Effectiveness of steam sterilization of reusable medical devices in primary and secondary care public hospitals in Nepal and factors associated with ineffective sterilization: A nation-wide cross-sectional study

Abstract

BackgroundInadequate sterilization of reusable medical devices can lead to healthcare associated infections (HAIs) through person-to-person or environmental transmission of pathogens. Autoclaving (steam sterilization) is most commonly used for sterilizing medical devices in healthcare facilities. We conducted a nation-wide cross-sectional study to evaluate the effectiveness of steam sterilization practices in primary and secondary care public hospitals in Nepal and to identify factors associated with ineffective sterilization.MethodsUsing a stratified clustered random sampling, 13 primary- and secondary-care public hospitals in Nepal were selected. 189 steam sterilization cycles from these hospitals were evaluated for their effectiveness using self-contained biological indicators, class-5 chemical indicators, autoclave indicator tape and physical parameters. Information about the hospitals and the types of autoclaves being used was also collected. Data were analysed to estimate the proportion of ineffective steam sterilization cycles. Logistic regression was used to identify factors associated with ineffective sterilization.FindingsIn primary and secondary care public hospitals in Nepal, 71.0% (95% CI 46.8% - 87.2%) of the autoclave cycles were ineffective (i.e. showed positive results) when tested with biological indicators and 69.8% (95% CI 44.4% - 87.0%) showed ‘reject’ results with class 5 chemical indicators. There was no statistically significant difference in proportions showing positive or reject results by hospital types for either biological (p = 0.51) or class 5 chemical (p = 0.87) indicators. Autoclave type and pressure achieved during sterilization were statistically significantly associated with steam sterilization failures, adjusted for holding period, evenness of pressure and barrier system used.ConclusionPrimary and secondary care hospitals in Nepal have a high proportion of steam sterilization failure, indicating a risk of person-to-person transmission of pathogens through reusable medical devices. There is an urgent need to improve steam sterilization processes in these hospitals.

Compliance of primary and secondary care public hospitals with standard practices for reprocessing and steam sterilization of reusable medical devices in Nepal: findings from nation-wide multicenter clustered audits

“…The mean percentage compliances for each process of the reprocessing cycle were less than 50%. These findings are in line with the high proportion of steam sterilization failures (reported elsewhere) in these hospitals [18]. One factor that may have led to overestimation of the mean percentage compliance is the presence of the researcher (auditor) during the reprocessing activities.…”

“…Panta et al previously reported a steam sterilization failure proportion of 69.8% (95% CI 44.4-87.0%) in primary and secondary care hospitals in Nepal [18]. To our knowledge, this proportion is the highest reported sterilization failure proportion in the world.…”

“…Similarly, only one hospital had spare parts for the sterilization equipment and none of the hospitals had equipment maintenance records. Moreover, only 1 to 3 staff were assigned for medical device reprocessing in these hospitals [18]. In this study, we found that, for more than 97% of the reprocessing cycles crucial processes, such as cleaning and autoclaving, were carried out by support staff (i.e.…”

“…The findings reported in this article are a part of a comprehensive observational study which comprised an estimation of steam sterilization failure proportions, an assessment of compliance of hospitals with standard medical device reprocessing practices, and a survey on knowledge and attitudes of healthcare workers towards sterilization and medical device reprocessing. The sample reported here was primarily developed for estimating steam sterilization failures in primary and secondary care public hospitals in Nepal and has been described in detail elsewhere [18].…”

“…The numbers of medical device reprocessing cycles to be audited in each hospital were 12, 15 and 15 for zonal, district and district-level hospitals, respectively. These numbers were primarily determined for estimating the proportion of steam sterilization failures in these hospitals and were based on the total number of hospitals within each category and a number of statistical assumptions including confidence level, margin of error required and impact of clustering [18]. The total number of medical device reprocessing cycles audited was 189 ( Table 1).…”