The Advancing Patient Safety Coalition petitioned a pair of Congressional committees to include in the latest FDA user fee agreements defined deadlines for implementing a system of unique medical device identifiers that will help track products and monitor post-market safety.
The coalition, which includes group purchasing organizations Premier and Novation as well as the American Medical Assn. and the American Heart Assn., asked House and Senate committees to mandate a 2-year timeline for launching the UDI system.
"Every day that goes by without such electronic identification of medical devices is a threat to patient safety and increases costs in the healthcare system," the coalition wrote in a letter to chairmen and ranking members of the Senate Committee on Health, Education, Labor & Pensions and the House Energy & Commerce Committee. "UDI is the missing link to better ensuring patient safety."
Congress initially approved the UDI program in 2006 to enable tracking of medical implants and to add medical devices to the Sentinel post-market surveillance program that currently monitors prescription drug safety.
The APS Coalition noted that the tracking system could save about $16 billion each year in costs incurred from inefficiencies in the medical products supply chain.
The FDA has held workshops on UDI systems, but has yet to issue a final rule as the measure has been languishing in the Office of Management & Budget since July 2011, according to the letter.
In March a quartet of Senators introduced the bipartisan Ensuring Safe Medical Devices for Patients Act, which would force the FDA to issue a final rule before the end 2012.
The legislators pointed to the slate of recent high-profile medical device recalls as evidence that the FDA needs more oversight in ensuring public safety.
Their efforts were endorsed by a clutch of advocacy groups, including Consumers Union, Premier Healthcare Alliance and the Union of Concerned Scientists.
The APS Coalition hopes to that lawmakers will include UDI deadlines in the "must-pass" FDA user fee bill which passed through both the House and Senate with flying colors and bipartisan support last month.
The APS Coalition included endorsements from the following groups:
- AARP
- Alliance for Advancing Nonprofit Health Care
- Alpha-1 Association
- Alpha-1 Foundation
- American Association of Neurological Surgeons
- American Association of Orthopaedic Surgeons
- American Congress of Obstetricians and Gynecologists
- American Heart Association
- American Medical Association
- American Nurses Association
- Association for Professionals in Infection Control and Epidemiology
- Association of American Medical Colleges
- Catholic Health Association of the United States
- Congress of Neurological Surgeons
- COPD Foundation
- Federation of American Hospitals
- Georgia Hospital Association
- MedicAlert Foundation
- National Association for Continence
- National Association of Public Hospitals and Health Systems
- National Rural Health Association
- Novation
- PeaceHealth
- Premier healthcare alliance
- Society for Cardiovascular Angiography and Interventions
- Society for Healthcare Epidemiology of America
- Texas Health Resources
- Truth in Medicine Incorporated
- University HealthSystem Consortium
- Valley Health System
- VHA Inc.
- West Virginia United Health System
