title: Adverse Events Involving Radiation Oncology Medical Devices: Comprehensive Analysis of US Food and Drug Administration Data, 1991 to 2015.
abstract: 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 χ2test 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.
authors.affiliation: 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.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Connor
authors.affiliation: Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.
authors.forename: Deborah C
authors.initials: DC
authors.lastname: Marshall
authors.affiliation: Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.
authors.forename: Vitali
authors.initials: V
authors.lastname: Moiseenko
authors.affiliation: Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.
authors.forename: Kevin
authors.initials: K
authors.lastname: Moore
authors.affiliation: Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.
authors.forename: Laura
authors.initials: L
authors.lastname: Cervino
authors.affiliation: Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.
authors.forename: Todd
authors.initials: T
authors.lastname: Atwood
authors.affiliation: Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.
authors.forename: Parag
authors.initials: P
authors.lastname: Sanghvi
authors.affiliation: Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.
authors.forename: Arno J
authors.initials: AJ
authors.lastname: Mundt
authors.affiliation: Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.
authors.forename: Todd
authors.initials: T
authors.lastname: Pawlicki
authors.affiliation: Department of Radiation Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
authors.forename: Abram
authors.initials: A
authors.lastname: Recht
authors.affiliation: Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California. Electronic address: jhattangadi@ucsd.edu.
authors.forename: Jona A
authors.initials: JA
authors.lastname: Hattangadi-Gluth
mesh_terms: D001918:Brachytherapy / Q000009:adverse effects / Q000295:instrumentation / Q000401:mortality / Q000706:statistics & numerical data; D016009:Chi-Square Distribution; D016208:Databases, Factual / Q000706:statistics & numerical data; D018795:Device Approval; D019544:Equipment Failure Analysis / Q000706:statistics & numerical data*; D004869:Equipment Safety / Q000401:mortality / Q000706:statistics & numerical data*; D006801:Humans; D065186:Interrupted Time Series Analysis; D016014:Linear Models; D019300:Medical Errors / Q000009:adverse effects / Q000706:statistics & numerical data; D057051:Product Recalls and Withdrawals; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data*; D018787:Radiation Oncology / Q000295:instrumentation* / Q000706:statistics & numerical data; D011878:Radiotherapy / Q000009:adverse effects / Q000295:instrumentation / Q000401:mortality / Q000706:statistics & numerical data; D011879:Radiotherapy Dosage; D011880:Radiotherapy Planning, Computer-Assisted / Q000295:instrumentation / Q000401:mortality; D000066908:Simulation Training; D012984:Software / Q000706:statistics & numerical data; D018709:Statistics, Nonparametric; D013679:Technology, Radiologic / Q000295:instrumentation / Q000706:statistics & numerical data; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration