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• Blood cold chain equipment must meet international standards, WHO minimum performance specifications and be correctly used and maintained by all personnel involved. • Cold chain equipment must be reviewed carefully, bearing in mind the possibility of relocation of some equipment to meet needs. • The design and quality of equipment should be carefully assessed so that it meets the needs of the laboratory and the users. • Assess the performance history of the equipment and market reports before making a decision. • Domestic refrigerators are NOT suitable for the storage of blood. • The need for a degree of standardization should be taken into account when procuring equipment as it assists in staff training and equipment maintenance. • The equipment should be ordered following agreed procedures. • The availability of back-up support, spare parts and maintenance services are important considerations in the selection of cold chain equipment. • Training for users and technicians must be taken into consideration before selecting any blood cold chain equipment. THE BLOOD COLD CHAIN – GUIDE TO THE SELECTION AND PROCUREMENT OF EQUIPMENT AND ACCESSORIES Some key factors to consider when procuring blood cold chain equipment The Blood Cold Chain Guide to the selection and procurement of equipment and accessories ISBN 92 4 154579 8 WHO Department of Blood Safety and Clinical Technology World Health Organization 1211 Geneva 27, Switzerland Fax: +41 22 791 4836 • E-mail: bct@who.int • www.who.int/bct/ Department of Blood Safety and Clinical Technology World Health Organization Geneva The Blood Cold Chain Guide to the selection and procurement of equipment and accessories Department of Blood Safety and Clinical Technology World Health Organization Geneva WHO Library Cataloguing-in-Publication Data World Health Organization The blood cold chain : guide to the selection and procurement of equipment and accessories. 1.Blood preservation – instrumentation 2.Plasma 3.Blood platelets 4.Refrigeration – methods 5.Equipment and supplies – standards 6.Guidelines I.Title ISBN 92 4 154579 8 (NLM classification: WH 460) Acknowledgements The Department of Blood Safety and Clinical Technology acknowledges the continued support of the Government of Luxembourg towards the WHO Blood Cold Chain Project, and to the production of these guidelines. The support of the WHO Department of Vaccines and Biologicals and the WHO Procurement Services are also gratefully acknowledged. This publication was prepared under the direction of Mr David Mvere, WHO Consultant, and edited by Ms Kay Bond, BCT/WHO. Printed: November 2002 Copies may be requested from: Department of Blood Safety and Clinical Technology World Health Organization 1211 Geneva 27, Switzerland Fax: +41 22 791 4836 E-mail: bct@who.int www.who.int/bct/ Information on procuring medical equipment may be obtained from: Department of Procurement Services World Health Organization 1211 Geneva 27, Switzerland E-mail: procurement@who.int © World Health Organization 2002 All rights reserved. Publications of the World Health Organization can be obtained from Marketing and Dissemination, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel: +41 22 791 2476; fax: +41 22 791 4857; e-mail: bookorders@who.int). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to Publications, at the above address (fax: +41 22 791 4806; e-mail: permissions@who.int). The mention of specific companies or their products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. The World Health Organization does not warrant that the information contained in this publication is complete and correct and shall not be liable for any damages incurred as a result of its use. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. Designed by minimum graphics Printed in France ••• Contents Important note to readers List of products featured in this guide Abbreviations Glossary Preface v vi vii viii ix Chapter 1. Introduction to the WHO Blood Cold Chain Project 1.1 The global challenge 1.2 Objectives of the WHO Blood Cold Chain Project Chapter 2. The blood cold chain process 2.1 WHO definition of blood components 2.2 The national blood cold chain 2.3 The blood cold chain as a work process 2.4 Blood cold chain personnel 2.5 Summary Chapter 3. Blood bank refrigerators 3.1 Overview 3.2 Standard electric blood bank refrigerator Description, functions and limitations of the equipment WHO minimum performance specifications Product information on equipment evaluated by WHO 3.3 Solar powered blood bank refrigerators Description, functions and limitations of the equipment WHO minimum performance specifications Product information on equipment evaluated by WHO 3.4 Ice lined blood bank refrigerators Description, functions and limitations of the equipment WHO minimum performance specifications Product information on equipment evaluated by WHO Chapter 4. Plasma freezers Description, functions and limitations of the equipment WHO minimum performance specifications Product information on equipment evaluated by WHO Chapter 5. Platelet agitators Description, functions and limitations of the equipment WHO minimum performance specifications Product information on equipment evaluated by WHO 1 1 2 5 5 5 6 6 8 10 10 10 10 11 11 15 15 16 16 17 17 18 18 20 20 20 21 23 23 23 24 iii Chapter 6. Plasma Thawing Equipment Description, functions and limitations of the equipment WHO minimum performance specifications Product information on equipment evaluated by WHO Chapter 7. Blood Transport Boxes and Coolants Description, functions and limitations of the equipment WHO minimum performance specifications Product information on equipment evaluated by WHO Chapter 8. Temperature monitoring devices 8.1 Overview 8.2 Electronic versions of temperature monitoring devices 8.3 Portable digital thermometers 8.4 Temperature data loggers 8.5 Blood time temperature indicators Product information on equipment evaluated by WHO Chapter 9. Accessories to the blood cold chain equipment 9.1 Voltage regulators 9.2 Standby generators 9.3 Blood and plasma trays or pack holders Product information on equipment evaluated by WHO Chapter 10. Equipment maintenance 10.1 Preventive maintenance 10.2 Management of repairs 10.3 Procuring essential spares for repairs and preventive maintenance 10.4 Common problems in managing an inventory of spare parts Chapter 11. Selecting and procuring blood cold chain equipment 11.1 Selecting manufacturers 11.2 Preparing tendering specifications 11.3 Factors to consider in selecting blood cold chain equipment 11.4 Donated equipment 11.5 Quantity 11.6 Methods of payment 11.7 Checklists 11.8 Purchasing equipment 26 26 26 27 30 30 31 31 35 35 35 35 35 36 37 41 41 41 43 44 45 45 45 46 46 48 48 49 49 50 52 53 54 55 Annex 1: Self Assessment Questionnaire on the Status of the Blood Cold Chain Annex 2: Chlorofluorocarbons (CFC) in Blood Cold Chain Equipment Annex 3: Description of codes used on page vi 57 59 61 iv BLOOD COLD CHAIN: GUIDE TO THE SELECTION AND PROCUREMENT OF EQUIPMENT AND ACCESSORIES ••• A Important note to readers… major objective of the WHO Department of Blood Safety and Clinical Technology (BCT) is to assist every Member State to ensure a safe and adequate blood supply that meets national needs at reasonable cost. Many countries face challenges in reaching this goal. These include limited resources and information, a lack of national policy and plans, transfusion transmissible infections such as the human immunodeficiency virus (HIV), and appropriate technology. Access to, and use of appropriate technology are essential for the safe storage and transportation of blood from donation to transfusion, a process referred to as the blood cold chain. The WHO Blood Cold Chain Project is meeting this challenge by providing appropriate technical and logistics information that will empower managers of health care programmes to improve management of the blood cold chain. This publication provides specific guidance in the selection and procurement of blood cold chain equipment and accessories. As mentioned in the copyright notice, WHO does not endorse or recommend manufacturers or their products listed in this publication over those not mentioned.The products featured are those that (i) were submitted by manufacturers that wished to participate in a WHO project to develop minimum performance specifications for all essential equipment and accessories needed for an effective blood cold chain; and that (ii) met the WHO minimum performance specifications after laboratory testing and field evaluation. The WHO Office of Procurement Services (procurement@who.int) can be consulted to provide up-to-date information on the procurement of medical equipment and supplies. v ••• Products featured in this guide* Equipment and Model Code1 Manufacturer Page Blood Refrigerators Standard Electric: BR320+ BB510+ BB710+ BBR 25SI-2A CT1-2A Solar Powered VC65F MB50DC+ Ice-lined MB50AC+ MRB 2000+ BR/01/2a BR/02/2a BR/03/2a BR/04/4a BR/05/2a BR/06/1b BR/07/1b BR/08/1c BR/09/1c Dometic, Luxembourg Huurre of Finland Huurre of Finland Jewett Refrigeration, USA Jewett Refrigeration, USA Dulas Ltd., UK Dometic, Luxembourg Dometic, Luxembourg Dometic, Luxembourg 11 12 13 13 14 16 17 18 19 Plasma Freezers FR160+ CTF406-2A PF/01/3 PF/02/2 Dometic, Luxembourg Jewett Refrigeration, USA 21 22 PA/01/i Helmer, USA Helmer, USA 24 24 Flatbed Platelet Agitators PFS15 PFS42 PFS84 PFS396 PA/02/f PA/03/f PA/04/f PA/05/f Helmer, USA Helmer, USA Helmer, USA Helmer, USA 25 25 25 25 Plasma Thawers CytothermDR CytothermD4+ Cytotherm4T+ DH8 PT/01/ PT/02/ PT/03/ PT/04/ Phototherm, USA Phototherm, USA Phototherm, USA Helmer, USA 27 27 28 29 Blood Transport Boxes MT25E/CF (blue) 3504/38/CF 55-CF MT12E/CF ICBB-13F CB/20/-CF BB/01/4 (PIS B4/05M) BB/02/1 (PIS B4/18M) BB/03/2 (PIS B4/57M) BB/04/3 (PIS B4/62M) BB/05/3 (PIS B4/72M) BB/06/3 (PIS B4/76M) Dometic, Luxembourg Thermos, USA Blow Kings, India Dometic, Luxembourg Apex Continental Ltd, India Blow Kings, India 31 32 32 33 33 34 Temperature Monitoring Devices T615 Recording thermometer AR10-GT-S Recording thermometer Tiny TTM Type G IP68 data logger Tiny TTM Type G data logger Autolog 2000TM data logger Thermo-tracer, data logger 80-1017 3M BTTI TD/01 (PIS E6/09) TD/02 (PIS E6/28) TD/03 (PIS E6/43) TD/04 (PIS E6/44) TD/05 (PIS E6/47) TD/06 (PIS E6/48) TD/07 Pacific Transducer Co., USA Hyoda Instuments Co., Japan Remonsys Ltd., UK Remonsys Ltd., UK Remonsys Ltd., UK Ocea Soft, France 3M/Berlinger & Co. AG, CH 37 37 38 38 39 39 40 Accessories FF500/4R voltage regulator for refrigerators VR/01 Advance Galatrek, UK 44 Platelet Agitators PFS42 Agitator in PC900 Incubator * Equipment laboratory tested and evaluated in the field (+indicates that field test results are still awaited). WHO-PIS codes included for ease of reference, where applicable. 1 vi Codes are: (1) product descrption; (ii) product number; (iii) product capacity, if relevant; (iv) product type, if relevant. Therefore, for example, BR/06/1b means: Blood Refrigerator, WHO/BCT Product No. 06, with a capacity to hold fewer than 50 blood packs, solar powered type product (see Annex 3 for full description). ••• Abbreviations ++ not tested IEC International Electricity Council AC Alternate current ISO International Standards Organization BCC WHO Blood Cold Chain Project kg(s) kilogramme(s) BCT WHO Department of Blood Safety and Clinical Technology kV(A) kilovolts Kwh Kilowatt-hours BTTI Blood Time Temperature Indicator LED Light-emitting diode BTS Blood Transfusion Services lts or l litres cc cubic centimetre m metre CIF Cost of item, insurance and freight to nearest port of destination, excluding customs clearance charges to be borne by buyer. max. maximum min. minimum mm millimetre No. Number NT not tested dB(A) decibels PC Personal Computer DC Direct current pk pack DIN Deutsche-Industrie-Norm, any of a series of technical standards PIS Product Information Sheets of WHO’S Expanded Programme on Immunization dxl diameter by length PVC Polyvinyl chloride plastic EN European Norms RH Relative humidity EXW Ex Works: factory price; everything else to be paid and organized by the buyer RPM Revolutions per minute SOP Standard Operating Procedures Free on Board. Cost of item and delivery cost cleared for export to the seller’s freight agent. All other expenses are for the buyer TTM Time Temperature Monitor V volt V&B WHO Department of Vaccines and Biologicals FOT free on truck VAC voltage alternating current HCFC Hydrochlorofluorocarbon VDC voltage direct current hr(s) hour(s) WHO World Health Organization Hz hertz (cycles per second) CFC Chlorofluorocarbon, found in some types of refrigerant gases CR Corrosion Resistance FOB vii ••• Glossary Cold life of a blood transport box: the amount of time from loading a box with frozen ice packs until the warmest internal temperature reaches +10 °C, given a constant external temperature of +43 °C. The door to the unit is kept closed. Compressor starting test: to assess the minimum voltage required for a compressor to start. Cooling down time: the time taken by the equipment to cool down effectively a full load of blood or plasma to acceptable temperature limits (see relevant WHO minimum performance specifications). This is important to know, since the faster the equipment is able to cool a load down, the faster the products reach a safe storage temperature. If the “cooling down time” is too long, it may be necessary to reduce the load by half or a quarter. Down time: the time between breakdown of a machine and its repair. Electrical safety rating: to assess against internationally accepted standards the safety of the equipment when exposed to electrical shock. Energy consumption: unlsess otherwise stated, this is measured at full load. Hold-over time: the length of time that the equipment can maintain the temperature of blood or plasma within acceptable limits (see WHO minimum performance specifications) when the energy supply for the equipment is interrupted for whatever reason, e.g. through a power failure. Incoterms: the International Chamber of Commerce official rules for the interpretation of delivery terms. De-rating: a generator’s performance is affected by different altitudes. There is a formula for correcting the performance rating of the generator according to the altitude of where it will be located (formula: 1% of its capacity for every 100 m above sea level, 1% for every 5.5° above 20 °C.) This is referred to as “de-rating” of the generator. It is necessary to do this to ensure the correct size of the generator purchased. Plasma pack puncturing test: to assess the effectiveness of transport boxes to prevent plasma packs being punctured during a simulated rough ride. Door opening test: to assess the effect of continual opening of the door of the refrigerator or freezer on the stable running temperature. Voltage fluctuation test: to assess the stability of the electronic temperature control devices when exposed to voltage fluctuations. viii Stable running temperature: the stability of the temperature of the equipment within set limits and test conditions. Temperature: all temperatures are plus (+) unless otherwise indicated. ••• Preface T his is the first WHO publication dedicated to assisting managers of blood programmes to select and procure equipment and devices for the blood cold chain. The safe storage and transportation of blood and blood products is an integral component of the WHO strategy for blood safety. It is estimated that approximately 2% of blood that has been found safe to transfuse may be discarded for various reasons. This percentage varies depending on the management of the inventory and the effectiveness of the blood cold chain, and is a waste of a scarce and valuable resource. WHO recognizes that there are differences in the handling of blood and vaccines in the field. These differences required the development of a blood cold chain that would follow the same principles as the vaccine cold chain, but be specific to blood and blood products. The temperature and volume of blood during storage, the short life span of blood components and their movement to and from the blood bank invariably require equipment with different specifications. The blood cold chain has therefore developed in parallel, and at a different pace to the vaccine cold chain. This publication aims to provide not only WHO minimum performance specifications and product information on equipment evaluated by WHO, but also basic information on the blood cold chain and guidelines on its management. A chapter on equipment maintenance has been especially included following recognition of the lack of knowledge on preventive maintenance and management of the inventory of spare parts in many countries. Manufacturing prices and exchange rates are not provided since these may well be out-of-date before the Guide is printed. In carrying out its work, the WHO Blood Cold Chain Project has been supported by manufacturers of blood cold chain equipment and national authorities who have participated in field evaluation programmes. Manufacturers’ equipment, evaluated under the WHO Project, appear in this Guide as examples of blood cold chain equipment only. It is hoped that the data obtained from the equipment evaluated and the minimum performance specifications identified will enable other manufacturers to promote equipment that meets or surpasses these specifications for blood storage and transportation. Future editions of this Guide may include such equipment, in collaboration with the manufacturers and subject to the rights of WHO. Furthermore, it is hoped that this Guide will assist managers and users of blood cold chain equipment to evaluate blood cold chain equipment in general. A cost-effective blood cold chain programme can only be achieved if technologically appropriate equipment for the storage of blood and blood components is affordable and accessible at all levels of the health care system. We hope you will find this Guide useful, and welcome your comments to enhance future editions of this work. Dr Jean C. Emmanuel Director Blood Safety and Clinical Technology ix