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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

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?

SUBMITTER: Panta G

PROVIDER: S-EPMC7542764 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Project description:BackgroundDue to increased requirement for personal protective equipment during the coronavirus disease 2019 pandemic, many medical centres utilized sterilization systems approved under Food and Drug Administration Emergency Use Authorization for single-use N95 mask re-use. However, few studies have examined the real-world clinical challenges and the role of ongoing quality control measures in successful implementation.AimsTo demonstrate successful implementation of quality control measures in mask reprocessing, and the importance of continued quality assurance.MethodsA prospective quality improvement study was conducted at a tertiary care medical centre. In total, 982 3M 1860 masks and Kimberly-Clark Tecnol PFR95 masks worn by healthcare workers underwent sterilization using a vaporized hydrogen peroxide gas plasma-based reprocessing system. Post-processing qualitative fit testing (QFT) was performed on 265 masks. Mannequin testing at the National Institute for Occupational Safety and Health (NIOSH) laboratory was used to evaluate the impact of repeated sterilization on mask filtration efficacy and fit. A locally designed platform evaluated the filtration efficiency of clinically used and reprocessed masks.FindingsIn total, 255 N95 masks underwent QFT. Of these, 240 masks underwent post-processing analysis: 205 were 3M 1860 masks and 35 were PFR95 masks. Twenty-five (12.2%) of the 3M masks and 10 (28.5%) of the PFR95 masks failed post-processing QFT. Characteristics of the failed masks included mask deformation (N=3, all 3M masks), soiled masks (N=3), weakened elastic bands (N=5, three PFR95 masks), and concern about mask shrinkage (N=3, two 3M masks). NIOSH testing demonstrated that while filter efficiency remained >98% after two cycles, mask strap elasticity decreased by 5.6% after reprocessing.ConclusionsThis study demonstrated successful quality control implementation for N95 mask disinfection, and highlights the importance of real-world clinical testing beyond laboratory conditions.

Project description:BackgroundDifferent 3D-printed materials polyactic acid (PLA), polyamide (PA), polycarbonates (PC), acrylonitrile butadiene styrene (ABS) and GreenTEC Pro®I have been considered for surgical templates, but there is a sparity of data about how these materials are affected by steam sterilization. The aim of the current study was to test if and how these materials change morphologically when high temperature, pressure and humidity are applied during the steam sterilization process. The overall aim is to create patient-specific sawing templates for performing corrective osteotomies. After the designing process, test-specimens with five different materials: PLA, PC, ABS, PA and GreenTEC Pro® were 3D-printed in two filling grades (30 and 100%). The FDM method was used for printing. After 3D-printing, the test-specimens were steam sterilized with a standard program lasting 20 min, at a temperature of 121 °C and a pressure of 2-3 bar. In order to measure the deviation of the printed model, we measured the individual test-specimens before and after steam sterilization using a sliding gauge.ResultsPC, PA and ABS showed great morphological deviations from the template after 3D-printing and steam sterilization (> 1%) respectively. ABS proved unsuitable for steam sterilization. PLA and GreenTEC Pro® demonstrated fewer morphological deviations both before and after sterilization. Therefore, we decided to perform a second test just with PLA and Green-TEC Pro® to find out which material has the highest stability and is probably able to be used for clinical application. The smallest deviations were found with the GreenTEC Pro® solid body. After autoclaving, the specimens showed a deviation from the planned body and remained below the 1% limit.ConclusionSteam sterilization causes morphological deviations in 3D printed objects. GreenTEC Pro® seems to be a suitable material for clinical use, not only for intraoperative use, but also for precise modeling. Microbiological examination, as well as biomechanical tests, should be performed to further assess whether intraoperative use is possible.

Project description:IntroductionThe present paper proposes a tool to follow up the compliance of staff and students with biosecurity rules, as enforced in a veterinary faculty, i.e., animal clinics, teaching laboratories, dissection rooms, and educational pig herd and farm.MethodsStarting from a generic list of items gathered into several categories (personal dress and equipment, animal-related items, infrastructures, waste management, management of material/equipment and behavior), a checklist was created for each sector/activity mentioned above, based on the rules and procedures compiled in the Faculty biosecurity standard operating procedures. Checklists were created as Excel™ files. For each sector, several sheets were elaborated, i.e., one per specific activity: for example, the following sheets were created for the equine clinic: class 1-2 hospitalization (class 1 = non-infectious conditions; class 2 = infectious disease with a low or non-existent risk of transmission), class 3 hospitalization (class 3 = infectious disease with a moderate risk of transmission; these patients are suspected of having an infectious disease and being contagious for other patients and/or for humans) and consultation.ResultsClass 4 area, which corresponds to the isolation unit and aims at housing patients suffering from infectious diseases with a significant risk of transmission (including notifiable conditions), was not audited at that period, as it was undergoing renovation works. The audit relied on observations performed by a unique observer to ensure standardization. Observed items were presented as yes/no and multiple-choice questions. A scale from 0 to 3 or 4 (depending on the item) allowed scoring each item, i.e., 0 corresponding to 100% compliance with the procedure and the highest score to the worst situation. A median and average global score was also estimated by category and by activity.DiscussionThe methodology described in the present paper allows estimating the compliance with biosecurity standard operating procedures in a specific sector and/or for a given activity. The identification of criteria needing improvement is a key point: it helps prioritizing actions to be implemented and awareness raising among people concerned. Regular internal auditing is an essential part of a biosecurity plan, the frequency being conditioned by the risk linked to a specific activity or area (i.e., more frequent audits in risky situations).

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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

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