2.1 Review Methodology
2.1.1 NHS HDL(2001)10 dated 9th February 2001 circulated copies of ‘The Decontamination of Surgical Instruments and Other Medical Devices’ report (see 1.2.1 to 1.2.3 above). The HDL required trusts to designate a senior manager to have overall responsibility for risk assessment and management processes relating to decontamination, infection control, medical devices management and cleaning services. It also required them, by 31st March 2001, to:
2.1.2 To assist the review process, SEHD developed a questionnaire that sought information from all acute and primary care trusts under the following headings:
2.1.3 Data from the duly completed questionnaires, authorised by trust Chief Executives, were summarised and collated by the Scottish Centre for Infection and Environmental Health (SCIEH). A synopsis of the outcome report is provided below.
2.2 Current Situation
2.2.1 There are 28 central sterile services departments (CSSDs) operating in Scotland, inclusive of the three Island Health Boards, three dental hospitals, Glasgow Victoria Linen processing unit and the commercial contractor Trust Sterile Supplies Ltd. (TSSL) based at Bellshill, Lanarkshire. A map of the locations is at Appendix B.1.
2.2.2 Only 4 of the 28 CSSDs are currently accredited to the required EN46002 quality standard (Appendix D.2 details), namely - Ayrshire Central Hospital (Irvine), Ninewells Hospital (Dundee), Victoria Hospital (Glasgow - linen processing unit) and TSSL, who currently provide decontamination services mainly to Lanarkshire Acute Hospitals Trust.
2.2.3 A further 3 CSSDs have committed investment to achieve EN46002 accreditation, namely - Foresterhill Hospital (Aberdeen), New Royal Infirmary (Edinburgh) and Falkirk Royal.
2.2.4 Excluding the Island Health Boards and TSSL, revenue costs are approximately £15 million per annum.
2.2.5 An estimated throughput of 37 million instruments is processed annually by approximately 450 whole time equivalents (WTEs) employed within NHSScotland.
2.2.6 A further (estimated) 32.3 million instruments are currently processed outwith CSSDs at local decontamination units (LDUs), i.e. 6.0 million instruments in the acute sector and 26.3 million in the primary care services managed by Primary Care Trusts.
2.2.7 The above figures exclude instruments processed locally by independent general medical and dental practitioners, currently estimated at 165 million instruments per annum.
2.2.8 The value of circulating stocks of instruments and theatre linen within NHS Scotland is currently unknown.
2.2.9 The majority of CSSDs currently operate significantly below optimum capacity of 70% - 80%.
2.2.10 Facilities are generally operated on a single day shift system 5 to 5.5 days per week with partially manned back and night shifts systems.
2.2.11 Staffing/productivity ratios differ between CSSDs with consequent variations in processing costs. The cost per item ranges between £1.11 and £0.16 against an average of £0.46.
2.2.12 Appendix C lists current activity levels and revenue costs by site, based on Trust provided information.
2.3.1 The Group considered the two key issues relative to the future provision of decontamination activity were:
2.3.2 The Group was aware that a considerable number of legislative and best practice standards exist for decontamination of re-usable medical devices. However, the Group’s primary concern was to address the potential risk of transmitting vCJD through such devices.
2.3.3 Accordingly, the Group devised a Technical Requirements matrix that categorises clinical procedures into the risk ratings of High, Medium and Low, and allocated the legislative/advisory standards against them at ‘Interim’ and ‘Full’ levels and across the function headings of Equipment, Facilities, Staff and Management. The risk matrix relates specifically to CJD and does not mirror the Carey/CSBS risk classification as drawn from the Microbiological Advisory Committee Manual.
2.3.4 The Technical Requirements matrix is at Appendix D.1A with supporting guidance notes at D.1B. A Decontamination Standards and Guidance Note is provided at Appendix D.2.
2.3.5 The Group considered that all CSSDs must comply with the Full Requirement by no later than March 2004. But in between, CSSDs dealing with high risk instruments must reach the Interim Requirement by December 2001 and all other CSSDs by end March 2002. The situation for primary care trusts and dental practitioners will be addressed and reported later.