190 results on '"DEVICE EVALUATION"'
Search Results
2. The impact of an active and passive industrial back exoskeleton on functional performance.
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Govaerts, Renée, De Bock, Sander, Provyn, Steven, Vanderborght, Bram, Roelands, Bart, Meeusen, Romain, and De Pauw, Kevin
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RESEARCH funding ,PRODUCT design ,MUSCULOSKELETAL system diseases ,MANN Whitney U Test ,DESCRIPTIVE statistics ,ROBOTIC exoskeletons ,ASSISTIVE technology ,WORK-related injuries ,BODY movement ,COMPARATIVE studies - Abstract
Due to differences in actuation and design, active and passive industrial back exoskeletons could influence functional performance, i.e., work performance, perceived task difficulty, and discomfort, differently. Therefore, this study investigated and compared the impact of the active CrayX (7 kg) and passive Paexo Back (4.5 kg) on functional performance. Eighteen participants performed twelve work-related tasks with both types of exoskeletons and without (NoExo). The CrayX hindered work performance up to 22% in multiple tasks, compared to the Paexo Back and NoExo, while work performance between NoExo and the Paexo Back condition was more comparable, except for stair climbing (13% hindrance). Perceived task difficulty and discomfort seldomly varied between both exoskeletons. Although the CrayX shows promise to benefit workers, limitations in hindrance and comfort should first be addressed. The Paexo Back has demonstrated an advantage in certain static tasks. However, increasing its potential across a broader range of tasks seems warranted. Practitioner Summary: Differences between industrial back exoskeletons with regard to functional performance, i.e. work performance, discomfort and perceived task difficulty, were investigated by evaluating the active CrayX and passive Paexo Back back exoskeletons. The CrayX significantly hindered functional performance, while the Paexo Back seldomly affected functional performance. Abbreviations: WMSD: Work-related musculoskeletal disorder; NoExo: No Exoskeleton; GD: General discomfort; PTD: Perceived task difficulty; BMI: Body Mass Index [ABSTRACT FROM AUTHOR]
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- 2024
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3. Incorporating a Hands-On Device-Based Activity in a Human Factors Biomedical Engineering Course in Sub-Saharan Africa
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Vweza, Alick O, Mehta, Sara, Wettergreen, Matthew, and Saterbak, Ann
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- 2024
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4. Evaluating cognitive and physical work performance: A comparative study of an active and passive industrial back-support exoskeleton.
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Govaerts, Renée, Turcksin, Tom, Vanderborght, Bram, Roelands, Bart, Meeusen, Romain, De Pauw, Kevin, and De Bock, Sander
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ROBOTIC exoskeletons ,COGNITIVE ability ,PHYSICAL activity ,WORK-related injuries ,REACTION time - Abstract
Occupational back-support exoskeletons, categorized as active or passive, hold promise for mitigating work-related musculoskeletal disorders. However, their impact on combined physical and cognitive aspects of industrial work performance remains inadequately understood, especially regarding potential differences between exoskeleton categories. A randomized, counterbalanced cross-over study was conducted, comparing the active CrayX, passive Paexo Back, and a no exoskeleton condition. A 15-min dual task was used to simulate both cognitive and physical aspects of industrial work performance. Cognitive workload parameters included reaction time, accuracy, and subjective measures. Physical workload included movement duration, segmented in three phases: (1) walking to and grabbing the box, (2) picking up, carrying, and putting down the box, and (3) returning to the starting point. Comfort of both devices was also surveyed. The Paexo significantly increased movement duration in the first segment compared to NoExo (Paexo = 1.55 ± 0.19 s; NoExo = 1.32 ± 0.17 s; p < .01). Moreover, both the Paexo and CrayX increased movement duration for the third segment compared to NoExo (CrayX = 1.70 ± 0.27 s; Paexo = 1.74 ± 0.27 s, NoExo = 1.54 ± 0.23 s; p < .01). No significant impact on cognitive outcomes was observed. Movement Time 2 was not significantly affected by both exoskeletons. Results of the first movement segment suggest the Paexo may hinder trunk bending, favoring the active device for dynamic movements. Both devices may have contributed to a higher workload as the movement duration in the third segment increased compared to NoExo. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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- View/download PDF
5. Evaluating cognitive and physical work performance: A comparative study of an active and passive industrial back-support exoskeleton
- Author
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Renée Govaerts, Tom Turcksin, Bram Vanderborght, Bart Roelands, Romain Meeusen, Kevin De Pauw, and Sander De Bock
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Exoskeletons ,device evaluation ,human factors ,wearable assistive device ,Mechanical engineering and machinery ,TJ1-1570 ,Electronics ,TK7800-8360 - Abstract
Occupational back-support exoskeletons, categorized as active or passive, hold promise for mitigating work-related musculoskeletal disorders. However, their impact on combined physical and cognitive aspects of industrial work performance remains inadequately understood, especially regarding potential differences between exoskeleton categories. A randomized, counterbalanced cross-over study was conducted, comparing the active CrayX, passive Paexo Back, and a no exoskeleton condition. A 15-min dual task was used to simulate both cognitive and physical aspects of industrial work performance. Cognitive workload parameters included reaction time, accuracy, and subjective measures. Physical workload included movement duration, segmented in three phases: (1) walking to and grabbing the box, (2) picking up, carrying, and putting down the box, and (3) returning to the starting point. Comfort of both devices was also surveyed. The Paexo significantly increased movement duration in the first segment compared to NoExo (Paexo = 1.55 ± 0.19 s; NoExo = 1.32 ± 0.17 s; p
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- 2023
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6. An Occupational Shoulder Exoskeleton Reduces Muscle Activity and Fatigue During Overhead Work.
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De Bock, Sander, Rossini, Marco, Lefeber, Dirk, Rodriguez-Guerrero, Carlos, Geeroms, Joost, Meeusen, Romain, and De Pauw, Kevin
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ROBOTIC exoskeletons , *MUSCLE fatigue , *SHOULDER , *MUSCLE growth , *HEART beat , *ANIMAL exoskeletons - Abstract
Objective: This paper assesses the effect of a passive shoulder exoskeleton prototype, Exo4Work, on muscle activity, muscle fatigue and subjective experience during simulated occupational overhead and non-overhead work. Methods: Twenty-two healthy males performed six simulated industrial tasks with and without Exo4Work exoskeleton in a randomized counterbalanced cross-over design. During these tasks electromyography, heart rate, metabolic cost, subjective parameters and performance parameters were acquired. The effect of the exoskeleton and the body side on these parameters was investigated. Results: Anterior deltoid activity and fatigue reduced up to 16% and 41%, respectively, during isometric overhead work, and minimized hindrance of the device during non-overhead tasks. Wearing the exoskeleton increased feelings of frustration and increased discomfort in the areas where the exoskeleton and the body interfaced. The assistive effect of the exoskeleton was less prominent during dynamic tasks. Conclusion: This exoskeleton may reduce muscle activity and delay development of muscle fatigue in an overhead working scenario. For dynamic applications, the exoskeleton’s assistive profile, which mimics the gravitational torque of the arm, is potentially sub-optimal. Significance: This evaluation paper is the first to report reduced muscle fatigue and activity when working with an occupational shoulder exoskeleton providing one third of the gravitational torque of the arm during overhead work. These results stress the potential of occupational shoulder exoskeletons in overhead working situations and may direct towards longitudinal field experiments. Additionally, this experiment may stimulate future work to further investigate the effect of different assistive profiles. [ABSTRACT FROM AUTHOR]
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- 2022
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7. Development of a colonoscopy simulator for the evaluation of colonoscopy devices
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Pakleppa, Markus, Keatch, Robert, and Vorstius, Jan
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616.3 ,Colonoscopy ,Surgical technique ,Simulator ,Device evaluation ,Phantom ,Tissue mimicking material - Abstract
Colonoscopy is the current standard for colorectal cancer screening. This procedure requires improvement since it causes patient pain and can even result in injury. Novel colonoscopy devices have to be evaluated to gain information about their performance. At the preclinical stage of the device development the evaluation is typically performed in laboratory experiments. For these experiments an artificial environment is required which can recreate the anatomical and biomechanical features of the colon. A colonoscopy simulator for the evaluation of colonoscopy devices was developed within the ERC funded CoDIR project (Colonic Disease Investigation by Robotic Hydrocolonoscopy). The here developed simulator had to provide a colon phantom with realistic biomechanical properties as well as a sensor setup to measure signals which can be used to quantify the performance of devices which are tested within the simulator. Related literature was reviewed and possible tissue mimicking materials were selected. The suitability of the selected materials was evaluated by testing the frictional and elastic properties of the materials and subsequently comparing the results to those of colon tissue. PVA cryogel was selected as the most suitable material as it exhibits comparable elasticity and coefficients of friction. The tissue mimicking materials were mould casted into phantoms which were designed to represent the anatomical features of the colon. A simulator environment was developed which integrates the phantom as well as force and pressure sensors into a functional system. The sensors measure mesenteric forces and intraluminal pressures which can be related to the performance of tested devices. The simulator allows the arrangement of the sensors and the phantoms in an adjustable, modular approach. The simulator environment was successfully applied in the evaluation of a novel colonoscopy device. The results indicate that PVA cryogels exhibit unique mechanical properties which can be compared to those of colon tissue. The developed colonoscopy simulator provides a promising tool which can aid the development of novel colonoscopy devices.
- Published
- 2016
8. Prospective randomized evaluation of the sustained impact of assistive artificial intelligence on anesthetists' ultrasound scanning for regional anesthesia.
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Kowa CY, Morecroft M, Macfarlane AJR, Burckett-St Laurent D, Pawa A, West S, Margetts S, Haslam N, Ashken T, Sebastian MP, Thottungal A, Womack J, Noble JA, Higham H, and Bowness JS
- Abstract
Objectives: Ultrasound-guided regional anesthesia (UGRA) relies on acquiring and interpreting an appropriate view of sonoanatomy. Artificial intelligence (AI) has the potential to aid this by applying a color overlay to key sonoanatomical structures.The primary aim was to determine whether an AI-generated color overlay was associated with a difference in participants' ability to identify an appropriate block view over a 2-month period after a standardized teaching session (as judged by a blinded assessor). Secondary outcomes included the ability to identify an appropriate block view (unblinded assessor), global rating score and participant confidence scores., Design: Randomized, partially blinded, prospective cross-over study., Setting: Simulation scans on healthy volunteers. Initial assessments on 29 November 2022 and 30 November 2022, with follow-up on 25 January 2023 - 27 January 2023., Participants: 57 junior anesthetists undertook initial assessments and 51 (89.47%) returned at 2 months., Intervention: Participants performed ultrasound scans for six peripheral nerve blocks, with AI assistance randomized to half of the blocks. Cross-over assignment was employed for 2 months., Main Outcome Measures: Blinded experts assessed whether the block view acquired was acceptable (yes/no). Unblinded experts also assessed this parameter and provided a global performance rating (0-100). Participants reported scan confidence (0-100)., Results: AI assistance was associated with a higher rate of appropriate block view acquisition in both blinded and unblinded assessments (p=0.02 and <0.01, respectively). Participant confidence and expert rating scores were superior throughout (all p<0.01)., Conclusions: Assistive AI was associated with superior ultrasound scanning performance 2 months after formal teaching. It may aid application of sonoanatomical knowledge and skills gained in teaching, to support delivery of UGRA beyond the immediate post-teaching period., Trial Registration Number: www.clinicaltrials.govNCT05583032., Competing Interests: JSB is a Senior Clinical Advisor for GE Healthcare (and previously Intelligent Ultrasound, receiving research funding and honoraria). MM was employed by Intelligent Ultrasound as a medical writer during this study. DBSL is a clinical advisor for Intelligent Ultrasound, receiving honoraria. NH is the President of Regional Anaesthesia UK. AJRM is the immediate Past-President of Regional Anaesthesia UK and has received honoraria from Intelligent Ultrasound and GE Healthcare. AP is a Past-President of Regional Anaesthesia UK, has received honoraria from GE Healthcare and has consulted for Pacira Biosciences. TA, MPS, AT and JW are board members of Regional Anaesthesia UK. JAN is a senior scientific advisor for Intelligent Ultrasound., (Copyright © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2024
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9. Mobility Technologies for Blind, Partially Sighted and Deafblind People: Design Issues
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Hersh, M. A., Pissaloux, Edwige, editor, and Velazquez, Ramiro, editor
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- 2018
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10. No frugal innovation without frugal evaluation: the Global IDEAL Sub-Framework.
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Bolton WS, Aruparayil NK, Cundill B, McCulloch P, Gnanaraj J, Bundu I, Culmer PR, Brown JM, Scott J, and Jayne DG
- Abstract
Objective: The Global IDEAL Sub-Framework Study aimed to combine the intended effects of the 2009/2019 IDEAL (Idea, Development, Exploration, Assessment, Long-term study) Framework recommendations on evaluating surgical innovation with the vision outlined by the 2015 Lancet Commission on Global Surgery to provide recommendations for evaluating surgical innovation in low-resource environments., Design: A mixture of methods including an online global survey and semistructured interviews (SSIs). Quantitative data were summarized with descriptive statistics and qualitative data were analyzed using the Framework Method., Participants: Surgeons and surgical researchers from any country., Main Outcome Measures: Findings were used to suggest the nature of adaptations to the IDEAL Framework to address the particular problems of evaluation in low-resource settings., Results: The online survey yielded 66 responses representing experience from 40 countries, and nine individual SSIs were conducted. Most respondents (n=49; 74.2%) had experience evaluating surgical technologies across a range of life cycle stages. Innovation was most frequently adopted based on colleague recommendation or clinical evaluation in other countries. Four themes emerged, centered around: frugal innovation in technological development; evaluating the same technology/innovation in different contexts; additional methodologies important in evaluation of surgical innovation in low/middle-income countries; and support for low-income country researchers along the evaluation pathway., Conclusions: The Global IDEAL Sub-Framework provides suggestions for modified IDEAL recommendations aimed at dealing with the special problems found in this setting. These will require validation in a stakeholder consensus forum, and qualitative assessment in pilot studies. From assisting researchers with identification of the correct evaluation stage, to providing context-specific recommendations relevant to the whole evaluation pathway, this process will aim to develop a comprehensive and applicable set of guidance that will benefit surgical innovation and patients globally., Competing Interests: Competing interests: PM is an editor-in-chief., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)
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- 2024
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11. New robotic platform for transoral robotic surgery: an IDEAL stage 0 study.
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Arora A, Faulkner J, Paleri V, Kapoor K, Al-Lami A, Olaleye O, Winter S, Oikonomou G, Ofo E, Ourselin S, Dasgupta P, Slack M, and Jeannon JP
- Abstract
Objectives: This study aims to assess the feasibility to perform transoral robotic surgery (TORS) with a new robotic platform, the Versius Surgical System (CMR Surgical, UK) in a preclinical cadaveric setting in accordance to stage 0 of the IDEAL-D framework., Design: IDEAL stage 0 preclinical assessment of the Versius Robotic System in TORS in human cadavers., Setting: All procedures were performed in a simulated operating theatre environment at a UK surgical training centre., Participants: 11 consultant head and neck surgeons from the UK, mainland Europe and the USA took part in TORS procedures on six human cadavers., Interventions: 3 key index procedures were assessed that represent the core surgical workload of TORS: lateral oropharyngectomy, tongue base resection and partial supraglottic laryngectomy., Main Outcome Measures: The primary outcome was the successful completion of each surgical procedure. Secondary outcomes included the optimisation of system setup, instrumentation and surgeon-reported outcomes for feasibility of each component procedural step., Results: 33 cadaveric procedures were performed and 32 were successfully completed. One supraglottic laryngectomy was not fully completed due to issues dividing the epiglottic cartilage with available instrumentation. Surgeon-reported outcomes met the minimal level of feasibility in all procedures and a consensus that it is feasible to perform TORS with Versius was reached. Available instrumentation was not representative of other robotic platforms used in TORS and further instrument optimisation is recommended before wider dissemination., Conclusions: It is feasible to perform TORS with the Versius Surgical System (CMR Surgical) within a pre-clinical cadaveric setting. Clinical evaluation is needed and appropriate with the system. Further instrument development and optimisation is desirable., Competing Interests: Competing interests: This study was funded by CMR Surgical Ltd. including providing access to laboratory space, cadavers and the robotic system. Mark Slack is a co-founder and current chief medical officer of CMR Surgical., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2024
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12. An assessment of introducers used for airway management
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P Carter, M Alderman, P. Phillips, L Price, Antony Robert Wilkes, G Hughes, Iljaz Hodzovic, and V Varadarajan
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Protocol (science) ,medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Tracheal intubation ,Equipment Design ,Airway devices ,Manikins ,Trachea ,DEVICE EVALUATION ,Anesthesiology and Pain Medicine ,Surveys and Questionnaires ,Clinical investigation ,Emergency medicine ,Anesthetists ,Intubation, Intratracheal ,medicine ,Humans ,Intubation ,Airway management ,Clinical Competence ,Airway Management ,business ,Airway - Abstract
Different introducers are available to assist with tracheal intubation. Subtle differences in the design of introducers can have a marked effect on safety and performance. The Difficult Airway Society's Airway Device Evaluation Project Team proposal states that devices should only be purchased for which there is at least a case-control study on patients assessing airway devices. However, resources are not currently available to carry out a case-control study on all introducers available on the market. This study comprised a laboratory and manikin-based investigation to identify introducers that could be suitable for clinical investigation. We included six different introducers in laboratory-based assessments (design characteristics) and manikin-based assessments involving the participation of 30 anaesthetists. Each anaesthetist attempted placement in the manikin's trachea with each of the six introducers in a random order. Outcomes included first-time insertion success rate; insertion success rate; number of attempts; time to placement; and distance placed. Each anaesthetist also completed a questionnaire. First-time insertion success rate depended significantly on the introducer used (p = 0.0016) and varied from 47% (Armstrong and P3) to 77% (Intersurgical and Frova). Median time to placement (including oesophageal placement) varied from 10 s (Eschmann and Frova) to 20 s (P3) (p = 0.0025). Median time to successful placement in the trachea varied from 9 s (Frova) to 22 s (Armstrong) (p = 0.037). We found that the Armstrong and P3 devices were not as acceptable as other introducers and, without significant improvements to their design and characteristics, the use of these devices in studies on patients is questionable. The study protocol is suitable for differentiating between different introducers and could be used as a basis for assessing other types of devices.
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- 2021
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13. Evaluation of a device to improve non-coring needle insertion into implanted intravenous ports.
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Barton, Andrew, Pamment, Keith, and Fitzpatrick, Dennis
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INTRAVENOUS therapy , *ARTERIAL catheterization , *SHARPS (Medical instruments) , *PATIENT satisfaction , *NURSES' attitudes , *EQUIPMENT & supplies - Abstract
Implanted intravenous ports (IPs) are increasingly used in health care. The experience of having IPs accessed can vary a great deal for patients. Successful IP access depends on the experience and skill of the health professional and wrongly positioned attempts are not only painful for the patient but can also cause damage to the outer casing of the IP. The more skin punctures made over the port, the higher the risk of infection in the subcutaneous tissue. The Portacator is a sterile, single-use product that sits on the skin over the IP insertion site. Its purpose is to enable the successful insertion of a non-coring needle into the centre of the IP. The device's efficacy was investigated using a port test rig and by conducting a clinical evaluation in two hospital units that support patients with IPs who require regular IV therapy infusions for long-term illness. The device provides an easy reference for central non-coring needle insertion, and users were able to insert the needle closer to the port chamber centre when using the device as only two fingers are used to hold it in place, which gave them a less obstructed view of the site. The device improved the rates of first-time IP puncture success with a non-coring needle. Patient satisfaction increased as they were more confident insertion would be successful first time so they would experience less pain. Nurses felt better supported and more confident they could achieve success at their first attempt at IP access using the device. [ABSTRACT FROM AUTHOR]
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- 2018
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14. Infusion Pumps: Usership and the Governance of Error
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Clécia, Mara, Souza, Dantas, and Faulkner, Alex
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- 2009
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15. Planarized Nb 4-Layer Fabrication Process for Superconducting Integrated Circuits and Its Fabricated Device Evaluation
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Naoki Takeuchi, Shuichi Nagasawa, Masamitsu Tanaka, Koki Yamazaki, Naonori Sega, Akira Fujimaki, Shigeyuki Miyajima, Hirotaka Terai, Nobuyuki Yoshikawa, Hiroaki Myoren, Yuki Yamanashi, Yuta Somei, Fumihiro China, Yoshinao Mizugaki, Taiki Yamae, and Mutsuo Hidaka
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DEVICE EVALUATION ,Fabrication ,Materials science ,business.industry ,Process (computing) ,Optoelectronics ,Electrical and Electronic Engineering ,business ,Superconducting integrated circuits ,Layer (electronics) ,Electronic, Optical and Magnetic Materials - Published
- 2021
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16. An Occupational Shoulder Exoskeleton Reduces Muscle Activity and Fatigue During Overhead Work
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Sander De Bock, Marco Rossini, Dirk Lefeber, Carlos Rodriguez-Guerrero, Joost Geeroms, Romain Meeusen, Kevin De Pauw, Physiotherapy, Human Physiology and Anatomy, Human Physiology and Sports Physiotherapy Research Group, Faculty of Physical Education and Physical Therapy, Faculty of Engineering, Applied Mechanics, Rectorate, and International Relations and Mobility
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Male ,Technology ,Shoulder ,electromyography ,Device evaluation ,wearable robotics ,Biomedical Engineering ,Exoskeletons ,Engineering ,DESIGN ,Humans ,industrial work ,UPPER-LIMB EXOSKELETON ,ASSISTANCE ,Muscle, Skeletal ,Engineering, Biomedical ,Fatigue ,Cross-Over Studies ,Science & Technology ,Electromyography ,Muscles ,Exoskeleton Device ,Biomechanical Phenomena ,Torque ,ergonomics ,Muscle Fatigue ,Task analysis ,MUSCULOSKELETAL DISORDERS - Abstract
OBJECTIVE: This paper assesses the effect of a passive shoulder exoskeleton prototype, Exo4Work, on muscle activity, muscle fatigue and subjective experience during simulated occupational overhead and non-overhead work. METHODS: Twenty-two healthy males performed six simulated industrial tasks with and without Exo4Work exoskeleton in a randomized counterbalanced cross-over design. During these tasks electromyography, heart rate, metabolic cost, subjective parameters and performance parameters were acquired. The effect of the exoskeleton and the body side on these parameters was investigated. RESULTS: Anterior deltoid activity and fatigue reduced up to 16% and 41%, respectively, during isometric overhead work, and minimized hindrance of the device during non-overhead tasks. Wearing the exoskeleton increased feelings of frustration and increased discomfort in the areas where the exoskeleton and the body interfaced. The assistive effect of the exoskeleton was less prominent during dynamic tasks. CONCLUSION: This exoskeleton may reduce muscle activity and delay development of muscle fatigue in an overhead working scenario. For dynamic applications, the exoskeleton's assistive profile, which mimics the gravitational torque of the arm, is potentially sub-optimal. SIGNIFICANCE: This evaluation paper is the first to report reduced muscle fatigue and activity when working with an occupational shoulder exoskeleton providing one third of the gravitational torque of the arm during overhead work. These results stress the potential of occupational shoulder exoskeletons in overhead working situations and may direct towards longitudinal field experiments. Additionally, this experiment may stimulate future work to further investigate the effect of different assistive profiles. ispartof: IEEE TRANSACTIONS ON BIOMEDICAL ENGINEERING vol:69 issue:10 pages:3008-3020 ispartof: location:United States status: published
- Published
- 2022
17. A Comprehensive Review on Tunnel Field-Effect Transistor (TFET) Based Biosensors: Recent Advances and Future Prospects on Device Structure and Sensitivity
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Nelaturi Nagendra Reddy and DEEPAK KUMAR PANDA
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010302 applied physics ,Review Paper ,Materials science ,Tunneling ,Human life ,Response time ,02 engineering and technology ,021001 nanoscience & nanotechnology ,Tunnel field-effect transistor ,01 natural sciences ,Electronic, Optical and Magnetic Materials ,Nanowire ,DEVICE EVALUATION ,Sensitivity ,TFET ,Subthreshold swing ,0103 physical sciences ,Electronic engineering ,Sensitivity (control systems) ,0210 nano-technology ,Biosensor ,Cmos compatible - Abstract
In this fast-growing technological world biosensors become more substantial in human life and the extensive use of biosensors creates enormous research interest among researchers to define different approaches to detect biomolecules. The FET based biosensors have gained a lot of attention among all because of its high detection ability, low power, low cost, label-free detection of biomolecules, and CMOS compatible on-chip integration. The sensitivity of the biosensor inversely proportional to device size since they detect low concentration yields quick response time. Although FET based biosensor is having a lot of advantages among others but the short channel effects (SCE’s) and the theoretical limitation on the subthreshold swing (SS > 60mv/dec) of the FET leads to restrict device sensitivity and also have higher power dissipation due to the thermionic emission of electrons. To avoid these problems researchers focus shifts to the new technology FET based biosensors i.e. TFET based biosensors which are having low power and superior characteristics due to Band to band tunneling of carrier and steep subthreshold swing. This manuscript describes the full-fledged detail about the TFET based biosensors right from unfolding the device evaluation to biosensor application which includes qualitative and quantitative parameters analysis study like sensitivity parameters and different factors affecting the sensitivity by comparing different structures and the mechanisms involved. The manuscript also describes a brief review of different sensitivity parameters and improvement techniques. This manuscript will give researchers a brief idea for developing for the future generation TFET biosensors with better performance and ease of fabrication.
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- 2020
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18. Regulatory Requirements for Clinical Trials of Medical Devices and Diagnostics
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Segal, Sharon A. and Witkin, Karen Becker, editor
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- 1998
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19. Feasibility of using real-world data in the evaluation of cardiac ablation catheters: a test-case of the National Evaluation System for Health Technology Coordinating Center
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Sanket S Dhruva, Guoqian Jiang, Amit A Doshi, Daniel J Friedman, Eric Brandt, Jiajing Chen, Joseph G Akar, Joseph S Ross, Keondae R Ervin, Kimberly Collison Farr, Nilay D Shah, Paul Coplan, Peter A. Noseworthy, Shumin Zhang, Thomas Forsyth, Wade L Schulz, Yue Yu, and Joseph P Drozda, Jr.
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Biomedical Engineering ,cardiac devices ,device evaluation ,Surgery ,real world evidence ,Original Research - Abstract
ObjectivesTo determine the feasibility of using real-world data to assess the safety and effectiveness of two cardiac ablation catheters for the treatment of persistent atrial fibrillation and ischaemic ventricular tachycardia.DesignRetrospective cohort.SettingThree health systems in the USA.ParticipantsPatients receiving ablation with the two ablation catheters of interest at any of the three health systems.Main outcome measuresFeasibility of identifying the medical devices and participant populations of interest as well as the duration of follow-up and positive predictive values (PPVs) for serious safety (ischaemic stroke, acute heart failure and cardiac tamponade) and effectiveness (arrhythmia-related hospitalisation) clinical outcomes of interest compared with manual chart validation by clinicians.ResultsOverall, the catheter of interest for treatment of persistent atrial fibrillation was used for 4280 ablations and the catheter of interest for ischaemic ventricular tachycardia was used 1516 times across the data available within the three health systems. The duration of patient follow-up in the three health systems ranged from 91% to 97% at ≥7 days, 89% to 96% at ≥30 days, 77% to 90% at ≥6 months and 66% to 84% at ≥1 year. PPVs were 63.4% for ischaemic stroke, 96.4% for acute heart failure, 100% at one health system for cardiac tamponade and 55.7% for arrhythmia-related hospitalisation.ConclusionsIt is feasible to use real-world health system data to evaluate the safety and effectiveness of cardiac ablation catheters, though evaluations must consider the implications of variation in follow-up and endpoint ascertainment among health systems.
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- 2021
20. Passive shoulder exoskeleton support partially mitigates fatigue-induced effects in overhead work
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Sander De Bock, Toon Ampe, Marco Rossini, Bruno Tassignon, Dirk Lefeber, Carlos Rodriguez-Guerrero, Bart Roelands, Joost Geeroms, Romain Meeusen, Kevin De Pauw, Human Physiology and Sports Physiotherapy Research Group, Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education and Physical Therapy, Faculty of Engineering, Rectorate, Applied Mechanics, and International Relations and Mobility
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Shoulder ,Technology ,MUSCLE FATIGUE ,Device evaluation ,DISORDERS ,Social Sciences ,Physical Therapy, Sports Therapy and Rehabilitation ,Human Factors and Ergonomics ,IMPEDANCE CONTROL ,MECHANISMS ,Upper Extremity ,MOVEMENT ,Engineering ,Humans ,Psychology ,POSITION ,Safety, Risk, Reliability and Quality ,Physical fatigue ,Engineering (miscellaneous) ,COORDINATION ,Cross-Over Studies ,Science & Technology ,Electromyography ,Wearable assistive device ,Exoskeleton Device ,KINEMATIC PATTERNS ,Muscle Fatigue ,Engineering, Industrial ,Task analysis ,RELIABILITY ,ADAPTATIONS ,Ergonomics ,Psychology, Applied - Abstract
BACKGROUND: Despite the potential of occupational passive shoulder exoskeletons (PSEs) to relieve overhead work, limited insights in overhead work precision performance impedes large-scale adoption in industry. OBJECTIVE: To investigate the effect of PSE support on the reduction in task performance caused by physical fatigue. METHODS: This experiment consisted of a randomized, counterbalanced cross-over design comparing Exo4Work PSE support and no support, in a physically fatigued state and a control condition. Precision performance was determined using execution speed and drilling errors. Muscle activity and shoulder joint kinematics were recorded. RESULTS: Fatigue altered task performance, shoulder joint kinematics, muscle activity and subjective experience during overhead work. The PSE support mitigated the fatigue-induced changes in shoulder kinematics. Additionally, a part of the fatigue-induced co-activation of shoulder stabilizing muscles was avoided when working with the PSE. The PSE support also reduced the activity of the anterior and medial deltoid. CONCLUSION: Physical fatigue provokes compensatory movements and increased co-contraction of muscles when executing overhead work. These fatigue-induced alterations are generally believed to increase the overall musculoskeletal load. The support provided by the PSE reduced muscle activity of muscles working to elevate the arm, but also partially mitigated those fatigue-induced effects. SIGNIFICANCE: This study shows that the effect of PSE support on precision performance is limited, and suggested that, apart from the known effects of PSE support during overhead work, wearing the exoskeleton in a physically fatigued state may provide additional advantages. ispartof: APPLIED ERGONOMICS vol:106 ispartof: location:England status: published
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- 2023
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21. Assessing the development status of intraoperative fluorescence imaging for perfusion assessments, using the IDEAL framework
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Yasuo Murai, Giovanni Dapri, Eric Vibert, Ronan A. Cahill, Charles Sabbagh, Ory Wiesel, Antonino Spinelli, Luigi Boni, Michele Diana, Elisa Cassinotti, Mahmoud Abu-Gazala, Michael Bouvet, Kiyoshi Hasegawa, Raul J. Rosenthal, Derek D. Muehrcke, Frédéric Ris, Michele Carvello, Thomas Carus, Muga Terasawa, Norihiro Kokudo, Sylke Schneider-Koriath, Peter McCulloch, Mikiya Takao, Kevin P. White, Rutger M. Schols, Steven D. Wexner, Fumihiro Matano, Fernando Dip, Takeaki Ishizawa, Tim Pruimboom, RS: NUTRIM - R2 - Liver and digestive health, MUMC+: MA AIOS Plastische Chirurgie (9), Plastische Chirurgie (PLC), and RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy
- Subjects
medicine.medical_specialty ,Reconstructive surgery ,RD1-811 ,Biomedical Engineering ,law.invention ,chemistry.chemical_compound ,Randomized controlled trial ,law ,Medical technology ,Medicine ,R855-855.5 ,Stage (cooking) ,Adverse effect ,health technology ,Original Research ,Ideal (set theory) ,business.industry ,device evaluation ,Colorectal surgery ,development study ,chemistry ,Surgery ,Radiology ,business ,Perfusion ,Indocyanine green - Abstract
ObjectivesIntraoperative fluorescence imaging is currently used in a variety of surgical fields for four main purposes: assessing tissue perfusion; identifying/localizing cancer; mapping lymphatic systems; and visualizing anatomy. To establish evidence-based guidance for research and practice, understanding the state of research on fluorescence imaging in different surgical fields is needed. We evaluated the evidence on fluorescence imaging for perfusion assessments using the Idea, Development,Exploration, Assessment, Long Term Study (IDEAL) framework, which was designed for describing the stages of innovation in surgery and other interventional procedures.DesignNarrative literature review with analysis of IDEAL stage of each field of study.SettingAll publications on intraoperative fluorescence imaging for perfusion assessments reported in PubMed through 2019 were identified for six surgical procedures: coronary artery bypass grafting (CABG), upper gastrointestinal (GI) surgery, colorectal surgery, solid organ transplantation, reconstructive surgery, and cerebral aneurysm surgery.Main outcome measuresThe IDEAL stage of research evidence was determined for each specialty field using a previously described approach.Results196 articles (15 003 cases) were selected for analysis. Current status of research evidence was determined to be IDEAL Stage 2a for upper GI and transplantation surgery, IDEAL 2b for CABG, colorectal and cerebral aneurysm surgery, and IDEAL Stage 3 for reconstructive surgery. Using the technique resulted in a high (up to 50%) rate of revisions among surgical procedures, but its efficacy improving postoperative outcomes has not yet been demonstrated by randomized controlled trials in any discipline. Only one possible adverse reaction to intravenous indocyanine green was reported.ConclusionsUsing fluorescence imaging intraoperatively to assess perfusion is feasible and appears useful for surgical decision making across a range of disciplines. Identifying the IDEAL stage of current research knowledge aids in planning further studies to establish the potential for patient benefit.
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- 2021
22. Preliminary evaluation of YUTIQ™ (fluocinolone acetonide intravitreal implant 0.18 mg) in posterior uveitis
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Carlos Pavesio and Ilaria Testi
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medicine.medical_specialty ,Intravitreal implant ,Pharmaceutical Science ,030226 pharmacology & pharmacy ,03 medical and health sciences ,Infectious uveitis ,0302 clinical medicine ,Fluocinolone acetonide ,Ophthalmology ,Device Evaluation ,medicine ,Humans ,Glucocorticoids ,Randomized Controlled Trials as Topic ,Drug Implants ,Dose-Response Relationship, Drug ,business.industry ,Uveitis, Posterior ,medicine.disease ,Drug Liberation ,Treatment Outcome ,Clinical Trials, Phase III as Topic ,Fluocinolone Acetonide ,Posterior uveitis ,Delayed-Action Preparations ,Chronic Disease ,030221 ophthalmology & optometry ,business ,Uveitis ,medicine.drug - Abstract
Uveitis is a major cause of ocular morbidity, potentially leading to significant visual impairment. The recent adoption of alternative drug delivery options has led to the development of new sustained-delivery corticosteroid systems, able to manage successfully chronic noninfectious posterior uveitis. The treatment goal is to target the site of inflammation with low dose of corticosteroids, delivered over an extended period of time, to minimize the cumulative damage resulting from repeated recurrences, reducing both injections frequency and ocular side effects. This article will review the pharmacology and preliminary clinical data of the 0.18 mg fluocinolone acetonide intravitreal implant (YUTIQ™), to show its efficacy and safety in the treatment of noninfectious posterior uveitis.
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- 2019
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23. Assessing the development status of intraoperative fluorescence imaging for perfusion assessments, using the IDEAL framework
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Ishizawa, Takeaki, McCulloch, Peter, Muehrcke, Derek, Carus, Thomas, Wiesel, Ory, Dapri, Giovanni, Schneider-Koriath, Sylke, Wexner, Steven S.D., Abu-Gazala, Mahmoud, Boni, Luigi, Cassinotti, Elisa, Sabbagh, Charles, Cahill, Ronan, Ris, Frederic, Carvello, Michele, Spinelli, Antonino, Vibert, Eric, Terasawa, Muga, Takao, Mikiya, Hasegawa, Kiyoshi, Schols, Rutger Merlijn, Pruimboom, Tim, Murai, Yasuo, Matano, Fumihiro, Bouvet, Michael, Diana, Michele, Kokudo, Norihiro, Dip, Fernando, White, Kevin, Rosenthal, Raúl Jacobo, Ishizawa, Takeaki, McCulloch, Peter, Muehrcke, Derek, Carus, Thomas, Wiesel, Ory, Dapri, Giovanni, Schneider-Koriath, Sylke, Wexner, Steven S.D., Abu-Gazala, Mahmoud, Boni, Luigi, Cassinotti, Elisa, Sabbagh, Charles, Cahill, Ronan, Ris, Frederic, Carvello, Michele, Spinelli, Antonino, Vibert, Eric, Terasawa, Muga, Takao, Mikiya, Hasegawa, Kiyoshi, Schols, Rutger Merlijn, Pruimboom, Tim, Murai, Yasuo, Matano, Fumihiro, Bouvet, Michael, Diana, Michele, Kokudo, Norihiro, Dip, Fernando, White, Kevin, and Rosenthal, Raúl Jacobo
- Abstract
Intraoperative fluorescence imaging is currently used in a variety of surgical fields for four main purposes: assessing tissue perfusion; identifying/localizing cancer; mapping lymphatic systems; and visualizing anatomy. To establish evidence-based guidance for research and practice, understanding the state of research on fluorescence imaging in different surgical fields is needed. We evaluated the evidence on fluorescence imaging for perfusion assessments using the Idea, Development,Exploration, Assessment, Long Term Study (IDEAL) framework, which was designed for describing the stages of innovation in surgery and other interventional procedures. Narrative literature review with analysis of IDEAL stage of each field of study. All publications on intraoperative fluorescence imaging for perfusion assessments reported in PubMed through 2019 were identified for six surgical procedures: coronary artery bypass grafting (CABG), upper gastrointestinal (GI) surgery, colorectal surgery, solid organ transplantation, reconstructive surgery, and cerebral aneurysm surgery. The IDEAL stage of research evidence was determined for each specialty field using a previously described approach. 196 articles (15 003 cases) were selected for analysis. Current status of research evidence was determined to be IDEAL Stage 2a for upper GI and transplantation surgery, IDEAL 2b for CABG, colorectal and cerebral aneurysm surgery, and IDEAL Stage 3 for reconstructive surgery. Using the technique resulted in a high (up to 50%) rate of revisions among surgical procedures, but its efficacy improving postoperative outcomes has not yet been demonstrated by randomized controlled trials in any discipline. Only one possible adverse reaction to intravenous indocyanine green was reported. Using fluorescence imaging intraoperatively to assess perfusion is feasible and appears useful for surgical decision making across a range of disciplines. Identifying the IDEAL stage of current research knowledge aids in, SCOPUS: ar.j, DecretOANoAutActif, info:eu-repo/semantics/published
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- 2021
24. Ferroelectric thin film for a capacitor-type synapse in neuromorphic systems
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Mutsumi Kimura, Eisuke Tokumitsu, Daiki Matsukawa, Hiroki Umemura, and Yuma Ishisaki
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Materials science ,business.industry ,law.invention ,Synapse ,DEVICE EVALUATION ,Capacitor ,Neuromorphic engineering ,Power demand ,Power consumption ,law ,Ferroelectric thin films ,Optoelectronics ,Biosimulation ,business - Abstract
The neuromorphic system is a hardware-level biosimulation system that implements neuron and synaptic elements. It has the same advantages as the human brain, such as low power consumption and small size. We proposed the synapse consisting of a memcapacitor for low power consumption. In this study, we created a capacitor-type synapses with ferroelectric thin films. Electrical characteristics were measured as a device evaluation, and they showed usefulness as a synapse. It is expected that if character correction learning is performed using the capacitor-type synapses, the modified pattern will match the memorized pattern, indicating successful training.
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- 2021
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25. Can a Novel Passive Shoulder Exoskeleton Reduce Shoulder Muscle Fatigue During Overhead Work?
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Sander De Bock, Marco Rossini, Carlos Rodriguez-Guerrero, Joost Geeroms, Romain Meeusen, Kevin De Pauw, Human Physiology and Sports Physiotherapy Research Group, Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education and Physical Therapy, Faculty of Engineering, Applied Mechanics, and International Relations and Mobility
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ergonomics ,device evaluation ,muscle fatigue ,Shoulder exosqueleton ,overhead work - Published
- 2021
26. Pathway map development for medical device event reporting in operating theatres: a human factors approach to improving the existing system.
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Tase A, Micocci M, Buckle P, Ni M, and Hanna G
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Objectives: This study aimed to develop the actual pathway to reporting and information transfer in operating theatres in relation to medical technology malfunction/failure. This with the aim of understanding the differences with the pathway published by NHS Improvement and identification of points for improvement., Design: This is a qualitative study involving stakeholder interviews with doctors, nurses, manufacturers, medical device safety officer and Medicines and Healthcare products Regulatory Agency., Setting: Data were collected on reporting pathway used in operating theatres. Clinical staff who took part worked in different trusts throughout UK while manufacturers provided devices in UK and EU/USA., Participants: Semistructured interviews were completed with 15 clinicians and 13 manufacturers. Surveys were completed by 38 clinicians and 5 manufacturers. Recognised methods of pathway development were used. The Lean Six Sigma principles adapted to healthcare were used to develop suggestions for improvement., Main Outcome Measures: To identify the differences between the set pathway to reporting and information transfer to what is occurring on a day-to-day basis as reported by staff. Identify points in the pathway where improvements could be applied., Results: The developed pathway demonstrated great complexity of the current reporting system for medical devices. It identified numerous areas that give rise to problems and multiple biases in decision making. This highlighted the core issues leading to under-reporting and lack of knowledge on device performance and patient risk. Suggestions for improvement were deduced based on end user requirements and identified problems., Conclusions: This study has provided a detailed understanding of the key problem areas that exist within the current reporting system for medical devices and technology. The developed pathway sets to address the key problems to improve reporting outcomes. The identification of pathway differences between 'work as done' and 'work as imagined' can lead to development of quality improvements that could be systematically applied., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2023
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27. Estimate and reporting of longevity for cardiac implantable electronic devices: a proposal for standardized criteria
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Massimo Zoni Berisso, Eugenio Mattei, Giuseppe Boriani, Renato Pietro Ricci, Giovanni Calcagnini, Maurizio Landolina, and Federica Censi
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medicine.medical_specialty ,media_common.quotation_subject ,medicine.medical_treatment ,Electric Countershock ,Biomedical Engineering ,Cardiac resynchronization therapy ,Clinical settings ,standardized criteria ,programming ,Implantable defibrillators ,Cardiac Resynchronization Therapy ,DEVICE EVALUATION ,longevity ,Humans ,Medicine ,Medical physics ,Cardiac Resynchronization Therapy Devices ,Electronics ,implantable cardioverter-defibrillators ,remote monitoring ,media_common ,business.industry ,Cardiac implantable electronic device ,Longevity ,Patient survival ,General Medicine ,pacemaker ,Defibrillators, Implantable ,Cardiac resynchronization ,Surgery ,business - Abstract
BACKGROUND Cardiac implantable electronic devices (CIEDs) are widely used according to consensus guidelines in various patient categories. The longevity of CIED is a major determinant of the frequency with which patients require device replacement. Given the mismatch between the useful life of the devices and patient survival, device replacement is often needed. There is a great variability in the criteria used by manufacturers to determine the longevity of pacemakers (PM), implantable defibrillators (ICDs) and devices for cardiac resynchronization therapy (CRT). Thus a fair comparison and an effective device evaluation is often difficult. METHODS The objective of this paper is to provide standardized criteria based on typical clinical settings for estimating the longevity of single and dual chamber ICDs, cardiac resynchronization defibrillators (CRT-D), single and dual chamber PMs and cardiac resynchronization PMs (CRT- P) to be used in heath technology assessment for an appropriate comparison among different devices. RESULTS The proposed parameters, if applied to the current marketed devices, provide longevity values in the range 5-17.2 years. CONCLUSION The values of longevity with the non-standardized criteria used by the manufacturers result in higher maximum values respect to the proposed standardized criteria for CRT-D, CRTD-MPP, CRT-P and Dual-chamber PM.
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- 2021
28. Exploring unique device identifier implementation and use for real-world evidence: a mixed-methods study with NESTcc health system network collaborators.
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Dhruva SS, Ridgeway JL, Ross JS, Drozda JP Jr, and Wilson NA
- Abstract
Objectives: To examine the current state of unique device identifier (UDI) implementation, including barriers and facilitators, among eight health systems participating in a research network committed to real-world evidence (RWE) generation for medical devices., Design: Mixed methods, including a structured survey and semistructured interviews., Setting: Eight health systems participating in the National Evaluation System for health Technology research network within the USA., Participants: Individuals identified as being involved in or knowledgeable about UDI implementation or medical device identification from supply chain, information technology and high-volume procedural area(s) in their health system., Main Outcomes Measures: Interview topics were related to UDI implementation, including barriers and facilitators; UDI use; benefits of UDI adoption; and vision for UDI implementation. Data were analysed using directed content analysis, drawing on prior conceptual models of UDI implementation and the Exploration, Preparation, Implementation, Sustainment framework. A brief survey of health system characteristics and scope of UDI implementation was also conducted., Results: Thirty-five individuals completed interviews. Three of eight health systems reported having implemented UDI. Themes identified about barriers and facilitators to UDI implementation included knowledge of the UDI and its benefits among decision-makers; organisational systems, culture and networks that support technology and workflow changes; and external factors such as policy mandates and technology. A final theme focused on the availability of UDIs for RWE; lack of availability significantly hindered RWE studies on medical devices., Conclusions: UDI adoption within health systems requires knowledge of and impetus to achieve operational and clinical benefits. These are necessary to support UDI availability for medical device safety and effectiveness studies and RWE generation., Competing Interests: Competing interests: SSD receives research support from the Medical Device Innovation Consortium (MDIC) as part of the National Evaluation System for health Technology Coordinating Center (NESTcc), Greenwall Foundation, National Institute for Health Care Management, Arnold Ventures and Department of Veterans Affairs. JSR currently receives research support through Yale University from Johnson & Johnson to develop methods of clinical trial data sharing, from the MDIC as part of the NESTcc, from the Food and Drug Administration for the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) programme (U01FD005938), from the Agency for Healthcare Research and Quality (R01HS022882), from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R01HS025164, R01HL144644), and from the Laura and John Arnold Foundation to establish the Good Pharma Scorecard at Bioethics International; in addition, JSR is an expert witness at the request of Relator’s attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen. JPD has received research support from Medtronic and Johnson & Johnson. His non-dependent son is an employee of Boston Scientific. NAW has received research support from the MDIC as part of the NESTcc, Patient-Centered Outcomes Research Institute, U.S. Food and Drug Administration, Johnson & Johnson, and Medtronic; serves on advisory committees for the AIM North America UDI Advisory Committee, Association for Health Care Resource reports consulting for Arizona State University’s Center for Healthcare Delivery and Policy, Mass General Brigham; and had purchased stock options in Vitreos Health. The remaining author has nothing to disclose., (This manuscript's contents are solely the responsibility of the authors and do not necessarily represent the official views nor the endorsements of the Department of Health and Human Services or the FDA.)
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- 2023
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29. Computational evaluation of inferior vena cava filters through computational fluid dynamics methods
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Northwest Radiology, Anand Rajan, Joshua D. Dowell, Mina S. Makary, and Thomas D. Martyn
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Vena Cava Filters ,Computer simulation ,business.industry ,Ivc filter ,Vena Cava, Inferior ,Computational fluid dynamics ,Inferior vena cava ,Finite element method ,DEVICE EVALUATION ,medicine.vein ,Filter (video) ,Interventional Radiology ,cardiovascular system ,Hydrodynamics ,Medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,Computer Simulation ,Cardiology and Cardiovascular Medicine ,business ,Simulation ,Device Removal ,Computer technology - Abstract
Numerical simulation is growing in its importance toward the design, testing and evaluation of medical devices. Computational fluid dynamics and finite element analysis allow improved calculation of stress, heat transfer, and flow to better understand the medical device environment. Current research focuses not only on improving medical devices, but also on improving the computational tools themselves. As methods and computer technology allow for faster simulation times, iterations and trials can be performed faster to collect more data. Given the adverse events associated with long-term inferior vena cava (IVC) filter placement, IVC filter design and device evaluation are of paramount importance. This work reviews computational methods used to develop, test, and improve IVC filters to ultimately serve the needs of the patient.
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- 2020
30. Authors’ response
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Cronenwett, Jack L, Beck, Adam, Bertges, Daniel, and Eldrup-Jorgensen, Jens
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Editorial ,lcsh:Medical technology ,vascular devices ,lcsh:R855-855.5 ,health care costs ,Biomedical Engineering ,lcsh:Surgery ,device evaluation ,Surgery ,lcsh:RD1-811 ,real world evidence - Published
- 2020
31. Clinical experience with the pREset stent retriever for the treatment of acute ischemic stroke-a review of 271 consecutive cases.
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Kurre, Wiebke, Aguilar-Pérez, Marta, Schmid, Elisabeth, Sperber, Wolfgang, Bäzner, Hansjörg, and Henkes, Hans
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- *
ASPIRIN , *COMMERCIAL product evaluation , *FISHER exact test , *MAGNETIC resonance imaging , *INTERVENTIONAL radiology , *SURGICAL stents , *TOMOGRAPHY , *U-statistics , *CLOPIDOGREL , *DATA analysis software , *STROKE patients , *DESCRIPTIVE statistics - Abstract
Introduction: The purpose of this study was to evaluate the safety and efficacy of the pREset stent retriever in a real-world clinical setting. Methods: Patients treated with pREset were selected from a prospectively maintained single-center database. A TICI score ≥2b after ≤3 passes was regarded as successful recanalization. All device-related complications and their clinical significance were reported. Parenchymal hematomas (PH) were classified according to ECASS, adding focal and diffuse subarachnoid hemorrhage (SAH) as categories. A 90-day mRS of 0-2 was defined as favorable outcome. In addition, we separately analyzed patients treated with >3 pREset passes and patients receiving other rescue maneuvers. Results: We included 271 patients. Successful recanalization was achieved in 76.4 %. Device-related complications occurred in 9.2 % of which 2.2 % were clinically significant. PH I, PH II, focal SAH, and diffuse SAH was observed in 5.2, 4.8, 12.2, and 2.2 %, respectively. A total of 39.5 % of patients had favorable clinical outcome. Considering treatments with >3 pREset passes or other rescue procedures, an additional 8.5 and 9.3 % of target vessels were recanalized. The chance of favorable clinical outcome decreased significantly with any kind of rescue therapy. In addition, the rate of PH I was significantly higher in patients treated with >3 pREset passes, whereas all other types of hemorrhage showed no difference. Conclusion: In terms of safety and effectiveness, pREset performed comparably to other stent retriever devices. To avoid futile recanalization and potential additional harm, escalation of therapy beyond three thrombectomy passes should only be performed after careful individual consideration of each case. [ABSTRACT FROM AUTHOR]
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- 2014
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32. Review of the Omnipod(®) 5 Automated Glucose Control System Powered by Horizon™ for the treatment of Type 1 diabetes
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Cari Berget, Erin Cobry, Laurel H. Messer, and Gregory P. Forlenza
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Insulin pump ,Blood Glucose ,medicine.medical_specialty ,endocrine system ,Glucose control ,endocrine system diseases ,medicine.medical_treatment ,Pharmaceutical Science ,030209 endocrinology & metabolism ,Artificial pancreas ,03 medical and health sciences ,0302 clinical medicine ,Insulin Infusion Systems ,immune system diseases ,Diabetes mellitus ,Device Evaluation ,medicine ,Humans ,Hypoglycemic Agents ,Insulin ,030212 general & internal medicine ,Intensive care medicine ,Type 1 diabetes ,Horizon (archaeology) ,business.industry ,Blood Glucose Self-Monitoring ,nutritional and metabolic diseases ,medicine.disease ,Clinical trial ,Diabetes Mellitus, Type 1 ,Glucose ,business - Abstract
Type 1 diabetes (T1D) is a medical condition that requires constant management, including monitoring of blood glucose levels and administration of insulin. Advancements in diabetes technology have offered methods to reduce the burden on people with T1D. Several hybrid closed-loop systems are commercially available or in clinical trials, each with unique features to improve care for patients with T1D. This article reviews the Omnipod® 5 Automated Glucose Control System Powered by Horizon™ and the safety and efficacy data to support its use in the management of T1D.
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- 2020
33. Embolization of medium-sized vessels with the penumbra occlusion device: evaluation of anchoring function
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Sohei Yoshida, Kazuya Kawashima, Makoto Hamano, Kunihiro Yoshioka, Kenichi Kato, and Tomohiro Suzuki
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Interventional radiology ,lcsh:Diseases of the circulatory (Cardiovascular) system ,New Technologies ,business.industry ,Penumbra ,medicine.medical_treatment ,Anchoring ,030204 cardiovascular system & hematology ,Penumbra occlusion device ,030218 nuclear medicine & medical imaging ,Embolization ,03 medical and health sciences ,DEVICE EVALUATION ,0302 clinical medicine ,Point of delivery ,lcsh:RC666-701 ,Occlusion ,Medicine ,Radiology, Nuclear Medicine and imaging ,Cardiology and Cardiovascular Medicine ,business ,Proximal occlusion ,Biomedical engineering - Abstract
Background The penumbra occlusion device (POD) is a recently developed metallic coil with a unique anchor segment. The purpose of this study was to investigate the anchoring function of the POD for embolization of medium-sized vessels in detail. Materials and methods We reviewed a series of cases of proximal embolization of medium-sized vessels in which the POD was used. Endovascular outcomes and complications were assessed. The distance between the distal end of the first-indwelled POD and the microcatheter tip was defined as the “landing distance,” and this was also evaluated via fluoroscopic analysis. Results POD deployment was successful in 17 of 18 patients. The median landing distance was 9.6 mm, and no distal POD migration was observed after the formation of anchor loops. Conclusions The specific anchoring function of the POD enables effective proximal occlusion of medium-sized vessels.
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- 2020
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34. Use of data from the Vascular Quality Initiative registry to support regulatory decisions yielded a high return on investment
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Erika Avila-Tang, Danica Marinac-Dabic, Andreas Schick, Nadezda Radoja, Josh Smale, Jack L. Cronenwett, Adam W. Beck, Roberta A Bloss, Melissa Hasenbank, Shengchun Wang, Peter Phillips, Jens Eldrup-Jorgensen, Frederic S. Resnic, Daniel J. Bertges, Gregory Pappas, and Art Sedrakyan
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Counterfactual thinking ,lcsh:Medical technology ,media_common.quotation_subject ,Biomedical Engineering ,lcsh:Surgery ,030204 cardiovascular system & hematology ,Time saving ,real world evidence ,healthcare costs ,Food and drug administration ,03 medical and health sciences ,DEVICE EVALUATION ,0302 clinical medicine ,vascular devices ,Return on investment ,Quality (business) ,Operations management ,030212 general & internal medicine ,health care economics and organizations ,media_common ,Original Research ,device evaluation ,lcsh:RD1-811 ,Cost savings ,lcsh:R855-855.5 ,Surgery ,Registry data ,Business - Abstract
BackgroundReal-world data (RWD) from the Society for Vascular Surgery Vascular Quality Initiative (VQI) registry has been used to support US Food and Drug Administration (FDA) regulatory decisions regarding vascular devices. The variables of cost and time needed for these registry-based studies have not been previously compared to traditional, independent, industry studies that would otherwise have been conducted to support regulatory decisions.ObjectivesTo determine the potential value (cost and time saving and return on investment) created by device evaluation studies using the VQI registry infrastructure.MethodsWe compared studies that used data from the VQI registry with estimated costs of independent industry studies (counterfactual studies) using an established model using design specifications determined by FDA reviewers.ResultsWe analyzed the initial six studies evaluating vascular devices for regulatory decisions using data from the VQI registry that generated evidence for four device manufacturers. Return on investment for these studies was estimated to be 143% and cost saving as 59% based on an actual per patient (with 5-year follow-up) cost of US$11K using VQI data versus US$26K from the counterfactual when averaged across all studies. Significant enrollment time savings (45%–71%) were also realized compared with industry-based estimates.ConclusionsThe use of RWD from the VQI registry in this study and the transcatheter valve treatment coordinated registry network in a prior study indicates that substantial value was added to device evaluation projects by the reuse of registry data, with additional potential savings if linked claims data can be used instead of costly long-term in-person follow-up.
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- 2020
35. When is a new implant not a new implant? Moving goalposts and orthopaedic trauma device evaluation
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William E. C. Poole, Piers Page, and Robert Handley
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DEVICE EVALUATION ,business.industry ,Dentistry ,Medicine ,General Medicine ,Implant ,business ,Orthopaedic trauma - Published
- 2021
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36. Development of a coordinated registry network for pelvic organ prolapse technologies.
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Baird CE, Chughtai B, Bradley CS, Kobashi K, Jung M, Sedrakyan A, Andrews S, Ferriter A, Cornelison T, and Marinac-Dabic D
- Abstract
Objectives: The accumulation of data through a prospective, multicenter Coordinated Registry Network (CRN) could be a robust and cost-effective way to gather real-world evidence on the performance of pelvic organ prolapse (POP) technologies for device-based and intervention-based studies. To develop the CRN, a group of POP experts consisting of representatives from professional societies, the Food and Drug Administration, academia, industry, and the patient community, was convened to discuss the role and feasibility of the CRN and to identify the core data elements important to assess POP technologies., Design: A Delphi method approach was employed to achieve consensus on a core minimum dataset for the CRN. A series of surveys were sent to the panel and answered by each expert anonymously and individually. Results from the surveys were collected, collated, and analyzed by the study design team from Weill Cornell Medicine. Questions for the next round were based on the analysis process and discussed with group members via conference call. This process was repeated twice over a 6-month time period during which consensus was achieved., Results: Twenty-one experts participated in the effort and proposed 120 data elements. Participation rates in the first and second round of the Delphi survey were 95.2% and 71.4%, respectively. The working group reached final consensus among responders on 90 data elements capturing relevant general medical and surgical history, procedure and discharge, short-term and long-term follow-up, device factors, and surgery and surgeon factors., Conclusions: The CRN successfully developed a set of core data elements to support the study of POP technologies through convening an expert panel on POP technologies and using the Delphi method. These standardized data elements have the potential to influence patient and provider decisions about treatments and include important outcomes related to efficacy and safety., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2022
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37. Developing minimum core data structure for the obesity devices Coordinated Registry Network (CRN).
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Long C, Tcheng JE, Marinac-Dabic D, Iorga A, Krucoff M, and Fisher D
- Abstract
Obesity continues to be a major public health issue, with more than two-thirds of adults in the USA categorized as overweight or obese. Bariatric surgery is effective and yields durable weight loss; however, few qualified candidates choose to undergo surgical treatment. Less-invasive alternatives to bariatric surgery are being developed to bridge the treatment gap. Recognizing the burden of conducting pivotal clinical trials and traditional post-approval studies for medical devices, the Food and Drug Administration (FDA) Center for Devices and Radiological Health has encouraged the development of real-world data content and quality that is sufficient to provide evidence for Total Product Life Cycle medical device evaluation. A key first step is to establish a minimum core data structure that provides a common lexicon for endoscopic obesity devices and its corresponding interoperable data elements. Such a structure would facilitate data capture across existing workflow with a 'coordinated registry network' capability. On July 29, 2016, a workshop entitled, 'GI Coordinated Registry Network: A Case for Obesity Devices' was held at the FDA White Oak Campus by the Medical Device Epidemiology Network public-private partnership and FDA to initiate the work of developing a common lexicon and core data elements in the metabolic device space, which marked the inauguration of the Gastrointestinal Coordinated Registry Network project. Several work groups were subsequently formed to address clinical issues, data quality issues, registry participation, and data sharing., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2022
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38. Towards early and broad evaluation of innovative surgical devices: integrating evidence synthesis, stakeholder involvement, and health economic modeling into the clinical research stages of the IDEAL framework.
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Scholte M, Woudstra K, Grutters JPC, Hannink G, Tummers M, Reuzel RPB, and Rovers MM
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Competing Interests: Competing interests: Maroeska M. Rovers is an Associate Editor of this journal.
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- 2022
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39. Considerations for reporting finite element analysis studies in biomechanics
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Erdemir, Ahmet, Guess, Trent M., Halloran, Jason, Tadepalli, Srinivas C., and Morrison, Tina M.
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BIOMECHANICS , *FINITE element method , *COMPUTER simulation , *BIOMEDICAL engineering , *SIMULATION methods & models , *DECISION making , *MATHEMATICAL models - Abstract
Abstract: Simulation-based medicine and the development of complex computer models of biological structures is becoming ubiquitous for advancing biomedical engineering and clinical research. Finite element analysis (FEA) has been widely used in the last few decades to understand and predict biomechanical phenomena. Modeling and simulation approaches in biomechanics are highly interdisciplinary, involving novice and skilled developers in all areas of biomedical engineering and biology. While recent advances in model development and simulation platforms offer a wide range of tools to investigators, the decision making process during modeling and simulation has become more opaque. Hence, reliability of such models used for medical decision making and for driving multiscale analysis comes into question. Establishing guidelines for model development and dissemination is a daunting task, particularly with the complex and convoluted models used in FEA. Nonetheless, if better reporting can be established, researchers will have a better understanding of a model''s value and the potential for reusability through sharing will be bolstered. Thus, the goal of this document is to identify resources and considerate reporting parameters for FEA studies in biomechanics. These entail various levels of reporting parameters for model identification, model structure, simulation structure, verification, validation, and availability. While we recognize that it may not be possible to provide and detail all of the reporting considerations presented, it is possible to establish a level of confidence with selective use of these parameters. More detailed reporting, however, can establish an explicit outline of the decision-making process in simulation-based analysis for enhanced reproducibility, reusability, and sharing. [Copyright &y& Elsevier]
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- 2012
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40. Extraglottic airway devices: technology update
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Chand Sahai, Bimla Sharma, and Jayashree Sood
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safety ,Computer science ,medicine.medical_treatment ,Biomedical Engineering ,Medicine (miscellaneous) ,Review ,Airway devices ,extraglottic airway devices ,03 medical and health sciences ,DEVICE EVALUATION ,0302 clinical medicine ,Laryngeal mask airway ,030202 anesthesiology ,medicine ,other extraglottic airway devices ,Difficult airway ,Flexibility (engineering) ,030208 emergency & critical care medicine ,respiratory system ,Project team ,Risk analysis (engineering) ,Airway management ,technology update ,laryngeal mask airway ,Corrigendum ,Airway - Abstract
Extraglottic airway devices (EADs) have revolutionized the field of airway management. The invention of the laryngeal mask airway was a game changer, and since then, there have been several innovations to improve the EADs in design, functionality, safety and construction material. These have ranged from changes in the shape of the mask, number of cuffs and material used, like rubber, polyvinylchloride and latex. Phthalates, which were added to the construction material in order to increase device flexibility, were later omitted when this chemical was found to have serious adverse reproductive outcomes. The various designs brought out by numerous companies manufacturing EADs resulted in the addition of several devices to the airway market. These airway devices were put to use, many of them with inadequate or no evidence base regarding their efficacy and safety. To reduce the possibility of compromising the safety of the patient, the Difficult Airway Society (DAS) formed the Airway Device Evaluation Project Team (ADEPT) to strengthen the evidence base for airway equipment and vet the new extraglottic devices. A preuse careful analysis of the design and structure may help in better understanding of the functionality of a particular device. In the meantime, the search for the ideal EAD continues.
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- 2017
41. Treatment of Tandem Internal Carotid Artery Aneurysms Using a Single Pipeline Embolization Device: Evaluation of Safety and Efficacy
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Christopher S. Ogilvy, Elad I. Levy, Paul M. Foreman, Hakeem J Shakir, Hussain Shallwani, Mark R. Harrigan, Ajith J. Thomas, Justin M. Moore, Nimer Adeeb, Jason M Davies, Christoph J. Griessenauer, Adnan H. Siddiqui, and Adam A Dmytriw
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Adult ,Carotid Artery Diseases ,Male ,medicine.medical_specialty ,medicine.medical_treatment ,030218 nuclear medicine & medical imaging ,Young Adult ,03 medical and health sciences ,DEVICE EVALUATION ,Postoperative Complications ,0302 clinical medicine ,medicine.artery ,Complete occlusion ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,cardiovascular diseases ,Embolization ,Intraoperative Complications ,Aged ,Retrospective Studies ,Aged, 80 and over ,High rate ,Interventional ,medicine.diagnostic_test ,business.industry ,Intracranial Aneurysm ,Retrospective cohort study ,Middle Aged ,Embolization, Therapeutic ,Cerebral Angiography ,Surgery ,Treatment Outcome ,cardiovascular system ,Female ,Neurology (clinical) ,Radiology ,Safety ,Internal carotid artery ,business ,Parent vessel ,Carotid Artery, Internal ,030217 neurology & neurosurgery ,Cerebral angiography - Abstract
BACKGROUND AND PURPOSE: Tandem aneurysms are defined as multiple aneurysms located in close proximity on the same parent vessel. Endovascular treatment of these aneurysms has rarely been reported. Our aim was to evaluate the safety and efficacy of a single Pipeline Embolization Device for the treatment of tandem aneurysms of the internal carotid artery. MATERIALS AND METHODS: A retrospective analysis of consecutive aneurysms treated with the Pipeline Embolization Device between 2009 and 2016 at 3 institutions in the United States was performed. Cases included aneurysms of the ICA treated with a single Pipeline Embolization Device, and they were divided into tandem versus solitary. Angiographic and clinical outcomes were compared. RESULTS: The solitary group (median age, 58 years) underwent 184 Pipeline Embolization Device procedures for 184 aneurysms. The tandem group (median age, 50.5 years) underwent 34 procedures for 78 aneurysms. Aneurysms were primarily located along the paraophthalmic segment of the ICA in both the single and tandem groups (72.3% versus 78.2%, respectively, P = .53). The median maximal diameters in the solitary and tandem groups were 6.2 and 6.7 mm, respectively. Complete occlusion on the last angiographic follow-up was achieved in 75.1% of aneurysms in the single compared with 88.6%% in the tandem group (P = .06). Symptomatic thromboembolic complications were encountered in 2.7% and 8.8% of procedures in the single and tandem groups, respectively (P = .08). CONCLUSIONS: Tandem aneurysms of the ICA can be treated with a single Pipeline Embolization Device with high rates of complete occlusion. While there appeared to be a trend toward higher thromboembolic complication rates, this did not reach statistical significance.
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- 2017
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42. Osteosynthesis Device Evaluation Using the Boundary Elements Method
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David Ojeda, Ivan Iglesias, Brizeida Gámez, and Marco Ciaccia
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DEVICE EVALUATION ,Materials science ,Osteosynthesis ,business.industry ,Elastic analysis ,Dynamic compression plate ,Forearm bone ,Boundary (topology) ,Domain decomposition methods ,Structural engineering ,business ,Boundary element method - Abstract
The elastic analysis of a dynamic compression plate (DCP) used for the forearm bone fracture reduction is presented. For this propose is employed a tool based on the Boundary Element Method (BEM) and an iterative domain decomposition technique with which is possible to develop 3D models and non-homogeneous materials. The numerical results obtained for the analysis has been validated establishing a comparison with an experimental test employing a DCP made of steel 316L with real dimensions. The results demonstrate that it is possible to use the BEM for the osteosynthesis devices design.
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- 2020
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43. Performance Goal Criteria for Device Evaluation in Lower Extremity Peripheral Vascular Intervention and the Need for Standardized Data Structure
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W. Schuyler Jones and Mitchell W. Krucoff
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Sound (medical instrument) ,medicine.medical_specialty ,business.industry ,030204 cardiovascular system & hematology ,PERIPHERAL VASCULAR INTERVENTION ,Data structure ,03 medical and health sciences ,DEVICE EVALUATION ,0302 clinical medicine ,Physical medicine and rehabilitation ,medicine ,030212 general & internal medicine ,Cardiology and Cardiovascular Medicine ,business - Published
- 2018
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44. Addressing the reporting chasm of artificial intelligence research: the DECIDE-AI reporting guidelines.
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Hanrahan JG, Khan DZ, and Marcus HJ
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Competing Interests: Competing interests: None declared.
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- 2022
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45. First in-human trial and prospective case series of an articulated laparoscopic camera system in minimally invasive surgery in gynecology: an IDEAL stage 1 and 2a study.
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Ng TY, Ngu SF, Kam TYD, Ng SY, and Lo PLB
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Objectives: Precision Robotics' Sirius Robotic Flexible Endoscopic System is a new, fully integrated, compact three-dimensional laparoscopic camera system with a disposable single-use flexible tip that can change its viewing direction. This IDEAL Stage 1 and 2a study assessed its safety, reliability and potential efficacy particularly for single incision laparoscopic surgery and vaginal natural orifice transluminal endoscopic surgery., Design: Prospective single-institution, single-surgeon study., Setting: The study was conducted in a multispecialty hospital., Participants: Women aged 18-70 years scheduled for gynecological laparoscopic surgery were invited to participate. An information sheet and consent was available for the women and an informed consent was obtained. Thirteen participants completed this study., Interventions: The laparoscopic procedures were done in the usual manner. The only difference was the Sirius System was used in place of the conventional laparoscope. All other procedures and instruments remained the same., Main Outcome Measures: Primary outcome was the proportion of women who successfully completed the intended procedure using the Sirius System without conversion to another camera system, camera users and surgeon's view and experience, and iterations and modifications to the system. Secondary outcomes were the incidence of intraoperative and postoperative complications during the first 6 weeks following surgery, and duration of surgery., Results: 85% (11/13) of women had their procedure completed successfully using the Sirius System. Two women required immediate conversion to the conventional laparoscope due to technical issues. There were no intraoperative complications. Users agreed that the improved field of view was beneficial for laparoscopic surgery. Iterative improvements were made in the imaging quality, user interface and manufacturing quality., Conclusions: Sirius System has early indications for safety and efficacy for intermediate and major minimally invasive laparoscopic procedures in gynecology. Further studies are needed to confirm it can replace a conventional laparoscope in the surgical workflow., Trial Registration Number: NCT05048407., Competing Interests: Competing interests: TYN is Clinical Advisor to Precision Robotics (Hong Kong) Limited, SYN is employee of Precision Robotics (Hong Kong) Limited, PLBL is employee of Precision Robotics (Hong Kong) Limited., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2022
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46. Identification of Diabetic Retinopathy and Ungradable Image Rate with Ultrawide Field Imaging in a National Teleophthalmology Program
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Mark B. Horton, Jennifer K. Sun, Jerry D. Cavallerano, Dawn Clary, Paolo S. Silva, Drew G. Lewis, and Lloyd Paul Aiello
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Adult ,Male ,medicine.medical_specialty ,Diabetic macular edema ,Population ,Telepathology ,Teleophthalmology ,030209 endocrinology & metabolism ,Diagnostic Techniques, Ophthalmological ,Macular Edema ,03 medical and health sciences ,DEVICE EVALUATION ,0302 clinical medicine ,Ophthalmology ,Photography ,medicine ,Humans ,education ,Aged ,Retrospective Studies ,education.field_of_study ,Diabetic Retinopathy ,medicine.diagnostic_test ,business.industry ,Fundus photography ,Outcome measures ,Diabetic retinopathy ,Middle Aged ,medicine.disease ,Cross-Sectional Studies ,030221 ophthalmology & optometry ,Optometry ,Female ,business - Abstract
To compare diabetic retinopathy (DR) identification and ungradable image rates between nonmydriatic ultrawide field (UWF) imaging and nonmydriatic multifield fundus photography (NMFP) in a large multistate population-based DR teleophthalmology program.Multiple-site, nonrandomized, consecutive, cross-sectional, retrospective, uncontrolled imaging device evaluation.Thirty-five thousand fifty-two eyes (17 526 patients) imaged using NMFP and 16 218 eyes (8109 patients) imaged using UWF imaging.All patients undergoing Joslin Vision Network (JVN) imaging with either NMFP or UWF imaging from May 1, 2014, through August 30, 2015, within the Indian Health Service-JVN program, which serves American Indian and Alaska Native communities at 97 sites across 25 states, were evaluated. All retinal images were graded using a standardized validated protocol in a centralized reading center.Ungradable rate for DR and diabetic macular edema (DME).The ungradable rate per patient for DR and DME was significantly lower with UWF imaging compared with NMFP (DR, 2.8% vs. 26.9% [P0.0001]; DME, 3.8% vs. 26.2% [P0.0001]). Identification of eyes with either DR or referable DR (moderate nonproliferative DR or DME or worse) was increased using UWF imaging from 11.7% to 24.2% (P0.0001) and from 6.2% to 13.6% (P0.0001), respectively. In eyes with DR imaged with UWF imaging (n = 3926 eyes of 2402 patients), the presence of predominantly peripheral lesions suggested a more severe level of DR in 7.2% of eyes (9.6% of patients).In a large, widely distributed DR ocular telehealth program, as compared with NMFP, nonmydriatic UWF imaging reduced the number of ungradable eyes by 81%, increased the identification of DR nearly 2-fold, and identified peripheral lesions suggesting more severe DR in almost 10% of patients, thus demonstrating significant benefits of this imaging method for large DR teleophthalmology programs.
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- 2016
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47. Sonography for Complete Evaluation of Neonatal Intensive Care Unit Central Support Devices
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David L. Schutzman, Mindy M. Horrow, David Saul, and Samuel Ajayi
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Male ,Catheterization, Central Venous ,Umbilical Veins ,medicine.medical_specialty ,Pediatrics ,Neonatal intensive care unit ,Critical Care ,Point-of-Care Systems ,Radiography ,medicine.medical_treatment ,Pilot Projects ,Peripherally-inserted central venous catheter ,Catheterization ,03 medical and health sciences ,DEVICE EVALUATION ,0302 clinical medicine ,Intensive Care Units, Neonatal ,030225 pediatrics ,Catheterization, Peripheral ,Intubation, Intratracheal ,medicine ,Humans ,Single-Blind Method ,Radiology, Nuclear Medicine and imaging ,Prospective Studies ,030212 general & internal medicine ,Ultrasonography, Interventional ,Endotracheal tube ,Radiological and Ultrasound Technology ,business.industry ,Infant, Newborn ,Arterial catheter ,Surgery ,Catheter ,Female ,business ,Vascular Access Devices ,Central venous catheter - Abstract
Objectives Neonates in the neonatal intensive care unit often require considerable support with endotracheal tubes, umbilical arterial and venous catheters, and peripherally inserted central venous catheters. Support device evaluation with radiography exposes neonates to ionizing radiation. This study evaluated the effectiveness of sonographic localization for endotracheal tubes, umbilical arterial and venous catheters, and peripherally inserted central venous catheters. Methods This blinded prospective Institutional Review Board-approved, Health Insurance Portability and Accountability Act-compliant study with informed consent compared sonography to radiography for endotracheal tube, umbilical arterial and venous catheter, and peripherally inserted central venous catheter localization. Participants were consecutively recruited NICU patients of any weight, gestation, and chronologic age who had an endotracheal tube, umbilical arterial catheter, umbilical venous catheter, or peripherally inserted central venous catheter placed or adjusted and had subsequent radiographic confirmation within 24 hours. Sonographic evaluation was obtained as soon as possible, without prior review of the radiograph, and results were compared. Results Thirty sonographic studies were performed in 25 patients (14 male and 11 female), for a total of 50 lines and tubes: 18 umbilical venous catheters, 12 umbilical arterial catheters, 11 peripherally inserted central venous catheters, and 9 endotracheal tubes. Forty-nine support devices (98%) were visualized with sonography, all concordant with radiography. Forty-four were correctly positioned, and 6 were malpositioned. Sonography identified the location of umbilical venous catheters in all 18 cases (100%), umbilical arterial catheters in all 12 (100%), peripherally inserted central venous catheters in 10 (91%), and endotracheal tubes in 9 (100%). Conclusions The effectiveness of sonography was excellent for evaluation of umbilical arterial and venous catheters, endotracheal tubes, and peripherally inserted central venous catheters. These results support the goal of further point-of-care training and accreditation to use sonography as a primary modality for complete evaluation of NICU support devices.
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- 2016
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48. Switch between AAI and DDD mode pacing-What is the mechanism?
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Maciej Dębski, Ewa Nowosielska-Ząbek, Andrzej Ząbek, Jacek Lelakowski, Barbara Małecka, and Krzysztof Boczar
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medicine.medical_specialty ,Pacemaker, Artificial ,business.industry ,Cardiac Pacing, Artificial ,General Medicine ,Case Reports ,030204 cardiovascular system & hematology ,Ventricular pacing ,03 medical and health sciences ,DEVICE EVALUATION ,Electrocardiography ,0302 clinical medicine ,Ecg findings ,Physiology (medical) ,Internal medicine ,medicine ,Cardiology ,Humans ,In patient ,Female ,030212 general & internal medicine ,cardiovascular diseases ,Cardiology and Cardiovascular Medicine ,business ,Aged - Abstract
The electrocardiogram (ECG) interpretation in patients with implantable pacemaker is often a perplexing problem. The difficulty in the device evaluation increases in the presence of novel timing cycles and additional functions. Authors describe a special function frequently encountered in Medtronic dual-chamber pacemakers and implantable cardioverter-defibrillator devices called managed ventricular pacing (MVP) and demonstrate its performance in the patient with undersensing episodes in ventricular channel. Intermittent ventricular undersensing in the device with MVP feature turned on caused repetitive mode switches between AAI and DDD mode. This report shows unexceptional occurrence of tricky ECG findings in patient with Medtronic dual-chamber device.
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- 2019
49. Evidence for biofilms in onychomycosis
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Aditya K. Gupta and Kelly A. Foley
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Antifungal ,Fusarium ,Antifungal Agents ,medicine.drug_class ,Dermatology ,Drug resistance ,medicine.disease_cause ,Microbiology ,030207 dermatology & venereal diseases ,03 medical and health sciences ,DEVICE EVALUATION ,0302 clinical medicine ,Drug Resistance, Fungal ,Onychomycosis ,medicine ,Humans ,biology ,business.industry ,Fungi ,Biofilm ,biology.organism_classification ,medicine.anatomical_structure ,Biofilms ,Nail (anatomy) ,Dermatophyte ,business - Abstract
Onychomycosis is a difficult to treat fungal infection of the nails. The chronic nature of onychomycosis contributes to high recurrence rates and the difficulty in treating both dermatophyte and non-dermatophyte infections. It has been hypothesized that the formation of biofilms, sessile, multicellular communities of fungi surrounded by a protective extracellular matrix, allow for fungi to evade current antifungal therapies and contribute to observed antifungal resistance. This review presents the experimental evidence that has accumulated in recent years implicating biofilms in the pathogenesis of onychomycosis. Dermatophytes, non-dermatophyte molds, and yeasts form biofilms in vitro and a model using ex vivo healthy nail fragments has demonstrated biofilm formation on nails for dermatophyte, Candida, and Fusarium species. Implications for disease management are discussed with further research required to incorporate biofilm formation into future drug/device evaluation and treatment protocols.
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- 2019
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50. Validation of the Hingmed WBP-02A device for ambulatory blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010
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Leonardo Vezzù, Ilaria Lazzaretto, C. Fania, and Paolo Palatini
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Male ,medicine.medical_specialty ,Ambulatory blood pressure ,Systole ,Adult population ,Diastole ,Blood Pressure ,030204 cardiovascular system & hematology ,Assessment and Diagnosis ,International Protocol of the European Society of Hypertension (ESH-IP) ,03 medical and health sciences ,DEVICE EVALUATION ,0302 clinical medicine ,Internal medicine ,ambulatory blood pressure (BP) monitoring, Hingmed, International Protocol of the European Society of Hypertension (ESH-IP) ,Internal Medicine ,medicine ,Humans ,030212 general & internal medicine ,Aged ,Advanced and Specialized Nursing ,Protocol (science) ,Aged, 80 and over ,business.industry ,General Medicine ,Blood Pressure Monitoring, Ambulatory ,Middle Aged ,Circumference ,Blood Pressure Monitors ,Blood pressure ,Hypertension ,Cardiology ,ambulatory blood pressure (BP) monitoring ,Hingmed ,Female ,Cardiology and Cardiovascular Medicine ,business - Abstract
The objective of this study was to determine the accuracy of the Hingmed WBP-02A device for ambulatory blood pressure (BP) monitoring according to the International Protocol of the European Society of Hypertension (ESH-IP). Device evaluation was carried out in 33 patients. The mean age was 69.8±13.8 years, the mean systolic BP was 137.6±27.0 mmHg (range: 96-172), the mean diastolic BP was 86.7±20.1 mmHg (range: 48-124) and the mean arm circumference was 30.1±6.2 cm (range: 20-43). The protocol requirements were followed precisely. Four different cuffs, small, standard, large, and extra-large were used. The device comfortably passed all ESH-IP requirements, as 84 out of 99 device-observer systolic BP differences and 97 of 99 diastolic BP differences were within ±5 mmHg thereby fulfilling the standards of the protocol. Device-observer BP differences were unrelated to arm circumference. These data show that the Hingmed WBP-02A device for ambulatory BP monitoring met the requirements for validation by the ESH-IP and can be recommended for clinical use in the adult population.
- Published
- 2019
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