Download or read book Introduction to Medical Equipment Inventory Management written by World Health Organization and published by World Health Organization. This book was released on 2011-12-15 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: WHO and partners have been working towards devising an agenda, an action plan, tools and guidelines to increase access to appropriate medical devices. This document is part of a series of reference documents being developed for use at the country level. The series will include the following subject areas: * policy framework for health technology * medical device regulations * health technology assessment * health technology management * needs assessment of medical devices * medical device procurement * medical equipment donations * medical equipment inventory management * medical equipment maintenance * computerized maintenance management systems * medical device data * medical device nomenclature * medical devices by health-care setting * medical devices by clinical procedures * medical device innovation, research and development. These documents are intended for use by biomedical engineers, health managers, donors, nongovernmental organizations and academic institutions involved in health technology at the district, national, regional or global levels. Once established, the inventory serves as the foundation for moving forward within the HTM system and ensuring safe and effective medical equipment. The inventory may be used to develop budgets for capital purchases, maintenance and running costs; to build and support an effective clinical engineering department, by allowing for workshop planning, hiring and training of technical support staff, and establishing and maintaining service contracts; to support an effective medical equipment management program, such as planning preventive maintenance activities and tracking work orders; and to plan the stock of spare parts and consumables. The inventory may also be used to support equipment needs assessment within the health-care facility and to record the purchase, receipt, retirement and discarding of equipment. Facility risk analysis and mitigation, and emergency and disaster planning, are also supported by an inventory.
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.
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
Download or read book WHO technical specifications for automated non invasive blood pressure measuring devices with cuff written by World Health Organization and published by World Health Organization. This book was released on 2020-05-11 with total page 72 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Package WHO Medical Device Technical Series written by World Health Organization and published by . This book was released on 2011-12-15 with total page 340 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book WHO List of Priority Medical Devices for Cancer Management written by World Health Organization and published by . This book was released on 2017-05-09 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the model list and clearing house of appropriate, basic, and priority medical devices based on the list of clinical interventions selected from clinical guidelines on prevention, screening, diagnosis, treatment, palliative care, monitoring, and end of life care. This publication addresses medical devices that can be used for the management of cancer and specifically describes medical devices for six types of cancer: breast, cervical, colorectal, leukemia, lung, and prostate. This book is intended for ministries of health, public health planners, health technology managers, disease management, researchers, policy makers, funding, and procurement agencies and support and advocacy groups for cancer patients.
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.
Download or read book Illustrated Glossary of Packaging Terminology written by Walter Soroka and published by DEStech Publications, Inc. This book was released on 2008 with total page 273 pages. Available in PDF, EPUB and Kindle. Book excerpt: Comprising over 4,500 definitions, this book provides explanation of the often arcane, English-language terminology that denotes the materials and manufacturing processes used in different phases of the packaging industry. It is suitable for those who use packaging technology.
Download or read book Human resources for medical devices the role of biomedical engineers written by World Health Organization and published by World Health Organization. This book was released on 2017-05-09 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This publication addresses the role of the biomedical engineer in the development, regulation, management, training, and use of medical devices. The first part of the book looks at the biomedical engineering profession globally as part of the health workforce: global numbers and statistics, professional classification, general education and training, professional associations, and the certification process. The second part addresses all of the different roles that the biomedical engineer can have in the life cycle of the technology, from research and development, and innovation, mainly undertaken in academia; the regulation of devices entering the market; and the assessment or evaluation in selecting and prioritizing medical devices (usually at national level); to the role they play in the management of devices from selection and procurement to safe use in healthcare facilities. The annexes present comprehensive information on academic programs, professional societies, and relevant WHO and UN documents related to human resources for health as well as the reclassification proposal for ILO. This publication can be used to encourage the availability, recognition, and increased participation of biomedical engineers as part of the health workforce, particularly following the recent adoption of the recommendations of the UN High-Level Commission on Health Employment and Economic Growth, the WHO Global Strategy on Human Resources for Health, and the establishment of national health workforce accounts. The document also supports the aim of reclassification of the role of the biomedical engineer as a specific engineer that supports the development, access, and use of medical devices within the national, regional, and global occupation classification system.
Download or read book Springer Handbook of Medical Technology written by Rüdiger Kramme and published by Springer Science & Business Media. This book was released on 2011-10-02 with total page 1503 pages. Available in PDF, EPUB and Kindle. Book excerpt: This concise, user-oriented and up-to-date desk reference offers a broad introduction to the fascinating world of medical technology, fully considering today’s progress and further development in all relevant fields. The Springer Handbook of Medical Technology is a systemized and well-structured guideline which distinguishes itself through simplification and condensation of complex facts. This book is an indispensable resource for professionals working directly or indirectly with medical systems and appliances every day. It is also meant for graduate and post graduate students in hospital management, medical engineering, and medical physics.
Download or read book Package of interventions for rehabilitation Module 1 Introduction written by World Health Organization and published by World Health Organization. This book was released on 2023-07-06 with total page 36 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Package of interventions for rehabilitation outlines the most essential interventions for rehabilitation for 20 health conditions. For each of the interventions, information on the required assistive products, equipment and consumables, and workforce that is usually skilled to deliver these interventions is available. As such, the Package of interventions for rehabilitation presents an indispensable resource for countries when planning for and budgeting the integration of rehabilitation services into their health systems. Module 1: introduction provides background information on rehabilitation and information on the scope and how to use the Package of interventions for rehabilitation. Furthermore, information on the methods that have been used to the develop the Package of interventions for rehabilitation is available in this module. Modules Module 1: Introduction Module 2: Musculoskeletal conditions Module 3: Neurological conditions Module 4: Cardiopulmonary conditions Module 5: Neurodevelopmental disorders Module 6: Sensory conditions Module 7: Malignant neoplasm Module 8: Mental health conditions
Download or read book Clinical Evaluation of Medical Devices written by Karen M. Becker and published by Springer Science & Business Media. This book was released on 2007-11-05 with total page 342 pages. Available in PDF, EPUB and Kindle. Book excerpt: The original edition of this text, Clinical Evaluation of Medical Devices: Principles and Case Studies, provided the first overview of key pr- ciples and approaches to medical device clinical trials, illustrated with a series of detailed, real-world case studies. The book is designed as a resource for clinical professionals and regulatory specialists working in the field of new medical device development and marketing. Since the first edition of this text was published in 1997, the rapid pace of inno- tion in health care technologies continues to yield exciting and important new products. The regulatory landscape has also evolved, reflecting some of the changes and needs within the medical device industry. The purpose of Clinical Evaluation of Medical Devices: Principles and Case Studies, Second Edition is to provide an updated and expanded presentation of the scientific methods and regulatory requirements applied to the study of new significant risk medical devices. The text now includes (1) new information on the requirements and process for gaining reimbursement of new products from Medicare and private insurers, with case studies of research specifically designed for this p- pose as well as health care technology assessment methods; (2) infor- tion on new statistical methodologies applied to medical device trials; and (3) all new case studies, including examples of combination pr- ucts, three-phase development models (i. e. , feasibility, FDA approval, Medicare reimbursement), and novel study designs.
Download or read book First WHO Model List of Essential In Vitro Diagnostics written by World Health Organization and published by World Health Organization. This book was released on 2019-05-16 with total page 73 pages. Available in PDF, EPUB and Kindle. Book excerpt: The objective of the list is to help countries develop or update their national essential diagnostics lists, raise awareness and political will, guide procurement and regulation policies and improve access to the most important in vitro diagnostics that all countries need to make available to their populations, particularly in low-resourced countries. It will also contribute towards health systems strengthening and realizing universal health coverage.
Download or read book The Electronic Packaging Handbook written by Glenn R. Blackwell and published by CRC Press. This book was released on 2017-12-19 with total page 937 pages. Available in PDF, EPUB and Kindle. Book excerpt: The packaging of electronic devices and systems represents a significant challenge for product designers and managers. Performance, efficiency, cost considerations, dealing with the newer IC packaging technologies, and EMI/RFI issues all come into play. Thermal considerations at both the device and the systems level are also necessary. The Electronic Packaging Handbook, a new volume in the Electrical Engineering Handbook Series, provides essential factual information on the design, manufacturing, and testing of electronic devices and systems. Co-published with the IEEE, this is an ideal resource for engineers and technicians involved in any aspect of design, production, testing or packaging of electronic products, regardless of whether they are commercial or industrial in nature. Topics addressed include design automation, new IC packaging technologies, materials, testing, and safety. Electronics packaging continues to include expanding and evolving topics and technologies, as the demand for smaller, faster, and lighter products continues without signs of abatement. These demands mean that individuals in each of the specialty areas involved in electronics packaging-such as electronic, mechanical, and thermal designers, and manufacturing and test engineers-are all interdependent on each others knowledge. The Electronic Packaging Handbook elucidates these specialty areas and helps individuals broaden their knowledge base in this ever-growing field.
Download or read book Plastics in Medical Devices written by Vinny R. Sastri and published by Elsevier. This book was released on 2010-03-05 with total page 289 pages. Available in PDF, EPUB and Kindle. Book excerpt: No book has been published that gives a detailed description of all the types of plastic materials used in medical devices, the unique requirements that the materials need to comply with and the ways standard plastics can be modified to meet such needs. This book will start with an introduction to medical devices, their classification and some of the regulations (both US and global) that affect their design, production and sale. A couple of chapters will focus on all the requirements that plastics need to meet for medical device applications. The subsequent chapters describe the various types of plastic materials, their properties profiles, the advantages and disadvantages for medical device applications, the techniques by which their properties can be enhanced, and real-world examples of their use. Comparative tables will allow readers to find the right classes of materials suitable for their applications or new product development needs.
Download or read book Advances in Patient Safety written by Kerm Henriksen and published by . This book was released on 2005 with total page 526 pages. Available in PDF, EPUB and Kindle. Book excerpt: v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.
Download or read book Packaging Technology and Engineering written by Dipak Kumar Sarkar and published by John Wiley & Sons. This book was released on 2020-09-08 with total page 539 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covers chemistry, physics, engineering, and therapeutic aspects of packaging—universal to pharmaceutical, medical, and food applications This book covers the chemistry, physics, materials science, engineering, and therapeutic aspects of many different types of packaging materials, emphasizing throughout the applicability of various aspects of packaging science and technology. It also provides a simultaneous discussion of interrelated fields, and addresses the universal issues within these fields’ application areas. Intended as a technical reference and as a study aid, it is relevant to anyone who studies or uses packaging or packaging materials. Packaging Technology and Engineering: Pharmaceutical, Medical and Food Applications begins with an overview of the history of the topic. It then offers chapters on the methods of obtaining raw materials, the chemistry of polymeric and non-polymeric packaging materials, physico-chemical quality parameters, and the manufacturing of packaging. Other topics look at: additives, use, suppliers, safety and environmental concerns, regulation, anti-fraud activities, new trends, and the future of packaging technology. The book also features numerous problems and worked solutions to aid student comprehension. Covers packaging and packaging materials, their properties and technologies Addresses the chemical engineering, physics, and chemistry of packaging materials, and the individual requirements for food, pharmaceutical, and medical device packaging Includes current issues such as environmental concerns and sustainability, recycling and after-use, anti-counterfeiting technology, and packaging regulations and guidelines Packaging Technology and Engineering: Pharmaceutical, Medical and Food Applications will appeal to all packaging technologists, scientists, and engineers in industry, and in regulatory agencies. It is also an excellent book for advanced students studying packaging courses, within pharmacy, pharmaceutical sciences, chemical sciences, biomedical sciences, medical sciences, engineering, product design and technology, and food science/technology.
