Fast Facts Device Identification, Synchronization Can Boost Patient Safety Key Talking Points on Unique Device Identification Device Recall Survey	Unique Device Identification (UDI) . . .Facts A patient today faces a significant risk that a recalled medical device could be used in his or her treatment because there is no way to quickly and reliably identify a medical device within a hospital.  Moreover, a defective device could remain undiscovered for a longer time and the ability to assess a device’s effectiveness is compromised today.  This is because, unlike other products in America, no uniform, unique numbering system, used with a bar code, exists for medical devices.  Unique identification of medical devices is a missing link to protect the safety of patients by improving processes for device recalls and corrections The rapidly rising number of device recalls, accelerated by the increasing complexity and variety of medical devices, points to the need for UDI for effective management of recalls. More than 600 medical device recalls are issued each year and, over the past four years, there have been over 60 Class 1 recalls (defined as dangerous or defective products that predictably could cause serious health problems or death). Manufacturers also issue many “device corrections” that can have serious consequences for patients if not handled correctly. Because of the absence of UDI hospitals often must use manual and imprecise systems. As one hospital executive stated, “This creates a significant work load impact, but more importantly, there is a significant risk of missing a patient who may have received a defective device.  This is of tremendous concern to the caregivers.” Unique device identification will strengthen the ability of FDA and manufacturers to monitor adverse events related to medical devices A national UDI system would create a common vocabulary for reporting and enhance tracking abilities. Currently, analysis of adverse event reports is limited by the fact that the specific devices involved in an incident are often not known with the required degree of specificity. Without a common vocabulary for medical devices, meaningful analysis based on data from existing voluntary systems (such as MAUDE and MedSUN) is extremely problematic.  Reliable identification of medical devices would enable data mining so that FDA and manufacturers could better identify potential problems or device defects.  Today this is done by FDA for drugs. Unique device identification is a key step in reducing medical errors and improving patient safety Correctly identifying devices, tracking them through the healthcare system and informing the proper practitioner about any potential dangers will reduce errors and improve patient safety. Specifically, UDI would improve patient safety and reduce errors by doing the following: Facilitating the identification of device compatibility problems Ensuring that the right device is available to the right patient at the right time Providing the ability to trace contaminated instruments or equipment back to patients Making sure no devices are left behind in patients during a surgical procedure Unique identification of medical devices will complete the electronic health record Electronic health records (EHR) will require that data standards—including those for medical devices—are in place and used by all institutions in order to transfer information.  Having a UDI for medical devices is a basic requirement that must be in place before automated identification systems are fully effective.  A common vocabulary for medical devices is necessary for healthcare providers to be able to effectively document devices in patient records.