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GHX proprietary information: Please do not copy or distributeGHX proprietary information: Please do not copy or distribute
UDI: From Regulation to Value
GHX proprietary information: Please do not copy or distribute1
Presented by Karen Conway, Industry Relations, GHX
What Hospitals and Healthcare Systems Can and Should Do, Now
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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
GHX proprietary information: Please do not copy or distribute
The Need for Standard IDs
3
Business Name
• Business NameBusiness 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
GHX proprietary information: Please do not copy or distribute
The Need for Standard IDs
4
Business Name
• Business NameBusiness 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
UDI compliant code
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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
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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 number.
GHX proprietary information: Please do not copy or distribute
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 DeadlinesSeptember 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
• 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
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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, life-saving, and life sustaining. They must be in full compliance by September 24, 2015,
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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
AIDC
Choice of auto id carrier• Linear barcode• 2-D barcode• RFID• Other
Direct Part Marking
1. Assign a UDI compliant code to covered products2. Label products with human and machine readable
codes3. Populate and maintain data in UDI database(s)
UDI Code
UDI: A Three-Part System
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Assigning UDIs to Different Packaging Levels
Each level of packaging requires a unique device identifier
0 0085412 00000 8
2 0085412 00000 4
5 0085412 00000 6
1 Each
Pack of 1 Each
Case of 10 Each
6 0085412 00000 9
Case of 10 Packs of 1 Each
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UDI: The Details
Populate the Global UDI Database (GUDID)
• 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)
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 15
GUDID Search and RetrievalTwo 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 16
DI RecordDI Record = Device Identifier (DI) + GUDID
attributes
FDA\CDRH\OSB\Informatics Staff 17
GMDN Description
Catalog Number
Production Identifier:
Lot Number
For Single Use
Labeler Name &Labeler Physical
Address
Brand Name
Production Identifier:
Expiration Date
Device Count
Storage and Handling
Support Contact
Information
Unique Device Identifier(DI & PI)
Size
UDI = Unique Device IdentifierDevice 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 deviceo 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 numbero Serial number o Expiration date o Manufacturing dateo For an HCT/P regulated as a device, the distinct identification code
18FDA\CDRH\OSB\Informatics Staff
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Device Identifier (GTIN) Production Data (Application Identifier or AI)
UDI Compliant Label: Linear Barcode
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Device Identifier
GTIN (Global Trade Item Number)
Labels shown are drafts for illustrative purposes only.
UDI Compliant Label: 2D/Data Matrix
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Production Data
Application Identifier• Lot / Batch / Expiration Date
Production Data
Labels shown are drafts for illustrative purposes only.
UDI Compliant Label: 2D/Data Matrix
GHX proprietary information: Please do not copy or distribute2222
UDI Compliant Code: ISBT 128
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Donor ID # (Lot)
UDI Compliant Code: ISBT 128
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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
• 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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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 multi-hospital information system – Mercy Health Systems
UDI Key to FDA Post Market Surveillance
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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
• Retrieve UDI (Device Identifier) from GUDID for ERP
• Utilize ERP as master source of UDI (Device Identifier) + attributes for EHR
Mercy data warehouse
ERP InventoryMgmt Cath Lab EHR
EDI Exchange
Registry Reporting
CathPCIRegistry
FDA GUDID
Core + Supplemental
AttributesLegendUDI Device IDUDI (Device ID + Production ID)UDI Attributes
scan
FDA GUDID
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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
GHX proprietary information: Please do not copy or distribute
UDI Implementation Project
• ERP/Supply Chain systems implementing UDI but working through bugs
• Clinical systems in planning phase for UDI
Mercy data warehouse
ERP InventoryMgmt Cath Lab EHR
EDI Exchange
Registry Reporting
CathPCIRegistry
FDA GUDID
Core + Supplemental
AttributesLegendIntegration developedIntegration not currently possible scan scan
FDA GUDID
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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
Stage 2 Final Rule
Stage 3 Recommendations
NEW – NOT IN STAGE 2
MENU objective: Eligible Physicians and Eligible Hospitals should record the FDA Unique Device Identifier (UDI) when patients have devices implanted for each newly implanted 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.
Proposed
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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)
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“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, 2014www.regulations.gov
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Implant Usage Still Documented Manually
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224
166
3722 5
Manually- paperManually- keyboardBarcodeRFID scanned into appRFID scanned- cabinetOther
Survey conducted with OR nurses attending the 2011 AORN Conference N = 326
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Value or Added Cost/Regulatory Burden?
Cook Medical ready to use GLNs and GTINs
8% of customers ordering using GTINs
<1% of customers ordering using GLNs
Rule went into effect in 2006 but slow adoption (despite proven value)
Efforts underway to help speed provider adoption of UDI
Lessons Learned from Pharmaceutical Barcode Rule
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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 • Clinical Efficacy• Supply Chain efficiency• Other
• Who needs to be involved? • Who, what is impacted?
UDI Readiness
Regulatory
Legal
Marketing
Packaging
SalesTechnologyInventor
yProcess engineering
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Find a Single Solution
• Build a Global Master Data Management Strategy
• Define ALL regulatory and commercial attributes (Super Spec)
• Connect globally
FDASubmissionAcknowledgement
UDI DataSubmission
Future UDI Databases
Global Providers
GPOs
US Providers
Data PoolLableler
Super Spec
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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, Australia, Argentina, India, UAE
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UDIDSA?
UDIDCA?
EU UDID(Eudamed)
GUDIDUSA
(FDA)UDIDAP ?
NETWORK
The IMDRF UDI Workgroup is
considering the issue of information
exchange between UDI databases
around the world
A Global UDI Database Network
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How can you achieve the most value from UDI?
Providers need to leverage UDI and product data for multiple purposes:
• Implant documentation• Supply chain transactions• Inventory management• Charge capture
• Reimbursement• Comparative Effectiveness• Total cost of care• What else?
Ask yourself: • 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?
Write Once,
Read Many
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A Coordinated Effort
UDI is a Team SportGetting 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
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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 athttp://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.html
Read and comment on the proposed EHR certification criteria at:https://www.federalregister.gov/articles/2014/02/26/2014-03959/voluntary-2015-edition-electronic-health-record-ehr-certification-criteria-interoperability-updates
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/CDRHPostmarketSurveillance/UCM348845.pdf
HL7 UDI Task Force http://hl7tsc.org/wiki/index.php?title=2013-11-21_TSC_UDI_Task_Force
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UDI Resources