Case Study: Hologic First to Meet UDI Requirements for Medical Device Manufacturers September 30,...
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Transcript of Case Study: Hologic First to Meet UDI Requirements for Medical Device Manufacturers September 30,...
Case Study: Hologic First to Meet UDI Requirements for Medical Device ManufacturersSeptember 30, 2014
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Session Overview• Hologic and The Science of Sure!• Platform for Success: Our Enterprise Solutions Architecture• Our UDI Story• National Breast Cancer Awareness Month
UDI at Hologic OOW 2014
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Hologic is a $2.5B global Medical Device companyWe use The Science of Sure to improve lives!By innovating and bringing to market the best diagnostics, detection and surgical technology in the world.
We integrate The Science of Sure into everything we do To help healthcare professionals discover, diagnose and treat their patients with progressive certainty… …and ever-greater peace of mind.
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Platform for Success: Our Enterprise Solutions Architecture
UDI at Hologic OOW 2014
Oracle Exadata, Oracle Database
Siebel CRM Sales
MFG
HR
SCM
FINANCIALS
CRM Servic
e
Agile PLM
Oracle eBusiness Suite R12
OBI OPLA
Hyperion
Oracle Fusion Middleware
ODI
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What is UDI (Unique Device Identifier)?
The US Food and Drug Administration (FDA) issued a final rule on September 23, 2013 to establish a system to identify medical devices through distribution and use.
FDA mandated (CFR 830 UDI Requirements) that the manufacturer (aka Labeler) assign a unique number to its devices in order to sell those products in the US.
Unique Device Identifier (UDI): A unique number assigned to medical devices by the manufacturer of the device.
UDI at Hologic OOW 2014
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Means Product Labels Must Include UDIThe label of EVERY medical device (including IVDs) must have a UDI
Plain Text
Barcode
EVERY device package must have a UDI.However, not every component of a kit requires a label
Individual single-use devices that are distributed together in a single device package, intended to be stored in that device package until removed for use, and which are not intended for individual commercial distribution are exempt.
The Packaging level labels – such as 4 boxes of 25 filters or a case of 3 NovaSure products – also displays the UDI.
UDI at Hologic OOW 2014
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Why UDI?
UDI at Hologic OOW 2014
Reduce Medical Errors• Standard
scanable barcode • Rapid and Precise
Identification of a Device
Increase patient safety• More accurate
adverse event reports
• More rapid development of solutions
Identify Device Through Distribution and Use• More effectively manage recalls• Support a secure global
distribution chain to address counterfeiting
To Provide a Single, Global System for Identification and Traceability of Every
Medical Device
UDI Compliance Timeline
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Class III devices compliant by Sept 24, 2014• Hologic Examples: Blood Screening, HPV (Aptima and
Cervista), MTDClass II devices to be compliant within 3 years (2016)• Hologic Examples: AccuProbe, InPlex, Eviva (Costa Rica)
Class I devices to be compliant within 5 years (2018)• Hologic Examples: Invader Products
UDI at Hologic OOW 2014
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GUDID – the FDA Database
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Manufacturer submits device identifier and
device information for each product
Device Identifier Data AttributesDevice Identifier (DI) InformationIssuing AgencyPrimary DI NumberDevice CountUnit of Use DI NumberLabeler DUNS NumberCompany NameCompany Physical AddressBrand NameVersion or Model NumberCatalog NumberDevice Description (max 2000 chars)Commercial DistributionDI Record Publish Date (mm/dd/yyyy)Commercial Distribution End DateCommercial Distribution StatusSecondary DISecondary DI Issuing AgencySecondary DI NumberPackage DIPackage DI NumberQuantity per PackageContains DI PackagePackage TypePackage Discontinue DatePackage Status
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Support ContactSupport Contact PhoneSupport Contact EmailDirect Marking (DM)Device Subject to DM, but ExemptDM DI Different from Primary DIDM DI Number Device StatusHuman Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)KitCombination Product FDA Product CodeProduct Code/Product Code NameFDA ListingFDA Listing NumberPremarketDevice Exempt from Premarket SubmissionFDA Premarket Submission NumberSupplement NumberGMDN (Global Medical Device Nomenclature)CodeNameDefinitionDevice CharacteristicsFor Single-Use
Production Identifier(s) on LabelLot or Batch NumberManufacturing DateSerial NumberExpiration DateLatex InformationDevice required to be labeled as containing natural rubber latex or dry natural rubber Device labeled as "Not made with latex"Prescription StatusPrescription Use (Rx)/Over the Counter (OTC)MRI Safety StatusIs the device labeled for MRI Safety? Clinically Relevant SizeSize Type/Size ValueSize Unit of MeasureSize Type TextStorage and Handling Storage and Handling TypeHigh Value/Low ValueUnit of MeasureSpecial Storage ConditionsSterilization MethodDevice Packaged as SterileRequires Sterilization Prior to Use
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UDI Information - FDA Database and Product Label
UDI at Hologic OOW 2014
Device Identifier (DI) Information
Components of a Unique Device Identifier (UDI)
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The UDI is composed of two parts: DI + PI
A device identifier (DI) – static identifier which identifies the device manufacturer (aka labeler), the specific device version or model, and device attributesA production identifier (PI) – dynamic identifier with specific control/production identifiers such as:‒ Lot / batch number
‒ Serial number
‒ The expiration date
‒ The date of manufacture
NOTE: Only the DI portion is submitted to the FDA
UDI at Hologic OOW 2014
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Device Identifier (DI)
Hologic uses the Global Trade Identifier Number (GTIN) numbering scheme for our Device Identifiers.
Components of GTIN (DI)
The GTIN is a fourteen-digit number composed of four sections (PMMMMMMMMIIIIC)
1. P=Packaging Level
2. M=Manufacturer (Hologic=54200455)
3. I – Item number (product identification)
4. C – check digit
Example: 35420045507429
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Production Identifier (PI)
Can be one or a combination of any of the following:
• Lot / batch number
• Serial number
• The expiration date
• The date of manufacture
Product Specific / each site responsible for its PI
Generated in Oracle EBS during the manufacturing process
Added to product label
UDI at Hologic OOW 2014
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Hologic UDI Project Highlights
Implementation across 5 global sites, 105 Class-III products
147 Device Identifiers submitted to GUDID (Global UDI Database)
100% UDI compliant as of 9/24 deadline
First company to process automatic submissions to the GUDID via FDA’s Electronic Submission Gateway
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Hologic Project at a glanceSteering Committee, Central core team, Global site-based teams – 60+ members for 10 months
Key partners: Inspirage, Oracle and USDM
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Hologic Agile Solution
UDI solution is fully integrated into existing Agile PLM workflows
• UDI rule requirements embedded into Agile’s intelligence. Users don’t have to know UDI in depth!
Device Identifier defined as a new Item Type in Agile
• Agile auto-generates 14-digit GTIN (Global Trade Identification Number) numbers
UDI information is automatically submitted to FDA upon ECO release. No additional steps needed!
• Team never logs in to GUDID. All work done in Agile!
UDI information is transferred to Oracle EBS for transaction processing
UDI at Hologic OOW 2014
Hologic UDI Process
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GUDID
Labeling
ORACLEEBS
ECO Release – Device
Identifier Information
• Generate & Store (PI) Attributes
• DHR (Lot, S/N and Labeling history)
Customers
FDA Automated
Confirmation
Product Device
Identification Data
Centrally Managed Product DI Data
AGILEPLM
• UDI (DI) Data captured within DMR data (product BOMs)
• Standard ECO process for approval of DI data.
• ECO release triggers automatic submission to FDA
• Automated acknowledgement from FDA to confirm successful transfer
DI Created & Assigned in Agile
ECO Release – BOM + GTIN
System Overview and Data Flow
UDI at Hologic OOW 2014
Oracle
PreliminaryPre-Production ProductionFDA/EBS
SendFDA/EBS
Send
DI DIECO/MCO
ECO
DI
Prototype/Preproduction
Preliminary
Production
NovaSure Devices UDI Example
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DI (01)Hologic ID=54200455Product ID = 01284Check Sum=2
PI(10) Lot(17) Exp Date
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Next Steps
EU and other jurisdictions likely to release requirements
Upcoming FDA deadlines:
Life sustaining Class-II devices by September 2015
All Class-II devices by September 2016
UDI at Hologic OOW 2014
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October is Breast Cancer Awareness Month
Please spread the word… 3D Mammography
Saves Lives! Hologic 3D technology is proven to
increase the detection of invasive breast cancers
by 41% and reduce the recall rate by 15% Insert Presentation Title Here