Adverse events of after-loading high dose rate brachytherapy reported to the United States Food and Drug Administration (FDA)

Abstract

Purpose: To provide an assessment of safety regarding high-dose-rate after-loading brachytherapy (HDR-BT) based on adverse events reported to the OpenFDA, an open access database maintained by the United States Food and Drug Administration (FDA).

Methods: OpenFDA was queried for HDR-BT events between 1993 and 2019. A brachytherapist categorized adverse events (AEs) based on disease site, applicator, manufacturer, event type, dosimetry impact, and outcomes. Important findings are summarized.

Results: 372 AEs were reported between 1993 and 2019, with a downwards trend after 2014. Nearly half of AEs (48.9%) were caused by a device malfunction, and 27.4% resulted in patient injury. Breast (49.2%) and Gyn (23.7%) were the most common disease sites of AEs. Applicator breaks cause the majority of AEs (64.2%) and breast balloon implants were the most common applicator to malfunction (38.7%). User error contributed to only 16.7% of events. 11.0% of events required repair of the afterloader. There were no reported staff injuries or patient deaths from an AE, however 24.7% of patients received resultant incorrect radiation dose, 16.4% required additional procedures to rectify the AE, and 3.0% resulted in unintended radiation to staff.

Conclusion: The OpenFDA database has shown a decreasing trend in AEs since 2014 for HDR-BT. Most AEs are not caused by user error and do not cause patient injury or incorrect radiation dose. Investigation into methods to prevent failures and improve applicators such as the breast balloon could improve safety. These results support the continued use of HDR-BT as a safe treatment modality for cancer.

Keywords: Adverse Events; Afterloading; Brachytherapy; Food and drug administration (FDA); High-dose-rate (HDR).