Add-On Devices for Vascular Access Systems Policy

1. Policy Statement

All clinicians who configure, assemble, or manage vascular access infusion systems shall use add-on devices only when a clearly defined clinical purpose exists, shall select devices with luer-lock or integrated connection mechanisms, and shall limit device burden to the minimum necessary for safe care delivery. Add-on devices shall be used in strict accordance with manufacturer instructions for use, shall be replaced according to defined triggers and institutional protocols, and shall never be reattached to a vascular access device hub after removal. Hub disinfection shall be performed before every add-on device replacement to protect patient safety and reduce catheter-associated infection risk.¹²

2. Purpose

• To define the categories of add-on devices used in vascular access infusion systems and establish the clinical indication requirement for their use
• To require luer-lock or integrated connection mechanisms for all add-on devices to prevent accidental disconnection, misconnection, and premature vascular access device loss
• To establish the principle of minimum necessary device burden and identify the patient safety risks associated with excessive add-on device use
• To specify configuration requirements for stopcocks, manifolds, and closed system transfer devices that minimize contamination risk
• To define the impact of add-on devices on infusion accuracy and establish consultation requirements for precision-dosing therapies
• To establish mandatory hub disinfection requirements preceding any add-on device replacement
• To define replacement triggers and intervals that apply universally across add-on device types

3. Scope

• All registered nurses, licensed practical nurses, advanced practice providers, pharmacists, and other licensed clinicians who assemble, configure, or manage peripheral or central vascular access infusion systems
• All peripheral intravenous catheters, midlines, peripherally inserted central catheters, tunneled central venous catheters, implanted ports, and hemodialysis access devices
• All add-on devices incorporated into vascular access infusion systems, including: single-lumen and multilumen extension sets, manifold assemblies, extension loops, cannula caps, needleless connectors, in-line filtration devices, stopcocks and three-way taps, closed system transfer devices (CSTDs), and safety release valves and connectors
• All clinical settings, including inpatient, ambulatory infusion, procedural, home health, and long-term care environments

4. Policy Requirements

4.1 Clinical Indication and Device Definition

4.1.1 Clinical Indication Requirement

4.1.1.1 Add-on devices shall only be incorporated into an infusion system when there is a clearly defined clinical purpose for each device. The clinical rationale for each add-on device shall be apparent from the plan of care or medication administration orders.

4.1.1.2 All add-on devices shall be used in accordance with the manufacturer’s instructions for use (IFU), including indications, contraindications, and compatibility requirements.

4.1.2 Definition and Scope of Add-On Devices

4.1.2.1 For the purposes of this policy, add-on devices include: single-lumen extension sets, multilumen extension sets, manifold assemblies, extension loops, cannula caps, needleless connectors, in-line filtration devices, stopcocks, three-way taps, closed system transfer devices (CSTDs), and safety release valves and connectors.

4.1.2.2 A catheter with a manufacturer-integrated extension set is considered part of the primary vascular access device and is not classified as an add-on device under this policy.

4.2 Connection Compatibility Requirements

4.2.1 Luer-Lock Requirement

4.2.1.1 All add-on devices incorporated into a vascular access infusion system shall feature luer-lock or integrated (bonded) connection mechanisms.

4.2.1.2 Luer-lock and integrated connections are required to: ensure device compatibility within the infusion system, establish secure connections that withstand patient movement and care activities, reduce the frequency of hub manipulation, and minimize the risks of fluid leaks, accidental disconnections, misconnections to unintended routes, and premature vascular access device loss.

4.2.1.3 Devices with slip-tip or non-locking connections shall not be incorporated into vascular access infusion systems.

4.3 Device Burden Minimization

4.3.1 Minimum Necessary Configuration

4.3.1.1 The number of add-on devices incorporated into any infusion system shall be limited to the minimum required to safely deliver the prescribed therapy.

4.3.1.2 Each additional add-on device incorporated into an infusion system increases the number of connection points available for microbial contamination and increases the overall complexity of the infusion system.

4.3.1.3 Clinicians shall evaluate the current add-on device configuration at each patient assessment and remove any device for which the clinical indication no longer exists.

4.4 Stopcock and Manifold Configuration

4.4.1 Preferred Configuration

4.4.1.1 When stopcocks or manifolds are required, configurations with integrated needleless connectors are preferred over configurations with solid caps on unused ports.

4.4.1.2 When a stopcock or manifold with a solid cap is present, the solid cap shall be replaced with a needleless connector as soon as clinically feasible. This configuration maintains a closed infusion system, reduces infection risk associated with open ports, and enables proper flushing of each port.

4.4.1.3 Stopcocks and three-way taps used as primary access ports shall be replaced with needleless connectors as soon as clinically indicated.

4.4.2 Contamination Risk Evidence

4.4.2.1 Research demonstrates that the method of port closure has a greater influence on contamination risk than the internal fluid displacement characteristics of the connector or stopcock. Closed systems with needleless connectors consistently demonstrate lower contamination rates than configurations with open stopcock ports.

4.5 In-Line Filtration in Add-On Device Configurations

4.5.1 Indication Requirement

4.5.1.1 Routine use of in-line filtration devices solely for the prevention of thrombophlebitis is not supported by evidence and shall not be used as the sole clinical indication for adding a filtration device to an infusion system.

4.5.1.2 Filtration decisions shall be based on specific clinical circumstances, including infusate type, patient population, and clinical risk factors, as defined in the Filtration in Vascular Access Device Management Policy.

4.5.2 Preferred Filter Integration

4.5.2.1 When in-line filtration is clinically indicated, administration sets with integrated in-line filters are preferred over separate add-on filter devices to minimize the total number of connection points in the infusion system.

4.6 Infusion Accuracy Considerations

4.6.1 Impact of Add-On Devices on Flow Characteristics

4.6.1.1 All add-on devices can alter the flow characteristics of an infusion system. Extra-long extension tubing, multiple in-line devices, and devices with high internal volumes affect the delivery accuracy of infusion pumps and gravity infusions.

4.6.1.2 When extra-long tubing or multiple in-line add-on devices are used in combination with an infusion pump, the clinician shall consult the infusion pump manufacturer’s IFU to confirm compatibility and assess potential impact on delivery accuracy.

4.6.1.3 Accuracy considerations are particularly significant for precision-dosing therapies, including vasoactive medications, insulin infusions, concentrated electrolyte infusions, and chemotherapy. Pharmacy consultation shall be obtained when accuracy concerns cannot be resolved by reference to manufacturer documentation.

4.7 Closed System Transfer Devices and Safety Release Valves

4.7.1 CSTDs

4.7.1.1 Closed system transfer devices shall be considered for use when administering hazardous drugs or other medications for which regulatory requirements or institutional policy mandates closed system handling.

4.7.1.2 CSTD use for other clinical applications shall be evaluated on a case-by-case basis. Clinicians and product selection committees shall monitor emerging literature on CSTD indications.

4.7.2 Safety Release Valves

4.7.2.1 Safety release valves and connectors shall be evaluated on a case-by-case basis. Use shall be guided by clinical indication and manufacturer IFU. Emerging literature shall be monitored.

4.8 Disinfection Before Add-On Device Access

4.8.1 Hub and Connection Point Disinfection

4.8.1.1 The hub or connection point of any add-on device shall be properly disinfected using active or passive disinfection technique per institutional protocols and manufacturer recommendations before any access through or replacement of the device.

4.8.1.2 Disinfection method, agent, contact time, and drying time requirements are specified in the Needleless Connectors for Vascular Access Devices Policy and shall apply to all connection points within the add-on device configuration.

4.9 Replacement Standards

4.9.1 New Vascular Access Device Insertion

4.9.1.1 All add-on devices shall be new at the time of attachment to a newly placed vascular access device. Previously used add-on devices shall not be transferred from a removed or discontinued VAD to a newly inserted VAD.

4.9.2 Administration Set Changes

4.9.2.1 When an add-on device is integrated into the primary or secondary administration set configuration, the add-on device shall be replaced at the time of the scheduled administration set change.

4.9.3 Disconnection from the Catheter

4.9.3.1 Any add-on device that has been disconnected from the vascular access device hub for any reason shall be replaced with a new device. Disconnected add-on devices shall not be reattached to the VAD hub.

4.9.4 Institutional Protocol Precedence

4.9.4.1 Facility-established replacement intervals and protocols that are more stringent than general recommendations shall supersede the general replacement standards in this policy.

4.9.5 Manufacturer Guidance

4.9.5.1 When manufacturer IFU specifies a maximum use duration or replacement criteria that differs from institutional protocol, the more restrictive requirement shall apply.

4.9.6 Loss of Product Integrity

4.9.6.1 Any add-on device demonstrating loss of product integrity shall be replaced immediately. Loss of integrity includes: visible contamination, suspected contamination, presence of residual blood or debris, device dysfunction, and any condition in which the sterility of the device cannot be confirmed.

4.9.7 Hub Disinfection at Replacement

4.9.7.1 The catheter hub shall be disinfected prior to replacing any add-on device, regardless of replacement reason.

4.9.7.2 The clinician shall verify that the disinfectant selected is compatible with both the catheter hub material and the add-on device material per manufacturer IFU before applying the disinfectant.

5. Compliance

5.1 Key Performance Indicators

• Percentage of infusion systems observed to contain only add-on devices with documented clinical indication
• Percentage of add-on device connections verified to use luer-lock or integrated connection mechanisms
• Rate of compliance with hub disinfection before add-on device replacement, as measured by direct observation audit
• Rate of compliance with the prohibition on reattaching removed add-on devices to the VAD hub
• Rate of documentation of pharmacist or pump manufacturer consultation when precision-dosing therapies are delivered through extended add-on device configurations
• Rate of stopcock and open-cap manifold port conversion to needleless connectors within institutional target timeframe

5.2 Enforcement

Non-compliance with add-on device requirements shall be addressed through the institution’s competency management, performance management, and patient safety reporting processes. Infusion system configurations observed to contain unnecessary add-on devices, incompatible connections, or reattached previously removed devices shall be corrected immediately. Repeated patterns of non-compliance shall be escalated to unit leadership and the Vascular Access Governance Committee. Adverse events attributable to add-on device misuse or configuration errors shall be entered into the institution’s event reporting system and reviewed by the Quality Improvement and Patient Safety programs.

6. Exceptions

Exceptions to the luer-lock connection requirement may be considered only in circumstances where no luer-lock compatible device exists for a required clinical function, and only with documented approval from the Vascular Access Governance Committee and the responsible prescriber. Any such exception shall be time-limited and subject to review. No exceptions are permitted to the prohibition on reattaching removed add-on devices to the VAD hub, the requirement for hub disinfection before device replacement, or the requirement that all add-on devices attached to a newly placed VAD be new.

7. Related Documents

• Needleless Connectors for Vascular Access Devices Policy
• Filtration in Vascular Access Device Management Policy
• Vascular Access Device Flushing and Locking Policy
• Central Venous Access Device Management Policy
• Peripheral Intravenous Catheter Management Policy
• Hazardous Drug Handling and Administration Policy
• Infusion Pump Safety and Operation Policy
• CLABSI Prevention Bundle Policy
• NIOSH Guidelines for Handling Hazardous Drugs in Healthcare Settings

8. Revision History

References