Reprocessing of flexible endoscopes and endoscopic accessories used in gastrointestinal endoscopy: Position Statement of the European Society of Gastrointestinal Endoscopy (ESGE) and European Society of Gastroenterology Nurses and Associates (ESGENA) - Update 2018.

This Position Statement from the European Society of Gastrointestinal Endoscopy (ESGE) and the European Society of Gastroenterology Nurses and Associates (ESGENA) sets standards for the reprocessing of flexible endoscopes and endoscopic devices used in gastroenterology. An expert working group of gastroenterologists, endoscopy nurses, chemists, microbiologists, and industry representatives provides updated recommendations on all aspects of reprocessing in order to maintain hygiene and infection control.

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).

Patients should be informed about the benefits and risks of endoscopic retrograde cholangiopancreatography (ERCP)Only specially trained and competent personnel should carry out endoscope reprocessing.Manufacturers of duodenoscopes should provide detailed instructions on how to use and reprocess their equipment.In the case of modifications to their equipment, manufacturers should provide updated instructions for use.Detailed reprocessing protocols based on the manufacturer's instructions for use should clearly lay out the different reprocessing steps necessary for each endoscope model.Appropriate cleaning equipment should be used for duodenoscopes in compliance with the manufacturer's instructions for use. Only purpose-designed, endoscope type-specific, single-use cleaning brushes should be used, to ensure optimal cleaning. As soon as the endoscope is withdrawn from the patient, bedside cleaning should be performed, followed by leak testing, thorough manual cleaning steps, and automated reprocessing, in order to: · Remove debris from external and internal surfaces;. · Prevent any drying of body fluids, blood, or debris;. · Prevent any formation of biofilms.. In addition to the leak test, visual inspection of the distal end as well as regular maintenance of duodenoscopes should be performed according to the manufacturer's instructions for use, in order to detect any damage at an early stage.The entire reprocessing procedure in endoscope washer-disinfectors (EWDs) should be validated according to the European and International Standard, EN ISO 15883. Routine technical tests of EWDs should be performed according to the validation reports.Microbiological surveillance of a proportion of the department's endoscopes should be performed every 3 months, with the requirement that all endoscopes used in the unit are tested at least once a year.In the case of suspected endoscopy-related infection, the relevant device (e. g., endoscope, EWD) should be taken out of service until adequate corrective actions have been taken. Outbreaks should be managed by a multidisciplinary team, including endoscopy, hygiene, and microbiology experts, manufacturers, and regulatory bodies, according to national standards and/or laws. In the case of suspected multidrug-resistant organism (MDRO) outbreaks, close cooperation between the endoscopy unit and the clinical health provider is essential (including infection control departments and hospital hygienists).

ESGE-ESGENA technical specification for process validation and routine testing of endoscope reprocessing in washer-disinfectors according to EN ISO 15883, parts 1, 4, and ISO/TS 15883-5.

1 Prerequisites. The clinical service provider should obtain confirmation from the endoscope washer-disinfector (EWD) manufacturer that all endoscopes intended to be used can be reprocessed in the EWD. 2 Installation qualification. This can be performed by different parties but national guidelines should define who has the responsibilities, taking into account legal requirements. 3 Operational qualification. This should include parametric tests to verify that the EWD is working according to its specifications. 4 Performance qualification. Testing of cleaning performance, microbiological testing of routinely used endoscopes, and the quality of the final rinse water should be considered in all local guidelines. The extent of these tests depends on local requirements. According to the results of type testing performed during EWD development, other parameters can be tested if local regulatory authorities accept this. Chemical residues on endoscope surfaces should be searched for, if acceptable test methods are available. 5 Routine inspections. National guidelines should consider both technical and performance criteria. Individual risk analyses performed in the validation and requalification processes are helpful for defining appropriate test frequencies for routine inspections.

Multisocieties position paper: Microbiological surveillance on flexible endoscopes.

Transmission with endoscopes, particularly duodenoscope, of potential lethal infections prompted different scientific societies to deliver recommendations aimed reducing this risk. Some International societies extended recommendations on microbial surveillance to all the endoscopes and devices used in the reprocessing procedure. Considering the relevance of the topic, 8 Italian scientific societies of physicians, nurses and technical operators prepared a concerted document taking into account Institutional advisories and facilities in Italy. The rules for a correct microbial surveillance on endoscopes were detailed in term of what, how and when to perform the procedure, also suggesting behaviors in case of contamination.