Many medical devices are designed to be reused. Such reusables must be reprocessed between use to ensure that infections are not passed from one patient to another. Manufacturers label these devices with the recommended cleaning and sterilization process.
The most common method of reprocessing is steam sterilization, which removes microorganisms and other contaminants through the heating of the device through exposure to saturated steam under pressurized conditions in an autoclave. Devices are usually heated to either 250° F (121° C) or 270° F (134° C) and sustained at that temperature for a predetermined period of time.
Before a new medial device can be approved for use, manufacturers must validate that the recommended sterilization procedure will effectively kill all contaminants. Such validation must meet standards set forth in ISO 17665 and the FDA guidance document, which means the procedure must result in acceptable sterility assurance levels. The American National Standards Institute (ANSI) and the Association for Advancement of Medical Instrumentation (AAMI) also publish standards for validation.
A Proven Process, our manufacturing engineers test all new medical devices at our C-GMP complaint facility to ensure that the recommended sterilization methods used for each device meet the standards of the ISO, FDA, ANSI, and AAMI. We employ worst-case scenario testing that involves contaminating the instrument with the most resistant microorganisms the device is likely to encounter and processing it with the least rigorous method recommended, which simulates a difficult sterilization challenge performed in a less than ideal manner. We aren’t satisfied until the process repeatedly surpasses acceptable sterility assurance levels.