CHENNAI: When a nonagenarian, using a non-invasive ventilator at night at home, complained of nausea in the mornings recently, little did she realise that she had been using a product that was recalled in the US. The device that she was using was manufactured by Philips.
In June, the company issued a recall for certain products in the US and a Field Safety Notification for other countries, including India. Certain models of their breathing devices had a problem related to the sound abatement foam which was either degrading and at risk of being inhaled by the user or emitting gases that could be toxic.
The nonagenarian’s daughter, activist Vidya Reddy, learnt of the recall only after she consulted the device’s service engineer when tests ruled out any medical issues.
“The service engineer told me to stop using the machine immediately and asked if I hadn’t received the alert,” said Reddy, whose mother has COPD and has been on full-time oxygen support since 2016.
“He asked me to take out the tube and turn on the machine. When I did so, small black foam particles emerged from the tube, covering the bed. I don’t know how long my mother was inhaling these toxic particles,” she said.
Reddy and her mother were lucky to learn of the issue relatively quickly. Even the Central Drugs Standard Control Organisation issued an alert about the issue only on August 9. Distributors are racing against time to reach out to customers but with no actual data on the number of home users, they fear they may be unable to reach all affected parties.
Worryingly, doctors said that the number of users of such devices in home settings had increased post Covid, spiking in April and May.
“Many people have started using non-invasive breathing machines at home during the second wave as some patients might still require low-level oxygen support,” said Dr C Arumugam, senior consultant, Cardiovascular and Thoracic Surgery, Rela Hospital.
One distributor said the company was making efforts to reach out to people and rectify or replace the devices.
“In the last 10 -15 days, we have made at least 50 home visits. We have told dealers to inform their customers, but are not sure if they are following up on it,” the distributor added.Doctors who have prescribed such devices are also in a position to alert potential affected parties.
“If the distributors alert us of any such issues, we can inform the patients,” said Dr R Jackin Moses, consultant pulmonologist, Dr Mehta’s Hospital.
Meanwhile, the State health department, which also procures devices from Phillips, is working with the company to resolve potential issues. “Over the past two years, we have procured about 600 Bi-PAP, CPAP devices and ventilators, of which four models are in the alert category. We have informed the Phillips team and are coordinating with them to rectify the issue or replace the devices,” said Deepak Jacob, Managing Director, Tamil Nadu Medical Services Corporation.
‘Will replace foam’
According to the CDSCO alert, users of the Bi-level PAP and CPAP devices were asked to discontinue use while those on life-sustaining mechanical ventilators were asked to seek physician support before altering therapy. The alert said the company would replace the defective foam and customers could register on https://www.philipssrcupdate.expertinquiry.com for support
TN COVID WATCH
New cases 1,523 l Deaths 21
Tests 1,50,948 l TPR 1%
Total deaths 34,835
Total recovered 25,61,376
Active cases 17,085
Tests total 4,21,66,911
Chennai 183