The National Medicine Safety Agency and Health Products requires the Group to replaced three quarters of the aircraft by the end of June. She also asks her to launch a study to accurately assess risks, especially those of cancer.
Le Monde with AFP
“Philips does not respect his commitments.” This is the observation, without appeal, from the National Medicine Safety Agency and Health Products (ANSM). The Industrial Group announced this summer the reminder of some 370,000 respiratory devices, especially used against sleep apnea, likely to create some health problems. Several months later, only 7% of them were taken over, ASM said Tuesday, February 8 at a press conference.
The situation is “no longer acceptable”, denounced the Assistant Director of the Agency, Caroline Semaille. Because if the short-term effects of these defective respirators are known – cough or headaches due to inhaled foam particles inhaled or ingested by the patient – the authority is concerned about a theoretical risk of cancer in the longer term evoked by Philips.
The ANSM requires the acceleration of the reminder
The Authority now wants to use the strong way against Philips: it will engage in the next few days a “sanitary police decision”, she announced Tuesday. In concrete terms, this means that Philips is exposed to criminal prosecution if he does not respect the schedule imposed by the ANSM. The Agency requires that the Group replaced three quarters of the aircraft by the end of June. She also asks her to launch a study to accurately assess risks, especially those of cancer.
These risks being at this stage only theoretical and the first data, resulting from a Canadian study, being rather reassuring, the ANSM invites patients concerned not to get rid of their devices while waiting for their replacement. “It is better to keep a defective device rather than no more device at all,” warned M SEMAIL. “What we do not want is that there is an alarmist wave.”
The Philips group, solicited by the France-Presse agency, did not wish to respond immediately. “We remain extremely concentrated on the repair and replacement of devices related to this reminder,” said the end of January Frans Van Houten, the President and CEO of the company, admitting that it should surely “several years” To restore the Group’s market share in the sleep sector.