As UDI deadlines roll out, OEMs are left with many questions on implementation and compliance, including: 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? What are best practices for entering submissions to GUDID? How is FDA enforcing UDI? FDA officials will speak on UDI adoption and UDI data quality. Bring your questions. Ample time will be saved for Q&A.

2. Unique Device
Identification (UDI)
Clearly identifying a device to improve patient
safety and healthcare efficiency
1
Terrie L. Reed, MS Industrial Engineering
Senior Advisor for UDI Adoption
Leslie Tompkins Steen, PhD
UDI Lead, Standards and Vocabulary

3. 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?

4. What is UDI?
accessgudid.nlm.nih.govAn identifier that lets us all call the
same product the same thing

5. What is UDI?
4
UDI = DI + PI

6. Establish a UDI System
5
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

7. 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)…

8. UDI System Compliance Dates
7
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

9. Medical Specialties in GUDID
(Data Current as of April 7, 2016)
8
Orthopedic
80%
General & Plastic Surgery 4%
Dental 4%
Anesthesiology 3%
Cardiovascular 3%
All Other 6%

10. Most Frequent FDA Product Code Terms in GUDID
(Data Current as of April 7, 2016)
9

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

12. AccessGUDID Trends
11
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

13. UDI Goals for 2016
12
GUDID
Accounts
GUDID
Records
User
Group
Sessions,
Helpdesk
Standards,
Guidances
UDI
integration in
health
information

14. 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

15. Comparing Access to Performance Data
Source: CDC/NCHS National Hospital Discharge Survey, 2010
Source: WardsAuto - 2010 New Vehicle Sales
2010
Hondas1,230,500
908,600 Nissans
358,500 Volkswagens
Cardiac Catheterizations1,000,000
719,000 Total Knee Arthroplasties
332,000 Total Hip Replacements
Medical Procedures New Cars Sold
1 2
1
2
2

16. UDI is important to…
PATIENTS
Care Providers
Manufacturers
Distributors
Healthcare supply chain
Risk Managers
Value Analysts
Government Agencies

17. First Focus: Implantable Devices
16

18. Patient Expectations
17
I don’t worry about my
implants. My doctors
take care of me and
would let me know if
there is a problem..

19. 18
Current Implant Information

20. 19
Device Identifier Standard Data
1888TC

21. Office of National Coordinator for Health IT
Create an Implantable device list
UDI in Common Clinical Data Set

22. MR # 00000000000
Active Implantable Device List
…….
…….
21
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

23. National Library of Medicine
accessgudid.nlm.nih.gov
Device Identification Data
Available to you TODAY

25. 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

26. 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

27. What is the
importance of Data
Quality in GUDID?
The value of UDI begins
with data quality

28. • GUDID - Separated
Labeler
Hospital
GUDID
Other
Request
Registries
• GUDID - Integrated
Labeler
Hospital Registries
Other
entities
GUDID
Role of GUDID

29. 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.

30. GUDID and FDA Registration and Listing
Product Codes in GUDID MNI
MNH
KWP
NKB
KWQ
HWC
HRS
JWH
OSH
MAX
Product codes in Registration
and Listing
MNI
MNH
KWP
HWC
KWQ
GEI
HRS
JWH
NKB
HQY
LPH
JDI
LZO
DZE
ITX
GEX

31. 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

32. 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

33. 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

34. 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)

35. 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]

36. 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

37. 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

38. Data Element: Size
• Designed to capture minimum data set
• Use pull-down lists, when possible
• Size Value cannot be entered
as a range

39. Data Element: Sterilization
• Designed to provide information to a healthcare
professional or patient/consumer
• Not intended to capture manufacturer’s sterilization
procedures

40. 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

41. Device Type: Unclassified
• Unclassified ≠ Exempt
• Unclassified devices may
be reviewed by 510k or
PMA process
• All devices should have a
FDA listing number

42. 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

43. 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

44. Compare your Data
Source System
Data
Data
submitted to
GUDID

45. Consistency
• Are related data elements such as GMDN and
Product code consistent?
• Does the data make sense?

46. Completeness
• Device record should
contain the same
information that appears
on the device label
• Optional data elements
add value:
• Device Description
• Catalog Number

47. Developing a Learning
UDI Community

48. AHRMM – Leading a Learning UDI Community
Device
Labelers
• Healthcare supply
chain
• Distributors
• Value Analysis
Professionals
• Device users
• Care providers
• Patients
• Device Surveillance

49. Linking Data across Data Sources
2015-06-16 48
Implantable
Device List
Care
Documents
FDA
Adverse
Event
Reporting
Incident
Report
Registry
Record
DI
PIDI
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

50. Questions?