More recalls have been ordered for a variety of ventilators made by Dutch electronics and technology manufacturer Philips. The company’s troubles started in fall of last year when lines of Philips CPAPs, BiPAPs, and ventilators were recalled over concerns that the sound dampening foam used in the devices could degrade. This degradation could allow particles of the foam to enter the breathing circuits of the machines and send them into patients’ lungs.
Concerns over the foam started out relatively mild as regulators cautioned that the foam particles could cause some irritation and asthmatic responses. Those warnings escalated, however, when the FDA added the risk of “toxic and carcinogenic effects” to the list. “Carcinogenic effects” is another way of saying that the foam particles could cause cancer in humans.
Earlier this week, the FDA took the step of reclassifying an existing recall of Philips ventilators that had been expanded to cover even more models as a Class I recall. The Class I recall is the agency’s most urgent and severe action and is reserved for those items whose continued use could lead to serious injury or death. The recall covers not only various lines of Philips ventilators, but also the repair kits used to service and replace parts in the units.
Philips was quick to note that a solution was already in place and, through a spokesman, indicated that it had “already reached the majority of affected customers and we will correct this issue via a repair (replacement of the foam) on site in the coming months.”
Repair and replacement of the foam in the ventilators is not likely to bring the swift conclusion to the issue that Philips may hope that it might. Reports surfaced late last year indicating that the recalls have opened a veil into the inner workings at Philips and regulators are now questioning just how much the company knew about the faulty foam and how long it knew before it did anything about it.
