Philips defends CPAP safety

Your recent reporting on silicone sound abatement foam in Philips Respironics CPAP devices is disappointing and irresponsible. It will cause unnecessary and unfounded anxiety among patients who use these and similar devices for life-enhancing of sleep apnea.

Silicone foam is commonly used across the CPAP industry. It has been extensively tested for Philips Respironics by multiple independent, certified laboratories in accordance with the applicable regulatory standards, and no safety issues have been identified.

In your article you raise formaldehyde, a compound omnipresent in daily life that could be a risk only when the exposure levels are above applicable regulatory thresholds. The levels of formaldehyde detected in all tested Philips Respironics devices that contain silicone foam were well below the World Health Organization’s limit, which is more than twice as strict as the threshold set by the Food and Drug Administration.

You omit these important facts, instead stating the foam “posed risks to patients” without any credible or verifiable backup and no such finding by any regulatory authority. The FDA has had the test results from the independent, certified laboratories for more than a year and has not changed its guidance that patients should continue to use their devices.

Our priority at Philips is patient safety and quality. It’s critical that patients and care providershave access to accurate information and know the foam is safe.

LESLIE MCGIBBON Head of Communications and Brand Philips