Safety and effectiveness of medical devices

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.

According to a report from the FDA’s Center for Devices and Radiological Health (CDRH), the number of annual medical device recalls increased by 97 percent between fiscal 2003 and 2012. The report attributes the increase largely to greater focus and attention on improving product “The most frequent causes for recalls are related to device design, software, and non-conforming material or component issues,” the report states. “If industry and CDRH can address these problems jointly, we may be able to prevent as many as 400 recalls each year.”

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.

In all healthcare settings, standards are both in place and evolving to assure best practices. This web page attempts to provide resources and tools to assist in the development and maintenance of those practices.