UDI: From Regulation
to Value
What Hospitals and Healthcare Systems
Can and Should Do, Now
Presented by Karen Conway,
Industry Relations, GHX
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What We Will Cover
• History and Purpose of Unique Device Identification
• What Manufacturers Have to Do and When
• Potential Regulatory Requirements for Providers
• Steps to Value for Suppliers and Providers
• Next Steps
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The Need for Standard IDs
Business Name
Business Name
Item Number Type
Item Number
BD
Mfg Catalog Number
329461
BD
GTIN
00382903294619
Cardinal Health
PV Order Number
BF329461
Owens & Minor
PV Order Number
0722329461
American Medical Depot
Vendor Catalog Number
777127217
Government Sci Source
Vendor Catalog Number
FSC1482679CS
Alliance Joint Venture
Vendor Catalog Number
888021932
Thomas Scientific
Vendor Catalog Number
8938M25
VWR International
Vendor Catalog Number
BD329461
• Business Name
GHX proprietary information: Please do not copy or distribute
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The Need for Standard IDs
Business Name
Business Name
Item Number Type
Item Number
BD
Mfg Catalog Number
329461
BD
GTIN
00382903294619
Cardinal Health
PV Order Number
BF329461
Owens & Minor
PV Order Number
0722329461
American Medical Depot
Vendor Catalog Number
777127217
Government Sci Source
Vendor Catalog Number
FSC1482679CS
Alliance Joint Venture
Vendor Catalog Number
888021932
Thomas Scientific
Vendor Catalog Number
8938M25
VWR International
Vendor Catalog Number
BD329461
• Business Name
GHX proprietary information: Please do not copy or distribute
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UDI compliant
code
From Problem to Regulation
Preventable Medical Errors and Device Recalls
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UDI: History and Purpose
• FDA Barcode Medication Rule Passed 2004
– Based on existing NDC standard
• Lack of identifier for medical devices
• UDI included in the FDAAA of 2007
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
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The US FDA Final Rule
Announced at UDI Conference on September 20, 2013
Published in Federal Register on September 24, 2013
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The Clock is Ticking for Suppliers
Risk-based Compliance Deadlines
September 24, 2014 - Class III devices (implants)
September 24, 2015 - “…devices that are implantable, life-saving,
and life sustaining” (DPM if required)
September 24, 2016 – Class II devices (DPM for Class III)
September 24, 2018 – non-exempt Class I devices, unclassified (DPM
for Class II if required)
September 24, 2020 – (DPM for Class I and unclassified, if required)
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The FDA Listens
Some Key Issues
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Date Format
Existing Inventory
Kits and Combo Products
Shelf Packs
MRI Compatability
Direct Part Marking for
Implantable Devices
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Direct Part Marking
Direct part marking
required for products
“intended to be used
more than once and
intended to be
reprocessed before each
use”
2 years after regular compliance
date except for those products
considered implantable, lifesaving, and life sustaining. They
must be in full compliance by
September 24, 2015,
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UDI: A Three-Part System
1. Assign a UDI compliant code to covered products
2. Label products with human and machine readable
codes
3. Populate and maintain data in UDI database(s)
UDI Code
Assign and label
products:
Device ID (static
data)
Production ID, e.g.,
lot, serial #,
expiration date
(dynamic data)
UDI Database
Device ID the key
Specific static data
Multiple methods
to populate
Publicly available
data
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AIDC
Choice of auto id
carrier
• Linear barcode
• 2-D barcode
• RFID
• Other
Direct Part Marking
Assigning UDIs to Different Packaging Levels
Each level of packaging requires a unique device identifier
Pack of 1 Each
Case of 10 Packs of 1 Each
1 Each
2 0085412 00000 4
6 0085412 00000 9
0 0085412 00000 8
Case of 10 Each
5 0085412 00000 6
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UDI: The Details
Populate the Global UDI Database (GUDID)
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Device Identifier From Accredited Issuing Agency
Manufacturer/Labeler Information (DUNS #)
Brand Name
Model/Version #
Catalog #
Device Description
Global Medical Device Nomenclature
Other attributes (GUDID Guidance Appendix B)
Patient Safety
• Contains Natural Rubber Latex?
• For Single-use?
• Prescription Status
• MRI Safety?
• Packaged as Sterile?
• Size (Define)
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GUDID Overview
GUDID Web Interface
• Secure Web Application
• Submission of device information one
record at a time by Labelers
• Search and Retrieval of published device
information by public users
FDA\CDRH\OSB\Informatics Staff
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GUDID Search and Retrieval
Two Search and Retrieval Options will be
available:
1) Web Interface Search and Retrieval
– Quick Search – enables search on Device
Identifier, Company Name, Brand Name,
Version or Model Number.
– Advanced Search – additional attributes
available for searching.
2) System to System Search and Retrieval
– Web Services – accepts a DI Number and returns
published attributes.
– Database Download capability – planned for the
future.
FDA\CDRH\OSB\Informatics Staff
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DI Record

DI Record = Device Identifier (DI) + GUDID
attributes
Brand Name
Size
GMDN Description
Production
Identifier:
Expiration Date
Catalog Number
Device Count
Production
Identifier:
Lot Number
Storage and
Handling
For Single Use
Labeler Name &
Labeler Physical
Address
Support
Contact
Information
FDA\CDRH\OSB\Informatics Staff
Unique Device Identifier
(DI & PI)
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UDI = Unique Device Identifier
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
Device Identifier(DI) + Production Identifier(s)(PI)
DI= mandatory, fixed portion of a UDI that
identifies the specific version or model of a
device and the labeler of that device
o Issued by FDA-accredited Issuing Agencies

PI= a conditional, variable portion of a UDI that
identifies one or more of the following when
included on the label of the device:
o Lot or batch number
o Serial number
o Expiration date
o Manufacturing date
o For an HCT/P regulated as a device, the distinct identification
code
FDA\CDRH\OSB\Informatics Staff
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UDI Compliant Label: Linear Barcode
Device Identifier (GTIN)
Production Data
(Application Identifier or AI)
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UDI Compliant Label: 2D/Data Matrix
Device Identifier
GTIN (Global Trade Item Number)
Labels shown are drafts for
illustrative purposes only.
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UDI Compliant Label: 2D/Data Matrix
Production Data
Production Data
Application Identifier
• Lot / Batch / Expiration Date
Labels shown are drafts for
illustrative purposes only.
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UDI Compliant Code: ISBT 128
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UDI Compliant Code: ISBT 128
Donor ID # (Lot)
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A Holistic Approach to UDI
“This is not about just being able to identify devices. We (FDA)
are talking about a holistic approach to integrating medical
device identification throughout the entire healthcare system.
UDI will be a fundamental piece of everything we do going
forward.”
Jay Crowley, former Sr. Adviser for Patient Safety,
U.S FDA Center for Devices and Radiological Health
FDA working on conforming amendments for:
• Premarket approvals
• Reports of Corrections and Removals
• Medical Device Recall Authority
• Quality System Regulation
• Medical Device Tracking Requirements
• Post Market Surveillance
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It’s All About Visibility
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Medical device recalls
Adverse event reporting
Traceability
Supply chain security
Anti-counterfeiting/diversion
Disaster/terror preparation
Shortages/substitutions
Point of Use Capture
Demand Signals
Supply Chain Efficiencies
Comparative Effectiveness
Value Analysis
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UDI Key to FDA Post Market Surveillance
Promote Adoption with other
Stakeholders
• Facilitate the incorporation of UDI into
electronic health records as part of EHR
Certification Criteria
• Complete an initial think tank report to
inform the development of a roadmap
for successful UDI implementation
• Complete a pilot demonstrating the
ability to incorporate UDI into a multihospital information system – Mercy
Health Systems
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UDI for Post Market Research
Unique Device Identifier Demonstration Project
• Utilize electronic health records and clinical registries to assess the safety and
effectiveness of medical devices after they have reached the marketplace
• Stents first, then ICDs
International Consortium of Orthopedic Registries
• Identify and capture clinical attributes that impact performance
• Address differences in orthopedic registries to better utilize available data
• Demonstration projects: bearing surface, femoral head size, fixed vs. mobile
knees, pediatric joints
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UDI Implementation Project
EDI
Exchange
FDA
GUDID
ERP
Inventory
Mgmt
Legend
UDI Device ID
UDI (Device ID + Production ID)
UDI Attributes
scan
Cath Lab
EHR
Registry
Reporting
Mercy data
warehouse
FDA
GUDID
Core +
Supplemental
Attributes
CathPCI
Registry
• Retrieve UDI (Device Identifier) from GUDID for ERP
• Utilize ERP as master source of UDI (Device Identifier) +
attributes for EHR
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UDI Implementation Project
• Exchange UDI with Suppliers using UDI (Device Identifier)
• Automated replenishment from Inventory Management
• Point of Use integrated to EHR for UDI
• Automated charge capture
• UDI + Attributes in EHR
• Electronic management of Expiration Date
• Electronic management of Recalls
• Longitudinal data warehouse and CathPCI Registry utilize
UDI (Device Identifier) + attributes from GUDID
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UDI Implementation Project
EDI
Exchange
FDA
GUDID
ERP
Inventory
Mgmt
Cath Lab
Legend
Integration developed
Integration not currently possible
scan
scan
EHR
Registry
Reporting
Mercy data
warehouse
CathPCI
Registry
• ERP/Supply Chain systems implementing UDI but
working through bugs
• Clinical systems in planning phase for UDI
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FDA
GUDID
Core +
Supplemental
Attributes
UDI Implementation Project
• Manual efforts maintaining item master in multiple
systems
• Workarounds required to incorporate UDI into EHR
• Clinical personnel not consistently scanning / proper
barcode
• Double scan in Inventory Mgmt and Cath Lab
• GLN vs. DUNS use (data mapping required)
• Device descriptions not standardized (GMDN from FDA
GUDID)
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UDI: Could Providers be Required?
• UDI in electronic medical records?
• UDI on claims forms?
• UDI as part of quality
measures?
Physician Value of UDI
• Revision surgery, e.g., which hip implanted
• Emergency cases, e.g., when patient en route
Under healthcare reform, we need to know which
products contribute to better outcomes at
lower costs.
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EHR Adoption – Meaningful Use WG
Stage 2
Final Rule
NEW –
NOT IN
STAGE 2
Stage 3 Recommendations
MENU objective: Eligible Physicians and
Eligible Hospitals should record the FDA Unique
Device Identifier (UDI) when patients have
devices implanted for
each newly implanted
Stage
device.
MENU Measure: Eligible Physicians and Eligible
Hospitals should record the UDI when patients
have the device implanted for 80% of patients
seen within the EHR reporting period.
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Proposed 2015 EHR Certification Criteria
New 2015 Edition certification criterion would
require EHR technology to be able to record and
display a unique device identifier (UDI)
“EHR technology could be leveraged in
conjunction with automated
identification and data capture (AIDC)
technology or other technologies to
streamline the capture and exchange
of UDIs and associated device data in
clinical and administrative workflows.”
FDA seeking comments through April 28, 2014
www.regulations.gov
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Implant Usage Still Documented Manually
2 2
5
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Manually- paper
Manually- keyboard
Barcode
RFID scanned into app
RFID scanned- cabinet
Other
224
166
Survey conducted with OR nurses attending the
2011 AORN Conference
N = 326
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Value or Added Cost/Regulatory Burden?
Lessons Learned from Pharmaceutical Barcode Rule
Rule went into effect in 2006
but slow adoption (despite
proven value)
Efforts underway to help
speed provider adoption of
UDI
Cook Medical ready to use GLNs and GTINs
8% of customers ordering using GTINs
<1% of customers ordering using GLNs
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Maximizing Value
To Achieve Return from Required Investment,
Manufacturers need to view as a strategy, not a project
• Consider Objectives, Benefits, Impacts: Why are you doing this?
• Regulatory compliance
• Regulatory master data management
• Competitive Advantage
• Customer Service
Packaging
Sales
• Clinical Efficacy
Marketing
Technology
• Supply Chain efficiency
• Other
Legal
Inventory
• Who needs to be involved?
• Who, what is impacted?
Regulatory
UDI
Readiness
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Process
engineering
Find a Single Solution
• Build a Global Master Data Management Strategy
• Define ALL regulatory and commercial attributes (Super Spec)
• Connect globally
US Providers
GPOs
Super
Spec
Lableler
Global
Providers
Data Pool
UDI Data
Submission
Submission
Acknowledgement
FDA
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Future UDI
Databases
UDI: A Global Issue
The Whole World is Watching
Other countries/regions looking at UDI:
European Union (draft regulations and common framework)
China, India, Japan, Korea, Netherlands, UK, Turkey, Canada,
Australia, Brazil, Argentina… , and Turkey, Canada,
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Australia, Argentina,
India, UAE
A Global UDI Database Network
UDID
CA?
EU UDID
(Eudamed)
GUDID
USA
(FDA)
The IMDRF UDI
Workgroup is
considering the issue
of information
exchange between
UDI databases around
the world
NETWORK
UDID
AP ?
UDID
SA?
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How can you achieve the most value from UDI?
Providers need to leverage UDI and product data for
multiple purposes:
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Implant documentation
Supply chain transactions
Inventory management
Charge capture
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Reimbursement
Comparative Effectiveness
Total cost of care
What else?
Ask yourself:
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Where can you use UDI?
What value can it deliver?
Where will you be required to use UDI?
Who needs to be involved?
How will you capture, share, store the required data?
What process changes are necessary?
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A Coordinated Effort
UDI is a Team Sport
Getting to Value Requires a Concurrent Effort
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Want to Learn More about UDI?
Check out the blog posts and videos
on UDI at The Healthcare Hub
http://www.thehealthcarehub.com
Read and comment on the proposed EHR certification
criteria at:
https://www.federalregister.gov/articles/2014/02/26/201403959/voluntary-2015-edition-electronic-health-record-ehrcertification-criteria-interoperability-updates
Check out AHRMM’s UDI information site:
http://www.ahrmm.org/ahrmm/ext/standards/UDI_index.htm
Visit the FDA’s UDI information page and sign up for regular updates
on UDI at
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueD
eviceIdentification/default.htm
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UDI Resources
UDI website - www.fda.gov/UDI
– UDI Help Desk
– Sign up for UDI alerts
– GUDID Draft Guidance
– Appendix B – Vocabulary
– Appendix C - UDI Specifications by Issuing Agency
Strengthening our National System for Medical Device
Postmarket Surveillance http://www.fda.gov/downloads/MedicalDevices/Safety/CDRHPostmarketSur
veillance/UCM348845.pdf
HL7 UDI Task Force
http://hl7tsc.org/wiki/index.php?title=2013-11-21_TSC_UDI_Task_Force
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