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Key Documents and Resources

Association for Advanced Medical Instrumentation (AAMI)

Association for Advanced Medical Instrumentation (AAMI) is comprised of professionals in engineering, medicine, nursing, the medical device industry, and governments with the common goal of increasing the understanding of and beneficial use of medical instrumentation.

ECRI Institute

The ECRI Institute website has a number of publicly available medical device safety resources.

Food and Drug Administration (FDA) medical device safety

The FDA monitors reports of adverse events and other problems with medical devices and alerts health professionals and the public when needed to ensure proper use of devices and the health and safety of patients. Lists of medical device recalls may be found on the FDA website.

GAO Report

GAO report, issued in August 2012, recommends a stronger FDA approach to manage risks posed by medical devices using wireless technology.

The Leader's Role in Medical Device Safety

Article in Healthcare Executive by IHI Executive Director, Frank Federico, about crucial role leaders must play in ensuring safe and patient-centered use of medical devices.

Premier Safety Institute

The Safety Institute maintains a website with resources on medical device safety, including: recalls and product notifications, FDA resources, and medical device reporting.