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GHTF Steering Committee Document Transmittal Record

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GHTF Steering Committee Document Transmittal Record

     GHTF/AH/(PD2)N2R2

    GHTF Draft Proposal for

     a draft guidance on

    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

    Larry Kelly, GHTF Chair

Copyright ? 2010 by the Global Harmonization Task Force

    UDI System AH/(PD2)N2R2: 2010 AHWG

TABLE OF CONTENTS

    Preamble ........................................................................................................................ 3

    1. Introduction ................................................................................................................. 6

    2. Rationale, purpose and scope ..................................................................................... 7

    2.1 Rationale 7

    2.2 Purpose 7

    2.3 Scope 8

    3. References .................................................................................................................. 8

    4. Definitions ................................................................................................................... 9

    5. Guidance for the UDI System .................................................................................... 11

    6. UDI ........................................................................................................................... 12

    7. UDI Carrier and placement ........................................................................................ 13

    8. UDI Database ............................................................................................................ 15

    9. Annexes .................................................................................................................... 21

    9.1 Annex I 21

    9.2 Annex II 24

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    UDI System AH/(PD2)N2R2: 2010 AHWG

Preamble

    This document was produced by the Global Harmonization Task Force, a voluntary group of representatives from medical device regulatory agencies and the regulated industry. The document is intended to provide non-binding guidance for use in the regulation of medical devices, and has been subject to consultation throughout its development.

    There are no restrictions on the reproduction, distribution or use of this document; however, incorporation of this document, in part or in whole, into any other document, or its translation into languages other than English, does not convey or represent an endorsement of any kind by the Global Harmonization Task Force.

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

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    UDI System AH/(PD2)N2R2: 2010 AHWG

    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.

Implementation issues of a global UDI

Labelling requirements will be phased in over a period of some years.

    The true benefit, in terms of patient safety, will only be achieved if all stakeholders (from manufacturer through to healthcare providers) use the globally harmonized UDI system.

    Local deviations (regional or country) will have negative impact on the main objective to increase patient safety. The risk that the entire UDI concept would become inconsistent and unmanageable is very high. Therefore the GHTF Ad Hoc Working Group strongly recommends to avoid those deviations.

    Due to the huge diversity of the medical device product portfolio a risk-based approach is essential. The „difficult to manage‟ assortment needs to be divided into portions, which can be

    handled easily.

    Medical devices are defined by different classes, according to their risk with regard to patient safety. Risk class systems are effectively used around the world and are therefore the basis for the UDI marking requirements.

    Medical devices need to be marked on the different packaging levels according to their risk class. Also the data granularity varies. The decision tree in Annex II should serve as guidance. This decision tree describes the minimal requirements. To encode more data into the AIDC carriers or to mark more packaging levels is allowed.

    The stepwise implementation process (for the UDI marking as well as the UDI Database), starting with medical devices belonging to the highest risk calls first, will help to reduce its complexity. All supply chain stakeholders will need sufficient time frames to prepare their systems, processes and staff, for the proper use of the UDI system. Between each implementation step it is planned to analyze the achieved results and make system adjustments, if necessary.

    The UDI system by definition shall facilitate traceability. But it is not intended to administer any dynamic supply chain data (i.e. ePedigree information) within the UDI database. That has to be defined and organized outside the UDI guidance.

    An important aspect regarding the effectiveness of the entire UDI system is the education of its users along the supply chain (from manufacturers to healthcare providers). Proper actions need to be planned and performed in time by the regional regulatory authorities.

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    UDI System AH/(PD2)N2R2: 2010 AHWG

    The Ad Hoc Working Group realize that several other issues will have to be addressed by the Administrations in charge of the implementation phase, such as the UDI for capital equipments with multiple subassemblies, for kits...

    The activities of this Ad Hoc Working Group were by nature 'open-ended'. It is clearly the involvement of the competent Administrations for the implementation which is important as the final design phase. The draft guidance proposed by the Ad Hoc Working Group ambition is to pave the way for a single and global Unique Device Identification of Medical Devices.

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