Medical Devices-Evidence and Research最新文献

{"title":"Revision of Failed Sacroiliac Joint Posterior Interpositional Structural Allograft Stabilization with Lateral Porous Titanium Implants: A Multicenter Case Series [Letter].","authors":"Timothy R Deer, Douglas P Beall, Steven M Falowski","doi":"10.2147/MDER.S385627","DOIUrl":"https://doi.org/10.2147/MDER.S385627","url":null,"abstract":"","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"365-366"},"PeriodicalIF":1.3,"publicationDate":"2022-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/80/f0/mder-15-365.PMC9586172.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40675605","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Risk Identification and Analysis in the Development of Medical Devices Among Start-Ups: Towards a Broader Risk Management Framework.","authors":"Omar Kheir,&nbsp;Alexis Jacoby,&nbsp;Stijn Verwulgen","doi":"10.2147/MDER.S375977","DOIUrl":"https://doi.org/10.2147/MDER.S375977","url":null,"abstract":"<p><strong>Introduction: </strong>Whilst risk management has become fundamental in the development of medical devices, enforced by regulations and international standards, there is still no comprehensive model that explains how risk management in medical devices' development should be tackled, especially with regard to the type of risks that should be addressed. Risk management in the medical devices' development field is currently focused on technical risks, comprising product, usability, and development process risks, in alignment with standards' requirements and regulations, without giving enough attention to non-technical risks, which include business and project risks. Start-ups within this heavily regulated domain have a key role in the innovation process, yet they suffer a structural lack of tangible, such as financial capacity, and intangible resources such as development, risk management, and regulations' compliance. Nonetheless, they can still optimize their risk identification coverage beyond the enforced requirements to increase their products' chances of success.</p><p><strong>Methods: </strong>A set of qualitative interviews, serving the adopted grounded theory building research method, with seven start-ups who are involved in the development, commercialization, and quality control of medical devices was accomplished. The purpose was to determine the applied risk management practices and most importantly identify the risk types covered by them. Since every start-up is a project by itself, a sample of project risks, as identified by the project management institute, was utilized to scope the risk coverage and flag missing non-technical risks by the participating start-ups.</p><p><strong>Results: </strong>Un-identified risk types, lack of involvement of the right teams, and other related loopholes were presented.</p><p><strong>Discussion: </strong>A list of requirements was developed and sketched in a user-friendly risk management framework, which is believed to be crucial in helping start-ups attain successful, safe, and regulatory compliant medical devices production, is shared in the discussion and proposed framework section of this paper.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"349-363"},"PeriodicalIF":1.3,"publicationDate":"2022-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/9f/3b/mder-15-349.PMC9507292.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33484276","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Lens Autofluorescence Based Advanced Glycation End Products (AGEs) Measurement to Assess Risk of Osteopenia Among Individuals Under the Age of 50.","authors":"Shaoyun Li,&nbsp;Yuefei Li,&nbsp;Xiyan Xu,&nbsp;Jian Shao,&nbsp;Ruifeng Xie,&nbsp;Sheng Liu,&nbsp;Li Peng,&nbsp;Jin Wang,&nbsp;Kaixin Zhou,&nbsp;Huyi Feng","doi":"10.2147/MDER.S381115","DOIUrl":"https://doi.org/10.2147/MDER.S381115","url":null,"abstract":"<p><strong>Introduction: </strong>Simple non-invasive biomarker is urgently needed to detect the largely silent osteopenia in order to prevent osteoporosis-related fracture later in life. The accumulation of advanced glycation end products (AGEs) has been related to reduced bone density and osteoporotic fractures. Whether lens autofluorescence (LAF) based AGEs (LAF-AGEs) measurement could be used to assess the risk of osteopenia is aimed to investigate in this paper.</p><p><strong>Methods: </strong>Through routine health examination, 368 individuals under the age of 50 were enrolled. A dual-energy X-ray absorptiometry (DXA) device was used to measure bone mineral density (BMD) of the forearm and determine osteopenia. AGE levels were derived with LAF along with the other demographic and laboratory parameters. After deriving the age-adjusted AGE levels (AALs), a linear regression analysis and an ordered logistic regression analysis were applied to examine the associations between osteopenia and LAF-AGEs as well as AALs.</p><p><strong>Results: </strong>Negative correlations (Pearson r = -0.16, p < 0.001) were found between LAF-AGEs and T-scores. Higher AALs were significantly associated (p = 0.004) with escalated level of osteopenia in the ordered logistic analysis.</p><p><strong>Discussion: </strong>After reviewing the relevant studies, it is concluded that LAF-AGE is a more stable measure of long-term metabolic dysfunction than circulating AGE. LAF-AGEs are a valid, practical and non-invasive parameter for osteopenia risk evaluation. Further studies with longer follow-up will be helpful to clarify its effectiveness for osteoporosis risk assessment.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"341-347"},"PeriodicalIF":1.3,"publicationDate":"2022-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/aa/e4/mder-15-341.PMC9467441.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40359285","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Retrospective Comparison of Clinical and Economic Outcomes of Non-Donor Patients Undergoing Radical Nephrectomy Using One of Two Different Linear Stapler Technologies for Transection of the Renal Vessels: Fixed-Height Gripping Surface Reloads vs Variable-Height Reloads.","authors":"Stephen S Johnston,&nbsp;Barbara H Johnson,&nbsp;Divya Chakke,&nbsp;Sanjoy Roy,&nbsp;Philippe Grange,&nbsp;Esther Pollack","doi":"10.2147/MDER.S372629","DOIUrl":"https://doi.org/10.2147/MDER.S372629","url":null,"abstract":"<p><strong>Purpose: </strong>To compare outcomes of non-donor patients undergoing radical nephrectomy using fixed-height gripping surface (FHGS) vs variable-height Tri-Staple™ (VHTS) reloads for transection of the renal vessels.</p><p><strong>Patients and methods: </strong>Using the Premier Healthcare Database of US hospital discharge records, we selected non-donor patients undergoing inpatient radical nephrectomy with dates of admission between 1 October 2015, and 31 December 2020 (first=index admission). The primary outcome was in-hospital hemostasis-related complications (hemorrhage, acute posthemorrhagic anemia, and/or procedure to control bleeding) during the index admission. Secondary outcomes included index admission intraoperative injury, blood transfusion, conversion from minimally invasive to open surgery, total hospital costs, length of stay (LOS), discharge status, and mortality as well as 30-day all-cause inpatient readmission. We used stable balancing weights to balance the FHGS and VHTS groups on numerous patient, procedure, and hospital/provider characteristics, allowing a maximum post-weighting standardized mean difference ≤0.01 for all covariates; we also exactly matched the groups on laterality (right vs left kidney) and intended surgical approach (open, laparoscopic, robotic). We used bivariate multilevel mixed-effects generalized linear models accounting for hospital-level clustering to compare the study outcomes between the FHGS and VHTS groups.</p><p><strong>Results: </strong>After weighting, the FHGS and VHTS groups comprised 2952 and 795 patients, respectively. The observed incidence proportion of the primary outcome of hemostasis-related complications during the index admission was similar between the groups (8.6% for FHGS vs 9.0% for VHTS, difference 0.4% [95% CI -3.2% to 2.5%], <i>P</i>=0.808). Differences between the FHGS and VHTS groups were not statistically significant for any of the secondary outcomes.</p><p><strong>Conclusion: </strong>Endoscopic surgical staplers have become common for transection of the renal vessels during radical nephrectomy, with FHGS and VHTS being the predominant reload types. In this retrospective study of 3747 non-donor patients undergoing radical nephrectomy, use of FHGS vs VHTS reloads was associated with similar clinical and economic outcomes.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"317-328"},"PeriodicalIF":1.3,"publicationDate":"2022-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/8b/a2/mder-15-317.PMC9450510.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33461347","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Improving Performance and Access to Difficult-to-Reach Anatomy with a Powered Articulating Stapler.","authors":"Zhifan F Huang,&nbsp;James A Vandewalle,&nbsp;Jeffrey W Clymer,&nbsp;Crystal D Ricketts,&nbsp;William J Petraiuolo","doi":"10.2147/MDER.S379717","DOIUrl":"https://doi.org/10.2147/MDER.S379717","url":null,"abstract":"<p><strong>Background: </strong>Modern surgical staplers should provide precise placement and transection, especially in tight spaces and on thick tissue. Ideally, a stapler would move to accommodate variations in the tissue and anatomy instead of having to move the tissue around to fit the stapler. This study was undertaken to evaluate the performance characteristics of the new Echelon 3000 Stapler (ECH3). Use of the ECH3 was compared to another marketed stapler, including tests for access, seal strength, staple formation in thick tissue, and end effector stability.</p><p><strong>Methods: </strong>Pelvic anatomy measurements were used to construct a virtual model of a Low Anterior Resection (LAR). Monte Carlo simulations were performed on the staplers to compare the probability of completing a transection with one or two firings. Using water infusion of stapled porcine ileum, pressure at first leak and percentage of leaks at critical pressures were measured. Rate of malformed staples was measured in thick tissue. End effector stability while firing and under moderate pressure were compared between staplers. After use, surgeons were surveyed on the functionality of the device.</p><p><strong>Results: </strong>ECH3 had a markedly higher probability of completing an LAR transection in one or two firings than the comparator stapler. Median initial leak pressure of stapled ileum was significantly higher, and rate of leaks was lower at 40 and 50 mmHg. ECH3 had fewer malformed staples for both 3.3- and 4.0-mm thick tissue. The end effector exhibited less angular movement during firing, and less deflection under a moderate load. Surgeons agreed the ECH3 provided precise placement and easy one-handed operation.</p><p><strong>Conclusion: </strong>The Echelon 3000 Stapler demonstrated improved access capability, tighter seals, fewer malformed staples, and greater end effector stability. These advantages were recognized by surgeons who evaluated the use of the device preclinically.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"329-339"},"PeriodicalIF":1.3,"publicationDate":"2022-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/ee/c8/mder-15-329.PMC9447447.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33455506","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of Common Nasal Cannulas in Neonatal Noninvasive Ventilation (NIV) Using a Novel Neonatal Nasal Model.","authors":"Ulf Borg,&nbsp;Jeffrey Aviano,&nbsp;Milan Ginani,&nbsp;Kun Li","doi":"10.2147/MDER.S374418","DOIUrl":"https://doi.org/10.2147/MDER.S374418","url":null,"abstract":"<p><strong>Purpose: </strong>Non-invasive ventilation (NIV) may reduce intubation rates and be especially beneficial in the care of preterm infants, in addition to other care modalities. Currently, ventilators do not display the pressure at the nares but the pressure in the ventilator tubing system. There are several nasal cannulas available for use to deliver NIV. The purpose of this study was to compare the inspiratory pressure on the ventilator to the measured pressure delivered at the nares using three cannula brands (Manufacturer A, Fisher & Paykel; Manufacturer B, Neotech RAM; and Manufacturer C, Hudson RCI).</p><p><strong>Patients and methods: </strong>This bench study utilized a 3D printed nasal model, including nares in multiple sizes to accommodate all nasal prongs studied. The nasal adaptors were connected to neonatal test lungs, to simulate patient breathing. Multiple sizes of nasal cannulas from the three manufacturers were tested for inspiratory vs delivered pressure at the patient side of the cannula, using eight combinations of ventilator settings. Each nasal cannula was tested on six Puritan Bennett™ 980 ventilators.</p><p><strong>Results: </strong>The measured delivered pressure at the nares was consistently lower than the clinician-set inspiratory pressure. Across all ventilator settings, 7 of the 11 cannulas delivered significantly less pressure at the nares compared to the inspiratory ventilator pressure (p < 0.01). For each cannula, as inspiratory pressure increased, the difference between delivered and inspiratory pressures also increased. The cannula from Manufacturer B consistently demonstrated the greatest differences between set inspiratory and delivered pressures for each ventilator setting.</p><p><strong>Conclusion: </strong>This study demonstrated substantial differences between ventilator inspiratory pressure and measured delivered pressure, which may have clinical significance. Being unaware of the actual airway pressure delivered to the patient may lead to erroneous adjustments to the level of ventilator pressure, which may be especially consequential to those with delicate and developing respiratory systems.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"307-315"},"PeriodicalIF":1.3,"publicationDate":"2022-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/5e/ae/mder-15-307.PMC9444233.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33448569","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of the Rheological Properties, Preclinical Safety, and Clinical Effectiveness of a New Dispersive Ophthalmic Viscoelastic Device for Cataract Surgery.","authors":"Claudia Palacio-Pastrana,&nbsp;Patricia Muñoz-Villegas,&nbsp;Fernando Dániel-Dorantes,&nbsp;Alejandra Sánchez-Ríos,&nbsp;Oscar Olvera-Montaño,&nbsp;Yareni I Martínez-Montoya,&nbsp;Juan D Quintana-Hau,&nbsp;Leopoldo M Baiza-Durán","doi":"10.2147/MDER.S379050","DOIUrl":"https://doi.org/10.2147/MDER.S379050","url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate the rheological properties of the ophthalmic viscoelastic device (OVD) PRO-149, its preclinical safety, and its effectiveness when used during cataract surgery in patients with age-related cataract.</p><p><strong>Material and methods: </strong>Control (HEC) and test (PRO-149) OVDs were compared through rheological measures, by two preclinical safety studies in rabbits, and under normal-use conditions during cataract removal and lens implantation in a parallel randomized clinical trial.</p><p><strong>Results: </strong>Rheological properties were determined. Preclinical studies did not find any evidence of safety issues or toxicity. In the clinical trial, 36 subjects were included. After 29 days, there were no statistically significant differences in mean percentage of endothelial cell count change or in the postoperative intraocular pressure between groups. There were no significant differences between OVDs for any safety parameter studied. Finally, PRO-149 showed a statistically significant improvement in surgeon rating for ease of use during extraction (p < 0.05).</p><p><strong>Conclusion: </strong>PRO-149 is a dispersive OVD. The rabbit models did not find evidence of clinical alterations or toxicity. The results of the clinical study support that the two studied OVDs were clinically similar in terms of safety and effectiveness for cataract surgery.</p><p><strong>Trial registration: </strong>The trial is registered at Clinical Trials.gov at NCT04702802 (21-01-11).</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"293-305"},"PeriodicalIF":1.3,"publicationDate":"2022-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/80/60/mder-15-293.PMC9421612.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40335916","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Design of Abnormal Heart Sound Recognition System Based on HSMM and Deep Neural Network.","authors":"Hai Yin,&nbsp;Qiliang Ma,&nbsp;Junwei Zhuang,&nbsp;Wei Yu,&nbsp;Zhongyou Wang","doi":"10.2147/MDER.S368726","DOIUrl":"https://doi.org/10.2147/MDER.S368726","url":null,"abstract":"<p><strong>Introduction: </strong>Heart sound signal is an important physiological signal of human body, and the identification and research of heart sound signal is of great significance.</p><p><strong>Methods: </strong>For abnormal heart sound signal recognition, an abnormal heart sound recognition system, combining hidden semi-Markov models (HSMM) with deep neural networks, is proposed. Firstly, HSMM is used to build a heart sound segmentation model to accurately segment the heart sound signal, and then the segmented heart sound signal is subjected to feature extraction. Finally, the trained deep neural network model is used for recognition.</p><p><strong>Results: </strong>Compared with other methods, this method has a relatively small amount of input feature data and high accuracy, fast recognition speed.</p><p><strong>Discussion: </strong>HSMM combined with deep neural network is expected to be deployed on smart mobile devices for telemedicine detection.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"285-292"},"PeriodicalIF":1.3,"publicationDate":"2022-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/16/b7/mder-15-285.PMC9398456.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33438578","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cold Plasmamed Beam as a Supporting Treatment of Soft Tissue Injuries in Severe Covid-19 Patients: A Preliminary Report.","authors":"Thanh Xuan Nguyen,&nbsp;Duc Hanh Nguyen,&nbsp;Truong Phu Ho-Man,&nbsp;Vinh Duc An Bui,&nbsp;Phuoc Ngoc Phan","doi":"10.2147/MDER.S372916","DOIUrl":"https://doi.org/10.2147/MDER.S372916","url":null,"abstract":"<p><strong>Background: </strong>Cold plasma has many characteristics that allow for effective wound healing. Due to its efficacy, we have applied it in treating patients with severe Covid-19 who have soft tissue skin lesions and diseases including burns, pressure ulcers, shingles, and contact or atopic dermatitis. This study aims to assess the general characteristics of Covid-19 patients with soft tissue lesions and to conduct a fundamental evaluation of the efficacy of cold plasmamed beams in treating soft tissue wounds in patients with severe Covid-19.</p><p><strong>Methods: </strong>This prospective study was conducted on 20 severe Covid-19 patients with soft tissue lesions at the Intensive Care Center for Covid-19 of Hue Central Hospital in Ho Chi Minh City from September 25 to November 11, 2021. These patients was performed cold plasma irradiation at any stage of wound progression, including new injuries and chronic wounds.</p><p><strong>Results: </strong>Among 915 severe Covid-19 patients treated at our center, 20 patients had soft tissue lesions. Grade I, II, and III pressure ulcers accounted for 70% of the 20 cases of soft tissue lesions and 1.53% of the total patients at the time of the survey. Pressure ulcers were present in only 0.55% of patients (5/915 patients). Eleven out of 20 patients (55.0%) had lesions before admission, and 9 (45.0%) had lesions that appeared after admission. After 14 days of treatment, 14/20 patients had complete epithelialization (70%), and in 18/20 patients, wound exudation had ceased. The wounds became painless; after 3 weeks, the rashes had completely disappeared.</p><p><strong>Conclusion: </strong>The study emphasizes that irradiation with cold plasma contributes to the wound healing process.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"277-283"},"PeriodicalIF":1.3,"publicationDate":"2022-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/3c/29/mder-15-277.PMC9394517.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40413538","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Usability of a Novel Enteral Feeding System: A Summative Study.","authors":"Osman Mohamed Elfadil,&nbsp;Edel Keaveney,&nbsp;Ankitaben Patel,&nbsp;Marwa G Abdelmagid,&nbsp;Ishani Patel,&nbsp;Jalpan Patel,&nbsp;Ryan T Hurt,&nbsp;Manpreet S Mundi","doi":"10.2147/MDER.S367100","DOIUrl":"https://doi.org/10.2147/MDER.S367100","url":null,"abstract":"<p><strong>Background: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"253-262"},"PeriodicalIF":1.3,"publicationDate":"2022-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/c2/41/mder-15-253.PMC9362904.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40690124","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}