Failure to adhere to Food and Drug Administration's (FDA) current good manufacturing practice (cGMP) requirements has cost the device manufacturer Physio-Control dearly, as the company signed a consent decree of permanent injunction related to Automatic External Defibrillators (AEDs) manufactured by it. The decree was signed by Physio-Control, Inc., its parent company Medtronic, Inc., and their two top executives.
The AEDs subject to the decree include Lifepak 12, 20, 500 and 1000, Lifepak CR Plus and Lifepak Express and their components and accessories, including the Lifenet systems.
The consent decree prohibits the manufacture, distribution and export of specified AEDs at or from Physio-Control's facility in Redmond, Wash, until the devices and facilities have been shown to be in compliance with the FDA's cGMP requirements, as set forth in the quality system regulation for devices.
Under terms of the decree, Physio-Control and Medtronic agreed to take necessary measures to ensure that AEDs manufactured and designed at the Redmond facility comply with cGMP requirements and FDA regulations for reporting device corrections and removals.
Manufacturing and distribution may resume once the FDA is satisfied that the Redmond facility is in compliance with the law. To ensure compliance, an outside expert will conduct yearly audit inspections for five years, submitting findings to the agency.
The decree also provides that the companies are subject to liquidated damages in the amount of $15,000 per day, if they failed 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.
AEDs are portable devices used to restore normal heart rhythm to patients in cardiac arrest (heart attack). Heart attacks can cause ventricular fibrillation, where the heart's electrical signals are uncoordinated and ineffective, resulting in a lack of blood pumped from the heart to the rest of the body. AEDs are applied outside 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, including 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. These deficiencies do not necessarily mean that the defibrillators currently on the market will harm patients, but FDA is requiring corrections to ensure the continued availability of safe, effective and reliable products.
Previous FDA inspections in 2000, 2003 and 2005 showed similar violations. FDA issued warning letters after the 2000 and 2005 inspections, citing the cGMP violations.