22 Responses

  1. Janet
    Janet July 8, 2013 at 5:01 am | | Reply

    I think the FDA will, most likely, screw it up and make things that much harder for diabetics to get the supplies they need. As usual. Kind of a negative thought. But, I don’t have much faith in the FDA. So, not surprising considering that fact.

  2. Scott E
    Scott E July 8, 2013 at 5:15 am | | Reply

    It’s a good thing I have enough lancets stockpiled to last, likely, the rest of my life. This new oversight is really not something I’d be looking forward to.

  3. Bruce Miller
    Bruce Miller July 8, 2013 at 5:15 am | | Reply

    More unnecessary regulatory fun and games…

    As Mike points out many (most?) reuse the lancets until they are dull so a box of 100 would last for years.

    Wish we could get a decent lobbing effort to regulate the meters and strips so they would be useful. Apparently the FDA folks are understaffed and under funded to look into the meter issue and must take the manufactures claims as true.

    Separate note or query – Is there any way to edit a post with typos that was posted before one was ready?

  4. StephenS
    StephenS July 8, 2013 at 5:32 am | | Reply

    I agree that breaking down the lancets into the four categories above doesn’t seem to be a big deal on the surface. But if you asked PWDs about it, they could probably give you about a dozen other things that they would rather see the FDA focus on at this time. I mean, I haven’t read of anyone being seriously injured or even seriously infected by a lancet yet… have you?

  5. Mary Dexter
    Mary Dexter July 8, 2013 at 6:17 am | | Reply

    Here in Wisconsin, a CDE at one of the prominent clinics got in trouble for using the same lancing device on several patients. They all had to be tested for HIV. It was a well-publicized liability issue.

    BD warns that if a lancet is used more than once, it increases the odds that the tip of the lancet could break off in the skin, causing infection. Supposedly, the more often the lancet is used, the greater the odds of this happening.

    I try to remember to dial to a new lancet after every use (just switched to the drum). When I was first dx, I was told by the CDE (at the same clinic as above) to ignore the USE ONE TIME ONLY and use them until I couldn’t stand the pain. My middle finger got infected, requiring antibiotics to heal (because as a diabetic I no longer fight infections as I did before). I learned to rotate which finger and used a fresh lancet practically every time.

    I wonder about the correlation between those who hate to test, those who complain about the pain of suffering, and those who brag about rarely changing the lancet.

    1. StephenS
      StephenS July 8, 2013 at 9:27 am | | Reply

      Mary, I knew that as soon as I posted that last sentence, I would see a comment like yours. Consider me corrected… thanks.

  6. Amy
    Amy July 8, 2013 at 7:12 am | | Reply

    It looks like lancet producers are lobbying to making the lancet one time only by force of design, which is regulated by the FDA, in order to increase sales.

    While this is not a definite move yet, I am going to buy a couple of boxes now. I LOVE that I spend so little money on lancets that I do not even budget for them right now. That would change with these regulations to be certain.

    It is irritating to hear that the FDA is wasting their time with this and diverting resources away from other more pressing D and non-D issues.

  7. Richard
    Richard July 8, 2013 at 7:24 am | | Reply

    The concern doesn’t really seem to be the safety of the lancets as such, but the safety of their usage. The transference of bacteria or whatever always requires two people to use the same lancet.

    It could be just me, but the solution would be to educate medical staff and pwds about this rather then put any control on the devices used.

    I mean look at category 4, yes, lancets that get used multiple times on multiple people should of course be disinfected between the different uses. But what exactly is their point, provide the disinfectant with the lancets? That still does not guarantee it will actually get desinfected between uses, in order to make sure that happens you need to educate the people actually using the lancets.

    Unless they want some lancetpen that automatically disinfects the used lancet after/before each usage, at which point I’d maintain you’d probably need to refill the disinfectant sooner or later so it is still a problem of how you use it, rather then the actual tools used.

  8. Bernard Farrell
    Bernard Farrell July 8, 2013 at 8:04 am | | Reply

    My belief (disclaimer) is that some health clinics/hospitals may be using meters that are intended for single patient use. So they have problems with using the same lancet device with multiple patients, that’s the 4th category above.

    Personally I think there are far more important things the FDA could focus on. If it’s true that a small company like Intuity could ‘persuade” the FDA to consider a new item like this, it doesn’t bode well for the future of medical regulation.

  9. Mary Dexter
    Mary Dexter July 8, 2013 at 8:25 am | | Reply

    Just received an email from theater re: liability of having multiple people testing their blood in the theater with their own meters as part of a World Diabetes Day event during a performance of The Sweet Lowdown. We would need consent forms, medical personnel and a responsible way to dispose of testing supplies. The board does not approve because of the potential cost and danger.

    1. Mary Dexter
      Mary Dexter July 8, 2013 at 8:41 pm | | Reply

      Even with consent form and with people using their own meters, lancets and test strips and disposing of them in a sharps container, the theater will not permit us to test as a group as part of the Big Blue Test on World Diabetes Day. It is “not comfortable with us doing it on theater property.” Hope they are ok with me testing before and during the production; I’m acting and dancing in my own show. Also, when I watch other people’s shows, I usually test in the audience. Didn’t realize I was such a threat. No wonder the FDA is changing how it authorizes lancets.

  10. Carina
    Carina July 8, 2013 at 8:27 am | | Reply

    All I can say is Animas Vibe. Quit wasting time on stupid insignificant lancets, clearly a make work project, and approve the dang Vibe!

  11. Kim
    Kim July 8, 2013 at 10:34 am | | Reply

    I wish the FDA would use their time to finally approve Medtronic’s new CGM and other new devices. But then again, I definitely subscribe to the one use theory— Memories of undergrad Microbiology.

  12. Gloria
    Gloria July 8, 2013 at 2:46 pm | | Reply

    *sigh* Yet another barrier to PWD managing their condition well. How silly and ridiculous. I guess next time I’m at the pharmacy, I’ll stock up on a gillion Microlets.

  13. Laszlo
    Laszlo July 8, 2013 at 4:54 pm | | Reply

    sounds like ObamaCare

  14. jim
    jim July 9, 2013 at 4:31 pm | | Reply

    I think someone needs to teach the FDA on how to prioritize the diabetes issues that they work on. This issue should be very close to the bottom of the list.

  15. Caroline Yeager, M.D.
    Caroline Yeager, M.D. July 11, 2013 at 9:34 pm | | Reply

    I use Delica lancets from OneTouch because they are 33g. What does this mean to me?

    I test about 6 times/day. I only use one finger because with the fine gauge, there is no thickening, pain, yada, yada.

    Medicare requires I justify this choice, and pay slightly more, but it’s worth it.

    The FDA? They ok’d Thalidomide when I was a kid, did they not? (Google it.) If gov’t regs are so good why aren’t Delica lancets #1?

  16. News & Views | War On Diabetes
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    [...] Lancet Needles.  ”Right now, the tiny needles that poke our fingers for blood sugar tests are one of the few diabetes supplies not scrutinized by FDA, which makes it easy for us to get them by the box-load without much hassle. But that may soon be changing.”  I don’t know about you, but I only use a lancet one time.  Yeah, I know – there are those who use them multiple times.  This is something that effects us all…read the article. [...]

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  18. mel@twicediabetes
    mel@twicediabetes September 12, 2013 at 3:08 am | | Reply

    OMG , they need to be hounded about strip accuracy but they’re jumping all over something that I haven’t heard giving anyone any problems. What a waste of money, time and effort that could be spent on things that are… life threatening.

    I change my lancet once a year if I’m lucky and I do test 5 or 6 times a day, never got an infection and my fingertips aren’t too tough.

  19. Ron Crouch
    Ron Crouch December 9, 2013 at 1:06 pm | | Reply

    As usual, the FDA is worrying about a problem that’s been present for 20+ years and has led to no major health crisis, while placing the Pogo one step and similar devices in purgatory…the result, people such as my elderly mother with poor vision simply don’t test their blood sugar. Seriously, the entire structure of the FDA is an embarrassment. Why are we worrying about the potential hypothetical problem that does not seem to surfaced despite hundreds of millions or billions or instances of lancing while ignoring the known health problem of life threatening complications of diabetes for people who can’t/won’t test their blood sugar?

  20. Lancet prices could go up
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    [...] prices could go up .. if the FDA has its way: @US_FDA to Stiffen Regulations on… Lancet Needles? #dblog #DOC Time to stock up on [...]

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