CDRH Considers Internet Forum To Aid Device Safety Surveillance

From the September 10, 2007, issue of "The Gray Sheet"

FDA's device center is assessing whether an online forum for physicians can help with its postmarket surveillance challenges.

Sermo, which calls itself the nation's largest online physician community, said Sept. 5 that it has signed an "evaluation agreement" with CDRH, allowing the center to temporarily access its content.

The company will work with FDA "to explore opportunities and introduce new ways in which physicians can become efficiently involved in the surveillance of medical product safety," said Alex Frost, Sermo VP-research initiatives.

The agreement allows the center to "take time and kind of kick the tires, try out different things and see what kind of value can be derived," Frost said.

Cambridge, Mass.-based Sermo says about 30,000 physicians in the United States actively participate in the community, launched a year ago. Bona fide physicians can join the Sermo community for free. The company plans to aggregate information from the community discussions and sell it to clients.

On the Sermo site, doctors make "observations from their daily practice and then - rapidly and in large numbers - challenge or corroborate each others' opinions, accelerating the emergence of trends and new insights on medications, devices and treatments," according to Sermo's Web site.

The site allows doctors to interact in linear discussion threads broken down by topics (initiated by members) and also lets them formulate quantitative survey questions to "provide insights into the bottom-line opinion ... of the practicing community," Frost said.

So, for instance, during a discussion about a certain type of adverse event, a participant could send out a survey question like "have you seen a similar issue" and the system will tabulate the results, he explained.

"The end result is not only a lot of discussion around the detail of these issues, but ... could be a simple poll that has 300 physicians responding and 72% saying they have actually seen similar cases in the last six months."

CDRH's stated top priority for the past two years has been to reform its postmarket activities and, in particular, to improve the quality of the data it receives on product safety.

Device adverse event reports to FDA are rapidly on the rise, with nearly 326,000 reports of device-associated injuries, deaths and malfunctions in 2006 - a 77% increase over 2005 ("The Gray Sheet" Aug. 27, 2007, p. 10).

CDRH has acknowledged that it lacks the capability to make complete sense of all the information.

Precisely how Sermo could be incorporated into the postmarket surveillance infrastructure of CDRH, or possibly FDA as a whole, remains to be seen. The agency did not respond to a request for comment on the issue.

Frost gave a presentation to the agency on Sermo in March during a public meeting on FDA's Sentinel Network initiative - an effort to create an integrated postmarket data network linking public- and private-sector information ("The Gray Sheet" March 12, 2007, p. 15).

In addition to playing a role in that broader project, the online community might complement the center's Medical Device Safety Network, a pilot program that has recruited and trained about 400 clinical facilities to actively report adverse events, be available for follow-up questions from FDA, and offer insights into quality improvements made at their facilities.

Frost says the Sermo system definitely has the potential to augment the agency's primarily passive safety surveillance system. He also said it can help with "signal-to-noise clarification."

If a safety issue arises, Sermo would allow FDA "to go out and ask in conversation format to physicians around the country, 'Hey, are you seeing this too,'" Frost explained. He added that because of the potential for communication in "both directions," the Web offers the potential to help out with one of the center's other postmarket priorities - improving communication of product risks and recalls to the medical community.

- David Filmore

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