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NHSScotland: Sterile Services Provision Review Group: Survey of Decontamination in General Dental Practice

SECTION 1: INTRODUCTION AND BACKGROUND

1.1 Introduction

Following the discovery of a new form of CJD, variant CJD (vCJD), in the UK during the 1990's there is a potential risk of person-to-person transmission of this disease via re-usable surgical instruments that have been inadequately decontaminated ^1-6. Decontamination is the combination of processes (including washing, disinfection and sterilization) employed to make re-usable items safe for handling by users and for use on patients. The effective decontamination of re-usable medical and dental devices is essential in reducing the risk of transmission of vCJD and a range of other infectious agents, including blood borne viruses.

This report forms one of a series of documents by a Group led by John Glennie (the 'Glennie Group') that has undertaken a review of sterile service provision across NHSScotland. The Group's initial remit was:

a. to identify the nature and scope of current sterile service provision in NHSScotland ('sterile services' are defined as those services that reprocess invasive medical devices for reuse through decontamination);
b. to develop a framework for change with specific regard to achieving the required technical and operational standards in the most cost-effective way possible; and
c. to identify the means of achieving change.
Initial work by the Glennie Group focused on activities which carried a high level of risk relative to vCJD ⁷. This work has revolved around centralised sterile service departments (CSSDs), all locally processed acute sector activity and minor procedures by general medical practitioners. Concerns about the transmission of vCJD via surgical procedures provided the initial stimulus for the review of decontamination facilities. However, the high level of healthcare associated infections and potential microbiological hazards to staff are also of significance. Obtaining data on cross-infection in primary care facilities is difficult due to the lack of surveillance data. However, there are a number of incidents of transmission of infectious agents in dental practice, for example hepatitis B ^8-14 and more recently

Methicillin Resistant Staphylococcus aureus (MRSA) ¹⁵, which highlight the potential for cross-infection if practice is poor.

1.2 Primary dental care services in Scotland

Primary care dental services in Scotland are provided under both NHS and private arrangements, with many individual courses of treatment encompassing both private and NHS treatment. Many dentists offer NHS and private services independently and some under contract to a Dental Body Corporate (company). General dental services may also be provided within a salaried framework under the management of an NHS Board.

Dental practices in Scotland offering any NHS services are subject to inspection under a national practice inspection scheme. In practical terms, such practices commonly offer both private and NHS care. Dental Bodies Corporate are subject to limited regulation by the General Dental Council and those offering NHS dental services will be subject to inspection under the practice inspection scheme. Wholly private dental practices are not currently subject to inspection. However, in Scotland, draft primary care dental standards have been developed jointly by the National Care Standards Committee and NHS Quality Improvement Scotland which cover both private and NHS dental services, including those delivered wholly privately.

1.3 Decontamination practice

The aim of decontamination is to make re-usable medical devices safe for use on a patient and for staff to handle without presenting an infection hazard.

The processes involved in decontamination are described using the model, developed by NHS Estates, of the "life-cycle" of re-usable surgical instruments (Figure 1).

Figure 1. Life-cycle of re-usable surgical instruments

To undertake decontamination effectively requires correct implementation of all the processes illustrated in the life cycle, with appropriate controls and monitoring in place. Achieving minimum standards at each stage of the life-cycle depends on location; facilities available; equipment used; how the process is managed, and the policies and procedures employed. The basic requirements for good decontamination practice are summarised in Table 1.

Table 1

Guidance and specific requirements relating to decontamination practice have been published over many years. As a general principle, guidance documents, such as SHTM 2010, allow users to fulfil their legal obligations if implemented fully. There are a number of legal imperatives to ensure appropriate facilities and management processes are in place at all sites undertaking decontamination of re-usable devices. The majority of the legislation that encompasses the decontamination of medical devices is enshrined within legal documents applicable to the whole of the European Union. Examples of these documents include:

The Consumer Protection Act (European Community Directive no. 85/37/374/EEC): In particular product liability, has implications for the reprocessing of devices used for patient care. It is essential to maintain adequate records that demonstrate how a particular device was processed and a description of the methods employed.

The Medical Devices Directive (93/42/EEC) - Implemented within the UK as the Medical Devices Regulations 2002: The European directives for medical devices were devised as part of the programme to create a single European market with the objective of enabling the free movement of goods by the removal of trade barriers. The health and safety of citizens is the responsibility of each European Union Member State. In order to allow free movement of goods the directives specify the essential requirements to be met by devices before they can be placed on the market. The CE mark means that the manufacturer is satisfied that his product complies with the essential requirements of the Medical Device Directive (MDD). The responsibility for ensuring a device complies with the requirements of the Directive falls directly on the manufacturer of that device. Manufacturers are required by the Medical Devices regulations to supply information to the user "on the appropriate processes to allow re-use, including cleaning, disinfection, packaging and where appropriate, the method of sterilisation of the device and any restriction on the number of re-uses". The MDD also applies to devices such as benchtop steam sterilizers and washer/disinfectors.

The Health and Safety at Work etc Act 1974; Management of Health and Safety at Work Regulations 1992: Regulations enacted under this act specify the detailed

requirements for ensuring Health and Safety at Work. Examples include many of the requirements for employers to ensure the health, safety and welfare at work of all their employees and others who might enter the work place, such as patients, "so far as is reasonably practical". Specifically, employers must ensure that the work place is safe and does not pose a risk to health and that materials used do not pose a risk to health (there are additional requirements under Control Of Substances Hazardous to Health Regulations, Reporting of Injuries, Diseases and Dangerous Occurrences Regulations. It is also incumbent that all the necessary information, instruction, training and supervision is provided. The 1992 regulations place emphasis on sound safety management and require a risk assessment to be carried out and appropriate measures taken to reduce risk.

General Dental Council Maintaining Standards, Guidance to Dentists on Professional and Personal Conduct: "There has always existed the risk of cross-infection in dental treatment. Therefore, a dentist has a duty to take appropriate precautions to protect patients and other members of the dental team from that risk. Detailed guidance on cross-infection control has been issued by the Health Departments and the British Dental Association, and is endorsed by the Council. Failure to employ adequate methods of cross-infection control would almost certainly render a dentist liable to a charge of serious professional misconduct."

1.4 Decontamination in primary dental care in Scotland

Initial estimates of the quantity of instruments re-processed in Scottish general dental practice suggested numbers in excess of 180 million items per annum ⁷. This volume of material represents a substantial component of the instrumentation reprocessed within the NHS, for which only scanty technical data were available. Previous studies of decontamination practice in primary dental care have either been questionnaire-based ¹⁶ or limited in number, using data collection forms that were not designed specifically for dental practices, for example reviews of 15 sites in England ¹⁷ and 5 sites in Scotland ⁵. In order to provide a more robust evidence base

of current decontamination practices within the general dental services of Scotland, a large-scale observational study was designed. This has been the largest survey of

decontamination ever to be undertaken in general dental practice, incorporating actual visits to individual premises to view processes. This study was limited to examining the decontamination of re-usable medical devices in general dental practice. Other infection control procedures, such as hand washing, were not reviewed.

1.5 Decontamination in other primary care settings

It is envisaged that the results from this study will also be applicable to other healthcare professionals in the primary care Independent sector, that undertake local reprocessing of devices. These include podiatry and general medical service.

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