Objective
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.
Methods
Cases of cancer involving CPAP devices were retrieved from the MAUDE database from 2014 to 2021 and analyzed with descriptive statistics.
Results
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%).
Conclusion
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.
Level of Evidence
4 Laryngoscope, 2022
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