Connor Michael J, Marshall Deborah C, Moiseenko Vitali, Moore Kevin, Cervino Laura, Atwood Todd, Sanghvi Parag, Mundt Arno J, Pawlicki Todd, Recht Abram, Hattangadi-Gluth Jona A
Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California; Department of Radiation Oncology, University of California Irvine School of Medicine, Irvine, California.
Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.
Int J Radiat Oncol Biol Phys. 2017 Jan 1;97(1):18-26. doi: 10.1016/j.ijrobp.2016.08.050.
Radiation oncology relies on rapidly evolving technology and highly complex processes. The US Food and Drug Administration collects reports of adverse events related to medical devices. We sought to characterize all events involving radiation oncology devices (RODs) from the US Food and Drug Administration's postmarket surveillance Manufacturer and User Facility Device Experience (MAUDE) database, comparing these with non-radiation oncology devices.
MAUDE data on RODs from 1991 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems) and 5 device problem categories (software, mechanical, electrical, user error, and dose delivery impact). Outcomes included whether the device was evaluated by the manufacturer, adverse event type, remedial action, problem code, device age, and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Results for RODs were compared with those for other devices by the Pearson χ test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions.
There were 4234 ROD and 4,985,698 other device adverse event reports. Adverse event reports increased over time, and events involving RODs peaked in 2011. Most ROD reports involved external beam therapy (50.8%), followed by brachytherapy (24.9%) and treatment planning systems (21.6%). The top problem types were software (30.4%), mechanical (20.9%), and user error (20.4%). RODs differed significantly from other devices in each outcome (P<.001). RODs were more likely to be evaluated by the manufacturer after an event (46.9% vs 33.0%) but less likely to be recalled (10.5% vs 37.9%) (P<.001). Device age and time since 510(k) approval were shorter among RODs (P<.001).
Compared with other devices, RODs may experience adverse events sooner after manufacture and market approval. Close postmarket surveillance, improved software design, and manufacturer-user training may help mitigate these events.
放射肿瘤学依赖于快速发展的技术和高度复杂的流程。美国食品药品监督管理局收集与医疗设备相关的不良事件报告。我们试图从美国食品药品监督管理局上市后监测的制造商和用户设施设备经验（MAUDE）数据库中描述所有涉及放射肿瘤学设备（ROD）的事件，并将这些事件与非放射肿瘤学设备进行比较。
将1991年至2015年ROD的MAUDE数据分为4个产品类别（外照射、近距离放射治疗、治疗计划系统和模拟系统）和5个设备问题类别（软件、机械、电气、用户错误和剂量输送影响）。结果包括设备是否由制造商评估、不良事件类型、补救措施、问题代码、设备使用年限以及自510（k）批准以来的时间。采用时间序列数据的线性回归进行描述性统计。通过对分类数据的Pearson χ检验和对分布的双样本Kolmogorov-Smirnov检验，将ROD的结果与其他设备的结果进行比较。
有4234份ROD不良事件报告和4985698份其他设备不良事件报告。不良事件报告随时间增加，涉及ROD的事件在2011年达到峰值。大多数ROD报告涉及外照射治疗（50.8%），其次是近距离放射治疗（24.9%）和治疗计划系统（21.6%）。最主要的问题类型是软件（30.4%）、机械（20.9%）和用户错误（20.4%）。在每个结果方面，ROD与其他设备有显著差异（P<0.001）。事件发生后，ROD更有可能由制造商评估（46.9%对33.0%），但召回的可能性较小（10.5%对37.9%）（P<0.001）。ROD的设备使用年限和自510（k）批准以来的时间较短（P<0.001）。
与其他设备相比，ROD在制造和市场批准后可能更快出现不良事件。密切的上市后监测、改进软件设计以及制造商-用户培训可能有助于减轻这些事件。
