A variety of implantable devices are used in aesthetic and reconstructive plastic surgery procedures.Tracking of these devices is critical to patient safety.Institutions must report any incident of death or serious injury relating to the use of a medical device.What regulatory agency,commission,or act mandates this process when medical devices fail or cause injury?

Question

Quizplus · Accepted Answer

Under the Safe Medical Device Act,institutions must report any incident of death or serious injury relating to the use of a medical device.The manufacturer of the device must have a mechanism to locate implantables after they have been distributed.Devices may be recalled for sterility issues,malfunction,or any event that is found to pose a serious health risk.The U.S.Food and Drug Administration (FDA)regulates the process of tracking medical devices and directs the tracking of devices whose failure would result in serious,adverse health consequences;devices that are intended to be implanted in the human body for more than 1 year;and devices that are life-sustaining and life-supporting and are used outside of a facility such as a hospital,nursing home,or ambulatory surgery center.

A Variety of Implantable Devices Are Used in Aesthetic and Reconstructive