Anthony D Andre, John F Mohr, Barbara W Cornelius, Matthew M Goodwin, Carson P Whitaker, Bhavini H Patel, Jessica A Huckleberry, Michael D Hassman
{"title":"用于皮下注射呋塞米的可穿戴式体外输液器的人为因素验证。","authors":"Anthony D Andre, John F Mohr, Barbara W Cornelius, Matthew M Goodwin, Carson P Whitaker, Bhavini H Patel, Jessica A Huckleberry, Michael D Hassman","doi":"10.2147/MDER.S462573","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>Furoscix<sup>®</sup> (subcutaneous furosemide) is administered using a wearable On-Body Infusor (OBI) and is approved for the treatment of congestion associated with heart failure (HF). The purpose of this study was to assess the safe and effective use of the OBI and Instructions for Use (IFU) by patients with HF, caregivers, and healthcare practitioners (HCPs).</p><p><strong>Methods: </strong>Sixty participants (patients, n=30; caregivers, n=15; HCPs, n=15) were evaluated on completion of OBI use tasks and IFU knowledge tasks in a simulated use environment. Fifteen of the patients received OBI/IFU training before evaluation.</p><p><strong>Results: </strong>Overall, 893/900 (99.2%) use tasks and 2211/2220 (99.6%) knowledge tasks were completed successfully, without differences due to training. The most common (n=6) use error was failure to wipe skin or cartridge tip with an alcohol wipe. Errors were due to forgetfulness/misinterpretation rather than IFU clarity.</p><p><strong>Conclusion: </strong>The subcutaneous furosemide OBI can be safely and effectively used by patients, caregivers, and HCPs, regardless of training.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"229-235"},"PeriodicalIF":1.3000,"publicationDate":"2024-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11212806/pdf/","citationCount":"0","resultStr":"{\"title\":\"Human Factors Validation of a Wearable, On-Body Infusor for Subcutaneous Administration of Furosemide.\",\"authors\":\"Anthony D Andre, John F Mohr, Barbara W Cornelius, Matthew M Goodwin, Carson P Whitaker, Bhavini H Patel, Jessica A Huckleberry, Michael D Hassman\",\"doi\":\"10.2147/MDER.S462573\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>Furoscix<sup>®</sup> (subcutaneous furosemide) is administered using a wearable On-Body Infusor (OBI) and is approved for the treatment of congestion associated with heart failure (HF). The purpose of this study was to assess the safe and effective use of the OBI and Instructions for Use (IFU) by patients with HF, caregivers, and healthcare practitioners (HCPs).</p><p><strong>Methods: </strong>Sixty participants (patients, n=30; caregivers, n=15; HCPs, n=15) were evaluated on completion of OBI use tasks and IFU knowledge tasks in a simulated use environment. Fifteen of the patients received OBI/IFU training before evaluation.</p><p><strong>Results: </strong>Overall, 893/900 (99.2%) use tasks and 2211/2220 (99.6%) knowledge tasks were completed successfully, without differences due to training. The most common (n=6) use error was failure to wipe skin or cartridge tip with an alcohol wipe. Errors were due to forgetfulness/misinterpretation rather than IFU clarity.</p><p><strong>Conclusion: </strong>The subcutaneous furosemide OBI can be safely and effectively used by patients, caregivers, and HCPs, regardless of training.</p>\",\"PeriodicalId\":47140,\"journal\":{\"name\":\"Medical Devices-Evidence and Research\",\"volume\":\"17 \",\"pages\":\"229-235\"},\"PeriodicalIF\":1.3000,\"publicationDate\":\"2024-06-24\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11212806/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Medical Devices-Evidence and Research\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.2147/MDER.S462573\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q4\",\"JCRName\":\"ENGINEERING, BIOMEDICAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Medical Devices-Evidence and Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2147/MDER.S462573","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/1/1 0:00:00","PubModel":"eCollection","JCR":"Q4","JCRName":"ENGINEERING, BIOMEDICAL","Score":null,"Total":0}
Human Factors Validation of a Wearable, On-Body Infusor for Subcutaneous Administration of Furosemide.
Purpose: Furoscix® (subcutaneous furosemide) is administered using a wearable On-Body Infusor (OBI) and is approved for the treatment of congestion associated with heart failure (HF). The purpose of this study was to assess the safe and effective use of the OBI and Instructions for Use (IFU) by patients with HF, caregivers, and healthcare practitioners (HCPs).
Methods: Sixty participants (patients, n=30; caregivers, n=15; HCPs, n=15) were evaluated on completion of OBI use tasks and IFU knowledge tasks in a simulated use environment. Fifteen of the patients received OBI/IFU training before evaluation.
Results: Overall, 893/900 (99.2%) use tasks and 2211/2220 (99.6%) knowledge tasks were completed successfully, without differences due to training. The most common (n=6) use error was failure to wipe skin or cartridge tip with an alcohol wipe. Errors were due to forgetfulness/misinterpretation rather than IFU clarity.
Conclusion: The subcutaneous furosemide OBI can be safely and effectively used by patients, caregivers, and HCPs, regardless of training.
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