GHX proprietary information: Please do not copy or distribute UDI: From Regulation to Value GHX...

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

GHX proprietary information: Please do not copy or distribute

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


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


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


From Problem to Regulation

Preventable Medical Errors and Device Recalls


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.


The US FDA Final Rule

Announced at UDI Conference on September 20, 2013

Published in Federal Register on September 24, 2013


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)


The FDA Listens

Some Key Issues

• Date Format• Existing Inventory• Kits and Combo Products• Shelf Packs• MRI Compatability• Direct Part Marking for

Implantable Devices


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,


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


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


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


Device Identifier (GTIN) Production Data (Application Identifier or AI)

UDI Compliant Label: Linear Barcode


Device Identifier

GTIN (Global Trade Item Number)

Labels shown are drafts for illustrative purposes only.

UDI Compliant Label: 2D/Data Matrix


Production Data

Application Identifier• Lot / Batch / Expiration Date

Production Data

Labels shown are drafts for illustrative purposes only.

UDI Compliant Label: 2D/Data Matrix


UDI Compliant Code: ISBT 128


Donor ID # (Lot)

UDI Compliant Code: ISBT 128


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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GHX proprietary information: Please do not copy or distributeGHX proprietary information: Please do not copy or distribute25

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


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


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


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



• 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



• 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



• 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)


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.


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


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


Implant Usage Still Documented Manually

35

224

166

3722 5

Manually- paperManually- keyboardBarcodeRFID scanned into appRFID scanned- cabinetOther

Survey conducted with OR nurses attending the 2011 AORN Conference N = 326


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


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


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


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


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


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


A Coordinated Effort

UDI is a Team SportGetting to Value Requires a Concurrent Effort


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

http://www.thehealthcarehub.com/

http://www.ahrmm.org/ahrmm/ext/standards/UDI_index.html


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

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


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

http://www.fda.gov/UDI

http://www.fda.gov/downloads/MedicalDevices/Safety/CDRHPostmarketSurveillance/UCM348845.pdf



http://hl7tsc.org/wiki/index.php?title=2013-11-21_TSC_UDI_Task_Force

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