Chapter Fourteen - Reprocessing of reusable medical devices

Abstract

Reusable medical devices are devices that healthcare providers can reprocess and reuse on multiple patients. To avoid any risk of infection by a contaminated device, reusable device needs to be cleaned and sterilized. A detailed, multistep process to clean and then disinfect or sterilize medical devices is termed as reprocessing. Reprocessed medical devices can be safely used more than once in the same patient, or in more than one patient if the labeling instructions for reprocessing are completely and correctly followed after each use of the device. In this chapter, FDA guidance on reprocessing, factor affecting quality of reprocessing, and cleaning validation of reusable medical devices will be discussed.