Analysis of Medical Device Reports That Contributed to a Class I Recall

The Food and Drug Administration (FDA) conducts postmarket review of medical devices as a part of its mission to protect patient safety and ensure product safety and effectiveness. Medical device reports (MDRs) are one way the FDA receives information on adverse events involving medical devices. Medical device reports can be submitted by manufacturers, importers, user facilities, and the public. User facilities are required to report device-related adverse events that resulted in a serious injury or death. In addition, user facilities are encouraged to submit voluntary medical reports where a device problem has the potential for patient harm. The FDA receives MDRs from user facilities through the MedWatch and Medical Product Safety Network programs. When reporters include detailed background information in their reports, they can directly contribute to meaningful action. Health technology management personnel, including clinical engineers, have unique insights into medical device problems and can provide valuable background information in MDRs. The highlighted examples hereinafter illustrate 2 cases where more detailed information included in MDRs was essential and contributed to a class I recall of a medical device.