Medical devices recalls analysis focusing on software failures during the last decade

Abstract

Medical devices play a vital role in the delivery of high quality healthcare. Although recent technological advancements have led to much more reliable and safer medical devices, potential risks of failure and the associated adverse incidents cannot be neglected. Medical device (MD) recalls by manufacturers contribute to the safe function of the devices, in order to avoid incidents that could lead to injuries and deaths. The purpose of the present work is to present up-to-date information concerning MD recalls due to software failures. For this purpose, data from the United States Food and Drug Administration (FDA) Enforcement Reports for the period 1999-2010 have been used. The outcomes from data collection and analysis are presented through the use of ratio indicators and their distribution over the time. Furthermore, classifications of the MD recalls according to reasons of failure and the level of health hazard have been performed. The results reveal that almost half of the medical devices being recalled make use of software for their operation, indicating the growing role of the software in the domain of medical equipment. Furthermore, four out of every ten medical devices incorporating software have failed due to a problem in the software itself, while compared to the total FDA MD recalls this reaches 18.3% of software failures during this period. The present recalls analysis has demonstrated significant increase of MD software failures during the last decade, compared to previous studies. © Springer International Publishing Switzerland 2014.