IN THE WAKE OF DEFIBRILLATOR RECALL, CARDIOLOGISTS’ GROUP TO PREPARE GUIDELINES FOR MANUFACTURERS TO FOLLOW WHEN PATTERN OF MALFUNCTIONS IS DISCOVEREDJun 23, 2005 | www.Newsinferno.com
The sudden recall of almost 50,000 implanted defibrillators manufactured by Guidant Corp. on June 17 has many experts questioning a monitoring system which essentially leaves the matter of disclosure, with respect to potential flaws in such critical medical devices, entirely to the manufacturer.
The current system is seen as problematic for a number of reasons. First, the ultimate decision may be based not only on patient safety issues but, also, on extraneous considerations such as potential legal liability and loss of market share to competitors. Second, the FDA does not collect comprehensive data on these devices after they are approved. Finally, hospitals and doctors do not notify the FDA about all device-related problems. Reporting of such incidents is spotty at best.
As a result, the Heart Rhythm Society will prepare a set of guidelines with respect to physician alerts and other actions that should be taken by defibrillator makers when they identify a pattern of malfunctions in the devices even if those failures are rare. The Society represents a branch of cardiology known as electrophysiology and is made up of cardiologists who specialize in implanting defibrillators.
In hindsight, there is no doubt that, while Guidant Corporation maintained its internal heart defibrillator (the Ventak Prizm 2 DR) was safe and extremely reliable, it was fully aware of an electrical problem in some 29,000 of those devices which could cause them to short-circuit when needed.
On May 24, Guidant disclosed for the first time that it had waited three years before disclosing it had been aware of the electrical problem that had caused some 28 of these defibrillators to malfunction.
As the story developed, the number of potentially defective defibrillators still in use reached almost 50,000; the 28,900 with the electrical problem and another 21,000 which could malfunction due to a computer memory error (the Vertak Prizm AVT, Vitality AVT, Renewal 3 AVT, and Renewal 4 AVT ICD). There had been 2 reports of failures associated with these other models. Neither report involved injury or death.
A third problem came to light with respect to another potential short-circuit risk associated with the Contak Renewal (Model H135) and the Comtak Renewal 2 (Model H155). Out of those 16,000 devices, 15 reports of failures had been received including one involving a death on May 30.
In issuing the recall, Guidant stated the Ventak Prizm 2 DR should be monitored and will be replaced if necessary by Guidant at no charge. For the models with potential memory errors, Guidant is recommending an in office programming change that can reduce the risk until Guidant is able to design a software solution. The remaining devices should be monitored at three-month intervals and undergo a complete trouble-shooting procedure if a yellow warning screen appears on the programmer.