Reuse Of Single Use Medical Devices

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Medical Device Regulations

Author : Michael Cheng
Publisher : World Health Organization
ISBN 13 : 9241546182
Total Pages : 54 pages
Book Rating : 4.2/5 (415 download)

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Book Synopsis Medical Device Regulations by : Michael Cheng

Download or read book Medical Device Regulations written by Michael Cheng and published by World Health Organization. This book was released on 2003-09-16 with total page 54 pages. Available in PDF, EPUB and Kindle. Book excerpt: The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.

Single-Use Medical Devices

Author : United States Accounting Office
Publisher : Createspace Independent Publishing Platform
ISBN 13 : 9781985285118
Total Pages : 38 pages
Book Rating : 4.2/5 (851 download)

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Book Synopsis Single-Use Medical Devices by : United States Accounting Office

Download or read book Single-Use Medical Devices written by United States Accounting Office and published by Createspace Independent Publishing Platform. This book was released on 2018-02-13 with total page 38 pages. Available in PDF, EPUB and Kindle. Book excerpt: HEHS-00-123 Single-Use Medical Devices: Little Available Evidence of Harm From Reuse, but Oversight Warranted

Medical Devices

Author : World Health Organization
Publisher : World Health Organization
ISBN 13 : 9241564040
Total Pages : 147 pages
Book Rating : 4.2/5 (415 download)

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Book Synopsis Medical Devices by : World Health Organization

Download or read book Medical Devices written by World Health Organization and published by World Health Organization. This book was released on 2010 with total page 147 pages. Available in PDF, EPUB and Kindle. Book excerpt: Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9

Reusable Elastomeric Respirators in Health Care

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309485150
Total Pages : 227 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Reusable Elastomeric Respirators in Health Care by : National Academies of Sciences, Engineering, and Medicine

Download or read book Reusable Elastomeric Respirators in Health Care written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-04-15 with total page 227 pages. Available in PDF, EPUB and Kindle. Book excerpt: Protecting the health and safety of health care workers is vital to the health of each of us. Preparing for and responding to a future influenza pandemic or to a sustained outbreak of an airborne transmissible disease requires a high-level commitment to respiratory protection for health care workers across the wide range of settings in which they work and the jobs that they perform. Keeping health care workers healthy is an ethical commitment both in terms of addressing the occupational risks faced by health care workers and of providing for the continuity of patient care and services needed to maintain the health of individuals and communities. During a public health emergency, challenges will arise concerning the availability of respiratory protective devices (i.e., respirators). Reusable respirators (specifically, reusable half-facepiece elastomeric respirators) are the standard respiratory protection device used in many industries, and they provide an option for use in health care that has to date not been fully explored. The durability and reusability of elastomeric respirators make them desirable for stockpiling for emergencies, where the need for large volumes of respirators can be anticipated. However, they are used infrequently in health care. Reusable Elastomeric Respirators in Health Care explores the potential for the use of elastomeric respirators in the U.S. health care system with a focus on the economic, policy, and implementation challenges and opportunities. This report examines the practicability of elastomeric use in health care on a routine basis and during an influenza pandemic or other large aerosol-transmissible outbreak, when demand for respiratory protective devices by U.S. health care personnel may be larger than domestic supplies. The report also addresses the issues regarding emergency stockpile management of elastomeric respiratory protective devices.

Humanizing Healthcare – Human Factors for Medical Device Design

Author : Russell J. Branaghan
Publisher : Springer Nature
ISBN 13 : 3030644332
Total Pages : 395 pages
Book Rating : 4.0/5 (36 download)

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Book Synopsis Humanizing Healthcare – Human Factors for Medical Device Design by : Russell J. Branaghan

Download or read book Humanizing Healthcare – Human Factors for Medical Device Design written by Russell J. Branaghan and published by Springer Nature. This book was released on 2021-02-21 with total page 395 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book introduces human factors engineering (HFE) principles, guidelines, and design methods for medical device design. It starts with an overview of physical, perceptual, and cognitive abilities and limitations, and their implications for design. This analysis produces a set of human factors principles that can be applied across many design challenges, which are then applied to guidelines for designing input controls, visual displays, auditory displays (alerts, alarms, warnings), and human-computer interaction. Specific challenges and solutions for various medical device domains, such as robotic surgery, laparoscopic surgery, artificial organs, wearables, continuous glucose monitors and insulin pumps, and reprocessing, are discussed. Human factors research and design methods are provided and integrated into a human factors design lifecycle, and a discussion of regulatory requirements and procedures is provided, including guidance on what human factors activities should be conducted when and how they should be documented. This hands-on professional reference is an essential introduction and resource for students and practitioners in HFE, biomedical engineering, industrial design, graphic design, user-experience design, quality engineering, product management, and regulatory affairs. Teaches readers to design medical devices that are safer, more effective, and less error prone; Explains the role and responsibilities of regulatory agencies in medical device design; Introduces analysis and research methods such as UFMEA, task analysis, heuristic evaluation, and usability testing.

Medical Devices and the Public's Health

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309212421
Total Pages : 318 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Medical Devices and the Public's Health by : Institute of Medicine

Download or read book Medical Devices and the Public's Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-11-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.

Manual of Infection Control Procedures

Author : N. N. Damani
Publisher : Cambridge University Press
ISBN 13 : 9781841101071
Total Pages : 368 pages
Book Rating : 4.1/5 (1 download)

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Book Synopsis Manual of Infection Control Procedures by : N. N. Damani

Download or read book Manual of Infection Control Procedures written by N. N. Damani and published by Cambridge University Press. This book was released on 2003 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides a comprehensive overview of the main aspects of infection control, and gives practical, evidence-based recommendations.

Global Gidelines for the Pevention of Surgical Site Infection

Author : World Health Organization
Publisher :
ISBN 13 : 9789241549882
Total Pages : 184 pages
Book Rating : 4.5/5 (498 download)

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Book Synopsis Global Gidelines for the Pevention of Surgical Site Infection by : World Health Organization

Download or read book Global Gidelines for the Pevention of Surgical Site Infection written by World Health Organization and published by . This book was released on 2017-01-27 with total page 184 pages. Available in PDF, EPUB and Kindle. Book excerpt: Surgical site infections are caused by bacteria that get in through incisions made during surgery. They threaten the lives of millions of patients each year and contribute to the spread of antibiotic resistance. In low- and middle-income countries, 11% of patients who undergo surgery are infected in the process. In Africa, up to 20% of women who have a caesarean section contract a wound infection, compromising their own health and their ability to care for their babies. But surgical site infections are not just a problem for poor countries. In the United States, they contribute to patients spending more than 400 000 extra days in hospital at a cost of an additional US $10 billion per year. No international evidence-based guidelines had previously been available before WHO launched its global guidelines on the prevention of surgical site infection on 3 November 2016, and there are inconsistencies in the interpretation of evidence and recommendations in existing national guidelines. These new WHO guidelines are valid for any country and suitable to local adaptations, and take account of the strength of available scientific evidence, the cost and resource implications, and patient values and preferences.

Core Topics in Airway Management

Author : Ian Calder
Publisher : Cambridge University Press
ISBN 13 : 9781139443043
Total Pages : 230 pages
Book Rating : 4.4/5 (43 download)

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Book Synopsis Core Topics in Airway Management by : Ian Calder

Download or read book Core Topics in Airway Management written by Ian Calder and published by Cambridge University Press. This book was released on 2005-01-06 with total page 230 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an easy-to-read introduction to this important topic that will be of value to a wide spectrum of healthcare professionals including anaesthetists, intensivists, ODPs, theatre and recovery nurses. Concise but comprehensive chapters from experts in the field cover everything from basic anatomy, physiology and applied physics, through the various methods of maintaining the airway under anaesthesia (supraglottic devices, tracheal intubation, tubes/cuffs, endobronchial and double-lumen tubes) to the problem airway (obstruction by infection, tumour or a foreign body, ENT and maxillo-facial surgery, aspiration, obstetrics, trauma, cervical spine disease, intensive care, the 'lost' airway, extubation and recovery), the paediatric airway, disinfection and cleaning of equipment and finally morbidity, mortality and medico-legal issues. 'Real' clinical scenarios, with patient management questions and model answers, are included throughout, to bring to life some of the key problems encountered in day-to-day practice and enhance the book's utility as a teaching and self-learning tool.

Safe Management of Wastes from Health-care Activities

Author : Yves Chartier
Publisher : World Health Organization
ISBN 13 : 9241548568
Total Pages : 327 pages
Book Rating : 4.2/5 (415 download)

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Book Synopsis Safe Management of Wastes from Health-care Activities by : Yves Chartier

Download or read book Safe Management of Wastes from Health-care Activities written by Yves Chartier and published by World Health Organization. This book was released on 2014 with total page 327 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the second edition of the WHO handbook on the safe, sustainable and affordable management of health-care waste--commonly known as "the Blue Book". The original Blue Book was a comprehensive publication used widely in health-care centers and government agencies to assist in the adoption of national guidance. It also provided support to committed medical directors and managers to make improvements and presented practical information on waste-management techniques for medical staff and waste workers. It has been more than ten years since the first edition of the Blue Book. During the intervening period, the requirements on generators of health-care wastes have evolved and new methods have become available. Consequently, WHO recognized that it was an appropriate time to update the original text. The purpose of the second edition is to expand and update the practical information in the original Blue Book. The new Blue Book is designed to continue to be a source of impartial health-care information and guidance on safe waste-management practices. The editors' intention has been to keep the best of the original publication and supplement it with the latest relevant information. The audience for the Blue Book has expanded. Initially, the publication was intended for those directly involved in the creation and handling of health-care wastes: medical staff, health-care facility directors, ancillary health workers, infection-control officers and waste workers. This is no longer the situation. A wider range of people and organizations now have an active interest in the safe management of health-care wastes: regulators, policy-makers, development organizations, voluntary groups, environmental bodies, environmental health practitioners, advisers, researchers and students. They should also find the new Blue Book of benefit to their activities. Chapters 2 and 3 explain the various types of waste produced from health-care facilities, their typical characteristics and the hazards these wastes pose to patients, staff and the general environment. Chapters 4 and 5 introduce the guiding regulatory principles for developing local or national approaches to tackling health-care waste management and transposing these into practical plans for regions and individual health-care facilities. Specific methods and technologies are described for waste minimization, segregation and treatment of health-care wastes in Chapters 6, 7 and 8. These chapters introduce the basic features of each technology and the operational and environmental characteristics required to be achieved, followed by information on the potential advantages and disadvantages of each system. To reflect concerns about the difficulties of handling health-care wastewaters, Chapter 9 is an expanded chapter with new guidance on the various sources of wastewater and wastewater treatment options for places not connected to central sewerage systems. Further chapters address issues on economics (Chapter 10), occupational safety (Chapter 11), hygiene and infection control (Chapter 12), and staff training and public awareness (Chapter 13). A wider range of information has been incorporated into this edition of the Blue Book, with the addition of two new chapters on health-care waste management in emergencies (Chapter 14) and an overview of the emerging issues of pandemics, drug-resistant pathogens, climate change and technology advances in medical techniques that will have to be accommodated by health-care waste systems in the future (Chapter 15).

Sterilization Technology for the Health Care Facility

Author : Marimargaret Reichert
Publisher : Jones & Bartlett Learning
ISBN 13 : 9780834208384
Total Pages : 328 pages
Book Rating : 4.2/5 (83 download)

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Book Synopsis Sterilization Technology for the Health Care Facility by : Marimargaret Reichert

Download or read book Sterilization Technology for the Health Care Facility written by Marimargaret Reichert and published by Jones & Bartlett Learning. This book was released on 1997 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Second Edition is a comprehensive resource on sterilization and disinfection of reusable instruments and medical devices

Practical Healthcare Epidemiology

Author : Ebbing Lautenbach
Publisher : Cambridge University Press
ISBN 13 : 1107153166
Total Pages : 455 pages
Book Rating : 4.1/5 (71 download)

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Book Synopsis Practical Healthcare Epidemiology by : Ebbing Lautenbach

Download or read book Practical Healthcare Epidemiology written by Ebbing Lautenbach and published by Cambridge University Press. This book was released on 2018-04-19 with total page 455 pages. Available in PDF, EPUB and Kindle. Book excerpt: A clear, hands-on outline of best practices for infection prevention that directly improve patient outcomes across the healthcare continuum.

A Practical Guide to Decontamination in Healthcare

Author : Gerald E. McDonnell
Publisher : John Wiley & Sons
ISBN 13 : 1118321316
Total Pages : 466 pages
Book Rating : 4.1/5 (183 download)

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Book Synopsis A Practical Guide to Decontamination in Healthcare by : Gerald E. McDonnell

Download or read book A Practical Guide to Decontamination in Healthcare written by Gerald E. McDonnell and published by John Wiley & Sons. This book was released on 2012-05-17 with total page 466 pages. Available in PDF, EPUB and Kindle. Book excerpt: Prevention is the first line of defence in the fight against infection. As antibiotics and other antimicrobials encounter increasing reports of microbial resistance, the field of decontamination science is undergoing a major revival. A Practical Guide to Decontamination in Healthcare is a comprehensive training manual, providing practical guidance on all aspects of decontamination including: microbiology and infection control; regulations and standards; containment, transportation, handling, cleaning, disinfection and sterilization of patient used devices; surgical instrumentation; endoscopes; and quality management systems. Written by highly experienced professionals, A Practical Guide to Decontaminationin Healthcare comprises a systematic review of decontamination methods, with uses and advantages outlined for each. Up-to-date regulations, standards and guidelines are incorporated throughout, to better equip healthcare professionals with the information they need to meet the technical and operational challenges of medical decontamination. A Practical Guide to Decontaminationin Healthcare is an important new volume on state-of-the-art decontamination processes and a key reference source for all healthcare professionals working in infectious diseases, infection control/prevention and decontamination services.

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

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309162904
Total Pages : 141 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Public Health Effectiveness of the FDA 510(k) Clearance Process by : Institute of Medicine

Download or read book Public Health Effectiveness of the FDA 510(k) Clearance Process written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-04 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Preventing HIV through safe voluntary medical male circumcision for adolescent boys and men in generalized HIV epidemics

Author :
Publisher : World Health Organization
ISBN 13 : 9240009663
Total Pages : 16 pages
Book Rating : 4.2/5 (4 download)

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Book Synopsis Preventing HIV through safe voluntary medical male circumcision for adolescent boys and men in generalized HIV epidemics by :

Download or read book Preventing HIV through safe voluntary medical male circumcision for adolescent boys and men in generalized HIV epidemics written by and published by World Health Organization. This book was released on 2020-08-21 with total page 16 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Sterilization Manual for Health Centers

Author : Silvia I. Acosta-Gnass
Publisher : Pan Amer Health Org
ISBN 13 : 9789275129265
Total Pages : 167 pages
Book Rating : 4.1/5 (292 download)

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Book Synopsis Sterilization Manual for Health Centers by : Silvia I. Acosta-Gnass

Download or read book Sterilization Manual for Health Centers written by Silvia I. Acosta-Gnass and published by Pan Amer Health Org. This book was released on 2010 with total page 167 pages. Available in PDF, EPUB and Kindle. Book excerpt: This updated sterilisation manual informs health workers about the simple protocols and procedures that have been developed to prevent hospital-acquired infections both inside and outside the sterilisation plant. The guidelines included in this manual show the steps to follow in cleaning, preparing, sterilizing, storing and transporting hospital equipment so as to obtain sterile material. It is very important to be aware of this information in order to provide patients with safe health care.

WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices

Author : World Health Organization
Publisher :
ISBN 13 : 9789241512350
Total Pages : 72 pages
Book Rating : 4.5/5 (123 download)

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Book Synopsis WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices by : World Health Organization

Download or read book WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices written by World Health Organization and published by . This book was released on 2017-05-09 with total page 72 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Model recommends guiding principles and harmonized definitions and specifies the attributes of effective and efficient regulation to be embodied within binding and enforceable law. Its main elements refer to international harmonization guidance documents developed by the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF). The Model is particularly relevant for WHO Member States with little or no regulation for medical devices currently in place but with the ambition to improve this situation. It foresees that such countries will progress from basic regulatory controls towards an expanded level to the extent that their resources allow. The Model is written for the legislative, executive, and regulatory branches of government as they develop and establish a system of medical devices regulation. It describes the role and responsibilities of a country's regulatory authority for implementing and enforcing the regulations. Also, it describes circumstances in which a regulatory authority may either "rely on" or "recognize" the work products from trusted regulatory sources (such as scientific assessments, audit, and inspection reports) or from the WHO Prequalification Team. Section 2 of this document recommends definitions of the terms "medical devices" and IVDs. It describes how they may be grouped according to their potential for harm to the patient or user and specifies principles of safety and performance that the device manufacturer must adhere to. It explains how the manufacturer must demonstrate to a regulatory authority that its medical device has been designed and manufactured to be safe and to perform as intended during its lifetime. Section 3 presents the principles of good regulatory practice and enabling conditions for effectively regulating medical devices. It then introduces essential tools for regulation, explaining the function of the regulatory entity and the resources required. Section 4 presents a stepwise approach to implementing and enforcing regulatory controls for medical devices as the regulation progresses from a basic to an expanded level. It describes elements from which a country may choose according to national priorities and challenges. Also, it provides information on when the techniques of reliance and recognition may be considered and on the importance of international convergence of regulatory practice.Section 5 provides a list of additional topics to be considered when developing and implementing regulations for medical devices. It explains the relevance of these topics and provides guidance for regulatory authorities to ensure that they are addressed appropriately. The Model outlines a general approach but cannot provide country-specific guidance on implementation. While it does not offer detailed guidance on regulatory topics, it contains references to relevant documents where further information may be found. It does not detail the responsibilities of other stakeholders such as manufacturers, distributors, procurement agencies, and health-care professionals, all of whom have roles in assuring the quality, safety, and performance of medical devices.