Effect of a hydrogen peroxide gas-plasma sterilization on physical integrity and quality of N95 respirators: An experimental study during the COVID-19 pandemic

Malathi Murugesan, S. Radha, Bhagteshwar Singh, P. Mathews, Suresh Devasahayam, P. Rupali
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Abstract

Background: N95 respirators have prevented transmission among health-care workers during the COVID-19 pandemic. During times of intense shortage of respirators and border closures during the pandemic, re-use strategies with available decontamination methods were necessitated. This in-house experimental study evaluated the effect of hydrogen peroxide gas-plasma sterilization on respirators and helped establish an evidence-based protocol for their re-use in a resource-poor setting. Materials and Methods: A three-dimensional experimental model using saline nebulization as the aerosol exposure and a particle counter to measure the filtration of particles through the mask pre- and post-sterilization was used. Multiple cycles of plasma sterilization were done till the physical integrity/fit was lost. Total filtration volume was used as a surrogate marker to assess the filtration efficiency (FE). Results: The total volume of particles filtered on a 3M respirator was 99.9%. Unused Halyard and Venus respirators were compared against 3M and found to have FE of 99.9% and 60.5%, respectively. After repeated sterilization cycles, the total volume of particles filtered was 59.3% for Halyard in the seventh cycle and 36.2% for Venus in the fifth cycle. When the physical integrity and fit was tested, the appropriate fit was lost after eight cycles of sterilization for Venus and was not lost for Halyard even after the tenth cycle. Conclusion: This low-cost experimental study helped implement an effective and safe decontamination strategy for safe re-use of N95 respirators in an emergent situation with no access to commercial testing in a resource poor health-care setting during the pandemic.
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双氧水等离子体灭菌对N95口罩物理完整性和质量影响的实验研究
背景:N95口罩在COVID-19大流行期间阻止了卫生保健工作者之间的传播。在大流行期间呼吸器严重短缺和边境关闭期间,有必要采用具有可用去污方法的重复使用战略。这项内部实验研究评估了过氧化氢气体等离子体灭菌对呼吸器的影响,并帮助建立了在资源匮乏环境下呼吸器再利用的循证方案。材料与方法:采用三维实验模型,以生理盐水雾化为气溶胶暴露,用粒子计数器测量灭菌前后面罩中颗粒的过滤情况。多次进行等离子体灭菌,直到失去物理完整性/契合度。以总过滤体积作为评价过滤效率的替代指标。结果:3M口罩过滤颗粒的总积为99.9%。将未使用的Halyard和Venus呼吸器与3M进行比较,发现其FE分别为99.9%和60.5%。经过多次循环灭菌,Halyard第7次和Venus第5次的颗粒过滤总量分别为59.3%和36.2%。当对身体完整性和契合度进行测试时,维纳斯的合适契合度在8个周期的消毒后就消失了,而哈利亚德的合适契合度在10个周期后也没有消失。结论:这项低成本的实验研究有助于在疫情期间,在资源匮乏的卫生保健环境中,在无法获得商业检测的紧急情况下,实施有效和安全的去污战略,安全重复使用N95口罩。
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