The Food and Drug Administration has announced that it is taking steps to improve its postmarketing surveillance of medical device safety, including moving ahead on a proposal to require electronic reporting of adverse events.
The agency said it has created an action plan based on a major review that was completed in 2005. That review looked at how the Center for Radiological Devices and Health (CDRH) handles recalls and enforcement actions against manufacturers that are not in compliance with FDA rules.
The report “details a number of action items that we believe will transform the postmarketing safety program,” Dr. Daniel Schultz, director of CDRH, said in a briefing with reporters.
The FDA will focus on improvements in four major areas: collaboration among experts within CDRH, data systems, communications with patients and physicians about risks and benefits, and enforcement.
CDRH leaders will encourage more cross-organizational collaboration so premarket, postmarket, and enforcement efforts are better coordinated, he said.
Some of the biggest changes will come in data collection and analysis. The agency hopes to integrate its passive adverse events reporting system (Manufacturer and User Facility Device Experience Database, also known as MAUDE) and its active system, the Medical Product Safety Device Network (MedSun), Dr. Schultz said. Currently, 350 hospitals have been trained to report device problems on MedSun. One goal is to recruit more facilities and upgrade reporting so it is closer to real-time.
The agency also hopes to require manufacturers and others to electronically report adverse events. Currently, FDA receives about 200,000 reports to MAUDE each year, and most are on paper, which delays entry into the system and analysis for safety signals, Dr. Schultz said. The FDA has been piloting an electronic reporting program, and is writing a rule to require electronic reporting, he said.
Once data are being reported and analyzed more quickly, enforcement will be more timely also. This will let the FDA focus enforcement efforts on the highest-risk products, Dr. Schultz said.