Safe Medical Devices Act of 1990 (SMDA)

How to Subscribe
MLS & MLT Comprehensive CE Package
Includes 137 CE courses, most popular
$95Add to cart
Pick Your Courses
Up to 8 CE hours
$50Add to cart
Histology CE Package$65Add to cart
Histology CE User Increase$65Add to cart
Individual course$20Add to cart
The page below is a sample from the LabCE course Risk Management in the Clinical Laboratory. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

Learn more about Risk Management in the Clinical Laboratory (online CE course)
Safe Medical Devices Act of 1990 (SMDA)

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, who will file the necessary reports.