The potential for severe allergic reactions to medical devices containing latex (natural rubber) was recognized as a result of adverse experience reports. These reactions occur in latex-sensitive people and appear to result from numerous exposures to latex proteins that are natural elements of rubber. Because latex is commonly used in numerous medical devices, including catheters, intubation tubes, anesthesia masks, dental dams and surgical and examination gloves, this potential for allergic reaction has widespread implications for medical practice. For example, one brand of latex-cuffed enema tips was taken off the market after several patients died of severe allergic and anaphylactic reactions during barium enema procedures.

In most cases, the reaction occurred after the enema tip was inserted, but before the barium was introduced. Investigative reports indicated that the cause of the allergic reaction was the latex tips rather than the barium.

Based on reports of adverse experiences and the medical literature, the FDA has advised health professionals to identify latex sensitive patients and be prepared to treat any allergic reactions swiftly.

http://www.fda.gov/medwatch/report/DESK/casestud.htm  

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“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”.

David A. Kessler, MD

Former Commissioner of

Food and Drugs

The Federal Food, Drug, and Cosmetic Act defines a medical device as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article,..which is..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.”  Therefore, medical devices are different from drugs, which work by chemical or metabolic reactions within or on the body to achieve their principal intended effects.

There are approximately 1800 categories of medical devices, and they vary in both complexity and risk potential.  Some of the more common medical devices include ventilators, heart valves, pacemakers, X-ray machines, infusion pumps, implants, biopsy equipment, and ultra sound.  Accessories to devices such as hoses, tubing, or software controlling a device are also regulated as devices.  Less complicated devices include sutures, bedpans, thermometers, sharps containers, and medical gloves.  Examples of lesser known products that are also regulated as devices are laboratory diagnostic tests; sterilants and disinfectants used for medical devices; water treatment used for dialysis; cementing agents; sunglasses; topical wound dressings; home diagnostic kits; and even leeches.