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(searched for: doi:(10.31354/*))
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Immacolata De Rosa, Alessandro Pepino, Gianluca Giaconia, Mario Guarino
Global Clinical Engineering Journal, Volume 2, pp 45-56; doi:10.31354/globalce.v2i3.86

Abstract:
Background and Objective. The deliberation n.7301 of 31/12/2001 provides for the inclusion of a call system with acoustic and luminous signalling within the minimum equipment of the recovery ward. However, traditional call systems are inefficient since they are based on the following incorrect assumptions: patients and staff are unmoving, information sources are static and assistance is unidirectional. Taking care of a patient involves different figures who should be dynamic and should be able to exchange information. Furthermore, the high number of clinical calls and alarms might be an issue, because on one hand they are essential to fulfil patients’ needs, but on the other hand they could cause stress and additional workload on medical staff. Indeed, they sometimes ignore some calls or waste a lot of time on non-urgent requests. In addition, the identification of an alarm and the prompt intervention seems to be more difficult during travelling. An ideal alarm system should have 100% sensitivity and specificity. Nevertheless, the alarms are designed to be extremely sensitive, at the expense of specificity. The alarm fatigue, that is the work overload due to an excessive alarms number exposition, is a critical problem in terms of safety in the current clinical practice because it involves desensitization and alarm loss, causing sometimes even the patient's death. Material and Methods. Therefore, appropriate approaches to notifications should be evaluated, including the effectiveness of mobile wireless technologies: linking patients, staff, data, services and medical devices simplifies communications and workflows. Several issues related to the communication among staff members, between patient and caregiver and to the alarms and vital parameters distribution in care-intensive environments have been analysed, focusing on the clinical effectiveness analysis of an innovative technology to support the Emergency Department of the Azienda Ospedaliera dei Colli activities. Afterwards, we have created a simulation model with Simul8, so that a digital twin reproduces direct and indirect activities in two cases: with and without (What If and As Is model) the aid of the technology. Results and conclusions. The model provides a set of Key Performance Indicators (number of performing activities, average alarm resolution time, waiting time) on which the compensatory aggregation method is applied to elaborate a single final score in both cases. This score is 52,5 in the As Is Model and 80 in the What If model. So, the clinical effectiveness has been demonstrated.
Francesca Pristerà, Alessandro Gallo, Salvatore Fregola, Sciprofile linkAlessio Merola
Global Clinical Engineering Journal, Volume 2, pp 35-44; doi:10.31354/globalce.v2i3.89

Abstract:
This work investigates the validity and reliability of a novel biomechatronic device providing an interactive environment in Augmented Reality (AR) for neuromotor rehabilitation. A RGB-depth camera and telemonitoring/remote signaling module are the main components of the device, together with a PC-based interface. The interactive environment, which implements some optimized algorithms of body motion capture and novel methodologies for human body motion analysis, enables neuromotor rehabilitation treatments that are adaptable to the performance and individual characteristics of the patient. The RGB-Depth camera module is implemented through a Microsoft Kinect, ORBBEC ZED2K devices; the telemonitoring module for teleassistance and therapy supervision is implemented as a cloud service. Within the module of body motion tracking, the abduction and adduction movements of the limbs of the full-body structure are tracked and the joints angles are measured in real-time; the most distinctive feature of the tracking module is the control of the trunk and shoulder posture during the exercises performed by the patient. Indeed, the device recognizes an incorrect position of the patient's body that could affect the objective of the exercise to be performed. The recognition of an incorrect exercise is associated to the generation of an alert both to the patient and the physician, in order to maximize the effectiveness of the treatment based on the user's potential and to increase the chances of a better biofeedback. The experimental tests, which have been carried out by reproducing several neuromotor exercises on the interactive environment, show that the feature recognition and extraction of the joints and segments of the musculo-skeletal structure of the patient's, and of wrong posture during exercises, can achieve good performance in the different experimental conditions. The developed device is a valid tool for patients affected by chronic disability, but it could be extended to neurodegenerative diseases in the early stages of the disease. Thanks to the enhanced interactivity in augmented reality, the patient can overcome some difficulties in interaction with the most common IT tools and technologies; at the meanwhile she/he can perform rehabilitation at home. The physician can also check in real time the results and customize the care pathway. The enhanced interactivity provided by the device during rehabilitation session increases both the motivation by the patient and the continuity of the care, as well as it supports low-cost remote assistance and telemedicine by optimizing therapy costs. The key points are: i) making rehabilitation motivating for the patient, becoming a "player"; ii) optimize effectiveness and costs; iii) possibility of low-cost remote assistance and telemedicine.
Jitendar Sharma, Sciprofile linkJoske Bunders, Sciprofile linkTeun Zuiderent-Jerak, Barbara Regeer
Global Clinical Engineering Journal, Volume 2, pp 24-34; doi:10.31354/globalce.v2i3.84

Abstract:
Health Technology Assessment focuses on equal appraisal of health technologies introduced into the market. This has made regulators and the governance of innovation reactive and dependent on the initiatives innovators take for technology development, thus making it supply driven. The policy makers’ role has become one of appraising technologies that are already developed rather than guiding the development agenda. This severely limits the possibility to ensure that health technologies sufficiently address major issues such as burden of disease, trade deficit and health inequalities. It places governments outside of the actor arena that co-shapes technologies in the early stages, restricting the involvement to facilitating scale up or not. It makes it hard to achieve health technology governance practices that maximally contribute to ensure technological developments that actually address public concerns. What is the potential of frameworks for changing this dynamics and how can evidence shape technology development agenda’s without falling into the traps of regulator lock-in or social engineering? The methodology presented in this study takes first but important steps towards an evidence based framework for priority setting to guide innovations, particularly in health and social sectors
Global Clinical Engineering Journal, Volume 2, pp 1-2; doi:10.31354/globalce.v2i3.101

Qing-Qing Zhou, Qian-Qian Hu, Xianfeng Yang, Yu-Chen Chen, Yu-Sheng Yu, Jue Zhang, Qinghong Ma, Gang-Ping Zhou, Hengle Wei, Bing Zhang, et al.
Global Clinical Engineering Journal, Volume 2, pp 15-23; doi:10.31354/globalce.v2i3.90

Abstract:
Background and Objective: We aimed to assess and verify the measurement accuracy and feasibility of semi-automatic magnetic resonance imaging (MRI) volume of interest (VOI) method by comparing its measurements with actual skeletal muscle volumes and discuss the clinical significance. Material and Methods: A total of 18 muscles from 2 pigs were measured by drainage method, VOI method (VVOI), the summation method (Vsum), and maximum section method (Vmax) respectively after MRI scanning. All measurements were performed by 2 musculoskeletal radiologists and repeated at 6 different times, recording the consuming time (minutes) of every muscle. The average result of the 2 radiologists was adopted. Results: The 3-D structure of the skeletal muscles was distinct and vivid. A Friedman test and the inter-class correlation coefficient (ICC) indicated the VOI method had a high intra- and inter-reliability. The root mean square error (RMSE) over 6 time-points was 1.101 mL. A Bland-Altman plot represented a superior consistency. Pairwise Mann–Whitney U testing demonstrated that the consuming time to measure each muscle by VOI method was short. Conclusions: The VOI method could semi-automatically display the 3-D reconstruct of the skeletal muscle clearly, conveniently, with a great accuracy, and high repeatability.
Rodrigo Mijares, Néstor Utrera, Zhayda Sierra, Sara González, Rubén Lugo, María Rincón, Raquel Mijares
Global Clinical Engineering Journal, Volume 2, pp 8-14; doi:10.31354/globalce.v2i3.83

Abstract:
Background and objective: medical devices and supplies increase productivity in health institutions, contributing to the reduction of morbidity and mortality rates. However, the use of medical devices has an associated level of risk. A third party must guarantee the safety and effectiveness of the medical team to grant a quality certification. In Venezuela, one of the institutions authorized by the regulatory entity (Ministry of Popular Power for Health) that grants quality certification is the Health Technology Management Unit (UGTS) attached to the Research and Development Foundation (FUNINDES ) from the Simón Bolívar University (USB). The objective of this work is to show the certification protocol by the UGTS and its results. Material and Methods; It based on the ISO 9001 standard for the processes. Five activities were determined: Prepare the teaching, technical and administrative staff as ISO auditors. Carry out an external audit, in order to make proposals for improvement; Plan changes in our quality management system and processes and Qualify as a supplier guided by the ISO 9001 philosophy by a prestigious international company. Results: Based on the results, general and particular proposals were proposed to improve the process. These were adopted by the group and later in the evaluation of an international company the USB was qualified as an approved supplier for the analysis of medical devices by the company Johnson & Johnson Medical S.C.S. when complying with ISO 9001 Standard. Conclusions: The UGTS is authorized by the Ministry of Popular Power for Health (MPPS) through the Sanitary Comptroller's Office to issue quality certificates to medical teams since 1999. Approximately 55 companies that have received service are registered in its database. In the period audited (2012 - 2014), 25 files were created. Its processes comply with ISO 9001.
Sciprofile linkMarcelo Antunes Marciano, Anderson Santos, Rodrigo Rezer, William Knob De Souza
Global Clinical Engineering Journal, Volume 2, pp 4-7; doi:10.31354/globalce.v2i3.60

Abstract:
It is under development in health establishment, a quality control through the calibration of biomedical equipment, in a systematic and comprehensive way of the wide range of available hospital technology. Thus, this work aims to propose and demonstrate a method of qualification of the apheresis equipment through of the equipment calibration, before to release it for the first time use. As results are shown the values obtained in a calibration of an apheresis equipment, relating to the MNC protocol (removal of mononuclear cells), the pressure of access and return pressure.
Adriana Velazquez
Global Clinical Engineering Journal, Volume 2, pp 5-6; doi:10.31354/globalce.v2i.100

Jin Zhang, Jiansheng Li, Zhiyong Wu
Global Clinical Engineering Journal, Volume 2, pp 35-38; doi:10.31354/globalce.v2i.97

Abstract:
COVID-19 was raging wildly across China. Although it is a war without gunpowder smoke, it is extremely fierce. Countless Medical staff at the frontline is fighting with death and the virus just to protect those infected who firmly believe in them.This artical describes the work of clinical engineers in Shanxi Province of China to fight against COVID-19.
Tchoutat Lionel Djankou, Vincenzo Albonico
Global Clinical Engineering Journal, Volume 2, pp 39-49; doi:10.31354/globalce.v2i.88

Abstract:
This article seeks to share our experience on the consequences of a poorly managed conflict and its impact on a healthcare institution. We further try to talk on what it takes to relocate, especially such a vital sector like cardiac surgery amidst the socio-economic and socio-political context in which the hospital happens to be situated. Bearing in mind that the promptness of a patient’s recovery in a healthcare facility depends immensely on how accurate the engineers were during the design and construction phase, how precise international standards are implemented in the various engineering sectors of the hospital is of capital importance. Following the Cameroonian mind set, wherein division of labor and meritocracy are usually far fetch realities, it is therefore of prime importance to choose experienced and qualified contractors, architects, project managers to take part in the implementation of healthcare projects. The process of relocating either temporarily or permanently some health services from a crisis stricken zone to a safer environment also demands a lot of tactfulness in decision making as well as personnel involvement. All personnels from the various sectors being relocated must work closely with the team leader such that all necessary equipment, consumables, surgical materials are put together in order to simplify logistics and even safeguard the logistical process.
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