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1.
Curr Opin Anaesthesiol ; 37(4): 362-370, 2024 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-38841991

RESUMO

PURPOSE OF REVIEW: The drug titration paradox describes that, from a population standpoint, drug doses appear to have a negative correlation with its clinical effect. This paradox is a relatively modern discovery in anesthetic pharmacology derived from large clinical data sets. This review will interpret the paradox using a control engineering perspective. RECENT FINDINGS: Drug titration is a challenging endeavor, and the medication delivery systems used in everyday clinical practice, including infusion pumps and vaporizers, typically do not allow for rapid or robust titration of medication being delivered. In addition, clinicians may be reluctant to deviate from a predetermined plan or may be content to manage patients within fixed goal boundaries. SUMMARY: This drug titration paradox describes the constraints of how the average clinician will dose a patient with an unknown clinical response. While our understanding of the paradox is still in its infancy, it remains unclear how alternative dosing schemes, such as through automation, may exceed the boundaries of the paradox and potentially affect its conclusions.


Assuntos
Anestésicos , Humanos , Anestésicos/administração & dosagem , Sistemas de Liberação de Medicamentos/métodos , Relação Dose-Resposta a Droga , Bombas de Infusão/normas
2.
PLoS Comput Biol ; 16(1): e1007218, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31986133

RESUMO

Precision medicine requires accurate technologies for drug administration and proper systems pharmacology approaches for patient data analysis. Here, plasma pharmacokinetics (PK) data of the OPTILIV trial in which cancer patients received oxaliplatin, 5-fluorouracil and irinotecan via chronomodulated schedules delivered by an infusion pump into the hepatic artery were mathematically investigated. A pump-to-patient model was designed in order to accurately represent the drug solution dynamics from the pump to the patient blood. It was connected to semi-mechanistic PK models to analyse inter-patient variability in PK parameters. Large time delays of up to 1h41 between the actual pump start and the time of drug detection in patient blood was predicted by the model and confirmed by PK data. Sudden delivery spike in the patient artery due to glucose rinse after drug administration accounted for up to 10.7% of the total drug dose. New model-guided delivery profiles were designed to precisely lead to the drug exposure intended by clinicians. Next, the complete mathematical framework achieved a very good fit to individual time-concentration PK profiles and concluded that inter-subject differences in PK parameters was the lowest for irinotecan, intermediate for oxaliplatin and the largest for 5-fluorouracil. Clustering patients according to their PK parameter values revealed patient subgroups for each drug in which inter-patient variability was largely decreased compared to that in the total population. This study provides a complete mathematical framework to optimize drug infusion pumps and inform on inter-patient PK variability, a step towards precise and personalized cancer chronotherapy.


Assuntos
Antineoplásicos/administração & dosagem , Antineoplásicos/farmacocinética , Cronofarmacoterapia , Medicina de Precisão/métodos , Antineoplásicos/uso terapêutico , Feminino , Humanos , Bombas de Infusão/normas , Masculino , Modelos Teóricos , Neoplasias/tratamento farmacológico
3.
BMC Palliat Care ; 19(1): 172, 2020 Nov 10.
Artigo em Inglês | MEDLINE | ID: mdl-33172459

RESUMO

BACKGROUND: Continuous subcutaneous infusion (CSCI) via ambulatory infusion pump (AIP) is a valuable method of pain control in palliative care. When using CSCI, low-dose methadone as add-on to other opioids might be an option in complex pain situations. This study aimed to investigate the effects, and adverse effects, of CSCI for pain control in dying patients, with particular interest in methadone use. METHODS: This was an observational cohort study. Imminently dying patients with pain, admitted to specialized palliative inpatient wards and introduced on CSCI, were monitored daily by staff for symptoms (Integrated Palliative Care Outcome Scale - IPOS), sedation (Richmond Agitation and Sedation Scale - RASS), performance status (Eastern Cooperative Oncology Group - ECOG) and delirium (Confusion Assessment Method - CAM). RESULTS: Ninety-three patients with a median survival of 4 days were included. Of the 47 patients who survived ≥3 days, the proportion of patients with severe/overwhelming pain decreased from 45 to 19% (p < 0.001) after starting CSCI, with only a moderate increase in morphine equivalent daily dose of opioids (MEDD). Alertness was marginally decreased (1 point on the 10-point RASS scale, p = 0.001), whereas performance status and prevalence of delirium, regardless of age, remained unchanged. Both patients with methadone as add-on (MET, n = 13) and patients with only other opioids (NMET, n = 34), improved in pain control (p < 0.05 and 0.001, respectively), despite that MET patients had higher pain scores at baseline (p < 0.05) and were on a higher MEDD (240 mg vs.133 mg). No serious adverse effects demanding treatment stop were reported. CONCLUSIONS: CSCI via AIP is an effective way to reduce pain in dying patients without increased adverse effects. Add-on methadone may be beneficial in patients with severe complex pain.


Assuntos
Bombas de Infusão/normas , Infusões Subcutâneas/normas , Manejo da Dor/normas , Cuidados Paliativos/métodos , Idoso , Idoso de 80 Anos ou mais , Analgésicos Opioides/uso terapêutico , Dor do Câncer/tratamento farmacológico , Dor do Câncer/fisiopatologia , Estudos de Coortes , Feminino , Humanos , Infusões Subcutâneas/métodos , Masculino , Pessoa de Meia-Idade , Manejo da Dor/métodos , Manejo da Dor/estatística & dados numéricos , Cuidados Paliativos/normas , Cuidados Paliativos/estatística & dados numéricos , Estatísticas não Paramétricas
4.
Br J Nurs ; 29(10): S15-S21, 2020 May 28.
Artigo em Inglês | MEDLINE | ID: mdl-32463759

RESUMO

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.


Assuntos
Antibióticos Antineoplásicos/administração & dosagem , Doxorrubicina/administração & dosagem , Doxorrubicina/toxicidade , Contaminação de Equipamentos/prevenção & controle , Guias como Assunto , Bombas de Infusão/normas , Exposição Ocupacional/prevenção & controle , Equipamentos de Proteção/normas , Humanos , Reino Unido
5.
Niger J Clin Pract ; 23(8): 1044-1047, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32788479

RESUMO

INTRODUCTION: Delivery of accurate volumes of fluid in surgical neonates and children is crucial for the good outcome of treatment. But how accurate are the calibrations on the fluid delivery devices? AIMS: This study seeks to verify the accuracy of these devices in common use in our practice. MATERIALS AND METHODS: This is a cross-sectional experimental study carried out in our center; a tertiary health facility in Southern Nigeria in May 2019. Fluid delivery devices (FDDs) used in the course of treatment of our pediatric patients were randomly included in the study. The number of drops per ml of each device was obtained by counting while the fluid dropped until a 1 ml volume was delivered. The data was then collated and analyzed. RESULTS: A total of 215 FDDs were included in this study. They comprised infusion giving set, Soluset (Burette) giving set, and blood giving set. The rate of delivery was 20 drops/ml (infusion giving sets), 60 drops/min (Burette/Soluset), and 15 drops/ml (Blood giving set). They were all in keeping with the labeled/assumed calibration in each of the types of FDDs P < 0.05. Therefore, the mean, median, and mode were the same. CONCLUSION: This study has demonstrated that the FDDs used our center are accurately calibrated and safe as they deliver volumes of fluid as labeled. The findings in this study reassure us of the dependability and accuracy of delivery of the FDDs we use in children in our center.


Assuntos
Segurança de Equipamentos/normas , Hidratação/instrumentação , Bombas de Infusão/normas , Administração Oral , Criança , Estudos Transversais , Feminino , Hidratação/métodos , Humanos , Recém-Nascido , Nigéria
6.
Comput Inform Nurs ; 37(6): 321-329, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31135469

RESUMO

Errors in healthcare are a leading cause of death in the United States. Equipment usability and user interfaces remain an area not fully elucidated. Infusion pumps play a vital role in care delivery, often essential for critical therapies. While pump function is comparatively simple, their programming, configuration, and form provide opportunity for error. Our purpose was to assess qualities nurses identified as important to pump operation by electronic survey. A self-developed usability survey was distributed to a random sample of 500 nurses, stratified by unit type and employed at the large academic quaternary care hospital. The overall response rate was 48% (n = 240). Descriptive and inferential statistics describe the responses and represent more than 5500 weekly infusions. Nurses described confident use of the system with some differences by unit type. Ninety percent of respondents indicated they have omitted use of the dose error reduction system, which should raise safety concerns. Users reported issues with the user interface and error prevention systems. Qualitative items elicited suggestions for improving aspects of the pump. Employing a usability survey in a clinical area proved to be a simple, inexpensive way to gather more information on the use and potential improvements of infusion pumps.


Assuntos
Atitude Frente aos Computadores , Pessoas Acamadas/estatística & dados numéricos , Bombas de Infusão/estatística & dados numéricos , Bombas de Infusão/normas , Cuidados de Enfermagem/métodos , Cuidados de Enfermagem/normas , Recursos Humanos de Enfermagem Hospitalar/psicologia , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários , Estados Unidos
7.
J Nurs Care Qual ; 34(1): 9-15, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-29634499

RESUMO

BACKGROUND: A 5-time designated Magnet academic medical center partnered with its infusion systems supplier to successfully integrate 1327 smart pumps across 45 departments with an aggressive 3-month timeline. The team also achieved quality improvement (QI) outcomes through increased drug library compliance and decreased alerts with their new technology. PROBLEM: This large academic medical center needed to implement innovative wireless infusion pump technology in a short time frame. APPROACH: The approach involved a strong partnership from the medical center and the supplier, with extensive planning and collaboration among the clinical nurse specialists and consultants from both organizations to accomplish QI goals. Lean principles were also followed to enhance efficiency and accountability. OUTCOMES: Quality improvement outcomes included 100% drug library compliance across all 6 intensive care units, a decrease in pump alert rates from 4.18% to 0.79%, and a decrease in pump programming correction rate from 0.36% to 0.06%. CONCLUSIONS: A partnership led to a large implementation being completed efficiently across an academic medical center. Through these joint efforts, quality of care was improved within a short period of time.


Assuntos
Comportamento Cooperativo , Implementação de Plano de Saúde , Bombas de Infusão/normas , Infusões Intravenosas , Inovação Organizacional , Melhoria de Qualidade , Centros Médicos Acadêmicos , Humanos , Internet , Erros de Medicação/prevenção & controle , Enfermeiros Clínicos
8.
Support Care Cancer ; 26(8): 2809-2814, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-29508140

RESUMO

PURPOSE: Hematopoietic cell transplant (HCT) recipients often require intravenous (IV) magnesium repletion due to poor dietary intake, gastrointestinal loss, and use of concomitant magnesium wasting medications. Prolonging the IV magnesium infusion rate has been postulated to reduce renal clearance and improve retention; however, limited evidence supports this hypothesis. METHODS: We reviewed autologous and allogeneic HCT recipients (n = 82) who received IV magnesium at our institution between 2014 and 2016: 41 patients received IV magnesium at a prolonged rate of 0.5 g/h and 41 patients at > 0.5 g/h (mean 2.07 g/h). Primary outcome was percent of days in which magnesium levels were in desired therapeutic range (2-2.7 mg/dL) during hospitalization. RESULTS: Baseline characteristics were similar between cohorts: no difference existed between groups in incidence of gastrointestinal graft-versus-host disease or the percentage of patients who received magnesium replacement in maintenance fluids, received concomitant oral magnesium supplementation, or received parenteral nutrition. Percent of days in desired therapeutic range was not different between groups (p = 0.3). No difference existed between groups with respect to total amount of IV magnesium repletion (22.5 vs. 21.4 g, p = 0.81) or number of days of IV replacement (7.2 vs. 6.2 days, p = 0.41). In terms of safety, there was no difference between groups with respect to incidence of hypomagnesemia or hypermagnesemia (p = 0.43 each). CONCLUSIONS: Overall, prolonging the infusion rate did not correlate with improved magnesium retention based on amount and frequency of magnesium repletion or attainment of goal levels in HCT patients.


Assuntos
Transplante de Células-Tronco Hematopoéticas/métodos , Bombas de Infusão/normas , Sulfato de Magnésio/uso terapêutico , Condicionamento Pré-Transplante/métodos , Feminino , Humanos , Infusões Intravenosas , Sulfato de Magnésio/administração & dosagem , Sulfato de Magnésio/farmacologia , Masculino , Pessoa de Meia-Idade
9.
Prehosp Emerg Care ; 22(5): 645-649, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29465284

RESUMO

OBJECTIVE: To assess the accuracy of multiple Intravenous Infusion Flow Regulators (IIFRs) at infusion rates and hanging heights common to the prehospital setting. METHODS: Five different manufacturer's IIFRs were tested over a range of infusion rates while hanging at heights equivalent to the gurney pole, ambulance ceiling hook, and manufacturer's recommended height (if available). Each IIFR was run over a 15-minute period at each infusion rate and height three times. Drip effluent was collected and measured for comparison of volumes. Intra- and inter-device accuracy at different infusion rates and heights was calculated. RESULTS: All devices deviated from the expected infusion volume regardless of infusion rate or height. There was inter-device variability across all IIFRs with some having reproducible though inaccurate volumes. Volumes were consistently below expected at lower heights and above expected at increased heights. Manufacturer recommended height guidelines provided slight improvements in accuracy. CONCLUSIONS: Significant deviations from expected IIFR volume were observed across all devices, flow rates, and heights in a static, laboratory environment. These findings would lend caution to the use of IIFRs as they could lead to inaccurate medication dosing (both over- or under-dosing) in the prehospital environment.


Assuntos
Serviços Médicos de Emergência/estatística & dados numéricos , Bombas de Infusão/estatística & dados numéricos , Infusões Intravenosas/instrumentação , Humanos , Bombas de Infusão/normas , Infusões Intravenosas/estatística & dados numéricos
10.
J Oncol Pharm Pract ; 24(3): 163-169, 2018 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-28077048

RESUMO

Purpose Elastomeric pumps are used to administer 46-hour infusions of 5-fluorouracil (5FU). Baxter suggests patients visually monitor their pumps to ensure that infusions are proceeding correctly. This can be confusing and lead to concerns about under- or over-dosing. Baxter has not considered weighing pumps as a validated method for monitoring. This study aims to validate weighing as a more accurate method for patients and healthcare professionals, and describe real life Baxter Infusor™ variability. Methods Patients who had been started on a 46-hour 5FU infusion returned to the clinic approximately 24 h after starting treatment. The pump was weighed on a StarFrit kitchen scale, and date, time, and weights recorded. Patients were asked if they had a preference for weighing or visually inspecting their pump. Results Pumps ( n = 103) were weighed between 17.25 and 27.5 h after connection. The average weight of a pump was 189 g. Of 103 pumps weighed, 99 weighed less than expected, corresponding to average flow rates of 5.69 mL/h over the elapsed time. The expected flow rate is 5 mL/h with 10% variability. Average flow rates within the 17.25- to 27.5-hour window were 4.561 mL/h, which is 8.78% slower than expected, but within the 10% known variability. Forty-seven percent of patients didn't have a preference for either method, but for those who did have a preference, more than twice as many preferred weighing. Conclusion With proper education, weighing Baxter Infusors at home with kitchen scales can be an accepted and objective alternative to the current recommendation of visual inspection.


Assuntos
Fluoruracila/administração & dosagem , Bombas de Infusão/normas , Polímeros/normas , Percepção Visual , Pesos e Medidas/normas , Adulto , Antimetabólitos Antineoplásicos/administração & dosagem , Elastômeros , Feminino , Humanos , Masculino
11.
Zhongguo Yi Liao Qi Xie Za Zhi ; 42(3): 219-221, 2018 May 30.
Artigo em Zh | MEDLINE | ID: mdl-29885133

RESUMO

Medical injection pump is a commonly used clinical equipment with high risk. Accurate detection of flow is an important aspect to ensure its reliable operation. In this paper, we carefully studied and analyzed the flow detection methods of three standards being used in medical injection pump detection in our country. The three standards were compared from the aspects of standard device, flow test point selection, length of test time and accuracy judgment. The advantages and disadvantages of these standards were analyzed and suggestions for improvement were put forward.


Assuntos
Equipamentos e Provisões/normas , Bombas de Infusão/normas , Injeções , Militares , Padrões de Referência
12.
Anesth Analg ; 125(4): 1203-1211, 2017 10.
Artigo em Inglês | MEDLINE | ID: mdl-28759483

RESUMO

BACKGROUND: Continuous medication infusions are commonly used during surgical procedures. Alarm settings for infusion pumps are considered important for patient safety, but limits are not created in a standardized manner from actual usage data. We estimated 90th and 95th percentile infusion rates from a national database for potential use as upper limit alarm settings. METHODS: We extracted infusion rate data from 17 major hospitals using intraoperative records provided by Multicenter Perioperative Outcomes Group for adult surgery between 2008 and 2014. Seven infusions were selected for study: propofol, remifentanil, dexmedetomidine, norepinephrine, phenylephrine, nitroglycerin, and esmolol. Each dosage entry for an infusion during a procedure was included. We estimated the 50th, 90th, and 95th percentile levels for each infusion across institutions, and performed quantile regression to examine factors that might affect the percentiles rates, such as use in general anesthesia versus sedation. RESULTS: The median 90th and 95th percentile infusion rates (with interquartile range) for propofol were 150 (140-150) and 170 (150-200) µg/kg/min. Quantile regression demonstrated higher 90th and 95th percentile rates during sedation for gastrointestinal endoscopy than for all surgical procedures performed under general anesthesia. For selected vasoactive medications, the corresponding median 90th and 95th percentile rates (with interquartile range) were norepinephrine 14.0 (9.8-18.1) and 18.3 (12.6-23.9) µg/min, and phenylephrine 60 (55-80) and 80 (75-100) µg/min. CONCLUSIONS: Alarm settings based on infusion rate percentile limits would be triggered at predictable rates; ie, the 95th percentile would be exceeded and an alarm sounded during 1 in 20 infusion rate entries. As a result, institutions could establish pump alarm settings consistent with desired alarm frequency using their own or externally validated usage data. Further study will be needed to determine the optimal percentile for infusion alarm settings.


Assuntos
Anestésicos Intravenosos/administração & dosagem , Alarmes Clínicos/normas , Falha de Equipamento , Bombas de Infusão/normas , Relatório de Pesquisa , Idoso , Anestésicos Intravenosos/efeitos adversos , Feminino , Humanos , Bombas de Infusão/efeitos adversos , Infusões Intravenosas , Complicações Intraoperatórias/prevenção & controle , Masculino , Pessoa de Meia-Idade , Propofol/administração & dosagem , Propofol/efeitos adversos , Estudos Retrospectivos , Resultado do Tratamento
13.
Paediatr Anaesth ; 27(6): 571-580, 2017 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-28370645

RESUMO

The Institute of Medicine has called for development of strategies to prevent medication errors, which are one important cause of preventable harm. Although the field of anesthesiology is considered a leader in patient safety, recent data suggest high medication error rates in anesthesia practice. Unfortunately, few error prevention strategies for anesthesia providers have been implemented. Using Toyota Production System quality improvement methodology, a multidisciplinary team observed 133 h of medication practice in the operating room at a tertiary care freestanding children's hospital. A failure mode and effects analysis was conducted to systematically deconstruct and evaluate each medication handling process step and score possible failure modes to quantify areas of risk. A bundle of five targeted countermeasures were identified and implemented over 12 months. Improvements in syringe labeling (73 to 96%), standardization of medication organization in the anesthesia workspace (0 to 100%), and two-provider infusion checks (23 to 59%) were observed. Medication error reporting improved during the project and was subsequently maintained. After intervention, the median medication error rate decreased from 1.56 to 0.95 per 1000 anesthetics. The frequency of medication error harm events reaching the patient also decreased. Systematic evaluation and standardization of medication handling processes by anesthesia providers in the operating room can decrease medication errors and improve patient safety.


Assuntos
Anestesia/normas , Análise do Modo e do Efeito de Falhas na Assistência à Saúde , Erros de Medicação/prevenção & controle , Anestesia/efeitos adversos , Criança , Rotulagem de Medicamentos/normas , Guias como Assunto , Hospitais Pediátricos , Humanos , Bombas de Infusão/normas , Salas Cirúrgicas/organização & administração , Segurança do Paciente , Pediatria , Melhoria de Qualidade , Resultado do Tratamento
14.
Undersea Hyperb Med ; 44(1): 17-25, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28768081

RESUMO

We present a standardized test methodology and results for our evaluation of the Carefusion Alaris PC infusion pump, comprising the model 8015 PC Unit and the model 8100 Large Volume Pump (LVP) module. The evaluation consisted of basic suitability testing, internal component inspection, surface temperature measurement of selected internal components, and critical performance testing (infusion rate accuracy and occlusion alarm pressure) during conditions of typical hyperbaric oxygen (HBO2) treatment in our facility's class A multiplace chamber. We have found that the pumps pose no enhanced risk as an ignition source, and that the pumps operate within manufacturer's specifications for flow rate and occlusion alarms at all stages of HBO2 treatments, up to 4.0 ATA and pressurization and depressurization rates up to 180 kPa/minute. The pumps do not require purging with air or nitrogen and can be used unmodified, subject to the following conditions: pumps are undamaged, clean, fully charged, and absent from alcohol cleaning residue; pumps are powered from the internal NiMH battery only; maximum pressure exposure 4.0 ATA; maximum pressurization and depressurization rate of 180 kPa/minute; LVP modules locked in place with retaining screws.


Assuntos
Segurança de Equipamentos/normas , Oxigenoterapia Hiperbárica , Bombas de Infusão/normas , Pressão Atmosférica , Alarmes Clínicos , Fontes de Energia Elétrica , Temperatura
15.
J Nurs Care Qual ; 32(2): 141-149, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-27500697

RESUMO

With the recognition that the introduction of new technology causes changes in workflow and may introduce new errors to the system, usability testing was performed to provide data on nursing practice and interaction with infusion pump technology. Usability testing provides the opportunity to detect and analyze potentially dangerous problems with the design of infusion pumps that could cause or allow avoidable errors. This work will reduce preventable harm through the optimization of health care delivery.


Assuntos
Segurança de Equipamentos/normas , Bombas de Infusão/normas , Enfermeiras e Enfermeiros/psicologia , Segurança de Equipamentos/enfermagem , Humanos , Bombas de Infusão/efeitos adversos , Erros de Medicação/enfermagem , Erros de Medicação/prevenção & controle , Enfermeiras e Enfermeiros/normas , Simulação de Paciente
16.
Anesth Analg ; 122(4): 1062-9, 2016 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-26702866

RESUMO

BACKGROUND: Rapid infusers are vital tools during massive hemorrhage and resuscitation. Sporadic reports of overheating and shutdown of the Belmont® Rapid Infuser, a commonly used system, have been attributed to 1-sided clot blockage of the fluid path. We investigated multiple causes of failure of this device. METHODS: Packed red blood cells and thawed fresh frozen plasma with normal saline solution were used as base fluids for serial 10-minute trials using standard disposable sets in 2 Belmont devices. Possible contributors to device failure, including calcium-containing solutions and external leakage currents, were evaluated. Thermographic images of the heater and disposable cartridges were recorded. The effects of complete unilateral clotting were modeled by sealing half of the disposable cartridge with epoxy. RESULTS: Clotting on the surface of the heat exchanger coil increased with calcium concentration and was only observed at calcium concentrations >12.0 mmol/L (P < 0.0001) in a 1:1 plasma:red blood cell mixture, resulting in high-pressure downstream occlusion alarms and interruption of flow. CONCLUSIONS: Clot-based occlusion can be induced in the Belmont Rapid Infuser under unrealistic conditions. In the absence of complete unilateral flow blockage, we did not observe any significant overheating of the infuser under extreme operating conditions.


Assuntos
Falha de Equipamento , Eritrócitos , Bombas de Infusão/normas , Plasma , Hidratação/métodos , Hidratação/normas , Humanos , Projetos Piloto
17.
Paediatr Anaesth ; 26(4): 425-8, 2016 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-26786058

RESUMO

BACKGROUND: The Ambu Smart-Infuser Pain Pump and the On-Q Pump with Select-a-Flow Variable Rate Controller are elastomeric devices with a flow regulator that controls the rate of infusion of a local anesthetic agent through a peripheral catheter. As a safety evaluation, we evaluated the infusion characteristics of these two devices when filled with manufacturer recommended standard volumes and when overfilled with a volume 50% in excess of that which is recommended. METHODS: Nineteen disposable devices from the two manufacturers were used in this study. Nine were filled with 0.9% normal saline according to the respective manufacturers' recommendations (four Ambu pumps were filled with 650 ml and five On-Q pumps were filled with 550 ml) and 10 devices were 150% overfilled (five Ambu pumps were filled with 975 ml and five On-Q pumps were filled with 825 ml). All of the devices were set to infuse at 10 ml · h(-1) at room temperature (21°C) for 12 h. The fluid delivered during each 2-h period was measured using a graduated column. RESULTS: The On-Q pump (in the settings of normal fill and 150% overfill) delivered a significantly higher output per hour than the set rate during the first 8 h, while the Ambu pump delivered a value close to the set rate of 10 ml · h(-1). No significant difference in the hourly delivered output was noted for either device when comparing the normal fill to the 150% overfill groups. CONCLUSIONS: This investigation demonstrates that no change in the hourly output occurs with overfilling of these home infusion devices. However, as noted previously, the hourly output from the On-Q device is significantly higher than the set rate during the initial 8 h of infusion which could have potential clinical implications.


Assuntos
Anestésicos Locais/administração & dosagem , Bombas de Infusão/normas , Cateterismo Periférico , Equipamentos Descartáveis , Bombas de Infusão/efeitos adversos , Infusões Parenterais
18.
Undersea Hyperb Med ; 43(1): 9-19, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27000009

RESUMO

We evaluated the Zyno Medical Z-800F, CME Body Guard 323 Color Vision, and Baxter Flo-Gard 6201 infusion pumps for monoplace chamber conditions. We adjusted pump occlusion pressure allowing infusion to 3 atmospheres absolute (atm abs). Baxter and Zyno pumps were connected to the chamber pass-through with rigid small-bore tubing. The CME infusion set was connected directly to the pass-through. We infused saline to a collection manifold inside a monoplace chamber at 1-100 mL/ hour under pressures ranging from 0.85-3.0 atm abs. We averaged results from three to five separate tests for each condition. At baseline, pumps performed within ±10% of expected (our measurement capability). However, clinical engineering verified performance within manufacturer specifications (±5% at atmospheric pressure). During a carbon monoxide hyperbaric protocol (3 atm abs/2 atm abs), measured flow with the Baxter, CME and Zyno pumps was ±5% of setting at 10 mL/hour (95%, 103%, 95%, respectively); at 1 mL/hour, average flow were 91%, 83%, 83%, respectively. During timed testing (volume recorded before decompression), pump accuracy was ±10% at 10 and 100 mL/hour. Tubing compliance compromised performance at lower flow rates, magnified by increased pressure. These pumps have potential for monoplace chamber use, although not supported by the manufacturers or FDA-cleared. At low flow rates, tubing compliance affects delivered volumes.


Assuntos
Pressão Atmosférica , Oxigenoterapia Hiperbárica/instrumentação , Bombas de Infusão/normas , Infusões Intravenosas/instrumentação , Teste de Materiais/métodos , Aprovação de Equipamentos , Desenho de Equipamento , Estudos de Avaliação como Assunto , Padrões de Referência , Cloreto de Sódio/administração & dosagem
19.
J Biomed Inform ; 53: 243-50, 2015 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-25460202

RESUMO

The focus of this paper is on the challenges and opportunities presented by developing scenarios of use for interactive medical devices. Scenarios are integral to the international standard for usability engineering of medical devices (IEC 62366:2007), and are also applied to the development of health software (draft standard IEC 82304-1). The 62366 standard lays out a process for mitigating risk during normal use (i.e. use as per the instructions, or accepted medical practice). However, this begs the question of whether "real use" (that which occurs in practice) matches "normal use". In this paper, we present an overview of the product lifecycle and how it impacts on the type of scenario that can be practically applied. We report on the development and testing of a set of scenarios intended to inform the design of infusion pumps based on "real use". The scenarios were validated by researchers and practitioners experienced in clinical practice, and their utility was assessed by developers and practitioners representing different stages of the product lifecycle. These evaluations highlighted previously unreported challenges and opportunities for the use of scenarios in this context. Challenges include: integrating scenario-based design with usability engineering practice; covering the breadth of uses of infusion devices; and managing contradictory evidence. Opportunities included scenario use beyond design to guide marketing, to inform purchasing and as resources for training staff. This study exemplifies one empirically grounded approach to communicating and negotiating the realities of practice.


Assuntos
Equipamentos e Provisões , Bombas de Infusão/normas , Informática Médica/métodos , Coleta de Dados , Aprovação de Equipamentos , Desenho de Equipamento , Segurança de Equipamentos , Hospitalização , Humanos , Gestão de Riscos , Sono , Software , Interface Usuário-Computador
20.
Br J Biomed Sci ; 72(3): 111-4, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26510266

RESUMO

Platelet concentrates are given to patients suffering with severe thrombocytopenia usually by a gravity transfusion procedure. Increasing patient numbers that are in need of this treatment increase the pressure on hospital staff and space. In order to combat time issues, the use of medical devices such as intravenous infusion pumps are thought to be beneficial for time and simultaneously for safety in transfusion practices. By using infusion pumps, platelet concentrates can be transfused in less time and provide accurate volume measurements. Manufacturers of infusion pumps claim that these devices are safe to be used for blood products including platelet concentrates. However, published studies were performed on older models and newer devices are on the market now. The purpose of this study is to evaluate infusion pumps, which are claimed to be suitable for blood products and to investigate the impact the pumps had on platelets. Furthermore, the study revealed if the intravenous infusion pumps are safe to be used for platelet transfusion as claimed by manufacturers. A simulated transfusion was performed using the Carefusion Alaris GP Plus volumetric pump and Fresenius Kabi Volumat Agilia infusion pump. Samples were taken from expired platelet concentrates before and after passage through the pump. All samples were investigated for full blood count that included platelet count, mean platelet volume (MPV), platelet distribution width (PDW) and a plateletcrit (PCT). The samples were then centrifuged to achieve platelet-poor plasma and then tested for lactate dehydrogenase (LDH). A power calculation performed on the statistical power analysis program G*power indicated a requirement of 82 samples for a power of 80%. Statistical analysis was performed with the IBM SPSS statistic software. A paired sample t-test was used to calculate mean, standard deviation and P values for the infusion pumps used. The Wilcoxon Signed Rank Test was used to evaluate results that had a non-normal distribution. No statistically significant changes were found for LDH, PDW and platelet count with the Carefusion infusion pump. PCT and MPV were found to have a statistically significant change with P values of 0.005 and 0.001, respectively, and showed a decrease in their values. The Fresenius Kabi infusion pump has shown no statistically difference in LDH, platelet count, PCT or PDW, with P values of 0.075, 0.425, 0.151 and 0.397, respectively. The MPV showed a statistically significant decrease in its value with a P value < 0.043. Although only two pumps were tested, the results achieved by testing the devices revealed that there was no influence on the platelet enzyme LDH or the platelet count as the main parameters. However, the findings showed that there was statistically significant differences in MPV of the expired platelet concentrates.


Assuntos
Plaquetas/citologia , Bombas de Infusão/normas , Transfusão de Plaquetas/instrumentação , Biomarcadores/análise , Plaquetas/química , Plaquetas/enzimologia , Gravitação , Técnicas In Vitro , L-Lactato Desidrogenase/análise , Volume Plaquetário Médio , Contagem de Plaquetas
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