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

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.

Preparation and Characterization of Human Adipose Tissue-Derived Extracellular Matrix, Growth Factors, and Stem Cells: A Concise Review

BACKGROUND: Human adipose tissue is routinely discarded as medical waste. However, this tissue may have valuable clinical applications since methods have been devised to effectively isolate adipose-derived extracellular matrix (ECM), growth factors (GFs), and stem cells. In this review, we analyze the literature that devised these methods and then suggest an optimal method based on their characterization results. METHODS: Methods that we analyze in this article include: extraction of adipose tissue, decellularization, confirmation of decellularization, identification of residual active ingredients (ECM, GFs, and cells), removal of immunogens, and comparing structural/physiological/biochemical characteristics of active ingredients. RESULTS: Human adipose ECMs are composed of collagen type I–VII, laminin, fibronectin, elastin, and glycosaminoglycan (GAG). GFs immobilized in GAG include basic fibroblast growth factor (bFGF), transforming growth factor beta 1(TGF-b1), insulin like growth factor 1 (IGF-1), vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF), BMP4 (bone morphogenetic protein 4), nerve growth factor (NGF), hepatocyte growth factor (HGF), and epithermal growth factor (EGF). Stem cells in the stromal-vascular fraction display mesenchymal markers, self-renewal gene expression, and multi-differentiation potential. CONCLUSION: Depending on the preparation method, the volume, biological activity, and physical properties of ECM, GFs, and adipose tissue-derived cells can vary. Thus, the optimal preparation method is dependent on the intended application of the adipose tissue-derived products.

Development of a Rapid Automated Fluorescent Lateral Flow Immunoassay to Detect Hepatitis B Surface Antigen (HBsAg), Antibody to HBsAg, and Antibody to Hepatitis C

BACKGROUND: Accurate, rapid, and cost-effective screening tests for hepatitis B virus (HBV) and hepatitis C virus (HCV) infection may be useful in laboratories that cannot afford automated chemiluminescent immunoassays (CLIAs). We evaluated the diagnostic performance of a novel rapid automated fluorescent lateral flow immunoassay (LFIA). METHODS: A fluorescent LFIA using a small bench-top fluorescence reader, Automated Fluorescent Immunoassay System (AFIAS; Boditech Med Inc., Chuncheon, Korea), was developed for qualitative detection of hepatitis B surface antigen (HBsAg), antibody to HBsAg (anti-HBs), and antibody to HCV (anti-HCV) within 20 minutes. We compared the diagnostic performance of AFIAS with that of automated CLIAs—Elecsys (Roche Diagnostics GmbH, Penzberg, Germany) and ARCHITECT (Abbott Laboratories, Abbott Park, IL, USA)—using 20 seroconversion panels and 3,500 clinical serum samples. RESULTS: Evaluation with the seroconversion panels demonstrated that AFIAS had adequate sensitivity for HBsAg and anti-HCV detection. From the clinical samples, AFIAS sensitivity and specificity were 99.8% and 99.3% for the HBsAg test, 100.0% and 100.0% for the anti-HBs test, and 98.8% and 99.1% for the anti-HCV test, respectively. Its agreement rates with the Elecsys HBsAg, anti-HBs, and anti-HCV detection assays were 99.4%, 100.0%, and 99.0%, respectively. AFIAS detected all samples with HBsAg genotypes A-F and H and anti-HCV genotypes 1, 1a, 1b, 2a, 2b, 4, and 6. Cross-reactivity with other infections was not observed. CONCLUSIONS: The AFIAS HBsAg, anti-HBs, and anti-HCV tests demonstrated diagnostic performance equivalent to current automated CLIAs. AFIAS could be used for a large-scale HBV or HCV screening in low-resource laboratories or low-to middle-income areas.

Efficacy evaluation of syringe pump developed for continuous drug infusion

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.