Mohamed Elfadil Osman, Keaveney Edel, Patel Ankitaben, Abdelmagid Marwa G, Patel Ishani, Patel Jalpan, Hurt Ryan T, Mundi Manpreet S
Division of Endocrinology, Diabetes, Metabolism and Nutrition, Mayo Clinic, Rochester, MN, USA.
Rockfield Medical Devices, Galway, Ireland.
Med Devices (Auckl). 2022 Aug 5;15:253-262. doi: 10.2147/MDER.S367100. eCollection 2022.
Utilization of long-term home enteral nutrition (HEN) for nutrition therapy is increasing across the world. However, HEN can be a mobility-limiting experience affecting quality of life (QoL). Improvement of QoL for patients receiving HEN is a universal goal within the nutrition community. This study evaluated usability of Mobility+, a novel enteral feeding system (EFS).
A summative study evaluating usability of the novel EFS was conducted with novices (NV), non-novices (NN), and healthcare professionals (HCP). Subjects in NV and NN groups received familiarization training where they were introduced to the novel EFS and walked through steps to fill pouch, simulate feeding, flush (rinse), and wear the system, using the Instructions for Use (IFU) booklet, followed by a testing session where they simulated system use on their own. HCP self-trained using the IFU and instructional videos. A fill from ready-to-hang (RTH) formula bag method was also tested in HCP. Participants' ability to loosely coil the tubing and sit, stand, and move around wearing a filled feeding pouch inside a crossbody bag was also evaluated.
Forty-five participants completed the study. All participants successfully and safely simulated use of the novel EFS, with 97.8% (44/45) doing so on first attempt. All participants could wear the novel EFS in crossbody bag and move around without any use errors or safety issues.
The examined novel EFS can be safely used in intended use population, with or without previous experience with enteral nutrition, on provision of basic familiarization training and written IFU. Additionally, HCP can successfully self-train on this system with instructional videos.
长期家庭肠内营养(HEN)用于营养治疗在全球范围内的使用正在增加。然而,HEN可能是一种限制活动的体验,会影响生活质量(QoL)。提高接受HEN治疗患者的生活质量是营养学界的一个普遍目标。本研究评估了新型肠内喂养系统(EFS)Mobility+的易用性。
对新手(NV)、非新手(NN)和医疗保健专业人员(HCP)进行了一项评估新型EFS易用性的总结性研究。NV组和NN组的受试者接受了熟悉培训,在培训中他们被介绍了新型EFS,并按照使用说明书(IFU)手册中的步骤,完成填充袋子、模拟喂食、冲洗(清洗)和佩戴系统的操作,随后进行测试环节,他们自己模拟系统的使用。HCP使用IFU和教学视频进行自我培训。还对HCP进行了从即挂即用(RTH)配方袋填充方法的测试。还评估了参与者将管路松散盘绕以及佩戴装满喂食袋的斜挎包坐下、站立和四处走动的能力。
45名参与者完成了研究。所有参与者都成功且安全地模拟了新型EFS的使用,97.8%(44/45)的参与者在首次尝试时就做到了。所有参与者都能将新型EFS佩戴在斜挎包中并四处走动,没有任何使用错误或安全问题。
经过测试的新型EFS在提供基本的熟悉培训和书面IFU的情况下,无论有无肠内营养经验的目标使用人群都可安全使用。此外,HCP可以通过教学视频成功地对该系统进行自我培训。