Factors influencing the reporting of adverse medical device events: qualitative interviews with physicians about higher risk implantable devices.
Approach to Improving Safety
Setting of Care
Regulatory agencies rely on physician reports of adverse events associated with medical devices in order to identify safety concerns. This qualitative interview study found that most physicians who implant devices do not regularly report adverse events related to particular devices. The authors recommend that postmarketing surveillance of medical devices be redesigned to foster detection of adverse events.