UDI: Best Practices for Compliance and Value Karen Conway, GHX Jackie Rae Elkin, Medtronic Tom Jones, Johnson & Johnson

OMTEC 2014 1

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UDI in Context

• Why are we doing this? • What do you have to do? By when? • Can you get value beyond compliance? • - For your organization? • - For your customers? • How do you get started, stay in compliance?

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From Problem to Regulation

Faster adverse event reporting and better data to enable more effective and innovative medical devices GHX proprietary information: Please do not copy or distribute

From Regulation to Value It’s All About Visibility • • • • • • • • • • •

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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

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UDI: Legislation FDA Amendment Acts of 2007 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.

Published in the U.S. Federal Register 24 September 2013 5

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Risk-based Compliance Deadlines 24 September 2014 - Class III devices (implants) 24 September 2015 - “…devices that are implantable, life-saving, and life sustaining” * 24 September 2016 – Class II devices 24 September 2018 – non-exempt Class I devices, unclassified Direct Marking required for multi-use, reprocessed devices. Deadline is immediate for these products; all others 2 years after compliance date.

Need more time? June 23 2014 – Deadline to request an extension for Class III products 6

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UDI: What do you have to do? 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)

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AIDC

UDI Database Device ID the key

Choice of auto id carrier:

Specific static data Web Submission and/or HL7 SPL Rules around roles and entry

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• • • •

1D/Linear 2D/Data matrix RFID Other

UDI: Step One Assign UDI Compliant Codes  Determine which products require codes and when  Get codes from one of the authorized issuing agencies (part of the ISO 15459 series of standards)

 Assign codes (Device Identifier) to covered products  Add production data (Production Identifier) for data currently on the product label related to how you manage production (e.g., lot/batch number, serial number, manufacture date, expiration date)  Assign UDIs at each packaging level  Add Direct Marking if required GHX proprietary information: Please do not copy or distribute

UDI: Step Two Label products w/ both human and machine readable codes  Determine which auto id carrier to use • Consider what is best for product AND customers

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Determine if existing labels have the required space. • Does artwork or packaging need to change? • What placement is easiest for the end user?

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Determine if your printing systems need upgrades. Can they handle dynamic data?

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How will you handle direct marking (for products “intended to be used more than once and intended to be reprocessed before each use”)? GHX proprietary information: Please do not copy or distribute

UDI: Packaging Hierarchy Unique Device Identification Database (UDID) – Package Illustration Package Configuration Examples Package configurations inherit the Base Package device attributes

Package DI =002 Base Package Primary DI = 001

Contains 4 units of Base Package DI 001 Quantity per package = 4

Box Box of of 100 100 gloves gloves Device Device Count Count == 100 100

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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

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UDI Compliant Label: GTIN as a Linear Barcode

Device Identifier (GTIN)

Production Data

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UDI Compliant Label: GTIN as Concatenated Linear Barcode Date Format = YYYY-MM-DD

Device Identifier

Production Identifiers 12

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UDI Application Example: HIBCC as Linear Barcode

Device Identifier (HIBC-LIC)

Production Data

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UDI Application: ISBT as 2D Matrix Barcode ICCBBA standard used for products of human origin

2D Matrix Barcode

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UDI Application: ICCBBA 2D Matrix Barcode ICCBBA standard used for products of human origin

Donor ID # (Lot)

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Some Areas of Ambiguity Existing Inventory

Returns Single Use Device Exception

Kits and Trays Standalone Software Shipping containers Exceptions/Alternatives Extensions Unpackaged, non sterile

Any Questions? GHX proprietary information: Please do not copy or distribute

That was the Easy Part!

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UDI: Step Three Populate the Global UDI Database (GUDID)  Required/Conditional/Optional Attributes (partial list) • • • • •

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Primary (secondary) Device • Kit or combo product (Yes or No) Identifiers • Sterile (Yes or No) Brand/Trade Name/Model • Single Use (Yes or No) Version Number • Contains Latex (Yes or No) DUNS # • MRI Compatibility (LOV) GMDN Code • If more than one size, then additional information required

Determine method of submission • Web interface • HL7 SPL (structured product labeling) xml files • Do it yourself or third party

 Create sustainable processes and data governance to stay in compliance GHX proprietary information: Please do not copy or distribute

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

ERP

High

Division 1 IT

Brand Name

System 123

High

Marketing

Functional Name

Sales Mgmt

Low

Sales

Effective Date

System XYZ

Low

Compliance

ERP 2

Medium

Division 2 IT

GTIN

Child GTIN

Data can be easy or hard to harvest

Etc.

Complete list of criteria

The data owners vary

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A Cross Functional Business Process

Sales

Packaging

Technology

Marketing

Inventory

Process Engineering

Legal

Regulatory

UDI

Labeling

UDI is more than IT, Labeling or Bar Codes GHX proprietary information: Please do not copy or distribute

What do you need to do?

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UDI: The Coordination Challenge • At one manufacturer, >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.

It’s a bit like herding cats

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The US FDA Rule is Only the Beginning The Whole World is Watching

Other countries/regions looking at UDI: European Union (Member states also threatening action) China, Brazil, S. Korea, Argentina, Japan …Argentina, India, UAE GHX proprietary information: Please do not copy or distribute

Unique Device Identification (UDI): A Global Perspective Jackie Rae Elkin Medtronic, Inc. Global Regulatory Affairs

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Global Advocacy for UDI

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AdvaMed Eucomed FDA – Public Meetings and Conferences GS1 Global Healthcare Public Policy IMDRF AIM (Automatic Identification Mobility) HTG (Healthcare Transformation Group)

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International Medical Device Regulators Forum (IMDRF)

UDI Work Group

IMDRF Guidance UDI for Medical Devices Final Version, December 9, 2013

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US FDA vs. IMDRF Requirement

US FDA IMDRF

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IMDRF - manufacturing date exemption

IMDRF - exemption for significant label space constraints and UDI on next higher package level FDA - does not require labeling of single packaged units of a multi-pack (except implants). IMDRF requires labeling at this level but limits to risk class A and B devices

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IMDRF - retail POS devices do not need Production Identifiers in AIDC. FDA limits this to class I devices

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IMDRF – if RFID is used for, a linear or 2D barcode is required on label as well FDA has exempted all GMP-exempt Class I devices FDA has an “existing inventory” exemption

IMDRF requires medical devices within a kit to have a UDI GHX proprietary information: Please do not copy or distribute

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US FDA vs. IMDRF Requirement

US FDA

IMDRF

FDA always requires both AIDC and HRI for labels IMDRF - if constraints limiting both AIDC and HRI, the AIDC format shall be favored

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FDA requires GMDN - IMDRF allows GMDN to be optional

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IMDRF requires serial no. for active implantable devices

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IMDRF requires the UDI of the implantable device must be identifiable prior to implantation (e.g., tag, peel-off label)

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IMDRF exempts orthopedic trays whose contents are configured for a specific order

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IMDRF has “rules” for how UDI is applied to configurable medical device systems – FDA has no rules (at least now)

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IMDRF has “rules” for how UDI is applied to stand-alone software (IMDRF uses the term Software as a Medical Device (SaMD)) – more detail than FDA GHX proprietary information: Please do not copy or distribute

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Global Unique Device Identification 2006

2006

2009

2007

2008

2012

2009

2010

2011

2012

2011

2014

2013

2014

2014

2015

2016

2017

2018

2013

Country

Timeline

STD

Label Requirements

Data Reporting

Spain

2006

GS1

Device Identifier, Production Identifiers to Unit of Use Level

Reimbursement SAS - Department of Health Andaluz

Turkey

2009

GS1 HIBC

Device Identifier, Production Identifiers to Unit of Use Level

TITUBB: Reimbursement SGK – Social Security Institute

Japan

2009

GS1 HIBC

Device Identifier, Production Identifiers to Unit of Use Level

MEDIS: Reimbursement Ministry of Health, Labor and Welfare

India

2012

GS1

Device Identifier, Production Identifiers to Unit of Use Level

Procurement Ministry of Health & Family Welfare

IMDRF

Release 2013

GS1 HIBC

Device Identifier, Production Identifiers to Unit of Use Level

UDI - International Medical Device Regulators Forum (IMDRF)

USA

Class III: 2014 All Implants, LS/ LS: 2015 Class II: 2016 Class I: 2018 (DM + 2 years)

GS1 HIBC ISBT

Device Identifier, Production Identifiers

UDI Database: Regulatory US Food and Drug Administration

Argentina

October, 2014?

GS1

Device Identifier, Production Identifiers and Database – Traceability Global Location Numbers (GLN) ANMAT GHX proprietary information: Please do not copy or distribute

Future Global Unique Device Identification

Country

Timeline

STD

Label Requirements

Data Reporting

EU

Proposal for Regulation Delayed. Possible 2015

GS1 HIBC

Device Identifier, Production Identifiers to Unit of Use Level

Eudamed Database: Regulatory European Commission

China

TBD

TBD

TBD

UDI

Brazil

TBD

TBD

To Follow IMDRF

UDI

S. Korea

TBD

TBD

TBD

UDI

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Interpretation Required ! The objective of UDI is to establish a system to adequately identify devices through distribution and use. The purpose is to rapidly and definitively identify a device and it is intended to lead to more accurate reporting of adverse events by making it easier to identify the device prior to submitting a report.  

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in·ter·pret \in-ˈtər-prət, -pət\ : to explain the meaning of (something) : to understand (something) in a specified way

Be able to identify a device through a UDI that will appear on the label and package of the device UDI, when provided through AIDC technology will allow rapid and accurate data acquisition, recording and retrieval. Eliminating the uncertainty concerning the identity of the device subject of an adverse report More effective FDA safety communication To be used in EHR of a patient implanted with device to strengthen the ability to identify a specific device and improve response to postmarket surveillance activities including adverse event reporting and recalls. GHX proprietary information: Please do not copy or distribute

UDI: The FDA Key for Master Data Management

The FDA Center for Devices and Radiological Health plans to make UDI the key for its master data management. Do you have a key to unlock your data? 32

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Master Data Management Master Data is that persistent, non-transactional data that defines a business entity for which there is, or should be, an agreed upon view across the organization.

* Compliments of Terrie Reed, Director of Informatics FDA\CDRH\OSB

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Components of MDM Strategy Data Standards Data Processes People & Governance Tools & Technologies

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UDI Data Implementation Questions ……………. • Data mapping - where does the data reside today? In what format? • How will it be consolidated? Internal database or Master Data • • •

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Management tools to be used as the data store? Who will be responsible for UDI submission to FDA? Data Governance needed - roles and responsibilities to be defined.  Shared responsibility for data maintenance (business units, global/local) All UDI data for a medical devices must be submitted to the GUDID before commercialization of the product – where is your trigger? How will you manage data sources from outside, i.e., 3rd party (DUNS, GMDN, FDA Listing No., etc.) Converting data into HL7 SPL before sending to GUDID Do you use a solution provider or services to assist? Operating under the Quality System Regulation - process and systems to capture the data must incorporate change control and be Part 11 compliant 34 GHX proprietary information: Please do not copy or distribute

Regulatory Master Data By using the UDI as the foundation Regulatory Master Data for regulatory master data, manufacturers can achieve a more consolidated view of product data that can be reuse for different regulatory submissions

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External Trends Affecting RIM Regulators are Developing Master Data Strategies • •

UDI requirements include electronic data about products. Regulated Product Submissions (RPS): standards for electronic submissions and electronic data about documents, common data elements for products.

Today

premarket

postmarket

Product Data Reporting in Silos with no Standardization

Future 510(k), PMA

FURLS, CECATS

UDI

ERP

UDI Connects

FDA FDA Systems/Data Systems/Data

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Registry

MAUDE

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 37

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UDI Across the Entire Product Lifecycle

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Unique Device Identification (UDI): The Provider Perspective Karen Conway GHX

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Simple Truth: Don’t Forget Your Customers How will they store your products? How will they capture UDI? How will better, more standardized data help them, help you?

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The FDA Vision for UDI

Source: FDA “Strengthening Our National System For Medical Device Postmarket Surveillance” April 2013

6/11/2014

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Full Circle Visibility Regulators and customers receive accurate information about product Manufacturer designs and markets product

Demand and efficacy data available

Product and clinical attribute efficacy understood; necessary actions taken

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Product Purchased/ Shipped/ Received

Visibility = Value

Product data captured in registries

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Product consumption documented at point of use in electronic patient record

Some Areas of Confusion Which barcode to scan?

Which scanner to use? How will your customer scan the product, store the product?

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UDI Implementation Project

EDI Exchange

FDA GUDID

ERP

Inventory Mgmt

Cath Lab

Legend Integration developed Integration not currently possible

scan

scan

EHR

Registry Reporting

Mercy data warehouse

CathPCI Registry

• ERP/Supply Chain systems implementing UDI but working through bugs • Clinical systems in planning phase for UDI GHX proprietary information: Please do not copy or distribute

FDA GUDID Core + Supplemental Attributes

Maximizing Value from a Required Investment Depends on how you look at UDI… …as a regulatory requirement

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Maximizing Value from a Required Investment Or as an opportunity to excel: • Regulatory MDM • Competitive Advantage • Customer Service • Supply Chain Efficiency • Clinical Efficacy for R&D, Sales • Other

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Unique Device Identification: A Path to UDI Compliance Tom Jones Johnson & Johnson Healthcare Customer & Logistics Services

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The First Milestone is Fast Approaching…

CLASS 3 Devices SEPTEMBER 24, 2014 REQUIRED:  LABELING  DATA SUBMISSION  DATE FORMAT

Chart from GS1

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Getting Started

Device Class

Population of Products

Label Changes

I II III Not - Classified

Direct Part Marking Yes? No?

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None? Date? Other?

GUDID Data Elements Source Master Data Major System Other

Developing a Plan • How well does your management understand and appreciate the complexity of UDI? • Do you have the right team in place, with representatives from ALL the impacted functions? • Do you have an in-house expert on the regulation to provide guidance and link to the FDA/industry? If not how will you get this guidance? • What is the scope of your UDI project? Are you appropriately funded and staffed? • What is your strategy for GUDID data collection, GUDID data submission, labeling changes and DPM?

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• How will you track your progress to insure that you’ll hit the deadline? GHX proprietary information: Please do not copy or distribute

Getting Organized UDI Steering Committee UDI Program Sponsor

UDI Program Director

UDI Expert FDA/Industry Liaison

Project Coordinator

GUDID Data Collection Lead and Team

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UDI Lead and Team

DPM Lead and Team

UDI Communications Lead

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UDI Steady State Lead and Team

Execution – Even More Decisions • Will you need to ask for an Extension for some devices? If so what is your company’s approach? • Which PI (Production Identifiers) will you choose to use on your labels? • Have you established the packaging hierarchy for your devices so you can put the correct UDI on each packaging level? • If you have only used month and year on your labels, how will decide what day is appropriate to meet the new requirements • Have you selected your GTIN provider? (The FDA-CDRH accredited agency to obtain the UDI information.) • Do you have a DUNS number supplier and an organization to issue GMDN codes for your devices? • When will you request “GUDID Accounts” for your company’s entities? • What will be your process for validating data before you load it into the FDA’s GUDID? • How and when will you load data into the FDA’s GUDID? GHX proprietary information: Please do not copy or distribute

A Few More Lessons Learned • Start early. While the deadlines are clear, it is not always clear how long certain FDA processes will take – for example receiving a GUDID Account. • Track progress carefully. There is little room for delays. • Stay on top of the regulation. We have already seen several changes since its initial release. Changes may affect your implementation timeline. • Do not underestimate the work involved. Even for a relatively small number of products, GUDID data collection can be a major undertaking depending on where the data resides in your company. • Communicate well. A UDI implementation is cross-functional and complex – keeping everyone informed is critical. • Don’t forget about your suppliers and external manufacturers. They have UDI responsibilities as well. • Start thinking about “steady state” early and work toward seamless integration of UDI into your day-to-day business practices. GHX proprietary information: Please do not copy or distribute

Where is the weakest link in the your UDI Plan?

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Want to Learn More about UDI? US FDA UDI website http://www.fda.gov/udi European Commission Recommendations for a Common UDI Framework http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:099:0017:0024:EN:PDF

Medical Device Postmarket Surveillance Plan http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDR H/CDRHReports/ucm301912.htm Video series and case studies www.ghx.com/udi Blog posts http://www.thehealthcarehub.com Search on UDI under topics on right How Cook Medical Adopted the GTIN System: Sleepless Nights and Peanut Butter

http://www.mddionline.com 55

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Questions and Answers

Contact: Karen Conway, [email protected] Jackie Rae Elkin [email protected] Tom Jones [email protected] GHX proprietary information: Please do not copy or distribute