the provisions therein is August 15, 2008.) The new administrative rule provides that the “use of lasers/pulsed light devices, or any energy source, chemical, or other modality that affects living tissue (when referring to the skin, anything below the stratum corneum), whether applied for surgical, therapeutic, or cosmetic purposes, is the practice of medicine.” As such, the ABME states that such services “must be performed directly by a licensed physician or under the supervision of a licensed physician by a delegate, as defined in the guidelines.” The new rule also stipulates that physicians who use or offer to use a laser/pulsed light device in any facility other than a “hospital” (as that term is defined in the Ala. Code § 22-21-20) must register with the ABME. Further, the ABME must be notified within three business days of the occurrence of an adverse event related to a procedure that results in hospitalization or third-degree dermal injury. To access a complete copy of the new Alabama administrative laser rule, go to the ABME Web site at: http://www.albme.org/Default.aspx. The ABME has also published a helpful discussion of the new rule, including questions/answers regarding its scope and application, in its July-September 2007 newsletter (a copy of which is available to the public on the ABME Web site). November 2007