What? Strategic Im plications of UDI and Contract Adm inistration 2014 Fall Conference Dec 9 – 11, 2014 OMNI Hotel, Chicago
Danny Adams Elizabeth Hilla President and CEO Senior Vice President, Health Industry Distributor Data Solutions (DDS) Distributors Association (HIDA) Executive Director, HIDA Educational Foundation Dennis Black Ellenmary Martin Director, e-Business Chief Strategy Officer BD Dennis DUKAL Corporation Cameron Hall Denise Odenkirk Director, Product Management Senior Director, Industry Solutions ValueCentric, LLC GHX Kevin Neuman Vice President of Marketing and Operations Innovative Healthcare Corporation 2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago
HIDA White Paper: Unique Device Identifier Improving Pricing Accuracy: (UDI) = Best Practices in • Device Identifier (DI) Contract + Communications • Production Identifier (PI) Guidelines for Manufacturers and Distributors GS1 GLN and GTIN Fifty Industry Manufacturer & Customer demands Distributor now for what they know UDI Thought will require later . Leaders identified contract pricing and process as our biggest problem and must be solved. UDI and Contracting /Pricing share process adaptations that are similar and simultaneous. They are both driven by long overdue efficiencies and GS1 standards, customer demands and now FDA regulations. Solutions are both strategic and IT deliverables 2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago
5.4.1 Product Data. • • 5.4.1.1 Access to GTINs and GDSN Certified Data Pool. Supplier must • (i) assign a GTIN to identify each Product at all applicable levels of packaging (e.g. case, box, each) and (ii) permit KPS and Kaiser Permanente to access all product attributes related to the Products using the services of a GS1 Global Data Synchronization Network (“GDSN”) Certified Data Pool Provider. Supplier represents and warrants that as of the Effective Date: (a) it has assigned a GTIN to all levels of packaging for all Products; (b) it has enrolled with a certified GDSN data pool; and (c) upon KPS’ or Kaiser Permanente’s request, it will participate in compliance testing to demonstrate that its data submissions conform to the GTIN requirements. If Supplier cannot comply with this Section 5.4.1 as of the Effective Date, then Supplier, KPS, and Kaiser Permanente must mutually agree upon (A) a clearly defined interim plan to facilitate the transmission of GTINs to KPS and the Customers, and (B) a timeline to become compliant. 2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago
2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago
2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago
2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago
Distributor UDI Impact • In the current, soon to be in the past, distributors have a level of product recall customer service responsibility to the customer but charged the manufacturer for the effort to identify and inform their customers and advise the manufacturer. • UDI holds the manufacturer 100% responsible with none for the distributor by using the UDI labels and GUDID to identify the manufacturer. • Not only manufacturers, distributors as well are being asked by their healthcare provider customers to have the products they stock carry UDI like labeled products. Manufacturers that do not UDI label will be pressured by distribution to do so in order for the distributor to stock and sell. Or find an alternative 2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago
UDI Introduction Dennis Black Director, e-Business BD 2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago
UDI Requirements – Overview • The following is a high level overview of the FDA UDI Regulation. • You will not be an expert on UDI after this review and should review the Federal Register for a complete review of the regulation and consult your legal counsel. 2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago
What is the FDA UDI? Appearing in two forms* : Easily readable plain-text , and Automatic identification and data capture or AIDC technology Composed of two parts : Device Identifier or DI - mandatory, fixed, identifies the labeler and the specific version or model of a device; and Production Identifier(s) or PI – conditional, variable identifies one or more of the following when included on the label of a device: lot or batch number serial number expiration date date manufactured for an HCT/P (Human Cell, Tissue or Cellular or Tissue-Based Product) regulated as a device, the International Council for Commonality in Blood Banking Automation (ICCBBA). For all exceptions refer to UDI Final Rule www.fda.gov/udi and FDA GUDID Guidance for Industry dated June 27, 2014 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM369248.pdf 2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago
PI & DI: Using GTINs PI Production Information (Lot, Expiry, etc.) DI GTIN (Global Trade Item Number) Uniquely identifies the product. (This label is intended to depict GS1 standards. It is not yet compliant with UDI regulations.) 2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago
FDA UDI Rule Overview • Label with AIDC (barcode) • UDI=Device Identifier(DI)+Production Identifier(PI) MARK • UDI=GTIN + Standardized Production Data • Label plain-text ISO format date YYYY-MM-DD • Publish UDI plus required data attributes to the Global UDI Data Base (GUDID) SUBMIT • GDSN is one mechanism to publish that data once to both the FDA and customers • Year 1 (2014 ): Class III and devices licensed under PHS Act • Year 2 (2015): Class II/I implants and life-supporting/sustaining COMPLY • Year 3 (2016): Remainder of Class II • Year 5 (2018): Class I • For Direct Marking- Compliance dates are extended by 2 years except for FDASIA implants and life-supporting/sustaining UDI Final Rule Sept 24, 2013 GS1 US website: www.gs1us.org/hcudi FDA UDI Website: www.fda.gov/gov and click on “UDI Help Desk” 2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago
2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago
Issuing Agencies • The UDI will be created and maintained by device labelers based on global standards managed by FDA- accredited Issuing Agencies. • Issuing Agencies are: • GS1 • HIBC • ICCBBA UDI Final Rule www.fda.gov/udi and FDA GUDID Guidance for Industry dated June 27, 2014 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM369248.pdf 2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago
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