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Text
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URL Address
<a href="http://doi.org/10.7759/cureus.4230" target="_blank" rel="noreferrer noopener">http://doi.org/10.7759/cureus.4230</a>
Pages
5
Issue
3
Volume
11
ISSN
2168-8184
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Title
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United States Food and Drug Administration's 510(k) Pathway: Drawing Implications from the Approvals of Brachytherapy Devices
Publisher
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Cureus
Date
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2019
2019-03
Subject
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premarket approval; adverse events; cancer; General & Internal Medicine; radiotherapy; brachytherapy; radiation therapy; device malfunction; keloids; medical devices
Creator
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Wang S; Manudhane A; Ezaldein H H; Scott J F
Description
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Introduction Innovations in cancer treatment coupled with an increasing number of cancer patients have led to the growth of brachytherapy devices. The objective of this study is to characterize the development and safety of brachytherapy devices marketed in the United States (US) over the last 15 years. Methods We reviewed records from a public US Food and Drug Administration (FDA) database detailing premarket approval of brachytherapy devices. All 510(k) submissions approved between January 1, 2000 and October 31, 2018 were examined. To assess the safety of these devices, we searched the manufacturer and user facility device experience (MAUDE) database for related adverse events. Results Twenty-two brachytherapy devices received 510(k) premarket approval, with the first device approved in 2005. Of the 22 devices, 20 (91%) were marketed with specific indications. The most common indications include treatment of skin cancers and keloids (n=7), breast cancer (n=4), and gynecologic/rectal cancers (n=2). A review of the MAUDE database revealed 64 reports of adverse events associated with brachytherapy devices. Common adverse effects include poor device design, use error, and device malfunction that led to the delivery of an inaccurate dose of radiation. Discussion Although there are some single center, short-term studies demonstrating adequate local control and satisfactory cosmesis with brachytherapy, data on long-term outcomes are lacking. Further research is warranted to define appropriate practice guidelines for brachytherapy devices in the treatment of various malignancies.
Identifier
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<a href="http://doi.org/10.7759/cureus.4230" target="_blank" rel="noreferrer noopener">10.7759/cureus.4230</a>
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Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).
2019
adverse events
brachytherapy
Cancer
Cureus
device malfunction
Ezaldein H H
General & Internal Medicine
June 2019 Update
keloids
Manudhane A
medical devices
NEOMED College of Medicine
NEOMED College of Medicine Student
NEOMED Student Publications
premarket approval
radiation therapy
Radiotherapy
Scott J F
Wang S