Medical Devices: Evidence and Research (Aug 2022)
Usability of a Novel Enteral Feeding System: A Summative Study
Abstract
Osman Mohamed Elfadil,1 Edel Keaveney,2 Ankitaben Patel,1 Marwa G Abdelmagid,1 Ishani Patel,1 Jalpan Patel,1 Ryan T Hurt,1,3,4 Manpreet S Mundi1 1Division of Endocrinology, Diabetes, Metabolism and Nutrition, Mayo Clinic, Rochester, MN, USA; 2Rockfield Medical Devices, Galway, Ireland; 3Division of Internal Medicine, Mayo Clinic, Rochester, MN, USA; 4Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USACorrespondence: Manpreet S Mundi, Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Mayo Clinic, 200 First St SW, Rochester, MN, 55905, USA, Tel +1 507-284-0106, Fax +1 507-284-5745, Email [email protected]: 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).Methods: 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.Results: 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.Conclusion: 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.Keywords: feeding system, enteral feeding, mobility, mobility-enhancing enteral feeding system, novel EFS
