A new survey of U.S. consumers pits safety concerns against the need for product innovation, finding that the vast majority of respondents were more concerned about patient safety than about speeding devices to market.
Of 1,000 people polled, 82% responded that "preventing safety problems is more important than limiting safety testing in order to prevent delays and encourage innovation."
The survey, conducted by Consumers Union as part of its Safe Patient Project initiative, targeted medical device industry complaints that the FDA represents a major hindrance to companies hoping to bring new life-saving devices to the U.S. market and continued growth in the medical device industry.
More than 90% of those surveyed said that every medical implant should undergo clinical trials ahead of commercial use, even if the device is considered similar to something already on the market. More than 70% said implants should not be able to rely on predicates that have had safety issues or been recalled.
Poll results also showed that 17% of respondents had a medical implant, and nearly half reported that a close friend or family member had an implant.
"Our poll shows that Americans support common sense reforms that would help improve medical device oversight and keep patients safe," Safe Patient Project director Lisa McGiffert said in prepared remarks. "The vast majority of the public wants strict requirements that ensure new implants are safe and effective."
Consumers Union, the policy advocacy arm of Consumer Reports, has been a loud voice in the debate over medical device regulation. It’s targeting this poll at Congressional bills aimed at lessening the burden on device makers.
The group, which has been in the mix in recent regulatory discussions involving FDA user fees for the medical device industry and clearance status for Aptus Endosystems’ HeliFX endostapling system, wants the federal watchdog agency to require clinical testing for more medical devices.
"Recent problems with metal hip implants and surgical mesh have shown how our current system fails to ensure medical devices are safe and effective," Consumers Union senior policy analyst Lisa Swirsky said in prepared remarks. "Congress should recognize that the public is far more concerned about making sure devices are safe and work than how quickly they are made available."
