Reprocessed Medical Devices

The biological material that attaches itself to a used device may be invisible and capable of entering any small entry point.

January 5, 2018

The FDA is charged with improving the safety of reused devices.
According to the FDA, "Reusable medical devices are devices that health care providers can reuse to diagnose and treat multiple patients. Examples of reusable medical devices include surgical forceps, endoscopes and stethoscopes." and "Reducing the risk of exposure to improperly reprocessed medical devices is a shared responsibility among various stakeholders. This includes the FDA; manufacturers responsible for providing adequate reprocessing instructions that are user-friendly and proven to work; health care facilities responsible for cleaning, sterilizing or disinfecting the devices; and other organizations"
FDA list of higher risk reusable devices    510 k submissions for these devices have to be very detailed in outlining their plans for safety.
AAMI has held joint conferences with the FDA and has publications to assist the industry.  "AAMI TIR12:2010, Technical Information Report.  Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical
device manufacturers" has a title long enough to describe its contents.
AAMI website

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