耳鼻喉科新医疗器械和治疗方法审批:2022 年最新进展回顾。

IF 1.8 Q2 OTORHINOLARYNGOLOGY OTO Open Pub Date : 2024-01-22 eCollection Date: 2024-01-01 DOI:10.1002/oto2.105
Franklin M Wu, Daniel Gorelik, Michael J Brenner, Masayoshi Takashima, Amit Goyal, Ashley E Kita, Austin S Rose, Robert S Hong, Waleed M Abuzeid, Peter S Maria, Ahmed A Al-Sayed, Michael E Dunham, Prajoy Kadkade, Scott R Schaffer, Alan W Johnson, Adrien A Eshraghi, Shireen Samargandy, Robert J Morrison, Philip A Weissbrod, Margaret B Mitchell, Cyrus C Rabbani, Neil Futran, Omar G Ahmed
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引用次数: 0

摘要

目的回顾食品药品管理局(FDA)在 2022 年批准的与耳鼻喉科相关的新药和器械:数据来源:美国食品和药物管理局关于 2022 年批准的药物和器械的公开数据:进行了初步筛选,以确定与耳鼻喉科相关的药物和器械。美国耳鼻咽喉头颈外科学会(AAO-HNS)医疗器械和药物委员会的成员进行了二次筛选,区分了小幅更新和新批准。药品和器械的最终清单被发送给每个亚专科的成员进行审查和分析:结论:经初步筛选,共确定了 1251 种器械和 37 种药物。结论:经初步筛选,共确定了 1251 种器械和 37 种药物,其中 329 种器械和 5 种药物已送交亚专科医生进一步审查,并从中选出 37 种器械和 2 种新型药物进行进一步分析。新批准的器械涉及耳鼻喉科的所有亚专科。许多新批准的设备旨在改善患者的就医体验,包括非处方助听器、睡眠监测设备和改进型 CPAP 设备。其他进展旨在改善手术室和诊所的手术通道、便利性或舒适度:每年都有许多新设备和药物获得批准,以改善患者护理和医疗服务。耳鼻喉科医生可以通过了解这些新技术的最新进展,利用新的创新技术来提高医疗服务的安全性和质量。鉴于这些设备最近才获得批准,因此需要进一步研究以评估其在耳鼻喉科领域的长期影响。
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New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review of 2022.

Objective: To review new drugs and devices relevant to otolaryngology approved by the Food and Drug Administration (FDA) in 2022.

Data sources: Publicly available FDA data on drugs and devices approved in 2022.

Review methods: A preliminary screen was conducted to identify drugs and devices relevant to otolaryngology. A secondary screen by members of the American Academy of Otolaryngology-Head and Neck Surgery's (AAO-HNS) Medical Devices and Drugs Committee differentiated between minor updates and new approvals. The final list of drugs and devices was sent to members of each subspecialty for review and analysis.

Conclusion: A total of 1251 devices and 37 drugs were identified on preliminary screening. Of these, 329 devices and 5 drugs were sent to subspecialists for further review, from which 37 devices and 2 novel drugs were selected for further analysis. The newly approved devices spanned all subspecialties within otolaryngology. Many of the newly approved devices aimed to enhance patient experience, including over-the-counter hearing aids, sleep monitoring devices, and refined CPAP devices. Other advances aimed to improve surgical access, convenience, or comfort in the operating room and clinic.

Implications for practice: Many new devices and drugs are approved each year to improve patient care and care delivery. By staying up to date with these advances, otolaryngologists can leverage new innovations to improve the safety and quality of care. Given the recent approval of these devices, further studies are needed to assess long-term impact within the field of otolaryngology.

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来源期刊
OTO Open
OTO Open Medicine-Surgery
CiteScore
2.70
自引率
0.00%
发文量
115
审稿时长
15 weeks
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