UDI Implementation “Making a Difference” · 2016: Making a Difference. Slide 11. GUDID Status (June 2015 slide) October 2014 • 240 Labeler Accounts • 33,000 DI Records •

Slide 1

UDI Implementation“Making a Difference”

Monday, April 18, 2016

Linda Sigg, MSAssociate Director, Informatics

FDA Center for Devices and Radiological Health

Slide 2

Statutes and Regulation

FDA Amendments Act, 2007

FDA Safety and Innovation Act, 2012

UDI Rule, September 24, 2013

Slide 3

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

Slide 4






Slide 5






Slide 6






Slide 7

UDI = DI + PIWhat is a UDI?

Slide 8

What is a

UDI?

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Slide 9

Compliance Date Must bear a UDI & submit data to GUDIDSeptember 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

Slide 10

Conference Themes

2014: Glancing Back; Striding Ahead

2015: We are “On Our Way”

2016: Making a Difference

Slide 11

GUDID Status (June 2015 slide)October 2014• 240 Labeler Accounts• 33,000 DI Records• 4,000+ Helpdesk

Inquiries• 91% Closure Rate

June 2015• 425 Labeler Accounts• 75,000 DI Records• 8,000+ Helpdesk

Inquiries• 95% Closure Rate

Slide 12

Making a Difference: Today’s #sOctober 2014 June 2015 April 2016

GUDID Labeler Accounts 240 425 1275

GUDID Records 33,000 75,000 570,000

Helpdesk Inquiries 4000+ 8000+ 16,400

Helpdesk Closure Rate 91% 95% 86%

Slide 13

Accomplishments• Convenience Kit• 801.57 Enforcement DiscretionDraft Guidances

• Regulatory Overview and GUDID Accounts• DI Record and HL7 SPL Submission OptionIndustry Basics Webinars

• RSS Feeds and APIs (Web Services)• Advanced Search and more APIsAccessGUDID

• ONC and CMS Rules• UDI Pilots in hospitals and registriesGUDID Integration

Slide 14

Goals for 2016

GUDID Accounts

GUDID Records

User Group Sessions, Helpdesk

Standards, Guidances

UDI inclusion as data source

Slide 15

AccessGUDID Trends

0

5000

10000

15000

20000

25000

30000

Site Visits

02000400060008000

100001200014000160001800020000

Nov-15 Dec-15 Jan-16 Feb-16 Mar-16

API Views

Slide 16

Data Quality Issues• Typos in labeler code• Incorrect checkdigit

calculations• Incorrect product

codes• And many more!

Slide 17

“Baking In” Data QualityGood recipe

+ Good ingredients+ Good process

Good product

Slide 18

New VersionOr Model

No longer in commercial distribution

Mergers & Acquisitions

InitialCompliance

Data Quality is an

OngoingProcess

Slide 19

Learning UDI Community (LUC)

• Stakeholders• Collaborating

together• Making it work

better

Let’s identify the issue

Help us figure it out!

What is best practice?

Slide 20

0

100

200

300

400

500

600

700

800

15-Apr 15-May 15-Jun 15-Jul 15-Aug 15-Sep 15-Oct 15-Nov 15-Dec 16-Jan 16-Feb 16-Ma

Account Requests Processed v. Received

Account Request Closed Cases Account Request New Cases

Slide 21

0

200

400

600

800

1000

1200

1400

1600

15-Apr 15-May 15-Jun 15-Jul 15-Aug 15-Sep 15-Oct 15-Nov 15-Dec 16-Jan 16-Feb 16-Ma

15-Apr 15-May 15-Jun 15-Jul 15-Aug 15-Sep 15-Oct 15-Nov 15-Dec 16-Jan 16-Feb 16-MarAll HD Cases Closed Cases 393 521 516 618 676 715 896 666 435 121 953 1254All HD Cases New Cases 457 509 622 745 1019 944 887 613 514 219 1457 1321

Helpdesk Cases Processed v. Received

Slide 22

UDI Websitewww.fda.gov/udi

Main menu on the left side of the web page

http://www.fda.gov/udi

Slide 23

UDI Websitewww.fda.gov/udi

These links are the same as much of the information presented at the conference.

UDI Basics

Benefits of a UDI System

Compliance Dates for UDI Requirements

http://www.fda.gov/udi

Slide 24

UDI Website• Request a GUDID Account• GUDID Web Interface• GUDID HL7 SPL• GUDID System Status• GUDID Enhancements/Fixes

Slide 25

UDI Website

• GS1• HIBCC• ICCBBA

Slide 26

UDI Website

Slide 27

UDI Website

• UDI Rule and Guidances• UDI Training for Industry• UDI-related Activities and

Communications

Slide 28

Teamwork!

Slide 29

UDI BenefitsUDI assigned to devices

DI as key to unlock standard data

Clearly identify the device

GUDID as authoritative source for key identification attributes

Link data sources to improve data capture, device evaluation and

decision-making

Integrate UDI into electronic health

information

Slide 30

UDI Benefits

More accurate reporting of adverse events, better recall management, better

comparative data

GUDID attributes as basis for clinical decision support – MRI, Latex, Sterile

More rapid and accurate device data capture and retrieval for patient care

Slide 31

Conference Highlights – Day 1• Laying the UDI Foundation – Erin Quencer• The Building Blocks of GUDID – Indira Konduri• Live demo of AIDC technologies – AIM Global• Understanding the impact of UDI – Terrie Reed• Case Studies and Lessons Learned

Slide 32

Conference Highlights – Day 2• Workshops – new to UDI, walk through Account Requests,

DI Module and HL7 SPL Submissions• Realizing the value of UDI – for those who have already

made the investment• Working collaboratively in the Learning UDI Community• Panel discussion on themes, what we heard/learned

Slide 33

Thank you for helping us Make a Difference!

UDI Implementation “Making a Difference” · 2016: Making a Difference. Slide 11. GUDID Status (June 2015 slide) October 2014 • 240 Labeler Accounts • 33,000 DI Records •

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