Foam Used In New Ventilators In Danger Of Disintegrating
Foam used in new ventilators in danger of disintegrating. These devices push air into the lungs of people with problems such as chronic obstructive pulmonary disease or sleep disorders, where breathing intermittently stops. The notification said the foam used in these devices to reduce sounds and vibrations were defective. It may break down into small particles and if inhaled, these particles could lead to short-term and long-term health issues.

“The potential risks of chemical exposure due to off-gassing include headache, irritation, hypersensitivity, nausea/vomiting, and possible toxic and carcinogenic effects. Philips has received no reports regarding patient impact related to chemical emissions,” it said. However, the fine print read that recall notification was for the US only. For the rest of the world it was just a a field safety notice.

On August 9, the Central Drugs Standard Control Organisation put out a medical device alert stating that Philips India Limited is voluntarily issuing field safety notification for necessary rectification and continued usage of the devices. While it warned the foam may enter the device air pathway, it also warned that high heat and high humidity environments may contribute to foam degradation in certain regions. The foam may emit chemicals and gases during initial operation and may continue throughout the device’s useful life, it said. It advised patients using Bi-Level PAP and CPAP devices to discontinue using these devices and consult their doctors.

Over the week, Tamil Nadu surveyed the devices in all government hospitals. “We have purchased four of the nearly dozen faulty models over a period. Our biomedical engineers are now reviewing them and are also collecting information about the machines present in government hospitals across the state received as donations. We are asking the manufacturer for a replacement or take needy measures in rectifying the issue” said Tamil Nadu Medical Services Corporation managing director Deepak Jacob.

However, the state or the company does not have a count on the number of people using these devices at private hospitals or at people’s homes in Tamil Nadu.