HEALTH TECHNICAL MEMORANDUM 2030 …

1 For queries on the status of this document contact or telephone 029 2031 5512 October 2013 HEALTH TECHNICAL MEMORANDUM 2030 Washer disinfectors: Operational management 1997 STATUS IN WALES ARCHIVED This document was superseded by Welsh HEALTH TECHNICAL MEMORANDUM 01-01 Decontamination of medical devices within acute services 2013 Washer-disinfectorsOperational managementHealth TECHNICAL MEMORANDUM 2030 London: The Stationery Office Crown copyright 1997. Published with permission of NHS Estates, an Executive Agency of the Department of HEALTH , on behalf of the Controller of Her Majesty s Stationery for reproduction should be made in writing to The Copyright Unit, Her Majesty s Stationery Office, St Clements House, 2 16 Colegate, Norwich NR3 published 1997 ISBN 0-11-322070-7 Standing order serviceAre you making full use of The Stationery Office sStanding Order Service?

2 The Standing Order Service is a free monitoring of thepublications of your choice from over 4000 classificationsin 30 major subject areas. We send you your books as theyare published, along with an a standing order for class you can besupplied automatically with further titles in this series asthey are benefits to you are: automatic supply of your choice of classification onpublication; no need for time-consuming and costly research,telephone calls and scanning of daily publicationlists; saving on the need and the costs of placingindividual can supply a wide range of publications on standingorder, from individual annual publications to allpublications on a selected subject. If you do not alreadyuse this free service, or think you are not using it to its full capacity, why not contact us and discuss yourrequirements?You can contact us at:The Stationery OfficeStanding Order DepartmentPO Box 276 London SW8 5 DTTel: 0171-873 8466; fax 0171-873 8222We look forward to hearing from TECHNICAL Memoranda (HTMs)give comprehensive advice andguidance on the design, installation andoperation of specialised building andengineering technology used for thedelivery of are applicable to new and existingsites, and are for use at various stagesduring the inception, design,construction, refurbishment andmaintenance of a TECHNICAL MEMORANDUM 2030 isbeing published in three managementis asummary of the information required bypersonnel responsible for themanagement of facilities in whichwasher-disinfectors are used.

3 It discussesthe various types of washer-disinfectors,for both clinical and laboratory use, andalso contains guidance on legal andpolicy matters, and on the appointmentand responsibilities of personnel. Itcovers all aspects of routine operationand maintenance stressing the need fora planned maintenance programmealong with the type of records to bekept. Advice on the safe and efficientoperation of washer-disinfectors isgiven, as well as procedures forreporting defects and accidents. Itshould be read by anyone consultingthis MEMORANDUM for the first time;Design considerationscontainsinformation relevant to the specificationand installation of new washer-disinfectors. It discusses therequirements for each type of washer-disinfector and outlines thespecifications to be included in anycontract. Practical considerations for theinstallation of washer-disinfectors arediscussed including siting, heatemission, ventilation, noise andvibration, and mains services with anemphasis on steam quality; Validation and verificationcovers allaspects of validation and periodictesting of washer-disinfectors.

4 It includesdetailed schedules and procedures fortests and checks to be carried out forcommissioning and performancequalification and for subsequentperiodic this publicationExecutive summaryHTM 2030 gives guidance on the choice, specification,purchase, installation, validation, periodic testing,operation and maintenance of washer-disinfectors (WDs)in use in the National HEALTH Service for processingmedical devices, laboratory ware and sanitary guidance is given on WDs intended for use inprocessing textiles or for dishwashers in general cateringapplications. This volume Operational Management is intended as a guide for management, TECHNICAL personnel withappropriate training and experience and also for usersresponsible for the day to day running of WDs. It will alsobe of interest to architects, planners, estates managers,supplies officers, and others in both the public and information on the planning and design of asterile services department including the provision of WDsis given in HEALTH Building Note 13 Sterile servicesdepartment (Scottish Hospital Planning Note 13 applies tothe NHS in Scotland).

5 Guidance for laboratory installationscan be found in HEALTH Building Note 15 Accommodation for pathology services (Scottish HospitalPlanning Note 15 applies to the NHS in Scotland).Although this edition of HTM 2030 reflects current WDtechnology it is recognised that considerable scope existsfor improvements in the operational and managementstandards used with WDs. 1 The term washer-disinfector is abbreviated to WD throughout this current British Standards for WDs, although only inforce since 1993, are expected to be replaced byEuropean Union (EU) Standards within the next two tothree years. These Standards include consideration of therequirements arising as a result of EU Directives onmedical devices which affect WDs in two ways: firstly,some WDs will themselves be considered to be medicaldevices and therefore must meet the relevantrequirements of the Medical Devices Directive; andsecondly, the manufacturer of a medical device which isintended to be reprocessed is required to specify themethod to be used for reprocessing which will include anynecessary washing and disinfecting practicable the information in this HTM has beenaligned with existing or anticipated standards and adviceis offered when no standard has yet been WDs described in this HTM may not be suitable,without modification, for safely processing articlescontaminated with either Hazard Group 4 pathogens orwith agents which are unusually resistant to disinfection.

6 The guidance previously given in Management policy hasbeen incorporated into this this publicationExecutive Disinfection in healthcare: an overviewpage Washer-disinfectors and the role ofmanagementpage Legal framework for washing and Medicinal Medical as medical of management Statutory requirementspage HEALTH and safety HEALTH and Safety at Work etc Act Management of HEALTH and Safety at Work Regulations Workplace ( HEALTH and Safety and Welfare)Regulations Provision and Use of Work EquipmentRegulations Pressure Systems and Gas ContainersRegulations Control of Substances Hazardous toHealth Regulations Reporting of Injuries, Diseases and DangerousOccurrences Regulations Manual Handling Operations Regulations Personal Protective Equipment at WorkRegulations Consumer Protection Act Compatibility Regulations Personnelpage Functional Competent Authorised Test Maintenance Control of infection Production Quality Laboratory safety Operational management.

7 An overviewpage Safety inspection and release forfurther Maintenancepage Planned maintenance (PM) Design of a PM Warranty Review of a PM Routine Inspection of pressure requiring special Steam Stainless steel Leak tightness of Door Chemical dosing Water sprays and Ultrasonic Water treatment Ventilation a washer-disinfector to Washer-disinfectors for human-wastecontainerspage Safety Load of cycle variables and chemical Washer-disinfectors for anaesthetic accessoriespage Product Load of cycle variables and chemical Washer-disinfectors for instruments andutensilspage Safety of cycle variables and chemical Washer-disinfectors for thermo-labileendoscopespage Product Load Selection of cycle Manually loaded ultrasonic washerspage Safety of cycle variables and

8 Chemical Liquid chemical disinfectorspage Safety Product Load Selection of cycle variables and chemical Laboratory washer-disinfectorspage Safety Product Load Selection of cycle variables and chemical releaseAppendix I: Glossary of termspage 50 Appendix II: Abbreviationspage 52 Appendix III: Useful addressespage 53 Referencespage 55 About NHSE statespage by washing and disinfection is a complex and subtleprocess. The testing, maintenance and reporting procedures described in thisHTM may seem excessive, but they are based upon good practice in both theUK and Europe, as formalised in European Standards designed to support theEC main purpose of washing and disinfection is to eliminate thehazard of contamination and infection. is the reduction of the number of viable micro-organismson a product to a level previously specified as appropriate for its intendedfurther handling or lethality of the process is less than that of sterilization buteliminates virtually all recognised pathogenic organisms, although notnecessarily all microbial forms, for example bacterial endospores.

9 Disinfectionis adequate for the preparation of many items intended for use in patientcare, but should not be used as a substitute for hospital infection committee should prepare and implement adisinfection policy. This requires consultation between the microbiologist,infection control officer, engineer, pharmacist, supplies officer andrepresentatives of medical, nursing and domestic use of chemical disinfectants should be avoided when heat can bereasonably used as an alternative, for example in thermal disinfection Disinfection in healthcare: an volume of HTM 2030 covers the maintenance and operation of thevarious types of WDs used in hospitals, laboratories and other used in washing and disinfection has long beeninconsistent and this has often lead to ambiguities. This HTM introduces a setof terms which, it is hoped, will provide workers in this field with a standardvocabulary and will also be consistent with the EU Standards which are to beintroduced in the near future.

10 The glossary contains defined terms referred toin this volume of HTM references for all the documents referred to in this part and also forselected documents providing additional information of which the readershould be aware are listed at the end of the NHS is no longer protected by Crown immunity and is now subjectto the full force of the law, notably in HEALTH and safety, medicinal productsand consumer legislation. Tighter statutory control, brought in by newEuropean Union Directives, will extend to almost every aspect of disinfection,and practices which were common a few years ago will no longer test, maintenance and reporting procedures described in this HTMare based upon good practice in both the United Kingdom and the rest ofEurope, as formalised in new European Standards designed to support the newEU Directives, and are designed to prevent the possibility of gross failure andserious staff morale is important.