From the Editors
FDA has been under fire recently for safety problems with medical devices already on the market. When big device companies like Guidant make headlines with serious safety issues, everyone takes notice—especially FDA.
So it is none too soon that FDA has launched a new program to “transform and strengthen medical device safety.” CDRH says that its “Postmarket Transformation Initiative” will allow the agency to identify and act on problems more quickly, including alerting the public sooner.
“With this initiative, FDA intends to improve the way it monitors the safety of medical devices and provide a strong safety net to protect public health,” said CDRH director Daniel Schultz, MD, in a press release.
The new program has three key components: postmarket problem identification, problem assessment, and public health response. Problem identification will use the medical device reporting system and reports from hospitals to gather information. Teams of FDA staffers and consultants will analyze those data and determine the nature and magnitude of each problem. CDRH will then set in motion the public health response with tools ranging from urgent alerts and media outreach to enforcement actions.
FDA undertook the initiative after a “year-long internal inventory” of the tools it was using to monitor the safety of medical devices once they were approved. The inventory considered how the agency identifies postmarket problems and how it assesses the information obtained. It also evaluated how FDA responds to that information through both stakeholder communication and through enforcement action.
The team heading the program will consist of senior-level FDA management and consultants who are “experienced in device safety and regulation,” according to FDA. The team's first order of business is to review the agency's 77-page report, “Ensuring the Safety of Marketed Medical Devices: CDRH's Medical Device Postmarket Safety Program.” FDA says the team is expected to have recommendations for improvement within four months. According to the report, the team will help the agency shift to a culture that places more emphasis on the importance of postmarket efforts. The team is tasked with improving collaboration—both internally and with industry— to solve postmarket problems. Specific areas that the team will focus on include
• Developing an electronic reporting system for adverse medical device events.
• Exploring unique ways to identify medical devices.
• Improving device information in patient records.
• Improving internal collaboration on postmarket safety issues.
• Improving safety through collaboration with industry.
The team will determine the factors that enhance or hinder collaboration within CDRH, particularly between premarket and postmarket activities, the report says.
This program looks great on paper—and it may help deflect some of the recent heat from FDA if it actually generates tangible improvements. The key is for FDA to focus on the objectives and avoid getting mired in bureaucracy.