A U.S. District Judge has ordered Philips North America, as well as two Philips officers, to cease manufacturing and distribution of automatic external defibrillators (AEDs) until they can comply with federal regulations in a consent decree, according to a statement from the Food and Drug Administration.
In a complaint filed with the decree, Philips North America in Andover, Mass., which operates as Philips Medical Systems and Philips Healthcare, sold compromised automatic external defibrillators and Q-CPR Meters in violation of current Federal Food, Drug and Cosmetic (FD&C) Act good manufacturing practice requirements. The injunction also applies to Carla Kriwet and Ojas Buch of the Patient Care and Monitoring Solutions business group, according to the statement .
According to the consent decree, Philips must suspend all operations at their Andover and Bothell, Wash., facilities, with limited exceptions, until all corrective measures have been completed. These measures include hiring a current good manufacturing practice expert who will inspect the Emergency Care and Resuscitation business unit to ensure it is following FD&C Act regulations, and submitting to an FDA inspection of both facilities.
“AEDs are life-saving tools and are designed to be used by the general public or professionals in an emergency. People rely on these devices to work when needed. By not adequately addressing corrective and preventative actions with their AEDs in a timely manner, Philips distributed adulterated products that put people at risk,” Melinda Plaisier, associate commissioner for regulatory affairs at the FDA said in the press release.
In an Oct. 11 statement , Carla Kriwet, head of Connected Care & Health Informatics at Royal Philips, said “We are committed to delivering high-quality, innovative products and solutions, and we take this matter very seriously. 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.”
Ms. Kriwet added that in the past several years Philips has made significant investments in its quality procedures and leadership.
The company recommends that Philips defibrillators currently in use by customers should remain in use, and should not be taken out of service as Philips has no reason to believe they pose a risk to patients.