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FDA’s Global Unique Device Identification Database (GUDID)
Jay Crowley Senior Advisor for Patient Safety
Food and Drug Administration [email protected]
301-980-1936
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GUDID – Account and User Roles
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Global UDI Database For each Device Identifier: • Manufacturer (DUNS), Make/model, Brand/Trade • Device version/mode/catalogue/reference numbers • Clinically relevant size • Contact information • Sterility information; Contains latex; Single-use • Controlled by – Lot and/or Serial Number; Exp. Date • FDA premarket authorization (510k, PMA); listing # • GMDN PT; FDA product code (procode) • Marketing Status/date • Higher levels packaging • Kit; combination product; Rx/OTC; HCT/P
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GUDID – DI Elements • Issuing Agency – organization accredited by FDA to
operate a system for the issuance of UDIs. • Primary DI Number – an identifier that is the primary
lookup. Located on the base package, which is the lowest level of a medical device containing a full UDI.
• Secondary DI – another DI issued from a different issuing agency
• Unit of Use DI Number – an identifier assigned to associate the use of a device on a patient. For use when a base package contains more than one device.
• DM DI Number – an identifier marked directly on the medical device and is different than the Primary DI.
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GUDID – Name Elements • Brand Name – the proprietary, trade, or brand name of
the medical device as used in device labeling. • Model/Version Number – the model or version number
found on the device label or accompanying packaging. • Catalog Number – the catalog, reference, or product
number found on the device label or accompanying packaging to identify a particular product.
• Device Description – additional clinically relevant information about the device that is not already captured as a distinct GUDID data attribute.
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GMDN Each GMDN Term consists of 3 parts: • Preferred Term Name: Insulin syringe, fixed-needle • Definition: A device consisting of a small, calibrated,
hollow barrel (cylinder) and a moveable plunger with a permanently-attached needle (usually capped for user protection) that is used to administer an injection of insulin to a patient subcutaneously…
• Code: 38501
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DI Record Status State Description System Save Possible actions
Draft DI record
Saved DI record that has not passed business rules
--purged after 180 calendar days; -- if edited and resaved as draft, 180 day cycle resets and starts over
- Unlimited Editing - Resave as Draft - Delete Draft - Must pass business rules to move states
Unpublished DI record
DI record that has passed business rules AND Publish Date > today
Saved indefinitely - Copy - Unlimited Editing - Publish (when Publish Date = today)
Published DI record
--DI record that has passed business rules AND Publish Date <= today
Saved indefinitely - Copy - Limited Editing per Grace Period Rules [Cannot be unpublished w/out FDA intervention]
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DI Record Life-Cycle
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Editing Un/Published DI Records
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Packaging Hierarchy
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FDA’s Global UDI Database
Distribution
Web based tool
Business Rules
Manufacturer (Acme)
3rd Parties (GDSN)
The label of Medical Device 123 Size 45: Device Identifier (Device XYZ123) Production Identifier (Lot #ABC) Expiration date (MMDDYYYY)
Sterile; Latex free
Bulk HL7 SPL
Minimum Data Set For each Device Identifier: • Manufacturer and model • GMDN Code • Other attributes
or
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FDA’s UDI Database
FDA
FDA Managed
Public User Interface
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GUDID Draft “User’s Guide” • Publish draft “user’s guide” in May • Explain how interaction with the database will work:
• Organizational module (DUNS structure, DUNS – match label, various user roles)
• Device Identifier module/life-cycle, published records, grace period
• Both web-base (UI) and HL7 SPL • Search
• Comments welcome • Future training and database access
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UDI Application Example
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UDI Application Example
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UDI Application Example
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UDI Application Example
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ISBT128 Device Identifier (Static): A9997T9017Z012 • A9997 is the processor identifier assigned by ICCBBA ≡
manufacturer identifier • T9017Z012 is the product identifier ≡ catalogue number Production Identifier: A999912123456102 • A999912123456 is the donation identification number ≡
Lot no. • 102 is the division number ≡ serial number
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Unique Device Identification www.fda.gov/UDI [email protected]
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