Comparing Apotel and Remifentanil for Multimodal Patient-Controlled Analgesia in Postoperative Pain Management Following Total Knee Arthroplasty Surgery: A Randomized Controlled Trial.

Background: Total knee arthroplasty (TKA) is a standard surgical procedure for individuals with debilitating knee arthritis. Effective postoperative pain management is essential for successful recovery, although traditional opioid-based methods have limitations. Objectives: This study aimed to compare the efficacy of Apotel and remifentanil patient-controlled analgesia in managing postoperative pain after TKA. Methods: This double-blind, randomized, controlled clinical trial took place at Amir-al-Momenin and Qods Hospitals in Arak, Iran, spanning from June 2022 to September 2023. Sixty-two eligible patients scheduled for knee joint replacement were randomly assigned to receive either Apotel (Group A) or remifentanil (Group R) as part of multimodal analgesia administered via a pain pump for postoperative pain relief in TKA. The study assessed hemodynamic parameters, pain levels (measured using the Visual Analog Scale), analgesic duration, and narcotic consumption. Statistical analyses were performed using SPSS v.27 and Plotly. Results: Subjects exhibited no statistically significant differences in age, gender distribution, duration of surgery, or anesthesia. The hemodynamic status assessment in the recovery room showed no significant differences in SPO2, PR, or MAP between the groups. However, remifentanil demonstrated superior effectiveness in reducing pain over 24 hours post TKA surgery compared to Apotel, as evidenced by lower average Visual Analog Scale (VAS) scores (P < 0.001), longer duration without the need for narcotic painkillers (P < 0.001), and lower cumulative opioid analgesic consumption in Group R (P < 0.001). Conclusions: Remifentanil demonstrates superior pain control in a multimodal pain management approach compared to Apotel, providing sustained pain reduction over 24 hours post-surgery. Moreover, remifentanil offers longer-lasting pain relief and results in lower cumulative narcotic painkiller consumption compared to Apotel.

[Translated article] Retrospective study of home antibiotic infusion therapy using elastomeric infusion pumps.

OBJECTIVES: To describe the experience of home antibiotic infusion therapy using elastomeric infusion pumps, administered to patients admitted to the Home Hospitalisation Unit of a tertiary hospital for 3 years and to analyse clinical evolution and mortality. METHOD: Retrospective observational study. The medical history of the patients included in the study was reviewed. Information was obtained on personal history, antimicrobial therapy received, and clinical evolution. Statistical analysis was performed using SPSS® 19 software. RESULTS: 81 patients were included, 61.7% men, with a mean age of 73.5±17.5 years. The most frequent comorbidities were diabetes mellitus (30.9%) and chronic kidney disease (28.4%). Patients received a mean of 11.9±8.5 days of antibiotic treatment in an elastomeric infusion pump. The main focus of infection was respiratory (27.2%), followed by bacteremia (16%) and skin and soft tissue infections (12.3%). Of the infections, 65.4% were monomicrobial, with Pseudomonas aeruginosa being the main microorganism involved (39.6%). The most commonly used antimicrobial was piperacillin/tazobactam (33.3%). The clinical course was good in 85.2% of the patients, but the mortality rate in the 30 days following the end of treatment was 24.7%. In the univariate analysis, a history of neoplasia in the last 5 years (p=.01) and having received fewer days of antibiotic therapy prior to the start of outpatient antimicrobial therapy in infusion pump (p=.04) were associated with worse clinical outcome. Age over 80 years was associated with better outcome (p=.03). The diagnosis of heart failure was associated with higher mortality (p=.026) and patients from surgical services, with lower mortality (p=.047). In the multivariate analysis, the presence of neoplasia was associated with unfavourable evolution (p=.012) and heart failure with higher mortality (p=.027). CONCLUSIONS: Outpatient antimicrobial therapy in elastomeric infusion pumps is an alternative in patients requiring prolonged intravenous treatment, and age is not a conditioning factor for inclusion in these programs. However, the presence of certain comorbidities can negatively affect the clinical course and mortality of patients.

Novel Two-Infusion Pump Technique for Exchange Transfusion in a Hyperbilirubinemic Neonate.

Neonatal hyperbilirubinemia is a common concern in newborns, with ABO blood group incompatibility serving as a significant risk factor for severe jaundice. This case report outlines the successful management of a 2.5 kg female infant born to a primigravida mother with ABO incompatibility-induced hyperbilirubinemia. The neonate, born at 38.4 weeks via lower segment cesarean section, exhibited signs of jaundice at 91 hours of life, prompting screening and subsequent confirmation of serum bilirubin levels 26.4. The decision was made using the American Academy of Pediatrics (AAP) and categorized the child under high risk according to age and bilirubin level to implement a complete exchange transfusion using a novel approach with two infusion pumps. The unique aspect of this case lies in introducing a two-infusion pump technique, one to infuse and one to extract blood by inserting the IV set in opposite directions in the infusion pump to perform the exchange transfusion, aiming to minimize complications associated with traditional methods. Careful handling of umbilical venous and arterial lines, coupled with aseptic precautions, sought to mitigate the risk of sepsis. The procedure, conducted over two hours, demonstrated stability in vital signs and was monitored with a transcutaneous bilirubinometer. Post-transfusion, repeat serum bilirubin tests showed a decrease in bilirubin of 10.1, indicating the success of the novel exchange transfusion method. The infant was discharged after a five-day hospital stay, showcasing this innovative approach's potential efficacy and safety. This case contributes to the evolving strategies in neonatal care and emphasizes the importance of tailored interventions in managing hyperbilirubinemia associated with ABO incompatibility.

Retrospective study of home antibiotic infusion therapy in elastomeric infusion pumps. / Estudio retrospectivo de la terapia de infusión de antibióticos domiciliaria en bombas de infusión elastoméricas.

OBJECTIVES: To describe the experience of home antibiotic infusion therapy using elastomeric infusion pumps, administered to patients admitted to the Home Hospitalization Unit of a tertiary hospital for three years and to analyse clinical evolution and mortality. METHOD: Retrospective observational study. The medical history of the patients included in the study was reviewed. Information was obtained on personal history, antimicrobial therapy received and clinical evolution. Statistical analysis was performed using SPSS® 19 software. RESULTS: Eighty-one patients were included, 61.7% men, with a mean age of 73.5 ± 17.5 years. The most frequent comorbidities were diabetes mellitus (30.9%) and chronic kidney disease (28.4%). Patients received a mean of 11.9 ± 8.5 days of antibiotic treatment in an elastomeric infusion pump. The main focus of infection was respiratory (27.2%), followed by bacteremia (16%) and skin and soft tissue infections (12.3%). Of the infections, 65.4% were monomicrobial, with Pseudomonas aeruginosa being the main microorganism involved (39.6%). The most commonly used antimicrobial was piperacillin/tazobactam (33.3%). The clinical course was good in 85.2% of the patients, but the mortality rate in the 30 days following the end of treatment was 24.7%. In the univariate analysis, a history of neoplasia in the last 5 years (p = 0.01) and having received fewer days of antibiotic therapy prior to the start of outpatient antimicrobial therapy in infusion pump (p = 0.04) were associated with worse clinical outcome. Age over 80 years was associated with better outcome (p = 0.03). The diagnosis of heart failure was associated with higher mortality (p = 0.026) and patients from surgical services, with lower mortality (p = 0.047). In the multivariate analysis, the presence of neoplasia was associated with unfavorable evolution (p = 0.012) and heart failure with higher mortality (p = 0.027). CONCLUSIONS: Outpatient antimicrobial therapy in elastomeric infusion pumps is an alternative in patients requiring prolonged intravenous treatment, and age is not a conditioning factor for inclusion in these programs. However, the presence of certain comorbidities can negatively affect the clinical course and mortality of patients.

Implementation of a national system for best practice delivery of paediatric infusions.

BACKGROUND: Standard concentration infusions and 'smart-pumps' are recognised as best practice in the paediatric setting. Implementation rates in European hospitals remain low. Children's Health Ireland (CHI) developed a paediatric 'smart-pump' drug library using standardised concentrations. At time of development, other Irish hospitals continued to use traditional pumps and weight-based paediatric infusions. AIM: To expand best paediatric infusion practices by nationalising use of the CHI drug library. SETTING: Tertiary paediatric, maternity and general acute hospitals, and associated transport services in Ireland. DEVELOPMENT: The CHI drug library was first developed for paediatric intensive care and then adapted over a 10-year period for use in emergency departments, general paediatric wards, neonatal units, adult intensive care and transport services. The original library (42 drug lines, 1 'care-unit') was substantially expanded (223 drug lines, 6 'care-units'). A neonatal sub-library was created. IMPLEMENTATION: Executive support, dedicated resources and governance structures were secured. Implementation and training packages were developed. Implementation has occurred across CHI, in paediatric and neonatal transport services, 58% (n = 11) of neonatal units, and 23% (n = 6) of paediatric sites. EVALUATION: A before and after study demonstrated significant reductions in infusion prescribing errors (29.0% versus 8.4%, p < 0.001). Direct observation of infusions (n = 1023) found high compliance rates (98.9%) and low programming errors (1.6%). 100% of nurses (n = 132) surveyed 9 months after general ward implementation considered the drug library had enhanced patient safety. CONCLUSION: Strategic planning and collaboration can standardise infusion practices. The CHI drug library has been approved as a National Standard of Care, with implementation continuing.

Data-based program management of system-wide IV smart pump integration.

PURPOSE: Smart pump bidirectional interoperability offers automated infusion programming and documentation that can improve patient safety and workflow efficiency. This technology has been poorly implemented across US hospitals, and there is little guidance on the tracking or monitoring of interoperability systems. The purpose of this report is to describe the successful implementation of intravenous (IV) smart pump interoperability in a large health system. SUMMARY: Bidirectional IV smart pump interoperability and compliance monitoring were implemented across a large Midwestern health system using ICU Medical's Plum 360 and LifeCare PCA devices and Smith Medical's MedFusion 4000 Syringe Pump devices. The hospital system's experience in implementing and monitoring IV smart pump compliance using automated reports and a dedicated medication safety integration nurse is described. Compliance trends suggest that the implementation of IV smart pump interoperability has achieved a reduction in programming outside of the dose error reduction system, manual overrides, and IV medication administration error rates. CONCLUSION: The monitoring of smart pump compliance has had demonstrated benefits in investigating usability concerns, recognizing system errors, and identifying increased needs for nurse training. This program can serve as an example for other healthcare systems adopting IV smart pump interoperability.

Prioritizing Patient Safety: Analysis of the Procurement Process of Infusion Pumps in Spain.

To understand whether patient safety and human factors are considered in healthcare technology procurement, we analyzed the case of infusion pumps as their use critically affects patient safety. We reviewed infusion pump procurements in the Spanish Public Sector Procurement Database. Sixty-three batches in 29 tenders for supplying 12.224 volumetric and syringe infusion pumps and consumables for an overall budget of EUR 30.4 M were identified and reviewed. Concepts related to "ease of use" were identified in the selection requirements of 35 (55.6%) batches, as part of the criteria for the selection of pumps in 23 (36.5%) batches, related to "intuitiveness" in the selection requirements of 35 (55.6%) batches, and in the criteria in 10 (15.9%) batches. No method to evaluate the ease of use, intuitiveness, or usability was mentioned. A review of the procurement teams responsible for the evaluation of the tenders showed no reported human factors or patient safety expertise. We conclude that infusion pump procurement considers usability as a relevant criterion for selection. However, no human factor experts nor specific methods for evaluation of the technology in this field are usually defined. Potential room for refining the selection of healthcare technology to improve patient safety is detected.

Effects of flow rate accuracy in two-day anticancer drug infusion with disposable pumps on plasma drug concentrations.

BACKGROUND: Elastomeric pumps have a curved infusion rate profile over infusion time. Chemically driven pumps can overcome such limitations of elastomeric pumps and infuse constantly. However, studies on the pharmacokinetic benefit of chemically-driven pumps are insufficient. OBJECTIVE: This study aimed to determine effects of constant infusion with a chemically-driven pump on plasma drug concentrations compared to elastomeric pumps. METHODS: Infusion rate profiles of a chemically driven pump and two elastomeric pumps were measured in vitro tests under three height conditions of drug reservoir. Plasma drug concentrations were estimated using a pharmacokinetic model of 5-fluorouracil (5FU). RESULTS: The chemically-driven pump was more accurate than elastomeric pumps during the total infusion time (Root-mean-square-error (RMSE): 3% vs. 13%) which thus reduced its deviation of plasma 5FU concentration over time to one-fifth of that with an elastomeric pump. The chemically-driven pump had less than 5% of RMSE despite the influence of height difference. CONCLUSION: Although chemically-driven pumps maintained plasma 5FU concentration successfully and elastomeric pumps did not, both pumps were proper for 5FU infusion because the time-dependent changes in infusion rate did not affect the area under the curve. Chemically driven pumps would be more advantageous for drugs that are sensitive to their plasma concentrations.

Feasibility, Effectiveness and Safety of Elastomeric Pumps for Delivery of Antibiotics to Adult Hospital Inpatients-A Systematic Review.

Elastomeric infusion pumps (EMPs) have been implemented in many fields, including analgesia, chemotherapy and cardiology. Their application in antimicrobials is mainly limited to the outpatient setting, but with a need to optimise inpatient antimicrobial treatment, the use of EMPs presents a potential option. This review aimed to identify if the use of EMPs within an inpatient setting is feasible, effective and safe for antimicrobial use. Criteria for inclusion were human studies that involved the treatment of an infection with intravenous antimicrobial agents via an EMP. A search strategy was developed covering both the indexed and grey literature, with all study designs included. The review found 1 eligible study enrolling 6 patients. There was strong patient preference for EMPs (6/6), and daily tasks were easily completed whilst attached to the EMP. Nurses (5/5) also preffered the pumps, and the majority reported them as easy to use. The review has identified the need for further research in the area. Evidence for the use of EMPs to administer antibiotics in the inpatient setting is scarce, and more work is needed to understand the advantages to patients, to healthcare workers and from an antimicrobial stewardship perspective. Potential disadvantages that may put patients at risk also need investigating.

Enterprise standardization and convergence of large-volume infusion pump drug libraries.

PURPOSE: With the implementation of a new electronic health record (EHR) system across Mayo Clinic, a project was approved to standardize and converge 9 region-specific large-volume infusion pump (LVP) drug libraries for Baxter SIGMA Spectrum pumps. SUMMARY: The objectives of the project were to (1) develop recommendations for identified variances in practice, (2) consolidate regional drug libraries into a converged enterprise library, (3) improve the drug library management process, and (4) maintain or exceed previous Dose Error Reduction System (DERS) compliance for infusions administered. Harmonization efforts with infusion pumps decreased the number of drug libraries maintained, reduced content maintenance time, and increased readiness for smart infusion pump-EHR interoperability. Seven of the 8 regions for which change in DERS compliance was assessed showed improved compliance relative to baseline in the 30-day postwashout period. Furthermore, when comparing pre- and postimplementation DERS compliance, the number of regions meeting the minimum compliance rate of 95% increased from 5 to 6 regions. CONCLUSION: The project improved the drug library management process, allowed for DERS compliance to be accurately compared across regions, and ensured that patients across the enterprise receive the same standard of care with the administration of intravenous medications.

More time in a community setting: A service evaluation of the impact of intrathecal drug delivery systems on place of care of patients with cancer pain.

BACKGROUND: Intrathecal Drug Delivery Systems are underutilised in the management of refractory cancer pain despite evidence of their efficacy. Not all patients who are offered this treatment modality accept it. There is no current evidence that indicates if the use of intrathecal drug delivery systems impacts on place of care for patients with cancer related pain. AIMS: This service evaluation compared place of care, place of death and morphine equivalent daily dose at end of life for patients in whom Intrathecal Drug Delivery was successfully established versus those who chose comprehensive medical management. SETTING/PARTICIPANTS: A retrospective longitudinal cohort study of 45 patients with cancer pain comparing those who had ongoing analgesia successfully delivered via an implanted Intrathecal Drug Delivery System (n = 28) with those who continued to receive comprehensive medical management (n = 17). RESULTS: There was a markedly greater time spent in the community in the intrathecal group than the medical management group (median 126.5vs 25.5 days; p = 0.002) and a lower morphine equivalent daily dose at end of life (median 127.5vs 440.0 p = 0.022). CONCLUSION: In patients with advanced cancer, the successful establishment of intrathecal analgesia is associated with more time in the community and a lower morphine equivalent daily dose at end of life. The study has low numbers, and the sample was retrospectively selected. Nevertheless, these findings suggest the initial investment of time in an inpatient setting may be beneficial. Further research is required, using larger, prospective studies of patient outcomes in this setting.

Flow rate accuracy of infusion devices within healthcare settings: a systematic review.

Background: One in five patients admitted to the hospital treated with intravenous (IV) fluid therapy suffer complications due to inappropriate administration. Errors have been reported in 13-84% of the preparation and administration of IV medications. The safe delivery of IV fluids requires precise rate administration. Objectives: This systematic review aims to determine the accuracy of infusion sets and devices and examine the factors that affect the flow rate accuracy of devices. Data Sources and Methods: Six databases (CINAHL, MEDLINE PubMed, EMBASE, Web of Science and Cochrane Database of systematic reviews) were systematically searched. Search terms included infusion pumps, infusion devices, flow rate accuracy, fluid administration rate, gravity-led infusion set and fluid balance. Studies were included if they examined infusion devices' flow rate accuracy and drop rates for fluids or non-oncological drugs. Findings were tabulated and synthesised qualitatively. The quality of the studies was examined based on the design of the studies due to their heterogeneity. Results: Eight studies were included: Four studies were conducted on human subjects in the hospital environment; studies recruited 182 participants between the ages of 18 and 94 years. Two studies examined flow rate accuracy in recruited patients across 509 observations and 2387 drip hours. No trials prospectively assessed the accuracy of infusion pumps in the clinical domain, and no studies were reported on patient safety outcomes. Four studies examined the impact of mechanical and physiological factors on the flow rate accuracies of infusion devices. Height and back pressure simulated vibrating conditions, the viscosity of IV fluid and the positions of patients were reported to have a significant impact on infusion volume and flow rates of infusion devices. Additionally, giving sets that vary from the manufacturer's specifications are reported to increase error percent by 10-20%. Conclusion: Infusion devices are an important source of error in administering IV fluids. Yet, there needs to be more prospective trial data to support their clinical accuracy and the impact on patient outcomes. Future flow variability and accuracy studies should capture their impact on patient safety and clinical outcomes.

Are the flow rate of infusion devices accurate in fluid administration? Background/Why was this study done? Nearly all patients in healthcare settings undergo treatment with fluid therapy that is administered through a vein. Inaccurate intravenous fluid administration causes patient harm. However, very little information in the literature explains how precisely intravenous fluid is administered. What did the researchers do? We reviewed the literature on flow rate accuracies of specific infusion devices and examined the factors that affect the flow rate accuracies of intravenous fluid administered to patients. What did the researchers find? We found that the flow rate accuracies of infusion devices vary greatly, and they are often affected by physiological and mechanical factors. However, the precise impact of this on patients' clinical outcomes is not often reported, representing a significant knowledge gap. What do the findings mean? We conclude that there is an urgent need to improve the reporting and precision of intravenous fluid rate administration and to understand how this impacts patient safety and clinical outcomes.

Infusion Therapies in the Treatment of Parkinson's Disease.

Oral levodopa is the gold-standard therapy for treating Parkinson's disease (PD) but after a few years of treatment the therapeutic window narrows, and patients often experience various treatment-related complications. Patients in this advanced PD stage may benefit from alternative therapy, such as continuous intrajejunal delivery of levodopa-carbidopa intestinal gel (LCIG; or carbidopa-levodopa enteral suspension), continuous intrajejunal delivery of levodopa-carbidopa-entacapone intestinal gel, or continuous subcutaneous apomorphine infusion. Consideration and initiation of infusion therapies in advanced PD are suggested before the onset of major disability. The present review summarizes clinical evidence for infusion therapy in advanced PD management, discusses available screening tools for advanced PD, and provides considerations around optimal use of infusion therapy.

Recovery time in target controlled infusion versus manual infusion of propofol in total intravenous anaesthesia for endoscopic retrograde cholangio-pancreatography procedure using laryngeal mask airway-gastro: A randomised comparative study.

Background and Aims: This study aimed to compare manual infusion versus target-controlled infusion (TCI) in total intravenous anaesthesia (TIVA) utilising laryngeal mask airway (LMA)-gastro during endoscopic retrograde cholangio-pancreatography (ERCP) procedures. Methods: This was a single-blind randomised trial. Patients were randomly allocated into two groups. TCI group included 27 patients, where TCI of propofol was implemented with the Schnider pharmacokinetic model driven by a computer-controlled syringe pump. The TIVA group included 27 patients with a loading dose of 2 mg/kg of propofol, followed by manual infusion of 15 mg/kg/h for the first 15 min, 13 mg/kg/h for the next 15 min, then 11 mg/kg/h for 30 min and 10 mg/kg/h for 60 min and finally maintained at 9 mg/kg/h. The primary objective was to compare recovery time following cessation of propofol infusion in both groups. The difference in the total dose of propofol, time to achieve anaesthesia induction, first attempt success rate, ease of LMA-gastro insertion, ease of insertion, success rate of endoscope device and post-anaesthesia care unit (PACU) discharge time were the secondary objectives. T-test and Chi-square test were used for statistical analysis. Results: The time required for the recovery was significantly less in the TCI group than in the TIVA group (mean ± standard deviation; 11.60 ± 2.27 versus 15.4 ± 3.25 minutes, P < 0.001). The duration of ERCP, ease of LMA and endoscope insertion were comparable between the groups. There was no post-operative recall of intra-operative events in the groups. Conclusion: TCI offers earlier recovery than TIVA in patients undergoing ERCP procedures using LMA-gastro.

The Impact of Smart Pump Technology in the Healthcare System: A Scope Review.

Smart infusion pump technology prevents errors caused by parenteral therapy. This paper aims to review the recent literature about smart pump uses, cases and adverse events, and strategies to minimize these disadvantages. Literature was explored from January 2000 to November 2021 using Google Scholar, PubMed, and ScienceDirect. There were assessments of the advantages and adverse effects of using smart pumps and strategies to overcome the adverse effects of smart pumps. The advantage of using smart pumps is that they decrease errors like incorrect rate and dose. Other benefits include a decrease in medication event rates and the ability to connect smart pumps to home health providers. However, compliance rates were negatively influenced by improper smart pumps and the overriding of soft alerts, which can cause alert fatigue and drug library update delays. Recent studies have tried to address the negative issues by improving drug library compliance and decreasing alerts to avoid alert desensitization. The investigations revealed that the smart pumps reduced errors but would only prevent some programming errors. Compliance with utilizing smart pump technology is critical in stopping medication errors. Opportunities for future improvement are broad, including integrating a smart pump infusion with the hospital system, implementing auto programming, and designing smart pump devices to be lighter, smaller, and more portable instead of the heavy, large smart pump used by most hospitals today.

Precision and reliability study of hospital infusion pumps: a systematic review.

BACKGROUND: Infusion Pumps (IP) are medical devices that were developed in the 1960s and generate fluid flow at pressures higher than that of normal blood pressure. Various hospital sectors make use of them, and they have become indispensable in therapies requiring continuity and precision in the administration of medication and/or food. As they are classified Class III (high risk) equipment, their maintenance is crucial for proper performance of the device, as well as patient and operator safety. The principal consideration of the pump is the volume infused, and the device demands great attention to detail when being calibrated. A lack of necessary care with this equipment can lead to uncertainty in volume and precision during the administration of substances. Because of this, it is essential to evaluate its reliability, to prevent possible failures at time of execution. This control aims at the quality of the intended infusion result, becoming an indication of quality. METHODS: This systematic review summarizes studies done over the last 10 years (2011 to December 2021) that address the reliability and accuracy of hospital infusion pumps, in order to identify planning of maintenance and/or other techniques used in management of the equipment. The Prisma method was applied and the databases utilized were Embase, MEDLINE/Pubmed, Web of Science, Scopus, IEEE Xplore, and Science Direct. In addition, similar reviews were studied in Prospero and the Cochrane Library. For data analysis, softwares such as Mendeley, Excel, RStudio, and VOSviewer were used, and Robvis helped in plotting risk of bias results for studies performed with Cochrane tools. RESULTS: The six databases selected produced 824 studies. After applying eligibility criteria (inclusion and exclusion), removing duplicates, and applying filters 1 and 2, 15 studies were included in the present review. It was found that the most relevant sources came from the Institute of Electrical and Electronics Engineers (IEEE) and that the most relevant keywords revolved around the terms ("device failure", "infusion pumps", "adverse effects", "complications", etc.). These results made clear that there remains substantial room for improvement as it relates to the study of accuracy and reliability of infusion. CONCLUSIONS: We verified that the reliability and precision analysis of hospital infusion pumps need to be performed in a more detailed and consistent way. New developments, considering the model and IP specification, are intended, clearly explaining the adopted methodology.

Is Sedation of Choice in Thyroplasty Surgery? A Study on the Effects of Sedatives on Voice Quality.

OBJECTIVE: In order to establish the ideal anesthetic protocol in thyroplasty type I surgery, where the intraoperative voice test is used to guide the medialization of the paralyzed fold, we have studied the effects of a sedation with midazolam premedication and adjusted intravenous doses of propofol and remifentanil on voice quality in patients without vocal fold pathology undergoing otorhinolaryngology surgery other than thyroplasty. STUDY DESIGN: Prospective cross-sectional study included 40 adult patients. METHOD: A voice recording was performed when the patient was fully awake and when an appropriate level of conscious sedation was reached. Following premedication with midazolam at anxiolytic doses, remifentanil and propofol were administrated by target controlled infusion pumps (TCI). These results were compared with those obtained in a previous study carried out by the same team using intravenous bolus (IV) according to weight. The recorded voice analysis was performed using the computer program Praat (v.5.3.39) for a sustained vowel. RESULTS: All the parameters obtained from the acoustic analysis of the voice were altered after sedation with target controlled infusion in a statistically significant way. Comparing with bolus intravenous, harmonic and noise ratio (HNR) was the only parameter that decreased less in the TCI group. CONCLUSION: The state of sedation obtained using midazolam premedication, propofol and remifentanil adjusted intravenous doses alters significantly all the voice parameters, although this alteration is considerably less than the changes produced by the medication administered in bolus IV. According to these results, the sedation and the voice test during thyroplasty surgery would present a series of limitations when it comes to guiding the medialization of the paralyzed vocal fold and therefore it could not be considered as the ideal anesthetic protocol in thyroplasty surgery.

A novel method for conformity assessment testing of infusion and perfusion pumps for post-market surveillance purposes.

BACKGROUND: Introduction of fluids, medicaments and nutrients into the human body during hospitalization is fundamental for treatment and healing of patients. Fluids are introduced by means of infusion pumps while nutrients and medicaments are introduced by perfusion pumps. It is of vital importance for these devices to deliver exact amounts of the aforementioned substances as significant deviations can result in severe patient harm. Therefore it is important to effectively monitor their performance and prevent failures. OBJECTIVE: This paper proposes a novel method for conformity assessment testing of infusion and perfusion pumps for post-market surveillance purposes. METHOD: The method was developed on the basis of metrology characteristics of the devices. In addition to the evaluation of essential safety and visual integrity of infusion and perfusion pumps, their performance in terms of delivered volumes was assessed and monitored. RESULTS: The developed method was validated between 2018 and 2021 in healthcare institutions of all levels. The results obtained during validation suggest that conformity assessment testing of infusion and perfusion pumps as a method used during PMS contributes to significant improvement in devices' accuracy and reliability. CONCLUSION: A standardized approach in conformity assessment testing of infusion and perfusion pumps during PMS, besides increasing reliability of the devices, is the first step in digital transformation of management of these devices in healthcare institutions opening possibility for use of artificial intelligence.

Loss of effectiveness with an implanted drug delivery system for intrathecal pain therapy due to corrosion.

INTRODUCTION: Intrathecal drug delivery is an established invasive treatment option. Most common complication is catheter malfunction, which can lead to overdose or withdrawal. CASE PRESENTATION: A 61-year-old female patient underwent an elective replacement of an intrathecal drug delivery pump. The patient complained about a loss of effectiveness over the past 2 years. Intraoperatively, a white mass corresponding to morphine precipitation in the pump pocket was found, which appeared to be due to corrosion at the pump-catheter connection site. CONCLUSIONS: Recommendations on how to deal with the decreasing effectiveness of intrathecal drug delivery and on intraoperative catheter handling are provided.

Standardized neonatal continuous infusion concentrations: A quality improvement initiative.

PURPOSE: Medication errors are a significant and preventable source of patient harm, especially in the neonatal population. Standardized infusion concentrations increase patient safety and streamline the workflow for pharmacists, nurses, and physicians. METHODS: Neonatal continuous infusion concentrations were standardized and implemented into the electronic health record using an automated order panel. Pre- and postimplementation data were collected to assess the impact of this quality improvement initiative. The primary endpoint was the proportion of neonatal intensive care unit infusion orders that were compatible with "bolus from infusion" functionality in the syringe pump. RESULTS: Before implementation, only 40% of eligible infusions were compatible with the "bolus from infusion" function, compared to 93% after implementation (P < 0.00001). Within the syringe pump, the ratio of total options to the number of concentrations per medication was reduced by 31%. CONCLUSION: Implementation of an order panel with defaulted standard infusion concentration selection improved workflow and optimized technology in the neonatal intensive care unit.