August 12, 2005
-
August 7, 2005
When a Heart Device Short-Circuits
Defibrillators that shock a chaotically beating heart back to normal and pacemakers that regulate a heart’s rhythm have saved or improved the lives of hundreds of thousands of people. But every so often one of these implanted devices fails to work when it is desperately needed. The story of how the Guidant Corporation, the nation’s second-biggest maker of cardiac devices, handled a flawed defibrillator provides a troubling glimpse into the murky world of medical device regulation.
The problems came to light after a college student with a genetic heart disease died in March while he was mountain biking in Utah. When Guidant analyzed the device, it found that the unit had short-circuited. Worse yet, the same model had short-circuited earlier in more than two dozen other patients. Yet when the dead student’s doctors asked Guidant officials how they planned to get the word out, the officials said they saw no reason to. It was only when The Times was about to publish an article by Barry Meier exposing the problem in late May that the company issued an alert. The article revealed that Guidant had known about the flaw for three years but told neither doctors nor patients.
The company’s justification for its reticence won’t wash. Guidant said it corrected the flaw in 2002 but saw no need to inform doctors because the devices made before then were highly reliable and the surgical risk of taking them out might outweigh the very low risk of failure. Incredibly, the company kept selling the potentially flawed devices from inventory for months after it began making improved versions. To this day it maintains that all the devices are highly reliable, but surely there are few doctors who would want to implant a device with a flaw that had been corrected in more recent units. By failing to disclose the flaw publicly, the company pre-empted a decision – whether to remove the flawed devices surgically – that should be made by doctors and patients.
With the company facing heightened scrutiny from regulators and a steady drumbeat of articles by Mr. Meier, Guidant has issued alerts or recalls on 20 models of defibrillators and pacemakers, comprising tens of thousands of devices in all. For the future, the company, the Food and Drug Administration, a heart rhythm medical society and the chairman of a Senate committee are all pondering ways to increase the flow of information on flaws in medical devices. It will be equally important to improve the monitoring of these devices after implantation. Their generally reliable performance must not obscure the fact that when they fail, the results can be catastrophic.
Copyright 2005 The New York Times Company Home Privacy Policy Search Corrections XML Help Contact Us Work for Us Back to Top
