The Impact of COVID-19 on Medical Device Reporting and Investigation

Authors

DOI:

https://doi.org/10.33940/data/2021.9.3

Keywords:

COVID-19, MAUDE database, medical device reporting

Abstract

visual abstract med device reporting

Introduction
The Manufacturer and User Facility Device Experience (MAUDE) database houses medical device reports submitted to the U.S. Food and Drug Administration (FDA). In May 2020, the FDA released guidance about medical device reporting during a pandemic, anticipating delays in reporting and investigating events involving medical devices.

Methods
We aimed to understand how the COVID-19 pandemic impacted medical device reporting by analyzing reports in the MAUDE database that mention COVID-19.

Results
From the 816,470 reports submitted between January 1 and July 31, 2020, 3,500 (0.43%) included phrases related to COVID-19. Of these reports, 4.8% (167/3,500) described adverse events during COVID-19 patients’ treatment, and 90.3% (3,161 /3,500) described barriers manufacturers faced investigating malfunctioning devices during the pandemic. 4.9% (172/3,500) of reports were not related to COVID-19. Malfunctions were clinically significant in 85.8% (3,004/3,500) of reports.

Discussion
Reports indicate challenges some manufacturers had when investigating medical devices during the pandemic. The pandemic made investigating implants uniquely difficult, as restrictions to person-to-person contact limited the type of care patients could receive. Because full-scale investigations into malfunctioning devices may be difficult to perform during the pandemic, safety issues may go unaddressed and result in future harm to patients.

Conclusion
The COVID-19 pandemic and the myriad of healthcare, travel, and shipping challenges it created impacted how manufacturers reported and investigated medical devices. At the current time, it is unclear how manufacturers will address delayed clinical management of implant devices and other uninvestigated malfunctions after the pandemic and how this will impact patient safety.

Author Biographies

Zoe Pruitt, MA, MedStar Health National Center for Human Factors in Healthcare

Zoe Pruitt (zoe.m.pruitt@medstar.net) is a human factors specialist at the MedStar Health National Center for Human Factors in Healthcare. She holds a Master of Arts in human factors and applied cognition from George Mason University. Her research interests include applying a human factors lens to the usability of medical devices and analyzing patient safety event databases for emerging trends.

Christian Boxley, BS, MedStar Health National Center for Human Factors in Healthcare

Christian Boxley is a senior research associate at the MedStar Health Research Institute and holds a Bachelor of Science in biology of global health from Georgetown University. He has project experience managing, analyzing, and visualizing large datasets using programming languages such as Python and SQL and software tools such as Excel and Tableau. Mr. Boxley’s current research involves analyzing trends and themes in patient safety event report data.

Seth Krevat, MD, MedStar Health National Center for Human Factors in Healthcare; Georgetown University School of Medicine

Seth A. Krevat is assistant vice president for Safety at MedStar Health and a faculty associate at the MedStar Health National Center for Human Factors in Healthcare. In addition, he is an attending physician, Palliative Medicine, MedStar Georgetown University Hospital. As assistant vice president for Safety, Dr. Krevat is responsible for the patient and staff safety and risk reduction programs. He focuses on understanding, coordinating, and measuring the performance of internal and external safety requirements in both the acute and non-acute care arenas.

Srijan Sengupta, PhD, North Carolina State University

Srijan Sengupta is an assistant professor in the Department of Statistics at North Carolina State University. He received his bachelor’s and master’s degrees in statistics from the Indian Statistical Institute and his doctorate in statistics from University of Illinois at Urbana‐Champaign. His research interests include statistical network analysis, bootstrap and related resampling/subsampling methods, and patient safety.

Raj M. Ratwani, PhD, MedStar Health National Center for Human Factors in Healthcare; Georgetown University School of Medicine

Raj M. Ratwani is the director of the MedStar Health National Center for Human Factors in Healthcare, vice president of Scientific Affairs at the MedStar Health Research Institute, and an associate professor of Emergency Medicine at Georgetown University School of Medicine. He has extensive experience applying human factors principles and theories from cognitive science to improve healthcare delivery, focusing on the design, development, implementation, and use of digital healthcare technologies.

Allan Fong, MS, MedStar Health National Center for Human Factors in Healthcare

Allan Fong is a senior research and data scientist at the MedStar Health National Center for Human Factors in Healthcare. He holds degrees in engineering and computer science from Columbia University, MIT, and the University of Maryland-College Park. Mr. Fong’s background is in computer science, human factors, and systems engineering. His interests and research areas are information synthesis, visualization, and modeling of human cognition and behavior. He has extensive experience applying neural networks, machine learning, and natural language processing (NLP) techniques to large datasets to develop robust models.

References

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Man with covid molecule for his head, sitting at a desk on his laptop, with tons of numbers going into the sky.

Published

2021-09-17

How to Cite

Pruitt, Z., Boxley, C., Krevat, S. A., Sengupta, S., Ratwani, R. M., & Fong, A. (2021). The Impact of COVID-19 on Medical Device Reporting and Investigation. Patient Safety, 3(3), 28–35. https://doi.org/10.33940/data/2021.9.3

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Section

Original Research and Articles
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