List of Tracked Devices

The U.S. Food and Drug Administration (FDA) requires manufacturers, hospitals, nursing homes, home health agencies, and other organizations that distribute medical devices to collect information about certain medical devices used in patient care so that the device can be promptly identified and recalled if it presents a serious risk to patients' health. The agency's requirements extend medical device tracking from the manufacturing facilities to the distributor networks, which can include healthcare providers, and, ultimately, to patients so that patients using the device can be identified if necessary.

Although the primary burden for collecting information for tracking lies with the medical device manufacturer, healthcare facilities support effective device tracking by gathering certain information about a tracked device at various times during its use and providing the information to the device manufacturer. For example, if the tracked device is a medical device implant, the facility collects information at three times: at receipt, at implantation, and at explantation or other permanent disposal of the device (e.g., patient death, permanent discard). See [Implants and...