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FDA offers guidelines for recycling medical devices
Posted
11-15-99 Washington. Amid increasing public concern, the Food and Drug Administration announced it will develop stricter regulations governing hospitals' growing practice of reusing medical devices intended for single use. Reuse can apply to simple products such as surgical clamps or to complex cardiac catheters, bronchoscopes, and angioplasty balloons. "We've heard estimates that up to one-third of hospitals reuse medical devices," said Rick Wade, senior vice president of the American Hospital Association. Under the agency's proposed strategy, medical devices will be classified into one of three categories: high-risk products that can be used only once, moderate-risk devices that would have to be proved safe for reuse, and low-risk items that can be sterilized and reused, a procedure known as "reprocessing." The regulations also require hospitals that reuse devices to register with the FDA. A public meeting to gather comments on these proposals is scheduled for Dec. 14. The makers of disposable medical devices say the products' often delicate material cannot withstand resterilization and reuse. Proponents counter that the practice saves money and holds down costs. Most clinical studies of specific devices have found them safe to reuse, according to Larry Kessler, director of the FDA's office of surveillance and biometrics. "But we have heard anecdotal evidence that reprocessed devices are sometimes not completely cleaned and sterilized," he said, adding that this is one reason the FDA has scheduled hearings on the practice. Opponents of reprocessing say that improperly sterilized devices spread disease and that these items cannot be safely reused. "The real issue is patient safety," said Josephine Torrente, president of the Association of Disposable Device Manufacturers, in a New York Times article. "Until you can prove otherwise, these devices are safe and effective for one use. After that, they're garbage."
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