Ensuring Safer Medical Devices
When a medical device is part of your treatment plan, it pays to pay attention to safety records and recalls.
There's no question that medical devices such as artificial joints and implanted defibrillators have improved the lives of countless patients worldwide. Unfortunately, the reverse is also true. Untold thousands have died or suffered after being fitted with medical devices that may have lacked effective testing before they went on sale.
You can find examples of problems on the Food and Drug Administration (FDA) list of device recalls for 2011 The roster includes more than three dozen entries, from soft contact lenses and catheters to blood sugar test strips and dialysis kits.
Case in Point
A recent example of a public health problem caused by the failure of a medical device involves the use of a metal-on-metal hip replacement design that was used in 100,000 patients. The FDA cleared the device for use in 2005 based on laboratory tests rather than clinical trials in patients.
Not long after doctors implanted the devices, they began to fail. About one in five had to be replaced after four years, and about half after six years.
In addition to undergoing two hip replacement surgeries, patients suffered from the movement of metal particles that entered nearby tissues as well as their bloodstreams.
In response to public safety concerns, in 2011 the FDA asked the Institute of Medicine (IOM) to analyze the process used to protect consumers from harm caused by medical devices.
An IOM committee found the review and approval process was flawed. The committee urged the FDA to develop procedures that would track and analyze medical devices before and after they go on sale to make sure they're safe and effective. The committee recommended the new system should:
- Be clear, fair, predictable, and science-based
- Support public health and innovation by approving medical devices quickly while monitoring their safety and effectiveness before and after they're implanted or prescribed
- Take patient risk into consideration
- Apply regulations and standards to devices to maintain patient safety
Enacting some of these recommendations would require legislation by Congress. Until then, you can increase your safety when medical devices are part of your treatment by following these recommendations:
- Stay informed. The websites that follow provide up-to-date safety and recall information on medical devices:
-FDA (www.fda.gov)-The FDA provides lots of information. For an updated list of medical device issues, search for "list of device recalls." You can sign up for email updates to learn of future problems. And there are links to medical devices by category, such as breast implants, defibrillators, and gastric banding. Search for "Resources for You (Medical Devices)," then click on "Consumers (Medical Devices)."
-ECRI Institute (www.mdsr.ecri.org)-This independent nonprofit group evaluates medical devices and procedures. Search for "Medical Device Safety Reports" and look at safety issues by specialty or hospital department.
- Learn about and take care of your medical device:
-Become familiar with all instructions regarding your device.
-Have emergency phone numbers for your doctor in case your device fails.
-Make sure your family and caregivers know about your device.
-Inform your doctor of any problems with your device so that corrective action can be taken.
By Barbara Floria, senior writer for Vitality. For more information, visit the Food and Drug Administration at www.fda.gov.
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