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General-purpose infusion pumps: evaluating the Hospira Plum A+ with MedNet.

This study updates ECRI's previous Evaluations of general-purpose infusion pumps, most notably those published in the October 2002 and October 2003 Health Devices. It features the results of our findings for the new dose error reduction system now included with the Hospira (formerly Abbott) Plum A+ with MedNet, and it includes updated information for the previously evaluated models that also include this safety feature. General-purpose infusion pumps allow the controlled delivery of liquid medications and other solutions to patients through intravenous (i.v.) or epidural routes. Dose error reduction systems, which are now available on several pump models, represent a significant advancement in infusion pump technology. ECRI believes that such systems can help hospitals reduce potentially fatal pump programming errors, and we recommend that hospitals purchasing new general-purpose infusion pumps consider only those models that offer a dose error reduction system.

Equipment Safety↗

Heuristic evaluation of infusion pumps: implications for patient safety in Intensive Care Units.

OBJECTIVE: The goal of this research was to use a heuristic evaluation methodology to uncover design and interface deficiencies of infusion pumps that are currently in use in Intensive Care Units (ICUs). Because these infusion systems cannot be readily replaced due to lease agreements and large-scale institutional purchasing procedures, we argue that it is essential to systematically identify the existing usability problems so that the possible causes of errors can be better understood, passed on to the end-users (e.g., critical care nurses), and used to make policy recommendations. DESIGN: Four raters conducted the heuristic evaluation of the three-channel infusion pump interface. Three raters had a cognitive science background as well as experience with the heuristic evaluation methodology. The fourth rater was a veteran critical care nurse who had extensive experience operating the pumps. The usability experts and the domain expert independently evaluated the user interface and physical design of the infusion pump and generated a list of heuristic violations based upon a set of 14 heuristics developed in previous research. The lists were compiled and then rated on the severity of the violation. RESULTS: From 14 usability heuristics considered in this evaluation of the Infusion Pump, there were 231 violations. Two heuristics, "Consistency" and "Language", were found to have the most violations. The one with fewest violations was "Document". While some heuristic evaluation categories had more violations than others, the most severe ones were not confined to one type. The Primary interface location (e.g., where loading the pump, changing doses, and confirming drug settings takes place) had the most occurrences of heuristic violations. CONCLUSION: We believe that the Heuristic Evaluation methodology provides a simple and cost-effective approach to discovering medical device deficiencies that affect a patient's general well being. While this methodology provides information for the infusion pump designs of the future, it also identifies important insights concerning equipment that is currently in use in critical care environments.

Humans↗

The performance of three portable infusion-pump devices set to deliver 2 mL/hr.

The performance of three portable infusion-pump devices set to deliver 2 mL/hr was studied. Portable infusion-pump devices (CADD-1, Paragon, and Singleday Infusor) were set to deliver 5% or 25% dextrose in water at 2 mL/hr for 24 hours at two environmental temperatures (25 and 35 degrees C). There were a total of 12 types of experimental runs, and each run was performed in triplicate. Flow rate accuracy and flow continuity were measured by a computerized gravimetric technique; effusate weights were measured and recorded at 30-second intervals for two hours at the beginning and two hours at the end of each run. Mean flow rates among the three devices did not differ significantly. Mean flow rate was significantly higher for the 5% dextrose solution than for the 25% dextrose solution, for the 35 degree C temperature than for the 25 degree C temperature, and during the first two hours of delivery than during the last two hours. The CADD-1 units showed an interruption of flow lasting about 30 seconds and recurring every 60 seconds; the other devices had fairly constant flow. Mean flow continuity differed significantly among the three devices. Mean flow continuity was significantly higher for the 5% dextrose solution and for the 25 degree C temperature. Flow continuity differed among three representative portable infusion-pump devices set to deliver 2 mL/hr, but flow rate accuracy did not. Fluid viscosity, environmental temperature, and elapsed time affected flow rate accuracy and flow continuity.

Analysis of Variance↗

Reducing home nursing visit costs using a remote access infusion pump system.

The use of a remote access infusion pump system in patients receiving intravenous therapy in the home provided a method to monitor patients and to reduce the number of unscheduled and after-hours nursing visits. Option Care of Rockwall, Texas, a locally owned IV company that is part of a national network, was able to avoid 13 nursing visits during a 4-month period with patients receiving pain management or continuous heparin therapy with the use of an infusion pump system that allowed remote access by telephone. An appreciable cost savings was documented with the use of this device.

Adult↗

Implantable infusion pump in the therapy of canine adrenal insufficiency.

To test the feasibility of a commercially available infusion pump in the treatment of human adrenal insufficiency, we employed the pumps initially in dogs. Two dogs underwent total adrenalectomy and placement of an Infusaid Model 400 infusion pump. These pumps have a drug reservoir of 45 ml and are refilled by percutaneous injection approximately every 2 weeks. Hydrocortisone phosphate was used as replacement glucocorticoid. Serum cortisol values correlated with the amount of drug delivered, and daily administration of 10 to 50 mg/day maintained the plasma cortisol level within the normal range (1 to 6 micrograms/dl). Mineralocorticoid replacement initially consisted of fludrocortisone by mouth and subsequently aldosterone via infusion pump. Serum electrolytes fluctuated with the amount of drug delivered, and doses of approximately 100 to 400 micrograms administered orally per day and 70 to 100 micrograms/day per pump maintained serum electrolytes within the normal range. Dependence upon and effectiveness of pump administration of steroids for long-term survival was demonstrated by: (1) ACTH-stimulation tests after operation and approximately 1 year later, (2) autopsy studies demonstrating total adrenalectomy, (3) repeatedly undetectable plasma cortisol levels during periods of no glucocorticoid supplementation, and (4) repeated hyperkalemia and hyponatremia during periods of no mineralocorticoid supplementation. This study demonstrates that glucocorticoid and mineralocorticoid preparations can remain bioactive for 2 to 3 weeks at 37 degrees C and can be delivered in amounts adequate to sustain a totally adrenalectomized dog via a commercially available infusion pump. In the adrenalectomized dog hydrocortisone sufficient to maintain plasma cortisol values in the normal range does not provide adequate mineralocorticoid replacement.

Adrenal Insufficiency↗

The infusion rate of most disposable, non-electric infusion pumps decreases under hypobaric conditions.

PURPOSE: To examine the delivery rates of four disposable, non-electric infusion pumps during hypobaric conditions. METHODS: Four models categorized by three different driving forces, one vacuum unit (Coopdech Syringector), one spring unit (Linear-fuser), and two elastomeric balloon-powered units (Multirate Infuser LV and Large DIB), were tested. Each infusion pump was placed in an airtight container, and the pressure in the container was decreased to 1,000, 900, and 800 hPa. The catheter tip of each pump was exposed either to atmospheric pressure (1,000 hPa) or to similar hypobaric conditions (800-1,000 hPa). RESULTS: Under normal atmospheric pressure, each pump showed an accurate delivery rate in the range of -2% to +8% of the set infusion rate (4.0-5.0 mL x hr(-1)). With the catheter tip exposed to atmospheric pressure, the infusion rate of each pump was reduced from 35% in the case of the Large DIB to 64% in the case of the Coopdech Syringector, depending on the magnitude of change in hypobaric pressure. When the pressure acting on the catheter tip was reduced to a level similar to that exerted on the pump body, infusion rate was reduced (by 19%-27%) in all three types of pump, and the Large DIB showed no significant difference in performance compared to normal atmospheric pressure. CONCLUSION: The infusion rates of disposable infusion pumps are reduced under hypobaric conditions. Even though we still do not know how the epidural pressure changes under hypobaric conditions, clinicians should be aware that the infusion rate of disposable infusion pumps is decreased under hypobaric conditions.

Analgesia, Epidural↗

Accurate continuous drug delivery at low infusion rate with a novel microvolumetric infusion pump (MVIP): pump design, evaluation and comparison to the current standard.

Infusion devices for continuous and precise drug administration are indispensable tools in anaesthesia and critical care medicine. Problems such as start-up delays, non-continuous flow and susceptibility to hydrostatic pressure changes at low infusion rates resulting in accidental bolus release or prolonged flow interruption are inherent to current infusion technology. In order to improve precise drug delivery, an innovative technical concept has been realised in a novel microvolumetric infusion pump (MVIP) device. The MVIP principle includes repeated filling and emptying of a non-compliant microsyringe without the use of valves. The performance of the MVIP prototype has been evaluated and compared with standard syringe infusion pump assemblies. The novel MVIP concept has thereby proven to eliminate most problems during infusion start-up, steady state flow and vertical pump displacement, and has the potential of revolutionising infusion technology and setting a new dimension in patient safety.

Drug Administration Schedule↗

Local anesthetic infusion pumps improve postoperative pain after inguinal hernia repair: a randomized trial.

Pain after an open inguinal hernia repair may be significant. In fact, some surgeons feel that the pain after open repair justifies a laparoscopic approach. The purpose of this study was to determine if the use of local anesthetic infusion pumps would reduce postoperative pain after open inguinal hernia repair. We performed a prospective, double-blind randomized study of 45 open plug and patch inguinal hernia repairs. Patients were randomized to receive either 0.25 per cent bupivicaine or saline solution via an elastomeric infusion pump (ON-Q) for 48 hours, at 2 cc/h. The catheters were placed in the subcutaneous tissue and removed on postoperative day 3. Both groups were prescribed hydrocodone to use in the postoperative period at the prescribed dosage as needed for pain. Interviews were conducted on postoperative days 3 and 7, and patient's questionnaires, including pain scores, amount of pain medicine used, and any complications, were collected accordingly. During the first 5 postoperative days, postoperative pain was assessed using a visual analog scale. Twenty-three repairs were randomized to the bupivicaine group and 22 repairs randomized to the placebo group. In the bupivicaine group, there was a significant decrease in postoperative pain on postoperative days 2 through 5 with P values <0.05. This significant difference continued through postoperative day 5, 2 days after the infusion pumps were removed. Patients who had bupivicaine instilled in their infusion pump had statistically significant lower subjective pain scores on postoperative days 2 through 5. This significant difference continued even after the infusion pumps were removed. Local anesthetic infusion pumps significantly decreased the amount of early postoperative pain. Pain relief persisted for 2 days after catheter and pump removal.

Adolescent↗

Patient-controlled analgesic infusion pumps.

Patient-controlled analgesic (PCA) infusion pumps allow patients to self-administer doses of pain-relieving medication as needed, rather than having to summon a caregiver. The most significant risk when using these pumps is overmedication leading to narcotic-induced respiratory depression. Several current PCA pumps offer advanced error-reduction features designed to minimize the odds of an accidental overdose: dose error reduction systems, bar-code readers, and computer-based pump-programming systems that entail downloading infusion protocols via a hardwired connection to a PC. The availability of these features plays a dominant role in our ratings. We tested 11 pumps from seven suppliers. Two pumps are rated Preferred because they offer easy-to-use advanced error-reduction features that have been proven effective in a hospital setting. Two other pumps offer computer-based programming and are rated Acceptable, although we note that not all facilities may be able to accommodate the workflow necessary to use the computer-based programming. The remaining pumps are rated Not Recommended because they lack advanced error-reduction features; although most of these pumps perform acceptably, better choices are available.

Analgesia, Patient-Controlled↗

Evaluating and selecting general-purpose infusion pumps.

Guidelines for evaluating and selecting general-purpose infusion pumps are provided, along with a discussion of an ECRI evaluation of these pumps. In an evaluation of 14 models from nine manufacturers, ECRI found that the pumps differed significantly in performance, features, and cost. ECRI's rating and ranking of specific infusion pump models are not provided in this article. Eight of the models studied were rated acceptable on the condition that users take precautions to prevent free flow. Concerns were raised about infusion sets that allow free flow if not manually clamped on set removal and pumps that do not always detect upstream occlusions.

Equipment Design↗

Stability of fentanyl citrate in 0.9% sodium chloride solution in portable infusion pumps.

The stability of fentanyl citrate diluted with 0.9% sodium chloride injection for use in portable infusion pumps was studied. The commercially available injection containing 50 micrograms of fentanyl per milliliter was diluted to a concentration of 20 micrograms/mL. Twelve 100-mL portions of the dilute solution were placed in polyvinyl chloride infusion pump drug reservoirs; six were stored at 3 degrees C and six at 23 degrees C; three at each temperature were overwrapped with polypropylene-Mylar. Initially and after 5, 10, 20, and 30 days of storage, 1-mL samples were taken from each reservoir, inspected for color change and precipitation, and assayed for fentanyl concentration by high-performance liquid chromatography. Initially and on day 30, pH of the samples was checked. No precipitation or change in color or pH was observed. No substantial decrease in fentanyl concentration was found in either the wrapped or unwrapped samples at either temperature, although concentrations on day 30 in the samples at 23 degrees C were slightly lower than those at 3 degrees C. Under the conditions studied, fentanyl citrate solutions containing 20 micrograms of fentanyl per milliliter can be stored for 30 days in polyvinyl chloride reservoirs for portable infusion pumps.

Chromatography, High Pressure Liquid↗

Infusion pump delivers over-dosage of propofol as a result of missing syringe support.

We describe the malfunction of a common drug infusion pump. The syringe saddle was missing and allowed the syringe barrel to contact the pump case, which decreased the outward displacement of the syringe clamp. Then, the infusion pump falsely detected a smaller syringe size and consequently delivered an increased infusion rate and overdose of propofol to the patient. More commonly, an incorrectly mounted syringe may increase the outward displacement of the syringe clamp so that the infusion pump falsely detects a larger syringe size, with resultant less than expected infusion rate.

Drug Delivery Systems↗

Infusion pump inspection frequencies. How often is inspection really needed?

As noted in this issue's Evaluation of infusion pump analyzers, the frequency at which a facility inspects its infusion pumps can help determine its need for one or more analyzers. It can also have a financial impact on the clinical engineering department. In this article, we discuss inspection issues affecting infusion pumps, including our recommendations and how facilities can set intervals for their equipment. (For ECRI's procedure for inspecting infusion devices, refer to Procedure/Checklist 416-0595 in the Health Devices Inspection and Preventive Maintenance [IPM] System; contact ECRI's Communications Department at [610] 825-6000, ext. 888, for more information about this publication.)

Biomedical Engineering↗

Effect of distance and infusion rate on operation of Medfusion 2010 infusion pump during magnetic resonance imaging.

STUDY OBJECTIVES: To determine the accuracy and reliability of intravenous infusion, as well as magnetic resonance image effect of the Medfusion 2010 infusion pump (Medex Medical Supplies, Inc., Duluth, GA) at distances of 2, 4, 8, 12, and 16 feet from a 1.5 Tesla MRI magnet over a four-week time interval, using infusion rates that would correspond to those of propofol administration. DESIGN: Prospective, open-label study. SETTING: Radiology department MRI in an American academic medical center. INTERVENTIONS: Five infusion pumps, including one outside the MRI suite as control, were tested. Pumps were evaluated at distances of 2, 4, 8, 12, and 16 feet from a 1.5 Tesla magnet. One pump at distances of 2 and 16 feet was tested during 30 and 90 hours of operation, respectively. Three pumps at distances of 4, 8, and 12 feet were tested during 120 hours of operation. Pump batteries were recharged for 18 hours outside the MRI suite between the 6-hour test periods. Distilled, deionized water was infused from a 30-mL or 60-mL syringe via a 36-inch Medex small-bore extension set into a graduated collection cylinder at rates of 5, 10.5, 21, or 42 mL/hr. Each rate was increased to the next infusion rate level at 30-hour weekly intervals. The collection cylinder with infused water was weighed on an electronic scale accurate to within +/-0.001 g. Analysis of variance and regression analysis were used to analyze data. A p < 0.05 value was considered statistically significant. MEASUREMENTS AND MAIN RESULTS: There was no significant difference comparing the grams weight of volume measured and the mL volume visualized within and between groups at varying distances from the magnet. Increasing infusion rates resulted in corresponding increases in volume delivered irrespective of the distance from the magnet. CONCLUSIONS: The Medfusion 2010 infusion pumps were found to be reliable and accurate, without causing failure or any significant degradation of MRI images compared to control at infusion rate of 42 mL/hr at a distance of 2 feet for 30 hours; and a rate of 5.0, 10.5, 21, and 42 mL/hr at 16 feet for 90 hours; and at 4, 8, and 12 feet for 120 hours of operation.

Anesthesiology↗

[Delayed rupture of a balloon reservoir in a disposable infusion pump].

We experienced delayed rupture of a balloon reservoir in a disposable infusion pump 3 hours after filling. The investigation revealed a sharp scratch in the reservoir. Furthermore, as we did not filtrate the drugs before filling, we speculate that ampule fragments could have provoked the rupture. When filling a disposable infusion pump with ampule solution, filtration against glass contamination is recommended.

Analgesics, Opioid↗

[Treatment of unstable diabetes with a portable insulin-infusion pump (author's transl)].

A portable insulin-infusion pump (Promedos Siemens) was used in 19 patients with unstable or brittle diabetes. Continuous insulin supply was via the intravenous route in nine, subcutaneously in ten patients. The insulin pump was used in those patients in whom, after hospitalization for two to three weeks, the diabetes remained poorly controlled. In all patients the carbohydrate metabolism was normalised. Subcutaneous insulin infusion was as effective as the intravenous one. In all instances it was possible, partly by transferring insulin uptake during the day and night to two subcutaneous injections, to improve conventional control even after the infusion period was over. Continuous, regulated insulin supply - intravenously or subcutaneously - is superior to conventional subcutaneous administration. Portable insulin infusion pumps can be used in individual patients even without glucose sensing.

Adolescent↗

Technical complications and durability of hepatic artery infusion pumps for unresectable colorectal liver metastases: an institutional experience of 544 consecutive cases.

BACKGROUND: Hepatic arterial infusion pump chemotherapy is an important component in the treatment of patients with hepatic metastases. Successful use of a hepatic arterial infusion pump requires a low technical complication rate. We evaluated the complications and longterm durability of these devices at our institution. STUDY DESIGN: Between April 1986 and March 2001, 544 patients underwent hepatic arterial infusion pump placement for treatment of unresectable colorectal liver metastases. Patient- and pump-related data were collected by chart review. Pump-related complications, duration of pump function, and overall patient survival were recorded. RESULTS: Median patient survival was 24 months after pump placement. The incidences of pump failure were 9% at 1 year and 16% at 2 years. Pump complications occurred in 120 (22%) of the patients. Complications that occurred early after operation (< 30 days) were more likely to be salvaged than those occurring late (70% versus 30%, p < 0.001). Increased pump complication rates occurred in the setting of variant arterial anatomy (28% versus 19%, p = 0.02), when the catheter was inserted into a vessel other than the gastroduodenal artery (42% versus 21%, p = 0.004), if the pump was placed during the first half of the study period (1986 to 1993, 25% versus 1994 to 2001, 18%; p = 0.05), and if the surgeon had performed fewer than 25 earlier procedures (< 25, 31% versus > or = 25, 19%; p < 0.002). CONCLUSIONS: In this large single institution experience, pump-related complications were low, the majority of early pump complications were salvaged, and pump complication rates improved as institutional experience accumulated. Longterm durability of pump function was excellent.

Catheterization↗

[Continuous intra-arterial infusion chemotherapy by implantable catheter access connected with a continuous infusion pump].

Eleven non-resectable cancer patients have been successfully treated by means of a one-shot and continuous intra-arterial infusion chemotherapy, utilizing an implantable vascular access device (Catheter Access) connected to a continuous infusion pump (Nipro portable syringe infusion pump) via a non-corning needle (Nipro coreless needle set). This result suggests that this simple and inexpensive method can be applied not only for cancer chemotherapy but also for intravenous hyper-alimentation and for treatment of epidural anesthesia.

Aged↗