New FDA Guidelines Aim To Prevent Hospital Infections from Endoscopes

Federal regulators are proposing new guidelines for cleaning reusable medical equipment, particularly endoscopes, which can be a source for acquiring hospital infections

The FDA released new draft guidance on cleaning and sterilizing reusable medical devices on Monday. The new guidance requires manufacturers to provide detailed, and proven, instructions on how to properly clean any medical device that will be reused on multiple patients. It also provides guidelines for cleaning those devices for health care professionals.

Reusable medical devices that are not thoroughly cleaned and sterilized could potentially carry bodily fluids and organic material from one patient to the next, which could spread infections.

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In a press release, the FDA reports that from January 1, 2007, to May 11, 2010, the agency received 80 reports of inadequate reprocessing, or cleaning, of endoscopes and 28 reports of hospital-acquired infections that were likely spread by endoscopes.

One string of incidents that gained national attention occurred at several VA hospitals located around the United States. In late 2008 and early 2009, more than 10,000 veterans were sent letters alerting them that they may have been exposed to Hepatitis and other infectious disease due to improperly cleaned endoscopes.

The colonoscopy contamination problems were discovered in December 2008 at the Alvin C. York Medical Center in Murfreesboro, Tennessee. A review of the procedures at all VA clinics over the months after the discovery led to the discovery of additional VA health center problems at the Charlie Norwood VA Medical Center in Augusta, Georgia, and the Miami Veterans Affairs Healthcare System in Florida.

After testing was completed, at least six patients tested positive for HIV, and dozens tested positive for hepatitis B and C. However, it is unclear whether the infections were contracted due to the improperly cleaned endoscopes.

Endoscopes are small cameras that are inserted into the body. They are frequently used in colonoscopy procedures, as well as ear, nose and throat procedures.

The FDA is planning a public workshop on June 8 and 9 to take input on the draft guidance from manufacturers, health care providers and other government agencies. The FDA would then move on to a final guidance. Guidance are recommended procedures usually recognized as federal standards. However they are not enforceable and following them is not a legal requirement.


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