From Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.
Head and Neck Institute, The Cleveland Clinic, Cleveland, Ohio, USA.
Laryngoscope. 2022 Nov;132(11):2270-2274. doi: 10.1002/lary.30117. Epub 2022 Mar 30.
In 2021 the U.S. FDA issued a Class 1 safety recall notice for specific devices due to a risk of carcinogen exposure. The objective of this study was to evaluate reports of cancer linked to CPAP devices to understand implications for the field of sleep medicine.
Cases of cancer involving CPAP devices were retrieved from the MAUDE database from 2014 to 2021 and analyzed with descriptive statistics.
A total of 2571 patient injuries were associated with CPAP. Reports of cancer (n = 209; 4.62%) were the second most commonly documented patient problem associated with CPAP, although 1950 (43.13%) patients had a device problem without an associated injury. Of the 209 cancer cases associated with CPAP, 200 (95.7%) of the adverse event reports were received by the FDA in 2021. There were 174 (9.15%) descriptions of the CPAP polyurethane sound abatement foam degrading in association with a cancer diagnosis, but degradation was more commonly not associated with malignancy (n = 1728; 90.85%). Other frequently documented CPAP device problems included broken devices (n = 279; 6.92%), fire (n = 182; 4.51%), and patient-device incompatibility (n = 144; 3.57%).
Malignancy associated with CPAP devices has been reported; however, future studies are required to establish causation. Given 95.7% of those documented cases were reported in 2021, otolaryngologists should be prepared to discuss the risks of carcinogenesis associated with CPAP. The otolaryngology community should also be aware of the potential bandwagon effect and the implications for CPAP compliance.
4 Laryngoscope, 132:2270-2274, 2022.
2021 年，美国食品药品监督管理局（FDA）因致癌风险发布了特定设备的 1 类安全召回通知。本研究的目的是评估与 CPAP 设备相关的癌症报告，以了解其对睡眠医学领域的影响。
从 2014 年至 2021 年，从 MAUDE 数据库中检索与 CPAP 相关的癌症病例，并进行描述性统计分析。
共有 2571 例 CPAP 相关患者损伤。CPAP 相关患者问题中，癌症报告（n=209；4.62%）是第二常见的记录问题，尽管 1950（43.13%）例患者存在设备问题而无相关损伤。在与 CPAP 相关的 209 例癌症病例中，200 例（95.7%）不良事件报告于 2021 年被 FDA 接收。有 174 例（9.15%）描述 CPAP 聚亚安酯隔音泡沫在与癌症诊断相关的情况下降解，但降解与恶性肿瘤更常见无关（n=1728；90.85%）。其他经常记录的 CPAP 设备问题包括设备破损（n=279；6.92%）、火灾（n=182；4.51%）和患者-设备不兼容（n=144；3.57%）。
已报告 CPAP 设备相关的恶性肿瘤；然而，需要进一步的研究来确定病因。鉴于有记录的病例中有 95.7%是在 2021 年报告的，耳鼻喉科医生应该准备好讨论与 CPAP 相关的致癌风险。耳鼻喉科医生也应该意识到潜在的随大流效应及其对 CPAP 顺应性的影响。
4 级喉镜，132：2270-2274，2022。
