U.S. Elastomeric Infusion Pumps: An Overview
Elastomeric infusion pumps have become a common medical device utilized in the U.S. for continuous subcutaneous drug delivery. These pumps provide a viable alternative to traditional syringe pumps for outpatient medication administration. In this article, we will explore elastomeric infusion pumps in more detail, including their usage, advantages over other pump types, and regulatory landscape.
How Elastomeric Pumps Work
Elastomeric infusion pumps consist of a flexible elastomeric bladder enclosed within a protective case. The bladder contains the prescribed medication and is pressurized via a one-way valve. This internal pressure provides the constant force needed to administer the drug over time through an attached intravenous or subcutaneous administration set.
No electricity or battery power is required to operate these "analog" pumps. Once primed and started, the constant pressure within the bladder gradually pushes the medication through the tubing at a precise flow rate, typically over 24-72 hours depending on the volume capacity. Common medications delivered via elastomeric pumps include antibiotics, chemotherapy drugs, hydration fluids, analgesics, and others requiring continuous subcutaneous infusion.
Uses and Advantages
Elastomeric pumps are often preferred over traditional syringe pumps for long-term outpatient infusion therapy. Their portability allows for discreet, continuous medication delivery anywhere the patient goes. This provides independence and mobility not afforded by large electric syringe pumps that require an AC power source.
Additionally, elastomeric pumps reduce the number of physician office or clinic visits needed for medication administration compared to intermittent bolus injections. Patients can self-administer or receive assistance from a caregiver with minimal training. This represents a cost savings over repeated medical professional involvement.
The constant, precise flow rate achieved by elastomeric pumps also provides steadier drug levels that bolus injections cannot match. This uniform delivery better mimics the body's natural release of many hormones and prevents peaks and troughs in concentration that could lead to toxic or sub-therapeutic levels.
Regulatory Considerations
As medical devices, elastomeric pumps fall under the purview of the U.S. Food and Drug Administration (FDA). In 2003, the FDA reclassified elastomeric pumps from class I to class II devices, subjecting them to additional premarket notification requirements under the 510(k) process.
This was done to address adverse event reports associated with pump malfunctions, primarily bladder ruptures that resulted in either insufficient or overdelivery of medication. Manufacturers were required to validate and demonstrate pump reproducibility, accuracy, and safety features able to prevent free-flow should a bladder rupture occur.
Subsequent iterations and improvements to elastomeric pump technology have addressed many of these early issues. Modern pumps feature durable casings, improved bladders composed of stable isoelastic copolymers, auto-off features, and additional safeguards against free-flow. Comprehensive documentation and testing provide assurance of consistent, accurate fluid delivery profiles for FDA clearance and clinical use.
Current Manufacturers and Products
Several major companies produce and market different elastomeric pump systems approved for use in the U.S. Baxter and Hospira are longtime leaders with their infusion pump lines. Baxter's Colleague Pump features pressure-indicating tech to ensure proper priming and a single-use disposable unit.
Hospira's Option Pump system uses color-coded cassettes paired to matching controllers offering 24, 48, or 72 hour capacities. Kendall offers a simpler single-use Pump ’n Go for brief infusions. West Pharmaceutical Services' On-Q PainBuster is commonly used for post-surgical patient-controlled analgesia with a choice of ports.
Newer players like Vygon with their Ecoflac Pump further expand options within this booming pump segment. Manufacturers constantly strive to develop more user-friendly, accurate, and durable elastomeric pump technologies to facilitate effective long-term home care.
Elastomeric infusion pumps have gained widespread acceptance and use since their introduction, providing an important alternative to electric syringe pump systems. Their self-contained design allows for true portability and autonomy ideal for outpatient therapy requiring continuous subcutaneous drug administration over extended periods.
Technological refinements and improvements to materials and safety features have answered early regulatory concerns. Manufacturers continue innovating to meet the diverse needs of patients, providers and healthcare facilities. As such, elastomeric pumps will likely retain their central role in ambulatory infusion for years to come.
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