The Food and Drug Administration (FDA) announced steps to help reduce the risk of exposure to improperly reprocessed devices that can lead to the transmission of diseases. Many medical devices are intended for repeated use in healthcare settings. One example of a reusable medical device is the endoscope, employed in over ten million medical procedures each year. Endoscopes use long, thin tubes with a camera threaded into the lungs, blood vessels or other cavities to visualize areas within the body. The FDA identified adverse event reports involving endoscopes for the last 3½ years, showing 80 reports of inadequate reprocessing and 28 reports of infection that may have occurred from inadequate reprocessing.
The FDA deems the risk of acquiring an infection from a reprocessed device to be relatively low and that the benefits of reusing these important devices outweigh the risks. The FDA is providing guidance to manufacturers for greater clarity on how to scientifically validate the reprocessing instructions that are part of the device labeling.
Healthcare facilities need to be on the lookout for changes in labeling to devices once the new guidelines have been put in place, so as to follow recommended instructions when reprocessing the devices for use on patients. Additionally, the FDA has developed helpful resources for healthcare facilities seeking to implement reprocessing quality assurance programs, including links to guidelines, self-audit tools, education, training materials and safety communications.
The announcement does not change the FDA's position on reprocessing single-use devices, which the agency recognizes can save costs and reduce medical waste. Before single-use medical devices can be reprocessed and reused, a third-party or hospital reprocessor must comply with the same requirements that apply to original equipment manufacturers, including:
- Submitting documents for premarket notification or approval
- Registering reprocessing firms and listing all products
- Submitting adverse event reports
- Tracking devices for which failure could have serious outcomes
- Correcting or removing unsafe devices from the market
- Meeting manufacturing and labeling requirements.