Administration Set Management
Establishes requirements for the appropriate selection, use, configuration, labeling, and replacement of primary and secondary administration sets for all infusion types, including standard solutions, parenteral nutrition, lipids, blood products, propofol, and hemodynamic monitoring systems.
Administration Set Management Policy
1. Policy Statement
All administration sets used for intravenous, intra-arterial, and other parenteral infusions at this institution must be selected, configured, used, labeled, and replaced in accordance with evidence-based standards that minimize the risk of infection, medication error, material incompatibility, and patient harm.12 Replacement frequency is determined by infusion type, patient condition, solution characteristics, and product integrity, and must be performed using Aseptic Non-Touch Technique (ANTT) at all times.
2. Purpose
The purpose of this policy is to:
2.1 Establish minimum requirements for administration set design, selection, and use across all care settings and infusion types.
2.2 Define replacement intervals for primary continuous, primary and secondary intermittent, parenteral nutrition (PN), lipid injectable emulsion, total nutrient admixture (TNA), propofol, blood and blood components, and hemodynamic monitoring systems.
2.3 Mitigate risks associated with sorption, leaching, shedding, and material incompatibility between infusates and administration set materials.
2.4 Standardize labeling requirements to support medication safety and route verification.
2.5 Prevent administration errors through system tracing requirements and safe-connection practices.
2.6 Support a quality improvement infrastructure that monitors dose delivery accuracy and set replacement practices.
3. Scope
This policy applies to:
3.1 All clinical staff authorized to initiate, manage, or discontinue intravenous or other parenteral infusions, including registered nurses, advanced practice providers, physicians, and pharmacy personnel.
3.2 All patient care settings within the organization where parenteral infusions are administered, including inpatient units, intensive care, perioperative services, ambulatory infusion, emergency department, and home infusion services operating under organizational oversight.
3.3 All administration set types: primary continuous, primary intermittent, secondary (piggyback), add-on devices (filters, stopcocks, extension sets), and specialty sets for PN, blood, propofol, and hemodynamic monitoring.
4. Policy Requirements
4.1 Definitions
4.1.1 Sorption
4.1.1.1 Sorption is a complex process encompassing adsorption—the interaction of a drug with the surface of an infusion container or administration set—and absorption, the penetration of a drug into administration set materials, both of which result in reduced drug delivery to the patient.
4.1.2 Leaching
4.1.2.1 Leaching is the process by which a solute becomes detached or extracted from its carrier substance, potentially introducing contaminants (e.g., plasticizers) into the infusate delivered to the patient.
4.1.3 Shedding
4.1.3.1 Shedding is the release of solid particles from an infusate container, administration set, or filter into the administered solution.
4.1.4 Continuous Administration Set
4.1.4.1 A continuous administration set remains connected to the vascular access device (VAD) throughout the infusion duration or until its scheduled replacement. Brief disconnection (e.g., for blood sampling or lumen transition) is permissible provided ANTT and needleless connector cleansing protocols are followed upon reconnection.
4.1.5 Intermittent Administration Set
4.1.5.1 An intermittent administration set is one that has been disconnected from its access point and remains disconnected following completion or interruption of an infusion. Upon disconnection, the distal tip must be protected aseptically using a new sterile end cap.
4.1.6 Continuous Infusion
4.1.6.1 A continuous infusion is a controlled intravenous administration conducted over several hours or longer without scheduled interruption.
4.1.7 Intermittent Infusion
4.1.7.1 An intermittent infusion is small-volume delivery administered via manual push or short infusion, typically over 30 to 60 minutes.
4.2 Administration Set Design Requirements
4.2.1 Anti-Free-Flow Mechanism
4.2.1.1 All administration sets used with electronic infusion devices must incorporate an anti-free-flow mechanism to prevent uncontrolled gravity infusion when the set is removed from the pump.
4.2.2 Luer-Lock Design
4.2.2.1 All administration sets must utilize luer-lock connections at all junctions to prevent inadvertent disconnection and to minimize the risk of tubing misconnections.
4.2.3 Single-Patient Use
4.2.3.1 Administration sets are designated for single-patient use only. Administration sets must never be reused between patients regardless of apparent condition, cleaning, or disinfection.
4.2.4 Epidural and Intrathecal Administration
4.2.4.1 Administration sets used for external epidural and intrathecal infusions must be entirely free of injection ports to eliminate any possibility of inadvertent epidural or intrathecal access via a parenteral route.
4.3 General Practice Standards
4.3.1 Standardization
4.3.1.1 Flow-control devices, administration sets, and drug concentrations must be standardized across the organization wherever clinically feasible to reduce variability and medication error risk.
4.3.2 Education Requirements
4.3.2.1 Education programs for all personnel managing infusion therapy must address the following: factors affecting drug dose delivery; proper use and limitations of flow-control devices; flow rate variability and its clinical implications; residual and dead space volume in administration sets and add-on devices; administration set compliance and its effect on infusion accuracy; and appropriate selection and use of add-on devices.
4.3.3 Integrated Add-On Devices
4.3.3.1 Administration sets with integrated add-on devices (e.g., in-line filters) are preferred over assemblies requiring multiple separate connections, as each additional connection point introduces contamination risk.12
4.3.4 Back-Check Valves
4.3.4.1 Primary continuous administration sets must contain a back-check valve, or the pump set must incorporate integrated mechanisms that prevent retrograde flow of secondary medications into the primary infusate container.
4.4 Aseptic Non-Touch Technique
4.4.1 ANTT Requirement
4.4.1.1 All administration set connections, disconnections, changes, and additions must be performed in accordance with ANTT. Clinicians must apply Standard-ANTT or Surgical-ANTT based on their assessment of risk and ability to protect Key-Sites and Key-Parts.
4.4.1.2 Any administration set suspected of contamination at any point during use must be replaced immediately without waiting for the scheduled replacement interval.
4.5 Material Compatibility: Sorption
4.5.1 Susceptible Medications
4.5.1.1 Medications with known or suspected susceptibility to sorption include, but are not limited to: nitroglycerin, diazepam, insulin, propofol, therapeutic proteins, granulocyte colony-stimulating factor (G-CSF), certain antibiotics, and amiodarone.
4.5.1.2 Administration sets constructed from composite materials recommended by the manufacturer for the specific drug must be used for medications identified as sorption-susceptible.
4.5.1.3 Clinical response must be monitored when administering sorption-susceptible medications, particularly at the initiation of therapy and with any set or container change.
4.6 Material Compatibility: Leaching and Shedding
4.6.1 Risk Evaluation
4.6.1.1 The risk of leaching and shedding must be evaluated before initiating infusion therapy and monitored throughout the duration of administration.
4.6.1.2 Risk factors for leaching and shedding include: infusate type (lipid-based, solvent-containing), compressive or shear forces applied to tubing, duration of patient contact with set materials, storage temperature of prepared solutions, and agitation during transport.
4.7 DEHP Avoidance
4.7.1 Lipid-Based Infusates
4.7.1.1 DEHP-free administration sets must be used for all lipid injectable emulsions (LIE) and total nutrient admixtures (TNA, 3-in-1). This requirement is of particular importance for neonatal, pediatric, and patients receiving long-term home infusion therapy.
4.7.2 Therapeutic Proteins
4.7.2.1 PVC infusion bags or containers known to contain di(2-ethylhexyl)phthalate (DEHP) must not be used for the dilution or administration of therapeutic proteins.
4.8 Labeling Requirements
4.8.1 Date of Placement
4.8.1.1 All administration sets must be labeled with the date of placement in accordance with organizational labeling policies. Labels must be applied at the time of set connection.
4.8.2 Multi-Site and Multi-Container Configurations
4.8.2.1 When a patient has multiple vascular access sites (e.g., peripheral, central, epidural, intraosseous, subcutaneous), all administration set tubing must be clearly labeled with the route of administration and the name of the medication or solution.
4.8.2.2 When multiple fluid containers are connected to a single VAD, tubing labels must be affixed near both the solution container connection point and near the patient’s access site.
4.9 System Tracing and Safety Verification
4.9.1 Pre-Connection Tracing
4.9.1.1 Before connecting or reconnecting any infusion system component, the clinician must trace all catheters, administration sets, and add-on devices from the patient’s access site to the solution container to confirm correct routing and configuration.
4.9.1.2 System tracing must be performed at each care transition to a new care setting or service and as a formal component of the handoff communication process.
4.9.2 Prohibited Configurations
4.9.2.1 The exposed male luer end of an administration set must never be looped back and attached to a port on the same administration set. This configuration creates a closed circuit that risks unintended delivery of contaminated or incompatible solutions.
4.10 Replacement Intervals by Infusion Type
4.10.1 Primary and Secondary Continuous Sets — Standard Solutions
4.10.1.1 Primary and secondary continuous administration sets used for standard intravenous solutions must be replaced at minimum every 7 days unless the manufacturer specifies a shorter interval, or sooner when clinically indicated by suspected contamination, visible dysfunction, or compromise of system integrity.3
4.10.1.2 Administration set changes should be coordinated with VAD changes (e.g., transition from peripheral intravenous catheter to central venous access device) or with the initiation of a new solution container whenever feasible.
4.10.1.3 If a secondary set is disconnected from the primary set, it is reclassified as a primary intermittent set and must subsequently be changed every 24 hours.
4.10.1.4 If any disconnection of a continuous or intermittent set occurs outside of a scheduled change, a new sterile compatible covering must be aseptically attached to the male luer end, and all connections must be re-verified before resuming infusion.
4.10.2 Primary and Secondary Intermittent Sets
4.10.2.1 All primary and secondary administration sets used for intermittent infusions must be changed every 24 hours. The repeated disconnection and reconnection inherent in intermittent use creates substantially elevated contamination risk compared to continuous-use sets.
4.10.3 Parenteral Nutrition, Total Nutrient Admixture, and Amino Acid-Dextrose Solutions
4.10.3.1 Solution containers and administration sets for parenteral nutrition (PN), total nutrient admixture (TNA), and amino acid-dextrose formulations must be replaced every 24 hours. Maximum hang time for any PN or TNA container must not exceed 24 hours.
4.10.4 Lipid Injectable Emulsion (Separate from PN)
4.10.4.1 The administration set must be replaced with each new infusion of lipid injectable emulsion administered separately from PN. Maximum hang time is 12 hours per container.
4.10.4.2 If the prescribed volume requires more than 12 hours for administration, a new container and new administration set must be initiated for the second 12-hour period.
4.10.4.3 DEHP-free administration sets are required for all lipid injectable emulsion infusions (see Section 4.7).
4.10.5 Total Nutrient Admixture (3-in-1)
4.10.5.1 Hang time for total nutrient admixture (3-in-1) formulations may extend to 24 hours. The reduced pH and increased osmolarity of these formulations inhibit bacterial growth relative to separate lipid emulsions.
4.10.5.2 DEHP-free administration sets are required for all TNA infusions (see Section 4.7).
4.10.6 Propofol
4.10.6.1 Administration sets and all add-on devices (including stopcocks) used for propofol infusions must be replaced at a minimum every 6 to 12 hours in accordance with the manufacturer’s instructions for use (IFU).
4.10.7 Blood and Blood Components
4.10.7.1 Blood administration sets must be changed in accordance with the manufacturer’s IFU. Standard blood filters have a maximum capacity of 4 units; manufacturer IFU must be followed for all filter and set replacements.
4.10.7.2 If the first unit of a blood transfusion requires 4 hours or longer for administration, the administration set and filter must not be reused for subsequent units.
4.10.7.3 When rapid blood resuscitation is required, the clinical team must evaluate whether add-on devices (stopcocks, needleless connectors) are limiting infusion flow rates and remove or reconfigure them accordingly.
4.10.8 Hemodynamic and Arterial Pressure Monitoring Systems
4.10.8.1 Disposable pressure transducers, continuous flush devices, flush solutions, and all associated administration set components used for hemodynamic and arterial pressure monitoring must be replaced every 96 hours, immediately upon suspected contamination, or when product or system integrity is compromised.
4.10.8.2 Evidence supports that 7-day replacement intervals for peripheral arterial line sets are noninferior to 4-day intervals with respect to infection outcomes. Institutions may adopt extended intervals for peripheral arterial monitoring systems in accordance with this evidence and local infection prevention review.
4.11 Quality Improvement
4.11.1 Monitoring Requirements
4.11.1.1 Quality data related to administration set management must be monitored and reviewed through an interprofessional process that includes representatives from vascular access, infusion therapy, pharmacy, infection prevention, and nursing leadership.
4.11.1.2 Quality monitoring must include assessment of accurate drug dose delivery and systematic evaluation of practice changes related to set replacement frequency.
4.11.1.3 Clinical practices must be adjusted in response to quality data analysis. Findings and action plans must be documented and reported through established quality improvement structures.
5. Compliance
5.1 Key Performance Indicators
5.1.1 Percentage of administration sets labeled with date of placement per audit cycle.
5.1.2 Compliance rate with infusion-type-specific replacement intervals (PN/TNA, propofol, blood, continuous, intermittent) assessed via direct observation and documentation audit.
5.1.3 Rate of DEHP-free set use for lipid-based infusates.
5.1.4 Percentage of staff completing administration set management education on an annual basis.
5.1.5 Documented system tracing compliance at care transitions, as assessed through unit-based safety audits.
5.1.6 Administration set-associated adverse event rate (contamination events, tubing misconnections, dose delivery failures) reported through the organizational event reporting system.
5.1.7 Blood culture contamination rate attributable to administration set or needleless connector access.
5.2 Enforcement
5.2.1 Compliance with this policy is the professional and institutional responsibility of all clinical personnel involved in the initiation and management of infusion therapy.
5.2.2 Identified non-compliance will be addressed through the applicable unit-based performance management process, with escalation to clinical leadership as warranted.
5.2.3 Recurring non-compliance at the unit level will trigger a targeted educational intervention and re-audit within 30 days.
5.2.4 Significant deviations from policy requirements that result in patient harm must be reported through the organizational event reporting system and reviewed by the Vascular Access Governance Committee.
6. Exceptions
6.1 Manufacturer-specified replacement intervals shorter than those defined in this policy supersede the intervals stated herein. Documentation of the manufacturer IFU must be maintained and available at the unit level.
6.2 Replacement intervals may be shortened at any time based on clinical judgment when contamination is suspected, system integrity is compromised, or patient safety requires immediate set change. No exception process is required for early replacement.
6.3 Institutional participation in approved clinical research protocols may modify replacement intervals per approved protocol parameters. Such modifications require Institutional Review Board (IRB) approval and must be documented in the research protocol on file.
6.4 Exceptions to the DEHP-free requirement for lipid-based infusates require documented review by Pharmacy and approval by the Vascular Access Governance Committee based on unavailability of compliant product with contemporaneous documentation of risk mitigation.
7. Related Documents
- ANTT Policy
- Needleless Connector Management Policy
- Parenteral Nutrition Administration Policy
- Blood and Blood Product Administration Policy
- Vascular Access Device Flushing and Locking Policy
- Infusion Therapy Medication Safety Policy
- Vascular Access Device Post-Insertion Care Policy
- Hazardous Drug Management Policy
- Product Management and Device Safety Policy
- Manufacturer Instructions for Use — Administration Set Products (on file, Pharmacy)
8. Revision History
| Version | Date | Author | Description |
|---|---|---|---|
| 1.0 | 2024-05-20 | Vascular Access Governance Committee | Initial policy |
| 1.1 | 2025-10-14 | Vascular Access Governance Committee | Updated replacement intervals for peripheral arterial monitoring to reflect 7-day noninferior evidence; clarified DEHP-free requirements for TNA and lipid emulsions; added quality improvement monitoring requirements |
References
Rupp ME, Majorant D. Prevention of vascular catheter-related bloodstream infections. Infect Dis Clin North Am. 2016;30(4):853-868. doi:10.1016/j.idc.2016.06.001 ↩︎ ↩︎
Buetti N, Marschall J, Drees M, et al. Strategies to prevent central line-associated bloodstream infections in acute-care hospitals: 2022 Update. Infect Control Hosp Epidemiol. 2022;43(5):553-569. doi:10.1017/ice.2022.87 ↩︎ ↩︎
O’Grady NP, Alexander M, Burns LA, et al. Guidelines for the prevention of intravascular catheter-related infections. Am J Infect Control. 2011;39(4 Suppl.):S1-S34. doi:10.1016/j.ajic.2011.01.003 ↩︎
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