The Tamil Nadu government has asked the company to modify or replace 600 ventilators

Chennai, August 26, 2021:

Two months after medical device maker Philips announced Philips Bi-Level PAP, Continuous Positive Airway Pressure (CPAP), and ventilator recall, the state government announced I asked the company to replace or fix it. Defects in at least 600 invasive and non-invasive ventilators used in government hospitals.

The company has issued safety warnings to address potential health risks, including toxic and carcinogenic effects associated with the components used in these devices. On June 14th, we started recall notification. These devices pump air into the lungs of people with problems such as chronic obstructive pulmonary disease and sleep disorders, causing intermittent respiratory arrest. According to the notification, the foam used to reduce noise and vibration in these devices is defective. It can break down into smaller particles that, when inhaled, can lead to short-term and long-term health problems.

“Potential risks of exposure to chemicals from gas release include headache, irritation, irritability, nausea / vomiting, and possible toxic and carcinogenic effects. Phillips is a chemical. We have not received any reports of discharge-related effects on patients. ” However, I read in fine print that the recall notice is for the United States only. In other parts of the world, it was just a “field safety notice.”

On August 9, the Central Drugs Standard Control Organization issued a medical device alert indicating that Philips India Limited is “voluntarily issuing field safety notices” for necessary modifications and continued use of the device. .. While warning that bubbles could enter the device’s airways, he also warned that “high heat and humidity environments can contribute to foam deterioration in certain areas.”

Foam can release chemicals and gases during initial operation and can continue throughout the life of the device, he said. Patients using Bi-Level PAP and CPAP devices were advised to discontinue use of these devices and consult their doctor. People using ventilators are advised not to stop using it without consulting a doctor.

Over the course of a week, Tamil Nadu surveyed all public hospital devices. “We purchased four of nearly twelve defective models over a period of time. Our biomedical engineers are currently reviewing them and received donations from machines in public hospitals throughout the state. We also collect information about Tamil Nadu Medical Services Corporation, said Deepak Jacob, Managing Director of Tamil Nadu Medical Services Corporation.

These devices were widely used in patients with moderate to severe illness during Covid-19. “There are suitable breathing devices, such as ventilators from different manufacturers and high-flow nasal cannulas that can be used as an alternative to failed devices. Our engineers ensure that this device is not in short supply everywhere,” he said. Added.

However, the state or company does not count the number of people using these devices in private hospitals or people’s homes in Tamil Nadu. One of the users, Vepery resident, 91-year-old Padma Reddy, who has been using a non-invasive ventilator at home for COPD at night since 2018, complained of nausea last week. After performing some tests, the doctor asked her family to repair the ventilator.

“At that time, a biomedical engineer told us that the machine was out of order. When we placed the tube on a white cloth, we saw some small black particles,” Phillips takes corrective action. Said her daughter, Vidya R, who was waiting for her.

Padma was lucky enough to find a flaw and find a replacement for the device, but pulmonologists say that many patients who use these devices at home may not yet be aware of it. “I registered with the company as soon as the alert was released.

They serviced 10 oxygen concentrators and 3 non-invasive ventilators. Our machine was in good condition and was okay, “said Dr Avinash Rajkumar of Nature Out Reach Medical Services, a home medical service provider. “But people who buy them for personal use may not be aware of maintenance or safety changes,” he said.

A senior Philips official told the TOI that it would replace the foam with new material on all failed devices. “We asked users to register their devices on our website or call 000800-852 1411 to register their devices,” he said. ET Health