As electronics manufacturer Philips struggles to cope with its second medical device recall of the year, the news regarding its first recall has just gotten significantly worse. Earlier this year, a variety of Philips ventilators, BiPAP, and CPAP machines were taken out of service and recalled over concerns that the sound-deadening foam used to insulate the machines and make them quieter could enter the breathing circuit and allow particles to enter patients’ lungs while they used the machine to help them breathe.
Initial reports focused on the possibility of irritation of the patients’ airways. However, new information indicates that the risks could be significantly more severe. Warning of “life-threatening…permanent impairment” that could “require medical intervention,” the FDA now says that in addition to asthmatic response and skin and airway irritation, the bits of polyester-based polyurethane foam could also have “toxic and carcinogenic effects” on those who are exposed to them. Carcinogenic is another way of saying that a substance causes cancer.
Millions of people are now faced with the possibility that the device they’ve been using to help keep them breathing could have been poisoning them the entire time.
According to Philips, about half of the four million units around the world affected by the recall are in service in the United States. Customers with affected machines are asked to register the devices with Philips and wait in line for a replacement unit, although the corporation appears to be woefully unprepared to handle a recall of this magnitude. Customers are sharing anecdotes of being told that there is no estimate on how long it will take to acquire the parts necessary to make the machines safe and that patients with “more advanced clinical needs” are being prioritized. Philips themselves have said that they “are not able to provide an immediate solution” to the problem.
Patients are advised to consult with their doctors about their continued use of the Philips devices, with the New York Times reporting of one patient whose doctor told her to immediately stop using her Philips CPAP device and immediately prescribed her a replacement made by a different company.
