Developed By: Committee on Quality Management and Departmental Administration
Original Approval: October 26, 2022
It is the position of ASA 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. This practice improves patient care during emergencies, patient throughput, and operational efficiency.
In the face of increasing production pressures seen across the perioperative spectrum, the ability to increase operational efficiency while maintaining patient safety is paramount. Recently, the action of pre-spiking IV fluid bags to increase efficiency has been raised as a possibly unsafe practice. Multiple studies confirmed the low risk of pre-spiked IV fluid bag and tubing contamination. This statement reviews prior guidelines concerning this topic as well as the relevant literature.
Most recently, the Joint Commission mandated that infusion of IV fluid bags must begin within one hour of spiking unless the bag is spiked in an ISO class 5 clean room. This recommendation stemmed from a recommendation put forth by the Association of Professionals in Infection Control and Epidemiology (APIC), which apparently misinterpreted the United States Pharmacopeia (USP) <797> rule that sets forth regulations concerning compounding of medications.1
Compounding has a variety of definitions, depending on the source. For example, the United States Food and Drug Administration’s (FDA) definition of compounding states:
“Compounding is generally a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient.”2
The USP defines sterile compounding more broadly as, “combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug or bulk drug substance to create a sterile medication.”3 USP <797> is currently under revision and the revision distinguishes between compounding and administration. The delivery of IV fluids consists of administration and does not constitute compounding.
There are multiple studies addressing the risk of contamination/infection of pre-spiked IV fluid bags and administration sets, generally known as “tubing.” For example, Stedman et al. researched the issue in a busy operating suite for 5 weeks.4 They collected 125 samples from five once-a-week pre-spiked IV bags that yielded 250 specimens. Their results showed that there was no culture growth in any of the specimens within 24 hours of IV bags being pre-spiked. Furthermore, Brock-Utne et al. evaluated pre-spiked Normal Saline and Lactated Ringers solution with dextrose stored in a non-sterile anesthesia workroom and found no bacterial or fungal growth up to 9 days after spiking.5 These findings were further confirmed by Haas et al., who found no difference in contamination rates between IV fluid bags spiked in a conventional perioperative environment versus under an ISO class 5 hood.6
The operating room is a rapidly changing environment which can be faced with multiple emergencies. These situations may demand the immediate availability of pre-spiked IV fluid bags to help stabilize hemodynamically unstable patients and maintain their safety. Limiting the use of pre-spiked IV fluid bags to within one hour of spiking is not practical and could potentially leave the anesthesiologist without the necessary supplies needed to stabilize a critically ill or rapidly deteriorating patient. This impact would be more detrimental in instances where intense and direct caring for a critically ill patient would require the anesthesiologist’s full attention and where anesthesia technicians or other care team members are not immediately available to help spike additional IV fluid bags. In addition, there are known risks of preparing IV fluid bags and tubing in an emergency, including the well-recognized possibility of administering a life-threatening air embolus from inadequately run-through tubing.
In conclusion: Based on our understanding of the definitions and guidance put forth by the FDA and USP, as well as the available evidence in the published literature to date, not substantiating any risk of infection or contamination, spiking IV fluid bags and using them within 24 hours for surgery/procedure appears to be an appropriate and safe practice. During the process, aseptic technique should be followed, and appropriately trained anesthesia technicians (or anesthesiologists) should perform the task to ensure sterility.
- Dolan SA, Arias KM, Felizardo G, et al. APIC position paper: Safe injection, infusion, and medication vial practices in health care. Am J Infect Control. 2016;44(7):750-757. doi:10.1016/j.ajic.2016.02.033
- U.S. Food and Drug Administration. FDA’s Human Drug Compounding Progress Report: Three Years After Enactment of the Drug Quality and Security Act (January 2017). https://www.fda.gov/drugs/human-drug-compounding/fdas-human-drug-compounding-progress-report-three-years-after-enactment-drug-quality-and-security. Accessed June 23, 2022.
- The United States Pharmacopeia Convention. <797> Pharmaceutical Compounding - Sterile Preparations. Rockville, MD. 2008.
Stedman JL, Yarmush JM, Joshi MC, Kamath S, Schianodicola J. How Long Is Too Long? The Prespiked Intravenous Debate. Anesth Analg. 2017;124(5): 1564-68.
- Brock-Utne, JG, Smith, SC, Banaei, N, Chang, SC, Alejandro-Harper, D, Jaffe, RA. Spiking of intravenous bags does not cause time-dependent microbial contamination: a preliminary report. Infect Control Hosp Epidemiol 2018; 39:1029–1030.
- Haas RE, Beitz E, Reed A, Burtnett H, Lowe J, Crist Jr AE, Stierer Sr KA, Birenberg AM. No bacterial growth found in spiked intravenous fluids over an 8-hour period. Am J Infect Control. 2017;45(4):448-450.