Clinical Safety and Performance Evaluation of New Personal Protective Equipment During the COVID-19 Pandemic

As the healthcare response to the COVID-19 pandemic continues, providing enhanced protection to frontline healthcare personnel exposed to aerosolized infectious material is essential. The rapid spread of the COVID-19 virus across the globe in early 2020 generated an overwhelming surge in demand for effective personal protective equipment (PPE), in particular, passive personal respirators (PPR). Global manufacturing of PPR was limited, and research and development of improved respirators were restricted by the availability of accredited laboratories for timely testing at the peak of the pandemic. The authors have described a clinical method of safety and efficacy testing of a new PPR, the TopBioShield, using portable capnography for the measurement of end-tidal pCO(2) (ETCO(2)) and bedside pulse oximetry to measure oxygen saturation (SpO(2)), respiratory rate (RR), and heart rate (HR) in healthy volunteers to overcome shortages of clinical testing capabilities during the height of the pandemic. Twenty-eight volunteers with a median age of 41 years (range 16–71) representing all 10 subgroups of head/face size were included. Only one participant asked to withdraw due to a feeling of claustrophobia after 30 min. Clinical monitoring while wearing TopBioShield revealed ETCO(2), SpO(2), respiratory rate, and heart rate measurements were within normal limits in all the subjects throughout the experiment. Bedside clinical monitoring is effective in demonstrating the physiological safety of PPR and is an important alternative to conventional mannequin testing. In this study all measured values over a 90-min experiment period were within normal limits, demonstrating the effectiveness of TopBioShield in preventing CO(2) retention. Clinical testing methods must adhere to the highest standards and are essential during times of shortage.