Slide 1

UDI as a Standard:UDI in Use

(June 8, 2017)

Terrie L. Reed, MS Ind EngSenior Advisor for UDI Adoption

Slide 2

UDI: Standard for Device ID• Consistent• Recognizable• Easy to use• High quality• Efficient• Globally

harmonized

Slide 3

Fact vs. Fiction

Slide 44

Who made it?What model?Has it been recalled?What do I do?What are problems/successes? Is pain normal? Did it hasten healing?What was expected life? Did it last longer than expected?

Patie

ntPo

pula

tion

Slide 5

UDI System Drivers• FDA commitment to UDI as a standard and

AccessGUDID a trusted reference data source• Health IT requirements in clinical data capture

leading to capture in supply chain, registries and other data sources

• Multiple coordinated initiatives working toward increasing value of the UDI system

• Global harmonization based upon IMDRF

Slide 6

FDA’s role in the UDI System • Use regulation and policy to ensure high-

quality UDI data be available in standardizedways so that the health care community can use it with confidence

• Coordinate with other stakeholders to address integration challenges and promote continuous improvement

Slide 7

Office of National Coordinator for Health IT 2015 Edition §170.315(a)(14) Implantable Device List

Implant

DI

LotSerial

Expiration Date

Mfr DateDIC

PIGMDN/

SNOMEDCompany

NameBrand Name

Model MRI Safe

Label Latex

As of 5/15/2017

Slide 8

AccessGUDID

• Key to value – One source for core data• Manufacturer submits to one source• Data submission is regulated BUT data is trusted and provides

value

Slide 9

Data in GUDID will be of acceptable quality to realize value across the device ecosystem

• Focus on key UDI attributes – DI, catalog, size, description, safety

• Manufacturer and FDA commit to ongoing improvements and integration

• Base actions on device use– US/International Device Initiatives

• Expect change and roadblocks “The real world is messy”

Slide 10

Participating in Initiatives• 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) • Association for Healthcare Resources and Materials Management

(AHRMM) Learning UDI Community (LUC)• International Medical Device Regulators Forum (IMDRF)

Slide 11

Medical Device Evaluation Paradigm Shift: Today and Tomorrow

Active SurveillanceLeverage RWE to

support regulatory decisions throughout

TPLC

Collect data during routine clinical care

Shared system to inform the entire Ecosystem (Patients, Clinicians,

Providers, Payers, FDA, Device Firms)

National Evaluation

System

Passive Surveillance

Challenging to find right pre/post

market balance without confidence in post-market data

Parallel Track to Clinical Practice

Inefficient one-off studies

Current

Slide 12

MDIC NEST

UDISystem

National Evaluation

System

Improve

Demonstrations

Executive Director – Rachael L. Fleurence, Ph.D

13

MDEpiNet: RAPIDGUDID REGISTRY 1 REGISTRY 2

Name Value Name Value Name Value

Device Identifier 08714729805885

Brand Name Epic™ Vascular Device Type

Epic Vascular Self Expanding Stent (120 CM

shaft) Desc.

Epic Vascular Stent System 9.0 mm x 100

mm

Company Name

BOSTON SCIENTIFIC CORPORATION Device Mfr Boston Scientific Mfr

Boston Scientific Corporation

Catalog Number H74939200091020

ProductNumber 39200-09102

Model or Version H74939200091020

14

GUDID: Impact on RegistriesManufacturer costs – submit to GUDID ($XXX)

XNumber of Manufacturers in a Registry (Y) $XXXX

Registry costs - receiving data and data checks for data duplicated in GUDID X

Number of Manufacturers in Registry (Y)

Manufacturer costs – submit to registry ($XXXX)X

Number of Manufacturers in a Registry (Y)

FDA CDRH costs - GUDID data submission/quality checksX

Number of Manufacturers in Registry (Y)$XXXX

$XXXX

$XXXX

+

+

+

+

+

+

15

Hospital costs – integrate GUDID data into health system – inventory + EHR X

Number of hospitals submitting data to Registry $XXXX

Hospital costs - manually enter device identification information into registryX

Number of hospitals submitting data to Registry$XXXX

++

GUDID: Impact on Registries

Slide 16

UDI as Standard for RegistriesWL GORE

Vascular Quality Initiative

Champions: Dr. Jack Cronenwett and Dr. Phil Goodney

Slide 17

MDIC CfQ - Outcome Analytics Initiative• 2016- demonstration of a

product quality dashboard to hospital value analysis teams

• 2017- collaboration with hospitals and other data owners to improve data quality in the product quality dashboards

• UDI as standard for:– Device identification data

capture– Linking information across

the Total Product Life Cycle to improve decision making – purchasing, clinical and research

18

AHRMM LUCLearning UDI Community

• Major Objectives:– Identify UDI adoption

hurdles– Identify UDI adoption

solutions– Host in the LUC

Resource Center

Learning UDI Community

Consumer Groups

Pilot Leaders

Supply Chain

Groups

Issuing Agencies

RegulatoryAgencies

Vendorsand

Distributors

Members at Large

Clinical Groups

Slide 19

Working as a Global Community

2013 – UDI principles and attributes Created by Global Harmonization Task Force=> IMDRF2017 - New EU MDR Regulations Approved Revisit Global implementation of UDI

Slide 20

What is your role in the UDI System? • Use UDI and associated attributes by

integrating in supply chain, clinical and research systems through pilots and early adoption

• Participate in initiatives and coordinate with relevant stakeholders to address integration challenges, support success, and promote continuous improvement

Slide 21

SummaryCommitment required by all of us to ensure:• UDI as strategic, structured. scannable, standard device

identifier• AccessGUDID value as reference data source• Demonstration of UDI value through use and commitment

to improvement• International global implementation that supports UDI as a

global standard

Slide 22

Success Story: Commitment to UDI System• Before UDI regulation: National Health Related Item Code

or National Drug Code used to identify and reimburse some devices in retail space

• Need: transition from NHRIC/NDC to create single device identification system based upon UDI

• Concern: potential disruption to existing reimbursement, supply chain and procurement processes based upon initial UDI compliance dates

Slide 23

FDA Guidance on the Elimination of “NHRIC” and “NDC”?

“FDA does not intend to enforce the prohibition against providing NHRIC and NDC numbers on device labels and device packages, with respect to finished devices that are manufactured and labeled prior to September 24, 2021.”Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices, 2016-8-30 https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM484092.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Slide 24

UDI as a Standard:UDI in Use

(June 8, 2017)

Dennis Black

Slide 25

• The retail industry has long utilized UPC codes as an identifier for medical devices and other products.

Legacy identifiers (Retail)

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• Retail also uses NHRIC/”NDC”/HRI Codes

• This process is deeply rooted in IT Systems

Legacy identifiers (Retail)

Slide 27

• Current Prescription Fulfillment Systems• Inventory Management Systems/Drug Supply Chain• Point of Sale Systems• Patient Safety Management Systems• Trading partners both business and regulatory which rely on consistent unique product identifiers for down

stream processing.– Rx Data Sharing Arrangements –NCPDP Product ID– PMP reporting-NCPDP Product ID– Patients– Health record reporting (immunizations)-NCPDP Product ID– Collaborative Practice Agreements which stipulate formularies for pharmacist prescribing based on

NCPDP PRODUCT ID formulary, generally at the therapeutic level.– Rx Medication History – NCPDP PRODUCT ID– Long Term Care facilities – NCPDP PRODUCT ID– Business Partner Reporting - NCPDP PRODUCT ID

How are NHRIC/”NDC” Numbers used in Pharmacies?

Slide 28

• The FDA UDI rule specifically states that medical devices can no longer use NDC/NHRIC (some exceptions for Combination Products.)

• “NDC”/NHRIC codes are going to be removed from products

“NDC”/NHRIC/HRI Numbers: Going Away

Slide 29

• BD will continue to utilize UPC Bar Codes for retail products • UDI will be added (See Sample Below)• “NDC”/NHRIC will be coming removed before 2012-09-24• Business processes must be modified in advance

Full UDI Label123456 = Fictitious Catalog NumberYYYY-MM-DD = Human Readable Dates01 = DI10 = Lot Number11 = Manufacturing Date (Some Markets)17 = Expiration Date

UDI in Retail Pharmacy

Slide 30

UDI as a Standard:UDI in Use

June 8, 2017

Margaret Weiker, NCPDP

Slide 31

Background• NCPDP

– American National Standards Institute (ANSI) accredited Standards Development Organization (SDO)

• Electronic standardization within the pharmacy services sector of the healthcare industry

– Billing, eprescribing, rebates

Slide 32

Background• Convened multi-stakeholder meeting to

address UDI adoption– Input on the prohibition against providing

National Health Related Item Code (NHRIC) or National Drug Code (NDC) numbers on device labels and device packages

Slide 33

Themes• Systems rely on an 11-digit identifier

– 10 years to incorporate all system changes– Standards would need to be modified and

adopted under HIPAA • Only DI of the UDI will be reported• Currently supports a 19-byte identifier for a product

Slide 34

Solution• Short-Term

– Reformat the GTIN12, GTIN14, or GLN (GTIN13) to a UPC to create an NCPDP 11-digit UPC

• Instructions are available in the NCPDP Identifier Standard Implementation Guide Version 1.3

– HIBCC not accommodated in the standard

Slide 35

Solution• Long -Term

– Modify standard(s)• Standards modifications completed and balloted

Slide 36

Questions?