As the voluntary recall of CPAP machines enters its second year, the pace is excruciatingly slow. Royal Philips says it has repaired or replaced about 1.7 million of 2.8 million affected devices in the U.S. That leaves millions of patients in the lurch.
Lower oxygen levels in the blood increase the risk of high blood pressure, recurrent heart attacks and strokes. People who are overweight or older than 50 are more likely to have sleep apnea.
was life-changing.” When she heard about the recall, she stopped using the device and became achy and exhausted. After months of waiting for a replacement, she finally paid $900 for a device made by another company, she said. When Philips announced the recall, it urged consumers to register so they could be sent replacement machines with different foam. But after the FDA complained that the notification efforts wereAdvertisement
The FDA has expressed skepticism about Philips’s test results, saying in May that certain data were “not persuasive” and rejecting the company’s argument that use of unapproved ozone cleaners is a main culprit. The agency has suggested the machines were not made properly in the first place. The FDA told The Post that many tests “are still outstanding” and that recommendations by the agency and Philips about the devices have not changed.
Dhruva, of UCSF, sees parallels between the infant formula crisis and the Philips problem. In both cases, he said, the FDA lacks the staff and resources needed to monitor companies to ensure “the successful and timely resolution of safety concerns.”Tom Wilson, a retired corporate executive, began using a Philips CPAP device in spring 2018 after being diagnosed with sleep apnea. By that fall, he started coughing excessively and vomiting.
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