fda update and q&a: udi
TRANSCRIPT
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
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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?