Sleep Apnea Device Recall Limits Choices

BiPAP and CPAP machines can restore health and harmony to the homes of sleep apnea sufferers. Hannah Fullmer of WHYY in Philadelphia recently wrote about the effects of a major recall on device users.

The Phillips Respironics Device Recall

The article discusses the difficult position of sleep apnea and other patients affected by the June 2021 recall by Phillips Respironics. The recall affects machines to treat both sleep apnea and respiratory failure. With a 12 month timeline for replacing the devices, patients face a situation with no easy remedy.

The recall stems from degrading sound-dampening foam. As it degrades the foam becomes black, inhalable particles that can cause a variety of health problems. Ranging from irritation to headaches and asthma, the particles may also cause cancer.

Sleep Apnea Patients Make Difficult Choices

Fullmer interviewed a Philadelphia resident who uses a BiPAP machine to treat his sleep apnea. If he stops using his machine he suffers from poor, interrupted sleep. The result is daytime sleepiness and irritability. 

In this case, it also creates an accident hazard, as this patient spends a lot of time on the road. He is torn between continuing to use a potentially dangerous device or leaving his serious condition untreated.

The recall received an FDA classification of Class 1. This level is indicated when “there is a reasonable probability that the product could cause serious health consequences or death.”

Patients like the man interviewed by Fullmer report frustration with the lack of organized communication about the recall and their options.

Options for Device Users

For many sleep apnea patients and others who rely on these devices, there are few good options. Some may qualify for a replacement device. This can be costly, however, and supply has dwindled.

Most patients end up choosing between using a potentially dangerous device and leaving their condition untreated. Fullmer talked to Dr. Fred Jaffe, a sleep physician at Temple Health, who recommended that device users talk to their doctors.

For some patients, dental and other positional devices may be effective during the wait. For others, stopping device usage is a serious risk to their health.

The recommended option will vary based on the seriousness of the condition being treated. Patients and their doctors are put in the uncomfortable position of deciding if the risks of treatment are less than or greater than the risks of the condition.

 

Sources:

https://whyy.org/articles/recall-of-sleep-apnea-aids-leaves-some-people-feeling-stuck-between-two-risky-choices/

https://www.usa.philips.com/healthcare/e/sleep/communications/src-update

https://www.fda.gov/medical-devices/safety-communications/certain-philips-respironics-ventilators-bipap-and-cpap-machines-recalled-due-potential-health-risks#actions

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