Philips is preparing to launch what it expects to be a year-long process of repairing and replacing the recalled components within millions of its sleep apnea and respiratory care devices sold internationally.
This past summer’s massive recall of CPAP machines and ventilators—spanning nearly two dozen models produced between 2007 and this year—was traced to a polyurethane foam used to line the inside of the device, designed to quiet the sounds of the motor while the user slept. However, pieces of the insulation were found to break off and could be inhaled or swallowed.
According to Philips, more than half of the at least 2.2 million affected devices are based in the U.S., with more than 80% belonging to the company’s first-generation DreamStation product family.
The company has now received a green light from the FDA to start replacing the sound abatement foam with a new material and plans to begin the work over the month of September.
Philips said it has already started replacing older devices with DreamStation 2 CPAP machines and is launching repair programs in other countries as well. The task is expected to be fully completed within about 12 months.
“We fully recognize that the timeframe for remediation of the affected devices places patients in a difficult situation,” CEO Frans van Houten said in a statement.
“We are mobilized to deliver a solution to them as fast as possible,” van Houten said. “We have significantly increased our production, service and rework capacity and further intensified our outreach to our customers and their patients. We urge patients with affected active devices to register these on the dedicated recall notification website.”
The difficult situation is being felt on Philips’ side as well. The recall put a dent in the company’s second-quarter sales, eating up the gains seen from its sales of hospital patient monitoring tech.
Meanwhile, the medtech’s sleep care competitor ResMed aims to meet the nightly needs of patients, who the FDA has urged to stop using the recalled devices immediately and contact Philips for a replacement.
However the surge in demand—and an international supply chain already crimped by the COVID-19 pandemic and a months-long shortage of computer chips—has forced ResMed to begin rationing out its hardware.
“We are focused on the highest acuity patient needs first,” ResMed CEO Mick Farrell said during a recent earnings call. “It's very similar to our approach to ventilator allocation during the peaks of the COVID crisis these last 18 months.”
Farrell said he expects to see the recalls drive $300 million to $350 million in additional sales for ResMed’s fiscal year, and the company recently launched a new connected sleep apnea machine to help pick up the slack left by Philips temporary absence.
According to the FDA’s Class I recall notice from the past summer—the agency’s most serious label—more than 1,200 complaints have been filed regarding the issue, with at least 100 injuries linked to the foam particles.
Elsewhere, regulators in the E.U., U.K. and Japan have advised patients to consult with clinicians before altering their therapy. By the end of this year, Philips said it aims to triple its ability to manufacture repair kits and replace units, ultimately ramping up to 80,000 per week.