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Eleven types of recycled medical devices no longer can be sold in the United States, according to the Food and Drug Administration (FDA). The FDA says that producers of the recycled devices failed to show that they're equivalent to the original products, as the FDA requires.
Many hospitals clean and reuse or sell some disposable medical devices that manufacturers rate as single-use only. Examples include cardiac catheters, angioplasty balloons, surgical saw blades, and forceps used for biopsies.
Recycling these devices is controversial. Citing infection and device failure risks, critics say reusing disposable devices isn't safe. But device reprocessors claim that their opponents simply want to sell more devices for onetime use.
The FDA requires data on sterilization and other procedures for devices to meet their reuse requirements. Eleven of the 44 devices for which they recently reviewed data didn't pass the FDA's review, although they'd passed earlier FDA reviews. The reprocessing companies may submit an application for FDA approval if they wish to sell their products in the United States again.
The FDA didn't identify the 11 devices or name the reprocessors involved in the current ruling. For more about reprocessed single-use devices that received a "not substantially equivalent" ruling, visit the FDA Web site at http://www.fda.gov/cdrh/Reuse/svs/faq.html.
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