scholarly journals 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

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Gopal Panta ◽  
Ann K. Richardson ◽  
Ian C. Shaw ◽  
Patricia A. Coope

Abstract 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.

Author(s):  
Gopal Panta ◽  
Ann K Richardson ◽  
Ian C Shaw

Abstract Reusable medical devices are decontaminated and sterilized often many times by healthcare facilities across the globe. Reprocessing of medical devices comprises several processes and water plays an important role in some of these, including cleaning and steam sterilization. The water used is required to have certain qualities to ensure the effectiveness of the processes. In this short communication, we report findings of our study which measured quality parameters (pH, total hardness) for water used for medical device reprocessing in 13 primary and secondary care public hospitals in Nepal. The mean pH of water used for reprocessing of medical devices varied from 6.48 to 8.05 across the hospitals whereas the mean total hardness of water varied from 5.93 to 402.50 mg/L CaCO3. Although the range of the mean water pH across hospitals fell within the recommended range, many of the hospitals had mean total hardness higher than recommended for cleaning medical devices. None of the hospitals had mean total hardness suitable for using as feed-water for steam generation. Public hospitals in Nepal should have appropriate water treatment systems so that the recommended water quality can be achieved to ensure effective decontamination and reprocessing of medical devices.


2014 ◽  
Vol 48 (4) ◽  
pp. 306-311
Author(s):  
Daniel Prince ◽  
Jozef Mastej ◽  
Isabel Hoverman ◽  
Raja Chatterjee ◽  
Diana Easton ◽  
...  

Validation by steam sterilization of reusable medical devices requires careful attention to many parameters that directly influence whether or not complete sterilization occurs. Complex implant/instrument tray systems have a variety of configurations and components. Geobacillus stearothermophilus biological indicators (BIs) are used in overkill cycles to to simulate worst case conditions and are intended to provide substantial sterilization assurance. Survival of G. stearothermophilus spores was linked to steam access and size of load in the chamber. By a small and reproducible margin, it was determined that placement of the trays in a rigid container into minimally loaded chambers were more difficult to completely sterilize than maximally loaded chambers.


2017 ◽  
Vol 19 (4) ◽  
pp. 37-43 ◽  
Author(s):  
Bailey Lorv ◽  
Robin Horodyski ◽  
Cynthia Welton ◽  
John Vail ◽  
Luca Simonetto ◽  
...  

2019 ◽  
Vol 13 (10) ◽  
pp. 858-864 ◽  
Author(s):  
Gopal Panta ◽  
Ann K Richardson ◽  
Ian C Shaw

Medical devices are sterilized before being used for invasive clinical procedures such as surgery, to prevent pathogen transfer. Failure to sterilize medical devices properly presents a risk of healthcare-associated infections. Studies and reports have indicated that inadequately sterilized medical devices are one of the causes of a higher rate of healthcare-associated infections in developing countries. Steam sterilization (autoclaving) is the most widely used method for sterilization and is considered the most robust and cost-effective method for sterilization of medical devices. The effectiveness of steam sterilization can be measured using biological indicators. A literature search was undertaken to understand the effectiveness of autoclaving in sterilizing reusable medical devices in healthcare facilities across the globe. Studies using biological indicators for measuring the effectiveness of autoclaving were obtained. Failures of steam sterilization practices were identified and discussed as a means of identifying factors that might be associated with the ineffectiveness of steam sterilization practices between different countries. The number of studies measuring the effectiveness of steam sterilization is small, and few evaluate the effectiveness of steam sterilization specifically in developing countries. There are fewer studies on higher level healthcare facilities than dental facilities. More evidence about the effectiveness of autoclaving in healthcare facilities is needed to draw firm conclusions, but the data suggest that there are inadequacies in autoclave procedures and operator education.


2021 ◽  
Author(s):  
Vivekanandan Kalaiselven ◽  
Shatrunajay Shukla ◽  
Nikita Mishra ◽  
Pawan Kumar

Medical devices are being used in healthcare facilities for diagnosis, monitoring, prevention and treatment of an array of diseases. To ensure user/patient safety associated with the medical devices being used in healthcare industry, it is of utmost importance to closely monitor the adverse events associated with the medical devices through a robust, sustainable and scaled surveillance. Materiovigilance Programme of India (MvPI) provides a reliable system to report adverse events associated with medical devices. Under MvPI, various modalities to report adverse events associated with medical devices have been developed. These modalities include an editable medical device adverse event reporting form, a toll-free helpline number and a field safety corrective action form (FSCA). FSCA form is used to notify the regulatory authority and healthcare professionals on corrective actions or recall by the manufacturer. Due to the emergence of the Coronavirus disease 2019 (COVID-19) pandemic, one-page editable form has been developed to boost the adverse event reporting of Personal Protective Equipments (PPEs). MvPI also coordinates with healthcare facilities and medical device industries across the country for reporting the medical device-related adverse events. The collected scientific data is utilized to develop regulatory policies and enhance measures to ensure the quality of medical devices. All the healthcare workers are, therefore, encouraged to report adverse events to MvPI. This chapter aims to describe the systems, procedures and modalities available for the reporting of Medical Device Adverse Events (MDAEs) in India, in order to intensify the nature of reporting and creating an environment that encourages the public to perform MDAE reporting.


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