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Medtronic Enlite - blood derived product used in sensor

Discussion in 'Parents of Children with Type 1' started by kiwiliz, Mar 22, 2012.

  1. kiwiliz

    kiwiliz Approved members

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    On opening the box of sensors I was shocked to read that the sensors actually have human serum derivatives in the sensor probe. When we did our trial the leaflet was not in the box of sensors. I would have preferred to have received this info before the trial so I could make an informed decision about whether to use them on our daughter.

    I have asked Medtronic to answer the following questions;

    The operator told me there was a permeable barrier over the sensor to allow glucose into the probe. Are the permeable "holes" large enough to allow prions through? Viruses?

    This is a blood byproduct isn't it? (ie. not sourced from cadavers.) Where do you source the blood and what screening systems are in place for it? (And it's donors) Is the blood sourced from America?

    What size the donor pool of blood is and at what temperature and for how long is the blood used pasteurized? And - is there a chemical step in the purification process.


    Has anyone else asked these questions? I am eager to find the answers to the above questions quickly as I was hoping to use the sensors on a school trip. The donor pool question is because the chances of contamination increase proportionally to the size of the donor pool.
     
  2. betty6333

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    I hope that it is a synthetic ( like our insulins are not from animals anymore but are now made sythethically)

    If human serum from live or dead people was used, that would be a concern for me too.

    I would be less concerned that they would screen for viruses ( would assume that they would have to check for the big stuff, hep, hiv, ect...) ... that they can screen for, than I would be concerned about the ones they can't' screen for or haven't identified yet. ( I would assume totally sterilizing would destroy the serum, as separating the blood from the serum can be a tricky process)
     
  3. emm142

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    Seriously? I had no idea and I'd definitely want more information about that.
     
  4. Mish

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    looks like it's possible that the regular MM sensors have the same, and this goes back to 2005.

    http://www.fda.gov/MedicalDevices/P...ovalsandClearances/PMAApprovals/ucm110704.htm

     
  5. TheFormerLantusFiend

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    If it was from humans, then use of the sensors would be on the list of things that would make us ineligible to donate blood, and since it's not, I would assume it's not from humans.
    Could be wrong :confused:
     
  6. NeurosurgeryNP

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    I believe that albumin is heat sterilized/treated if it is used. Interesting though.
     
  7. kiwiliz

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    Still no reply from Medtronic! The phone operator I spoke to definitely said that it was a human blood product used though.
     
  8. betty6333

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    Wow, I am sure they had to meet some sort of minimum standard and show that quantities are really small, but it amazes me they do this at all. Plasma is what is used to test for a lot of diseases and hormones.

    Even a blood pregnancy test, the plasma is separated from the blood, they dont event test the blood because the concentration of the pregnancy hormone is in the plasma... They test the plasma and I wonder how much they can get rid of with their process... I doubt they can filter out all the pregnancy hormone or estrogen ect even if they get all the viruses. And while one sensor doesn't have a lot I am sure, when you use 10 sensors a month over the course of several years, that " insignificant amount " could be a concern. That is 121 sensors a year, or 486 insertions of a tiny amount over 4 years ( pump life if you use the integrated part)
     
  9. mmgirls

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    This has me so wondering, exactly what is used. I mean using plasma proucts on a person that IS autoimmune?
     
  10. hawkeyegirl

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    I've gotta say with the conservative nature of the FDA at this point in time, I'm really completely unconcerned.
     
  11. zoomom456

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    There is recombinant human serum albumin available. It is basically made like insulin - the gene for albumin is inserted into bacterium or yeast, and then the microorganism makes albumin. This is identical to what humans produce. It is then purified and processed. While not made in human blood it is a human blood product. Whether or not this is what Medtronic uses I have no idea. Albumin is typically used to stabilize blood and extracellular fluids.
     
  12. kiwiliz

    kiwiliz Approved members

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    When I spoke with the UK Medtronic call centre person, she told me categorically that it was a blood product sourced in the US. She didn't know anything else and has forwarded my queries to the US, and I still haven't had a reply from them. Whether you are personally concerned or not relies on how happy you are to make a decision without any specific information. I prefer to make informed decisions, especially when it comes to my children, and am very ticked that I wasn't even given the pamphlet that comes with the sets BEFORE we trialled the Enlites. The longer they wait to answer my questions, the more ticked (peeved/irritated/concerned) I am.
     
  13. hawkeyegirl

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    Thanks for more than implying that I don't care about making informed decisions for my children. :rolleyes:

    I said I'm not concerned because I'm not. If you are, that's fine, but that's no reason to take a shot at people who don't find this alarming.
     
  14. Jeff

    Jeff Founder, CWD

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    I've reached out to my contacts at Medtronic and will report back as soon as I have something.
     
  15. mmgirls

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    Thank you.

    We do not even use these but find it very interesting, it may be totally nothing and of no concern, but as the OP addressed it is about making an informed choice. Omission is not ok.
     
  16. MommaKat

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    Completely and totally agree with this. Maybe it's nothing, but informed consent is a very important concept in medicine, and failure to provide it is a huge issue.
     
  17. Mish

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    Well there is a booklet that comes in every box of sensors. Perhaps "informed consent" means something else to you.
    Page 3


    So it seems that in the US product this is of no concern. Perhaps someone (the OP) will view the package insert in other countries and type out exactly what she read.
     
    Last edited: Mar 27, 2012
  18. kiwiliz

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    "....Glucose oxidase....(same)...and cross-linked to HSA, purified and dried albumin fraction V, derived from pasteurized human serum with gluteraldehyde. Since less than 0.4ug of glucose oxidase and less than 0.7ug of HSA is used to manufacture each sensor, the risks of tissue reactions and viral transmission are considered minimal."

    When I spoke to the operator she told me that they used to use bovine but have moved to human. She did not state that this was confined to places outside the US! Perhaps someone could check their pamphlet.

    When we did our trial - they did not show us this pamphlet - therefore we were uninformed. It was only upon purchasing the product, after we had completed a trial, that I was able to read this. It is listed under the heading "Reagents" and not exactly highlighted. If you were skimming the pamphlet for info on how to actually use the sensor you could well miss it!
     
  19. Mish

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    I was reading from the pamphlet in the US (which I found in my box and online). The sensors your using are not here in the US but I have no doubt that when they are they'll use the same as yours (that link I posted many posts back about the FDA giving approval for it.)

    It's up to the consumer to be aware of the products they're using. MM has made the info available. As in informed consumer I guess it's your job to look it up. I had no trouble finding the info. Like I said, it's on page 3 in my booklet, it is not in any tiny fine print. Not sure what else they could do. That it's a safe product for use, to me, indicates that there need not be any specific warning. You didn't ask for any documentation originally, and used the product anyway. I'm not sure what else they can do. You're informed now.

    If it bothers you, stop using the product.
     
  20. kiwiliz

    kiwiliz Approved members

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    Mish - I'm not sure you understand what I am getting at. When you trial the product the pamphlet is not in the box. If I hadn't said anything - everyone would have assumed it was some sort of lovely enzyme thing - or something grown in yeast! If the pasteurisation and chemical sterilisation of the blood product is thorough (which we don't know yet), then, perhaps I will be satisfied that this product is safe, when weighed against the alternatives, and useful for me. Until I know what processes have been used I will not trust the FDA or pharmaceutical company to make a judgement about whether "the risks of tissue reactions and viral transmission are considered minimal". It is up to us to consider - not Medtronic. When they make a change from Bovine to Human I think they have a moral obligation to make sure that everyone knows. People who have been thorough and read through the entire set of documentation that goes with this will have made sure they are happy with it. If the company changes an element - as Jonah says "If it was from humans, then use of the sensors would be on the list of things that would make us ineligible to donate blood, and since it's not, I would assume it's not from humans.
    Could be wrong " without making it clear to all users then - they should! They should also be ready to answer questions about the process used to sterilise the product if someone asks it. As you can see from this paper there is a wide range of screening methods for blood products - with varying degrees of efficiency. http://virology-online.com/general/InfectionControl3.htm
    This paper doesn't even reference the problem of prions - vCJD - for instance.
    And for the record - we haven't used it yet - or should I say - since our trial. It is still sitting in it's box!

    http://www.plosone.org/article/info:doi/10.1371/journal.pone.0023169
     
    Last edited: Mar 27, 2012

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