Ask HRC: Implant Identification Cards and SMDA Requirements
January 22, 2008 | Healthcare Risk, Quality, & Safety Guidance
A hospital recently contacted Healthcare Risk Control(HRC) asking the need to complete implant information cards provided by manufacturers and overlapping requirements under the Safe Medical Devices Act (SMDA), which includes requirements for tracking certain medical devices and reporting information to the U.S. Food and Drug Administration (FDA).
HRC recommended that the facility review the Risk Analysis Medical Device Tracking, which describes the regulatory requirement, to ensure that the organization is in compliance with FDA’s rule. The facility should have measures in place to become aware of additions and deletions to FDA’s list of tracked devices and make changes as required. HRC alerts its members of changes to the tracking...