Saline Flush, medical device or drug?
- 0Aug 7, '12 by pineauDear 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,
- 2Aug 7, '12 by Asystole RNSaline 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.
- 1Aug 8, '12 by Asystole RNQuote from pineaumost 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.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?
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.
- 0Aug 14, '12 by Asystole RNQuote from pineauAgain, 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.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?
I cannot cite all the brands that make prefilled syringes but if it was intended to flush, it is a device.