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Taking OR to the Office
Health care practitioners are the primary users of medical devices for direct patient care. As such, they are in the best position to recognize problems that result from the use of medical devices. The sooner that the Food And Drug Administration (FDA) learns about a problem, the sooner the agency can take action to protect patient and user safety. Often a single report can initiate this action.
Definition of a Medical Device
The Federal Food, Drug, and Cosmetic Act (Safe Medical Device Act [SMDA]) defines a medical device as "an instrument, apparatus, implement, machine, contrivance, implant, or other similar or related article, ...intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.., or intended to affect the structure or any function of the body.., and which does not achieve any of its principal intended purposes through chemical action within or on the body... and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes." In other words, a device is anything used in treatment or diagnosis that is not a drug.
According to the former Commissioner of the FDA, Dr. David Kessler, "There probably are not many terms in the English language that cover as much ground as `medical devices.' Those words encompass a great diversity of products from bandages to heart valves, from thermometers to the most advanced therapeutic and diagnostic machinery" (Kessler, 1994). Examples of devices include: catheters, pacemakers, restraints, infusion and feeding pumps, defibrillators, X-ray machines, blood glucose monitors, ventilators, wheelchairs, syringes, heating pads, hearing aids, sutures, etc.
Surgical Lasers
Surgical lasers are classified as medical devices (Federal Register, 1985) according to potential hazard of exposure and are subject to regulation:
Class 1 - Enclosed system -- considered safe based on current medical knowledge. No light emission escapes the enclosure.
Class 2 - Limited to visible light (400-780 nm). Output power is 1 mW or less. Momentary viewing (0.25 second maximum permissible exposure) is not considered hazardous. Staring into the beam is not recommended. Protective eyewear of the correct optical density should be worn.
Class 3A - Emitted laser light viewed directly through collecting optics would cause permanent eye...