United States – Federal officials announced today that Phillips Respironics, the company that has recalled millions upon millions of defective sleep apnea machines since 2021, must renovate the production of the machines prior to the recalled production in the United States, and no more.
Agreement Reached for Overhaul
In a deal hashed out between Phillips and the company, the latter should make radical changes to its manufacturing and quality control systems and bring in independent auditors to backstop the re-engineering. Additionally, as indicated by the court, Phillips should continue replacing, fixing, or returning all the damaged devices to U.S. customers who have defective ones, as reported by HealthDay.
FDA Hails Resolution of Major Recall
The U.S. Food and Drug Administration (FDA) noted that such action resolves one of the biggest medical device recalls, which has lasted nearly three years and affected over 15 million units globally.
“The finalization of this decree is a significant milestone. Throughout this recall, we have provided patients with important health information by issuing numerous safety communications and have taken actions rarely used by the agency to help protect those impacted by this recall,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in an agency news release. “Today’s action is a culmination of those efforts and includes novel provisions aimed at helping ensure that patients receive the relief they have long deserved.”
The major product category that is subject to a recall is a continuous positive airway pressure machine. These machines move air over a mask in order to ward off closing of the mouth and nose while asleep. Persistent sleep apnea that is untreated can raise the risk of heart attack.
Recalled machines can release various particulates and fumes due to the aging foam inside the machines. Therefore, users are exposed to such harmful contaminants while sleeping.
Recalled Machines Pose Health Risks
Jeffrey Reed from Marysville, Ohio, had to deal with seven years of sinus infections and two episodes of pneumonia while using a Philips CPAP machine.
“I worry about my long-term health,” Reed told the Associated Press. “I used this machine for years, and no matter what money I might get from this, what’s going to happen?”
Reed got a newer device made by Philips after sending back his old kit; however, he rather opts for a product from a competitor, as reported by HealthDay.
“I don’t trust the company,” Reed uttered. “I am not into it.”
User Concerns and Legal Action
Reed is amongst the more than 750 people who have precipitated personal injury lawsuits against the firm by the devices. The federal court with jurisdiction over these cases is located in Pennsylvania, based on the AP reports.