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10 Responses

  1. Mike Ratrie
    Mike Ratrie September 12, 2013 at 7:27 am | | Reply

    Thanks for the update on this important issue, Mike!

    I have to wonder if the industry wouldn’t want to fund independent testing and standards that might preclude the FDA from rule-making AND be robust enough to satisfy PWDs that rely on the meters/strips. Surely, there are testing labs out there for all sorts of medical devices and they could add meters/strips to their portfolio.

    1. Tim Steinert
      Tim Steinert September 12, 2013 at 11:37 am | | Reply

      If we trusted the industry to police itself we wouldn’t be having this conversation and insisting that we need enforcement of CURRENT standards by the FDA. I remember all the independent studies funded by the tobacco industry saying for years that smoking didn’t harm you when they knew that it did.

  2. Caroline Yeager, M.D.
    Caroline Yeager, M.D. September 12, 2013 at 10:14 pm | | Reply

    If you gave this job to an eighth grade person, they could do it online, and you’d only have to pay them with peanut butter sandwiches. lol

    Most of these guys only sit around and pontificate. They haven’t actually done anything for years. Besides, Vigersky “pointed out that some at the meeting — patients included — didn’t fully grasp what the agency’s powers are and what they can or can’t do.”

    Then, please explain it to them and us in simple and unambiguous words. Geeze.

  3. StephenS
    StephenS September 13, 2013 at 3:21 am | | Reply

    Mike, thanks for a very thorough recap of this meeting, which I was unable to attend. A question: Was there representation from Congress at the meeting?

    Also, I love the fact that everyone likes the idea of putting post-market testing in place. The important part after that will be: What will happen if inaccuracies are found post-market? What will happen then? I guess the devil will be in the details.

    1. Bennet
      Bennet September 18, 2013 at 10:13 am | | Reply

      Thanks for the great round up Mike.

      I found it bit ironic that the FDA said that the public didn’t understand the FDA role, admitted that the Agency does a poor job of communicating and can’t tell us the means by which they protect us.

      How is it our fault we don’t appreciate their role? Coverage like this is a step to understanding. Keep it coming!

      Letting our elected officials know we have concerns is part of the process of change.

      Feel free to use this sample letter of support for independent testing:
      http://www.stripsafely.com/sample-page/

      Find and Tweet you representatives here:
      http://www.stripsafely.com/the-twitter-page/

  4. RickH
    RickH September 14, 2013 at 4:36 pm | | Reply

    While I’m encouraged by the positive attitude about improving enforcement of standards, to me the main problem isn’t actually enforcement at all, it’s that the current accuracy standards frankly suck. +/- 20% is horrible! You wouldn’t accept a speedometer that could read anywhere from 44-66 MPH at highway speeds, why tolerate it in such a directly health critical device?

    I think the core problem is lack of competition to drive tech innovation. As long as all meters only get certified pass/fail, there’s little reason for any company to invest in improving the tech. I’d love to see a real “Consumer Reports on steroids” solution adopted, by an impartial outside organization like a big diabetes web site or other PWD group. I’d gladly cough up an annual donation to fund a group that would, say, annually test each major strip and meter combo against a high-accuracy lab tester and publish the results, maybe by doing 10 tests on the same blood draw and giving the average result difference and standard deviation of differences from the lab equipment.

    That would put some serious pressure on the meter makers to find ways to improve their accuracy; I know I’d be much more likely to spend my strip money on the better scorers, even if it wasn’t covered by my health plan. And insurers might well favor the more accurate devices for coverage as well, when the price difference wasn’t too high, since it might lower their long-term diabetic patient care costs.

    But without any incentive to improve, meter makers are actually better off investing their money in prettier boxes or something.

  5. Jessica Beer
    Jessica Beer September 17, 2013 at 7:11 am | | Reply

    I am continually astonished at the slow progress of technology in diabetes care. Five to 6 years is simply unacceptable…we have a federal healthcare law that took 4 years to implement and we can’t establish and implement standards for blood glucose monitors within a reasonable amount of time?

  6. Andy O'Hara
    Andy O'Hara September 19, 2013 at 8:01 am | | Reply

    This is a very fair and well-presented summary of the issues discussed at the DTS meeting. Many different perspectives were presented by many different interests—and reminded me that “what you see and hear is filtered greatly by where you sit.” No regulator or manufacturer or caregiver can truly understand the impact of the dispute over an acceptable standard (e.g., +/- 20%) in the same way a PWD experiences it. My understanding is improved because of the meeting and other PWD publications/ posts, and I will apply that understanding each day.

  7. Tony Trevino
    Tony Trevino October 11, 2013 at 2:20 pm | | Reply

    I may be new to this disease, but accuracy is a concept that knows no bounds. Will just one of the manufacturers of any glucose meter step up and say that their meter is better than +- 20 %, and back it up. Hey manufacturer, if your product is better, you will probably sell more meters. Show me the websit that says they tested meters to the FDA standard and give me a top ten. You don’t even have to give me the cost. I just want to know how accurate they are. I see consumer reports has a list, but I don’t know how it relates to the 20% standard.

    We hear a lot of talk about meters, but it is not about meters, is it. It’s about test strips. I’ll give you a free meter and you need to buy the related test strips. How do we know they are consistently accurate? We don’t. And those w/o insurance could be wasting their own money to buy inaccurate equipment. The market is just not working here, because, I suspect, some sort of monopoly in the background. Follow the money.

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