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Open-source automated insulin delivery (AID) systems are used by many patients with type 1 diabetes. Data are needed on the efficacy and safety of an open-source AID system.In this multicenter, open-label, randomized, controlled trial, we assigned patients with type 1 diabetes in a 1:1 ratio to use an open-source AID system or a sensor-augmented insulin pump (control). The patients included both children (defined as 7 to 15 years of age) and adults (defined as 16 to 70 years of age). The AID system was a modified version of AndroidAPS 2.8 (with a standard OpenAPS 0.7.0 algorithm) paired with a preproduction DANA-i insulin pump and Dexcom G6 CGM, which has an Android smartphone application as the user interface. The primary outcome was the percentage of time in the target glucose range of 70 to 180 mg per deciliter (3.9 to 10.0 mmol per liter) between days 155 and 168 (the final 2 weeks of the trial).A total of 97 patients (48 children and 49 adults) underwent randomization (44 to open-source AID and 53 to the control group). At 24 weeks, the mean (±SD) time in the target range increased from 61.2±12.3% to 71.2±12.1% in the AID group and decreased from 57.7±14.3% to 54.5±16.0% in the control group (adjusted difference, 14 percentage points; 95% confidence interval, 9.2 to 18.8; P0.001), with no treatment effect according to age (P = 0.56). Patients in the AID group spent 3 hours 21 minutes more in the target range per day than those in the control group. No severe hypoglycemia or diabetic ketoacidosis occurred in either group. Two patients in the AID group withdrew from the trial owing to connectivity issues.In children and adults with type 1 diabetes, the use of an open-source AID system resulted in a significantly higher percentage of time in the target glucose range than the use of a sensor-augmented insulin pump at 24 weeks. (Supported by the Health Research Council of New Zealand; Australian New Zealand Clinical Trials Registry number, ACTRN12620000034932.).

Diabetes technology has rapidly evolved, and insulin infusion pumps (IIPs) have gained worldwide acceptance in diabetes care. The safety of medical equipment is highly discussed, imposing complex challenges in its use. The accuracy of IIPs can be determined through laboratory tests, generally following the IEC 60601-2-24 protocol. Studies have evaluated the accuracy and precision of IIPs, and there are discrepant results. So, we conducted a Systematic Literature Review to assess the methodologies used to evaluate the accuracy of IIPs, organizing the findings in a compiled perspective. The methodology was based on Kitchenham and Biolchini guidelines, and when possible it was carried out the Bayesian meta-analyses to compare the accuracy of IIPs. Most studies used the microgravimetric technique to evaluate the device accuracy, and some proposed adaptations for the standard protocol. The variation of results was recurrent, and the establishment of a protocol, especially to evaluate patch pumps, is necessary. The present study gives enough data to understand the scenario of the IIPs evaluation, as well as the different protocols that can be explored for its evaluation. This highlights the need for a reliable, practical, and low-cost methodology to assist the evaluation of IIPs.

The expanded criteria donor is any donor over the age of 60 years or a donor over the age of 50 years with 2 of the following 3 items: (1) history of high blood pressure, (2) serum creatinine ≥1.5 mg/dL, and (3) death due to stroke. To accept an expanded criteria donor kidney may significantly decrease the amount of time a person waits for transplant but requires written informed consent from the recipient. Although expanded criteria donor kidneys have predictably shorter outcomes than standard criteria donors, the exact risk is unknown. At 5 years follow-up, 50% of expanded criteria donor kidneys are still working. Regardless of donor status of these kidneys as expanded criteria or standard criteria, the transplant recipients have higher survival rates compared with candidates who remain on the wait list. The success rate may be increased when a perfusion pump is used to preserve the kidneys. Sometimes the function of a single kidney from an expanded criteria donor is deemed insufficient. In this situation, a pair of marginally functioning kidneys may be transplanted as a dual-kidney transplant. This dual transplant option offers acceptable outcomes as good as a single-kidney transplant with normal function and can effectively address the shortage of donor organs. The use of a perfusion pump allows the clinician to decide whether or not to use a particular expanded criteria donor kidney. Expanded criteria donors may be justified by meticulous selection of each donor for recipients, along with more sophisticated surgical techniques to maximize the kidney donor pool.

Background Infusion start time, completion time, and interruptions are the key data points needed in both area under the concentration–time curve (AUC)- and trough-based vancomycin therapeutic drug monitoring (TDM). However, little is known about the accuracy of documented times of drug infusions compared with automated recorded events in the infusion pump system. A traditional approach of direct observations of infusion practice is resource intensive and impractical to scale. We need a new methodology to leverage the infusion pump event logs to understand the prevalence of timestamp discrepancies as documented in the electronic health records (EHRs). Objectives We aimed to analyze timestamp discrepancies between EHR documentation (the information used for clinical decision making) and pump event logs (actual administration process) for vancomycin treatment as it may lead to suboptimal data used for therapeutic decisions. Methods We used process mining to study the conformance between pump event logs and EHR data for a single hospital in the United States from July to December 2016. An algorithm was developed to link records belonging to the same infusions. We analyzed discrepancies in infusion start time, completion time, and interruptions. Results Of the 1,858 infusions, 19.1% had infusion start time discrepancy more than ± 10 minutes. Of the 487 infusion interruptions, 2.5% lasted for more than 20 minutes before the infusion resumed. 24.2% (312 of 1,287) of 1-hour infusions and 32% (114 of 359) of 2-hour infusions had over 10-minute completion time discrepancy. We believe those discrepancies are inherent part of the current EHR documentation process commonly found in hospitals, not unique to the care facility under study. Conclusion We demonstrated pump event logs and EHR data can be utilized to study time discrepancies in infusion administration at scale. Such discrepancy should be further investigated at different hospitals to address the prevalence of the problem and improvement effort.

Peristaltic pumps have been put to use in various biomedical applications like devices for the transfer of body fluids as well as devices for controlled release of medication, including implantable infusion pumps. Out of the various components of a peristaltic pump, tubing is considered the most vulnerable part. This study focuses on the performance of Silicone micro-pump tubing used in such an implantable drug delivery device. Long-term implantable medical devices are expected to be operational for about 10 years. But experimental testing of the reliability of components under normal working speeds are time-consuming and thus delays the product development cycle. While simulating the conditions in the laboratory under accelerated speeds, the effect of increasing the speed must be accounted. In this study, the effect of accelerated speed and rotor material on pump tubing life is investigated. A test jig is developed which simulates the running conditions of the infusion pump for long-duration operation. Different rotor speeds and material configurations are investigated to obtain their effect on long-duration performance. Thermal effects on the roller junctions are studied and found that the Delrin silicone combination has twice the rise in junction temperature than the titanium silicone combination. The failure modes are inspected using microstructure analysis and the best configuration is identified.

Purpose Although outpatient parenteral antibiotic therapy (OPAT) can be a good approach to treatment of infections, a lack of data regarding antibiotic stability in portable elastomeric infusion devices restricts its safe, appropriate, and effective use. The objective of this work was to complete a systematic peer-reviewed analysis of published articles about antibiotic stability in elastomeric infusion devices that provide evidence supporting their use in OPAT. Summary A systematic review following PRISMA guidelines was conducted in January 2021 to identify published articles about antibiotic stability in portable elastomeric infusion devices. The databases used were PubMed, Embase, Web of Science, and a Cochrane database. A total of 1,615 original studies and conference communications were found. After title, abstract, and full-text review, 33 articles met the inclusion criteria. The data obtained included information about the stability of 30 different antibiotics. To our knowledge, this is the first review to summarize the available published data on the stability of antibiotics in portable elastomeric infusion devices. The results highlight the poor stability of some antibiotics in solution and the variability of the laboratory conditions in the included studies. Conclusion This systematic review can serve as a useful resource for healthcare professionals involved in providing OPAT using portable elastomeric infusion devices. However, further stability studies should be performed, especially high-quality studies simulating real-life time and temperature conditions.

The use of an in-line, 1.2-μm filter is recommended for the intravenous (IV) infusion of parenteral nutrition (PN), also known as 3-in-1, total nutrient admixture (TNA), or all-in-one, and injectable lipid emulsions (ILEs) infused alone through a separate IV line. While filtration of TNA was mandated in 1994 to improve patient safety, the recommendation for filtering lipid emulsions alone is relatively new and has not been adopted by all clinicians. In addition, literature references and postmarket surveillance data cite the occurrence of infusion pump occlusion alarms, which may be indicative of a clogged filter. The following review article provides an overview of filter recommendations for PN and ILE, describes the challenges of filtration with PN and ILE, and includes recommendations to minimize pump occlusion alarms that may occur from a clogged filter.

Secondary infusion by large-volume iv smart pump is used extensively in the acute care setting for one-time or intermittent administration of medications such as antibiotics, electrolyte replacements, and some oncology drugs. Consistent and accurate delivery of secondary medications requires a full understanding of the system and setup requirements. Unfortunately, it is not uncommon for nurses to find a secondary medication only partially administered when their programming should have resulted in a complete infusion. This article discusses the technical requirements that every nurse should know when administering secondary medications using an iv smart pump.

Mechanical stress on red blood cells is associated with using infusion pumps for blood administration. Current standards in North America leave it to healthcare facilities to consult with manufacturers about infusion pump safety for transfusion; studies on various pumps and red blood cell (RBC) conditions are scarce.RBC units were pumped through four infusion pumps on d22 (22 days postcollection), d40, d28 after gamma irradiation on d14 (I14d28), and d22 after irradiation on d21 (I21d22). For each experiment, three units were pooled and split among four bags. Samples were collected at gravity and after pumping at clinical nonemergency rates. Hemolysis %, microvesicles, potassium, lactate dehydrogenase, mechanical fragility index levels, and morphology evaluations were performed (n = 5-6).Hemolysis levels of Piston and Linear Peristaltic pump samples were not different from hemolysis of corresponding gravity samples. Peristaltic samples had significantly higher hemolysis compared to gravity, and other pumps, however, maximum mean difference was limited to 0.05%. Pumping at 50 mL/h resulted in the highest hemolysis level. Change in hemolysis % due to pumping was significantly higher in d40 and I21d22 units. No combination of pumps and RBCs conditions led to hemolysis0.8%. Besides hemolysis, lactate dehydrogenase release was the only marker that demonstrated some differences between infusions via pump versus gravity.The pump design affects the degree of hemolysis. However, for all tested pumps and RBC conditions, this increase was minimal. Hemolysis measurement on d40 and I21d22 at 50 mL/h were concluded to be appropriate parameters for pump evaluation.

Portable infusion pumps are an interesting solution to continue outpatient parenteral antimicrobial therapy (OPAT) at the patient's home. However, the use of ceftazidime for such applications is challenging in view of its relatively poor stability in solution. In this study, elastomeric infusion pumps with 6 or 7 g of ceftazidime were deflated over 24 h in an oven at 33°C while ceftazidime and its degradation product, pyridine, were regularly monitored. Hereto, a fast and sensitive liquid chromatographic (LC) method has been developed using a Kinetex® C18 (150 × 3 mm, 2.6 μm) column with gradient elution. Ammonium formate 20 mM and acetonitrile (ACN) were mixed in a ratio of 98:2 v/v for mobile phase A and 85:15 v/v for mobile phase B. Both were adjusted to pH 4.5 with formic acid. The flow rate was set at 0.4 mL/min. The solution with a starting dose of 6 g ceftazidime was found to be degraded 10% after an average of 19 h 11 min so that an administration of 6 g to the patient was not reached. For the solution with a starting dose of 7 g of ceftazidime, 10% degradation was observed after an average of 18 h 42 min. However, by starting from a higher dose, an average of 6.56 g of ceftazidime could be administered over 24 h. In addition, 1.0% of pyridine versus ceftazidime pentahydrate with sodium carbonate (=mixture for injection) was formed over 24 h.

Made available in DSpace on 2022-04-29T08:46:12Z (GMT). No. of bitstreams: 0 Previous issue date: 2021-10-01 The objective of this study was to verify the influence of the gravitational infusion method or syringe infusion pump on changes in hemolysis markers of irradiated and nonirradiated packed red blood cells (PRBCs) in vitro administered in a neonate peripheral intravenous catheter. An experimental study was conducted in a laboratory under controlled environmental conditions. Irradiated and nonirradiated PRBCs were administered in triplicate by the gravitational method and 10-mL/hour syringe infusion pump, in peripheral intravenous catheter, Vialon, 24-G caliber. Aliquots were collected directly from the PRBC bag, after manual filling of the infusion system and after infusion by the catheters. The following hemolytic markers were analyzed: degree of hemolysis (%), hematocrit (Ht, %), free hemoglobin (fHb, g/dL), potassium (K, mmol/L), and lactate dehydrogenase (LDH, U/L). Mann-Whitney and Student's t tests were used, P ≤ .05. The gravitational method significantly influenced increasing fHb (P = .007), Ht (P = .002), K (P = .002), and LDH (P = .003) values after PRBC irradiated infusion. The infusion of irradiated and non-irradiated PRBCs interferes with changes in hemolytic markers with the gravitational method. Syringe infusion pump proved to be a beneficial and safe alternative to irradiated and nonirradiated PRBC transfusion in newborns. Nursing School, Federal University of São Paulo, São Paulo, Brazil (Drs Orsi and Avelar and Mss Kita and de Souza); and Department of Biostatistics, Paulista State University Julio de Mesquita Filho, Botucatu, São Paulo, Brazil (Dr Tsunemi)

The most common symptom in heart failure (HF) is congestion, which can be refractory to diuretic treatment. To verify whether, in patients with advanced HF and diuretic resistance, subcutaneous furosemide or furosemide in an oral solution can improve the clinical-analytical status. From 2018 to 2020, 27 consecutive outpatients with diuretic resistance, not candidates for other alternatives, were recruited. Patients were treated either with subcutaneous furosemide in elastomeric pump (n: 10) or with oral solution (n: 17) for 5 days. The functional status (NYHA) improved with subcutaneous administration (predose: 3.8 ± 0.5 vs. postdose: 3.1 ± 0.7; p: 0.02) and oral solution (predose: 3.7 ± 0.3 vs. postdose: 2.5 ± 0.7; p: 0.0001). Weight loss was greater with the oral solution (predose: 85.5 ± 19.5 vs. postdose: 81.3 ± 18.8Kg; p: 0.0001) than subcutaneous (predose: 81.6 ± 15.9 vs. postdose: 80.4 ± 15.1kg; p: 0.16). Creatinine showed a non-significant increase in both groups. The number of hospital visits showed no difference between both options. The administration of furosemide, both subcutaneously by elastomeric pump or drinking the oral solution, is effective for the treatment of congestion in advanced HF refractory to diuretic treatment.

Background Postoperative pain after complex revision spine surgery, especially for the treatment of persistent spinal pain syndrome (PSPS), is frequently severe and can be debilitating, requiring the use of intravenous and oral opioids. To the best of our knowledge, the present study is the first to evaluate the effectiveness and safety of a continuous infusion regional anesthesia pump placed after thoracopelvic fusion for the treatment of PSPS. Methods We performed a retrospective comparative study of consecutive patients who had undergone thoracopelvic fusion for PSPS. The patients included in the present study had either had a continuous infusion regional anesthesia pump placed during surgery or had not (control). Demographics, use of preoperative and postoperative opioids, postoperative adverse events, length of hospital stay, and 90-day readmission were recorded. Results The patients in the pump group (n = 14) had used fewer opioids during their hospital stay compared with the control group (n = 12; P = 0.6). This difference was greater for postoperative days 1 and 2 (P = 0.3 and P = 0.2, respectively). No significant difference was found in opioid usage during the first 14 days after surgery (P = 0.8) or at the 3-month postoperative follow-up evaluation (P = 0.8). Furthermore, no significant difference was found between the 2 groups in terms of postoperative complications. The pump group had a 1.4-day shorter hospital stay (P = 0.7). The control group had more 90-day readmissions than did the pump group (P = 0.2). Conclusions Despite showing a trend toward less usage of opioids during the first 2 days after surgery and a shorter hospital stay with no increased complications in the pump group, the study data failed to demonstrate a statistically significant difference between the two groups.

Background Medication dosing errors can occur during microinfusions when there is vertical pump displacement or multidrug infusion through a single intravenous path. We compared flow rate variability between new-generation cylinder-type infusion pumps and conventional infusion pumps under simulated conditions. Methods We evaluated the flow rates during microinfusions using different infusion pumps (syringe pump with 10/30/50-mL syringes, peristaltic pump, and cylinder pump). Two visible dyes were used as model drugs. The study samples were quantified using spectrophotometry. For vertical displacement, the infusion pumps were moved up and down by 60 cm during microinfusions at 0.5 mL·h-1 and 2 mL·h-1. In the multi-infusion study, the second drug flow was added through 4 linearly connected stopcocks either upstream or downstream of the first drug. We compared the total error dose between the cylinder pump and the syringe pump with a Mann-Whitney U test and additionally estimated the effects of the infusion pumps on total error doses by linear regression analysis. Results There were repetitive patterns of temporary flow increases when the pump was displaced upward and flow decreases when the pump was displaced downward in all settings. However, the amount of flow irregularities was more pronounced at the lower infusion rate and in the syringe-type pump using larger volume syringes. The total error dose increased in the syringe pump loaded with a 50-mL syringe compared to that of the new cylinder pump (regression coefficient [β] = 4.66 [95% confidence interval {CI}, 1.60-7.72]; P = .008). The initiation and cessation of a new drug during multidrug microinfusion in the same intravenous path affected the lower rate first drug leading to a transient flow rate increase and decrease, respectively. The change in flow rate was observed regardless of the port selected for addition of the second drug, and the total error dose of the first drug did not significantly vary when an upstream or a downstream port was selected. Conclusions In the microinfusion settings, attention must be paid to the use of the syringe pump loaded with large-volume syringes. The novel cylinder pump could be considered as a practical alternative to syringe pumps with small syringes given its flow stability without the need for frequent drug replacement.

OBJECTIVES Errors involving chemotherapy or intravenous medications may cause serious patient harm. Dose error reduction software (DERS) for "smart" infusion pumps offers additional safety protection for their administration. Our institution uses DERS software hospital-wide; however, the hematology/oncology areas were noted to have reduced compliance with DERS recommendations. In response, we sought to review the DERS content and survey hematology/oncology end users' satisfaction with the software. METHODS A multidisciplinary working group was formed to review the current DERS entries for medications, fluids, and blood products. The review included details such as dose, rate, and concentrations. Dose error reduction software compliance was determined using vendor-supplied Continuous Quality Improvement software. An electronic survey assessing clinicians' satisfaction with the current DERS library and any challenges in its use was conducted before and after the review. RESULTS Ninety-one changes were made to 71 medications by the working group. Compliance with the DERS library went from 81.5% before the review to 87.3% after the review (P = 0.257). Fifty-eight survey responses were received (30 prereview and 28 postreview) with improvements in staff satisfaction with the DERS library (83.3%-92.8%, P < 0.05). Near-miss events changed after the review from 2 to 0, and the number of alerts caused by values outside the DERS library reduced from 8788 before the review to 3383 after the review (P ≤ 0.05). CONCLUSIONS Review of a hematology/oncology DERS library found improvements that better met the needs of end users. Engagement with relevant stakeholders, in conjunction with ongoing communication and review, is required to improve compliance and satisfaction with DERS.

Patients with primary immunodeficiency (PID) are at a higher risk of developing serious infections than healthy individuals. Immunoglobulin G (IgG) replacement therapy reduces this risk, as it raises a patient's antibody levels to help fight off infections. IgG replacement therapy can be performed as an intravenous or subcutaneous (under the skin) infusion. The subcutaneous route is associated with improved quality of life for patients, as therapy can be carried out at home by the patient, allowing for more flexibility, convenience and autonomy. Wearable drug-delivery systems are devices that stick to the body and automatically deliver doses of a drug to the patient. In this study, we investigated whether a novel Investigational Wearable Infusor device could deliver the subcutaneous IgG replacement therapy, IgPro20, in patients with PID. We show that the new infusion device can deliver IgG replacement therapy and allows for similar levels of IgG to be achieved in patients as a comparator device. This wearable drug delivery device simplifies drug administration and could help address some of the challenges associated with self-injection such as complicated infusion preparation, needle phobia and concerns about pain.

This study was conducted to advance understanding of intravenous (IV) smart pump medication administration practices using the Baxter Spectrum IQ. The primary objective was to observe adherence with manufacturer required IV smart pump system setup at the point of care during actual clinical use.The study was conducted in a 285-bed acute care community hospital near Boston, Massachusetts. The study design was observational and noninterventional, and all data were collected by a single observer. Observations included measurement and documentation of adherence with the Baxter Spectrum IQ system setup requirements.A total of 200 primary and secondary IV medication administration observations were included: 101 in critical care and 99 in medical-surgical. Overall adherence was found to be: 6.5% with IV smart pump position relative to the patient (aim 1); 6.5% with required position of the primary infusion bag (aim 2); and 69.5% adherence with required position of the secondary medication infusion bag (aim 3). Additional exploratory data were also collected.These results add to the emerging body of knowledge, which support that adherence to required system setup for head-height dependent IV smart pumps is low and difficult to achieve during actual clinical use. Consideration of alternative human factors-designed technology to replace the current manual setup requirements is needed to improve the process of acute care IV medication administration in this very important area of patient safety.

After spinal cord injury (SCI) in mammals, there is only limited repair and, consequently, only moderate recovery. One mechanism frequently discussed to be involved in this recovery is plasticity (i.e., adaptations in spared neuronal circuitries). In the current study, we tested the effect of an intrathecal application of the TrkB agonist antibody, 29D7, on plasticity after cervical SCI in adult rats. Treatment with 29D7 for 4 weeks resulted in an ∼50% increase in collateral sprouting of severed corticospinal tract fibers above the lesion compared to the control group and enhanced branching in the gray matter rostral to the injury. Growth-associated protein 43 immunoreactivity in the spinal cord rostral to the level of the injury as well as contralateral to the lesion was also increased. These indications of enhanced plasticity by 29D7 were paralleled by improved performances of the mildly affected paw, as assessed by Montoya and tray reaching tasks. The reaching behaviors of the paw ipsilateral to the side of severe injury to the cortico- and rubrospinal tract were not altered by the treatment. The present study suggests that 29D7 may be a potential candidate to promote plasticity and functional recovery, especially after moderate SCI. Future studies confirming these results, along with a potential combinatory therapy including rehabilitative training, will be needed to evaluate the clinical value of such a treatment.

Transfusion of red blood cell (RBC) concentrates is a common procedure to restore blood volume and tissue oxygen delivery in patients with trauma. Although RBC warmers may prevent hypothermia, some warming or infusion equipment may lead to haemolysis and patient injury.The aim of this study was to test the effect of (i) RBC warming and (ii) administration via manual vs. pump infusion on haemolysis.This experimental ex vivo study studied haemolysis markers of RBC injury. The sample consisted of 90 RBC infusions in two simulations, randomly, 45 warmed RBC infusions and 45 nonwarmed RBC infusions, in two or three stages: before the intervention (baseline-warming, N= 45; nonwarming, N= 45), after water bath warming at 42 °C (warmed, N= 45), and then after the warmed or nonwarmed RBCs were infused by manual or pump infusion at a rate of 100 mL/h (infusion-warming, N= 45; nonwarming, N= 45).Warmed RBCs showed significantly lower total haemoglobin (Hb) and haematocrit levels and increase in free Hb levels, haemolysis levels, and lactate dehydrogenase (LDH) activity (all p0.05) than baseline RBCs. Pump infusion RBCs were associated with reduced total Hb and increased free Hb, haemolysis, and potassium (K) levels (all p0.05) compared with warmed RBCs. In contrast, manual infusion of warmed RBCs resulted in significantly reduced total Hb levels and increased LDH activity (both0.05). After infusion, total Hb, free Hb, haematocrit, haemolysis, and LDH values were significantly different for warmed vs. nonwarmed RBCs (p0.05).Haemolysis biomarkers increase with RBC warming and infusion, especially when using infusion pumps. Critically ill patients should be carefully monitored for possible complications during and after RBC infusion.

RATIONALE: Cannabidiol (CBD) reduces craving in animal models of alcohol and cocaine use and is known to modulate nicotinic receptor function, suggesting that it may alleviate symptoms of nicotine withdrawal. However, preclinical evaluation of its efficacy is still lacking. OBJECTIVES: The goal of this study was to test the preclinical efficacy of a chronic CBD treatment in reducing nicotine dependence using measures of withdrawal symptoms including somatic signs, hyperalgesia, and weight gain during acute and protracted abstinence. METHODS: Male and female Wistar rats were made dependent on nicotine using osmotic minipumps (3.15 mg/kg/day) for two weeks, after which minipumps were removed to induce spontaneous withdrawal. Three groups received CBD injections at doses of 7.5, 15, and 30 mg/kg/day for two weeks, starting one week into chronic nicotine infusion. The control groups included rats with nicotine minipumps that received vehicle injections of sesame oil instead of CBD; rats implanted with saline minipumps that received sesame oil injections (double vehicle) or the highest dose of CBD 30mg/kg/day. Throughout the experiment, serum was collected for determination of CBD and nicotine concentrations, mechanical sensitivity threshold and withdrawal scores were measured, and body weight was recorded. RESULTS: CBD prevented rats from exhibiting somatic signs of withdrawal and hyperalgesia during acute and protracted abstinence. There was no dose-response observed for CBD, suggesting a ceiling effect at the doses used and the potential for lower effective doses of CBD. The saline minipump group did not show either somatic signs of withdrawal or hyperalgesia during acute and protracted abstinence, and the highest dose of CBD used (30mg/kg/day) did not alter these results. CONCLUSIONS: This preclinical study suggests that using CBD as a strategy to alleviate the withdrawal symptoms upon nicotine-cessation may be beneficial.

Management of chemotherapies is a strategic issue for european healthcare. Dose-banding enables to reduce waiting time of patients in day care units and drug wastage. The aim of this study was to assess the stability of 5-Fluorouracile (5-FU) at standardised rounded doses of 4 and 5 g in MyFuser® portable infusion pump for in-advance preparation. Ten MyFuser® (4 and 5 gr 5-FU added to NaCl 0.9%) were prepared under aseptic conditions and stored at room temperature (23 ± 2 °C) for 28 days then at 30 °C for three days. Physical stability tests were periodically performed: visual and microscopic inspection, pH measurements and optical densities. The concentration of solutions was measured by High Performance Liquid Chromatography/UV detector. Results confirm the stability of 5-FU at selected SRD of 4 g and 5 g with NaCl 0.9% in MyFuser® for at least 28 days at room temperature and three days at 30 °C, allowing in-advance preparation.

Rapid infusion pumps employing filters, roller pumps, and heat exchangers for the administration of blood products are not approved for platelets or cryoprecipitate. This technology may decrease platelet count and degrade coagulation proteins. The effect of rapid infusers on the hemostatic potential of whole blood is unknown.Five units of low titer O+ whole blood were obtained from anonymous donors. Each unit was subjected to infusion by five different techniques: (1) gravity infusion without a filter, (2) gravity infusion with a filter, (3) Belmont rapid infuser at 70 mL/min, (4) Belmont at 100 mL/min, and (5) pressurized infusion with a pneumatic pressure bag and filter. After infusion, platelet count, platelet function, thrombin generation, and hemostatic potential were measured for each aliquot. Infusion techniques were compared, using gravity infusion without a filter as the control.There was a significant decrease in platelet count from baseline (168,000) in the BELMONT70 (97,000) and BELMONT100 (94,000) groups (P 0.05). However, there were no differences in platelet function (all P 0.20). While there were no differences in thromboelastography parameters between control and infusion models (all P 0.20), there were significant increases in thrombin generation parameters by CAT in both the BELMONT70 and BELMONT100 groups (all P 0.05).The use of a rapid infuser decreases the platelet count of WB but does not decrease platelet function or overall hemostatic potential. In fact, thrombin generation and thrombin potential are actually increased. Rapid infusers are safe for the transfusion of WB.

Intrauterine growth restriction affects up to 10% of all pregnancies, leading to fetal programming with detrimental consequences for lifelong health. However, no therapeutic strategies have so far been effective to ameliorate these consequences. Our previous study has demonstrated that a single dose of nutrients administered into the amniotic cavity, bypassing the often dysfunctional placenta via intra-amniotic administration, improved survival at birth but not birthweight in an intrauterine growth restriction rabbit model. The aim of this study was to further develop an effective strategy for intra-amniotic fetal therapy in an animal model. Intrauterine growth restriction was induced by selective ligation of uteroplacental vessels on one uterine horn of pregnant rabbits at gestational day 25, and fetuses were delivered by cesarean section on GD30. During the five days of intrauterine growth restriction development, three different methods of intra-amniotic administration were used: continuous intra-amniotic infusion by osmotic pump, multiple intra-amniotic injections, and single fetal intraperitoneal injection. Technical feasibility, capability to systematically reach the fetus, and survival and birthweight of the derived offspring were evaluated for each technique. Continuous intra-amniotic infusion by osmotic pump was not feasible owing to the high occurrence of catheter displacement and amnion rupture, while methods using two intra-amniotic injections and one fetal intraperitoneal injection were technically feasible but compromised fetal survival. Taking into account all the numerous factors affecting intra-amniotic fetal therapy in the intrauterine growth restriction rabbit model, we conclude that an optimal therapeutic strategy with low technical failure and positive fetal impact on both survival and birthweight still needs to be found.

Objectives Haemolysis caused by the use of peristaltic infusion pumps (PIPs) has been described in human and canine packed red blood cells (pRBCs). The aim of this study was to evaluate the effects of two different linear PIPs on the haemolysis of feline pRBC units stored for a long time. Methods Feline pRBC units stored with adenine, dextrose, mannitol and sodium chloride (SAGM) were manufactured. After 35–42 days of storage at 2–4°C, a line administration system with a 180 µm filter was attached to every pRBC bag, the system was drained by gravity alone (8 drops/min) and a 1.3 ml sample was collected (G). A NIKI V4 pump was then used at a flow rate of 25 ml/h, the flow was stopped when the infusion system was filled with blood coming from the infusion pump and another 1.3 ml sample was collected (NK). Finally, an Infusomat FmS pump was evaluated, collecting another 1.3 ml sample (IM). Packed cell volume (PCV) was measured in all samples by microhaematocrit centrifugation, total haemoglobin (HGB) was measured using a specific haemoglobin analyser and, after centrifugation, free HGB was determined by spectrophotometry. The percentage of haemolysis was calculated. Friedman’s test was used to compare the samples. Results Fifteen feline pRBC units were evaluated. The average degree of haemolysis for sample G (gravity-assisted) was 1.12%. Comparison of the degree of gravity-assisted haemolysis with haemolysis in PIP NK (1.13%) and IM (1.14%) samples revealed no significant differences, with differences of only 0.01% and 0.02%, respectively. Conclusions and relevance The results of this study demonstrate that the use of two common PIPs in veterinary hospitals does not produce levels of haemolysis that are significantly different than that caused by gravity alone during transfusion of feline pRBCs at a rate of 25 ml/h.

For effective patient therapy and improved patient safety, it is critical to administer medication accurately in accordance with doctor’s prescription. However, accidents owing to the erroneous programing of infusion pumps caused by users have been consistently reported in several documents. In this study, the authors propose a novel surveillance technique for infusion pumps to continuously monitor the variations in panel digits using a convolutional neural network model, and evaluate the performance of the implemented technique. During the experimental evaluation, 1st-step ROIs and 2nd-step ROIs were successfully extracted from the frame images regardless of the ambient lighting conditions. The final accuracies of the implemented CNN model are 99.9% for both the training (172,800 images) and validation (1080 images) dataset while the final losses for the training and validation datasets are 0.48 and 0.45 after 13th epoch, respectively. In the 24-h continuous monitoring test, the accuracy of the model for volume recognition considering all the 1440 measurements (960 for day-lighting and 480 for night-lighting) is 95.5%, whereas in day-lighting and night-lighting modes the accuracies of the model are 98.2% and 90.0%, respectively. Based on these experimental results, the proposed surveillance technique incorporating infusion pumps is expected to improve the safety of patients who need long-term treatments via infusion pumps, reducing the burden on the nurses and hospitals.

In the UK, Parkinson's disease (PD) is estimated to affect an annual incidence of 15–20 per 100 000 of the population over the age of 60. Service users living with advanced-stage PD require the use of apomorphine, which is generally used to control symptoms. The district nursing service plays a key role in monitoring and in the administration of apomorphine therapy. Although apomorphine is effective, skin problems such as nodules are commonly reported adverse events that can complicate efficiency of treatment. A sublingual delivery route to apomorphine has been known for years as a feasible alternative to subcutaneous route. Collaboration between the multidisciplinary team is essential to meet the complex needs of service users with advanced PD. However, due to the increase in demands of the district nurse service, this time crucial intervention can be unpredictable to meet. An alternative route can enable district nurses to become less task-orientated. However, an increased risk of oral cavity related adverse events should be taken into consideration with the sublingual administration of apomorphine.

10 instructions of infusion pumps were contrasted and analyzed in order to explore the problems of instructions, furthermore improve the product safety.Analyzed the scopes of application, requirements of infusion apparatus, maintenance methods and cycles, battery maintenance, and service life, etc.There were 5 products in 10 which did not indicate contraindications. One product only provided the thickness range of the tube wall of the infusion apparatus instead of specific brands. The cleaning cycles of 9 products varied from 2 to 12 months. One product did not clarify the service life.It is recommended that manufactures should improve the product instructions to ensure the safety of infusion pumps.

Introduction: Continuous glucose monitoring (CGM) provides detailed information about glucose level fluctuations over time. The method is increasingly being used in pregnant women with type 1 diabetes. However, only one previous study compared CGM results related to pregnancy outcomes in women using insulin pumps with those administering multiple daily injections (MDI). We performed a secondary analysis of CGM metrics from an observational cohort of pregnant women with type 1 diabetes and compared insulin pump and MDI therapies in relation to maternal and neonatal outcomes. Material and methods: The study included 185 pregnant Swedish women with type 1 diabetes undergoing CGM throughout pregnancy. Women were divided according to insulin administration mode, ie MDI (n = 131) or pump (n = 54). A total of 91 women used real-time CGM and 94 women used intermittently viewed CGM. Maternal demographics and maternal and neonatal outcome data were collected from medical records. CGM data were analyzed according to predefined glycemic indices: mean glucose; standard deviation; percentage of time within, below and above glucose target range; mean amplitude of glycemic excursion; high and low glucose indices; and coefficient variation in percent. Associations between insulin administration mode and CGM data, on the one hand, and maternal and neonatal outcomes, on the other, were analyzed with analysis of covariance and logistic regression, respectively, adjusted for confounders. Results: There were no differences in maternal characteristics or glycemic indices between the MDI and pump groups, except for a longer duration of type 1 diabetes and higher frequencies of microangiopathy and real-time CGM among pump users. Despite improvement with each trimester, glucose levels remained suboptimal throughout pregnancy in both groups. There were no differences between the MDI and pump groups concerning the respective associations with any of the outcomes. The frequency of large for gestational age was high in both groups (MDI 49% vs pump 63%) and did not differ significantly. Conclusions: Pregnant women with type 1 diabetes did not differ in glycemic control or pregnancy outcome, related to MDI or pump administration of insulin. Glycemic control remained suboptimal throughout pregnancy, regardless of insulin administration mode. (Less)

Purpose To evaluate the safety and tolerability of subcutaneous IgPro20 (Hizentra®, CSL Behring, King of Prussia, PA, USA) administered at high infusion parameters (> 25 mL and > 25 mL/h per injection site) in patients with primary immunodeficiency. Methods The Hizentra® Label Optimization (HILO) study was an open-label, parallel-arm, non-randomized study (NCT03033745) of IgPro20 using a forced upward titration design for infusion parameters. Patients experienced with pump-assisted IgPro20 infusions received weekly IgPro20 infusions at a stable dose in the Pump-Assisted Volume Cohort (N = 15; 25–50 mL per injection site) and in the Pump-Assisted Flow Rate Cohort (N = 18; 25–100 mL/h per injection site). Responder rates (percentage of patients who successfully completed ≥ 75% of planned infusions), safety outcomes, and serum immunoglobulin G (IgG) trough levels were evaluated. Results Responder rates were 86.7% (13/15, 25 mL) and 73.3% (11/15, 40 and 50 mL) in the Volume Cohort, and 77.8% (14/18, 25 and 50 mL/h), 66.7% (12/18, 75 mL/h), and 61.1% (11/18, 100 mL/h) in the Flow Rate Cohort. Infusion compliance was ≥ 90% in all patients in the Volume Cohort and in 83.3% of patients in the Flow Rate Cohort. The number of injection sites (Volume Cohort) and the infusion duration (Flow Rate Cohort) decreased with increasing infusion parameters. The rate of treatment-emergent adverse events per infusion was low (0.138 [Volume Cohort] and 0.216 [Flow Rate Cohort]). Serum IgG levels remained stable during the study. Conclusion Pump-assisted IgPro20 infusions are feasible at 50 mL and 100 mL/h per injection site in treatment-experienced patients, which may result in fewer injection sites and shorter infusion times. Trial Registration NCT03033745; registered January 27, 2017

Infusion pumps have been widely used in clinical settings for the administration of medications and fluids. We present the digital droplet infusion (DDI) device, a low-cost, high-precision digital infusion system, utilizing a microfluidic discretization unit to convert continuous flow into precisely delivered droplet aliquots and a valving unit to control the duration and frequency of flow discretization. The DDI device relies on a distinct capillarity-dominated process of coalescence and pinch-off of droplets for the flow digitization, which is monitored by a pair of conductive electrodes located before and after the junction. The digital feedback-controlled flowrate can be employed to adjust a solenoid valve for refined infusion management. With this unique digital microfluidic approach, the DDI technology enables a simple yet powerful infusion system with an ultrahigh resolution of digital droplet transfer volume, as small as 57nL, which is three orders of magnitude lower than that of the clinical standard infusion pumps, as well as a wide range of digitally adjustable infusion rates ranging from 0.1mL/h to 10mL/h, in addition to an array of programmable infusion profiles and safety features. Its modular design enables fast assembly using only off-the-shelf and 3D-printed components. Overall, benefiting from its simple device architecture and excellent infusion performance, the DDI technology has the great potential to become the next-generation clinical standard for drug delivery with its high precision and ultimate portability at a low cost.

Infusion pumps are frequently used when transferring critically ill patients via patient transport cart, ambulance, or helicopter. However, the performance of various infusion pumps under these circumstances has not been explored. The aim of this study was to evaluate the flow rate accuracy of infusion pumps under various clinical vibration conditions. Experiments were conducted with four different types of pumps, including two conventional syringe pumps (Injectomat MC Agilia, Fresenius Kabi and TE-331, Terumo), one conventional peristaltic pump (Volumed μVP7000; Arcomed), and one new cylinder pump (H-100, Meinntech). The flow rate was measured using an infusion pump analyzer on a stable table (0 m/s2) for 1 h with 1 ml/h and 5 ml/h. Experiments were repeated in mild vibration (2 m/s2) (representing vibration of patients in a moving stretcher or ambulance), and in moderate vibration (6 m/s2) (representing vibration in helicopter transport). Any accidental bolus occurrence in extreme vibration situations (20 m/s2) was also analyzed. Simulated vibrations were reproduced by a custom-made vibration table. In the resting state without vibration and in mild vibration conditions, all pumps maintained good performance. However, in moderate vibration, flow rates in syringe pumps increased beyond their known error ranges, while flow rates in peristaltic pumps remained stable. In extreme vibration, accidental fluid bolus occurred in syringe pumps but not in peristaltic pumps. The newly developed cylinder pump maintained stable performance and was unaffected by external vibration environments.

This article discusses the practicalities of syringe drivers (subcutaneous continuous infusion pumps) for symptom control in patients requiring palliative or end-of-life care, which may form part of an advance care plan. It includes a discussion of palliative and end-of-life care, advance care planning, and when a syringe driver might be beneficial for the patient. It also provides step-by-step clinical guidance on setting up a syringe driver.

Objectives Alternative dosing strategies for β-lactams – the most common antibiotics used to treat critically ill patients with respiratory tract infections – have been recommended to maximize the duration of exposure and reduce drug resistance. The objective of this study was to evaluate whether extended infusion of antipseudomonal β-lactams improves mortality and clinical efficacy. Methods Two independent authors identified eligible trials by searching the PubMed, Cochrane Library, Scopus, and ICHUSHI databases, in both English and Japanese, up to June 2019. Data were extracted from both randomized controlled and observational trials comparing extended infusion (≥3 h) with intermittent infusion in critically ill patients. The primary outcome was all-cause mortality. Risk differences (RD) and 95% confidential intervals (CI) were calculated using a random-effects model and subgroup analyses were performed. Sensitivity and heterogeneity were also evaluated. Results Nine studies involving 1508 participants were included in the meta-analysis. Mortality was lower for extended infusion than for intermittent infusion (RD −0.10; 95% CI −0.15 to −0.04). However, no significant between-group differences in clinical success, length of ICU stay, length of hospital stay, and antibiotic duration were observed. Conclusions Extended infusions of β-lactams were associated with reduced mortality rates but not with clinical success.

Background Neuronal ceroid lipofuscinosis type 2 or CLN2 disease is a rare, autosomal recessive, neurodegenerative lysosomal storage disorder caused by tripeptidyl peptidase 1 deficiency. Cerliponase alfa, a recombinant human tripeptidyl peptidase 1 enzyme, is the first and only approved treatment for CLN2 disease and the first approved enzyme replacement therapy administered via intracerebroventricular infusion. Methods A meeting of health care professionals from US institutions with experience in cerliponase alfa treatment of children with CLN2 disease was held in November 2018. Key common practices were identified, and later refined during the drafting of this article, that facilitate safe chronic administration of cerliponase alfa. Results Key practices include developing a multidisciplinary team of clinicians, pharmacists, and coordinators, and institution-specific processes. Infection risk may be reduced through strict aseptic techniques and minimizing connections and disconnections during infusion. The impact of intracerebroventricular device design on port needle stability during extended intracerebroventricular infusion is a critical consideration in device selection. Monitoring for central nervous system infection is performed at each patient contact, but with flexibility in the degree of monitoring. Although few institutions had experienced positive cerebrospinal fluid test results, the response to a positive cerebrospinal fluid culture should be determined on a case-by-case basis, and the intracerebroventricular device should be removed if cerebrospinal fluid infection is confirmed. Conclusions The key common practices and flexible practices used by institutions with cerliponase alfa experience may assist other institutions in process development. Continued sharing of experiences will be essential for developing standards and patient care guidelines.

There has been a surging interest in using elastomeric infusion devices to deliver outpatient parenteral antimicrobial therapy (OPAT), which is more cost-effective than standard antibiotic administration, which requires multiple daily home visits. This has been particularly important since the outbreak of the coronavirus pandemic, because reducing patient contact can also help to minimise transmission of COVID-19 to outpatients who are at a high risk of COVID-19-triggered complications. In this retrospective study, the clinical effectiveness of intravenous (IV) infusion of flucloxacillin using an elastomeric device was explored in a convenience sample of patients. Patients with three primary infective diagnoses—bloodstream infection, non-vertebral osteomyelitis and vertebral osteomyelitis—were included in the analyses. In non-vertebral osteomyelitis patients, Accufuser antibiotic infusion shortened the course of OPAT care relative to standard antibiotic administration (p

Background Processes for delivery of high-risk infusions in pediatric intensive care units (PICUs) are complex. Standard concentration infusions (SCIs), smart-pumps, and electronic prescribing are recommended medication error reduction strategies. Implementation rates in Europe lag behind those in the United States. Since 2012, the PICU of an Irish tertiary pediatric hospital has been using a smart-pump SCI library, interfaced with electronic infusion orders (Philips ICCA). The incidence of infusion errors is unknown. Objectives To determine the frequency, severity, and distribution of smart-pump infusion errors in PICUs. Methods Programmed infusions were directly observed at the bedside. Parameters were compared against medication orders and autodocumented infusion data. Identified deviations were categorized as medication errors or discrepancies. Error rates (%) were calculated as infusions with errors and errors per opportunities for error (OEs). Predefined definitions, multidisciplinary consensus and grading processes were employed. Results A total of 1,023 infusions for 175 patients were directly observed over 27 days between February and September 2017. The drug library accommodated 96.5% of infusions. Compliance with the drug library was 98.9%. A total of 133 infusions had ≥1 error (13.0%); a further 58 (5.7%) had ≥1 discrepancy. From a total of 4,997 OEs, 153 errors (3.1%) and 107 discrepancies (2.1%) were observed. Undocumented bolus doses were most commonly identified (n = 81); this was the only deviation in 36.1% (n = 69) of infusions. Programming errors were rare (0.32% OE). Errors were minor, with just one requiring minimal intervention to prevent harm. Conclusion The error rates identified are low compared with similar studies, highlighting the benefits of smart-pumps and autodocumented infusion data in PICUs. A range of quality improvement opportunities has been identified.

Advanced age is an important risk factor for adverse events (AEs) during propofol sedation for endoscopic procedures. This study aimed to evaluate the safety and efficacy of nonanesthesiologist-administered propofol (NAAP) sedation with a target-controlled infusion (TCI) system in elderly patients during ERCP.This study retrospectively analyzed 482 patients who underwent ERCP under propofol sedation with a TCI system at Iwakuni Medical Center between January 2014 and October 2016. Patients were divided into 3 groups according to their age: group A, 70 years (n = 130); group B, ≥70 and 85 years (n = 224); and group C, ≥85 years (n = 125). We compared the propofol dose and AEs during ERCP.The median total infusion dose and minimum and maximum target blood concentrations of propofol were 336 mg, 2.2 μg/mL, and 2.2 μg/mL in group A; 184 mg, 1.0 μg/mL, and 1.4 μg/mL in group B; and 99 mg, .6 μg/mL, and 1.0 μg/mL in group C, respectively, with older groups requiring a lower dose (P .0001). Hypotension was observed in 23 patients (4.8%), with no significant difference between groups (group A, 2.3%; group B, 6.3%; group C, 4.8%; P = .24). Hypoxemia was observed in 16 patients (3.3%), with no significant difference between groups (group A, 3.1%; group B, 4.9%; group C, .8%; P = .17). All AEs were immediately resolved, and no procedures were aborted.NAAP sedation with a TCI system during ERCP may be acceptable in elderly patients with a lower dose of propofol than that used in younger patients.

Background Elderly patients with rib fractures carry a high morbidity rate, particularly due to pulmonary complications as decreased respiratory efforts ensue secondary to pain. Risk of bleeds in the elderly on anticoagulant therapy is high. The effort to reduce narcotic use in patients is now a health care priority. We propose that the use of paravertebral analgesia (PVA) pumps is an alternative pain control method with less risk and easy placement. Methods Two hundred and seventy-nine patients were admitted with multiple fractured ribs to the Trauma Center of Community Hospital and treated with the application of continuous PVA via a pump (72 patients). Pain scores were recorded before and after the initiation of the pump. These patients were compared with a group of the remaining 207 patients who received intravenous narcotics only. Results The mean change from baseline in pain scores for all patients was 1.43 (SD = 2.75). The mean change in pain for the treatment group was 1.93 (SD = 2.60), and the change in pain for the control group was 1.24 (SD = 2.79). Change in pain differed between groups (1.3 vs 1.8; P = .01) although it was a small difference. After adjusting for age, gender, Injury Severity Score, Glasgow Coma Scale, number of fractures, and comorbid conditions, there was no significant difference in pain post-procedure (odds ratio = 0.75; P = 0.39) with an effect size of 30% and total sample size of 279. Conclusion The PVA pump using bupivacaine is an effective safe and alternative method for managing elderly patients with rib fractures eliminating the serious side effects associated with narcotics.

This guideline will inform physicians, nurses, dieticians, pharmacists, caregivers and other home parenteral nutrition (HPN) providers, as well as healthcare administrators and policy makers, about appropriate and safe HPN provision. This guideline will also inform patients requiring HPN. The guideline is based on previous published guidelines and provides an update of current evidence and expert opinion; it consists of 71 recommendations that address the indications for HPN, central venous access device (CVAD) and infusion pump, infusion line and CVAD site care, nutritional admixtures, program monitoring and management. Meta-analyses, systematic reviews and single clinical trials based on clinical questions were searched according to the PICO format. The evidence was evaluated and used to develop clinical recommendations implementing Scottish Intercollegiate Guidelines Network methodology. The guideline was commissioned and financially supported by ESPEN and members of the guideline group were selected by ESPEN.

Background: Administration of doxorubicin via bolus injection may result in environmental contamination and a risk of nurses becoming exposed. Small spills are frequently observed by nurses when syringes are connected to, and disconnected from, infusion lines. Aims: The effect of a closed-system drug transfer device (CSTD) on the release of doxorubicin was studied during administration via bolus injections. Methods: 10 administrations with the currently used technique and 10 administrations using the CSTD were compared by analysis of doxorubicin contamination on gauze pads, tissues and gloves. Findings: Using the current technique, contamination was found during nine administrations, which was mainly on the gauze pads and, to a lesser extent, on the tissues and gloves, indicating release of doxorubicin during administration. With use of the CSTD, contamination was found only on one pair of gloves. Conclusion: Use of a CSTD significantly decreased the number of spills and level of contamination compared with the currently used technique and, consequently, the use of such devices offers a safer working environment for nurses.

Purpose Meropenem and vaborbactam is an intravenous beta-lactam/beta-lactamase inhibitor combination antibiotic active against multidrug resistant gram-negative bacteria. It may be a suitable treatment for inpatient and outpatient management of infections, and the intravenous admixture stability is therefore important for optimal utilization. The purpose of this study was to determine the stability of meropenem and vaborbactam in polyvinyl chloride (PVC) infusion bags and elastomeric pumps at room and refrigerated temperatures. Methods Meropenem and vaborbactam vials were reconstituted according to manufacturer instructions and diluted in PVC infusion bags to final concentrations of 4, 8, and 16 mg/mL and in elastomeric pumps to 11.4 mg/mL (n = 5 replicates per concentration and per temperature). PVC bags and elastomeric pumps were stored at room temperature (~24 °C) or in the refrigerator (~4 °C) and sampled over 12 and 144 h, respectively. Stability was defined as the duration that meropenem and vaborbactam concentrations remained ≥90% of the original concentrations. Findings All room temperature replicates across the tested concentrations retained meropenem and vaborbactam stability over 12 h and displayed concentration-dependent degradation. Refrigerated studies resulted in meropenem and vaborbactam stability at all tested concentrations up to 120 h. Implications Meropenem and vaborbactam in PVC bags (4, 8, and 16 mg/mL) and elastomeric pumps (11.4 mg/mL) were stable for 12 h at room temperature and 120 h when refrigerated. These stability data allow for enhanced flexibility in the preparation, storage, wastage, and administration of meropenem and vaborbactam in the hospital and outpatient setting. (Clin Ther. 2020; 42:XXX–XXX) © 2020 Elsevier HS Journals, Inc.

Background Baclofen pumps provide treatment of symptoms of spasticity for disease processes such as cerebral palsy and traumatic brain injury. These devices provide continuous infusion or periodic dosing of intrathecal baclofen (ITB). Traditionally, these pumps have been placed subcutaneously. Subcutaneous device placement has been associated with infection and extrusion. Baclofen pumps are large and range from 8 to 10 cm in diameter and 4 to 8 cm in width. Patients requiring device placement typically have a paucity of subcutaneous tissue. Cachexia coupled with the size and bulk of these devices leads to increased protusion and friction. Submuscular placement provides a well-vascularized pocket that directs the device inward eliminating protrusion and decreasing the potential for soft tissue breakdown. Methods A retrospective chart review of ITB pump placement in a submuscular plane by a single plastic surgeon at a major academic center in conjunction with a neurosurgeon was performed. Inclusion criteria were cases of primary placement or replacement of ITB pumps and spasticity requiring ITB. Major complications included infection, extrusion, and reoperation. Results Five patients during a 5-month period were treated with submuscular placement of ITB pumps. Average age of patients included was 18.4 years. Average preoperative body mass index was 18.8 kg/m, with values ranging from 15.8 to 20.1 kg/m. Medical histories of patients included diagnoses of cerebral palsy and traumatic brain injury causing spasticity. The most frequently cited reason for plastic surgical consultation preoperatively was cachexia. Two patients had previous baclofen pumps placed subcutaneously. Average follow-up was 6 months and ranged from 3 to 13 months. There were no major complications. One patient had a small seroma that spontaneously resolved. No patient had wound healing problems, and there were no extrusions of implanted devices or reoperations. Conclusion Submuscular placement of baclofen pumps provides a well-vascularized and stable environment for device placement that minimizes the dangers of pump extrusion and infection. Patients who require treatment with ITB commonly have severe cachexia, which makes subcutaneous device placement high risk. Submuscular placement should be performed in all patients with body mass index less than 20 kg/m.

Background: The optimal goal of naloxone infusion in intensive care units is to ameliorate opioid-induced side effects in therapy or eliminate the symptoms of opioid toxicity in overdoses. Accurately monitoring and regulating the doses is critical to prevent adverse effects related to naloxone administration. The present study aimed to compare treatment outcomes when using two methods of intravenous naloxone infusion: an infusion pump or the standard method. Methods: This study involved 80 patients with signs and symptoms of opioid overdose. The patients were randomly assigned into two groups with respect to intravenous infusion of naloxone by either an infusion pump or the standard method. Results: Comparison of study parameters between the two groups at 12 and 24 hours after intervention showed significantly more compensatory acid-base imbalance in the naloxone infusion pump group. In the group that received naloxone by pump, only one patient experienced withdrawal symptoms, but withdrawal symptoms appeared in 12 patients (30.0%) in the standard intravenous infusion group within 12 hours and in seven additional patients (17.5%) within 24 hours of intervention. In the group receiving pump-based naloxone infusion therapy, no another complications were reported; however in the standard infusion group, the 12-hour and 24-hour complication rates were 55.0% and 32.5%, respectively. The length of hospital stay was 2.85±1.05 and 4.22±0.92 days for the pump and standard infusion groups, respectively (P

Vancomycin hydrochloride is an antibiotic belonging to the glycopeptide family and acts by inhibiting the synthesis of the peptidoglycan wall. This antibiotic is active against Gram-positive aerobic and anaerobic bacteria1 2 and is commonly used in hospitals to treat serious infections.3 4 Vancomycin has slow bactericidal time-dependent activity and can be administered by continuous or intermittent intravenous infusion. In France, administering vancomycin by continuous infusion over 24 hours is recommended.5 6 The Summary of Product Characteristics (SmPC) recommends reconstituting a 1 g vial with 20 mL of water for injection (WFI), then diluting it in 100 mL of saline solution. The amount of vancomycin to treat an adult infection is superior to 1 g and so the volume administered can be higher than 100 mL. This volume must be limited in children or in patients on water restriction, such as those suffering from hyponatraemia and cardiovascular diseases or are in intensive care.7 Some studies on vancomycin stability have already been performed. Solutions at 5 and 10 mg/mL were stable for 58 days at +4°C in 100 mL polyvinyl chloride (PVC) infusion bags with no specification with regard to protection from light.8 Vancomycin was stable at 5 mg/mL in PVC bags for 48 hours at +22°C without protection from light and for 7 days at +4°C with protection from light.9 Raverdy et al 10 examined the stability of vancomycin diluted in 5% dextrose at high concentration (83 mg/mL) and was stable for 72 hours at +37°C. However, none of these studies reflects real infusion conditions as vancomycin is usually administered at 30 mg/kg/day.11 12 In practice, clinical services infuse vancomycin into electric syringe pumps using 50 mL (for adults) or 20 mL (for children) syringes. No stability study has yet been performed for such concentrations, in 50 or 20 mL syringes, at room temperature, nor has the reconstitution procedure13 been …

The systemic delivery of bleomycin (BLM) to mice through subcutaneously implanted osmotic minipumps may be used to experimentally mimic the typical features of systemic sclerosis and related interstitial lung diseases. The published studies on this model principally have focused on induced dermal modifications, probably because lung lesions are typically mild, subpleurally localized, and difficult to analyze. The use of high BLM doses to increase their severity has been proposed but is ethically questionable because of the compromising of animal welfare. We propose a tailored histomorphometric method suitable to detect and quantify this type of mild lung lesions. Using a two-step automated image analysis, a peripheral region of interest with a depth of 250 µm from the pleural edge was defined on whole slide images, and the fibrotic foci were histomorphometrically characterized. The effects of different BLM doses on lung alterations were evaluated in C57BL/6 mice and 60 U/kg resulted in a fair compromise between fibrotic lesions and animal welfare. This dose was also tested in time course experiments. The analysis revealed a peak of histological fibrotic-like alterations, cytokine expression, metalloprotease, and macrophagic activation between the 21st and 28th day after pump implant. The induced dermal fibrosis was characterized by the progressive loss of the white dermal adipose layer, an increase in dermal thickness, dermal hyperplasia, and more compacted collagen fibers. Despite the trend toward spontaneous resolution, our model allowed a double organ readout of the BLM effect and the identification of a therapeutic window for testing pharmacological compounds without using life-threatening doses.

Colorectal liver metastasis (CRLM) is a leading cause of morbidity and mortality in patients with colorectal cancer. Hepatic arterial infusion (HAI) chemotherapy has been demonstrated to improve survival in patients with resected CRLM and to facilitate conversion of technically unresectable disease.Between 2016 and 2018, n = 22 HAI pumps were placed for CRLM. All patients received systemic chemotherapy concurrently with HAI floxuridine/dexamethasone. Overall survival (OS) and progression-free survival (PFS) were assessed using the Kaplan-Meier method.HAI pumps were placed in seven patients with completely resected CRLM and 15 patients with unresectable disease. Twenty-one patients received HAI floxuridine with a median of 5 total HAI cycles (interquartile range: 4-7). Biliary sclerosis was the most common HAI-related complication (n = 5, 24%). Of the 13 patients treated to convert unresectable CRLM, 3 (23%) underwent hepatic resection with curative intent after a median of 7 HAI cycles (range: 4-10). For all HAI patients, the mean OS was 26.7 months from CRLM diagnosis, while the median PFS and hepatic PFS from pump placement were 9 and 13 months, respectively.Concomitant HAI and systemic therapy can be utilized at multidisciplinary programs for patients with advanced CRLM, both in the adjuvant setting and to facilitate conversion of unresectable disease.

Analyze and conclude the new quality control process, so as to improve the quality control efficiency.Statistical analysis was conducted on the flow rate quality control data of infusion pump in 2020, with a total of 330 times of quality control data.The pump with qualified flow rate entered and maintained the qualified state from the third minute, while the pump with unqualified flow rate entered and maintained the unqualified state from the second minute.Take the third minute to enter the qualified range and continue for 2 minutes to judge that the flow rate quality control is qualified. The accuracy of this new rule is as high as 100%, and the time of flow rate quality control can be reduced from 60 minutes to 10 minutes, which greatly improves the work efficiency.

The objective of this study was to assess the frequency, type, and severity of errors associated with intravenous medication administration before and after smart pump interoperability.We conducted an observational study at a community healthcare system before and after implementing smart pump interoperability. Point prevalence methodology was used to collect data on medication administration and errors in adult inpatient settings.Observations were completed for 350 infusions preintervention (178 patients) and 367 postintervention (200 patients). Total errors significantly decreased from 401 (114.6 per 100 infusions) to 354 (96.5 per 100 infusions, P = 0.02). Administration errors decreased from 144 (41.1 per 100 infusions) to 119 (32.4 per 100 infusions, P = 0.12). Expired medication errors significantly reduced from 11 (3.1 per 100 infusions) to 2 (0.5 per 100 infusions, P = 0.02). Errors involving high-risk medications significantly reduced from 45 (12.8 per 100 infusions) to 25 (6.8 per 100 infusions, P = 0.01). Errors involving continuous medications significantly reduced from 44 (12.6 per 100 infusions) to 22 (6.0 per 100 infusions, P = 0.005). When comparing programming type, manual programming resulted in 115 (77.2%) of administration and user documentation errors compared with 34 errors (22.8%) that occurred when autoprogramming was used. Of these, errors involving high-risk medications reduced from 21 (84.0%) to 4 (16.0%) after using autoprogramming.Smart pump interoperability resulted in a 16% reduction in medication administration errors. Despite using dose error reduction software and autoprogramming, some types of errors persisted. Further studies are needed to understand how technology use can be optimized.