GHTF Draft Proposal for a Unique Device Identification (UDI) System for Medical Devices
Authoring Group: GHTF SC UDI AHWG Proposed by the Global Harmonization Task Force
Date: November 4, 2010
Authoring Group: GHTF SC UDI AHWG Proposed by the Global Harmonization
Task Force Date: November 4, 2010
Rationale for a UDI draft guidance document
The objective of the GHTF UDI ad-hoc working group is essentially to increase patient safety by:
- facilitating traceability of devices
- improving the identification of devices in adverse events
- facilitating field service corrective actions
It is anticipated that a UDI System may facilitate the reduction of medical errors. The objectives pursued by the ad hoc working group were not:
- to find a solution to counterfeit devices
- to enable better control of purchasing and distribution
To be more specific the aim of traceability translates into the reduction of implication of medical devices in medical errors by:
- Providing a single, globally-accepted source for positive identification of medical devices. Health care professionals and patients will no longer have to access multiple, inconsistent, and incomplete sources in an attempt to identify a device, its key attributes, and a designated source for additional information.
- Ensuring the adequate identification of the device through its distribution and use.
- Providing rapid access to key attributes relating to the device. The UDI system will allow rapid retrieval of information from a dedicated data base system that focuses on the identification of devices.
- Simplifying integration of information on device use into medical records. The UDI system must ensure compatibility with electronic health records.
In addition the traceability capability can facilitate the resolution of device problems, by:
- Making it possible to more rapidly identify devices involved in adverse events. UDIs will be available for inclusion in adverse event reports, allowing greater accuracy in reporting, and more rapid aggregation of related reports.
- Providing for more rapid resolution of confirmed problems. UDIs will allow the Health Authorities to more rapidly collate and analyze problem reports and identify the most appropriate solution to a particular concern. UDIs will also allow more accurate target safety alerts, recalls, and other corrective actions on the specific devices that are of concern.
- Providing a single, globally-accepted “key” that can be used to link and integrate existing government, hospital, and corporate data bases that relate to medial devices. UDIs will allow for improved procurement, inventory management, and accounting. The existence of a “key” to link disparate data bases will allow creative new medical and business applications, and synergy among those applications.
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