BMED: A WEB BASED APPLICATION TO ANALYZE THE PERFORMANCE OF MEDICAL DEVICES

2014 ◽  
Vol 26 (03) ◽  
pp. 1450036 ◽  
Author(s):  
Mana Sezdi ◽  
Ersin Ozdemir
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Preventive Maintenance ◽  
Performance Test ◽  
Spare Part ◽  
Test Results ◽  
Stock Management ◽  
Software Application ◽  
Repair Costs ◽  
Electrosurgical Unit

In this study, a software application was developed to analyze the performance test results of medical devices. The software (BMED) provides a medical device database and analyses problems with medical devices. The BMED application analysis reports incompatible performance test results in accordance with international safety and inspection standards. The BMED also contains performance test measurement history of all medical devices in the BMED medical device database. The main purpose of this study is to make analysis of the performance control of medical devices faster, easier, mobile and more efficient. The increasing number of medical devices in a hospital is another reason to use applications such as this. The BMED software application was tested using sample data collected during performance test results of a total of 1553 medical devices. The devices were defibrillator, electrocardiography, pulse oximeter, anaesthesia unit, vaporizer, ventilator, electrosurgical unit, physiological monitor, sphygmomanometer, surgical aspirator, phototherapy unit and infant incubator. The performance tests of these medical devices were performed by the biomedical personnel in accordance with the inspection and preventive maintenance system (IPM) procedures, which were developed by the emergency care research institute (ECRI institute) and their results were also interpreted in accordance with the same procedures. The results of application testing showed that the BMED is a very successful application used to analyze performance test results of medical devices. Its usage is very easy, fast and comfortable. The main advantage of BMED is that it can be accessed with mobile devices from anywhere. This feature increases the performance and efficiency of biomedical staff. Additionally, this study showed that the BMED application provides consistent data for medical device problems. Spare part stock management and preventive maintenance activities decreased the repair costs and minimized the number of fault device conditions within the BMED application. All the analysis results also affected the selection and purchasing decisions of medical devices and their technologies. In short, the BMED served a manageable solution to combine all distributed data from a large number of medical devices located in different departments of a hospital — the location of the device, the biomedical number, the device name, the manufacturer, the serial number, the interpretation of the performance test results and the analysis results — into one platform. Thus, the management of medical device inventory was made easier. The future study will be the evaluation of the analysis for other medical devices. It is expected that usage of the tool will increase and it will be a very useful application for biomedical personnel.

PENGARUH MODEL PEMBELAJARAN KELILING KELOMPOK (ROUND CLUB) TERHADAP KETERAMPILAN MENULIS LAPORAN PERJALANAN SISWA KELAS V SDN 01 NAGARI BUKIK SIKUMPA

2020 ◽  
Author(s):  
Wirda Linda
Keyword(s):  
Standard Deviation ◽  
Performance Test ◽  
Writing Skills ◽  
Learning Model ◽  
Homogeneity Test ◽  
Test Results ◽  
Class V ◽  
Average Value ◽  
Normality Test ◽  
Lecture Method

This research is motivated by the low desire of students in writing travel reports. The lack of students' knowledge of the report concept, the lack of students' knowledge of the 5W + 1H report points of good and correct language, the lack of students' knowledge of the spatial, time and topic pattern and not yet reached KKM 75. The method used by the teacher has not been interesting, lecture method. The purpose of this study is to describe the skills of writing travel reports by using Round Club learning model which is viewed from the aspect of understanding the report concept, the use of 5W +1H report points, the spatial, time, and topic pattern.The population of this study is the students of class V Lessons Year 2017/2018 which amounted to 2 classes with the number 80. The sample of research as much as two classes taken by the sample of propotional.Class V.1 as experimental class and class V.2 as control class. The research instrument used is performance test. Provide an assessment by specifying the subject of the 5W + 1H report, as well as the spatial, time and topic pattern. Data were analyzed by 't' test by first testing normality, homogeneity, and hypothesis testing.The results showed that the average control class 68 with more than enough qualifications with standard deviation 16.96. 83 experimental class with good qualification and standard deviation of 15.42 and there is a significant influence on the result of writing skill of class V SDN 01 Nagari Bukik SikumpaSubdistrict, Lima Puluh Kota. This is evidenced by the average value of writing skills in the experiment class higher than the average value in the control class. Normality test results indicate that the two sample classes of  Lo  values in the control class -0.2141 are smaller than the normal 0.190 Lt distributed. Homogeneity test results that the variation of this study is homogeneous at a real level of 0.05, because Ftable 2.16 > Fhitung 1.21 and the results of data analysis then obtained = 2.78 > 1.70 t table, so H0 rejected and H1 accepted. It can be concluded that there is Influence. Using  Learning  Model of Student Group Writing  Skills Travel Report of students of class V SDN 01 Nagari Bukik Sikumpa Subdistrict, Kabupaten Lima Puluh Kota.KeyWords: model pembelajaran round club, menulis laporan perjalanan.

Regulating Medical Devices in the United States

2020 ◽  
Author(s):  
Patricia J. Zettler ◽  
Erika Lietzan
Keyword(s):  
United States ◽  
Medical Device ◽  
Medical Devices ◽  
Complete Information ◽  
The United States ◽  
Risk Level ◽  
Management Tools ◽  
Medical Technologies ◽  
The Us ◽  
Medical Device Regulation

This chapter assesses the regulation of medical devices in the United States. The goal of the US regulatory framework governing medical devices is the same as the goal of the framework governing medicines. US law aims to ensure that medical devices are safe and effective for their intended uses; that they become available for patients promptly; and that manufacturers provide truthful, non-misleading, and complete information about the products. US medical device law is different from US medicines law in many ways, however, perhaps most notably because most marketed devices do not require pre-market approval. The chapter explores how the US Food and Drug Administration (FDA) seeks to accomplish its mission with respect to medical devicecough its implementation of its medical device authorities. It starts by explaining what constitutes a medical device and how the FDA classifies medical devices by risk level. The chapter then discusses how medical devices reach the market, the FDA's risk management tools, and the rules and incentives for innovation and competition. It concludes by exploring case studies of innovative medical technologies that challenge the traditional US regulatory scheme to consider the future of medical device regulation.

Medical Device Regulation: Requirements for Dental Professionals Who Prescribe and Manufacture Custom-Made Devices

2021 ◽  
Vol 10 (1) ◽  
pp. 64-88
Author(s):  
James I. J. Green
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Transition Period ◽  
Eu Directive ◽  
Custom Made ◽  
Dental Setting ◽  
The Uk ◽  
Dental Professionals ◽  
The Eu ◽  
Medical Device Regulation

A custom-made device (CMD) is a medical device intended for the sole use of a particular patient. In a dental setting, CMDs include prosthodontic devices, orthodontic appliances, bruxism splints, speech prostheses and devices for the treatment of obstructive sleep apnoea, trauma prevention and orthognathic surgery facilitation (arch bars and interocclusal wafers). Since 1993, the production and provision of CMDs have been subject to European Union (EU) Directive 93/42/EEC (Medical Device Directive, MDD) given effect in the UK by The Medical Devices Regulations 2002 (Statutory Instrument 2002/618), and its subsequent amendments. Regulation (EU) 2017/745 (Medical Device Regulation, EU MDR) replaces the MDD and the other EU Directive pertaining to Medical Devices, Council Directive 90/385/EEC (Active Implantable Medical Device Directive, AIMDD). The EU MDR was published on 5 April 2017, came into force on 25 May 2017 and, following a three-year transition period was due to be fully implemented and repeal the MDD on 26 May 2020, but was deferred until 26 May 2021 due to the coronavirus disease 2019 (COVID-19) pandemic. In the UK, in preparation for the country’s planned departure from the EU, the EU MDR, with necessary amendments, was transposed into UK law (Medical Devices (Amendment etc.) (EU Exit) Regulations 2019, UK MDR). The UK left the Union on 31 January 2020 and entered a transition period that ended on 31 December 2020, meaning that, from 1 January 2021, dental professionals in Great Britain who prescribe and manufacture CMDs are mandated to do so in accordance with the new legislation while Northern Ireland remains in line with the EU legislation and implementation date. This paper sets out the requirements that relate to the production and provision of CMDs in a UK dental setting.

Physical and performance characteristics related to starter status, position, and division in Japanese collegiate American-football players

2021 ◽  
pp. 1-8
Author(s):  
Junta Iguchi ◽  
Minoru Matsunami ◽  
Tatsuya Hojo ◽  
Yoshihiko Fujisawa ◽  
Kenji Kuzuhara ◽  
...  
Keyword(s):  
Performance Test ◽  
Vertical Jump ◽  
American Football ◽  
Football Players ◽  
Jump Height ◽  
Test Results ◽  
Repetition Maximum ◽  
Vertical Jump Height ◽  
Division 1 ◽  
And Performance

BACKGROUND: Few studies have investigated the variations in body composition and performance in Japanese collegiate American-football players. OBJECTIVE: To clarify what characterizes competitors at the highest levels – in the top division or on the starting lineup – we compared players’ body compositions and performance test results. METHODS: This study included 172 players. Each player’s body composition and performance (one-repetition maximum bench press, one-repetition maximum back squat, and vertical jump height) were measured; power was estimated from vertical jump height and body weight. Players were compared according to status (starter vs. non-starter), position (skill vs. linemen), and division (1 vs. 2). Regression analysis was performed to determine characteristics for being a starter. RESULTS: Players in higher divisions and who were starters were stronger and had more power, greater body size, and better performance test results. Players in skill positions were relatively stronger than those in linemen positions. Vertical jump height was a significant predictor of being a starter in Division 1. CONCLUSION: Power and vertical jump may be a deciding factor for playing as a starter or in a higher division.

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