Recent News and Developments GPO endorses GS1 supply chain standards Premier Tells Medical Device Makers to Adopt GS1 Supply Chain Standards     Contact   John David White, Manager, Federal Affairs, PAC & Grassroots 202.879.8008 JohnDavid_White@premierinc.com	Unique Device Identification (UDI) for Medical Devices: The Case for Patient Safety When food manufacturers discovered a salmonella outbreak in peanut butter, the grocery industry successfully identified and removed every potentially contaminated jar of peanut butter from stores within hours. That’s because each peanut butter jar – like all other food and medication packaging – has a unique product identification number, a UPC, that can track the item from the manufacturing site to the store shelf. Unlike foods or medications, however, medical devices don’t have an industry-wide tracking and identification system – the lack of which can pose life-threatening patient safety concerns during a medical device recall.  A Growing Patient Safety Concern Every year, more than 600 medical devices are recalled –10 percent of which can potentially cause serious health problems or death – and the percentage of health problems continues to rise. Manufacturers also issue countless device corrections each year that have serious health implications for patients, such as adding new instructions to devices to prevent device misuse and potential harm. Even safe medical devices can pose dangerous health threats to patients if used together with other incompatible devices or machinery. For instance, certain pacemakers can negatively interact with the magnetic fields in magnetic resonance imaging (MRI) machines, causing life-threatening injuries – and even death – to thousands of patients undergoing routine imaging procedures. Without an industry-wide identification and tracking system for medical devices however, healthcare providers cannot identify device incompatibilities in time to avoid these devastating patient safety errors. Although many device manufacturers bar code their products, an industry-wide device identification system with a common vocabulary does not exist, preventing hospitals from consistently tracking their overall device inventory. As a result, most hospitals are left to manually enter data about devices and review countless records and patient charts when recalls occur – a labor-intensive process that poses a high risk for overlooking affected patients. The lack of an industry-wide device identification system also burdens Food and Drug Administration (FDA) resources – the agency must weed through large data bases of reported device problems from physicians and patients to identify trends that need follow up. FDA must then flag potential device defects for the public. The Way Forward By developing a national, industry-wide unique device identification (UDI) system, hospitals can improve efficiency and patient safety by easily identifying and contacting all affected patients about important device issues. A UDI system also can benefit the FDA by allowing the agency to improve processes for monitoring and rapidly identifying device malfunctions. In addition, a UDI system has the potential to advance patient safety efforts by helping the healthcare industry: • Determine when devices are incompatible for use together • Guarantee that devices are not unintentionally left in patients after surgery • Ensure patients are not treated or touched with medical devices which they may be allergic to • Detect counterfeit medical devices and prevent them from entering the hospital supply chain • Upload patient medical device information onto electronic health records (EHRs) A Chorus of Support Recognizing the potential benefits of implementing a national UDI system, the FDA invited input on how to construct a UDI system that can reduce medical errors, facilitate device recalls and improve device malfunction reporting. In response to the FDA’s request, healthcare industry leaders united to create the "Advancing Patient Safety Coalition" to provide supporting evidence and rally Congressional support for the adoption of a national UDI system. The coalition comprises prominent hospital, physician, nursing, research, quality and patient advocacy organizations committed to improving safety processes for our nation’s hospitals and the patients they serve.