CDSCO asks Philips India to discontinue continuous and non continuous ventilators
Mumbai, July 7, 2021
The medical devices and diagnostics division of the Central Drugs Standard Control Organisation (CDSCO) has asked Philips India Limited to discontinue continuous and non-continuous ventilators due to some problems.
CDSCO, through a notification issued alert for continuous ventilators, minimum ventilatory support, facility use, continuous ventilator and non-life supporting and non-continuous ventilators.
The notification said, “Philips India, Gurgoan is voluntarily recalling the mentioned devices due to two issues related to the polyester-based polyurethane (PEPUR) sound abatement foam used in continuous and non-continuous ventilators.”
“PEPUR foam may degrade into particles which may enter the device’s air pathway and be ingested in inflated by the user. PEPUR foam may off gas certain chemicals. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone, and off gassing may occur initial operation and may possibly continue throughout the useful life,” the notification said.
CDSCO also issued immediate action to be taken by user as; “Discontinue use of your device and work with your physician or durable medical equipment provider to determine the most appropriate options continued treatment, to continue use of the device due to lack of alternatives, consult with your physician to determine the benefit of continuing therapy with your device outweighs the risks identified in this later.
“The user should register device it is using on the recall website www.philips.com/src-updates. The firm is deploying a permanent corrective action to address the two issues described in the recall notice,” the statement added.
To date, Philips has produced millions of Bi-Level PAP, CPAP and mechanical ventilator devices using the PE-PUR sound abatement foam.
Philips India Limited through Philips Respironics CPAB and Ni-Level PAP Devices has issued field safety notice considering sound abatement foam and susceptibility to degradation and volatile organic compound emission.
Philips Respironics has received several complaints regarding the presence of black debris/particles within airpath circuit (extending from the device outlet, humidifier, tubing and mask). PharmaBiz