Improving the Reprocessing Quality of Flexible Thermolabile Endoscopes: How to Learn from Mistakes.

Background: Failure in the reprocessing of thermolabile flexible endoscopes has been reported as one of the most important threats to patient health. Method: A case report and observational study was conducted, from August 2014 to December 2019, in the Digestive Endoscopy Unit of a University Hospital in Italy, where two cases of Klebsiella pneumoniae carbapenemase (KPC)-producing Klebsiella pneumoniae infections in patients undergoing endoscopic retrograde cholangio-pancreatography were observed. Following the risk/safety management practices, an epidemiological investigation was started, duodenoscopes were removed from use and the reprocessing practices reviewed. Moreover, microbiological surveillance of endoscopes was carried out according to the CDC guidelines. Results: In the first phase of sampling, 10/10 (100%) endoscopes were found to be non-compliant, of which 7 showed results for high-concern organisms (HCOs), such as KPC-K. pneumoniae, P. aeruginosa and E. coli. After implementing corrective actions, 12 out of 17 endoscopes were found to be non-compliant (70.5%), of which 8 showed results for HCOs, such as KPC-K. oxytoca and P. aeruginosa. During the last year of regular microbiological surveillance, only 23% of endoscopes (35/152) were found to be non-compliant, of which 7 showed results for HCOs, such as NDM-K. pneumoniae, P. aeruginosa and A. baumannii. The crucial issues were related to samples collected from the internal channels of duodenoscopes. Conclusion: Managing the risk associated with the reprocessing of digestive endoscopes, through risk assessment at every stage of the process, is important for the prevention of infections associated with the use of these device.

COVID-19 Emergency Management: From the Reorganization of the Endoscopy Service to the Verification of the Reprocessing Efficacy.

Microbiological surveillance carried out in order to verify the effectiveness of endoscope reprocessing does not include the research of viruses, although endoscopes may be associated with the transmission of viral infections. This paper reports the experience of the University Hospital of Pisa in managing the risk from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during an endoscopy. A review of the reprocessing procedure was conducted to assess whether improvement actions were needed. To verify the reprocessing efficacy, a virological analysis was conducted both before and after the procedure. Five bronchoscopes and 11 digestive endoscopes (6 gastroscopes and 5 colonoscopes) were sampled. The liquid samples were subjected to concentration through the use of the Macrosep Advance Centrifugal Devices (PALL Life Sciences, Port Washington, NY, USA) and subsequently analyzed using the cobas® SARS-CoV-2 Test (Roche Diagnostics, Basel, Switzerland), together with eSwab 490 CE COPAN swabs (COPAN, Brescia, Italy), which were used to sample surfaces. In accordance with the first ordinance regarding the coronavirus disease 2019 (COVID-19) emergency issued by the Tuscany Region in March 2020, a procedure dedicated to the management of the COVID-19 emergency in endoscopic practices was prepared, including the reprocessing of endoscopes. The virological analysis carried out on samples collected from endoscopes after reprocessing gave negative results, as well as on samples collected on the endoscopy column surfaces and the two washer-disinfectors that were dedicated to COVID-19 patients. The improvement in endoscope reprocessing implemented during the COVID-19 emergency was effective in ensuring the absence of SARS-CoV-2, thus reducing the risk of infections after an endoscopy on COVID-19 patients.