(Reuters) – The National Medicines Safety Agency (ANSM) on Friday called on Philips to speed up the replacement of its faulty respiratory devices that could expose users to toxic particles.
The Dutch health technology group recalled some of its respiratory aid devices in June due to a risk of degradation and toxicity of a foam component which could become carcinogenic.
“The replacement plan for all affected devices announced by the manufacturer has made very little progress,” the ANSM said in a statement, adding that as of February 4, Philips Respironics had replaced only 7% of faulty devices.
The ANSM says it has therefore taken a “health policy decision” to accelerate the recall. According to this decision, Philips will have to have replaced with service providers or repaired 75% of the devices concerned by June 2022, and 100% by December of this year.
Between three and four million sleep apnea therapy devices and mechanical ventilators are targeted, Philips later said.
In France, 370,000 patients are concerned for devices used mainly at home by patients suffering from sleep apnea or requiring respiratory assistance, said the ANSM.
(Report Kate Entringer in Gdansk, edited by Blandine Hénault)
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