The reprimand is tied to the company's massive recall last June of ventilators, sleep apnea machines, and other breathing-assistance devices.

Amanda Pedersen

March 11, 2022

5 Min Read
FDA reprimands Philips for inadequate recall notification
Image courtesy of Nerthuz / Alamy Stock Photo

It's been nine months since Philips initiated a massive recall involving millions of breathing-assistance machines, and yet the company's notification efforts have been inadequate, according to FDA.

The agency issued a notification order to Philips Respironics requiring the company to notify patients and others of the company’s June 14, 2021, recall of certain ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines, and the unreasonable risk of substantial harm to the public health posed by the degradation of the polyester-based polyurethane (PE-PUR) sound abatement foam used in those products.

“The FDA has heard 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,” said Jeff Shuren, MD, director of FDA’s Center for Devices and Radiological Health. “Taking this action today enables the FDA to mandate that Philips Respironics improve its communication about the recall and the serious risk posed by the foam used in the recalled products with patients and the public and to ensure that individuals who rely on these essential devices are receiving the important information they need from the company.”

The agency ordered the company to notify all device users, durable medical equipment (DME) suppliers, distributors, retailers, and healthcare providers who prescribe the products about the recall and the health risks posed by the foam used in the recalled products. The order also directs Philips to maintain language to patients regarding the risk of using ozone cleaners on the recalled devices on their main webpage for the recall, and to provide instructions for device users to register their devices on the Philips website. 

Along with these actions, FDA recommended additional measures for Philips to take to better communicate with the public regarding the recall. Specifically, the agency recommends that Philips provide monthly updates to device users who register their devices on the Philips website that include information on expected time for replacement and current rate of replacement of recalled devices. FDA also recommends that Philips provide detailed information to device users, DME suppliers, distributors, retailers, and healthcare providers on the replacement process. 

In June 2021, Philips Respironics initiated a recall of certain ventilators, CPAP and BiPAP machines due to potential health risks related to PE-PUR sound abatement foam used in those devices. This particular foam may break down and can result in serious injury, which can be life-threatening, cause permanent impairment and/or require medical intervention to prevent permanent injury to users. 

Since the initiation of the recall, FDA says it has engaged with Philips on several fronts about the effectiveness of its communications with the public regarding the recall and the risks presented by the recalled products and has expressed concern that it is likely a significant portion of patients and consumers using the recalled products are unaware of the health risks presented by those products. 

Under FDA's order, Philips has 45 days to to provide the necessary notification.

Meanwhile, ResMed is seeing 'seemingly infinite demand' from the Philips recall

ResMed is seeing "almost unlimited demand" for its sleep apnea machines, thanks to the Philips recall. The problem is that the San Diego, CA-based company is not immune to global supply constraints, particularly the semiconductor chip shortage and increasing freight costs.

That's why, despite growing double digits year-over-year during its second fiscal quarter (which ended at the end of calendar year 2021), ResMed fell short of meeting all the current market demand, company executives said during an earnings call in late January.

ResMed products are used to help treat sleep apnea, COPD, asthma and other respiratory chronic diseases. The company's software solutions have helped to distinguish ResMed in the market place from its competitors.

The company expects to have at least 12 more months of this "incredible demand" for ResMed products, CEO Mick Farrell said, based on the latest information available about the Philips recall. The good news is that the company does seem to have a clear plan of action to try to both mitigate the supply constraints as best it can and to prioritize how outbound product will be allocated to meet the needs of the patients who most need the machines, regardless of whether they are "Philips customers" or "ResMed customers."

"We have established an allocation process with clear guiding principles that give priority to the production and delivery of devices to meet the needs of the highest acuity patients first," Farrell said. "In addition to component supply issues, the ongoing challenges of sea freight and air freight are impacting our ability to respond as rapidly as we would like to the demand for ResMed products. Freight costs are increasing across the board on inbound components from suppliers and on outbound products to our distribution centers and for ultimate delivery to our customers."

Philips has initiated a repair and replacement program that is well underway in the United States and in several other countries, CEO Frans van Houten said during the company's third-quarter earnings call in October. He also noted that the company had produced more than 750,000 units of repair kits and replacement devices at that point, of which more than 250,000 units had reached customers. 

"We have substantially increased our overall production volume in the third quarter to 55,000 units per week, and are on track to reach 80,000 units per week in the fourth quarter. We expect to complete the repair and replacement programs within 12 months," he said. "We have a strong program management in place, to see the corrective actions through as fast as possible."

About the Author(s)

Amanda Pedersen

Amanda Pedersen is a veteran journalist and award-winning columnist with a passion for helping medical device professionals connect the dots between the medtech news of the day and the bigger picture. She has been covering the medtech industry since 2006.

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