Background: Reusable medical devices in healthcare facilities are decontaminated and reprocessed following standard practices before each clinical procedure. Reprocessing of critical medical devices (those used for invasive clinical procedures) comprises several processes including sterilization, which provides the highest level of decontamination. Steam sterilization is the most used sterilization procedure across the globe. Noncompliance with standards addressing reprocessing of medical devices may lead to inadequate sterilization and thus increase the risk of person-to-person or environmental transmission of pathogens in healthcare facilities. We conducted nationwide multicenter clustered audits to understand the compliance of primary- and secondary-care public hospitals in Nepal with the standard practices for medical device reprocessing, including steam sterilization.
Methods: We developed an audit tool to assess compliance of hospitals with the standard practices for medical device reprocessing including steam sterilization. Altogether, 189 medical device reprocessing cycles which included steam sterilization were assessed in 13 primary and secondary care public hospitals in Nepal using the audit tool. Percentage compliance was calculated for each standard practice. Mean percentage compliances were obtained for overall primary and secondary care hospitals and for each hospital type, specific hospital and process involved.
Results: For all primary and secondary care hospitals in Nepal, the mean percentage compliance with the standard practices for medical device reprocessing including steam sterilization was 25.9% (95% CI 21.0-30.8%). The lower the level of care provided by the hospitals, the lower was the mean percentage compliance, and the difference in the means across the hospital types was statistically significant (p < 0.01). The mean percentage compliance of individual hospitals ranged from 14.7 to 46.0%. The hospitals had better compliance with the practices for cleaning of used devices and transport and storage of sterilized devices compared with the practices for other processes of the medical device reprocessing cycle.
Conclusion: The primary and secondary care hospitals in Nepal had poor compliance with the standard practices for steam sterilization and reprocessing of medical devices. Interventions to improve compliance of the hospitals are immediately required to minimize the risks of person-to-person or environmental transmission of pathogens through inadequately reprocessed medical devices.
Keywords: Audits; Medical devices; Reprocessing; Steam sterilization.