The National Drug Agency (ANSM) has requested the replacement of respiratory assistance devices for home patients after a report from the American manufacturer Medtronic regarding serious potential risks, such as cancers, linked to a substance in the soundproofing foam.
Less than 200 devices of the model in question, the Puritan Bennett 500 ventilator marketed between 2010 and 2023, are still in use to this day, according to an estimate from the manufacturer communicated by the agency. The ANSM recommends on its website «to proceed with the replacement of the devices still in use with devices from another brand, within a period of six months».
In 2023, the manufacturer Medtronic identified during a risk reassessment of these devices that a volatile compound from the soundproofing foam exceeded authorized exposure thresholds after fourteen years of continuous use. This leads to a «potential increased risk of cancer and infertility, and in pregnant women, of congenital malformations or abnormal fetal development,» specified the ANSM.
According to the manufacturer, these risks have not been confirmed in human studies so far, as reported by the agency. And no reports related to this issue have been received as part of market surveillance, according to the agency. The drug agency advises patients not to stop using the ventilators in question on their own, ensuring that their home healthcare provider will contact them to inform them and that their doctor will prescribe a different model.
It is crucial for patients using these respiratory assistance devices to follow the recommendations of the ANSM and consult with their healthcare provider regarding the replacement of their current devices. The potential risks associated with continued use of these devices should not be taken lightly, and proactive steps should be taken to ensure the safety and well-being of the patients. It is also essential for healthcare providers to stay informed about such recalls and communicate effectively with their patients to address any concerns or questions they may have.