Characteristics of rapidly manufactured ventilators: a scoping review
Mikkelsen, Katie Lynn
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The mechanical ventilator shortage caused by the Sars-CoV-2 (Covid-19) respiratory virus revealed healthcare systems worldwide were not equipped to handle mass-casualty events. Rapidly manufactured ventilators (RMVs) are low-cost machines made from readily available materials capable of performing the basic requirements of mechanical ventilation and posed a potential solution when intensive care unit ventilators were occupied. In the current literature, a plethora of RMVs exist in a variety of designs and capabilities; however, a lack of universal standards regarding their design and testing procedures restrict their safe introduction into the clinical setting. Standards for medical devices, like the International Organization for Standardization (ISO), help ensure safe, reliable and effective performance while also reducing the risk for recalls or adverse events. This scoping review collected and synthesized all available evidence on RMVs for critically ill patients. In April 2022, a systematic search was completed in numerous databases, resulting in the inclusion of 52 articles (53 RMVs). Four categories (operating, performance, other general features, and engineering components) created based on the information from six RMV guidance documents described the characteristics of the RMV designs and are presented in textual and graphical form. There was a large amount of variability in the characteristics of the RMVs, with some including several design elements and quality testing, while others including very few. Based on the synthesis of the 53 RMVs and six previously published RMV guidance documents, 11 suggestions regarding RMV design, performance and testing are provided. These suggestions may serve as a useful tool for development of universal standards such as those published by the ISO or for teams wishing to design their own RMV.