As well as the risks of malformations in pregnant women…
Used as respiratory aids, ventilators manufactured by Medtronic could promote the development of cancers, according to the alert issued by the Medicines Agency on July 10, 2024. “These ventilators are used in France at home for ventilator-dependent children and adults” specifies theANSM which was “informed by the manufacturer Medtronic of a potential risk of cancer associated with exposure to a volatile organic compound exceeding the authorized threshold after 14 years of continuous use of ventilators.”
The ventilators were marketed between 2010 and 2023 and 935 devices were placed on the French market. To date, the manufacturer estimates that fewer than 200 ventilators are still in use. In 2023, during its reassessment of biological risks, Medtronic identified an increased risk associated with continuous exposure for 14 years to the volatile organic compound “1,3-dichloro2propanol” from the soundproofing foam of the devices. “This is a potential increased risk of cancer and infertility and, in pregnant women, of congenital malformations or abnormal development of the fetus.” informs the drug agency. According to the manufacturer, these risks have not yet been confirmed in humans and “no customer complaints have been received.”
The affected ventilator models are the Puritan Bennett 500 series (PB500, PB560, 520 Ventilator) from Medtronic. As a precaution, the drug agency recommends replacing devices still in use with devices from another brand. “within 6 months”. Patients currently using this device should not stop or change their treatment on their own. The home health care provider should contact them to inform them and the physician will prescribe another model of ventilator.