Unique Device Identification (UDI) Updates on US Activities · Some UDI adoption activity has led to rework with labels and UDI master data. ... MDIC and the NEST initiative are aligned

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Unique Device Identification (UDI)Updates on US Activities

U.S. - China Healthcare Cooperation SeriesChina FDA Medical Device Executive Development Delegation Visit

Symposium and Reception

2017-07-25

Dennis Black, Director, e-Business


Agenda:

• UDI Overview• UDI Serves Multiple Purposes• Significant UDI Updates:

– UDI Adoption Activity– UDI Collaboration between all participants– FDA Implementation Date Extensions and Revised

Guidance• Summary


UDI Overview: How to Establish a UDI System

• Develop a standardized system to create the UDI• Place UDI on label and (sometimes) the device• Create and maintain the Global UDI Database• Adoption and Implementation

Product Analysis Verification

Legacy Process/Label Review

Classification

Planning/Process Redesign

Implementation

Analysis of Global Impact and Regulatory Implications GUDID Data Customer

Implementation


UDI: Serves Multiple Purposes

Supply Chain Healthcare Provider Scanning UDI Requirements

• Our product identification system serves many requirements

• The healthcare industry is incapable of efficiently implementing multiple product identification systems

• It is our hope that the pending CFDA UDI Regulation (and other emerging UDI regulations) are harmonized with existing UDI regulations and market needs


Significant UDI Updates:

1) UDI Adoption Activity

2) UDI Collaboration between all participants

3) FDA Implementation Date Extensions and Revised Guidance


• The goal of the 2007 FDA UDI rule was to ensure all medical devices could be tracked for safety purposes (compliance for recalls/adverse events)

• However the healthcare industry is moving “beyond compliance” to scanning and tracking medical devices throughout the healthcare continuum

FDA UDI Rule is Accelerating this Future State

Healthcare provider adoption of UDI is causing some rework.

Improve Supply Chain Track Products Point of Care Scanning Outcomes Analysis

UDI Adoption: Future State


UDI Adoption: EHR Integration

Unique Device Identifier Device Identifier (DI)

= 00382902365006

BD SAP Material Master Patient’s Electronic Health Record

FDA GUDID


“To make that vision a reality, we must develop systems to ensure that data quality is appropriate and sufficient for regulatory decision making, that data flows seamlessly between systems, and that unique device identifiers (UDI)are routinely incorporated into electronic health information.”

UDI Adoption: FDA Strategic Priorities


UDI Collaboration: Device Manufacturers are working with Healthcare Providers

Examples:• Sharing product master data• Seeking input on barcode formats• Barcode placement• Supply Chain Processes• Point-of-Care Scanning

Some UDI adoption activity has led to rework with labels and UDI master data.


UDI Collaboration: Industry Groups

• Advanced Medical Technology Association (AdvaMed)

• Association for Healthcare Resources and Materials Management (AHRMM) Learning UDI Community (LUC)

• Medical Device Innovation Consortium (MDIC) National Evaluation System for health Technology (NEST)

• Medical Device Epidemiology Network (MDEpiNET)– Registry Assessment of Peripheral Artery Devices (RAPID)– Building UDI into Longitudinal Date for Medical Device

Evaluation (BUILD)

• MDIC Case for Quality (CFQ)


AHRMM Learning UDI Community (LUC)

• Level Below Each• Bar Code Logistics • Business Case for UDI• Catalog Number Field• Clinically Relevant Size• Device Categorization• HCT/P • High Risk Implants• Low Unit-of-Measure• Multiple DI Work Group

Learning UDI Community

Consumer Groups

Industry Groups

Supply Chain

Groups

Issuing Agencies

RegulatoryAgencies

Vendorsand

Distributors

Members at Large

Clinical Groups

Device Manufacturers, Distributors, Healthcare Providers, Clinicians, and FDA working together to solve specific UDI related challenges.


Medical Device Innovation Consortium (MDIC)

• This is a public-private partnership to advance medical device regulatory science for patient benefit

• National Evaluation System for health Technology (NEST) is focused on real-word evidence

MDIC and the NEST initiative are aligned with FDA and the goal of using real-world evidence for patient care.


Implementation Date Extensions

• Certain Class II Products (2016-09-06)– Collections of two or more products– Repackaged single-use devices

• Soft Contact Lens Extension (2017-03-30)

• Class I Product Extension (2017-06-02)

Several Guidance Documents have been issued.


Extension: Certain Class II Products

• Applies to:– Collections of two or more

products– Repackaged single-use devices

• Distributors often remove products from UDI Compliant packages

• Date extended from 2016-09-24 until 2018-09-24

Device Manufacturers, Distributors, Healthcare Providers, and FDA are working on low unit-of-measure challenges.


Extension: Soft Contact Lens

• Current industry practices is to assign a different device identifier (DI) for each prescription

• Would have created and exceptionally large number of GUDID records

• Some manufacturers have already implemented UDI

Device Manufacturers and FDA working towards a solution.


Extension: Class I Products

• Class I Products extended for two years 2017-09-20

• Time to resolve complex technical issues (trays w/implants, etc.)

• Renewed focus on GUDID data quality

GUDID data quality is an area of focus.


Summary

• True UDI adoption is starting to occur in the US• Much industry collaboration on UDI• FDA is an active industry participant• Some UDI requirements have evolved• We are optimistic that UDI will achieve the desired

benefits in the U.S.

Global Harmonization of UDI requirements is essential.