(2) how much his Department spent on improving decontamination services for surgical equipment in the NHS in each financial year since 2000-01.
The Department can confirm that it has not issued formal guidance on the use of independent sector decontamination services. However, a statement has been made on overall policy in the area of surgical equipment decontamination. This is contained in the “2007 Clarification and Policy Summary—Decontamination of Re-Usable Medical Devices in the Primary, Secondary and Tertiary Care Sectors (NHS and Independent providers)”. This document sets out guidelines to ensure universally high standards of decontamination practice and outcome, whether the provider of the decontamination service is an independent sector supplier or within the national health service. Copies of the document have been placed in the Library and are also available from the Department’s website at:
Capital allocations made by the Department to the NHS for improving decontamination services, during the period referred to, are shown in the following table.
£ million 2000-01 0.00 2001-02 25.26 2002-03 59.76 2003-04 29.00 2004-05 70.00 2005-06 29.85 2006-07 21.59 2007-08 8.72 Total 244.18
Where decontamination services are provided only for internal use by the same NHS Trust or another national health service body, then policy requires compliance with the ‘essential requirements’ of the Medical Devices Directive (93/42 EC) and associated Regulations. These are referred to in 2007 “Clarification and Policy Summary—Decontamination of Re-Usable Medical Devices in the Primary, Secondary and Tertiary Care Sectors (NHS and Independent providers)”. Copies are available in the Library.
Where NHS units provide services to other NHS bodies or to independent sector providers then they are subject to the full requirements of the Medical Devices Regulations 2002 (SI 618) and 2003 Amendments (SI 1697). In these instances the unit will be subject to a third party audit programme by a recognised Notified Body. The Competent Authority, The Medicine and Healthcare products Regulatory Agency will carry out one or more conformity assessments as described in annexes to the Regulations.
National surveys of the quality systems related to effectiveness and efficiency of both national health service and independent sector suppliers of decontamination have been undertaken since 1999. The most recent published report is ‘The Decontamination of Surgical Instruments in the NHS in England - Update report - A step change’, published in June 2005. This demonstrates improvements in virtually all areas of quality systems and control over the 1999 to 2004 period. Copies of this publication have been placed in the Library.
The Chief Medical Officer has requested a further survey during the present year. This is referred to as the National Decontamination Survey 2008 and is currently in progress. The survey will visit some 35 NHS trusts including several which use commercial suppliers of decontamination services. The trusts have voluntarily agreed to take part and the focus is on those institutions that pursue high-risk tissue surgery in respect of the theoretical risk of human prion disease transmission. It is expected that the full survey will be complete by August 2008.