Ensuring patient safety during cystocopy: risk assessment of device reprocessing through healthcare failure mode and effects analysis

Abstract

Introduction: Flexible cystoscopy is a widely performed urological procedure, with millions conducted annually. However, cystoscope contamination rates are relatively high, ranging from 2 to 21%, and infections may go undetected. Proper reprocessing of cystoscopes is a critical step in ensuring the safe use of these devices, which underscores the importance of studying it more thoroughly. The aim of this article is to describe the stages of cystoscope reprocessing in the Urology Department of a tertiary Hospital, identifying the potential failures of the system before they occur, quantifying its risks and recommending improvement actions to enhance overall safety and efficiency.

Material and methods: This qualitative study was conducted using the Failure Mode and Effects Analysis methodology in different phases. First, data on structure, equipment and work processes were collected through direct observation and staff interviews. Then, processes and sub-processes were described along with their possible failures and underlying causes. Risks of this potential failures (failure modes) were quantified using the Risk Priority Number (RPN), calculated as the product of their frequency, severity and detectability. Improvement actions to mitigate failures with the highest NRP were proposed based on expert consensus and literature review.

Key findings and limitations: 9 processes and 11 sub-processes were identified, along with 16 failure modes. The key failure modes, those with an RPN > 100 included incorrect manual high-level disinfection, incorrect cleaning due to lack of brushing and lack of traceability. These failures were primarily caused by insufficient staff training, short intervals between procedures, and inadequate infrastructure. To address these issues, expert recommendations included providing comprehensive training for staff, improving reprocessing infrastructure by optimizing room layout, and ensuring an adequate supply of cystoscopes to reduce time constraints. Additionally, prioritizing automatic high-level disinfection and implementing a traceability system were proposed to enhance process reliability and patient safety.

Conclusion: Inadequate organizational structure and equipment can compromise patient safety during high-care activities. After analyzing cystoscope reprocessing at our center, three critical failure modes (NPR > 100) were identified: lack of traceability, improper cleaning due to insufficient brushing, and improper manual high-level disinfection (HLD). To address these issues, we proposed actions including improve staff training, increase the cystoscope supply, and enhance the unit's infrastructure. These findings may guide other healthcare professionals in improving reprocessing safety.

Keywords: Cystoscope; Failure mode and effects analysis; Infection prevention; Patient safety; Risk analysis; Sterilization.

Fig. 1

Reprocessing flowchart