They help millions of French people to breathe at night. But some respirators can be dangerous. seven months ago, the manufacturer Philips has announced the recall of breathing aids because of a risk of cancer due to the degradation of a component.
Except that these reminders take a lot of delay, only a tiny part of the 370,000 French users suffering from sleep apnea or COPD, chronic bronchitis, were able to exchange their device. According to the ANSM, only 7% of patients were able to change their respirator.
At the origin of the problem: a sound-absorbing foam inside the device, which, as it degrades, releases two volatile organic compounds, risking causing irritation, headaches, asthma and even potentially cancer.
Despite its reminder launched in mid-June worldwide for several of its models manufactured before April 26, 2021 (the list is available here), lhe Dutch manufacturer is dragging on replacing these machines. However, Philips holds the monopoly on these various respirators intended for the very many people who require oxygen at home.
The ANSM, the Medicines Safety Agency, brought together all the players to try to move the file forward. For its part, Philips promises to replace all devices by the end of the year. But the Medicines Safety Agency insists: we must go faster.
On Tuesday, February 8, the authority indicated that it was taking a “health policy decision“in the coming days, a kind of formal notice aimed at forcing Philips to ensure a rapid replacement of the devices concerned.
“Today we know that only 7% of devices have been replaced by Philips. This situation is not acceptable with regard to all the patients who, today, are today exposed to a device Phillips. Also, we absolutely hope that by June 2022, 75% of the devices will have been replaced. We also want patients to be clearly informed and for us to have a very precise monthly progress report from Philips with regard to these device replacements.“, indicates Dr Caroline Semaille, Deputy Director General of ANSM.
In the absence of an alternative, doctors, the Learned Society of Pneumology still advise patients to continue to use these devices while waiting for their replacement. The benefit of these ventilators outweighs the risk, argue specialists.
ANSM’s advice in the context of the global recall of certain Philips ventilation and CPAP devices: