Flexible Endoscopes: Terminal Sterilization and Impact to Patient Safety

Flexible endoscopes are implicated in deaths from healthcare-associated infections (HAIs), in particular antibiotic-resistant infections. This article analyzes whether terminal sterilization should be required as part of endoscope reprocessing to reduce or eliminate HAIs and thus improve patient safety. Reusable flexible endoscopes are processed to make them ready for clinical use by the processing department of the healthcare facility. Unlike most critical and semicritical medical devices, the final step of processing an endoscope is high-level disinfection and not terminal sterilization. This is because most flexible endoscopes come in contact with mucosal membranes (versus contact with direct blood stream) and cannot withstand sterilization. However, sterilization currently is performed by a small number of U.S. healthcare facilities on reusable flexible endoscopes with the belief that they are safer for use compared to flexible endoscopes that are high-level disinfected. Based on the analysis in this article, terminal sterilization is not a required or necessary step to eliminate HAIs.