To protect the safety of the patient, the Joint Commission and United States Pharmacopeia (USP) advise to always spike IV bags in an ISO Class 5 Cleanroom environment. Following best practices for advance spiking of IV bags helps prevent microbial growth, safeguard the health of the patient, and preserve the beyond-use date (BUD), expiration date, of the IV bag.
What is spiking an IV bag?
Spiking an intravenous (IV) bag occurs when a healthcare professional punctures an IV bag for injecting medication or for that attachment of IV tubes for patient infusion (Ref. 1). To save time, many operating rooms (ORs) will advance spike IV bags for ease of use during procedures. Safe storage and preparation will help ensure the quality of the IV medication.
Advance Spiking of IV Bags Regulations
The Joint Commission
The Joint Commission is a nonprofit organization that evaluates and certifies healthcare organizations while setting standards to improve the safety and quality of healthcare practices. Recently, the Joint Commission released a standard or best practice that states that an infusion must be used within one hour of spiking unless the IV bag was spiked in an ISO Class 5 Cleanroom (Ref. 2). If an IV bag was spiked in an ISO Class 5 Cleanroom environment, then the healthcare professional can follow the USP 797 guidelines for the beyond-use date.
Similarly, USP 797 dictates that if an injection or infusion medication is punctured or spiked in worse than ISO Class 5 air, then the medication must be used within one hour and the remaining contents must be discarded (Ref. 3).
What is an ISO Class 5 Cleanroom?
The International Organization for Standardization (ISO) sets guidelines for the maximum number of particles allowed per cubic meter in order to meet the standardization. The chart below illustrates the differences between ISO 1 – ISO 8 Cleanrooms. Only particle sizes of 0.1 µm, 0.3 µm, and 0.5 µm have been listed below but the standardization also includes particle sizes of 0.2 µm, 1 µm, and 5 µm (Ref. 4).
Advanced Spiking IV Bags Best Practices Solutions
To easily adhere to the Joint Commission and USP 797 regulations, healthcare professionals can compound, spike, and store IV bags in an ISO Class 5 Cleanroom IV Hood. These compact and portable units offer easy installation while still providing vital protection. Converting an entire room to ISO Class 5 Cleanroom environment can be a difficult and costly expenditure. IV Hoods provide the necessary safety precautions in an economical and compact package that can be utilized in any department. Also, IV hoods provide convenient IV bag racks to allow healthcare professionals to prepare up to 7 or 10 bags ahead of time while conforming to the Joint Commission’s standard.
How do IV Hoods work?
1. Ambient room air is pulled into the system with a powerful fan.
2. Air is processed through a MERV 8 pre-filter, where some particles are captured.
3. Air is filtered by passing through a final HEPA or ULPA filter to remove particulate down to 0.3 microns (HEPA) or 0.12 microns (ULPA) of the remaining particulate from the ambient air.
4. The filtered air is discharged into the work area of the hood in a vertical laminar flow pattern, creating a reduced particulate environment.
Contact us today to learn more about portable IV Hoods.
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1. “Spiking Your IV Bag.” Infuserve America. https://www.infuserveamerica.com/106/spiking-your-iv-bag/.
2. The Joint Commission. “Medication Preparation – Spiking Intravenous (IV) Bags in Advance of Administration,” Standards FAQs. 03 March 2021. https://www.jointcommission.org/standards/standard-faqs/home-care/medication-management-mm/000002246/.
3. “Proposed Revisions 797,” USP Compounding Expert Committee. December 2015.
4. “American Cleanroom Systems presents Cleanroom Classifications.” American Cleanroom Systems, 2021. https://www.americancleanrooms.com/cleanroom-classifications/.