The FDA is not happy with the pace of Philips’ response to an issue with multiple lines of respiratory devices. The corporation recalled millions of the devices almost a year ago and has yet to provide customers at home and at hospitals with a plan to replace the machines that, according to the recall, could be sending carcinogenic foam particles into their lungs and increasing their risk of cancer.
The agency required Philips to formally notify customers of the recall in March after it became apparent that many were still using the machines and unaware of their dangers. Now, as we near the anniversary of the initial recall order, the FDA is considering ordering Philips to present formal plans for its response to the issue or risk refunding the purchase price of every affected device.
The recall stems from the sound insulating foam used in the construction of the devices. The materials in the foam can break down over time and send particles into the breathing circuit. As the devices are used in respiratory cases, the presence of these particles in the breathing circuit of the machine means that patients are directly inhaling them into their lungs.
Initial reports of ailments from the foam were bad but did not rise to the level of an increased risk of cancer. However, August of last year saw the recall enter Class I status with the FDA as fears grew that compounds in the foam could also be carcinogenic.
The recall has thrown patients reliant on the devices into crisis as they wait for a solution from a company that appears to have no interest in helping them. Patients have been told to expect waits of up to and over a year for a replacement device – and that was before pandemic-related supply chain issues affected the movement and availability of goods for nearly every industry on the planet.
The recall has motivated federal investigators to look deeper into operations at Philips, and questions are now being raised over how much the company knew about the foam and how long they knew about it before the recalls put the devices into the national spotlight. Various form filings show that issues specific to the noise deadening foam had been brought to Philips’ attention as early as 2016, and no less than 14 filings had been issued between then and January of 2021.