Recall on CPAP Machines Leads to Shortage
Recently we have had calls from people who stopped using a CPAP machine due to a recall notice that said using the machine could make them sick or give them cancer.
They are, of course, referring to the recall by Philips on various models of Continuous Positive Airway Pressure (CPAP) machines and mechanical ventilator devices. The recall addressed health risks associated with polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. The soundproofing foam can degrade and result in a patient inhaling or ingesting diethylene glycol (DEG).
Diethylene glycol (DEG) is used as a solvent. It is used to manufacture polyester resins and polyurethanes, as well as brake fluid. As you can imagine, breathing it or ingesting it is not a good thing.
Here is the problem, people have been told by Philips that they should check with their doctor on whether or not to use the machines until a new unit could be obtained.
Since no one has been documented to have gotten sick, you would think that doctors would give the green light to use the machines short-term until a new device could be obtained.
But that apparently has not been the case.
Instead, probably because they’re afraid of being sued, many doctors tell people not to use the machines.
But because so many machines have been taken out of service, many callers complain that they can’t get replacement machines.
Now keep in mind that people who have been prescribed CPAP machines by doctors have severe breathing problems that require the use of such a machine to survive.
Some CPAP users can even risk death if they have a severe condition and fail to use a machine. But because of the unavailability of replacement machines, people are being told that it may be months before they can get one, and they are doing their best to survive without such a machine.
One lady called to say that she couldn’t sleep at night for several months and was getting very ill.
Another person called to explain that his sister, who stopped using a recalled unit, had developed pneumonia, and her doctor finally told her she must start using the machine again. But she’s deathly afraid of using it and won’t use it.
If the question is between certain death by not using a medical device and possible long-term harm by using the medical device, you would think that medical providers would sit down with a patient and come up with a plan that is in the best interest of the patient.
So, due to a recall of a strategic medical device, for which there is no replacement immediately available, the user’s health has been put at significant risk.
But is there a legal remedy? My guess is that if one of these patients sued to seek compensation due to worsening health created by the recall, a court would find the law ill-equipped to deal with the situation.
Here’s our suggestion: the FDA should immediately work with the Phillips company to test the recalled machines by an independent lab to determine if they are temporarily safe to use for several months while replacement machines are manufactured and shipped.
If a machine is not immediately harmful, the patient should know that fact and have the opportunity to decide what is in their best interest with their doctor. If a machine is tested and presents an immediate danger, the patient should be told.
Patients, of course, could try to find testing labs on their own. But, many are on social security and would have no way to pay what could be a hefty fee to test the product.
Sometimes the courts are not able to offer the best remedy. Sometimes it’s another branch of government.