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Medical Device Recalls in Radiation Oncology: Analysis of U.S. Food and Drug Administration Data, 2002–2015
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Abstract
Purpose
Medical devices in radiation oncology have undergone remarkable technological advancement over the last two decades. The U.S. Food and Drug Administration (FDA) administers recalls of medical devices posing safety risks. We analyzed all recalls involving radiation oncology devices (RODs) from the FDA’s recall database, comparing these to non-radiation oncology device recalls to identify discipline-specific trends that may inform improvements in device safety.
Methods and Materials
Recall data on RODs from 2002–2015 were sorted into four product categories (external beam, brachytherapy, planning systems, and simulation systems). Outcomes included determined cause of recall, recall class (severity), quantity in commerce, time until recall termination (date FDA determines recall is complete), and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Results for RODs were compared to those for other devices by Pearson’s Chi-squared test for categorical data and two-sample Kolmogorov-Smirnov test for distributions.
Results
There were 502 ROD recalls and 9,534 other class II device recalls from 2002–2015. Most recalls were for external beam devices (66.7%) and planning systems (22.9%), and recall events peaked in 2011. RODs differed significantly from other devices in all recall outcomes (p≤0.04). Recall cause was commonly software-related (49% vs. 10% for other devices). Recall severity was more often moderate among RODs (97.6% vs. 87.2%) instead of severe (0.2% vs. 4.4%; p<0.001). Time from 510(k) market approval to recall was shorter among RODs (p<0.001), and progressively shortened over time. RODs had fewer recalled devices in commerce than other devices (p<0.001).
Conclusions
Compared to other class II devices, RODs experience recalls sooner after market approval and are trending sooner still. Most of these recalls were moderate in severity and software issues are prevalent. Comprehensive analysis of recall data can identify areas for device improvement, such as better system design among RODs.