Checks and tests for newly-delivered medical devices

Checks and tests for newly-delivered medical devices PDF Author: Great Britain. Medical Devices Agency
Publisher:
ISBN:
Category : Management
Languages : en
Pages : 23

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Book Description

Checks and tests for newly-delivered medical devices

Checks and tests for newly-delivered medical devices PDF Author: Great Britain. Medical Devices Agency
Publisher:
ISBN:
Category : Management
Languages : en
Pages : 23

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Book Description


Inspection of Medical Devices

Inspection of Medical Devices PDF Author: Almir Badnjević
Publisher: Springer Nature
ISBN: 3031434447
Category : Technology & Engineering
Languages : en
Pages : 441

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Book Description
This comprehensive guide invites nations worldwide to embark on a transformative journey, implementing independent third-party verification systems that ensure medical devices comply with both international and national regulations. Prepare to be captivated as we delve into the intricate processes, unveil essential procedures, and illuminate the paramount importance of establishing traceability for medical device measurements. Imagine a world where medical devices undergo rigorous independent safety and performance verification, guaranteeing the utmost reliability for patient diagnoses and treatment. This book takes you on a compelling exploration of precisely that vision. Focusing on cutting-edge diagnostic and therapeutic devices, it captures the very essence of the latest international directives and regulations, ensuring you stay ahead of the curve. This new edition goes beyond the conventional, delving into the realms of innovation and progress. Unveiling in-depth maintenance regimes within healthcare institutions, we provide you with invaluable insights into post-market surveillance. As the world embraces the transformative potential of artificial intelligence, we pave the way for evidence-based management of medical device maintenance—a concept poised to reshape the healthcare landscape. Imagine a future where medical devices are seamlessly integrated into the legal metrology system, while fully operational national laboratories for medical device inspection set new standards of excellence. This book vividly illustrates how such a powerful union can elevate the reliability of medical devices in diagnosis and patient care. Brace yourself for a paradigm shift that not only enhances efficacy but also leads to significant cost reductions within your country's healthcare system. Join us on this extraordinary journey as we unveil the untapped potential of medical device inspection. With our innovative approach and unrivaled expertise, together we can revolutionize healthcare, transforming the lives of countless patients worldwide. Get ready to be inspired, informed, and empowered—welcome to the future of healthcare!

The Role of Human Factors in Home Health Care

The Role of Human Factors in Home Health Care PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 0309156297
Category : Medical
Languages : en
Pages : 322

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Book Description
The rapid growth of home health care has raised many unsolved issues and will have consequences that are far too broad for any one group to analyze in their entirety. Yet a major influence on the safety, quality, and effectiveness of home health care will be the set of issues encompassed by the field of human factors research-the discipline of applying what is known about human capabilities and limitations to the design of products, processes, systems, and work environments. To address these challenges, the National Research Council began a multidisciplinary study to examine a diverse range of behavioral and human factors issues resulting from the increasing migration of medical devices, technologies, and care practices into the home. Its goal is to lay the groundwork for a thorough integration of human factors research with the design and implementation of home health care devices, technologies, and practices. On October 1 and 2, 2009, a group of human factors and other experts met to consider a diverse range of behavioral and human factors issues associated with the increasing migration of medical devices, technologies, and care practices into the home. This book is a summary of that workshop, representing the culmination of the first phase of the study.

Registries for Evaluating Patient Outcomes

Registries for Evaluating Patient Outcomes PDF Author: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
ISBN: 1587634333
Category : Medical
Languages : en
Pages : 396

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Book Description
This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

Pregnancy, Childbirth, Postpartum and Newborn Care

Pregnancy, Childbirth, Postpartum and Newborn Care PDF Author: World Health Organization
Publisher:
ISBN: 9789241549356
Category : Health & Fitness
Languages : en
Pages : 0

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Book Description
Intended to provide evidence-based recommendations to guide health care professionals in the management of women during pregnancy, childbirth and postpartum, and newborns, and the post abortion, including management of endemic deseases like malaria, HIV/AIDS, TB and anaemia. This edition has been updated to include recommendations from recently approved WHO guidelines relevant to maternal and perinatal health. These include pre-eclampsia & eclampsia; postpartum haemorrhage; postnatal care for the mother and baby; newborn resuscitation; prevention of mother-to- child transmission of HIV; HIV and infant feeding; malaria in pregnancy, interventions to improve preterm birth outcomes, tobacco use and second-hand exposure in pregnancy, post-partum depression, post-partum family planning and post abortion care.

Facilities for Surgical Procedures

Facilities for Surgical Procedures PDF Author: NHS Estates
Publisher: The Stationery Office
ISBN: 9780113224951
Category : Medical
Languages : en
Pages : 96

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Book Description
Supplies guidance relevant to facilities for surgical procedures in all healthcare settings. This volume covers the facilities required to support in-patient operating theatres in an acute general hospital.

Usability Testing of Medical Devices

Usability Testing of Medical Devices PDF Author: Michael E. Wiklund, P.E.
Publisher: CRC Press
ISBN: 1466595892
Category : Medical
Languages : en
Pages : 472

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Book Description
Usability Testing of Medical Devices covers the nitty-gritty of usability test planning, conducting, and results reporting. The book also discusses the government regulations and industry standards that motivate many medical device manufacturers to conduct usability tests.Since publication of the first edition, the FDA and other regulatory groups h

Epidural Analgesia in Acute Pain Management

Epidural Analgesia in Acute Pain Management PDF Author: Carolyn Middleton
Publisher: John Wiley & Sons
ISBN: 0470033754
Category : Medical
Languages : en
Pages : 218

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Book Description
Epidurals are increasingly popular and have become more versatile, with applications in adult surgery, trauma, obstetrics and paediatric practice. This book of best practice guidelines aims to help develop and improve patient care, stimulate learning and highlight ideas for nursing research. It can be used as a quick reference guide for clinical practice or as a framework for developing individual local epidural services and practice guidelines. outlines the specific responsibilities of the multidisciplinary healthcare team in relation to epidural practice reviews the issues of risk benefit analysis and informed consent provides an overview of the physiology of acute pain, epidural catheter insertion procedure and the pharmacodynamics and pharmacokinetics of the commonest classes of drugs describes the equipment required to ensure safe and effective delivery of epidural solution to patients An overview of the nature and frequency of the observations required for close monitoring of patients and a practical guide to the removal of the catheter are also provided. Clinical governance and competency-based training are also addressed, and a framework provided to fit the training into the Agenda for Change Knowledge and Skills framework.

Regulatory Requirements for Medical Devices

Regulatory Requirements for Medical Devices PDF Author:
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 440

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Book Description


Public Health Effectiveness of the FDA 510(k) Clearance Process

Public Health Effectiveness of the FDA 510(k) Clearance Process PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309162904
Category : Medical
Languages : en
Pages : 141

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Book Description
The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.