scholarly journals Using Role-Playing Simulations to Teach Quality Control in the Design of Medical Devices

2018 ◽  
Author(s):  
J. Christopher Bouwmeester ◽  
Vicki Komisar ◽  
Arushri Swarup
Keyword(s):  
Quality Control ◽  
Risk Analysis ◽  
Human Factors ◽  
Medical Devices ◽  
Regulatory Agency ◽  
Teaching Assistants ◽  
Role Playing ◽  
Team Based Learning ◽  
Individual Accountability ◽  
A Company

Abstract – A simulation is used to facilitate cooperative and team-based learning to introduce concepts of human factors, risk analysis, and quality control applied to the design of medical devices. We further use a friendly game-based approach to simulate the dynamics between a customer, a regulatory agency, and competitive manufacturers. Students are divided into manufacturing teams/companies and teaching assistants act as the customer and regulator. To promote positive interdependence and individual accountability, each student within a company is assigned roles of CEO, inspector, marketer, and designer. The goal for each company is to design and produce as many eye patch medical devices as possible, which must be approved by the regulator, within a tight deadline. Products are evaluated by the customer, who decides what price to pay for each unit, at the end of production. The most successful company is determined by the greatest amount of money earned after two rounds of production and sales.

DRUG REGULATORY PROCEDURES IN TANZANIA: A GLIMPSE

2015 ◽  
Vol 3 (2) ◽  
pp. 1-7 ◽  
Author(s):  
Achin Jain ◽  
M P Venkatesh M P ◽  
Pramod T.M. Kumar
Keyword(s):  
Quality Control ◽  
Medical Devices ◽  
Emerging Market ◽  
Well Being ◽  
New Drugs ◽  
Regulatory Body ◽  
Herbal Drugs ◽  
Drug Products ◽  
Set Up

In Tanzania, Tanzania Food and Drugs Authority (TFDA), is a regulatory body responsible for controlling the quality,safety and effectiveness of food, drugs, herbal drugs, cosmetics and medical devices. The Authority has been ensuringsafety, efficacy and quality of medicines by quality control tests; in addition to other quality assessment mechanisms.The guidelines laid by TFDA have also emanated from commitment to democracy and gives strong emphasis to thefulfilment of the needs of the less privileged rural population.Tanzania is an emerging market; the pharmaceutical market is valued at over US$250 million, and is growing at anannual rate of around 16.5% and is expected to reach approximately US$550 billion in 2020. Currently, the market ishighly dependent on imports, which account for around 75% of the total pharmaceutical market.The procedures and approval requirements of new drugs, variations, import, export and disposal have been set up bythe TFDA, which help in maintaining quality of the drug products that are imported as well being produced locally 

History Matching Standards; Quality Control and Risk Analysis for Simulation

2006 ◽  
Author(s):  
R.O. Baker ◽  
S. Chugh ◽  
C. Mcburney ◽  
R. McKishnie
Keyword(s):  
Quality Control ◽  
Risk Analysis ◽  
History Matching

Human Factors Considerations in the Migration of Medical Devices from Clinical to Homecare Settings

2004 ◽  
Vol 48 (15) ◽  
pp. 1685-1689 ◽  
Author(s):  
Melanie J. Turieo ◽  
Marlene A. Devine ◽  
Rodney Hasler ◽  
Ronald Kaye ◽  
Wendy A. Rogers
Keyword(s):  
Human Factors ◽  
Medical Devices

scholarly journals ANALISIS KUALITAS PRODUK MENGGUNAKAN METODE STATISTIC PROCESS CONTROL (SPC) MINITAB DAN TIME-CHARTING DI PT. COCA-COLA BOTTLING INDONESIA UNIT LAMPUNG

2017 ◽  
Vol 1 (2) ◽  
Author(s):  
Joko Saryono ◽  
Keyword(s):  
Quality Control ◽  
Process Control ◽  
Statistical Process Control ◽  
Control Method ◽  
Production Data ◽  
Statistical Process ◽  
Research Results ◽  
Statistic Process Control ◽  
Gas Volume ◽  
A Company

Abstract PT. COCA-COLA BOTTLING INDONESIA is a company engaged in the field of Agro-industry is bottling soft drinks and not sparkling. The products produced are Coca-Cola, Sprite, Fanta, and Tea. To be able to compete with similar industries then the company implements quality control by Statistical Process Control method. In the development of this SPC many methods there are manual or who use the software. Currently PT. Coca-Cola Bottling Indonesia in quality control using Time Charting method, but since the transition from Minitab to Time Charting the tendency of the value of capability below standard, whereas production data is almost the same as using Minitab. The purpose of this research is to analyze the inequality of Statistical Process Control between Minitab 13 and Time Charting. Time Charting method is a new method that is given by the headquarters for the process of quality control can be fast and accurate. Quality control with the Statistical Process Control of Minitab and Time Charting methods after the results of the research results was found to be part of different LSL and USL charging, and Calculate Statistic Using different from Minitab method should still be 6 but in written procedure 3. For writing LSL And USL if the Time Charting is determined by the head office while Minitab analysts fill in based on experiments on the decrease of gas volume marketed in previous years. From the research results obtained Cpk data for Minitab method 13 is Sprite 390 ml 1.47, Sprite 1000 ml 1.90 and Sprite 1500 ml 1.38. The result of the research was using Minitab method and the Charting Time of Capacity that is above 1.33 average. The causes of the resulting inequality of both methods are the LSL, USL and Calculate Statistic Using values. The smaller the value of Calculate Statistic Using the higher Cpk produced. Keywords: Production, Statistical Process Control, Quality.

scholarly journals Why Should We Have a Periodic Safety and Performance Program for Medical Devices

2018 ◽  
Author(s):  
A Tavakoli Golpaygani
Keyword(s):  
Quality Control ◽  
High Risk ◽  
Medical Devices ◽  
Medical Equipment ◽  
Control Program ◽  
Electrical Safety ◽  
Leakage Currents ◽  
Quality Control Program ◽  
Periodic Safety ◽  
And Performance

Nowadays, more than 10,000 different types of medical devices can be found in hospitals.These devices used in medical centers and hospitals for monitoring and treatment of patients require periodic safety and performance checking in order to have confidence in their functioning and operation. Physicians need better accurate medical measurements in order to better diagnose diseases, monitor patients and deliver treatments, in this way failure to ensure appropriate measurements will certainly have diverse effects. Safety and performance testing of medical devices in the medical sector is a one of the key factor in improving public health. Acquiring results of some investigations indicate a need for new and severe regulations on periodic performance verifications and medical equipment quality control program especially in highrisks instruments.The metrological reliability of four high risk medical devices, Electrosurgical unit, Defibrillator, Syringe pump and Infant incubator in use some hospitals (privates and publics) in one of the province of Iran according to international and national standards was evaluated. Quantitative analysis of Some parameters that impact the safety and performance showed the amount of the obtained results in some equipment are in critical range and have higher values than standard limitations. General electrical safety evaluations for measuring the patient leakage currents and patient auxiliary currents carried out for all of groups,in some cases the amount of leakage currents were over the standard limitations.Acquiring results indicate a need for new and severe regulations on periodic performance verifications and medical equipment quality control program especially in high risk instruments. It is also necessary provide training courses for operating staff in the field of meterology in medicine and what’s the critical parameters and how they can get good accuracy results equipment.

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