Wayne State University School of Medicine, Detroit, Michigan.
American Academy of Dermatology Association, Evanston, Illinois.
J Am Acad Dermatol. 2015 Jan;72(1):175-80. doi: 10.1016/j.jaad.2014.10.016. Epub 2014 Nov 11.
Tanning lamps have long been considered a class I medical device under regulation by the Food and Drug Administration (FDA). A growing body of research has repeatedly documented the association between elective indoor tanning and several negative health consequences. These accepted findings have prompted action by the FDA to officially reclassify tanning lamps as a class II medical device. The main purpose of this review is to update practitioners on the current state of tanning lamp classification and highlight the practical implications of this recent change. This information can be used by clinicians to easily reference this important action, and empower patients with a better understanding of the risks associated with indoor tanning.
日光浴灯长期以来一直被认为是食品和药物管理局(FDA)监管的 I 类医疗器械。越来越多的研究反复记录了选择性室内晒黑与多种负面健康后果之间的关联。这些公认的发现促使 FDA 采取行动,正式将日光浴灯重新归类为 II 类医疗器械。本次综述的主要目的是向从业者更新日光浴灯分类的现状,并强调这一近期变化的实际意义。临床医生可以利用这些信息轻松参考这一重要举措,并使患者更好地了解与室内晒黑相关的风险。