It is a health policy decision. The National Agency for the Safety of Medicines and Health Products (ANSM), took Friday, February 11 a binding measure against the industrial giant Philips in order to force it to speed up the replacement of defective breathing apparatus, used in particular against sleep apnea.
ANSM “takes a health policy decision to speed up the replacement of certain devices” Philips, she said in a statement, days after announcement that she would take such a measure. The Dutch group announced in June 2021 that he reminded the world of several models of devices intended to help patients breathe better, which are used in particular against sleep apnea.
These devices, which are used by 370,000 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 the device and could therefore be inhaled or ingested by the patient. This can cause irritation and headaches. The group also mentioned a risk “potential” long-term cancers, even if it is not proven.
But, more than six months after this announcement, the French authorities regret too much slowness of Philips to replace the defective devices. According to the ANSM, “As of February 4, 2022, Philips has replaced only 7% of defective devices”. The “health policy decision” is a binding order. If Philips does not respect it, it will incur criminal proceedings.
Replace 100% of devices by the end of the year
In detail, the ANSM requires that 75% of devices be replaced or repaired by June 2022, then 100% in December 2022. The agency also wants Philips to undertake a precise study of the risks represented by its devices. and send him his results within a year.
But the ANSM, which also fears a wave of panic among patients, also recalled that it was much better to keep your defective respirator than to get rid of it without replacement. She writes on her website: “We remind you, in consultation with healthcare professionals, that patients must continue their treatment. Stopping treatment presents a proven short-term risk, for example accident-prone drowsiness, increased cardiovascular risk, or even worsening of respiratory failure. According to the first available data, the risk of cancer associated with the use of these ventilators and CPAP devices [pression positive continue] concerned is not proven. »