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Medical Device Safety

Medical device safety and effectiveness play a critical role in healthcare. Medical devices can range from a simple wooden tongue depressors or examination glove, to complex or life-saving equipment, such as pacemakers or medical imaging equipment. These medical devices are used in hospitals, doctors’ offices and in the home to diagnose, treat and prevent illness. Medical devices are an essential part of patient care, but if a defective or unsafe device enters widespread use it can have severe consequences.

The development, delivery, management and use of safe and effective medical devices, instrumentation and related technologies are critical to patient outcomes and healthcare worker safety. Optimum safety and performance require cooperation among all involved in the life cycle of a medical device: the government, the manufacturer, the importer/vendor, the user and the public – each has a specific role to play in reducing risks related to use of a medical devices.

The FDA opens in a new tab monitors reports of adverse events and other problems with medical devices and alerts health professionals and the public, when needed,  to analyses and recommendations for patients and health care providers about ongoing medical device safety issues.

The FDA also posts summaries of information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could cause serious health problems or death. Learn more about medical device recalls here opens in a new tab.