Flow-Control Devices for Infusion Therapy Policy

1. Policy Statement

It is the policy of this organization that flow-control devices for infusion therapy shall be selected, programmed, and monitored in a manner that ensures safe, accurate delivery of prescribed infusion therapy and minimizes the risk of infusion-related medication errors. Electronic infusion pumps with dose error-reduction systems (smart pumps) shall be the standard for medication and solution administration in acute care settings. All flow-control devices shall be used in accordance with manufacturer specifications, organizational drug library requirements, and the clinical needs of the patient. Patient safety considerations, including alarm management, shall be integrated into all infusion device programs.

2. Purpose

This policy exists to:

• Define criteria for appropriate flow-control device selection based on patient, therapy, and setting factors.
• Establish standards for non-electronic and electronic flow-control device use.
• Mandate smart pump drug library utilization and compliance requirements.
• Define alarm management responsibilities to reduce alarm fatigue.
• Establish infusion monitoring requirements during therapy.
• Specify organizational standardization requirements for pump types and cross-patient use prevention.
• Define care transition and patient education requirements for home settings.

3. Scope

This policy applies to:

• All licensed clinical personnel selecting, programming, and monitoring infusion flow-control devices.
• All care settings including acute inpatient, ambulatory, perioperative, procedural, radiology, emergency, infusion center, and home care.
• All electronic and non-electronic infusion flow-control devices used within this organization.

4. Policy Requirements

4.1 Flow-Control Device Selection Principles

4.1.1 Flow-control device selection shall be individualized and shall account for the following patient-specific factors:

• Patient age, condition, and mobility
• Ability and preference for self-administration (particularly in home care)
• Lifestyle considerations affecting device portability or management

4.1.2 Therapy-related factors guiding device selection include:

• Vascular access device type
• Infusion therapy type, frequency, dosing, and stability
• Required infusion rate precision and potential for adverse effects
• Prescribed flow rate and rate variability risk

4.1.3 Healthcare setting and reimbursement constraints shall be considered as secondary factors when patient safety needs are met.

4.2 Non-Electronic Flow-Control Devices

4.2.1 Non-electronic flow-control devices are appropriate for low-risk infusions where flow rate variation does not pose a clinically significant risk. Acceptable non-electronic options include:

• Gravity infusion sets
• Mechanical pumps: elastomeric balloon, spring-based, and negative-pressure designs
• Manual flow regulators (milliliters-per-hour rate setting)
• Electronic drip monitors used with gravity administration sets

4.2.2 Gravity infusion is an appropriate alternative to electronic pumps for the following specific scenarios:

• Intravenous hydration
• Select intravenous antibiotics per organizational formulary designation
• Non-high-alert medications with wide therapeutic indices
• Peripheral vesicant infusions when electronic pump is not available

4.2.3 Manual flow regulators shall be preferred over roller clamps for gravity infusions requiring more consistent rate delivery. Roller clamps shall not be used as the primary rate-control mechanism for any regulated infusion.

4.2.4 Non-electronic flow-control devices shall not be used for highly viscous infusions (e.g., colloids), high-alert medications, or therapies requiring precise rate delivery. Electronic infusion pumps are required for these applications.

4.2.5 Elastomeric devices may be used in home care settings as a viable alternative to electronic pumps for defined outpatient infusion indications, including home intravenous antibiotherapy. The following requirements apply:

• Needleless connectors shall be fully engaged to eliminate flow restriction
• Environmental temperature effects on drug stability shall be evaluated for continuous elastomeric infusions
• Organizational criteria for elastomeric pump candidacy shall be applied before dispensing to home care patients

4.3 Electronic Infusion Pumps

4.3.1 Electronic infusion pumps shall be used for all therapies requiring precise flow control for safe administration, including but not limited to:

• High-alert medications (vasoactive agents, insulin, anticoagulants, chemotherapy)
• Continuous infusions of any medication with a narrow therapeutic index
• Neonatal and pediatric small-volume infusions requiring microbore delivery
• Epidural and intrathecal infusions (on designated epidural-only pumps)

4.3.2 All electronic infusion pumps used within this organization shall have the following minimum safety features:

• Anti-free-flow protection
• Air-in-line detection
• Pressure and occlusion alarms
• Audible alarms functioning properly and audible to both staff and patients

4.3.3 Alarm limits shall be set appropriately for patient condition and shall not be disabled or set outside the manufacturer-approved range without documented clinical justification.

4.3.4 Administration sets used with electronic infusion pumps shall include anti-free-flow mechanisms and be compatible per manufacturer specifications.

4.4 Smart Pump Dose Error-Reduction Systems

4.4.1 Electronic infusion pumps with dose error-reduction software (smart pumps) are the required standard for intravenous medication and solution administration throughout all acute care settings including ambulatory, perioperative, procedural, radiology, emergency, and infusion center environments.¹

4.4.2 Drug library use is mandatory. Manual programming outside the drug library and override of drug library alerts are prohibited except in documented exceptional circumstances with attending physician authorization. Each exception shall be logged and reviewed by pharmacy.

4.4.3 An interprofessional team including pharmacy and clinical nurse specialists shall monitor smart pump dose error-reduction software compliance monthly. Drug library compliance shall be maintained at 95% or greater. Results shall be reported to the patient safety committee.²

4.4.4 When available, smart pumps shall permit separate programming and limits for bolus/loading doses and continuous infusion rates to optimize safe delivery.

4.4.5 Drug libraries shall be updated on a regular schedule to reflect new drugs, revised protocols, drug shortages, and formulary changes. Drug library updates shall minimize unnecessary alert burden. End-user input shall be incorporated into drug library design and revision processes.³⁴

4.4.6 Smart pumps with electronic health record interoperability shall be configured to reduce manual programming errors, decrease false alarms, improve documentation completeness, and reduce wrong-patient infusion risk.⁵⁶⁷ Bidirectional EHR integration shall be a priority in all future device procurement decisions.⁸

4.4.7 Multichannel infusion pumps shall be used for single patients only. Simultaneous therapies delivered by different routes (e.g., intravenous and epidural) shall never be combined on the same pump channel.

4.5 Infusion Monitoring

4.5.1 Clinicians shall monitor all infusions during administration to verify safe and accurate delivery at prescribed rates and volumes. Monitoring frequency shall conform to organizational nursing standards and the risk level of the infused medication.

4.5.2 Medications requiring uninterrupted primary infusion shall be identified by pharmacy and documented in the drug library programming guidance to support appropriate co-infusion pump programming.

4.5.3 Accessory devices including administration sets, syringes, and filters shall be compatible with the selected flow-control device per manufacturer specifications. Syringe pumps delivering small-volume infusions shall use accessory devices with minimal internal volume (microbore tubing, shorter lengths) to minimize residual volume and prevent under-delivery.

4.5.4 Manually regulated infusion sets require regular assessment with flow verification through drop counting and infusion volume monitoring. The frequency of assessment shall conform to organizational policy and patient acuity.⁹

4.5.5 Clinicians shall recognize that electronic infusion pumps cannot detect infiltration or extravasation. Routine vascular access device site assessment shall be performed independently of pump monitoring, at intervals consistent with organizational policy.

4.6 Organizational Standardization

4.6.1 Pump type standardization within the organization shall be maintained to promote user familiarity with device operation and reduce programming errors attributable to unfamiliar interfaces.

4.6.2 Designated pump types shall be used for epidural infusions, enteral infusions, and irrigations to visually and functionally distinguish these from vascular access infusions. Channel labeling and delivery set color-coding shall support route differentiation.

4.6.3 Infusion pumps shall accompany patients during intra- and inter-facility transfers to minimize re-establishment of infusions and associated interruption or error risk.

4.6.4 End-users shall be included in flow-control device evaluation, selection, and implementation processes to enhance safety, usability, and adoption.

4.7 Alarm Fatigue Management

4.7.1 The organization shall implement an active program to reduce alarm and alert fatigue associated with infusion flow-control devices. This program shall include:

• Evidence-based alarm parameter settings following professional organization and manufacturer guidance
• Regular review of alarm frequency data by clinical unit and device type
• Targeted quality improvement efforts in areas with high alarm burden
• Collaboration with clinical staff, pharmacy, and biomedical engineering to identify and remediate persistent false alarm sources

4.7.2 Pump and infusate height relative to the patient shall be standardized according to manufacturer recommendations to reduce gravity-related flow and alarm variation.

4.7.3 Smart pump drug library alert rates shall be reviewed during monthly compliance audits. Excessive nuisance alerts shall be reviewed for library revision.

4.8 Care Transitions and Patient Education

4.8.1 Organizational policy shall address flow-control device management across care transitions. Patients arriving with personal infusion devices (e.g., insulin pumps) shall have those devices managed according to a documented protocol addressing device continuation, pump assessment, and clinical monitoring.

4.8.2 Patients and caregivers using flow-control devices in home care settings shall receive thorough education prior to discharge or initiation of home therapy, including:

• Safe and effective device operation
• Identification of device malfunction or therapy failure
• Backup plans and escalation procedures for failure scenarios
• Available resources for support and troubleshooting
• Infection prevention requirements specific to the device in use

4.8.3 Patient education shall be documented in the health record and patient competency return-demonstration shall be completed prior to home therapy initiation.

5. Compliance

5.1 Monitoring. Compliance shall be monitored through:

• Monthly smart pump drug library compliance audits (target: ≥95%)
• Tracking of library override events and clinical justification review
• Alarm frequency data review by unit and device
• Adverse drug event surveillance related to infusion programming errors
• Patient education documentation review for home care discharges
• Biomedical engineering maintenance and calibration records

5.2 Key Performance Indicators.

• Smart pump drug library compliance rate (target: ≥95%)
• Infusion-related adverse drug events (target: zero preventable events; trended)
• Drug library override rate (tracked and reviewed monthly)
• Patient home care education documentation completion (target: 100%)
• Alarm fatigue interventions implemented (tracked annually)

5.3 Enforcement. Bypassing the smart pump drug library without documented clinical justification and attending authorization constitutes a medication safety violation. First occurrence shall trigger immediate education and documentation review. Repeated violations shall be escalated to clinical governance and performance management processes.

6. Exceptions

6.1 Manual programming outside the drug library may occur in rare clinical circumstances where the prescribed therapy is not represented in the current drug library, provided attending physician authorization is documented and pharmacy is notified immediately for expedited drug library update.

6.2 Use of non-electronic flow-control devices in settings normally requiring electronic pumps may be authorized during device shortage periods by designated organizational leadership, with documented clinical risk assessment and compensatory monitoring measures.

7. Related Documents

• POL-003: Evidence-Based Selection and Clinical Monitoring Standards
• POL-012: Documentation in the Health Record for Vascular Access
• POL-009: Patient Education and Infusion Therapy
• Hazardous Drug Management Policy (this collection)
• Controlled Substance Diversion Prevention Policy (this collection)
• Blood and Fluid Warming Policy (this collection)
• Organizational Drug Library and Pharmacy Policy (Pharmacy Department)
• Institute for Safe Medication Practices (ISMP) Guidelines on Safe Pump Use

8. References

9. Revision History