Grid Technology in Telepatology and Personalised Treatment

2010 ◽  
pp. 117-128 ◽  
Author(s):  
O. Ferrer-Roca ◽  
F Marcan ◽  
ME. Vidal ◽  
E. Ruckhaus ◽  
Roberto Fernández-Baíllo ◽  
...  
Keyword(s):  
Quality Control ◽  
Medical Devices ◽  
Diagnostic Errors ◽  
Grid Technology ◽  
Iso 17025 ◽  
Collaborative Tools ◽  
Relevant Role ◽  
Literature Based Discovery ◽  
Grid Networking ◽  
Personalised Treatment

Histopathology requires automation, quality control and global collaborative tools. Usually the PIMS (Pathology information management system) automates samples, images and reports and progressively incorporates the PI (Pathology informatics), the D-PATH (digital pathology), e-PATH (electronic pathology), the PPH (Patho-pharmacology), virtual autopsy (VA) and all type of translational research in the PMIS. Not being subject to a specific standard, quality control follows ISO-13485:2003 on services and medical devices, ISO 17025:2005 on technical aspects; and ISO-15198:2003 for automate and quantifiable procedures that will be affected by the new European Directive on medical devices. For the non-standardized pathology procedures, consumer’s requirements are what define test and calibration procedures. The paper analysed the non-standardized procedures: VS (Virtual Slides), GRID networking and Literature Based Discovery as tools for knowledge discovery of relevant relationships on image-diagnosis and personalized treatments. Standardized procedures available for search and annotation are the ISO/IEC 11179 Information Technology Metadata Registries specification, the ISO/IEC 13250:2003 for topics maps or MPEG-7 & 21 for images and the ISO/IEC 24800-3 for JPEG query search. The forthcoming innovations prepare to quality certify the so called “solo-pathology” robotic labs, supported by telepathology to reduce diagnostic errors and carrying out a relevant task on personalized treatment through GRID technology. In this environment the JPEG query search play a relevant role on images which metadata can be annotated on natural language.

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 

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.

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.

Quality Assurance in the Analytical Chemistry Laboratory

2007 ◽  
Author(s):  
D. Brynn Hibbert
Keyword(s):  
Analytical Chemistry ◽  
Quality Control ◽  
Quality Assurance ◽  
Metrological Traceability ◽  
International Standards ◽  
Chemistry Laboratory ◽  
Iso 17025 ◽  
Control Procedures ◽  
Analytical Services ◽  
The Right

Analytical chemical results touch everyones lives can we eat the food? do I have a disease? did the defendant leave his DNA at the crime scene? should I invest in that gold mine? When a chemist measures something how do we know that the result is appropriate? What is fit for purpose in the context of analytical chemistry? Many manufacturing and service companies have embraced traditional statistical approaches to quality assurance, and these have been adopted by analytical chemistry laboratories. However the right chemical answer is never known, so there is not a direct parallel with the manufacture of ball bearings which can be measured and assessed. The customer of the analytical services relies on the quality assurance and quality control procedures adopted by the laboratory. It is the totality of the QA effort, perhaps first brought together in this text, that gives the customer confidence in the result. QA in the Analytical Chemistry Laboratory takes the reader through all aspects of QA, from the statistical basics and quality control tools to becoming accredited to international standards. The latest understanding of concepts such as measurement uncertainty and metrological traceability are explained for a working chemist or her client. How to design experiments to optimize an analytical process is included, together with the necessary statistics to analyze the results. All numerical manipulation and examples are given as Microsoft Excel spreadsheets that can be implemented on any personal computer. Different kinds of interlaboratory studies are explained, and how a laboratory is judged in proficiency testing schemes is described. Accreditation to ISO 17025 or OECD GLP is nearly obligatory for laboratories of any pretension to quality. Here the reader will find an introduction to the requirements and philosophy of accreditation. Whether completing a degree course in chemistry or working in a busy analytical laboratory, this book is a single source for an introduction into quality assurance.

Indication System Weight Calculation on Quality Control of Production Process for Medical Devices

2014 ◽  
Vol 513-517 ◽  
pp. 3139-3142
Author(s):  
Hong Xing Zhang ◽  
Yang Liu ◽  
Xue Kui Shi
Keyword(s):  
Quality Control ◽  
Analytic Hierarchy Process ◽  
Medical Devices ◽  
Analysis Model ◽  
Analytic Hierarchy ◽  
Basic Work ◽  
Weight Calculation ◽  
Productive Process ◽  
Indication System ◽  
Hierarchy Process

Medical devices is playing an increasingly important role in the course of people's life, it has a very important significance to strengthen the quality control of medical devices productive process. For the difficult issues of evaluation on quality control of productive process, this paper is based on quantitative analysis, using Analytic Hierarchy Process method to research. Firstly, to construct the indication system hierarchical analysis model, and to describe each indicators ; Then, on the basis of clarifying the advantages of Analytic Hierarchy Process, to set up mathematical model, including constructing judgment matrix and single-level sorting in two steps. Finally, to calculate the weight of indication system according to the solving steps. The research contents of this paper, is the basic work of evaluation for the quality control of medical device productive process, for the safe production of medical devices companies to provide technical and methodological support.

RISK-BASED TESTING APPROACH FOR MEDICAL DEVICES SOFTWARE

2020 ◽  
Vol 70 (4) ◽  
Author(s):  
Ivan Ivanov ◽  
V. Gueorguiev ◽  
D. Georgieva ◽  
M. Nenova ◽  
B. Ivanov
Keyword(s):  
Quality Control ◽  
Quality Assessment ◽  
Medical Device ◽  
Medical Devices ◽  
Development Process ◽  
Functional Requirements ◽  
Device Development ◽  
Stage Of Development ◽  
Requirements Specifications ◽  
Testing Approach

A successful "medical device" development requires the collaboration be-tween designers, developers, and quality engineers to be able to assess needs, functional requirements, specifications, and problems at every stage of development. The quality control of the developing process is achieved through a predefined set of policies, quality assessment, and the management of activities to eliminate defects and weaknesses wherever the development process.

scholarly journals Influence of different test gases in a non-destructive 100% quality control system for medical devices

2016 ◽  
Vol 2 (1) ◽  
pp. 587-591
Author(s):  
Thomas Pollack ◽  
Hermann Seitz
Keyword(s):  
Risk Management ◽  
Quality Control ◽  
Intensive Care ◽  
Control System ◽  
Intensive Care Units ◽  
Medical Devices ◽  
Quality Control System ◽  
Critical Ill Patients ◽  
Non Destructive ◽  
Critical Ill

AbstractThe purpose of this research is to evaluate the detectability of defect membranes in intravenous (IV) infusion filter systems. The device under test (DUT) protects critical ill patients and has a high priority for the risk management of intensive care units. The developed quality control system stands out from other filter integrity methods because no method located on this topic represents such a simple, reliable, fast and non-destructive technique, examined without liquid. The invented method works as a pressure driven test and uses gas to identify defects. Previous studies have demonstrated the capability of detecting various types of errors. In this paper the influence of different test gases on the detectability of smallest defects is presented.

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