1.1 Introduction
1.1.1 This report, the Glennie Framework, is the first of a series of reports by a Group led by John Glennie, Chief Executive Borders General Hospital NHS Trust that reviews the current and possible future configuration and provision of NHS sterile services across Scotland. The need for the review stems from clinical opinion that there is a potential risk of person to person transmission of vCJD via re-usable surgical instruments that have not been properly decontaminated.
1.1.2 For this report, ‘sterile services’ are defined as those services that reprocess invasive medical devices for reuse through decontamination. Decontamination is the combination of processes (including washing, disinfection and sterilisation) used to make re-usable items safe for handling by staff and use on patients. The effective decontamination of re-usable medical devices2 is essential in reducing the risk of transmission of infectious agents.
1.1.3 As part of a major initiative by the Scottish Executive Health Department (SEHD) to address Healthcare Associated Infection (see 1.4.3), NHS trusts have been tasked with developing action plans to bring their decontamination processes for medical devices up to required standards by March 2004. This report reviews the current state of decontamination services in Scotland and, against that background, provides a framework within which NHS trusts can develop the required action plans.
1.1.4 The Framework covers the activity for all centralised sterile service departments (CSSDs), all locally processed acute sector activity, dental hospital activity, and minor procedures by general medical practitioners. It does not cover locally processed primary care trust (PCT) activity or dental activity in community healthcare facilities and by private or independent dental practitioners. Further data is being collected for these areas of activity and will be reported upon at a later stage.
1.1.5 The action plans above are to be with SEHD by the end of October 2001. A second report, in November, will make recommendations on service reconfiguration and resource implications for the acute sector managed services. The third report, early next year, will cover the issues of locally processed PCT and dental activity.
1.2 Need for Review
1.2.1 The Glennie Group was established following a recommendation by a working group led by Dr David Old, then Reader in Microbiology at the University of Dundee Medical School. Dr Old’s Group reviewed NHSScotland’s compliance with published guidance on the decontamination of medical devices, and the adequacy of the guidance. Similar to this report, its driver was a public health requirement to minimise the potential risk of person to person transmission of vCJD via re-usable surgical instruments.
1.2.2 To assist the Old Group, SEHD commissioned NHS Estates and the Scottish Centre for Infection and Environmental Health (SCIEH) to carry out a review of decontamination practices in healthcare premises in Scotland.
1.2.3 The Old Group’s report ‘The Decontamination of Surgical Instruments and other Medical Devices’ was issued in February 2001 under cover of NHS HDL (2001) 10. It reported that, whilst there were examples of good practice, many decontamination processes fell below current standards. In some cases, practice was unacceptably poor. The Group’s recommendations led to the establishment of two further working groups, namely the Glennie Group and the Carey Group that have linked interests.
1.2.4 The remit of the Carey Group, chaired by Richard Carey, Chief Executive of Highland Acute Hospitals NHS Trust, was to review and develop guidance and standards on managing the risk of Healthcare Associated Infection. The Group’s work and report concentrated on the management action needed to identify, quantify, manage and, through the application of set standards, control risk in the areas of infection control, hospital cleaning services and the decontamination of medical devices.
1.2.5 The Carey Group subsequently produced draft decontamination standards. Management responsibility for these standards (and those for infection control and hospital cleaning) has passed to the Clinical Standards Board for Scotland (CSBS) and Trusts have been asked to undertake a baseline assessment of their compliance with these standards. The results will be fed back to CSBS who aim to collaborate in an UK-wide approval scheme for decontamination services for NHS trusts early in 2002.
1.2.6 The development and implementation of plans to reduce the potential risk of vCJD transmission through surgical instruments in the UK involves close collaboration among the four Health Departments. With regard to sterile service provision, the aim is to ensure a commonality of approach particularly with regard to standards and time-scales. This is driven in part by the recommendation of the Philips Inquiry into BSE that arrangements need to be in place for a synchronised approach to common problems of animal or human health.
1.2.7 The Glennie Group (membership at Appendix A.1) was established in December 2000 with a remit to identify:
1.2.8 The review rested on a self-assessment survey of decontamination practices and procedures across NHSScotland trusts undertaken in March 2001. The survey collected data on the management and operational.htmects of service provision, which has been used for the Main Review that is reported further at Section 2 below.
1.2.9 Subsequent to the Main Review being commissioned, concerns were expressed by the UK Government’s Spongiform Encephalopathy Advisory Committee (SEAC) about the higher theoretical risk of person to person transmission of vCJD through surgical instruments used in neurosurgery and posterior eye surgery.
1.2.10 To address the SEAC concerns, a more in-depth ‘fast track’ external assessment was made of the decontamination processes in the 10 units in Scotland that provide sterilisation services for the clinical activities concerned. The results of the assessment, and plans to remedy identified processing deficiencies, were presented to a sub-group of the Glennie Group (membership at Appendix A.2). The ‘Fast Track’ review is covered in more detail at Section 3 below.
1.3 Report Coverage and Next Steps
1.3.1 The Glennie Framework addresses the first two remit items at 1.2.7 above. It focuses mainly on the acute sector, which carries a high level of risk relative to vCJD, covering all centralised sterile service departments (CSSDs) activity, all locally processed acute sector activity, dental hospital activity, and minor procedures by general medical practitioners.
1.3.2 The Framework does not cover, in any great detail, locally processed primary care trust (PCT) activity nor dental activity in community healthcare facilities and by private or independent dental practitioners. Further data is being collected for these areas of activity and will be reported upon at a later stage.
1.3.3 The technical requirements and guidance contained in this report regarding the decontamination of surgical instruments relates to where the sterilisation phase includes the application of a time-temperature-pressure stage. Currently, flexible endoscopes undergo sterilisation utilising chemical methods. The Medical Devices Agency and the UK Health Departments are currently revising the guidance on the decontamination of endoscopes. Accordingly, this report does not cover in detail the provision of services to decontaminate such medical devices.
1.3.4 With regard to decontamination processes for dentistry, the Scottish Executive Health Department’s Chief Dental Officer (CDO) has established a Group to consider the requirements for reducing the potential risk of transmission of vCJD through surgical instruments. Between the CDO and Glennie Groups, further work will be taken forward to review compliance with standards in primary care dentistry and the implications of developing remedial measures to meet agreed standards.
1.3.5 In considering the framework for developing and securing improvements in decontamination services, the Glennie Group has refrained from drafting a blue print for future service provision. Instead the Framework provides NHS trusts and Island Health Boards with data and a range of options on which to develop and cost local solutions to suit local circumstances. In so doing it seeks to encourage collaboration and joint working between trusts.
1.3.6 It is clear from survey work undertaken to date that most sterile service sites fail to meet the technical requirements (see Section 2.3 and Appendix D.1) to reduce the potential risk of transmitting vCJD. Therefore, as well as undertaking the CSBS baseline assessment mentioned at 1.2.5 above, acute trusts (initially) have been requested to prepare action plans to reach the set technical requirements for consideration by the Glennie Group in November 2001. The timing for similar action by primary care trusts, and covering general dental activities, will be determined later.
1.3.7 The Glennie Group plans to issue a second report in the latter part of 2001 that will summarise the acute trusts’ proposals, make costed recommendations for reconfiguring decontamination services, and the pace of implementation. Similar action will be taken early in 2002 for the primary care sector.
1.4 Future Funding Considerations
1.4.1 The Group acknowledged that implementation of the finally agreed reconfiguration model will have resource implications. It was noted that health boards ‘Indicative Revenue Allocations letter for 2002-03 & 2003-04’ (6th April 2001) listed ‘improving decontamination procedures’ as a financial pressure to be taken into account when preparing future financial plans. Therefore, the Group considered that any resources made available should be:
1.4.2 In cases where central investment is approved, it will be necessary for trusts and health boards to follow the Health Department’s normal business case criteria and procedures.