Has anyone heard that providing the prefilled sterile syringes inside a PICC kit, if subjected to a certain kind of sterilization (can't remember if it was gas or UV), changes the pH of the saline to 10?
I am told this is why some manufacturers provide glass ampules for saline, and others provide sterile saline PFS packaged separately.
Thanks
Holly Hess
I have done a lot of work with the major PFS manufacturer's and I have never heard this. Give me a couple of days I will see what I can find out. I know that there are valid reasons why PFS are not included in many sterile kits, just can't remember what that is. Lynn
Lynn Hadaway, M.Ed., RN, BC, CRNI
Lynn Hadaway Associates, Inc.
126 Main Street, PO Box 10
Milner, GA 30257
Website http://www.hadawayassociates.com
Office Phone 770-358-7861
The new Bard Power PICC trays use sterile PFS, but they are attached to the outside of the tray in separate packaging. They are probably added after the tray is sterilized.
Daniel Juckette RN, CCRN, VA-BC
EO should not be used on any liquids or medicines as it does change the pH or even the chemical composition. For instance if you run water through Ethylene Oxide( what most PICC kits go through) you end up with....Antifreeze!! Ethylene Glycol. This is actually how some antifreeze is made! Whoever told you this is correct IF the kits were sterilized using EO gas, you can tell because the sterilization method is right on the kit. Glass ampules would be unaffected by the EO gas. There are safe ways to sterilize liquids and that is why you often see separate packages on some PICC kits with syringes attached.
Stephen Harris RN, CRNI, VA-BC
Chief Clinical Officer
Carolina Vascular Wellness
I checked with a resource and repeat sterillization with ETO does alter the pH of saline inside a prefilled syringe to the point where it is beyond the acceptable USP level. Prefilled syringes can be made in several ways.
Aseptic filling - just like your pharmacy would do, bring a sterile syringe and fliud together inside a laminar airflow workbend, no additional sterilization once it is packaged in the overwrap
Terminally sterile - the sterile syringe is filled with sterile saline, then they are sterilized and then placed in the overwrap. The fluid pathway is sterile and must meet a higher standard that those that are aseptically filled but the overwrap simply acts as a dust cover.
totally sterile - the syringe is filled with saline, placed in the stronger packaging, and then sterilized.
Manufacturers of prefilled syringes do not recommend that these be placed in a kit and be sterilized again due to the change in pH, however I do not have any information about what the pH changes to or if different types of sterilization produces the same effect. This applies to ETO. If I get any more information I will post it.
Lynn
Lynn Hadaway, M.Ed., RN, BC, CRNI
Lynn Hadaway Associates, Inc.
126 Main Street, PO Box 10
Milner, GA 30257
Website http://www.hadawayassociates.com
Office Phone 770-358-7861
Radiation sterilization differs from gas. I think you will find pre-filled syringes that are sterile have been radiation sterilized.
You will note that packages in aluminum foil under gas sterilization in kits such as swabsticks do not say contents are sterile. Gas does not penetrate foil. You will find those packages for skin prep under gas sterilization do not make claims for being sterile.
commonly liquids are radiation sterilized and not gas sterilized.
Maybe Lynn can shed more light on this process
Kathy