The Benefits of UDI and GUDID in Improving Patient Safety

The Benefits of UDI and GUDID
in Improving Patient Safety
Dental Trade Alliance Workshop
October 8, 2014 – San Antonio, TX
Grant Hodgkins
VP of Commercial Practice
Office: 805.259.1227; Mobile: 817.691.2271
[email protected]
• Introductions
• UDI Defined
• Business Context
• Q&A
Grant Hodgkins
VP of Commercial Solutions and Services at USDM Life Sciences
Grant assists USDM Life Sciences clients with Pharmaceutical Track
and Trace, Medical Device UDI, GS1 standards adoption, ERP, MES,
PIM/PLM, and other enterprise solutions. Grant has three decades
of life sciences industry experience designing, implementing and
managing complex global programs and operations. Grant also
served on key industry action committees driving adoption of GS1
standards and solutions across the end-to-end supply chain from
manufacturer to provider.
USDM Life Sciences at a Glance
Exclusive Life Sciences Industry Professional Services Firm
Compliance and Strategy partner for Life Sciences Companies,
Industry Organizations, and best of breed solution Vendors
We help clients improve business value through technology
Recognized Industry thought leaders in all relevant and emerging
Life Sciences Topics
Healthcare Provider service offerings based on, and consistent
with, service offerings across the entire Healthcare Value Chain
Services and solutions for the emerging, mid-tier, and large Life
Science companies
Multi-national client engagements
Strategic and tactical delivery models
Leader in the life sciences cloud
Solve Compliance Issues
Founded in 1999
Headquartered in Santa
Barbara, CA
Assist clients under regulatory distress
Over 1,000 projects in over 300 life sciences organizations
• Introductions
• UDI Defined
• Business Context
• Q&A
US FDA UDI Rule Intent/Objective
• Provide standardized granular identification of medical devices
and associated meta-data to support public health initiatives
• Most notably to support FDA’s postmarket surveillance activities:
– adverse event reporting/aggregation
– recalls
– device and disease specific registries
– EHRs
– large population-based data sets, e.g., claims data
– others
Text + Barcode
DI + PI **
Direct Part Mark
Inner Pack
Share UDI
Device Identifiers
Mark UDI
Create & Assign DI
UDI = Unique Device Identification
Other Uses
** UDI = DI + PI
DI = Device Identifier (static industry-standard product identifier)
PI = Production Identifier (variable info, such as Lot, Expiry)
Printed in Text and in a Barcode, on every fixed-quantity packaging level
UDI Compliance Defined
• UDI Assignment and Marking
– Key compliance dates for product marking and GUDID entries
Class III
FDASIA Implants
(Class I and II)
Class II
Class I
Class II DPM
Class I DPM
– UDI assigned to in-scope packaging levels
– UDI marked in a barcode on those packaging levels
• Including DI + PI data: DI, Lot, Expiry, Manufacturing Date, and/or Serial Number
– Standard Date Format marked on all packaging levels (YYYY-MM-DD)
– Manage new items / changes per applicable standards
• UDI Attribute Data loaded into FDA GUDID
– Share master data elements related to every DI
Create and Assign DI’s
• Work with one (or more) FDA accredited issuing agencies –
• Assign Device Identifiers to all devices – including kits,
complex systems, combination products
A new DI is required whenever:
• A change to a device results in a new version or model
• Create a new device package (including changes to #)
• Various other situations
Mark UDI – GS1 Example
Mark UDI – HIBCC Example
Mark UDI – ICCBBA Example
Submit Data to FDA GUDID
The Medical Device Label:
Device Identifier (Device XYZ123)
Production Identifier (Lot #ABC)
Expiration date (YYYY-MM-DD)
For each Device Identifier
Web based tool
FDA Managed
3rd Parties (e.g., GDSN)
Public User
GUDID Data Attributes
Device Identifier (DI) Information
– Issuing Agency
– Primary DI Number
– Device Count
– Unit of Use DI Number
– Labeler DUNS Number
– Company Name
– Company Physical Address
– Brand Name
– Version or Model Number
– Catalog Number
– Device Description (max 2000 characters)
Commercial Distribution
– DI Record Publish Date (mm/dd/yyyy)
– Commercial Distribution End Date
– Commercial Distribution Status
Secondary DI
– Secondary DI Issuing Agency
– Secondary DI Number
Package DI
– Package DI Number
– Quantity per Package
– Contains DI Package
– Package Type
– Package Discontinue Date
– Package Status
Support Contact
– Support Contact Phone
– Support Contact Email
Direct Marking (DM)
– Device Subject to Direct Marking (DM), but
– DM DI Different from Primary DI
– DM DI Number
Device Status
– Human Cell, Tissue or Cellular or Tissue-Based
Product (HCT/P)
– Kit
– Combination Product
FDA Product Code
– Product Code
– Product Code Name
FDA Listing
– FDA Listing Number
– Device Exempt from Premarket Submission
– FDA Premarket Submission Number
– Supplement Number
GMDN (Global Medical Device Nomenclature)
– Code
– Name
– Definition
Device Characteristics
– For Single-Use
Production Identifier(s) on Label
– Lot or Batch Number
– Manufacturing Date
– Serial Number
– Expiration Date
Latex Information
– Device required to be labeled as containing
natural rubber latex or dry natural rubber (21
CFR 801.437)
– Device labeled as "Not made with natural
rubber latex"
Prescription Status
– Prescription Use (Rx)
– Over the Counter (OTC)
MRI Safety Status
– Is the device labeled for MRI Safety?
Clinically Relevant Size
– Size Type
– Size Value
– Size Unit of Measure
– Size Type Text
– Storage and Handling
Storage and Handling Type
– High Value
– Low Value
– Unit of Measure
– Special Storage Conditions
Sterilization Method
– Device Packaged as Sterile
– Requires Sterilization Prior to Use
• Introductions
• UDI Defined
• Business Context
• Q&A
Public Health Benefits of UDI
The UDI system provides global visibility and supports:
• Medical device recalls
• Adverse event reporting
• Track and trace
• Supply chain security
• Anti-counterfeiting/diversion
• Disaster/terror preparation
• Shortages/substitutions
• Reduction of medical errors (e.g., bedside scanning)
• An easily accessible source of device information for patients
and clinicians
(Theoretical/Future) Benefits of UDI
Provides foundation for (but requires enabling changes):
• Documentation of use/implantation in EHRs/PHRs
• Claims/reimbursement – CMS and private payors
• Internal efficiencies in supply chain, clinical, other areas
• Stage 3 Meaningful Use
• Value Analysis
• Consignment management
• Others?
But how will this be done…?
more questions that answers
Current Business Context
Many US Medical Products
marked with barcodes,
limited data content,
multiple standards
Virtually all US medical
products marked with UDI
barcodes, with extended
data content
Providers can now begin
investments with
GUDID and other product
catalogs available to
synchronize product
master data
Extended transaction
information available for
Pharma products (DSCSA)
UDI Barcodes will become
readily available
Data to drive business
systems already available
Key Provider Challenges
• Providers facing significant pressures to be more efficient
Declining top-line revenue due to Affordable Care Act (ACA) provisions
“Meaningful Use” provisions coming soon
Robust “Value Analysis” solutions becoming more urgent
High sense of urgency to address these needs quickly (i.e., NOW)
• Current provider business models are fragmented and further
split into “supply chain” and “clinical” operations
– Insufficient coordinated actions across operations
– Inability to share information across Provider systems – supply chain
through point-of-care clinical systems
– Difficult to quantify benefits to convince Provider management to invest
Common Provider Solutions Needed Today
Supply Chain Operations
• Requisition to Pay Automation
• Barcode scanning across enterprise
• Master Data synchronized with Suppliers
• Replenishment automation
• Consignment management optimization
• Recall enhancements
Clinical Operations
• Interface Supply Chain information into Clinical Operations systems
• Point of Care barcode scanning into EHR
• Advanced logic to detect expiry product, wrong product, wrong time, wrong
dosage, drug interactions
• Value Analysis, Meaningful Use, other outcomes-based solutions
So What’s Missing?
• A continuing dialogue about UDI application and use
– Specific, documented use cases (yes, it is a chicken and egg discussion – you can’t
“prove”/demonstrate UDI benefits until you have them)
• Understanding the costs of different UDI applications – and discussion of the
trade-offs for “more” UDI
• Manufactures need to talk to each other – and to their customers
• Customers need to engage – adoption of UDI internally will help drive
manufacturers towards providing more capabilities
• Jointly develop a path which allows and encourages manufactures to
iteratively change/evolve their UDI programs to meet changing market
What Could the Future Look Like?
End-to-End Visibility using UDI
No-Touch ‘Perfect Orders’ and ‘Perfect Payments’
EHR Bedside Scanning of Items and Services
Implant Registries tied to EHR and other systems
Value Analysis by UDI and GMDN categories
Low-Touch incoming receiving
Auto-replenishment of consignment inventory triggered by consumption
And the list goes on and on…
A Path Forward
• Real-Life Business Cases
– Financial-based, confirmed value of UDI adoption for Providers and Suppliers
• Build the Foundation – Drive UDI Adoption
– Strategy, master plan, solutions design, deployment and implementation
– Supply Chain, Clinical, Pharmacy segments of Provider business
– Barcodes – adoption of UDI barcodes, scanner selection, integration into systems
• Improve the Foundation – Integration and Data Sharing
– Strategy, solution design, and deployment across Provider systems
– Integration of master data between Suppliers and Providers and other trading partners
• Build the House – Business Process Renovation
– Define and implement 1 improvement from the previous slide
– Capture and quantify benefits
– Use the savings to fund the next project, then repeat
• Introductions
• UDI Defined
• Business Context
• Q&A
• What are your thoughts about the situation?
• What do you think are some immediate actions that
we can all take to drive progress?
• How do we break the ‘chicken and egg’ dilemma?
• What other reactions do you have?
Thank You!
Follow-up Resources
Ask Questions, Share Ideas
Connect with USDM Life Sciences with Social Media
Contact USDM Life Sciences Directly:
(888) 231-0816 ext 161
[email protected]

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