AAMI Publishes Revision of Sterilization Guidance
For the first time in 10 years, AAMI has revised its technical information report (TIR) that focuses on the compatibility of materials subject to sterilization. The revised TIR expands the scope of the existing document — TIR 17:1997 — to address compatibility with a wider range of sterilization methods.
To comply with existing industrial sterilization standards, manufacturers must implement a program to demonstrate or “qualify” that the company’s sterilization methods do not degrade the quality, safety, or performance of a product throughout the product’s shelf life or expiration date.
The previous document — TIR 17: 1997, Compatibility of materials subject to sterilization — offered guidance on complying with these conditions when using radiation sterilization. But many requests have come in from the manufacturing industry to expand the information on materials compatibility.
AAMI TIR 17:2008, Compatibility of
materials subject to sterilization LIST PRICE: $95 MEMBER DISCOUNT PRICE: $50 ORDER CODE: TIR17 SOURCE CODE: HA To order copies, call (877) 249-8226 |
So the new document—TIR 17:2008, Compatibility of materials subject to sterilization — has an expanded scope that includes the following sterilization modalities:
- Radiation
- Ethylene Oxide
- Moist Heat (Steam)
- Dry Heat
- Hydrogen Peroxide
- Ozone
The revised document is intended to provide guidance for device manufacturers in the selection and qualification of materials — such as ceramics and metals — that are used in making healthcare products that must be sterilized.
The TIR also addresses the concept of accelerated aging, or storing healthcare products at elevated temperatures and/or in other intensified environmental conditions to simulate real-time aging in a short amount of time. The document notes that the most reliable means of validating the safe and effective performance of a medical device throughout its shelf life is to let the device age on a real-time basis for the duration of its shelf-life and then test its functionality.
However, the TIR states that “for most materials, there are safe and conservative alternatives.” The document provides methods and formulas intended to help determine the most appropriate alternatives for different materials.