Coalition Calls on FDA to Release System for Medical Devices

July 21, 2010 – The Advancing Patient Safety Coalition sent a letter to the U.S. Food and Drug Administration earlier this month, urging the agency to immediately issue rules on unique device identification (UDI), which have been three years in the making. The Coalition says the UDI rules are critical to improving patient safety, implementing electronic health records (EHRs) and saving money in the healthcare system.

In the letter, the Coalition claims a UDI system would help improve patient safety by tracking recipients of recalled products as well as adverse events. Having a UDI system would also maximize the value of EHRs, the letter says, because the EHRs will then be able to ensure that all institutions are using the appropriate data standards for medical devices.

The Coalition also writes that a UDI system would increase the efficiency of the U.S. healthcare supply system, saving an estimated $16 billion annually in supply chain costs, according to researchers at Arizona State.

The Coalition membership includes the following organizations:

• Alliance for Advancing Nonprofit Health Care
• American Academy of Orthopaedic Surgeons
• American Gastroenterological Association
• American Hospital Association
• American Medical Student Association
• American Nurses Association
• American Urological Association
• Association for Healthcare Resources and Materials Management
• Association for Professionals in Infection Control and Epidemiology
• Catholic Health Association of the United States
• National Association for Continence
• Novation
• PeaceHealth
• Premier
• Society for Cardiovascular Angiography and Interventions
• Society for Healthcare Epidemiology of America
• Texas Health Resources
• The Hip Society
• The National Association of Public Hospitals and Health Systems
• The North American Spine Society
• University HealthSystem Consortium
• VHA Inc.
• West Penn Allegheny Health System
• West Virginia United Health System
• White River Medical Center