Jung, Bongsu
(Medical Device Development Center, Daegu-Gyeongbuk Medical Innovation Foundation)
,
Seo, Kwang-Suk
(Department of Dental Anesthesiology, School of Dentistry, Seoul National University)
,
Kwon, Suk Jin
(Department of Dental Anesthesiology, School of Dentistry, Seoul National University)
,
Lee, Kiyoung
(R&D Center, Bionet Co., Ltd.)
,
Hong, Suyong
(R&D Center, Bionet Co., Ltd.)
,
Seo, Hyounsoon
(R&D Center, Bionet Co., Ltd.)
,
Kim, Gi-Young
(Medical Device Development Center, Daegu-Gyeongbuk Medical Innovation Foundation)
,
Park, Geun-Mook
(Medical Device Development Center, Daegu-Gyeongbuk Medical Innovation Foundation)
,
Jeong, Juhee
(Medical Device Development Center, Daegu-Gyeongbuk Medical Innovation Foundation)
,
Seo, Soowon
(Medical Device Development Center, Daegu-Gyeongbuk Medical Innovation Foundation)
Background: 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...
Background: 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. Methods: 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. Results: 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. Conclusions: 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.
Background: 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. Methods: 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. Results: 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. Conclusions: 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.
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제안 방법
A test was performed to compare the newly developed Neo syringe pump to others currently in use, including the PerfusorR space syringe pump system (B. Braun Medical Inc., Melsungen, Germany) and OrchestraR Modular DPS (Fresenius Kabi AG, Frankfurt, Germany). As shown in Fig.
After the preliminary tests, other tests were also performed on continuous leakage current and patient leakage current measurements, the prevention of excessive perfusion under a free perfusion condition, and peak perfusion pressure (PPP). In addition to these, the service life of the drug infusion pump was tested, and reflux/siphon action, auto-clamp, and lockout time function tests were performed [7].
For the measurement of short-term accuracy, pump performance was evaluated for 2 h by using IDA-5 with flow rates of 1 and 25 ml/h. For long-term accuracy, the test was performed for 24 h with flow rates of 1 and 25 ml/h.
Above all, the efficacy evaluation on the safety and reliability technology of measuring the accuracy of total dose and flow rate takes precedence over anything [6]. The authors performed efficacy testing to obtain MFDS approval for a newly developed syringe pump and aimed to report the test methods used and the results obtained, with the intent of using the findings for developing other types of medical devices.
이론/모형
2, the infusion speed was increased from 1 to 5 ml/h in 10-min intervals over 100 min by using a 50-ml syringe. In this experiment, the XPE 205 scale (Mettler-Toledo C., Barcelona) was used.
참고문헌 (11)
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5 International Electrotechnical Commission (IEC) Medical electrical equipment—part 2-24: Particular requirements for the safety of infusion pumps and controllers 2012 IEC 60601-2-24
6 Lonnqvist PA Lofqvist B Design flaw can convert commercially available continuous syringe pumps to intermittent bolus injectors Intensive Care Med 1997 23 998 1001 9347374
7 Miller KE Arnold R Capan M Campbell M Zern SC Dressler R Improving infusion pump safety through usability testing J Nurs Care Qual 2016 [Epub ahead of print]
8 Masuda A Arai Y Hirota K Shibuya N Ito Y Misuse of infusion pump during propofol anaesthesia Can J Anaesth 1998 45 187
10 Rooke GA Bowdle TA Syringe pumps for infusion of vasoactive drugs: Mechanical idiosyncrasies and recommended operating procedures Anesth Analg 1994 78 150 156 8267151
11 Deckert D Buerkle C Neurauter A Hamm P Lindner KH Wenzel V The effects of multiple infusion line extensions on occlusion alarm function of an infusion pump Anesth Analg 2009 108 518 520 19151281
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