A common goal of medical device manufacturers is to produce safe products. Sterility is essential to the safety of many medical devices. Most single use devices are terminally sterilized by ethylene oxide gas or gamma or electron beam radiation. The sterilization process must be validated for each product to verify that it effectively and reliably kills any organisms that may be present on the pre-sterilized product. 

By means of the cGMP medical device regulations, FDA has established some of the requirements for an acceptable sterility assurance program. More specific guidelines for validation of the sterilization processes are developed and published by AAMI in conjunction with ISO. We recommend that clients review current AAMI publications which pertain to the method of sterilization used for their products. Some of the more relevant publications are listed below. To obtain these documents, contact AAMI at 703-525-4890, 800-332-2264 or www.aami.org.

The FDA Center for Devices and Radiological Health (CDRH) can provide assistance to medical device manufacturers. The CDRH Section of the FDA website has extensive information on a variety of topics, including the following:

• GMP issues
• Sterility and Biocompatibility
• 510K, PMA, IDE
• Electronic Docket /Facts-on-Demand
• Publications only
• In Vitro Diagnostic Products

Download printable version of our booklet Sterility Assurance Compliance - A Guide for Medical Device Manufacturers (PDF).

Explore our Downloads section to view PowerPoint presentations on sterilization validations.