A recent article gives the FDAs strategy and opinion on the standards that are currently in existence and new standards that are being developed for sterilizers, sterilization processes, and associated devices for low-temperature vaporized hydrogen peroxide (VH2O2) sterilization. VH202 is being used to sterilise reusable devices where...
Global supply chain shortages continue to have an impact on the availability of sterilisation capacity. Ethylene Oxide (EO) sterilization facility shutdowns and raw material scarcity are affecting the medical device industry. In order to alleviate these disruptions, the FDA announced a 510k Sterility Pilot Program which...
The SfSAP will be well represented at the upcoming Kilmer conference in Athens Greece - June 13 - 16 June 2022. We are planning an interactive presentation titled: A structured pathway to support, attract, retain and develop professionals involved in E2E sterility. The Society for Sterility Assurance...