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Accuracy and consistency of drop delivery in infusion pumps.

Advances in intensive care medicine has made us more depend on infusion pumps to deliver accurate amounts of fluids to sick newborns, children and adults. When infusing rapid-acting critical drugs to patients, it is important not only to deliver accurate fluid-volume amounts over a specified time, but also to deliver the fluid at a constant rate with minimal fluctuation. The accuracy of drop delivery in four infusion pumps (IVAC 530, IVAC 560, IMED 922 and IMED 960) at different infusion rates were examined in a laboratory setting by using a photoelectric sensor and a computer. When it was not in its cassette-filling period, the IMED 960 was the most accurate at delivering fluid-drops, with a coefficient of variance (CV) of less than 10% at each flow rate. Yet, like other piston-cylinder cassette pumps, its cassette filling time and stabilizing period after cassette filling were longer at lower flow rates. Both the IVAC 530 and the IMED 922 delivered fluids irregularly with large coefficients of variance (CVs). IVAC 560 had the best results for consistency of drop-delivery over a 4-hour period.

Humans↗

Comparison of three intravenous infusion pumps for monoplace hyperbaric chambers.

We compared the infusion accuracy of the Baxter Flo-Gard 6201, IVAC 530 and Abbott Lifecare 3HB pumps with saline and enteral formula at chamber pressures from 86.1 kPa (0.85 atm abs) to 304 kPa (3.0 atm abs). The Baxter pump infused +/- 10% saline at all tested pressures and rates (1-1,999 ml/hr). At 1 ml/hour, the IVAC infused 18% more saline than expected (86.1 kPa). The Abbott infused -15% and -23% than expected at 202.6 kPa (999 ml/hr) and 304 kPa (800 ml/hr), respectively. A 10-minute chamber compression and decompression (86.1-304-86.1 kPa) resulted in lower-than-expected measured volumes during compression (64-112%) and higher-than-expected measured volumes during decompression (62-114%) at rates of 1, 5, and 10 ml/hr for all pumps. Enteral infusions (100 ml/hour) resulted in -20% to +12% fluid volume discrepancies. In conclusion, the Baxter pump had the best overall performance. Changes observed during compression and decompression may be clinically important.

Atmosphere Exposure Chambers↗

Ambulatory insulin infusion pumps.

We evaluated nine ambulatory insulin infusion pumps from seven manufacturers, basing our ratings primarily on human factors--size, weight, battery type, and adequate reservoir capacity (i.e., 48 hr insulin supply). Of these, seven were rated Acceptable, and two were rated Acceptable-Not Recommended.

Evaluation Studies as Topic↗

Portable data acquisition and control apparatus for implanted drug infusion pump interrogation.

Now that implantable drug infusion pumps are well established clinically, methods for diagnosing suspected pump failures are needed. The authors previously constructed a benchtop data acquisition and control apparatus to assist our work in developing new pump technology. Although this device is technically capable of in vivo pump monitoring, it is cumbersome. Thus, they recently created a portable interrogation unit with more limited features. This portable pump interrogation apparatus consists of a 32 bit MS-DOS labtop computer, data acquisition software, an analog/ASCII interface, a pressure transducer, and appropriate fluid conduits. Communication between the device and the implanted pump is via a percutaneous needle puncture of the drug reservoir refill septum. This procedure is identical to that employed in a standard pump refill. Pump performance is evaluated by incrementally filling the pump reservoir while simultaneously measuring reservoir pressure. The resulting data are presented on the computer screen as a plot of pressure versus volume that quickly and simply either eliminates or confirms the reservoir pressure source as a failure mode. Diagnostic runs are saved on file for archival purposes. Their benchtop apparatus has been a valuable and reliable tool over many years of use. The authors believe that their portable apparatus will be equally beneficial.

Data Collection↗

I.v. regulation device vs. infusion pump: a cost-savings study.

A study of intravenous infusion pump usage patterns showed that nurses frequently were using this device for convenience rather than for clinical need. Patient charges and actual cost savings were calculated based on substitution of a manual flow regulation device for an infusion pump. A potential savings of $674,508 in capital costs and $271,408 in annual patient costs were realized when nurses' practice was changed.

Cost Savings↗

I.v. therapy: selection, use and management of infusion pumps.

A locally agreed, coordinated policy is essential for the selection and purchase of infusion pumps, and should form part of overall policy for medical device management. When developing a purchasing policy the core needs of all relevant professional groups should be addressed, to ensure that an informed, integrated strategy evolves. This will enhance the wider responsibilities associated with, for example, device training and education, and medical device maintenance, as well as the basic clinical requirements of the infusion pump. The Medical Devices Agency provides guidance on the selection and purchasing of infusion pumps through its medical device evaluation programme, which uses evidence-based systems that categorize devices by clinical infusion risk.

Humans↗

Continuous subcutaneous pump infusion of somatostatin analogue SMS 201-995 versus subcutaneous injection schedule in acromegalic patients.

Diurnal serum GH patterns were determined in 10 acromegalic patients before treatment, after 3 d continuous s.c. pump infusion and then after 3 d with three equal daily s.c. injections in both instances totalling 100 micrograms/24 h. Subcutaneous injections (33 micrograms) induced impressive suppression of serum GH lasting 3-6 h in eight patients followed by escape to pretreatment values before the next injection. In contrast, continuous infusion resulted in greater and more stable 24 h suppression to the levels reached at the nadir between injections. Suppression of mean 24 h serum GH below 5 ng/ml was achieved by pump treatment in four patients, while two patients had mean values between 5 ng/ml and 10 ng/ml. In four patients occasional or all levels were above 10 ng/ml (24 h average 12.4-102 ng/ml) implying either that adequate suppression by the SMS 201-995, was impossible during the 3 d pump infusion period, or that the dose administered was inadequate. Carbohydrate tolerance was unaffected in either regimen, indicating that reduction in insulin antagonistic hormones balanced inhibition of insulin release. Interestingly, and in contrast to somatostatin, SMS 201-995 did not inhibit TSH release. No untoward effects were observed at the moderate dosage and blood clinical chemistry was unchanged. Fairly constant diurnal serum SMS 201-995 values were obtained during pump infusion, while levels undulated inversely with serum GH during injection treatment. Average diurnal serum somatostatin-C immunoreactivity (all patients) decreased from 496 +/- 129 (mean +/- SD) to 385 +/- 100 ng/ml (P less than 0.003) during pump treatment and did not decrease further during the following 3 d injection treatment (363 +/- 76 ng/ml). The normal adult mean is 179 +/- 40 ng/ml. Computer tomographic (CT) scans of the sellar region were performed in all patients before and after the experimental week. Two patients had extracellular tumours whose size decreased from 8.2 to 4.1 cm3 and from 12.6 to 10.5 cm3. The results demonstrate that superior and stable suppression of GH secretion is obtained during continuous s.c. pump infusion of SMS 201-995.

Acromegaly↗

The Panomat P-10 micro-volumetric infusion pump is suitable for continuous drug administration at minimal flow rates.

PURPOSE: To evaluate the performance of the Panomat P-10 micro-volumetric infusion pump for its use in drug administration at minimal flow rates (microL x hr(-1); e.g., intrathecal application). METHODS: Fluid delivery at steady state conditions, and after vertical displacement of the syringe pump by -50 cm was determined gravimetrically. The Panomat P-10 infusion pump was evaluated at 4, 10, 20, 50 and 100 microL x hr(-1), and compared to a conventional syringe pump assembly at 100, 200, 500 and 1000 microL x hr(-1). Measurements were repeated twice with two different devices of each syringe pump system, and with two syringes. Data are reported as mean +/- SD. RESULTS: Steady state fluid delivery of the Panomat P-10 infusion pump revealed less than 5% deviation to set flow rate at 10, 20, 50 and 100 microL x hr(-1), and 12% deviation at 4 microL x hr(-1). Mean zero-drug delivery time (ZDDT) after lowering the pump by 50 cm at 4 microL x hr(-1) flow rate was 38.4 +/- 7.3 min. At 100 microL x hr(-1) and with original infusion line ZDDT was almost 20 times shorter when compared to the conventional syringe pump assembly (1.5 +/- 0.5 min vs 28.5 +/- 5.0 min). CONCLUSION: The tested Panomat P-10 micro-volumetric pump shows an acceptable flow accuracy as well as a low susceptibility to vertical displacement, and is therefore suitable for continuous drug administration at minimal flow rates. The technology used in this pump carries potential implications for a new generation of syringe pumps.

Drug Delivery Systems↗

Hemodynamic response to intentionally altered flow continuity of dobutamine and dopamine by an infusion pump in infants.

STUDY OBJECTIVE: To evaluate the effect of an intentional alteration in infusion pump flow continuity on the hemodynamic stability of infants receiving either dobutamine or dopamine. DESIGN: Prospective, open-label study. SETTING: A university-affiliated children's hospital. PATIENTS: Ten hemodynamically stable infants (age 2 wks-10 mo) in intensive care receiving dobutamine (5) or dopamine (5). Three patients received both agents and were studied at independent times. INTERVENTIONS: Dobutamine and dopamine were administered using the Flo-Gard VP pump that delivers an intentional alteration of flow continuity (rate pulse). Heart rate and mean arterial pressure (MAP) were recorded every second. Analysis was based on the measurements obtained from the first 5 minutes on the study pump and the 2 minutes before and after the rate pulse. MEASUREMENTS AND MAIN RESULTS: Although hemodynamic changes in pre- and post-rate pulses were statistically significant (p < 0.05) in some individuals, only one infant had a greater that 10% change in MAP 2 minutes after the rate pulse. Alterations in hemodynamics were not consistent among or within patients. CONCLUSION: In infants requiring dobutamine or dopamine, no clinically significant pharmacodynamic effects were associated with alteration in continuity of drug delivery caused by the single positive rate pulse. Therefore, we conclude there is no contraindication to the use of this infusion pump in hemodynamically stable infants receiving these drugs.

Cardiotonic Agents↗

The hybrid model: a new pharmacokinetic model for computer-controlled infusion pumps.

Classical pharmacokinetic models used in computer-controlled infusion pumps (CCIPs) assume instantaneous mixing of drug in blood; however, the average recirculation time of blood in man is approximately one minute. To investigate the effects of recirculation dynamics on the transient performance of CCIPs, we propose a hybrid physiologically-based pharmacokinetic model for the narcotic alfentanil. A three-compartment model was derived from the response of the hybrid model to a short infusion and used to compute a CCIP infusion targeting 450 micrograms/l. For this infusion, the hybrid model predicts that the arterial plasma concentration will overshoot the target concentration by 39 percent with an average prediction error of 3 percent. The overshoot and average prediction error increase to 100 and 25 percent respectively when using a three-compartment pharmacokinetic model derived from a bolus. The overshoot can be reduced by decreasing the maximum possible infusion rate, or by increasing the zero-order hold infusion interval.

Alfentanil↗

A simple analytical solution to the three-compartment pharmacokinetic model suitable for computer-controlled infusion pumps.

The disposition of many drugs following an intravenous bolus injection can be described by a biexponential or triexponential equation. Computer-controlled infusion pumps have been developed which dose intravenous drugs based on models of drug disposition. These pumps can maintain steady plasma drug concentrations and facilitate controlled increases and decreases in drug concentration, enhancing titration of intravenous drugs. Several investigators have proposed analytical solutions to the biexponential and triexponential disposition functions for use in computer-controlled infusion pumps. Because of the complexity of these analytical solutions, other investigators have used numerical techniques to approximate the analytical solution. We have derived an extremely simple analytical solution to polyexponential disposition functions. This solution simplifies both the prediction of the plasma drug concentration by a computer-controlled infusion pump and the stepwise calculation of the infusion rate required to maintain constant plasma drug concentrations.

Infusion Pumps↗

Intelligent intravenous infusion pumps to improve medication administration safety.

Intravenous (IV) medications are vital in the management of hospitalized patients. Inpatients frequently receive several IV medications concurrently, and these are commonly delivered with infusion pump systems. In particular, critically ill patients receive potent "high-alert" IV drugs, many with narrow safety margins requiring careful nursing titration. However, while intravenous medications have important benefits, errors associated with IV medication administration can result in severe or life-threatening adverse drug events (ADEs). Although errors in prescribing are often intercepted, administration errors do not get caught with most current systems While several safety improvements in IV infusion pump design have reduced mechanical complications, errors with IV drug administration such as incorrect programming persist. Intelligent IV infusion pumps have integrated software to provide point of care decision support (DS). This software includes drug library profiles configured for specific patient care units and includes programming of safety limits for drug/dose calculations.

Decision Making, Computer-Assisted↗

The initial experience with the use of a portable infusion pump in the delivery of human menopausal gonadotropins.

The initial experience with the use of a portable infusion pump for the delivery of human menopausal gonadotropins (hMG) in the therapy of ovulation dysfunction of women who failed to conceive following (1) either clomiphene citrate (five patients with polycystic ovary syndrome) or danazol (three patients with mild endometriosis) and (2) standard intramuscular hMG-human chorionic gonadotropin therapy is reported. In six of these patients this approach was used because of suboptimal response of serum estradiol levels to standard hMG therapy, and all six patients had an increase in estradiol response with infusion therapy; therapy duration and total dosage of hMG were similar in both treatment modalities. Sonography suggested stimulation of several follicles with infusion therapy. Advantages and disadvantages of the use of the infusion pump for hMG therapy are discussed. In conclusion, hMG therapy via the infusion pump is feasible. This mode of administration appears to lead to more satisfactory follicular development in selected patients. Multiple follicular stimulation is to be expected. Self-administration of medication is readily achieved by the educated patient. Further consideration and exploration of hMG infusion therapy is suggested.

Adult↗

General-purpose infusion pumps.

In this issue, we are publishing our fourth evaluation of general-purpose infusion pumps. Although the basic technology is stable, we evaluated the performance of the new models on the market because many offer new features and hospitals rely on these devices for an increasing variety of IV therapies. The many consultation calls we receive from member hospitals are about the benefits and deficiencies of a given pump, as well as its reliability and ease of servicing. We evaluated 14 general-purpose infusion pumps from 9 manufacturers. The pumps differed significantly in performance, features, and cost. Areas of concern are infusion sets that allow free flow if not manually clamped on removal and detection of upstream occlusions. Most of the units are rated Conditionally Acceptable on the condition that users accept the responsibility of preventing free flow.

Cost-Benefit Analysis↗

PUMPSIM: a software package for simulating computer-controlled drug infusion pumps.

Advances in microcomputer technology have lead to the development of volumetric infusion pumps which can be controlled by a remote computer. Such pumps offer powerful capabilities for the administration of medications and fluids. Complex control strategies can be preprogrammed and the pump allowed to run with a minimum of supervision. The safety of patients is of the utmost importance. Therefore, great care must be taken to implement robust error avoidance, detection and correction protocols in the host control program. This paper describes a software simulator of a commercial infusion pump (Abbott Lifecare Model 4). Using the simulator in the development and debugging of control programs has several advantages over using the real pump: it provides detailed pump status information and it can stimulate various error and alarm conditions to comprehensively test the error recovery procedures of the control program.

Computer Simulation↗

The management of variant arterial anatomy during hepatic arterial infusion pump placement.

BACKGROUND: The success of hepatic arterial infusion pump (HAIP) placement in patients with variant arterial anatomy has not been well described. METHODS: Patients who underwent HAIP placement over a 5-year time period were evaluated. Arterial- and catheter-related pump complication rates and pump survival were compared between patients with normal and variant arterial anatomy. RESULTS: Pumps were placed in 265 patients. Variant anatomy was present in 98 (37%) patients. The presence of variant versus normal anatomy did not increase pump complication rates (8% vs. 4%; P =.18) or decrease pump survival (P =.12). In all patients with an isolated variant right or left hepatic artery (n = 56), ligation of the variant vessel and cannulation of the gastroduodenal artery (GDA) resulted in complete hepatic perfusion and no pump complications. Cannulation of vessels other than the GDA (n = 22) was associated with increased pump complication rates (27% vs. 4%; P =.0001) and decreased pump survival (P =.002). CONCLUSIONS: In this study, HAIP placement in patients with variant anatomy was not associated with increased pump complication rates or decreased pump survival. An optimal strategy for managing variant anatomy is to ligate isolated variant vessels and cannulate the GDA.

Catheterization, Peripheral↗

[Electrical infusion pump for patient-controlled analgesia].

Electrical infusion pumps (pump) were featured with the focus on patient-controlled analgesia (PCA). The specification and functional aspects of four types of PCA pumps were briefly summarized and listed in two tables. The clinical application of these PCA pumps should benefit both patients and medical staffs. For the successful introduction of PCA pumps into clinical practice, a medical team must be organized, where not only anesthesiologists but also nurses, pharmacists, medical electronic engineers and surgeons are expected to participate.

Analgesia, Patient-Controlled↗

Acute complications associated with insulin infusion pump therapy. Report of experience with 161 patients.

We determined the frequency of acute complications associated with insulin pump therapy in 161 insulin-dependent patients followed up for a total of 2,978 patient-months. Diabetes control improved substantively with pump therapy, but 42% of the patients experienced one or more acute complications while using insulin pumps. Infected infusion sites, ketoacidosis, and hypoglycemic coma occurred once in every 27, 78, and 175 patient-months, respectively. More patients experienced ketoacidosis after the onset of pump therapy than in an equivalent interval immediately before the onset of pump therapy. Ketoacidosis also occurred in more patients using pump therapy than in a comparison group of 165 patients receiving conventional insulin injections surveyed during an equivalent period. The frequency of hypoglycemic coma was not significantly changed by pump therapy.

Acute Disease↗