As part of a consent decree with FDA, Philips is prohibited from manufacturing, processing, packing, holding, or distributing certain devices made by its Emergency Care and Resuscitation (ECR) business at its Andover, MA and Bothell, WA facilities until quality control problems are fixed. Philips' ECR unit makes automatic external defibrillators (AEDs) and Q-CPR meters.
FDA said the consent decree is with Philips North America, Carla Kriwet, business group leader for the Patient Care and Monitoring Solutions (PCMS) group, and Ojas Buch, vice president and head of quality and regulatory for PCMS. The ECR unit is part of the company's PCMS business group.
A Philips spokesperson told MD+DI the consent decree does allow the company to manufacture and distribute certain AED models. Philips will also continue to service ECR devices and provide consumables and relevant accessories. The company also noted in a press release that its AEDs 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.
According to the complaint filed with the consent decree, Philips was responsible for the manufacture and distribution of adulterated devices because its AEDs and Q-CPR Meters were made in violation of current good manufacturing practice (CGMP) requirements under the FD&C Act based on noncompliance with quality system regulations. The complaint notes that the company failed to establish and maintain adequate processes regarding its corrective and preventative action procedures, design verification and validation controls, and product specifications.
“AEDs are life-saving tools and are designed to be used by the general public or professionals in an emergency,” said Melinda Plaisier, associate commissioner for regulatory affairs at FDA. “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.”
The agreement also requires Philips to hire a third-party CGMP expert to inspect its ECR business unit to ensure it is fulfilling the quality system regulation requirements of the FD&C Act. The expert will provide FDA with a report on the company’s compliance and the agency will conduct an inspection of both manufacturing facilities before allowing Philips to resume manufacturing the impacted devices.
The complaint was filed by the U.S. Department of Justice on behalf of FDA.