UDI: The Global Value Proposition - medsc.org Conway - UDI.pdf · GHX proprietary information:...

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UDI: The Global Value Proposition

GHX proprietary information: Please do not copy or distribute 1

Medical Device Supply Chain Council/Europe

Presented by Karen Conway

2 October 2013

GHX proprietary information: Please do not copy or distribute

UDI: The Reality


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)


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 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


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)


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


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


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


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


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

14


UDI: What is it?

15

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


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)


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”?


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


Device Identifier (GTIN) Production Data (Application Identifier or AI)


Device Identifier GTIN (Global Trade Item Number)

Labels shown are drafts for illustrative purposes only.


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

GHX proprietary information: Please do not copy or distribute 23 23

UDI Application: ICCBBA

GHX proprietary information: Please do not copy or distribute 24 24

UDI Application: ICCBBA

Donor ID # (Lot)


That was the Easy Part!


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


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


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


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


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.


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


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

32


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


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


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

36

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


Healthcare is a System

37

…and we are all in the same boat


Value-based Healthcare: A Global Debate

38

Healthcare providers around the world seeking to understand what drives greater value for our healthcare dollar


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)

39

Cos

t Foc

us

© Copyright GHX 2013


Want to Learn More about UDI?

40

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

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:099:0017:0024:EN:PDF�





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Questions and Answers

Contact: Karen Conway, [email protected]

mailto:[email protected]�

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