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Published: 11 May 2020
Global Clinical Engineering Journal, Volume 2, pp 15-23; doi:10.31354/globalce.v2i3.90
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.
Global Clinical Engineering Journal, Volume 2, pp 8-14; doi:10.31354/globalce.v2i3.83
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.
Global Clinical Engineering Journal, Volume 2, pp 4-7; doi:10.31354/globalce.v2i3.60
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.
Published: 26 April 2020
Global Clinical Engineering Journal, Volume 2, pp 5-6; doi:10.31354/globalce.v2i.100
Published: 22 April 2020
Global Clinical Engineering Journal, Volume 2, pp 35-38; doi:10.31354/globalce.v2i.97
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.
Published: 17 April 2020
Global Clinical Engineering Journal, Volume 2, pp 39-49; doi:10.31354/globalce.v2i.88
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.
Published: 15 April 2020
Global Clinical Engineering Journal, Volume 2, pp 31-34; doi:10.31354/globalce.v2i.95
Transcript of March 24, 2020 Webinar (on behalf of AIIC & IFMBE/CED)
Published: 13 April 2020
Global Clinical Engineering Journal, Volume 2, pp 7-30; doi:10.31354/globalce.v2i.94
On the basis of reports and questions forwarded to the Clinical Risk Managers of the Italian Network for Health Safety (INSH) from physicians working on the front line, a series of recommendations have been developed referring to documents and papers published by national institutions (ISS) and Italian and international scientific societies and journals. We have arranged the process to describe organising the work system according to the SEIPS Human Factors approach. This document is re-posted with permission from Riccardo Tartaglia (President of Italian Network for Safety in Health Care).
Published: 31 March 2020
Global Clinical Engineering Journal, Volume 2, pp 1-2; doi:10.31354/globalce.v2i.92
Published: 1 March 2020
Global Clinical Engineering Journal, Volume 2, pp 26-36; doi:10.31354/globalce.v2i2.49
BACKGROUND AND OBJECTIVE: There are in Brazil 896.917 indigenous and 47% of them dwell in the Amazon rainforest region. In order to avoid expensive displacement for this population, especially for surgeries such as hernias and cataracts, the Expedicionários da Saúde NGO attends this specific population three times a year since 2003 organized as a work party regime. This attending is done through a Field Hospital (FH) and is supported by Clinical Engineering (CE). This article presents the characteristics of logistics as well as operation of medical and hospital devices in remote sites of Amazon region. The object of this paper is to describe the transportation processes, installation, operation and maintenance used to ensure safe use of medical devices in one FH in the Amazon forest and to present solutions to proposed adverse conditions throughout the course of several expeditions. MATERIAL AND METHODS: It was Initially done a survey of the processes of transportation, installation, operation and maintenance of medical devices collected from 24 expeditions to the Amazon forest in a period of 8 years, since the implementation of CE team. A Task Analysis processes was performed to systematically identifying the process used for plan, prepare, transport and operate the medical devices in those past expeditions. Understanding the complexity and the specificities of each expedition a evolutive planning process based on Software Development Spiral Model was used to describes a continuous activity flow, prone to implement and test improvements in each new expedition. Besides the continuous improvement the model also takes in consideration budget solutions once all the work done by the ONG is voluntary. The efficacy of the method was evaluated from indicators of use of medical equipment, the assessment of reported adverse events and the interviews with the professionals of the EC team, users of the medical devices and opinion of the responsible for the managing of the expedition. RESULTS: Several improvements were observed speciality in the transporting and installation processes, mainly through the adoption of customized packages and manuals for assembly and disassembly of the parts of the medial equipment. Further enhancements were obtained through customizations and adaptations of the devices to the hostile characteristics of the environment. Both physicians and nurses were satisfied with the performance of the devices, and few procedures for repair and calibrate were required after the equipments were installed. CONCLUSION: The CE team is crucial to the implementation of FHs, being essential in the management of medical technology and in the planning and operation of this type of health structure. The spiral planning method were shown to be very satisfactory mainly because it takes into account the experiences and needs of the past expeditions and for allowing the continuous improvement of the already used processes. Given the great complexity of the RainForest environment in which the technologies will be used and the unpredictability of the risks and challenges to be faced by the EC team the evolutionary work approach presents itself as an applicable solution to planning of future expeditions.