This week, Consumers Union issued a news release on a new Consumer Reports poll showing overwhelming public support for strong medical device safety oversight. The poll results come at a time when Congress is considering legislation that could weaken current safety standards that would make it easier for potentially unsafe devices to enter the market. Check out some of our poll coverage in Bloomberg BNA and The Consumerist.
The House Energy and Commerce Health Subcommittee’s draft bill would significantly weaken device safety oversight in favor of speedier device approvals and should be rejected by Congress. While the Senate Health, Education, Labor and Pensions Committee’s draft bill provides some additional protections for patients once devices are on the market, but it should be strengthened to require stricter safety testing of new implants and life sustaining devices.
The vast majority of medical devices do not have to undergo safety and efficacy tests before they are sold, or implanted in, us. Instead, the FDA is allowed to approve a new medical device based on whether it is similar to one already on the market, even if that older device has been recalled because of safety problems.
Yet, 82% of Americans believe that preventing safety problems is more important than limiting safety testing in order to prevent delays and encourage innovation.
91% of poll respondents said each implant should be safety tested before being sold even when similar implants were in use.
71% said that a new device should not be allowed to be sold based on its similarity to an existing implant that has a safety problem or has been recalled.
94% indicated that medical device makers should be required to do long-term monitoring of implants if there are safety concerns or problems with a particular device. Existing law gives the FDA only limited authority to require such long-term safety monitoring.
95% said that effective consumer protections for medical implants should include a nationwide system for tracking medical implants so patients can be notified about safety problems or recalls. No such system currently exists in the U.S. even though it was required by Congress’ previous reauthorization of the law.
66% indicated a high level of concern about safety decisions or recommendations made by expert committees that included doctors who had current financial relationships with medical device makers.
Consumers Union’s Safe Patient Project has called on Congress to require more rigorous safety testing before medical implants and life sustaining devices are allowed on the market and to establish a better system for monitoring devices after approval, including a national system for notifying doctors and patients when safety problems arise. For more details, see the Safe Patient Project’s Improve the Safety of Medical Devices fact sheet.
You can keep track of medical device safety news on our website. If you or someone you know has a medical device story to share, please take a moment to share it with us here. Your story will help us call attention to the issues that need to be addressed by Congress in order to improve medical device safety.