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FDA Targets Risks From Reused Medical Devices


12/29/2011 7:57:46 AM

SILVER SPRING, Md., Dec. 28, 2011 /PRNewswire via COMTEX/ -- Some medical devices are reused many times in surgical and exploratory procedures. They include instruments used in surgery (like clamps and forceps), and endoscopes (like bronchoscopes and colonoscopes) used to visualize areas inside the body.

FDA has received reports of patient exposure to microscopic amounts of blood, body fluids, and tissue from other patients that may have occurred because the reusable devices were inadequately "reprocessed" and these contaminants were not removed. (Reprocessing means cleaning and high-level disinfection or sterilization.) Transmission of infection was extremely rare, but the potential was there.

The agency is working with manufacturers and healthcare providers to reduce the risk of infection from the inadequate "reprocessing" of these durable devices designed for repeated use.

Learn about questions you can ask your own healthcare providers at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm284636.htm

Sign up for e-mail notices of new FDA Consumer Updates at https://service.govdelivery.com/service/subscribe.html?code=USFDA_9

View the FDA Consumer Update RSS feed at http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/Consumers/rss.xml

FDA Consumer Updates may be posted and published elsewhere without permission. Please credit "FDA Consumer Health Information ( www.fda.gov/consumer )" as the source. FDA values feedback on its consumer health information. Send questions, comments, or story ideas to: consumerinfo@fda.hhs.gov.

Media Contact: Erica Jefferson, 301-796-4988, Erica.Jefferson@fda.hhs.gov

SOURCE U.S. Food and Drug Administration



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