As regulations and requirements around the world change, so too do the testing protocols for medical devices, sending OEMs to consult expert partners.
Testing methods and approaches continue to be shaped by regulatory changes. At the end of 2019, the Association for the Advancement of Medical Instrumentation (AAMI) completed a new Technical Information Report (TIR 76), Entitled “Sterilization of Health Care Products—Radiation—Substantiation of a Selected Sterilization Dose at a Specified Sterility Assurance Level: Method VDmaxSD-S.” “This document allows a company to optimize the sterilization dose so it corresponds exactly to its bioburden count, or the company can select a sterilization dose slightly or significantly higher, depending on the specific need of company and product,” said Martell Winters, director of scientific competency for Nelson Labs, a Salt Lake City, Utah-based provider of testing for medical devices.
