Originally Published MDDI September 2005
|“MedSun isn't really the key basis for postmarket safety.” —Jonathan Kahan|
An Internet-based FDA surveillance program is currently being reevaluated to see how reporting can be improved. Contrary to a published report, the agency says it has no plans to halt the program before it is fully implemented.
The Medical Product Surveillance Network (MedSun) allows user facilities to report problems with devices via the Internet. When the pilot program began in 2002, the agency set an initial goal to connect to 500 hospitals. In July, the Boston Globe reported that FDA had frozen the project at 350 facilities.
Marilyn Flack, MedSun project officer for FDA, says this isn't the case. “We haven't halted the program.” Rather, the agency is doing a “prudent review,” says Flack, a senior public health analyst.
Upon reaching 350 hospitals, the MedSun project team realized that they weren't fully tapping into the current sites. The agency decided to focus on improving reporting at these facilities, rather than try to recruit more in the coming year. The program already has more than 3000 reports from the group of hospitals enrolled.
“It seemed prudent to stop and take a look,” says Flack. “We need to learn from what we have right now before we push bigger.” MedSun has developed specific educational materials and is targeting reporting in operating rooms and labs at the current sites. Funding is expected to remain the same.
In the next fiscal year, one of MedSun's goals is to replace hospitals that aren't reporting with active participants. A few more sites will probably join, including pediatric hospitals. Flack also wants to target surveillance of specific devices at the hospitals.
The review of the program isn't expected to hinder safety monitoring either. Companies can provide information to FDA through the medical device reporting mechanism or the corrections and removals regulation.
“[MedSun is] an interesting approach with the hospitals but isn't really the key basis for evaluating postmarket safety,” says Jonathan Kahan, partner at Hogan & Hartson LLP (Washington, DC). “I'd rather see them make the MDR program much more streamlined and important.”
The 500-hospital goal is not considered all that important, says Flack. “We really didn't have a good way of picking a number,” she says. “We thought we could handle about 500 facilities. In the beginning, we could've easily said that 200 hospitals are all we could handle.”
Copyright ©2005 Medical Device & Diagnostic Industry