Saline Flush, medical device or drug?

  1. 0
    Dear all,

    I heard that some saline flush were licensed as a drug , others as a device.
    Can you explain me the difference?
    Is it an advantage to be licensed as a drug?
    what are the implication of being licensed as a drug? in terms of logistics, storage distribution, price...?

    thanks for your answers,
    Best regards,
    Antoine Pineau
  2. 9 Comments so far...

  3. 2
    Saline flushes and heparin flushes are classified as a class II medical device that require FDA 510(k) clearance.

    There is a committee within the FDA that determines the class of the medical devices and drugs. Flushes are considered a device because of the nature of their use. They are meant to physically move material within a catheter and physically occupy a space. The saline and heparin is not intended to do anything but act as a liquid mass, the thrombogenic properties of heparin being classed as a secondary effect. Drugs are classified as such because their primary purpose is to interact chemically with the body.
    NRSKarenRN and mandomania like this.
  4. 0
    It's interesting that flushes can be considered a device. I had not heard that before. Thanks for posting this thread. Asystole, in your response did you mean "thrombolytic" properties of Heparin? Thanks, take it easy.
  5. 0
    Quote from mandomania
    It's interesting that flushes can be considered a device. I had not heard that before. Thanks for posting this thread. Asystole, in your response did you mean "thrombolytic" properties of Heparin? Thanks, take it easy.
    Yes, thank you.
  6. 0
    If it is licensed as a device, who is in charge of ordering it? Is the phrarmacy allowed to do so?
  7. 0
    i heard that some practitioners were using prefilled syringes of saline flush to make reconstitution or dilution of drugs?
    is it something that often happen? what is your opinion about that?
  8. 0
    Quote from pineau
    If it is licensed as a device, who is in charge of ordering it? Is the phrarmacy allowed to do so?
    The pharmacy can order whatever it wants. The ordering process would be regulated by the facility ordering policy.
  9. 1
    Quote from pineau
    i heard that some practitioners were using prefilled syringes of saline flush to make reconstitution or dilution of drugs?
    is it something that often happen? what is your opinion about that?
    most drugs call for reconstitution by adding preservative free sterile water. the use of flushes to dilute medications is again technically a physical property, you add the medication to the flush to physically dilute the medication, not to chemically alter the medication.

    the book answer would be to read the fda510(k) clearance for the device and only do those things approved and to follow the instructions that come with the medication.
    mandomania likes this.
  10. 0
    Thankks for your answer!
    Do you know if all brands license saline flush in prefilled syringes as a device or some license it as a drug?
  11. 0
    Quote from pineau
    Thankks for your answer!
    Do you know if all brands license saline flush in prefilled syringes as a device or some license it as a drug?
    Again, depends upon the intended use of the saline flush which you would have to ascertain the intention and approval of the product by reading the insert or looking up what FDA approval.

    I cannot cite all the brands that make prefilled syringes but if it was intended to flush, it is a device.


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