Philips to suspend some defibrillator manufacturing in US: 5 things to know

The North American subsidiary of Amsterdam-based Royal Philips reached an agreement on a consent decree with the U.S. Department of Justice, representing the Food and Drug Administration, the company announced Oct. 11.

The consent decree, which will become effective once it's approved by the U.S. District Court for the District of Massachusetts, relates to Philips North America's defibrillator manufacturing in the U.S.

Here are five things to know about the agreement.

1. The consent decree related to Philips North America's compliance with current good manufacturing practice requirements in the U.S. The agreement arose from FDA inspections in and before 2015, which focused on the company's emergency care and resuscitation business operations in Andover, Mass., and Bothell, Wash.

2. Under the agreement, Philips North America will suspend manufacturing and distribution of external defibrillators at facilities in Andover and Bothell, with exceptions related to select automated external defibrillator models. However, the company will continue to service all previously sold emergency care and resuscitation devices.

3. Philips North America plans to recommence manufacturing and distribution of external defibrillators in the U.S. facilities after the FDA inspects and certifies their compliance with the quality system regulation, or current good manufacturing practices.

4. The consent decree also mandates a temporary period of increased scrutiny over Philips North America's quality system regulation compliance with the company's other patient care businesses manufactured and distributed in Andover and Bothell.

5. Philips North America recommends customers who already have the company's defibrillators continue to use them. Officials said there is no reason to believe they pose a risk to patients.

"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," said Carla Kriwet, chief business leader of connected care and health informatics at Royal Philips.

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