Medtronic’s Physio-Control unit indefinitely suspended shipments of external defibrillators and other emergency-response gear because of quality-control problems at a factory in Redmond, Washington. The suspension will address weaknesses in “the overall quality system” in the Redmond factory that were identified by the U.S. Food and Drug Administration and the company, Medtronic spokesman Rob Clark said. The quality issues are related to manufacturing processes and not any individual products, he said. No products are being recalled. The halting of product shipments means that Medtronic will delay the spinoff of Physio-Control as an independent public company, which had been planned for mid-2007.
Medtronic did not fix defibrillator flaws
In a letter made public June 21, 2005, the U.S. Food and Drug Administration warned Medtronic Emergency Response System, a unit of Medtronic, Inc., that its failure to correct manufacturing problems or investigate complaints regarding its LifePak 12 external defibrillators may force the company to face civil and legal penalties. External defibrillators deliver powerful electrical shocks to the chest in order to restore the heart’s natural rhythm.
The letter highlighted a problem with the LifePak 12 involving broken or bent pins in therapy cables connected to the device, which is used to treat patients experiencing sudden cardiac arrest. The damaged cables in some of the LifePak 12 defibrillators caused them to deliver inappropriate energy levels while in use, resulting in numerous complaints.
The FDA inspected Medtronic’s plant in Redmond, WA, in February and March, 2005, on several occasions after Medtronic recalled about 87,000 units of another implantable defibrillator after the discovery of battery failures. At that time Medtronic promised to remedy manufacturing problems despite citing an “internal analysis” of the LifePak 12, which they claimed revealed no issues with the device. The recently published letter by the FDA states that Medtronic has failed to adequately correct manufacturing problems related to its defibrillators. The company also violated its own internal safety procedures when it did not open an investigation on a defibrillator complaint involving a patient death. The letter stated, “There have been continued complaints of broken pins in the therapy cables used with the new redacted connector” intended to remedy the flaw. The FDA pointed to inadequate inspection procedures as one possible source of the problem.
Earlier this year, Medtronic recalled 1,924 LifePak 500 external defibrillators due to 54 incident reports about a malfunction in the model that caused the units to display a “connect electrodes” message even when the device was properly connected. This flaw prevented patients from being properly defibrillated. The Redmond facility in which they were manufactured was previously owned by Physio-Control, a Washington company that first commercialized the defibrillator. Manufacturing in the facility was shut down for an entire year in 1992 after an FDA inspection raised questions about its quality-control procedures.
FDA Shutdown in 1992
In 1992, Physio-Control voluntarily shut down production of its defibrillators and patient monitors after a review by the U.S. Food and Drug Administration found the company had failed to follow “good manufacturing practices,” including inadequate failure investigations, not properly inspecting critical components of its products, and failing to adequately document manufacturing and testing procedures in writing.
Although the FDA never claimed that patients had been harmed by malfunctions of the medical equipment, and no recalls were ordered, Physio-Control signed a consent decree outlining steps it would take before resuming production. Richard O. Martin, former vice president of business development who had succeeded Anderson as president and chief executive in 1991, later told the Puget Sound Business Journal that Physio-Control “truly, fundamentally believed” that it was in compliance with all FDA requirements. He blamed the sanctions on political pressure then being brought to bear on the FDA to become more forceful in its interpretation of the rules.
Reaction
Fire Engineering EMS Editor Mike McEvoy said the Medtronic announcement is reminiscent of the 18 month shutdown in 1992 after the FDA found the company had failed to follow “good manufacturing practices.” With over 600,000 defibrillators and AEDs deployed in the United States, Medtronic Emergency Response Systems controls some 70% of the US EMS market and nearly 50% of the in-hospital market for external defibrillators.
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