Dynamic behavior analysis of drug delivery devices using a dynamic gravimetric method

Lee, Seok-Hwan; Kang, Wanmo; Chun, Sejong

doi:10.1016/j.flowmeasinst.2018.03.009

Cited by 12 publications

(12 citation statements)

References 8 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…To measure the precise amount of infusion, it is important to prevent the evaporation of the fluid during the test while minimizing the influence of uncertainties, such as evaporation and vibration [ 25 26 ]. Therefore, moisture exchange with the outside air should be prevented, and the balance should be on an anti-vibration table.…”

Section: Methodsmentioning

confidence: 99%

Performance evaluation study of a commercially available smart patient-controlled analgesia pump with the microbalance method and an infusion analyzer

Park¹,

Jung

2022

J Dent Anesth Pain Med

View full text Add to dashboard Cite

Background Patient-controlled analgesia (PCA) has been widely used as an effective medical treatment for pain and for postoperative analgesia. However, improper dose errors in intravenous (IV) administration of narcotic analgesics from a PCA infusion pump can cause patient harm. Furthermore, opioid overdose is considered one of the highest risk factors for patients receiving pain medications. Therefore, accurate delivery of opioid analgesics is a critical function of PCA infusion pumps. Methods We designed a microbalance method that consisted of a closed acrylic chamber containing a layer and an oil layer with an electronic balance. A commercially available infusion analyzer (IDA-5, Fluke Co., Everett, WA, USA) was used to measure the accuracy of the infusion flow rate from a commercially available smart PCA infusion pump (PS-1000, UNIMEDICS, Co., Ltd., Seoul, Korea) and compared with the results of the microbalance method. We evaluated the uncertainty of the flow rate measurement using the ISO guide (GUM:1995 part3). The battery life, delay time of the occlusion alarm, and bolus function of the PCA pump were also tested. Results The microbalance method was good in the short-term 2 h measurement, and IDA-5 was good in the long-term 24 h measurement. The two measurement systems can complement each other in the case of the measurement time. Regarding battery performance, PS-1000 lasted approximately 5 days in a 1 ml/hr flow rate condition without recharging the battery. The occlusion pressure alarm delays of PS-1000 satisfied the conventional alarm threshold of occlusion pressure (300-800 mmHg). Average accuracy bolus volume was measured as 63%, 95%, and 98.5% with 0.1 ml, 1 ml, and 2 ml bolus volume presets, respectively. A 1 ml/hr flow rate measurement was evaluated as 2.08% of expanded uncertainty, with a 95% confidence level. Conclusion PS-1000 showed a flow accuracy to be within the infusion pump standard, which is ± 5% of flow accuracy. Occlusion alarm of PS-1000 was quickly transmitted, resulting in better safety for patients receiving IV infusion of opioids. PS-1000 is sufficient for a portable smart PCA infusion pump.

show abstract

Section: Methodsmentioning

confidence: 99%

Performance evaluation study of a commercially available smart patient-controlled analgesia pump with the microbalance method and an infusion analyzer

Park¹,

Jung

2022

J Dent Anesth Pain Med

View full text Add to dashboard Cite

show abstract

“…Infusion pumps are evaluated using the dynamic gravimetric facility [16]. In this study, droplet volume is calculated from droplet mass.…”

Section: Methodsmentioning

confidence: 99%

A study on the change of droplet volume by the increase of flow rate

Horiuchi

2020

SN Appl. Sci.

View full text Add to dashboard Cite

Drip-control type infusion pumps cause a flow rate error when the volume of the droplet dropping in the drip chamber changes. Therefore, the purpose of this study is to accurately measure the volume of one droplet as the flow rate increases. For measurement of droplet volume, a droplet bypassing device was prototyped. In the case of a 20 drop/mL drip nozzle, a volume error of + 7.6% occurred at a flow rate of 500 mL/min, compared to the theoretical volume of 50.0 mm 3. In the case of a 60 drop/mL drip nozzle, a volume error of − 17.4% occurred at a flow rate of 300 mL/min, compared to the theoretical volume of 16.7 mm 3. Moreover, the standard deviation of the measured value of the droplet volume increased as the flow rate increased. It was shown that even with proper use of the infusion set, significant flow rate errors can occur depending on the flow rate settings. Therefore, it is considered that the drip-control type infusion pump needs to be controlled by correcting the volume change due to the increase in the flow rate.

show abstract

“…The accuracy of medical electrical equipment including volumetric or syringe pump is normally assessed by administering a test solution at a constant rate over a period of time and subsequently measuring the weight of the actually administered solution [ 8 , 9 ]. However, because the TCI mode can be interpreted as variable infusion rates, it is not feasible to apply the gravimetric method to a syringe pump operating in TCI mode.…”

Section: Methodsmentioning

confidence: 99%

“…All experiments were performed with sterile, disposable 50 ml BD infusion syringes, which are identical to the syringes used in the clinical trial [ 6 ]. Pump accuracy was evaluated in terms of deviation as defined by the following equation [ 8 , 9 ]:…”

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Accuracy assessment of a PION TCI pump based on international standards

Doh

Lee

2019

Anesth Pain Med

Self Cite

View full text Add to dashboard Cite

Background Inaccuracies associated with target-controlled infusion (TCI) delivery systems are attributable to both software and hardware issues, as well as pharmacokinetic variability. However, little is known about the inaccuracy of the syringe pump operating in TCI mode. This study aimed to evaluate the accuracy of the TCI pump based on international standards. Methods A test apparatus for accuracy evaluation of a syringe pump (PION TCI ® , Bionet Co. Ltd.) was designed to apply the gravimetric method. Pump accuracy was evaluated in terms of deviation defined by the following equation: infusion rate deviation (%) = ( Rate mea − Rate est ) / Rate est × 100, where Rate mea is the infusion rate (ml/h) as measured by the gravimetric system, and Rate est is the infusion rate (ml/h) as estimated by the pump. An infusion rate representing TCI mode was determined from previous clinical trial data which evaluated the predictive performance of the pharmacokinetic model. The PION TCI pump used in that clinical trial was used to evaluate accuracy of the syringe pump. The distribution of infusion rates obtained from the clinical trial was calculated, and the median value of the distribution was determined as the representative value. Results The representative infusion rate representing TCI mode was 31 ml/h, at which the infusion rate deviation was 4.5 ± 1.6%. Conclusions The inaccuracy of the syringe pump contributing to TCI system inaccuracy is insignificant.

show abstract

Dynamic behavior analysis of drug delivery devices using a dynamic gravimetric method

Cited by 12 publications

References 8 publications

Performance evaluation study of a commercially available smart patient-controlled analgesia pump with the microbalance method and an infusion analyzer

Performance evaluation study of a commercially available smart patient-controlled analgesia pump with the microbalance method and an infusion analyzer

A study on the change of droplet volume by the increase of flow rate

Accuracy assessment of a PION TCI pump based on international standards

Contact Info

Product

Resources

About