The article “User Interface Software Errors in Medical Devices: Study of US Recall Data”, by Paolo Masci, at the time of its writing, researcher of HASLab, was selected as best research article in 2019. The article analysed software errors in the user interface of commercial medical devices, and was distinguished by Association for the Advancement of Medical Instrumentation (AAMI).
This research, developed in partnership with the Food and Drug Administration (FDA), focused on examining medical device “recall” data in the US, namely data concerning devices that manufacturers needed to remove from the market and fix, due to several reported incidents or complaints. The analysed data covered the period between 2012 and 2015, and included nearly 8,000 recalls. This analysis aimed to understand the impact and nature of user interface software errors in medical devices.
Based on the analysis results, there were more than 400 occurrences caused, partially or entirely, by software errors in the user interface, corresponding to almost half of the cases of software errors in the same period.
This study also explored the root causes in system design of the user interface errors that caused the recall of devices, and created a detailed classification with 20 different categories of design issues. It’s important to mention that this classification can be used by device manufacturers, end users and regulatory authorities to raise awareness of the type and impact of errors on medical devices’ user interfaces. In addition, it can also provide stakeholders with an evidence-based way to assess and evaluate the quality of user interface software installed on medical devices
The article was accepted and published in the May/June 2019 edition of Biomedical Instrumentation & Technology (BI&T), a peer reviewed journal dedicated to medical instrumentation and technology programmers, managers and users, by the AAMI, a leading US organisation that promotes the development of standards for the safe and effective use of medical technology.
Paolo Masci emphasised the importance of this distinction by the Editorial Board of BI&T of AAMI. “This article is an important milestone for me and my research team, since it is the first of its kind for the scale and level of detail”, he said. “I hope this can be used by everyone to further improve the safety of healthcare systems”, he concluded.
It’s worth noting that Paolo Masci, who is currently working at the National Institute of Aerospace (NIA) and NASA Langley, developed this work in 2018, when he was a post-doctoral researcher at Haslab and INESC TEC, within the framework of a long-term collaboration with the FDA.