Analysis and Classification of Medical Device Recalls

Medical device recalls by manufacturers contribute to the safe and qualitative function of the devices, in order that incidents which could lead to injuries and deaths are avoided. The present work aims to analyze the data available from the major medical device vigilance systems concerning recalls due to software problems. For this purpose, records from the United States Food and Drug Administration (FDA) for the period 1999–2005 are used. The results from data collection and analysis are presented through the use of ratio indicators and their distribution over the time. Furthermore, classification of the recalls by device categories is performed. The results reveal that one in every three medical devices, making use of software for their operation, has been recalled due to failure in the software itself. In percentage ratios, 11.3% of the total FDA recalls are attributable to software failures. Comparison with previous studies demonstrates increased number of software failure recalls. This indicates the growing importance of software in the domain of medical equipment. The present analysis reveals the tendencies and the areas to focus for the achievement of highest level of safety and quality in biomedical technology.