Slides from ID Technology's "Ensure UDI Success!" event covering the new Unique Device Identification rule from the FDA.

1. Welcome

2. Seminar Agenda
Welcome and Introductions
UDI – what is it all about?
GS1 or HIBCC?
Flexcon’s View on UDI
GUDID Database
Resources for moving forward
Live demos and networking

3. Who We Are…
Thanks to our sponsor…
Alice Faile
Peter Gallo
Joe Simas

4. Who We Are…
Thanks to our guest speaker…
Ron Ducharme

5. Who We Are…

6. Who We Are…
http://moteam.co/Mo-Technology

7. A Medical Device is…
"an instrument, apparatus, implement, machine, contrivance, implant, in vitro
reagent, or other similar or related article, including a component part, or accessory
which is:
recognized in the official National Formulary, or the United States
Pharmacopoeia, or any supplement to them,
intended for use in the diagnosis of disease or other conditions, or in the
cure, mitigation, treatment, or prevention of disease, in man or other
animals, or
intended to affect the structure or any function of the body of man or other
animals, and which does not achieve its primary intended purposes through
chemical action within or on the body of man or other animals and which is not
dependent upon being metabolized for the achievement of any of its primary
intended purposes."

8. What’s UDI All About?
“The Food and Drug Administration
(FDA) is issuing a final rule to
establish a system to adequately
identify devices through distribution
and use…”

9. What’s UDI All About?
”This rule requires the label of
medical devices to include a
unique device identifier
(UDI)…”
“The labeler must submit product
information concerning devices to FDA's
Global Unique Device Identification
Database (GUDID)…”

10. What’s UDI All About?
OK, so we have to identify things with some UDI thingy &
send some info to a database?
Sounds easy enough!
Let’s look in a little more detail…

11. Know your DUNs No and
D&B Address
Ensure you have your
company prefix from your
chosen Issuing Agency
Get all the data together for
labeling and for the GUDID
Database
Have your GMDN account
and get the nomenclature
for your products
Develop labels and package
marking for each layer of
packaging
QA Plan to validate labeling
and barcodes
Test – Validate – Test some more!
Sign up for GUDID access.
Determine how you’ll
upload data

12. What’s UDI All About?
What Items Need UDI and When?

13. What’s UDI All About?
UDI Acronyms
Meaning
DUNS
D&B Number – needed for GUDID
UDI
Unique Device Identification
GLN
Global Location Number GS1
GTIN
Global Trade Item Number GS1
GMDN
Global Medical Device Nomenclature
GUDID
Global UDI Database
DI
Device Identifier
PI
Production Identifier
AIDC
Automatic Identification and Data Capture
GS1
The GS1 Standards Organization
HIBCC
Health Industry Business Communications Council
ICCBBA
Bonus points if you know this one!

14. What’s UDI All About?
What is a UDI?
The UDI is defined as consisting of 2 parts:
The company is called
“The Labeler “ in the Rule
Device Identifier – DI
This identifies the company and the model of the device
Production Identifier – PI
Production data such as Lot number, Expiration Date, Serial Number
The information must be provided in plain text and in AIDC form.
The Rule is flexible on what AIDC technology is used!

15. What’s UDI All About?
What is Device Identifier (DI)?
DI = the static part of the UDI.
Consists of:
Company Prefix + Item Number
These will depend on the Standards being used
?

16. What’s UDI All About?
What is Production Identifier (PI)?
PI = the dynamic part of the UDI.
Consists of one or more of:
Lot number
Serial number
Expiration date
Manufacturing date

17. What’s UDI All About?
Barcode Standards

18. What’s UDI All About?
Barcode Standards

19. What’s UDI All About?
Barcode Standards

20. What’s UDI All About?
Barcode Standards
+ EXP DATE
+LOT/BATCH
+SERIAL NUMBER

21. What’s UDI All About?
Barcode Standards

22. What’s UDI All About?
Barcode Standards
Expiration Date
Data Identifier
Data Identifier
Supplier LIC &
Part Number
Data Identifier
Lot Number
Issuing Agency Code (RH)
Data Identifier
Data Identifier
Packaging Level (0 = unit of use)
Manufacture Date

23. What’s UDI All About?
Barcode Standards
Datamatrix Code
QR Code
Aztec Code
Micro PDF Code

24. What’s UDI All About?
Barcode Standards
GS1
HIBCC
Making inroads in medical
Well established standard
GTIN is numeric only
Can use existing cat. #s
Huge international presence
Mainly in North America
Annual fee
One time fee
Standard in many logistics chains
?
If I were a betting man…

25. What’s UDI All About?
RFID Standards
FDA, GS1 & HIBCC all allow for RFID
Note that HIBCC suggests 13.56Mhz

26. What’s UDI All About?
ICCBBA ISBT 128
International Council for Commonality in Blood Banking Automation

27. Flexcon’s View
AIDC in Modern Healthcare

28. What is a medical device?
The Product Code assigned to a device is based upon the medical device
product classification designated under 21 CFR Parts 862-892. Three
classes exist today.
A very wide range of medical products such
as:
Traditional hospital based devices (beds, ventilator, monitors, infusion pumps)
Implants (teeth, hips, etc…)
Patient/home use devices (glucometers)
Disposables, accessories (glucose test strips, catheters)
In vitro diagnostic devices (IVDs) – both clinical lab and Point of Care (POC).
Those used in alternative sites – e.g., homecare, dental
Health Information Technology (HIT)
Convenience kits, Combination products
28

29. Today’s view without UDI
 Product tracking efforts and recall difficult
 Current systems allow product re-identification by every stakeholder in the supply
chain today
 Healthcare Supply Chain will be able to use the same Unique Device Identifier!
Manufacturer
Product # 305905
Distributor
Product
# MT305905
Hospital or Healthcare Provider
Product # M-5905
Courtesy of Jackie Rae Elkin of Medtronic, Inc.
Global Process Owner - Standard Product Identification
29

30. Two FDA systems are UDI and SNI
UDI: Unique Device Identification
FINAL Rule!!!
Medical devices
Patient care, diagnostic or treatment devices
Moving forward
SNI: Standardized Numeric Identification
Prescription drugs
Pharmaceuticals
Biologics
Vaccines
Stalled due to recent politics
Guidance

31. Timelines of Final Rule
Implementation (compliance) timeframes are
generally the same from Proposed Rule:
Year 1: class III and devices licensed under PHS Act
Year 2: class II/I implants and lifesupporting/sustaining
Year 3: rest of class II
Year 5: class I
Note For Direct Marking!
Compliance dates are extended by 2 years
Except for FDASIA (year 2) devices – still at year 2.
The start date is 9/24/13

32. What Changed from Proposed
Rule High Level?
DIFFERENCES from the PROPOSED RULE:
Combination Products and Kits topics
ironed out
Packaged Single Use Devices (SUDs)
exempt with a common sense
approach (the band-aid in the box
issue)
Direct Marking for direct patient reuse / sterilization equipment
Direct part marking for organic
implants not mandated is another
common sense logical concession that
was well received
•
•
•
•
•
•
New Version or Model revised
NDC/NHRIC Numbers
UPC Exception for Class 1 more
logical approach
Definitions are clearer in the rule
GUDID database has more quality
attributes
Issuing Agencies are now only
private entities and not nonprofit, public, or government.

33. What does a possible UDI look like?
E.g., The new GTIN that is purchased and linked to the Enterprises’
production information enables the benefits of the UDI initiative

34. Goals of the UDI Initiative
Reduction of medical errors
Identify compatibility issues
Improve medical device reports (MDRs)
Identify and reduce product counterfeiting
More efficient purchasing, reimbursement, and supply chain
management, thus lowering costs
Enhance medical device asset utilization
Enhance in post-market device surveillance
Support recall of medical devices
Enable chain of custody tracking
Capture device information in Electronic Health Record

35. UDI Transactions are Three Parts
Reformat your data using an approved
registration authority
Encode the data in AIDC format
Print your label
Label your product
Register your UDI in the FDA data base
Ship the Product

36. FDA’s UDI Database
Database will be an open, public
database, access shall be free of charge
UDI Device Identifier will be primary key in
the database with associated product
data elements defined
Manufacturers will be responsible for
submitting and maintaining their own
data in the database
All data submissions will need to be in the
HL7 Structured Product Labeling (SPL)
format.
Guidance Released 9/24/13

37. History of the UDI Regulation
1999 IOM Report – To Err is Human
2004 FDA Pharmaceutical Barcode Rule
2005 and 2006 FDA/FDLI Meeting on UDI with IOM Famous Quote
2006 Public Meeting and Docket FDA-2006N-0292
2007 FDA Amendments Act of 2007 (Congress Passes Law)
2007-2009 – UDI Database Pilots
2008 GHTF Ad-Hoc Working Group on UDI
2009 UDI Workshop and Docket FDA-2008-N-0661
2011 GHTF UDI Guidance published
2012 July 10th - UDI Proposed Regulation Publishes
2012 FDASIA provisions added and Congressional Law to Publish
2012 November 7th – comment period closes for Proposed Rule
2012 November 19th – FDASIA amendment (Dec 19) - “Med Tax”
2013 June– UDI Final Rule sent to OMB
2013 UDI Conference in Baltimore
YOU ARE HERE on 9/24/13
2013 Final Rule Published

38. The Status as of 9/24/2013
Published Final Rule with comment period
 http://www.fda.gov/MedicalDevices/Devi
ceRegulationandGuidance/UniqueDeviceI
dentification/
Courtesy FLEXcon 2013

39. FLEXcon® MedFLEX™
A series of polyester products UL-recognized
2 mil silver matte, clear and white
Topcoat is more universally printable
High performance acrylic adhesives
Printable via UV, Emulsion and UV Ink jet
Liner is suitable for optical scanning
IEC compliance pending
Overlaminates
Choice of 1 mil clear and clear matte polyester films

40. Thank you

41. The Database

42. GUDID
Interestingly, not a database of UDI’s
Management of UDI’s with manufacturer
!

43. GUDID

44. GUDID

45. GUDID – sending data
Upload HL7 XML file
Tools already exist to help
Use the web tool
Pay a 3rd party

46. Exemptions

47. Printing Your UDIs
TTO – print on flexible packaging
Zebra printers for durable labels
Laser marking solutions
for direct part marking
IDT Labelers – cases and pallets

48. Printing Your UDIs
GS1 Datamatrix

49. Printing Your UDIs
ID Technology labels made from
Flexcon Medflex materials

50. Know your DUNs No and
D&B Address
Ensure you have your
company prefix from your
chosen Issuing Agency
Get all the data together for
labeling and for the GUDID
Database
Have your GMDN account
and get the nomenclature
for your products
Develop labels and package
marking for each layer of
packaging
QA Plan to validate labeling
and barcodes
Test – Validate – Test some more!
Sign up for GUDID access.
Determine how you’ll
upload data

51. Resources
FDA’s UDI Site: http://idt.gs/fda-udi
Draft DUDID Guide: http://idt.gs/dudid-guide
GS1 Healthcare: http://idt.gs/GS1-Healthcare
HIBCC UID & Standards: http://idt.gs/HIBCC-UDI
Labeling News: http://www.labelingnews.com
Contact me: dholliday@idtechnology.com

52. Thank you!!