Poll: Public In Favor of Increased Medical Device Regulation

A poll commissioned by industry watchdog group Consumer Reports indicates the vast majority of consumers are in favor of a risk-averse regulatory framework for medical devices, giving ammunition to the group at a time when it is seeking to influence the debate over the reauthorization of the Medical Device User Fee Act.

Consumers Union has taken the position that medical devices-particularly those cleared through the US Food and Drug Administration's (FDA) 510(k) pathway-are not proven to be sufficiently safe, to the detriment of patients.

"Recent problems with metal hip implants and surgical mesh have shown how our current system fails to ensure medical devices are safe and effective," said Lisa Swirsky, senior policy analyst for Consumers Union, in a press statement.

Among the findings of the Consumers Union poll (1,000 respondents, +/- 3%, 95% C.I.):

• eighty-two percent of respondents prioritized safety over the promotion of innovation and the mitigation of delays
• ninety-five percent of respondents expressed favor at the idea of a nationwide system for tracking medical device implants
• sixty-six percent of respondents expressed concern about conflicts of interest within expert advisory committees used by FDA
• ninety-one percent of respondents believed all medical device implants should be tested before marketing approval
• ninety-four percent of respondents indicated medical devices that are the subject of safety concerns should be subject to long-term monitoring
• seventy-one percent of respondents did not believe substantial equivalence was sufficient to ensure medical device safety                

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