Philips auditioned by the ANSM over its faulty respirators

Philips auditioned by the ANSM over its faulty respirators

“Avoidive” or even “non-existent” answers, and patients between anger, fear and uncertainty. Nearly a year after the Philips group recalled many of its respiratory devices due to potential health risks to their users, the National Agency for the Safety of Medicines (ANSM) convened an ad hoc expert committee on Wednesday to better understand the potential risks. . Objective: to push the group to accelerate the replacement rate of the devices in question and to answer the many questions of the patients who were left concerned.

These devices, prescribed mainly against sleep apnea and used by around 350,000 patients in France and 1.5 million throughout Europe, have been the subject of an international recall since last summer due to a new material in their composition: a foam sound-absorbing material from which the group noted that particles came out of certain devices and could therefore be inhaled or ingested by patients. However, Philips is slow to replace faulty devices. The ANSM in response initiated a “health policy decision” against the group, ordering it to replace or repair three-quarters of the devices in question by mid-2022, a rate that is unlikely to be achieved. Much to the chagrin of patient users.

“Philips remained absolutely deaf and dumb to our questions”

The group “Philips was absolutely deaf and dumb to our questions”, lamented Christian Trouchot, member of the French Federation of Respiratory Insufficiencies and representative of the main patient associations during this day of hearing. However, there are many questions about the potential risks associated with these faulty devices, which can cause coughing, irritation, or even headaches. More worryingly, the group also mentioned a “potential” risk of long-term cancers.

However, the group has made no commitment to allay the questions and concerns of patients using its breathing devices. “If Philips is a manufacturer of medical devices, it is not an information manufacturer,” said Christian Trouchot. Our federations have asked Philips for the name of the manufacturer of the foam, and if they supply other manufacturers of similar devices, but we have been opposed by the group on the trade secret, so we have not had an answer, ”he lamented.

“Device replacement schedule”, “toxicological analysis, clinical trials, real risks for the patient, carcinogenic risk: during these long months of hearings, we have multiplied the questions. But Philips’ responses were evasive or simply non-existent, he added. Patients are between a rock and a hard place, the hammer being the patient’s pathology, the anvil his machine”.

Cautionary Reminders, but Concerned Patients

Also questioned by the ANSM, the Philips representatives emphasized the fact that this recall campaign had been initiated as a pure precaution and had been followed by more in-depth tests to find out at what point these devices release potentially threatening particles. “These tests really take a lot of time,” explained Dr. John Cronin, medical director of respiratory devices at Philips. But “to date we have received around 10 reports of damage, reporting generally limited effects such as cough, headache or congestion,” he said. And there is no evidence of cancer or death” related to these devices.

However, there is very little information to reassure patients who use these devices on a daily basis. The announcement of the withdrawal last summer “provoked a very strong uptick in contacts with providers, materializing the anxiety of patients in the face of the aforementioned risks,” confirmed Alexandra Duvauchelle, general delegate of the Federation of Home Health Providers (FEDEPSAD) . This campaign has caused a tsunami of much-needed support for us, with no prospect of replacement dates for these devices,” she told ANSM.

Torn between the potential risks associated with their ventilator and those proven to endanger their health if they stop using it, worried patients are at a loss. “There is an anxiety linked to this risk of cancer and the change of device, but also to the confidence that the patient has in his machine” and that is difficult to maintain when it is called into question. For his part, Dr. Cronin asked patients “not to make any decision without consulting your doctor.”

If the group has not yet communicated about its ability to replace its devices implicated in France within the time allowed, the ANSM, after this day of hearings, plans to issue an opinion in the coming weeks and could review its recommendations to continue with the treatments. , issued last summer.

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