UDI: From Regulation to Value

1. UDI: From Regulation to Value What Hospitals and Healthcare Systems Can and Should Do, Now Presented by Karen Conway, AHRMM Board and Executive Director, Industry Relations, GHX

2. What We Will Cover • History and Purpose of Unique Device Identification • What Manufacturers Have to Do and When • Potential Regulatory Requirements for Providers • Steps to Value for Suppliers and Providers • Next Steps

3. The Need for Standard IDs Only UDI compliant code on list

4. From Problem to Regulation Preventable Medical Errors and Device Recalls

5. UDI: History and Purpose • FDA Barcode Medication Rule Passed 2004 • Based on existing NDC standard • Lack of identifier for medical devices • UDI included in the FDAAA of 2007 The Secretary shall promulgate regulations establishing aunique 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.

6. UDI: A Three-Part System • Assign a UDI compliant code to covered products • Label products with human and machine readable codes • Populate and maintain data in UDI database(s) UDI Database Device ID the key Specific static data Multiple methods to populate Publicly available data UDI Code • AIDC • Choice of auto id carrier • Linear barcode • 2-D barcode • RFID • Other • Direct Part Marking Assign and label products: Device ID (static data) Production ID, e.g., lot, serial #, expiration date (dynamic data)

7. The US FDA Final Rule Announced at UDI Conference on September 20, 2013 Published in Federal Register on September 24, 2013

8. The FDA Listened • Some Key Issues • Date Format • Existing Inventory • Kits and Combo Products • Shelf Packs • MRI Compatability • Direct Part Marking for Implantable Devices

9. Direct Part Marking Direct part marking required for products “intended to be used more than once and intended to be reprocessed before each use” 2 years after regular compliance date except for those products considered implantable, life-saving, and life sustaining. They must be in full compliance by September 24, 2015.

10. The Clock is Ticking for Suppliers • Risk-based Compliance Deadlines • September 24, 2014 - Class III devices (implants) • September 24, 2015 - “…devices that are implantable, life-saving, and life sustaining” (DPM for required devices in this category)) • September 24, 2016 – Class II devices (DPM for Class III) • September 24, 2018 – non-exempt Class I devices, unclassified (DPM for Class II if required) • September 24, 2020 – (DPM for Class I and unclassified, if required)

11. Assigning UDIs - Different Packaging Levels Each level of packaging requires a unique device identifier Pack of 1 Each Case of 10 Packs of 1 Each 1 Each 2 0085412 00000 4 6 0085412 00000 9 Case of 10 Each 0 0085412 00000 8 5 0085412 00000 6

12. UDI: The Details • Populate the Global UDI Database (GUDID) • Device Identifier From Accredited Issuing Agency • Manufacturer/Labeler Information (DUNS #) • Brand Name • Model/Version # • Catalog # • Device Description • Global Medical Device Nomenclature • Other attributes (GUDID Guidance Appendix B) Patient Safety • Contains Natural Rubber Latex? • For Single-use? • Prescription Status • MRI Safety? • Packaged as Sterile? • Size (Define)

13. GUDID Overview

14. GUDID Web Interface • Secure Web Application • Submission of device information one record at a time by Labelers • Search and Retrieval of published device information by public users FDA\CDRH\OSB\Informatics Staff

15. GUDID Search and Retrieval Two Search and Retrieval Options will be available: 1) Web Interface Search and Retrieval • Quick Search – enables search on Device Identifier, Company Name, Brand Name, Version or Model Number. • Advanced Search – additional attributes available for searching. 2) System to System Search and Retrieval • Web Services – accepts a DI Number and returns published attributes. • Database Download capability – planned for the future. FDA\CDRH\OSB\Informatics Staff

16. Device Identifier (DI) Record DI Record = Device Identifier (DI) + GUDID attributes FDA\CDRH\OSB\Informatics Staff

17. UDI= Unique Device Identifier • Device Identifier(DI) + Production Identifier(s)(PI) • DI= mandatory, fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device • Issued by FDA-accredited Issuing Agencies • PI= a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of the device: • Lot or batch number • Serial number • Expiration date • Manufacturing date FDA\CDRH\OSB\Informatics Staff

18. UDI Compliant Label: Linear Barcode Device Identifier or DI (GTIN) Production Data (Application Identifier or AI)

19. UDI Compliant Label: 2D/Data Matrix Device Identifier: GTIN Labels shown are drafts for illustrative purposes only.

20. UDI Compliant Label: 2D/Data Matrix Production Data Application Identifier • Lot / Batch / Expiration Date Production Data Labels shown are drafts for illustrative purposes only.

21. UDI Compliant Code: ISBT 128 21

22. UDI Compliant Code: ISBT 128 Donor ID # (Lot) 22

23. A Holistic Approach to UDI “This is not about just being able to identify devices. We (FDA) are talking about a holistic approach to integrating medical device identification throughout the entire healthcare system. UDI will be a fundamental piece of everything we do going forward.” Jay Crowley, former Sr. Adviser for Patient Safety, U.S FDA Center for Devices and Radiological Health FDA working on conforming amendments for: • Premarket approvals • Reports of Corrections and Removals • Medical Device Recall Authority • Quality System Regulation • Medical Device Tracking Requirements • Post Market Surveillance

24. It’s All About Visibility • Medical device recalls • Adverse event reporting • Traceability • Supply chain security • Anti-counterfeiting/diversion • Disaster/terror preparation • Shortages/substitutions • Point of Use Capture • Demand Signals • Supply Chain Efficiencies • Comparative Effectiveness • Value Analysis

25. UDI is Foundational Strengthening Our National System for Medical Device Postmarket Surveillance -U.S. FDA, April 2013

26. Adoption is Key to the FDA’s Vision • Promote Adoption with other Stakeholders • Facilitate the incorporation of UDI into electronic health records as part of EHR Certification Criteria • Create an initial think tank report to inform the development of a roadmap for successful UDI implementation • Complete a pilot demonstrating the ability to incorporate UDI into a multi-hospital information system – Mercy Health Systems

27. UDI for Post Market Research Unique Device Identifier Demonstration Project • Utilize electronic health records and clinical registries to assess the safety and effectiveness of medical devices after they have reached the marketplace • Stents first, then ICDs International Consortium of Orthopedic Registries • Identify and capture clinical attributes that impact performance • Address differences in orthopedic registries to better utilize available data • Demonstration projects: bearing surface, femoral head size, • fixed vs. mobile knees, pediatric joints

28. UDI Implementation Project • Retrieve UDI (Device Identifier) from GUDID for ERP • Utilize ERP as master source of UDI (Device Identifier) + attributes for EHR

29. UDI Implementation Project • Exchange UDI with Suppliers using UDI (Device Identifier) • Automated replenishment from Inventory Management • Point of Use integrated to EHR for UDI • Automated charge capture • UDI + Attributes in EHR • Electronic management of Expiration Date • Electronic management of Recalls • Longitudinal data warehouse and CathPCI Registry utilize UDI (Device Identifier) + attributes from GUDID

30. UDI Implementation Project • ERP/Supply Chain systems implementing UDI but working through bugs • Clinical systems in planning phase for UDI

31. UDI Implementation Project • Manual efforts maintaining item master in multiple systems • Workarounds required to incorporate UDI into EHR • Clinical personnel not consistently scanning / proper barcode • Double scan in Inventory Mgmt and CathLab • GLN vs. DUNS use (data mapping required) • Device descriptions not standardized (GMDN from FDA GUDID)

32. UDI: Could Providers be Required? • UDI in electronic medical records? • UDI on claims forms? • UDI as part of quality • measures? • Physician Value of UDI • Revision surgery, e.g., which hip implanted • Emergency cases, e.g., visibility into implants before patient arrives Under healthcare reform, we need to know which products contribute to better outcomes at lower costs.

33. EHR Adoption – Meaningful Use WG Stage Proposed

34. Proposed 2015 EHR Certification Criteria New 2015 Edition certification criterion would require EHR technology to be able to record and display a unique device identifier (UDI) “EHR technology could be leveraged in conjunction with automated identification and data capture (AIDC) technology or other technologies to streamline the capture and exchange of UDIs and associated device data in clinical and administrative workflows.” FDA seeking comments through April 28, 2014 www.regulations.gov

35. Implant Usage Documented Manually Survey conducted with OR nurses attending the 2011 AORN Conference, N = 326

36. 7: Who enters the implant info in the Implant Log? Survey conducted with OR nurses attending the 2011 AORN Conference, N = 326

37. 8: Who records the usage for payment & restocking purposes? Survey conducted with OR nurses attending the 2011 AORN Conference, N = 326

38. 9: Who records usage for patient billing ? Survey conducted with OR nurses attending the 2011 AORN Conference, N = 326

39. How can you achieve the most value? • Providers need to leverage UDI and product data for multiple purposes: • Reimbursement • Comparative Effectiveness • Total cost of care • What else? • Implant documentation • Supply chain transactions • Inventory management • Charge capture Write Once, Read Many • Ask yourself: • Where can you use UDI? • What value can it deliver? • Where will you be required to use UDI? • How will you capture, share, store the required data? • What data do you need to capture? • What process changes are necessary? • Who needs to be involved

40. Why are you waiting? Focus on Implantables. The FDA is.

41. Implant Costs: Up or Down? • Recent Average Price Trends for Implantable Medical Devices, 2007-2011* • Specifically the study reported a 17 percent drop for artificial knees, 23 percent for artificial hips and 34 percent for drug eluting stents. • Variability in Costs Associated with Total Hip and Knee Replacement Implants • Average selling prices of hip and knee implants have increased more than 100 percent over the past decade. Who do you believe? What’s your experience?? “there is almost a complete lack of understanding of how much it costs to deliver patient care, must less how those costs compare with the outcomes achieved.” Kaplan and Porter, The Big Idea: How to Solve the Cost Crisis in Health Care

42. The Little Things Count “overall costs for the devices related to the surgery has not declined as much as claimed because of peripheral products that remain “under the radar…. Peripheral products like cutting guides for knees, antibiotic bone cement instead of regular cement, pin guides for surgical navigation systems, disposable instruments, and biologics … These ‘implant related’ costs have increased from about 3% of costs several years ago to 6% of implant costs in 2012.” Stan Mendenhall, Orthopedic Network News September 27, 2013

44. Maximizing Value • To Achieve Return from Required Investment, • Manufacturers need to view as a strategy, not a project • Consider Objectives, Benefits, Impacts: Why are you doing this? • Regulatory compliance • Regulatory master data management • Competitive Advantage • Customer Service • Clinical Efficacy • Supply Chain efficiency • Other • Who needs to be involved? • Who, what is impacted?

45. Find the Best Path • Build a Global Master Data Management Strategy • Define ALL regulatory and commercial attributes (Super Spec) • Find a solution that works globally

46. UDI: A Global Issue The Whole World is Watching Other countries/regions looking at UDI: European Union (draft regulations and common framework) China, India, Japan, Korea, Netherlands, UK, Turkey, Canada, Australia, Brazil, Argentina… , and Turkey, Canada, Australia, Argentina, India, UAE

47. A Global UDI Database Network UDID CA? EU UDID (Eudamed) NETWORK GUDID USA (FDA) UDID AP ? The IMDRF UDI Workgroup is considering the issue of information exchange between UDI databases around the world UDID SA?

48. A Coordinated Effort UDI is a Team Sport Getting to Value Requires a Concurrent Effort

49. Want to Learn More about UDI? Check out blog posts and videos on UDI at The Healthcare Hub http://www.thehealthcarehub.com Check out AHRMM’s UDI information site: http://www.ahrmm.org/ahrmm/ext/standards/UDI_index.htm Visit the FDA’s UDI information page and sign up for regular updates on UDI at http://www.fda.gov/udi Strengthening our National System for Medical Device Postmarket Surveillance -http://www.fda.gov/downloads/MedicalDevices/Safety/ CDRHPostmarketSurveillance/UCM348845.pdf