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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     a draft guidance on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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1. Introduction

    In the interests of patient safety against a background of globalisation it is desirable to address traceability of medical devices at a global level. A key element in achieving global traceability of medical devices is the development of a Unique Device Identifier (UDI). The primary aim of a UDI System is to increase patient safety.

    It will also improve the work of market surveillance authorities in case of field safety corrective actions, and for instance, in the fight against counterfeiting.

    In addition, the development of an international approach will make the medical device market more secure for all the stakeholders (health authorities, hospitals, manufacturers, distributors, etc).

    This is why many regional regulatory authorities and industry at large see the introduction of UDI as an effective tool in the efficient protection of public health. It is mainly for patient safety reasons that all the actors in the sector support the development of UDI for medical devices.

    For the GHTF regional jurisdictions, it is of great importance that a globally applicable UDI System without regional adaptations is developed. The design and construction of a UDI System should be addressed in a forum like GHTF, in order to encourage the use of a harmonised UDI System by all regulatory jurisdictions. Therefore the aim of this UDI Ad Hoc Working Group (AHWG), established at the Ottawa GHTF Steering Committee (SC), is to ensure the design of a globally acceptable UDI System.

    The aim of this document is to pave the way for the establishment of a global UDI System in the medical device sector. It provides guidance to build a global UDI System. Further additional guidance may need to be developed once these core elements are accepted.

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2. Rationale, purpose and scope

    2.1 Rationale

    There is currently no global definition of what constitutes a UDI System. As a consequence, discrepancies between different national approaches do exist and will most likely increase.

    Common worldwide UDI requirements would offer significant benefits to manufacturers, users and/or patients, and Regulatory Authorities.

    In addition, eliminating or reducing differences between jurisdictions decreases the cost of gaining regulatory compliance.

    In order to achieve global traceability the UDI System should be promoted among all stakeholders, including regulatory agencies, medical device manufacturers, distributors, hospitals, and medical professionals.

2.2 Purpose

    The main goal of a UDI System is to improve patient safety by:

    - facilitating traceability of devices

    - enhancing the identification of devices in case of adverse events, - assisting in the event of a field safety correction

    It is anticipated that a UDI System may facilitate the reduction of medical errors.

    In addition, this guidance aims to avoid prescriptive country-specific requirements regarding the core elements of the UDI System by developing common guidance to: - create, use and maintain a unique "Device Identifier"

    - develop and apply a "UDI Carrier"

    Page 7 of 24

- establish the "UDI Database" with a defined list of Data Elements

2.3 Scope

    This document applies to all products to be placed on the market that fall within the definition of a medical device that appears within the GHTF document "Information

    Document Concerning the Definition of the Term “Medical Device”". Replacement

    components or spare parts (e.g. power cord, circuit board) used for servicing or maintenance of a Medical Device are exempt from the requirements of this document.

3. References

    GHTF final documents

    SG1/N29:2005 Information Document Concerning the Definition of the Term “Medical

    Device”

    SG1/N43:2005 Labelling for Medical Devices

    SG1/N055:2009 Definitions of the Terms Manufacturer, Authorized Representative,

    Distributor and Importer Registration and Listing

    SG1 (PD)/N65 Registration of Manufacturers and other Parties and Listing of Medical

    Devices

    International standards

     When considering International standards relevant to UDI, within the scope of work of ISO/IEC JTC 1/SC 31, the Sub-committee responsible for Automatic Identification and Data Capture Techniques standardization

    http://www.iso.org/iso/iso_technical_committee.html?commid=45332, there are many standards that may apply.

     When considering the AIDC identification and marking aspects of UDI, attention should be directed to the scope of work and complete body of standards of this group for applicable

    Page 8 of 24

    documents. Other healthcare related standards may also be relevant, e.g. those of GS1 Healthcare and Health Industry Business Communication Council (HIBCC).

4. Definitions

    UDI

    UDI means Unique Device Identifier. The UDI is a series of numeric or alphanumeric characters that is created through a coding system. It allows the unambiguous identification of a specific product on the market and represents the “access key” to device related information stored in the UDI Database. The UDI comprises the Device Identifier and Production Identifier.

    Note: The word "Unique" does not imply serialisation of every single device, e.g. those devices marketed in lots and batches.

UDI System

    The framework for the production of a Unique Device Identifier (UDI), the application of the UDI on the label or directly on product, and the storage of the UDI and additional device related information in a UDI Database.

    UDI - Device Identifier (static)

    Is a unique numeric or alphanumeric code specific to a medical device and that is also used as the "access key" to information stored in a UDI Database.

    UDI - Production Identifier (dynamic)

    Is a numeric or alphanumeric code providing information reflecting how the device is controlled. The different types of Production Identifier(s) can include any combination of serial number, lot/batch number, manufacturing or expiration date.

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UDI Carrier

    UDI Carrier is the means to convey the UDI by using automatic identification and data

    1 and if applicable human readable information (HRI). capture (AIDC)

UDI Database (UDID)

    The UDID is an organized collection of information associated with medical device identification and labelling.

Label

    Written, printed or graphic information provided upon the medical device itself. Where physical constraints prevent this happening, this term includes information provided on the packaging of each unit or on the packaging of multiple devices. GHTF/SG1/N43:2005

Labelling/ information supplied by the manufacturer

    Written, printed or graphic matter

    ;;affixed to a medical device or any of its containers or wrappers, or,

    ;;accompanying a medical device,

    relating to identification, technical description, and use of the medical device, but

    excluding shipping documents.

    Note: Some regional and national regulations refer to „Labelling‟ as „Information supplied by the manufacturer‟ (Source – ISO 13485) GHTF SG1/N43:2005

1 See Annex I (list of AIDC)

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