A leading medical company’s decision to recall millions of ventilators and sleep apnea machines after discovering the presence of a potentially cancer-causing toxin is raising more questions than answers.
Philips announced a recall of approximately four million medical machines over issues with the foam that is installed in the devices. A press release explains that the polyester-based polyurethane sound abatement foam component – which is used to muffle the noise of the machines – could potentially release carcinogenic and cancer-causing toxins as it degrades over time. There is also a potential risk of chemical exposure due to off-gassing in the devices that could also have toxic and carcinogenic effects, states the release.
Read More“It really is hard to know much about how they discovered this and the testing they used,” he explained after looking over the data provided by Philips. “I do not know how they found out about this, or how long they have known about the problem.”
Dr. Boon applauded Philips for coming forward and issuing a voluntary recall, but also noted that in this day and age it is inevitable that this design flaw would have been noticed by another party if not the machine’s maker. He also explained that this recall will have a major impact as the number of Americans diagnosed with sleep apnea continues to climb.
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“This is for two reasons,” he explained of the increase. “The first is the obesity epidemic in this country. More people are overweight which means more people have trouble sleeping.”
He continued: “The second reason is awareness. Now that sleep apnea has become more common, more and more people are aware of the symptoms and are getting examinations.”
Philips suggests that individuals who own a Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), or mechanical ventilator return these devices so that they can be outfitted with a new material. Philips notes in its release that all individuals should first check with their physician or a medical expert to determine if the benefit of continuing therapy with their device outweighs the risks identified in the recall notification.
Dr. Boon told SurvivorNet that it would be a unique challenge for Philips to replace this problematic foam, especially in ventilators providing life support to patients. He also explained that some individuals who suffer from sleep apnea may also struggle with the recall since many cannot go a night without their CPAP machines. And this is all further complicated by the fact that there is no suggestion as to just how carcinogenic the toxins are from either the particulate matter or chemical exposure.
"We deeply regret any concern and inconvenience that patients using the affected devices will experience because of the proactive measures we are announcing today to ensure patient safety," said Royal Philips' CEO Frans van Houten. "In consultation with the relevant regulatory agencies and in close collaboration with our customers and partners, we are working hard towards a resolution, which includes the deployment of the updated instructions for use and a comprehensive repair and replacement program for the affected devices. Patient safety is at the heart of everything we do at Philips."
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