United States: The company responsible for causing the global recall of sleep apnea machines will be unable to revert to producing them in US facilities until they meet certain safety requirements, following the settlement announced today by federal officials.
More about the court’s order
As per a U.S. Department of Justice’s order which was announced recently, Philips would have to recalibrate its manufacturing and quality control departments and seek the assistance of independent experts to scrutinize the changes, according to the court order.
Moreover, the company must continually top up the fund to compensate US customers who had to defect or repair a particular device.
According to ABC News, this measure is the main turning point in solving the issue of the biggest medical device recall in history, which has haunted the country for about two years now.
Generally, the majority of the recalled products are machines that are used to increase the air pressure in airways with the name of continuous positive airway pressure, or CPAP.
They did this by using a mask to provide air and go through the nose and mouth, thus keeping them open during sleep. These things can be expected if sleep apnea is not treated; sleepiness can lead to danger, and the risk of having heart problems increases.
During the hearing, the lawyers representing the federal government claimed that the company did not comply with the good manufacturing practices required to fulfill the device’s safety. However, the company denied the allegations as per the filing in court.
U.S. Attorney Eric Olshan stated, “This office, the FDA, and our partner agencies are committed to holding manufacturers accountable when they violate the law and put the public at risk,” as ABC News reported.
Requirement of independent auditor by the company
Under the legal arrangement, Philips must utilize external auditor to prepare a roadmap that would address manufacturing problems and also for monitoring the sleep devices here.
Afterward the plan agrees with the Food and Drug Administration (FDA). Among other experts’ certifications, they must confirm that new foam chosen by the company has passed FDA safety precautions as well.
Jeffrey Reed, who lived in Marysville, Ohio, had suffered repeated sinus infections and two pneumonias three times during the seven years warranting the use of a Philips air purifier.