Industry News
Erik Swain
US FDA in January unveiled a new programme transforming the way it monitors the safety of medical devices once they reach the market. The Postmarket Transformation Initiative aims to identify, analyze, and respond to problems in the field more quickly. It also intends to alert the public faster to potential problems concerning devices.
“With this initiative, FDA intends to improve the way it monitors the safety of medical devices and provide a strong safety net to protect the public health,” says Daniel Schultz, director of the Center for Devices and Radiological Health (CDRH).
The agency’s postmarket surveillance practices had come under intense criticism in the past year. At first, the focus of the complaints was on drugs, but attention shifted to CDRH after problems with Guidant Corp.’s (Indianapolis, IN, USA) internal cardioverter defibrillators were revealed.
Efforts to devise an electronic reporting system for adverse device events and to improve device information in patient records are at the core of the initiative. CDRH will also reform how it collaborates internally on postmarket safety issues. This began last year when it shifted responsibility for monitoring postmarket clinical studies to the Office of Surveillance and Biometrics.
CDRH also pledged to work with industry and clinicians to identify opportunities to improve the safety of devices. And it promised to come up with unique ways to identify devices, to make it easier to recognize problems mentioned in reports.
“Over the next decade, medical technology innovations will fundamentally transform the healthcare and delivery system, providing new solutions with medical devices that will challenge existing paradigms and revolutionize the way treatments are administered,” says Scott Gottlieb, MD. He is FDA’s deputy commissioner for medical and scientific affairs. “Under the leadership of [CDRH’s] expert staff, we are working to develop even better ways to evaluate new technologies to maximize benefits and minimize risk, including ways to develop more-effective postmarket systems that can support safer medical practices as well as continued innovation.”
The initiative came about after a yearlong investigation of the tools CDRH uses to monitor postmarket safety. Senior FDA management and several consultants have been tapped to guide its implementation.
The investigation produced four recommendations for action. The first is to develop a “culture of collaboration” on postmarket safety within CDRH. Factors that enhance and inhibit collaboration will be identified. The use of external experts will also be considered.
The second is to develop world-class data sources and systems. The center will champion a global standardized nomenclature system, and suggest incentives for system users. It will partner with the Centers for Medicare and Medicaid Services and other agencies to obtain population-based data. It will incorporate literature references and media reports into its adverse-event gathering process. And it will develop strategies to get better postmarket information out of industry.
The third is to enhance risk/benefit communications. CDRH will assess the communication tools it has and make improvements where needed. It will also ensure that all staff knows how to use these tools.
The fourth is to improve enforcement strategies. Current enforcement procedures will be evaluated as to how they affect postmarket issues, and improvements will be made where necessary.
More information about the initiative can be found at www.fda.gov/cdrh/postmarket/mdpi.html.
