ABSTRACT
Instructions for reprocessing a reusable medical device must be validated before the device is marketed. The validation must be available for inspection and supplied to the Food and Drug Administration upon request. This chapter focuses on laboratory testing that is performed to demonstrate the effectiveness of a cleaning method. Manufacturers of medical devices that are intended for reuse must submit evidence of the validation of their reprocessing instructions. During the course of the cleaning process, the devices are visually inspected to verify that the artificial soil has been removed. After completing the cleaning process, the devices are extracted to recover any remaining tag spores by means of mechanical rotation, flushing and/or exposure to ultrasound. Extraction of the remaining tag spores from the cleaned devices is accomplished by placing each device in an individual sterile vessel. A comparison is made between cleaned and uncleaned devices.
