Seemingly still dissatisfied with Philips’ handling of its ongoing respiratory device recall, the FDA is now considering taking further action to force the Dutch medtech to tighten up its response to the safety event.
In an update shared Monday, the agency proposed issuing an order that would require Philips to repair, replace or refund all 5.2 million ventilators, CPAP and BiPAP machines and other devices included in the June 2021 Class I recall—a process that the devicemaker has already begun, albeit slowly.
Before the FDA makes the order official, Philips will have the chance to participate in an informal hearing with the agency. If it decides to proceed with the order after the hearing, Philips would have to submit a plan detailing how it will complete the repairs, replacements and refunds—the last of which allows for the subtraction of a “reasonable allowance for use if the device has been in possession of the user for one year or more,” per the FDA.
The regulator has the power to make the order under section 518(b) of the Federal Food, Drug and Cosmetic Act, which allows the FDA to step in amid a company’s recall efforts if it determines that a federal order is the only practical way to ensure the safety issue is properly taken care of.
In a statement sent to Fierce Medtech, the company said of the proposed order, “Philips is studying the information and intends to share its views with the FDA. We have been and continue to cooperate with the FDA. To date, Philips Respironics has produced a total of 1.1 million replacement devices and repair kits for customers and patients in the U.S., and aims to complete the vast majority of the repair and replacement program in 2022.”
The proposal comes not long after the FDA took action under section 518(a) of the same legislation. That order, issued in March, gave Philips 45 days to notify all affected users, distributors, suppliers, retailers and prescribing healthcare providers about the recall. It was spurred by the FDA’s conclusion that “the company’s notification efforts to date have been inadequate.”
The agency said it had previously communicated with Philips several times regarding its concerns that many people using the affected devices were unaware of the safety risks. It also recommended that Philips provide more regular updates about its repair and replacement process to affected customers, sellers and healthcare providers.
In response to that order, Philips said it had already contacted “the vast majority” of affected U.S. patients and was keeping them updated through its DreamMapper mobile app, but would continue working with the FDA to “further increase awareness” of the recall.
Meanwhile, the recall is facing further federal scrutiny, this time in the form of a subpoena from the Department of Justice.
“At this time, it’s a subpoena for information,” CEO Frans van Houten said on a call with investors at the end of April. “That means they are preparing an investigation, and we just have to accept that.”
When the recall began last June, it encompassed between 3 million and 4 million devices that included a polyester-based polyurethane foam that was found to be at risk of breaking down over time, potentially sending dangerous debris into a user’s airflow.
Philips got the go-ahead in September to begin repairing and replacing those devices, using a new silicone-based alternative. At the time, it said it was aiming to ramp up its production capabilities to churn out about 80,000 repair kits and replacement units per week by the end of 2021.
By the beginning of this year, the company had expanded the recall to include a total of 5.2 million devices distributed around the world since late 2015. During the April call with investors, van Houten said Philips had so far manufactured about 2.2 million repair kits and replacement devices for global distribution.