Study: Unsafe medical devices gain FDA approval through loophole
Editor's Note A study done by investigators from Yale, Harvard, and the University of California-San Francisco, published on January 10 in JAMA, found that “many medical devices subject to recall had received Food and Drug Administration (FDA) approval based, in part, on the products’ similarities to earlier devices,” Healthcare Purchasing…
ANSI/AAMI ST98 provides cleaning validation requirements for device manufacturers
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…
Legislation to improve medical device cybersecurity introduced, supported by AHA
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…
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