The Safe Medical Devices Act (SMDA) of 1990 requires user facilities (e.g., hospitals, nursing homes) to report suspected medical device-related deaths to both the FDA and the manufacturers. Medical device-related serious injuries must be reported to the manufacturer. However, if the medical device manufacturer is unknown, the serious injury is reported by the facility to the FDA. Laboratory personnel should familiarize themselves with their institution's procedures for reporting adverse events to the FDA.
Medical devices that are included in this reporting requirement (if they may have caused serious injury to a patient or patient death) are laboratory instruments, reagents, or devices used during phlebotomy procedures. If it appears that a device has caused injury, it is important that the device and packaging be saved and any serial or lot numbers noted. An incident report should be completed within 24 hours. The incident report must then be handled by the institution's Risk Management Department, which will file the necessary reports.
