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1997-11-14 09:31:55


Defective Pacemakers = Patients at Risk = Lawsuits



The Veterans Administration interviewed five companies about their pacemakers. Not one company's products were y2k compliant. One firm simply refused to discuss the matter. The problem is embedded chips.

Here is Ann Couffou's testimony before the House Subcommittee on Technology.

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In a very simplified explanation, every time a heart pacemaker detects an irregular heartbeat it sends a shock to the system and then records the time the event occurred. This information is regularly downloaded to a computer system so it can be analyzed by medical personnel. Whenever the information is downloaded, the pacemaker resets itself. The downloaded information is used by cardiologists to detect patterns and irregularities in the patientís heart rhythms. If the software in the receiving system starts recording faulty times for the shock deliveries, the cardiologist could misinterpret the results and administer improper medical care.

The U.S. Veteranís Administration funded a project to interview the top five pacemaker manufacturers to see if they were aware of this potential problem. One company was aware of the problem and said they would have it corrected by the end of 1997. Two companies said that the problem would be fixed before the Year 2000, one before 1998. Finally, one company flatly refused to acknowledge the problem and when pushed declined to discuss the topic any further.

A physician in a heart clinic in Spartanburg, South Carolina, related that a new shipment of heart defribulators the clinic received recently were recalled by the manufacturer. The defribulators use an embedded device that calculates the time since last maintenance similar to elevators. Like the elevator, if the time since the last maintenance check surpasses a certain time frame, the defribulator will not operateóthereby reducing the possibility of malfunctioning on a patient. The manufacturer voluntarily recalled their products when they discovered they were not designed to handle the change in century.

The legal ramifications for these and other medical system malfunctions have the ability to become enormous, precedent-setting lawsuits, not to mention the backlash effect on physician malpractice insurance.


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