In preparing this guidance the Advisory Committee received evidence that effective methods for removing CJD infectivity from instruments are likely to be available and widely introduced within 5 years. Therefore any recommendations in this guidance for changes in practice needed to be both practical and achievable within a short time frame. The recommendations take into account many potential difficulties in implementation, such as current problems with availability and quality of single-use instruments and imperfections in instrument tracking systems, in addition to a major exercise in cost effectiveness modelling.
1.1 For high-risk surgical procedures (intradural operations on the brain and operations on the retina or optic nerve – 'high-risk tissues'):
Steps should be taken urgently to ensure that instruments that come into contact with high-risk tissues do not move from one set to another. Practice should be audited and systems should be put in place to allow surgical instruments to be tracked, as required by Health Service Circular 2000/032: 'Decontamination of medical devices' and described in the NHS Decontamination Strategy.
Supplementary instruments that come into contact with high-risk tissues should either be single use or should remain with the set to which they have been introduced. Hospitals should ensure without delay that an adequate supply of instruments is available to meet both regular and unexpected needs.
A full list of high-risk procedures is given in appendix C (see PDF of the full guidance).
1.2 For neuroendoscopy:
Rigid neuroendoscopes should be used whenever possible. They should be of a kind that can be autoclaved and they should be thoroughly cleaned and autoclaved after each use.
All accessories used through neuroendoscopes should be single use.
1.3 A separate pool of new neuroendoscopes and reusable surgical instruments for high-risk procedures should be used for children born since 1 January 1997 (who are unlikely to have been exposed to BSE in the food chain or CJD through a blood transfusion) and who have not previously undergone high-risk procedures. These instruments and neuroendoscopes should not be used for patients born before 1 January 1997 or those who underwent high-risk procedures before the implementation of this guidance.
1.4 For all procedures considered in this guidance, with the exception of those involving neuroendoscopy accessories, the evidence on cost effectiveness related to the risk of possible transmission of CJD does not support a change to single-use instruments, based on current costs. This includes all other neurosurgery, eye surgery, tonsillectomy, laryngoscopy and endoscopy procedures.
1.5 Single-use instruments should be manufactured and procured to specifications equivalent to those used for reusable instruments and should be subject to high standards and consistent quality control. Single-use instruments which are not similar in quality to the reusable instruments which they replace have the potential to harm patients and should not be purchased or used.
1.6 This guidance has been developed on the assumption that new and more effective decontamination methods are likely to become available for routine use in the NHS within the next 5 years. Rigorous evaluation of the safety of these methods and of their efficacy against human prions is urgently required.
Until then, the current Advisory Committee on Dangerous Pathogens Transmissible Spongiform Encephalopathies (ACDP TSE) guidelines on decontamination should be followed.
The Institute will review this guidance after 2 years or sooner if important new information becomes available, including evidence on:
new decontamination methods, which are safe and effective against human prions
the epidemiology of CJD, including data on the prevalence of vCJD infectivity in the UK population
cases of transmission of CJD via surgery
the availability and performance of single-use instruments in high-risk specialties.