Dr. Liljana Babinkostova and Dr. Marion Scheepers
According to the Food and Drug Administration (FDA) a recall is the removal or correction of medical devices that do not abide by the laws governed by the FDA and threaten patient health and safety. A Class I recall is the most severe and shows the most significant danger of death, while Class II and III are intermediate and low levels of danger. The main issues with medical device recalls include the interference of patient health and adherence to treatment for different diseases. Software issues were the number one cause of medical device recalls in 2019. As more devices connect to the internet, issues with cybersecurity have become more prominent. Although there are currently no reported malicious attacks to these devices, it is possible to exploit these vulnerabilities to deplete batteries, affect drug dosing, or access private health data. Our goal is to compile the FDA reports from the medical device recalls and run statistical tests to determine if there is a significant increase in cybersecurity vulnerabilities. In addition, we are compiling resources from health organizations regarding protocol to respond to cybersecurity incidents in medical devices and develop a cyber-awareness framework for patients, manufacturers, and product developers. Improving the security of medical devices is vital to ensuring patient health, safety, and privacy.
Leone, Rachel N.; Babinkostova, Liljana; Scheepers, Marion; Garcia, Kristen; Jimenez, Sulema; and Alomar, Tabarak, "An Analysis on Medical Device Recalls and Cybersecurity Implications on Patient Safety" (2020). 2020 Undergraduate Research Showcase. 104.