December 2007
Medical devices: Problems on the rise
Surgically implanting a device to help a damaged organ can seem like a great convenience--or even a lifesaver. Implanted infusion
pumps, for example, automatically deliver doses of drugs, replacing daily injections or pills. Tiny stents can be used to
prop open coronary arteries. But how well do medical devices work, and are they being given to the right patients?
We commissioned the nonprofit National Institute for Computer-Assisted Reporting to help analyze reports from the Food and Drug Administration's database of adverse events involving all types of medical devices. The reports are collected by the agency from such sources as manufacturers, hospitals, and health-care providers. While the reports list devices as "suspect" they do not prove they caused the adverse event.
Our analysis shows that reports of deaths linked to medical devices are at an all-time high, with 2,712 fatality reports in 2006, more than double the number in 1997. Reports of hospitalizations linked to those devices are also up since 1997, though the categories might overlap.
In September the FDA issued its own report for its fiscal year 2006, saying it had seen a 25 percent increase in adverse events linked to medical devices over FY 2005, including 2,830 deaths, 116,086 injuries, and 96,485 device malfunctions.
Heart devices were cited in a relatively high number of 2006 fatality reports in our analysis. They included some types of drug-eluting coronary stents, graft systems used to repair bulging arterial walls, and implantable cardioverter defibrillators.
Certain infusion pumps that deliver drugs were linked to reports of hospitalizations. And so were drug-eluting coronary stents, which some research has implicated in heart attacks and death when used "off-label," or in ways not approved by the FDA.
The agency "recognizes that the number of adverse-event reports is increasing," said a spokeswoman for the FDA by e-mail. She said that possible explanations include rapid industry growth, increasingly complex devices, and more-responsible reporting.
But our analysis suggests there might be more afoot. The fact that recalled devices were involved in significantly more adverse-event reports in 2005 and 2006 than in preceding years suggests that more problematic devices make it to market and might cause harm before being pulled. And most reports of devices linked to deaths in 2004 through 2006 involved complex "Class 3" devices, which are supposed to be the most tightly regulated, suggesting a need for more oversight. The FDA spokeswoman denied that there was a failure in the approval process and said that "adverse events are a natural consequence of device use."
Since the FDA and manufacturers don't track how many devices are in use overall, it's unclear how the growth in device use relates to the rise in adverse event reports.
"If these data reflect an actual increase in deaths from medical devices, then we need more strict regulation and quicker action on recalls," says Marvin M. Lipman, M.D., chief medical adviser for Consumers Union, publisher of Consumer Reports. Consumers Union has filed a friend of the court brief in a case before the U.S. Supreme Court regarding the liability of device manufacturers for adverse events.
WHAT YOU CAN DO
If your doctor recommends an implantable device, ask about its safety record and whether there are alternative treatments that might work as well. Consider getting a second opinion before going ahead with the implant.
If you currently have a device that's been linked to serious adverse events, ask your doctor what you should watch out for. If you experience a problem, ask your doctor to report it to the FDA. You can report problems yourself and keep abreast of safety alerts by going to the FDA's Web site.
We commissioned the nonprofit National Institute for Computer-Assisted Reporting to help analyze reports from the Food and Drug Administration's database of adverse events involving all types of medical devices. The reports are collected by the agency from such sources as manufacturers, hospitals, and health-care providers. While the reports list devices as "suspect" they do not prove they caused the adverse event.
Our analysis shows that reports of deaths linked to medical devices are at an all-time high, with 2,712 fatality reports in 2006, more than double the number in 1997. Reports of hospitalizations linked to those devices are also up since 1997, though the categories might overlap.
In September the FDA issued its own report for its fiscal year 2006, saying it had seen a 25 percent increase in adverse events linked to medical devices over FY 2005, including 2,830 deaths, 116,086 injuries, and 96,485 device malfunctions.
Heart devices were cited in a relatively high number of 2006 fatality reports in our analysis. They included some types of drug-eluting coronary stents, graft systems used to repair bulging arterial walls, and implantable cardioverter defibrillators.
Certain infusion pumps that deliver drugs were linked to reports of hospitalizations. And so were drug-eluting coronary stents, which some research has implicated in heart attacks and death when used "off-label," or in ways not approved by the FDA.
The agency "recognizes that the number of adverse-event reports is increasing," said a spokeswoman for the FDA by e-mail. She said that possible explanations include rapid industry growth, increasingly complex devices, and more-responsible reporting.
But our analysis suggests there might be more afoot. The fact that recalled devices were involved in significantly more adverse-event reports in 2005 and 2006 than in preceding years suggests that more problematic devices make it to market and might cause harm before being pulled. And most reports of devices linked to deaths in 2004 through 2006 involved complex "Class 3" devices, which are supposed to be the most tightly regulated, suggesting a need for more oversight. The FDA spokeswoman denied that there was a failure in the approval process and said that "adverse events are a natural consequence of device use."
Since the FDA and manufacturers don't track how many devices are in use overall, it's unclear how the growth in device use relates to the rise in adverse event reports.
"If these data reflect an actual increase in deaths from medical devices, then we need more strict regulation and quicker action on recalls," says Marvin M. Lipman, M.D., chief medical adviser for Consumers Union, publisher of Consumer Reports. Consumers Union has filed a friend of the court brief in a case before the U.S. Supreme Court regarding the liability of device manufacturers for adverse events.
WHAT YOU CAN DO
If your doctor recommends an implantable device, ask about its safety record and whether there are alternative treatments that might work as well. Consider getting a second opinion before going ahead with the implant.
If you currently have a device that's been linked to serious adverse events, ask your doctor what you should watch out for. If you experience a problem, ask your doctor to report it to the FDA. You can report problems yourself and keep abreast of safety alerts by going to the FDA's Web site.
