DECONTAMINATION & STERILISATION ‘‘
The researchers examined 24 clinically used bronchoscopes. After manual cleaning, 100% of bronchoscopes had residual contamination
published in Chest, by Ofstead et al (2018).9
This study involved direct
observation of reprocessing methods for flexible bronchoscopes, multifaceted evaluations performed after manual cleaning and after high-level disinfection, and assessments of storage conditions.
Visual inspections
Visual inspections of ports and channels were performed using lighted magnification and borescopes, and contamination was detected using microbial cultures and tests for protein, haemoglobin, and adenosine triphosphate (ATP). Researchers assessed reprocessing practices, and storage cabinet cleanliness was evaluated by visual inspection and ATP tests. The researchers examined 24 clinically used bronchoscopes. After manual cleaning, 100% of bronchoscopes had residual contamination. Microbial growth was found in 14 fully reprocessed bronchoscopes (58%), including mould, Stenotrophomonas maltophilia, and Escherichia coli/Shigella species. Visible irregularities were observed in 100% of bronchoscopes, including retained fluid; brown, red, or oily residue; scratches; damaged insertion tubes and distal ends, and filamentous debris in channels.
Inadequate reprocessing practices Ofstead et al concluded that damaged and contaminated bronchoscopes were in use at all sites, and commented that inadequate reprocessing practices may have contributed to bioburden found on bronchoscopes. Two of the three study sites failed completely to observe routine reprocessing guidelines, while further issues were identified around disengaging an automated cleaning cycle. The study also uncovered sub-optimal bronchoscope storage practices and substandard routine maintenance of EWDs/AERs. However, even when guidelines were followed, high-level disinfection was not always effective. The authors suggested that a shift towards the use of sterilised bronchoscopes should be recommended. However, in the meantime, “quality management programmes and updated reprocessing guidelines were needed”. In the UK, MHRA and Department of Health HTM 01-06 guidance have also sought to address the issue of infection transmission via endoscopes. An incident reported from Northern Ireland, in 2004, uncovered inappropriate
decontamination practices, following a ‘look-back’ exercise. This prompted the MHRA to issue MDA/2004/028 – ‘Flexible
and rigid endoscopes’, which required Trusts to carry out an immediate assessment of all endoscope decontamination processes.
An Endoscope Task Force was set up in England to look into the decontamination of flexible endoscopes, and this classified problems into: n There were incompatibilities between endoscope and the EWD.
n Endoscopy staff were unfamiliar with the decontamination process specific to the particular endoscope.
n Communication between endoscope manufacturers and EWD manufacturers was poor.
which have since been revised and updated in the Department of Health’s HTM 01-06. These include: n Compatibility: Ensure compatibility with the existing decontamination processes, including the EWD, when purchasing any new endoscopes.
In response to these efforts, the MHRA issued its “Top Ten Tips” in October 2005,10
n Instructions: Ensure that all equipment is operated and controlled in accordance with the manufacturer’s instructions, local endoscope decontamination policy, and associated risk assessments.
n Track and trace: Auto-identification and associated data capture should be used to track and trace all endoscopes, reusable accessories, and EWDs, to ensure appropriate maintenance, correct decontamination, and traceability to associated patients.
n Lumen connection: Check that all lumens in each endoscope can be connected to the EWD using the correct connectors/connection sets provided.
n Manual cleaning: Ensure that endoscopes and reusable accessories are manually cleaned immediately after use, including the flushing of all lumens – even if they have not been used during the procedure.
n Chemical compatibility: Only use chemicals that are compatible with the endoscope and its reusable accessories, and observe the correct process parameters that have been validated and demonstrated to be effective.
n Essential Quality Requirements and Best Practice: Endoscopes should always be decontaminated and maintained to a level specified in Essential Quality Requirements. A continuous process of evaluation and improvement should be in place to progress towards locally determined best practice.
n Planned preventative maintenance: Have planned preventative maintenance and associated record- keeping in place to ensure all parts of the endoscope decontamination and management systems are optimally effective.
n Staff training: Ensure all staff, including new appointees, involved in the decontamination process are specifically trained in their role, and in the broad context of endoscope management, decontamination, and recontamination prevention, and that this training is kept up-to-date.
n Incident reporting: Report any potential failure in the management and decontamination of endoscopes, including equipment problems relating to endoscopes, EWDs, or process chemicals, to a line manager.
An assessment should also be carried out before endoscopy to identify patients with, or at increased risk of, CJD or vCJD. Trusts should aim to minimise the risks associated with prion contamination by closely following the Department of Health’s HTM 01-06 guidance on decontamination of endoscopes. This has been updated to take account of changes to the Advisory Committee on Dangerous Pathogens’ Transmissible Spongiform Encephalopathy (ACDP TSE) Subgroup’s general principles of decontamination (Annex C).
Bedside cleaning
Important changes include a focus on the need for bedside cleaning immediately after the procedure. After manually cleaning according to the manufacturer’s recommendations, the scope should also be passed through an endoscope washer-disinfector as soon as possible after use.
The updated HTM-01-06 guidance11 also
places increased emphasis on testing regimes, taking on board the Advisory Committee’s recommendation that: “A routine test for washer-disinfectors could be developed to measure the cleaning efficacy at validation and routine testing, such as daily or weekly tests. This method could be based on a process challenge device system that will monitor the optimised wash cycles; the results must be quantifiable and objective.” This update focuses on improving the washing and cleaning process, reducing the time from patient use to the decontamination process, and monitoring the cleaning efficacy of endoscope washer-disinfectors.
It is also important to point out that the Advisory Committee’s Annex C deprecates the use of Ninhydrin in the detection of protein levels because of its insensitivity.
The Department of Health states that October 2019 Health Estate Journal 97
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