Medical equipment company Philips has recalled millions of machines used to treat sleep apnoea in the United States because of fears of potential serious harm to users.
But it has not done the same in Britain. The decision could have serious health consequences.
On 14 June Philips announced a recall of many of its Continuous Positive Airway Pressure (Cpap) and Bilevel Positive Airway Pressure (Bipap) machines—used to treat sleep apnoea. And it recalled ventilators that are used to treat respiratory failure.
Sleep apnoea is a disorder in which breathing is disturbed temporarily during sleep. It may stop or become very shallow and is often associated with fatigue and daytime sleepiness.
Serious cases can lead to hypertension, heart attack or stroke.
Philips’ machines contain foam that lessens the sound the machines make. It has now been revealed that the foam may break down and be inhaled or ingested. And it may produce compounds resulting in adverse effects to organs—and even cancer.
In an announcement to doctors, Philips explained that these hazards could result in “serious injury which can be life-threatening or cause permanent impairment”.
Yet the recall notice was only for the US. For the rest of the world there is just a “field safety notice” that recommends “discontinued use”.
In June the British Medicines and Healthcare products Regulatory Agency, a government body, put out a national patient safety alert.
It called for a series of actions by health trusts and other bodies—by 17 December 2021. It includes an instruction to “source alternative devices where clinically appropriate”.
But machine users that Socialist Worker spoke to say they haven’t heard from the hospitals that provided their machines.
One said, “It’s worrying to think the machine that I use for eight hours a night might be harming my health. Why isn’t this being discussed everywhere?”
Philips’ recall statement was combined with reassurance to investors. It said, “Philips anticipates that the expected revenue headwinds in the Sleep & Respiratory Care business in 2021 will be compensated by the strength of the company’s other businesses.
“Therefore, the full year comparable sales growth margin guidance provided on April 26, 2021 remains unchanged.”
The US law firm Berger Montague is preparing a class action against the firm for potential harm to device users.
It alleges, “Philips knew about these substantial and material risks from its Cpap machines long before the recall.
“The complaint alleges that patients who used the affected devices have complained to Philips about black particles in their machines for many years, but Philips did not warn the public about the hazards until late April 2021 and did not recall its machines until June 2021.
“The Complaint also alleges that Philips self-servingly timed its recall to coincide with its launch of its next generation of Cpap products that do not suffer from the same issues.
“Thus, the only safe option that Philips offers to its customers—many of whom need and rely on the recalled breathing machines—is to purchase Philips's newer model, profiting Philips further.”
The NHS should immediately take action to inform patients of what’s happening. Patients should be compensated and Philips must pay all the costs for their failures.