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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
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 5
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 6
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 7
UDI = DI + PIWhat is a UDI?
Slide 8
What is a
UDI?
*+X999123ABC0/$$31905151234AB/S5678EDFG/16D20151001J*
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
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
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!