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Endoscope Task Force Report

  • Last modified date:
    9 February 2007

In May 2004 an incident was reported from Northern Ireland concerning failure to decontaminate adequately a flexible gastrointestinal endoscope. This incident led to a look back exercise which did not yield any cases of cross infection. A survey of other units in the Province brought several other instances of inappropriate decontamination to light.

In response to the Northern Ireland incident, the Medicines and Healthcare Regulatory Agency (MHRA) issued MDA 2004/28 - Flexible and Rigid Endoscopes on 23rd June 2004. The action was to carry out an immediate assessment of all endoscope decontamination processes. If a problem was identified that could raise concerns for public health or infection control, clinicians were required inform the local Consultant in Communicable Disease Control. In addition, an Endoscope Task Force, was set up to look into the decontamination of flexible endoscopes.

In response to the Device Alerts, a total of 21 incidents were reported to the Task Force in England. These incidents were reviewed by an Expert Advisory sub-group of the Task Force and the sub-group's findings were sent to the full Task Force for approval.

The review of incidents classified problems into:-

  • incompatibilities between endoscope and the automated reprocessor
  • endoscopy staff unfamiliar with the decontamination process specific for the particular endoscope
  • poor communications between endoscope manufacturers and endoscope automated reprocessor manufacturers.

The Task Force concluded that current guidelines are sufficient to cover the identified problems, but that there was a need to ensure that endoscope users were aware of such guidance. The Task Force advised the Chief Medical Officer that lookback investigations were NOT indicated on the basis that:

  • the look back exercise in Northern Ireland did not identify any cases of transmission of blood-borne viruses.
  • the literature review indicated that endoscopy carried a very low risk of transmission of blood-borne viruses (this has been forwarded for publication).
  • the English incidents carried a low risk of transmission (some centres carried out lookback investigations and no cases of transmission were identified).
  • these groups confirmed that corrective action had been taken in Trusts.
  • the risk of transmission needed to be balanced against the impact on patients and the NHS.

Sir Liam Donaldson, the Chief Medical Officer has considered the Task Force's recommendations and has agreed that in the reported incidents a look back investigation will not be necessary, with the caveat that all Decontamination Staff (nurses and technicians) should be fully trained in the decontamination of the types of endoscopes that they were expected to clean.

The MHRA will be shortly issuing a poster displaying action points that arose from the review together with advice on how they should be addressed. This will be titled 'Ten Top Tips'. It will be disseminated by the MHRA Medical Device Alert cascade to all appropriate end-users and be accessible on the MHRA website.

October 2005

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