Reusable Medical Device Validation

A reusable medical device is one intended for repeated use either on the same or different patients, with appropriate cleaning and disinfection or sterilization steps between uses. Reusable medical devices have been widely used in clinical practice for more than a century. Manufacturers of reusable medical devices have the responsibility to provide instructions for device reprocessing such as cleaning, disinfection and sterilization as well as to conduct test to validate these instructions. Testing should not be limited to the efficacy of device reprocessing, functional performance of the medical device at the beginning, middle, and end of a device's life cycle should be considered as well. Validation data regarding cleaning, disinfection, and sterilization must be included in the 510(k) for submission to the FDA.

STEMart provides cleaning, disinfection and sterilization validation in compliance with AAMI, ISO, and FDA guidance documents to help manufacturers ensure that medical devices processed in a health care facility are safe for their intended use or reuse. Functionality testing is also paired with validated cleaning, disinfection, and/or sterilization processes to ensure safety and compliance with regulatory requirements for third-party reprocessing.

Reusable Medical Device Validation

STEMart provides a full range of validation services to help manufacturer test and validate the labeling claims for reprocessing of reusable medical devices in a health care facility. If you want to learn more detail about our reusable medical device validation services, or would like to consult with the experts at STEMart, please feel free to contact us.