Press Releases ________________________
Premier healthcare alliance endorses supply chain standards to enhance patient safety, reduce costs
Publications ________________________
Lawmakers urge FDA to move forward on Unique Device Identification
July 31, 2008
Initiative offers better tracking of medical products and devices to improve patient safety and healthcare efficiency
Unlike virtually every other product in commerce, medical supplies and devices cannot be identified in a systematic and consistent manner because there is no uniform numbering system that would enable bar codes or radio-frequency identification (RFID) for tracking purposes. A unique, standardized numbering system is what enabled tainted peanut butter, spinach and dog food to be quickly and efficiently recalled. In an effort to bring this same protection to patients who have received implanted medical devices, the Premier healthcare alliance has launched an initiative that will enable hospitals in the alliance to rely on standard identification of medical devices and other products, leading to better patient safety and more efficient healthcare delivery.
Adoption of GS1 standards will improve patient safety
- The Premier healthcare alliance has announced that it will require all its contracted suppliers to adopt device identification standards known as GS1 standards. Use of the standards will allow for definitive identification of medical products and devices, tracking them through the healthcare system and placing them within a standardized product database called the Global Data Synchronization Network (GDSN).
- Having a uniform numbering system will facilitate recalls of defective devices, help protect against counterfeit devices, and enable data mining to identify adverse events that may occur with a device. This can not be done today and was a significant motivation for Congress deciding to mandate that FDA develop a mandatory unique device identification (UDI) system.
- This initiative, which will impact hundreds of thousands of medical devices and supplies, will also enable synchronization of devices with other devices and with drugs to ensure optimal patient safety and accelerate improvement efforts.
Adoption of standard identification will help hospitals become more efficient, directing more resources toward patient care
- Hospitals spend $200 billion a year on medical supplies, which is second only to their labor costs. Most experts agree that one of the factors driving increased supply costs is the lack of a unique device identification (UDI) system.
- A 2003 study by the Coalition for Healthcare eStandards and the Health Care eBusiness Collaborative found that the healthcare supply chain wastes 24 to 30 percent of supply administration time on data cleaning and corrections at a cost of billions of dollars. These inefficiencies displace valuable resources from patient care and quality improvement initiatives.
Adoption of GS1 Standards will compliment and strengthen FDA’s efforts to create a uniform, nation-wide system
- These compelling reasons are why a coalition of organizations ranging from AARP to the American Medical Association to the American Heart Association as well as all the hospital organizations have united to call for rapid implementation of a uniform numbering system.
- It is also for these reasons that committees in the Premier healthcare alliance made up of hospital chief executives and alliance board members have strongly endorsed moving to a uniform numbering system for medical devices. Premier anticipates that the FDA will issue its requirement to manufacturers to use a uniform system that recognizes the GS1 standard.
- “The FDA's Jay Crowley, a senior adviser for patient safety in the device center, acknowledged that Premier's announcement supports the agency's general direction and said it will be helpful in getting health care facilities and providers to use information from the systems once they are in place.” (Health News Daily, July 22, 2008)
What's being said?
“That’s really the Achilles heel of all this. Once [a product] leaves the device manufacturer, the visibility of that product drops off exponentially.”
- Jay Crowley, senior advisory for patient safety, FDA Center for Devices and Radiological Health (Health News Daily, July 22, 2008)
“This is a huge step forward for the healthcare community. As a GPO, Premier’s announcement will have far reaching effects in driving the implementation of GS1 standards across the healthcare supply chain.”
- Dennis Harrison, president of GS1 HealthcareAbout Premier Inc., 2006 Malcolm Baldrige National Quality Award recipient
Serving more than 2,000 U.S. hospitals and more than 53,000-plus other healthcare sites, the Premier healthcare alliance and its members are transforming healthcare together. Owned by not-for-profit hospitals, Premier operates one of the leading healthcare purchasing networks and the nation's most comprehensive repository of hospital clinical and financial information. A world leader in helping healthcare providers deliver dramatic improvements in care, Premier is working with the United Kingdom's National Health Service North West and the Centers for Medicare and Medicaid Services to improve hospital performance. Premier's Safety Institute provides publicly available safety resources and tools to promote a safe healthcare delivery environment for patients, workers, communities and the environment. Headquartered in San Diego, Premier has offices in Charlotte, N.C., Philadelphia, and Washington. For more information, visit www.premierinc.com.