UDI: From Compliance to Value OMTEC June 2013 Karen Conway

Transcription

1 UDI: From Compliance to Value OMTEC June 2013 Karen Conway 1 GHX GHX proprietary information: Please do not not copy copy or or distribute

2 UDI: The Reality

3 UDI: The Reality

4 UDI: The Reality

5 UDI: The Reality

6 UDI: The How and the Why Idea dates back to To Err is Human report Led to FDA Barcode Medication Rule Based on existing NDC standard CDRH realized lack of similar identifier for medical devices UDI included in the FDAAA of 2007 FDASIA requires final rule by June 2013 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. 6

7 UDI: The What UDI: A Three-Part System 1. Assign a UDI compliant code to covered products 2. Label products with human and machine readable codes 3. Populate and maintain data in UDI database(s) UDI Code Assign and label products: Device ID (static data) Production ID, e.g., lot, serial #, expiration date (dynamic data) UDI Database Device ID the key Specific static data Web Submission and/or HL7 SPL Rules around roles and entry AIDC Choice of auto id carrier Linear barcode 2-D barcode RFID Other 7

8 Assign Codes UDI: The Details 1) Determine which products require codes and when Current Proposed Timelines: Class III devices 12 months after publication of final rule Implants & life sustaining / supporting devices 24 months after publication of final rule (FDASIA requirement) Class II devices 36 months after publication of final rule Class I devices 60 months after publication of final rule Kits and combination products have their own UDIs UDIs at each packaging level 2) Get codes from one of the authorized issuing agency (part of the ISO series of standards) 3) Add production data (serial and/or lot numbers; expiration dates) if production is controlled by such information

9 UDI: Packaging Hierarchy Unique Device Identification Database (UDID) Package Illustration Package Configuration Examples Base Package Primary DI = 001 Package DI =002 Package configurations inherit the Base Package device attributes Contains 4 units of Base Package DI 001 Quantity per package = 4 Box of 100 gloves Device Count = 100 Package DI =003 Package DI = 004 Contains 10 units of Base Package DI 001 Quantity per package = 10 Contains 5 units of Base Package DI 003 Quantity per package = 5 9 9

10 UDI: The Steps Label products w/ both human and machine readable codes 1) Determine which auto id carrier to use Consider what is best for product, for customers 2) Determine if existing labels have the required space. Does artwork or packaging need to change? 3) Determine if your printing systems need upgrades. Can they handle dynamic data? 4) How will you handle direct part marking if required?

11 UDI Application Example (GSI) Device Identifier (GTIN) Production Data

12 UDI Application Example: HIBCC Device Identifier (HIBC-LIC) Production Data 12

13 UDI Application: ICCBBA 13 13

14 UDI Application: 2-D Barcode Product Identification GTIN (Global Trade Item Number) Product Information Lot / Batch / Expiration Date Labels shown here are drafts for illustrative purposes only. Not to be used for product labeling.

15 UDI Application: 2-D Barcode Production Data Product Identification GTIN (Global Trade Item Number) Product Information Lot / Batch / Expiration Date Labels shown here are drafts for illustrative purposes only. Not to be used for product labeling.

16 More Labeling Considerations Where are covered products produced? Into which markets are they sold? Do you need to add printing capabilities to accommodate dynamic (production) data? If so, how will that impact space and layout on the production floor? How will you handle validation of new IT equipment and processes? Do you perform late-stage labeling in warehouses or with third party logistics providers? How will their operations be affected? Do you have kits or combo products? Do you label each of them late-stage and then combine?

17 That was the Easy Part!

18 UDI: The Details Populate the Global UDI Database Sample list of attributes (from User Acceptance Testing, 2012) Device Identifier Storage Conditions Lot, Batch, Serial number Sterilization Information Brand/Trade Name/Model For Single Use? Manufacturer Contact Contains Latex Y/N? Kit Product? DUNS #* Combo Product? FDA Listing #** Determine method of submission Web interface HL7 SPL (structured product labeling) xml files * Will be key to validating data entry ** Not included in the publicly available data

19 FDA Global UDI Database Manufacturer (Acme) Minimum Data Set For each Device Identifier: Manufacturer and model GMDN Code Other attributes The label of Medical Device 123 Size 45: Device Identifier (Device XYZ123) Production Identifier (Lot #ABC) Expiration date (MMDDYYYY) Sterile; Latex free FDA Managed Distribution FDA 3 rd Parties (GDSN) or Web based tool or Bulk HL7 SPL Business Rules Public User Interface FDA s UDI Database

20 The Devil is in the Data Relatively Easy Assign Codes Very Hard / Time Consuming Publish (Accurate/Complete) Data Stakeholder engagement We help here Data identification Data attribute collection Data management process Comply with regulations Rinse and repeat forever Relatively Easy Label Products Orthopedic Specific Considerations Huge potential number of SKUs and sizes OEM collaboration and compliance Direct Part Marking (DPM) considerations Field inventory management and compliance Multiple customer integration scenarios

21 FDA GDSN/FDA UDI Pilot Attributes Full List of Attributes from the 2012 GDSN/FDA UDI Pilot (sample reference only) Issuing Agency Model/Version # Storage and Handling Type Primary DI # Model/Version # part of Device Family Storage Low Value Unit of Use DI # Device Description Storage High Value Product Exempt from Direct Part Marking (DPM) Marketing Status Special Storage Conditions Exempt Reason DI Record Publish Date Device packaged as Sterile DPM DI different from Primary DI? Date Device Discontinued Require Sterilization prior to use? DPM DI # Product Code Sterilization Method Issuing Agency of Secondary DI Product Code Name Contain Latex? Secondary DI # GMDN Code For single-use? Contact Type Preferred Term Contain Human Tissue? Contact First Name Term Definition Kit Product? Contact Last Name Product Exempt from Premarket Authorization? Combo Product Contact Authorization # Controlled By Lot #? Contact Phone Supplement # Controlled By Serial #? DUNS # FDA Listing # Controlled By Manufacture Date? Company Name Size Type Controlled By Expiration Date? Company Physical Address Size Value Device Count Brand Name Size Unit of Measure Package DI # Brand Name part of Device Family? Size Text Quantity per Package Contains DI Package

22 UDI: A Master Product Data Initiative The data required for the FDA s Global UDI Database (GUDID) are often in multiple locations and formats (some electronic, some physical) Attributes Location Availability Owner Etc. GTIN ERP High Division 1 IT Brand Name System 123 High Marketing Functional Name Sales Mgmt Low Sales Effective Date System XYZ Low Compliance Child GTIN ERP 2 Medium Division 2 IT Complete list of criteria Data can be easy or hard to harvest The data owners vary

23 A Cross Functional Business Process Packaging Sales Technology Marketing Inventory Legal Process Engineering Regulatory UDI Labeling UDI is more than IT, Labeling or Bar Codes

24 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 Packaging Sales Clinical Efficacy Supply Chain efficiency Other Legal Who needs to be involved? Who, what is impacted? Marketing Technology Regulatory UDI Readiness Inventory Process engineering

25 UDI for Regulatory Master Data Management The FDA plans to make UDI the key for master data management within the Center for Devices and Radiological Health, and as manufacturers we need to think similarly within our organization. By using the UDI as the foundation for their regulatory master data, manufacturers can achieve a more consolidated view of product data within their own organizations that they can use for different regulatory submissions. Jackie Elkin, Global Process Owner Standard Product Identification Medtronic 25

26 UDI for Competitive Advantage Cook Medical Marketing Campaign 26 Source: Centerfold Ad in Healthcare Contracting Journal, 4 th Qtr. 2012

27 UDI for Operational Efficiency Operational Resources: Simplifies supply chain management Cook Medical s unique one point of contact significantly improves supply chain efficiency. Improves information quality Reduces labor and supply chain costs More efficient payment/reporting SHARED SERVICE CENTER Ordering Shipping Billing

28 UDI: Back to Why UDI Central to FDA Post Market Surveillance Plans Medical device recalls Adverse event reporting Tracking and tracing Supply chain security Anti-counterfeiting/diversion Disaster/terror preparation Shortages/substitutions Reduction of medical errors An easily accessible source of device information for patients and clinicians sandtobacco/cdrh/cdrhreports/ucm pdf

29 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

30 UDI: A Global Issue Regulatory bodies around the world are watching the US and beginning work on their own regulations US: Final rule expected this year (statutory deadline June 2012) Europe : Draft regulations (Sept. 2012); Vision for common system (April 2013) Other countries/regions looking at UDI: China, Japan, Korea, and Turkey, Canada, Australia, Argentina, and Turkey, Canada, Australia, Argentina, India, UAE

31 UDI: Global Harmonization International Medical Device Regulatory Forum (IMDRF) replaced Global Harmonization Task Force (GHTF) Updating UDI guidance document Capital Equipment IVD Kits Non-IVD Kits Direct Part Marking Software Comments accepted through July 31, 2013 Updated document by end of the year GHTF UDI Guidance Document ices_ahwg-udi-n2r3.pdf IMDRF Draft Guidance Update 31

32 UDI: Europe September 2012: 3 directives merged into 2 new proposed regulations (September 2012) April 2013: EU Commission Recommendation for a Common Framework for UDI Importance of globally harmonised systems Device Identifier, Production Data, UDI Database Provisions on identification and traceability One Step Up, One Step Down traceability Potential interoperability with personal health systems Likely out 2014 if acted on before Parliament elections; if not 2016

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

34 UDI: Back to Reality To meet expected UDI requirements, GHX suppliers have identified individual attributes to collect depending on the product. At one customer, >60 individuals from 10+ functional areas with 5 sister companies are involved in UDI compliance efforts. After 6 months of work, one supplier found that both an owned, US-based OEM and a foreign division were duplicating efforts. Initial customer test loads into GHX s GDSN certified data pool routinely resulted in rejection of 50% of lines due to format, accuracy and incomplete records.

35 Want to Learn More about UDI? Visit the FDA s UDI information page/sign up for regular updates ication/default.htm National Medical Device Postmarket Surveillance Plan H/CDRHReports/ucm htm Video series and case studies: Blog posts: Search on UDI under topics on right How Cook Medical Adopted the GTIN System: Sleepless Nights and Peanut Butter 35

36 Questions and Answers Contact: Karen Conway,