PMID- 34088594
OWN - NLM
STAT- MEDLINE
DCOM- 20211101
LR  - 20211101
IS  - 1873-1449 (Electronic)
IS  - 1538-4721 (Linking)
VI  - 20
IP  - 5
DP  - 2021 Sep-Oct
TI  - Adverse events of after-loading high dose rate brachytherapy reported to the 
      United States Food and Drug Administration (FDA).
PG  - 1053-1061
LID - S1538-4721(21)00098-2 [pii]
LID - 10.1016/j.brachy.2021.04.005 [doi]
AB  - 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.
CI  - Copyright (c) 2021 American Brachytherapy Society. Published by Elsevier Inc. All 
      rights reserved.
FAU - Provenzano, Destie
AU  - Provenzano D
AD  - Division of Radiation Oncology, The George Washington University School of 
      Medicine and Health Sciences, Washington, DC; Department of Biomedical 
      Engineering, The George Washington University, Washington, DC.
FAU - Rao, Kevin
AU  - Rao K
AD  - Department of Biomedical Engineering, Johns Hopkins University, Baltimore, MD.
FAU - Cifter, Gizem
AU  - Cifter G
AD  - Division of Radiation Oncology, The George Washington University School of 
      Medicine and Health Sciences, Washington, DC.
FAU - Taunk, Neil
AU  - Taunk N
AD  - Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA.
FAU - Fischer-Valuck, Benjamin
AU  - Fischer-Valuck B
AD  - Department of Radiation Oncology, Emory University, Atlanta, GA.
FAU - Lin, Alexander
AU  - Lin A
AD  - Department of Radiation Oncology, Washington University in St. Louis, Saint 
      Louis, MO.
FAU - Sarfaraz, Mehrdad
AU  - Sarfaraz M
AD  - Division of Radiation Oncology, The George Washington University School of 
      Medicine and Health Sciences, Washington, DC.
FAU - Aghdam, Hamid
AU  - Aghdam H
AD  - Division of Radiation Oncology, The George Washington University School of 
      Medicine and Health Sciences, Washington, DC.
FAU - Ojong-Ntui, Martin
AU  - Ojong-Ntui M
AD  - Division of Radiation Oncology, The George Washington University School of 
      Medicine and Health Sciences, Washington, DC.
FAU - Loew, Murray H
AU  - Loew MH
AD  - Department of Biomedical Engineering, The George Washington University, 
      Washington, DC.
FAU - Goyal, Sharad
AU  - Goyal S
AD  - Division of Radiation Oncology, The George Washington University School of 
      Medicine and Health Sciences, Washington, DC.
FAU - Rao, Yuan James
AU  - Rao YJ
AD  - Division of Radiation Oncology, The George Washington University School of 
      Medicine and Health Sciences, Washington, DC; Department of Biomedical 
      Engineering, The George Washington University, Washington, DC. Electronic 
      address: yrao@mfa.gwu.edu.
LA  - eng
PT  - Journal Article
DEP - 20210602
PL  - United States
TA  - Brachytherapy
JT  - Brachytherapy
JID - 101137600
SB  - IM
MH  - *Brachytherapy/methods
MH  - Humans
MH  - Radiometry
MH  - Radiotherapy Dosage
MH  - United States/epidemiology
MH  - United States Food and Drug Administration
OTO - NOTNLM
OT  - Adverse Events
OT  - Afterloading
OT  - Brachytherapy
OT  - Food and drug administration (FDA)
OT  - High-dose-rate (HDR)
EDAT- 2021/06/06 06:00
MHDA- 2021/11/03 06:00
CRDT- 2021/06/05 05:32
PHST- 2021/01/21 00:00 [received]
PHST- 2021/04/26 00:00 [revised]
PHST- 2021/04/28 00:00 [accepted]
PHST- 2021/06/06 06:00 [pubmed]
PHST- 2021/11/03 06:00 [medline]
PHST- 2021/06/05 05:32 [entrez]
AID - S1538-4721(21)00098-2 [pii]
AID - 10.1016/j.brachy.2021.04.005 [doi]
PST - ppublish
SO  - Brachytherapy. 2021 Sep-Oct;20(5):1053-1061. doi: 10.1016/j.brachy.2021.04.005. 
      Epub 2021 Jun 2.