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1、Unique Device IdentificationJay Crowley Senior Advisor for Patient Safety Food and Drug Administration jay.crowleyfda.hhs.gov 301-980-19361Current Device Identification Non-standard device identification systems; standards used in different ways Not necessary unique or unambiguous Does not include a
2、ll 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 captured2Future Device Iden
3、tificationDevelop a system to identify medical devices, which is: Consistent Unambiguous (differentiates among all dimensions) Standardized Unique at all levels of packaging Harmonized internationallyAnd facilitates the: Storage, Exchange, and Integration of data and systems3UDI brings Global Visibi
4、lity 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 error
5、s Documenting medical device use in patients EHR/PHR, hospital information systems, claims data Sentinel Initiative - strengthening FDAs ability to query data systems for relevant device information4FDA Amendments Act of 2007September 27, 2007, the FDAAA signed into law: The Secretary shall promulga
6、te 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 ade
7、quately identify the device through distribution and use, and may include information on the lot or serial number.5GHTF UDI ADWG Formed October 2008 EC Chair (Laurent Selles) Members US (FDA, AdvaMed), Europe (EC, Eucomed, EDMA), Japan, Canada AHWP recently joined (China) Washington April 2010; Brus
8、sels June 2010; Ottawa September 2010 Guidance submitted to Nov 2010 SC meeting Public Document available at: http:/www.ghtf.org/ahwg/ahwg-proposed.html Comments due by 30 April 2011.6Establishing a UDI System Combination of 4 distinct steps: n Develop a standardized system to develop the unique dev
9、ice identifiers (UDI) n Place the UDI in human readable and/or AutoID on a device, its label, or both n Create and maintain the UDI Database n Adoption and Implementation71st Developing the UDI Develop UDI code according to ISO 15459 GS1, HIBCC Created and maintained by the manufacturer Concatenatin
10、g Device and Production Identifier Device Identifier (DI): static Manufacturer, make, model i.e., each catalogue number Production Identifier (PI): dynamic however product is currently controlled serial, lot number; expiration, manufacturing date82nd UDI ApplicationUnique UDI applied to all levels o
11、f packaging, down to the lowest level (patient use/ unit of use) Human readable and/or encoded in a form of automatic identification technology No specific technology would be identified (technology neutral) Identify a series of standards (linear barcode, 2 -dimensional barcode, RFID) Direct Part Ma
12、rking (DPM) for some devices9UDI Application Example10UDI Application Example11UDI Application Example12Combination Products and KitsLike other devices intended to facilitate identification: Combination product (device) has its own UDI; each device should have its own UDI. Each kit (devices only) ha
13、s its own UDI; each device in a kit should also have its own UDI.133rd Global UDI Database Device Identifier Type/Code GTIN, HIBCC Make/model; Brand/Trade Name; Size; Description Device model number (or reference number) Unit of Measure/Packaging level/quantity Controlled by Lot and/or Serial Number
14、; Exp. Date Contact name, phone, email GMDN Classification code/term Storage condition; Single Use; Sterility Contains known, labeled allergen (e.g., latex) FDA premarket authorization (510k, PMA) FDA Listing Number14FDAs UDI DatabaseDistributionWeb based toolBusiness RulesManufacturer (Acme)GSI GDS
15、NThe label of Medical Device 123 Size 45: Device Identifier (Device XYZ123) Production Identifier (Lot #ABC) Expiration date (MMDDYYYY) Sterile; Latex freeBulk HL7 SPLMinimum Data Set For each Device Identifier: Manufacturer and model GMDN Code Other attributesororFDAs UDI DatabaseFDAFDA ManagedPubl
16、ic User InterfaceHL7 SPL15Implementation Based on premarket risk class: class III 12 months after final rule class II 36 months after final rule class I 60 months after final rule Allows stakeholders to jointly learn and for mid- course corrections Phase out national numbering system (NDC/NHRIC) Robust alternate placement and exception
