In a study published in February 2026 by the American Journal of Infection Control, researchers explored the use of Failure Mode and Effects Analysis (FMEA) to minimize errors during endoscope reprocessing, particularly focusing on gastrointestinal endoscopes.
The research took place in a hospital's Central Sterile Supply Department (CSSD), where they identified potential failures and their impacts across multiple steps of the reprocessing cycle for these devices. The study employed FMEA, a proactive risk assessment methodology that identifies and prioritizes critical failure modes and suggests preventive actions to mitigate their effects.
In the endoscope reprocessing process, several critical steps were identified: cleaning, high-level disinfection (HLD), visual inspection, and drying. FMEA was applied to each step, and a series of potential failures were documented. For instance, failures during the cleaning stage included inadequate rinsing, insufficient brush use, and missed areas.
The researchers then quantified the severity, occurrence, and detectability of these failures, using scales from 1 (low) to 10 (high). They also assigned a risk priority number (RPN) for each failure by multiplying the three values together. High-risk failures with RPNs above a certain threshold were targeted for corrective action development.
The study reported that many failures occurred during cleaning and visual inspection, leading to increased attention being focused on these steps in the endoscope reprocessing workflow. They also highlighted the importance of ongoing training and education for CSSD staff regarding proper reprocessing procedures to reduce errors. The researchers noted that the FMEA methodology was a valuable tool in identifying and addressing potential failure points within the endoscope reprocessing process, ultimately enhancing patient safety.