Editor's Note The Association for the Advancement of Medical Instrumentation (AAMI) on August 24 announced the publication of a new standard: “ANSI/AAMI ST98:2022, Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices.” The new standard not only provides manufacturers with a formalized…
Editor's Note On Friday, June 24, the American Hospital Association (AHA) voiced support for the Protecting and Transforming Cyber Health Care Act (PATCH Act)—legislation that would “require medical device manufacturers to meet certain cybersecurity requirements when seeking approval for devices that are internet connected or include software” in order to…