Citing a need for improvement in the way Philips has handled its duty to notify patients of the recall of a variety of its ventilators and breathing aids, the FDA issued an order to the corporation earlier this month mandating a more open flow of information.
In a statement on the agency’s website, the director of its Center for Devices and Radiological Health acknowledged the “frustration expressed by patients and durable medical equipment suppliers who are unaware of the recall and have received insufficient information on their next steps regarding the recall process.”
Given that the Philips ventilator, CPAP, and BiPAP recall has reached Class I status with the FDA, the lack of information being provided to patients and the medical community by all involved is startling. The Class I recall is the agency’s most severe and urgent action and indicates that continued use of the recalled item could cause serious injury or death for the consumer.
The recall is based on evidence indicating that the sound dampening foam used within certain models of Philips ventilators, CPAP, and BiPAP machines can degrade over time and enter the breathing circuit of the machine. Initially thought to be a trigger for a variety of respiratory ailments like asthma, as well as an irritant to the body’s respiratory system, warnings were eventually updated to include the fact that the foam could have carcinogenic effects as well. This would put the patient at a heightened risk for certain cancers. As a result of the recall, regulators are also probing how much Philips knew about the risks associated with its foam and how long they had known that it could be an issue.
The FDA said in its release that despite the heightened alert and recall status, it fears that “a significant portion of patients and consumers using the recalled products are unaware of the health risks presented by those products.” Philips now has 45 days from the date the order was issued to create and execute a more robust notification plan for “device users, health care providers who prescribe or use the device, and any other person who should receive notification to eliminate such risk.”