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)

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.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 CDRHFor CDRH –Standard Vocabularies –Standard Methods of Data Exchange –Alignment of Database Information GOAL of Health InformaticsGOAL 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 4/2/2010Event Problem Codes – Fully Live 4/2/2010 Evaluation Codes – Under DevelopmentEvaluation Codes – Under Development Global Medical Device Nomenclature (GMDN)Global Medical Device Nomenclature (GMDN) Product Dictionary – Unique Device Identifier (UDI)Product Dictionary – Unique Device Identifier (UDI)

6 CDRH Informatics Work (cont’d) Examples of Standard Methods of Data Exchange Health Level Seven (HL7)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 =>UDIProduct 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, 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.

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

9 Current Device Identification Non-standard device identification systems;Non-standard device identification systems; Standards used in different waysStandards used in different ways Not necessarily unique or unambiguousNot necessarily unique or unambiguous Manufacturers’ own number/catalogue numberManufacturers’ own number/catalogue number Distributors’ – apply different, proprietary number; lot or serial number not capturedDistributors’ – apply different, proprietary number; lot or serial number not captured Hospital – yet different identification number/codeHospital – yet different identification number/code –Information on use not usually captured –Control numbers rarely captured

10 Current Device Identification Business Name Item Number Type Item Number BD Mfg Catalog Number BDGTIN BDGTIN BDGTIN Cardinal Health PV Order Number BF Owens & Minor PV Order Number Owens & Minor PV Order Number American Medical Depot Vendor Catalog Number American Medical Depot Vendor Catalog Number Government Sci Source Vendor Catalog Number FSC CS Government Sci Source Vendor Catalog Number FSC PK Alliance Joint Venture Vendor Catalog Number Thomas Scientific Vendor Catalog Number 8938M25 Thomas Scientific Vendor Catalog Number 8938M28 VWR International Vendor Catalog Number BD329461

11 UDI Can Improve… Visibility Medical device recallsMedical device recalls Adverse event reporting and postmarket surveillanceAdverse event reporting and postmarket surveillance Tracking and tracing, supply chain security; and anti- counterfeiting/diversion (location systems)Tracking and tracing, supply chain security; and anti- counterfeiting/diversion (location systems) Comparative effectiveness (e.g., registries)Comparative effectiveness (e.g., registries) Disaster/terror preparation and shortages/substitutionsDisaster/terror preparation and shortages/substitutions Reduce medical errorsReduce medical errors Documenting medical device use in patient’s EHR/PHR, hospital information systems, claims dataDocumenting 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 informationSentinel Initiative - strengthening FDA’s ability to query data systems for relevant device information

12 Medical Device Identification Develop a system to identify medical devices, which is: ConsistentConsistent Unambiguous (differentiates among all dimensions)Unambiguous (differentiates among all dimensions) StandardizedStandardized Unique at all levels of packagingUnique at all levels of packaging Harmonized internationallyHarmonized internationally And facilitates the: Storage,Storage, Exchange, andExchange, and Integration of data and systemsIntegration of data and systems

13 Future Information Lifecycle Distributor Hospital EHR Population databases Surveillance Recall Manufacturer Registries Clinical Use Re/order Safe? Recalled? UDI Device X Lot/serial Y Exp Date Z Reimbursement Expiration date? Counterfeit AE reporting Effectiveness

14 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.

15 HR 3962 – Health Care Reform SEC 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 the electronic 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.

16 1 st – Developing the Identifying Code –Develop UDI code according to ISO [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)

17 2 nd – Applying code to Label Applied at all levels of packaging, down to the lowest level (the patient use level or unit of use)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 technologyHuman 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)

18 3 rd – Developing UDI Database to Store Code and Other Attributes (GHTF) Labeler Contact name, phone, Labeler Contact name, phone, Device Identifier Type/Code [GTIN, HIBCC]Device Identifier Type/Code [GTIN, HIBCC] Brand/Trade Name; DescriptionBrand/Trade Name; Description Device model number (or reference number)Device model number (or reference number) Size; Unit of Measure/Packaging level/quantitySize; Unit of Measure/Packaging level/quantity Control – Lot and/or Serial Number; Exp. DateControl – Lot and/or Serial Number; Exp. Date GMDN Classification code/termGMDN Classification code/term Storage condition; Sterility;Storage condition; Sterility; Contains known, labeled allergen (e.g., latex)Contains known, labeled allergen (e.g., latex) URL for additional information – Web addressURL for additional information – Web address For more details - see GHTF Draft Discussion Paper: tion=display&doc_id=5556&userservice_id=1 tion=display&doc_id=5556&userservice_id=1

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

20 4 th - Adoption and Implementation Resolve technology issues – barcodes, RFID, DPM 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

21 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.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.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.Users (hospitals) liked UDID – it provided data they regularly need - e.g. information related to recalls and identifying alternate products/manufacturers for recalls.

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

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

24 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.

25 Unique Device Identification DeviceRegulationandGuidance/ UniqueDeviceIdentifiers