Saturday, September 17, 2005

More Concerns About Delayed Reporting of Faulty Medical Devices

We have posted about a series of stories suggesting that manufacturers of implantable cardiac defibrillators (ICDs) and the US Food and Drug Administration (FDA) were slow to warn the public about serious defects in these devices that lead to premature device failure.
As stories of failing ICDs have received more attention, more editorials are calling for improved behavior by device manufacturers and a revamp of how the FDA regulates these devices.
The Indianapolis Star stated its editorial position, "medical device makers need to better disclose malfunctions to doctors and the public."
The St. Petersburg Times charged that "the Food and Drug Administration once again has demonstrated a level of incompetence that threatens public health." Already, "Americans have lost faith in the FDA for the agency's lax policing of prescription drugs and failure to share information about drug safety with consumers. This episode makes the government look inept even if it wanted to be more responsive." So Congress "needs to reform an agnecy that serves as a critical watchdog for Americans."
And just to add more fuel to the fire, the FDA just released a report that the failure rate of ICDs is increasing. According to the Washington Post, "in the mid-1990s, some 7.9 ICDs per 1000 implants were replaced because of malfunctions. That rose to a high of 38.6 per 1000 implants in 2001 before dropping slightly to a rate of 20.7 the following year. " Of these failures, "eighty percent were device hardware problems, such as with electrical connections."
Again, physicians and patients need accurate data about benefits and harms of treatments, especially expensive, invasive treatments that are meant to prevent future problems, not immediately treat disease, like ICDs. Information that such devices fail more frequently in clinical use than they did in controlled trials performed in ideal conditions is important in the clinical decision-making process. Neither the financial self-interest of device manufacturers nor the bureaucracy of government regulatory agencies should keep this information from doctors and the public.

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