Statement on Intravenous (IV) Fluid Bag Spiking

Developed By: Committee on Quality Management and Departmental Administration
Last Amended: October 18, 2023 (original approval: October 26, 2022)

Revised statement to reflect changes in U.S. Pharmacopeia General Chapter <797>.

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 in short-duration procedures, and operational efficiency. This statement reviews prior guidelines concerning this topic and relevant literature, as well as recent updates.

In 2016, The Joint Commission mandated that infusion of IV fluid bags must begin within one hour of spiking unless the bag was spiked in an ISO class 5 clean room. This stemmed from a recommendation put forth by the Association of Professionals in Infection Control and Epidemiology (APIC)¹, which apparently misinterpreted the United States Pharmacopeia (USP) General Chapter <797> rule² that sets forth regulations concerning compounding of medications.

Compounding has a variety of definitions, depending on the source, none of which apply to the preparation of commercially prepared IV fluids. 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.”³

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.”⁴

In response to The Joint Commission interpretive guidelines, multiple studies were conducted to address the risk of contamination/infection of IV fluid bags and administration sets, generally known as “tubing.” Stedman et al. researched the issue in a busy operating suite for 5 weeks.⁵ They collected 125 samples from five once-a-week 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 commercially prepared intravenous fluid stored in a non-sterile anesthesia workroom and found no bacterial or fungal growth up to 9 days after spiking.⁶

These studies and others involving different commercially prepared IV solutions⁷ served to support the advocacy that the American Society of Anesthesiologists had undertaken to revise USP Chapter <797>. In November 2022, USP revised its Chapter <797>, and within its new guidance, clarified that IV solution administration is outside the scope of Chapter <797> .⁸

With the new specification, The Joint Commission has no specific requirement regarding pre-spiking of IV bags.

The new Joint Commission guidance states:

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.⁹

Thus, they now recommend that each health care facility/organization should develop policies in which they have guidance for IV solution preparation and administration. Anesthesiologists, in partnership with experts and interested parties should lead the development of institutional policies that support patient safety, emergency preparedness and perioperative/periprocedural workflows. Policies should consider applicable federal and state regulations. All perioperative staff should be educated on the institutional policies pertaining to IV fluid preparation and administration.

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.

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
The United States Pharmacopeia Convention. <797> Pharmaceutical Compounding - Sterile Preparations. Rockville, MD. 2008.
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 May 5, 2023
The United States Pharmacopeia. General Chapter <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.
Baronos S, Yarmush JM, Stedman JL, Kamath S, Xavier C, Ahmed K. Normal Saline and dextrose 5% in water do not support bacterial growth 24 hours after being spiked in the perioperative environment. Anesth Analg 2019;128:1185–7
The United States Pharmacopeia. General Chapter <797> Pharmaceutical Compounding - Sterile Preparations. Rockville, MD. 2008.
The Joint Commission. Does The Joint Commission have any requirements regarding pre-spiking of IV Bags? November 2, 2022. https://www.jointcommission.org/standards/standard-faqs/office-based-surgery/medication-management-mm/000002448/. Accessed June 15, 2023.