Case outsourcing medical device reprocessing.

Science.gov (United States)

Haley, Deborah

2004-04-01

IN THE INTEREST OF SAVING MONEY, many hospitals are considering extending the life of some single-use medical devices by using medical device reprocessing programs. FACILITIES OFTEN LACK the resources required to meet the US Food and Drug Administration's tough quality assurance standards. BY OUTSOURCING, hospitals can reap the benefits of medical device reprocessing without assuming additional staffing and compliance burdens. OUTSOURCING enables hospitals to implement a medical device reprocessing program quickly, with no capital investment and minimal effort.

Medical device-related pressure ulcers

Directory of Open Access Journals (Sweden)

Black JM

2016-08-01

Full Text Available Joyce M Black,1 Peggy Kalowes2 1Adult Health and Illness Department, College of Nursing, University of Nebraska Medical Center, Omaha, NE, 2Nursing Research and Innovation, Long Beach Memorial Miller Children’s & Women’s Hospital, Long Beach, CA, USA Abstract: Pressure ulcers from medical devices are common and can cause significant morbidity in patients of all ages. These pressure ulcers appear in the shape of the device and are most often found from the use of oxygen delivery devices. A hospital program designed to reduce the number of pressure ulcers from medical devices was successful. The program involved the development of a team that focused on skin, the results were then published for the staff to track their performance, and it was found that using foam dressings helped reduce the pressure from the device. The incidence of ulcers from medical devices has remained at zero at this hospital since this program was implemented. Keywords: pressure ulcer, medical device related

Human Factors and Medical Devices

International Nuclear Information System (INIS)

Dick Sawyer

1998-01-01

Medical device hardware- and software-driven user interfaces should be designed to minimize the likelihood of use-related errors and their consequences. The role of design-induced errors in medical device incidents is attracting widespread attention. The U.S. Food and Drug Administration (FDA) is fully cognizant that human factors engineering is critical to the design of safe medical devices, and user interface design is receiving substantial attention by the agency. Companies are paying more attention to the impact of device design, including user instructions, upon the performance of those health professionals and lay users who operate medical devices. Concurrently, the FDA is monitoring human factors issues in its site inspections, premarket device approvals, and postmarket incident evaluations. Overall, the outlook for improved designs and safer device operation is bright

[Medical Devices Law for pain therapists].

Science.gov (United States)

Regner, M; Sabatowski, R

2016-08-01

Medical Devices Law is a relatively new legal system, which has replaced the Medical Devices Regulations still well-known in Germany. German Medical Devices Law is based on European directives, which are, in turn, incorporated into national law by the Medical Devices Act. The Medical Devices Act is a framework law and covers a number of regulations that address specific topics within Medical Devices Law. In turn, in individual regulations, reference is made to guidelines, recommendations, etc. from other sources that provide detailed technical information on specific topics. Medical Devices Law is a very complex legal system, which needs to be permanently observed due to constant updating and adjustment. In the current article, the design and the structure of the system will be described, but special emphasis will be laid on important problem areas that need to be considered when applying and operating medical products, in this case by pain therapists in particular.

Disputed Memory

DEFF Research Database (Denmark)

, individual and political discourse and electronic social media. Analyzing memory disputes in various local, national and transnational contexts, the chapters demonstrate the political power and social impact of painful and disputed memories. The book brings new insights into current memory disputes...... in Central, Eastern and Southeastern Europe. It contributes to the understanding of processes of memory transmission and negotiation across borders and cultures in Europe, emphasizing the interconnectedness of memory with emotions, mediation and politics....... century in the region. Written by an international group of scholars from a diversity of disciplines, the chapters approach memory disputes in methodologically innovative ways, studying representations and negotiations of disputed pasts in different media, including monuments, museum exhibitions...

延边地区医疗纠纷相关情况调查%INVESTIGATION ON THE MEDICAL DISPUTES RELATIONSHIP IN YANBIAN AREA

Institute of Scientific and Technical Information of China (English)

张锦玉; 赵潇潇

2011-01-01

[Objective] To investigate occurrence and related factors of disputes in Yanbian.[Methods]With self-designed questionnaire we survey 358 physicians in Yanbian. [Results] There're no Significant difference between in general ho spitals and in specialty hospitals on medical dispute cases of doctors experienced (p＞0.05), but there'e significantdifferences with different gender age, title and profesional experience of the physicians in medical disputes rate (P ＜0.05).Physicians considered the main respo nsibility of medical disputes were both of physicians and patients, which mainly due to inadequate physician-patient communication (68.7％) , to mislead public opinion (64.8％) and too high dem anded of patients (51.4％) ; measures to ease the conflict would be to strengthen the doctor-patient communication (88.5％) , improve the health care system (69.8％), and improve the medical technology (56.4％). [Conclusion] Medical disputes was universality, which would be prevented through strengthening medical humanities education, enhancing effective physician-patient communication,establishing medical management system , standardizing medical practice and lechnology and so on.%[目的] 了解延边地区医疗纠纷发生情况及相关因素.[方法] 采用自行设计的问卷调查方式,对延边地区358名医务人员进行调查.[结果] 三级综合医院和二级专科医院的医务人员经历医疗纠纷的情况差异无统计学意义(P>0.05),不同的性别、年龄、职称和专业的医务人员经历医疗纠纷的情况差异均有统计学意义(P<0.05).医务人员认为医疗纠纷的责任主体是医患双方,其主要原因为医患交流不够(68.7%)、社会舆论误导(64.8%)和患方要求过高(51.4%),缓解医患冲突的措施为加强医患沟通(88.5%)、完善医疗制度(69.8%)、提高医疗技术(56.4%).[结论] 医疗纠纷的发生具有普遍性,应通过加强医生人文教育,增强医患有效沟通,建立医务管理体制,规范医疗操作技术等措施防范医疗纠纷的发生.

Basic concepts and issues: a primer on distribution and sales representative agreements in the medical device and durable medical equipment industries.

Science.gov (United States)

Burow, Heiko E; Kolls, Raymond C

2006-01-01

Counsel for a manufacturer of medical devices or durable medical equipment must have working knowledge of various legal disciplines to draft contracts with intermediaries (sales representatives and distributors) for the marketing and sale of the manufacturer's products. If the manufacturer wishes to sell its products abroad, counsel must become familiar with the laws and business practices of the target country, and methods of gaining access to the foreign market. This Article gives readers an overview of the applicable legal principles, under U.S. and foreign laws, in the areas of agency, contracts, healthcare regulation, consumer protection, intellectual property protection, and dealer protection. To aid counsel in drafting intermediary agreements, specific contractual terms and issues are explored in depth, including: appointment clauses, performance provisions, provisions concerning pricing and payment, protective clauses (shielding the manufacturer from liability), term and termination provisions, independent contractor clauses, export control clauses, recordkeeping and audit provisions, choice of law clauses, and dispute resolution clauses.

22 CFR 192.33 - Dispute.

Science.gov (United States)

2010-04-01

... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Dispute. 192.33 Section 192.33 Foreign Relations DEPARTMENT OF STATE HOSTAGE RELIEF VICTIMS OF TERRORISM COMPENSATION Medical Benefits for Captive... Director, Department of State, for a determination. If the person bringing the claim is not satisfied with...

Medical device software: defining key terms.

Science.gov (United States)

Pashkov, Vitalii; Gutorova, Nataliya; Harkusha, Andrii

one of the areas of significant growth in medical devices has been the role of software - as an integral component of a medical device, as a standalone device and more recently as applications on mobile devices. The risk related to a malfunction of the standalone software used within healthcare is in itself not a criterion for its qualification or not as a medical device. It is therefore, necessary to clarify some criteria for the qualification of stand-alone software as medical devices Materials and methods: Ukrainian, European Union, United States of America legislation, Guidelines developed by European Commission and Food and Drug Administration's, recommendations represented by international voluntary group and scientific works. This article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. the legal regulation of software which is used for medical purpose in Ukraine limited to one definition. In European Union and United States of America were developed and applying special guidelines that help developers, manufactures and end users to difference software on types standing on medical purpose criteria. Software becomes more and more incorporated into medical devices. Developers and manufacturers may not have initially appreciated potential risks to patients and users such situation could have dangerous results for patients or users. It is necessary to develop and adopt the legislation that will intend to define the criteria for the qualification of medical device software and the application of the classification criteria to such software, provide some illustrative examples and step by step recommendations to qualify software as medical device.

Medical devices regulations, standards and practices

CERN Document Server

Ramakrishna, Seeram; Wang, Charlene

2015-01-01

Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors' practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards. Provides readers with a global perspective on medical device regulationsConcise and comprehensive information on how to desig

21 CFR 892.2040 - Medical image hardcopy device.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical image hardcopy device. 892.2040 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical...

[Consideration of Mobile Medical Device Regulation].

Science.gov (United States)

Peng, Liang; Yang, Pengfei; He, Weigang

2015-07-01

The regulation of mobile medical devices is one of the hot topics in the industry now. The definition, regulation scope and requirements, potential risks of mobile medical devices were analyzed and discussed based on mobile computing techniques and the FDA guidance of mobile medical applications. The regulation work of mobile medical devices in China needs to adopt the risk-based method.

Surgical tools and medical devices

CERN Document Server

Jackson, Mark

2016-01-01

This new edition presents information and knowledge on the field of biomedical devices and surgical tools. The authors look at the interactions between nanotechnology, nanomaterials, design, modeling, and tools for surgical and dental applications, as well as how nanostructured surfaces can be created for the purposes of improving cell adhesion between medical devices and the human body. Each original chapter is revised in this second edition and describes developments in coatings for heart valves, stents, hip and knee joints, cardiovascular devices, orthodontic applications, and regenerative materials such as bone substitutes. There are also 8 new chapters that address: Microvascular anastomoses Inhaler devices used for pulmonary delivery of medical aerosols Surface modification of interference screws Biomechanics of the mandible (a detailed case study) Safety and medical devices The synthesis of nanostructured material Delivery of anticancer molecules using carbon nanotubes Nano and micro coatings for medic...

Medical device development.

Science.gov (United States)

Panescu, Dorin

2009-01-01

The development of a successful medical product requires not only engineering design efforts, but also clinical, regulatory, marketing and business expertise. This paper reviews items related to the process of designing medical devices. It discusses the steps required to take a medical product idea from concept, through development, verification and validation, regulatory approvals and market release.

Overview of alternative dispute resolution in healthcare disputes.

Science.gov (United States)

Saravia, A

1999-01-01

Various methods of alternative dispute resolution have gained wide acceptance in general commercial disputes. With the ever-increasing commercialization of the healthcare industry, many participants are examining ADR as a means of resolving disputes in this area as well. This Commentary provides an overview of the two most prevalent forms of ADR (arbitration and mediation), and discusses ongoing legislative, judicial, and industry activities that will guide the application of ADR in the healthcare arena.

Mediating environmental disputes

Energy Technology Data Exchange (ETDEWEB)

Lake, L.M.

1977-09-01

Environmental disputes and lawsuits are examined. Site-specific disputes focus on visible physical phenomena, such as a power plant or local river, and have an immediacy and intensity about them that make it politically hazardous for public officials to assume responsibility for resolving them. As new precedents in environmental case law become less frequent and the number of disputes increases, alternative processes for environmental conflict resolution, such as third-party intervention, become appropriate. Third-party intervention techniques of fact finding, conflict avoidance, conciliation and mediation have been applied to international, labor, prison, school, racial, and hospital disputes. Underlying concepts are described. Two case studies, the Snoqualmie Dam dispute in Washington and the West Side Highway dispute in New York City, illustrate the basic elements associated with third-party intervention. 1 map, 17 references.

International Standards for Radiation Sterilization of Medical Devices

International Nuclear Information System (INIS)

Miller, A.

2007-01-01

For a terminally sterilized medical device to be designated '' STERILE '', probability of finding the viable micro-organisms in the device shall be equal to or less than 1 x 10 -6 (EN 556-1:2001: Sterilization of medical devices - Requirements for medical devices to be designated '' STERILE '' - Part 1: Requirements for terminally sterilized medical devices). Author presents the main legal aspects of the international standards for radiation sterilization of medical devices

Institut Pasteur v. United States: the AIDS patent dispute, the Contract Disputes Act and the international exchange of scientific data.

Science.gov (United States)

Singer, H L

1989-01-01

In the case of Institut Pasteur v. United States, the Institut Pasteur (Pasteur) claimed that the National Cancer Institute (NCI) had breached express and implied contracts to share research on AIDS virus samples provided to NCI by Pasteur. NCI scientists allegedly used the samples to acquire information which allowed NCI to file patent applications for an AIDS blood test kit. The United States Claims Court dismissed the complaint by holding that the Institut Pasteur had not complied with certain administrative procedures required by the Contract Disputes Act before bringing its suit. The United States Court of Appeals for the Federal Circuit reversed the decision of the Claims Court by holding that the disputed contracts did not fit within the scope of the Contract Disputes Act. Soon after the Court of Appeals decision, President Reagan and Prime Minister Chirac announced a settlement agreement whereby the lawsuit was to be dropped, American and French scientists were to share credit for having discovered the AIDS virus, and both parties to the suit were to share the patent rights for the AIDS blood test kit. This settlement suggest that international legal disputes involving urgent scientific and medical matters may require dispute resolution techniques that serve as alternatives to national courts.

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.

48 CFR 5452.233-9001 - Disputes: Agreement To Use Alternative Dispute Resolution (ADR).

Science.gov (United States)

2010-10-01

... Alternative Dispute Resolution (ADR). 5452.233-9001 Section 5452.233-9001 Federal Acquisition Regulations... of Provisions and Clauses 5452.233-9001 Disputes: Agreement To Use Alternative Dispute Resolution... Alternative Dispute Resolution (ADR) (APR 2001)—DLAD (a) The parties agree to negotiate with each other to try...

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.

Disputes over science and dispute resolution approaches - A survey of Bureau of Reclamation employees

Science.gov (United States)

Burkardt, Nina; Ruell, Emily W.

2012-01-01

Water resources in parts of the Western United States are over-allocated, which intensifies the pressure to support water management decisions with strong scientific evidence. Because scientific studies sometimes provide uncertain or competing results or recommendations, science can become a source of disputes during decision-making processes. The Bureau of Reclamation (Reclamation) is an important water manager in the Western United States, and Reclamation decision processes are often contested by a variety of affected constituencies. We conducted a Web-based survey of Reclamation employees to determine (1) which types of disputes over science are occurring and how common they are, (2) which approaches have been used by Reclamation to try to resolve these different types of disputes, (3) how useful Reclamation employees find these approaches at resolving these types of disputes, (4) the final outcomes of these disputes and the decision-making processes that were hindered by the disputes over science, and (5) the potential usefulness of several different types of dispute resolution resources that Reclamation could provide for employees that become involved in disputes over science. The calculated minimum response rate for the survey was 59 percent. Twenty-five percent of respondents indicated that they had been involved in a dispute over science while working at Reclamation. Native species and species listed under the Endangered Species Act of 1973 were the most common issue types reported in these disputes over science. Survey respondents indicated that they used a variety of approaches to resolve disputes over science and rated most approaches as either neutral or somewhat helpful in these endeavors. Future research is needed to determine whether there are additional variables underlying these disputes that were not measured in this survey that may identify when dispute resolution methods are most effective, or whether resolving aspects of these disputes, such as

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.

ALTERNATIVE DISPUTE RESOLUTION

Directory of Open Access Journals (Sweden)

Mihaela Irina IONESCU

2016-05-01

Full Text Available Alternative dispute resolution (ADR includes dispute resolution processes and techniques that act as a means for disagreeing parties to come to an agreement short of litigation. It is a collective term for the ways that parties can settle disputes, with (or without the help of a third party. Despite historic resistance to ADR by many popular parties and their advocates, ADR has gained widespread acceptance among both the general public and the legal profession in recent years. In fact, some courts now require some parties to resort to ADR of some type, before permitting the parties' cases to be tried. The rising popularity of ADR can be explained by the increasing caseload of traditional courts, the perception that ADR imposes fewer costs than litigation, a preference for confidentiality, and the desire of some parties to have greater control over the selection of the individual or individuals who will decide their dispute. Directive 2013/11/EU of the European Parliament and of the Council on alternative dispute resolution for consumer disputes and amending Regulation (EC No 2006/2004 and Directive 2009/22/EC (hereinafter „Directive 2013/11/EU” aims to ensure a high level of consumer protection and the proper functioning of the internal market by ensuring that complaints against traders can be submitted by consumers on a voluntary basis, to entities of alternative disputes which are independent, impartial, transparent, effective, simple,quick and fair. Directive 2013/11/EU establishes harmonized quality requirements for entities applying alternative dispute resolution procedure (hereinafter "ADR entity" to provide the same protection and the same rights of consumers in all Member States. Besides this, the present study is trying to present broadly how are all this trasposed in the romanian legislation.

Resolution of consumer disputes through arbitration with special regard on insurance disputes

Directory of Open Access Journals (Sweden)

Tomić-Petrović Nataša

2014-01-01

Full Text Available Efficient resolution of consumer disputes contributes to the strengthening of consumer protection. As the increasing of number of consumer contracts necessary increase consumer disputes, there is an interest in developing the Alternative Disputes Resolution. The paper is devoted to the question of arbitrability of consumer disputes. At the beginning of the paper author points out at the difference between European and American approach to the arbitration of consumer disputes. Having in mind the premise that classic (commercial arbitration is not a priori suitable on consumer disputes author advocates introduction of specific consumer arbitration. The largest part of the paper deals with the characteristics of proposed consumer arbitration in order to prevent clause of arbitration to be void as unfair contract term. It is underlined the importance of free and informed consent of consumer on arbitration clause. At the conclusion, author cites approach of European Court of Justice according to which national courts have to look after unfair character of arbitration clause contained in consumer contract ex officio.

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)

The Restorative Role of Apology in Resolving Medical Disputes: Lessons From Chinese Legal Culture.

Science.gov (United States)

Lin, Nuannuan

2015-12-01

This article is the first exploration of the Chinese notion of apology from a comparative legal perspective. By reviewing the significance of apology in the context of Chinese culture, the article presents a three-dimensional structure of apology that, in contrast to the understanding the research community now has, defines acknowledgement of fault, admission of responsibility, and offer of reparation as three essential elements of an apology. It is the combination of these three elements that enables apology to serve as a form of reparation. The article further places the three-dimensional apology in the context of the Chinese concept of "the relations of humanity," arguing that an apology accompanying admission of fault and responsibility may help to restore the harmony of relations and, by so doing, resolve medical disputes positively.

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...

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.

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.

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.

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.

Alternative Dispute Resolution to the Rescue.

Science.gov (United States)

Kassberg, Maria

1989-01-01

Examines the use of mediation and arbitration to settle civil disputes which have been traditionally settled through the courts. Discusses the advantages of alternative forms of dispute resolution. Describes the operations of dispute resolution centers and provides information about the individuals who serve as dispute mediators. (KO)

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...

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.

The Body Language Behaviours of the Chairs of the Disputes According to the Disputants

Science.gov (United States)

Caliskan, Nihat

2009-01-01

The perception form of the body language behaviours of the session chairs by disputants affects the efficiency of the process. Therefore, it is important to determine the effects of the mimic, gesture, physical appearance and tonality and accent of the chairs on disputants. That research was conducted to clarify how the disputants perceive the…

The Northwest Passage Dispute

DEFF Research Database (Denmark)

Burke, Danita Catherine

2018-01-01

This is an article written for the Oxford Research Group "Sustainable Security" series. It gives an overview of the dispute of the Northwest Passage and discusses factors which will contribute to the evolution of the dispute in the 21st century. This short contribution summarizes and adds to the ...... to the research recently published by the author through Palgrave Macmillan, Danita Catherine Burke, 2018, International Disputes and Cultural Ideas in the Canadian Arctic...

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...

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...

22 CFR 226.90 - Disputes.

Science.gov (United States)

2010-04-01

... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Disputes. 226.90 Section 226.90 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT ADMINISTRATION OF ASSISTANCE AWARDS TO U.S. NON-GOVERNMENTAL ORGANIZATIONS Miscellaneous § 226.90 Disputes. (a) Any dispute under or relating to a grant or agreement shall...

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).

International Construction Disputes in Denmark

DEFF Research Database (Denmark)

Cavaleri, Sylvie Cécile

2016-01-01

The article discusses whether the very peculiar Danish system of resolution of construction disputes, which is an hybrid between arbitration and State-Court proceedings, is geared for disputes involving non-Danish parties, comes to the conclusion that it is not, and proposes amendments to the sys......The article discusses whether the very peculiar Danish system of resolution of construction disputes, which is an hybrid between arbitration and State-Court proceedings, is geared for disputes involving non-Danish parties, comes to the conclusion that it is not, and proposes amendments...

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...

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...

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...

Make her a virgin again: when medical disputes about minors are cultural clashes.

Science.gov (United States)

Kopelman, Loretta M

2014-02-01

Recalcitrant disputes among health care providers and patients or their families may signal deep cultural differences about what interventions are needed or about clinicians's professional duties. These issues arose in relation to a mother's request for hymenoplasty or revirgination for her minor daughter to enable an overseas, forced marriage and protect her from an honor killing. The American College of Obstetrics and Gynecology committee recommends against members performing a hymenoplasty or other female genital cosmetic surgeries due to a lack of data concerning their safety and efficacy. A key issue in such cases is how to determine what is in the minor's best interest and the scope of health care moral or professional's duties. The Best Interests Standard can serve as a powerful moral tool for resolving cross-cultural disputes and identifying needed policy.

Territorial disputes in international arbitration practice

Directory of Open Access Journals (Sweden)

Tubić Bojan

2014-01-01

Full Text Available This paper deals with the issue of territorial disputes settlement in international arbitrations. The arbitration represents an efficient way of determining state borders, together with diplomatic means of dispute resolution and procedure before the International Court of Justice. Parties in a dispute choose arbiters, rules of procedure and commit themselves to accept and implement arbitration award, which is based on international law. States can create an ad hoc tribunal or they can decide to resolve the dispute before the Permanent Court of Arbitration in The Hague. In arbitration practice there were cases of successful arbitrations, especially in situations when a dispute was primarily factual and when major economic and political interests were not involved.

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...

48 CFR 1433.214 - Alternative dispute resolution (ADR).

Science.gov (United States)

2010-10-01

... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Alternative dispute... GENERAL CONTRACTING REQUIREMENTS PROTESTS, DISPUTES, AND APPEALS Disputes and Appeals 1433.214 Alternative dispute resolution (ADR). DOI strongly encourages the use of ADR in the resolution of disputes in lieu of...

48 CFR 3033.214 - Alternative dispute resolution (ADR).

Science.gov (United States)

2010-10-01

..., DISPUTES, AND APPEALS Disputes and Appeals 3033.214 Alternative dispute resolution (ADR). (c) The Administrative Dispute Resolution Act (ADRA) of 1996, as amended, 5 U.S.C. 571, et seq., authorizes and... 48 Federal Acquisition Regulations System 7 2010-10-01 2010-10-01 false Alternative dispute...

46 CFR 205.5 - Contracts containing disputes article.

Science.gov (United States)

2010-10-01

... 46 Shipping 8 2010-10-01 2010-10-01 false Contracts containing disputes article. 205.5 Section 205... AUDIT APPEALS; POLICY AND PROCEDURE § 205.5 Contracts containing disputes article. When a contract contains a disputes article, the disputes article will govern the bases for negotiating disputes regarding...

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

Alternative Dispute Resolution – Justice without Trial?

Directory of Open Access Journals (Sweden)

Angelica Roşu

2012-05-01

Full Text Available This research is proposed to analyze the alternative means of dispute resolution, as an alternativeof justice, or as a justice alternative, after studying both European critical literature and national one. Thephrase „alternative dispute resolution” means any alternative way of dispute resolution method whereby two ormore people try using a third party to reach a solution to the problem that precludes them, whether it ismediation, conciliation, assisted negotiation. In this research, we proposed to use the observation as a commonmethod. We concluded that the main reason of the alternative means for dispute resolution results from thepossibility to avoid the judicial system that makes it available for the litigants. It was also shown that users ofalternative means for dispute resolution not seek to resolve the dispute outside a court as an amicablesettlement, negotiated, consensual of their dispute.

SETTLEMENT OF BANKING DISPUTE IN INDONESIA

Directory of Open Access Journals (Sweden)

Denico Doly

2014-03-01

Full Text Available This article talks about dispute between costumer and the bank. Settlement of disputes should be resolved by the principle of fast, accurate and cheap. Issues raised in this paper is how an ideal dispute resolution process to resolve dispute banking. This paper describes the advantages and disadvantages in any dispute resolution process both through litigation and non litigation. Based in the principles of fast, accurate and cheap it is explained that banks in Indonesia must resolve their disputes through non litigation or ADR. Tulisan ini membicarakan mengenai penyelesaian sengketa antara nasabah dengan bank. Penyelesaian sengketa harusnya diselesaikan dengan prinsip cepat, tepat dan murah. Permasalahan yang diangkat dalam tulisan ini yaitu bagaimana proses penyelesaian sengketa yang ideal dalam menyelesaikan sengketa perbankan. Tulisan ini menggambarkan mengenai kelebihan dan kekurangan dalam setiap proses penyelesaian sengketa baik melalui jalur litigasi maupun non litigasi. Berdasarkan prinsip cepat, tepat dan murah maka dipaparkan bahwa perbankan di Indonesia harus menyelesaikan sengketanya melalui jalur non litigasi atau ADR.

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...

The uses of alternative dispute resolution to resolve genetic disputes. Final report

Energy Technology Data Exchange (ETDEWEB)

Stein, Robert E.

2003-01-01

The report sets out lessons learned while carrying out the study. It concludes that genetic disputes will increase in number and that ADR processes including mediation, arbitration, the use of independent experts and court-appointed masters can be helpful in resolving them. It suggests additional effort on bioremediation, and workplace disputes and training for ADR neutrals.

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...

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 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.

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

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...

48 CFR 33.214 - Alternative dispute resolution (ADR).

Science.gov (United States)

2010-10-01

... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Alternative dispute... GENERAL CONTRACTING REQUIREMENTS PROTESTS, DISPUTES, AND APPEALS Disputes and Appeals 33.214 Alternative dispute resolution (ADR). (a) The objective of using ADR procedures is to increase the opportunity for...

International trade disputes in modern regulatory paradigm

Directory of Open Access Journals (Sweden)

Tamara Gordeeva

2013-09-01

Full Text Available This article studies the latest trends observed in the area of contradictory relations between countries with regard to international trade, which cause changes in the paradigm of international trade disputes. It has been found out that any state of inconsistent relations between the countries is recently characterized as a «trade war». It has been analyzed the notions of «dispute», «conflict», «war» according to international regulatory documents and determined the applicability of these terms depending on a number of criteria. It has been studied the evolution of the objects of international trade disputes since the time of ancient Greece until today, and new trends based on this have been revealed with regard to use of trade policy instruments that cause disputes between countries. Several specific examples of international trade disputes and causes of their occurrence have been considered. A quantitative analysis of international trade disputes in general and in relations between the leading countries in terms of a number of the trade disputes in which they were involved has been performed.

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...

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

13 CFR 130.630 - Dispute resolution procedures.

Science.gov (United States)

2010-01-01

... organization has supplied the Committee with all requested documentation. (b) Programmatic (non-financial... DEVELOPMENT CENTERS § 130.630 Dispute resolution procedures. (a) Financial Disputes. (1) A recipient organization wishing to resolve a financial Dispute formally must submit a written statement describing the...

47 CFR 1.18 - Administrative Dispute Resolution.

Science.gov (United States)

2010-10-01

... adopted an initial policy statement that supports and encourages the use of alternative dispute resolution... policy to encourage the fullest possible use of alternative dispute resolution procedures in its... provisions dealing with confidentiality, shall also be applied in Commission alternative dispute resolution...

14 CFR 17.31 - Use of alternative dispute resolution.

Science.gov (United States)

2010-01-01

... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Use of alternative dispute resolution. 17... PROCEDURAL RULES PROCEDURES FOR PROTESTS AND CONTRACTS DISPUTES Alternative Dispute Resolution § 17.31 Use of alternative dispute resolution. (a) The Office of Dispute Resolution for Acquisition shall encourage the...

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.

5 CFR 9701.705 - Alternative dispute resolution.

Science.gov (United States)

2010-01-01

... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Alternative dispute resolution. 9701.705... HUMAN RESOURCES MANAGEMENT SYSTEM Appeals § 9701.705 Alternative dispute resolution. The Department and OPM recognize the value of using alternative dispute resolution methods such as mediation, an...

48 CFR 1233.214 - Alternative dispute resolution (ADR).

Science.gov (United States)

2010-10-01

... Alternative dispute resolution (ADR). (c) The Administrative Dispute Resolution Act (ADRA) of 1990, Public Law... Specialist, who is responsible for the operations of the Center for Alternative Dispute Resolution, (C-4... alternative means of dispute resolution set forth in the ADRA, 5 U.S.C. 571(3) on a non-reimbursable basis for...

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...

Construction dispute research conceptualisation, avoidance and resolution

CERN Document Server

2014-01-01

There are three specific purposes of Construction Dispute Research. First, this volume aims to summarise studies on construction dispute. Second, apart from the theoretical constructs, where appropriate empirical tests are also included. This approach serves to go beyond the commonly used anecdotal approach for the subject matters. Third, it is the sincere hope of the authors that this book will help shaping research agenda of construction dispute.  The studies are mostly framed from a management perspective drawing on methods and concepts in contract law, economics, psychology and management science.   The book has twenty chapters that are arranged in four parts covering conceptualisation, avoidance, negotiation and mediation. Part 1 is devoted for dispute conceptualisation. A building is only as strong as its foundation. Thus it is no better start to study construction dispute by conceptualisation. The theme of Part 2 is dispute avoidance. The conventional wisdom of ‘prevention is better than cure’ se...

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...

Alternative dispute resolution mechanisms, plea bargain and ...

African Journals Online (AJOL)

Conflicts, disputes, disagreements, problems and issues are inevitable in human affairs. Most of these disputes and problems in some circumstances give rise to offences for which a criminal prosecution becomes necessary. One can say that Alternative Dispute Resolution (ADR) is used all round the world to resolve ...

20 CFR 627.805 - Alternative dispute resolution.

Science.gov (United States)

2010-04-01

... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Alternative dispute resolution. 627.805... Law Judges § 627.805 Alternative dispute resolution. (a) Parties to a complaint under § 627.801 of... administrative hearing before the OALJ by choosing to transfer the settlement of their dispute to an individual...

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.)

A clinical analysis of 500 medico-legal claims evaluating the causes and assessing the potential benefit of alternative dispute resolution.

Science.gov (United States)

B-Lynch, C; Coker, A; Dua, J A

1996-12-01

1. To evaluate the common causes of medico-legal dispute in obstetrics and gynaecology. 2. To assess the potential benefit of early alternative dispute resolution. A prospective analysis of over 500 cases submitted from over 100 solicitors between 1984 and 1994 for medical expert opinion on potential medico-legal claims. Five hundred consecutive cases that met the inclusion criteria: 488 from the United Kingdom and 12 from abroad (Hong Kong, Republic of Ireland). The main principles underlining medico-legal disputes and causes of such claims. Analysis of 500 claims show 46% were misguided allegations, 19% incompetent care, 12% error of judgement, 9% lack of expertise, 7% failure of communication, 6% poor supervision and 1% inadequate staffing. Of the misguided allegations 119/225 cases (59%) were obstetric and 111/275 (40%) cases were gynaecological. The most common cause of obstetric dispute was "cerebral palsy' (22%), while the commonest cause of gynaecological dispute was failed sterilisation (19%). Settled claims were under-reported by solicitors. Because of the high percentage (46%) of misguided allegations, an alternative course of dispute resolution must be a realistic way forward. This course of action, combined with improved communication, could result in a major reduction in the costs of potential medical litigation. Early alternative dispute resolution should be considered in an attempt to reduce the escalating quantum of damages and costs. We recommend recruiting independent, experienced and unbiased consultants in active practice within the appropriate specialty to review such cases at the level of hospital complaints management as an in house review procedure, particularly for small and moderate-sized claims, as a means whereby doctors can retain control of medico-legal disputes, in contrast to control by the legal profession.

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.

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...

[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.

48 CFR 6101.54 - Alternative dispute resolution [Rule 54].

Science.gov (United States)

2010-10-01

... CONTRACT APPEALS, GENERAL SERVICES ADMINISTRATION CONTRACT DISPUTE CASES 6101.54 Alternative dispute resolution [Rule 54]. (a) Availability of alternative dispute resolution (ADR) procedures at the Board. The... 48 Federal Acquisition Regulations System 7 2010-10-01 2010-10-01 false Alternative dispute...

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.

25 CFR 1000.422 - How must disputes be handled?

Science.gov (United States)

2010-04-01

... Title I-eligible program disputes may use non-binding informal alternative dispute resolution at the... this alternative dispute resolution any time before the issuance of an initial decision of a formal appeal(s). The appeals timetable will be suspended while alternative dispute resolution is pending. ...

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.

14 CFR 17.33 - Election of alternative dispute resolution process.

Science.gov (United States)

2010-01-01

... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Election of alternative dispute resolution... TRANSPORTATION PROCEDURAL RULES PROCEDURES FOR PROTESTS AND CONTRACTS DISPUTES Alternative Dispute Resolution § 17.33 Election of alternative dispute resolution process. (a) The Office of Dispute Resolution for...

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.

International Regulations Dealing with Alternative Dispute Resolution for International Commercial Disputes

Directory of Open Access Journals (Sweden)

Angelica Rosu

2009-06-01

Full Text Available At present, no generally applied international ADR rules exist. However, manylegislative initiatives registered in time. The United Nations Commission on International TradeLaw adopted, thus, a Model Law on International Commercial Conciliation in 2002. The EuropeanUnion has also been active in the area of ADR presenting in May 2008 a Directive on CertainAspects of Mediation in Civil and Commercial Matters that represents its most important initiativesin this field. There are also various international conventions that deal with dispute resolution suchas the International Convention on the Settlement of Investment Disputes. The many legislativeinitiatives are useful, even necessary.

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.

Financial System of Malaysia: the Concept of Financial Dispute

Directory of Open Access Journals (Sweden)

Evgenia E. Frolova

2017-01-01

Full Text Available Purpose: the article examines the main problems associated the new regulatory acts of Malaysia – the Financial Services Act of 2013 and the Islamic Financial Services Act of 2013; The characteristics of the legal status of the "Ombudsman for financial services" are listed, types of financial disputes subject to settlement under the "financial ombudsman scheme" are listed, parties to the financial dispute are identified. To achieve this goal, the article must solve the following tasks: to determine whether there are institutions in Malaysia that provide services for resolving financial disputes; to investigate the main problems associated with the definition of the concept and types of financial dispute, the conditions for the transfer of a financial dispute to the competent authority. Methods: this article is based on an interdisciplinary concept of research, which allowed to distinguish the distinctive features of the legal regulation of the settlement of financial disputes in Malaysia. Results: according to the provisions of the new laws of Malaysia, namely the Financial Services Act of 2013 and the Islamic Financial Services Act of 2013, a financial dispute should be understood as a dispute, to which the parties are a financial consumer and a financial service provider provider. Financial disputes include disputes in the field of insurance and Islamic insurance, as well as disputes over bank cards, bank accounts, ATMs, Internet banking, mobile banking, and others. The main body for the settlement of financial disputes is the Financial Ombudsman. The competence of the financial ombudsman is limited by the amount of the claim of 250,000 ringgit (about 4.5 million rubles, under insurance claims – 10,000 ringgit, in the field of unauthorized transactions – 25,000 ringgit. The procedure for resolving a financial dispute, which in Malaysia is referred to as the "scheme of a financial ombudsman", is established by the Central Bank of Malaysia

76 FR 55217 - Procedures for Protests and Contracts Dispute

Science.gov (United States)

2011-09-07

... an alleged breach of that contract. A contract dispute does not require, as a prerequisite, the...-0840; Amdt. No. 17-1] RIN 2120-AJ82 Procedures for Protests and Contracts Dispute AGENCY: Federal... contract disputes brought against or by the FAA. It also adds a voluntary dispute avoidance and early...

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.

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

48 CFR 5433.214. - Alternative Dispute Resolution (ADR).

Science.gov (United States)

2010-10-01

... 48 Federal Acquisition Regulations System 7 2010-10-01 2010-10-01 false Alternative Dispute Resolution (ADR). 5433.214. Section 5433.214. Federal Acquisition Regulations System DEFENSE LOGISTICS AGENCY, DEPARTMENT OF DEFENSE PROTESTS, DISPUTES AND APPEALS 5433.214. Alternative Dispute Resolution (ADR). The...

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

48 CFR 833.214 - Alternative dispute resolution (ADR).

Science.gov (United States)

2010-10-01

... Alternative dispute resolution (ADR). Contracting officers and contractors are encouraged to use alternative dispute resolution (ADR) procedures. CBCA guidance on ADR may be obtained at http://www.cbca.gsa.gov. ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Alternative dispute...

Dispute resolution by Courts and Dispute resolution in court. Partners or rivals?

Directory of Open Access Journals (Sweden)

Kristin Hero

2011-12-01

Full Text Available This session of the workshop was dedicated to alternative dispute resolutions (ADR, which consists of dispute resolution processes and techniques through which disagreeing parties come to an agreement without having to litigate. Despite historic resistance, over the years ADR has gained widespread acceptance among both the general public and the legal profession. In the discussion there was a specific emphasis on mediation and arbitration. Kathrin Nitschmann, a lawyer and mediator from Saarbruecken, Germany, talked about “Professionalisation in mediation”. In addition to participation aspects she determined both the risks and the perspectives of professionalization in mediation. Luigi Cominelli, Assistant Professor of Sociology of Law at the University of Milan, Italy, reported on “Regulating Mediation in the EU”. He described the history of regulating mediation in the EU as well as domestic regulations since the beginning of modern mediation movement in the western world since the 1970s. Claude Witz, a French civil law professor at the University of Saarland, Germany, referred to “His experience in arbitration.” After highlighting some aspects of his experience, he pointed out the importance of arbitration in international commercial disputes. Alec Stone Sweet, Leitner Professor of Law, Politics, and International Studies, Yale Law School, United States, was reporting on “Arbitration and judicialization.” Initially, he presented arbitration as a triadic dispute resolution and then focused on judizialization in arbitration. Sir David Edward, former Judge of the Court of Justice of the European Communities and Professor Emeritus of the School of Law of the University of Edinburgh, United Kingdom, spoke about “The view of an arbitrator.” While elaborating on multiple reasons for ADR, he honed focus on mediation and arbitration. Finally Heike Jung, Professor Emeritus of Penal Law of the University of the Saarland, Germany

DISPUTE RESOLUTION AND MEDIATION ON CAPITAL MARKET

Directory of Open Access Journals (Sweden)

CRISTIAN GHEORGHE

2011-04-01

Full Text Available Capital Market is usually depicted as a place for experts, for people with high trading skills. This is a half truth. There are entities established and functioning under strict scrutiny of Romanian National Securities Commission (RNSC, in compliance with Capital Market Law and regulations. There are also the investors, in many cases individuals involved in shares/financial instruments trade. In both cases disputes can rise. Disputes are inevitable a part of human interaction, hence the need for dispute resolution. First option is the judicial court system. Alternative dispute resolution comprises arbitration and mediation. Arbitration is an alternative choice to provide simpler, speedier and more accessible justice than ordinary courts as well as expertise in matters that are technical in nature and require special knowledge to adjudicate upon. Capital Market environment provides an institutional arbitration court for all participants, including investors. In many cases the agreement executed between participants under RNSC scrutiny The other option for settling disputes outside the court is mediation. Mediation can provide a much cheaper and quick extrajudicial resolution of disputes in commercial matters without time consuming procedures and rigid rules. Agreements resulting from mediation are more likely to be complied with voluntarily and are more likely to foster the commercial relationship between the parties. The interaction between investors and brokerage houses is based on investment services agreement concluded by parties. This is the usual framework for disputes between parties and the usual “landscape” for mediation on capital market.

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

Disputing strategies in medieval Scandinavia

DEFF Research Database (Denmark)

Orning, Hans Jacob

In Scandinavia the study of disputes is still a relatively new topic: The papers offered here discuss how conflicts were handled in Scandinavian societies in the Middle Ages before the emergence of strong centralized states. What strategies did people use to contest power, property, rights, honour...... studies. With introductory sections on social structure, sources materials, and the historiography of Scandinavian dispute studies....

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...

13 CFR 134.216 - Alternative dispute resolution procedures.

Science.gov (United States)

2010-01-01

... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Alternative dispute resolution....216 Alternative dispute resolution procedures. At any time during the pendency of a case, the parties may submit a joint motion requesting that the Judge permit the use of alternative dispute resolution...

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.

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

The Anglo-Iranian oil dispute

International Nuclear Information System (INIS)

Ferrier, R.W.

1988-01-01

This paper traces the history of the Anglo-Iranian oil dispute. It is short-sighted to consider the Anglo-Iranian oil dispute just as a contest between Musaddiq and the AIOC: it is of wider and greater significance. The dispute illustrates a transitional phase in the difficult process of the adjustment of relations between industrialized and less developed societies for the exploitation of raw materials. Oil was already becoming a political and economic factor at the end of the Qajar period and became important during the reign of Riza Shah with his emphasis on a national program of modernization. After more attention had been focused on it during the second world war it was inevitable that it would increase in influence. The issues of the oil dispute referred back to the concessional controversies of the late nineteenth century in tobacco, mining, communications, utilities, banking even gambling, with their political and social implications; and they referred forward to the issues of the sovereignty of national resources, the transfer of technology and economic growth in relation to the standard of living. These are aspects of the North-South debate, which have yet to be satisfactorily resolved

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...

Trend Spotting: NAFTA Disputes After Fifteen Years

OpenAIRE

Lawrence L. Herman

2010-01-01

Cross-border investment disputes have supplanted trade disputes as the main focus of legal actions under the North American Free Trade Agreement (NAFTA), according to this study. The author finds a growing number of these investment disputes entail challenges by American investors against Canada's provincial, as opposed to federal, laws and regulations. So important constitutional issues need clarifying between Ottawa and the provinces. He notes as party to the treaty, Ottawa must carry the b...

Prediction of future dispute concerning nuclear power generation

International Nuclear Information System (INIS)

1981-04-01

This investigation is the third research on the public acceptance of nuclear power generation by the National Congress on Social Economics. In this study, how the energy dispute including that concerning nuclear power generation will develop in 1980s and 1990s, how the form of dispute and the point of controversy will change, were predicted. Though the maintenance of the concord of groups strongly regulates the behavior of people, recently they have become to exercise individual rights frequently. The transition to the society of dispute is the natural result of the modernization of society and the increase of richness. The proper prediction of social problems and the planning and execution of proper countermeasures are very important. The background, objective, basic viewpoint, range and procedure of this investigation, the change of social dispute, the history of the dispute concerning nuclear power generation, the basic viewpoint in the prediction of the dispute concerning nuclear power generation, the social situation in 1980s, the prediction and avoidance of the dispute in view of social and energy situations, and the fundamental strategy for seeking a clue to the solution in 1980s and 1990s are described. The establishment of neutral mediation organs and the flexible technologies of nuclear reactors are necessary. (Kako, I.)

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 ...

Mediation in complex multi-party disputes

NARCIS (Netherlands)

Kamminga, Y.P.; Blohorn-Brenneur, B.

2013-01-01

Mediation is on the rise but it is lagging behind in certain fields such as in the resolution of complex disputes. This article addresses how biases in the decision-making process for selecting either mediation or litigation surrounding dispute resolution works in the disadvantage of mediation. It

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.

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.

25 CFR 42.4 - What are alternative dispute resolution processes?

Science.gov (United States)

2010-04-01

... 25 Indians 1 2010-04-01 2010-04-01 false What are alternative dispute resolution processes? 42.4... What are alternative dispute resolution processes? Alternative dispute resolution (ADR) processes are... use them, contact the Office of Collaborative Action and Dispute Resolution by: (1) Sending an e-mail...

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.

Instituting dispute resolution procedures in the Apostolic Faith Mission in Zimbabwe church

Directory of Open Access Journals (Sweden)

Norman Chivasa

2018-01-01

Full Text Available The need to institute dispute resolution procedures in the Apostolic Faith Mission (AFM in Zimbabwe church informs this study. Remarkably, one of the most critical problems facing the AFM in Zimbabwe church is intrachurch disputes, which manifest in diverse forms such as pastors’ transfers disputes, election disputes and pastors’ performance disputes. Such disputes have produced undesirable consequences not only for pastors but also for the wellbeing of the church in general. Intrachurch disputes require internal mechanisms to manage them so that constructive rather than destructive results are achieved. To do this, internal dispute resolution procedures become critical as they provide a framework for the constructive resolution of disputes. The lived experience of disputes in the AFM in Zimbabwe church confirms the appropriateness of systems theory, which states that social institutions are vulnerable to disharmony owing to differing interacting elements. To mitigate the negative impact associated with disputes, this study proposes the need to institute dispute resolution procedures in the AFM in Zimbabwe, because the church currently relies only on disciplinary procedures to address disputes. The study further emphasises that instituting dispute resolution procedures will help the church handle disputes from within its ranks without necessarily involving local courts, which may have negative financial and relationship implications. Finally, the study develops a model for dispute resolution procedures as an instrument that can assist local churches in AFM in Zimbabwe church to handle disputes as and when they arise.

10 CFR 2.338 - Settlement of issues; alternative dispute resolution.

Science.gov (United States)

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Settlement of issues; alternative dispute resolution. 2... alternative dispute resolution under paragraph (b) of this section. (b) Settlement judge; alternative dispute... alternative dispute resolution as the Commission may provide or to which the parties may agree. The order...

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.

Disputing strategies in medieval Scandinavia

DEFF Research Database (Denmark)

Orning, Hans Jacob

In Scandinavia the study of disputes is still a relatively new topic: The papers offered here discuss how conflicts were handled in Scandinavian societies in the Middle Ages before the emergence of strong centralized states. What strategies did people use to contest power, property, rights, honour......, and other kinds of material or symbolic assets? Seven essays by Scandinavian scholars are supplemented by contributions from Stephen White, John Hudson and Gerd Althoff, to provide a new baseline for discussing both the strategies pursued in the political game and those used to settle local disputes. Using...... practice and process as key analytical concepts, these authors explore formal law and litigation in conjunction with non-formal legal proceedings such as out-of-court mediation, rituals, emotional posturing, and feuding. Their insights place the Northern medieval world in a European context of dispute...

[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.

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...

28 CFR 36.506 - Alternative means of dispute resolution.

Science.gov (United States)

2010-07-01

... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Alternative means of dispute resolution... dispute resolution. Where appropriate and to the extent authorized by law, the use of alternative means of dispute resolution, including settlement negotiations, conciliation, facilitation, mediation, factfinding...

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.

PENYELESAIAN SENGKETA BISNIS MELALUI ALTERNATIVE DISPUTE RESOLUTION (ADR

Directory of Open Access Journals (Sweden)

Joko Nur Sariono

2006-07-01

Full Text Available ADR represent alternative of solving of extrajudical done law dispute that is passing process of negonisasi and of mediasi and of abitrase for the process of and negonisasi of mediasi represent process of is solving of dispute compromisely with result of troubleshooting with while abitrasi represent process of solving of dispute by compromise of negonisasi compete which decision have the character of final.

24 CFR 7.5 - EEO Alternative Dispute Resolution Program.

Science.gov (United States)

2010-04-01

... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false EEO Alternative Dispute Resolution... Provisions § 7.5 EEO Alternative Dispute Resolution Program. In accordance with the Secretary's Policy Statement regarding Alternative Dispute Resolution (ADR) located on the Department's website and 29 CFR 1614...

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.

Industrial Disputes in the Construction Sector

Directory of Open Access Journals (Sweden)

L.J Perry

2012-11-01

Full Text Available The Cole Royal Commission enquiry into the building and construction (abbreviated to ‘construction’ sector recommended controversial workplace-relation reforms for that sector. The recommended changes are likely to be enshrined in legislation within the year. The Commission drew on analyses of industrial disputes that focused, in the main, on quite recent experience. This paper attempts to give a broader historical perspective on disputes in that sector by considering the pattern of disputes for the entire post-World War II period. Accordingly, data on disputes and employees during the entire period are gathered from Australian Bureau of Statistics current and archived sources. These data are classified according to sector (construction versus non-construction and analysed. It is found that the strike rate has, on average, been greater in the construction sector than in the non-construction sector. However, there have been periods during which disputes in the construction sector have been relatively low. The most recent period was during the period of the Accord (1983-96, during which the strike rate in the construction sector fell relatively strongly. The analysis of this relatively broad historical period draws attention, among other things, to the possibility that the sort of strategies employed during the Accord years – strategies of cooperation and consensus building – may provide a more effective means of bringing industrial peace to the workplace relations scene of the construction sector than policies that are relatively confrontational.

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.

Cognitive behaviour therapy territory model: effective disputing approach.

Science.gov (United States)

Lam, D

1997-06-01

This paper proposes a disputing model (territory model) which is particularly useful and effective for disputing clients who persistently hold on to their dysfunctional thinking and/or core irrational beliefs. Their 'stubbornness' to change is compounded by unhealthy negative emotions during sessions. The intense emotion makes it difficult to access the belief system, and therefore any attempt to dispute it often proves futile. This model advocates the shift of disputing onto a different 'territory/ground' where the client can be facilitated to acquire higher, abstract and objective thinking, and at the same time his/her emotional level is susceptible to rational and logical arguments. The new thinking would act as a catalyst for the client to reflect on his/her dysfunctional thought/irrational beliefs. In this paper, the author uses a case example to illustrate and discuss the ineffectiveness of the 'traditional' way of disputing the dysfunctional thinking/core beliefs of a difficult and emotional client. This is contrasted with the 'territory' model.

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...

28 CFR 35.176 - Alternative means of dispute resolution.

Science.gov (United States)

2010-07-01

... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Alternative means of dispute resolution... DISABILITY IN STATE AND LOCAL GOVERNMENT SERVICES Compliance Procedures § 35.176 Alternative means of dispute resolution. Where appropriate and to the extent authorized by law, the use of alternative means of dispute...

4 CFR 22.24 - Alternative Dispute Resolution [Rule 24].

Science.gov (United States)

2010-01-01

... 4 Accounts 1 2010-01-01 2010-01-01 false Alternative Dispute Resolution [Rule 24]. 22.24 Section... GOVERNMENT ACCOUNTABILITY OFFICE CONTRACT APPEALS BOARD § 22.24 Alternative Dispute Resolution [Rule 24]. (a) Docketed appeals. The Board considers Alternative Dispute Resolution (ADR) to be an efficient way to timely...

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...

29 CFR 1603.108 - Settlement and alternative dispute resolution.

Science.gov (United States)

2010-07-01

... 29 Labor 4 2010-07-01 2010-07-01 false Settlement and alternative dispute resolution. 1603.108... Settlement and alternative dispute resolution. (a) The parties are at all times free to settle all or part of... a neutral mediator or to any other alternative dispute resolution process authorized by the...

24 CFR 7.26 - EEO Alternative Dispute Resolution Program.

Science.gov (United States)

2010-04-01

... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false EEO Alternative Dispute Resolution...-Complaint Processing § 7.26 EEO Alternative Dispute Resolution Program. (a) The aggrieved person may elect... chosen, the EEO Counselor shall advise the aggrieved person that if the dispute is resolved during the...

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

Primary medical care in Irish prisons

OpenAIRE

ALLWRIGHT, SHANE PATRICIA ANN; DARKER, CATHERINE; BARRY, JOSEPH; O'DOWD, THOMAS

2010-01-01

PUBLISHED Background: An industrial dispute between prison doctors and the Irish Prison Service (IPS) took place in 2004. Part of the resolution of that dispute was that an independent review of prison medical and support services be carried out by a University Department of Primary Care. The review took place in 2008 and we report here on the principal findings of that review. Methods: This study utilised a mixed methods approach. An independent expert medical evaluator (one of ...

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.

76 FR 2035 - Procedures for Protests and Contracts Dispute

Science.gov (United States)

2011-01-12

... an alleged breach of that contract. A contract dispute does not require, as a prerequisite, the...-0840; Notice No. 10-18] RIN 2120-AJ82 Procedures for Protests and Contracts Dispute AGENCY: Federal... brought against the FAA and contract disputes brought against or by the FAA. It would also add a voluntary...

29 CFR 5.11 - Disputes concerning payment of wages.

Science.gov (United States)

2010-07-01

... 29 Labor 1 2010-07-01 2010-07-01 true Disputes concerning payment of wages. 5.11 Section 5.11... Provisions and Procedures § 5.11 Disputes concerning payment of wages. (a) This section sets forth the procedure for resolution of disputes of fact or law concerning payment of prevailing wage rates, overtime...

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.)

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.

Study on Investor-State Dispute Settlement (‘ISDS’) and Alternatives of Dispute Resolution in International Investment Law

DEFF Research Database (Denmark)

Hindelang, Steffen

aken the public concerns about current developments in the area of the European International Investment Policy, the European Parliament’s INTA Committee launched a study on Investor-State Dispute Settlement and Possible Alternatives of Dispute Resolution in International Investment Law....... In a nutshell, the study suggests that ISDS is a useful means of enforcing substantive investment protection standards contained in international investment agreements. The mechanism should therefore continue to form part of European international investment policy. However, the EU has to address four major...... challenges tied to this dispute settlement tool, i.e. (1) mitigating inconsistency, (2) securing the right balance between private and public interests, (3) establishing integrity of arbitral proceedings and (4) preventing misuse, allowing for error-correction and managing financial risk associated with ISDS...

[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...

ARBITRABILITY OF DISPUTES RELATED TO INTELECTUAL PROPERTY RIGHTS

Directory of Open Access Journals (Sweden)

Ruxandra I. CHIRU

2017-05-01

Full Text Available The present study is aimed for the intellectual property rights holders and specialists in intellectual property law, that are invited to use, promote and implement arbitration as a winning alternative means of solving disputes. The author presents the arbitration as the main method of alternative dispute resolution and analyses the conditions in which arbitration may be used for settling disputes related to intellectual property rights. In this respect, the paper largely presents the main conditions: the dispute has to be liable for settlement by means of arbitration, the parties have to conclude an arbitration agreement, the arbitration agreement has to be valid and effective and the dispute has to be included in the provisions of the arbitration agreement. The author also reviews the types of arbitration used by the World Intellectual Property Organization Centre for Arbitration and Mediation, the World Trade Organization, the Romanian Copyright Office and the Court of International Commercial Arbitration attached to the Chamber of Commerce and Industry of Romania, presenting some ruling of arbitral tribunals concerning arbitrability issues.

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

76 FR 55136 - Implementation of the Alternative Dispute Resolution Program

Science.gov (United States)

2011-09-06

... NUCLEAR REGULATORY COMMISSION [NRC-2011-0208] Implementation of the Alternative Dispute Resolution... stakeholders on its Alternative Dispute Resolution (ADR) Program in the Office of Enforcement (OE). The meeting... INFORMATION: I. Background Congress enacted the Administrative Dispute Resolution Act (Act) which requires...

14 CFR Appendix A to Part 17 - Alternative Dispute Resolution (ADR)

Science.gov (United States)

2010-01-01

... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Alternative Dispute Resolution (ADR) A...—Alternative Dispute Resolution (ADR) A. The FAA dispute resolution procedures encourage the parties to..., pursuant to the Administrative Dispute Resolution Act of 1996, Pub. L. 104-320, 5 U.S.C. 570-579, and...

Primary medical care in Irish prisons

OpenAIRE

Barry, Joe M; Darker, Catherine D; Thomas, David E; Allwright, Shane PA; O'Dowd, Tom

2010-01-01

Abstract Background An industrial dispute between prison doctors and the Irish Prison Service (IPS) took place in 2004. Part of the resolution of that dispute was that an independent review of prison medical and support services be carried out by a University Department of Primary Care. The review took place in 2008 and we report here on the principal findings of that review. Methods This study utilised a mixed methods approach. An independent expert medical evaluator (one of the authors, DT)...

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...

Mediation for resolving family disputes

Directory of Open Access Journals (Sweden)

Kamenecka-Usova M.

2016-01-01

Full Text Available Nowadays the understanding of the institute of marriage and its importance in the society has changed. Marriage is no longer assumed to be a commitment for a lifetime. As the principle of equality has replaced hierarchy as the guiding principle of family law it gave more grounds for family disputes and it became socially acceptable to leave marriages that are intolerable or merely unfulfilling. The aim of this article is to suggest an alternative dispute resolution method-mediation as a worthy option for resolving family conflicts.

The South China Sea Dispute: Perspective of International Law

OpenAIRE

Ma, Xuechan

2016-01-01

This article discusses the South China Sea dispute from the perspective of international law. First, it introduces some basic knowledge about international law in this field. In the second part, Spratly islands dispute is used as a concrete example to show how international law analyzes this kind of dispute. Finally, it analyzes the arbitration case between the Philippines and China.

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.

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.

5 CFR 2424.10 - Collaboration and Alternative Dispute Resolution Program.

Science.gov (United States)

2010-01-01

... Alternative Dispute Resolution; Requesting and Providing Allegations Concerning the Duty To Bargain § 2424.10 Collaboration and Alternative Dispute Resolution Program. Where an exclusive representative and an agency are... and Alternative Dispute Resolution Program (CADR). Upon request, and as agreed upon by the parties...

48 CFR 852.233-70 - Protest content/alternative dispute resolution.

Science.gov (United States)

2010-10-01

.../alternative dispute resolution. 852.233-70 Section 852.233-70 Federal Acquisition Regulations System... Provisions and Clauses § 852.233-70 Protest content/alternative dispute resolution. As prescribed in 833.106, insert the following provision: Protest Content/Alternative Dispute Resolution (JAN 2008) (a) Any protest...

48 CFR 6302.30 - Alternative dispute resolution methods (Rule 30).

Science.gov (United States)

2010-10-01

... TRANSPORTATION BOARD OF CONTRACT APPEALS RULES OF PROCEDURE 6302.30 Alternative dispute resolution methods (Rule... Alternative Dispute Resolution (ADR): Settlement Judges and Mini-Trials. These procedures are designed to... 48 Federal Acquisition Regulations System 7 2010-10-01 2010-10-01 false Alternative dispute...

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...

46 CFR 5.71 - Maritime labor disputes.

Science.gov (United States)

2010-10-01

... 46 Shipping 1 2010-10-01 2010-10-01 false Maritime labor disputes. 5.71 Section 5.71 Shipping... REGULATIONS-PERSONNEL ACTION Statement of Policy and Interpretation § 5.71 Maritime labor disputes. Under no circumstances will the Coast Guard exercise its authority for the purpose of favoring any party to a maritime...

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%.

40 CFR 22.18 - Quick resolution; settlement; alternative dispute resolution.

Science.gov (United States)

2010-07-01

...; alternative dispute resolution. 22.18 Section 22.18 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY...; alternative dispute resolution. (a) Quick resolution. (1) A respondent may resolve the proceeding at any time... complaint. (d) Alternative means of dispute resolution. (1) The parties may engage in any process within the...

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.

Real Estate Agent Commission Disputes

Directory of Open Access Journals (Sweden)

Anida Duarte

2015-06-01

Full Text Available The purpose of this study was to examine the relationship among Procuring Cause Law, real estate agent years of experience, and real estate commission disputes. A pilot survey was conducted in the southwestern United States among real estate agents, realtor(s, and brokers. After testing the hypothesis, the decision was made to fail to reject the hypothesis and conclude that real estate agent experience and not Procuring Cause Law produced favorable outcomes in disputes. As a result, the following recommendations were made: (a Agency seller and buyer’s agreements should be used in each transaction to avoid disputes, (b proper expectations and guidelines should be reviewed prior to starting any real estate transaction, (c a checklist may assist in the assurance that all valuable information is reviewed, (d agents could benefit from fully understanding Procuring Cause Law and sharing this information with their clients, (e state and national regulatory requirements of the law could be modified for easier understanding and use, and (f consumers who willfully violate the law could be subject to monetary penalties.

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

The Various forms of Alternative Dispute Resolution (ADR in International Commercial Disputes

Directory of Open Access Journals (Sweden)

Angelica Rosu

2009-06-01

Full Text Available Alternative dispute resolution, usually referred to by the acronym ADR, is the focus ofgrowing interest in the business world, and particularly the international business world. Contractdrafters are continuously inventing new ADR procedures, most of which are derived from, or inspiredby mediation, although in fact this is only one type of alternative dispute resolution. There is no doubtthat ADR has emerged out of practice. At present, there is a very broad range of alternative means ofdispute resolution used in equally broad array of circumstances. An exhaustive list of different typesof ADR cannot be drawn because ADR lends itself to numerous derivatives consisting ofcombinations of common types. Of all the ADR types, mediation is the most traditional and the mostcentral, around which all the other derivatives gravitate.

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.

25 CFR 170.934 - Are alternative dispute resolution procedures available?

Science.gov (United States)

2010-04-01

... 25 Indians 1 2010-04-01 2010-04-01 false Are alternative dispute resolution procedures available... alternative dispute resolution (ADR) procedures is to provide an inexpensive and expeditious forum to resolve... (including for non-construction the mediation and alternative dispute resolution options listed in 25 U.S.C...

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? ...

DISPUTE RESOLUTION MECHANISM IN COMMERCIAL CONSTRUCTION PROJECTS: A REVIEW

OpenAIRE

Priyanka Sakate*, Dr.Arun W. Dhawale

2017-01-01

The number and complexity of contract disputes have increased dramatically in recent years. At the same time, the delays and costs associated with litigation have become more significant. This section provides an overview of dispute resolution methods commonly used. The increasing trend to alternative methods of resolving disputes suggests a considerable dissatisfaction with the traditional litigation process, at least in certain types of construction cases. However, it must be emphasized tha...

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.

Dispute Resolution in Special Education: An Introduction to Litigation Alternatives.

Science.gov (United States)

Goldberg, Steven S.; Huefner, Dixie Snow

1995-01-01

Reviews the advantages and disadvantages of common methods of conflict resolution used in special-education disputes. Argues that "principled negotiation" has been underutilized at the early phase of special-education disputes and shows promise as a means of settling many disputes without the need for mediation or adversarial processes.…

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.

Transparency and public participation in WTO dispute settlement

NARCIS (Netherlands)

Ahlborn, C.S.; Pfitzer, J.H.

2009-01-01

In order to offer a comprehensive analysis of transparency and public participation in the WTO dispute settlement system, this memorandum first considers the current participatory practice throughout the various steps of the dispute settlement process. Secondly, the current state of the DSU

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.

29 CFR 1403.3 - Obtaining data on labor-management disputes.

Science.gov (United States)

2010-07-01

... 29 Labor 4 2010-07-01 2010-07-01 false Obtaining data on labor-management disputes. 1403.3 Section... FUNCTIONS AND DUTIES § 1403.3 Obtaining data on labor-management disputes. When the existence of a labor-management dispute comes to the attention of the Federal Service upon a request for mediation service from...

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 Effectiveness of Alternative IEP Dispute Resolution Practices

Science.gov (United States)

Scanlon, David; Saenz, Lauren; Kelly, Michael P.

2018-01-01

Alternative Individualized Education Program (IEP) dispute resolution models should respond to limitations of current options. An experimental IEP dispute resolution program provides parents and schools with an evidence-supported neutral perspective on what is needed for free and appropriate education (FAPE) and least restrictive environment…

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.

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.

Future Scenarios of the South China Sea Maritime Disputes

OpenAIRE

Shee, Poon Kim

2014-01-01

The focus of this paper is to analyze three future scenarios in the maritime disputes in the South China Sea. These namely are No War Scenario, Impasse Scenario and Peace Scenario. Ultimately, the way forward towards a viable solution to resolving the South China Sea maritime disputes between China and other claimant states depends on the political wisdom, will and determination of the disputing states. Lofty nationalistic aspirations have to be tempered with a degree of flexibility and pragm...

Alternative dispute resolution: a conflict management tool in health care.

Science.gov (United States)

Liberman, A; Rotarius, T M; Kendall, L

1997-12-01

This article focuses on methods of resolving conflict either within or between health care organizations using an alternative dispute resolution (ADR) strategy. After identifying the principal sources of contemporary disagreements within health services settings, the authors describe the basis of ADR. This is followed by a discussion of some common obstacles to settling a dispute. The principal communication guidelines and stages of a mediation session are presented. An alternative dispute resolution framework is proposed that includes an Office of Dispute Resolution (ODR). Also provided is a series of attributes that together comprise the core of mediation as a discipline.

Public private partnership construction project disputes in Nigeria ...

African Journals Online (AJOL)

This research examines the possibility of operating a smooth Public Private Partnership (PPP) project for the entire concession period following financial closure, without recourse to litigation or arbitration for settlement of disputes by studying the causes and effects of disputes in construction projects procured in Nigeria ...

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.

ALTERNATIVE DISPUTE RESOLUTION (ADR DALAM PENYELESAIAN SENGKETA KONSUMEN

Directory of Open Access Journals (Sweden)

Taufikkurrahman Taufikkurrahman

2015-06-01

Full Text Available Consumers often consume goods and / or services resulting in damage, pollution and the loss on himself. So that the rights and obligations himself always disproportionate (balanced. So that consumer rights are not permanently harmed by businesses or otherwise,  the Republic country of Indonesia established a law that became the basis for consumers, businesses, Non-governmental organization and the Government to take  the legal actions as a result of violations committed by parties who are not responsible responsibility. Through UU No. 8 the year 1999 on Consumer Protection became the constitutional basis for businesses and consumers, especially in solving problems (disputes that happened to himelf. Legal effort in problem solving (dispute can use the lines outside the court  (Non-Litigation and through the courts (Litigation. The lines outside the court  carried out by the Consumer Dispute Settlement Board (BPSK. BPSK in resolving disputes of consumer through mediation, arbitration or conciliation.

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...

developing countries and the wto dispute resolution system

African Journals Online (AJOL)

OLAWUYI

outstanding outcomes of the Uruguay round.2 WTO principles are largely based on the ..... In practice it is the preference giving country. (usually a ... Prominent amongst them are; Pakistan, Hong Kong, Malaysia and South ..... 89 World Trade Organization – Dispute Settlement: Dispute DS308 'Mexico – Tax Measures on.

Literacy, Numeracy and Alternative Dispute Resolution: Support Document

Science.gov (United States)

Cumming, J. Joy; Wilson, Janice M.

2005-01-01

This document was produced by the authors based on their research for the report "Literacy, Numeracy and Alternative Dispute Resolution," and is an added resource for further information. It contains the appendices: (1) Published statistics on mediation/alternative dispute resolution in Australian courts and tribunals over the period…

Alternative Dispute Resolution : A Viable Method for Settling Government Contract Disputes

Science.gov (United States)

1993-06-01

Estoppel : Using Preclusion to Shape Procedural Choices," 63 Tulane Law Review 20, 1988. Murray, "Lawyers and Alternative Dispute Resolution Success," 14...1988. Shell, "Res Judicata and Collateral Estoppel Effects of Commercial Arbitration," 35 UCLA Law Review 623, 1988. Shell, "The Role of Public Law in

Dispute Settlement Patterns on The Village Chief Election at Bondowoso Regency

Directory of Open Access Journals (Sweden)

Fauziyah Fauziyah

2015-06-01

Full Text Available Village elections (Pilkades is a direct election procedure and mirrors implementation of democratic life in Indonesia. Article 37 and 38 of the regency Regional Regulation No. 7 of 2006 states that if the Pilkades process turns dispute, the dispute does not stop the next stage. The regency government normatively based on Article 37 guarantees the completion stage of the elections until the inauguration phase and form a team of supervisors who communicate with those who feel aggrieved to get agreement dispute resolution. Until this research is done, there is only one case submitted to the District Court, but then the plaintiffs draw their lawsuit. Dispute settlement pattern research was conducted through interviews and providing information to the bureaucrats and the judiciary in the area of dispute. The involvement of these parties is important that the results of this activity followed up by an independent institution in Pilkades dispute resolution with consideration of existing regional regulations. How To Cite: Fauziyah, F., & Praptianingsih, S. (2015. Dispute Settlement Patterns on The Village Chief Election at Bondowoso Regency. Rechtsidee, 2(1, 11-20. doi:http://dx.doi.org/10.21070/jihr.v2i1.8

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).

FEATURES OF WTO DISPUTE SETTLEMENT. THE STANDING OF THE EU

Directory of Open Access Journals (Sweden)

Costin Horia Rogoveanu

2010-09-01

Full Text Available The WTO has an innovative system of dispute settlement, with the following features: sui-generis, integrated, resolving the disputes according to the WTO agreements, excluding unilateral solutions, interstate system. These features are detailed in the present article. Another level of analysis concerns the standing of the EU in the WTO, in general, and in the Geneva proceedings for dispute settlement, in particular. Generated by the quality of the European Communities statute as an original member of the Organisation, the EU has become one of the main users of the WTO dispute settlement system. One of the main challenges of the WTO dispute settlement mechanism is the implementation of decisions. In view of the cases assessed, while the execution record of the EU is a quite satisfactory one, it is apparent that implementation of decisions in more intricate cases creates difficulties at the Union level.

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.

14 CFR 17.35 - Selection of neutrals for the alternative dispute resolution process.

Science.gov (United States)

2010-01-01

... dispute resolution process. 17.35 Section 17.35 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PROCEDURAL RULES PROCEDURES FOR PROTESTS AND CONTRACTS DISPUTES Alternative Dispute Resolution § 17.35 Selection of neutrals for the alternative dispute resolution process. (a) In...

An expert system to manage dispute resolutions in construction projects in Egypt

Directory of Open Access Journals (Sweden)

A.A. Elziny

2016-03-01

Full Text Available This study attempts to shed a great deal of light on the problem of construction disputes in the Egyptian projects. This paper presents a comprehensive review of the available literature on analysis of disputes. The objective of this paper was to provide an expert system can evaluate the overall dispute settlement procedures at company’s projects. A questionnaire has been used to study dispute sources and resolution methods. Four case study applications have been provided to check the validity of the proposed system. Results confirmed that the most important source of disputes was contract management 74.04%, the second was contract documents 71.49%, the third was financial issues 67.80%, the fourth was project related issues 63.92%, and the lowest one was other sources (such as force majeure 61.58%. Finally, the expert program facilitates dispute resolution by using alternative dispute resolution methods instead of going direct to arbitration or litigation.

THE DISPUTE RESOLUTION MODEL OF VILLAGE HEAD ELECTION THROUGH NON LITIGATION

Directory of Open Access Journals (Sweden)

Sri Praptianingsih

2017-06-01

Full Text Available Article Number 6 of 2014 clauses 37 verses (5 and (6 provides that the regent in the district must resolve the dispute over the election result of the village head within 30 days. At the district level, the Regional Regulations governing the settlement of village head election disputes and regulations are effective in the dispute profession.However, the laws and regulations at the local / district level have not yet clearly defined the form / format of the outcome of the dispute over the election of the village mayors. The specific purpose of this research is to formulate the model form in the effort to solve the disputes of Village mayors Election by doing syncretism of existing strategy. The Urgency of this research that is (a need to build juridical system in handling dispute of village head election; (b the synchronization of district regulations governing the handling of village head election disputes both vertically and horizontally (c needs a dispute resolution strategy by developing a model of settlement that provides protection of constitutional rights and ensures that government agenda.Research activities in Jember, Bondowoso and Lumajang districts, with a total sample of 150 people. Data collection techniques use Participatory Action Research (PAR and Focus Group Discussion (FGD methods. The Data analysis technique using qualitative analysis.The result of this research is the policy of settlement of disputes of village head election is set forth in juridical instrument at local level, result of settlement stated in peace agreement.This Agreement is then submitted to the Court for the issuance of the Deed of Peace in order to ensure the validity of the legal force for the parties.

Alternative Dispute Resolution in Ethiopia - A Legal Framework

African Journals Online (AJOL)

Nekky Umera

position of usage and acceptance in its modern form. Recent ... bound to be consequences arising out of such struggles. ... though a court may order the process itself, the parties in dispute are ... wishes to recommend to solving disputes among African .... rights, actions and claims in a suit, it automatically results in the ...

Alternative Dispute Resolution in Ethiopia- A Legal Framework ...

African Journals Online (AJOL)

This article will attempt to explore the regime of Alternative Dispute Resolution in Ethiopia, its legal framework, current practices and the way forward. The implication of the need to embrace the use of Alternative Dispute Resolution by all stakeholders was also be analyzed. African Research Review Vol. 2 (2) 2008 pp. 265- ...

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.

Let's talk conflict: using mediation in healthcare security disputes.

Science.gov (United States)

Armstrong, Brad

2013-01-01

Healthcare security administrators face weekly, if not daily challenges and conflict. This article considers that security leaders must anticipate disputes in highly complex healthcare systems. When disputes cannot be resolved by organizational efforts, security administrators may be in a position to recommend or participate in mediation. Here the concept of mediation is introduced to healthcare security leaders as a viable means to resolve disputes with patients, visitors, and the community. This includes a description of the facilitative versus evaluative mediation processes, as well as pragmatic guidance when preparing for mediation.

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 

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.

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...

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.

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

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...

Dispute Resolution and Technology: Revisiting the Justification of Conflict Management

OpenAIRE

Koulu, Riikka

2016-01-01

This study, Dispute Resolution and Technology: Revisiting the Justification of Conflict Management, belongs to the fields of procedural law, legal theory and law and technology studies. In this study the changes in dispute resolution caused by technology are evaluated. The overarching research question of this study is how does implementing technology to dispute resolution challenge the justification of law as a legitimised mode of violence? Before answering such an abstract research question...

Disputes About Disputes: Understanding the South China Sea

Directory of Open Access Journals (Sweden)

Bill Hayton

2017-12-01

Full Text Available Steve Chan. China’s Troubled Waters: Maritime Disputes in Theoretical Perspectives. Cambridge: Cambridge University Press, 2016. Do Thanh Hai. Vietnam and the South China Sea: Politics, Security and Legality. New York: Routledge, 2017. The two books under review here demonstrate some of the diversity of writing within the discipline of international relations. In China’s Troubled Waters: Maritime Disputes in Theoretical Perspectives, political scientist Steve Chan, following Kant, describes his style as “nomothetic,” “which emphasizes attention to classes of events rather than specific episodes” (vii. Strategic and defense studies scholar Do Thanh Hai’s Vietnam and the South China Sea: Politics, Security and Legality is an example of what Chan calls the “idiographic approach,” focusing “on the more unique or specific aspects of the situation” (vii. Chan wants to be able to generalize and compare, and he explicitly eschews narratives of “who did what to whom.” Hai, on the other hand, is keen to make clear that it is China who did something to Vietnam. The most obvious criticism to make of his book is that it is written from an overtly Vietnamese perspective. That is a weakness, but also potentially a draw for those interested in the formulation of Vietnamese policy. Chan writes from an ostensibly neutral position, but, as we shall see, his analysis is rooted within a Chinese world view.

Dismissal Disputes and the Incentives to Bargain: Estimates of the Contract Zone

OpenAIRE

Benoit P. Freyens

2011-01-01

In many countries the arbitration of dismissal disputes by public tribunals and state agencies is regarded as slow and expensive. Some common law countries, including the United States and Australia, are privatizing dispute resolution on the premise that this is more efficient than using statutory channels, and it is thus perceived as a better method of settling disputes. Previous advances in statutory law regarding the arbitration of dismissal disputes have been either rescinded or circumven...

5 CFR 2423.2 - Alternative Dispute Resolution (ADR) services.

Science.gov (United States)

2010-01-01

... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Alternative Dispute Resolution (ADR) services. 2423.2 Section 2423.2 Administrative Personnel FEDERAL LABOR RELATIONS AUTHORITY, GENERAL COUNSEL... Filing, Investigating, Resolving, and Acting on Charges § 2423.2 Alternative Dispute Resolution (ADR...

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...

Emotion and ideology in the nuclear dispute

International Nuclear Information System (INIS)

Hillerbrand, M.

1982-01-01

The author attempts to examine the dispute over nuclear energy, not from an isolated viewpoint but from more generous perspectives. He provides parallels to economic theories and above all analyses the social political aspects. Here he reveals that behind the passionate confrontation are not scientific, objective criteria but highly subjective emotions based on everyday experiences. In conclusion the author shows that the nuclear energy dispute is part of a fundamental discussion on the industrial performance society. (orig./HP) [de

ALTERNATIVE DISPUTE RESOLUTION IN BANYUMAS REGENCY: IN THE PERSPECTIVE OF CULTURAL STUDIES

Directory of Open Access Journals (Sweden)

Singkir Hudijono

2012-11-01

Full Text Available This study discusses about an Alternative Dispute Resolution in BanyumasRegency as a non-litigation dispute resolution. The problem observed was a breakthroughtaken by the Society in Banyumas Regency in overcoming the so far deadlock of lawenforcement and the attitude of not trusting the justice enforcement. It has been a publicsecret that the dispute resolutions employing the legal centralism paradigm have beendominated by the judicial network. This has caused the acknowledgement of the state lawto decrease, being a commodity that can be traded. The research aims at finding out anddescribing how the alternative dispute resolution (ADR emerges as an alternativemechanism in deconstructing the legal centralism; interpreting and describing what ismeant by the alternative dispute resolution (ADR in the development of progressive law.This research was conducted employing qualitative method. In this context, theresearcher explored various pieces of related information with the reason that the societyin Banyumas Regency has chosen the alternative dispute resolution mechanism as themechanism in deconstructing the legal centralism. The research was conducted asfollows: the problems were identified, the theories for analyzing the data were selected,the primary and secondary data were collected, the collected data were analyzed andinterpreted, and finally, the results of the research were written and constructed. Thetheories employed were critical legal studies, deconstruction, and large narration criticismtheories.The results of the research show that: firstly, the alternative dispute resolution hasemerged because of the awakened local knowledge, as the form of anticipation to theineffective formal law domination. With regard to the effect of global intercourse, thealternative dispute resolution has emerged because of the refusal against the culturalhomogeneity. Secondly, the implementation of the alternative dispute resolution hasbecome the preferred

Litigation and the Timing of Settlement: Evidence from Commercial Disputes

OpenAIRE

Peter Grajzl; Katarina Zajc

2015-01-01

Although an overwhelming proportion of all legal disputes end in settlement, the determinants of the timing of settlement remain empirically underexplored. We draw on a novel dataset on the duration of commercial disputes in Slovenia to study how the timing of settlement is shaped by the stages and features of the litigation process. Using competing risk regression analysis, we find that events such as court-annexed mediation and the first court session, which enable the disputing parties to ...

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

75 FR 57233 - 340B Drug Pricing Program Administrative Dispute Resolution Process

Science.gov (United States)

2010-09-20

... administrative procedures associated with alternative dispute resolution. Systems must be put in place that... that the alternative dispute resolution process would involve some type of hearing. The hearing could... available to HRSA, such as audits and alternative dispute resolution, the Affordable Care Act provides HRSA...

ALTERNATIVE DISPUTE RESOLUTION – CREATING VALUE OUT OF CONFLICT

Directory of Open Access Journals (Sweden)

ADRIANA ALMASAN

2011-04-01

Full Text Available The paper is deemed to present the advantages of resolving a dispute or a potential dispute throughout negotiation. This alternative of dispute resolution to legal proceedings in front of the law court may be considered as more favorable to the parties in conflict, from an economical perspective. Therefore the scope of the paper herein is eventually to establish that a conflict may generate value by negotiation. Further to the conclusion that by negotiation, a conflict may be solved more efficiently, the objectives of the paper are to identify (i the role played by the legal counsel in identifying the values thereto and (ii the mechanisms leading to such effect, as well as (iii the intrinsic connection between law and economics in an adequate approach of the negotiation throughout a commercial dispute. Not lastly, the paper has as objective identifying the key elements of a settlement agreement that are reflecting the added value.

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.

Potential of mediation for resolving environmental disputes related to energy facilities

Energy Technology Data Exchange (ETDEWEB)

None

1979-12-01

This study assesses the potential of mediation as a tool for resolving disputes related to the environmental regulation of new energy facilities and identifies possible roles the Federal government might play in promoting the use of mediation. These disputes result when parties challenge an energy project on the basis of its potential environmental impacts. The paper reviews the basic theory of mediation, evaluates specific applications of mediation to recent environmental disputes, discusses the views of environmental public-interest groups towards mediation, and identifies types of energy facility-related disputes where mediation could have a significant impact. Finally, potential avenues for the Federal government to encourage use of this tool are identified.

The South China Sea Dispute : Perspective of International Law

NARCIS (Netherlands)

Ma, Xuechan

2016-01-01

This article discusses the South China Sea dispute from the perspective of international law. First, it introduces some basic knowledge about international law in this field. In the second part, Spratly islands dispute is used as a concrete example to show how international law analyzes this kind of

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.

46 CFR 502.411 - Mediation and other alternative means of dispute resolution.

Science.gov (United States)

2010-10-01

... 46 Shipping 9 2010-10-01 2010-10-01 false Mediation and other alternative means of dispute... PROVISIONS RULES OF PRACTICE AND PROCEDURE Alternative Dispute Resolution § 502.411 Mediation and other alternative means of dispute resolution. (a) Parties are encouraged to utilize mediation or other forms of...

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...

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.

The mutual agreement procedure and arbitration of double taxation disputes

OpenAIRE

Ilias Bantekas

2008-01-01

It is in the interest of most states to eliminate double taxation (i.e. the payment of the same tax in two jurisdictions) of transnational commercial enterprises. Because such disputes involve, on the one hand, the state imposition of taxes, a right universally asserted by all states, and private entities on the other, taxation disputes between such parties are not, on their face, easily susceptible to arbitration. This article analyzes two dispute settlement procedures-the OECD First Model T...

Dispute settlement process under GATT/WTO diplomatic or judicial ...

African Journals Online (AJOL)

This paper probes the mechanisms of the dispute resolution process under the World Trade Organisation (WTO) and the General Agreement on Tariff and Trade (GATT). It tries to analyse the evolution of the dispute process which was initially based on diplomatic procedures and gives an account of its evolution and ...

#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...

Infanticide for handicapped infants: sometimes it's a metaphysical dispute.

Science.gov (United States)

Long, T A

1988-01-01

Since 1973 the practice of infanticide for some severely handicapped newborns has been receiving more open discussion and defence in the literature on medical ethics. A recent and important argument for the permissibility of infanticide relies crucially on a particular concept of personhood that excludes the theological. This paper attempts to show that the dispute between the proponents of infanticide and their religious opponents cannot be resolved because one side's perspective on the infant is shaped by a metaphysics that is emphatically rejected by the other. In such a situation philosophical argument is powerless to bring about a resolution because there can be no refutation of one side by the other. PMID:2969052

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.

Influence of Course in Medical Ethics and Law on Career Plans of Medical Students

Science.gov (United States)

Cheng, Shi-Yann; Lin, Lih-Hwa; Kao, Chung-Han; Chan, Tzu-Min

2015-01-01

Background: The significant increase in medical disputes and lawsuits in recent years in Taiwan has severely affected behavior and ecology in medical practice. For this reason, we designed integrated courses on ethics and law and conducted a questionnaire-based career plan study to understand whether these issues influence their specialty…

Settlement of Tax Disputes in the Russian Federation and Germany

Directory of Open Access Journals (Sweden)

Anastasiya Alexandrovna Konyukhova

2015-01-01

Full Text Available This article is devoted to the settlement of tax disputes in the Russian Federation and the Federal Republic of Germany. The features of the conflict settlement mechanism are both shown in the stage of administrative and judicial review. In accordance with German law, the administrative stage of dispute resolution, carried out by the tax authority, always precedes the filing of a complaint to a court. Consequently, the taxpayer submits his first application in writing to the tax authority that issued the tax act, though in some cases to a higher tax authority. This obligatory procedure was borrowed by the Russian tax system. The trial stage of tax dispute settlement in Germany is carried out by specialized courts, forming a two-level system for legal proceedings. Thus, the tax dispute submitted to the Court is settled first by the financial lands courts and then by the higher Federal Financial Court. However, the Federal Financial Court takes into consideration only certain categories of actions listed in the Act (the Regulations of finance courts (Finanzgerichtordnung. In Russia appeals of administrative review of tax conflicts, unlike in the German system, are handled by arbitration and general jurisdiction courts. The Supreme Arbitration Court of the Russian Federation is the supreme judicial body for settling economic disputes and other cases considered by arbitration courts in implementing federal procedural judicial supervision over their activities and provides explanations regarding judicial practices. Arbitration courts established at the level of the Federation to resolve disputes involving commercial entities, e.g. enterprises and entrepreneurs, resolve the bulk of tax disputes. These courts are composed of specially created panels of judges known as bars, i.e. groups of judges who specialize in reviewing taxation cases.

From Conciliation to Mediation in Family Disputes-Harmonization of Croatian Family Legislation on Peaceful Resolution of Family Disputes with EU law

Directory of Open Access Journals (Sweden)

Paula Poretti

2015-01-01

Full Text Available The reform process of family law was initiated with one aim to promote protection of family and children and harmonize Croatian law with European and international standards in this field. In this respect, the intervention institute governed by Croatian family law with the purpose to facilitate reconciliation or in cases where reconciliation between spouses is not achieved, to provide information regarding legal consequences of divorce and possibly to achieve agreement between spouses as for their relationship in future was deemed inadequate in regards to the approach provided by European documents on regulation of peaceful resolution of family disputes. Under the influence thereof, new family legislation redefines intervention and introduces mandatory counselling and family mediation as foundations of the system of alternative dispute resolution of all family disputes in Croatian law.

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.

FINANCIAL SYSTEM OF JAPAN: THE LEGAL REGULATION OF DISPUTES BETWEEN FINANCIAL SERVICES PROVIDERS AND CONSUMERS

Directory of Open Access Journals (Sweden)

E. E. Frolova

2018-01-01

Full Text Available Purpose: the article examines the main problems associated the regulatory acts of Japan – The Financial Instruments and Exchange Act, The Banking Act, The  Insurance Business Act, lists the types of financial disputes subject to alternative settlement, identified the parties to the financial dispute. To achieve this goal, the article must solve the following tasks: to determine whether there are institutions in Japan that provide services for resolving financial disputes; to investigate the main problems associated with the definition of the concept and types of financial dispute, the conditions for the transfer of a financial dispute to the competent authority.Methods: this article is based on an interdisciplinary concept of research, which allowed to distinguish the distinctive features of the legal regulation of the settlement of financial disputes in Malaysia.Results: acts of Japan – The Financial Instruments and Exchange Act, The Banking Act, The Insurance Business Act, – refer to financial disputes – disputes resolved by "Designated Dispute Resolution Organizations", the so-called "financial DDRO". Financial disputes are disputes between suppliers and consumers of financial services. The Financial Instruments and Exchange Act details the persons, whose activities fall within the definition of financial provider services. A brief list of financial service providers is available on the website of Japan's main financial regulator, the Financial Services Agency. The list include: Japanese banking institutions, branches and representative offices of foreign banks, business operators of financial instruments, insurance companies, trust companies, financial markets, foreign audit firms. However, unlike other countries of the Asia-Pacific region, consumers of financial services can be both physical and legal entities.Conclusions and Relevance: the materials presented in the article show the special role of "Designated Dispute Resolution

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.

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...

China's Crisis Bargaining in the South China Sea Dispute (2010-2013)

OpenAIRE

Ramadhani, Eryan

2014-01-01

As one of China’s most intricate territorial dispute, the South China Sea dispute has sufficiently consumed significant amount of Chinese leaders’ attention in Beijing. This paper reveals that China exerts signaling strategy in its crisis bargaining over the South China Sea dispute. This strategy contains reassurance as positive signal through offering negotiation and appearing self-restraint and of negative signal by means of escalatory acts and verbal threats. China’s crisis bargaining in t...

Health care alliances and alternative dispute resolution: managing trust and conflict.

Science.gov (United States)

Rotarius, T; Liberman, A

2000-03-01

The U.S. health care industry has entered an unprecedented era of alliance activity. These alliances involve medical groups and hospitals, as well as many of the newer health care entities such as managed care organizations and integrated delivery systems. The increase in organizational collaboration has resulted in an increase in organizational conflict. Alternative dispute resolution (ADR) techniques can serve as a valuable tool for mitigating this type of conflict. The role of ADR is to refocus partners' attentions away from an adversarial posture and toward a complementary existence. This will permit the partners to realize the intended outcomes of the collaboration.

Territorial disputes simmer in areas of South China Sea

International Nuclear Information System (INIS)

Anon.

1992-01-01

This paper reports that China's award of an exploration cooperation contact in the Nansha area of the South China Sea has revived territorial disputes in the area centering ton the Spratly and Paracel islands. The key dispute is between China and Viet Nam, which earlier engaged in military action over ownership of the islands, believed to have world class potential for hydrocarbon discoveries. Those two nations, as well as Brunei, Malaysia, Philippines, and Taiwan, lay claim to overlapping boundaries of the Spratly Islands. Separately, China and Viet Nam dispute territorial claims in the Paracels. Tensions continue to mount, and regional governments are trying to negotiate compromises to avoid a repeat of warfare

DISPUTE RESOLUTION OF FOREIGN DIRECT INVESTMENT IN CHINA

Directory of Open Access Journals (Sweden)

Fiska Silvia Raden Roro

2012-09-01

Full Text Available Corruption activity in this modern era keeps hurting the implementation of foreign investment in Indonesia, especially for the dispute settlement aspect. Unfortunately, today, Indonesia is one of the interesting place for foreign investment destination, especially for consumer goods manufacturers. This situation happened because of Indonesia’s great resources which is totally supportive to business development activity. This article was intended to spur the development of Indonesia’s legal system, especially about foreign investment, and also to explain how the dispute resolution on foreign investment in Chinese Regime perspective, including considerations of how Chinese culture and settlement in foreign investment, methods of negotiation, mediation, arbitration. It will also be discussed how the practice of the settlement of disputes through litigation also the enforcement of foreign arbitral awards and the enforcement of a foreign court related to Chinese Regime.

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.

Decision making in civil disputes

Directory of Open Access Journals (Sweden)

Victoria Gilliland

2008-10-01

Full Text Available The present study investigates the effect of framing and legal role on the propensity to accept a settlement offer by litigants in a simulated legal dispute. Participants were given four different scenarios that factorially combined legal role (plaintiff vs. defendant and frame (positive vs. negative. The results indicated that positively framed litigants were more willing to settle than negatively framed litigants independently of legal role. These results were replicated in a second experiment that also asked participants to state their subjective probability of winning. This revealed that the propensity to settle was a joint function of frame and the perceived chance of winning. In contrast to previous research, no systematic effect of legal role was found. It is concluded that the rate of negotiated settlements of legal disputes may be increased by manipulating both of these factors.

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.

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.

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.

Alternative dispute resolution (ADR) for dentists: a better way.

Science.gov (United States)

Freudman, L

1998-06-01

Any dentist faced with a legal or potential legal dispute should consider all the options available to handle the dispute. Selection of the appropriate process may be approached from a consumer's perspective, with the emphasis on service, value and satisfaction. Awareness of ADR and its proper utilization can assist the dentist in choosing the method that will result in the most satisfactory outcome.

The role of health care ADR (alternative dispute resolution) in reducing legal fees.

Science.gov (United States)

Joseph, D M

1995-11-01

An increasingly complex health care system undergoing rapid changes is an ideal set-up for frequent conflicts among the numerous participants. While conflict is inevitable, the manner in which it is handled can markedly affect the outcome of the dispute and the future relationship of the parties, as well as the emotional and financial cost of the dispute. This article presents an overview of the principles and processes of alternative dispute resolution (ADR), and describes how these processes are currently being used to resolve health care disputes.

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.)

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.

Physician perspectives on legal processes for resolving end-of-life disputes.

Science.gov (United States)

Chidwick, Paula; Sibbald, Robert

2011-01-01

In order to understand how to effectively approach end-of-life disputes, this study surveyed physicians' attitudes towards one process for resolving end-of-life disputes, namely, the Consent and Capacity Board of Ontario. In this case, the process involved examining interpretation of best interests between substitute decision-makers and medical teams. Physicians who made "Form G" applications to the Consent and Capacity Board of Ontario that resulted in a decision posted on the open-access database, Canadian Legal Information Institute (CanLii), were identified and surveyed. This purposive sample led to 13 invitations to participate and 12 interviews (92% response rate). Interviews were conducted using a prescribed interview guide. No barriers to the Consent and Capacity Board process were reported. Applications were made when physicians reached an impasse with the family and further treatment was perceived to be "unethical." The most significant challenge reported was the delay when appeals were launched. Appeals extended the process for an indefinite period of time making it so lengthy it negated any perceived benefits of the process. Benefits included that a neutral third party, namely the Consent and Capacity Board, was able to assess best interests. Also, when decisions were timely, further harm to the patient was minimized. Physicians reported this particular approach, namely the Consent and Capacity Board has a mechanism that is worthwhile, patient centred, process oriented, orderly and efficient for resolving end-of-life disputes and, in particular, determining best interests. However, unless the appeal process can be adjusted to respond to the ICU context there is a risk of not serving the best interest of patients. Physicians would recommend framing end-of-life treatment plans in the positive instead of negative, for example, propose palliative care and no escalation of treatment as opposed to withdrawal.

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

A conflict model for the international hazardous waste disposal dispute

International Nuclear Information System (INIS)

Hu Kaixian; Hipel, Keith W.; Fang, Liping

2009-01-01

A multi-stage conflict model is developed to analyze international hazardous waste disposal disputes. More specifically, the ongoing toxic waste conflicts are divided into two stages consisting of the dumping prevention and dispute resolution stages. The modeling and analyses, based on the methodology of graph model for conflict resolution (GMCR), are used in both stages in order to grasp the structure and implications of a given conflict from a strategic viewpoint. Furthermore, a specific case study is investigated for the Ivory Coast hazardous waste conflict. In addition to the stability analysis, sensitivity and attitude analyses are conducted to capture various strategic features of this type of complicated dispute.

A conflict model for the international hazardous waste disposal dispute.

Science.gov (United States)

Hu, Kaixian; Hipel, Keith W; Fang, Liping

2009-12-15

A multi-stage conflict model is developed to analyze international hazardous waste disposal disputes. More specifically, the ongoing toxic waste conflicts are divided into two stages consisting of the dumping prevention and dispute resolution stages. The modeling and analyses, based on the methodology of graph model for conflict resolution (GMCR), are used in both stages in order to grasp the structure and implications of a given conflict from a strategic viewpoint. Furthermore, a specific case study is investigated for the Ivory Coast hazardous waste conflict. In addition to the stability analysis, sensitivity and attitude analyses are conducted to capture various strategic features of this type of complicated dispute.

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.

Conciliation as the traditional method of disputes settlement in PRC

Directory of Open Access Journals (Sweden)

Svetlana F. Litvinova

2011-12-01

Full Text Available The author of the article researches one of the peculiarities of civil disputes settlement in China. This peculiarity is the conciliatory method that is used during disputes settlement. The using of the method is based on Confucianism. The content of the method has been viewed in the article.

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.

Investor-State Dispute Settlement Mechanism: The Quest for a Workable Roadmap

Directory of Open Access Journals (Sweden)

Sachet Singh

2013-01-01

Full Text Available The last decade has witnessed an unprecedented increase in the use of investor-State arbitration, highlighting numerous shortcomings of the existing investor-State dispute settlement system. The legitimacy of the International Investment regime has been under severe criticism due to the growing discontent amongst the investors as well as the host States. The increased litigation has led to both the process and the outcome being questioned and has undermined the growth of harmonious relationships between foreign investors and host States. The object of this paper is to explore a workable roadmap for the investor-State dispute settlement mechanism by tracing the evolution of the existing system and by analysing the dispute settlement mechanism in major international investment agreements. Furthermore, it highlights the causes and the possible consequences of the denunciation of Bilateral Investment Treaties ('BITs' and the International Centre for Settlement of Investment Disputes ('ICSID' by host nations, which have been plagued by a myriad of investment suits. The authors suggest the need for doing away with highly protective investor-State dispute settlement mechanisms ('ISDSMs' in future investment agreements and recommend the need for designing an appellate mechanism for bringing consistency and predictability to the system.

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

["The severe degree of negligence" and its application in the settle of medical malpractice].

Science.gov (United States)

Wang, You-Min; Zhang, Qin-Chu

2006-04-01

To found the quantifiable index of "The severe degree of negligence" in describing the general severity degree of medical malpractice or medical dispute. "The severe degree of negligence" can be calculated by the way of multiplying the coefficient of medical malpractice's grade by the coefficient of responsibility degree. There are 15 grades of "The severe degree of negligence" through calculation, from the severest degree of 1 to the lightest degree of 20. "The severe degree of negligence" can give an order of severe degree to different grade and different responsibility of medical malpractice. According to this order, the operation of medical malpractice and medical dispute settle will be easier and more rationality.

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.

10 CFR 904.13 - Disputes.

Science.gov (United States)

2010-01-01

... disputing Contractor's remedy lies with the appropriate Federal court. Any claim that a final decision of... Federal court of competent jurisdiction within one (1) year after final refusal by the Administrator to... Commercial Arbitration Rules of the American Arbitration Association. The two arbitrators thus selected shall...

43 CFR 431.8 - Disputes.

Science.gov (United States)

2010-10-01

... decision becoming final, the disputing Contractor's remedy lies with the appropriate Federal court. Any... such claim is filed in a Federal court of competent jurisdiction within one year after final refusal by... arbitrator shall be named as provided in the Commercial Arbitration Rules of the American Arbitration...

ARBITRATION – AN ALTERNATIVE SETTLEMENT OF INTERNATIONAL TRADE DISPUTES

Directory of Open Access Journals (Sweden)

Gabriel MIHAI

2016-07-01

Full Text Available Arbitration is today considered a form of justice adjusted specifically for disputes between traders, representing a special attraction for the business world. Arbitration can be considered as a refuse reflex from the traders to obey close-minded forms of common law procedure, characterized by excessive rigor or conservatism and as an expression of their propensity towards more malleable means of settling disputes, specific to arbitration.

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.

42 CFR 422.311 - RADV audit dispute and appeal processes.

Science.gov (United States)

2010-10-01

... Organizations § 422.311 RADV audit dispute and appeal processes. (a) Risk adjustment data validation (RADV) audits. In accordance with § 422.2 and § 422.310(e), CMS annually conducts RADV audits to ensure risk... 42 Public Health 3 2010-10-01 2010-10-01 false RADV audit dispute and appeal processes. 422.311...

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

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.

Language as an Instrument for Dispute Resolution in Modern Justice

Directory of Open Access Journals (Sweden)

Drabarz Anna K.

2017-12-01

Full Text Available The frustration in Polish society arising from excessive costs of conducting court proceedings and lengthy delays for dispute resolution has resulted in a genuine limitation in access to judicial justice for citizens. This paper argues that the answer to the dilemma between ensuring both justice and efficiency lies in language being a tool for the active participation of the parties in building mutual trust and shaping solutions in conflictual circumstances. How should the postulate of effective communication leading to dispute resolution in modern justice be achieved? The authors present the advantages of oral communication in proceedings on the way to finding agreement, pointing out the content and quality of language that make dispute resolution possible.

18 CFR 385.606 - Confidentiality in dispute resolution proceedings (Rule 606).

Science.gov (United States)

2010-04-01

... be required to disclose, any information concerning any dispute resolution communication or any communication provided in confidence to the neutral, unless: (1) All participants in the dispute resolution... reducing the confidence of participants in future cases that their communications will remain confidential...

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...

77 FR 23539 - WTO Dispute Settlement Proceeding Regarding European Communities and Certain Member States...

Science.gov (United States)

2012-04-19

... OFFICE OF THE UNITED STATES TRADE REPRESENTATIVE [Dispute No. WTO/DS316] WTO Dispute Settlement... Organization (``WTO Agreement''). That request may be found at www.wto.org contained in a document designated... a WTO dispute settlement panel. Consistent with this obligation, USTR is providing notice that it...

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

Supporting Children to Resolve Disputes

Science.gov (United States)

Church, Amelia; Mashford-Scott, Angie; Cohrssen, Caroline

2018-01-01

Teacher intervention in children's disputes most commonly features cessation strategies, despite evidence showing the value of modelling problem-solving behaviours. Existing research has categorized strategies used by teachers in early childhood settings, but in this article we aim to illustrate how these practices are realized. Using the method…

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...

The supply chain of tobacco as disputes field

Directory of Open Access Journals (Sweden)

Alex Alexandre Mengel

2017-08-01

Full Text Available The paper analyzes the existing conflicts in the tobacco production chain in Brazil and the strategies historically established by each agent. Therefore, we interpret the tobacco production chain as a field of disputes. As methodological tools we conducted to literature review and semi-structured interviews. Among the results, we found that, in general, the actors in the tobacco field take three types of strategies: 1 the defense of the field; 2 intermediate strategic positions mulling conflicting historical disputes in the field; 3 positions contrary to the tobacco field.

African Countries and WTO´s Dispute Settlement Mechanism

DEFF Research Database (Denmark)

Alavi, Amin

2007-01-01

The WTO Dispute Settlement Mechanism was designed, inter alia, to secure the 'rule of law' within international trade and provide all members with opportunities to exercise their rights under multilateral trade agreements. But, after ten years, no sub-Saharan African country has yet used the option...... to initiate a dispute. This article examines what prevents the WTO Africa Group from using the system and critically reviews the solutions they have proposed to remedy this. It concludes by discussing how this reflects broader problems concerning African participation in WTO, and puts forward some alternative...

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.

Oil and Gas Development in Disputed Waters under UNCLOS

OpenAIRE

Yiallourides, Constantinos

2016-01-01

Maritime delimitation is crucial in determining which coastal States may exercise control and jurisdiction over certain hydrocarbon deposits. Although international law has recently become more precise on the matter, boundary disputes are frequently resolved only after several or even many years. Even while coastal States are in a deadlock over delimitation issues, the need to explore and exploit the disputed areas’ resources remains imperative for reasons of energy security, social welfare a...

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.

44 CFR 327.4 - Disputes.

Science.gov (United States)

2010-10-01

... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Disputes. 327.4 Section 327.4 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY, DEPARTMENT OF HOMELAND SECURITY PREPAREDNESS POLICY ON USE OF GOVERNMENT-OWNED INDUSTRIAL PLANT EQUIPMENT BY PRIVATE INDUSTRY (DMO-10A) § 327.4...

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)

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

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.

Forms and causes of labor disputes

Directory of Open Access Journals (Sweden)

Denada Keçiçi

2016-07-01

Full Text Available Labor disputes can be small or large, individual or collective, refer to a particular job or lie in more than one enterprise. The causes of these disputes are numerous and diverse, ranging from a simple appeal of one individual employee for the right of compensation, in a collective complaint of the employees about the unsafe or unhealthy conditions of work, or termination of work by all employees in a workplace, claiming that they are prevented from setting up a union to protect their interests. The product of this process is a binding agreement for its implementation and is the result of ongoing cooperation between employees and employers based on consensual decision. Organizations of employees are important actors of collective conflict resolution procedures of labor relations, and particularly those held in the offices of reconciliation, should revitalize their role.

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

Islamic Banking in Malaysia: Arbitration Resolution of Financial Disputes and Obstacles to its Spread