RISKS OF LASER USE: STANDARDS AND REGULATIONS

Because lasers are potentially dangerous technologic devices, their clinical use is subject to some degree of federal regulation and to voluntary consensus standards to minimize possible risks. The U.S. Food and Drug Administration (FDA) controls the manufacture and marketing of medical laser equipment. However, there are no mandatory federal safety precautions or regulations governing the clinical use of lasers. Institutions using lasers clinically should subscribe to the standards published in the American National Standard for the Safe Use of Lasers in Health Care Facilities (Z136.3-1988) by the American National Standards Institute (ANSI). ANSI Z136.3-1988 is available from the American National Standards Institute (1430 Broadway, New York, NY 10018) or from the Laser Institute of America (5151 Monroe St., 102W, Toledo, Ohio 43623). These standards reflect a consensus of governmental, industrial, and professional opinions on the methods used to define and control the risks of laser use, define and standardize training, and assess and ensure safety. The FDA also has suggested a set of regulations that have been adopted and modified by several states.^[11] The safety guidelines proposed by ANSI and the FDA should be followed to the maximal extent possible.

Although it is patients who are at most risk from the surgical use of lasers, injuries to staff have not been rare. Accordingly, the U.S. Occupational Safety and Health Administration (OSHA) is empowered to intervene if the medical use of lasers threatens the health of employees. Data regarding the true incidence of laser-related injury

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