A nationwide study on endoscope contamination was undertaken to determine cross-sectional sampling by local staff and 13% of all endoscopes were contaminated. The study revealed contamination is not related to wear and tear, and Margreet questioned whether reprocessing is too complex. “Human error and inaccurate handling is certainly a pitfall,” she noted. “In terms of storage, the use of a drying/storage cabinet and use of compressed air are recommended, but how long should the storage time be? With biofilms, research shows a correlation between the growth of bacterial biofilm in flexible endoscopes and endoscope reprocessing methods. “Microbiological surveillance is costly and demanding, and adhering to the guidelines is difficult as the recommended frequency differs. We need a recommended frequency. The solution is sterilisation. Gastrointestinal endoscopy has been associated with more healthcare associated outbreaks than any other medical device, so the burden of disease has to be determined. Recent outbreaks related to duodenoscopes have occurred despite guidelines being followed, and this is just the tip of the iceberg.” Highlighting the need to work together with manufacturers, Margreet concluded: “People want – and expect – no transmission by any medical instrument, so there is a collective responsibility for manufacturers, health systems and providers to ensure reprocessing is mistake-proof.

“So what are the solutions? Brand new endoscopes for every procedure? Sterilisation? Or a new design which will not become contaminated? I believe we should focus on microbiological surveillance, provide teaching in cleaning, and monitor outcomes.”

Test soils and wraps

Richard Bancroft, science technical director at Steris opened the first of two corporate presentations, discussing the use of test soils and surrogate devices to validate endoscope and surgical instrument decontamination. Addressing duodenoscopes, Richard noted the importance of cleaning and washing, either by mechanical or chemical means. “Soiling microorganisms cannot be seen by the naked eye,” he said. “The Advisory Committee on Dangerous Pathogens’ Transmissible Spongiform Encephalopathy (ACDP TSE) subgroup rules that there should be no more than five micrograms – or less – of protein in situ or on the side of an instrument. “The revision of EN ISO 15883-44, published in December 2018 is important. Part four addresses the requirements for tests for washer disinfectors employing chemical disinfection for thermolabile endoscopes, and there are changes to type testing of washer disinfectors and processes.

“Cleaning challenges exist with all reusable medical devices, but there are products available that demonstrate appropriate cleaning with all such devices on a regular basis.”

The second corporate presentation was

hosted by Joy Markey from Clinipak, who discussed risk factor considerations for single use and reusable wraps. Addressing the need to decontaminate, Joy said the ultimate aim was patient safety by preventing infection. Providing a packaging systems checklist, Joy warned of the risks when reprocessors are not properly trained, highlighting one situation in which instruments were kept in a brown envelope. Addressing evaluation, she asserted: “Any fundamental change to the practice for reprocessing should be risk evaluated to ensure compliance and ‘sterility assurance’ of the end product.

“If a change to the wrapping material or protection products used to sterilise is required, this should not exceed the limits at which the original commission loan was validated, tested to, and signed off as. The end user should determine the methodology best suited to their process, and wrapping training – and validation – should be agreed, and rolled out across the site.” Following a debate on the existing arrangements for the external audit of decontamination quality management systems, which will be covered in the next issue of The Clinical Services Journal, Paul Caesar from Tjongerschans Regional Hospital in the Netherlands, discussed the

Gastrointestinal endoscopy has been associated with more healthcare associated outbreaks than anyother medicaldevice, so the

burden of disease has to be determined. Margreet C. Vos, Erasmus MC


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