Update on CDRH Informatics/UDI Work

1. In attempting to arrive at the truth, I have applied everywhere for information, but in scarcely an instance have I been able to obtain hospital records fit for any purposes of comparison. If they could be obtained, …they would show how…money was being spent, what amount of good was really being done with it..; and… these improved statistics would tell us more of the relative value of particular operations and modes of treatment .. and the truth thus ascertained would enable us to save life and suffering, and to improve the treatment and management of the sick… Florence Nightingale Notes on hospitals (1859, revised 1863)

2. Update on CDRH Informatics/UDI Work Terrie Reed Senior Policy Analyst FDA Center for Devices and Radiological Health 3/12/10

3. How do you define Health Informatics? • Methods used to optimize the acquisition, storage, retrieval, and analysis of health information. Tools include not only computers but also clinical guidelines, formal medical terminologies, and information and communication systems.

4. How do you define Health Informatics? • For CDRH • Standard Vocabularies • Standard Methods of Data Exchange • Alignment of Database Information • GOAL of Health Informatics • Facilitate sharing of data across TPLC and with other Stakeholders

5. CDRH Informatics Work Examples of Standard Vocabularies • Event Problem Codes – Fully Live 4/2/2010 • Evaluation Codes – Under Development • Global Medical Device Nomenclature (GMDN) • Product Dictionary – Unique Device Identifier (UDI)

6. CDRH Informatics Work (cont’d) Examples of Standard Methods of Data Exchange • Health Level Seven (HL7) • Regulated Product Submission (RPS) – STED • Individual Case Safety Report (ICSR) - eMDR • Structure Product Labeling (SPL) Product Information + Content of the Label Examples of Aligning Databases – • Product Codes =>UDI

7. The Need for UDI • US Has No Good System To Track Medical Implants • AP Enterprise: United States Has No Reliable System To Track • Defective Medical Implants • (AP) New York October 5, 2009. Three years ago, the maker of a surgical clip called the Hem-o-lok issued an urgent recall notice warning doctors to stop using the fasteners on living kidney donors. It said the clips could dislodge. in their bodies, with "serious, even life-threatening consequences.“ Not everyone got the message. Last October, a surgeon in Brooklyn used one of the clips to tie off Michael King's renal artery when he donated a kidney to his ailing wife. Twelve hours later, the clip popped off. King bled to death internally in the hospital as his wife lay helplessly nearby. He was 29. http://www.cbsnews.com/stories/2009/10/05/ap/health/main5364655.shtml

8. Device Information Lifecycle Rentals GPOs Clinical Substitution Manufacturer Sold Distributor Device X Lot Y Exp Date Z Physicianpreference Hospital Reuse Direct Recall Reorder Off-master purchase Clinical Use Unit Sales Rep Hoarding Reimbursement AE Reporting EHR Postmarket Surveillance Population Databases Registries ComparativeEffectiveness FDA’s Sentinel System 8

9. Current Device Identification • Non-standard device identification systems; • Standards used in different ways • Not necessarily unique or unambiguous • 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

10. UDI Can Improve… 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

11. Medical 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

12. Future Information Lifecycle Reimbursement Re/order Hospital Expiration date? Clinical Use Distributor Effectiveness UDI Device X Model Y Recalled? Manufacturer EHR Safe? AE reporting Recall Registries Surveillance Population databases Counterfeit Closed System

13. 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.

14. HR 3962 – Health Care Reform SEC. 2571. NATIONAL MEDICAL DEVICE REGISTRY (b) Electronic Exchange and Use in Certified Electronic Health Records of Unique Device Identifiers- … (2) STANDARDS, IMPLEMENTATION CRITERIA, AND CERTIFICATION CRITERIA- The Secretary of Health and Human Services, acting through the head of the Office of the National Coordinator for Health Information Technology, shall adopt standards, implementation specifications, and certification criteria for theelectronic exchange and use in certified electronic health records of a unique device identifier for each covered device referred to in paragraph (1), if such an identifier is required by section 519(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(f)) for the device. (c) Unique Device Identification System- The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue proposed regulations to implement section 519(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(f)) not later than 6 months after the date of the enactment of this Act.

15. 1st – Developing the Identifying Code • Develop UDI code according to ISO 15459 [GS1, HIBCC] • Created and maintained by the manufacturer • Concatenating Device and Production Identifier • Device Identifier (DI): [static] Manufacturer, make, model [i.e., each catalogue number] • Production Identifier (PI): [dynamic] if currently serialized – serial number; if currently identified at the lot, the lot number, and expiration date • Risk based approach – DI; DI + lot; DI + serial (or lot and serial)

16. 2nd – Applying code to Label • Applied at all levels of packaging, down to the lowest level (the patient use level or unit of use) • Human readable and/or encoded in a form of automatic identification technology • Direct Part Marking (DPM) for some devices • No specific technology would be identified (technology neutral) • Identify a series of standards (linear barcode, 2-dimensional barcode, RFID)

17. 3rd – Developing UDI Database to Store Code and Other Attributes (GHTF) • Labeler Contact name, phone, email • Device Identifier Type/Code [GTIN, HIBCC] • Brand/Trade Name; Description • Device model number (or reference number) • Size; Unit of Measure/Packaging level/quantity • Control – Lot and/or Serial Number; Exp. Date • GMDN Classification code/term • Storage condition; Sterility; • Contains known, labeled allergen (e.g., latex) • URL for additional information – Web address For more details - see GHTF Draft Discussion Paper: http://ec.europa.eu/enterprise/newsroom/cf/document.cfm?action=display&doc_id=5556&userservice_id=1

18. FDA’s UDI Database The label of Medical Device 123 Size 45: Device Identifier (Device XYZ123) Production Identifier (Lot #ABC) Expiration date (MMDDYYYY) Sterile; Latex free Manufacturer (Acme) Distribution FDA Minimum Data Set For each Device Identifier: • Manufacturer and model • GMDN Code • Other attributes FDA Managed Business Rules FDA’s UDI Database GSI GDSN SPL or Other options HIBCC UPN or Public User Interface Labeler

19. 4th - Adoption and Implementation • Resolve technology issues – barcodes, RFID, DPM • Develop appropriate UDI Database • Facilitate distributor uptake and use • Facilitate hospital uptake and use • Facilitate use of UDI throughout device lifecycle • Develop medical error reduction (e.g., latex) • Drive integration – MMIS-Clinical • Drive appropriate use of UDI in EMRs • Determine appropriate role in reimbursement • Address privacy concerns

20. UDI Database Pilot Phase 1-3 Purpose: Assess the feasibility of collecting, storing, and retrieving UDI data from initial creation (manufacturer) to point of use (hospital) . Results: Data suppliers (manufacturers) had concerns about data definitions, obtaining the data from various sources and manipulating for UDI upload. Participants confused about the purpose/use of UDID. Users (hospitals) liked UDID – it provided data they regularly need - e.g. information related to recalls and identifying alternate products/manufacturers for recalls. 20

21. UDI Database Pilot Phase 4 Purpose: Assess how UDI data will impact FDA device information use in current systems Method: Vendors submit data via spreadsheets FDA analyze data for completeness and accuracy FDA analyze data for impact on current systems FDA use results to inform development of UDI Database Results: Pending 21

22. Limitations of UDI and UDID UDID contains only “static” information. Includes identifying information and other attributes about the device. UDID does NOT contain production information, such as lot or serial numbers. UDID is NOT track/trace or other similar purposes requiring the full UDI UDID provides link to Better Product Information- not a replacement for Recalls/Adverse Event Databases. 22

23. Conclusion: UDI as Foundational Element UDI will facilitate integration of data across disparate systems in the supply chain: • more efficient and effective device recalls, • improved postmarket surveillance, • better adverse event reporting, • better device identification in registries, • ability to document specific device use in patient’s Electronic Health Records, • collection of device information in population-based data sets. BUT – only if UDI is captured, stored, integrated and exchanged by ALL stakeholders.

24. Unique Device Identification www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentifiers Email: cdrhudi@fda.hhs.gov