Update: 2012 Medical devices safety law pros and cons

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Medical devices are much more loosely regulated when it comes to safety than prescription drugs. Which is why this year Consumers Union launched a major campaign to make implants safer. Tens of thousands of you added your voices and pressured Congress for improvements. While we failed to close some of the major loopholes – due in part to intense lobbying from the medical device industry — we did have some incremental victories in the bipartisan bill that was singed into law in July by President Obama:

  • Within six months, regulations are due out that will require implants and high-risk devices carry a unique identifier so if there a safety problem arises, patients can be quickly notified. Once these regs are out, the FDA has two years to get them in place (granted, this may seem like a long time, but prior to this bill no action had been taken to require identifiers be used, despite being on the books).  You can read the proposed rule and submit your comments to the government here.
  •  Requires makers of medical devices pay more in ‘user fees’ which help cover the government’s cost of reviewing them for safety and clearing them for sale. With more implants coming on the market, the FDA has lacked adequate funding.  Makes it easier and quicker for the FDA to reclassify problem implants that have caused serious harm to patients so similar device applications in the future will require more scrutiny. On the down-side, this also allows FDA to more quickly down-classify devices, which could place certain future implants under LESS scrutiny than before.
  • Allows FDA to put a hold on the approval of risky clinical trials that could cause harm to the study participants or for other reasons established by FDA regulation.
  • Offers loose deadlines for when companies have to begin safety studies of their products already on the market. In the past, many of these studies have been delayed for long periods of time, during which problem devices continue to be implanted into patients.

What the new law doesn’t do, but should:

  • Stop allowing approval of new devices based on their similarity to products that have been recalled for safety problems. While this seems like a no-brainer, we could not close this safety loophole in Congress, despite taking out an ad, having patient safety advocates call attention to this problem, and detailed stories from Consumer Reports about this other safety issues.
  • Don’t let people with financial conflicts of interest be on advisory panels that decide which drugs and devices are to be approved for market. The new law allows those with conflicts to serve as long as a public report on members’ conflicts is made, and the FDA does more outreach to find committee members without conflicts.
  • Require clinical safety testing for medical implants before they are put on the market. Currently, too many implants are cleared for sale through the FDA’s 510(k) pathway, which doesn’t require necessary safety testing.

ConsumersUnionwill continue to work on making implants safer for you. We recently participated in hearings about the safety of metal-on-metal implants after the FDA has received at least 17,000 reports of adverse events with these products. Despite much testimony from doctors that these implants should not be used, the advisory panel failed to recommend to the FDA that it stop allowing their use.

And just last week, two members of Congress sent a letter to the FDA requesting that the agency remove the loophole that allows recalled devices be used as the basis for allowing similar devices onto the market. The letter also asks the FDA to update its database of 510(k) cleared devices to show which ones have been recalled due to safety flaws and which ones were approved based on their substantial equivalence to a device that was recalled.

With your help, we will continue to speak out for safer medical devices and make sure you have the latest information on emerging safety issues – so you can live a happier, and longer, life.