Believe It Or Not, People Want More Oversight Of Implanted Medical Devices

It seems almost silly to think that anyone would want to scale back the amount of regulatory control on the safety of medical devices, and a new poll shows that an overwhelming number of Americans believe in strong oversight of these products. Yet members of the House and Senate are considering legislation that could allow potentially unsafe items to hit the market.

Congress is currently going through the process of reauthorizing the statute governing the approval of medical devices. The laws on the books allow the FDA to approve a new medical device if it is similar to an existing, previously approved device, even if that older device has been recalled because of safety problems. This means that fewer than 1% of new devices go through the FDA’s strenuous Pre-Market Approval process.

And the draft legislation put together by the House Energy and Commerce Health Subcommittee would actually allow the approval process to go even faster. The Senate Health, Education, Labor and Pensions Committee’s draft bill does provide some additional protections for patients once devices are on the market, but does nothing new to prevent potentially unsafe medical devices from being sold in the first place.

But according to a new poll by our publishing pals Consumer Reports, 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.

Industry lobbyists have been pushing lawmakers to weaken current rules designed to prevent such conflicts of interest. The Senate and House discussion drafts remove current caps on the percentage of expert committee members that can be granted waivers if they have a conflict of interest, a provision championed by consumer advocates five years ago.

“Recent problems with metal hip implants and surgical mesh have shown how our current system fails to ensure medical devices are safe and effective,” said Lisa Swirsky, senior policy analyst for Consumers Union. “Unfortunately, the House bill weakens current standards to speed up device approvals rather than improving safety oversight. The Senate bill offers some improvements but it should be strengthened to require stricter safety testing of new implants and life sustaining devices. 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.”

“Our poll shows that Americans support common sense reforms that would help improve medical device oversight and keep patients safe,” said Lisa McGiffert, director of Consumers Union’s Safe Patient Project. “The vast majority of the public wants strict requirements that ensure new implants are safe and effective.”

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.

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  1. crispyduck13 says:

    I’ll never understand why we allow our country to be led around by “industry lobbyists” when their goals are often the exact opposite of the American people’s.

  2. AustinTXProgrammer says:

    Are talking about all medical devices or just implantable? Right now they have it so regulated the bassinets in a hospital nursery are regulated as medical devices.

    • FatLynn says:

      Yup. I once did some regulatory testing for a manufacturer, and when we wanted to sell our wheelchairs with different color vinyl, I had to do about 2 weeks worth of testing/paperwork.

      • AustinTXProgrammer says:

        I was asking if the poll of people was all devices. Medicine is the most regulated industry in our country. It is also the most expensive. While regulation isn’t the sole cause you know there is a connection

        • FatLynn says:

          Right, I’m agreeing that asking lay people about “medical devices” may or may not mean anything.

          As you point out, that may include a huge number of things, in FDA terms, that the average person wouldn’t consider. I am further pointing out that requiring testing of “similar” devices (as the first question asks), depends on what “similar” means. Are you talking about a material difference in form or function, or a cosmetic change.

          I am, in general, for regulation, and I don’t believe in letting industries police themselves, but I don’t think that “Joe off the street” should be the one to decide what is appropriate, especially when I think Joe would change his mind if he saw examples of what he is really being asked.

  3. TuxthePenguin says:

    “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.”

    Sorry, that just scares the crap out of me. That essentially allows anyone with access to that database to know with a great deal of accuracy what the medical condition its treating.

  4. voogru says:

    And people wonder why health care costs are skyrocketing.

  5. StarKillerX says:

    Yeah, people want years and years of drug safety testing before they are sold on the market also, although that’s only until they hear of something that looks promising that is stuck in testing in the US years after it’s been on the market overseas.

    The problems with polls like this is that it’s all a matter of wording, which of course these companies know this and use it to prove whatever point they wish to make.

    • voogru says:

      More people die from waiting for good drugs to be approved in the United States, than the amount of ‘lives saved’ from preventing bad drugs to get on the market.

      The FDA has a bias, if they approve a drug and it was bad, they get pulled into Congress. If they don’t approve a drug and more people die because they can’t get it, nobody says a thing.

      • TuxthePenguin says:

        Exactly. I’ve always wondered why we don’t have “approved” drugs and “experimental” drugs. Why can’t someone who is terminal with current medication opt into taking a drug that hasn’t been approved yet? Heck, anyone, if they sign a waiver that “Yes, this drug is not approved but I want to risk it anyway.”

        • voogru says:

          Because it would destroy the profit margins of big pharma if anyone could make experimental drugs.

          If you are a small time university researcher and you find a cure for cancer you will never be able to allowed to market it because you won’t have the six hundred million dollars you need for FDA approval. And big pharma won’t want it cause it will destroy profit margins in other things.

          • Bsamm09 says:

            So if someone found a cure for cancer there wouldn’t be a group of investors anywhere who would come up with the money to fund FDA testing? What about those drug company CEOs who were fired and paid large sums in golden parachutes? They wouldn’t want to stick it to their old companies by coming out with their own company that would put them out of business? I thought they were evil.

            I’m sure if someone found a cure for cancer, there would be people lining up to invest and bring the drug to market. They wouldn’t care if it brought down big pharma. They would be paid handsomely and to hell with any other companies in the industry.

            • voogru says:

              “So if someone found a cure for cancer there wouldn’t be a group of investors anywhere who would come up with the money to fund FDA testing?”

              The profits they might make from a cancer cure would destroy their far higher profits in the way cancer is currently dealt with.

              A cure for cancer would be a one time thing. Why have a cure when you can just make them dependant on you for the rest of your life? Much more money in that.

              This nonsense only happens because the FDA is basically captured by the drug companies.

              Regulatory capture. Look it up.

              • unpolloloco says:

                Then find a different group of investors…

                • voogru says:

                  Because investors are going to risk their capital when they know that the deck is stacked against them, even if their investment turns out to be a success they can still get shot down by the government regulator who is controlled by… their competitors.

              • Firethorn says:

                Hmm…. Let’s take this cure for cancer:
                1. ‘Cancer’ is actually a couple thousand different related conditions.
                2. Even ‘evil’ CEOs get cancer. You’d think they’d be interested in their own health.
                3. Cancer isn’t a ‘one time’ deal if you survive it – people today are often surviving 3-4 bouts of it. It’s a bit like the flu shot that way. Each flu shot ideally makes you immune to 3 strains. There are hundreds out in the wild. Ergo, one shot a year, and you’re actually less likely to get the flu if you’ve had the last 3-5 shots, than just one. More strains are covered.
                4. European countries(and the rest of the world) would be very interested in a cure for cancer, seeing as how they’re not as tied to the pharmaceutical industry. They should be able to afford to look for the economical cures that American commercial interests theoretically aren’t interested in. I wonder why we don’t hear about loads of drugs approved for use over in Europe but not here? Why there aren’t senate hearings about European wonder drugs that aren’t allowed over here?
                5. Curing cancer is tough, because the cancer cells are still ours. They’re so similar that targeting just cancer cells is extremely difficult.

                Back on the OP – I want a certain amount of oversight, but let’s face it. If a medical device has had problems, such that it’s been recalled, it means that FDA certification has already failed once. Will going through the same process again for a ‘similar device’ make any difference? Heck, what if the ‘similar device’ is one that incorporates the fix for the problem that caused the recall in the first place?

                We complain about cost, and regulation/liability is often the biggest cost for these devices – buy one for your dog and it’s a whole heck of a lot cheaper.

            • voogru says:

              “They wouldn’t care if it brought down big pharma.”

              Psst: Big pharma owns the FDA. Do you really think they’re going to approve something that they know will bring them down?

              Don’t worry, you can trust the Fox guarding the hen house.

      • StarKillerX says:

        Exactly!

  6. clippy2.0 says:

    No one wants the strenuous tedious testing. As a diabetic, I am often angered by the news of different insulin devices, as you often hear of them being “on trial” for years, sometimes decades, before being available in the US. A huge problem for these devices, even the non-implanted, is the technology in them is years behind technology that is already available to the consumer market. Things like being able sync up with a smartphone, or even wirelessly, are still considered “new technology”. Its absurd that our European counterparts get access to these devices so much early than us in the US, so that by the time it can even be used its already outdated. Articles like these never mention the fact that the biggest problem with bringing new medical technology to the US is really just the FDA, who doesn’t have the resources to properly test these devices. It’s not that they’re not safe, its that the FDA is underfunded. Completely unfair to the patients.

    • scoosdad says:

      I second this. There’s a new and improved implanted glucose sensor used with certain insulin pumps available just about everywhere except the US, and it’s all due to the FDA dragging its feet in approving it.

      Part of the hangup is the way the FDA approves improved devices that can be implanted for a longer period of time than the device it replaces. It’s common knowledge the original sensors could be used for more than the 3 day FDA-approved use period, and this sensor is being marketed everywhere else as a 6 day use device.

      • clippy2.0 says:

        OMG I hate that so much. I have the new Minimed glucose/pump combo, and I had to argue with my trainer, because I’ve always had Minimed, about how long I could wear the sets, if it was “waterproof”, and everything else. I finally just asked “Has the device at all changed, or has there been updates to the training”, at which point the trainer said “the device is the same”, and we just agreed we would consider me “trained”. So stupid, over 10 years ago I was using the same infusion set, and it hasn’t changed one bit, and now it has to be listed as 3days. Even worse? Getting prescriptions filled, for the exact same reason. The doctor has to write a minimum prescription that covers changed every 3 days, and then when you don’t refill immediately they’re on you for prescription fraud for ordering a 90day but billing it as a 60day. So insane. Hate you FDA, hate you so much

        • scoosdad says:

          Clippy, my pump hardware now lasts me about 4 days, mostly due to my lower than normal insulin demands lately, although my doctor insists that the insulin sitting in the pump subjected to body heat much beyond three days is not going to be as effective. My uploaded data doesn’t support that, though. And I was using the original glucose sensors for six, seven, sometimes eight days, and then replacing when only they fell out of calibration (or just plain fell off). I stopped using them at first because they were such a pain in the ass to use, and finally when my employer went with a different plan and I had to pay out a huge copay on everything. The infusion sets and reservoirs I needed to live, but not the glucose sensors.

          But nobody ever gave me any grief about refilling my orders at greater than my prescribed interval, though.

          • clippy2.0 says:

            yeah having to pay a co-pay on the glucose monitor sets, but not the infusion sets, blows my mind. my insurance even wanted me to pay for part of the pump, because the glucose portion of it could be billed separately. I strangled a whole box of kittens the day I heard that. It’s like, its the exact same device…. but with a different radio turned on. So much rage

          • clippy2.0 says:

            Oh I just realize, you have my issue backwords. My sets last 5-6 days. But I’m told my sets “last” 3 days. So when the company calls in 45 days to refill me, and I tell them I don’t need it, they get all hissy that I didn’t order a 60 day, saying that I ordered a 90, but claimed I was ordering a 60. It’s stupid. It’s purely an insurance problem. So much rage.

            • Firethorn says:

              Welcome to the reason why I think our current system combines the worst aspects of socialized healthcare and free market healthcare.

              My personal option would be that you’d have a ‘heathcare saving account’ that you deposit $X amount of money into. Because you have an endemic condition, the government would dump $Y in as well. You then use those monies to treat your condition, saving the insurance for the actual emergencies – for which they’re severely restricted in their ability to not pay out.

  7. Mr. Fix-It says: "Canadian Bacon is best bacon!" says:

    Believe it or not, Aaaah’m walkin’ on air,
    I never thought I could feel so fr-

    Er, sorry; knee-jerk reaction. Also, where the hell does one buy those robot emotion chips? The Sirius Cybernetics Corporation?

  8. JohnDeere says:

    “new york who” didnt they go bankrupt years ago, when the whole digital revolution started?

  9. ferndave says:

    I just went through a matter involving an implant recall. The flags went up overseas long before they did in the US because they had an implant registries and could monitor the failure rates. Why can’t we have a similar system?

  10. unpolloloco says:

    The current testing requirements (typical approval timeframes for a new medical device are >5 years) are already pushing medical device companies overseas (where they can get approved for sale and then use patient data to get approved for sale in the US)…

  11. scoosdad says:

    (first woman:) “Stapling machine, Mr. Clark!”

    (her companion, confidentially to Mr. Clark:) “New brain….”

    http://www.youtube.com/watch?v=M9Q3xRsZY00

  12. HogwartsProfessor says:

    Nuke all the lobbyists from orbit. It’s the only way to be sure.