ESGE and ESGENA recently issued a statement pertaining to the use of removable caps on duodenoscopes:
You may be aware of the recent debate regarding the suggestions by some regulatory authorities (e.g. the US Food and Drug Administration [FDA]) of the need to use removable caps (reusable or single use) on duodenoscopes, and furthermore advocating the development of fully disposable duodenoscopes.
The duodenoscope is an indispensable tool for performing endoscopic retrograde cholangiopancreatography (ERCP). ERCP has significantly decreased the morbidity and mortality related to a wide range of pancreatobiliary diseases. At the same time, the potential for infection transmission through these instruments, although extremely rare, has become a public health concern and it is therefore crucial to intensify efforts to prevent infection by implementing recommendations for optimal duodenoscope reprocessing.
Recently, ESGE and ESGENA collaborated to produce Position Statements on this topic, stressing that regardless of duodenoscope design, there are two crucial points:
– standardized and validated duodenoscope reprocessing should be performed by appropriately trained, dedicated, and competent staff;
– microbiological surveillance and regular maintenance of duodenoscopes should be performed to identify any problems at an early stage.
The current discussion is focused on the fact that fixed endcap duodenoscopes have a plastic or rubber cap permanently glued to the metal edges around the distal tip to prevent tissue injury. Because they are fixed (non-removable) these caps may reduce accessibility to clean the crevices at the distal end of the duodenoscope, increasing the potential for infection transmission. Removable and single-use caps have already been adapted to some duodenoscope models. However, even duodenoscopes with single-use caps require a thorough and optimal reprocessing of the entire duodenoscope, including its working channel system and distal tip. Moreover, postmarket surveillance studies to evaluate these new duodenoscope designs, and verify that they reduce contamination rates and infection transmissions, have yet to be published and are eagerly awaited. The results of these studies will better inform the development of reliable recommendations. Regarding the development of fully disposable duodenoscopes, it is essential to assess the potential risks related to their use as well as their reliability, both technically and practically. This is essential before they are introduced into routine clinical practice. All aspects of these duodenoscopes must be assessed and compared to current standard-of-care clinical practice.
Therefore, at this stage, ESGE and ESGENA realize that it is impractical from both from the clinical and patient safety perspectives that current duodenoscopes be withdrawn from clinical practice. High level evidence regarding emerging duodenoscope designs must be produced before further revision of our current Position Statements.
1. FDA News Release. FDA recommends health care facilities and manufacturers begin transitioning to duodenoscopes with disposable components to reduce risk of patient infection. August 29, 2019.
2. Beilenhoff U, Biering H, Blum R, et al. 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. Endoscopy 2018; 50: 1205–1234
3. Beilenhoff U, Biering H, Blum R, 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: 1098–1106
4. Statement of the European Society of Gastroenterology and Endoscopy Nurses and Associates: European Curriculum for endoscope reprocessing. 2019. esgena.org
Sources: European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates