“Philips is not meeting its commitments. » This is the observation, without appeal, of the National Agency for the safety of medicines and health products (ANSM). The industry group had announced this summer the recall of some 370,000 breathing apparatus, mostly used for sleep apnea, which can create certain health problems. Several months later, only 7% of them were taken over, the ANSM said on Tuesday, February 8, at a press conference.
The situation is not “more acceptable”, denounced the deputy director of the agency, Caroline Semaille. Because if the short-term effects of these defective respirators are known – coughing or headaches due to sound–absorbing foam particles inhaled or ingested by the patient – the authority is concerned regarding a theoretical longer-term cancer risk mentioned by Philips.
The ANSM demands the acceleration of the recall
The authority now wants to use the strong way once morest Philips: it will initiate, in the coming days, a “health police decision”, she announced on Tuesday. In practical terms, this means that Philips faces criminal prosecution if it does not comply with the timetable imposed by the ANSM. In particular, the Agency requires the group to have replaced three-quarters of the devices by the end of June. She also asks him to launch a study to accurately assess the risks, especially those of cancer.
These risks being at this stage only theoretical and the first data, from a Canadian study, being rather reassuring, the ANSM invites the patients concerned not to dispose of their devices while waiting for their replacement. “It is better to keep a faulty device rather than not having a device at all”, warned MI Sow. “What we don’t want is for there to be an alarmist wave. »
The Philips Group, contacted by Agence France-Presse, had no immediate comment. “We remain extremely focused on repairing and replacing devices related to this recall”, had said at the end of January Frans van Houten, the president and CEO of the company, admitting that it would surely “several years” to restore the group’s market share in the sleep sector.
