FDA Briefing Addresses Problems in Postmarket Medical Device Surveillance System
FDA officials on Thursday held a "rare media briefing" to detail "problems they face in monitoring" medical devices after they have been approved, the Minneapolis Star Tribune reports.
Daniel Schultz, director of the FDA Center for Devices and Radiological Health, said the center has been challenged by the growth in the medical device industry, the complexity of devices, their increasing popularity and the competing interests of safety and approving new technology that could benefit patients. "As we approve more and more products with more and more technological complexities, basically there's less margin for error," he said, adding, "I think that's sort of one of the lessons that we learned" from the recent problems with Guidant.
Minnesota-based Guidant in the past year has recalled an estimated 300,000 implantable cardioverter defibrillators because of the possibility that the devices could malfunction. According to the Star Tribune, the doctors of an ICD patient who died "went public with their concerns" after learning that Guidant was aware of the possibility of malfunction "but did not notify physicians and patients about the potential problem."
In the briefing on Thursday, Schultz said, "We need to be even more vigilant, if that's possible, in terms of how we monitor these devices once they get to market." He added that FDA is working to improve its efforts to communicate with the public but said that the agency faces some difficulty because of patient privacy concerns, regulatory or criminal issues that have not yet been made public, and preserving trade secrets. Schultz said, "We recognize that one of our biggest challenges is in terms of providing useful information, and we understand that a lot of the concerns that have been raised over the course of the last few months to a year is with regard to the information that we present -- the quantity of the information and the timeliness of that information."
In response to the problems with Guidant, FDA's CDRH recently announced a plan to improve the agency's ability to identify, analyze and act on postmarket safety data (Blake, Minneapolis Star Tribune, 2/3). Under the "Postmarket Transformation Initiative" the agency said it will develop an electronic reporting system for adverse reactions, standardize the identification process, obtain the medical records of patients who use the devices and increase communication with professional organizations and the medical device industry (California Healthline, 1/23).
Speaking on Thursday, Susan Gardner, director of CDRH's Office of Surveillance and Biometrics, said the initiative has established its agenda for gathering information and plans to submit recommendations in the next four or five months. Schultz said, "Our priority for the next year, or however long it takes, is to try to make sure that we have a postmarket safety net that is equal to our premarket review process" (Minneapolis Star Tribune, 2/3).