- Philips Respironics Receives FDA Notification Order, published on 10 March 2022 in an FDA Press Release
Philips openly acknowledged product safety risks with certain sleep apnea and ventilator machines. On June 24, 2021, the Dutch company initiated a voluntary recall notification.
“Philips’ Attempts To Alert Users Are Inadequate”
However, the U.S. Food and Drug Administration (FDA) is aware of frustration expressed by patients, users, and durable medical equipment suppliers. Some are unaware of the recall and have received insufficient information on their next steps regarding the recall process. Now, the FDA has taken action, but this problem concerns consumers worldwide.
“Philips’ previous attempts to alert customers about a sleep device recall are inadequate”, according to the FDA. A news release from March 10, 2022 announced that a notification order to Philips Respironics has been issued. The company is ordered to notify all device users, durable medical equipment (DME) suppliers, distributors, retailers, and health care 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 prominently displayed information” to patients regarding the risk of using ozone cleaners on the recalled devices on their main web page for the recall and provide instructions for device users to register their devices on the Philips website.
In November 2021 we published the article: Philips is liable for health problems’ say users of apnea devices. Four Dutch users of a Philips device used to treat sleep apnea, the Dreamstation 1, are holding the manufacturer liable for health problems. Their lawyer Mr. Mark de Hek has announced this in a letter to the company. The users say they suffer from headaches or breathing problems or have cancer.
“Philips Does Not Provide Patients And Other Consumers With Adequate Information”
The order comes nine months after Philips issued a Class I recall for some sleep apnea and ventilator units. Despite its efforts to have Philips “voluntarily enhance” communication efforts, the FDA continues to hear from patients who are uninformed of the recall. In addition to concerns over the recall’s notice, the FDA states that it has worriment that Philips does not provide patients and other consumers with adequate information on the recall’s status and the process for receiving replacement devices.
Philips issued the official recall due to the breaking down of foam used to dampen sound in machines. That provides a risk of particles being breathed or consumed by users, potentially exposing them to harmful substances. More than 5 million devices were recalled as a result of the recall.
“Once broken down, the foam can result in serious injury, including injuries that can be life-threatening, can cause permanent impairment and/or require medical intervention to prevent permanent injury”, according to the FDA in Thursday’s statement.
The FDA ordered Philips to alert all device users, durable medical equipment suppliers, distributors, retailers, and healthcare providers who prescribe the recalled items about the health hazards posed by the foam. Other orders from the FDA are to improve the information on Philips’ website and that the company must provide a link to testing done on devices using the foam.
Philips has 45 days from the time of the order to comply. We will keep you up to date on the latest developments.