New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review of 2021.
New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review of 2021.
复制标题
DOI：
10.1177/2473974x221126495
复制
发表时间：
2022-07
期刊：
影响因子：
1.5
通讯作者：
Ahmed, Omar G.
中科院分区：
文献类型：
--
作者：
Choi, Alexander M.;Brenner, Michael J.;Gorelik, Daniel;Erbele, Isaac D.;Crowson, Matthew G.;Kadkade, Prajoy;Takashima, Masayoshi;Santa Maria, Peter L.;Hong, Robert S.;Rose, Austin S.;Ostrander, Benjamin T.;Rabbani, Cyrus C.;Morrison, Robert J.;Weissbrod, Philip A.;Tate, Alan D.;Kain, Joshua J.;Lina, Ioan A.;Shaffer, Scott R.;Ahmed, Omar G.
评估美国食品和药物管理局（FDA）于2021年批准的与耳鼻喉头颈部手术相关的新医疗器械和药物。耳鼻喉科（耳鼻喉科）、麻醉、神经外科、整形外科和普通外科FDA委员会公开提供的FDA设备和药物批准。FDA设备和治疗批准由美国耳鼻喉头颈外科医学设备和药物委员会的成员确定和审查。两名独立审稿人评估了设备和药物与耳鼻喉科医生的相关性。然后将医疗设备和药物分配到各自的亚专业领域，以便根据现有的科学文献进行严格审查。医疗器械和药物委员会审查了在2021年获得FDA批准的1153个器械和52个新药（耳鼻喉科67个，麻醉106个，普通外科和整形外科618个，神经外科362个）。与耳鼻喉科相关的23种设备和1种治疗剂被纳入最新技术综述。所有亚专科都取得了进步，包括耳科的非处方助听器选择，鼻科鼻炎的扩大治疗选择，喉科的创新激光安全气管内管，面部整形手术的新型面部再生和植入技术，以及阻塞性睡眠呼吸暂停的非侵入性和外科治疗选择的进步。FDA对新技术和药物的批准为耳鼻喉科的亚专科提供了新的机会。临床医生对这些创新的安全性、优势和局限性的细致理解确保了患者护理的持续进展。
To evaluate new medical devices and drugs pertinent to otolaryngology–head and neck surgery that were approved by the Food and Drug Administration (FDA) in 2021. Publicly available FDA device and drug approvals from ENT (ear, nose, and throat), anesthesia, neurosurgery, plastic surgery, and general surgery FDA committees. FDA device and therapeutic approvals were identified and reviewed by members of the American Academy of Otolaryngology–Head and Neck Surgery’s Medical Devices and Drugs Committee. Two independent reviewers assessed the relevance of devices and drugs to otolaryngologists. Medical devices and drugs were then allocated to their respective subspecialty fields for critical review based on available scientific literature. The Medical Devices and Drugs Committee reviewed 1153 devices and 52 novel drugs that received FDA approval in 2021 (67 ENT, 106 anesthesia, 618 general surgery and plastic surgery, 362 neurosurgery). Twenty-three devices and 1 therapeutic agent relevant to otolaryngology were included in the state of the art review. Advances spanned all subspecialties, including over-the-counter hearing aid options in otology, expanding treatment options for rhinitis in rhinology, innovative laser-safe endotracheal tubes in laryngology, novel facial rejuvenation and implant technology in facial plastic surgery, and advances in noninvasive and surgical treatment options for obstructive sleep apnea. FDA approvals for new technology and pharmaceuticals present new opportunities across subspecialties in otolaryngology. Clinicians’ nuanced understanding of the safety, advantages, and limitations of these innovations ensures ongoing progress in patient care.