Brian Nissen and Sopheak Srun of QTS Medical Device Outsourcing have co-authored a presentation on risk-based alternate SALs that will be presented on November 10 at the International Meeting on Radiation Processing (IMRP) conference in Vancouver, Canada. Brian and Sopheak have been actively involved in the AAMI Sterilization Standards Committee Working Group 15 (Assurance of Sterility), including a task group that is working on revising AAMI ST67, which is the U.S. standard on sterility assurance. The presentation at IMRP will provide an update on the new risk-based approach that is being proposed in AAMI ST67.
In order to label a product as “sterile,” a sterilization process must be validated that demonstrates a maximal sterility assurance level (SAL) of 10-6. In other words, the probability of a non-sterile device may be no more than 1 in 1 million. While an SAL of 10-6 is attainable for the vast majority of medical devices, many new novel or combination devices are unable to withstand the sterilization processes that would be required to attain an SAL of 10-6. The work that Brian and Sopheak have done as part of AAMI ST WG15 will provide a much clearer pathway for medical device companies to be able to perform a risk analysis that can be submitted to the relevant regulatory agencies to obtain approval for an alternate SAL for such products.
The IMRP conference is typically held approximately every three years in various cities around the world.
Additional information on the presentation may be found here.
Find out more about the IMRP conference at on their website.