Derry Li, Sujata K. Bhatia

Abstract: Given the stresses placed on healthcare during the COVID-19 pandemic, and the critical role of computed tomography (CT) scanners in diagnosing cancers and other disorders, this project is designed to investigate the impact of the COVID-19 pandemic on reported malfunctions, injuries (and deaths) attributed to CT scans. Data were extracted from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. Yearly numbers of adverse event (AE) reports attributed to CT scanners including malfunctions, injuries, and deaths were recorded for the last 10 years (2012 to 2021). Monthly numbers of reports were also recorded for the 12 months immediately preceding the pandemic (2019/03 to 2020/03), as well as all the months after WHO declared COVID-19 a global pandemic (since 2020/03). It was found that the reported rates of injuries and malfunctions for CT scanners increased during the COVID-19 pandemic. The analysis also revealed unusual trends such as spikes in the malfunction rates from 2015 to 2018 compared to the preceding years, as well as in injuries and deaths. Manufacturers most responsible for these AE spikes included Philips, Superdimension, GE Healthcare, Siemens, etc. The FDA Recall Database was further mined, and similar trends were identified in the yearly recalls over 2015- 2018, which correlated well with the malfunction rates (less apparent for injuries and deaths). While this project was originally centered around adverse pandemic-related effects on CT scanners, the important pre-pandemic findings warrant further research. These results might help prevent future AEs caused not only by CT scans but also by other medical devices.

Keywords: Computed tomography, COVID-19 Pandemic, Adverse Event, Malfunctions, Injuries

Date Published: September 15, 2022
DOI: 10.11159/jbeb.2022.003

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