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Laser and Other Light-Emitting Medical Devices Used in Healthcare Settings—Considerations Regarding Device Safety

Erchul, Daniel MS; Kaushiva, Anchal MS; Ogden, Neil MS

doi: 10.1097/JCE.0000000000000181
FEATURE ARTICLES: ONLINE ONLY
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Light-emitting medical devices are used for a variety of purposes in healthcare facilities, and these devices can differ widely in output characteristics, indications for use, and in safety precautions. This article is intended to provide some technical background, applications, and common safety considerations for these devices. It also touches on the mechanisms for reporting serious adverse effects and medical device malfunctions involving these devices to the US Food and Drug Administration.

Daniel Erchul, MS, is a biomedical engineer in the US Food and Drug Administration’s (FDA’s) Office of Device Evaluation. He can be reached at danny6572@sbcglobal.net.

Anchal Kaushiva, MS, is a supervisory biomedical engineer in FDA’s Office of Surveillance and Biometrics.

Neil Ogden, MS, is a supervisory biologist in FDA’s Office of Device Evaluation.

The authors declare no conflicts of interest.

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