2. Agenda
Welcome and Introductions
Gain an understanding of UDI in practical terms
View the planned timeline for proposed FDA UDI regulations
Evaluate the benefits of implementing bar-coding using GS1
standards
Understand how labeling systems can remove the perceived
complexities of FDA UDI regulations
Learn how to implement UDI with minimal impact on your
organization
6. Device Information Lifecycle
GPOs Rentals
Clinical
Manufacturer Substitution
Sold
Distributor
Device X
Reuse Lot Y Direct Hospital Physician
Exp Date Z preference
Recall
Reorder Off-master
purchase
Clinical Use Unit
Sales Rep Hoarding
Reimbursement
AE Reporting
EHR Postmarket
Registries Population Databases Surveillance
Comparative FDA’s Sentinel System
Effectiveness
FDA
7. The History of FDA’s UDI
• 1999 IOM Report – To Err is Human
• 2004 FDA Barcode Rule
• 2005 and 2006 FDA/FDLI Meeting on UDI
• 2005 FDA Contracted White Papers on UDI
• 2006 FDA Public Meeting
• 2006 Docket No. FDA-2006N-0292
• 2007 FDA Amendments Act of 2007
• 2008 GHTF Ad-Hoc Working Group on UDI
• 2009 FDA Workshop on UDI
• 2009 Docket No. FDA-2008-N-0661
• 2009 GHTF AHWG submits recommendations
FDA
8. Current Device Identification
• Non-standard device identification systems; standards
used in different ways
• Not necessary unique or unambiguous
• Does not include all necessary levels of uniqueness
• Manufacturers’ own number/catalogue number
• Distributors’ – apply different, proprietary number; lot
or serial number not captured
• Hospital – yet different identification number/code
• Information on use not usually captured
• Control numbers rarely captured
FDA
9. Current Device Identification
Business Name Item Number Type Item Number
BD Mfg Catalog Number 329461
BD GTIN 00382903294619
BD GTIN 30382903294610
BD GTIN 50382903294614
Cardinal Health PV Order Number BF329461
Owens & Minor PV Order Number 0722329461
Owens & Minor PV Order Number 0723329461
American Medical Depot Vendor Catalog Number 777127217
American Medical Depot Vendor Catalog Number 777127218
Government Sci Source Vendor Catalog Number FSC1482679CS
Government Sci Source Vendor Catalog Number FSC1482679PK
Alliance Joint Venture Vendor Catalog Number 888021932
Thomas Scientific Vendor Catalog Number 8938M25
Thomas Scientific Vendor Catalog Number 8938M28
VWR International Vendor Catalog Number BD329461
FDA
10. Medical Device Adverse Events
For 2007, we received ~ +100k reports
• ~ 15% lacked model or catalogue number
• ~ 50% lacked lot or other identifier
• ~ 10% lacked both
The face of things to come…
(01)00802526255410(17)080531(10)6062151
FDA
11. Medical Device Recalls (2007)
• 41 Class I recalls
• 931 Class II recalls
• 78 Class III recalls
• Class I – 28M units (devices by lots, kits, etc)
Range 4-27M (Moistureplus Solution)
• For March 2007 – 142 Class II recalls
35M individual units (just one month)
Range 1-33M (Lifescan one touch test strips)
FDA
12. UDI Can Improve… Visibility
• Medical device recalls
• Adverse event reporting and postmarket surveillance
• Tracking and tracing, supply chain security; and anti-
counterfeiting/diversion (location systems)
• Comparative effectiveness (e.g., registries)
• Disaster/terror preparation and shortages/substitutions
• Reduce medical errors
• Documenting medical device use in patient’s
EHR/PHR, hospital information systems, claims data
• Sentinel Initiative - strengthening FDA’s ability to
query data systems for relevant device information
FDA
13. Medical Device Identification
Develop a system to identify medical devices, which is:
• Consistent
• Unambiguous (differentiates among all dimensions)
• Standardized
• Unique at all levels of packaging
• Harmonized internationally
And facilitates the:
• Storage,
• Exchange, and
• Integration of data and systems
FDA
14. UDI Public Workshop
12 February 09 - 300 people attended; 4000
webcast
4 Panels addressed issues related to:
• Developing standardized UDIs
• Placing the UDI in human readable and/or AutoID
on a device, its label, or both
• Creating and maintaining the UDI Database
• Promoting adoption and implementation
Received 60 written comments.
FDA
15. GHTF UDI ADWG
• Formed October 2008
• EC Chair (Laurent Selles)
• Members US (FDA, AdvaMed), Europe (EC,
Eucomed, EDMA, Matthias Neumann), Japan
(Hiroshi Ishikawa), Canada (Chris Rose)
• AHWP recently joined (China)
• Public Document – available at:
www.ghtf.org/documents/AHWG-PD1-N2R1.doc
• Final guidance due for Nov 2010 SC meeting
FDA
16. FDA Amendments Act of 2007
September 27, 2007, the FDAAA signed into law:
The Secretary shall promulgate regulations
establishing a unique device identification system
for medical devices requiring the label of devices
to bear a unique identifier, unless the Secretary
requires an alternative placement or provides an
exception for a particular device or type of device.
The unique identifier shall adequately identify the
device through distribution and use, and may
include information on the lot or serial number.
FDA
17. Establishing a UDI System
Combination of 4 distinct steps:
1. Develop a standardized system to develop the
unique device identifiers (UDI)
2. Place the UDI in human readable and/or AutoID on
a device, its label, or both
3. Create and maintain the UDI Database
4. Adoption and Implementation
FDA
18. 1 st – Developing the UDI
• Develop UDI code according to ISO 15459 [GS1,
HIBCC]
• Created and maintained by the manufacturer
• Concatenating Device and Production Identifier
• Device Identifier (DI): [static] Manufacturer, make,
model [i.e., each catalogue number]
• Production Identifier (PI): [dynamic] if currently
serialized – serial number; if currently identified at
the lot, the lot number, and expiration date
• Risk based approach – DI; DI + lot; DI + serial (or
lot and serial)
FDA
19. 2 nd – UDI Application
• Applied at all levels of packaging, down to the
lowest level (the patient use level or unit of use)
• Human readable and/or encoded in a form of
automatic identification technology
• Direct Part Marking (DPM) for some devices
• No specific technology would be identified
(technology neutral)
• Identify a series of standards (linear barcode, 2-
dimensional barcode, RFID)
FDA
21. 3rd - UDI Database
Development
• Device Identifier Type/Code [GTIN, HIBCC]
• Make/model; Brand/Trade Name; Description
• Device model number (or reference number)
• Size; Unit of Measure/Packaging level/quantity
• Control – Lot and/or Serial Number; Exp. Date
• Contact name, phone, email
• GMDN Classification code/term
• Storage condition; Single Use; Sterility; Restricted Use
• Contains known, labeled allergen (e.g., latex)
• URL for additional information – Web address
• Special Instruction for use
FDA
22. • Device Identifier: GS1 2081090010024
• Endopath Dextrus Finger Mounting Locking Forceps
• Ethicon Endo-Surgery Inc, Cincinnati, Ohio
• Jane Smith; 1-888-888-8888; JSmith@JNJ.com
• Controlled by Lot; Expiration Date
• Packaged sterile; Single Use; Prescription
• GMDN code: 12345; Manufactured in Israel
• Package of 1; Storage conditions: between 0-24º C
• Does not contain latex or PVC
FDA
23. FDA’s UDI Database
The label of Medical Device 123 Size 45:
Device Identifier (Device XYZ123)
Manufacturer
Production Identifier (Lot #ABC) Distribution
(Acme)
Expiration date (MMDDYYYY)
Sterile; Latex free
Minimum Data Set
FDA
For each Device Identifier:
• Manufacturer and model
• GMDN Code FDA Managed
• Other attributes
GSI GDSN
HL7 SPL Business FDA’s UDI
Rules Database
Other options
or
HIBCC UPN
or Public User
FDA eList Interface
24. 4th – Adoption and
Implementation
• Resolve technology issues – barcodes, RFID, DPM
• Develop appropriate UDI Database
• Facilitate distributor uptake and use
• Facilitate hospital uptake and use
• Facilitate use of UDI throughout device lifecycle
• Develop medical error reduction (e.g., latex)
• Drive integration – MMIS-Clinical
• Drive appropriate use of UDI in EMRs
• Determine appropriate role in reimbursement
• Address privacy concerns
FDA
25. Limitations of UDI and UDID
• UDI is a foundational element – it unambiguously
identifies a specific device (at its unit of use).
• Benefits accrue only if used by all stakeholders.
• UDID contains only “static” identifying and product
information.
• UDID does NOT contain production information, such
as lot or serial numbers – and is NOT track/trace or
other similar purposes requiring the full UDI.
• UDID provides link to Better Product Information- not
a replacement for Recalls/Adverse Event Databases.
FDA
48. Application Labeling
More than
just print
time
variables
Thin/ Thick Approval
Client Management
GMP based
PRISYM Version
Control
Medica
21 CFR Part
Audit History
11
Data Driven
Printing
49. Summary
GS1
The right Good
software Design
UDI can be
implemented
without
Derailing
Production
50. Q FDA – Jay Crowley
T + 1 301-980-1936
A
E jay.crowley@fda.hhs.gov
W www.fda.gov
GS1 Global Office – Janice Kite
T + 32 2 788 78 00
W www.gs1.org
PRISYM ID
T +44 1189364403
E hollypurchase@prisymid.com
W www.prisymid.com