Safe Medical Devices Act: Reporting and Nurse Responsibilities

Course overview

This course covers the Safe Medical Devices Act (SMDA) of 1990, FDA regulatory framework for medical devices, mandatory reporting triggers for device malfunction and patient injury, MedWatch Form 3500A reporting timelines, and the MAUDE database and Florida-specific device regulations. Upon completion, participants will apply SMDA reporting obligations, execute device sequestration procedures, and fulfill responsibilities in post market surveillance, implantable device tracking, and promoting a culture of device safety.