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A simple, mechanical infusion pump that employs a constant force, nonferromagnetic spring to squeeze a syringe is described. The contrast infusion rate is determined by the spring force, gadolinium solution viscosity, and the resistance of either a user-selected needle or a precision oriffice according to Poiseuille's Law or the Bernoulli effect. Its use in dynamic, gadolinium-enhanced 3D MR angiography is described.
General-purpose infusion pumps deliver liquid medications and other solutions to patients through intravenous (i.v.) or epidural routes at specified flows. They are most often used when greater accuracy or higher flows are needed than can be provided by manually adjusted gravity systems. In this Evaluation (which updates our February 1997 and April-May 1998 studies), we present our findings for four newly evaluated pumps from three suppliers: the Abbott Plum A+, the Alaris Medley Medication Safety System (MSS), and the Baxter Colleague CX and 3 CX. We also summarize our findings and update our ratings for 22 additional models. As our findings show, the factors that distinguish one pump from another are not performance issues, but rather patient safety considerations. Most of the currently available pumps perform reliably and accurately when properly used. However, not all models offer the same level of protection against pump programming errors and other events that can lead to i.v. medication errors. The pumps that we now recommend for consideration all incorporate a new type of safety feature that warns users when a programmed dose falls outside pre-defined "safe" limits. We call this feature a dose error reduction system. In addition, the recommended models all offer set-based free-flow protection that cannot be defeated. Pumps that lack one or both of these features are now rated either Not Recommended or Unacceptable.
We have developed a computer-controlled infusion pump to achieve rapidly and then maintain stable plasma thiopental concentrations in rats. Initially we derived the parameters of a triexponential pharmacokinetic model for thiopental, administered as a brief infusion to 10 rats, using nonlinear regression and standard pharmacokinetic equations. These parameters were incorporated into the pharmacokinetic model of a computer-controlled infusion pump. In a second group of animals this device was used to maintain three consecutive target thiopental concentrations ranging from 5 to 100 micrograms/ml in a stepwise fashion. Arterial blood gases were kept normal through controlled ventilation when necessary. The plasma thiopental concentrations in this second group of animals were generally higher than the target concentrations. The bias in pump performance (median prediction error) was +25%, and the inaccuracy (median absolute prediction error) was 26%. We fit the parameters of a three-compartment model to the plasma thiopental concentrations observed in the second group of animals. This produced a second set of thiopental pharmacokinetic parameters with the unique characteristic of having been derived from a computer controlled infusion study. These parameters were tested prospectively with a computer-controlled infusion pump in a third group of animals. This second set of thiopental pharmacokinetic parameters performed better, with a median prediction error of 0% and a median absolute prediction error of 15%. This study shows that it is possible to achieve rapidly and maintain steady plasma thiopental concentrations in the rat. Our results suggest that it is feasible to derive robust pharmacokinetic parameters from unusual drug dosing approaches, such as employed by a computer-controlled infusion pump.(ABSTRACT TRUNCATED AT 250 WORDS)
The delivery of continuous iv bleomycin and 5-fluorouracil to nine ambulatory cancer patients was studied using a novel disposable portable infusion pump, the Ar/Med Infusor. Although the chemotherapy was satisfactorily delivered, there were significant mechanical problems, including variable flow rates and substantial drug cartridge failure. Most therapy courses were finished within 10% of the projected termination time. Serious venous complications did not occur. While further exploration of various devices for outpatient continuous iv therapy is recommended, we believe that technical improvements are needed for the Ar/Med Infusor.
BACKGROUND: Many hyperbaric facilities use infusion pumps inside the chamber. It is therefore important to ensure that this equipment will perform accurately during hyperbaric conditions. The authors tested the function and accuracy of the Imed 965 and Infutec 520 volumetric infusion pumps, the Easy-pump MZ-257 peristaltic infusion pump, and the Graseby 3100 syringe pump. METHODS: The authors calculated the deviations of infused volumes at low and high rates (12-18 and 60-100 ml/h) on three different hyperbaric protocols (up to 2.5, 2.8, and 6 atmospheres absolute [ATA]), resembling a standard hyperbaric oxygen treatment and US Navy treatment tables used for decompression illness and for arterial gas embolism. Two examples of each pump model were examined in every experiment. RESULTS: The Easy-pump MZ-257 failed to function completely beyond a chamber pressure of 1.4 ATA, making it unsuitable for use inside the hyperbaric chamber. The Graseby 3100 failed to respond to all keyboard functions at 2.5-2.8 ATA, making it unsuitable for use in most hyperbaric treatments. The Imed 965 performed within an acceptable volume deviation (< or =10%) during most hyperbaric conditions. During the compression phase of the profiles used, and for the low infusion rates only, exceptional volume deviations of 20-40% were monitored. The Infutec 520 demonstrated an acceptable deviation (within 10%) throughout all the hyperbaric profiles used, unaffected by changes in ambient pressure or infusion rate. CONCLUSIONS: Commercially available infusion pumps operating during hyperbaric conditions demonstrate substantial variations in performance and accuracy. It is therefore important that the hyperbaric facility staff make a careful examination of such instruments to anticipate possible deviations in the accuracy of the equipment during use.
A computerized system was developed to examine the performance characteristics of infusion pumps. This system collects solution delivered by an infusion pump through an intravenous needle into a collection vessel. Using an inductor-type weight sensor and a semiconductor type of strain-gauge pressure sensor, the weight of the collection vessel and the pressure at the needle were monitored over a specific period (the sampling time), and changes in pressure, flow rate, and volume of fluid were calculated. This system was applied to five volumetric infusion pumps with different pumping mechanisms. Test conditions involved two different solutions, two sizes of needle gauge, and seven flow rates, for a total of 28 measurements per pump. Results showed considerable variation in the infusion pumps' performances based on differences in these indices. Use of an inductance weight sensor as a means to evaluate gravimetric performance appears to be an improvement over conventional methods, which use analytical balances for data generation. The results indicate that this system will be useful in evaluating the performances of commercially available infusion pumps as well as those in development.
BACKGROUND: The vast majority of infusion pumps used for rapid transfusion of large amounts of blood have never been properly examined regarding their influence on the quality of the red blood cells (RBCs) infused. In this study, we evaluated the effect of two different infusion pumps on the degree of RBC destruction following rapid experimental blood transfusion. METHODS: Divided into 2 groups according to age, 30 u of SAGM RBCs were infused through an experimental transfusion model by either a manual roller pump (MRP) or a pressure infusor pump (PIP). Fresh (i.e stored for 8-11 d) RBCs, 20 u, and 10 u of older (i.e. stored for 25-33 d) RBCs were randomly allocated to infusion with either of the two pumps. The rate of infusion was as fast as possible with the MRP, and with the PIP adjusted with an external applied pressure of 300 mm Hg. RBC samples collected before and after infusion were analyzed for total haemoglobin, free haemoglobin, haematocrit, total free potassium, lactate dehydrogenase (LDH) and the percentage of haemolysis. The time spent for each transfusion was measured by a stop watch. RESULTS: Following infusion, a marginal increase (i.e. considerably below 0.8%) in the percentage of haemolysis and LDH content was seen with both pumps. This increase was only statistically significant when RBCs stored for 8-11 d were used (P = 0.002 for both parameters). Irrespective of the age of the RBCs, no differences between the two pumps could be detected. Compared to the PIP, infusion with the MRP could be accomplished significantly faster, i.e. median 5.9 ml/s (5.2-6.4 ml/s) versus 2.9 ml/s (2.5-3.2 ml/s), (P < 0.0001). CONCLUSIONS: Both the pumps used in this study are safe alternatives for rapid transfusion of RBCs; however, with MRP this can be accomplished approximately twice as fast as with the PIP.
We designed and constructed a new miniature, open-loop insulin infusion pump specifically to overcome the problems of many first generation insulin infusers. Special features are small size, adjustable volumetric basal infusion rate, rapid electronically mediated prandial insulin boosts, facility for doubling and halving the basal infusion rate and/or prandial delivery, and alarms for low battery state, motor over-run, stoppage, and control circuit malfunction. The infuser takes a specially designed syringe prefilled with short-acting insulin, sufficient in most diabetic patients for at least 7 days treatment with 100 U/ml insulin. To test clinical efficacy nine insulin-dependent diabetic patients received continuous subcutaneous insulin infusion (CSII) with the new infuser for periods up to 6 mo. Four patients previously CSII-treated with a first-generation pump and five who were new to CSII achieved and maintained the expected degree of near-normoglycemia. There were no pump breakdowns and a questionnaire completed by patients during the study confirmed ease and simplicity of operation and an appreciation of the advantages of the new pump compared with one widely used first-generation infuser.
The stability of fluorouracil in four portable infusion pumps under simulated infusion conditions was studied. Three commercially available fluorouracil aqueous solutions (50 mg/mL) were used. Samples adjusted to six pH levels were examined for precipitate. Drug reservoirs of four different portable infusion pumps were filled with 70 mL of each fluorouracil injection. Under conditions simulating actual use, the reservoirs were attached to the pumps and the solutions were pumped at a rate of 10 mL/24 hours over a seven-day period at 25 degrees C and 37 degrees C. Samples at the distal end of the extension tubing were collected hourly for the first 10 hours and at 12-hour intervals thereafter. Visual observations and pH determinations were made immediately. Drug concentrations were determined by reverse-phase high-performance liquid chromatography. Diethylhexylphthalate (DEHP) concentrations (the result of leaching from the plastic tubing and container) were determined by gas chromatography. In the pH study, precipitate appeared immediately in all fluorouracil injections below pH 8.52; precipitate was observed after two to four hours at pH 8.60-8.68. Under simulated infusion conditions, no apparent changes in concentration or pH were detected with any of the brands of drugs or portable infusion devices. At 25 degrees C, a fine white precipitate was observed in the extension tubing of all devices with the Roche brand of fluorouracil 48 to 96 hours after the pumping cycle began. The amount of DEHP leached from the drug reservoirs over the seven-day period was less than 1 ppm at both temperatures. All tested brands of fluorouracil injection were found to be stable under simulated infusion conditions over a seven-day period at 37 degrees C.
OBJECTIVE: To report a continuous infusion of intrathecal meperidine via an implanted infusion pump for nonmalignant, chronic pain. CASE SUMMARY: A 69-year-old white woman had chronic, nonmalignant low-back pain and bilateral leg pain. Multiple drug therapies and other interventional techniques had failed. The patient achieved significant pain relief by a continuous infusion of intrathecal meperidine via an implanted infusion pump. DISCUSSION: To our knowledge, this is the first report of meperidine administered intrathecally by continuous infusion. Continuous infusion of intrathecal and epidural opiates by implanted infusion pumps is becoming more widely recognized as an alternative treatment for patients with chronic, benign pain. Epidural and intrathecal meperidine is an effective analgesic for short-term surgical procedures. Data reporting effective relief and safety with continuous intrathecal meperidine remain limited. CONCLUSIONS: Continuous intrathecal meperidine via an implantable infusion pump may be an effective alternative in the treatment of chronic pain.
The authors evaluated two platelet infusion pump systems, the Abbott Lifecare 5000 and the Omniflow 4000, for evidence of in vitro platelet damage and in vivo platelet recovery. When compared with gravity infusion, there was no significant difference in levels of LDH discharge, beta-thromboglobulin release, cell counts, or morphology score after platelet concentrates were infused through these pumps. When the pumps were compared to gravity infusion in thrombocytopenic oncology patients, no differences were noted in platelet-corrected count increments at 1-4 hours or 12-24 hours post-transfusion. The authors conclude that these infusion systems do not significantly injure or activate platelets and that they are efficacious for transfusing platelet concentrates to thrombocytopenic patients. These infusion pumps may be of clinical benefit to pediatric or adult patients with a history of prior transfusion reactions, when precise control of the rate and volume of platelet transfusion is desired.
Ultra slow infusion dynamic MR imaging using an infusion pump(IP-MRI) was performed in six patients with metastatic liver tumor or unresectable gastric cancer to evaluate ant-cancer drug distribution. We used un implanted port for the infusion of Gd-DTPA by infusion pump. On IP-MRI, the speed of Gd-DTPA infusion was very slow (0.01 ml/sec) , the same as drug infusion at chemotherapy. The contrast enhancement of tumors was extremely clear. Therefore, IP-MRI was considered feasible for the evaluation of drug distribution.
Infusion pumps are used in the hospital setting, nursing home, and increasingly, in the home. Medical Device Reports to the Food and Drug Administration of adverse events during the use of infusion pumps for a 10-year period are described. Examples of cases reported to the Food and Drug Administration are provided. The problems reported by medical facilities (hospitals, medical centers, hospital pharmacies, or nursing homes) are compared with those that occur in the home or reported by home health care agencies. Overall, there were no differences in the types of adverse events reported by medical facilities when compared with reports from home health care agencies. However, there were differences in the location of use of some of the infusion pumps studied, which could reflect the trend toward home care over the past decade.
The authors used in clinical practice an infusion pump driven by a rotation system with an occlusive pathway whereby the movement of the rotor is ensured by a stepper with reduction of the steps to 12,800 microsteps per revolution. As regards the degree of mechanical damage of the inserted tube of the infusion set this system did not differ from the keyboard system which is used by the majority of manufacturers as the driving unit of infusion pumps. Mechanical damage of the infusion set made from PVC was evaluated by the authors with regard to the amount of phthalic acid extracts which are added to PVC as softening agents and are not chemically linked. The authors recorded an increase of the temperature of the infusion solution during the flow through the driving unit in both investigated systems, however, the increase was smaller in the keyboard system. The increase of temperature was, however, in both instances small and has no impact on clinical practice. Contrary to the infusion pump with the keyboard system, the infusion pump with a rotor in an occlusive pathway and a microstep motor (12,800 microsteps per revolution) was significantly more accurate as regards dosage (evaluated as the difference between the required and actually achieved value of flow). The revealed difference was statistically significant at the 1% level. This greater precision of dosage can be ascribed to the point compression of the inserted and to the microvibrations transmitted from the rotor to the inserted tube of the infusion set which helps to recover after every compression the original volume (circular shape of section) of the inserted tube.
UNLABELLED: Syringe drivers are used in anaesthetics, intensive care and emergency medicine to deliver small volumes of highly potent drugs with continuous, constant and reproducible flow. For early recognition of interruptions of the drug delivery caused by occlusion of the infusion system, an alarm is triggered as soon as the system pressure exceeds a certain limit. The sensitivity of this alarm depends on the flow rate, type-specific cut-off pressure and the elastic parameters of the infusion system. The sudden release of pressure built up in the system after occlusion occurred can cause delivery of an uncontrolled drug bolus and hence an additional hazard. METHODS: Six syringe drivers that are widely used in clinical practice were tested for alarm delay and bolus delivery in the event of an occlusion in the system. First, the alarm pressures at flow rates of 10, 50 and 100 ml/h were measured. Then the alarm delay time and bolus volumes post-occlusion were assessed, using a basic infusion system (syringe + single infusion set). Finally, several alterations to the system like extension, tap battery with germ filters or branching were made and their impact on alarm delay and bolus volume measured. RESULTS: Because of the great differences in alarm pressures between the devices tested, there were marked differences in the alarm delay at same flow rates. Predictably, there was an indirect proportional link between alarm delay and flow rate. Using the basic infusion system, alarm delays between 23 s and 143 min were measured. In two of the tested syringe drivers, a pressure-release mechanism is activated with the pressure alarm, which prevented bolus application. In the other devices, release of the pressure in the occluded system caused boli of 0.5-7 ml. Variations in the actual syringe volume and insertion of a second connection tube had no impact on alarm delay and bolus volume. Tap batteries, parallel running syringe drivers or trapped air in the system, however, caused marked increase in both alarm delay (107%) and bolus volume (+147%). DISCUSSION: Unidentified occlusions of the system cause grave malfunctioning of syringe drivers. While applying highly potent drugs, the discontinuation of drug delivery with subsequent bolus application can cause vital danger to the patient. As a result of the significant time delays in the pressure alarms, the devices tested do not provide sufficient protection against unrecognized system occlusion. Syringe drivers with adjustable alarm pressure can be set close to the actual infusion pressure. A further important point is that one should aim at a reduction in the elastic properties of the infusion set because of the great impact on alarm delay and bolus volume.
We found in mice that repeated single daily subcutaneous (s.c.) isoproterenol (ISO) injections, like constant infusions using osmotic minipumps, caused increased biventricular mass or weight relative to body weight (VW/BW). We found that 5 (1/d) s.c. injections of 2, 10, or 20 microg/g body weight caused equivalent VW/BW increases as compared with 5-d infusions at 20 microg/(g.d)). While it is often presumed that ISO elicits hypertrophy by a direct effect on the myocytes, growth may also be secondary to systemic hemodynamic effects. The 2 modes of ISO administration had different effects on mean arterial blood pressure (MABP) and heart rate. Using telemetry we observed that single injections of ISO (0, 0.5, 2, and 10 microg/g) were associated with hypotension and tachycardia with a duration but not a magnitude that was dose dependent. MABP dropped rapidly to 60 mm Hg for more than 2 h at the highest dose. Constant s.c. infusion of ISO at 20 microg/(g.d) initially lowered MABP to about 70 mm Hg for 24 h. At 48 h MABP was normal, but rose 10 mm Hg higher than baseline by day 5. Thus, different routes of administration of ISO that cause comparable increases in VW/BW had different effects on MABP. Thus when evaluating mouse models of ISO-induced cardiac hypertrophy, both repeated daily injections or infusions can cause similar increases in VW/BW, but the daily doses that are required are not the same. Furthermore, these different routes of administration have different hemodynamic sequelae and could potentially evoke different cardiac phenotypes.
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The use of rate controlled syringe infusion pumps has spread to departments where the need for accurate infusion exists. The simplicity in using these pumps has led to a false feeling of safety. A case of hazardous use of a syringe infusion pump has been reviewed. An Ohmeda 9000- and a Terumo STC 521 syringe pump was here tested, n = 20. The occlusion pressures of the two pumps were different. The occlusion pressure changed with different infusion rates for both pumps. The pressure was built up in a straight linear fashion. The bolus release depended on the occlusion pressure and the amounts given were in the range of 1.0-1.6 ml, both pumps included. The time from occlusion to alarm depended on the occlusion pressures. There might be an advantage in using a soft infusion system. It is recommended not to use syringe pump infusion via peripheral veins so as to avoid the risk of pressure build-up in the subcutaneous tissue in case of infiltration. In the event of occlusion disconnect the infusion system prior to reopening. Don't rely on the occlusion alarm. Use a smooth infusion system.