DECONTAMINATION STANDARDS AND GUIDANCE
The standards and guidance summarised below comprise the principal references relevant to the achievement of the technical requirements detailed in Appendices D.1 and D.1A.
British Standards
Independently accredited compliance with BS EN ISO 9002, and BS EN 46002 is essential for decontamination units which are required to be registered as manufacturers under the Medical Devices Regulations. These standards together with the associated guidance standard BS EN 724, provide a framework for all the.htmects of management control that need to be considered in the provision of an appropriate decontamination service. Harmonised European standards, e.g. EN 554, afford a presumption of compliance to the relevant essential requirements given in Annex 1 of the Medical Devices Directive. All healthcare facilities should be complying with these standards and hospitals were advised of this in Medical Devices Bulletin 18a.
British Standards such as BS 5295 (clean rooms), 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 sterilise 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.
Guidance documents
Scottish Health Technical Memoranda (SHTM)
SHTMs are produced to provide healthcare facilities with a framework of best practice in the choice, purchasing, installation, validation, and 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:
SHTM 2025 Ventilation in healthcare premises
SHTM 2025 provides guidance on the legal requirements, design implications, maintenance and operation of specialist ventilation in all types of healthcare premises. SHTM 2025 is published in four volumes:
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.
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 sterilising, 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.
DB2000(05): Guidance on the Purchase, Operation and Maintenance of Vacuum Benchtop Steam Sterilizers
This bulletin is supplementary to DB9804 and provides guidance on the purchase, operation and maintenance of benchtop steam sterilizers that have a forced air removal system to provide Type B or Type S sterilization cycles. These sterilizers are marketed as vacuum benchtop steam sterilizers or porous load benchtop steam sterilizers. It also covers periodic testing.
DB2000(04): Single-Use Medical Devices: Implications and Consequences of Reuse
This bulletin replaces DB9501 and draws attention to the hazards and risks associated with reprocessing and reusing single-use medical devices. It covers the legal issues and regulatory requirements of such actions. It also considers the implications of damage to the materials or construction of the device and inadequate decontamination procedures.
DB2000(02): Medical Devices and Equipment Management: Repair and Maintenance Provision
This bulletin builds on and provides additional guidance to that contained within MDA Bulletin DB9801, covering the management of the repair and maintenance process, and setting out good practice for the organisation that carried it out.
DB9804: The Validation and Periodic Testing of Benchtop Vacuum Steam Sterilizers
This bulletin provides guidance for owners, managers and users of vacuum benchtop steam sterilizers in order to minimise risks to patients and operators. It gives details of daily and weekly tests and checks needed, and test protocols for medical physicists and Test Persons (sterilizers).
DB9801: Medical Device and Equipment Management for Hospital and Community-based Organisations
This bulletin replaces HEI 98 and emphasises training and maintenance as being the two factors with the greatest impact on the safe use of medical devices. It highlights user knowledge and skills as having major implications for safety and outlines the need for both generic and specific training. Planned preventative maintenance, which follows manufacturer’s guidance, is also emphasised in ensuring that devices are safe and reliable.
DB9801 Supplement 1: Checks and Tests for Newly-delivered Medical Devices
DB9607: Decontamination of endoscopes
This bulletin is concerned with those problems associated with the decontamination of endoscopes and their accessories. Attention is drawn to areas of particular concern and advice and guidance offered to both users and manufacturers (of both the devices and the processing equipment) in resolving these issues. It also draws together existing advice, with particular reference to disinfectant contact times, upon which those personnel with responsibility for decontamination and infection control may base their processing procedures.
DB9605: The Purchase, Operation and Maintenance of benchtop steam sterilizers
This bulletin is aimed at all owners and users of small benchtop steam sterilizers and should be of particular interest to: General Practitioners, community healthcare workers, dental practitioners, podiatrists, and staff in operating theatres, Intensive Care Units, Day Surgery Units, Accident & Emergency departments and Out-patient departments. It is also relevant to tattooists and acupuncturists. It contains advice regarding the purchase, installation and validation, periodic testing, maintenance, technical.htmects, safety considerations, legal and insurance considerations as relevant to this equipment.
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.
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.