Reusable medical devices have been used in healthcare facilities for more than a century. Today’s designs are complex and sophisticated, and the process of cleaning, disinfecting, and sterilizing reusable devices can be complex. Manufacturers of reusable medical devices are required to back their claims for product reuse. This involves providing instructions for reuse and conducting tests that validate the instructions.
Proving sterilization validation or disinfection efficacy is only part of the equation; other issues related to medical device function, physical integrity, and biocompatibility testing must also be addressed. Reusable medical devices must be designed to function safely and effectively following sterilization in a health-care setting. By definition, they must be designed to withstand multiple exposures to sterilants or disinfectants without losing their ability to function effectively.
Testing should not be limited to the efficacy of the sterilization cycle; biocompatibility and functional performance of the medical device should be considered as well. This can be accomplished by exposing a product to multiple cycles equivalent to the projected maximum useful life of the device, including any cleaning steps performed between cycles. Following these exposures, functionality, physical integrity, and biocompatibility should be demonstrated through adequate testing.
NAMSA recommends and conducts studies along the lines of those recommended in AAMI TIR 12, under sterilization efficacy testing, to provide data to demonstrate that the recommended instructions provide the product with an equivalent sterility assurance level of 10–6.
- Disinfection validation
- Cleaning studies
- Repeat sterilization cycles