1. Unique Device Identification and HL7 Messages HL7 Working Groups 27 th Annual Plenary Meeting September 2013 Terrie Reed, Associate Director, Informatics Leslie Tompkins, Informatics Staff FDA, Center for Devices & Radiological Health

2. Types of Medical Devices and Examples Capital Equipment –cribs, beds, scales, wheelchairs, IV poles, infusion pumps, bathing tubs, blood pressure equipment, MRI and CAT scanners, radiology equipment Instruments –surgical staplers, glucose meters, orthopedic tools and hardware Monitoring Systems –cardiac, telemetry, vital sign monitors, pulse oximeters Clinical Lab –IVD tests and reagents –Chemistry analyzers Disposables & Accessories –ventilator breathing circuits, filters –needles, syringes, trocars, IV catheters, IV tubing, foley catheters, feeding tubes, gloves –electrodes Implantable –defibrillators, breast implants, ventriculoperitoneal shunts,, tissue expanders, pacemakers Computerized Medical Systems –Workstations, hardware –software 2

3. Identifying a single device: BD 1/2 mL Insulin Syringe/28 G needle Business NameItem Number TypeItem Number BDMfg Catalog Number329461 BDGTIN00382903294619 Cardinal HealthPV Order NumberBF329461 Owens & MinorPV Order Number0722329461 American Medical DepotVendor Catalog Number777127217 Government Sci SourceVendor Catalog NumberFSC1482679CS Alliance Joint VentureVendor Catalog Number888021932 Thomas ScientificVendor Catalog Number8938M25 VWR InternationalVendor Catalog NumberBD329461 3 Easier to identify the dogfood you bought at the grocery store…..

4. UDI Legislation: Standardizing Device Identification FDAAA 2007; FDASIA 2012 label of devices identify the device through distribution and use lot or serial number implement the final regulations with respect to devices that are implantable, life-saving, and life sustaining not later than 2 years after the regulations are finalized Not later than December 31, 2012, the Secretary shall issue proposed 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. The Secretary shall finalize the proposed regulations not later than 6 months after the close of the comment period and shall implement the final regulations with respect to devices that are implantable, life-saving, and life sustaining not later than 2 years after the regulations are finalized, taking into account patient access to medical devices and therapies. 4

5. Unique Device Identifier (UDI) A globally unique device Identifier: To be obtained from an FDA-accredited issuing agency To be applied by manufacturer to the label of devices To be submitted by manufacturer to Globally Unique Device Identification Database (GUDID) along with associated device attributes – Common Product Model To be made publically available at no charge To be used by FDA applications (MAUDE, Recalls) and external systems (EHRs, Claims, Inventory Systems) as the device ID standard 5

6. UDI Representation (01) 00643169001763(17) 160712 (21) 21A11F4855 UDI = DI (Device Identifier) + PI (Production Identifier) –Placed on the Device Label –DI is lookup key for pulling out other attributes from GUDID –Scanners/middleware can parse out PI (lot, serial, expiration and manufacturer date) from the UDI barcode (where available) –GUDID will capture ONLY the DI portion (static portion of UDI) –Manufacturers or hospitals/end users are responsible for recording PI information on individual device packages 6

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8. Global Unique Device Identification Database - GUDID –Submission of DI records made through web interface and HL7 SPL –Stores DI and other regulatory device identification information –Download, Webservice and Search for Device Information – no charge from FDA –Potential to link device information in procurement, inventory control, recalls, clinical care (including registries and clinical trials), clinical material management, incident systems etc. 8

9. GUDID – Characteristics Device Catalog - Contains static device information NOT a Patient Registry – does NOT contain patient or device specific production information, such as lot or serial numbers NOT for track/trace or other similar purposes requiring the full UDI Provides link to product information – not a replacement for FDA Recalls/Adverse Event Databases GUDID is not a requirement for hospitals – it is a tool that will provide the following benefits if all stakeholders buy in EHRs, Claims, Inventory Systems, Incident Systems, Clinical Maintenance… 9

10. Example: Parsing a UDI *– (01)51022222233336(11)141231(17)150707(10)A213B1(21)1234 Issuing Agency Identifying SymbolIdentifierData type Human Readable Barcode Field Size Database Field Size GS1(01)DInumeric1614 GS1(11) Manufacturing Date numeric [YYMMDD] 86 GS1(17) Expiration Date numeric [YYMMDD] 86 GS1(10)Lot Numberalphanumeric2220 GS1(21) Serial Number alphanumeric2220 GS1 Base UDIalphanumeric7666 10 *http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM369248.pdf

11. SPL R5 – DI Representation SPL collects the Device Identifier without its production identifiers Device Identifier indicated by code (00643169001763) Issuing agency indicated by codeSystem (GS1=1.3.160)

12. ICSR R1 –UDI Representation in Adverse Event Reporting Unique Device Identifier includes the Issuing agency prefix, device identifier and production identifiers

13. HL7 v 2.x Messages - Representation of UDI Insert Solution Here 13

14. FHIR – Representation of UDI Insert Solution Here 14

15. GUDID attributes (see Appendix B in Guidance) Device Identifier* (DI of UDI) –From Accredited Issuing Agency * Manufacturer/Labeler Information (DUNS #) Brand Name * Model/Version # * Catalog # Device Description In Commercial Distribution Procode (3-digit code, name) GMDN Preferred Term –5-digit code –Term name –Definition PMA/510K number FDA listing # Size –Dimension –Number –Unit of measure Storage and Handling –temperature, humidity Controlled by: –Serial# –Lot# –Manufacturing date –Expiration date –HCT/P Contains Natural Rubber Latex? * For Single-use? * Convenience Kit? * Combination Product? * Human Cell, Tissue or Cellular- or Tissue-based Product (HCT/P)? Prescription Status MRI Safety? Packaged as Sterile? * Device Count * Packaging Info –(box, carton, case, etc)

16. Which Attributes to Retrieve from GUDID and Store? How to Retrieve? How to Transmit? Basics Device Identifier* (DI of UDI) –From Accredited Issuing Agency * Manufacturer/Labeler Information (DUNS #) Brand Name * Model/Version # * Catalog # Device Description In Commercial Distribution GMDN Preferred Term –5-digit code –Term name –Definition Patient Safety Contains Natural Rubber Latex? * For Single-use? * Prescription Status MRI Safety? Packaged as Sterile? Size –Dimension –Number –Unit of measure 16

17. Criteria for selecting the Data Elements * Does it reflect natural patient care documentation? Is it useful in patient care communication and transfer of care? How does the data element assist in charging? 17 Adapted From Stella Mandl Plenary Session

18. EHR Adoption – Meaningful Use Stage 3 Stage Stage 2 Final Rule Stage 3 Recommendations NEW – NOT IN STAGE 2 MENU objective: Eligible Physicians and Eligible Hospitals should record the FDA Unique Device Identifier (UDI) when patients have devices implanted for each newly implanted device. MENU Measure: Eligible Physicians and Eligible Hospitals should record the UDI when patients have the device implanted for 80% of patients seen within the EHR reporting period.

19. 19 UDI Requirements Patient’s implant is documented in EHR and other relevant systems as part of patient care by: Representing UDI as the standard code to document device use Providing parsing instructions for decoding and storing DI + PI Using DI portion of UDI to obtain other relevant attributes that link to patient episode of care (from GUDID or inventory system or ??) Making links between EHR, inventory and claims systems - store DI, PI and sufficient clinical and administrative attributes to maximize benefit to patient, care providers, hospital systems (materials management, biomedical engineering, risk management, recalls)

20. Potential Future Benefits The UDI of an implanted medical device could be captured upon implant and become a permanent part of a patient’s medical record. Then: –A clinician could view all of the patient’s implanted devices and associated UDI’s in the same manner as a medication list is viewed. –This hospital would be able to report adverse events using the UDI (and appropriate associated attributes) linked to the EHR patient record. –If an implantable device recall occurred, the hospital or physician would be able to use the UDIs of the recalled devices to pull up all patients in their EHR that have in their record the device identifier, and lot/batch/serial number combination specified in the recall notice. 20

21. Devices would be better identified as part of care UDI and other implantable device information could be provided at time of patient transition in : –View, Download and Transmit functions (VDT) –Summary of Care documents –Transition of Care documents –After visit summary documents 21

22. UDI and HL7 - questions Which HL7 Standards need to support UDI for capturing implant and linking to patient surgical procedure? Does an HL7 standard need to define the UDI attributes to link to patient? If not, what standard would? Should UDI representation be resolved by M&M? Should there be an Implementation Guide to define how to represent UDI in SPL, v2.x, FHIR, medical device interoperability? Who coordinate? 22

23. UDI Resources now available UDI website – Portal for all Resources –www.fda.gov/UDIwww.fda.gov/UDI UDI Help Desk GUDID Draft Guidance –http://www.fda.gov/downloads/MedicalDevi ces/DeviceRegulationandGuidance/Guidan ceDocuments/UCM369248.pdfhttp://www.fda.gov/downloads/MedicalDevi ces/DeviceRegulationandGuidance/Guidan ceDocuments/UCM369248.pdf Appendix B – Vocabulary Appendix C - UDI Specifications by Issuing Agency 23