Four U.S. Senators have introduced legislation requiring the Food and Drug Administration to issue a final rule establishing a unique device identifier for implantable devices by the end of 2012.
Sens. Jeff Merkley (D-Oregon), Charles Grassley (R-Iowa), Michael Bennett (D-Colo.) and Herb Kohl (D-Wis.) introduced the Ensuring Safe Medical Devices for Patients Act. It does not yet have a bill number, but soon will be available at congress.gov.
The identifier envisioned in the legislation would enable implantable devices to be tracked through the distribution chain and when they are used with patients, according to a statement from the senators. The bill also would add medical devices to the federal Sentinel post-marketing surveillance system that monitors the safety of prescription drugs following FDA approval.
The FDA in July 2011 sent for review to the Office of Management and Budget a proposed rule to create a unique medical device identifier. The rule still sits in OMB, which must approve rules before they are published.
Premier Inc., one of about a dozen health care and consumer organizations supporting the new legislation, says a unique identifier “is the missing link to protect patient safety.” In a statement, the provider alliance adds: “Enabling health care providers to track medical devices electronically in the supply chain will improve the speed and accuracy of product recalls, as well as adverse event reporting. In addition to these important safety benefits, automating the now manual process of tracking medical devices is projected to save the health care industry approximately $16 billion each year from greatly improved efficiencies.”
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