In June, Philips initiated a recall of sleep apnea and ventilator machines due to safety risks associated with polyester-based polyurethane (PE-PUR) foam used to dampen the sound of the devices. The foam was found to break down over time and be ingested or inhaled by users, possibly exposing them to toxic chemicals.
The recall was labeled a Class I event by the FDA and ultimately impacted over 5 million devices.
The FDA's most recent action is now labeling the 2018 corrective action from Philips a Class I recall; the agency created an entry in its recall database on March 18.
The agency discovered the corrective action during a recent facility inspection following the June recall.
In the FDA's facility inspection form, called a Form 483, the agency wrote that the company did not notify the agency despite having reports of foam breaking down in Trilogy and other machines as early as 2014.
The field correction was initiated in response to several complaints and at least one failure from a Trilogy machine caused by foam degradation, and the foam was later found to be "mutagenic, cytotoxic, carcinogenic, and non-biocompatible."
"Additionally, per a complaint analysis performed by this firm on 04/09/2021, this firm received approximately 30 complaints related to foam degradation of Trilogy devices from 2014 to 2017, and approximately 80 complaints related to degraded foam on other [continuous positive airway pressure] and [bilevel positive airway pressure] devices from 2014 to 2017," the FDA stated in the November document.
Risks to patients from the breakdown of the PE-PUR foam would ultimately spur the June recall.
Philips said that in response to the agency's Form 483, a "retroactive report was made to the FDA about the 2018 Preventative Maintenance protocol update."
According to the March 18 database entry, the Class I recall impacts Trilogy 100/200, Garbin Plus, Aeris and LifeVent Continuous Ventilators machines.
The company's response to the recall of millions of devices has been criticized by both patients and the FDA. On March 10, the FDA published orders for the company to improve its communication efforts after finding that patients and suppliers were unaware of the recall after it was initiated, calling Philips' previous communication efforts "inadequate."
Philips is also facing about 100 class-action lawsuits as of Dec. 31, as well as approximately 120 personal injury lawsuits in the U.S. which were consolidated into multi-district litigation in the U.S. District Court for the Western District of Pennsylvania in October.
As of January , the company has set aside 725 million euros to address the recall, which was equal to about $825 million at the time of the announcement.
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AdvaMed backed the nomination, noting a new Medicare rule that gives developers of FDA-designated breakthrough devices the potential to sell them and be reimbursed on the day of market approval.
Aging medtech and increasingly sophisticated criminals are leaving hospitals highly vulnerable to attacks.
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