How to Improve Reprocessing of Flexible Endoscopes Nationwide? Data from the German Colorectal Cancer Screening Program

Background and Aims. International studies revealed prevalences of around 50% of microbiological contaminations in reprocessed flexible endoscopes. In Germany a system was installed where the qualification for refund for colonoscopies was made conditional on successfully passing twice annually a microbiological surveillance test of reprocessed endoscopes. This study is an implementation and outcome evaluation as well as a general discussion of the quality assessment assurance in colonoscopy in Germany. Methods. German data from 2003–2008 were analysed: number of endoscopic units performing therapeutic and/or screening colonoscopies; results of all microbiological surveillance tests of reprocessing quality; number of failed surveillance tests and retests; number of qualifications for refund from the public health system cancelled due to repeated failure of microbiological surveillance tests. Results. After the introduction of the quality assessment assurance, the percentage of failed microbiological surveillance tests dropped significantly and steadily from close to 17% to below 5%. Conclusions. This study evidences (1st) the successful implementation of the quality assessment assurance in Germany and (2nd) a substantial improvement in the quality of reprocessing flexible endoscopes achieved by these measures. 1. Introduction Flexible endoscopes invariably become contaminated with microorganisms during clinical use. With the more widespread use of flexible endoscopy 30 years ago, nosocomial infections associated with oesophago-gastroduodenoscopy, colonoscopy, endoscopic retrograde cholangiopancreaticography (ERCP), or bronchoscopy were observed and described in the literature [1–9]. A survey in the 70ies yielded an estimated risk of 1 per 10,000 endoscopic examinations (oesophagogastroduodenoscopies und colonoscopies) [10]. More recently, optimistic estimates suggest a lower risk of 1 in 1.8 million [11] or 1 in 5 million procedures [12] given millions of endoscopic examinations worldwide. Data from the late nineteen-seventies report an infection rate of 0.74 and 0.93% following endoscopic retrograde cholecysto-pancreaticoscopy (ERCP) [7, 8, 13]. The risk for transmission of, for example, Helicobacter pylori has been considered to be likely around of 2-3 per 1000 oesophagogastroduodenoscopies [14–16]. The problem of possible infections originating from endoscopic examinations has been controversially discussed by the media, that is, in Germany [17] and the US [18]. In Germany, this culminated in the repeated statement of a notable hygienist that he