Reprocessing of Reusable Medical Devices

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) and highlights some of the issues risk managers should be aware of related to improperly reprocessed instruments.

In healthcare facilities, the SPD is the hub through which medical, surgical, and patient care equipment passes to be reprocessed for reuse. This department is responsible for the cleaning/decontamination, disinfection, inspection, assembly, packaging, sterilization, storage, and distribution of sterile and nonsterile reusable equipment and supplies.

Although this guidance article refers to the area as the SPD, the department that reprocesses medical devices may go by many other names, including:

The activities and structure of this department vary depending on facility policies and procedures. In addition, not all devices and supplies being reprocessed at the facility will necessarily go through sterile processing. Certain items may instead be reprocessed in another location,...