Medical Device Recalls in Radiation Oncology: Analysis of US Food and Drug Administration Data, 2002-2015.

ABSTRACT:

Purpose

To analyze all recalls involving radiation oncology devices (RODs) from the US Food and Drug Administration (FDA)'s recall database, comparing these with 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 to 2015 were sorted into 4 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 with those for ot

SUBMITTER: Connor MJ 

PROVIDER: S-EPMC5518627 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature