A committee of experts, which met more than a month ago, notably concluded that “the overall testing strategy followed by the Philips company is not understandable and that it is not possible to determine the potential risks associated with use” machines.
A communication from the Dutch group on its test program at the end of June on its site “does not call into question the conclusions” of these experts, specified the ANSM.
The Dutch group announced last summer that it was recalling worldwide several models of devices intended to help patients breathe better and which are used in particular once morest sleep apnea.
These devices, used by 350,000 patients in France and 1.5 million across Europe, contain sound-absorbing foam. It is this that is in question: the group noticed that particles came out of certain devices and might therefore be inhaled or ingested by the patient.
This can cause irritation, such as headaches.
A potential risk of long-term cancer mentioned in 2021
The group had also mentioned in June 2021 a risk “potential” long-term cancers.
But Philips having “presumably confused” a carcinogenic compound -dimethyldiazem- with another non-carcinogenic -acetone-, the risk linked to the carcinogenic compound “is not proven, for lack of proof of its presence” at this point, according to experts.
The committee also recommended continuing epidemiological studies, particularly on the risk of cancer and obstructive lung disease, with patients exposed for more than 7 and 10 years.
The particles resulting from the degradation of the foam must be “more characterized” to be able to conclude on a possible impact on health.
French authorities have demanded that all devices be replaced by the end of 2022
Since the recall was announced, Philips has been slow to replace defective devices. French health authorities demanded that three quarters of them be replaced or repaired by mid-2022, a rate that was not reached, then all of them by the end of the year.
Philips said “planning as of June 30 to ship 47% of CPAP (continuous positive airway pressure) devices” for replacement, according to the ANSM.
Faced with this delay, the agency “evaluate possible sequels”.
As for patients, the agency maintained that it was better to keep a defective ventilator than to dispose of it without replacement, given the “proven short-term risk” discontinuation of treatment (accidentogenic drowsiness, increased cardiovascular risk, worsening of respiratory failure).
And all the more so since Philips has confirmed that the risk associated with the carcinogenic compound mentioned a year ago is not “probably more proven”, depending on the agency.
With AFP
