ensure udi success!
DESCRIPTION
Slides from ID Technology's "Ensure UDI Success!" event covering the new Unique Device Identification rule from the FDA.TRANSCRIPT
Welcome
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
Thanks to our sponsor…
Who We Are…
Alice FailePeter GalloJoe Simas
Thanks to our guest speaker…
Who We Are…
Ron Ducharme
Who We Are…
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."
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…”
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)…”
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…
Know your DUNs No and D&B Address
Have your GMDN account and get the nomenclature for your products
Ensure you have your company prefix from your chosen Issuing Agency
Get all the data together for labeling and for the GUDID Database
Develop labels and package marking for each layer of packaging
QA Plan to validate labeling and barcodes
Sign up for GUDID access.Determine how you’ll upload data
Test – Validate – Test some more!
What’s UDI All About?What Items Need UDI and When?
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!
What’s UDI All About?What is a UDI?
The UDI is defined as consisting of 2 parts:
Device Identifier – DIThis identifies the company and the model of the device
Production Identifier – PIProduction 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!
The company is called “The Labeler “ in the Rule
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 ?
What’s UDI All About?What is Production Identifier (PI)?
PI = the dynamic part of the UDI.
Consists of one or more of:Lot numberSerial numberExpiration dateManufacturing date
What’s UDI All About?Barcode Standards
What’s UDI All About?Barcode Standards
What’s UDI All About?Barcode Standards
What’s UDI All About?Barcode Standards
+ EXP DATE+LOT/BATCH+SERIAL NUMBER
What’s UDI All About?Barcode Standards
What’s UDI All About?Barcode Standards
Data Identifier
Data Identifier Data Identifier
Data IdentifierData Identifier
Issuing Agency Code (RH)
Supplier LIC &Part Number
Packaging Level (0 = unit of use)
Lot Number
Manufacture Date
Expiration Date
What’s UDI All About?Barcode Standards
Datamatrix Code
QR Code
Aztec Code
Micro PDF Code
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…
What’s UDI All About?RFID Standards
FDA, GS1 & HIBCC all allow for RFID
Note that HIBCC suggests 13.56Mhz
What’s UDI All About?ICCBBA ISBT 128
International Council for Commonality in Blood Banking Automation
Flexcon’s View
AIDC in Modern Healthcare
What is a medical device?
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
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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.
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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!
Distributor Product
# MT305905
Hospital or Healthcare Provider Product # M-5905
Courtesy of Jackie Rae Elkin of Medtronic, Inc.Global Process Owner - Standard Product Identification
Today’s view without UDIToday’s view without UDI
Manufacturer Product # 305905
Two FDA systems are UDI and SNITwo FDA systems are UDI and SNI
UDI: Unique Device Identification Medical devices
Patient care, diagnostic or treatment devices Moving forward
SNI: Standardized Numeric Identification Prescription drugs Pharmaceuticals
Biologics Vaccines
Stalled due to recent politics
FINAL Rule!!!
Guidance
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 life-supporting/sustaining
Year 3: rest of class IIYear 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
Timelines of Final RuleTimelines of Final 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 re-use / 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 non-profit, public, or government.
DIFFERENCES from the PROPOSED RULE:
What Changed from Proposed Rule High Level?What Changed from Proposed Rule High Level?
E.g., The new GTIN that is purchased and linked to the Enterprises’ production information enables the benefits of the UDI initiative
What does a possible UDI look like?What does a possible UDI look like?
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
Goals of the UDI InitiativeGoals of the UDI Initiative
Reformat your data using an approved registration authority
Encode the data in AIDC formatPrint your label
Label your productRegister your UDI in the FDA data base
Ship the Product
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UDI Transactions are Three PartsUDI Transactions are Three Parts
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.
FDA’s UDI DatabaseFDA’s UDI Database
Guidance Released 9/24/13
1999 IOM Report – To Err is Human 2004 FDA Pharmaceutical Barcode Rule
2005 and 2006 FDA/FDLI Meeting on UDI with IOM Famous Quote2006 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 Publish2012 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 Baltimore2013 Final Rule Published
History of the UDI RegulationHistory of the UDI Regulation
YOU ARE HERE on 9/24/13
Published Final Rule with comment periodhttp://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/
Courtesy FLEXcon 2013
The Status as of 9/24/2013The Status as of 9/24/2013
FLEXcon® MedFLEX™
A series of polyester products UL-recognized2 mil silver matte, clear and white
Topcoat is more universally printableHigh performance acrylic adhesives
Printable via UV, Emulsion and UV Ink jetLiner is suitable for optical scanning
IEC compliance pending
OverlaminatesChoice of 1 mil clear and clear matte polyester films
Thank you
The Database
GUDID
Interestingly, not a database of UDI’sManagement of UDI’s with manufacturer !
GUDID
GUDID
GUDID – sending data
Use the web tool
Upload HL7 XML fileTools already exist to help
Pay a 3rd party
Exemptions
Printing Your UDIs
Zebra printers for durable labels
TTO – print on flexible packaging
IDT Labelers – cases and pallets
Laser marking solutionsfor direct part marking
Printing Your UDIs
GS1 Datamatrix
Printing Your UDIs
ID Technology labels made from Flexcon Medflex materials
Know your DUNs No and D&B Address
Have your GMDN account and get the nomenclature for your products
Ensure you have your company prefix from your chosen Issuing Agency
Get all the data together for labeling and for the GUDID Database
Develop labels and package marking for each layer of packaging
QA Plan to validate labeling and barcodes
Sign up for GUDID access.Determine how you’ll upload data
Test – Validate – Test some more!
Resources
FDA’s UDI Site: http://idt.gs/fda-udiDraft DUDID Guide: http://idt.gs/dudid-guide
GS1 Healthcare: http://idt.gs/GS1-HealthcareHIBCC UID & Standards: http://idt.gs/HIBCC-UDI
Labeling News: http://www.labelingnews.com
Contact me: [email protected]
Thank you!!