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DECONTAMINATION & STERILISATIONV


associated with the use of duodenoscopes. This included recommendations for: n Microbiological culturing. n Ethylene Oxide sterilisation. n Use of a Liquid Chemical Sterilant processing system.


n Repeat high-level disinfection.


On 10 December 2018, the FDA issued a further Safety Communication to provide interim results from the mandated surveillance. Interim results from these studies indicated higher than expected contamination rates after reprocessing, with up to 3% of properly collected samples testing positive for enough low concern organisms to indicate a reprocessing failure, and up to 3% of properly collected samples testing positive for high concern organisms. High concern organisms included E. coli and Pseudomonas aeruginosa.5 The FDA issued the following recommendations, pending the final results and further investigation of the cause of the failures: n Meticulously clean the elevator mechanism and the recesses surrounding the elevator mechanism by hand, even when using an endoscope washer-disinfector (EWD)/automated endoscope reprocessor (AER).


n Raise and lower the elevator throughout the manual cleaning process to allow brushing and flushing of both sides. After cleaning, carefully inspect the elevator recess, and repeat cleaning if any soil or debris is visible.


n Implement a comprehensive quality control programme for reprocessing duodenoscopes. The reprocessing programme should include written procedures for monitoring training and adherence to the programme, and documentation of equipment tests, processes, and quality monitors, used during the reprocessing procedure.


n Follow the duodenoscope manufacturer’s recommendations for inspection, leak testing, and maintenance of the duodenoscope.


n Prior to each use, closely inspect and remove from service for assessment, and repair or replace, any


duodenoscope that shows visible signs of damage, as recommended in the duodenoscope instruction manuals. Examples of damage may include: loose parts, protrusions or abnormal bulging from the endoscope, kinks or bends in tubing, cracks and gaps in the adhesive that seals the device’s distal cap, or other signs of wear or damage.


n During each reprocessing cycle, conduct leak testing and remove from service for assessment, and repair and replace, any duodenoscope that shows signs of leakage. Follow the duodenoscope manufacturer’s leak


96 Health Estate Journal October 2019


testing instructions for angulating the bending section and elevator during leak testing.


n As recommended in the duodenoscope instruction manuals, return the duodenoscope to the duodenoscope manufacturer for inspection, servicing, and maintenance of the device at least once per year.


Contributing factors


The FDA made it clear that while there may be reprocessing failures occurring at many hospital sites, there are also contributing factors arising from the design of these scopes, which make decontamination challenging.6,7


n Only purpose-designed, endoscope type-specific, single-use cleaning brushes should be used, to ensure optimal cleaning.


n 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, and prevent any formation of biofilms.


n In addition to the leak test, visual inspection of the distal end, as well as regular maintenance of


In an FDA


statement, Jeff Shuren, MD, commented: “It has become clear that following the manufacturer’s reprocessing and maintenance instructions, while critical, is not sufficient to avoid all infections associated with the use of duodenoscopes.


“That is why the FDA has also been working with developers on new product designs, including disposable components. Technological advances in product design hold promise to reduce the risk of contamination and enhance patient safety.”


Position statement


The European Society of Gastrointestinal Endoscopy (ESGE) and European Society of Gastroenterology Nurses and Associates (ESGENA) have responded to the risk by also issuing a position statement.8


A


number of recommendations were issued by the organisations, underscoring the FDA’s advice that hospitals must strictly follow manufacturers’ instructions on reprocessing, while adding that:


duodenoscopes, should be performed according to the manufacturer’s instructions for use, in order to detect any damage at an early stage.


n The entire reprocessing procedure in endoscope washer-disinfectors (EWDs) should be validated according to the European and International Standard, EN ISO 15883.


n Routine technical tests of EWDs should be performed according to the validation reports.


n Microbiological surveillance of a proportion of the department’s endoscopes should be performed every three months, with the requirement that all endoscopes used in the unit are tested at least once a year.


n In the case of suspected endoscopy- related infection, the relevant device (eg: endoscope, EWD) should be taken out of service until adequate corrective actions have been taken.


Issues have also been highlighted around the reprocessing of flexible bronchoscopes and endobronchial ultrasound bronchoscopes by a study


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