Dr David Old (Chair)
Reader in Medical Microbiology
University of Dundee
Ninewells Hospital,
Dundee
Dr Mary Hanson
Clinical Microbiologist
Western General,
Edinburgh
Ms Mary Henry
Consultant Nurse Epidemiologist
SCIEH
Glasgow
Mrs Sue Johnson
Theatre Manager
Ninewells Hospital,
Dundee
Mr J McLuckie
Director
NHSiS Property and Environment Forum Executive
Glasgow
Ms Joan Sneddon
Senior Nursing Adviser Infection Control
Lanarkshire Health Board
Hamilton
Dr Andrew Smith
Microbiologist
Dental Hospital
Glasgow
Dr D Taylor
Microbiologist
SEDECON 2000
Edinburgh
Mr Gerry Watson
Medical Director
Crosshouse Hospital,
Kilmarnock
Dr. Ros Skinner
Principal Medical Officer
SEHD
Dr. Martin Donaghy
Senior Medical Officer
SEHD
Mr. Matthew Cormack
Health Policy Division
SEHD
Decontamination is the combination of processes, including cleaning, disinfection and/or sterilization, used to render a re-useable item safe for further use. The decontamination process is intended to:
Cleaning is the process that physically removes soiling including large numbers of micro-organisms and the organic material on which they thrive.
Disinfection is the reduction of the number of viable micro-organisms on a product to a level previously specified as appropriate for its intended further handling or use.
Sterilization is the process used to render a product sterile. EN 556 specifies that to be labelled ‘sterile’ a medical device should have been subjected to a validated sterilization process so that there is less than a 1 x 10-6 probability of a surviving micro-organism.
Medical device is defined in the Medical Device Directive as "an instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper application, which –
The term Medical Device also includes accessories necessary for the correct functioning of the medical device. Washer-disinfectors and sterilizers for use in healthcare facilities are classified as medical devices.
Benchtop (steam) sterilizers are intended for the sterilisation of unwrapped instruments and utensils for use in the immediate patient environment. They require no permanent connections or installation, and are capable of being moved manually from one site to another without the need for lifting tackle
Porous-load sterilizer is a clinical sterilizer designed to process, by exposure to high temperature steam under pressure, porous items such as towels, gowns and dressings, and also medical devices that are wrapped in porous materials such as paper or fabrics.
Ethylene Oxide sterilizer is a clinical sterilizer designed to sterilise loads by exposure to ethylene oxide gas or EO gas mixtures
Washer Disinfector is a machine intended to clean and disinfect medical devices and other articles used in the context of medical, dental. pharmaceutical and veterinary practice. Dedicated washer disinfectors are available which are intended specifically for processing endoscopes. These may incorporate a chemical disinfection or sterilization stage, or may require that after processing in the washer disinfector, the endoscope is terminally sterilized using a suitable low temperature sterilization process.
Ultrasonic machines use ultrasound energy to effect the mechanical removal of soiling from the surface of the product.
Independently accredited compliance with BS EN ISO 9002, and BS EN 46002 is only essential for decontamination units which are required to be registered as manufacturers under the Medical Device Regulations. However, these standards together with the associated guidance standard BS EN 724, provide a framework for all the aspects of management control that need to be considered in the provision of an appropriate decontamination service. It is in that context that these standards were used as the basis of the survey.
Harmonised European standards, eg EN 554, afford a presumption of compliance to the relevant essential requirements given in Annex 1 of the Medical Device Directive. All healthcare facilities should be complying with these standards and hospitals were advised of this in Medical Device Bulletin 18a.
British Standards such as BS 5295 (cleanrooms), BS 2745 (Washer – disinfectors) and BS 3970 (sterilizers) are being replaced by International and/or European standards but in the meantime represent the extant position in the UK.
BS EN ISO 9002: 1994 Quality systems. Model for quality assurance in production, installation and servicing
Quality system requirements for use where a supplier’s capability to supply conforming product to an established design needs to be demonstrated.
The standard’s requirements are based on the concept of an organisation providing:
The standard also calls attention to specific consideration at the various stages in the product life-cycle.
The requirements are complementary, not alternative, to technical requirements for the product and are generic and thus independent of any specific industry. In order to tailor the requirements of the standard to the medical device industry, BS EN ISO 9002 is supplemented by the requirements of BS EN 46002.
BS EN 46002: 1997 Specification for Application of EN ISO 9002 to the manufacture of medical devices
EN ISO 9002 is intended to be a general standard defining quality system requirements. EN 46002 provides particular requirements for suppliers of medical devices that are more specific than the general requirements specified in EN ISO 9002
In conjunction with EN ISO 9002, this European Standard defines requirements for quality systems relating to the production, installation and servicing of medical devices. It embraces the principles of good manufacturing practice (GMP) widely used in the manufacture of medical devices. It can only be used in the manufacture of medical devices. It can only be used in combination with EN ISO 9002 and is not a ‘stand alone’ standard.
The key areas in which EN 46002 specifies requirements particular for medical devices may be summarised as:
reporting advisory notices and recalls;
BS EN 724: 1995 Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002
This European Standard provides guidance to organisations providing a non-active medical device who wish to ensure that they will comply with EN 29001/EN 29002 and the particular requirements given in EN 46001/EN 46002. It is also intended to provide guidance for certifying and regulatory bodies. The guidance in this standard for the fulfilment of requirements should always be in relation to the products being manufactured and interpreted accordingly.
This standard needs to be read in conjunction with the EN 29000 series of standards with which compliance is sought. This standard is not intended as a replacement for EN 29004, which has its own very distinct relationship with the EN 29000 series of standards.
The combination of EN 29001/EN 46001 and EN 29002/EN 46002 embraces the principles of Good Manufacturing Practices (GMP) which have been in operation in the manufacture of non-active medical devices for a number of years.
This document seeks to assist in the transition from GMP to quality systems by presenting familiar concepts under the relevant paragraphs of EN 29001/EN 46001 and EN 29002/EN 46002.
BS EN 554: 1994 Sterilization of medical devices – Validation and routine control of sterilization by moist heat
The object of this European Standard is standardisation in the field of validation and routine monitoring of most heat sterilization processes and procedures that are carried out by those who sterilize medical devices. The validation of sterilization procedures presupposes that the sterilizer complies with appropriate specifications.
This standard contains requirements for the validation and routine monitoring of sterilization by moist heat and guidance on its application.
BS 2745: 1993 Washer-disinfectors for medical purposes
This standard specifies washer-disinfectors in which the load remains within the machine until the cycle is completed. All such machines within the scope of this standard are required to include a heat disinfection stage during the cleansing cycle. This heat disinfection stage raises all parts of the maximum permitted load to a specified temperature and maintains that temperature for a specified period of time. Thermal disinfection is achieved by use of hot water or steam in direct contact with all potentially contaminated surfaces after the complete removal of soil.
If the specified temperature is not reached or is not held for the required time, this has to be clearly indicated and it has to be ensured that it will not be possible to remove the contents without appreciating that such a failure has occurred, even when the operator is unfamiliar with the machine. The specified disinfection temperature and holding time should have a lethality sufficient to reduce the number of viable micro-organisms in a load but which may not necessarily inactivate some viruses and bacterial spores.
In addition, the machine’s washing sequence should remove all visible evidence of any soiling likely to have occurred during the normal use of each item of a load or any soil deposited on the chamber walls during the process, provided that the total load does not exceed the specified maximum. This specification should ensure that a machine is safe to operate and conforms to any relevant existing standards, taking account of all legal requirements given in the Acts and documents detailed in this foreword. This standard avoids unnecessary restrictions on size, shape and materials to be used.
BS 2745 has been prepared on the basis that every individual washer-disinfector will be subjected to functional performance tests. Unless otherwise stated in this standard, conformity to the performance requirements is checked by visual inspection or direct measurement.
The test methods and requirements of this British Standard are equally applicable for assessing the functional performance of the washer-disinfector throughout its life.
BS 5295:1989 Environmental cleanliness in enclosed spaces
In the preparation of this revision of this British Standard, account was taken of:
a) The United States of America Federal Standard 209D ‘Clean rooms and work station requirements, controlled environment’, and proposals for its revision;
b) The Institute of Environmental Sciences Tentative Recommended Practice IES-RP-CC006-84-T November 1984 ‘Testing clean rooms’.
BS 5295 sets out, in detail, the requirements to which clean rooms and clean air devices are to conform in order to provide assurance of achieving the requisite level of cleanliness expressed as a particulate concentration in air. Methods of test and of monitoring to demonstrate these levels are given, together with details of procedures and methods of working which will enable the levels to be maintained.
1. Scottish Health Technical Memoranda (SHTM)
SHTMs are produced to provide healthcare facilities with a framework of best practice in the choice, purchasing, installation, validation, monitoring and routine operation of equipment. They are compatible with existing British and European standards and as far as practicable anticipate standards which are currently being developed in Europe.
SHTM 2010 Sterilization
Scottish Health Technical Memoranda (SHTM) 2010 Sterilization gives guidance on the choice, specification, purchase, installation, validation, periodic testing, operation and maintenance of the types of sterilizers commonly found in the National Health Service. SHTM 2010 is published in five volumes:
1 – Management policy – is a summary of the information required by non-technical personnel responsible for the management of sterilization services. It discusses the various types of sterilizer, for both clinical and laboratory use, and also contains guidance on legal and policy matters, and on the appointment and responsibilities of personnel.
2 – Design considerations – contains information relevant to the specification and installation of new sterilizing equipment. It discusses the requirements for each type of sterilizer and outlines the specifications to be included in any contract. Practical considerations for the installation of sterilizers are discussed, including siting, heat emission, ventilation, noise and vibration, and mains services with an emphasis on steam quality.
3 – Validation and verification – covers all aspects of validation and periodic testing of sterilizers. It includes detailed schedules and procedures for tests and checks to be carried out for commissioning and performance qualification and for subsequent periodic testing.
4 – Operational management with Part 6 – Testing and validation protocols – covers all aspects of the routine operation and maintenance of sterilizers, stressing the need for a planned maintenance programme along with the type of records to be kept. Advice on the safe and efficient operation of sterilizers is given, as well as procedures for reporting defects and accidents; and Part 6 – provides step-by-step guidance on testing and validation of processes.
5 – Good practice guide – provides supplementary advice on a number of matters concerned with the effective usage of sterilizers.
SHTM 2030 Washer-disinfectors
SHTM 2030 provides guidance on the choice, specification, purchase, installation, validation, periodic testing, operation and maintenance of the types of washer-disinfectors (WDs) commonly found in the National Health Service. The guidance is currently produced in three volumes:
SHTM 2031 Clean steam for sterilization
SHTM 2031 is published in a single volume covering the nature of contamination in steam supplies, regulatory requirements for steam quality, the new "clean steam" specification, engineering measures for the generation of clean steam, validation and periodic testing of clean steam supplies, and guidance on the analysis of steam samples. It is designed to supplement the guidance on steam quality in SHTM 2010 Sterilization.
2. Planning/Building notes
SHPN 13 Sterile services department
Scottish Hospital Planning Note 13 provides guidance for the planning and design of a sterile services department, with particular requirements for cleaning, disinfecting and sterilizing, storage and materials handling and good manufacturing practice.
Health Building Note 13 Supplement 1: Ethylene oxide sterilization section – provides guidance for the planning and design of a dedicated ethylene oxide sterilization section integrated within a sterile services department.
3. Guidance produced by the Institute of Sterile Services Management
Quality Standards and Recommended Practices for Sterile Service Departments (SSD)
This document succeeds the "Guide to Good Manufacturing Practice" (GMP) issued by the Institute in 1989. It aims to provide a framework for SSD Management to audit compliance against quality standards and recommended practices. It also updates the data provided in the GMP guide, and in particular, provides references to the relevant European or British Standards.
4. Guidance produced UK Government Scientific Advisory Committees
The Advisory Committee on Dangerous Pathogens: Spongiform Encephalopathy Advisory Committee (SEAC) "Transmissible Spongiform Encephalopathy Agents: Safe Working and the Prevention of Infection".
This guidance gives advice on work with transmissible spongiform encephalopathy agents (TSEs) in experimental and clinical settings.
Separate information (listed in the bibliography to this guidance) is available to cover incidental exposure such as in farms, abattoirs or other work with animals.
Mrs Sue Johnson
Theatre Manager
Ninewells Hospital,
Dundee
Dr David Taylor
Microbiologist
SEDECON 2000
Edinburgh
Mr Mark Lavery
Sterile Service Manager
City Hospital
Edinburgh
Dr Ken Liddell
Microbiologist
Law Hospital,
Carluke
Mrs Alison G McEwan
Theatre Nurse
St. John’s Hospital
Livingston
Ms Joan Sneddon
Senior Nursing Adviser Infection Control
Lanarkshire Health Board
Hamilton
Mr Gordon Muir
TSSD Manager
Ninewells Hospital,
Dundee
Mr Paul Howard
Scottish Healthcare Supplies
Edinburgh
Dr Andrew Hay
Microbiologist
Raigmore Hospital,
Inverness
Ms Maggie McCowan
Infection Control Nurse
Victoria Infirmary,
Glasgow
Ms Carole Reed
Infection Control Nurse
Royal Alexandra Hospital,
Paisley
Ms Fiona Kennedy
Stafford
Ms Mary Henry (Project Co-ordinator)
Consultant Nurse Epidemiologist
SCIEH
Glasgow
Mr David Hurrell (Technical Co-ordinator)
Microbiologist
Healthcare Science Ltd
Hitchin