U.S. FDA Says It's Improving Post-market Device Checks

CLEVELAND (Reuters) - U.S. regulators are working to improve their post-approval tracking of safety problems with medical devices and to inform the public of risks more quickly, a Food and Drug Administration official said on Tuesday.

"We must do more than ever to monitor the performance of (device) products after they are approved, and make sure that we are quickly discovering and sharing information about problems that do arise," said Dr. Scott Gottlieb, FDA deputy commissioner for medical and scientific affairs.

The safety of medical devices has been in the spotlight in recent months after Guidant Corp. disclosed various problems with implanted heart devices that could cause them to malfunction. A 21-year-old college student died when a Guidant implanted defibrillator short-circuited.

Speaking at the Cleveland Clinic's Medical Innovation Summit, Gottlieb said medical devices had become "smaller, hardier and more sophisticated. This sometimes also means that there is more opportunity for small errors to have bigger consequences."

"This means we need to be looking harder, after devices and engineering changes are approved, for new potential problems with their performance," he said.

The FDA is "focusing more attention on the kinds of systems and processes we have in place to monitor products after they are approved," he said.

Officials are taking several steps to improve post-market monitoring, including moving toward getting "real time" data from hospital and lab networks that have agreed to supply information, he said.

The agency also is changing internal procedures for reviewing and analyzing data, and planning to issue guidelines to improve the format for submitting information so it's easier to review, he said.

An advisory panel of doctors also may be created to review post-approval data and provide recommendations to the FDA, he said.

Gottlieb said the agency was "mindful that we depend on product developers to collect this information and to help analyze it" and that officials did not want to impose "unnecessary costs or time delays on the development of potentially lifesaving new medical products."

Steve Ubl, president of the Advanced Medical Technology Association, said the device industry would work with the FDA to improve post-market surveillance.

"The FDA has broad post-market authority today, but there is a need for fine-tuning," he said.

The efforts to strengthen device monitoring follow several steps the FDA has taken to more closely watch prescription drugs after approval, a move that gained steam after Merck & Co. Inc. withdrew its arthritis pill Vioxx in September 2004.