Contract sterilization is rapidly growing within the medical device industry, as contracting the sterilization of manufactured health care products to an external organization simplifies the later parts of the fabrication process. However, experience indicates that contract sterilization procedures require enhanced communications between the manufacturer and contract sterilizer, since responsibilities must be divided appropriately between the two parties.
This and related concerns are addressed by AAMI TIR14:2016 (R2020) – Contract sterilization using ethylene oxide, the latest revision of the technical information report (TIR) that provides guidance on contract sterilization of medical devices through the use of ethylene oxide.
This report applies to both medical manufacturers that use contract sterilization facilities and the operations of those facilities themselves. It covers the different aspects of contract sterilization that apply to each of these two groups and the interactions between them, including the selection of a sterilization facility, the establishment of an agreement between the product manufacturer and the contract sterilizer, and the process for validating the sterilization procedure.
Users should note that AAMI TIR14:2016 (R2020) – Contract sterilization using ethylene oxide is a technical information report and not a standard, meaning that it was not subject to a formal process of committee approval, public review, and resolution of all comments through a consensus process. Because of this, TIRs aren’t intended to provide compliance recommendations, but they can be extremely helpful in identifying underlying safety or performance issues.
In fact, AAMI TIR14:2016 (R2020) is part of a series of technical information reports, which include:
AAMI TIR15:2016 (2020) – Physical aspects of ethylene oxide sterilization
AAMI TIR16:2017 (R2020) – Microbiological aspects of ethylene oxide sterilization
AAMI TIR28: 2016 (R2020)- Product adoption and process equivalence for ethylene oxide sterilization
AAMI TIR56:2013 (R2020)- Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices
AAMI TIR74:2016 (R2021) – Change summary for ISO 11135:2014, Sterilization of health care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices
Together, these TIRs provide additional guidance for ISO 11135:2014 – Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices, which details many specifications for sterilizing medical devices with ethylene oxide in both health care facilities and industrial settings.
Clearly, by the presence of the ISO 11135 standard and its many supplementary technical information reports, it is advantageous for manufacturers and sterilizers of medical devices and health care equipment to follow standard practices while using ethylene oxide. As the key alternative for sterilizing medical devices are not compatible with conventional high temperature steam sterilization, the manner in which ethylene oxide is used can be incredibly important.
And, as the sole action performed to suitably clean and sanitize medical products before they are put into use, sterilization needs to be done correctly. Each TIR to this standard lets the compliant users narrow their focus so that they can adequately complete every task needed to sterilize the manufactured products.
AAMI TIR14:2016 (R2020)- Contract sterilization using ethylene oxide is available now on the ANSI Webstore.