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The French National Agency for the Safety of Medicines and Health Products (ANSM) has ordered the immediate withdrawal of Puritan Bennett 500 respirators, suspected of presenting an increased risk of cancer. These respiratory assistance devices are used by patients at home.
A risk reported by the manufacturer to the health authorities
According to the press release from the French National Agency for the Safety of Medicines and Health Products (ANSM), Puritan Bennett 500 respirators contain components whose degradation could release carcinogenic substances.
It was the manufacturer Medtronic that informed the agency of a potential cancer risk associated with exposure to a volatile organic compound exceeding the authorized threshold after 14 years of continuous use of the ventilator.
An increased risk of cancer, infertility and birth defects
This volatile organic compound (1,3-dichloro2propanol) from the soundproofing foam of the devices could cause a potential increased risk of cancer and infertility and, in pregnant women, of congenital malformations or abnormal development of the fetus.
According to the manufacturer, these risks have not yet been confirmed in human studies. No reports of this problem have been received through market surveillance.
What to do for patients who have these ventilators
The ANSM is implementing a monitoring system for replacements of Medtronic ventilators. The PB500 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.
For patients who may be in possession of this product, the ANSM gives the following recommendations:
- Do not stop or change your treatment on your own;
- Your home health provider will contact you to inform you;
- Your doctor will prescribe another model of ventilator for you.