Unique Device Identification (UDI) Clearly identifying a device to improve patient safety and healthcare efficiency

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Terrie L. Reed, MS Industrial Engineering Senior Advisor for UDI Adoption Leslie Tompkins Steen, PhD UDI Lead, Standards and Vocabulary

Questions First

• How does FDA recommend we direct mark screws and small implants?

• How should we proceed as we await the guidance on the Convenience Kit exemption?

• How is FDA enforcing UDI? • What are best practices for entering submissions

to GUDID?

What is UDI? accessgudid.nlm.nih.gov An identifier that lets us all call the

same product the same thing

What is UDI?

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UDI = DI + PI

Establish a UDI System

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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

What is UDI? 1st requirement …the label of every medical device shall bear a unique device identifier (UDI)…

2nd requirement…the labeler of a device must provide the information required … for each model or version required to bear a unique device identifier (UDI)…

UDI System Compliance Dates

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Compliance Date Must bear a UDI & submit data to GUDID September 24, 2014 • Class III devices, incl. class III stand alone software

• Devices licensed under the PHS Act

September 24, 2015 • Implantable, life-supporting and life-sustaining (I/LS/LS) devices, incl. stand alone software

• Direct Marking of I/LS/LS for certain intended uses

September 24, 2016 • Class II devices

• Direct Marking for class III devices and devices licensed under the PHS Act, for certain intended uses

September 24, 2018 • Class I devices and devices not classified class I, II or III

• Direct Marking of class II devices for certain intended uses

September 24, 2020 • Direct Marking of class I devices and devices not classified into class I, II or III, for certain intended uses

Medical Specialties in GUDID (Data Current as of April 7, 2016)

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Orthopedic 80%

General & Plastic Surgery 4%

Dental 4%

Anesthesiology 3%

Cardiovascular 3%

All Other 6%

Most Frequent FDA Product Code Terms in GUDID (Data Current as of April 7, 2016)

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11 Companies =>10,000+ Records (Data Current as of April 6, 2016)

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7. Synthes GmbH

8. Zimmer, Inc.

9. NuVasive, Inc.

10. Aesculap, Inc.

11. L&K Biomed Co., Ltd.

1. Biomet, Inc.

2. Smith & Nephew, Inc.

3. Medtronic, Inc.

4. Stryker Corporation

5. Globus Medical, Inc.

6. Smiths Medical MD, Inc.

AccessGUDID Trends

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0

5,000

10,000

15,000

20,000

25,000

30,000

Site Visits

0

50,000

100,000

150,000

200,000

250,000

API Views

UDI Goals for 2016

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GUDID Accounts

GUDID Records

User Group Sessions, Helpdesk

Standards, Guidances

UDI integration in health information

Why is Unique Device Identification Important? What you see and hear depends a good deal on where you are standing; it also depends on what kind of a person you are.

~C.S. Lewis

Comparing Access to Performance Data

Source: CDC/NCHS National Hospital Discharge Survey, 2010

Source: WardsAuto - 2010 New Vehicle Sales

2010

Hondas 1,230,500

908,600 Nissans

358,500 Volkswagens

Cardiac Catheterizations 1,000,000

719,000 Total Knee Arthroplasties

332,000 Total Hip Replacements

Medical Procedures New Cars Sold 1 2

1

2 2

UDI is important to… PATIENTS

Care Providers Manufacturers

Distributors Healthcare supply chain

Risk Managers Value Analysts

Government Agencies

First Focus: Implantable Devices

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Patient Expectations

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I don’t worry about my implants. My doctors take care of me and

would let me know if there is a problem..

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Current Implant Information

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Device Identifier Standard Data

1888TC

Office of National Coordinator for Health IT

Create an Implantable device list UDI in Common Clinical Data Set

MR # 00000000000 Active Implantable Device List

……. …….

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DI Lot

Serial Expiration Mfr Date

DIC

Description (GMDN or SNOMED)

Company Name

Brand Name Model MRI Safe Labeled as containing

latex

05414734501743 Lot: 123456

Exp:12/31/2025

Endocardial pacing lead

St. Jude Medical

Inc.

TendrilTM ST Labeling does not

contain MRI Safety

Information

No

Link Patient to Device Identifier

National Library of Medicine

accessgudid.nlm.nih.gov

Device Identification Data Available to you TODAY

How is UDI important to Public Health

• Establishing a National Evaluation System for medical devices is one of FDA’s 2016-2017 strategic priorities. • Collaborative public private system that monitors, links,

and analyzes real-world data from many different sources • Data Sources: clinical registries, electronic health records,

and medical billing claims, GUDID • Goal: Better understanding of how medical devices

perform to improve decision-making

Orthopaedics National Coordinated Registry Network (CRN)

• Supports goals of National Evaluation System • Purpose:

• Link registries together with diverse data sources to promote knowledge for regulatory and reimbursement decisions, best practice recommendations, patient information and innovation opportunities for manufacturers.

• Partners: • American Joint Replacement Registry, FORCE TJR, and Kaiser

Permanente; Two other registries expressed interest (Michigan State and Health East)

• UDI: AccessGUDID and UDI on label could provide link to replace catalog number that is used now

What is the

importance of Data Quality in GUDID?

The value of UDI begins with data quality

• GUDID - Separated

Labeler

Hospital

GUDID

Other Request

Registries

• GUDID - Integrated

Labeler

Hospital Registries Other entities

GUDID

Role of GUDID

Start with GOOD data

• Tools are provided in the GUDID to support data review

• Published records are made available to the public, via AccessGUDID (after a 30-day Grace Period

• Once public, records can be consumed by NES, registries, EHRs, hospital systems, etc.

GUDID and FDA Registration and Listing

Product Codes in GUDID MNIMNHKWPNKBKWQHWCHRSJWHOSHMAX

Product codes in Registration and Listing

MNIMNHKWPHWCKWQGEIHRSJWHNKBHQYLPHJDILZODZEITXGEX

Device Identifier is the Primary Key

• GS1 Healthcare GTIN Allocation Rules • Indicator digit + GS1 Company Prefix + Item Reference + Check Digit

• HIBCCs-Guide-to-GUDID-Device-Identifiers • Labeler Identification Code (LIC) + Product/Catalog Code +

Unit of Measure

• ICCBBA - Processor Product Identification Code • Facility Identification Number (FIN) + Facility Product (FPC) +

Product Description Code

Brand Name

• Brand Name must be limited to the name of the device • Including Size, Version, Model and other data that

is collected in other fields in the database is not recommended

• If the device does not have a Brand Name, refer to Data Elements Reference Table (DERT) for a recommendation

Model Number

• Model or Version of a product is used to further help identify the product. • It should be a way to distinguish the product from its family • When entering data, do not repeat the word ‘Model’ or ‘Version’ • It should be easy to remember and use

DI Record Vocabulary

• DUNS • FDA Classification Product Codes (Procodes) • GMDN • MRI Safety Information (ASTM F2503-13) • Sterilization methods (FDA Guidance) • Unified Code for Units of Measure (UCUM)

Product code • Product code in GUDID must match the Product

Code assigned to the device in Registration & Listing and premarket review • Example:

• R&L - FGE [FGE - Catheter, Biliary Diagnostic]

• GUDID - MIR & MAF [MAF – Stent, Coronary] [MIR - Shunt, Portosystemic, Endoprosthesis]

GMDN Data Entry

• GMDN Code is a required element of DI record • Term name and definition will be auto-populated

• DI Record will only accept active GMDN Codes • It is the labeler’s responsibility to update obsolete GMDN

Codes in a DI record [21 CFR 830.330(b)] • See Final GUDID Guidance

DERT = Data Element Reference Table

• GUDID Data Elements Reference Table - May 1, 2015 (XLS - 104KB) – Data Element Name – Description – Data Entry Notes – Edit rule after Grace Period – Required – Data Type and Length – Entry List of Values – New DI Trigger

Data Element: Size

• Designed to capture minimum data set • Use pull-down lists, when possible • Size Value cannot be entered

as a range

Data Element: Sterilization

• Designed to provide information to a healthcare professional or patient/consumer

• Not intended to capture manufacturer’s sterilization procedures

Data Element: Single Use

Definition • Device is intended for one use

or on a single patient during a single procedure

Implementation • If device does not meet the

definition, Single Use = ‘No’

• Device may be reviewed as single use, but packaged as multiple single use

• GUDID ‘Single Use’ does not affect pre-market review

Device Type: Unclassified

• Unclassified ≠ Exempt • Unclassified devices may

be reviewed by 510k or PMA process

• All devices should have a FDA listing number

Device Type: Kit

• UDI and DI record represent kit as a ‘device’ • Some data elements are confusing to answer when

describing a kit vs single device: • Device Count • Device Description • GMDN

• Size • Sterilization • Storage & Handling

Call to Action

• Review and understand the GUDID data elements

• Be sure to understand the DI record edit rules

• Utilize the resources available on our website

• Make data quality a priority

Compare your Data

Source System Data

Data submitted to

GUDID

Consistency

• Are related data elements such as GMDN and Product code consistent?

• Does the data make sense?

Completeness

• Device record should contain the same information that appears on the device label

• Optional data elements add value: • Device Description • Catalog Number

Developing a Learning UDI Community

AHRMM – Leading a Learning UDI Community

Device Labelers

• Healthcare supply chain

• Distributors • Value Analysis

Professionals

• Device users • Care providers • Patients • Device Surveillance

Linking Data across Data Sources

2015-06-16 48

Implantable Device List

Care Documents

FDA Adverse

Event Reporting

Incident Report

Registry

Record DI PI DI

PI

DI PI

DI PI

DI PI

Point of Implant

Item Master

DI PI

FDA Device Recalls

FDA GUDID

via NLM DI PI

DI PI

Questions?

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