Medical Safety Device Act

Introduction

Effective July 31, 1996.

Requires hospital to submit a report to the manufacturer &/or FDA when it becomes aware that a medical device may have contributed to serious injury or death.

This is called an MDR reportable event.

MDR reports must be completed during the shift they occur. The include instances of failure, misuse or error. Equipment must be saved for inspection.

Procedures to track medical devices implanted in patients are required to facilitate notification of patients in the event of device recall or failure.