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Table 4 Outcomes of the inserted studies

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

Study outcomes

Study

Intervention

Outcomes

Author, year

Sample

Análise/Ensaio realizado

Precision

Reliability

Others

[26]

1538 incidents with medications reported from 2005 to 2010

The errors related to technology were analyzed to identify the type of technology responsible and the causes. The errors were divided into (i) errors related to technologies; (ii) errors unrelated to technologies. Within the group of errors related to technologies there was the division in: sociotechnical errors (which have human interaction) and device errors (related to technical defects of the device).

Not applicable

Not applicable

This study concludes that during 5 years analyzed most errors were sociotechnical that involved human interaction. The most common causes of tech related errors were: problems at the interface between equipment and user, non-compliance with existing procedures and inadequate procedures.

[32]

Syringe and peristaltic pumps, not informed quantity

The main objective of the study is to allow for traceable volume, flow and pressure measurements of existing drug distribution devices (such as infusion pumps and analyzers) and online sensors that operate at flow rates below 100 nL/min to avoid imprecise measurement results. The study also investigated rapid changing flow rates, liquid mixing behavior and occlusion phenomena in multi-infusion systems to improve dosage accuracy in each infusion line.

The study was developed under a precision linear stage actuator to ensure results in standards themselves.

Not applicable

By improving the measurement precision of the delivery device flow rate of drugs, with the development of new measurement methods, errors of dosage will be reduced and lives will be saved. This can be achieved for the acceptance of a wider spectrum range of traceable calibrations of low flow infusion devices and ultra-low and by advanced knowledge device calibration address of drug delivery in clinical trials, especially in the case of multiple infusion systems.

[34]

Incident reports involving IP of the pediatric intensive care unit of a general hospital and teaching.

The objective of this study was to carry out a FMEA (analysis of failure and effect modes) on the risk points in the use of intelligent IP in a pediatric intensive care unit before and after devices are implemented to identify possible improvement actions and Evaluate the effects that these improvements may have at risk points has detected.

Not applicable

Not applicable

Various periodic revisions of the medicines library, the development of support documents and the inclusion of improvement in the system profile were carried out, so that alarms fired by actual programming errors can be distinguished from those caused by the incorrect use of the system. Eighteen months after implementation, these measures have helped reduce the likelihood of occurrence of each risk point and increase the likelihood of their detection.

[28]

19 IP Brand B Braun Infusomat Space Model

Registration errors were analyzed in typing the requirements, using the 5-key keyboard. The results were employed to determine the distribution of probability for the errors found.

Accuracy is evaluated by the proportion of the occurrence of typing errors

Reliability was not calculated by MTTF times, but can be associated with probability distributions of volume (VTBI) and infusion rate (rate)

The values obtained for reliability provide information for improving the reliability of the equipment via project improvement.

[29]

Historical data from hospital files

The test of the likelihood ratio was used to check trends in system fault data subject to repairs, with censored and uncensored data.

Not applicable

Concludes on the test method of the likelihood ratio, proposed to check trends in faulty data with censorship.

The work proposes to use the likelihood test ratio to verify the trends in faulty data with censorship. A recursive procedure is used to resolve the main technique problem to calculate the expected values in step and requiring numerical integration. The proposed method was used to perform a trend analysis of some components of an audible component general IP, chassis/housing and battery using a hospital maintenance data.

[30]

Infusion pump recalls data

Analyzes the amount and type of failures in the different classes of infusion pumps

Not applicable

Not applicable

The author points to the need to develop new technology associated with the project of infusion pumps, aiming to improve usability and security.

[27]

50 IP of 04 distinct marks, the models were not specified

They performed tests to verify that the device pumps the flow rate, volume and bolus required with the required precision rate. They verified whether occlusion alarms are activated during emergency conditions and the device is safe for use of the patient and the operator. In addition, electric safety tests were made.

Precision of flow rate, accuracy of total infused volume, occlusion pressure, bolus and batteries most of the analyzed pumps had the precision of the flow rate with a percentage error between 10% and 20%, followed by errors above 20%.

Not applicable

They found that they use inadequate infusion sets such as tubes and syringes increases the percentage of error and inaccuracy of 10 to 20%. The position of the droplet detector installed in the inappropriate place increases the percentage of error by up to 25% and low-quality batteries allow the flow rate of 10 to 30%

[24]

Nexus syringe pump

A gravimetric method was used to quantify the measuring error of the water volumetric flow of 1000 \(\mu\)L/h to 1 \(\mu\)L/h distributed by a syringe pump in different experimental conditions that replicate the current microfluidic settings.

Connectants of temperature uncertainties, water density, air density, mass density, initial and final time, initial and fine mass, expansion coefficient, evaporation, buoyancy and repeatability were taken from the literature, calibration, certificate or estimation, measures, standards and estimates.

Not applicable

In the article in question, experiments were prepared to test the installation microflux of the Portuguese Quality Institute up to 1 \(\mu\)L/h and verify that the gravimetric traceability of devices operating in this range can b achieved. In addition, several tests were performed with different types of removable syringes and tubes to evaluate the variation of the measurement error and uncertainty in actual working conditions. The results show that the errors obtained with PP syringes are considerably higher than those obtained with glass syringes due to the adhesion effect.

[25]

Syringe Pump Nexus 3000

It presents comparative data for validation of the method and apparatus developed, interferometry, compared to the gravimetric method. Calibration and calculation of uncertainty; validation of the interferometry method, comparing with gravimetric method

The evaluation of precision is made by measuring uncertainty.

Not applicable

This study can be employed to illustrate the microvider calibration, using interferometry and calculating measuring uncertainty.

[35]

03 syringe infusion pumps

The assay aims to verify how variations in the height and density of the solution may influence the precision of syringe IP. The pumps were studied in two infusion rates of 0.5 ml/h and 10.0 ml/h. The solutions studied were saline and parenteral nutrition. Syringe IPs were placed at the distal output of the infusion line, 30 cm above and 30 cm below.

After 2 h infusion, precision loss was mainly verified at 0.5 ml/h with a significant influence of placement of the infusion pump (p <0.001). 10.0 ml/h, there were differences between the saline and parenteral solution at the same level (p <0.004) and 30 cm above (p <0.001). After 2 h of infusion, the superior the error rate identified was 20.1%.

Not applicable

The article concludes that the position of the syringe infusion pump may influence the amount of infused volume. The influence was more evident at the low infusion rate. These variants should be considered in intravenous therapy with syringe infusion pumps in pediatric patients to reduce medication errors triggered by changes in hydrostatic pressure and system compliance.

[36]

07 Syringe infusion pump sets

Seven series of syringe infusion pump currently marketed were evaluated in an in vitro study during initialization, vertical displacement maneuvers and infusion line occlusion at a defined flow rate of 1 ml H ⌃- 1. The measured data were used As input to a pharmacokinetic simulation simulation of plasma concentration during a continuous neonatal pattern of epinephrine infusion.

The mean time from the beginning of the infusion pump until the steady state flow ranged from 89 to 1622 s. The delivery time of the zero drug after lowering the pump ranged from 145 to 335 s. In all sets tested, occlusion alarm delays and flow irregularities measured during vertical displacement maneuvers resulted in relevant plasma deviations Concentration of epinephrine (> 25%) calculated by the pharmacokinetic simulation model.

Not applicable

The article concludes that problems with the performance of the syringe infusion pump sets may have a considerable impact on the plasma concentration of the drug when highly concentrated short-acting cardiovascular drugs are administered in low streaming quotes. The problems, which affected all. The sets tested are mainly related to the functioning principle of syringe infusion pumps and will be solved only partially by incremental improvements of existing equipment.

[37]

30000 data General use infusion pumps

Analysis of incidence of failures and costs of acquisition and maintenance, lifelong, in 4 types of infusion pumps of a database only from Veteran’s Health Administration (VHA)

Not applicable

The study measures the reliability of the IP of 4 unspecified manufacturers of Veteran’s Health Administration (VHA) database. The study made a caught of the services generated when the maintenance of said pumps was requested.

The author concludes that when observing the percentage of devices with Generic User Error (UES), it is possible to know which manufacturers manufacture pumps with fewer problems people are using. Not only is this low UE occurrence indicate less frustration for nurses’ learning and the use of the new equipment, but this means that the probability for the occurrence of an adverse patient safety event decreases.

[31]

371 Peristaltic Volumetric IPs

The objective of the essay is to carry out a situational diagnosis related to the preventive maintenance of peristaltic volumetric infusion pumps, through a descriptive, quantitative research, carried out in a federal hospital in the city of Rio de Janeiro. 371 peristaltic volumetric IPs, two distinct brands were analyzed.

Not applicable

Not applicable

This situational diagnosis revealed an outdated technological park, with significant lag in relation to the validity of preventive maintenance of peristaltic volumetric IPs. The improvement actions started with the updating of patrimonial data for the amount of peristaltic volumetric infusion pumps from hospital. Finally, monitoring of the conditions of the peristaltic volumetric infusion pump system was initiated, so that there is a continuous control of the conditions of this equipment.

[32]

05 Devices Syringe IP - (two standard and three low weight) to 300, 1700 and 3000 m altitude.

A comparative bench study was performed. The objective of this study was to compare the infusion flow rates provided by low-weight (syringe infusion pumps) versus standard pump devices, in the stage of pre-hospital emergency medicine, at different altitudes.

Interquartile IQR track. Medium infusion flow rates (p = 0.83) and interquartile intervals (p = 0.27) did not differ between syringe infusion pump devices. Median Infusion flow rates (p = 0.15) and interquartile intervals (p = 0.71) did not differ depending on altitude. Medium infusion flow rates (P for interaction = 0.32) and interquantal intervals (P for interaction = 0.66) for syringe infusion pumps did not vary significantly with altitude.

Not applicable

Low weight devices provide bolus instead of continuous flow. Even if they are ten times heavier, standard devices seem to be more reliable even at different altitudes. Only automatic instant flow measurement showed this very important difference between the devices. We believe that there are precision standards may not be relevant to use in the prehospital environment. However, manufacturers must provide instant flow information.

[33]

Pressure-based pump, syringe pump and drug administration device.

In this study, drug delivery devices, namely, IP and syringes, were evaluated by a dynamic gravimetric method. The flow rates of the syringe pump, IP and pressure-based pump were measured in various flow rates (0.5–60 mL / h) using a dynamic gravimetric method and a flow meter.

The uncertainty of the measurement error of each pump was obtained using the gravimetric calibration method tric and flow meters. For the purpose of analyzing the pump pulsating flows of syringe and infusion, the period of pulse and pulse amplitude tion were obtained with respect to the flow.

Not applicable

The article confirms that bombs had distinct performances as a result of their different principles of work. In addition, the dosage rate of the medicine can be altered by various reasons, such as mixed flow, the effect of the blood circulatory flow, and the alvocontrolled infusion method. Therefore, these pulse flow rates can be measured using the dynamic gravimetric method in medical applications