A committee of experts met more than a month ago and came to this conclusion “Philips’ overall testing strategy is not understood and the potential risks associated with its use cannot be identified” machines.
A message from the Dutch group about its test program at the end of June on its website “Don’t question the conclusions” Of these experts, select ANSM.
So you will ANSM “Requests Philips to clarify its risk assessment strategy, including testing.”
The Dutch group announced last summer that it would be called up worldwide Several models of devices that aim to help patients breathe better and are specifically used against sleep apnea.
These devices, which are used by 350,000 patients in France and 1.5 million patients across Europe, contain sound-absorbing foam. This is called into question: the group noted that the particles exited from certain devices and thus could be inhaled or swallowed by the patient.
This can cause irritation, such as a headache.
Possible long-term cancer risk reported in 2021
The group had also reported in June 2021 risk “Ability” Long-term cancers.
But Philips has ‘You’re probably confused’ Carcinogenic compound – dimethyldiazem – with another non-carcinogenic substance – acetone -, the danger associated with the carcinogenic compound “It has not been proven because there is no evidence of its existence.” At this point, according to experts.
The committee also recommended continuing epidemiological studies, particularly on the risks of cancer and obstructive lung disease, with patients exposed for more than 7 and 10 years.
The particles produced by the decomposition of the foam should be “more distinguished” To be able to infer a possible effect on health.
The French authorities have called for all devices to be replaced by the end of 2022
Since the recall was announced, Philips has been slow to replace faulty hardware. French health authorities have demanded that three-quarters of them be replaced or repaired by mid-2022, a rate that has not been reached, and then all of them by the end of the year.
Phillips said “As of June 30, I plan to ship 47% of our CPAP devices.” For replacement, according to ANSM.
In the face of this delay, the agency “Evaluation of possible consequences”.
As for patients, the agency emphasized that it is better to keep the faulty ventilator than to throw it away without replacing it ‘Verified short-term risks’ Discontinuation of treatment (accidental drowsiness, increased risk of cardiovascular disease, exacerbation of respiratory failure).
What’s more, since Philips confirmed that the risks associated with the carcinogenic compound mentioned a year ago are not “Perhaps more proof”, According to the agency.
with AFP
