Understanding sterilization and reuse of medical devices in Nepal.
Thesis DisciplineHealth Sciences
Degree GrantorUniversity of Canterbury
Degree NameDoctor of Philosophy
Background: It has been estimated that 7.1% (95% CI 6.5% - 7.8%) and 10.2% (95% CI 9.0% - 13.0%) of hospitalized patients acquire healthcare-associated infections (HAIs) in developed and developing countries respectively. HAIs can cause long-term disability, increase the financial burden for health systems, increase costs for patients and their families, and can also result in deaths. Though scientific estimates of HAIs in Nepal are not available, studies have reported that the proportion of patients developing surgical site infections after undergoing surgery in hospitals in Nepal is high. Reusable medical devices can be a source of such infections, if they are not sterilized adequately. Steam sterilization (autoclaving) is the most commonly used method of sterilizing reusable medical devices in healthcare facilities, including in primary and secondary care hospitals in Nepal. Appropriate strategies and interventions could be developed and implemented for ensuring adequate sterilization of medical devices if the effectiveness of steam sterilization in these hospitals is established, compliance of these hospitals with standard steam sterilization practices is understood, and factors associated with inadequate sterilization of medical devices are known.
Objectives: This study sought to: (i) estimate the effectiveness of steam sterilization practices in primary and secondary care hospitals in Nepal, (ii) understand compliance of these hospitals with standard steam sterilization practices, and (iii) investigate the knowledge and attitudes of healthcare workers towards sterilization and reuse of medical devices.
Methods: A quantitative descriptive cross-sectional study was used for this research. A total of thirteen primary and secondary care public hospitals were selected for this study, using cluster-sample design. Basic information about each of the hospitals was collected using a Hospital Summary Information sheet. Within these hospitals, 189 steam sterilization cycles were evaluated for their effectiveness, using self-contained biological indicators containing 1.3 x 106 spores Geobacillus stearothermophilus and class 5 chemical indicators. The same medical device reprocessing cycles were audited using an audit tool for medical device reprocessing with steam sterilization. A knowledge and attitude survey was carried out among healthcare workers, including doctors, nurses, paramedics and autoclave operators; a total of 219 healthcare workers participated in the survey. Descriptive statistical analysis of data was carried out using IBM Statistical Package for the Social Sciences (IBM SPSS statistics 24). The analysis included, but was not limited to, calculation of proportions, assessing associations between variables, and some regression analyses. Required ethical clearance was obtained from the University of Canterbury Human Ethics Committee and the Nepal Health Research Council to conduct this study.
Results: About 90% of the autoclaves used in primary and secondary care hospitals in Nepal were basic pressure-cooker type autoclaves. The proportion of steam sterilization cycles showing positive results (i.e. ineffective sterilization) with the biological indicators was 71.0% (95% CI 46.8% - 87.2%). Also, a similar proportion (69.8%; 95% CI 44.4% - 87.0%) of steam sterilization cycles showed “reject” results with class 5 chemical indicator. The pressure achieved during the holding period, and the autoclave type, were statistically significantly associated with ineffective steam sterilization. For all primary and secondary care hospitals, the mean percentage compliance with the standard practices for reprocessing of medical devices with steam sterilization was 25.9% (95% CI 21.0% - 30.8%). More than 70% of healthcare workers had appropriate knowledge about key aspects of the sterilization and reuse of medical devices, and overall, the attitudes of healthcare workers towards issues related to sterilization and reuse of medical devices were found to be positive. Compared with nurses, paramedics and office assistants were statistically significantly less likely to have correct knowledge or positive attitudes towards many of the medical device reprocessing issues, adjusted for duration of healthcare work, infection control training, employment status, and practice of autoclave operation.
Conclusion: This study provided an overall picture of steam sterilization and the reuse of medical devices in primary and secondary care public hospitals in Nepal. A high proportion of steam sterilization cycles in these hospitals was ineffective in killing spores of Geobacillus stearothermophilus, indicating a possibility of transmission of infectious agents to patients through reusable medical devices. Adequate management and support processes, including appropriate policies, infrastructure, equipment, education, and monitoring are required for ensuring effective sterilization of medical devices in these hospitals.