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UDI: The Global Value Proposition
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Medical Device Supply Chain Council/Europe
Presented by Karen Conway
2 October 2013
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From Problem to Regulation Preventable Medical Errors, Lack of a Medical Device Standard,
and Highly Publicized Medical Device Recalls
The proposals adopted today significantly tighten the controls so as to ensure that only safe devices are placed on the European Union's market at the same time, they foster innovation and contribute to maintaining the competitiveness of the medical device sector.“
Health and Consumer Policy Commissioner John Dalli
More Effective and Innovative Medical Devices (and Healthcare)
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From Regulation to Value
• 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
It’s All About Visibility
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From Regulation to Value
• 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
It’s All About Visibility
From Visibility to Innovation
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The US FDA Final Rule
2007: FDA Amendment Acts require “a unique device identification system for medical devices requiring the label of devices to bear a unique identifier…[to]…identify the device through distribution and use, and may include information on the lot or serial number.”
July 2012: Proposed Rule Published
July-November 2012: Comment Periods
September 24, 2013: Final Rule Published (The Countdown Begins)
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A Collaborative Process
Issues Addressed/Changed: • Date Format • Implantable Devices • Existing Inventory • Kits and Combo Products • Shelf Packs • OTC Products with UPC • Special AIDC Symbol • MRI Compatability
The Entire Industry Spoke and the FDA Listened
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UDI: The European Process
September 2012: 2 new proposed regulations for both medical devices and IVDs (September 2012)
April 2013: EU Commission Recommendation for a Common Framework for UDI
ENVI Committee Vote last week on MD only
Plenary vote scheduled for this month
• Importance of globally harmonised systems
• Device Identifier, Production Data, UDI Database
• Provisions on identification and traceability
• Interoperability with personal health systems
• Likely out 2014, if acted on before Parliament elections (with
specifics in 2015 or 2016); if not 2016
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UDI: A Global Issue
The Whole World is Watching
Other countries/regions looking at UDI: China, India, Japan, Korea, Netherlands, UK, Turkey, Canada, Australia, Brazil, Argentina… , and Turkey, Canada, Australia, Argentina, India, UAE
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UDI: Global Harmonisation
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Work begun by Global Harmonisation Task Force (GHTF) continued by International Medical Device Regulatory Forum (IMDRF)
Updating UDI guidance document • Capital Equipment • IVD Kits • Non-IVD Kits • Direct Part Marking • Software
Comments accepted through 31 August 2013 Updated document by end of the year Will consider FDA final rule changes GHTF UDI Guidance Document
http://www.gs1.org/docs/healthcare/GHTF_The_UDI_System_for_Medical_Devices_AHWG-UDI-N2R3.pdf
IMDRF Draft Guidance Update http://imdrf.org/docs/imdrf/final/consultations/imdrf-cons-udi-130417.pdf
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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, Sr. Adviser for Patient Safety, U.S FDA Center for Devices and Radiological Health
FDA has incorporated UDI into conforming amendments for: • Premarket approvals • Reports of Corrections and Removals • Medical Device Recall Authority • Quality System Regulation • Medical Device Tracking Requirements • Post Market Surveillance
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UDI: What is it?
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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: • 1D/Linear • 2D/Data matrix • RFID • Other
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
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UDI: The Steps
Assign Codes
1) Determine which products require codes and when • Final US Timelines
• Class III devices – 12 months after final rule publication (24 September ‘14) • Devices that are “implantable, life-saving, and life-sustaining.”– 24 months
(Separate legislative requirement- FDASIA) • Class II devices – 36 months after final rule publication • Class I devices – 60 months after final rule publication
• UDIs at each packaging level
2) Get codes from one of the authorized issuing agency (part of the ISO 15459 series of standards)
3) Add production data for data currently on label (e.g., lot/batch number, serial number, manufacturing date, expiration date)
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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 for products “intended to be used more than once and intended to be reprocessed before each use”?
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Product Configuration: Kits
Description Vicryl Suture Vicryl Suture Dispenser Box
Vicryl Suture Dispenser Box
Vicryl Suture Dispenser Box
E-Pack Procedure Kit
Sales Code J765 J765D J765Z J765D 8689E Package Envelope Box of 12
Sutures Box of 36 Sutures
Box w/ Multi-Lingual Label
Procedure Kit
UOM EA BX BX BX KT GTIN 1 0705031 04283 4 3 0705031 04283 8 3 0705031 04284 5 3 0705031 01937 3 1 0705031 01905 8
Unit of Sale NO YES YES YES YES
• Product EACH is sold in multiple package configurations and languages
• Product may also be sold individually and/or as a kit component
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Device Identifier (GTIN) Production Data (Application Identifier or AI)
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Device Identifier GTIN (Global Trade Item Number)
Labels shown are drafts for illustrative purposes only.
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Production Data Application Identifier • Lot / Batch / Expiration Date
Production Data
Labels shown are drafts for illustrative purposes only.
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UDI Application Example: HIBCC
Device Identifier (HIBC-LIC)
Production Data
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UDI Application: ICCBBA
Donor ID # (Lot)
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UDI: The Details
Populate the Global UDI Database (GUDID) Sample list of attributes (from U.S. User Acceptance Testing, 2012) • Device Identifier • Lot, Batch, Serial number • Brand/Trade Name/Model • Manufacturer Contact • Kit or Combo Product?
• Storage Conditions • Sterilization Information • For Single Use? • Contains Latex Y/N? • DUNS #*
Flexibility in methods of submission and who enters and for which products/divisions
• Web interface • HL7 SPL (structured product labeling) xml files
An Ongoing Process * Will be key to validating data entry ** Not included in the publicly available data
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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 TypePrimary DI # Model/Version # part of Device Family Storage Low ValueUnit of Use DI # Device Description Storage High ValueProduct Exempt from Direct Part Marking (DPM) Marketing Status Special Storage ConditionsExempt Reason DI Record Publish Date Device packaged as SterileDPM DI different from Primary DI? Date Device Discontinued Require Sterilization prior to use?DPM DI # Product Code Sterilization MethodIssuing 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 ProductContact Email 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 CountBrand Name Size Unit of Measure Package DI #Brand Name part of Device Family? Size Text Quantity per Package
Contains DI Package
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FDA Global UDI Database
Distribution
Web based tool
Business Rules
Manufacturer (Acme)
3rd Parties (GDSN)
The label of Medical Device 123 Size 45: Device Identifier (Device XYZ123) Production Identifier (Lot #ABC) Expiration date (MMDDYYYY) Sterile; Latex free
Bulk HL7 SPL
Minimum Data Set For each Device Identifier: • Manufacturer and model • GMDN Code • Other attributes
or
or
FDA’s UDI Database
FDA
FDA Managed
Public User Interface
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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
Complete list of criteria
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
The data owners vary Data can be easy or hard to harvest
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UDI: Back to Reality
• To meet expected UDI requirements, GHX suppliers have identified 70 – 120 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.
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UDI is more than IT, Labeling or Bar Codes
UDI Regulatory
Legal
Marketing
Packaging Sales
Technology
Inventory
Process Engineering
Labeling
A Cross Functional Business Process
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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
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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?
UDI
Readiness Regulatory
Legal
Marketing
Packaging Sales
Technology
Inventory
Process engineering
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A UDI Database Network?
UDID SA?
UDID CA?
EU UDID (Eudamed)
GUDID USA
(FDA) UDID AP ?
NETWORK
The IMDRF UDI Workgroup is
considering the issue of information
exchange between UDI databases around
the world
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UDI for Post Market Research
Unique Device Identifier Demonstration Project (Mercy) • 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 (Kaiser Permanente) • Identify and capture clinical attributes that impact performance (link from UDI) • Address differences in orthopedic registries to better utilize available data • Demonstration projects: bearing surface, femoral head size, fixed vs. mobile
knees, pediatric joints
Manufacturers involved in both of these efforts.
UDI could become part of regulatory requirements for providers • Meaningful Use of EHRs • Reimbursement
HTG Mercy, Mayo, Kaiser
Intermountain, Geisinger
Device Manufacturers
Provide GTIN, UDI & attribute data and labeling
Facilitate/negotiate GTIN, UDI, and attribute adoption
Item Master
ACC, SCA&I
Define additional clinically relevant
attributes ERP Cath Lab EHR
Data submitted to CathPCI registry
ACC NCDR
Enterprise Data
Warehouse
Data Marts
Real-time Messaging
Hub
Comparative Effectiveness Research
Post-market Device Surveillance
Business and Clinical Processes/Systems
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Integrate UDIs into EHR Link EHR with ERP and
clinical software Create data sets for analysis
and sharing with FDA and partnering health systems
Link to national registries Link with other health systems
Making it all work together
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Healthcare is a System
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…and we are all in the same boat
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Value-based Healthcare: A Global Debate
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Healthcare providers around the world seeking to understand what drives greater value for our healthcare dollar
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Collaborative Healthcare Value Model
Patient
Hig
h
Price
Valu
e Fo
cus
Supply Chain Focus
Nar
row
B
road
Low
Best Price
Total Cost of Ownership
Total Cost of Care
Total Cost to Serve
Total Value of Care
Degree of Collaboration
(Data Visibility)
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Cos
t Foc
us
© Copyright GHX 2013
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Want to Learn More about UDI?
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European Commission Recommendations for a Common UDI Framework http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:099:0017:0024:EN:PDF
US FDA UDI website http://www.fda.gov/udi
Video series and case studies http://www.ghx.com/udi
Blog posts http://www.thehealthcarehub.com (Search on UDI on right)
How Cook Medical Adopted the GTIN System: Sleepless Nights and Peanut Butter http://www.mddionline.com
Teleflex- The Challenges of Global Standards Integration http://www.ghx.com/product-pages/industry-resources/document-download.aspx?EntryId=1903
US FDA Medical Device Postmarket Surveillance Plan http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm301912.htm
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Questions and Answers
Contact: Karen Conway, [email protected]