DECONTAMINATION & STERILISATION


alternative available technologies should be considered for the detection of residual proteins on the internal surfaces of flexible endoscopes following reprocessing. It advises that reprocessing units should: n Consider the available technologies, and make a risk-based decision on the methodology to be adopted (for example BS EN ISO 14971).


n Use technologies with the best available sensitivity, consistent measurement standards, and quantifiable results, to measure effective control of residual protein levels.


n Use trend analysis as a tool for self- improvement to demonstrate decreasing protein levels over time, both on the outside of the endoscope, and the lumens, using available testing technologies.


Testing cleaning efficacy It is vital that Trusts test their cleaning efficacy and identify issues with their processes. The HTM 01-06 document offers extensive recommendations, but some of the key messages include the need to use test soils and process challenge devices to demonstrate that EWDs are working to a defined level of cleaning efficacy.


Residual protein detection tests should be carried out quarterly for each EWD. In addition, a leak test should be carried out to determine if liquid can gain access to the inner cavity of an endoscope, thereby causing extensive damage. A leak test is carried out manually before the endoscope is cleaned, and again by the EWD, either at the start of the process cycle, or throughout the cycle. It is important that the air used to pressurise an endoscope does not exceed the limit set by the endoscope manufacturer, normally about 250 mbar. The guidance also makes


recommendations for a lumen patency detection test, and states: “EWDs for endoscopes should be fitted with means to ensure that each of the lumens is patent, so that disinfectant and rinse solutions will flow through each lumen, even those that have a control wire. In addition, a test is required to demonstrate that if an endoscope lumen becomes disconnected it will be detected.” Other tests covered in detail by the document include sections on the: ‘EWD self-disinfection test’, ‘disinfectant concentration test’, and ‘microbiological and temperature tests’ of disinfection efficacy.


Complying with best practice Ultimately, complying with best practice will go a long way to tackling the issues around infection transmission via endoscopes. Nevertheless, there is some


98 Health Estate Journal October 2019


evidence to suggest that adhering to best practice may not eliminate all of the risks associated with the use of some types of endoscope. Manufacturers of devices will need to work more closely with other stakeholders to reduce the challenges around infection prevention and decontamination, though improvements to design. In the meantime, UK hospitals should follow the HTM-01-06 guidance, ensuring adequate cleaning is carried out immediately after use, then ensuring that reprocessing is carried out in a timely manner via an EWD. Lastly, implementing a rigorous test regime to ensure that scopes are contamination- free will give peace of mind, and help ensure that issues are quickly identified – thereby improving patient safety, and reducing the risks of disease transmission.


References 1 Guidance for Decontamination of Equipment for Gastrointestinal Endoscopy. The Report of a Working Party of the British Society of Gastroenterology Endoscopy Committee, April 2017. [Accessed at: https://www.bsg.org.uk/resource/ guidance-on-decontamination-of- equipment-for-gastrointestinal- endoscopy-2017-edition.html].


2 Rutala WA, Gergen MF, Weber DJ. Inactivation of Clostridium difficile spores by disinfectants. Infection Control Hosp Epidemiol 1993; 14: 36-9).


3 Petersen BT. Duodenoscope reprocessing: risk and options coming into view. Gastrointestinal Endoscopy 2015; 82: 484-6).


4 Department of Health. Health and Social Care Act. [Accessed at: https://www.gov.uk/government/ publications/the-health-and-social-care-


act-2008-code-of-practice-on-the- prevention-and-control-of-infections- and-related-guidance].


5 FDA safety communication. Accessed at: https://www.fda.gov/MedicalDevices/ Safety/AlertsandNotices/ucm628020.htm


6 FDA warns duodenoscope manufacturers about failure to comply with required postmarket surveillance studies to assess contamination risk, March 2018. [Accessed at: https://www.fda.gov/ NewsEvents/Newsroom/


PressAnnouncements/ucm600388.htm].


7 FDA, Factors Affecting Quality of Reprocessing. [Accessed at: https://www.fda.gov/MedicalDevices/ ProductsandMedicalProcedures/ ReprocessingofReusableMedicalDevices/ ucm454622.htm].


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8 Beilenhoff Ulrike et al. Prevention of multidrug-resistant infections from contaminated duodenoscopes: Position Statement of the European Society of Gastrointestinal Endoscopy (ESGE) and European Society of Gastroenterology Nurses and Associates (ESGENA), Endoscopy 2017; 49.


9 Ofstead CL, Effectiveness of


Reprocessing for Flexible Bronchoscopes and Endobronchial Ultrasound Bronchoscopes. Chest 2018; 154 (5): 1024-34. doi: 10.1016/j.chest.2018.04.045. Epub 2018 May 31.


10 MHRA ‘Top Ten Tips’. [Accessed at: https://webarchive.nationalarchives. gov.uk/20121102181742/http:// www.dh.gov.uk/prod_consum_dh/ groups/dh_digitalassets/@dh/@en/ documents/digitalasset/dh_4120887.pdf].


11 Department of Health, Management and decontamination of flexible endoscopes (HTM 01-06). [Accessed at: https://www.gov.uk/government/ publications/management-and- decontamination-of-flexible-endoscope].


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