Human Factors Validation of a Wearable, On-Body Infusor for Subcutaneous Administration of Furosemide.

IF 1.3 Q4 ENGINEERING, BIOMEDICAL Medical Devices-Evidence and Research Pub Date : 2024-06-24 eCollection Date: 2024-01-01 DOI:10.2147/MDER.S462573

Anthony D Andre, John F Mohr, Barbara W Cornelius, Matthew M Goodwin, Carson P Whitaker, Bhavini H Patel, Jessica A Huckleberry, Michael D Hassman

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Abstract

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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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。

目的：Furoscix®（皮下注射呋塞米Furoscix®（皮下注射呋塞米）使用可穿戴式体外输液器 (OBI) 给药，已被批准用于治疗心力衰竭 (HF) 引起的充血。本研究的目的是评估心力衰竭患者、护理人员和医护人员（HCPs）使用 OBI 和使用说明（IFU）的安全性和有效性：对 60 名参与者（患者，30 人；护理人员，15 人；医护人员，15 人）在模拟使用环境中完成 OBI 使用任务和 IFU 知识任务的情况进行评估。其中 15 名患者在评估前接受了 OBI/IFU 培训：总体而言，893/900 例（99.2%）使用任务和 2211/2220 例（99.6%）知识任务均顺利完成，没有因培训而出现差异。最常见的使用错误（n=6）是没有用酒精擦拭布擦拭皮肤或药筒头。错误的原因是遗忘/误解，而非 IFU 的清晰度：无论受过何种培训，患者、护理人员和 HCP 都可以安全有效地使用皮下呋塞米 OBI。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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