Growing from 6,000 companies in 1997, to 15,000 in 2006, medical device manufacturers are producing 100,000 products compared to 84,000 in 1997. With this new influx of products, the Center for Devices and Radiological Health (CDRH) has launched the Medical Device Postmarket Transformation Initiative, which will allow the FDA to identify, analyze and act on problems with medical devices more quickly, including alerting the public sooner of potential problems.
After completing a yearlong inventory in 2005, the CDRH found difficulties surrounding the reporting of problems, or adverse events, associated with the use of devices.
"Devices are increasing in complexity," says Dr. Daniel Schultz, director of CDRH, "and they are being miniaturized so that there's more technology in a tiny little device." Schultz cited implantable cardioverter defibrillators -- devices that are surgically placed in a patient to jump-start the heart when dangerous rhythms are detected-as an example of a device that has increased in memory capacity and shrunk in size over the past decade.
Additionally, manufacturers continue to modify devices to fit more features into smaller spaces, increasing the number of parts that can potentially fail. Also new technologies and stronger materials create longer -- lasting devices that remain in use for a decade or more, extending the time for problems to arise.
The CDRH has already begun to address postmarket device safety by planning postmarket studies of devices even before they are approved. The agency already requires manufacturers of certain devices, such as long-term implants, to continue studying the devices after they are on the market.
Some useful Web sites include:
Medical Device Postmarket Transformation Initiative:
Medical Device Information for Consumers:
New Device Approvals:
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