ensure udi success!

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…

Who We Are…

http://moteam.co/Mo-Technology

http://moteam.co/Mo-Technology

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…”


”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)…”


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


+ EXP DATE+LOT/BATCH+SERIAL NUMBER


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


Datamatrix Code

QR Code

Aztec Code

Micro PDF Code


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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2

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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

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/



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 – 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]

http://idt.gs/fda-udi



http://idt.gs/dudid-guide

http://idt.gs/dudid-guide

http://idt.gs/GS1-Healthcare

http://idt.gs/GS1-Healthcare

http://idt.gs/HIBCC-UDI

http://idt.gs/HIBCC-UDI

http://www.labelingnews.com/

http://www.labelingnews.com/

mailto:[email protected]

Thank you!!