Unique Device Identification：唯一的设备标识.ppt

CDRH Human Factors Program Unique Device Identification Jay Crowley Senior Advisor for Patient Safety Food and Drug Administration jay.crowley@ 301-980-1936 Current Device Identification Non-standard device identification systems; standards used in different ways Not necessary unique or unambiguous Does not include all necessary levels of uniqueness Manufacturers’ own number/catalogue number Distributors’ – apply different, proprietary number; lot or serial number not captured Hospital – yet different identification number/code Information on use not usually captured Control numbers rarely captured Future Device Identification Develop a system to identify medical devices, which is: Consistent Unambiguous (differentiates among all dimensions) Standardized Unique at all levels of packaging Harmonized internationally And facilitates the: Storage, Exchange, and Integration of data and systems UDI brings… Global Visibility Medical device recalls Adverse event reporting and postmarket surveillance Tracking and tracing, supply chain security; and anti-counterfeiting/diversion (location systems) Comparative effectiveness (e.g., registries) Disaster/terror preparation and shortages/substitutions Reduce medical errors Documenting medical device use in patient’s EHR/PHR, hospital information systems, claims data Sentinel Initiative - strengthening FDA’s ability to query data systems for relevant device information FDA Amendments Act of 2007 September 27, 2007, the FDAAA signed into law: The Secretary shall promulgate regulations establishing a unique device identification system for medical devices requiring the label of devices to bear a unique identifier, unless the Secretary requires an alternative placement or provides an exception for a particular device or type of device. The unique identifier shall adequately identify the device through distribution and use, and may include information on the lot or serial number. GHTF UDI ADWG Formed October 2008 EC Chair (Lauren