Our facility is trying to standardize our policies, physician orders, and documentation concerning flushing protocols for all vascular access devices. Currently our policy is to flush PIV lines q8 hours (if not used for continuous infusions) and prn after each use with 3ml NS. We flush all central lines (except Diaylsis and Apheresis lines) q12 hours and after each use with 10ml NS and 3ml 100:1 Heparin. We have managed to create an order set which spells out the flushing protocols for each line, but we're stuck on the documentation piece. Our pharmacy tell us flushes do not need to be documented in the medication record because the FDA has labeled flushes as devices and not medications. Is anyone out there documenting their PRN flushes of saline and Heparin in the medication record? If not there, are you documenting it someplace else? We are documenting the routine flushes on the medication record, but not the prn/after each use flushes.
There has also been concerned raised that we should be keeping track of these flushes in a patient's I&O record, particularly if they're in the ICU and getting multiple intermittant infusions throughout the day.
Has there been any research or are there articles or studies I could read aound this issue?
Any advise you could provide would be greatly appreciated.
Greg Bowman, RN
Clinical Supervisor, Vascular Access
Swedish Medical Center, Seattle WA
Our pharmacists allowed us to put them on the mar, and so we put them on the order sheets. We created standardized order forms that had the different flushing protocols for different CVADs to make it easier for the MDs to fill out. We also put needleless connector changes on as well.
Mari Cordes, BS RN
Mari Cordes, BS RNIII VA-BC
Vascular Access Department
University of Vermont Medical Center
Our facility documents saline flushes on the MAR. We only use Heparin flushes with a specific physician order and also document those on the MAR. We do document the flushes on our I & O because this affects many of our cardiac and renal patients specifically and others in general.
We consider these to be medications. I just called my Director of Pharmacy after I read your post and he said he has not heard/read that they are labeled devices rather than medications.
Carole
Prefilled syringes of saline and heparin come to market through the FDA as combination products - the prefilled syringe is a device, the heparin is the drug, the saline is the drug delivery system. So they are a combination of all these 3. At the FDA, there is now an Office of Combination Products that reviews application for these types of products. Remember the FDA regulates manufacturers only and does not have any jurisdiction over how those products are used by healthcare professionals. So I am not surprised that a pharmacist may not know these FDA processes.
Lynn Hadaway, M.Ed., RN, BC, CRNI
www.hadawayassociates.com
Lynn Hadaway, M.Ed., RN, NPD-BC, CRNI
Lynn Hadaway Associates, Inc.
PO Box 10
Milner, GA 30257
Website http://www.hadawayassociates.com
Office Phone 770-358-7861
Kathy Kokotis
Bard Access Systems
What your pharmacist is speaking of is there is no longer an NDC or billing number for pre-filled saline syringes. Since it has no drug code it is not a drug. It is not a drug by the way.
How to keep track:
I suggest as far as I/O re-do the I/O sheet to indicate flushes and volume. That way if it is in column by itself it will be recorded
As far as the MAR goes. They are bar coded the saline flushes that is. The vials are or the pre-filled syringes are so if you are electronic I see no issue with having them on the MAR and scanned in. Have pharmacy read the Harnage article in the JVAD on reduction of CR-BSI and that saline flushes on the MAR was part of this reduction. That may give you support for your MAR arguement.
Kathy Kokotis
Kathy Kokotis
Bard Access Systems
Lynn,Kathy or any one else...
Could you give me a reference for what the bottom line is on prefilled saline syringes? Drug,device or what? FDA,CMS,JCAHO rulings?
Thanks for any help,
David
Prefilled saline syringes are a device. Prefilled heparinzed saline for locking is all three. The syringe is the device, the heparin is the drug and the saline to dilute the heparin is a drug delivery system. They are considered to be a single dose system and that is the method that is preferred by INS standards, CDC guidelines, JCAHO, ISMP, etc. FDA regulates what the manufacturers state, not clinical practice. So I am not quite sure what you are asking about their rulings.
Lynn Hadaway, M.Ed., RN, BC, CRNI
www.hadawayassociates.com
Lynn Hadaway, M.Ed., RN, NPD-BC, CRNI
Lynn Hadaway Associates, Inc.
PO Box 10
Milner, GA 30257
Website http://www.hadawayassociates.com
Office Phone 770-358-7861
Lynn-
What I am looking for is whether the syringes are considered a "drug" per se that has to be subject to the same procedures as any other drug. For example,ordered by a physician,billed by pharmacy,kept secured on a unit,and so on. We recently started to have to keep saline flush syringes under lock and key and it just seems a little extreme. We can keep saline tubules at the bedside for respiratory cares,regular syringes are in the bedside cart but the combination of the two is in a locked cabinet.
Thanks
David
The answer to your question may be related to your state pharmacy laws. These have more direct influence on how you must manage it rather than how the FDA cleared it for market. Actually the saline inside the syringe makes it a combination product. They do contain the Rx only legend and and NDC code. So ask your pharmacy if there are state laws directing this decision. If not, it should be easy to change this practice.
Lynn Hadaway, M.Ed., RN, BC, CRNI
www.hadawayassociates.com
Lynn Hadaway, M.Ed., RN, NPD-BC, CRNI
Lynn Hadaway Associates, Inc.
PO Box 10
Milner, GA 30257
Website http://www.hadawayassociates.com
Office Phone 770-358-7861