Our results identified key areas for improvement in three processes: in cystoscope reception, lack of traceability (RNP = 100), in the cleaning phase, inadequate immersion in enzymatic detergent and lack of brushing (RNP = 100) and in disinfection, incorrect manual HLD (RNP = 125).

This finding aligns with other studies, which emphasize that cleaning and manual disinfection are the most critical steps in cystoscope reprocessing and report the highest failure rates in these stages [9, 18, 19]. On one hand, cleaning plays a crucial role in removing all visible soil and significantly reducing the bioburden, thus facilitating the biocidal process. Both the interior and exterior of the cystoscope must be thoroughly cleaned, as this step is vital for the success of subsequent microbicidal processes used for disinfection or sterilization [11]. In our study, the lack of brushing was due to time constrains and had a significant impact, contributing to one of the highest NRP values.

On the other hand, the most frequent error, with the highest NPR, was incorrect manual HLD, resulting from either failing to fully immerse the cystoscope and its accessories in the high-level disinfectant, or from immersing them for an insufficient amount of time. The effectiveness of disinfectants is influenced by the physical condition of the endoscope (such as cracks or lumens), the microbial load and, most importantly, the concentration, water temperature and exposure time to the chemical solution. These variables are difficult to control in manual disinfection processes. Therefore, whenever feasible, automated HLD is strongly recommended. Manual decontamination methods do not ensure standardized procedures or effective removal of biofilms from cystoscope channels [20]. Moreover, automated methods eliminate the risk of staff exposure to disinfectants and the potential toxicity from direct skin contact or inhalation of vapours. A study by Ofstead et al. analysed the benefits of automated versus manual endoscope reprocessing. It found that personnel performing manual reprocessing adhered to cleaning guidelines only 1.4% of the time, compared to a compliance rate of 75.4% for those using automated washer disinfectors. The study also revealed that staff using manual methods reported significantly more health issues, such as physical injuries or symptoms related to chemical inhalation, than those who used automated disinfection [19]. Additionally, automated endoscopes reprocessing has proven to be cost-effective. In countries where productivity improvements can translate into revenue, transitioning to automated reprocessing has a positive financial impact, with capital investment being amortized within months [21]. This savings from automated endoscope reprocessing quickly offset the initial cost associated with purchasing and maintaining the equipment [20]. While automated cystoscope reprocessing does have some drawbacks, such as material compatibility issues, the risk of residual contamination, higher costs, and the potential for technical failures, it has been demonstrated to be a faster, more reliable, and safer reprocessing method [22]. At our centre, the high volume of functional tests performed, combined with their short duration—usually less than 5 min—and the limited number of available cystoscopes (5) led to a preference for manual reprocessing, as it is faster than automatic reprocessing.

Moreover, the lack of documentation for reprocessing procedures significantly impedes traceability and product control, both of which are critical for ensuring patient safety and demonstrating compliance with regulatory requirements. In fact, the implementation of a traceability system could soon become mandatory. The new EU Regulation 2017/745 on Medical Devices (MDR) emphasizes of the importance of traceability by introducing a unique device identification (UDI) system for all marketed medical devices [23]. Effective traceability systems not only enhance patient safety but also contribute to process improvement, optimized productivity, efficient device management, and the prevention of healthcare-associated infections [24,25,26]. In our center, the lack of traceability was due to the absence of a work log, coupled with a lack of awareness regarding the importance of traceability.

We identified several causes of failure including insufficient staff supervision and training, lack of time for reprocessing between procedures and inadequate equipment or infrastructure. Availability issues are a common concern in many centres among urologists. According to a survey conducted in 2020 in Germany, France and the UK, 19.1% of urologists report frequent problems with cystoscope availability, while 65.8% noted that they occasionally had to wait for a cystoscope to arrive before beginning an examination [1]. There are two possible solutions to increase the availability of cystoscopes without compromising the quality of their disinfection: switching to disposable cystoscopes, thereby eliminating cleaning and disinfection times, or increasing the number of reusable cystoscopes. A recent study described the experience of a centre that transitioned to 100% disposable cystoscopes, reporting similar costs and a reduction in waste and water consumption compared to reusable devices. However, the study focused on a single cystoscope model in one centre, which introduces limitations to its generalizability [28]. Regarding environmental impact, another study compared the carbon footprint of a disposable cystoscope, from manufacturing to recycling, with that of a reusable flexible endoscope undergoing standard HLD with peracetic acid. The single-use cystoscope showed a 33% reduction in the climate change category [29]. On the other hand, other articles have shown a lower carbon footprint with the use of reusable devices compared to disposable devices, as long as HLD is performed using automatic methods [30]. Finally, after evaluating the options and given that the evidence on the feasibility and environmental impact of using disposable cystoscopes is controversial, one of our proposed improvement measures was to increase the number of reusable cystoscopes available from 5 to 8. This adjustment would align with the volume of procedures performed and facilitate the use of automatic reprocessing, ensuring a more sustainable and efficient workflow.

Lack of training of the reprocessing personnel was also a critical step found. Proper training helps ensure that cleaning and disinfection procedures are performed correctly, safeguarding patient safety and maintaining the integrity of the devices. Properly trained technicians demonstrate better compliance with protocols, greater confidence in their work, and higher satisfaction levels [32]. In this regard, the brand supplying the cystoscopes was approached to provide training. Finally, the lack of adequate equipment and infrastructure in the reprocessing area was identified as another contributing factor to several failure modes. It was observed that instruments were not stored properly in a clean, dust-free and well-ventilated area, increasing the risk of cystoscope contamination during storage [31]. Therefore, improving the infrastructure of the unit was proposed to ensure a clear separation between soiled and clean workspaces, with sinks large enough to fully immerse cystoscopes and their accessories and proper storage conditions for equipment after cleaning and disinfection. These proposed changes were deemed not only feasible at the organisational level, but also highly impactful. They would significantly improve the reprocessing procedures, modernize the unit and create a solid foundation for implementing.

HFMEA is a methodology typically implemented in order to identify potential failures and assess their severity. In our study, we applied this methodology to tackle a challenge that is difficult to address with quantitative techniques: evaluating errors in the reprocessing of medical instruments [14], a problem that can lead to serious adverse events, particularly cross-infections [3]. This issue is especially significant given that cystoscopy is generally considered a low-risk procedure and is not routinely monitored. However, studies investigating infection rates and morbidity associated with cystoscopy have revealed that up to half of patients the report urinary symptoms, such as dysuria, increased urinary frequency or haematuria after the procedure, with the incidence of infection following flexible cystoscopy ranging from 2% to 21.2% [32,33,34,35]. Even at the lower end of this spectrum, the high volume of procedures performed each year would result in a substantial public health impact.

Our study has several limitations. First, the FMEA process relies on the expertise and observations of committee members to identify failures, which means that there is a possibility that some failure modes might go undetected, potentially overlooking areas for improvement. Moreover, certain aspects of FMEA, such as the concept of detectability, and scoring of risks are inherently subjective and led to some debate within the team members [37]. To address this, FMEA was used as an active tool to systematically analyse potential failures and investigate their causes. This is especially important as we do not have good systems for detecting failures once they have occurred (cystoscope sampling systems are not comprehensive, UTI symptoms are mistaken for common complaints after cystoscopy and there are no cystoscope-patient traceability systems). Therefore, the use of proactive methodologies, such as FMEA, to identify failure points and prevent the occurrence of the event are essential. Moreover, being a qualitative study, some data were collected through staff interviews, which may have introduced some subjectivity in the information. To mitigate this, the researchers conducted multiple visits to the reprocessing unit and held interviews with staff on several occasions to ensure more comprehensive and consistent data collection. Additionally, identifying risks in collaboration with the staff involved has facilitated the implementation of changes, fostering a culture of safety and collaboration between departments, and producing results tailored to the unique needs of each unit.

This study shows that the infection control team should be more present in the units where invasive procedures are performed and should not reduce its tasks to microbiological surveillance but also include visits and audits to verify staff competency and adherence to the recommended reprocessing practices and provide continuous feedback. Studies have shown that strict adherence to all steps of manual endoscope reprocessing is rare, and critical tasks are often omitted, with the risk of cystoscope contamination that this entails. Furthermore, our results coincide with those of the literature consulted, indicating that our areas for improvement are likely to be assessed by other centres. In addition, the FMEA methodology is simple and widely validated, and it can be used in any centre.

Future research should focus on evaluating the cost-effectiveness of reusable devices, considering both their upfront costs and long-term sustainability, as it would play a crucial role in optimizing healthcare practices and ensuring efficient use of resources.