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Should the FDA regulate medical devices more stringently?

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  • Liz

    The FDA also needs to make the process of submitting an adverse effect on a product easier to fill out, since the Doctors or the Hospitals are NOT required to do so, it is left to the injured individual to do this. The numbers for a defective device would be a lot higher, if people were able to easily fill out these FDA forms.

  • http://www.facebook.com/dawn.rasmusbrown Dawn Rasmus-Brown

    The FDA needs to recall all medical devices if their 510(K) original device is recalled !!!!!

  • Jan

    Funding for the FDA is not sufficient to protect U.S. citizens–to the extent we want to be protected–from dangerous medical devices, drugs or food. Also, the “revolving door” that exists between food and drug companies and FDA administrators means that we often don’t get unbiased decisions from these officials. Both of these areas need to be addressed before we can expect quality decisions from this agency. Till then, buyer beware!

  • http://www.facebook.com/people/Kathy-Day/100000711671956 Kathy Day

    Didn’t we all assume they did? I assumed that until I learned from my friend Joleen Chambers and others from the Consumers Union. Without strict regulation, we are all guinea pigs for the industry.

  • Bruce Ramshaw

    This is much more complex than a yes or no answer. I have presented to the FDA several times about a group of medical devices (hernia mesh) that is causing harm in a sub-population of people. They were all approved through the 510(K) process. But, these same devices have helped many more people than they have harmed. If they were taken off of the market, many people would suffer. The question is not should the the FDA be more stringent. The question is how we should all work together to apply the principles of complexity science to learn which people should receive which treatments and which sub-populations of people will be harmed by which treatments and which devices. This is a post-market real-world need that I believe is necessary for a sustainable healthcare system. This science was applied to the consumer food industry decades ago (see Malcolm Gladwell’s TED talk about spaghetti sauce). It is time that we apply this science in healthcare or we will continue to get the results the system is currently producing.

  • K5r4

    correct to an extent because congress is not providing enough funding to the regulatory agency so it can hire enough inspectors.

  • k5r4

    True, but many Americans would consider that as a rationing of healthcare.

  • Bruce Ramshaw

    When it is done by government or “expert” committee as a global mandate it is. When it is done in a shared decision process with the patient ultimately making an informed decision, with data generated locally through the principles of clinical quality improvement data collection (transparent outcomes based on value for the patient), then it is just the right thing to do.

  • Betty B.

    Dr.’s and hospitals should be required to submit adverse event reports. Then the real “damages” could be shown. Relying on injured patients who just have a hard time sitting or even getting out of bed is ridiculous. There should also be strict fines enforcing them to honestly report the event without prejudice.

  • http://www.facebook.com/gwen.marshall.75 Gwen Marshall

    All drugs adverse reactions also need to be better tracked. My mother suffered from multiple mini strokes from Aricept and now they know that no one with low blood presssure should ever be on that drug.