Sleep Apnea Sufferers Scramble After Philips Recall of Critical Machine
The recent recall of sleep apnea devices made by Royal Philips NV affects about two million people across the United States. The company warned in June that an internal sound-dampening foam in the machines could release potentially harmful gases or particles into users' airways. While the company has vowed to repair or replace the affected devices, it will take about a year to complete. The Philips recall primarily affects CPAP and BiPaP machines. However since the recall was launched, physicians have been fielding many calls from concerned patients, and prices for sleep apnea devices made by RedMed Inc., Philips' primary competitor, have increased. The devices have also become harder to obtain. Some frustrated patients have opted to either remove the foam themselves or are buying new or used machines and paying out of pocket, rather than deal with insurance.
FDA has given the recall its most serious classification, indicating there is a reasonable likelihood that using the device could result in serious health issues. According to Asha Singh, director of sleep medicine at the Oregon Health & Science University (OHSU), in many cases, the risks of withdrawing treatment likely outweigh those posed by the device. Singh notes that she is trying to find alternative sleep apnea machines for patients affected by the recall; however, in situations where that is not possible, she generally advises patients to keep using their device. "The patients are on it for a reason," Singh said. "I'm really worried about patients with serious cardiovascular issues stopping their machines." OHSU has hired about eight new nurses to answer a 24-hour hotline for calls about the recall. One obstacle for physicians is that Philips has not provided much detail about the complaints that resulted in the recall, making it hard to gauge the risks of continued use. The recall notice said the number of complaints was small compared with the overall number of machines sold, about 0.03% in 2020, with no deaths reported.
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