TRIMEDX, a member of the Alliance for Quality Medical Device Servicing, opposes proposed legislation that could impact the medical device servicing industry by broadly defining remanufacturing in a manner that serves original equipment manufacturer (OEM) competitive interests while potentially undermining patient safety and increasing healthcare costs. H.R. 7253 is unsupported by data, is vague and overly broad, is unduly burdensome, and fails to allow access to the materials needed to comply with its provisions. The Alliance urges Congress to set aside the bill and allow the FDA to complete its guidance on remanufacturing, considering input from all stakeholders. Read the Alliance’s full response here.
About the Alliance for Quality Medical Device Servicing
The Alliance for Quality Medical Device Servicing is an informal coalition of five leading independent medical device service organizations which support healthcare providers across the United States. The members of the Alliance are TRIMEDX, Sodexo, Crothall, Agiliti, and the InterMed Group. The Alliance represents some of the largest participants in the Independent Service Organization (“ISO”) segment of the U.S. medical device service industry. Alliance members collectively employ tens of thousands of associates across all fifty states and actively service and maintain millions of medical devices.