Jung Bongsu, Seo Kwang-Suk, Kwon Suk Jin, Lee Kiyoung, Hong Suyong, Seo Hyounsoon, Kim Gi-Young, Park Geun-Mook, Jeong Juhee, Seo Soowon
Medical Device Development Center, Daegu-Gyeongbuk Medical Innovation Foundation, Daegu, Korea.
Department of Dental Anesthesiology, School of Dentistry, Seoul National University, Seoul, Korea.
J Dent Anesth Pain Med. 2016 Dec;16(4):303-307. doi: 10.17245/jdapm.2016.16.4.303. Epub 2016 Dec 31.
In dental intravenous sedation, continuous intravenous infusion of a low-dose drug requires an infusion pump such as a syringe pump. To develop a new syringe pump for clinical use, the functions of the pump must meet certain international standards. Various safety and efficacy tests must be performed on the syringe pump, as stipulated by these standards, and an approval must be received from the approving agency based on such test results.
The authors of the present study developed a novel syringe pump and performed efficacy evaluation by testing its infusion speed at 1 and 25 ml/h, and infusion performance testing at 2 and 24 h. Moreover, performance evaluation was conducted by comparing the novel pump to an existing pump with the infusion speed varied from 1 to 5 ml/h.
In the efficacy testing on the newly developed syringe pump, infusion with the infusion speed initially set to 1 ml/h resulted in infusion speeds of 1.00 and 0.99 ml/h in the 2- and 24-h assessment, respectively. Changing the infusion speed setting to 25 ml/h resulted in an infusion speed of 25.09 and 23.92 ml/h in the 2- and 24-h assessment, respectively. These results show no significant differences when compared with other commercially available pumps.
The efficacy testing of the newly developed syringe pump showed the accuracy to be within tolerance. Based on these findings, we believe that the newly developed syringe pump is suitable for clinical use.
在牙科静脉镇静中，持续静脉输注低剂量药物需要使用输液泵，如注射泵。为开发一种供临床使用的新型注射泵，该泵的功能必须符合某些国际标准。必须按照这些标准对注射泵进行各种安全性和有效性测试，并根据测试结果获得审批机构的批准。
本研究的作者开发了一种新型注射泵，并通过测试其在1和25ml/h的输注速度以及在2和24小时的输注性能进行有效性评估。此外，通过将新型泵与现有泵在1至5ml/h的输注速度下进行比较来进行性能评估。
在对新开发的注射泵进行的有效性测试中，最初将输注速度设置为1ml/h时，在2小时和24小时评估中的输注速度分别为1.00和0.99ml/h。将输注速度设置改为25ml/h时，在2小时和24小时评估中的输注速度分别为25.09和23.92ml/h。与其他市售泵相比，这些结果显示无显著差异。
新开发的注射泵的有效性测试表明其准确性在公差范围内。基于这些发现，我们认为新开发的注射泵适用于临床使用。
