AAMI are holding a 3.5 days advanced course is designed for professionals experienced in working with an ethylene oxide (EO) sterilization but who are now challenged with ensuring effectiveness and assessing change for the product or process. The event will be virtual and held between 29 August and...
The link below is to an article that provides an overview of the cleaning requirements described in the soon-to-be-published American National Standard, AAMI ST98, Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices. AAMI ST98 Article. ...
On June 7, 2022, the FDA announced it was considering a master file pilot program for premarket approval (PMA) holders whose approved devices are sterilized using radiation, including gamma radiation. The FDA is considering this pilot program due to global supply chain constraints and to...