It was a case of good and bad — last week the Senate passed legislation to oversee medical device safety, and while Senators agreed to increase fees to help fund some safety oversight, they missed the opportunity to include important medical device safety provisions that thousands of activists helped support.
This week, the House passed their own version of the legislation, which also failed to include these critical patient safety provisions that Consumers Union has urged Congress to adopt. To make matters worse, the House bill left out some of the good provisions included in the Senate package.
The debate over FDA oversight has been the subject of intense industry lobbying, and the lobbyists managed to block efforts to require device makers to make sure high-risk devices undergo clinical safety testing before they’re put on the market. Given high profile safety failures with complex medical implants, Congress should be strengthening the FDA’s ability to oversee this industry.
Naturally, we are disappointed that these bills failed to include the patient safety measures we think are essential. But we are grateful that Senator Harkin, Chairman of the Senate Health, Education, Labor and Pensions Committee, and his staff, worked diligently to keep the Senate bill from including things that are outright offensive to consumers – a tall order given the money and omnipresence of the medical device lobby in Congress over the past year.
It’s clear that our current system for approving medical devices has significant safety gaps. More than 90 percent of medical devices do not require clinical testing before the FDA clears them for sale. Instead, the FDA clears these devices through its fast track 510(k) process based on whether they are “substantially equivalent” to devices that are already on the market.
By law, the FDA can only consider whether the new device is similar to one already being sold and no evidence of clinical testing is required – even when the device it is based on has been recalled by the manufacturer due to safety problems. We thought this practice was so ridiculous that we placed an ad in Politico to call attention to it.
Consumers Union and other consumer and public health organizations have pushed for an amendment that would provide FDA with the authority to reject new devices based on their similarity to devices recalled by the manufacturer for safety. At the very least, the FDA should have the authority to require manufacturers to prove they have fixed the safety flaw, which it currently does not have.
Along with other consumer groups, we have had the help of a number of patient safety activists, many who have suffered harm from a medical device. Their contribution to the debate on this issue has been invaluable.
While we have been able to raise the profile of medical device safety problems with lawmakers and the media, we still have a lot of work to do. It may take another 5 years before we can remind Congress to close the absurd safety loophole that allows new devices to be cleared for sale based on recalled devices. Do you have any ideas for how medical devices safety could be improved? Leave a comment below.