1 

Welcome to today’s 

FDA/CDRH Webinar

Thank you for your patience while we register all of 

today’s participants.

If you have not connected to the audio portion of the 

webinar, please do so now, dial:

U.S. Callers: 877-891-6976 

International Callers: 1-212-287-1678 

Participant Passcode: 6211806 
Optimizing GUDID Data Quality

Thursday, August 3, 2017
3 

Agenda 

• Target audience: Labelers with GUDID 

accounts for all classes of devices

• Goal: 

–Share observations/impacts of data quality 

(DQ) issues in GUDID

–Identify “best practices” for GUDID data 

submission 

–Encourage dialog about GUDID data quality 

to better understand challenges
4 

GUDID Status

• Total DI Records ~1,500,000#*

• GUDID Production Accounts ~4500* 

#Includes Published & Unpublished DI records

*Data as of August 1, 2017
5 

GUDID Data --> EHR Information
6 

FDA’s Focus

• Data in GUDID is of acceptable quality to realize public 

health benefits and a return on investment across the 

entire healthcare ecosystem. 

• Sufficient confidence in the accuracy and 

completeness of the data to ensure UDI integration 

from manufacturing through supply chain to patients, 

electronic health records (EHRs) and registries.

• Engage with stakeholders to address challenges and 

optimize data quality and utility for higher-risk devices 
7 

Value of UDI

GUDID Registry1 Registry2

Field 

Name Field Value

Field 

Name Field Value

Field 

Name Field Value

Device 

Identifier 

(DI) 08714729805885

Brand 

Name EpicTM Vascular

Device 

Type

Epic Vascular Self 

Expanding Stent 

(120 CM shaft)

Device 

Name

Epic Vascular 

Stent System 9.0 

mm x 100 mm

Company 

Name

BOSTON 

SCIENTIFIC 

CORPORATI 

Device 

Manuf. Boston Scientific

Device 

Manuf.

Boston Scientific 

Corporation

Catalog 

Num.

H749392000910

20

Product

Num. 39200-09102

Model or 

Version

H749392000910

20
8 

Data Sources Not Consistent

GUDID Registry1 Registry2

Field 

Name Field Value

Field 

Name Field Value

Field 

Name Field Value

Device 

Identifier 

(DI) 08714729805885

Brand 

Name EpicTM Vascular

Device 

Type

Epic Vascular Self 

Expanding Stent 

(120 CM shaft)

Device 

Name

Epic Vascular 

Stent System 9.0 

mm x 100 mm

Company 

Name

BOSTON 

SCIENTIFIC 

CORPORATI 

Device 

Manuf. Boston Scientific

Device 

Manuf.

Boston Scientific 

Corporation

Catalog 

Num.

H749392000910

20

Product

Num. 39200-09102

Model or 

Version

H749392000910

20
9 

Data Sources Not Consistent

GUDID Registry1 Registry2

Field 

Name Field Value

Field 

Name Field Value

Field 

Name Field Value

Device 

Identifier 

(DI) 08714729805885

Brand 

Name EpicTM Vascular

Device 

Type

Epic Vascular Self 

Expanding Stent 

(120 CM shaft)

Device 

Name

Epic Vascular 

Stent System 9.0 

mm x 100 mm

Company 

Name

BOSTON 

SCIENTIFIC 

CORPORATI 

Device 

Manuf. Boston Scientific

Device 

Manuf.

Boston Scientific 

Corporation

Catalog 

Num.

H749392000910

20

Product

Num. 39200-09102

Model or 

Version

H749392000910

20
10

Data Profiling

• The process of analyzing the data for 

– Correctness

– Completeness

– Uniqueness

– Consistency

– Reasonability
11

Internal/External Checks 

• Look for logical inconsistencies within the 

database

• Check related fields together

– GMDN and Device Description

– GMDN and FDA Product code

– Version/Model and Catalog #

ProcodeGMDN Term Count

OVD Polymeric spinal fusion 

cage, sterile

475

OVD Composite-polymer surgical 

glove, non-powdered

1 

FDA Product code 

aligns with GMDN 

term except in one 

case – likely mistake
12

Key Data Elements

(Short-Term Focus)

- Device Identifier (DI)

- Brand Name

- Version/Model

- Catalog Number

- Description

- Size

- MRI Safety

- Latex

- DUNS Number/Company Name

- GMDN/FDA Product Code
13

GUDID Data Elements Reference 

Table (DERT)

• GUDID Data Element Reference Table (DERT)

– Understand GUDID data element definitions and 

business rules
14

Device Identifiers in GUDID

• GS1 Healthcare GTIN Allocation Rules

Indicator Digit + GS1 Company Prefix + Item Reference 

+ Check Digit

• HIBCC 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
15

Multiple DIs

• DQ Issue: Records with the same ‘Brand 

Name’, ‘Version and Model’, but different DIs

• Steps to address: Proposed Learning UDI 

Community (LUC) workgroup to address 

multiple DI issue

– Issuing Agency DI rules

– Labeler’s internal processes

– FDA DI triggers
16

Brand Name 

• DQ Issue: ‘Brand Name’ field contains more 

than the brand name of the device

– Including size, version, model and other data that is 

collected in other fields in GUDID is not 

recommended 

• Steps to address: Include only device brand 

name

– If the device does not have a brand name, or any 

name on the label of the device, enter “NA”
17

Version or Model

• DQ Issue: Entries in ‘Version or Model’ field not 

sufficient to help identify the product

• Steps to address: 

–Distinguish the product from its family

–Do not repeat the words “Model” or 

“Version” in the entry

– Easy to remember and use

Example: long strings or calculated numbers may be a 

challenge for users
18

Catalog Number 

• DQ Issue: ‘Catalog Number’ field is often left 

blank

– Although an optional entry in GUDID, catalog 

number is a legacy identifier and is necessary to link 

to the DI for lookup

• Steps to address: LUC Working Group to discuss 

and address with best practices
19

Clinically Relevant Size

• DQ Issue: Clinically relevant size entries 

inconsistent within a device group

– Avoid using “Device Size Text, Specify” rather than 

List of Values in GUDID

• Steps to address: Requires effort to define size 

for each device group

– RAPID WG – Stent 

– LUC WG
20

Device Description

• DQ Issue: ‘Device Description’ is often left blank or 

not descriptive

– Although an optional entry in GUDID, ‘Device 

Description’ is displayed on the search results screen of 

AccessGUDID

– Including data from other GUDID fields (e.g., size) not 

recommended 

• Steps to address: Enter device description. 

Recommend using: 

– Cleared/approved indications for use

– Links to labels or more information
21

GMDN and Product Code

• DQ Issue : GMDN and FDA Product Code 

information is inconsistent

• Steps to address: Ensure GMDN and FDA 

Product Code align and are consistent with 

the device

– Device Categorization LUC WG

– GMDN/SNOMED
22

Data Quality Recap 

Data Element Data Quality Best Practices

Device Identifier Ensure DI is correct – validate check digits

One Primary DI per version/model of device

Brand Name Do not include data from other fields (e.g., size)

Version or Model Enter value only, do not restate field name

Catalog Number Include catalog number, if available

Clinically 

Relevant Size

Do not include size in ‘Device Description’ or ‘Brand 

Name’

Use List of Values in GUDID vs. “Device Size Text, 

Specify” 

Device 

Description 

Include device description. Recommend 

approved/cleared indications for use

GMDN Code One code sufficient for most medical devices
23

Future: Enter Once and Reuse 

GUDID

Registries

Hospitals 

Distributors

Payers

Labeler
24

We want to hear from you...

• What are your challenges with identifying and 

correcting data quality issues?

• What changes do you recommend to help 

improve GUDID data quality?

• How do you solicit and use feedback from your 

customers on their use of your GUDID data?
25

Thank you for participating! 

Please send your comments to:

FDA UDI Help Desk at www.fda.gov/udi 

Subject: Aug 3 Webinar Comments

Slide Presentation, Transcript and Webinar Recording will be available at:

http://www.fda.gov/training/cdrhlearn

Under the Heading: UDI System 

Please complete a short survey about your FDA CDRH webinar experience. The 

survey can be found at www.fda.gov/CDRHWebinar

immediately following the conclusion of the live webinar.