FDA Tries To Improve Device Monitoring

January 26, 2006–ConsumerAffairs.com–Stung by criticism that it was slow to detect problems in Guidant’s heart devices, the Food and Drug Administration says it is launching a new program to transform and strengthen the way it monitors the safety of medical devices after they reach the market — both new technology and existing products. In June 2005 the FDA recalled implantable defibrillators made by the Guidant Corporation, but only after the company announced a problem. The device has failed in at least 26 cases and is suspected in two deaths, including a college student who died in March 2005. Guidant admitted that it had known about the defect for three years, but only notified doctors in May 2005 after it became aware that The New York Times was about to publish a story about the problems with the device.

The FDA then issued a recall but allowed the resumption of device sales after assurances the problem had been corrected. However, at the end of last year, the FDA issued a stern letter to Guidant, expressing doubt that the defect had been completely corrected. It said that would likely result in restrictions on its ability to bring new heart devices to the market. In establishing the FDA Center for Devices and Radiological Health’s (CDRH) Postmarket Transformation Initiative, the agency said it will better protect the public health by being able to identify, analyze and act on problems more quickly, including alerting the public sooner of potential medical device issues.

“Over the next decade, medical technology innovations will fundamentally transform the health care and delivery system, providing new solutions with medical devices that will challenge existing paradigms and revolutionize the way treatments are administered,” said Dr. Scott Gottlieb, FDA’s Deputy Commissioner for Medical and Scientific Affairs. “Under the leadership of our device center’s expert staff, we are working to develop even better ways to evaluate new technologies to maximize benefits and minimize risk, including more efficient ways to develop more effective post-market systems that can support safer medical practices as well as continued innovation.”

The FDA said it undertook this initiative after a comprehensive, year-long internal inventory of the tools used to monitor the safety of medical devices after they are approved.