The National Medicines Agency (ANSM) has requested the withdrawal, in pediatrics, of ventilation devices used in hospitals, after the report by the manufacturer Dräger of a potentially harmful substance in the sound-absorbing foam, she said. announced Tuesday. Around 150 devices of the model in question – called Carina – are present in around 60 health establishments in France, according to the Agency, which specified that manufacturing had ceased in 2019.
These ventilators “should no longer be used in children”, recommended the ANSM, which asked Dräger to withdraw them from pediatric wards and to “propose an alternative solution”. “The withdrawal will be made in the coming days,” ANSM director of medical devices, Thierry Thomas, told AFP, citing “a precautionary measure”.
These devices are used, in adults and children, in shock rooms in emergency departments, in post-intervention monitoring rooms or in intensive care for short-duration ventilation in adults. These masks placed on the face contain a sound-absorbing foam. These devices have been tested by the German manufacturer Dräger “in the context of the Philips file”, according to Thierry Thomas.
The Dutch group announced in the summer of 2021 the recall of defective respirators, mainly used against sleep apnea. Particles of sound-absorbing foam came out of the devices and could be inhaled or ingested, with possible irritation, headaches, and even a “potential” risk of long-term cancers.
In the case of Dräger, the manufacturer has identified, in its tests, that a molecule originating from the sound-absorbing foam (1,3-dichloro-2-propanol) exceeded the authorized exposure thresholds during prolonged continuous use ( more than 30 days) in children. “1,3-dichloro-2-propanol is a substance classified as potentially carcinogenic,” noted the ANSM. But, underlined Thierry Thomas, “we are not in the same conditions as the Philips file”. “We are on a precautionary measure,” he added.
According to the health authority, the manufacturer will intervene, “from the 4th quarter of 2023”, on the devices concerned in health establishments so that they are equipped with new covers without soundproofing foam. Until then and if there is “no [option] alternative”, “the ventilators can be used in adults only, under certain conditions which make it possible to maintain the concentrations of the substance within the authorized limits”, she indicated.