Body Implanted Medical Device Communications

Science.gov (United States)

Yazdandoost, Kamya Yekeh; Kohno, Ryuji

The medical care day by day and more and more is associated with and reliant upon concepts and advances of electronics and electromagnetics. Numerous medical devices are implanted in the body for medical use. Tissue implanted devices are of great interest for wireless medical applications due to the promising of different clinical usage to promote a patient independence. It can be used in hospitals, health care facilities and home to transmit patient measurement data, such as pulse and respiration rates to a nearby receiver, permitting greater patient mobility and increased comfort. As this service permits remote monitoring of several patients simultaneously it could also potentially decrease health care costs. Advancement in radio frequency communications and miniaturization of bioelectronics are supporting medical implant applications. A central component of wireless implanted device is an antenna and there are several issues to consider when designing an in-body antenna, including power consumption, size, frequency, biocompatibility and the unique RF transmission challenges posed by the human body. The radiation characteristics of such devices are important in terms of both safety and performance. The implanted antenna and human body as a medium for wireless communication are discussed over Medical Implant Communications Service (MICS) band in the frequency range of 402-405MHz.

„FOUR STARS CHARTER QUALITY“ U CHARTER-DJELATNOSTI REPUBLIKE HRVATSKE

OpenAIRE

Gračan, Daniela; Zadel, Zrinka; Rudančić Lugarić, Andreja

2011-01-01

Potaknuti situacijom na tržištu charter-djelatnosti, autorice su nastojale istaknuti važnost sastanka u organizaciji Yachtpoola, gdje je bila namjera uvesti standard kvalitete charter-djelatnosti i izdvojiti renomirane charter-tvrtke koje posao obavljaju profesionalno, štiteći tako ugled nautičkoga turizma, ali i svih s njim povezanih partnera. Sve renomirane takve tvrtke nisu ujedno i partneri Yachtpoola, no Yachtpool je imao viziju u sklopu svoje Four Stars kvalitete stvoriti brand i pečat ...

Charter School Teacher Job Satisfaction

Science.gov (United States)

Roch, Christine H.; Sai, Na

2017-01-01

We examine whether working conditions in charter schools and traditional public schools lead to different levels of job satisfaction among teachers. We distinguish among charter schools managed by for-profit education management organizations (EMOs) and non-profit charter management organizations (CMOs) and stand-alone charter schools. We…

Medical Devices

NARCIS (Netherlands)

Verkerke, Gijsbertus Jacob; Mahieu, H.F.; Geertsema, A.A.; Hermann, I.F.; van Horn, J.R.; Hummel, J. Marjan; van Loon, J.P.; Mihaylov, D.; van der Plaats, A.; Schraffordt Koops, H.; Schutte, H.K.; Veth, R.P.H.; de Vries, M.P.; Rakhorst, G.; Shi, Donglu

2004-01-01

The development of new medical devices is a very time-consuming and costly process. Besides the time between the initial idea and the time that manufacturing and testing of prototypes takes place, the time needed for the development of production facilities, production of test series, marketing,

Classification and evaluation of medical devices

Directory of Open Access Journals (Sweden)

Edina Vranić

2003-05-01

Full Text Available Medical devices and medical disposables contribute significantly to the quality and effectiveness of the health care system. It is necessary to commit scientifically sound regulatory environment that will provide consumers with the best medical care. This includes continued services to small manufacturers, readily available guidance on FDA requirements, predictable and reasonable response times on applications for marketing, and equitable enforcement. But in the public interest, this commitment to the industry must be coupled with a reciprocal commitment: that medical device firms will meet high standards in the design, manufacture, and evaluation of their products. The protections afforded our consumer, and the benefits provided the medical device industry, cannot be underestimated.

Designing Smart Charter School Caps

Science.gov (United States)

Dillon, Erin

2010-01-01

In 2007, Andrew J. Rotherham proposed a new approach to the contentious issue of charter school caps, the statutory limits on charter school growth in place in several states. Rotherham's proposal, termed "smart charter school caps," called for quality sensitive caps that allow the expansion of high-performing charter schools while also…

Contextual inquiry for medical device design

CERN Document Server

Privitera, Mary Beth

2015-01-01

Contextual Inquiry for Medical Device Design helps users understand the everyday use of medical devices and the way their usage supports the development of better products and increased market acceptance. The text explains the concept of contextual inquiry using real-life examples to illustrate its application. Case studies provide a frame of reference on how contextual inquiry is successfully used during product design, ultimately producing safer, improved medical devices. Presents the ways contextual inquiry can be used to inform the evaluation and business case of technologyHelps users

Medical device market in China.

Science.gov (United States)

Boyer, Philip; Morshed, Bashir I; Mussivand, Tofy

2015-06-01

With China's growing old-age population and economic presence on the international stage, it has become important to evaluate its domestic and foreign market contribution to medical devices. Medical devices are instruments or apparatuses used in the prevention, rehabilitation, treatment, or knowledge generation with respect to disease or other abnormal conditions. This article provides information drawn from recent publications to describe the current state of the Chinese domestic market for medical devices and to define opportunities for foreign investment potential therein. Recent healthcare reforms implemented to meet rising demand due to an aging and migrating population are having a positive effect on market growth-a global market with a projected growth of 15% per year over the next decade. Copyright © 2015 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

Legislative aspects of the development of medical devices.

Science.gov (United States)

Marešová, Petra; Klímová, Blanka; Krejcar, Ondřej; Kuča, Kamil

2015-09-01

European industry of medical device technologies represents 30% of all worlds sales. New health technologies bring effective treatment approaches, help shorten stays in hospital1),bring better treatment results and accelerate rehabilitation which leads to the earlier patients recovery.Legislative aspects are one of the key areas influencing the speed of development of medical devices and their launching. The aim of this article is to specify current state of legislation in the development of medical devices in the European Union in comparison with the market leaders such as China, Japan and USA.The best established market of medical devices is in the USA. Both Japan and China follow the USA model. However, a non-professional code of ethics in China in some respect contributes to the decrease of quality of medical devices, while Japan as well as the EU countries try really hard to conform to all the regulations imposed on the manufacturing of medical devices.

Mobile medical device connectivity: real world solutions.

Science.gov (United States)

Pettus, Dan

2004-01-01

Mobile medical devices, such as infusion pumps, provide an important therapeutic function. They are also valuable sources of information about treatment patterns at the point of care. However, these mobile devices have been independent islands of valuable information, unable to share the data they gather with other hospital information resources on a real time basis. Although data from these devices can provide significant improvements for medical safety and vital information needed for clinical best practice development, gathering that data poses significant challenges when interfacing with hospital information systems. Mobile medical devices move from place to place as independent actors, raising a series of security and identification issues when they need to be disconnected and reconnected using traditional tethered cable connections. The continuing lack of accepted communications protocol standards, in spite of the concentrated efforts of organizations like the IEEE and the Medical Information Bus (IEEE 1073) to establish them, has made integration into the hospital information system a complex and non-standard task. The rapid spread in availability and adoption of high-speed 802.11 wireless systems in hospitals offers a realistic connectivity solution for mobile medical devices. Inspite of this, the 802.11 standard is still evolving, and current security methods designed for user-based products like PDAs and laptop computers are not ideal for unmanned mobile medical devices because they assume the availability of a human operator to authenticate a wireless session. In the absence of accepted standards, manufacturers have created practical and innovative solutions to support the collection of clinical data from mobile medical devices and the integration of that data with hospital information systems. This paper will explore the potential benefits of integrating mobile medical devices into the hospital information system, and describe the challenges in

Analytical Chemistry in the Regulatory Science of Medical Devices.

Science.gov (United States)

Wang, Yi; Guan, Allan; Wickramasekara, Samanthi; Phillips, K Scott

2018-06-12

In the United States, regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all Food and Drug Administration-regulated products. Good regulatory science facilitates consumer access to innovative medical devices that are safe and effective throughout the Total Product Life Cycle (TPLC). Because the need to measure things is fundamental to the regulatory science of medical devices, analytical chemistry plays an important role, contributing to medical device technology in two ways: It can be an integral part of an innovative medical device (e.g., diagnostic devices), and it can be used to support medical device development throughout the TPLC. In this review, we focus on analytical chemistry as a tool for the regulatory science of medical devices. We highlight recent progress in companion diagnostics, medical devices on chips for preclinical testing, mass spectrometry for postmarket monitoring, and detection/characterization of bacterial biofilm to prevent infections.

An update on mobile phones interference with medical devices.

Science.gov (United States)

Mahmoud Pashazadeh, Ali; Aghajani, Mahdi; Nabipour, Iraj; Assadi, Majid

2013-10-01

Mobile phones' electromagnetic interference with medical devices is an important issue for the medical safety of patients who are using life-supporting medical devices. This review mainly focuses on mobile phones' interference with implanted medical devices and with medical equipment located in critical areas of hospitals. A close look at the findings reveals that mobile phones may adversely affect the functioning of medical devices, and the specific effect and the degree of interference depend on the applied technology and the separation distance. According to the studies' findings and the authors' recommendations, besides mitigating interference, using mobile phones at a reasonable distance from medical devices and developing technology standards can lead to their effective use in hospital communication systems.

An update on mobile phones interference with medical devices

International Nuclear Information System (INIS)

Pashazadeh, A. M.; Aghajani, M.; Nabipour, I.; Assadi, M.

2013-01-01

Mobile phones' electromagnetic interference with medical devices is an important issue for the medical safety of patients who are using life-supporting medical devices. This review mainly focuses on mobile phones' interference with implanted medical devices and with medical equipment located in critical areas of hospitals. A close look at the findings reveals that mobile phones may adversely affect the functioning of medical devices, and the specific effect and the degree of interference depend on the applied technology and the separation distance. According to the studies' findings and the authors' recommendations, besides mitigating interference, using mobile phones at a reasonable distance from medical devices and developing technology standards can lead to their effective use in hospital communication systems. (authors)

Quality charters or quality members? A control theory perspective on team charters and team performance.

Science.gov (United States)

Courtright, Stephen H; McCormick, Brian W; Mistry, Sal; Wang, Jiexin

2017-10-01

Though prevalent in practice, team charters have only recently received scholarly attention. However, most of this work has been relatively devoid of theory, and consequently, key questions about why and under what conditions team charter quality affects team performance remain unanswered. To address these gaps, we draw on macro organizational control theory to propose that team charter quality serves as a team-level "behavior" control mechanism that builds task cohesion through a structured exercise. We then juxtapose team charter quality with an "input" team control mechanism that influences the emergence of task cohesion more organically: team conscientiousness. Given their redundant effects on task cohesion, we propose that the effects of team charter quality and team conscientiousness on team performance (through task cohesion) are substitutive such that team charter quality primarily impacts team performance for teams that are low (vs. high) on conscientiousness. We test and find support for our hypotheses in a sample of 239 undergraduate self-managing project teams. Our study contributes to the groups and teams literature in the following ways: first, relative to previous studies, we take a more theory-driven approach toward understanding team charters, and in doing so, uncover when and why team charter quality impacts team performance; second, we integrate two normally disparate perspectives on team effectiveness (team development and team selection) to offer a broader perspective on how teams are "built"; and third, we introduce team charter quality as a performance-enhancing mechanism for teams lower on conscientiousness. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Charters as a Driver of Resegregation

Science.gov (United States)

Ayscue, Jenn; Nelson, Amy Hawn; Mickelson, Roslyn Arlin; Giersch, Jason; Bottia, Martha Cecilia

2018-01-01

Expanding school choice through charter schools is among the top education priorities of the current federal administration as well as many state legislatures. Amid this push to expand the charter sector, it is essential to understand how charter schools affect students who attend them, as well as the ways charter schools impact traditional public…

Leveraging Quality Charters

Science.gov (United States)

Young, Caprice

2012-01-01

Charter public schools serve a variety of roles in education reform: innovation labs, havens from failing traditional schools; and competitors for pubic resources. Education leaders have the opportunity to use high quality charter schooling to innovate not only in developing transformative schools but, more importantly, in creating great public…

Medical devices and human engineering

CERN Document Server

Bronzino, Joseph D

2014-01-01

Known as the bible of biomedical engineering, The Biomedical Engineering Handbook, Fourth Edition, sets the standard against which all other references of this nature are measured. As such, it has served as a major resource for both skilled professionals and novices to biomedical engineering.Medical Devices and Human Engineering, the second volume of the handbook, presents material from respected scientists with diverse backgrounds in biomedical sensors, medical instrumentation and devices, human performance engineering, rehabilitation engineering, and clinical engineering.More than three doze

Medical device reliability and associated areas

National Research Council Canada - National Science Library

Dhillon, Balbir S

2000-01-01

.... Although the history of reliability engineering can be traced back to World War II, the application of reliability engineering concepts to medical devices is a fairly recent idea that goes back to the latter part of the 1960s when many publications on medical device reliability emerged. Today, a large number of books on general reliability have been...

Charter Schools and Market Segmentation

Science.gov (United States)

Batie, Michael

2009-01-01

This dissertation was undertaken to examine the effect(s) of charter school marketing on the Los Angeles Unified School District (LAUSD) education landscape with respect to the stratification of charter schools. Information from four sources: school websites, a survey of charter school parents, existing online statistics and data, and various…

Model-based engineering for medical-device software.

Science.gov (United States)

Ray, Arnab; Jetley, Raoul; Jones, Paul L; Zhang, Yi

2010-01-01

This paper demonstrates the benefits of adopting model-based design techniques for engineering medical device software. By using a patient-controlled analgesic (PCA) infusion pump as a candidate medical device, the authors show how using models to capture design information allows for i) fast and efficient construction of executable device prototypes ii) creation of a standard, reusable baseline software architecture for a particular device family, iii) formal verification of the design against safety requirements, and iv) creation of a safety framework that reduces verification costs for future versions of the device software. 1.

[Ethic review on clinical experiments of medical devices in medical institutions].

Science.gov (United States)

Shuai, Wanjun; Chao, Yong; Wang, Ning; Xu, Shining

2011-07-01

Clinical experiments are always used to evaluate the safety and validity of medical devices. The experiments have two types of clinical trying and testing. Ethic review must be done by the ethics committee of the medical department with the qualification of clinical research, and the approval must be made before the experiments. In order to ensure the safety and validity of clinical experiments of medical devices in medical institutions, the contents, process and approval criterions of the ethic review were analyzed and discussed.

Contextualizing the Physician Charter on Professionalism in Qatar: From Patient Autonomy to Family Autonomy.

Science.gov (United States)

Ho, Ming-Jung; Alkhal, Abdullatif; Tekian, Ara; Shih, Julie; Shaw, Kevin; Wang, Chung-Hsiang; Alyafei, Khalid; Konopasek, Lyuba

2016-12-01

The Physician Charter on medical professionalism has been endorsed by professional organizations worldwide, yet it is unclear if this Western framework of professionalism is applicable in non-Western countries. This study examines how physicians practicing in a Middle Eastern context perceive the terms, principles, and commitments outlined in the charter. In May 2013, the authors conducted 6 focus groups with 43 clinician-educators practicing at Hamad Medical Corporation in Doha, Qatar, to discuss the applicability of the Physician Charter in a local context. The research team coded and analyzed transcripts to identify sociocultural influences on professionalism. Participants generally expressed agreement with the applicability of the charter's principles to physician professionalism in Qatar. However, 3 contextual factors (religious beliefs and practices, family-centered decision making, and multinationality) complicated the application of the core principles of patient autonomy and social justice. Islamic beliefs reinforced the importance of professional values such as altruism, but presented a barrier to the principle of self-determination for female patients. The family-centered culture in Qatar called for enlarging the scope of patient-centered decision making to include the patient's family. Qatar's multinational population prompted debate over equal treatment and how to conceptualize and implement the principle of social justice. Several sociocultural contexts influence the conceptualization of the principles of medical professionalism in Qatar. The findings suggest that contextual factors should be considered when developing or adopting a professionalism framework in an international setting and context.

A concept ideation framework for medical device design.

Science.gov (United States)

Hagedorn, Thomas J; Grosse, Ian R; Krishnamurty, Sundar

2015-06-01

Medical device design is a challenging process, often requiring collaboration between medical and engineering domain experts. This collaboration can be best institutionalized through systematic knowledge transfer between the two domains coupled with effective knowledge management throughout the design innovation process. Toward this goal, we present the development of a semantic framework for medical device design that unifies a large medical ontology with detailed engineering functional models along with the repository of design innovation information contained in the US Patent Database. As part of our development, existing medical, engineering, and patent document ontologies were modified and interlinked to create a comprehensive medical device innovation and design tool with appropriate properties and semantic relations to facilitate knowledge capture, enrich existing knowledge, and enable effective knowledge reuse for different scenarios. The result is a Concept Ideation Framework for Medical Device Design (CIFMeDD). Key features of the resulting framework include function-based searching and automated inter-domain reasoning to uniquely enable identification of functionally similar procedures, tools, and inventions from multiple domains based on simple semantic searches. The significance and usefulness of the resulting framework for aiding in conceptual design and innovation in the medical realm are explored via two case studies examining medical device design problems. Copyright © 2015 Elsevier Inc. All rights reserved.

Diverse Charter Schools

Science.gov (United States)

Russo, Alexander

2013-01-01

In February 2009, newly elected President Barack Obama and First Lady Michelle Obama visited Capital City Public Charter School in northwest Washington, D.C. This was the First Family's first official public-school visit, just a few short weeks after President Obama was sworn into office. Obama's enthusiastic support for charter schools was one of…

Power Approaches for Implantable Medical Devices

Directory of Open Access Journals (Sweden)

Achraf Ben Amar

2015-11-01

Full Text Available Implantable medical devices have been implemented to provide treatment and to assess in vivo physiological information in humans as well as animal models for medical diagnosis and prognosis, therapeutic applications and biological science studies. The advances of micro/nanotechnology dovetailed with novel biomaterials have further enhanced biocompatibility, sensitivity, longevity and reliability in newly-emerged low-cost and compact devices. Close-loop systems with both sensing and treatment functions have also been developed to provide point-of-care and personalized medicine. Nevertheless, one of the remaining challenges is whether power can be supplied sufficiently and continuously for the operation of the entire system. This issue is becoming more and more critical to the increasing need of power for wireless communication in implanted devices towards the future healthcare infrastructure, namely mobile health (m-Health. In this review paper, methodologies to transfer and harvest energy in implantable medical devices are introduced and discussed to highlight the uses and significances of various potential power sources.

Teacher community in elementary charter schools.

Directory of Open Access Journals (Sweden)

Marisa Cannata

2007-05-01

Full Text Available The organizational context of charter schools may facilitate the formation of a strong teacher community. In particular, a focused school mission and increased control over teacher hiring may lead to stronger teacher professional communities. This paper uses the 1999-2000 Schools and Staffing Survey to compare the level of teacher community in charter public and traditional public schools. It also estimates the effect of various charter policy variables and domains of school autonomy on teacher community. Charter school teachers report higher levels of teacher community than traditional public school teachers do, although this effect is less than one-tenth of a standard deviation and is dwarfed by the effect of a supportive principal, teacher decision-making influence, and school size. Charter public schools authorized by universities showed lower levels of teacher community than those authorized by local school districts. Teachers in charter schools that have flexibility over tenure requirements and the school budget report higher levels of teacher community. This study reveals that charter schools do facilitate the formation of strong teacher communities, although the effect is small. The analysis also suggests that the institutional origin of the charter school and specific areas of policy flexibility may influence teacher community.

Towards sustainable design for single-use medical devices.

Science.gov (United States)

Hanson, Jacob J; Hitchcock, Robert W

2009-01-01

Despite their sophistication and value, single-use medical devices have become commodity items in the developed world. Cheap raw materials along with large scale manufacturing and distribution processes have combined to make many medical devices more expensive to resterilize, package and restock than to simply discard. This practice is not sustainable or scalable on a global basis. As the petrochemicals that provide raw materials become more expensive and the global reach of these devices continues into rapidly developing economies, there is a need for device designs that take into account the total life-cycle of these products, minimize the amount of non-renewable materials consumed and consider alternative hybrid reusable / disposable approaches. In this paper, we describe a methodology to perform life cycle and functional analyses to create additional design requirements for medical devices. These types of sustainable approaches can move the medical device industry even closer to the "triple bottom line"--people, planet, profit.

78 FR 21129 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

Science.gov (United States)

2013-04-09

... radiofrequency band ranging between 13 megahertz to 27.12 megahertz and is intended for the treatment of medical...] Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices...

Assessing the Implementation of Ghana's Patient Charter

Science.gov (United States)

Abekah-Nkrumah, Gordon; Manu, Abubakar; Atinga, Roger Ayimbillah

2010-01-01

Purpose: This paper seeks to assess the implementation of Ghana's Patients' Charter by investigating the level of awareness and knowledge of the Charter's content, some socio-demographic factors that may influence awareness and knowledge of the Charter and how providers have discharged their responsibilities under the Charter.…

Anti-malware software and medical devices.

Science.gov (United States)

2010-10-01

Just as much as healthcare information systems, medical devices need protection against cybersecurity threats. Anti-malware software can help safeguard the devices in your facility-but it has limitations and even risks. Find out what steps you can take to manage anti-malware applications in your devices.

Practice of Regulatory Science (Development of Medical Devices).

Science.gov (United States)

Niimi, Shingo

2017-01-01

Prototypes of medical devices are made in accordance with the needs of clinical practice, and for systems required during the initial process of medical device development for new surgical practices. Verification of whether these prototypes produce the intended performance specifications is conducted using basic tests such as mechanical and animal tests. The prototypes are then improved and modified until satisfactory results are obtained. After a prototype passes through a clinical trial process similar to that for new drugs, application for approval is made. In the approval application process, medical devices are divided into new, improved, and generic types. Reviewers judge the validity of intended use, indications, operation procedures, and precautions, and in addition evaluate the balance between risk and benefit in terms of efficacy and safety. Other characteristics of medical devices are the need for the user to attain proficiency in usage techniques to ensure efficacy and safety, and the existence of a variety of medical devices for which assessment strategies differ, including differences in impact on the body in cases in which a physical burden to the body or failure of a medical device develops. Regulatory science of medical devices involves prediction, judgment, and evaluation of efficacy, safety, and quality, from which data result which can become indices in the development stages from design to application for approval. A reduction in the number of animals used for testing, improvement in efficiency, reduction of the necessity for clinical trials, etc. are expected through rational setting of evaluation items.

MDR (Medical Device Reporting)

Data.gov (United States)

U.S. Department of Health & Human Services — This database allows you to search the CDRH's database information on medical devices which may have malfunctioned or caused a death or serious injury during the...

78 FR 68714 - Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug

Science.gov (United States)

2013-11-15

... amendments), as ``preamendments devices.'' FDA classifies these devices after the Agency takes the following.... FDA-2012-N-1238] Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug AGENCY: Food... scleral plugs in order to provide a reasonable assurance of safety and effectiveness of the device. The...

75 FR 39220 - Charter Schools Program (CSP) Grants for Replication and Expansion of High-Quality Charter Schools

Science.gov (United States)

2010-07-08

... DEPARTMENT OF EDUCATION Charter Schools Program (CSP) Grants for Replication and Expansion of High-Quality Charter Schools AGENCY: Office of Innovation and Improvement, Department of Education. ACTION... notice inviting applications for new awards for FY 2010 for the Charter Schools Program Grants for...

Use of mobile devices for medical imaging.

Science.gov (United States)

Hirschorn, David S; Choudhri, Asim F; Shih, George; Kim, Woojin

2014-12-01

Mobile devices have fundamentally changed personal computing, with many people forgoing the desktop and even laptop computer altogether in favor of a smaller, lighter, and cheaper device with a touch screen. Doctors and patients are beginning to expect medical images to be available on these devices for consultative viewing, if not actual diagnosis. However, this raises serious concerns with regard to the ability of existing mobile devices and networks to quickly and securely move these images. Medical images often come in large sets, which can bog down a network if not conveyed in an intelligent manner, and downloaded data on a mobile device are highly vulnerable to a breach of patient confidentiality should that device become lost or stolen. Some degree of regulation is needed to ensure that the software used to view these images allows all relevant medical information to be visible and manipulated in a clinically acceptable manner. There also needs to be a quality control mechanism to ensure that a device's display accurately conveys the image content without loss of contrast detail. Furthermore, not all mobile displays are appropriate for all types of images. The smaller displays of smart phones, for example, are not well suited for viewing entire chest radiographs, no matter how small and numerous the pixels of the display may be. All of these factors should be taken into account when deciding where, when, and how to use mobile devices for the display of medical images. Copyright © 2014 American College of Radiology. Published by Elsevier Inc. All rights reserved.

77 FR 72924 - Taxable Medical Devices

Science.gov (United States)

2012-12-07

... in hospitals, doctors offices and other medical institutions, such as x-ray machines, magnetic... the medical device context include sales to hospitals and other medical service providers. Although... of a taxable article to charity constitutes a taxable use under section 4218. However, the IRS and...

Development of Implantable Medical Devices: From an Engineering Perspective

Directory of Open Access Journals (Sweden)

Yeun-Ho Joung

2013-09-01

Full Text Available From the first pacemaker implant in 1958, numerous engineering and medical activities for implantable medical device development have faced challenges in materials, battery power, functionality, electrical power consumption, size shrinkage, system delivery, and wireless communication. With explosive advances in scientific and engineering technology, many implantable medical devices such as the pacemaker, cochlear implant, and real-time blood pressure sensors have been developed and improved. This trend of progress in medical devices will continue because of the coming super-aged society, which will result in more consumers for the devices. The inner body is a special space filled with electrical, chemical, mechanical, and marine-salted reactions. Therefore, electrical connectivity and communication, corrosion, robustness, and hermeticity are key factors to be considered during the development stage. The main participants in the development stage are the user, the medical staff, and the engineer or technician. Thus, there are three different viewpoints in the development of implantable devices. In this review paper, considerations in the development of implantable medical devices will be presented from the viewpoint of an engineering mind.

Preventing medical device recalls

CERN Document Server

Raheja, Dev

2014-01-01

Introduction to Medical Device RequirementsIntroductionThe ChallengesSources of ErrorsUnderstanding the Science of Safety     Overview of FDA Quality System Regulation     Overview of Risk Management Standard ISO 14971     Overview of FDA Device Approval Process     Overview of Regulatory Requirements for Clinical TrialsSummaryReferencesPreventing Recalls during Specification WritingIntroductionConduct Requirements Analysis to Identify Missing RequirementsSpecifications for Safety, Durability, and

78 FR 26786 - Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Science.gov (United States)

2013-05-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Microbiology Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...

76 FR 48871 - Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Science.gov (United States)

2011-08-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Immunology Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...

Product-based Safety Certification for Medical Devices Embedded Software.

Science.gov (United States)

Neto, José Augusto; Figueiredo Damásio, Jemerson; Monthaler, Paul; Morais, Misael

2015-01-01

Worldwide medical device embedded software certification practices are currently focused on manufacturing best practices. In Brazil, the national regulatory agency does not hold a local certification process for software-intensive medical devices and admits international certification (e.g. FDA and CE) from local and international industry to operate in the Brazilian health care market. We present here a product-based certification process as a candidate process to support the Brazilian regulatory agency ANVISA in medical device software regulation. Center of Strategic Technology for Healthcare (NUTES) medical device embedded software certification is based on a solid safety quality model and has been tested with reasonable success against the Class I risk device Generic Infusion Pump (GIP).

34 CFR 300.7 - Charter school.

Science.gov (United States)

2010-07-01

... 34 Education 2 2010-07-01 2010-07-01 false Charter school. 300.7 Section 300.7 Education Regulations of the Offices of the Department of Education (Continued) OFFICE OF SPECIAL EDUCATION AND... DISABILITIES General Definitions Used in This Part § 300.7 Charter school. Charter school has the meaning given...

On the impact of medical device regulations on software architecture

DEFF Research Database (Denmark)

Hansen, Klaus Marius; Manikas, Konstantinos

2016-01-01

Compliance to regulations and regulatory approval are requirements for many medical device software systems. In this paper, we investigate the implications of medical device software regulations to the design of software systems. We do so by focusing on the American and European regulatory author...... of the device. Moreover, we review software modularity in the implementation of software medical device and propose a set of preliminary principles for architectural design of software medical device based on a set of constrains identified from the reviewed regulations....

[Industry regulation and its relationship to the rapid marketing of medical devices].

Science.gov (United States)

Matsuoka, Atsuko

2012-01-01

In the market of medical devices, non-Japanese products hold a large part even in Japan. To overcome this situation, the Japanese government has been announcing policies to encourage the medical devices industry, such as the 5-year strategy for medical innovation (June 6, 2012). The Division of Medical Devices has been contributing to rapid marketing of medical devices by working out the standards for approval review and accreditation of medical devices, guidances on evaluation of medical devices with emerging technology, and test methods for biological safety evaluation of medical devices, as a part of practice in the field of regulatory science. The recent outcomes are 822 standards of accreditation for Class II medical devices, 14 guidances on safety evaluation of medical devices with emerging technology, and the revised test methods for biological safety evaluation (MHLW Notification by Director, OMDE, Yakushokuki-hatsu 0301 No. 20 "Basic Principles of Biological Safety Evaluation Required for Application for Approval to Market Medical Devices").

76 FR 7220 - Medical Device Innovation Initiative; Request for Comments

Science.gov (United States)

2011-02-09

... medical device innovation. 6. Other actions CDRH should take to facilitate the development, assessment...] Medical Device Innovation Initiative; Request for Comments AGENCY: Food and Drug Administration, HHS... availability of a document for public comment entitled ``Medical Device Innovation Initiative'' (the report...

Beacon Charter School Needs a School: A Case of Capital Outlay of Charters in a Public District

Science.gov (United States)

Wronowski, Meredith L.

2017-01-01

The case study presented below is a representation of a real-world, ongoing situation involving a public school district's capital outlay for charter schools within its boundaries. One particular charter, Beacon Charter School, was promised a permanent building by the public school district that also acts as its authorizer. However, recent events…

78 FR 68853 - International Medical Device Regulators Forum; Medical Device Single Audit Program International...

Science.gov (United States)

2013-11-15

... its inaugural meeting in Singapore in 2012, identified a Work Group (WG) to develop specific documents... Assessment Method for the Recognition and Monitoring of Medical Device Auditing Organizations;'' and IMDRF...

New Mexico Charter Schools Annual Report

Science.gov (United States)

New Mexico Public Education Department, 2013

2013-01-01

In 2011, the New Mexico legislature passed changes to the Charter School Act that provided more accountability for both charters and authorizers in New Mexico. As part of that law, the Public Education Department (PED) is asked to submit an annual report on the status of charter schools in New Mexico. This is the first report submitted under that…

European Charter Airlines and In-Flight Catering Provision

OpenAIRE

Duncan, Tara

2005-01-01

This report examines the main UK and European charter airlines. The report will be split into three main sections which correspond to the three main European charter markets, • the UK, • Germany and • Scandinavia/Benelux. Each section considers the current market demand for charter flights before looking more closely at each individual charter carriers. As this report is focussing on charter airline’s onboard catering provision, the report will look at eac...

The current situation and development of medical device testing institutes in China.

Science.gov (United States)

Yang, Xiaofang; Mu, Ruihong; Fan, Yubo; Wang, Chunren; Li, Deyu

2017-04-01

This article analyses the current situation and development of Chinese medical device testing institutes from the perspectives of the two most important functions - testing functions and medical device standardization functions. Areas Covered: The objective of the Chinese government regulations for medical device industry is to ensure the safety and effectiveness of medical devices for Chinese patients. To support the regulation system, the Chinese government has established medical device testing institutes at different levels for example, the national, provincial, and municipal levels. These testing institutes also play an important role in technical support during medical device premarket registration and post market surveillance, they are also the vital practitioners of Chinese medical device standardization. Expert Commentary: Chinese medical device testing institutes are technical departments established by government, and serve the regulatory functions of government agency. In recent years, with the rapid development of medical device industry as well as constantly increasing international and domestic medical device market, the importance of medical device testing institute is more prominent, However, there are still some problems unsolved, such as their overall capacity remains to be improved, construction of standardization is to be strengthened, etc.

Medical devices for the anesthetist: current perspectives

Directory of Open Access Journals (Sweden)

Ingrande J

2014-03-01

Full Text Available Jerry Ingrande, Hendrikus JM LemmensDepartment of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, CA, USAAbstract: Anesthesiologists are unique among most physicians in that they routinely use technology and medical devices to carry out their daily activities. Recently, there have been significant advances in medical technology. These advances have increased the number and utility of medical devices available to the anesthesiologist. There is little doubt that these new tools have improved the practice of anesthesia. Monitoring has become more comprehensive and less invasive, airway management has become easier, and placement of central venous catheters and regional nerve blockade has become faster and safer. This review focuses on key medical devices such as cardiovascular monitors, airway equipment, neuromonitoring tools, ultrasound, and target controlled drug delivery software and hardware. This review demonstrates how advances in these areas have improved the safety and efficacy of anesthesia and facilitate its administration. When applicable, indications and contraindications to the use of these novel devices will be explored as well as the controversies surrounding their use.Keywords: catheters, echocardiography, ultrasound, fiberoptic bronchoscope, laryngeal mask airway, closed-loop anesthesia

77 FR 18829 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

Science.gov (United States)

2012-03-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory...

76 FR 71983 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

Science.gov (United States)

2011-11-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory...

42 CFR 410.36 - Medical supplies, appliances, and devices: Scope.

Science.gov (United States)

2010-10-01

... 42 Public Health 2 2010-10-01 2010-10-01 false Medical supplies, appliances, and devices: Scope... Services § 410.36 Medical supplies, appliances, and devices: Scope. (a) Medicare Part B pays for the following medical supplies, appliances and devices: (1) Surgical dressings, and splints, casts, and other...

75 FR 57968 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

Science.gov (United States)

2010-09-23

...] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory... committee will discuss, make recommendations, and vote on information related to the PMA for the LAP-BAND...

76 FR 55398 - Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of...

Science.gov (United States)

2011-09-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of Meeting AGENCY... postponing the meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee scheduled...

A Medical Delivery Device

DEFF Research Database (Denmark)

2010-01-01

The present invention relates to a medical delivery device comprising at least two membrane electrode assembly units each of which comprises three layers: an upper and a lower electrode and a selective ionic conductive membrane provided there-between. At least one of the three layers are shared...

The Charter School Experience: Autonomy in Practice

Science.gov (United States)

McDonald, Tonya Senne

2013-01-01

While traditional public school and charter school systems continue to undergo dramatic reforms in response to the educational crisis, charter schools are praised as possessing the distinguishing characteristic of maintaining autonomy in exchange for increased accountability (Buckley & Schneider, 2009). The expectations for charter schools are…

Challenges of Charter Schools with Special Education: Issues of Concern for Charter School Authorizers and Service Providers

Directory of Open Access Journals (Sweden)

Leman Kaniturk Kose

2013-04-01

Full Text Available Charter schools, as one type of school choice, have been attracting a growing number of students since first inception in Minnesota in 1991. Although charter schools are a fledgling reform, they are already a significant part of the federal and state efforts to improve schools and have a growing number of students. Like traditional public schools, charter schools accept all students equally. As a result, they are also obligated to support and serve students with disabilities and meet the requirements of constitutional provisions and federal laws enacted for students with disabilities. This article intends to provide a succinct literature review examining the operational and organizational challenges regarding the design and delivery of special education in the young charter school movement so that charter school authorizers and service providers are cognizant of the issues of concern when serving students with disabilities at charter schools. The literature was located through searching through the Educational Resources Information Center (ERIC, Google Scholar, and the Dissertation Abstracts International. Other information is gleaned from the U.S. Department of Education, Center for Education Reform, and the federal and state statutes regarding students with disabilities.

Charter Halibut Limited Access Program

Data.gov (United States)

National Oceanic and Atmospheric Administration, Department of Commerce — This limited access system limits the number of charter vessels that may participate in the guided sport fishery for halibut in area 2C and 3A. NMFS issues a charter...

Medical Device Integration Model Based on the Internet of Things

Science.gov (United States)

Hao, Aiyu; Wang, Ling

2015-01-01

At present, hospitals in our country have basically established the HIS system, which manages registration, treatment, and charge, among many others, of patients. During treatment, patients need to use medical devices repeatedly to acquire all sorts of inspection data. Currently, the output data of the medical devices are often manually input into information system, which is easy to get wrong or easy to cause mismatches between inspection reports and patients. For some small hospitals of which information construction is still relatively weak, the information generated by the devices is still presented in the form of paper reports. When doctors or patients want to have access to the data at a given time again, they can only look at the paper files. Data integration between medical devices has long been a difficult problem for the medical information system, because the data from medical devices are lack of mandatory unified global standards and have outstanding heterogeneity of devices. In order to protect their own interests, manufacturers use special protocols, etc., thus causing medical decices to still be the "lonely island" of hospital information system. Besides, unfocused application of the data will lead to failure to achieve a reasonable distribution of medical resources. With the deepening of IT construction in hospitals, medical information systems will be bound to develop towards mobile applications, intelligent analysis, and interconnection and interworking, on the premise that there is an effective medical device integration (MDI) technology. To this end, this paper presents a MDI model based on the Internet of Things (IoT). Through abstract classification, this model is able to extract the common characteristics of the devices, resolve the heterogeneous differences between them, and employ a unified protocol to integrate data between devices. And by the IoT technology, it realizes interconnection network of devices and conducts associate matching

Handbook of materials for medical devices

National Research Council Canada - National Science Library

Davis, J. R

2003-01-01

... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii Introduction Chapter 1 Overview of Biomaterials and Their Use in Medical Devices . . . . . . . . . . . . . . . . 1 Uses for Biomaterials...

Cybersecurity and the Medical Device Product Development Lifecycle.

Science.gov (United States)

Jones, Richard W; Katzis, Konstantinos

2017-01-01

Protecting connected medical devices from evolving cyber related threats, requires a continuous lifecycle approach whereby cybersecurity is integrated within the product development lifecycle and both complements and re-enforces the safety risk management processes therein. This contribution reviews the guidance relating to medical device cybersecurity within the product development lifecycle.

BIOANALYTICAL STANDARDIZING FOR SEROLOGICAL DIAGNOSTIC MEDICAL DEVICES

OpenAIRE

A. Yu. Galkin; A. G. Komar; A. A. Grigorenko

2015-01-01

In article we analyzed national and international regulations concerning the quality and safety of medical devices for in vitro diagnostics. We discussed the possibility of a partial application of the recommendations of the State Pharmacopoeia of Ukraine to this type of product. The main guiding regulatory documents establishing requirements for quality and safety tools for the serological diagnosis products are The technical regulation on medical devices for the diagnosis in vitro, DSTU ISO...

75 FR 61507 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

Science.gov (United States)

2010-10-05

...] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice... announcing an amendment to the notice of meeting of the General and Plastic Surgery Devices Panel of the..., FDA announced that a meeting of the General and Plastic Surgery Devices Panel of the Medical Devices...

National Transuranic Program Charter

International Nuclear Information System (INIS)

1994-10-01

The National Transuranic Program Plan and Charter describes the functional elements of the National TRU Program, organizational relationships, programmatic responsibilities, division of work scope among the various DOE organizations that comprise the program, and program baselines against which overall progress will be measured. The charter defines the authorities and responsibilities of various organizations involved in the management of TRU waste throughout the DOE complex

Medical device risk management and its economic impact

Directory of Open Access Journals (Sweden)

Katerina Krsteva Jakimovska

2013-10-01

Full Text Available The importance of medical devices in everyday users/patients lives is imensse. This is the reason why emphasis must be put on safety during their use. Satisfactory safety level can be achived by implementation of quality and risk management standards. Medical device manufacturers must learn to deal with the potential risks by using theoretical and practical examples and measures in order to protect their users/patients and themselves from suffering huge losses arising from adverse events or recall of their products. The best moment for implementation of risk management methods and analysis begins from the device design and development through manufacturing, sales and distribution. These way medical device manufacturers will succseed in protecting their users/patients from serious adverse events and at the same time protect their brand and society status, while minimizing economic losses.

75 FR 26919 - Charter Renewals

Science.gov (United States)

2010-05-13

...: Notice of Renewal of the Advisory Committee on Commercial Remote Sensing Charter. SUMMARY: In accordance... Commercial Remote Sensing (ACCRES) is in the public interest in connection with the performance of duties imposed on the Department by law. The ACCRES Charter was renewed on April 1, 2010. SUPPLEMENTARY...

75 FR 47606 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

Science.gov (United States)

2010-08-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of... General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee scheduled for August...

[Design and application of implantable medical device information management system].

Science.gov (United States)

Cao, Shaoping; Yin, Chunguang; Zhao, Zhenying

2013-03-01

Through the establishment of implantable medical device information management system, with the aid of the regional joint sharing of resources, we further enhance the implantable medical device traceability management level, strengthen quality management, control of medical risk.

78 FR 16684 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

Science.gov (United States)

2013-03-18

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

77 FR 20642 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

Science.gov (United States)

2012-04-05

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

76 FR 14415 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

Science.gov (United States)

2011-03-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

76 FR 62419 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

Science.gov (United States)

2011-10-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

75 FR 49940 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

Science.gov (United States)

2010-08-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

78 FR 30928 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

Science.gov (United States)

2013-05-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

76 FR 39882 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

Science.gov (United States)

2011-07-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0478] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

Design considerations for medical devices in the home environment.

Science.gov (United States)

Kaufman-Rivi, Diana; Collins-Mitchell, Janette; Jetley, Raoul

2010-01-01

Patient demographics, economic forces, and technological advancements contribute to the rise in home care services. Advanced medical devices and equipment originally designed for use by trained personnel in hospitals and clinics are increasingly migrating into the home. Unlike the clinical setting, the home is an uncontrolled environment with additional hazards. The compatibility of the device with the recipient's knowledge, abilities, lifestyle, and home environment plays a significant role in their therapy and rehabilitation. The advent of new device technologies such as wireless devices and interoperability of systems lends a new and complex perspective for medical device use in the home that must also be addressed. Adequately assessing and matching the patient and their caregiver with the appropriate device technology while considering the suitability of the home environment for device operation and maintenance is a challenge that relies on good human factors principles. There is a need to address these challenges in the growing home care sector In this article, the authors take a look at some important considerations and design issues for medical devices used in the home care environment.

Pelagic Charter Boat Patrons (1999-2001)

Data.gov (United States)

National Oceanic and Atmospheric Administration, Department of Commerce — This study describes several aspects of the charter fishing experience, including patrons' motivations for coming to Hawaii and going charter fishing, their related...

Implantable Medical Devices; Networking Security Survey

Directory of Open Access Journals (Sweden)

Siamak Aram

2016-08-01

Full Text Available The industry of implantable medical devices (IMDs is constantly evolving, which is dictated by the pressing need to comprehensively address new challenges in the healthcare field. Accordingly, IMDs are becoming more and more sophisticated. Not long ago, the range of IMDs’ technical capacities was expanded, making it possible to establish Internet connection in case of necessity and/or emergency situation for the patient. At the same time, while the web connectivity of today’s implantable devices is rather advanced, the issue of equipping the IMDs with sufficiently strong security system remains unresolved. In fact, IMDs have relatively weak security mechanisms which render them vulnerable to cyber-attacks that compromise the quality of IMDs’ functionalities. This study revolves around the security deficiencies inherent to three types of sensor-based medical devices; biosensors, insulin pump systems and implantable cardioverter defibrillators. Manufacturers of these devices should take into consideration that security and effectiveness of the functionality of implants is highly dependent on the design. In this paper, we present a comprehensive study of IMDs’ architecture and specifically investigate their vulnerabilities at networking interface.

MedMon: securing medical devices through wireless monitoring and anomaly detection.

Science.gov (United States)

Zhang, Meng; Raghunathan, Anand; Jha, Niraj K

2013-12-01

Rapid advances in personal healthcare systems based on implantable and wearable medical devices promise to greatly improve the quality of diagnosis and treatment for a range of medical conditions. However, the increasing programmability and wireless connectivity of medical devices also open up opportunities for malicious attackers. Unfortunately, implantable/wearable medical devices come with extreme size and power constraints, and unique usage models, making it infeasible to simply borrow conventional security solutions such as cryptography. We propose a general framework for securing medical devices based on wireless channel monitoring and anomaly detection. Our proposal is based on a medical security monitor (MedMon) that snoops on all the radio-frequency wireless communications to/from medical devices and uses multi-layered anomaly detection to identify potentially malicious transactions. Upon detection of a malicious transaction, MedMon takes appropriate response actions, which could range from passive (notifying the user) to active (jamming the packets so that they do not reach the medical device). A key benefit of MedMon is that it is applicable to existing medical devices that are in use by patients, with no hardware or software modifications to them. Consequently, it also leads to zero power overheads on these devices. We demonstrate the feasibility of our proposal by developing a prototype implementation for an insulin delivery system using off-the-shelf components (USRP software-defined radio). We evaluate its effectiveness under several attack scenarios. Our results show that MedMon can detect virtually all naive attacks and a large fraction of more sophisticated attacks, suggesting that it is an effective approach to enhancing the security of medical devices.

Risk evaluation of medical and industrial radiation devices

International Nuclear Information System (INIS)

Jones, E.D.; Cunningham, R.E.; Rathbun, P.A.

1994-03-01

In 1991, the NRC, Division of Industrial and Medical Nuclear Safety, began a program to evaluate the use of probabilistic risk assessment (PRA) in regulating medical devices. This program represents an initial step in an overall plant to evaluate the use of PRA in regulating the use of nuclear by-product materials. The NRC envisioned that the use of risk analysis techniques could assist staff in ensuring that the regulatory approach was standardized, understandable, and effective. Traditional methods of assessing risk in nuclear power plants may be inappropriate to use in assessing the use of by-product devices. The approaches used in assessing nuclear reactor risks are equipment-oriented. Secondary attention is paid to the human component, for the most part after critical system failure events have been identified. This paper describes the risk methodology developed by Lawrence Livermore National Laboratory (LLNL), initially intended to assess risks associated with the use of the Gamma Knife, a gamma stereotactic radiosurgical device. For relatively new medical devices such as the Gamma Knife, the challenge is to perform a risk analysis with very little quantitative data but with an important human factor component. The method described below provides a basic approach for identifying the most likely risk contributors and evaluating their relative importance. The risk analysis approach developed for the Gamma Knife and described in this paper should be applicable to a broader class of devices in which the human interaction with the device is a prominent factor. In this sense, the method could be a prototypical model of nuclear medical or industrial device risk analysis

Operationalization of the Ghanaian Patients' Charter in a Peri-urban Public Hospital: Voices of Healthcare Workers and Patients.

Science.gov (United States)

Yarney, Lily; Buabeng, Thomas; Baidoo, Diana; Bawole, Justice Nyigmah

2016-04-23

Health is a basic human right necessary for the exercise of other human rights. Every human being is, therefore, entitled to the highest possible standard of health necessary to living a life of dignity. Establishment of patients' Charter is a step towards protecting the rights and responsibilities of patients, but violation of patients' rights is common in healthcare institutions, especially in the developing world. This study which was conducted between May 2013 and May 2014, assessed the operationalization of Ghana's Patients Charter in a peri-urban public hospital. Qualitative data collection methods were used to collect data from 25 healthcare workers and patients who were purposively selected. The interview data were analyzed manually, using the principles of systematic text condensation. The findings indicate that the healthcare staff of the Polyclinic are aware of the existence of the patients' Charter and also know some of its contents. Patients have no knowledge of the existence or the contents of the Charter. Availability of the Charter, community sensitization, monitoring and orientation of staff are factors that promote the operationalization of the Charter, while institutional implementation procedures such as lack of complaint procedures and low knowledge among patients militate against operationalization of the Charter. Public health facilities should ensure that their patients are well-informed about their rights and responsibilities to facilitate effective implementation of the Charter. Also, patients' rights and responsibilities can be dramatized and broadcasted on television and radio in major Ghanaian languages to enhance awareness of Ghanaians on the Charter. © 2016 by Kerman University of Medical Sciences

An Analysis of the Charter School Facility Landscape in Ohio

Science.gov (United States)

Hesla, Kevin; Johnson, Jessica M.; Chambers, Darlene; Truett, Jesse; Conry, Julie; Hatt, Trint; Holliman, RaShaun; Ziebarth, Todd

2016-01-01

In the spring of 2015, the National Charter School Resource Center (NCSRC), the Colorado League of Charter Schools (the League), the Ohio Alliance for Public Charter Schools (OAPCS), and the National Alliance for Public Charter Schools (the Alliance) collaborated to collect data and information about charter school facilities and facilities…

An Analysis of the Charter School Facility Landscape in Albuquerque

Science.gov (United States)

Hesla, Kevin; Johnson, Jessica; Callahan, Kelly; Roskom, Greta; Ziebarth, Todd

2017-01-01

In 2016, the National Charter School Resource Center (NCSRC), the Colorado League of Charter Schools (the League), the New Mexico Coalition for Charter Schools (NMCCS), and the National Alliance for Public Charter Schools (the Alliance) collaborated to collect data and information about charter school facilities and facilities expenditures in the…

An Analysis of the Charter School Facility Landscape in Delaware

Science.gov (United States)

Hesla, Kevin; Johnson, Jessica M.; Massett, Kendall; Ziebarth, Todd

2018-01-01

In the spring of 2016, the National Charter School Resource Center (NCSRC), the Colorado League of Charter Schools (the League), the Delaware Charter Schools Network (DCSN), and the National Alliance for Public Charter Schools (the Alliance) collaborated to collect data and information about charter school facilities and facilities expenditures in…

Autonomy and Flexibility in Charters

Science.gov (United States)

Paisner, Eric J.

2011-01-01

In this article, the author reports on how several locally authorized charter schools generate academic gains through their freedom to significantly alter staff development and school culture. Although many districts authorize public charter schools, the school districts maintain no role in the day-to-day operations. This separation has given…

Value-based purchasing of medical devices.

Science.gov (United States)

Obremskey, William T; Dail, Teresa; Jahangir, A Alex

2012-04-01

Health care in the United States is known for its continued innovation and production of new devices and techniques. While the intention of these devices is to improve the delivery and outcome of patient care, they do not always achieve this goal. As new technologies enter the market, hospitals and physicians must determine which of these new devices to incorporate into practice, and it is important these devices bring value to patient care. We provide a model of a physician-engaged process to decrease cost and increase review of physician preference items. We describe the challenges, implementation, and outcomes of cost reduction and product stabilization of a value-based process for purchasing medical devices at a major academic medical center. We implemented a physician-driven committee that standardized and utilized evidence-based, clinically sound, and financially responsible methods for introducing or consolidating new supplies, devices, and technology for patient care. This committee worked with institutional finance and administrative leaders to accomplish its goals. Utilizing this physician-driven committee, we provided access to new products, standardized some products, decreased costs of physician preference items 11% to 26% across service lines, and achieved savings of greater than $8 million per year. The implementation of a facility-based technology assessment committee that critically evaluates new technology can decrease hospital costs on implants and standardize some product lines.

Medical instruments and devices principles and practices

CERN Document Server

Schreiner, Steven; Peterson, Donald R

2015-01-01

Medical Instruments and Devices: Principles and Practices originates from the medical instruments and devices section of The Biomedical Engineering Handbook, Fourth Edition. Top experts in the field provide material that spans this wide field. The text examines how biopotential amplifiers help regulate the quality and content of measured signals. It includes instruments and devices that span a range of physiological systems and the physiological scale: molecular, cellular, organ, and system. The book chronicles the evolution of pacemakers and their system operation and discusses oscillometry, cardiac output measurement, and the direct and indirect methods of measuring cardiac output. The authors also expound on the mechanics and safety of defibrillators and cover implantable stimulators, respiration, and the structure and function of mechanical ventilators. In addition, this text covers in depth: Anesthesia Delivery Electrosurgical Units and Devices Biomedical Lasers Measuring Cellular Traction Forces Blood G...

An Analysis of the Charter School Facility Landscape in Massachusetts

Science.gov (United States)

National Alliance for Public Charter Schools, 2013

2013-01-01

In the spring of 2012, the Massachusetts Charter Public School Association, the Colorado League of Charter Schools, and the National Alliance for Public Charter Schools worked to collect data that would reveal and accurately portray the adequacy of charter school facilities and the average spending for facilities out of charter schools' operating…

Instructions included? Make safety training part of medical device procurement process.

Science.gov (United States)

Keller, James P

2010-04-01

Before hospitals embrace new technologies, it's important that medical personnel agree on how best to use them. Likewise, hospitals must provide the support to operate these sophisticated devices safely. With this in mind, it's wise for hospitals to include medical device training in the procurement process. Moreover, purchasing professionals can play a key role in helping to increase the amount of user training for medical devices and systems. What steps should you take to help ensure that new medical devices are implemented safely? Here are some tips.

The potential of medical device industry in technological and economical context.

Science.gov (United States)

Maresova, Petra; Penhaker, Marek; Selamat, Ali; Kuca, Kamil

2015-01-01

The high quality of public health improves not only healthy life expectancy, but also the productivity of labor. The most important part of the health care sector is the medical technology industry. The aim of this study is to analyze the current situation in the medical device industry in Europe, its potential strengths and weaknesses in the context of topical economic and demographic development. The contribution specifies an analysis of the economic state of the medical device industry in the context of demographic development of European Union's macroeconomic indicators and views of experts in the field of medical device development, concerning the opportunities for entities involved in the medical device market. There is fierce competition on the European market. The innovative activity is stable and well regulated by responsible authorities. Worldwide, the medical device market is expected to grow.

77 FR 14272 - Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological...

Science.gov (United States)

2012-03-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2012-N-0165] Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus... AND MICROBIOLOGY DEVICES 0 1. The authority citation for 21 CFR part 866 continues to read as follows...

Details from the Dashboard: Charter Schools by Geographic Region

Science.gov (United States)

National Alliance for Public Charter Schools, 2012

2012-01-01

While a majority of charter schools nationwide operate in urban and suburban areas, charter schools exist in all corners of the nation, and are expanding into all types of communities. This "Details from the Dashboard" report presents statistics on the number of charter schools and students enrolled in charter schools by the four geographic…

12 CFR 704.17 - State-chartered corporate credit unions.

Science.gov (United States)

2010-01-01

... provided under the laws of the state in which it was chartered. (b) A state-chartered corporate credit... 12 Banks and Banking 6 2010-01-01 2010-01-01 false State-chartered corporate credit unions. 704.17... CORPORATE CREDIT UNIONS § 704.17 State-chartered corporate credit unions. (a) This part does not expand the...

Regulatory affairs for biomaterials and medical devices

CERN Document Server

Amato, Stephen F; Amato, B

2015-01-01

All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance.Addresses global regulations and regulatory issues surrounding biomaterials and medical devicesEspecially useful for smaller co

Charter School Replication. Policy Guide

Science.gov (United States)

Rhim, Lauren Morando

2009-01-01

"Replication" is the practice of a single charter school board or management organization opening several more schools that are each based on the same school model. The most rapid strategy to increase the number of new high-quality charter schools available to children is to encourage the replication of existing quality schools. This policy guide…

INTERFACE ELECTRONIC MEDICAL CARD ON MOBILE DEVICE

Directory of Open Access Journals (Sweden)

Y. L. Nechyporenko

2013-05-01

Full Text Available The concept designed by electronic medical card for heterogeneous environment of medical information systems at various levels. Appropriate model and technical solution. Done evaluating operating systems for mobile devices. Designed and produced by the project mobile application on Android OS as an electronic medical record on a Tablet PC Acer.

Growing pains: medical device interoperability. Regulators and new standards are helping to bring about the convergence of medical devices and information management systems on IT networks.

Science.gov (United States)

Degaspari, John

2011-07-01

Both provider organizations and medical device vendors have made significant, if slow-going, progress over the last several years to network their digitally-enabled medical devices. Recent strides in both the regulatory and standards arenas have provided renewed impetus on the part of both stakeholder groups to bring more interoperability to disparate medical devices, resulting in better security and quality of patient data.

78 FR 18233 - Medical Devices; Technical Amendment

Science.gov (United States)

2013-03-26

... human environment. Therefore, neither an environmental assessment nor an environmental impact statement..., Confidential business information, Medical devices, Medical research, Reporting and recordkeeping requirements... revising the second sentence in paragraph (a) to read as follows: Sec. 870.3600 External pacemaker pulse...

Charter Schools and Student Compositions of Traditional Public Schools

Directory of Open Access Journals (Sweden)

Nevbahar Ertas

2013-06-01

Full Text Available One of the most contentious urban education policy issues in the United States today is the expansion of charter schools and its repercussions. Does the expansion of charter schools affect the racial and socioeconomic composition of traditional public schools in the United States? This study provides empirical evidence on this question by relying on a panel design that uses school-level data from two states that have experimented with charter schools for more than 15 years: Ohio and Texas. Using county-level, spatial, and enrollment-based measures of charter exposure, the changes from pre- to post-charter-legislation stages in the student compositions of public schools that do and do not face competition from charters are examined. The results suggest that charter school presence contributes to aggregate-level changes in the share of non-Hispanic White and free-lunch-eligible students in traditional public schools in both states in different ways.

The Effect of Charter School Legislation on Market Share

Directory of Open Access Journals (Sweden)

Simona Kúscová

2004-11-01

Full Text Available Many proponents of school choice use the claim of the market’s capability to enhance efficiency and improve performance to call for its expansion. But no markets are perfectly competitive, and the local market for public goods is filled with institutional arrangements that make it differ from the neoclassical ideal. In this paper, we look at a particular institution—the provisions of charter school legislation—and assess how it affects the ability of charter schools to gain market share. Using data from the 36 states that had passed charter legislation by 2000, and controlling for a variety of other factors, we estimate a model of the effects of various provisions in the charter laws on charter school market share. We find that two such provisions, one concerning the sponsorship of charters and another their funding sources, appear to have a strong effect on the market share of charter schools.

Charters and the Common Good: The Spillover Effects of Charter Schools in New York City

Science.gov (United States)

Cordes, Sarah A.

2018-01-01

Charter Schools represent a small share of the national education market: just 6.2 percent of all public schools and 4.6 percent of all students. But their rapid growth over the past two decades has captured an outsized measure of public attention, especially in communities where district and charter schools operate side by side. At New York…

76 FR 65200 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of...

Science.gov (United States)

2011-10-20

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of... Administration (FDA) is postponing the meeting of the General and Plastic Surgery Devices Panel of the Medical...

Prospects of radiation sterilization of medical devices

International Nuclear Information System (INIS)

Hosobuchi, Kazunari

1992-01-01

Since radiation sterilization was first introduced in the United States in 1956 in the field of disposable medical devices, it has become an indispensable technique for sterilization because of the following reasons: (1) introduction into dialyzers, (2) introduction in medical device makers, (3) development of disposable medical devices associated with developing both high molecular chemistry and cool sterilization, (4) rationality of sterilization process, and (5) problems of sterilization with ethylene oxide gas. To promote the further development of radiation sterilization, the following items are considered necessary: (1) an increase in the number of facilities for radiation sterilization, (2) recommendation of the international standardization of sterilization method, (3) decrease in radiation doses associated with sterilization, (4) development of electron accelerators and bremsstrahlung equipments for radiation sources, and (5) simplification of sterilization process management. Factors precluding the development of radiation sterilization are: (1) development of other methods than radiation sterilization, (2) development of technique for sterile products, (3) high facility cost, (4) high irradiation cost, (5) benefits and limits of sterilization markets, and (6) influences of materials. (N.K.)

12 CFR 34.24 - Nonfederally chartered commercial banks.

Science.gov (United States)

2010-01-01

... 12 Banks and Banking 1 2010-01-01 2010-01-01 false Nonfederally chartered commercial banks. 34.24... LENDING AND APPRAISALS Adjustable-Rate Mortgages § 34.24 Nonfederally chartered commercial banks. Pursuant to 12 U.S.C. 3803(a), a State chartered commercial bank may make ARM loans in accordance with the...

Religious Charter Schools: Gaining Ground yet Still Undefined

Science.gov (United States)

Weinberg, Lawrence D.

2009-01-01

This article examines charter schools from the perspective of religious institutions and parents that may want to open such schools. Religion-based charter schools also pose unique policy and legal questions because charter schools are a singular reform method. It examines the relevant, recent and historical, legal cases, and relevant examples of…

Assurance Cases for Medical Devices

Science.gov (United States)

2011-04-28

the patient, and the hospital setting. Some pumps allow the patient to control part of the injection process (e.g. to inject more painkiller ...overdose, incorrect therapy, etc.   Design and development decisions that bear on safety and effectiveness http://www.fda.gov/MedicalDevices

Electronic medical devices: a primer for pathologists.

Science.gov (United States)

Weitzman, James B

2003-07-01

Electronic medical devices (EMDs) with downloadable memories, such as implantable cardiac pacemakers, defibrillators, drug pumps, insulin pumps, and glucose monitors, are now an integral part of routine medical practice in the United States, and functional organ replacements, such as the artificial heart, pancreas, and retina, will most likely become commonplace in the near future. Often, EMDs end up in the hands of the pathologist as a surgical specimen or at autopsy. No established guidelines for systematic examination and reporting or comprehensive reviews of EMDs currently exist for the pathologist. To provide pathologists with a general overview of EMDs, including a brief history; epidemiology; essential technical aspects, indications, contraindications, and complications of selected devices; potential applications in pathology; relevant government regulations; and suggested examination and reporting guidelines. Articles indexed on PubMed of the National Library of Medicine, various medical and history of medicine textbooks, US Food and Drug Administration publications and product information, and specifications provided by device manufacturers. Studies were selected on the basis of relevance to the study objectives. Descriptive data were selected by the author. Suggested examination and reporting guidelines for EMDs received as surgical specimens and retrieved at autopsy. Electronic medical devices received as surgical specimens and retrieved at autopsy are increasing in number and level of sophistication. They should be systematically examined and reported, should have electronic memories downloaded when indicated, will help pathologists answer more questions with greater certainty, and should become an integral part of the formal knowledge base, research focus, training, and practice of pathology.

Wearable Devices in Medical Internet of Things: Scientific Research and Commercially Available Devices.

Science.gov (United States)

Haghi, Mostafa; Thurow, Kerstin; Stoll, Regina

2017-01-01

Wearable devices are currently at the heart of just about every discussion related to the Internet of Things. The requirement for self-health monitoring and preventive medicine is increasing due to the projected dramatic increase in the number of elderly people until 2020. Developed technologies are truly able to reduce the overall costs for prevention and monitoring. This is possible by constantly monitoring health indicators in various areas, and in particular, wearable devices are considered to carry this task out. These wearable devices and mobile apps now have been integrated with telemedicine and telehealth efficiently, to structure the medical Internet of Things. This paper reviews wearable health care devices both in scientific papers and commercial efforts. MIoT is demonstrated through a defined architecture design, including hardware and software dealing with wearable devices, sensors, smart phones, medical application, and medical station analyzers for further diagnosis and data storage. Wearables, with the help of improved technology have been developed greatly and are considered reliable tools for long-term health monitoring systems. These are applied in the observation of a large variety of health monitoring indicators in the environment, vital signs, and fitness. Wearable devices are now used for a wide range of healthcare observation. One of the most important elements essential in data collection is the sensor. During recent years with improvement in semiconductor technology, sensors have made investigation of a full range of parameters closer to realization.

Perspectivas sobre las escuelas charter: Una resena para padres de familia (Perspectives on Charter Schools: A Review for Parents). ERIC Digest.

Science.gov (United States)

Donahoo, Saran

Recently, charter schools have gained popularity with parents, students, and others as alternatives to public schools, but what are charter schools and what effects are they having? This Spanish-language Digest defines charter schools and clarifies some of the administrative and legal details surrounding such schools. The Digest also lays out some…

The Style Evolution of Glasses: Acknowledging Well-being for Wearable Medical Device

Directory of Open Access Journals (Sweden)

Lydia Royeen

2015-10-01

Full Text Available The focus of Peta Bush’s work is to create wearable medical devices that address all qualities of the individual, including physical, mental, emotional, and psychosocial aspects. Peta is completing a practice-based research PhD titled “Therapeutic jewelry: The craft of people-centric devices for wellbeing.” Her passion for creating wearable medical devices that are multi-dimensional stems from her personal experiences, as she has Ehlers-Danlos syndrome. In addition, she uses her knowledge of well-being and the biopsychosocial model when creating her wearable medical devices. Peta currently uses technology, such as 3D printing, as one method to fabricate her collection. Her aspirations are for this concept of wearable medical devices to become mainstream, similar to glasses, and to remove the stigma associated with wearable medical devices.

78 FR 12329 - Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements; Draft...

Science.gov (United States)

2013-02-22

... medical devices to take timely action to correct violative devices or remove them from the marketplace...] Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements; Draft Guidance for... draft guidance entitled ``Distinguishing Medical Device Recalls From Product Enhancements; Reporting...

Does Charter Status Determine Preferences? Comparing the Hiring Preferences of Charter and Traditional Public School Principals

Science.gov (United States)

Cannata, Marisa; Engel, Mimi

2012-01-01

The academic success of any school depends on its teachers. However, relatively little research exists on the qualities principals value in teacher hiring, and we know almost nothing about charter school principals' preferences. This article addresses this gap in the literature using survey results for a matched sample of charter and traditional…

School Segregation, Charter Schools, and Access to Quality Education*

Science.gov (United States)

Logan, John R.; Burdick-Will, Julia

2015-01-01

Race, class, neighborhood, and school quality are all highly inter-related in the American educational system. In the last decade a new factor has come into play, the option of attending a charter school. We offer a comprehensive analysis of the disparities among public schools attended by white, black, Hispanic, Asian, and Native American children in 2010–2011, including all districts in which charter schools existed. We compare schools in terms of poverty concentration, racial composition, and standardized test scores, and we also examine how attending a charter or non-charter school affects these differences. Black and Hispanic (and to a lesser extent Native American and Asian) students attend elementary and high schools with higher rates of poverty than white students. Especially for whites and Asians, attending a charter school means lower exposure to poverty. Children’s own race and the poverty and charter status of their schools affect the test scores and racial isolation of schools that children attend in complex combinations. Most intriguing, attending a charter school means attending a better performing school in high-poverty areas but a lower performing school in low-poverty areas. Yet even in the best case the positive effect of attending a charter school only slightly offsets the disadvantages of black and Hispanic students. PMID:27616813

[Thoughts on the Witnessed Audit in Medical Device Single Audit Program].

Science.gov (United States)

Wen, Jing; Xiao, Jiangyi; Wang, Aijun

2018-02-08

Medical Device Single Audit Program is one of the key projects in International Medical Device Regulators Forum, which has much experience to be used for reference. This paper briefly describes the procedures and contents of the Witnessed Audit in Medical Device Single Audit Program. Some revelations about the work of Witnessed Audit have been discussed, for reference by the Regulatory Authorities and the Auditing Organizations.

The Greek charter of the Hungarian King Stephen I

Directory of Open Access Journals (Sweden)

Stojkovski Boris

2016-01-01

Full Text Available The first Hungarian Christian ruler, King Stephen I (997-1038 issued several charters that have survived to this day. One of them is the charter issued on behalf of the nuns from the Monastery of the Holy Theotokos in Veszprémvölgy. The charter was written in the Greek language, and has been the subject of many studies. The original has not been preserved; what remains is a copy from the time of King Coloman, dated to 1109. The charter has not been published in a critical edition in any language other than Hungarian and even though it has been examined by numerous Hungarian scholars, many questions remain open. The aim of the author is to provide a critical edition and an English translation of the charter, but also to clarify some remaining doubts about the charter and its contents. Furthermore, some comparisons will be made with the Byzantine charters issued at the beginning of the 11th and during the 12th century.

Medical device development: managing conflicts of interest encountered by physicians.

Science.gov (United States)

Baim, Donald S; Donovan, Aine; Smith, John J; Briefs, Nancy; Geoffrion, Richard; Feigal, David; Kaplan, Aaron V

2007-04-01

New technologies introduced over the past three decades have transformed medical diagnosis and treatment, and significantly improved patient outcomes. These changes have been mediated by the introduction of new medical devices, particularly for the treatment of cardiovascular, orthopedic, and ophthalmic disorders. These devices, in turn, have created large markets and spawned a burgeoning medical device industry, including six Fortune 500 companies whose combined market capitalization now exceeds 400 billion dollars. This success story, which has unquestionably benefited patients and society alike, has been dependent upon an intense collaboration among industry, clinicians, and regulatory authorities. However, when physicians actively involved in patient care participate in such collaborations, they are increasingly vulnerable to creating potential conflicts between these two (clinical and device development) roles. Such conflicts, which may ultimately erode public trust, have important consequences not only for the individual physicians, but also for their parent institutions, their patients, sponsoring companies, and the entire clinical research enterprise that makes the development and introduction of new devices possible. The third Dartmouth Device Development Symposium held in October 2005 brought together thought leaders within the medical device community, including academicians, clinical investigators, regulators from the Food and Drug Administration and Centers for Medicare and Medicaid Services (CMS), large and small device manufacturers and the financial (venture capital and investment banks) community. The Symposium examined the conflicts of interest encountered during the early development and commercialization of a medical device. The goal of these discussions was to (1) identify and characterize the conflicts that arise and (2) provide strategies to address these conflicts. This manuscript was prepared by a writing committee to provide a summary

75 FR 68200 - Medical Devices; Radiology Devices; Reclassification of Full-Field Digital Mammography System

Science.gov (United States)

2010-11-05

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 892 [Docket No. FDA-2008-N-0273] Medical Devices; Radiology Devices; Reclassification of Full- Field Digital... and Drugs, 21 CFR part 892 is amended as follows: PART 892--RADIOLOGY DEVICES 0 1. The authority...

Identification of Bodies by Unique Serial Numbers on Implanted Medical Devices.

Science.gov (United States)

Blessing, Melissa M; Lin, Peter T

2018-05-01

Visual identification is the most common identification method used by medical examiners but is not always possible. Alternative methods include X-ray, fingerprint, or DNA comparison, but these methods require additional resources. Comparison of serial numbers on implanted medical devices is a rapid and definitive method of identification. To assess the practicality of using this method, we reviewed 608 consecutive forensic autopsies performed at a regional medical examiner office. Of these, 56 cases required an alternative method of identification due to decomposition (n = 35), gunshot wound (n = 9), blunt trauma (n = 6), or charring (n = 6). Of these 56 cases, eight (14.3%) were known to have an implanted medical device. Of these eight cases, five (63%) could be positively identified by comparing serial numbers. If an implanted medical device is known to be present, and medical records are available, identification by medical device serial number should be a first-line method. © 2017 American Academy of Forensic Sciences.

MEDIC: medical embedded device for individualized care.

Science.gov (United States)

Wu, Winston H; Bui, Alex A T; Batalin, Maxim A; Au, Lawrence K; Binney, Jonathan D; Kaiser, William J

2008-02-01

Presented work highlights the development and initial validation of a medical embedded device for individualized care (MEDIC), which is based on a novel software architecture, enabling sensor management and disease prediction capabilities, and commercially available microelectronic components, sensors and conventional personal digital assistant (PDA) (or a cell phone). In this paper, we present a general architecture for a wearable sensor system that can be customized to an individual patient's needs. This architecture is based on embedded artificial intelligence that permits autonomous operation, sensor management and inference, and may be applied to a general purpose wearable medical diagnostics. A prototype of the system has been developed based on a standard PDA and wireless sensor nodes equipped with commercially available Bluetooth radio components, permitting real-time streaming of high-bandwidth data from various physiological and contextual sensors. We also present the results of abnormal gait diagnosis using the complete system from our evaluation, and illustrate how the wearable system and its operation can be remotely configured and managed by either enterprise systems or medical personnel at centralized locations. By using commercially available hardware components and software architecture presented in this paper, the MEDIC system can be rapidly configured, providing medical researchers with broadband sensor data from remote patients and platform access to best adapt operation for diagnostic operation objectives.

Medical applications for pharmacists using mobile devices.

Science.gov (United States)

Aungst, Timothy Dy

2013-01-01

Mobile devices (eg, smartphones, tablet computers) have become ubiquitous and subsequently there has been a growth in mobile applications (apps). Concurrently, mobile devices have been integrated into health care practice due to the availability and quality of medical apps. These mobile medical apps offer increased access to clinical references and point-of-care tools. However, there has been little identification of mobile medical apps suitable for the practice of pharmacy. To address the shortage of recommendations of mobile medical apps for pharmacists in daily practice. Mobile medical apps were identified via the iTunes and Google Play Stores via the "Medical" app categories and key word searches (eg, drug information, medical calculators). In addition, reviews provided by professional mobile medical app review websites were used to identify apps. Mobile medical apps were included if they had been updated in the previous 3 months, were available in the US, used evidence-based information or literature support, had dedicated app support, and demonstrated stability. Exclusion criteria included apps that were not available in English, had advertisement bias, used nonreferenced sources, were available only via an institution-only subscription, and were web-based portals. Twenty-seven mobile apps were identified and reviewed that involved general pharmacy practice, including apps that involved drug references, clinical references, medical calculators, laboratory references, news and continuing medical education, and productivity. Mobile medical apps have a variety of features that are beneficial to pharmacy practice. Individual clinicians should consider several characteristics of these apps to determine which are suitable to incorporate into their daily practice.

Developing medical device software in compliance with regulations.

Science.gov (United States)

Zema, M; Rosati, S; Gioia, V; Knaflitz, M; Balestra, G

2015-08-01

In the last decade, the use of information technology (IT) in healthcare has taken a growing role. In fact, the adoption of an increasing number of computer tools has led to several benefits related to the process of patient care and allowed easier access to social and health care resources. At the same time this trend gave rise to new challenges related to the implementation of these new technologies. Software used in healthcare can be classified as medical devices depending on the way they are used and on their functional characteristics. If they are classified as medical devices they must satisfy specific regulations. The aim of this work is to present a software development framework that can allow the production of safe and high quality medical device software and to highlight the correspondence between each software development phase and the appropriate standard and/or regulation.

21 CFR 801.122 - Medical devices for processing, repacking, or manufacturing.

Science.gov (United States)

2010-04-01

....122 Medical devices for processing, repacking, or manufacturing. A device intended for processing... act if its label bears the statement “Caution: For manufacturing, processing, or repacking”. ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices for processing, repacking, or...

Handheld Diagnostic Device Delivers Quick Medical Readings

Science.gov (United States)

2014-01-01

To monitor astronauts' health remotely, Glenn Research Center awarded SBIR funding to Cambridge, Massachusetts-based DNA Medical Institute, which developed a device capable of analyzing blood cell counts and a variety of medical biomarkers. The technology will prove especially useful in rural areas without easy access to labs.

Medical device problem reporting for the betterment of healthcare.

Science.gov (United States)

1998-08-01

Given that there are nearly 5,000 individual classes of medical devices, tens of thousands of medical device suppliers, and millions of healthcare providers around the world, device-related problems are bound to happen. But effective problem reporting can help reduce or eliminate many of these problems--not only within an institution, but also potentially around the world. In this article, we trace the problem reporting process from its beginnings in the hospital to its global impact in making critical information available throughout the healthcare community.

Home Healthcare Medical Devices: A Checklist

Science.gov (United States)

... not using it. Contact your doctor and home healthcare team often to review your health condition. * Check ... assurance of their safety and effectiveness. A home healthcare medical device is any product or equipment used ...

Radiation sterilization of medical devices

International Nuclear Information System (INIS)

Kaluska, I.; Stuglik, Z.

1996-01-01

Overview of sterilization methods of medical devices has been given, with the special stress put on radiation sterilization. A typical validation program for radiation sterilization has been shown and also a comparison of European and ISO standards concerning radiation sterilization has been discussed. (author). 13 refs, 1 fig., 2 tabs

77 FR 19534 - Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological...

Science.gov (United States)

2012-04-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2012-N-0165] Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological Reagents; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; correction...

BIOANALYTICAL STANDARDIZING FOR SEROLOGICAL DIAGNOSTIC MEDICAL DEVICES

Directory of Open Access Journals (Sweden)

A. Yu. Galkin

2015-04-01

Full Text Available In article we analyzed national and international regulations concerning the quality and safety of medical devices for in vitro diagnostics. We discussed the possibility of a partial application of the recommendations of the State Pharmacopoeia of Ukraine to this type of product. The main guiding regulatory documents establishing requirements for quality and safety tools for the serological diagnosis products are The technical regulation on medical devices for the diagnosis in vitro, DSTU ISO 13485 “Medical devices. Quality management system. Regulatory requirements”, and DSTU ISO/IEC 17025 “General requirements for the competence of testing and calibration laboratories”. Similar requirements of the State Pharmacopoeia of Ukraine which are used for drug standardization can not be directly applied to the medical devises for in vitro diagnostics due to a number of features, namely, the serological diagnosis products pre-designed to determine the unknown concentration of a particular analyte in a biological material, the diagnostic kits has to include the control samples (internal standard systems that need to be calibrated. It was determined following parameters of bioanalytical standardization and validation characterization for of qualitative (semi quantitative test-kits for serological diagnosis: precision (convergence, intralaboratory precision and reproducibility, diagnostic and analytical specificity, diagnostic sensitivity. It’s necessary to inspect additional parameters for quantitative test-kits such as accuracy (precision, linearity, analytical sensitivity and range.

Sustainable development - the ICC business charter

International Nuclear Information System (INIS)

Santaholma, J.

1992-01-01

The International Chamber of Commerce (ICC) prepared and approved, in November 1990, the ''Business Charter for Sustainable Development; a set of principles for environmental management''. Environmental protection is a necessary part of sustainable development but, too often, the performance of business is seen by society as inadequate. Improved environmental performance is essential if business is to regain public trust, reduce the pressures on governments to over-legislate, and strengthen the business voice in debate on public policy. The Charter has been prepared as a major pro-active business initiative by enterprises around the world. This is timely in view of the extensive international debate on environmental issues and the widespread acceptance of the ''Sustainable Development'' concept. Sustainable development involves meeting the needs of the present without compromising the ability of future generations to meet their own needs. Although the objective of the Charter is that the widest range of enterprises as organizations commit themselves to improving their environmental performance in accordance with the Principles of the Charter, an individual branch of industry may also meet the goals of the Charter. The paper evaluates how the practices implemented in the field of nuclear energy are in harmony with the principles. The conclusion is that nuclear is in the avant garde within the wide spectrum of industrial activities. This conclusion should assist nuclear energy to improve its public acceptance. (author)

Liability for damage caused by shortage and failure to use necessary medical devices

Directory of Open Access Journals (Sweden)

Cvetković Mihajlo

2014-01-01

Full Text Available In order to provide for successful, safe and high quality medical services, health care institutions need to be equipped with adequate medical devices. For this reason, every medical institution is legally obliged to have relevant medical devices. In case a patient has been deprived of some medical service for the lack of necessary medical devices (which the institution has been obliged to provide, the medical institution is responsible for the damage and harm sustained by the patient. The responsibility implies non-contractual liability (in tort law or pre-contractual liability (in contract law. In both cases, the liability is based on the presumed culpability. In order to be excluded from liability, the medical institution has to prove that the patient has been deprived of medical service (or that the institution has refused to enter into a medical service provider agreement on justifiable grounds, i.e. due to the lack of necessary medical devices. On the other hand, in case the medial institutions fail to provide needed care or violate their obligation to use medical devices when necessary, it is regarded as medical negligence (professional error. In most cases, it implies the liability of medical institutions for damage, injury or harm caused to the patient by medical services provided without applying a relevant medical device, whose use has been medically indicated. The liability is even more substantial in cases where the medical device has been available but the medical institutions has not applied it in medial treatment (even though its use has been medically indicated; such conduct is qualified as gross negligence.

Virtual Charter Schools: Realities and Unknowns

Science.gov (United States)

Torre, Daniela

2013-01-01

Virtual charter schools have emerged over the last decade as an increasingly popular alternative to traditional public schooling. Unlike their face-to-face counterparts, virtual charter schools educate students through blended or entirely online curricula. They present a host of new policy issues that should be scrutinized in order to ensure that…

Medical Device Plug-and-Play Interoperability Standards and Technology Leadership

Science.gov (United States)

2017-10-01

Award Number: W81XWH-09-1-0705 TITLE: “Medical Device Plug-and-Play Interoperability Standards and Technology Leadership” PRINCIPAL INVESTIGATOR...Sept 2016 – 20 Sept 2017 4. TITLE AND SUBTITLE “Medical Device Plug-and-Play Interoperability 5a. CONTRACT NUMBER Standards and Technology ...efficiency through interoperable medical technologies . We played a leadership role on interoperability safety standards (AAMI, AAMI/UL Joint

Transmitting patient and device data via GSM--central management for decentral mobile medical devices.

Science.gov (United States)

Bachmor, T; Schöchlin, J; Bolz, A

2002-01-01

Equipping medical devices with long range telemetry opens completely new possibilities for emergency response, home care and remote diagnosis. Mobile communications nowadays seem to be a generally accepted part of our modern world, but bridging the gap between new (consumer-) technologies and medical devices still is a challenge today. Providing a telemetry link (GSM) is just the trivial part--ensuring security, reliability and service management are the more critical tasks that need to be addressed. Therefore, a complete system concept consists of an automatic fleet management (e.g. periodic device-initiated service calls) as well as customer relationship management (CRM), including technical service and a trouble-ticket system.

Medical device integration: CIOs must bridge the digital divide between devices and electronic medical records.

Science.gov (United States)

Raths, David

2009-02-01

To get funding approved for medical device integration, ClOs suggest focusing on specific patient safety or staff efficiency pain points. Organizations that make clinical engineering part of their IT team report fewer chain-of-command issues. It also helps IT people understand the clinical goals because the engineering people have been working closely with clinicians for years. A new organization has formed to work on collaboration between clinical engineers and IT professionals. For more information, go to www.ceitcollaboration.org. ECRI Institute has written a guide to handling the convergence of medical technology and hospital networks. Its "Medical Technology for the IT Professional: An Essential Guide for Working in Today's Healthcare Setting" also details how IT professionals can assist hospital technology planning and acquisition, and provide ongoing support for IT-based medical technologies. For more information, visit www.ecri.org/ITresource.

Cybersecurity and medical devices: A practical guide for cardiac electrophysiologists

Science.gov (United States)

Kramer, Daniel B.; Foo Kune, Denis; Auto de Medeiros, Julio; Yan, Chen; Xu, Wenyuan; Crawford, Thomas; Fu, Kevin

2017-01-01

Abstract Medical devices increasingly depend on software. While this expands the ability of devices to perform key therapeutic and diagnostic functions, reliance on software inevitably causes exposure to hazards of security vulnerabilities. This article uses a recent high‐profile case example to outline a proactive approach to security awareness that incorporates a scientific, risk‐based analysis of security concerns that supports ongoing discussions with patients about their medical devices. PMID:28512774

International Charter `Space and Major Disasters' Collaborations

Science.gov (United States)

Jones, B. K.

2017-12-01

The International Charter aims at providing a unified system of space data acquisition and delivery to national disaster authorities of countries affected by natural or man-made disasters. Each of the sixteen Member Agencies has committed resources to support the objectives of the Charter and thus helping to mitigate the effects of disasters on human life and property, getting critical information into the hands of the disaster responders so that they can make informed decisions in the wake of a disaster. The Charter Member Agencies work together to provide remotely sensed imagery to any requesting country that is experiencing a natural or man-made disaster. The Space Agencies contribute priority satellite taskings, archive retrievals, and map production, as well as imagery of the affected areas. The imagery is provided at no cost to the affected country and is made available for the immediate response phase of the disaster. The Charter also has agreements with Sentinel Asia to submit activation requests on behalf of its 30+ member countries and the United Nations Office of Outer Space Affairs (UN OOSA) and United Nations Institute for Training and Research (UNITAR)/ United Nations Operational Satellite Applications Programme (UNOSAT) to submit activations on behalf of United Nations relief agencies such as UNICEF and UNOCHA. To further expand accessibility to the Charter Member Agency resources, the Charter has implemented the Universal Access initiative, which allows any country's disaster management authority to submit an application, attend a brief training session, and after successful completion, become an Authorized User able to submit activation requests without assistance from Member Agencies. The data provided by the Charter is used for many purposes including damage assessments, reference maps, evacuation route planning, search and rescue operations, decision maker briefings, scientific evaluations, and other response activities.

Earth Charter, ESD and Chinese Philosophies

Science.gov (United States)

Liu, Yunhua; Constable, Alicia

2010-01-01

This article examines the relationship between the Earth Charter and education for sustainable development (ESD), as part of the UN Decade of Education for Sustainable Development. The areas of shared interest between the two are assessed and the invaluable nature of the Earth Charter as a resource outlining global values and principles for a…

Medical device registration, agreements on mutual recognition - a step forward to global harmonization?

International Nuclear Information System (INIS)

Eidenberger, R.Reiner

2000-01-01

The purpose of this article is to give a short overview of some different regulations in Europe and the United States with regard to the clearance of medical devices and to give an outlook of what the Agreements on Mutual Recognition will bring in terms of Global Harmonization. Recent European legislation, the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (Medical Device Directive, MDD), requires that all medical devices placed on the European market bear the CE marking. From 14 June 1998, medical devices fall under the scope of this European Medical Device Directive and there is a harmonization within the European market. Similar to this, but for another market, are the USA FDA requirements, Premarket Approval (PMA) and Premarket notification (510(k)). The same medical device, the same goal - a safe product - but different legislation and thus duplication of registration procedures. The European Commission is presently discussing a series of agreements with third countries, Australia, New Zealand, USA, Canada, Japan and Eastern European countries wishing to join the EU, concerning the mutual acceptance of inspection bodies and, ultimately, proof of conformity (for example reports on examination, certificates, licenses and marks of conformity) in connection with medical devices. Meanwhile agreements with Australia, New Zealand, USA and Canada came into force. (author)

The potential of medical device industry in technological and economical context

Directory of Open Access Journals (Sweden)

Maresova P

2015-10-01

Full Text Available Petra Maresova,1 Marek Penhaker,1,2 Ali Selamat,1,3 Kamil Kuca1,41Faculty of Informatics and Management, University of Hradec Králové, Hradec Králové, Czech Republic; 2Department of Cybernetics and Biomedical Engineering, Faculty of Electrical Engineering and Computer Science, Technical University of Ostrava, Poruba, Czech Republic; 3Faculty of Computing, Universiti Teknologi Malaysia, Johor Bahru, Johor, Malaysia; 4Center for Biomedical Research, University Hospital Hradec Králové, Hradec Králové, Czech RepublicAbstract: The high quality of public health improves not only healthy life expectancy, but also the productivity of labor. The most important part of the health care sector is the medical technology industry. The aim of this study is to analyze the current situation in the medical device industry in Europe, its potential strengths and weaknesses in the context of topical economic and demographic development. The contribution specifies an analysis of the economic state of the medical device industry in the context of demographic development of European Union’s macroeconomic indicators and views of experts in the field of medical device development, concerning the opportunities for entities involved in the medical device market. There is fierce competition on the European market. The innovative activity is stable and well regulated by responsible authorities. Worldwide, the medical device market is expected to grow.Keywords: technology context, medical device, Europe, expenditure, review

77 FR 4252 - Additional Spectrum for the Medical Device Radiocommunication Service

Science.gov (United States)

2012-01-27

... licensed users in these frequency bands to continue providing service. Medical Micro-Power Networks (MMNs...). Under this approach, medical devices would operate in the band on a shared, non-exclusive basis with...Radio Service rules for devices operating in the 413-457 MHz band. These definitions were for a Medical...

Program Baseline Change Control Board charter

International Nuclear Information System (INIS)

1993-02-01

The purpose of this Charter is to establish the Program Baseline Change Control Board (PBCCB) for the Office of Civilian Radioactive Waste Management (OCRWM) Program, and to describe its organization, responsibilities, and basic methods of operation. Guidance for implementing this Charter is provided by the OCRWM Baseline Management Plan (BMP) and OCRWM Program Baseline Change Control Procedure

Optical tests for using smartphones inside medical devices

Science.gov (United States)

Bernat, Amir S.; Acobas, Jennifer K.; Phang, Ye Shang; Hassan, David; Bolton, Frank J.; Levitz, David

2018-02-01

Smartphones are currently used in many medical applications and are more frequently being integrated into medical imaging devices. The regulatory requirements in existence today however, particularly the standardization of smartphone imaging through validation and verification testing, only partially cover imaging characteristics with a smartphone. Specifically, it has been shown that smartphone camera specifications are of sufficient quality for medical imaging, and there are devices which comply with the FDA's regulatory requirements for a medical device such as a device's field of view, direction of viewing and optical resolution and optical distortion. However, these regulatory requirements do not call specifically for color testing. Images of the same object using automatic settings or different light sources can show different color composition. Experimental results showing such differences are presented. Under some circumstances, such differences in color composition could potentially lead to incorrect diagnoses. It is therefore critical to control the smartphone camera and illumination parameters properly. This paper examines different smartphone camera settings that affect image quality and color composition. To test and select the correct settings, a test methodology is proposed. It aims at evaluating and testing image color correctness and white balance settings for mobile phones and LED light sources. Emphasis is placed on color consistency and deviation from gray values, specifically by evaluating the ΔC values based on the CIEL*a*b* color space. Results show that such standardization minimizes differences in color composition and thus could reduce the risk of a wrong diagnosis.

Laser direct writing of micro- and nano-scale medical devices

Science.gov (United States)

Gittard, Shaun D; Narayan, Roger J

2010-01-01

Laser-based direct writing of materials has undergone significant development in recent years. The ability to modify a variety of materials at small length scales and using short production times provides laser direct writing with unique capabilities for fabrication of medical devices. In many laser-based rapid prototyping methods, microscale and submicroscale structuring of materials is controlled by computer-generated models. Various laser-based direct write methods, including selective laser sintering/melting, laser machining, matrix-assisted pulsed-laser evaporation direct write, stereolithography and two-photon polymerization, are described. Their use in fabrication of microstructured and nanostructured medical devices is discussed. Laser direct writing may be used for processing a wide variety of advanced medical devices, including patient-specific prostheses, drug delivery devices, biosensors, stents and tissue-engineering scaffolds. PMID:20420557

Open-source hardware for medical devices.

Science.gov (United States)

Niezen, Gerrit; Eslambolchilar, Parisa; Thimbleby, Harold

2016-04-01

Open-source hardware is hardware whose design is made publicly available so anyone can study, modify, distribute, make and sell the design or the hardware based on that design. Some open-source hardware projects can potentially be used as active medical devices. The open-source approach offers a unique combination of advantages, including reducing costs and faster innovation. This article compares 10 of open-source healthcare projects in terms of how easy it is to obtain the required components and build the device.

School Food Environment of Charter Schools in St. Louis

Science.gov (United States)

Linsenmeyer, Whitney; Kelly, Patrick; Jenkins, Steve; Mattfeldt-Berman, Mildred

2013-01-01

Purpose/Objectives: The purpose of this study was to explore the school food environment of charter schools in Saint Louis, Missouri. The objectives were to: (1) describe the participation of charter schools in the National School Lunch Program and (2) describe the prevalence of competitive foods in charter schools. Methods: School administrators…

Evaluating and Predicting Patient Safety for Medical Devices With Integral Information Technology

Science.gov (United States)

2005-01-01

323 Evaluating and Predicting Patient Safety for Medical Devices with Integral Information Technology Jiajie Zhang, Vimla L. Patel, Todd R...errors are due to inappropriate designs for user interactions, rather than mechanical failures. Evaluating and predicting patient safety in medical ...the users on the identified trouble spots in the devices. We developed two methods for evaluating and predicting patient safety in medical devices

Modelling degradation of bioresorbable polymeric medical devices

CERN Document Server

Pan, J

2015-01-01

The use of bioresorbable polymers in stents, fixation devices and tissue engineering is revolutionising medicine. Both industry and academic researchers are interested in using computer modelling to replace some experiments which are costly and time consuming. This book provides readers with a comprehensive review of modelling polymers and polymeric medical devices as an alternative to practical experiments. Chapters in part one provide readers with an overview of the fundamentals of biodegradation. Part two looks at a wide range of degradation theories for bioresorbable polymers and devices.

77 FR 8260 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device...

Science.gov (United States)

2012-02-14

... will be used to evaluate risks associated with medical devices which will enable FDA to take...] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Reporting... comment in response to the notice. This notice solicits comments on medical device reporting (MDR...

Applying the Ottawa Charter to inform health promotion programme design.

Science.gov (United States)

Fry, Denise; Zask, Avigdor

2017-10-01

There is evidence of a correlation between adoption of the Ottawa Charter's framework of five action areas and health promotion programme effectiveness, but the Charter's framework has not been as fully implemented as hoped, nor is generally used by formal programme design models. In response, we aimed to translate the Charter's framework into a method to inform programme design. Our resulting design process uses detailed definitions of the Charter's action areas and evidence of predicted effectiveness to prompt greater consideration and use of the Charter's framework. We piloted the process by applying it to the design of four programmes of the Healthy Children's Initiative in New South Wales, Australia; refined the criteria via consensus; and made consensus decisions on the extent to which programme designs reflected the Charter's framework. The design process has broad potential applicability to health promotion programmes; facilitating greater use of the Ottawa Charter framework, which evidence indicates can increase programme effectiveness. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Use-related risk analysis for medical devices based on improved FMEA.

Science.gov (United States)

Liu, Long; Shuai, Ma; Wang, Zhu; Li, Ping

2012-01-01

In order to effectively analyze and control use-related risk of medical devices, quantitative methodologies must be applied. Failure Mode and Effects Analysis (FMEA) is a proactive technique for error detection and risk reduction. In this article, an improved FMEA based on Fuzzy Mathematics and Grey Relational Theory is developed to better carry out user-related risk analysis for medical devices. As an example, the analysis process using this improved FMEA method for a certain medical device (C-arm X-ray machine) is described.

Home Use Devices: How to Prepare for and Handle Power Outages for Medical Devices That Require Electricity

Science.gov (United States)

... to Create a Personal Emergency File My personal emergency file contains: □ Instructions for using the medical device and all device manuals. □ First aid kit □ Medical records □ Insurance cards □ Current home care doctor’s orders □ Plan of treatment □ What a family ...

Forging Inclusive Solutions: Experiential Earth Charter Education

Science.gov (United States)

Hill, Linda D.

2010-01-01

Forging Inclusive Solutions describes the aims, methodology and outcomes of Inclusive Leadership Adventures, an experiential education curriculum for exploring the Earth Charter. Experiential education builds meaningful relationships, skills, awareness and an inclusive community based on the Earth Charter principles. When we meet people where they…

Understanding District-Charter Collaboration Grants. Final Report

Science.gov (United States)

Tuttle, Christina; McCullough, Moira; Richman, Scott; Booker, Kevin; Burnett, Alyson; Keating, Betsy; Cavanaugh, Michael

2016-01-01

In November 2012, the Bill & Melinda Gates Foundation invested in seven innovative district-charter partnerships with "the potential capacity and commitment to accelerate student college ready rates through deep collaboration and sharing of best practices" (District-Charter Collaboration Grant Request for Proposal [RFP]). These…

Charter School Autonomy: The Mismatch between Theory and Practice

Science.gov (United States)

Finnigan, Kara S.

2007-01-01

In theory, the charter school concept is based on a trade-off or exchange: greater autonomy for increased accountability. Although charter schools have been operating for more than 10 years, little is known about charter school autonomy in practice. This mixed-methods study used survey and case study data to examine the degree of autonomy of…

Extended device profiles and testing procedures for the approval process of integrated medical devices using the IEEE 11073 communication standard.

Science.gov (United States)

Janß, Armin; Thorn, Johannes; Schmitz, Malte; Mildner, Alexander; Dell'Anna-Pudlik, Jasmin; Leucker, Martin; Radermacher, Klaus

2018-02-23

Nowadays, only closed and proprietary integrated operating room systems (IORS) from big manufacturers are available on the market. Hence, the interconnection of components from third-party vendors is only possible with increased time and costs. In the context of the German Federal Ministry of Education and Research (BMBF)-funded project OR.NET (2012-2016), the open integration of medical devices from different manufacturers was addressed. An integrated operating theater based on the open communication standard IEEE 11073 shall give clinical operators the opportunity to choose medical devices independently of the manufacturer. This approach would be advantageous especially for hospital operators and small- and medium-sized enterprises (SME) of medical devices. Actual standards and concepts regarding technical feasibility and the approval process do not cope with the requirements for a modular integration of medical devices in the operating room (OR), based on an open communication standard. Therefore, innovative approval strategies and corresponding certification and test procedures, which cover actual legal and normative standards, have to be developed in order to support the future risk management and the usability engineering process of open integrated medical devices in the OR. The use of standardized device and service profiles and a three-step testing procedure, including conformity, interoperability and integration tests are described in this paper and shall support the manufacturers to integrate their medical devices without disclosing the medical devices' risk analysis and related confidential expertise or proprietary information.

Capitalization of Charter Schools into Residential Property Values

OpenAIRE

Scott A. Imberman; Michael Naretta; Margaret O’Rourke

2015-01-01

While prior research has found clear impacts of schools and school quality on property values, little is known about whether charter schools have similar effects. Using sale price data for residential properties in Los Angeles County from 2008 to 2011 we estimate the neighborhood level impact of charter schools on housing prices. Using an identification strategy that relies on census block fixed-effects and variation in charter penetration over time, we find little evidence that the availabil...

76 FR 22322 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

Science.gov (United States)

2011-04-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2010-N-0026] Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass Assessment Score Test System; Correction AGENCY: Food and Drug Administration, HHS. ACTION...

Just a piece of equipment? The importance of medical device education.

Science.gov (United States)

Brand, Darren

2012-12-01

The use of medical devices is an increasingly important element of a healthcare professional's role. It is crucial that users receive regular teaching and education to ensure that they are competent in the use of devices. This is particularly relevant in the increasingly litigious society in which we live. This article focuses upon the importance of a medical device education.

New IEEE 11073 Standards for interoperable, networked Point-of-Care Medical Devices.

Science.gov (United States)

Kasparick, Martin; Schlichting, Stefan; Golatowski, Frank; Timmermann, Dirk

2015-08-01

Surgical procedures become more and more complex and the number of medical devices in an operating room (OR) increases continuously. Today's vendor-dependent solutions for integrated ORs are not able to handle this complexity. They can only form isolated solutions. Furthermore, high costs are a result of vendor-dependent approaches. Thus we present a service-oriented device communication for distributed medical systems that enables the integration and interconnection between medical devices among each other and to (medical) information systems, including plug-and-play functionality. This system will improve patient's safety by making technical complexity of a comprehensive integration manageable. It will be available as open standards that are part of the IEEE 11073 family of standards. The solution consists of a service-oriented communication technology, the so called Medical Devices Profile for Web Services (MDPWS), a Domain Information & Service Model, and a binding between the first two mechanisms. A proof of this concept has been done with demonstrators of real world OR devices.

Protecting computer-based medical devices: defending against viruses and other threats.

Science.gov (United States)

2005-07-01

The increasing integration of computer hardware has exposed medical devices to greater risks than ever before. More and more devices rely on commercial off-the-shelf software and operating systems, which are vulnerable to the increasing proliferation of viruses and other malicious programs that target computers. Therefore, it is necessary for hospitals to take steps such as those outlined in this article to ensure that their computer-based devices are made safe and continue to remain safe in the future. Maintaining the security of medical devices requires planning, careful execution, and a commitment of resources. A team should be created to develop a process for surveying the security status of all computerized devices in the hospital and making sure that patches and other updates are applied as needed. These patches and updates should be approved by the medical system supplier before being implemented. The team should consider using virtual local area networks to isolate susceptible devices on the hospital's network. All security measures should be carefully documented, and the documentation should be kept up-to-date. Above all, care must be taken to ensure that medical device security involves a collaborative, supportive partnership between the hospital's information technology staff and biomedical engineering personnel.

The Relative Efficiency of Charter Schools: A Cost Frontier Approach

Science.gov (United States)

Gronberg, Timothy J.; Jansen, Dennis W.; Taylor, Lori L.

2012-01-01

Charters represent an expansion of public school choice, offering free, publicly funded educational alternatives to traditional public schools. One relatively unexplored research question concerning charter schools asks whether charter schools are more efficient suppliers of educational services than are traditional public schools. The potential…

Charter Schools: The Smiling Face of Disinvestment.

Science.gov (United States)

Molnar, Alex

1996-01-01

Despite the rosy image projected by child-centered reformers, zealots and profiteers are really driving the charter school movement. Charter schools cannot flourish without drastic wage reductions or huge spending increases, nor will they benefit America's poorest children. The market, which has already destroyed kids' neighborhoods and parents'…

Teacher Accountability at High Performing Charter Schools

Science.gov (United States)

Aguirre, Moises G.

2016-01-01

This study will examine the teacher accountability and evaluation policies and practices at three high performing charter schools located in San Diego County, California. Charter schools are exempted from many laws, rules, and regulations that apply to traditional school systems. By examining the teacher accountability systems at high performing…

Charter School Spending and Saving in California

Science.gov (United States)

Reed, Sherrie; Rose, Heather

2015-01-01

Examining resource allocation practices, including savings, of charter schools is critical to understanding their financial viability and sustainability. Using 9 years of finance data from California, we find charter schools spend less on instruction and pupil support services than traditional public schools. The lower spending on instruction and…

21 CFR 892.2010 - Medical image storage device.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical image storage device. 892.2010 Section 892.2010 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED..., and digital memory. (b) Classification. Class I (general controls). The device is exempt from the...

[Impact of an automated dispensing system for medical devices in cardiac surgery department].

Science.gov (United States)

Clou, E; Dompnier, M; Kably, B; Leplay, C; Poupon, E; Archer, V; Paul, M

2018-01-01

To secure medical devices' management, the implementation of automated dispensing system in surgical service has been realized. The objective of this study was to evaluate security, organizational and economic impact of installing automated dispensing system for medical devices (ASDM). The implementation took place in a cardiac surgery department. Security impact was assessed by comparing traceability rate of implantable medical devices one year before and one year after installation. Questionnaire on nurses' perception and satisfaction completed this survey. Resupplying costs, stocks' evolution and investments for the implementation of ASDM were the subject of cost-benefit study. After one year, traceability rate is excellent (100%). Nursing staffs were satisfied with 87.5% by this new system. The introduction of ASDM allowed a qualitative and quantitative decrease in stocks, with a reduction of 30% for purchased medical devices and 15% for implantable medical devices in deposit-consignment. Cost-benefit analysis shows a rapid return on investment. Real stock decrease (purchased medical devices) is equivalent to 46.6% of investment. Implementation of ASDM allows to secure storage and dispensing of medical devices. This system has also an important economic impact and appreciated by users. Copyright © 2017 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.

[Regulatory Program for Medical Devices in Cuba: experiences and current challenges].

Science.gov (United States)

Pereira, Dulce María Martínez; Rodríguez, Yadira Álvarez; Valdés, Yamila Cedeño; Ribas, Silvia Delgado

2016-05-01

Regulatory control of medical devices in Cuba is conducted through a system based on the Regulatory Program for Medical Devices as a way to ensure the safety, efficacy, and effectiveness of these technologies, which are in use by the National Health System. This program was launched in 1992, when the Regulations for State Evaluation and Registration of Medical Devices were approved. Its successive stages and the merging of regulatory activities for drugs and medical equipment have meant progress toward stronger, more transparent strategies and greater control of industry and the National Health System. Throughout its course the Cuban program has met with challenges and difficulties that it has addressed by drawing on its own experiences. During the new period, the greatest challenges revolve around ensuring that regulatory systems incorporate scientific evaluation, risk levels, maximum rigor through the use of technical standards, and the implementation of international recommendations, together with the application of the ISO 13485 certification scheme, enhanced market monitoring, and classification of medical devices in accordance with their relevance to the country's national health policies. From the regional standpoint, the greatest challenge lies in working toward regulatory convergence. The Collaborating Centre for the Regulation of Health Technologies will support the proposed regulatory strategy and established regional priorities, in particular in connection with the implementation of actions involving medical devices.

78 FR 59880 - Enhanced Consumer Protections for Charter Air Transportation

Science.gov (United States)

2013-09-30

... Protections for Charter Air Transportation AGENCY: Office of the Secretary (OST), U.S. Department of... charter air transportation. First, this proposal would require air taxis and commuter air carriers that sell charter air transportation but rely on others to perform that air transportation to make certain...

Charter Schools and the Teacher Job Search

Science.gov (United States)

Cannata, Marisa

2011-01-01

This article examines the position of charter schools in prospective elementary teachers' job search decisions. Using a labor market segmentation framework, it explores teacher applicants' decisions to apply to charter schools. The data come from a mixed-methods longitudinal study of prospective teachers looking for their first job. This article…

76 FR 16292 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

Science.gov (United States)

2011-03-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2011-N-0026] Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian... of Food and Drugs, 21 CFR part 866 is amended as follows: PART 866--IMMUNOLOGY AND MICROBIOLOGY...

Safety evaluation in the development of medical devices and combination products

CERN Document Server

Gad, Shayne C

2008-01-01

Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-life problems in the field.The Third Edition explores these key current trends:global device marketscontinually advancing technologythe increasing harmonization of device safety regulation worldwideEach aspect of safety evaluation is considered in ter

Inhaled medication for asthma management: evaluation of how asthma patients, medical students, and doctors use the different devices

Directory of Open Access Journals (Sweden)

Muniz Janaína Barbosa

2003-01-01

Full Text Available Asthma results from a combination of three essential features: airflow obstruction, hyperresponsiveness of airways to endogenous or exogenous stimuli and inflammation. Inadequacy of the techniques to use different inhalation devices is one of the causes of therapeutic failure. The main purpose of this study was to evaluate how 20 medical students, 36 resident physicians of Internal Medicine/Pediatrics, and 40 asthma patients used three devices for inhalation therapy containing placebo. All patients were followed at the Pulmonary Outpatient Service of Botucatu Medical School and had been using inhaled medication for at least six months. The following devices were evaluated: metered dose inhalers (MDI, dry powder inhalers (DPI, and MDI attached to a spacer device. A single observer applied a protocol containing the main steps necessary to obtain a good inhaler technique to follow and grade the use of different devices. Health care professionals tested all three devices and patients tested only the device being used on their management. MDI was the device best known by doctors and patients. MDI use was associated with errors related to the coordination between inspiration and device activation. Failure to exhale completely before inhalation of the powder was the most frequent error observed with DPI use. In summary, patients did not receive precise instruction on how to use inhaled medication and health care professionals were not well prepared to adequately teach their patients.

Methodological considerations in observational comparative effectiveness research for implantable medical devices: an epidemiologic perspective.

Science.gov (United States)

Jalbert, Jessica J; Ritchey, Mary Elizabeth; Mi, Xiaojuan; Chen, Chih-Ying; Hammill, Bradley G; Curtis, Lesley H; Setoguchi, Soko

2014-11-01

Medical devices play a vital role in diagnosing, treating, and preventing diseases and are an integral part of the health-care system. Many devices, including implantable medical devices, enter the market through a regulatory pathway that was not designed to assure safety and effectiveness. Several recent studies and high-profile device recalls have demonstrated the need for well-designed, valid postmarketing studies of medical devices. Medical device epidemiology is a relatively new field compared with pharmacoepidemiology, which for decades has been developed to assess the safety and effectiveness of medications. Many methodological considerations in pharmacoepidemiology apply to medical device epidemiology. Fundamental differences in mechanisms of action and use and in how exposure data are captured mean that comparative effectiveness studies of medical devices often necessitate additional and different considerations. In this paper, we discuss some of the most salient issues encountered in conducting comparative effectiveness research on implantable devices. We discuss special methodological considerations regarding the use of data sources, exposure and outcome definitions, timing of exposure, and sources of bias. © The Author 2014. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

[Study on the reform and improvement of the medical device registration system in China].

Science.gov (United States)

Wang, Lanming

2012-11-01

Based on the theories of the Government Regulation and Administrative Licensure, aiming at the current situations of medical device registration system in China, some policy suggestions for future reform and improvement were provided as follows. (1) change the concepts of medical device registration administration. (2) perfect the regulations of medical device registration administration. (3) reform the medical device review organizational system. (4) Optimize the procedure of review and approval. (5) set up and maintain a professional team of review and approval staff. (6) reinforce the post-marketing supervision of medical devices. (7) foster and bring into play of the role of non-government organizations.

State Policy Regimes and Charter School Performance

Science.gov (United States)

Pelz, Mikael L.

2015-01-01

The policy diffusion framework is critical to understanding the spread of policy innovations such as charter schools in the United States. This framework, however, is less instructive in explaining the state-by-state configuration of these policies. What explains the wide variation in charter school policy among states? This study addresses this…

75 FR 70112 - Medical Devices; General and Plastic Surgery Devices; Classification of Non-Powered Suction...

Science.gov (United States)

2010-11-17

.... FDA-2010-N-0513] Medical Devices; General and Plastic Surgery Devices; Classification of Non-Powered... risks. Adverse tissue reaction Material degradation Improper function of suction apparatus (e.g., reflux.... Material degradation Section 8. Stability and Shelf Life. [[Page 70113

Campaign to gather medical devices containing radium: results

International Nuclear Information System (INIS)

Pierre, J.P.; Vidal, J.P.; Martin, J.C.; Pasquier, J.L.

2002-01-01

Campaign to gather medical devices containing radium: results. On December 1, 1999, at the request of the French Health Ministry, OPRI and ANDRA launched a campaign to gather medical devices containing radium, formerly used in brachytherapy. This campaign addressed a public health issue because of the risks actually involved in a careless handling of these objects. Moreover the growing number of reported scattered radium medical devices in the last few years reinforced the necessity of the campaign. The gathering was initiated by a call of the owners (hospitals, caring centers, retired doctors or their heirs) to a toll free number. OPRI or ANDRA then appreciated the situation urgency. Priority was given to private people because most of them did not have suitable storage facilities. OPRI teams operated according a strict protocol guaranteeing their own safety, proper procedures and compliance with transport regulations for radioactive materials. 517 objects amounting to an activity of 1.32 x 10 11 Bq have been gathered in 90 operations. Properly packaged they were transported to and safely stored at the CEA Saclay site before their permanent storage in the ANDRA facilities. (author)

Drugs and Medical Devices: Adverse Events and the Impact on Women's Health.

Science.gov (United States)

Carey, Jennifer L; Nader, Nathalie; Chai, Peter R; Carreiro, Stephanie; Griswold, Matthew K; Boyle, Katherine L

2017-01-01

A large number of medications and medical devices removed from the market by the US Food and Drug Administration over the past 4 decades specifically posed greater health risks to women. This article reviews the historical background of sex and gender in clinical research policy and describes several approved drugs and devices targeted for use in women that have caused major morbidity and mortality. The intended population for the medications and devices, population affected, approval process, and the basic and legal actions taken against the medication/drug company are also discussed. It is recognized that women are still at risk for harm from unsafe medications and devices, and continued improvements in legislation that promotes inclusion of sex and gender into the design and analysis of research will improve safety for both men and women. Copyright © 2017 Elsevier HS Journals, Inc. All rights reserved.

PROJECT LIFE CYCLE OF LEASING MARINE VESSEL OWNERS AND CHARTERERS

Directory of Open Access Journals (Sweden)

Алла Витальевна БОНДАРЬ

2016-03-01

Full Text Available Based on the study of the basic types of the bareboat charter, presented algorithms decision on the justification of the respective projects. It was found that the initiator of the project can be both owners who wants to pass the boat rental and the charterer, and also who is the owner, who wants to take a boat for rent. It is proved that the implementation of these specific operations requires careful preparation, and using of the project approach will greatly enhance their effectiveness. We describe the life of the project finance lease from the standpoint of the marine vessel, the ship-owner and charterer. It is established that such projects characterized by four-phase structure of the life cycle: preparation, let's call it as the principal decision on (from the chartering of the vessel, the investment - to select the optimal variant (from the charter and the conclusion of the bareboat charter, the phase of operation of the vessel and the fourth - the closure of the project at the end of term bareboat charter. Skill description of the content of each phase, which will continue for the main participants of the project to determine the value of each phase and the value of the whole project.

Charter School Movement: History, Politics, Policies, Economics & Effectiveness. Second Edition

Science.gov (United States)

Grey House Publishing, 2009

2009-01-01

From zero in 1991 to 3,800 eighteen years later, charter schools (public schools under contract) today educate well over a million students. This updated, second edition examines the unusual experiment that is charter education and the controversies that surround public choice and charter schools as a means of educational reform. Written by…

Charter Schools, Civil Rights and School Discipline: A Comprehensive Review

Science.gov (United States)

Losen, Daniel J.; Keith, Michael A., II; Hodson, Cheri L.; Martinez, Tia E.

2016-01-01

This report, along with the companion spreadsheet, provides the first comprehensive description ever compiled of charter school discipline. In 2011-12, every one of the nation's 95,000 public schools was required to report its school discipline data, including charter schools. This analysis, which includes more than 5,250 charter schools, focuses…

76 FR 71982 - Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices...

Science.gov (United States)

2011-11-21

... Multiplexed Microbiology Devices: Their clinical application and public health/clinical needs; inclusion of...] Advancing Regulatory Science for Highly Multiplexed Microbiology/ Medical Countermeasure Devices; Public... Multiplexed Microbiology/ Medical Countermeasure Devices'' that published in the Federal Register of August 8...

Electromagnetic compatibility of WLAN adapters with life-supporting medical devices.

Science.gov (United States)

Calcagnini, G; Mattei, E; Censi, F; Triventi, M; Lo Sterzo, R; Marchetta, E; Bartolini, P

2011-05-01

This paper investigates the electromagnetic compatibility of 45 critical care medical devices (infusion pumps, defibrillators, monitors, lung ventilators, anesthesia machines and external pacemakers) with various types of wireless local area network (WLAN, IEEE 802.11 b/g, 2.45 GHz, 100 mW) adapters. Interference is evaluated by performing ad-hoc tests according to the ANSI C63.18 recommended practice. The behavior of the devices during the tests was monitored using patient simulators/device testers specific for each device class. Electromagnetic interference cases were observed in three of 45 devices at a maximum distance of 5 cm. In two cases the interference caused malfunctions that may have clinical consequences for the patient. The authors' findings show that the use of these wireless local area network adapters can be considered reasonably safe, although interference may occur if they are operated at very close distance (<10 cm) to the medical devices.

77 FR 6028 - Taxable Medical Devices

Science.gov (United States)

2012-02-07

... sold as part of an x-ray system. Commentators also requested information on the tax treatment of..., mitigation, treatment, or prevention of disease; or intended to affect the structure or any function of the... subject to an IDE is not a ``taxable medical device'' under the proposed regulations. VI. Dental...

78 FR 33849 - Battery-Powered Medical Devices Workshop: Challenges and Opportunities; Public Workshop; Request...

Science.gov (United States)

2013-06-05

... after the public workshop on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/Workshops..., compact, and mobile, the number of battery-powered medical devices will continue to increase. While many...] Battery-Powered Medical Devices Workshop: Challenges and Opportunities; Public Workshop; Request for...

Charter Schools and Students with Disabilities: Legal and Practice Considerations

Science.gov (United States)

Dunn, Michelle E.; Katsiyannis, Antonis; Ryan, Joseph B.

2018-01-01

As of the 2013-2014 school year, about 2.5 million school-age students attended charter schools nationwide. Because charter schools are publicly funded entities, they are required to adhere to all federal nondiscriminatory laws as well as the Individuals With Disabilities Education Act. This legal brief provides an overview of charter schools,…

The Uneven Performance of Arizona's Charter Schools

Science.gov (United States)

Chingos, Matthew M.; West, Martin R.

2015-01-01

Arizona enrolls a larger share of its students in charter schools than any other state in the country, but no comprehensive examination exists of the impact of those schools on student achievement. Using student-level data covering all Arizona students from 2006 to 2012, we find that the performance of charter schools in Arizona in improving…

Solving the Policy Implementation Problem: The Case of Arizona Charter Schools.

Science.gov (United States)

Garn, Gregg A.

1999-01-01

Analyzes how Arizona charter school policymakers succeeded in preserving the legislative intentions of the state's charter school program. Identifies four key features of policy implementation that created the charter school policy: communication, financial resources, implementor attitudes, and bureaucratic structure. (SLD)

75 FR 68972 - Medical Devices; General and Plastic Surgery Devices; Classification of Tissue Adhesive With...

Science.gov (United States)

2010-11-10

.... FDA-2010-N-0512] Medical Devices; General and Plastic Surgery Devices; Classification of Tissue... running to unintended areas, etc. B. Wound dehiscence C. Adverse tissue reaction and chemical burns D..., Clinical Studies, Labeling. Adverse tissue reaction and chemical Biocompatibility Animal burns. Testing...

77 FR 32644 - Medical Devices; Exemption From Premarket Notification: Wheelchair Elevator

Science.gov (United States)

2012-06-01

...] Medical Devices; Exemption From Premarket Notification: Wheelchair Elevator AGENCY: Food and Drug... elevator devices commonly known as inclined platform lifts and vertical platform lifts. These devices are... behalf of Bruno Independent Living Aids, Inc., for wheelchair elevator devices (commonly known as...

Views of patients and professionals about electronic multicompartment medication devices: a qualitative study.

Science.gov (United States)

Hall, Jill; Bond, Christine; Kinnear, Moira; McKinstry, Brian

2016-10-17

To explore the perceived acceptability, advantages and disadvantages of electronic multicompartment medication devices. Qualitative study using 8 focus groups and 10 individual semistructured interviews. Recordings were transcribed and analysed thematically. Strategies were employed to ensure the findings were credible and trustworthy. Community pharmacists (n=11), general practitioners (n=9), community nurses (n=12) and social care managers (n=8) were recruited from the National Health Service (NHS) and local authority services. Patients (n=15) who were current conventional or electronic multicompartment medication device users or had medication adherence problems were recruited from community pharmacies. 3 informal carers participated. Electronic multicompartment medication devices which prompt the patient to take medication may be beneficial for selected individuals, particularly those with cognitive impairment, but who are not seriously impaired, provided they have a good level of dexterity. They may also assist individuals where it is important that medication is taken at fixed time intervals. These are likely to be people who are being supported to live alone. No single device suited everybody; smaller/lighter devices were preferred but their usefulness was limited by the small number/size of storage compartments. Removing medications was often challenging. Transportability was an important factor for patients and carers. A carer's alert if medication is not taken was problematic with multiple barriers to implementation and no consensus as to who should receive the alert. There was a lack of enthusiasm among professionals, particularly among pharmacists, due to concerns about responsibility and funding for devices as well as ensuring devices met regulatory standards for storage and labelling. This study provides indicators of which patients might benefit from an electronic multicompartment medication device as well as the kinds of features to consider when

Left to their own devices: medical learners' use of mobile technologies.

Science.gov (United States)

Ellaway, Rachel H; Fink, Patricia; Graves, Lisa; Campbell, Alanna

2014-02-01

Although many medical learners and teachers are using mobile technologies within medical education, there has been little evidence presented describing how they use mobile devices across a whole curriculum. The Northern Ontario School of Medicine (NOSM) introduced a new mobile device program in 2010. Incoming undergraduate medical learners received a laptop and an iPad and learners entering year three of the four-year program received a laptop and an iPhone. A survey was sent to all learners to gather information on their use of and attitudes toward these devices. A combination of quantitative and qualitative methods was used to analyze the data and to generate a series of themes that synthesized student behaviors, perceptions and attitudes. Context and learner autonomy were found to be important factors with learners using multiple devices for different purposes and adopting strategic approaches to learning using these devices. The expectation that school-issued devices would be regularly and enthusiastically used to replace more traditional study media was not reflected in practice. Learners' approaches to using mobile devices are heterogeneous as is the extent to which they use them. Learners adapt their use of mobile devices to the learning cultures and contexts they find themselves in.

Advancing medical device innovation through collaboration and coordination of structured data capture pilots: Report from the Medical Device Epidemiology Network (MDEpiNet) Specific, Measurable, Achievable, Results-Oriented, Time Bound (SMART) Think Tank.

Science.gov (United States)

Reed, Terrie L; Drozda, Joseph P; Baskin, Kevin M; Tcheng, James; Conway, Karen; Wilson, Natalia; Marinac-Dabic, Danica; Heise, Theodore; Krucoff, Mitchell W

2017-12-01

The Medical Device Epidemiology Network (MDEpiNet) is a public private partnership (PPP) that provides a platform for collaboration on medical device evaluation and depth of expertise for supporting pilots to capture, exchange and use device information for improving device safety and protecting public health. The MDEpiNet SMART Think Tank, held in February, 2013, sought to engage expert stakeholders who were committed to improving the capture of device data, including Unique Device Identification (UDI), in key electronic health information. Prior to the Think Tank there was limited collaboration among stakeholders beyond a few single health care organizations engaged in electronic capture and exchange of device data. The Think Tank resulted in what has become two sustainable multi-stakeholder device data capture initiatives, BUILD and VANGUARD. These initiatives continue to mature within the MDEpiNet PPP structure and are well aligned with the goals outlined in recent FDA-initiated National Medical Device Planning Board and Medical Device Registry Task Force white papers as well as the vision for the National Evaluation System for health Technology.%. Published by Elsevier Inc.

Possibilities of radiation sterilization for re-usage of medical devices in the medical management

International Nuclear Information System (INIS)

Tabei, Masae; Kudo, Hisaaki; Katsumura, Yosuke

2004-01-01

The rule for re-usage of medical single-use devices was established in US in 2000 based on the concept of Managed Care (total management of medicare on cost, quality and patients' satisfaction) and 20-30% of those devices are re-used at present. The re-usage is conducted in not only US but also Canada, Denmark, UK, India, China etc. Standing on the viewpoint, this paper described and discussed the possibility of re-usage of the single-use devices now prohibited in Japan, possible re-sterilization, possible re-usage of hollow fiber-type hemodialyzer following γ-ray sterilization with consideration for D-values against bacteria and viruses, cost estimation of electron beam sterilization for re-usage, and radiation sterilization of waste water and plastic materials. Radiation sterilization for re-usage of medical devices was concluded possible if their materials and records for their usage processes are proper, and should be conducted in a large scale after sufficient examinations by industries/government/academia. (N.I.)

77 FR 2095 - Charter Renewal for Humanities Panel

Science.gov (United States)

2012-01-13

... NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES Charter Renewal for Humanities Panel AGENCY: The National Endowment for the Humanities. ACTION: Notice of Charter Renewal for Humanities Panel...-463, 86 Stat. 770), as amended, the National Endowment for the Humanities (NEH) gives notice that the...

Charter Schools: A Viable Public School Choice Option?

Science.gov (United States)

Geske, Terry G.; And Others

1997-01-01

Overviews the charter-school phenomenon and these schools' basic design. Discusses the government's role in education and identifies various school-choice options. Explores overall autonomy via legislative provisions and examines empirical evidence on charter schools' innovative features, teacher and student characteristics, and parental contracts…

76 FR 67482 - NASA Advisory Council; Charter Renewal

Science.gov (United States)

2011-11-01

... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-108)] NASA Advisory Council; Charter Renewal AGENCY: National Aeronautics and Space Administration (NASA). ACTION: Notice of renewal and amendment of the charter of the NASA Advisory Council. SUMMARY: Pursuant to sections 14(b)(1) and 9(c) of...

78 FR 66964 - NASA Advisory Council; Charter Renewal

Science.gov (United States)

2013-11-07

... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (13-130)] NASA Advisory Council; Charter Renewal AGENCY: National Aeronautics and Space Administration (NASA). ACTION: Notice of renewal and amendment of the charter of the NASA Advisory Council. SUMMARY: Pursuant to sections 14(b)(1) and 9(c) of...

14 CFR 399.21 - Charter exemptions (except military).

Science.gov (United States)

2010-01-01

... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Charter exemptions (except military). 399.21 Section 399.21 Aeronautics and Space OFFICE OF THE SECRETARY, DEPARTMENT OF TRANSPORTATION... Authority § 399.21 Charter exemptions (except military). In deciding applications for exemptions from...

Third-year medical students' knowledge of privacy and security issues concerning mobile devices.

Science.gov (United States)

Whipple, Elizabeth C; Allgood, Kacy L; Larue, Elizabeth M

2012-01-01

The use of mobile devices are ubiquitous in medical-care professional settings, but information on privacy and security concerns of mobile devices for medical students is scarce. To gain baseline information about third-year medical students' mobile device use and knowledge of privacy and security issues concerning mobile devices. We surveyed 67 third-year medical students at a Midwestern university on their use of mobile devices and knowledge of how to protect information available through mobile devices. Students were also presented with clinical scenarios to rate their level of concern in regards to privacy and security of information. The most used features of mobile devices were: voice-to-voice (100%), text messaging (SMS) (94%), Internet (76.9%), and email (69.3%). For locking of one's personal mobile phone, 54.1% never physically lock their phone, and 58% never electronically lock their personal PDA. Scenarios considering definitely privacy concerns include emailing patient information intact (66.7%), and posting de-identified information on YouTube (45.2%) or Facebook (42.2%). As the ease of sharing data increases with the use of mobile devices, students need more education and training on possible privacy and security risks posed with mobile devices.

Low power signal processing electronics for wearable medical devices.

Science.gov (United States)

Casson, Alexander J; Rodriguez-Villegas, Esther

2010-01-01

Custom designed microchips, known as Application Specific Integrated Circuits (ASICs), offer the lowest possible power consumption electronics. However, this comes at the cost of a longer, more complex and more costly design process compared to one using generic, off-the-shelf components. Nevertheless, their use is essential in future truly wearable medical devices that must operate for long periods of time from physically small, energy limited batteries. This presentation will demonstrate the state-of-the-art in ASIC technology for providing online signal processing for use in these wearable medical devices.

Stakeholder challenges in purchasing medical devices for patient safety.

Science.gov (United States)

Hinrichs, Saba; Dickerson, Terry; Clarkson, John

2013-03-01

This study identifies the stakeholders who have a role in medical device purchasing within the wider system of health-care delivery and reports on their particular challenges to promote patient safety during purchasing decisions. Data was collected through observational work, participatory workshops, and semi-structured qualitative interviews, which were analyzed and coded. The study takes a systems-based and engineering design approach to the study. Five hospitals took part in this study, and the participants included maintenance, training, clinical end-users, finance, and risk departments. The main stakeholders for purchasing were identified to be staff from clinical engineering (Maintenance), device users (Clinical), device trainers (Training), and clinical governance for analyzing incidents involving devices (Risk). These stakeholders display varied characteristics in terms of interpretation of their own roles, competencies for selecting devices, awareness and use of resources for purchasing devices, and attitudes toward the purchasing process. The role of "clinical engineering" is seen by these stakeholders to be critical in mediating between training, technical, and financial stakeholders but not always recognized in practice. The findings show that many device purchasing decisions are tackled in isolation, which is not optimal for decisions requiring knowledge that is currently distributed among different people within different departments. The challenges expressed relate to the wider system of care and equipment management, calling for a more systemic view of purchasing for medical devices.

7 CFR 25.502 - Nominations by State-chartered economic development corporations.

Science.gov (United States)

2010-01-01

... 7 Agriculture 1 2010-01-01 2010-01-01 false Nominations by State-chartered economic development... AND ENTERPRISE COMMUNITIES Special Rules § 25.502 Nominations by State-chartered economic development corporations. Any rural area nominated by an economic development corporation chartered by a State and...

A nordic charter for universal design.

Science.gov (United States)

Björk, Evastina

2014-02-01

The aim of this paper is to present the result of a pioneer project; A Nordic Charter for Universal Design, which was initiated by the Norwegian Directorate for Children, Youth and Family Affairs in 2011. The purpose of the Charter was to present rationales that stated prerequisites for successful investment in Universal Design, and to establish a platform for further research and good practice. It was also meant to contribute to spreading of information and knowledge about the importance of guidance by the concept of Universal Design of initiatives with effects on the public arena. A Nordic group of researchers and professionals in the field ended up after 8 months of work with a written document: "A Nordic Charter for Universal Design", which was presented at the International Conference in Universal Design in Oslo, Norway (UD 2012). A Nordic Charter for Universal Design. Persons with disabilities often experience the public arenas environments, products and services as poorly-designed to fit their abilities and/or their needs. Together with the demographic changes in the Nordic societies with an increasing number of elderly people, it needs initiatives to improve independence, accessibility and participation in society. A strategy which aims to make design and composition of different environments, products, communication, information technology and services accessible, usable and understandable to as many as possible is Universal Design.

[Software as medical devices/medical apps : Tasks, requirements, and experiences from the point of view of a competent authority].

Science.gov (United States)

Terhechte, Arno

2018-03-01

Software can be classified as a medical device according to the Medical Device Directive 93/42/EEC. The number of software products and medical apps is continuously increasing and so too is the use in health institutions (e. g., in hospitals and doctors' surgeries) for diagnosis and therapy.Different aspects of standalone software and medical apps from the perspective of the authority responsible are presented. The quality system implemented to establish a risk-based systematic inspection and supervision of manufacturers is discussed. The legal framework, as well as additional standards that are the basis for inspection, are outlined. The article highlights special aspects that occur during inspection like verification of software and interfaces, and the clinical evaluation of software. The Bezirksregierung, as the local government authority responsible in North Rhine-Westphalia, is also in charge of inspection of health institutions. Therefore this article is not limited to the manufacturers placing the software on the market, but in addition it describes the management and use of software as a medical device in hospitals.The future legal framework, the Medical Device Regulation, will strengthen the requirements and engage notified bodies more than today in the conformity assessment of software as a medical device.Manufacturers, health institutions, notified bodies and the authorities responsible are in charge of intensifying their efforts towards software as a medical device. Mutual information, improvement of skills, and inspections will lead to compliance with regulatory requirements.

Research on dose setting for radiation sterilization of medical device

International Nuclear Information System (INIS)

Zhang Tongcheng; Liu Qingfang; Zhong Hongliang; Mi Zhisu; Wang Chunlei; Jiang Jianping

2002-01-01

Objective: To establish the radiation sterilization dose for medical devices using data of bioburden on the medical device. Methods: Firstly determination of recovery ratio and correction coefficient of the microbiological test method was used according to ISO11737 standard, then determination of bioburden on the products, finally the dose setting was completed based on the Method 1 in ISO11137 standard. Results: Fifteen kinds of medical devices were tested. Bioburden range was from 8.6-97271.2 CFU/device, recovery ration range 54.6%-100%, correction co-efficiency range 1.00-1.83, D 10 distribution from 1.40 to 2.82 kGy, verification dose (dose at SAL = 10 -2 ) range 5.1-17.6 kGy and sterilization dose (dose at SAL 10 -6 ) range 17.5-32.5 kGy. Conclusion: One hundred samples of each kind of product were exposed to the pre-determined verification dose and then the sterility test was performed. Each sterility test showed positive number was not greater than two. This indicated that the sterilization dose established for each kind of product was statistically acceptable

77 FR 32642 - Medical Devices; Exemption From Premarket Notification: Powered Patient Transport

Science.gov (United States)

2012-06-01

...] Medical Devices; Exemption From Premarket Notification: Powered Patient Transport AGENCY: Food and Drug... received a petition requesting exemption from the premarket notification requirements for powered patient... necessary to provide a reasonable assurance of safety and effectiveness. Under the Medical Device Amendments...

76 FR 14414 - Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Science.gov (United States)

2011-03-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA-2011-N-0002] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Microbiology...

Medical Device Plug-and-Play Interoperability Standards and Technology Leadership

Science.gov (United States)

2010-10-01

American Telemedicine Association), we demonstrated how continuous monitoring of the patient’s SpO2 and respiratory rate could detect the onset of...designed to monitor sepsis infection sounded its alarm continually, day and night. The device was built with an innovative algorithm to detect sepsis, but...transport Figure 3. This medical device has misread its sensors and inserted false data into patient’s permanent medical record. SPECIal FEaTuRE October

INTERNAL AUDIT CHARTER

International Development Research Centre (IDRC) Digital Library (Canada)

sblanchard

2015-03-30

Mar 30, 2015 ... Assurance and Advice to Support Innovating for Development ... IDRC's Board of Governors approves the Internal Audit Charter which outlines the ... the principles of integrity, objectivity, confidentiality, and competency, and IDRC's Code of. Conduct and the Values and Ethics Code for the Public Service;.

12 CFR 611.1010 - Bank charter amendment procedures.

Science.gov (United States)

2010-01-01

... change that is properly the subject of a bank charter; (b) Upon approval of an appropriate resolution by the bank board, the certified resolution, together with supporting documentation, shall be submitted... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Bank charter amendment procedures. 611.1010...

Restoring Shanker's Vision for Charter Schools

Science.gov (United States)

Kahlenberg, Richard D.; Potter, Halley

2015-01-01

In 1988, education reformer and American Federation of Teachers president Albert Shanker proposed a new kind of public school--"charter schools"--which would allow teachers to experiment with innovative approaches to educating students. Publicly funded but independently managed, these schools would be given a charter to try their fresh…

21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; Spanish-language version of....16 Medical devices; Spanish-language version of certain required statements. If devices restricted to prescription use only are labeled solely in Spanish for distribution in the Commonwealth of Puerto Rico where...

12 CFR 614.4080 - Loans and chartered territory-banks for cooperatives.

Science.gov (United States)

2010-01-01

... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Loans and chartered territory-banks for cooperatives. 614.4080 Section 614.4080 Banks and Banking FARM CREDIT ADMINISTRATION FARM CREDIT SYSTEM LOAN POLICIES AND OPERATIONS Chartered Territories § 614.4080 Loans and chartered territory—banks for...

Integrated Forest Management Charter

Energy Technology Data Exchange (ETDEWEB)

Hansen, Leslie A. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

2015-08-24

The purpose of this charter is to establish, maintain, and implement programs for the protection, preservation, and enhancement of the land and water resources of Los Alamos National Laboratory in a changing climate.

Health Care: Reprocessed Medical Single-Use Devices in DoD

National Research Council Canada - National Science Library

2002-01-01

... for decontamination and resterilization. The emergence of new materials and sterilization methods, and the increasing costs of health care, resulted in the development of medical single-use devices and the practice of reprocessing the devices...

Management information system of medical equipment using mobile devices

Science.gov (United States)

Núñez, C.; Castro, D.

2011-09-01

The large numbers of technologies currently incorporated into mobile devices transform them into excellent tools for capture and to manage the information, because of the increasing computing power and storage that allow to add many miscellaneous applications. In order to obtain benefits of these technologies, in the biomedical engineering field, it was developed a mobile information system for medical equipment management. The central platform for the system it's a mobile phone, which by a connection with a web server, it's capable to send and receive information relative to any medical equipment. Decoding a type of barcodes, known as QR-Codes, the management process is simplified and improved. These barcodes identified the medical equipments in a database, when these codes are photographed and decoded with the mobile device, you can access to relevant information about the medical equipment in question. This Project in it's actual state is a basic support tool for the maintenance of medical equipment. It is also a modern alternative, competitive and economic in the actual market.

Free to Lead: Autonomy in Highly Successful Charter Schools. Issue Brief

Science.gov (United States)

Ableidinger, Joe; Hassel, Bryan C.

2010-01-01

Autonomy is a key component of the charter school concept. By allowing charter schools to have autonomy over decisions concerning finance, personnel, scheduling, curriculum and instruction, states have enabled many of these schools to produce stellar results for their students. This issue brief explores autonomy at five excellent charter schools…

Principal Turnover: Upheaval and Uncertainty in Charter Schools?

Science.gov (United States)

Ni, Yongmei; Sun, Min; Rorrer, Andrea

2015-01-01

Purpose: Informed by literature on labor market and school choice, this study aims to examine the dynamics of principal career movements in charter schools by comparing principal turnover rates and patterns between charter schools and traditional public schools. Research Methods/Approach: This study uses longitudinal data on Utah principals and…

Regulatory Science in Practice (Pharmaceuticals and Medical Devices Agency).

Science.gov (United States)

Hojo, Taisuke

2017-01-01

Review, safety, and relief services of the Pharmaceuticals and Medical Devices Agency are primarily focused on scientifically evaluating pharmaceuticals, medical devices, and cellular and tissue-based products referring to their quality, efficacy, and safety, which requires a variety of scientific knowledge and methods. Pharmaceutical regulation should be established based on the most advanced scientific expertise at all times. In order to evaluate products that use cutting-edge technology such as induced pluripotent stem cells and information and communication technology adequately, since fiscal year 2012 the Science Committee has been established as a platform to exchange opinions among members from top-ranking domestic and international academia and to enhance personnel exchanges through the Initiative to Facilitate Development of Innovative Drugs. In addition, the Regulatory Science Center will be established in 2018 to increase the integrity of our services for product reviews and safety measures. In particular, requiring electronic data submissions for clinical trial applications followed by an advanced approach to analysis should not only enhance the quality of reviews of individual products but should also support the development of pharmaceuticals and medical devices by providing pharmaceutical affairs consultations on research and development strategies with various guidelines based on new insights resulting from product-bridging data analysis. Moreover, a database including electronic health records with comprehensive medical information collected mainly from 10 cooperating medical institutions will be developed with the aim of developing safety measures in a more timely manner using methods of pharmacoepidemiological analysis.

31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

Science.gov (United States)

2010-07-01

... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false In-kind donations of medicine...-kind donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of medicine...

Pricing and reimbursement of drugs and medical devices in Hungary.

Science.gov (United States)

Gulácsi, L; Dávid, T; Dózsa, Cs

2002-01-01

Similarly to other countries of Central and Eastern Europe, Hungary has witnessed massive diffusion of healthcare technology such as drugs and medical devices since 1990. While substantial new pharmaceuticals, medical devices, and procedures have been liberalized, there has been no proper evaluation or training in their use. Healthcare providers have come to find themselves as entrepreneurs in private practice, while patients are acquiring an increasing awareness as customers of healthcare,demanding services in return for their taxes and contributions. This has led to extremely irrational patterns of investment in technology, with most an obvious waste of resources, while leaving basic needs unmet. Both the National Health Insurance Fund and the Ministry of Finance believe that the current pharmaceutical and medical device bill is too high. However, introducing a more transparent and flexible pricing and reimbursement framework may enable a more efficient allocation of the limited resources to be achieved.

The European Energy Charter Treaty

International Nuclear Information System (INIS)

Jones, K.

1996-01-01

The history, purpose, scope and the main topics of the treaty are highlighted. Special attention is paid on problems of trading, competition, transit, technology transfer and access to capital markets; support and protection of investments; resolution of disputes; provisional clauses governing trade with GATT non-member states; structural and institutional provisions concerning the execution and function of the protocol, tasks of the Charter conference and secretariat including their equipment, rules of conduct and financing. The Charter is setting up a framework for co-operation, trade and investment in energy products and services with countries of Eastern Europe and the former Soviet Union, based on principles of free-markets and non-discrimination

75 FR 1395 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

Science.gov (United States)

2010-01-11

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0606] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice...) is announcing an amendment to the notice of a meeting of the General and Plastic Surgery Devices...

University Involvement with Charter Schools: Unique Opportunities for Service and Support

Directory of Open Access Journals (Sweden)

Dr. Julie Hentges

2017-06-01

Full Text Available Charter schools are a controversial, but vibrant, component of the current educational landscape, now serving over 3.1 million students in approximately 6900 schools across the United States.  A unique aspect of this movement has been the establishment of alternative authorizers, and specifically universities, to approve and provide oversight to these public schools.  Campus leaders and policy makers must consider numerous variables regarding a university’s involvement with charter schools.  What are the implications of school choice on university policies and practices? Should universities be “authorizers”, granting charters to schools in direct competition with the traditional public school system? Can universities provide the required “oversight” mandated by the charter school laws, as well as providing “support” for the schools? What opportunities for partnerships and practicum experiences exist?  The article provides an overview of issues that arise with public charter schools authorized by universities.  With 18 years of experiences as a public university on the forefront of enabling charter legislation and the “sponsorship” of inner-city public charter schools, the authors provide a historical perspective of the role of universities within the school choice movement, including oversight roles and supportive programs within the unique and growing phenomenon of school choice.

Towards automated assistance for operating home medical devices.

Science.gov (United States)

Gao, Zan; Detyniecki, Marcin; Chen, Ming-Yu; Wu, Wen; Hauptmann, Alexander G; Wactlar, Howard D

2010-01-01

To detect errors when subjects operate a home medical device, we observe them with multiple cameras. We then perform action recognition with a robust approach to recognize action information based on explicitly encoding motion information. This algorithm detects interest points and encodes not only their local appearance but also explicitly models local motion. Our goal is to recognize individual human actions in the operations of a home medical device to see if the patient has correctly performed the required actions in the prescribed sequence. Using a specific infusion pump as a test case, requiring 22 operation steps from 6 action classes, our best classifier selects high likelihood action estimates from 4 available cameras, to obtain an average class recognition rate of 69%.

Student Achievement in Ohio Charter Schools: A Comparative and Longitudinal Study

Science.gov (United States)

Kotler, Ruth M.

2012-01-01

The purpose of this study was to investigate fifth-grade student achievement in Ohio public charter schools as compared to student achievement in traditional public schools, and to determine whether the performance of charter schools changed over time. Research questions asked 1) how does student achievement in Ohio's public charters compare to…

Recent advances in medical device triage technologies for chemical, biological, radiological, and nuclear events.

Science.gov (United States)

Lansdowne, Krystal; Scully, Christopher G; Galeotti, Loriano; Schwartz, Suzanne; Marcozzi, David; Strauss, David G

2015-06-01

In 2010, the US Food and Drug Administration (Silver Spring, Maryland USA) created the Medical Countermeasures Initiative with the mission of development and promoting medical countermeasures that would be needed to protect the nation from identified, high-priority chemical, biological, radiological, or nuclear (CBRN) threats and emerging infectious diseases. The aim of this review was to promote regulatory science research of medical devices and to analyze how the devices can be employed in different CBRN scenarios. Triage in CBRN scenarios presents unique challenges for first responders because the effects of CBRN agents and the clinical presentations of casualties at each triage stage can vary. The uniqueness of a CBRN event can render standard patient monitoring medical device and conventional triage algorithms ineffective. Despite the challenges, there have been recent advances in CBRN triage technology that include: novel technologies; mobile medical applications ("medical apps") for CBRN disasters; electronic triage tags, such as eTriage; diagnostic field devices, such as the Joint Biological Agent Identification System; and decision support systems, such as the Chemical Hazards Emergency Medical Management Intelligent Syndromes Tool (CHEMM-IST). Further research and medical device validation can help to advance prehospital triage technology for CBRN events.

Vertus Charter School

Science.gov (United States)

EDUCAUSE, 2015

2015-01-01

The academic model of this charter high school for boys in Rochester, New York has four pillars: 1) strong relationships, 2) personalized year-round academics, 3) character education, and 4) career preparation. The two-page grantee profiles from Next Generation Learning Challenges (NGLC) provide factual information about the secondary school and…

31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

Science.gov (United States)

2010-07-01

... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false In-kind donations of medicine....515 In-kind donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of medicine...

31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

Science.gov (United States)

2010-07-01

... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false In-kind donations of medicine... Licensing Policy § 597.511 In-kind donations of medicine, medical devices, and medical services. (a... incident to the provision by nongovernmental organizations that are U.S. persons of in-kind donations of...

ANSTO and CSIRO: supporting the medical devices and sensors industry in Australia

International Nuclear Information System (INIS)

Triani, Gerry; Doe, Simon

2005-01-01

The Australian Nuclear Science and Technology Organisation (ANSTO) and the Commonwealth Scientific and Industrial Research Organisation (CSIRO) have provided support to the Medical Devices and Sensors Industry in Australia for many years. In particular the Institute of Materials and Engineering Science at ANSTO and CSIRO Manufacturing and Infrastructure Technology have worked independently and jointly on a number of projects to provide technical services and support to small to medium sized companies. A recent venture to capture their capabilities in the WTIA's Medical Devices and Sensors Industry Sectoral Project, part of the WTIA National Diffusion Networks Project, has produced substantial technical and financial gains for its participants. The aim of this article is to highlight the infrastructure and capabilities that ANSTO and CSIRO can provide to component manufacturers and industry clusters that offer a range of manufacturing processes needed for medical devices and sensors. Several case studies illustrate how ANSTO and CSIRO have provided support to the medical devices industry

Building Excellence: How Helping Charters Access Facilities Can Improve Opportunity for Idaho Kids

Science.gov (United States)

Robson, Kelly; Squire, Juliet

2016-01-01

To better understand charter leaders' experiences acquiring facilities, the authors conducted a survey of all charter school leaders in the state of Idaho. The leaders of 26 brick-and-mortar charter schools responded, representing 65 percent of all such charter schools in the state. The survey gathered a number of facilities-related data points,…

Sterilization and reprocessing of materials and medical devices--reusability.

Science.gov (United States)

Jayabalan, M

1995-07-01

Problems associated with reprocessing of disposable medical devices such as hemodialysers with resterilization for reuse and changes in material properties with resterilization of polymeric (PVC, polypropylene, polyester, polycarbonate) materials intended for development of disposable devices are reviewed. Reprocessing of hospital supplies, polystyrene microtiter plate and angiographic catheter for reuse is also discussed.

Air charter leisure traffic and organised tourism in Poland: Are charters passé?

Directory of Open Access Journals (Sweden)

Taylor Zbigniew

2016-12-01

Full Text Available Data from a number of tourism and transport sources are used in this analysis, concentrating on Poland: the largest tour operators and areas in which air carriers are likely to have the greatest impact. The top 25 air charter carriers identified are examined closely in terms of connections, and the geographical characteristics of these links are highlighted. The research reveals substantial differences in models of air leisure traffic between Western Europe and Poland. These are of a quantitative, but also a qualitative nature, and reflect the disparate levels of affluence of societies, different mobility patterns, and various experiences, adventures and demands on the part of travellers. Overall, charter traffic in Poland is still seen to be flourishing, while that in Western Europe is in relative decline.

Home Healthcare Medical Devices: Infusion Therapy - Getting the Most Out of Your Pump

Science.gov (United States)

... Medical Procedures Home Health and Consumer Devices Brochure - Home Healthcare Medical Devices: Infusion Therapy - Getting the Most ... if needed. What is the role of your home healthcare provider and supplier in your infusion therapy? ...

Details from the Dashboard: Estimated Number of Public Charter Schools & Students, 2014-2015

Science.gov (United States)

National Alliance for Public Charter Schools, 2015

2015-01-01

During the 2014-15 school year, almost 500 new public charter schools opened. An estimated 348,000 additional students were attending public charter schools in the 2014-15 school year compared with the previous school year. With the addition of new charter schools and students, there are now more than 6,700 public charter schools enrolling about…

Bang for the Buck: Autonomy and Charter School Efficiency in Milwaukee

Science.gov (United States)

Flanders, Will

2017-01-01

Charter schools are a relatively new phenomenon in American education. Since the first charter school opened in Minnesota in 1991, they have expanded to 42 states and represent 6.2% of all public schools in the country. This growth has been attributed to a number of factors, chief among them evidence that charter schools can improve performance…

76 FR 42713 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

Science.gov (United States)

2011-07-19

...] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice... announcing an amendment to the notice of meeting of the General and Plastic Surgery Devices Panel of the... INFORMATION: In the Federal Register of July 7, 2011, FDA announced that a meeting of the General and Plastic...

OR.NET: a service-oriented architecture for safe and dynamic medical device interoperability.

Science.gov (United States)

Kasparick, Martin; Schmitz, Malte; Andersen, Björn; Rockstroh, Max; Franke, Stefan; Schlichting, Stefan; Golatowski, Frank; Timmermann, Dirk

2018-02-23

Modern surgical departments are characterized by a high degree of automation supporting complex procedures. It recently became apparent that integrated operating rooms can improve the quality of care, simplify clinical workflows, and mitigate equipment-related incidents and human errors. Particularly using computer assistance based on data from integrated surgical devices is a promising opportunity. However, the lack of manufacturer-independent interoperability often prevents the deployment of collaborative assistive systems. The German flagship project OR.NET has therefore developed, implemented, validated, and standardized concepts for open medical device interoperability. This paper describes the universal OR.NET interoperability concept enabling a safe and dynamic manufacturer-independent interconnection of point-of-care (PoC) medical devices in the operating room and the whole clinic. It is based on a protocol specifically addressing the requirements of device-to-device communication, yet also provides solutions for connecting the clinical information technology (IT) infrastructure. We present the concept of a service-oriented medical device architecture (SOMDA) as well as an introduction to the technical specification implementing the SOMDA paradigm, currently being standardized within the IEEE 11073 service-oriented device connectivity (SDC) series. In addition, the Session concept is introduced as a key enabler for safe device interconnection in highly dynamic ensembles of networked medical devices; and finally, some security aspects of a SOMDA are discussed.

El Centro de Cardioestimuladores del Uruguay. CCC Medical Devices

Directory of Open Access Journals (Sweden)

Pablo Darscht

2011-05-01

Full Text Available Estudio de caso del Centro de Cardioestimuladores del Uruguay - CCC Medical Devices preparado a solicitud de Ingenio en el marco del proyecto financiado por la Iniciativa para Incubadoras de InfoDev - Grupo Banco Mundial. Este estudio detalla los pasos seguidos por una empresa nacional con un fuerte factor de innovación y los cambios producidos en el entorno de los negocios de la empresa. El comienzo de una pequeña empresa de marcapasos que tras pasar por diferentes etapas hoy gana mercados en el área de ingeniería para dispositivos médicos para diferentes empresas de investigación biomédica a nivel internacional.AbstractCase study of the Centro de Cardioestimuladores del Uruguay - CCC Medical Devices prepared on behalf of Ingenio within the project financed by de Incubator Initiative of InfoDev-World Bank Group. This study refers to the steps followed by a highly innovative local company and to the changes in its business environment. The start up of a small pacemakers company that after going through different stages is presently increasing its market share in the area of engineering of medical devices for biomedic research companies worldwide.

Current status of the regulation for medical devices

OpenAIRE

Shah Anuja; Goyal R

2008-01-01

In the light of escalating use of medical devices, stringent regulatory standards are required to ensure that the devices are safe, well studied and have least adverse reactions. Recently introduced guidelines and the amendment in the law will provide adequate guidance for both the manufacturers and competent authorities to manage cases efficiently and appropriately. India has emerged as one of the leaders in pharmaceutical industry. Like many other amendments in Drugs and Cosmetics Act that ...

Post market surveillance in the german medical device sector - current state and future perspectives.

Science.gov (United States)

Zippel, Claus; Bohnet-Joschko, Sabine

2017-08-01

Medical devices play a central role in the diagnosis and treatment of diseases but also bring the potential for adverse events, hazards or malfunction with serious consequences for patients and users. Medical device manufacturers are therefore required by law to monitor the performance of medical devices that have been approved by the competent authorities (post market surveillance). Conducting a nationwide online-survey in the German medical device sector in Q2/2014 in order to explore the current status of the use of post market instruments we obtained a total of 118 complete data sets, for a return rate of 36%. The survey included manufacturers of different sizes, producing medical devices of all risk classes. The post market instruments most frequently reported covered the fields of production monitoring and quality management as well as literature observation, regulatory vigilance systems, customer knowledge management and market observation while Post Market Clinical Follow-up and health services research were being used less for product monitoring. We found significant differences between the different risk classes of medical devices produced and the intensity of use of post market instruments. Differences between company size and the intensity of instruments used were hardly detected. Results may well contribute to the development of device monitoring which is a crucial element of the policy and regulatory system to identify device-related safety issues. Copyright © 2017 Elsevier B.V. All rights reserved.

Characteristics of Competitive Pressure Created by Charter Schools: Charter Schools, Their Impact on Traditional Public Districts and the Role of District Leadership

Science.gov (United States)

Cummins, Cathy

2014-01-01

This mixed methods sequential explanatory designed study applied the economic theory of marketplace competition as a way to frame superintendents' perceptions of the characteristics of students and parents seeking charter schools. Although studies on charter schools are abundant, there is limited literature on this particular aspect of market…

Image Quality Characteristics of Handheld Display Devices for Medical Imaging

Science.gov (United States)

Yamazaki, Asumi; Liu, Peter; Cheng, Wei-Chung; Badano, Aldo

2013-01-01

Handheld devices such as mobile phones and tablet computers have become widespread with thousands of available software applications. Recently, handhelds are being proposed as part of medical imaging solutions, especially in emergency medicine, where immediate consultation is required. However, handheld devices differ significantly from medical workstation displays in terms of display characteristics. Moreover, the characteristics vary significantly among device types. We investigate the image quality characteristics of various handheld devices with respect to luminance response, spatial resolution, spatial noise, and reflectance. We show that the luminance characteristics of the handheld displays are different from those of workstation displays complying with grayscale standard target response suggesting that luminance calibration might be needed. Our results also demonstrate that the spatial characteristics of handhelds can surpass those of medical workstation displays particularly for recent generation devices. While a 5 mega-pixel monochrome workstation display has horizontal and vertical modulation transfer factors of 0.52 and 0.47 at the Nyquist frequency, the handheld displays released after 2011 can have values higher than 0.63 at the respective Nyquist frequencies. The noise power spectra for workstation displays are higher than 1.2×10−5 mm2 at 1 mm−1, while handheld displays have values lower than 3.7×10−6 mm2. Reflectance measurements on some of the handheld displays are consistent with measurements for workstation displays with, in some cases, low specular and diffuse reflectance coefficients. The variability of the characterization results among devices due to the different technological features indicates that image quality varies greatly among handheld display devices. PMID:24236113

"Joint Workshop on High Confidence Medical Devices, Software, and Systems (HCMDSS) and Medical Device Plug-and-Play (MD PnP) Interoperability"

National Research Council Canada - National Science Library

Goldman, Julian M

2008-01-01

Partial support was requested from TATRC, with joint funding from NSF, for a joint workshop to bring together the synergistic efforts and communities of the High Confidence Medical Devices, Software, and Systems (HCMDSS...

Value driven innovation in medical device design: a process for balancing stakeholder voices.

Science.gov (United States)

de Ana, F J; Umstead, K A; Phillips, G J; Conner, C P

2013-09-01

The innovation process has often been represented as a linear process which funnels customer needs through various business and process filters. This method may be appropriate for some consumer products, but in the medical device industry there are some inherent limitations to the traditional innovation funnel approach. In the medical device industry, there are a number of stakeholders who need to have their voices heard throughout the innovation process. Each stakeholder has diverse and unique needs relating to the medical device, the needs of one may highly affect the needs of another, and the relationships between stakeholders may be tenuous. This paper describes the application of a spiral innovation process to the development of a medical device which considers three distinct stakeholder voices: the Voice of the Customer, the Voice of the Business and the Voice of the Technology. The process is presented as a case study focusing on the front-end redesign of a class III medical device for an orthopedics company. Starting from project initiation and scope alignment, the process describes four phases, Discover, Envision, Create, and Refine, and concludes with value assessment of the final design features.

ISO 13485 a complete guide to quality management in the medical device industry

CERN Document Server

Abuhav, Itay

2011-01-01

Although complex and lengthy, the process of certification for the ISO 13485 can be easily mastered using the simple method outlined in ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry. Written by an experienced industry professional, this practical book provides a complete guide to the ISO 13485 Standard certification for medical device manufacturing. Filled with examples drawn from the author's experience and spanning different sectors and fields of the medical device industry, the book translates the extra ordinary requirements and objectives of the standard

The Charter: Conditions of Diffuse Socialization in Schools.

Science.gov (United States)

Meyer, John W.

The effects of a school on diffuse attributes of students such as their values are seen as produced by the wider social definition of the products of the school--here called its "charter". Schools or systems of schools which are chartered to confer major status gains and entry into diffusely-defined elites are seen as more likely to have broad…

Stretchable bioelectronics for medical devices and systems

CERN Document Server

Ghaffari, Roozbeh; Kim, Dae-Hyeong

2016-01-01

This book highlights recent advances in soft and stretchable biointegrated electronics. A renowned group of authors address key ideas in the materials, processes, mechanics, and devices of soft and stretchable electronics; the wearable electronics systems; and bioinspired and implantable biomedical electronics. Among the topics discussed are liquid metals, stretchable and flexible energy sources, skin-like devices, in vitro neural recording, and more. Special focus is given to recent advances in extremely soft and stretchable bio-inspired electronics with real-world clinical studies that validate the technology. Foundational theoretical and experimental aspects are also covered in relation to the design and application of these biointegrated electronics systems. This is an ideal book for researchers, engineers, and industry professionals involved in developing healthcare devices, medical tools and related instruments relevant to various clinical practices.

A model of user engagement in medical device development.

Science.gov (United States)

Grocott, Patricia; Weir, Heather; Ram, Mala Bridgelal

2007-01-01

The purpose of this paper is to address three topical themes: user involvement in health services research; determining the value of new medical technologies in patient care pathways, furthering knowledge related to quality in health and social care; and knowledge exchange between manufacturers, health service supply chain networks and device users. The model is being validated in a case study in progress. The latter is a "proving ground" study for a translational research company. Medical devices play a pivotal role in the management of chronic diseases, across all care settings. Failure to engage users in device development inevitably affects the quality of clinical outcomes. A model of user engagement is presented, turning unmet needs for medical devices into viable commercial propositions. A case study investigating the perceptions of individuals with Epidermolysis Bullosa (EB), their lay and professional carers into unmet needs. EB is an inherited condition affecting the skin and mucosal linings that leads to blistering and wounds. Qualitative data are being collected to generate understanding of unmet needs and wound care products. These needs are being translated into new design concepts and prototypes. Prototypes will be evaluated in an n = 1 experimental design, generating quantitative outcomes data. There are generalisations from the case study, and the model outlined. New products for managing EB wounds can logically benefit other groups. The model is transferable to other clinical problems, which can benefit from research and technological advances that are integral to clinical needs and care.

78 FR 57903 - Aerospace Safety Advisory Panel; Charter Renewal

Science.gov (United States)

2013-09-20

... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: 13-116] Aerospace Safety Advisory Panel... and amendment of the charter of the Aerospace Safety Advisory Panel. SUMMARY: Pursuant to sections 14... determined that renewal and amendment of the charter of the Aerospace Safety Advisory Panel is in the public...

76 FR 65750 - Aerospace Safety Advisory Panel; Charter Renewal

Science.gov (United States)

2011-10-24

... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-105)] Aerospace Safety Advisory Panel... and amendment of the charter of the NASA Aerospace Safety Advisory Panel. SUMMARY: Pursuant to... determined that a renewal and amendment of the charter of the NASA Aerospace Safety Advisory Panel is in the...

How can cardiothoracic and vascular medical devices stay in the market?

Science.gov (United States)

Wong, Kathie A; Hodgson, Luke; Garas, George; Malietzis, George; Markar, Sheraz; Rao, Christopher; von Segesser, Ludwig K; Athanasiou, Thanos

2016-12-01

Surgeons, as the consumers, must engage in commercial activity regarding medical devices since it directly has impacts on surgical practice and patient outcomes. Unique features defy traditional economic convention in this specific market partly because consumers do not usually pay directly. Greater involvement with commercial activity means better post-market surveillance of medical devices which leads to improved patient safety. The medical device industry has exhibited astonishing levels of growth and profitability reaching $398 billion on a global scale with new product development focusing on unmet clinical need. The industry has rapidly emerged within the context of an ageing population and a global surge in healthcare spending. But the market remains fragmented. The split of consumer, purchaser and payer leads to clinical need driving demand for new product development. This demand contributes to potentially large profit margins mainly contained by regulatory burden and liability issues. Demographic trends, prevalence of diseases and a huge capacity to absorb technology have sustained near unparalleled growth. To stay in the market, incremental development over the short term is essentially aided by responsiveness to demand. Disruptive product development is now more likely to come from multinational companies, in an increasingly expensive, regulated industry. Understanding healthcare organization can help explain the highly complex process of diffusion of innovations in healthcare that include medical devices. The time has come for surgeons to become actively involved with all aspects of the medical device life cycle including commercial activity and post-market surveillance. This is vital for improving patient care and ensuring patient safety. © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Effects of Medical Device Regulations on the Development of Stand-Alone Medical Software: A Pilot Study.

Science.gov (United States)

Blagec, Kathrin; Jungwirth, David; Haluza, Daniela; Samwald, Matthias

2018-01-01

Medical device regulations which aim to ensure safety standards do not only apply to hardware devices but also to standalone medical software, e.g. mobile apps. To explore the effects of these regulations on the development and distribution of medical standalone software. We invited a convenience sample of 130 domain experts to participate in an online survey about the impact of current regulations on the development and distribution of medical standalone software. 21 respondents completed the questionnaire. Participants reported slight positive effects on usability, reliability, and data security of their products, whereas the ability to modify already deployed software and customization by end users were negatively impacted. The additional time and costs needed to go through the regulatory process were perceived as the greatest obstacles in developing and distributing medical software. Further research is needed to compare positive effects on software quality with negative impacts on market access and innovation. Strategies for avoiding over-regulation while still ensuring safety standards need to be devised.

An Institutional Theory Analysis of Charter Schools: Addressing Institutional Challenges to Scale

Science.gov (United States)

Huerta, Luis A.; Zuckerman, Andrew

2009-01-01

This article presents a conceptual framework derived from institutional theory in sociology that offers two competing policy contexts in which charter schools operate--a bureaucratic frame versus a decentralized frame. An analysis of evolving charter school types based on three underlying theories of action is considered. As charter school leaders…

78 FR 66941 - Design Considerations for Pivotal Clinical Investigations for Medical Devices; Guidance for...

Science.gov (United States)

2013-11-07

.... 66, rm. 2110, Silver Spring, MD 20993-0002, 301- 796-5750. For devices regulated by CBER: Stephen... the best clinical and statistical practices for investigational medical device studies. A medical...

Hopes, Fears, & Reality: A Balanced Look at American Charter Schools in 2011

Science.gov (United States)

Lake, Robin J., Ed.; Gross, Betheny, Ed.

2012-01-01

Charter schools are public schools. Historically, however, the relationship between school districts and charters has been nonexistent at best, antagonistic at worst. As the charter sector continues to grow steadily, an analysis of the national landscape explores how that relationship needs to start changing--and where it already has. This year's…

A Study of the Factors Influencing Parental Choice of a Charter School

Science.gov (United States)

Ekanem, Imaobong Columba

2013-01-01

The study discussed in this dissertation identified and examined the factors that influence parent charter school choice. The study was conducted for a rural K-8 charter school in Delaware. The survey instrument used was a parent questionnaire which contained questions that examined the reasons for parent charter school choice, the features of…

OR.NET RT: how service-oriented medical device architecture meets real-time communication.

Science.gov (United States)

Pfeiffer, Jonas H; Kasparick, Martin; Strathen, Benjamin; Dietz, Christian; Dingler, Max E; Lueth, Tim C; Timmermann, Dirk; Radermacher, Klaus; Golatowski, Frank

2018-02-23

Today's landscape of medical devices is dominated by stand-alone systems and proprietary interfaces lacking cross-vendor interoperability. This complicates or even impedes the innovation of novel, intelligent assistance systems relying on the collaboration of medical devices. Emerging approaches use the service-oriented architecture (SOA) paradigm based on Internet protocol (IP) to enable communication between medical devices. While this works well for scenarios with no or only soft timing constraints, the underlying best-effort communication scheme is insufficient for time critical data. Real-time (RT) networks are able to reliably guarantee fixed latency boundaries, for example, by using time division multiple access (TDMA) communication patterns. However, deterministic RT networks come with their own limitations such as tedious, inflexible configuration and a more restricted bandwidth allocation. In this contribution we overcome the drawbacks of both approaches by describing and implementing mechanisms that allow the two networks to interact. We introduce the first implementation of a medical device network that offers hard RT guarantees for control and sensor data and integrates into SOA networks. Based on two application examples we show how the flexibility of SOA networks and the reliability of RT networks can be combined to achieve an open network infrastructure for medical devices in the operating room (OR).

Charter Schools and the Teacher Job Search in Michigan

Science.gov (United States)

Cannata, Marisa

2010-01-01

This paper examines the position of charter schools in prospective elementary teachers' job search decisions. Using a labor market segmentation framework, it explores teacher applicants' decisions to apply to charter schools. The data come from a mixed-methods longitudinal study of prospective teachers looking for their first job. This paper finds…

Scouting For Approval: Lessons on Medical Device Regulation in an Era of Crowdfunding from Scanadu's "Scout".

Science.gov (United States)

Smith, Colleen

2015-01-01

Internet crowdfunding, a new and increasingly popular method of raising capital to develop products and businesses, has recently come into conflict with the Food and Drug Administration's (FDA's) regulation of medical devices. This Article examines the issues that arise when companies pre-sell medical devices via crowdfunding campaigns before gaining FDA approval of the devices. Because Internet crowdfunding has only been in use for a few years, little has been written about it academically, particularly about its interaction with FDA regulations. The rising interest in crowdfunding, coupled with the downturn in investment in the American medical device industry, make this a salient issue that is ripe for FDA review. This Article uses the crowdfunding campaign Scanadu, a medical device company, conducted in 2013 to raise money to develop its in-home diagnostic device, the "Scout," as a starting point for this analysis. Because it is extremely costly to develop a device and obtain FDA approval, medical device companies should be able to utilize crowdfunding to raise the necessary capital. However, because of the possible dangers medical devices pose, FDA needs to review the risks created by allowing companies to crowdfund medical devices and should issue guidance to help companies comply with FDA regulations while still allowing them to take advantage of the benefits of crowdfunding. This guidance should ensure the continued commitment to consumer safety that is at the core of FDA regulation.

Internal Audit Charter, Mar2017

International Development Research Centre (IDRC) Digital Library (Canada)

Jessica Perkins

March 2017 ... Assurance and Advice to Support Innovating for Development ... IDRC's Board of Governors approves the Internal Audit Charter which ... Performing advisory services related to governance, risk management and control, at the.

Monitoring of Vital Signs with Flexible and Wearable Medical Devices.

Science.gov (United States)

Khan, Yasser; Ostfeld, Aminy E; Lochner, Claire M; Pierre, Adrien; Arias, Ana C

2016-06-01

Advances in wireless technologies, low-power electronics, the internet of things, and in the domain of connected health are driving innovations in wearable medical devices at a tremendous pace. Wearable sensor systems composed of flexible and stretchable materials have the potential to better interface to the human skin, whereas silicon-based electronics are extremely efficient in sensor data processing and transmission. Therefore, flexible and stretchable sensors combined with low-power silicon-based electronics are a viable and efficient approach for medical monitoring. Flexible medical devices designed for monitoring human vital signs, such as body temperature, heart rate, respiration rate, blood pressure, pulse oxygenation, and blood glucose have applications in both fitness monitoring and medical diagnostics. As a review of the latest development in flexible and wearable human vitals sensors, the essential components required for vitals sensors are outlined and discussed here, including the reported sensor systems, sensing mechanisms, sensor fabrication, power, and data processing requirements. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Details from the Dashboard: Charter School Race/Ethnicity Demographics

Science.gov (United States)

National Alliance for Public Charter Schools, 2012

2012-01-01

This "Details from the Dashboard" report examines race/ethnicity breakouts for public charter schools and traditional public schools at the state and the school district level. The data in this report indicate that in the large majority of states, the race/ethnicity student demographics of charter schools are almost identical to those of the…

Medical devices and the Middle East: market, regulation, and reimbursement in Gulf Cooperation Council states

Directory of Open Access Journals (Sweden)

Howard JJ

2014-11-01

Full Text Available Jason J Howard Division of Paediatric Orthopaedics, Department of Surgery, Sidra Medical and Research Center, Doha, Qatar Abstract: With some of the richest economies in the world, the Gulf Cooperation Council (GCC is undergoing rapid growth not only in its population but also in health care expenditure. Despite the GCC's abundance of hydrocarbon-based wealth, the drivers of the medical device industry in the GCC are still in flux, with gains yet to be made in areas of infrastructure, regulation, and reimbursement. However, the regional disease burden, expanding health insurance penetration, increasing privatization, and a desire to attract skilled expatriate health care providers have led to favorable conditions for the medical device market in the GCC. The purpose of this article is to investigate the current state of the GCC medical device industry, with respect to market, regulation, and reimbursement, paying special attention to the three largest medical device markets: Saudi Arabia, the United Arab Emirates, and Qatar. The GCC would seem to represent fertile ground for the development of medical technologies, especially those in line with the regional health priorities of the respective member states. Keywords: medical devices, regulation, reimbursement, Middle East 

Energy Charter as means of achieving sustainable energy production and consumption

Energy Technology Data Exchange (ETDEWEB)

Lubbers, R.F.M.

1995-12-31

The present paper deals with the European Energy Charter covering policy agreements on energy efficiency and relating environmental aspects. The Energy Charter was signed by the participating countries in 1994

34 CFR 226.23 - May charter schools use grant funds for administrative costs?

Science.gov (United States)

2010-07-01

... 34 Education 1 2010-07-01 2010-07-01 false May charter schools use grant funds for administrative... administrative costs? (a) Except as provided in paragraph (b) of this section, charter school subgrantees may use... OF ELEMENTARY AND SECONDARY EDUCATION, DEPARTMENT OF EDUCATION STATE CHARTER SCHOOL FACILITIES...

Mobile devices in medicine: a survey of how medical students, residents, and faculty use smartphones and other mobile devices to find information*

Science.gov (United States)

Boruff, Jill T.; Storie, Dale

2014-01-01

Objectives: The research investigated the extent to which students, residents, and faculty members in Canadian medical faculties use mobile devices, such as smartphones (e.g., iPhone, Android, Blackberry) and tablet computers (e.g., iPad), to answer clinical questions and find medical information. The results of this study will inform how health libraries can effectively support mobile technology and collections. Methods: An electronic survey was distributed by medical librarians at four Canadian universities to medical students, residents, and faculty members via departmental email discussion lists, personal contacts, and relevant websites. It investigated the types of information sought, facilitators to mobile device use in medical information seeking, barriers to access, support needs, familiarity with institutionally licensed resources, and most frequently used resources. Results: The survey of 1,210 respondents indicated widespread use of smartphones and tablets in clinical settings in 4 Canadian universities. Third- and fourth-year undergraduate students (i.e., those in their clinical clerkships) and medical residents, compared to other graduate students and faculty, used their mobile devices more often, used them for a broader range of activities, and purchased more resources for their devices. Conclusions: Technological and intellectual barriers do not seem to prevent medical trainees and faculty from regularly using mobile devices for their medical information searches; however, barriers to access and lack of awareness might keep them from using reliable, library-licensed resources. Implications: Libraries should focus on providing access to a smaller number of highly used mobile resources instead of a huge collection until library-licensed mobile resources have streamlined authentication processes. PMID:24415916

Mobile devices in medicine: a survey of how medical students, residents, and faculty use smartphones and other mobile devices to find information.

Science.gov (United States)

Boruff, Jill T; Storie, Dale

2014-01-01

The research investigated the extent to which students, residents, and faculty members in Canadian medical faculties use mobile devices, such as smartphones (e.g., iPhone, Android, Blackberry) and tablet computers (e.g., iPad), to answer clinical questions and find medical information. The results of this study will inform how health libraries can effectively support mobile technology and collections. An electronic survey was distributed by medical librarians at four Canadian universities to medical students, residents, and faculty members via departmental email discussion lists, personal contacts, and relevant websites. It investigated the types of information sought, facilitators to mobile device use in medical information seeking, barriers to access, support needs, familiarity with institutionally licensed resources, and most frequently used resources. The survey of 1,210 respondents indicated widespread use of smartphones and tablets in clinical settings in 4 Canadian universities. Third- and fourth-year undergraduate students (i.e., those in their clinical clerkships) and medical residents, compared to other graduate students and faculty, used their mobile devices more often, used them for a broader range of activities, and purchased more resources for their devices. Technological and intellectual barriers do not seem to prevent medical trainees and faculty from regularly using mobile devices for their medical information searches; however, barriers to access and lack of awareness might keep them from using reliable, library-licensed resources. Libraries should focus on providing access to a smaller number of highly used mobile resources instead of a huge collection until library-licensed mobile resources have streamlined authentication processes.

75 FR 13735 - Office of Innovation and Improvement; Overview Information; Charter Schools Program (CSP): State...

Science.gov (United States)

2010-03-23

... financial assistance for the planning, program design, and initial implementation of charter schools, and to... process for the denial of an application for a charter school. Priority 4--High Degree of Autonomy (10 points). The State ensures that each charter school has a high degree of autonomy over the charter school...

Implantable Medical Devices; Networking Security Survey

OpenAIRE

Siamak Aram; Rouzbeh A. Shirvani; Eros G. Pasero; Mohamd F. Chouikha

2016-01-01

The industry of implantable medical devices (IMDs) is constantly evolving, which is dictated by the pressing need to comprehensively address new challenges in the healthcare field. Accordingly, IMDs are becoming more and more sophisticated. Not long ago, the range of IMDs’ technical capacities was expanded, making it possible to establish Internet connection in case of necessity and/or emergency situation for the patient. At the same time, while the web connectivity of today’s implantable dev...

Emergency Response and the International Charter Space and Major Disasters

Science.gov (United States)

Jones, B.; Lamb, R.

2011-12-01

Responding to catastrophic natural disasters requires information. When the flow of information on the ground is interrupted by crises such as earthquakes, landslides, volcanoes, hurricanes, and floods, satellite imagery and aerial photographs become invaluable tools in revealing post-disaster conditions and in aiding disaster response and recovery efforts. USGS is a global clearinghouse for remotely sensed disaster imagery. It is also a source of innovative products derived from satellite imagery that can provide unique overviews as well as important details about the impacts of disasters. Repeatedly, USGS and its resources have proven their worth in assisting with disaster recovery activities in the United States and abroad. USGS has a well-established role in emergency response in the United States. It works closely with the Federal Emergency Management Agency (FEMA) by providing first responders with satellite and aerial images of disaster-impacted sites and products developed from those images. The combination of the USGS image archive, coupled with its global data transfer capability and on-site science staff, was instrumental in the USGS becoming a participating agency in the International Charter Space and Major Disasters. This participation provides the USGS with access to international members and their space agencies, to information on European and other global member methodology in disaster response, and to data from satellites operated by Charter member countries. Such access enhances the USGS' ability to respond to global emergencies and to disasters that occur in the United States (US). As one example, the Charter agencies provided imagery to the US for over 4 months in response to the Gulf oil spill. The International Charter mission is to provide a unified system of space data acquisition and delivery to those affected by natural or man-made disasters. Each member space agency has committed resources to support the provisions of the Charter and

Framework conditions and requirements to ensure the technical functional safety of reprocessed medical devices.

Science.gov (United States)

Kraft, Marc

2008-09-03

Testing and restoring technical-functional safety is an essential part of medical device reprocessing. Technical functional tests have to be carried out on the medical device in the course of the validation of reprocessing procedures. These ensure (in addition to the hygiene tests) that the reprocessing procedure is suitable for the medical device. Functional tests are, however, also a part of reprocessing procedures. As a stage in the reprocessing, they ensure for the individual medical device that no damage or other changes limit the performance. When determining which technical-functional tests are to be carried out, the current technological standard has to be taken into account in the form of product-specific and process-oriented norms. Product-specific norms primarily define safety-relevant requirements. The risk management method described in DIN EN ISO 14971 is the basis for recognising hazards; the likelihood of such hazards arising can be minimised through additional technical-functional tests, which may not yet have been standardised. Risk management is part of a quality management system, which must be bindingly certified for manufacturers and processors of critical medical devices with particularly high processing demands by a body accredited by the competent authority.

Earth Charter and nuclear energy

International Nuclear Information System (INIS)

Grippi, Sidney

2006-01-01

The chapter presents Earth Charter, where are listed the principles in 4 sections: 1) respect and take care of the life community; 2) environmental integrity; social and economic welfare; 4) democracy, no-violence and peace

77 FR 3781 - Pediatric Medical Devices; Public Workshop; Reopening of Comment Period

Science.gov (United States)

2012-01-25

... devices. DATES: Submit either electronic or written comments by March 5, 2012. ADDRESSES: Submit.... Designing pediatric medical devices can be challenging; children are often smaller and more active than adults; body structures and functions change throughout childhood, and children may be long-term device...

A Maturity Grid Assessment Tool for Environmentally Conscious Design in the Medical Device Industry

DEFF Research Database (Denmark)

Moultrie, James; Sutcliffe, Laura Francesca Rose; Maier, Anja

2016-01-01

. This intervention tool provides designers and product marketers with insights on how to improve the design of their medical devices and specifically allows consideration of the complex trade-offs between decisions that influence different life-cycle stages. Through the tool, actionable insight is created......The medical device industry is growing increasingly concerned about environmental impact of products. Whilst there are many tools aiming to support environmentally conscious design, they are typically complex to use, demand substantial data collection and are not tailored to the specific needs...... of the medical device sector. This paper reports on the development of a Maturity Grid to address this gap. This novel design tool was developed iteratively through application in five case studies. The tool captures principles of eco-design for medical devices in a simple form, designed to be used by a team...

Initiatives in the Australian Medical Devices Industry

International Nuclear Information System (INIS)

Whelan, Luke

2005-01-01

The medical device industry is as diverse as it is specialised and calls on the innovative use of design and components and utilises all facets of precision manufacturing from printed circuit boards, injection-moulded plastics to engineering, using a wide range of materials. It generally requires exacting standards, starting with design, particularly for devices that are invasive or have direct contact with the human body. Of course this brings the further consideration of sterilisation and whether it is for single or multiple use. There is an ever-present need to produce more accurate less invasive and cheaper devices. The driving motivation appears to be meeting clinical needs at a reduced cost. The push to treat people outside the hospital is growing, creating new demands and directions. The advent of the Internet and wireless technology has opened a whole new direction of research and development opportunities

Follow the Money: An Initial Review of Elementary Charter School Spending in Michigan.

Science.gov (United States)

Prince, Hank

1999-01-01

Examined whether Michigan's elementary charter schools' expenditures differ from those of comparable-enrollment local districts. During 1995-96, charters spent an average of 57 percent of revenues on instruction and about 43 percent on support services, compared to 65 and 35 percent for comparable districts. Charters' administrative expenditures…

78 FR 27971 - Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting

Science.gov (United States)

2013-05-13

...] Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Dental Products Panel of the Medical Devices Advisory Committee. General Function of the Committee: To... regulatory classification for dental devices known as Endosseous Dental Implants (Blade-form), one of the...

Biomaterials and medical devices a perspective from an emerging country

CERN Document Server

Hermawan, Hendra

2016-01-01

This book presents an introduction to biomaterials with the focus on the current development and future direction of biomaterials and medical devices research and development in Indonesia. It is the first biomaterials book written by selected academic and clinical experts experts on biomaterials and medical devices from various institutions and industries in Indonesia. It serves as a reference source for researchers starting new projects, for companies developing and marketing products and for governments setting new policies. Chapter one covers the fundamentals of biomaterials, types of biomaterials, their structures and properties and the relationship between them. Chapter two discusses unconventional processing of biomaterials including nano-hybrid organic-inorganic biomaterials. Chapter three addresses biocompatibility issues including in vitro cytotoxicity, genotoxicity, in vitro cell models, biocompatibility data and its related failure. Chapter four describes degradable biomaterial for medical implants...

Additive Manufacturing for Robust and Affordable Medical Devices

OpenAIRE

Wolozny Gomez Robelo, Daniel Andre

2016-01-01

Additive manufacturing in the form of 3D printing is a revolutionary technology that has developed within the last two decades. Its ability to print an object with accurate features down to the micro scale have made its use in medical devices and research feasible. A range of life-saving technologies can now go from the laboratory and into field with the application of 3D-printing. This technology can be applied to medical diagnosis of patients in at-risk populations. Living biosensors a...

Charters and foundations: are we losing control of our public schools?

Science.gov (United States)

Levine, Murray; Levine, Adeline

2014-01-01

From their inception, United States public schools have been subject to reform efforts. The most recent, and perhaps the most potent, is the current effort to establish charter schools as replacements for traditional public schools. They are supposed to be the analog of private schools, providing choices to parents, financed by public funds, but operating largely free of state and local regulations. The schools are organized under charters specified by state laws and authorized by public agencies. This essay traces the development and growth of charter schools and note changes in their original mission to improve public education. It concludes with the role that very wealthy foundations play in promoting charter schools. In effect, they control public education policy without real accountability to the public. (c) 2014 APA, all rights reserved.

Medical professionalism in China and the United States: a transcultural interpretation.

Science.gov (United States)

Nie, Jing-Bao; Smith, Kirk L; Cong, Yali; Hu, Linying; Tucker, Joseph D

2015-01-01

As in other societies, medical professionalism in the Peoples' Republic of China has been rapidly evolving. One of the major events in this process was the endorsement in 2005 of the document, "Medical Professionalism in the New Millennium: A Physician Charter," by the Chinese Medical Doctor Association (hereafter, the Charter)(1). More recently, a national survey, the first on such a large scale, was conducted on Chinese physicians' attitudes toward the fundamental principles and core commitments put forward in the Charter. Based on empirical findings from that study and comparing them to the published results of a similar American survey, the authors offer an in-depth interpretation of significant cross-cultural differences and important transcultural commonalities. The broader historical, socio-economic, and ethical issues relating to salient Chinese cultural practices such as family consent, familism (the custom of deferring decisions to family members), and the withholding of medical information, as well as controversial topics such as not respecting patients' autonomy, are examined. The Chinese Survey found that Chinese physicians supported the principles of the Charter in general. Here we argue that Chinese culture and traditional medical ethics are broadly compatible with the moral commitments demanded by modern medical professionalism. Methodologically and theoretically-recognizing the problems inherent in the hoary but still popular habit of dichotomizing cultures and in relativism-a transcultural approach is adopted that gives greater (due) weight to the internal moral diversity present within every culture, the common ground shared by different cultures, and the primacy of morality. Genuine cross-cultural dialogue, including a constructive Chinese-American dialogue in the area of medical professionalism, is not only possible, but necessary. Copyright 2015 The Journal of Clinical Ethics. All rights reserved.

Charter Revocations: Legal Considerations Concerning Procedure. Education Policy Briefs. Volume 3, Number 1, Fall 2004

Science.gov (United States)

Eckes, Suzanne E.; Plucker, Jonathan A.

2004-01-01

Charter schools are given greater autonomy than traditional public schools, and in return they are held more accountable to the public. As such, if a charter school fails to meet its educational objectives, the charter may be revoked or not renewed. Revocation is the withdrawal of a school's charter during its term, while renewal relates to the…

An extended protocol for usability validation of medical devices : Research design and reference model

NARCIS (Netherlands)

Schmettow, M.; Schnittker, R.; Schraagen, J.M.

2017-01-01

This paper proposes and demonstrates an extended protocol for usability validation testing of medical devices. A review of currently used methods for the usability evaluation of medical devices revealed two main shortcomings. Firstly, the lack of methods to closely trace the interaction sequences

Distribution of microorganisms in medical devices and their inactivation effects by gamma-irradiation

International Nuclear Information System (INIS)

Ito, Hitoshi; Ishigaki, Isao

1986-01-01

Radiation treatment is getting important position for sterilizing medical devices and for packaging films of foods. Recently, survey of bioburden is an important technique for evaluation of sterility doses for medical devices. However, many studies have been done mainly on the irradiation effects of spore-forming bacteria in medical devices. In this study, radiation sensitivity of spore-forming bacteria and fungi were examined after the survey on distribution of microorganisms in several kinds of medical devices. The main contaminant in disposable syringes, needles and conical flasks were consisted of Bacillus, with lesser amount of Micrococcus, Pseudomonas, Peptococcaceae and fungi as positive of 5 - 60 % in the medical devices which cultivated in thioglycolate broth. Bacillus group were identified as B. pumilus, B. sphaericus, B. coagulans, B. megaterium and etc. Fungi were isolated a lesser amounts compared with spore-forming bacteria and identified as Blastomyces, Penicillium, Haplosporangium, Euricoa and Audeobasidium. Peptococaceae were not isolated after irradiation with a dose of 0.1 Mrad even the samples were contaminated with high percentage. The D 10 values of dryed endospores of Bacillus-isolates which attached to the filter paper with pepton-glycerin were obtained to be 0.11 - 0.19 Mrad. The D 10 values of many isolates of fungi in dry condition were obtained below 0.08 Mrad. However, the isolate of Aureobasidium is radiation-resistant, and it's D 10 values was obtained as 0.28 Mrad under aerobic and anaerobic dry condition. (author)

Medical devices of the head, neck, and spine.

Science.gov (United States)

Hunter, Tim B; Yoshino, Mark T; Dzioba, Robert B; Light, Rick A; Berger, William G

2004-01-01

There are many medical devices used for head, neck, and spinal diseases and injuries, and new devices are constantly being introduced. Many of the newest devices are variations on a previous theme. Knowing the specific name of a device is not important. It is important to recognize the presence of a device and to have an understanding of its function as well as to be able to recognize the complications associated with its use. The article discusses the most common and important devices of the head, neck, and spine, including cerebrospinal fluid shunts and the Codman Hakim programmable valve; subdural drainage catheters, subdural electrodes, intracranial electrodes, deep brain stimulators, and cerebellar electrodes; coils, balloons, adhesives, particles, and aneurysm clips; radiation therapy catheters, intracranial balloons for drug installation, and carmustine wafers; hearing aids, cochlear implants, and ossicular reconstruction prostheses; orbital prostheses, intraocular silicone oil, and lacrimal duct stents; anterior and posterior cervical plates, posterior cervical spine wiring, odontoid fracture fixation devices, cervical collars and halo vests; thoracic and lumbar spine implants, anterior and posterior instrumentation for the thoracic and lumbar spine, vertebroplasty, and artificial disks; spinal column stimulators, bone stimulators, intrathecal drug delivery pumps, and sacral stimulators; dental and facial implant devices; gastric and tracheal tubes; vagus nerve stimulators; lumboperitoneal shunts; and temperature- and oxygen-sensing probes. Copyright RSNA, 2004

Metrological Reliability of Medical Devices

Science.gov (United States)

Costa Monteiro, E.; Leon, L. F.

2015-02-01

The prominent development of health technologies of the 20th century triggered demands for metrological reliability of physiological measurements comprising physical, chemical and biological quantities, essential to ensure accurate and comparable results of clinical measurements. In the present work, aspects concerning metrological reliability in premarket and postmarket assessments of medical devices are discussed, pointing out challenges to be overcome. In addition, considering the social relevance of the biomeasurements results, Biometrological Principles to be pursued by research and innovation aimed at biomedical applications are proposed, along with the analysis of their contributions to guarantee the innovative health technologies compliance with the main ethical pillars of Bioethics.

Beyond Ideological Warfare: The Maturation of Research on Charter Schools

Science.gov (United States)

Smith, Joanna; Wohlstetter, Priscilla; Farrell, Caitlin C.; Nayfack, Michelle B.

2011-01-01

Philosophical debate about charter schools often results in theory and anecdotes overshadowing empirical research. This systematic review of trends in the charter school research over the last decade helps determine where empirical evidence exists and where new research is necessary. Findings reveal that student and school outcomes are the most…

Abbott Students Attending Charter Schools: Funding Disparities and Legal Implications

Science.gov (United States)

Bulkley, Katrina

2007-01-01

Most of New Jersey's charter schools are located in the state's poorer, urban school districts, or "Abbott" districts, and exclusively serve students from those communities. A number of other schools are located outside of the Abbott districts but enroll students from these districts. Specifically, of the 50 charter schools operating in…

Charter School Competition, Organization, and Achievement in Traditional Public Schools

Science.gov (United States)

Davis, Tomeka M.

2013-01-01

Market models of education reform predict that the growth of charter schools will infuse competition into the public school sector, forcing traditional public schools to improve the practices they engage in to educate students. Some scholars have criticized these models, arguing that competition from charter schools is unlikely to produce…

Review of "Going Exponential: Growing the Charter School Sector's Best"

Science.gov (United States)

Garcia, David

2011-01-01

This Progressive Policy Institute report argues that charter schools should be expanded rapidly and exponentially. Citing exponential growth organizations, such as Starbucks and Apple, as well as the rapid growth of molds, viruses and cancers, the report advocates for similar growth models for charter schools. However, there is no explanation of…

Collision Course: Embracing Politics to Succeed in District-Charter Collaboration

Science.gov (United States)

Jochim, Ashley; Yatsko, Sarah; Opalka, Alice

2018-01-01

Many who attempt district-charter collaboration point to "politics" as a constraint that affects their work, but little is understood about why some collaborations enjoy broad support while others become mired in conflict. Drawing upon CRPE's multiyear study of district-charter collaborations in dozens of cities as well as research on…

Early-stage valuation of medical devices: the role of developmental uncertainty.

Science.gov (United States)

Girling, Alan; Young, Terry; Brown, Celia; Lilford, Richard

2010-08-01

At the concept stage, many uncertainties surround the commercial viability of a new medical device. These include the ultimate functionality of the device, the cost of producing it and whether, and at what price, it can be sold to a health-care provider (HCP). Simple assessments of value can be made by estimating such unknowns, but the levels of uncertainty may mean that their operational value for investment decisions is unclear. However, many decisions taken at the concept stage are reversible and will be reconsidered later before the product is brought to market. This flexibility can be exploited to enhance early-stage valuations. To develop a framework for valuing a new medical device at the concept stage that balances benefit to the HCP against commercial costs. This is done within a simplified stage-gated model of the development cycle for new products. The approach is intended to complement existing proposals for the evaluation of the commercial headroom available to new medical products. A model based on two decision gates can lead to lower bounds (underestimates) for product value that can serve to support a decision to develop the product. Quantifiable uncertainty that can be resolved before the device is brought to market will generally enhance early-stage valuations of the device, and this remains true even when some components of uncertainty cannot be fully described. Clinical trials and other evidence-gathering activities undertaken as part of the development process can contribute to early-stage estimates of value.

75 FR 18219 - Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and...

Science.gov (United States)

2010-04-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0142] Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and Supplier Controls; Public Educational Forum AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public...

Mobility Charters and Manifestos

DEFF Research Database (Denmark)

Jensen, Ole B.

2010-01-01

This paper explore a number of different cases of articulating notions of ‘correct’ mobility behavior and practice by looking into charters, manifestos and codes of mobility regulation. Within such discourses of ‘correct mobility’ more or less subtle expressions of power as well as normative and ...... ‘Highway Code Booklets’ from the 1930’s, 40’s and 50’s, the ‘City Slow Charter’, the ‘New Urbanism Charter’ as attempts to codify and order mobility and mobile practices.......This paper explore a number of different cases of articulating notions of ‘correct’ mobility behavior and practice by looking into charters, manifestos and codes of mobility regulation. Within such discourses of ‘correct mobility’ more or less subtle expressions of power as well as normative...... and ethical positions on mobility prevail. Such ‘imagined correct mobility behavior’ are drawing on larger issues of societal change that need to be brought out in a critical analysis and discussion reflecting the attempts to control, design and orchestrate mobility patterns. The paper therefore argues within...

Design of point-of-care (POC) microfluidic medical diagnostic devices

Science.gov (United States)

Leary, James F.

2018-02-01

Design of inexpensive and portable hand-held microfluidic flow/image cytometry devices for initial medical diagnostics at the point of initial patient contact by emergency medical personnel in the field requires careful design in terms of power/weight requirements to allow for realistic portability as a hand-held, point-of-care medical diagnostics device. True portability also requires small micro-pumps for high-throughput capability. Weight/power requirements dictate use of super-bright LEDs and very small silicon photodiodes or nanophotonic sensors that can be powered by batteries. Signal-to-noise characteristics can be greatly improved by appropriately pulsing the LED excitation sources and sampling and subtracting noise in between excitation pulses. The requirements for basic computing, imaging, GPS and basic telecommunications can be simultaneously met by use of smartphone technologies, which become part of the overall device. Software for a user-interface system, limited real-time computing, real-time imaging, and offline data analysis can be accomplished through multi-platform software development systems that are well-suited to a variety of currently available cellphone technologies which already contain all of these capabilities. Microfluidic cytometry requires judicious use of small sample volumes and appropriate statistical sampling by microfluidic cytometry or imaging for adequate statistical significance to permit real-time (typically medical decisions for patients at the physician's office or real-time decision making in the field. One or two drops of blood obtained by pin-prick should be able to provide statistically meaningful results for use in making real-time medical decisions without the need for blood fractionation, which is not realistic in the field.

A Phenomenological Narrative Study: Elementary Charter School Principals' Managerial Roles

Science.gov (United States)

Cetinkaya, Ahmet

2016-01-01

This study was a phenomenological narrative research investigating the managerial roles of elementary charter school principals. Managerial leadership practices were investigated under three categories personnel management, student management, and finance management. Elementary charter school principals provided positive feedback for having small…

Charter Schools: An Experiment in School Reform. ASPIRA Issue Brief.

Science.gov (United States)

Dittmar, Belinda Corazon; And Others

Charter schools incorporate the focus of magnet schools but often go beyond their academic specialization to more social goals. They can operate at both elementary and secondary levels, although they are always quite small. The greatest difference, however, between charter schools and other public schools is their status as a bridge between public…

Developing and Rewarding Excellent Teachers: The Scottish Chartered Teacher Scheme

Science.gov (United States)

Ingvarson, Lawrence

2009-01-01

The Scottish Chartered Teacher Scheme was designed to recognise and reward teachers who attained high standards of practice. The scheme emerged in 2001 as part of an agreement between government, local employing authorities and teacher organisations. Policies such as the chartered teacher scheme aim to benefit students in two main ways: by…

Comparing New School Effects in Charter and Traditional Public Schools

Science.gov (United States)

Kelly, Andrew P.; Loveless, Tom

2012-01-01

This study investigates whether student achievement varies during the institutional life span of charter schools by comparing them to new public schools. The results show that there is little evidence that new public schools struggle with initial start-up issues to the same extent as new charter schools. Even after controlling for school…

#DDOD Use Case: Consolidated reporting of medical device recalls

Data.gov (United States)

U.S. Department of Health & Human Services — SUMMARY DDOD use case request for consolidated, consistent reporting of medical device recalls. WHAT IS A USE CASE? A “Use Case” is a request that was made by the...

A tale of two charters : Political crisis, political realignment and administrative reform in Belgium

NARCIS (Netherlands)

S.G.J. Van de Walle (Steven); N. Thijs (Nick); G. Bouckaert (Geert)

2005-01-01

markdownabstractCharters are official commitments to quality and reform. Belgium introduced its Charter of the User of Public Services in 1993. The federal administration’s Copernicus reform began in 1999 and had a strong external outlook. It therefore may be considered as a second User Charter. In

A service protocol for post-processing of medical images on the mobile device

Science.gov (United States)

He, Longjun; Ming, Xing; Xu, Lang; Liu, Qian

2014-03-01

With computing capability and display size growing, the mobile device has been used as a tool to help clinicians view patient information and medical images anywhere and anytime. It is uneasy and time-consuming for transferring medical images with large data size from picture archiving and communication system to mobile client, since the wireless network is unstable and limited by bandwidth. Besides, limited by computing capability, memory and power endurance, it is hard to provide a satisfactory quality of experience for radiologists to handle some complex post-processing of medical images on the mobile device, such as real-time direct interactive three-dimensional visualization. In this work, remote rendering technology is employed to implement the post-processing of medical images instead of local rendering, and a service protocol is developed to standardize the communication between the render server and mobile client. In order to make mobile devices with different platforms be able to access post-processing of medical images, the Extensible Markup Language is taken to describe this protocol, which contains four main parts: user authentication, medical image query/ retrieval, 2D post-processing (e.g. window leveling, pixel values obtained) and 3D post-processing (e.g. maximum intensity projection, multi-planar reconstruction, curved planar reformation and direct volume rendering). And then an instance is implemented to verify the protocol. This instance can support the mobile device access post-processing of medical image services on the render server via a client application or on the web page.

[Hospital-based health technology assessment in France: how to proceed to evaluate innovative medical devices?].

Science.gov (United States)

Martelli, N; van den Brink, H; Denies, F; Dervaux, B; Germe, A F; Prognon, P; Pineau, J

2014-01-01

Innovative medical devices offer solutions to medical problems and greatly improve patients' outcomes. Like National Health Technology Assessment (HTA) agencies, hospitals face numerous requests for innovative and costly medical devices. To help local decision-makers, different approaches of hospital-based HTA (HB-HTA) have been adopted worldwide. The objective of the present paper is to explore HB-HTA models for adopting innovative medical devices in France and elsewhere. Four different models have been conceptualized: "ambassador" model, "mini-HTA" model, "HTA unit" model and "internal committee". Apparently, "HTA unit" and "internal committee" (or a mixture of both models) are the prevailing HB-HTA models in France. Nevertheless, some weaknesses of these models have been pointed out in previous works. Only few examples involving hospital pharmacists have been found abroad, except in France and in Italy. Finally, the harmonization of the assessment of innovative medical devices in France needs a better understanding of HB-HTA practices. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

Exploring Quality Programs for English Language Learners in Charter Schools: A Framework to Guide Future Research

Science.gov (United States)

Garcia, Peggie; Morales, P. Zitlali

2016-01-01

Although there has been a great deal of debate about the effectiveness of charter schools in the research literature, there has been surprisingly little attention paid to English language learners (ELLs) in charter schools. Moreover, the charter school research has predominantly focused on whether or not charter schools are effective rather than…

Human Resources Management: Onboarding Program and Trainer's Guide for Charter School Employees

Science.gov (United States)

Cook, Jeannette

2016-01-01

The applied dissertation project focused on the development of a comprehensive onboarding program and Trainer's Guide specifically developed for charter school management employees. Charter school education has grown significantly in the last several decades with over 6,100 charter schools that are currently serving students nationwide. Formal or…

Finding Balance: The Professional Life of a Charter School Teacher

Science.gov (United States)

Clark, Marjorie

2010-01-01

This phenomenological study of one charter school teacher sought to answer the question, what is it like to be a teacher in a charter school? Exploring issues of preparation, working conditions, and job satisfaction, this teacher expressed a range of emotions about her chosen work environment. I found that the pervasive stress surrounding her work…

A Comparative Analysis of Charter Schools and Traditional Public Schools

Science.gov (United States)

Smith, Jodi Renee Abbott

2014-01-01

The focus of this descriptive research study was to compare charter and traditional public schools on the academic knowledge of fifth grade students as measured by Arizona's Instrument to Measure Standards (AIMS) in a suburb of a large southwestern city. This analysis also compared charter and traditional public schools on AYP status. It was…

Pediatric medical device development by surgeons via capstone engineering design programs.

Science.gov (United States)

Sack, Bryan S; Elizondo, Rodolfo A; Huang, Gene O; Janzen, Nicolette; Espinoza, Jimmy; Sanz-Cortes, Magdalena; Dietrich, Jennifer E; Hakim, Julie; Richardson, Eric S; Oden, Maria; Hanks, John; Haridas, Balakrishna; Hury, James F; Koh, Chester J

2018-03-01

There is a need for pediatric medical devices that accommodate the unique physiology and anatomy of pediatric patients that is increasingly receiving more attention. However, there is limited literature on the programs within children's hospitals and academia that can support pediatric device development. We describe our experience with pediatric device design utilizing collaborations between a children's hospital and two engineering schools. Utilizing the academic year as a timeline, unmet pediatric device needs were identified by surgical faculty and matched with an engineering mentor and a team of students within the Capstone Engineering Design programs at two universities. The final prototypes were showcased at the end of the academic year and if appropriate, provisional patent applications were filed. All twelve teams successfully developed device prototypes, and five teams obtained provisional patents. The prototypes that obtained provisional patents included a non-operative ureteral stent removal system, an evacuation device for small kidney stone fragments, a mechanical leech, an anchoring system of the chorio-amniotic membranes during fetal surgery, and a fetal oxygenation monitor during fetoscopic procedures. Capstone Engineering Design programs in partnership with surgical faculty at children's hospitals can play an effective role in the prototype development of novel pediatric medical devices. N/A - No clinical subjects or human testing was performed. Copyright © 2017 Elsevier Inc. All rights reserved.

Wireless communication with implanted medical devices using the conductive properties of the body.

Science.gov (United States)

Ferguson, John E; Redish, A David

2011-07-01

Many medical devices that are implanted in the body use wires or wireless radiofrequency telemetry to communicate with circuitry outside the body. However, the wires are a common source of surgical complications, including breakage, infection and electrical noise. In addition, radiofrequency telemetry requires large amounts of power and results in low-efficiency transmission through biological tissue. As an alternative, the conductive properties of the body can be used to enable wireless communication with implanted devices. In this article, several methods of intrabody communication are described and compared. In addition to reducing the complications that occur with current implantable medical devices, intrabody communication can enable novel types of miniature devices for research and clinical applications.

Measuring up to the Model: A Ranking of State Public Charter School Laws. Ninth Annual Edition

Science.gov (United States)

Ziebarth, Todd; Palmer, Louann Bierlein

2018-01-01

This ninth edition of "Measuring up to the Model: A Ranking of State Charter School Laws" presents the latest activity in charter public school legislation across the country. For the second year in a row, the 2018 rankings measure each state's charter school law against the National Alliance's updated model charter school law, "New…

Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey.

Science.gov (United States)

Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

2015-01-01

In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA) pathway. We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives.

A study of the Healthy Growth Charter in socially disadvantaged children

Directory of Open Access Journals (Sweden)

Massimo Musicco

2011-12-01

Full Text Available The Healthy Growth Charter is an educational and health-promoting project aimed at an active involvement of the primary school children in health surveillance and protection. Being duly acquainted of the matter, scholars are asked to fill by their own a questionnaire on height, weight, sport attendance and other items of medical and demographic interest. According to the project, problems suitable of corrective measures, such as amblyopia, are signalled to the families and dealt individually. The project has been previously tested on about 1500 boys and girls from various Italian regions, showing that, despite the limits of self-reported data, it provides information in line with literature. Health inequalities in children remain an important problem also in Italy, and a second test of the Healthy Growth Charter was launched in a group of socially disadvantaged children. As reported in this paper, overweight, reduced physical activity, visual problems and other items markedly differed in this with respect to the previous study. These results provide some indication on the potential role of social disadvantage and poverty on health status of children. To better tackle the problem of health inequalities, the actual surveillance systems should be empowered, preferably with an active educational involvement of children, translating the information into public health intervention policies.

78 FR 35940 - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft...

Science.gov (United States)

2013-06-14

...] Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft Guidance for... draft guidance entitled ``Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.'' This guidance identifies cybersecurity issues that manufacturers should consider in preparing...

State Policy Snapshot: School District Facilities and Public Charter Schools

Science.gov (United States)

Simnick, Russ

2015-01-01

One of the greatest challenges to the health of the public charter school movement is access to adequate facilities in which the schools operate. Public charter school facilities are rarely funded on par with school district facilities. Over the years, more states have come to realize that they have an obligation to ensure that all public school…

A Peek Into the Classrooms of Indiana's Best-Performing Charter Schools

Science.gov (United States)

Quick, Marilynn; Conrad, Amy L.

2013-01-01

This study focused on how successful Indiana charter schools implemented their planned goals and how their instructional strategies supported sound, research-based practices for improving student achievement. After identifying the three charter schools that consistently earned Indiana's academic designation of "exemplary progress" over a…

The Introduction of Religious Charter Schools: A Cultural Movement in the Private School Sector

Science.gov (United States)

Bailey, Marcia J. Harr; Cooper, Bruce S.

2009-01-01

Charter schools are opening, and religious associations are also sponsoring these schools since religious groups find private school tuitions to be high and prohibitive. This study includes studies of Tarek ibn Ziyad Academy, a Minnesota Arabic charter school (Blaine and Inver Grove Heights, MN); Ben Gamla Charter School, a Florida English-Hebrew…

Getting Inside the Black Box: Examining How the Operation of Charter Schools Affects Performance

Science.gov (United States)

Zimmer, Ron; Buddin, Richard

2007-01-01

In recent years, a series of articles have examined the performance of charter schools with mixed results. Some of this research has shown that charter school performance varies by charter type or the age of the school (Bifulco & Ladd, 2006; Buddin & Zimmer, 2005; Hanushek, Kain, & Rivkin, 2002; Sass, 2006). However, this research has…

Wireless energy transfer platform for medical sensors and implantable devices.

Science.gov (United States)

Zhang, Fei; Hackworth, Steven A; Liu, Xiaoyu; Chen, Haiyan; Sclabassi, Robert J; Sun, Mingui

2009-01-01

Witricity is a newly developed technique for wireless energy transfer. This paper presents a frequency adjustable witricity system to power medical sensors and implantable devices. New witricity resonators are designed for both energy transmission and reception. A prototype platform is described, including an RF power source, two resonators with new structures, and inductively coupled input and output stages. In vitro experiments, both in open air and using a human head phantom consisting of simulated tissues, are employed to verify the feasibility of this platform. An animal model is utilized to evaluate in vivo energy transfer within the body of a laboratory pig. Our experiments indicate that witricity is an effective new tool for providing a variety of medical sensors and devices with power.

BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES – BRIEF REVIEW ON SOME DENTISTRY PRODUCTS.

Directory of Open Access Journals (Sweden)

Maya Lyapina

2015-02-01

Full Text Available Defining a given product as a medical device and interpretation of the application of the classification rules fall within the competence of the competent authorities of the Member States where the product is on the market. Different interpretations of Community legislation occur, and, can put public health at risk and distort the internal market. Borderline cases are considered to be those cases where it is not clear from the outset whether a given product is a medical device, an in vitro diagnostic medical device, an active implantable medical device or not. Classification cases can be described as those cases where there exists a difficulty in the uniform application of the classification rules as laid down in the Medical Devices Directive (MDD, or where for a given device, depending on interpretation of the rules, different classifications can occur. The aim of the present work is to make a brief review on discussion on classification in the community regulatory framework for medical devices of some dentistry products.

The Biological Responses to Magnesium-Based Biodegradable Medical Devices

Directory of Open Access Journals (Sweden)

Lumei Liu

2017-11-01

Full Text Available The biocompatibility of Magnesium-based materials (MBMs is critical to the safety of biodegradable medical devices. As a promising metallic biomaterial for medical devices, the issue of greatest concern is devices’ safety as degrading products are possibly interacting with local tissue during complete degradation. The aim of this review is to summarize the biological responses to MBMs at the cellular/molecular level, including cell adhesion, transportation signaling, immune response, and tissue growth during the complex degradation process. We review the influence of MBMs on gene/protein biosynthesis and expression at the site of implantation, as well as throughout the body. This paper provides a systematic review of the cellular/molecular behavior of local tissue on the response to Mg degradation, which may facilitate a better prediction of long-term degradation and the safe use of magnesium-based implants through metal innovation.

Academic Optimism, Organizational Citizenship Behaviors, and Student Achievement at Charter Schools

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Guvercin, Mustafa

2013-01-01

The purpose of this study was to examine the relationship among academic optimism, Organizational Citizenship Behaviors (OCBs), and student achievement in college preparatory charter schools. A purposeful sample of elementary school teachers from college preparatory charter schools (N = 226) in southeast Texas was solicited to complete the…

The Society for Radiological Protection: incorporated by Royal Charter. How it was achieved

International Nuclear Information System (INIS)

Hunt, John; Scott, John

2008-01-01

The Society for Radiological Protection (the Society) began to consider the potential for incorporation by Royal Charter, an important goal for many professional bodies in the UK, in the mid-1980s. Impetus grew during the 1990s; contributing to this in 1998 was the Society's new status as direct UK IRPA associate. In 2002, to emphasise that the Society is active over all sectors of radiation protection, sectorial committees were established, dealing with professional interests in the component sectors. Application for a Charter begins with a Memorandum to Her Majesty the Queen's Privy Council Office (PCO) with details of the Society, its achievements and why grant of a Charter would be in the public interest. The Society prepared a Memorandum and submitted it to the PCO in 2003. In 2004, the application was declined for several reasons, which were then considered. Contacts in Government Departments were briefed on the Society's activities. The Society and the Institute of Radiation Protection (IRP) had been considering amalgamation, and in 2005 the annual general meetings of the Society and IRP agreed to proposals for a merger. A new Memorandum was submitted to the PCO in 2005, and early in 2006 it was accepted. It was then necessary to draft a Charter and a Petition to HM the Queen in Council. One of the opportunities incorporated in the Charter is the provision to award the title 'Chartered Radiation Protection Professional' with the post-nominal letters 'CRadP' to suitable members. Draft documents were presented to the Society's 2007 annual general meeting, and passed through Society's governance procedures. Public consultation by the PCO took place during summer 2007. On 10 October 2007 an order granting a Charter of Incorporation was approved at the Privy Council held by the Queen. The Charter was presented to the Society on 11 December 2007. (author)

Denver Expands Choice and Charters

Science.gov (United States)

Osborne, David

2016-01-01

Some of the most dramatic gains in urban education have come from school districts using what is known as a "portfolio strategy." Under this approach, districts negotiate performance agreements with public schools--traditional, charter, and hybrid models. The arrangement affords school leaders substantial autonomy to handcraft their…

Communication during pediatric asthma visits and child asthma medication device technique 1 month later.

Science.gov (United States)

Sleath, Betsy; Carpenter, Delesha M; Ayala, Guadalupe X; Williams, Dennis; Davis, Stephanie; Tudor, Gail; Yeatts, Karin; Gillette, Chris

2012-11-01

This study investigated how provider demonstration of and assessment of child use of asthma medication devices and certain aspects of provider-patient communication during medical visits is associated with device technique 1 month later. Two hundred and ninety-six children aged 8-16 years with persistent asthma and their caregivers were recruited at five North Carolina pediatric practices. All of the medical visits were audio-tape recorded. Children were interviewed 1 month later and their device technique was observed and rated. If the provider asked the child to demonstrate metered dose inhaler technique during the medical visit, then the child was significantly more likely to perform a greater percentage of inhaler steps correctly 1 month later. Children with higher asthma management self-efficacy scores were significantly more likely to perform a greater percentage of diskus steps correctly. Additionally, children were significantly more likely to perform a greater percentage of diskus steps correctly if the provider discussed a written action plan during the visit. Children were significantly more likely to perform a greater percentage of turbuhaler steps correctly if they asked more medication questions. Providers should ask children to demonstrate their inhaler technique during medical visits so that they can educate children about proper technique and improve child asthma management self-efficacy. Providers should encourage children to ask questions about asthma medication devices during visits and they should discuss asthma action plans with families.

Mission vs. Mandate: How Charter School Leaders Conceptualize and Address Market-Based and Performance-Based Accountability Demands

Science.gov (United States)

Blitz, Mark H.

2011-01-01

Charter school research has examined the relationship between charter school mission and issues of school accountability. However, there is a lack of research focusing on how charter school leaders frame and solve problems regarding multiple accountability demands. Given this gap, I investigate the question: How do charter school leaders…

French Sizing of Medical Devices is not Fit for Purpose

International Nuclear Information System (INIS)

Kibriya, Nabil; Hall, Rebecca; Powell, Steven; How, Thien; McWilliams, Richard G.

2013-01-01

PurposeThe purpose of the study is to quantify the variation in the metric equivalent of French size in a range of medical devices, from various manufacturers, used in interventional radiology.MethodsThe labelling of a range of catheters, introducers, drains, balloons, stents, and endografts was examined. Products were chosen to achieve a broad range of French sizes from several manufacturers. To assess manufacturing accuracy, eight devices were selected for measurement using a laser micrometer. The external diameters of three specimens of each device were measured at centimeter intervals along the length of the device to ensure uniformity.ResultsA total of 200 labels of interventional radiology equipment were scrutinized. The results demonstrate a wide variation in the metric equivalent of French sizing. Labelled products can vary in diameter across the product range by up to 0.79 mm.The devices selected for measurement with the non-contact laser micrometer demonstrate acceptable manufacturing consistency. The external diameter differed by 0.05 mm on average.ConclusionsOur results demonstrate wide variation in the interpretation of the French scale by different manufacturers of medical devices. This has the potential to lead to problems using coaxial systems especially when the products are from different manufacturers. It is recommended that standard labelling should be employed by all manufacturers conveying specific details of the equipment. Given the wide variation in the interpretation of the French scale, our opinion is that this scale either needs to be abandoned or be strictly defined and followed

77 FR 38177 - TRICARE; Off-Label Uses of Devices; Partial List of Examples of Unproven Drugs, Devices, Medical...

Science.gov (United States)

2012-06-27

... drugs, devices, and medical treatments or procedures and adding the TRICARE definition of unlabeled or... labeling. We are now modifying the definition of ``unlabeled or off-label drug'' to ``off-label use of a... reference back to the definition of the term in 199.2. ``Off-label uses of drugs and devices'' includes off...

75 FR 20854 - Medical Device Use in the Home Environment: Implications for the Safe and Effective Use of...

Science.gov (United States)

2010-04-21

...] Medical Device Use in the Home Environment: Implications for the Safe and Effective Use of Medical Device... related to the safe and effective use of medical device technology in the home environment. The workshop... the home environment. FDA will solicit feedback on: 1. The agency's current working definition of...

Medical devices and the Middle East: market, regulation, and reimbursement in Gulf Cooperation Council states.

Science.gov (United States)

Howard, Jason J

2014-01-01

With some of the richest economies in the world, the Gulf Cooperation Council (GCC) is undergoing rapid growth not only in its population but also in health care expenditure. Despite the GCC's abundance of hydrocarbon-based wealth, the drivers of the medical device industry in the GCC are still in flux, with gains yet to be made in areas of infrastructure, regulation, and reimbursement. However, the regional disease burden, expanding health insurance penetration, increasing privatization, and a desire to attract skilled expatriate health care providers have led to favorable conditions for the medical device market in the GCC. The purpose of this article is to investigate the current state of the GCC medical device industry, with respect to market, regulation, and reimbursement, paying special attention to the three largest medical device markets: Saudi Arabia, the United Arab Emirates, and Qatar. The GCC would seem to represent fertile ground for the development of medical technologies, especially those in line with the regional health priorities of the respective member states.

Protecting Geoheritage - Geodiversity Charter for England

Science.gov (United States)

Dunlop, Lesley

2016-04-01

The Geodiversity Charter for England, launched in 2014, sets out the clear vision that England's 'geodiversity is recognised as an integral and vital part of our environment, economy and heritage that must be safeguarded and managed for current and future generations'. England is privileged to be among the most geodiverse places in the world with 700 million years of geological history revealed by our rocks. The white cliffs of Dover, honey coloured Cotswold limestone, granite Dartmoor Tors, are examples of this geodiversity. To maintain and enhance our geodiversity it is important to recognise its role in: • the understanding of England's geological history and global geosciences • natural heritage, both terrestrial and marine, and landscapes in all their diversity • supporting habitats and species and the many essential benefits they provide for society • adaptation to changes in climate and sea-level through sustainable management of land and water and working with natural processes • sustainable economic development • the history, character and cultural development of our society through intellectual growth and creative expression alongside industrial and technological development • public health, quality of life and national well-being and connecting people with the natural environment including active promotion of geotourism. Geodiversity, however, is an often overlooked environmental asset. The vision of the Charter and the work of the English Geodiversity Forum is to encourage good practice and to act as a focus in order to: • raise awareness of the importance, value and relevance of geodiversity to our economic prosperity and comfort and its wider links with the natural environment, landscape, cultural and historical heritage and sense of place • encourage a sense of pride through education and learning, promotion and interpretation • promote careful management of geodiversity through conservation and enhancement of its special

Medical Device-Associated Candida Infections in a Rural Tertiary Care Teaching Hospital of India

Directory of Open Access Journals (Sweden)

Sachin C. Deorukhkar

2016-01-01

Full Text Available Health care associated infections (HCAIs add incrementally to the morbidity, mortality, and cost expected of the patient’s underlying diseases alone. Approximately, about half all cases of HCAIs are associated with medical devices. As Candida medical device-associated infection is highly drug resistant and can lead to serious life-threatening complications, there is a need of continuous surveillance of these infections to initiate preventive and corrective measures. The present study was conducted at a rural tertiary care hospital of India with an aim to evaluate the rate of medical device-associated Candida infections. Three commonly encountered medical device-associated infections (MDAI, catheter-associated urinary tract infection (CA-UTI, intravascular catheter-related blood stream infections (CR-BSI, and ventilator-associated pneumonia (VAP, were targeted. The overall rate of MDAI in our hospital was 2.1 per 1000 device days. The rate of Candida related CA-UTI and CR-BSI was noted as 1.0 and 0.3, respectively. Untiring efforts taken by team members of Hospital Acquired Infection Control Committee along with maintenance of meticulous hygiene of the hospital and wards may explain the low MDAI rates in our institute. The present surveillance helped us for systematic generation of institutional data regarding MDAI with special reference to role of Candida spp.

Compiling a Medical Device File and a Proposal for an International Standard for Rehabilitation Robots

NARCIS (Netherlands)

Römer, GertWillem R.B.E.; Stuyt, Harry J.A.

2007-01-01

Medical devices produced by manufacturers are subject to regulatory review by authorities. Usually, medical devices are developed at universities and other research institutes. This implies that regulatory activities are to be carried out by the designer at these organizations also. And as early as

78 FR 56719 - Challenging Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of...

Science.gov (United States)

2013-09-13

...] Challenging Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Metabolic Diseases... announcing a public workshop entitled ``Changing Regulatory and Reimbursement Paradigms for Medical Devices... registration information on the AGA Web site. If you need special accommodations due to a disability, please...

Medical Device Integrated Vital Signs Monitoring Application with Real-Time Clinical Decision Support.

Science.gov (United States)

Moqeem, Aasia; Baig, Mirza; Gholamhosseini, Hamid; Mirza, Farhaan; Lindén, Maria

2018-01-01

This research involves the design and development of a novel Android smartphone application for real-time vital signs monitoring and decision support. The proposed application integrates market available, wireless and Bluetooth connected medical devices for collecting vital signs. The medical device data collected by the app includes heart rate, oxygen saturation and electrocardiograph (ECG). The collated data is streamed/displayed on the smartphone in real-time. This application was designed by adopting six screens approach (6S) mobile development framework and focused on user-centered approach and considered clinicians-as-a-user. The clinical engagement, consultations, feedback and usability of the application in the everyday practices were considered critical from the initial phase of the design and development. Furthermore, the proposed application is capable to deliver rich clinical decision support in real-time using the integrated medical device data.

Radiation as a microbiological contamination control of drugs, cosmetics and medical devices

International Nuclear Information System (INIS)

Ishizeki, Chuichi

1985-01-01

This paper deals with current status of radiation sterilization or disinfection of drugs, cosmetics, their materials, and medical devices, and with quality control as a tool for securing microbiological safety, especially current status of sterilization tests. Ointment containing tetracyclin, steroid hormones, gelatin, and enzymes are presented as drug samples to be irradiated, and explanations for radiation sterilization of these drugs are provided. An outline of the application of radiation in cosmetics and medical devices is given. Issues are also provided from the viewpoint of safey and effectiveness of radiation sterilization. (Namekawa, K.)

Civic Fragmentation or Voluntary Association? Habermas, Fraser, and Charter School Segregation

Science.gov (United States)

Wilson, Terri S.

2010-01-01

In this essay, Terri Wilson puts the argument developed by Kathleen Knight Abowitz that charter schools could be considered as counterpublic spaces into interaction with empirical research that explores patterns of voluntary self-segregation in charter schools. Wilson returns to the theoretical tension between Jurgen Habermas and Nancy Fraser over…

Limited Awareness of the Essences of Certification or Compliance Markings on Medical Devices.

Science.gov (United States)

Foo, Jong Yong Abdiel; Tan, Xin Ji Alan

2017-06-01

Medical devices have been long used for odiagnostic, therapeutic or rehabilitation purposes. Currently, they can range from a low-cost portable device that is often used for personal health monitoring to high-end sophisticated equipment that can only be operated by trained professionals. Depending on the functional purposes, there are different certification or compliance markings on the device when it is sold. One common certification marking is the Conformité Européenne affixation but this has a range of certification mark numbering for a variety of functional purposes. While the regulators and medical device manufacturers understand the associated significance and clinical implications, these may not be apparent to the professionals (using or maintaining the device) and the general public. With portable healthcare devices and mobile applications gaining popularity, better awareness of certification marking will be needed. Particularly, there are differences in the allowed functional purposes and the associated cost derivations of devices with a seemingly similar nature. A preferred approach such as an easy-to-understand notation next to any certification marking on a device can aid in differentiation without the need to digest mountainous regulatory details.

Feasibility of energy harvesting techniques for wearable medical devices.

Science.gov (United States)

Voss, Thaddaeus J; Subbian, Vignesh; Beyette, Fred R

2014-01-01

Wearable devices are arguably one of the most rapidly growing technologies in the computing and health care industry. These systems provide improved means of monitoring health status of humans in real-time. In order to cope with continuous sensing and transmission of biological and health status data, it is desirable to move towards energy autonomous systems that can charge batteries using passive, ambient energy. This not only ensures uninterrupted data capturing, but could also eliminate the need to frequently remove, replace, and recharge batteries. To this end, energy harvesting is a promising area that can lead to extremely power-efficient portable medical devices. This paper presents an experimental prototype to study the feasibility of harvesting two energy sources, solar and thermoelectric energy, in the context of wearable devices. Preliminary results show that such devices can be powered by transducing ambient energy that constantly surrounds us.

Dosimetric studies for gamma radiation validation of medical devices

International Nuclear Information System (INIS)

Soliman, Y.S.; Beshir, W.B.; Abdel-Fattah, A.A.; Abdel-Rehim, F.

2013-01-01

The delivery and validation of a specified dose to medical devices are key concerns to operators of gamma radiation facilities. The objective of the present study was to characterize the industrial gamma radiation facility and map the dose distribution inside the product-loading pattern during the validation and routine control of the sterilization process using radiochromic films. Cardboard phantoms were designed to achieve the homogeneity of absorbed doses. The uncertainty of the dose delivered during validation of the sterilization process was assessed. - Highlights: ► Using γ-rays for sterilization of hollow fiber dialyzers and blood tubing sets according to ISO 11137, 2006. ► Dosimetry studies of validations of γ-irradiation facility and sterilized medical devices. ► Places of D min and D max have been determined using FWT-60 films. ► Determining the target minimum doses required to meet the desired SAL of 10 −6 for the two products.

75 FR 22070 - Pacific Halibut Fisheries; Guided Sport Charter Vessel Fishery for Halibut; Recordkeeping and...

Science.gov (United States)

2010-04-27

... period for submission of Alaska Department of Fish and Game Saltwater Sport Fishing Charter Trip Logbook... of Alaska Department of Fish and Game (ADF&G) Saltwater Sport Fishing Charter Trip Logbook (charter... fishery. To avoid duplicative surveys of, and reporting by, industry, NMFS depends on data gathered by the...

Field Safety Notes in Product Problems of Medical Devices for Use in Pulmonology.

Science.gov (United States)

Hannig, Jürgen; Siekmeier, Rüdiger

2015-01-01

The current European system for medical devices is governed by three EC directives: the Medical Device Directive 93/42/EEC, the In-Vitro Diagnostic Directive 98/79/EC and the Active Implantable Medical Device Directive 90/385/EEC and regulates marketing and post-market surveillance of medical devices in the European Economic Area. In cases of incidents and field safety corrective actions (FSCA) manufacturers have to inform the responsible Competent Authority, which is the Federal Institute for Drugs and Medical Devices (BfArM) and the public by field safety notices (FSN). In this study we analyzed FSN of medical devices exclusively serving for diagnostics or treatment in pulmonology (e.g. nebulizers, oxygen concentrators, pulse oximeters, lung function analyzers, and non-active devices for treatment). FSCA and FSN publicized by BfArM in 2005-2013 were analyzed in respect to the MEDDEV 2.12-1 rev 8. In total 41 FSCA were publicized for the included products. German and English FSN were found in 36/35 cases, respectively. FSN were clearly characterized as FSN in 22/20 cases and declaration of the type of action was found in 27/26 cases, respectively. Product names were provided in all cases. Lot numbers or other information for product characterization were available in 7/8 and 26/24 cases, respectively. Detailed information regarding FSCA and product malfunction were found in 27/33 and 36/35 cases, respectively. Information on product related risks with previous use of the affected product was provided in 24/23 cases. In 34/34 cases manufacturers provided information to mitigate product related risks. Requests to pass FSN to persons needing awareness were found in 10/14 cases. Contact data were provided in 30/30 cases. Confirmation that the Competent Authority was informed was found in 12/14 cases and in 19/18 cases a customer confirmation was included. The obtained data suggest that there is an increasing annual number of FSCA and most FSN fulfill the criteria of

Burnout Factories: The Challenge of Retaining Great Teachers in Charter Schools

Science.gov (United States)

Fusco, Mark

2017-01-01

In its well-intentioned effort to create alternatives to public school dropout factories, the charter school sector has created teacher burnout factories. But it does not have to be this way. Charter schools can continue to maintain high standards while creating a more sustainable work environment for teachers. This article examines the teacher…

Parent Involvement in Urban Charter Schools: New Strategies for Increasing Participation

Science.gov (United States)

Smith, Joanna; Wohlstetter, Priscilla; Kuzin, Chuan Ally; De Pedro, Kris

2011-01-01

Decades of research point to the benefits of parent involvement in education. However, research has also shown that White, middle-class parents are disproportionately involved. Charter schools, as schools of choice, have been assumed to have fewer involvement barriers for minority and low-income parents, but a 2007 survey of charter leaders found…

The Influence of News Framing on Support for Charter School Reform

Science.gov (United States)

Feuerstein, Abe

2015-01-01

This study examined the influence of media framing on attitudes toward charter school reform. Participants in an Internet-based experiment were presented, at random, with one of three manipulated news articles framing charter school reform as (a) supportive of values such as freedom, choice, and innovation; (b) conflicting with values such as…

Making Americans: UNO Charter Schools and Civic Education. Policy Brief 6

Science.gov (United States)

Feith, David

2013-01-01

This policy brief is the third in a series of in-depth case studies exploring how top-performing charter schools have incorporated civic learning in their school curriculum and school culture. The UNO Charter School Network includes 13 schools serving some 6,500 students across Chicago. Located in predominantly Hispanic neighborhoods, the…

Citizen's Charter in a primary health-care setting of Nepal: An accountability tool or a "mere wall poster"?

Science.gov (United States)

Gurung, Gagan; Gauld, Robin; Hill, Philip C; Derrett, Sarah

2018-02-01

Despite some empirical findings on the usefulness of citizen's charters on awareness of rights and services, there is a dearth of literature about charter implementation and impact on health service delivery in low-income settings. To gauge the level of awareness of the Charter within Nepal's primary health-care (PHC) system, perceived impact and factors affecting Charter implementation. Using a case study design, a quantitative survey was administered to 400 participants from 22 of 39 PHC facilities in the Dang District to gauge awareness of the Charter. Additionally, qualitative interviews with 39 key informants were conducted to explore the perceived impact of the Charter and factors affecting its implementation. Few service users (15%) were aware of the existence of the Charter. Among these, a greater proportion were literate, and there were also differences according to ethnicity and occupational group. The Charter was usually not properly displayed and had been implemented with no prior public consultation. It contained information that provided awareness of health facility services, particularly the more educated public, but had limited potential for increasing transparency and holding service providers accountable to citizens. Proper display, consultation with stakeholders, orientation or training and educational factors, follow-up and monitoring, and provision of sanctions were all lacking, negatively influencing the implementation of the Charter. Poor implementation and low public awareness of the Charter limit its usefulness. Provision of sanctions and consultation with citizens in Charter development are needed to expand the scope of Charters from information brochures to tools for accountability. © 2017 The Authors Health Expectations Published by John Wiley & Sons Ltd.

BioInnovate Ireland--fostering entrepreneurial activity through medical device innovation training.

Science.gov (United States)

Bruzzi, M S; Linehan, J H

2013-09-01

In the midst of a rich environment for medical device development and manufacturing, universities can play a critical role by developing relevant training programs to produce entrepreneurs who can be efficient and successful in creating early stage companies by understanding deeply the issues involved in creating a useful device, how to raise money, designing early clinical studies and locating manufacturing partners.

The Energy Charter: what is it?

International Nuclear Information System (INIS)

Anon.

1992-01-01

The European Energy Charter is a European Community initiative put forward by the Netherlands' Prime Minister Lubbers in June 1990. The intent of the Charter is to set up a framework for co-operation, trade and investment in energy products and services with countries of Eastern Europe and the former Soviet Union, based on principles of free-markets and non-discrimination. A Working Group has been tasked with the development of the protocol on nuclear energy. The basic intent is to facilitate co-operation between the signatories across the entire peaceful nuclear fuel cycle and in related fields and activities. Particular emphasis is placed on achieving and maintaining a high level of nuclear safety. The protocol has a preamble and four parts, dealing with: objectives and commitments; principles of responsible nuclear conduct; trade; investment and technology transfer and administrative arrangements. (author)

Hacking medical devices a review - biomed 2013.

Science.gov (United States)

Frenger, Paul

2013-01-01

Programmable, implantable and external biomedical devices (such as pacemakers, defibrillators, insulin pumps, pain management pumps, vagus nerve stimulators and others) may be vulnerable to unauthorized access, commonly referred to as “hacking”. This intrusion may lead to compromise of confidential patient data or loss of control of the device itself, which may be deadly. Risks to health from unauthorized access is in addition to hazards from faulty (“buggy”) software or circuitry. Historically, this aspect of medical device design has been underemphasized by both manufacturers and regulatory bodies until recently. However, an insulin pump was employed as a murder weapon in 2001 and successful hacking of an implantable defibrillator was demonstrated in 2008. To remedy these problems, professional groups have announced a variety of design standards and the governmental agencies of several countries have enacted device regulations. In turn, manufacturers have developed new software products and hardware circuits to assist biomedical engineering firms to improve their commercial offerings. In this paper the author discusses these issues, reviewing known problems and zero-day threats, with potential solutions. He outlines his approach to secure software and hardware challenges using the Forth language. A plausible scenario is described in which hacking of an implantable defibrillator by terrorists results in a severe national security threat to the United States.

Monitoring of biofilm formation on different material surfaces of medical devices using hyperspectral imaging method

Science.gov (United States)

Kim, Do-Hyun; Kim, Moon S.; Hwang, Jeeseong

2012-03-01

Contamination of the inner surface of indwelling (implanted) medical devices by microbial biofilm is a serious problem. Some microbial bacteria such as Escherichia coli form biofilms that lead to potentially lifethreatening infections. Other types of medical devices such as bronchoscopes and duodenoscopes account for the highest number of reported endoscopic infections where microbial biofilm is one of the major causes for these infections. We applied a hyperspectral imaging method to detect biofilm contamination on the surface of several common materials used for medical devices. Such materials include stainless steel, titanium, and stainless-steeltitanium alloy. Potential uses of hyperspectral imaging technique to monitor biofilm attachment to different material surfaces are discussed.

The Paperwork Pile-Up: Measuring the Burden of Charter School Applications

Science.gov (United States)

McShane, Michael Q.; Hatfield, Jenn; English, Elizabeth

2015-01-01

In 1988, Albert Shanker, head of the United Federation of Teachers, suggested that small groups of teachers could design charter (performance-based)schools as alternatives to local public schools. In theory, charter school teachers would be held in check by a performance contract but would be otherwise free from rules, norms, and regulations that…

State of the art of medical devices featuring smart electro-rheological and magneto-rheological fluids

Directory of Open Access Journals (Sweden)

Jong-Seok Oh

2017-10-01

Full Text Available Recently, smart fluids have drawn significant attention and growing a great interest in a broad range of engineering applications such as automotive and medical areas. In this article, two smart fluids called electro-rheological (ER fluid and magneto-rheological (MR fluid are reviewed in terms of medical applications. Especially, this article describes the attributes and inherent properties of individual medical and rehabilitation devices. The devices surveyed in this article include multi-degree-of-freedom haptic masters for robot surgery, thin membrane touch panels for braille readers, sponge-like tactile sensors to feel human tissues such as liver, rehabilitation systems such as prosthetic leg, and haptic interfaces for dental implant surgery. The operating principle, inherent characteristics and practical feasibility of each medical device or system are fully discussed in details.

Practical design control implementation for medical devices

CERN Document Server

Justiniano, Jose

2003-01-01

Bringing together the concepts of design control and reliability engineering, this book is a must for medical device manufacturers. It helps them meet the challenge of designing and developing products that meet or exceed customer expectations and also meet regulatory requirements. Part One covers motivation for design control and validation, design control requirements, process validation and design transfer, quality system for design control, and measuring design control program effectiveness. Part Two discusses risk analysis and FMEA, designing-in reliability, reliability and design verific

Medical Device Plug-and-Play Interoperability Standards and Technology Leadership

Science.gov (United States)

2016-10-01

death,” The Boston Globe, April 3 2010. 27. Arney D, Pajic M, Goldman JM, Lee I, Mangharam R, Sokolsky O, “Toward Patient Safety in Closed - Loop Medical ...becoming increasingly clear. We have been providing medical device interoperability domain expertise to assist the Veterans Administration in a...15. Wallroth C, Goldman J, Manigel J, Osborn D, Roellike T, Weininger S, Westenskow D, “Development of a Standard for Physiologic Closed Loop

Remote Access: A Vision for Mobile Medical Devices

Directory of Open Access Journals (Sweden)

Herbert Ernst

2005-11-01

Full Text Available During the Symposium for Remote Engineering and Virtual Instrumentation held at Brasov in early July 2005 an outlook was presented regarding the future potential of remote engineering for mobile medical devices. It is the intention of this article to recapitulate the content of the initiated discussions and to stimulate work in this complex and until now largely neglected field of application.

How does the knowledge environment shape procurement practices for orthopaedic medical devices in Mexico?

Science.gov (United States)

Lingg, Myriam; Wyss, Kaspar; Durán-Arenas, Luis

2016-07-08

In organisational theory there is an assumption that knowledge is used effectively in healthcare systems that perform well. Actors in healthcare systems focus on managing knowledge of clinical processes like, for example, clinical decision-making to improve patient care. We know little about connecting that knowledge to administrative processes like high-risk medical device procurement. We analysed knowledge-related factors that influence procurement and clinical procedures for orthopaedic medical devices in Mexico. We based our qualitative study on 48 semi-structured interviews with various stakeholders in Mexico: orthopaedic specialists, government officials, and social security system managers or administrators. We took a knowledge-management related perspective (i) to analyse factors of managing knowledge of clinical procedures, (ii) to assess the role of this knowledge and in relation to procurement of orthopaedic medical devices, and (iii) to determine how to improve the situation. The results of this study are primarily relevant for Mexico but may also give impulsion to other health systems with highly standardized procurement practices. We found that knowledge of clinical procedures in orthopaedics is generated inconsistently and not always efficiently managed. Its support for procuring orthopaedic medical devices is insufficient. Identified deficiencies: leaders who lack guidance and direction and thus use knowledge poorly; failure to share knowledge; insufficiently defined formal structures and processes for collecting information and making it available to actors of health system; lack of strategies to benefit from synergies created by information and knowledge exchange. Many factors are related directly or indirectly to technological aspects, which are insufficiently developed. The content of this manuscript is novel as it analyses knowledge-related factors that influence procurement of orthopaedic medical devices in Mexico. Based on our results we

Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey

Directory of Open Access Journals (Sweden)

Ross JS

2015-05-01

Full Text Available Joseph S Ross, Katrina L Blount, Jessica D Ritchie, Beth Hodshon, Harlan M Krumholz Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA Background: In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA pathway. Methods and results: We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%, nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Conclusion: Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives. Keywords: FDA, PMA pathway, post-market surveillance

21 CFR 801.125 - Medical devices for use in teaching, law enforcement, research, and analysis.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices for use in teaching, law enforcement, research, and analysis. 801.125 Section 801.125 Food and Drugs FOOD AND DRUG ADMINISTRATION... Directions for Use § 801.125 Medical devices for use in teaching, law enforcement, research, and analysis. A...

[Radiotherapy and implantable medical device: example of infusion pumps].

Science.gov (United States)

Abrous-Anane, S; Benhassine, S; Lopez, S; Cristina, K; Mazeron, J-J

2013-12-01

Indication for radiotherapy is often questioned for patients equipped with implantable medical devices like infusion pumps as the radiation tolerance is poor or not known. We report here on the case of a patient who we treated with pelvic radiotherapy for cervical cancer and who had an infusion pump in iliac fossa. We conducted a series of tests on five identical pumps that insured that the treatment protocol is harmless to the implanted device. Copyright © 2013 Société française de radiothérapie oncologique (SFRO). Published by Elsevier SAS. All rights reserved.

A prospective window into medical device-related pressure ulcers in intensive care.

Science.gov (United States)

Coyer, Fiona M; Stotts, Nancy A; Blackman, Virginia Schmied

2014-12-01

The aim of this study was to determine the prevalence, severity, location, aetiology, treatment and healing of medical device-related pressure ulcers (PUs) in intensive care patients for up to 7 days. A prospective repeated measures study design was used. Patients in six intensive care units of two major medical centres, one each in Australia and the USA, were screened 1 day per month for 6 months. Those with device-related ulcers were followed daily for up to 7 days. The outcome measures were device-related ulcer prevalence, pain, infection, treatment and healing. Fifteen of 483 patients had device-related ulcers and 9 of 15 with 11 ulcers were followed beyond screening. Their mean age was 60·5 years, and most were men, overweight and at increased risk of PU. Endotracheal (ET) and nasogastric (NG) tubes were the cause of most device-related ulcers. Repositioning was the most frequent treatment. Four of 11 ulcers healed within the 7-day observation period. In conclusion, device-related ulcer prevalence was 3·1%, similar to that reported in the limited literature available, indicating an ongoing problem. Systematic assessment and repositioning of devices are the mainstays of care. We recommend continued prevalence determination and that nurses remain vigilant to prevent device-related ulcers, especially in patients with NG and ET tubes. © 2013 The Authors. International Wound Journal © 2013 Medicalhelplines.com Inc and John Wiley & Sons Ltd.

On-line integration of computer controlled diagnostic devices and medical information systems in undergraduate medical physics education for physicians.

Science.gov (United States)

Hanus, Josef; Nosek, Tomas; Zahora, Jiri; Bezrouk, Ales; Masin, Vladimir

2013-01-01

We designed and evaluated an innovative computer-aided-learning environment based on the on-line integration of computer controlled medical diagnostic devices and a medical information system for use in the preclinical medical physics education of medical students. Our learning system simulates the actual clinical environment in a hospital or primary care unit. It uses a commercial medical information system for on-line storage and processing of clinical type data acquired during physics laboratory classes. Every student adopts two roles, the role of 'patient' and the role of 'physician'. As a 'physician' the student operates the medical devices to clinically assess 'patient' colleagues and records all results in an electronic 'patient' record. We also introduced an innovative approach to the use of supportive education materials, based on the methods of adaptive e-learning. A survey of student feedback is included and statistically evaluated. The results from the student feedback confirm the positive response of the latter to this novel implementation of medical physics and informatics in preclinical education. This approach not only significantly improves learning of medical physics and informatics skills but has the added advantage that it facilitates students' transition from preclinical to clinical subjects. Copyright © 2011 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

Innovative medical devices and hospital decision making: a study comparing the views of hospital pharmacists and physicians.

Science.gov (United States)

Billaux, Mathilde; Borget, Isabelle; Prognon, Patrice; Pineau, Judith; Martelli, Nicolas

2016-06-01

Objectives Many university hospitals have developed local health technology assessment processes to guide informed decisions about new medical devices. However, little is known about stakeholders' perceptions and assessment of innovative devices. Herein, we investigated the perceptions regarding innovative medical devices of their chief users (physicians and surgeons), as well as those of hospital pharmacists, because they are responsible for the purchase and management of sterile medical devices. We noted the evaluation criteria used to assess and select new medical devices and suggestions for improving local health technology assessment processes indicated by the interviewees. Methods We randomly selected 18 physicians and surgeons (nine each) and 18 hospital pharmacists from 18 French university hospitals. Semistructured interviews were conducted between October 2012 and August 2013. Responses were coded separately by two researchers. Results Physicians and surgeons frequently described innovative medical devices as 'new', 'safe' and 'effective', whereas hospital pharmacists focused more on economic considerations and considered real innovative devices to be those for which no equivalent could be found on the market. No significant difference in evaluation criteria was found between these groups of professionals. Finally, hospital pharmacists considered the management of conflicts of interests in local health technology assessment processes to be an issue, whereas physicians and surgeons did not. Conclusions The present study highlights differences in perceptions related to professional affiliation. The findings suggest several ways in which current practices for local health technology assessment in French university hospitals could be improved and studied. What is known about the topic? Hospitals are faced with ever-growing demands for innovative and costly medical devices. To help hospital management deal with technology acquisition issues, hospital

75 FR 12328 - Application of Charter Air Transport, Inc. for Commuter Authority

Science.gov (United States)

2010-03-15

... DEPARTMENT OF TRANSPORTATION Office of the Secretary Application of Charter Air Transport, Inc... interested persons to show cause why it should not issue an order finding Charter Air Transport, Inc., fit, willing, and able, and awarding it Commuter Air Carrier Authorization. DATES: Persons wishing to file...

Utilizing national and international registries to enhance pre-market medical device regulatory evaluation.

Science.gov (United States)

Yue, Lilly Q; Campbell, Gregory; Lu, Nelson; Xu, Yunling; Zuckerman, Bram

2016-01-01

Regulatory decisions are made based on the assessment of risk and benefit of medical devices at the time of pre-market approval and subsequently, when post-market risk-benefit balance needs reevaluation. Such assessments depend on scientific evidence obtained from pre-market studies, post-approval studies, post-market surveillance studies, patient perspective information, as well as other real world data such as national and international registries. Such registries provide real world evidence and are playing a more and more important role in enhancing the safety and effectiveness evaluation of medical devices. While these registries provide large quantities of data reflecting real world practice and can potentially reduce the cost of clinical trials, challenges arise concerning (1) data quality adequate for regulatory decision-making, (2) bias introduced at every stage and aspect of study, (3) scientific validity of study designs, and (4) reliability and interpretability of study results. This article will discuss related statistical and regulatory challenges and opportunities with examples encountered in medical device regulatory reviews.

CORPORATE GOVERNANCE, CHARTER VALUE, TIPE KEPEMILIKAN, DAN PENGAMBILAN RISIKO PERBANKAN DI INDONESIA

Directory of Open Access Journals (Sweden)

Hikmatul Fitri

2016-01-01

Full Text Available Penelitian ini menguji pengaruh corporate governance dan charter value terhadap pengambilan risiko perbankan pada bank yang terdaftar di Bursa Efek Indonesia periode 20042013. Jenis data dalam penelitian ini adalah data panel tidak berimbang. Corporate governance diukur dengan jumlah komisaris, persentase komisaris independen, kualitas manajemen risiko, dan jumlah rapat gabungan komisari dan direksi per tahun. Charter value diukur dengan Tobins’Q. Proksi pengambilan risiko yang digunakan adalah berdasarkan data pasar saham (market based measure dan data akuntansi (accounting based measure. Hasil penelitian ini menunjukkan bahwa corporate governance dan charter value mampu mendisiplinkan pengambilan risiko perbankan. Kepemilikan asing dan domestik sebagai ultimate shareholder di suatu bank, tidak menunjukkan perbedaan terkait pengambilan risiko mereka. Kedua kelompok kepemilikan tersebut menginginkan return yang lebih tinggi. Hasil penelitian ini juga menunjukkan bahwa pengambilan risiko yang dilakukan oleh pihak manajemen bank lebih tercermin dalam pengukuran risiko berdasarkan data akuntansi, karena pengukuran tersebut memberikan hasil yang lebih konsisten.Kata kunci: corporate governance, charter value, tipe kepemilikan, pengambilan risiko, z-score

European Energy Charter. ; Status of basic agreement negotiation. Oshu energy kensho; Kihon kyotei kosho no jokyo

Energy Technology Data Exchange (ETDEWEB)

Ijuin, T. (Agency of Natural Resources and Energy, Tokyo (Japan))

1993-02-10

From its title, the European Energy Charter has tended to lead to a misunderstanding that it is an European framework. However, a first expanded European Energy Charter meeting was held where the charter was established as an international framework. An article in the Charter calls for continuing a discussion on a basic agreement to be used as an international treaty and protocols by areas. The Charter text itself that has no legal binding power has been agreed by more than 40 charter participating nations based on the draft prepared by EC. However, no consensus has been reached on the negotiation for the basic agreement that has a legal binding power and the protocols in several important points. The basic agreement is a multi-national treaty specifying basic rules important in leading the former Soviet Union and East European nations to market economy and promoting energy development utilizing the investments from private sectors in the West. This paper describes the investment liberalization and investor protection, consistency with GATT, and its influence to the energy industries when Japan has joined the charter as a member nation.

Biofilm eradication and prevention: a pharmaceutical approach to medical device infections

National Research Council Canada - National Science Library

Shunmugaperumal, Tamilvanan

2010-01-01

"Biofilm Eradication and Preventions presents the basics of biofilm formation on medical devices, diseases related to this formation, and approaches pharmaceutical researchers need to take to limit this problem...

International Charter "Space and Major Disasters": Typical Examples of Disaster Management Including Asian Tsunami

Science.gov (United States)

Cubero-Castan, Eliane; Bequignon, Jerome; Mahmood, Ahmed; Lauritson, Levin; Soma, P.; Platzeck, Gabriel; Chu, Ishida

2005-03-01

The International Charter 'Space and Major Disaster', now entering its 5th year of operation, has been activated nearly 80 times to provide space-based data and information in response to natural disasters. The disasters ranged from volcanic eruption in Columbia, floods in Europe, Argentina, Sudan to earthquakes in Iran, from landslides in Philippines to the tragic tsunami in Asia, all resulting in major loss of life and property. The Charter provided imagery and the related information were found to be useful in disaster relief and assessment. Since July 1st 2003, a framework cooperation agreement has been allowing United Nations organizations involved in disaster response to request activation of the Charter.The purpose of the Charter is to provide assistance in situations of emergencies caused by natural and technological disasters by pooling together the space and associated ground resources of the Charter participants, which are currently the European (ESA), French (CNES), Canadian (CSA), Indian (ISRO), American (NOAA), Argentinean (CONAE) and Japanese (JAXA) space organizations.This paper will point out some of the best cases of Charter activation for different disasters leading to change detection imagery and damage assessment products which could be used for disaster reduction in close co-ordination with the end users after the crisis period.

Commercial viability of medical devices using Headroom and return on investment calculation

NARCIS (Netherlands)

Markiewicz, Katarzyna; van Til, Janine Astrid; Steuten, Lotte Maria Gertruda; IJzerman, Maarten Joost

2016-01-01

The market success of a medical product depends on its commercial viability, yet this may be hard to predict during the development process of medical devices. This paper aims to determine if applying the Headroom method combined with return on investment (ROI) analysis allows for estimation of the

76 FR 34845 - Medical Devices; Ear, Nose, and Throat Devices; Classification of the Wireless Air-Conduction...

Science.gov (United States)

2011-06-15

... control by other users with a similar medical device. Exposure to non-ionizing radiation Wireless... relating to EMC and wireless technology and human exposure to non-ionizing radiation. Therefore, on March... electro magnetic compatibility (EMC) and safety of exposure to non-ionizing radiation; (2) Design...

Review of "Charter-School Management Organizations: Diverse Strategies and Diverse Student Impacts"

Science.gov (United States)

Fuller, Bruce

2012-01-01

This report details how charter schools are increasingly run by private, nonprofit management organizations called charter school management organizations (CMOs). The researchers find that most CMOs serve urban students from low-income families, operate small schools that offer more instructional time, and attract teachers loyal to each school's…

Examining Charter School Policy and Public School District Resource Allocation in Ohio

Science.gov (United States)

Linick, Matthew A.

2016-01-01

This project focuses on the competitive pressure, or the threat of competitive pressure, generated by charter school policy. This paper uses longitudinal district-level data and multiple quasi-experimental designs to examine the relationship between two Ohio charter school policies and changes in public school district instructional resource…

Closed-loop approach for situation awareness of medical devices and operating room infrastructure

Directory of Open Access Journals (Sweden)

Rockstroh Max

2015-09-01

Full Text Available In recent years, approaches for information and control integration in the digital operating room have emerged. A major step towards an intelligent operating room and a cooperative technical environment would be autonomous adaptation of medical devices and systems to the surgical workflow. The OR staff should be freed from information seeking and maintenance tasks. We propose a closed-loop concept integrating workflow monitoring, processing and (semi-automatic interaction to bridge the gap between OR integration of medical devices and workflow-related information management.

Hawaii Charter Fishing Cost Earnings Survey 2012

Data.gov (United States)

National Oceanic and Atmospheric Administration, Department of Commerce — These data represent a cost-earnings study of the main Hawaiian Island Charter fishing fleet in 2012. Data collected include fisher classification, vessel...

Why Not Charter School Boards?

Science.gov (United States)

Schlechty, Phillip C.; Cole, Robert W.

1993-01-01

Claiming that individual school board members act in selfish ways, proposes electing entire school board as a slate. Board would collectively be held responsible for performance of the school system and all of its employees. State legislation would be required to specify how interested groups would select a slate and create a charter, which is the…

78 FR 72600 - Proposed Priorities, Requirements, and Definitions-Charter Schools Program (CSP) Grants for...

Science.gov (United States)

2013-12-03

... financial assistance for the planning, program design, and initial implementation of charter schools; (2.... Charter schools are explicitly designed to have the autonomy to employ innovative, promising [[Page 72601

Mobile Devices, Learning and Clinical Workplaces: Medical Student Use of Smartphones in Parisian Hospitals

Science.gov (United States)

Phelps, Megan; Scott, Karen M.; Chauffeté-Manillier, Martine; Lenne, Frédéric; Le Jeunne, Claire

2017-01-01

Mobile devices are ubiquitous worldwide, including in hospitals. "Just in time" learning provided by these devices is important for students. We investigated current use of, and learning with, smartphones and other mobile devices by medical students in Parisian hospitals. A survey with quantitative and qualitative items previously used…

Microbiological Load Of Ethylene Oxide Sterilized Medical Devices And Its Elimination By Cobalt 60 Source

International Nuclear Information System (INIS)

Bashir, R.; Afroze, B.; Zulfiqar, H. F.; Saleem, R.; Saleem, F.; Aslam, F.; Naz, S.

2016-01-01

Objective: To determine the residing microbial flora of ethylene oxide (EtO) sterilized medical devices and optimization of safe dose of gamma radiation (Cobalt 60 source) for the complete elimination of microbial load. Study Design: Experimental study. Place and Duration of Study: Department of Biotechnology, Lahore College for Women University, Lahore, Pakistan from September 2014 to June 2015. Methodology: Thirty-six samples of EtO sterilized medical devices of same batch of three different companies were collected for this study. Isolation and enumeration of microbes were done by using different selective and differential media. Gram staining and biochemically characterization by API 20 (Bio Merieux, France) kit was done for identification of the microorganisms. The medical devices having high microbial load were sent to Pakistan Radiation Services (PARAS) for gamma irradiations at 3 different selected doses (20 KGy, 25 KGy, and 30 KGy). Result: Different types of Gram positive bacteria (Staphylococcus epidermidis, Staphylococcus aureus and Bacillus subtilis) were isolated from the EtO sterilized samples. Gram negative bacteria and fungi were not detected on these medical devices. Gamma irradiations Result showed that 30 KGy was optimized dose for complete elimination of microbial flora on endotracheal, Nelaton, and tracheostomy tubes. Conclusion: Gamma radiations (Co 60 source) effectively decontaminate the microbial flora on the equipment previously sterilized by the ethylene oxide gas; and 30 KGy is the optimized dose for all these medical devices. (author)

Characterization of Bacterial Etiologic Agents of Biofilm Formation in Medical Devices in Critical Care Setup

Directory of Open Access Journals (Sweden)

Sangita Revdiwala

2012-01-01

Full Text Available Background. Biofilms contaminate catheters, ventilators, and medical implants; they act as a source of disease for humans, animals, and plants. Aim. Critical care units of any healthcare institute follow various interventional strategies with use of medical devices for the management of critical cases. Bacteria contaminate medical devices and form biofilms. Material and Methods. The study was carried out on 100 positive bacteriological cultures of medical devices which were inserted in hospitalized patients. The bacterial isolates were processed as per microtitre plate. All the isolates were subjected to antibiotic susceptibility testing by VITEK 2 compact automated systems. Results. Out of the total 100 bacterial isolates tested, 88 of them were biofilm formers. A 16–20-hour incubation period was found to be optimum for biofilm development. 85% isolates were multidrug resistants and different mechanisms of bacterial drug resistance like ESBL, carbapenemase, and MRSA were found among isolates. Conclusion. Availability of nutrition in the form of glucose enhances the biofilm formation by bacteria. Time and availability of glucose are important factors for assessment of biofilm progress. It is an alarm for those who are associated with invasive procedures and indwelling medical devices especially in patients with low immunity.

An evaluation of adherence to the patient's rights charter among patients and physicians at the emergency department of Imam Khomeini Hospital, Tehran

Directory of Open Access Journals (Sweden)

Seyyed Hassan Emami Razavi

2006-03-01

Full Text Available It is the cherished goal of the health care providers to observe the patient rights. An official order to install the patient rights charter in all crowded places of hospitals motivated us to evaluate the patient rights both from the patients' and resident points of view. "nThis is a descriptive survey with cross-sectional method. The research was conducted to examine the patients and residents awareness of the contents of "Patients' Rights Charter" in emergency department of Imam Khomeini hospital in Tehran and their views on the adherence of the cares to the articles of the charter. 140 patients and 70 residents were chosen by simple randomized method by Cochrane formula and the data was gathered by questionnaires. "n57.9% of patients were not aware of this announcement. 78% of patients believed that patients' rights is being carried out relatively. 88.6% of residents believed that they complied with the rights of patients. The patients were relatively satisfied with the nursing cares, medical services and hospital equipments (69% were satisfied with availability of physicians in necessary situations, 47% satisfied with the nursing cares and 93.6% satisfied with the hospital equipments."nTwo years after installation of the charter, patients and residents awareness of installation were low. According to the patient views, patients' rights were relatively adhered. Unawareness of patients of their rights may limit their expectations from physicians and if they become aware of the contents of charter, their satisfaction from current situation may alter.

Hopes, Fears, & Reality: A Balanced Look at American Charter Schools in 2006

Science.gov (United States)

Lake, Robin J., Ed.; Hill, Paul T., Ed.

2006-01-01

This is the second annual report from the National Charter School Research Project (NCSRP) at the University of Washington's Center on Reinventing Public Education. Like last year's debut edition of Hopes, Fears, & Reality, the 2006 volume explores some of the most current and controversial issues facing the charter school movement. This…

Medical and welfare device session. Toward medical treatment and welfare of tomorrow; Iryo fukushi kiki session. Ashita no iryo fukushi ni mukete

Energy Technology Data Exchange (ETDEWEB)

NONE

2000-09-01

This paper is the material distributed in the medical and welfare device session held under the auspices of NEDO in September 2000. Diversification of needs in the medical and welfare areas and handling of age advancement are the growing issue. NEDO is putting efforts toward enhancement of quality of life (QOL) and realization of the nation with great life by providing high-quality and high-efficiency medical and welfare services. The NEDO's efforts cover the areas of treating adult diseases such as cancers and cardiac diseases whose seriousness is growing, early diagnoses of diseases, medical treatment with low invasion, elderly people helping, reduction of helpers' burden, reduction of handicaps to elderly people and mentally and physically handicapped persons, and assistance to participation in the society. To achieve these goals, NEDO is implementing the following four projects: research and development of medical and welfare device technologies, researches of medical science and engineering collaboration type, and promotion of developing welfare techno-systems and practical application of welfare appliances. Developments are being made toward practical application of medical and welfare devices with excellent safety and convenience, of low cost and high performance. The session gave the keynote addresses related to medical treatment and prevention of brain diseases; brain, the universe and MRI (the world of mind as seen in images), and high-tech medical treatments to protect brain (challenge to brain that starts now). (NEDO)

Charter school education in Texas: Student achievement on the exit level assessment in math and science

Science.gov (United States)

Turner, Jeffery E.

Public schools in the state of Texas are held accountable for performance and quality of education. Accountability is important to all schools, but it is critical to open-enrollment charter schools to remain in good standing. The current economic situation in Texas public education has brought attention as well as the need for alternative education programs such as charter schools. It is of the utmost importance for charter schools to illustrate that they are meeting the academic needs of the target market. This study addressed student achievement, as well as expenditure per student in both charter schools and traditional schools in the Region 10 educational service center. The datum for the study were obtained from the Texas Education Agency (TEA) website, specifically the Academic Excellence Indicator System Data (AEIS) files for the 2011-2012. The study sample included 30 open-enrollment charters schools and 30 traditional high schools within the Region 10 educational service center during the school year of 2011-2012. The research study determined significant statistical differences between open-enrollment charter schools and traditional high schools. The potential for the study was to gain additional knowledge and insight along with additional data for the open-enrollment charter schools and traditional schools in the Region 10 Educational Service Center. The study has potentially increased the information for researchers and practitioners in education. In addition this study has proved charter schools are a viable and an effective educational tool for the future.

Using Mobile Devices in Physical Education to Enhance Learning and Physical Activity for At-Risk Girls

Science.gov (United States)

Gibbone, Anne; Perez, Samantha L.; Virgilio, Stephen J.

2014-01-01

The purpose of the article is to illustrate how a physical education program uses mobile devices to motivate at-risk girls attending an urban charter school. Permitting students to use mobile devices in physical education gives students a "technological freedom" that has been removed in other contexts. The apps described in this article…

Analysis of liquid medication dose errors made by patients and caregivers using alternative measuring devices.

Science.gov (United States)

Ryu, Gyeong Suk; Lee, Yu Jeung

2012-01-01

Patients use several types of devices to measure liquid medication. Using a criterion ranging from a 10% to 40% variation from a target 5 mL for a teaspoon dose, previous studies have found that a considerable proportion of patients or caregivers make errors when dosing liquid medication with measuring devices. To determine the rate and magnitude of liquid medication dose errors that occur with patient/caregiver use of various measuring devices in a community pharmacy. Liquid medication measurements by patients or caregivers were observed in a convenience sample of community pharmacy patrons in Korea during a 2-week period in March 2011. Participants included all patients or caregivers (N = 300) who came to the pharmacy to buy over-the-counter liquid medication or to have a liquid medication prescription filled during the study period. The participants were instructed by an investigator who was also a pharmacist to select their preferred measuring devices from 6 alternatives (etched-calibration dosing cup, printed-calibration dosing cup, dosing spoon, syringe, dispensing bottle, or spoon with a bottle adapter) and measure a 5 mL dose of Coben (chlorpheniramine maleate/phenylephrine HCl, Daewoo Pharm. Co., Ltd) syrup using the device of their choice. The investigator used an ISOLAB graduated cylinder (Germany, blue grad, 10 mL) to measure the amount of syrup dispensed by the study participants. Participant characteristics were recorded including gender, age, education level, and relationship to the person for whom the medication was intended. Of the 300 participants, 257 (85.7%) were female; 286 (95.3%) had at least a high school education; and 282 (94.0%) were caregivers (parent or grandparent) for the patient. The mean (SD) measured dose was 4.949 (0.378) mL for the 300 participants. In analysis of variance of the 6 measuring devices, the greatest difference from the 5 mL target was a mean 5.552 mL for 17 subjects who used the regular (etched) dosing cup and 4

Biomaterials in medical devices: an interview with Jörg Vienken of Fresenius Medical Care, Germany.

Science.gov (United States)

Vienken, Jörg

2012-06-01

Biomaterial and biopolymer research have significant impact on the development as well as application of biotechnology. Biotechnology Journal recently attended the "Nanomaterials for Biomedical Technologies 2012" conference. We were privileged to have the opportunity to ask Prof. Dr. Jörg Vienken, VP of BioSciences at Fresenius Medical Care, a few questions relating to medical devices, the importance of publishing for industry, and also his advice for young scientists/engineers looking for a career in industry. Copyright © 2012 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Medical applications of superconducting quantum interference devices

International Nuclear Information System (INIS)

Uehara, Gen

2011-01-01

SQUIDs (Superconducting Quantum Interference Devices) are applied to clinical areas and basic medical science fields because of their potential for measuring a minute magnetic signal from the human body. Magnetoencephalography, one of their applications, is used for the functional mapping of the brain cortex before surgery and the localization of focus of epilepsy. Recently, their applications to the early-stage detection of dementia and the localization of brain ischemia are suggested. Another application of SQUIDs is magnetospinography, which detects the conduction block in spinal cord signal propagation. (author)

Design controls for the medical device industry

CERN Document Server

Teixeira, Marie B

2013-01-01

The second edition of a bestseller, Design Controls for the Medical Device Industry provides a comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure your company's design control program evolves in accordance with current industry practice. The text assists in the development of an effective design control program that not only satisfies the US FDA Quality System Regulation (QSR) and ISO 9001 and 13485 standards, but also meets today's third-party auditor/investigator expectations and saves you valuable time and money.The author's cont

Consequences of team charter quality: Teamwork mental model similarity and team viability in engineering design student teams

Science.gov (United States)

Conway Hughston, Veronica

Since 1996 ABET has mandated that undergraduate engineering degree granting institutions focus on learning outcomes such as professional skills (i.e. solving unstructured problems and working in teams). As a result, engineering curricula were restructured to include team based learning---including team charters. Team charters were diffused into engineering education as one of many instructional activities to meet the ABET accreditation mandates. However, the implementation and execution of team charters into engineering team based classes has been inconsistent and accepted without empirical evidence of the consequences. The purpose of the current study was to investigate team effectiveness, operationalized as team viability, as an outcome of team charter implementation in an undergraduate engineering team based design course. Two research questions were the focus of the study: a) What is the relationship between team charter quality and viability in engineering student teams, and b) What is the relationship among team charter quality, teamwork mental model similarity, and viability in engineering student teams? Thirty-eight intact teams, 23 treatment and 15 comparison, participated in the investigation. Treatment teams attended a team charter lecture, and completed a team charter homework assignment. Each team charter was assessed and assigned a quality score. Comparison teams did not join the lecture, and were not asked to create a team charter. All teams completed each data collection phase: a) similarity rating pretest; b) similarity posttest; and c) team viability survey. Findings indicate that team viability was higher in teams that attended the lecture and completed the charter assignment. Teams with higher quality team charter scores reported higher levels of team viability than teams with lower quality charter scores. Lastly, no evidence was found to support teamwork mental model similarity as a partial mediator of the team charter quality on team viability

76 FR 18227 - Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of...

Science.gov (United States)

2011-04-01

...] Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting... comment period for the notice announcing a meeting of the Molecular and Clinical Genetics Panel (the panel... Clinical Genetics Panel of the Medical Devices Advisory Committee, and the opening of a public docket to...

High-risk medical devices, children and the FDA: regulatory challenges facing pediatric mechanical circulatory support devices.

Science.gov (United States)

Almond, Christopher S D; Chen, Eric A; Berman, Michael R; Less, Joanne R; Baldwin, J Timothy; Linde-Feucht, Sarah R; Hoke, Tracey R; Pearson, Gail D; Jenkins, Kathy; Duncan, Brian W; Zuckerman, Bram D

2007-01-01

Pediatric mechanical circulatory support is a critical unmet need in the United States. Infant- and child-sized ventricular assist devices are currently being developed largely through federal contracts and grants through the National Heart, Lung, and Blood Institute (NHLBI). Human testing and marketing of high-risk devices for children raises epidemiologic and regulatory issues that will need to be addressed. Leaders from the US Food and Drug Administration (FDA), NHLBI, academic pediatric community, and industry convened in January 2006 for the first FDA Workshop on the Regulatory Process for Pediatric Mechanical Circulatory Support Devices. The purpose was to provide the pediatric community with an overview of the federal regulatory process for high-risk medical devices and to review the challenges specific to the development and regulation of pediatric mechanical circulatory support devices. Pediatric mechanical circulatory support present significant epidemiologic, logistic, and financial challenges to industry, federal regulators, and the pediatric community. Early interactions with the FDA, shared appreciation of challenges, and careful planning will be critical to avoid unnecessary delays in making potentially life-saving devices available for children. Collaborative efforts to address these challenges are warranted.

"It's Our Best Choice Right Now": Exploring How Charter School Parents Choose

Science.gov (United States)

Villavicencio, Adriana

2013-01-01

One of the underlying premises of the charter school movement is that quality drives consumer choice. As educational consumers, parents are viewed as rational actors who, if given the choice, will select better performing school. In examining the choice processes of charter school parents, however, this study calls into question the extent to…

Software-Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health.

Science.gov (United States)

Ronquillo, Jay G; Zuckerman, Diana M

2017-09-01

Policy Points: Medical software has become an increasingly critical component of health care, yet the regulation of these devices is inconsistent and controversial. No studies of medical devices and software assess the impact on patient safety of the FDA's current regulatory safeguards and new legislative changes to those standards. Our analysis quantifies the impact of software problems in regulated medical devices and indicates that current regulations are necessary but not sufficient for ensuring patient safety by identifying and eliminating dangerous defects in software currently on the market. New legislative changes will further deregulate health IT, reducing safeguards that facilitate the reporting and timely recall of flawed medical software that could harm patients. Medical software has become an increasingly critical component of health care, yet the regulatory landscape for digital health is inconsistent and controversial. To understand which policies might best protect patients, we examined the impact of the US Food and Drug Administration's (FDA's) regulatory safeguards on software-related technologies in recent years and the implications for newly passed legislative changes in regulatory policy. Using FDA databases, we identified all medical devices that were recalled from 2011 through 2015 primarily because of software defects. We counted all software-related recalls for each FDA risk category and evaluated each high-risk and moderate-risk recall of electronic medical records to determine the manufacturer, device classification, submission type, number of units, and product details. A total of 627 software devices (1.4 million units) were subject to recalls, with 12 of these devices (190,596 units) subject to the highest-risk recalls. Eleven of the devices recalled as high risk had entered the market through the FDA review process that does not require evidence of safety or effectiveness, and one device was completely exempt from regulatory review

District-Charter Collaboration Grant Implementation: Findings from Teacher and Principal Surveys. Summary Brief

Science.gov (United States)

Richman, Scott; Burnett, Alyson; Dillon, Erin; Goble, Lisbeth; McCullough, Moira; Tuttle, Christina Clark

2016-01-01

In November 2012, the Bill & Melinda Gates Foundation invested in seven innovative district-charter partnerships with "the potential capacity and commitment to accelerate student college ready rates through deep collaboration and sharing of best practices" (District-Charter Collaboration Grant Request for Proposal). These…

75 FR 61761 - Renewal of Charter for the Chronic Fatigue Syndrome Advisory Committee

Science.gov (United States)

2010-10-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Renewal of Charter for the Chronic Fatigue Syndrome... renewal of the charter for the Chronic Fatigue Syndrome Advisory Committee (CFSAC). FOR FURTHER... research about the epidemiology and risk factors relating to chronic fatigue syndrome, and identifying...

77 FR 24690 - Exemplary Charter School Collaboration Awards; Proposed Definitions, Requirements, and Selection...

Science.gov (United States)

2012-04-25

... DEPARTMENT OF EDUCATION Exemplary Charter School Collaboration Awards; Proposed Definitions... definitions in section 5210 of the ESEA, which include the definition of charter school, we are proposing the... schools. (b) For non-tested grades and subjects: Alternative measures of student learning and performance...

Real-time volume rendering of digital medical images on an iOS device

Science.gov (United States)

Noon, Christian; Holub, Joseph; Winer, Eliot

2013-03-01

Performing high quality 3D visualizations on mobile devices, while tantalizingly close in many areas, is still a quite difficult task. This is especially true for 3D volume rendering of digital medical images. Allowing this would empower medical personnel a powerful tool to diagnose and treat patients and train the next generation of physicians. This research focuses on performing real time volume rendering of digital medical images on iOS devices using custom developed GPU shaders for orthogonal texture slicing. An interactive volume renderer was designed and developed with several new features including dynamic modification of render resolutions, an incremental render loop, a shader-based clipping algorithm to support OpenGL ES 2.0, and an internal backface culling algorithm for properly sorting rendered geometry with alpha blending. The application was developed using several application programming interfaces (APIs) such as OpenSceneGraph (OSG) as the primary graphics renderer coupled with iOS Cocoa Touch for user interaction, and DCMTK for DICOM I/O. The developed application rendered volume datasets over 450 slices up to 50-60 frames per second, depending on the specific model of the iOS device. All rendering is done locally on the device so no Internet connection is required.

47 CFR 95.1119 - Specific requirements for wireless medical telemetry devices operating in the 608-614 MHz band.

Science.gov (United States)

2010-10-01

... devices operating in the 608-614 MHz band. For a wireless medical telemetry device operating within the... 47 Telecommunication 5 2010-10-01 2010-10-01 false Specific requirements for wireless medical telemetry devices operating in the 608-614 MHz band. 95.1119 Section 95.1119 Telecommunication FEDERAL...

OpenICE medical device interoperability platform overview and requirement analysis.

Science.gov (United States)

Arney, David; Plourde, Jeffrey; Goldman, Julian M

2018-02-23

We give an overview of OpenICE, an open source implementation of the ASTM standard F2761 for the Integrated Clinical Environment (ICE) that leverages medical device interoperability, together with an analysis of the clinical and non-functional requirements and community process that inspired its design.

The U.S. Charter School Landscape: Extant Literature, Gaps in Research, and Implications for the U.S. Educational System

Science.gov (United States)

Gawlik, Marytza A.

2016-01-01

More than 20 years into the implementation of public charter schools, the U.S. experience can inform policymakers and others about how to achieve the best possible results through charter school policies. This paper describes the history and current state of the charter school movement, presents a conceptual model of the charter school system, and…

Lessons learned: mobile device encryption in the academic medical center.

Science.gov (United States)

Kusche, Kristopher P

2009-01-01

The academic medical center is faced with the unique challenge of meeting the multi-faceted needs of both a modern healthcare organization and an academic institution, The need for security to protect patient information must be balanced by the academic freedoms expected in the college setting. The Albany Medical Center, consisting of the Albany Medical College and the Albany Medical Center Hospital, was challenged with implementing a solution that would preserve the availability, integrity and confidentiality of business, patient and research data stored on mobile devices. To solve this problem, Albany Medical Center implemented a mobile encryption suite across the enterprise. Such an implementation comes with complexities, from performance across multiple generations of computers and operating systems, to diversity of application use mode and end user adoption, all of which requires thoughtful policy and standards creation, understanding of regulations, and a willingness and ability to work through such diverse needs.

21 CFR 801.1 - Medical devices; name and place of business of manufacturer, packer or distributor.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; name and place of business of manufacturer, packer or distributor. 801.1 Section 801.1 Food and Drugs FOOD AND DRUG ADMINISTRATION... § 801.1 Medical devices; name and place of business of manufacturer, packer or distributor. (a) The...

The future of the pharmaceutical, biological and medical device industry

Directory of Open Access Journals (Sweden)

Burgess LJ

2011-09-01

Full Text Available Lesley J Burgess, Marli TerblancheTREAD Research/Cardiology Unit, Department of Internal Medicine, Tygerberg Hospital and University of Stellenbosch, Parow, South AfricaAbstract: Numerous factors contribute to the declining pharmaceutical industry on the one hand and the rapidly growing generic industry together with the growing importance of medical devices and biologicals on the other. It is clear that the pharmaceutical industry is going to undergo a change in the next decade in order to meet the current challenges facing it and ultimately sustain its profitability and growth. This paper aims to identify a number of fairly obvious trends that are likely to have a significant impact on the product development pipeline in the next decade. It is more than clear that the current production pipeline for pharmaceutical, biotechnology and medical device industries is no longer sustainable and that urgent interventions are required in order to maintain its current level of profitability.Keywords: pharmaceutical industry, personalized medicine, trends, generics, biotechnology

Hydrophilic Polymer Embolism: Implications for Manufacturing, Regulation, and Postmarket Surveillance of Coated Intravascular Medical Devices.

Science.gov (United States)

Mehta, Rashi I; Mehta, Rupal I

2018-03-19

Hydrophilic polymers are ubiquitously applied as surface coatings on catheters and intravascular medical technologies. Recent clinical literature has heightened awareness on the complication of hydrophilic polymer embolism, the phenomenon wherein polymer coating layers separate from catheter and device surfaces, and may be affiliated with a range of unanticipated adverse reactions. Significant system barriers have limited and delayed reporting on this iatrogenic complication, the full effects of which remain underrecognized by healthcare providers and manufacturers of various branded devices. In 2015, the United States Food and Drug Administration acknowledged rising clinical concerns and stated that the agency would work with stakeholders to further evaluate gaps that exist in current national and international device standards for coated intravascular medical technologies. The present article reviews current knowledge on this complication as well as factors that played a role in delaying detection and dissemination of information and new knowledge once hazards and clinical risks were identified. Furthermore, organ-specific effects and adverse reaction patterns are summarized, along with implications for device manufacturing, safety assurance, and regulation. Qualitative and quantitative particulate testing are needed to optimize coated intravascular device technologies. Moreover, general enhanced processes for medical device surveillance are required for timely adverse event management and to ensure patient safety.

Value-based procurement of medical devices: Application to devices for mechanical thrombectomy in ischemic stroke.

Science.gov (United States)

Trippoli, Sabrina; Caccese, Erminia; Marinai, Claudio; Messori, Andrea

2018-03-01

In the acute ischemic stroke, endovascular devices have shown promising clinical results and are also likely to represent value for money, as several modeling studies have shown. Pharmacoeconomic evaluations in this field, however, have little impact on the procurement of these devices. The present study explored how complex pharmacoeconomic models that evaluate effectiveness and cost can be incorporated into the in-hospital procurement of thrombectomy devices. As regards clinical modeling, we extracted outcomes at three months from randomized trials conducted for four thrombectomy devices, and we projected long-term results using standard Markov modeling. In estimating QALYs, the same model was run for the four devices. As regards economic modeling, we firstly estimated for each device the net monetary benefit (NMB) per patient (threshold = $60,000 per QALY); then, we simulated a competitive tender across the four products by determining the tender-based score (on a 0-to-100 scale). Prices of individual devices were obtained from manufacturers. Extensive sensitivity testing was applied to our analyses. For the four devices (Solitaire, Trevo, Penumbra, Solumbra), QALYs were 1.86, 1.52, 1,79, 1.35, NMB was $101,824, $83,546, $101,923, $69,440, and tender-based scores were 99.70, 43.43, 100, 0, respectively. Sensitivity analysis confirmed findings from base-case. Our results indicate that, in the field of thrombectomy devices, incorporating the typical tools of cost-effectiveness into the processes of tenders and procurement is feasible. Bridging the methodology of cost-effectiveness with the every-day practice of in-hospital procurement can contribute to maximizing the health returns that are generated by in-hospital expenditures for medical devices. Copyright © 2018 Elsevier B.V. All rights reserved.

Financial Management of New York's Charter Schools: A Normative, Descriptive, and Prescriptive Analysis

Science.gov (United States)

Brent, Brian O.; Finnigan, Kara S.

2009-01-01

Surprisingly little is known about the financial management practices of charter schools. The literature offer policymakers only anecdotal answers to the following important questions: Who manages charter school finances and what educational and previous employment experiences do they bring to their positions? What do audited financial statements…

Polymer coating embolism from intravascular medical devices - a clinical literature review.

Science.gov (United States)

Chopra, Amitabh M; Mehta, Monik; Bismuth, Jean; Shapiro, Maksim; Fishbein, Michael C; Bridges, Alina G; Vinters, Harry V

Over the past three decades, lubricious (hydrophobic and/or hydrophilic) polymer-coated devices have been increasingly adopted by interventional physicians and vascular surgeons to access and treat a wider range of clinical presentations. Recent clinical literature highlights the presence of polymer coating emboli within the anatomy - a result of coating separation from an intravascular device - and associates it with a range of adverse clinical sequelae. The 2015 U.S. Food and Drug Administration safety communication titled "Lubricious Coating Separation from Intravascular Medical Devices" acknowledges these concerns and concludes that it will work with stakeholders to develop nonclinical test methodologies, establish performance criteria, and identify gaps in current national and international device standards for coating integrity performance. Despite this communication and multiple case reports from interventional physicians, pathologists, dermatologists and other involved physician specialties, polymer coating embolism remains clinically underrecognized. This article consolidates the available literature on polymer coating embolism (1986-2016) and highlights the following relevant information for the physician: (a) the history and elusive nature of polymer coating embolism; (b) potential incidence rates of this phenomenon; (c) reported histologic findings and clinical effects of polymer emboli in the anatomy; (d) the importance of the collaborative clinician-pathologist partnership to report polymer embolism findings; and (e) the importance to study particulate release from intravascular devices so as to further understand and potentially evolve coated interventional technologies. Preliminary research on coatings highlights the potential of using iterations of coatings on medical devices that attain the desired therapeutic result and mitigate or eliminate particulates altogether. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.