guidance on regulations for the transport of infectious substances

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  • EPIDEMIC AND PANDEMICALERT AND RESPONSE

    Guidance on regulations fortheTransport of InfectiousSubstances2007 2008

    Applicable as from 1 January 2007

    WHO/CDS/EPR/2007.2

  • Guidance on regulations fortheTransport of InfectiousSubstances2007 2008

    Applicable as from 1 January 2007

  • World Health Organization 2007

    All rights reserved.

    The designations employed and the presentation of the material in this publication do not imply theexpression of any opinion whatsoever on the part of the World Health Organization concerning the legalstatus of any country, territory, city or area or of its authorities, or concerning the delimitation of itsfrontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may notyet be full agreement.

    The mention of specific companies or of certain manufacturers products does not imply that they areendorsed or recommended by the World Health Organization in preference to others of a similar nature thatare not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished byinitial capital letters.

    All reasonable precautions have been taken by the World Health Organization to verify the informationcontained in this publication. However, the published material is being distributed without warranty of anykind, either express or implied. The responsibility for the interpretation and use of the material lies with thereader. In no event shall the World Health Organization be liable for damages arising from its use.

    Acknowledgement

    The extracts from the Recommendations on the Transport of Dangerous Goods, ModelRegulations, 14th revised edition, New York and Geneva, United Nations, 2005 arereproduced by kind permission of the United Nations.

  • WHO/CDS/EPR/2007.2 Guidance on regulations for the transport of infectious substances 2007

    Contents

    Introduction ............................................................................................................................................2 International regulations.......................................................................................................................2 National regulations .............................................................................................................................3

    Definitions and classification.................................................................................................................3 Infectious substances............................................................................................................................3 Cultures ................................................................................................................................................4 Patient specimens .................................................................................................................................4 Biological products ..............................................................................................................................5 Genetically modified microorganisms and organisms .........................................................................5 Medical or clinical wastes ....................................................................................................................5

    Exceptions ...............................................................................................................................................5 General preparation of shipments for transport.................................................................................6

    Basic triple packaging system..............................................................................................................7 Packaging, labelling and documentation requirements for infectious substances in Category A ..7

    Packaging .............................................................................................................................................7 Marking ................................................................................................................................................9 Labelling ..............................................................................................................................................9 Documentation ...................................................................................................................................11

    Packaging, labelling and documentation requirements for infectious substances in Category B 13 Packaging ...........................................................................................................................................13 Marking ..............................................................................................................................................14 Documentation ...................................................................................................................................14

    Overpacks .............................................................................................................................................15 Refrigerants ..........................................................................................................................................15 Training.................................................................................................................................................15 Recommendations for countries that have not adopted the United Nations system......................16 Transport planning ..............................................................................................................................16

    The shipper (sender, consignor) .........................................................................................................17 The carrier ..........................................................................................................................................17 The receiver (consignee) ....................................................................................................................17

    Requirements for air mail ...................................................................................................................17 Spill clean-up procedure......................................................................................................................18 Incident reporting ................................................................................................................................18 Annex 1 Additional information on the United Nations System for the Transport of Dangerous Goods.....................................................................................................................................................19 Annex 2 Examples of infectious substances included in Category A...............................................20 Annex 3 Packing Instruction P620 .....................................................................................................22 Annex 4 Packing Instruction P650 .....................................................................................................23 Annex 5 Flowchart for the classification of infectious substances and patient specimens ............26

  • WHO/CDS/EPR/2007.2 Guidance on regulations for the transport of infectious substances 2007

    2

    Introduction

    These guidelines provide practical guidance to facilitate compliance with current international regulations for the transport of infectious substances and patient specimens by all modes of transport, both nationally and internationally, and include the changes that apply from 1 January 2007. They replace the guidelines issued by the World Health Organization (WHO) in 2005 (document WHO/CDS/CSR/LYO/2005.22). This publication, however, does not replace national and international transport regulations. The latest regulations are based on a completely new system and are no longer related to the Risk Group concept used until the end of 2004. The rationale for the new system is set out in document WHO/CDS/CSRL/LYO/2004.9 entitled Background to the amendments adopted in the 13th revision of the United Nations Model Regulations guiding the transport of infectious substances (http://www.who.int/csr/resources/publications/WHO_CDS_CSR_LYO_2004_9/en/). The following guidelines provide information for classifying infectious substances for transportation and ensuring their safe packaging. They stress the importance of developing a working relationship between those involved the sender, the carrier and the receiver in order to provide for safe and expeditious transport of these materials. Postal, airline and other transport industry personnel have concerns about the possibility of becoming infected as the result of exposure to infectious microorganisms that may escape from broken, leaking or improperly packaged material. The packaging of infectious substances for transport must therefore be designed to minimize the potential for damage during transport. In addition, the packaging must ensure the integrity of the materials and so, in turn, timely and accurate processing of specimens. There are no recorded cases of illness attributable to the release of infectious substances or diagnostic specimens during transport, although there are reported incidents of damage to improperly and sometimes even properly packaged materials. The shipment of unmarked and unide

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