The administration of IV bags in excess of 1 hour of spiking was previously, considered an issue due to USP-797/sterility. However the new version of USP-797 has been fully adopted, changes have been made with regards to spiking IV bags. The FAQs section of USP-797 has taken the view that:
“spiking an IV bag of a conventionally manufactured sterile product without any further manipulation is considered administration rather than compounding and is out of the scope of <797>. If the dose is further mixed with another product, it would be considered compounding and subject to the requirements of <797>USP 797.”
The Studies
One study has shown that no bacterial growth in Normal Saline, and D5W 1000 mL up to 24 hours after spiking the IV fluid in a nonsterile area.
A second study found there was no bacterial growth in prespiked normal saline IV bags in a perioperative environment. Thus, prespiking of normal saline IV bags in advance should pose no risk of infection to a patient if prepared within 4 hours.
JCAHO
The Joint Commission has no specific requirement regarding the pre-spiking of IV bags. USP released an FAQ on November 1, 2022, stating that a facility's policies and procedures regarding spiking IV fluids are outside the scope of the USP 797 chapter. The Joint Commission will survey the organization's policies and procedures regarding the pre-spiking of IV bags.
Organization policies and procedures staff education/competencies should also consider:
Product and device manufacturer’s instructions for use
Evidence based guidelines for safe administration practices.
Applicable law and regulation.
AAAHC and QUAD-A
We are in the process of contacting both AAAHC and QUAD-A for their statement and views on spiking of IV fluids.
ASA
The American Society of Anesthesiologist has specifically come up with the following:
“In summary: The recent updates to USP <797>, The Joint Commission guidance, and review of relevant literature support the principle that commercially available intravenous (IV) fluid bags may be safely connected to tubing and prepared (“spiked”), and then used within 24 hours without presenting any substantial risk of infection or contamination. Facilities must develop policies providing guidance for IV solution and preparation.”
What does this mean for your Center
1. Spiking IV bags without immediate administration REQUIRES labeling of the date and time, regardless of this recent change in which a spiked IV may be prepared.
2. Centers should consider manufacturer’s instructions.
3. Follow recent studies and applicable laws.
4. Must follow accrediting bodies information.
5. If the Center decides to extend the time allowed to spike IV bags beyond, policies must be adjusted accordingly and reviewed by the governing board. The policy should include references to studies and the Medical Director should be part and approve this process.
References:
2. How Long Is Too Long? The Prespiked Intravenous Debate. Anesth Analg. 2017;124(5): 1564-68.
3. https://pubmed.ncbi.nlm.nih.gov/31094786/
