unique device identification (udi) · under 21 cfr 801.45, “[a] device that must bear a unique...

Tom Jones UDI Program Director, Supply Chain Visibility Johnson & Johnson Supply Chain June 14, 2018

Unique Device Identification (UDI)US Implementation and Benefits of Global Harmonization

SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00, 0000

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Today’s Discussion

Food and Drug Administration’s (FDA) UDI regulation Activities, current progress, benefits and lessons learned Impact to Medical Device Manufacturers Scope and effort to achieve compliance UDI Evolved into Global Requirement Challenges, opportunities and benefits with gaining alignment across global UDI requirements

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Authentication Identify counterfeits and ensure only genuine products are used

Product Availability Improve supply chain efficiencies

Safety Only appropriate devices are used for the procedure

Knowledge Accurate identification of devices for performance analysis

Pre- Surgery

During Surgery

Post- Surgery

UDI Benefits Patient benefits before, during, and after their surgical procedure



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UDI Overview Common components included in UDI regulations

UDI regulations published by FDA and European Commission include a series of compliance milestones by device class and regulation components displayed above

Data Repositories

Label Requirements

Direct Marking



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FDA UDI Milestones Progress to date Final

RuleSept24,2014

Sept24,2015

Sept24,2016

Sept24,2017

Sept24,2018

Sept24,2019

Sept24,2020

ProductsmustbesubmittedtoFDAUDIDatabase

Fina

lRulePu

blishDa

te

Septem

ber2

4,2013

ClassIII

NonClassIIIImplantable,

LifeSupporting,

LifeSustaining

ClassII(remainder)

ClassIandNoClass

(remainder)Label&PackagingmustcontainUDI

Non-SterileproductsmanufacturedmusthaveUDIinformationavailableatpointofuse

ClassIII

NonClassIIIImplantable,

LifeSupporting,

LifeSustaining

ClassII(remainder)

ClassI(remainder)

ProductsintendedtobeusedmorethanoncemusthaveDPM

ClassIII ClassII ClassI

P P P

Achieving compliance provides insights into efforts related to data collection, labeling, and direct marking

Enforcement Discretion



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Operating Companies Participating in UDI Program

Our efforts spanned the entire company We have products defined as medical devices in all of our franchises:

Consumer, Medical Device, Pharmaceutical, and Vision Care



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Implementation Details - Timing Lessons Learned

US FDA first regulatory body to implement their UDI regulation. Their use of staggered milestones, based upon device class, worked well.

•  Implementation lead time ‒  12 months: publish to 1st milestone ‒  Scramble to design, develop, and test

•  Staggered milestones ‒  FDA: worked well for GUDID ‒  EU MDR: Eudamed ‘big bang’

•  Other considerations: ‒  Pilot ‒  Awareness of device class

Risk Device Class Low A

Low to Medium B Medium to High C

High D



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Implementation Details – Treatment of Existing Inventory Lessons Learned

•  Disposition of existing, non-compliant product ‒  FDA: 3 year consumption period ‒  Linked to compliance milestones

•  Impact on existing inventory ‒  Devices with long shelf life ‒  Product already in commercial distribution

US FDA UDI regulation included 3 year window to deplete existing, non-compliant product. Given many devices have a 5-10 year shelf life, a 5 year window would have helped mitigate significant inventory remediation efforts.



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Implementation Details – Data Elements Lessons Learned

•  Global Unique Device Identification Database ‒  Mandatory / Optional ‒  Fields that trigger new Device Identifier (DI) ‒  Business rules, free text, list of values (LOV)

•  Value of Pilot ‒  Opportunity to review data / process ‒  Does submitted data match expectations? ‒  Can Providers use this data?

The US FDA UDI provided a list of fields required for GUDID submissions. Many of these

fields had strict requirements, while others were ‘free text’ and could vary based upon

interpretation.

GUDID Data Elements Reference Table - FDA https://www.fda.gov/downloads/medicaldevices/ucm396592.xls



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Implementation Details – Barcode Standards Lessons Learned

•  Linear and 2D ‒  Both are acceptable by FDA

•  Considerations ‒  2D helpful, especially on small packages ‒  Can providers scan 2D barcodes?

Source: https://www.gs1us.org/documents?Command=Core_Download&EntryId=160

The US FDA UDI regulation allows for either a linear or 2D

barcodes. Many manufacturers include both on their labels as many providers may not yet have the capability

to scan 2D barcodes.



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Implementation Details – Direct Marking Lessons Learned

•  US FDA Definition: Under 21 CFR 801.45, “[a] device that must bear a unique device identifier (UDI) on its label must also bear a permanent marking providing the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.”

•  Observed differences ‒  US FDA: Human Readable (HR) or

Automatic Identification and Data Capture (AIDC)

‒  EU MDR: Needs both HR and AIDC

Including either of these markings would satisfy the US FDA UDI regulation. The EU

MDR regulation requires both



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Implementation Details – Issuing Agency Lessons Learned

•  GS1, HIBCC, ICCBBA ‒  Varies by product type (traditional device vs.

blood / tissue) ‒  Significant majority of GUDID uses GS1

•  June 6th Query of US FDA GUDID ‒  GS1: 1,446,969 (~83%) ‒  HIBC: 295,200 (~17%) ‒  ICCBBA: 56 (<0.01%) ‒  NDC / NHRIC: 146 (<0.01%) ‒  Source: https://accessgudid.nlm.nih.gov/

GS1 appears to be the universally accepted issuing

agency for Global UDI regulations. Future

regulations should include GS1 as an option.



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Implementation Details – Nomenclature Lessons Learned

•  Global Medical Device Nomenclature (GMDN): From the www.gmdnagency.org website:

•  Considerations ‒  Recommended by International Medical Device Regulators Forum (IMDRF) ‒  Some countries have expressed concern related to cost.



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Implementation Details – Help Desk Lessons Learned

•  Established Help Desk ‒  Account setup assistance ‒  GUDID and UDI specific questions

•  Ongoing Support ‒  Training (webinars) ‒  Online documents

The US FDA UDI developed a support system to assist users in establishing accounts and

address educational needs when changes are implemented.

Source: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/ucm368904.htm



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Implementation Details – Exceptions / Exemptions Lessons Learned

•  Need for exceptions / exemptions ‒  Difficult to create ‘one size fits all’ ‒  Medical devices – very diverse

•  Consideration for impact to patient ‒  Critical need ‒  Availability

The US FDA UDI established a mechanism for device

manufacturers to share their insights with the FDA

regarding specific situations where elements of the legislation may not be

appropriate for a given device.

Examples: •  Contact Lens •  Implants •  Use of UPC for certain products



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Impact to Device Manufacturers Scoping to Achieve Compliance

•  Accurate Inventory of Commercially Available Products

•  Determining Device Class

•  Determining Data “Source of Truth” Scoping this effort begins with determining the products available for sale in that country, confirming their respective device classes, and identifying the ‘source of truth’ for data elements.



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Impact to Device Manufacturers Activities to Achieve Compliance

•  Data: Compiling Records

•  Labels: Assessment and Updates

•  Direct Marking: Assessment and Updates

•  Steady State: Policies and Procedures: UDI becomes standard way to operating

Execution is a significant effort, requiring coordination across many functions to achieve compliance with data submissions, labeling, direct marking, and the creation of policies and procedures.



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Moving to a Global Perspective Regulations and Customer Requirements

•  Regulations

•  Customer Requirements

US FDA UDI

EU MDR

Turkey (UTS)

South Korea UDI

India UDI

Many regulatory bodies have either published or have signaled that they will be publishing UDI Regulations

China UDI

Saudi Arabia UDI



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Moving to a Global Perspective Regulations and Customer Requirements

•  Regulations

•  Customer Requirements

UK – National Health Service

Qatar – Hamad Medical Corporation

UAE - Cleveland Clinic

Many customers are requesting GS1 compliant barcodes

Major customers within a given region are also driving requirements similar to UDI, often with requirements associated with data pools and labeling



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Challenges to Alignment Examples of key differences

Direct marking •  FDA: May use plain text or barcode •  EU MDR: Requires 2D Barcode

Data Fields: MRI Compatibility •  FDA: List of Values •  Turkey: Yes / No

Device Class •  FDA: III, Implantable / Life Sustaining / Life Supporting, II, and I •  UK NHS: III, IIb, IIa, and I

Human Readable 2D Barcode

MRICompatibilityUS FDA

•  MR Safe •  MR Unsafe •  MR Conditional •  Labeling does not contain MRI Safety

Information

Turkey UTS •  Yes •  No

Differences in regulations require manufacturers to continually evaluate their strategies and can create additional transformation efforts when trying to leverage work from

previously published regulations



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Imagine – Sharing Data Globally Opportunities with alignment in UDI regulations

Country A

Country B

Country C

•  Easier sharing of Outcomes data •  Adverse events / recalls •  Global vs. regional analysis

Given compatible device identifications across regions, practitioners, researchers and

manufacturers may consolidate data for a global, rather than a regional view



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Imagine – Global rather than Regional Inventory Opportunities with alignment in UDI regulations

Global Inventory

Region A Inventory

Region B Inventory

Region C Inventory

Region D Inventory

versus

•  Improved response to global surgery demands •  Overall increase to product availability •  Supply Chain efficiencies

Global alignment on labeling and direct marking standards will help mitigate the need for inventory dedicated solely for

a specific region, driving improved availability for

patient procedures



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Imagine – Benefits for Patients and Hospitals Opportunities with alignment in UDI regulations

Common Data Elements

Common Labels and Direct Marking

Product Availability Easier to share inventory across regions if regional differences minimized

Supply Chain Integrity Global awareness to counterfeits is easier if fewer label varieties exist

Patient Safety Commonality in DM could reduce misinterpretations if HCP serves multiple regions

Patient Outcomes Analysis based on global rather than regional data

Easier Identification Common definitions and data elements allow patients to search multiple repositories for additional information on their device



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7 Billion Reasons to Care


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