ANDOVER — A federal court ordered Philips North America, headquartered in Andover, to cease distributing certain models of its automated external defibrillators until the company complies with federal quality manufacturing regulations for medical devices.
The U.S. District Court in Boston issued the injunction against Philips Tuesday barring the company and two of its executives from distributing the devices until the company complies with the Quality System Regulation, a set of medical device manufacturing standards administered by the Food and Drug Administration.
The affected products include the Q-CPR meter, a battery used in the Heartstart MRx defibrillator, and the HeartStart HS1 and FRx defibrillators. Philips has stopped making the products at its Andover and Bothell, Washington, facilities.
The Department of Justice filed a complaint on Oct. 11 after being requested to do so by the FDA. The complaint lists allegations from two inspections by the FDA in 2015 at the Andover and Bothell, Washington, locations. Allegedly, the inspections discovered at these locations that the company had failed to put in place corrective and preventative procedures, as is federally mandated.
“The Department of Justice is committed to protecting consumers and patients by ensuring that medical device manufacturers comply with the law,” Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division said in a statement. “When a company fails to comply with legally required manufacturing standards, patients may be put at risk. The Department of Justice is committed to working with the FDA to prevent these violations.”
Philips signed a consent decree and has stopped making and distributing the devices in question for the time being until their facilities can be inspected by the FDA for compliance with the Quality Product Regulation and good manufacturing practices.
“We are committed to delivering high quality, innovative products and solutions, and we take this matter very seriously,” said Carla Kriwet of Philips. “We are fully prepared to fulfill the terms of the decree, and we hope to resume the suspended defibrillator production in the course of 2018. Over the last years, we have made significant investments in our Quality Management System, with the change in our company-wide quality leadership and the launch of new standards and initiatives across all our businesses and markets. We will continue this program to further enhance our quality management throughout Philips.”
According to a press release issued by Philips on Oct. 11: “Philips defibrillators currently in use by customers are recommended by Philips to remain in use, and should not be taken out of service as Philips has no reason to believe they pose a risk to patients.”
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