Reprocessing of Reusable Medical Devices

October 11, 2018 | Healthcare Risk, Quality, & Safety Guidance

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Guidance: Overview of Infection Prevention and Control

Guidance: Reprocessing of Flexible Endoscopes

Self-Assessment: Instrument Sterilization and Disinfection Practices

In recent years, several high-profile news stories involving outbreaks linked to problems with reprocessing of medical equipment have led to raised concerns about the safety of reprocessed devices. Proper cleaning, disinfection, and sterilization of medical devices involves a host of complicated steps that must be followed diligently and consistently. If even one step in the process is missed or not completed properly, it can result in contaminated instruments—and potentially devastating effects for patients.

According to U.S. Food and Drug Administration (FDA), the risk of acquiring an infection from an inadequately reprocessed medical device is relatively low, given the number of reprocessed medical devices in use (FDA “Reprocessing"). However, when an outbreak does occur, not only does it compromise patient safety, but it also can lead to bad publicity, loss of faith from the community, and even lawsuits for the healthcare facility where the outbreak occurred. Consider the following examples:

Although some healthcare facilities contract out reprocessing duties to a third party, many facilities have a centralized area for reprocessing such equipment and supplies. This guidance article provides an overview of the activities performed by the sterile processing department (SPD)...

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