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Guidance for Decontamination of Equipment for Gastrointestinal Endoscopy

Guidance on Decontamination of Equipment for Gastrointestinal Endoscopy: 2017 Edition

The Report of a Working Party of the British Society of Gastroenterology Endoscopy Committee

April 2017

Flexible endoscopes are complex reusable instruments that require unique consideration with respect to decontamination. Their external surfaces and internal channels for air, water, aspiration and accessories are all potentially exposed to body fluids and other contaminants.

In contrast to rigid endoscopes, flexible endoscopes are heat labile and cannot be autoclaved. Most flexible endoscopes are classed as "semi-critical devices" as they come into contact with mucous membranes during use and present a moderate degree of infection risk if contaminated at the time of use. The process of flexible endoscope decontamination is referred to as "high level disinfection". This is the term given to a process that eliminates or kills all vegetative bacteria, mycobacteria, fungi and viruses, except for small numbers of bacterial spores.

The Health and Social Care Act: Code of Practice on the prevention and control of infections and related guidance was published in England in 2008 (updated in 2015). This stipulates the roles of decontamination leads and decontamination programmes. It emphasises the need for staff to be trained in decontamination processes and to hold appropriate competencies for their role. It decrees the need for monitoring systems to ensure that decontamination processes are fit for purpose and meet required standards. Finally it requires that there are systems in place for tracking reusable medical devices (such as endoscopes and reusable accessories) through decontamination processes, not only to assist with assuring their quality, but also to enable the identification of patients on whom the medical devices have been used. Similar guidance is employed in the other UK devolved nations.

The BSG first published guidelines on decontamination in 1998. Over the years many changes have occurred in recommendations for the decontamination of flexible endoscopes. In order to be responsive to these changes this document has been revised as guidance, this allows the flexibility to update this document in line with changes issued by Government agencies and other professional bodies.


Simethicone Residue in Endoscopes

March 2017

Dr Helen Griffiths, Nurse Consultant & Decontamination Advisor British Society of Gastroenterology

A publication in 2016 in the American Journal of Infection control (Ofstead et al) outlined a potential risk following the identification of residual simethicone in endoscopes following the decontamination process in the United States.

At that time expert opinion in the UK concluded that the decontamination process was not well described and that bacteria found on processed scopes were suggestive of operator contamination and not compromised decontamination. Whilst not seen as a basis for modifying the use of simethicone at that time it has continued to be monitored.

Recently there has been an issue identified in the Republic of Ireland when a colonoscope was sent to Olympus for repair. Preliminary investigation showed what appeared to be signs of Simethicone residue ( Hypromellose, an ingredient of Infacol) in the auxiliary water channel of that colonoscope and subsequently a further two colonoscopes. At this time investigation is ongoing but evidence suggests that scopes were reprocessed in accordance with manufacturers instructions including use of MH-946 injection tube (octopus device).

Simethicone was administered via the flushing pump at a dilution of 25mls (40mgs/ml) in 2 litres of water.

There has been no evidence of resultant infection but until further investigation and testing on compatibility and following discussion with the Decontamination Professional Expert Communication Forum (DPECF) it is advised that Simethicone is administered either orally or via the biopsy port of endoscopes and NOT via either the water bottle or flushing pump devices. This will ensure that manual brushing of relevant channels can take place post procedure. The strength of the dilutent should also be kept to a minimum to achieve the desired effect.


Potential transmission of multi resistant bacteria and duodenoscopes.

October 2015

Recent reports in the media have highlighted the potential for transmission of infection associated with duodenoscopes. A recent peer reviewed publication (Endoscopy (2015) 47: 493-502) described an outbreak of VIM-2 producing Pseudomonas aeruginosa and identified an issue with the design and reprocessing of a recently introduced duodenoscope with a specific modified design. This may be similar to the outbreaks in the US (Gastrointestinal Endoscopy (2015) 82(3): 477-83).

The BSG would like to highlight the following points to staff carrying out the decontamination of flexible endoscopes, in particular duodenoscopes:

  • Adherence to manufacturers' instructions at all times is essential.
  • The pre clean procedure should take place at the patient bedside, as described in the instructions from the UK suppliers and BSG guidance.
  • The cover on the raiser bridge mechanism at the distal tip should be removed prior to brushing all areas of the distal tip and cleaning with detergent and replaced on completion of the decontamination process. The brush must be used on all surface areas of the distal tip ensure that all debris is removed.
  • The elevator wire channel should be flushed with detergent during the manual cleaning ensuring the correct size syringe is used. If automated flushing systems are used for this stage of the process, staff should ensure that this channel is included.
  • Staff should ensure that the endoscope washer disinfector has the capability of flushing the elevator wire channel with detergent, disinfectant and rinse water.
  • If stored in a drying cabinet, the elevator wire channel should be flushed with HEPA filtered air along with all the other channels. If this channel is not flushed with air, the endoscope should be used within 3 hours or the endoscope reprocessed before patient use. Not all cabinets have this facility. An EN standard, EN 16442, has now been published for endoscope storage drying cabinets.
  • Routine microbiological surveillance of processed endoscopes is not recommended. However, this may be carried out on advice from the infection prevention and control team if an outbreak is known or suspected.
  • Staff should receive comprehensive training, and a record retained, on all aspects of the decontamination of endoscopes, in particular, duodenoscopes.

Choice Framework for Local Policy and Procedures CFPP 01-06

These documents offer best practice guidance on the management and decontamination of flexible endoscopes. They consist of five documents covering operational management, design and installation, testing methods, validation and verification and policy and management. These are large documents that will be subject to periodic updates and therefore it is recommended that rather than download all or part of the guidance the link is made available on endoscopy desktops. These guidelines are designed to provide information and guidance to those working within endoscopy services in England, please see the link below for relevant guidelines for Scotland, Wales and Northern Ireland.

Audit

Audit is key to understanding and ensuring that the decontamination environment and the processes within it are safe and effective. The MHRA (August 12) talks about the legal implications if there are failures in both understanding and practices in decontamination. The CFPP 0106 reminds us that the Health Act Code of Practice (2006) recommends that healthcare organisations comply with guidance establishing Essential Quality Requirements (EQR) and demonstrate that a plan is in place for progression to Best Practice (BP). There are a number of audit tools available for use within endoscopy to demonstrate compliance with EQR and allow planning to achieve BP. The Infection Prevention society has developed comprehensive audit tools to sit alongside the guidance in CFPP 01-06. These tools are now recommended by the member committees of the Professional Expert Communication Forum (PECF): Decontamination of medical devices as the UK wide audit tool of choice.

Access IPS audit tools here

Access list of member organisations of the Professional Expert Communication Forum (PECF) here

"Transmissible Spongiform Encephalopathy Agents: Safe Working and the Prevention of Infection"

As part of its remit for the whole of the UK the Department of Health ACDP TSE Risk Management Subgroup produces the guidance document Transmissible spongiform encephalopathy agents: safe working and the prevention of infection. The aim of the guidance is the minimisation of the risk of transmission of CJD, and vCJD. This has recently been reviewed by a working party of the subgroup and updated (February 2015) and it is recommended that decontamination teams review the changes to these documents.

Read the entire updated document on the Department of Health's 'Advisory Bodies' website:

MHRA Guidelines

View documentation "Top ten tips" revised 2012 on MHRA website:

DOPS training and assessment tool for manual cleaning processes in endoscopic decontamination

Following collaboration between Olympus, Pentax and Aquilant, the BSG and the Decontamination Professional Expert Communication Forum (DPECF)  are pleased to announce the launch of this DOPS training and assessment tool.

Background

There have been numerous reports on the potential transmission of multi resistant bacteria with particular reference to duodenoscopes and the manual cleaning of these instruments.

There is the potential to transmit infection via any endoscope through poor adherence to manual cleaning processes and to date there has been no single way of assessing and validating these processes. Knowledge and practice varies significantly between departments and indeed individuals and there is a need to have a standardised approach and pathway that can be quality assured and validated to minimise the risk to patients and staff from endoscopically transmitted infection.

Purpose and use

The purpose of this DOPs form is to provide a universal and standarised training and assessment tool for continuity when training in manual cleaning processes. It consists of two parts:

  • PART 1. Manufacturers will deliver the initial specific product training as they currently do, traceable to the product reprocessing instructions and confirming the topics covered in the training from the listed criteria (shaded grey on the DOPS form)
  • PART 2. The employer will then undertake an assessment of competency to undertake manual cleaning of endoscopes as part of the Skills for Health END21 competency and as annual revalidation of practice from the listed criteria on the form, including validation of competency in the topics covered in the manufacturer's training.

Each section/topic should be signed and dated by the individual delivering the training or assessing the competency. This should then form part of annual appraisal and revalidation of practice.

If you have any questions or queries please email This e-mail address is being protected from spambots. You need JavaScript enabled to view it or contact your endoscope manufacturer.