 "Breathe easy! Philips says its sleep apnea devices safe for use in India")
Dutch healthcare company Philips says it has completed remediation of its faulty sleep therapy devices in India, asserting that based on the current testing, their continued use is not expected to cause any “appreciable” health harm.
The company has faced scrutiny after certain models of Bi-Level Positive Airway Pressure (BiPAP) machines were found to have issues with foam degradation, leading to breathing issues and health risks for its users.
BiPAP and Continuous positive airway pressure (CPAP) therapy devices are used to treat sleep apnea. Sleep apnea is a serious sleep disorder in which breathing repeatedly stops and starts.
In its response, Philips in June 2021 issued a field safety notice regarding CPAP and BiPAP devices, citing concerns over the degradation of the sound abatement foam, which led to the release of particles and chemicals into the air pathway.
This was done after users reported symptoms like headache and sinus infection, likely due to exposure to black debris and emitted chemicals.
The notice advised users not to use the device, register for corrective action, and consult with healthcare providers for alternative treatments. In India, Philips offered support through a hotline and website.
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On queries sent by Business Standard recently to Philips India, the company said, “In 2021, Philips issued a field safety notification for certain sleep and respiratory care devices across the world including India. Patient safety and quality are our highest priority, and we took important steps to resolve the consequences of this field safety notice. The remediation of the sleep therapy devices for patients is almost complete and the test results to date show the use of these devices is not expected to result in appreciable harm to health.”
“We no longer sell the old devices with polyester-based polyurethane (PE-PUR) sound abatement foam. All devices being sold in India today comprise new silicone sound abatement foam, a material that is commonly used in the medical device industry. These products are approved for sale in India by the CDSCO,” it said while commenting on the current state of those machines.
The company, however, did not disclose the number of CPAP and BiPAP devices sold in India, nor has it provided information on how many of these have been replaced. It remains unclear whether they have reached out directly to Indian consumers regarding the issues with these machines.
Providing industry’s perspective, Ravi Rathod, Technical Officer- Government Affairs & Policy, Association of Indian Medical Device Industry (AiMeD), said, “Following reports of potential harm to patients due to faulty input filters in respiratory devices, the incident underscores the critical importance of robust regulations in the medical device industry.”
“The recall serves as a catalyst for heightened scrutiny and reinforces the necessity for stringent safety measures. As part of India's commitment to patient safety, the introduction of the Medical Devices Regulations aims to prevent such occurrences, mandating licences for high-risk Class C & D devices by October 2023. This underscores the nation's dedication to ensuring the highest standards of medical device safety,” Rathod said.
Philips recently reached a $1.1 billion agreement to settle lawsuits from users in the US against some of the company's sleep therapy machines.