Philips tested by ANSM on defective respirators

Answers “evasive” or even “non-existent”, patients between anger, fear and uncertainty. Nearly a year after the Philips group recalled several of its respiratory devices due to the potential risks to the health of its users, the National Agency for the Safety of Medicines (ANSM) convened a panel of experts on Wednesday. customized in order to better understand the potential risks. Objective: To push the group to speed up the rate of replacement of the devices involved, and to answer many questions of patients who were left in anxiety.

These devices, prescribed primarily against sleep apnea and used by about 350,000 patients in France and 1.5 million across Europe, have been the subject of an international recall since last summer due to an incoming substance. In its composition: a sound-absorbing foam from which the group noted that the particles exited from certain devices and therefore could be inhaled or swallowed by patients. However, Philips is slow to replace faulty devices. In response, ANSM launched a “health policy resolution” against the group, which had ordered three-quarters of the devices involved to be replaced or repaired by mid-2022, a rate that will probably not be reached. Much to the dissatisfaction of patients.

“Philips has remained completely deaf and mute to our questions”

The group “Philips remained completely deaf and dumb to our questions,” Christian Trochot, a member of the French Federation of Respiratory Diseases and representative of the main patient associations, lamented during the hearing day. However, there are many questions about the potential risks associated with these defective organs, which can cause coughing, irritation, or even headaches. Even more worrisome, the group also reported a “potential” risk of developing long-term cancers.

However, the group did not undertake to allay the doubts and fears of patients using their respiratory devices. “If Philips is a manufacturer of medical devices, it is not a manufacturer of information, Christian Trochot said. Our unions asked Philips for the name of the manufacturer of the foam, and whether it supplies other manufacturers of similar devices, but the group opposed us about the confidentiality of the work, so we did not We receive no response,” he said.

“Device replacement timeline,” “Toxicological analyzes, clinical trials, real patient risks, cancer risks: During these long months of hearings, we doubled down on questions. But he added that Phillips’ responses were either evasive or simply non-existent. Patients are between the rock and the hard place.” The hammer is the patient’s pathology, and the anvil is the machine he uses.”

Preventive reminder but patient concern

Philips representatives, when questioned by ANSM, also stressed the fact that this recall campaign had started as a purely precautionary measure and was followed by more in-depth testing to find out the point at which these devices release potentially threatening particles. “These tests really take a long time,” explained Dr. John Cronin, medical officer for respirators at Philips. But “so far, we’ve had about a dozen reports of harm, reporting generally limited effects such as coughing, headaches or congestion, he reassured. There is no evidence of cancer or death” associated with these devices.

However, there is little information to reassure patients who use these devices on a daily basis. Alexandra Dufuchelle, General Delegate of the Home Health Providers Association, Alexandra Dufuchelle, asserted that the announcement of the impeachment last summer “led to a significant rise in contacts with providers, exemplifying patients’ concern in the face of said risks.” This campaign has created a tsunami of much-needed support for us, with no prospect of replacement dates for these devices,” she told ANSM.

Torn between the potential dangers associated with a ventilator and those — which have been shown — to put their health at risk by discontinuing their use, anxious patients have been lost. “There is anxiety associated with the risk of cancer and with the device change, but there is also anxiety associated with the patient’s confidence in their device” which is hard to maintain when questioned. For his part, Dr Cronin called on patients “not to make any decision without discussing the matter with their doctor.”

If the group has not yet communicated about its ability to replace its implicated devices in France within the time allowed, ANSM, after this day of hearings, plans to issue an opinion in the coming weeks, and can review its recommendations for further treatment. Released last summer.

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