Brenner Michael J, Shenson Jared A, Rose Austin S, Valdez Tulio A, Takashima Masayoshi, Ahmed Omar G, Weissbrod Philip A, Hong Robert S, Djalilian Hamid, Wolf Jeffrey S, Morrison Robert J, Santa Maria Peter L, Erbele Isaac D
Medical Devices and Drugs Committee, American Academy of Otolaryngology-Head and Neck Surgery, Alexandria, Virginia, USA.
Department of Otolaryngology-Head and Neck Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.
OTO Open. 2021 Nov 10;5(4):2473974X211057035. doi: 10.1177/2473974X211057035. eCollection 2021 Oct-Dec.
To evaluate new drugs and devices relevant to otolaryngology-head and neck surgery that were approved by the US Food and Drug Administration (FDA) in 2020.
Publicly available device and therapeutic approvals from ENT (ear, nose, and throat), anesthesia, neurology (neurosurgery), and plastic and general surgery FDA committees.
Members of the American Academy of Otolaryngology-Head and Neck Surgery's Medical Devices and Drugs Committee reviewed new therapeutics and medical devices from a query of the FDA's device and therapeutic approvals. Two independent reviewers assessed the drug's or device's relevance to otolaryngology, classified to subspecialty field, with a critical review of available scientific literature.
The Medical Devices and Drugs Committee reviewed 53 new therapeutics and 1094 devices (89 ENT, 140 anesthesia, 511 plastic and general surgery, and 354 neurology) approved in 2020. Ten drugs and 17 devices were considered relevant to the otolaryngology community. Rhinology saw significant improvements around image guidance systems; indications for cochlear implantation expanded; several new monoclonal therapeutics were added to head and neck oncology's armamentarium; and several new approvals appeared for facial plastics surgery, pediatric otolaryngology, and comprehensive otolaryngology.
New technologies and pharmaceuticals offer the promise of improving how we care for otolaryngology patients. However, judicious introduction of innovations into practice requires a nuanced understanding of safety, advantages, and limitations. Working knowledge of new drugs and medical devices approved for the market helps clinicians tailor patient care accordingly.
评估2020年美国食品药品监督管理局（FDA）批准的与耳鼻咽喉-头颈外科相关的新药和设备。
来自耳鼻喉科（耳、鼻、喉）、麻醉科、神经科（神经外科）以及整形外科和普通外科FDA委员会的公开可用设备和治疗批准信息。
美国耳鼻咽喉-头颈外科学会医疗器械和药物委员会的成员通过查询FDA的设备和治疗批准信息，对新的治疗方法和医疗器械进行了综述。两名独立评审员评估了该药物或设备与耳鼻咽喉科的相关性，并按亚专业领域进行分类，同时对现有科学文献进行了严格审查。
医疗器械和药物委员会审查了2020年批准的53种新治疗方法和1094种设备（89种耳鼻喉科、140种麻醉科、511种整形外科和普通外科以及354种神经科）。十种药物和17种设备被认为与耳鼻咽喉科领域相关。鼻科学在图像引导系统方面有显著改进；人工耳蜗植入的适应症有所扩大；头颈肿瘤学的治疗手段中增加了几种新的单克隆治疗药物；面部整形手术、小儿耳鼻咽喉科和综合耳鼻咽喉科也有几项新的批准。
新技术和药物有望改善我们对耳鼻咽喉科患者的护理方式。然而，在实践中明智地引入创新需要对安全性、优势和局限性有细致入微的理解。了解市场上批准的新药和医疗器械的实用知识有助于临床医生相应地调整患者护理。
