Device manufacturer Physio-Control Inc, Redmond, Wash, its parent company Medtronic Inc, and their two top executives have signed a consent decree of permanent injunction related to automatic external defibrillators (AEDs) manufactured by Physio-Control.
The decree prohibits the manufacture, distribution, and export of specified AEDs at or from Physio-Control’s facility until the devices and facilities comply with the FDAs Good Manufacturing Practice (cGMP) requirements, set forth in the Quality System regulation for devices.
AEDs are portable devices used to restore normal heart rhythm to patients in cardiac arrest (heart attack), which are applied outside of the body and deliver an electric shock that stuns the heart for a moment, giving it the chance to resume beating effectively.
FDA inspections conducted in October 2006 and January 2008 revealed cGMP deficiencies, such as failure to establish and maintain adequate procedures for validating the device design and failure to establish and maintain adequate procedures for implementing corrective and preventive actions. The deficiencies do not necessarily mean defibrillators on the market will harm patients.
FDA inspections in 2000, 2003, and 2005 showed similar violations, and the agency issued warning letters after the 2000 and 2005 inspections citing the cGMP violations.
AEDs subject to the decree include:
• LIFEPAK 12
• LIFEPAK 20
• LIFEPAK 500
• LIFEPAK 1000
• LIFEPAK CR PLUS
• LIFEPAK EXPRESS
• and their components and accessories, including the LIFENET Systems
Physio-Control and Medtronic agreed to comply with the decree. Manufacturing and distribution may resume after the FDA is satisfied the facility complies with the law.
An outside expert will conduct yearly audit inspections for 5 years, submitting findings to the agency.
The decree also provides that the companies are subject to liquidated damages in the amount of $15,000 a day if they fail to comply with any of the provisions of the decree, and an additional sum of $15,000 for each violation of the consent decree, the Federal Food, Drug, and Cosmetic Act, or FDA regulations.
The decree, filed on April 25, 2008, in the US District Court for the Western District of Washington, is subject to court approval.