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Executive Summary
Endoscopes are instruments used to obtain a view of the interior of the body. Their diagnostic and therapeutic benefits are well recognised and their increasing use is testament to this. Nevertheless, endoscopes and in particular flexible endoscopes are delicate but complex medical devices with very particular requirements for decontamination between uses. They often have multiple channels of very small internal diameter making cleaning difficult. Decontaminating them involves pre-cleaning, leak testing, cleaning, disinfection, rinsing, inspection, transport and storage. For these to be effective, all the process stages need to be conducted correctly, with controls and monitoring in place. Endoscope washer disinfectors ( EWD) can control many of the stages automatically. However they must be fit for the purpose of decontaminating specific endoscopes. This requires that each EWD is subjected to validation and periodic testing and planned preventive maintenance.
It is well established that endoscopy carries a very low (but probably underestimated) risk of infection. In virtually all cases, the diagnostic and therapeutic benefits of endoscopy will far outweigh the risk of infection. Compliance with best practice guidance however is essential if healthcare providers wish to keep the risk low and avoid legal liability for any adverse events following endoscopy.
In June 2004 an incident occurred in Northern Ireland which gave rise to concern about endoscope decontamination. A Scottish Action Group ( SAG) was set up to oversee any actions resulting from the NI incident. A Hazard Notice (HAZ(SC)04/05) was issued which instructed that an immediate review and assessment of all endoscope reprocessing facilities be undertaken and where deficiencies in processes were identified, implicated endoscopes be withdrawn from use. Subsequently the Chief Medical Officer requested that HPS undertake a review to provide assurance that the actions taken in response to the notice had been effective and to inform him of any concerns about practice.
The identification and inclusion of clinical units using and/or decontaminating endoscopes in the review was the responsibility of NHS Boards and independent sector hospitals in Scotland. An assessment methodology was developed by HPS to collect information on:
- endoscope details (recognition of model number and channels etc),
- manual cleaning procedures,
- endoscope reprocessing equipment,
- process chemicals (detergents and chemical disinfectants),
- validation, maintenance and testing of reprocessing equipment.
NHS Boards' nominees had the responsibility for ensuring the accuracy and completeness of the dataset which was then submitted to HPS electronically. In almost all instances, the staff responsible were professionals either directly involved in endoscope decontamination or were in close and direct consultation with those directly involved in decontamination of endoscopes. The submitted data were anonymised, analysed by an accredited professional with appropriate experience, cross-checked by one or both of two other appropriately qualified professionals and then tabulated to identify current practice in endoscopy decontamination, related in particular to the scope of the Hazard Notice. Preliminary findings and emerging recommendations were discussed with a range of professionals directly or indirectly involved in decontamination.
The reports received from 153 clinical units provided data on 1403 flexible endoscopes of which 156 (11.1%) could not be identified as a model supplied by any manufacturer known to HPS. Only 664 endoscopes (59%) with a recognised model number were demonstrated to have a complete match of the reported channels compared with information supplied by the endoscope manufacturer.
The results indicate that considerably less than half the endoscopes were cleaned and disinfected in accordance with current guidance and endoscope and EWD manufacturer's instructions (referred to in the report as the 'preferred method'). However, when allowance is made for endoscopes in which the channels were not correctly identified, the overall estimated rate of compliance with the 'preferred method' fell to 17%.
The facilities for manual washing were often not to the required standard and many of the EWDS in use were technically inadequate by current standards. Most had not been suitably validated and tested to the standards described in current best practice guidance. Where validation studies had been undertaken this usually did not include cleaning efficacy tests, which are an essential element of validation.
The Hazard Notice required identification of all endoscope channels. The results of the review indicate that this has yet to be fully achieved. A significant proportion of endoscopes (11%) were not identifiable with any manufacturers' model of endoscope. Only 59% of endoscopes of recognised model gave a complete match for the different channels present in the endoscope.
The development and application of the tool for endoscope decontamination has highlighted and quantified issues that were not revealed by previous observation and local review. While noting that there were instances of good practice, the overall picture is one of non-compliance with current best practice guidance.
The most important remedial action is to ensure that the requirements of the HAZ(SC)04/05 are fully implemented. Remedying the non-compliance with current best practice guidance will entail considerable effort. It should only be commenced after a review of current priorities related to the control of HAI and in particular those related to medical device decontamination. HPS therefore recommends that:
- The CMO should write to the service drawing attention to the need to ensure that all actions required under the Hazard Notice have been fully implemented. In particular to ensure that all channels in all endoscopes currently in use have been identified together with appropriate procedures for cleaning and disinfecting all channels.
- Priorities in respect of medical device decontamination should be reappraised in light of the review findings.
- Following a review of priorities, SEHD should consider establishing a National Endoscopy Strategy Group, to assess the implications of the review report and plan any action necessary.
- A National Endoscopy Forum should be established to promote and share good decontamination practice experience.
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