Functional Requirements and Quality Assurance Necessary for Successful Incorporation of Electroporation-Based Therapies Into Clinical Practice

2020 ◽  
Vol 14 (1) ◽  
Author(s):  
Eva Pirc ◽  
Matej Reberšek ◽  
Damijan Miklavčič
Keyword(s):  
Quality Assurance ◽  
Clinical Practice ◽  
Medical Device ◽  
Development Process ◽  
Functional Requirements ◽  
Socioeconomically Disadvantaged ◽  
Pulse Parameters ◽  
Disadvantaged Populations ◽  
Safety Guidelines

Abstract Electroporation-based therapies have a huge potential for implementation into clinical practice in socioeconomically disadvantaged populations. Currently, the price of electroporators and electrodes is relatively high, but custom low budget devices can be developed. In the paper, we describe three most established applications in medicine, with the focus on the basic mechanisms, which should be taken into account during the development process of a clinical electroporator. Also, typical pulse parameters used in each of the described applications are defined. In the second part of the paper, we describe technical functional requirements for a clinical electroporator and safety guidelines, with the focus on medical device standard. At the end of the paper, the focus moves to a more general problematic, such as quality assurance and the importance of measurement during the pulse delivery, which we firmly believe is necessary for successful electroporation.

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.

User-Oriented Healthcare Translation and Communication

2020 ◽  
pp. 430-451
Author(s):  
Meng Ji ◽  
Kristine Sørensen ◽  
Pierrette Bouillon
Keyword(s):  
Health Literacy ◽  
Socioeconomically Disadvantaged ◽  
Disadvantaged Populations ◽  
Medical Translation ◽  
Medical Interpreting ◽  
Literacy Research

Healthcare translation provides a useful and powerful intervention tool to facilitate the engagement with migrants with diverse language, cultural, and health literacy backgrounds. The development of culturally effective and patient-oriented healthcare translation resources has become increasingly pressing. In this chapter, the authors explore, firstly, patient-focused and culturally effective healthcare and medical translation methodologies by integrating insights from health literacy research and corpus-based textual readability evaluation and, secondly, user-oriented criteria which can be used in the development and evaluation of new medical interpreting technologies with a view to enhancing the usability among patients from refugee, migrant, or other socioeconomically disadvantaged populations.

scholarly journals Conflicts of Interest in Clinical Practice Guidelines: Accelerating an Evolution. An Endocrine Society Consensus Statement*

2018 ◽  
Vol 103 (12) ◽  
pp. 4339-4342 ◽  
Author(s):  
Christopher R McCartney ◽  
Clifford J Rosen
Keyword(s):  
Clinical Practice ◽  
Best Practices ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Development Process ◽  
Consensus Statement ◽  
Conflicts Of Interest ◽  
Best Interests ◽  
Endocrine Society ◽  
Open Payments

Abstract An analysis of the Endocrine Society’s clinical practice guidelines (CPGs) published from 2010 to 2017—presented by Irwig et al. in the current issue of The Journal of Endocrinology and Metabolism—suggested that the Endocrine Society met five of seven National Academy of Medicine (NAM) standards concerning financial conflicts of interest in CPGs. As current contributors to the Endocrine Society’s CPG efforts, we offer additional context related to the 2011 NAM standards and the current environment concerning industry support in medicine, and we comment on the nature of industry support received by the Society’s CPG authors according to Irwig and colleagues’ analysis of the Centers for Medicare and Medicaid Services’ Open Payments database. Perhaps most importantly, we outline the Society’s recent and ongoing efforts to enhance the value of its CPGs. Such efforts include a 2016 revision of CPG author conflict of interest rules—a change that was invisible to the investigatory methods used by Irwig et al.—in addition to other processes designed to enhance CPG objectivity. We conclude our commentary by recognizing that good-faith attempts to enhance transparency and to reduce conflicts of interest (real or apparent) in CPGs will ultimately serve the best interests of patients and providers; we confirm the Endocrine Society’s resolute commitment to providing high-quality, evidence-based clinical guidance via a CPG development process that faithfully accords with current CPG best practices.

scholarly journals THE MEDICAL PHYSICIST - SCIENTIST BEHIND THE CURTAIN

2021 ◽  
Vol 10 (4) ◽  
pp. 3212-3213
Author(s):  
Anurag A. Luharia
Keyword(s):  
Quality Assurance ◽  
Clinical Practice ◽  
Radiation Protection ◽  
Medical Physics ◽  
Analytical Techniques ◽  
Modern Medicine ◽  
Quality Assurance Program ◽  
Medical Physicist ◽  
Accurate Treatment ◽  
Medical Physicists

Ionizing radiation has validated its existence and effectiveness in modern medicine for both diagnostic and therapeutic use. For the last decade rapid growth in medical radiation application has witnessed in India towards the betterment of mankind, for safe and quality clinical practice, radiation protection and quality assurance. At the end of the 19th century Physics brought paradigm shift in the field of radiation-based medical diagnosis and treatment and giving rise to the modern medical physicist profession and revolutionized the practice of medicine. Medical Physicists are the scientists with Post graduation / PhD degrees, and certified from A.E.R.B as Radiological Safety Officer, deals with utilization of Physics knowledge in developing not only lifesaving tools & technology but also diagnosis and treatments of various medical conditions that help humans live longer and healthier. Medical Physicists are responsible to carry out the commissioning, establishment of entire Radiation facility and get the clearance of statutory compliances form authorities in order to start the clinical practice are also responsible for research, developing and evaluating new analytical techniques, planning and ensuring safe and accurate treatment of patients also provide advice about radiation protection, training and updating healthcare, scientific and technical staff , managing radiotherapy quality assurance program, mathematical modeling ,maintaining equipment ,writing reports, teaching ,laboratory management and administration. Now it’s a time to raise the curtain from the Medical Physics profession and utilize their services up to maximum extent in the field of scientific research, academic, teaching, diagnosis, treatment and safety.

scholarly journals Development and Evaluation of Clinical Practice Guideline for Delirium in Long-Term Care

2020 ◽  
Vol 17 (21) ◽  
pp. 8255
Author(s):  
Eunhye Jeong ◽  
Jinkyung Park ◽  
Sung Ok Chang
Keyword(s):  
Clinical Practice ◽  
Development Process ◽  
Healthcare Professionals ◽  
Long Term Care ◽  
Structured Interviews ◽  
Term Care ◽  
Barriers To Implementation ◽  
Selection For ◽  
Search Quality

Delirium is highly prevalent and leads to several bad outcomes for older long-term care (LTC) residents. For a more successful translation of delirium knowledge, Clinical Practice Guidelines (CPGs) tailored to LTC should be developed and applied based on the understanding of the barriers to implementation. This study was conducted to develop a CPG for delirium in LTC and to determine the barriers perceived by healthcare professionals related to the implementation of the CPG. We followed a structured, evidence- and theory-based procedure during the development process. After a systematic search, quality appraisal, and selection for eligible up-to-date CPGs for delirium, the recommendations applicable to the LTC were drafted, evaluated, and confirmed by an external group of experts. To evaluate the barriers to guideline uptake from the users’ perspectives, semi-structured interviews were conducted which resulted in four major themes: (1) a lack of resources, (2) a tendency to follow mindlines rather than guidelines, (3) passive attitudes, and (4) misunderstanding delirium care in LTC. To minimize adverse prognoses through prompt delirium care, the implementation of a CPG with an approach that comprehensively considers various barriers at the system, practice, healthcare professional, and patients/family levels is necessary.

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