With Consent Decree, Physio-Control Sees Light at Tunnel's End
The April 28 signing by Physio-Control Inc. and FDA of a consent decree moves the Medtronic, Inc.-owned manufacturer closer to the day when it can again make and ship automated external defibrillators from its Redmond, Wash., plant, company President Brian Webster states in a May 1 letter to customers. Physio voluntarily suspended U.S. shipments from the plant in January 2007 to address quality issues identified by Physio, Medtronic, and FDA, with Medtronic announcing that the suspension interrupted its plan to spin off Physio.
The consent decree bars Physio from manufacturing, distributing, and exporting these AEDs: LIFEPAK 12, LIFEPAK 20, LIFEPAK 500, LIFEPAK 1000, LIFEPAK CR PLUS, and LIFEPAK EXPRESS, and their components and accessories including the LIFENET Systems, until those devices and the Redmond facilities have been shown to be in compliance FDA Good Manufacturing Practice requirements.
Webster's letter says Paragraph 5 of the agreement allows Physio to make a limited selection of product available "to meet the most critical needs of emergency response customers," and he said this exception applies worldwide.
Webster also says Physio has made significant investments and improvements in the past year to its quality system. "We are confident in our ability," he writes, "to make the necessary final improvements and updates to our quality system in a timely manner. We have the right people in the organization to execute to the plan and we are optimistic that these final efforts will be completed in the near future."
FDA said to ensure compliance, an outside expert will conduct yearly audit inspections at the Redmond plant for five years and will submit findings to FDA. Physio and Medtronic are subject to liquidated damages of $15,000 per 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 was filed April 25 in a federal court for the Western District of Washington and is subject to court approval.