Safety assessment of medical devices includes sterilization and biological evaluation or biocompatability testing. Sterilization by ETO gas is criticised for their carcinogenic potency or even banned. Mutual acceptance of biological evaluation test results is promoted by a laboratory accreditation and qualification program. (Author)
Edlich, Richard F; Long, William B; Gubler, K Dean; Rodeheaver, George T; Thacker, John G; Borel, Lise; Chase, Margot E; Cross, Catherine L; Fisher, Allyson L; Lin, Kant Y; Cox, Mary J; Zura, Robert B
During the last 25 years, scientific experimental and clinical studies have documented the dangers of cornstarch powder on examination and surgical gloves because the cornstarch promotes wound infection, causes serious peritoneal adhesions and granulomatous peritonitis, and is a well-documented vector of the latex allergy epidemic in the world. Realizing the dangers of cornstarch on examination and surgical gloves, Germany's regulations of personal protective equipment banned the use of surgical glove powder cornstarch in 1997. In 2000, the Purchasing and Supply agency for the United Kingdom ceased to purchase any gloves lubricated with cornstarch. Realizing the dangers of cornstarch-powdered gloves, many hospitals and clinics in the United States have banned the use of cornstarch-powdered examination and surgical gloves. Hospitals that have banned cornstarch in their examination and surgical gloves have noted a marked reduction in the latex allergy epidemic in their facilities. Realizing the dangers of cornstarch-powdered examination and surgical gloves, Dr Sheila A. Murphey, branch chief, Infection Control Devices Branch, Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation, Center for Devices and Radiological Health of the Food and Drug Administration (FDA), recommended that a Citizen's Petition be filed to the FDA to ban cornstarch on surgical and examination gloves. The 12 authors of this report have attached the enclosed petition to the FDA to ban the use of cornstarch on all synthetic and latex examination and surgical gloves used in the United States.
At the University of Twente we have been researching mobile healthcare applications since 1999. Since 2002 the University of Twente and partners have been developing health Body Area Networks (BANs) and a BAN service platform. We define a BAN as a network of communicating devices worn on, around or
Jones, Val; Jones, Val
At the University of Twente we have been researching mobile healthcare applications since 1999. Since 2002 the University of Twente and partners have been developing health Body Area Networks (BANs) and a BAN service platform. We define a BAN as a network of communicating devices worn on, around or in the body which provides mobile services to the user. The BAN may also communicate to remote users such as healthcare providers via external network services such as GPRS or UMTS. The generic BAN...
Fragkos, Vasileios; Katzis, Konstantinos; Despotou, Georgios
Recent advances in medical and electronic technologies have introduced the use of Body Area Networks as a part of e-health, for constant and accurate monitoring of patients and the transmission as well as processing of the data to develop a holistic Electronic Health Record. The rising global population, different BAN manufacturers and a variety of medical systems pose the issue of interoperability between BANs and systems as well as the proper way to propagate medical data in an organized and efficient manner. In this paper, we describe BANs and propose the use of certain web technologies to address this issue.
A medical device is any product used to diagnose, cure, or treat a condition, or to prevent disease. They ... may need one in a hospital. To use medical devices safely Know how your device works. Keep ...
Implantable Electronic Medical Devices provides a thorough review of the application of implantable devices, illustrating the techniques currently being used together with overviews of the latest commercially available medical devices. This book provides an overview of the design of medical devices and is a reference on existing medical devices. The book groups devices with similar functionality into distinct chapters, looking at the latest design ideas and techniques in each area, including retinal implants, glucose biosensors, cochlear implants, pacemakers, electrical stimulation t
... Artery Disease Venous Thromboembolism Aortic Aneurysm More Implantable Medical Devices Updated:Sep 16,2016 For Rhythm Control ... a Heart Attack Introduction Medications Surgical Procedures Implantable Medical Devices • Life After a Heart Attack • Heart Attack ...
Baarda, Marianne; Jones, Valerie M.; Stemerding, Dirk
The University of Twente and partners are developing and prototyping Body Area networks (BANs) for healthcare. We define a BAN as a network of devices worn on or around the body which communicate amongst themselves and perform a set of services for the user. Our work began with the European
Ogrodnik, Peter J
The Case Studies in Medical Devices Design series consists of practical, applied case studies relating to medical device design in industry. These titles complement Ogrodnik's Medical Device Design and will assist engineers with applying the theory in practice. The case studies presented directly relate to Class I, Class IIa, Class IIb and Class III medical devices. Designers and companies who wish to extend their knowledge in a specific discipline related to their respective class of operation will find any or all of these titles a great addition to their library. Class 1 Devices is a companion text to Medical Devices Design: Innovation from Concept to Market. The intention of this book, and its sister books in the series, is to support the concepts presented in Medical Devices Design through case studies. In the context of this book the case studies consider Class I (EU) and 510(k) exempt (FDA) . This book covers classifications, the conceptual and embodiment phase, plus design from idea to PDS. These title...
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.
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
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
Regner, M; Sabatowski, R
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.
Fahy, Declan; Trench, Brian; Clancy, Luke
The Irish workplace smoking ban has been described as possibly a tipping point for public health worldwide. This article presents the first analysis of the newspaper coverage of the ban over the duration of the policy formation process. It adds to previous studies by analyzing how health communication strategists engaged, over time, with a newsworthy topic, viewed as being culturally controversial. It analyzes a sample of media content (n = 1,154) and firsthand accounts from pro-ban campaigners and journalists (n = 10). The analysis shows that the ban was covered not primarily as a health issue: Economic, political, social, democratic, and technical aspects also received significant attention. It shows how coverage followed controversy and examines how pro-ban campaigners countered effectively the anti-ban communication efforts of influential social actors in the economic and political spheres. The analysis demonstrates that medical-political sources successfully defined the ban's issues as centrally concerned with public health.
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.
LaDou, Joseph; Castleman, Barry; Frank, Arthur; Gochfeld, Michael; Greenberg, Morris; Huff, James; Joshi, Tushar Kant; Landrigan, Philip J.; Lemen, Richard; Myers, Jonny; Soffritti, Morando; Soskolne, Colin L.; Takahashi, Ken; Teitelbaum, Daniel; Terracini, Benedetto; Watterson, Andrew
Background All forms of asbestos are now banned in 52 countries. Safer products have replaced many materials that once were made with it. Nonetheless, many countries still use, import, and export asbestos and asbestos-containing products, and in those that have banned other forms of asbestos, the so-called “controlled use” of chrysotile asbestos is often exempted from the ban. In fact, chrysotile has accounted for > 95% of all the asbestos used globally. Objective We examined and evaluated the literature used to support the exemption of chrysotile asbestos from the ban and how its exemption reflects the political and economic influence of the asbestos mining and manufacturing industry. Discussion All forms of asbestos, including chrysotile, are proven human carcinogens. All forms cause malignant mesothelioma and lung and laryngeal cancers, and may cause ovarian, gastrointestinal, and other cancers. No exposure to asbestos is without risk. Illnesses and deaths from asbestos exposure are entirely preventable. Conclusions All countries of the world have an obligation to their citizens to join in the international endeavor to ban the mining, manufacture, and use of all forms of asbestos. An international ban is urgently needed. There is no medical or scientific basis to exempt chrysotile from the worldwide ban of asbestos. PMID:20601329
Ramakrishna, Seeram; Wang, Charlene
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 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...
Peng, Liang; Yang, Pengfei; He, Weigang
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.
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...
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.
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
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.
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
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,
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.
Privitera, Mary Beth
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
Since March 1, 2008 there has been a ban on wireless telephone and electronic : communication devices in New Jersey while operating a motor vehicle. But from general : observation on any roadway, it appears that there are still drivers who are talkin...
Boyer, Philip; Morshed, Bashir I; Mussivand, Tofy
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.
Marešová, Petra; Klímová, Blanka; Krejcar, Ondřej; Kuča, Kamil
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 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
Wang, Yi; Guan, Allan; Wickramasekara, Samanthi; Phillips, K Scott
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.
Durham, André-Dante; Bergier, Samuel; Morisod, Xavier; Locatelli, Isabella; Zellweger, Jean-Pierre; Huynh, Cong Khanh; Cornuz, Jacques
Hospitality workers are a population particularly at risk from the noxious effects of environmental tobacco smoke (ETS). The Canton of Vaud, Switzerland banned smoking in public places in September 2009. This prospective study addresses the impact of the ban on the health of hospitality workers. ETS exposure was evaluated using a passive sampling device that measures airborne nicotine; lung function was assessed by spirometry; health-related quality of life, ETS exposure symptoms and satisfaction were measured by questionnaire. 105 participants (smokers and non-smokers) were recruited initially and 66 were followed up after one year. ETS exposure was significantly lower after the ban. Hospitality workers had lower pre-ban forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) values than expected. FEV1 remained stable after the ban, with a near-significant increase in the subgroup of asthmatics only. FVC increased at one year follow-up from 90.42% to 93.05% (p = 0.02) in the entire cohort; women, non-smokers and older participants gained the greatest benefit. The health survey showed an increase in physical wellbeing after the ban, the greatest benefit being observed in non-smokers. ETS exposure symptoms were less frequent after the ban, especially red and irritated eyes and sneezing. The new law was judged useful and satisfactory by the vast majority of employees, including smokers. The recent cantonal ban on smoking in public places brought about an improvement in lung function, physical well-being and ETS symptoms of hospitality workers, including smokers.
Mahmoud Pashazadeh, Ali; Aghajani, Mahdi; Nabipour, Iraj; Assadi, Majid
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.
Pashazadeh, A. M.; Aghajani, M.; Nabipour, I.; Assadi, M.
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)
Bronzino, Joseph D
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
and Batasuna. These parties were banned by Spanish authorities for their integration in a terrorist network led by Euskadi Ta Askatasuna. The hypotheses are that democracies ban anti-system parties a) that do not unambiguously eschew violence; b) when alternatives to proscription are not effective. and c) when...... relevant office holders, or those holding a majority in parliament, have reason to believe they will not be disadvantaged electorally for supporting the ban....
Dhillon, Balbir S
.... 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...
Full Text Available The issues surrounding Direct-To-Consumer Advertising of pharmaceuticals are ripe for scrutiny through the lens of Human Rights analysis. Among the human rights most decisively engaged by DTCA is the right to autonomy in health-related decision making, which in turn incorporates right of access to health-related information. The latter incorporates, in part, right of access to reliable and beneficial information through the avenues of commercial speech among others. Another crucial human right is the right not to be harmed by unsafe consumer products through corporate malfeasance or negligence. The most commonly invoked policy options in the context of DTCA are either an outright ban or strengthening regulatory oversight in combination with voluntary guidelines. Banning Direct-To-Consumer Advertising risks being both over inclusive and under inclusive as a policy option. A wholesale ban risks being over inclusive in that it could deprive consumers of information about medications with a positive benefit-risk profile, ones that could enhance their quality of health and well being. Thus it risks being overly paternalistic. Banning DTCA, by itself, is under inclusive in that it is insufficient to address the ways that unadvertised drugs can pose significant risks to consumers. Other policy measures would be most optimal to deal with the very serious deficits in the processes by which prescription drugs undergo clinical trials, and garner regulatory approval prior to their promotion in the marketplace. A more finely tuned approach to regulatory oversight is endorsed, one involving a proactive and precautionary approach reliant upon prior approval. Such an approach could help to address the very serious concerns about potential infringements of the human right not to be harmed by unsafe consumer products through corporate malfeasance or negligence.
Ray, Arnab; Jetley, Raoul; Jones, Paul L; Zhang, Yi
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.
Shuai, Wanjun; Chao, Yong; Wang, Ning; Xu, Shining
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.
Hagedorn, Thomas J; Grosse, Ian R; Krishnamurty, Sundar
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.
Achraf Ben Amar
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.
Lopez-Trigo, Paula; Khanfar, Nile M; Alameddine, Sarah; Harrington, Catherine
CVS Health has taken a strategic marketing move by banning tobacco sales. They risk losing customers who buy medications and cigarettes at their drugstores. They estimate they will lose 2 billion dollars by banning cigarette sales. CVS Health believes they will benefit from being regarded as health care partner by insurers and banning cigarette sales is an important step in being recognized as such. The Affordable Care Act expanded access to pharmacy-based medical clinics, increased affordability of medications, and expanded the clinical role of pharmacists. CVS Health is positioning itself to take advantage of these changes.
Hanson, Jacob J; Hitchcock, Robert W
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.
... 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...
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.
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.
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...
... 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...
Hirschorn, David S; Choudhri, Asim F; Shih, George; Kim, Woojin
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.
... 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...
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.
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
... 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...
... 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...
Neto, José Augusto; Figueiredo Damásio, Jemerson; Monthaler, Paul; Morais, Misael
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).
Full Text Available Objectives: More and more countries introduce a total ban on smoking tobacco in public places. The aim of this work was to evaluate the effectiveness of “The Act of 8 April 2010 on amendment of the act on protection of health against the consequences of consumption of tobacco and tobacco products and act on National Sanitary Inspectorate” and assess the frequency of complying with the smoking bans by the students of the Medical University of Lodz, Poland. Material and Methods: Between 2007–2011, at the Social Medicine Institute of the Medical University of Lodz, a study using random survey was carried out involving students who were starting their studies at the Health Department of the Medical University of Lodz. The analysis of the collected material showed that 1038 people reported being smokers at the time of the study. Among that group, 530 students were included in the study prior to, and 508 after the introduction of the amendment. In order to verify their compliance with the smoking ban, the respondents were asked whether they smoked only in designated areas or wherever they wanted to. Results: The ratio of people claiming they smoked anywhere they wanted to, disregarding the smoking ban, was 60% (N = 318 and after the amendment had been introduced, this ratio was 62.2% (N = 316, it increased by 2.2 percentage points. The observed difference was statistically irrelevant (Chi2 = 0.530, p > 0.05. Conclusions: The Act ”On amendment of the act on protection of health against the consequences of consumption of tobacco and tobacco products and Act on National Sanitary Inspectorate” in Poland did not result in the expected changes in the frequency of complying with the smoking ban by the 1st year students.
Full Text Available Background Although Japan is a nation where the world first epidemiological evidence on the health effect of secondhand smoke was produced, no indoor smoking ban was realized on a national level. In 2013, Tokyo was selected as the city of 2020 Olympic Paralympic Games, since when the Japanese Ministry of Health, Labour and Welfare (MHLW and various concerned parties have been working to realize smoking ban in public places. However, as of July, 2017, the legislation has been unsuccessful. We chronologically reviewed the related events to clarify underlying obstacles to the legislation. Methods Events related to the movement of the national smoking ban in Japan were extracted from the internet and public available data sources. The concerned bodies were classified into five categories (academic/medical, administration, politics, industry, and advocacy, and chronological relations were analyzed. Results Academic/medical and administrative bodies closely collaborated and effectively released scientific rationale of smoking ban in 2016. The MHLW's draft policy released in Mar. 2017 included an exception of smoking ban for restaurants and bars (allowing designated smoking rooms. However, even this partial banning policy was faced with fierce objections from the allied industry including restaurant, hotel businesses and tobacco industry. Diet members in the ruling Liberal Democratic Party acted in a coordinated manner; reportedly 90% of the Diet members attending the party committee on health, labour and welfare objected to the MHLW's draft policy. The allied industry spread a signature collecting activity earlier and much more organizationally than academic/medical and advocacy groups. The party committee of the LDP was held only twice. Although the MHLW proposed a temporary amendment, the committee failed to reach an agreement. Conclusions The series of events suggest that the tobacco lobbies are more powerful in the policy-making process in Japan
Hansen, Klaus Marius; Manikas, Konstantinos
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....
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").
It is argued that if nuclear disarmament is the aim then some arms control treaties have been counterproductive. The two great powers have conducted, albeit underground, more nuclear explosions in the 12 years since the partial test ban than they did in the preceding 18 years, 1945 to 1963. The partial test ban treaty obliges the parties to negotiate a ban on 'all test explosions of nuclear weapons for all time'. After 12 years of negotiations very little progress has been made to this end. The USA and the USSR signed a bilateral Threshold Test Ban Treaty in 1974 banning 'any underground nuclear weapon tests having a yield exceeding 150 kilo-tons... beginning 31 March, 1976', a protocol describes how compliance is to be verified, and Article III requires that an agreement is to be negotiated governing peaceful nuclear explosions. From the point of view of disarmament it would be much better if the threshold test ban treaty were not ratified and a comprehensive test ban treaty were negotiated instead. The main official reason given for the failure to negotiate such a treaty is the problem of verification. However it is argued that due to recent progress in seismology there are no longer significant technical obstacles to the negotiation of a comprehensive test ban treaty. But there is lack of political will to obtain such a treaty. (U.K.)
... 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...
... 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...
Yang, Xiaofang; Mu, Ruihong; Fan, Yubo; Wang, Chunren; Li, Deyu
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.
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
... 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...
... 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 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...
...] 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...
... 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...
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...
Palosuo, Timo; Antoniadou, Irini; Gottrup, Finn
Many hospitals have implemented policies to restrict or ban the use of devices made of natural rubber latex (NRL) in healthcare as precautionary measures against the perceived risk of NRL allergy. Changes in glove technology, progress in measuring the specific allergenic potential of gloves...... properties of NRL and synthetic gloves and the role of glove powder. The review shows that NRL medical gloves, when compared with synthetic gloves, tend to be stronger, more flexible and better accepted by clinicians. The introduction of powder-free gloves has been associated with reductions in protein...
Hao, Aiyu; Wang, Ling
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
The Italian smoking ban entered into force on January 10th, 2005, and banned smoking from enclosed workplaces and hospitality premises (HPs), even though provided separated smoking areas. Actually, only 1-2%of HPs built these areas, while no figures are available on the prevalence of smoking rooms in workplaces other than HPs. Italians were more in favour of the law after the ban. In 2008 Italians were the Europeans most in favour of a national smoking ban (88%). Measurements of environmental nicotine and particulate matter with a diameter hospitality sector against the ban in 2004, no studies on impact of the ban on hospitality industry businesses were conducted in Italy. We used the conceptual model for the evaluation of the impact of smoke-free policies, proposed by the International Agency for Research on Cancer (IARC), to compare Italian and Scottish evaluations of the bans. The Scottish evaluation was planned some years before the implementation, and was based on a network of researchers of different disciplines. The quantification of decrease in second-hand smoke (SHS) exposure in the general population and in hospitality workers was one of the main objectives of the Scottish evaluation. The Italian evaluation devoted more attention to distal (reduction of hospital admissions) and incidental effects of the law (trend in smoking prevalence, cigarette consumption). Qualitative studies in bars, homes, and communities recording changes in attitudes on tobacco smoking after the introduction of the ban, were conducted only in Scotland. In Italy the main problem was to develop and fund a network of researchers involved on a shared evaluation plan.
Davis, J. R
... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii Introduction Chapter 1 Overview of Biomaterials and Their Use in Medical Devices . . . . . . . . . . . . . . . . 1 Uses for Biomaterials...
Jones, Richard W; Katzis, Konstantinos
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.
A. Yu. Galkin; A. G. Komar; A. A. Grigorenko
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...
...] 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...
Katerina Krsteva Jakimovska
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.
... 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...
Cao, Shaoping; Yin, Chunguang; Zhao, Zhenying
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.
... 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...
... 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...
... 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...
... 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...
... 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...
... 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...
... 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...
Kaufman-Rivi, Diana; Collins-Mitchell, Janette; Jetley, Raoul
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.
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.
Zhang, Meng; Raghunathan, Anand; Jha, Niraj K
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.
Jones, E.D.; Cunningham, R.E.; Rathbun, P.A.
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
Obremskey, William T; Dail, Teresa; Jahangir, A Alex
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.
Schreiner, Steven; Peterson, Donald R
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...
Søgaard, Thomas Friis
of patrons as rational actors, as well as linear notions of cause and effect, this article challenges such conceptions. Instead, this article draws on actor network theory, and an understanding of banned youth as situated in networks of relations, in order to provide insights into how the effects of banning...
Keller, James P
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.
Maresova, Petra; Penhaker, Marek; Selamat, Ali; Kuca, Kamil
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.
... 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...
Amato, Stephen F; Amato, B
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
Lewis, K E; Shin, D; Davies, G
A group of United Kingdom (UK) hospitals. To estimate the current smoking habits of health care professionals (HCPs) in a country with active tobacco control measures, and to record their attitudes to national and hospital tobacco bans. A cross-sectional survey of 500 HCPs. HCPs reported a lower rate of current smoking (7%) than the general population (24%). Doctors (2.6%) and medical students (3.8%) were less likely to be current smokers than both nurses (8.7%) and allied health professionals (10.9%, P smoking in health care premises. A higher proportion of UK doctors (69%) than nurses (52%) favoured a complete ban (odds ratio 2.01, 95% confidence interval 1.14-3.56). Self-reported smoking patterns in UK health professionals are lower than previously and compared to other industrialised and developing countries. Support for bans is very high, but differences remain in behaviour and especially attitudes to local bans according to professional status, although this gap is also narrowing.
Y. L. Nechyporenko
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.
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.
Although the adverse implications of physician advertising are the subject of a fierce and sustained debate, there is almost no scholarly discussion on the ethical repercussions of physician advertising bans. The present paper draws attention to these repercussions as they exist today in most of the world, with particular focus on three serious implications for the public: (a) uncertainty about the physician's interests, namely, that patients must trust the physician to put patient wellbeing ahead of possible gains when taking medical decisions; (b) uncertainty about alternative treatments, namely, that patients must trust in the physician's treatment decisions; and (c) uncertainty about the exclusive patient-physician relationship, namely, that patients must develop and maintain a good relationship with one physician. Physician advertising bans continue to tell the public in most of the modern world that these are irrelevant or inappropriate issues, meaning that they are effectively left to the public to resolve.
... 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...
The Comprehensive Nuclear Test-Ban Treaty was adopted by the General Assembly on 10 September 1996 (Res/50/245) and was open for signature by all states on 24 September 1996. It will enter into force 180 days after the date of deposit of the instruments of ratification by all states listed in Annex 2 to the Treaty. This document reproduces the text of the Treaty and the Protocol to the Comprehensive Nuclear Test-Ban Treaty Protocol to the Comprehensive Nuclear Test-Ban Treaty. 4 tabs.
The Comprehensive Nuclear Test-Ban Treaty was adopted by the General Assembly on 10 September 1996 (Res/50/245) and was open for signature by all states on 24 September 1996. It will enter into force 180 days after the date of deposit of the instruments of ratification by all states listed in Annex 2 to the Treaty. This document reproduces the text of the Treaty and the Protocol to the Comprehensive Nuclear Test-Ban Treaty Protocol to the Comprehensive Nuclear Test-Ban Treaty
... 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...
This paper discusses the Limited Test Ban Treaty which came at the end of nearly five years of frustrated efforts to obtain a comprehensive test ban. Negotiations toward that end had begun in October 1958. At the same time a voluntary, informal moratorium on tests was initiated. The negotiations soon stalled over the Soviet Union's resistance to internationally supervised inspections on its soil. In April 1959 a phased ban that was to be limited at first to atmospheric tests conducted below an altitude of 50 kilometers. Such tests were thought to be easily verifiable. The Soviets rejected this idea and continued to insist that a complete test ban need not require numerous inspections. The two sides nevertheless appeared to be nearing agreement on a treaty to ban all but relatively small underground tests when, in May 1960, an U.S. U-2 reconnaissance plane was shot down over Soviet territory. After a thorough review of the U.S. position, the Kennedy administration proposed in April 1961 a draft treaty that made several concessions toward the Soviet position. Nevertheless, the Soviets, still disagreeing with the provisions for verification and with the makeup of the control organization, rejected it
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.)
Joshua C. Hall; Christopher Shultz; E. Frank Stephenson
Concerns about harmful effects arising from the increased use of hydraulic fracturing (fracking) to extract underground fuel resources has led to efforts to ban the practice. Many townships in western New York, which lies above the gas-rich Marcellus shale formation, have enacted bans or moratoria. Using spatial econometric techniques, we examine factors related to townships' choice to adopt fracking bans and document the importance of spatial dependence when analyzing fracking bans. We find ...
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
Weitzman, James B
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.
Haghi, Mostafa; Thurow, Kerstin; Stoll, Regina
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.
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.
... 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...
Wen, Jing; Xiao, Jiangyi; Wang, Aijun
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.
Baim, Donald S; Donovan, Aine; Smith, John J; Briefs, Nancy; Geoffrion, Richard; Feigal, David; Kaplan, Aaron V
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
... 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...
Blessing, Melissa M; Lin, Peter T
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.
Wu, Winston H; Bui, Alex A T; Batalin, Maxim A; Au, Lawrence K; Binney, Jonathan D; Kaiser, William J
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.
Aungst, Timothy Dy
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.
Zema, M; Rosati, S; Gioia, V; Knaflitz, M; Balestra, G
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.
....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...
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.
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.
... 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 ...
Kaluska, I.; Stuglik, Z.
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
... 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...
A. Yu. Galkin
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.
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.
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
Bachmor, T; Schöchlin, J; Bolz, A
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.
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.
Kramer, Daniel B.; Foo Kune, Denis; Auto de Medeiros, Julio; Yan, Chen; Xu, Wenyuan; Crawford, Thomas; Fu, Kevin
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
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)
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
... 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...
Bernat, Amir S.; Acobas, Jennifer K.; Phang, Ye Shang; Hassan, David; Bolton, Frank J.; Levitz, David
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.
Gittard, Shaun D; Narayan, Roger J
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
Niezen, Gerrit; Eslambolchilar, Parisa; Thimbleby, Harold
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.
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 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.
... 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...
Liu, Long; Shuai, Ma; Wang, Zhu; Li, Ping
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.
... 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 ...
Janß, Armin; Thorn, Johannes; Schmitz, Malte; Mildner, Alexander; Dell'Anna-Pudlik, Jasmin; Leucker, Martin; Radermacher, Klaus
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.
... 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...
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.
Kasparick, Martin; Schlichting, Stefan; Golatowski, Frank; Timmermann, Dirk
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.
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.
... continued marketing of the device as presently labeled, is important, material, or significant in relation to the benefit to the public health from its continued marketing. (2) In determining whether a device... marketing of the device presents a substantial deception or an unreasonable and substantial risk of illness...
... 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...
Clou, E; Dompnier, M; Kably, B; Leplay, C; Poupon, E; Archer, V; Paul, M
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.
Pereira, Dulce María Martínez; Rodríguez, Yadira Álvarez; Valdés, Yamila Cedeño; Ribas, Silvia Delgado
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.
Baker, Philip J; Harris, Stephen; Webbon, Charlotte C
Pressure to ban the hunting of foxes with hounds in Britain has fuelled debate about its contribution to the control of fox populations. We took advantage of a nationwide one-year ban on fox-hunting during the outbreak of foot-and-mouth disease (FMD) in 2001 to examine this issue and found that the ban had no measurable impact on fox numbers in randomly selected areas. Our results argue against suggestions that fox populations would increase markedly in the event of a permanent ban on hunting.
... 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...
Carpenter, Christopher S; Nguyen, Hai V
We provide new evidence on the effects of increasingly common driver cellphone bans on self-reported overall, handheld, and hands-free cellphone use while driving by studying Ontario, Canada, which instituted a 3-month education campaign in November 2009 followed by a binding driver cellphone ban in February 2010. Using residents of Alberta as a control group in a difference-in-differences framework, we find visual and regression-based evidence that Ontario's cellphone ban significantly reduced overall and handheld cellphone use. We also find that the policies significantly increased hands-free cellphone use. The reductions in overall and handheld use are driven exclusively by women, whereas the increases in hands-free use are much larger for men. Our results provide the first direct evidence that cellphone bans have the unintended effect of inducing substitution to hands-free devices. Copyright © 2014 John Wiley & Sons, Ltd.
Gad, Shayne C
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
Muniz Janaína Barbosa
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.
Jalbert, Jessica J; Ritchey, Mary Elizabeth; Mi, Xiaojuan; Chen, Chih-Ying; Hammill, Bradley G; Curtis, Lesley H; Setoguchi, Soko
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: firstname.lastname@example.org.
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.
.... 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
Pierre, J.P.; Vidal, J.P.; Martin, J.C.; Pasquier, J.L.
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)
Carey, Jennifer L; Nader, Nathalie; Chai, Peter R; Carreiro, Stephanie; Griswold, Matthew K; Boyle, Katherine L
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.
Hofmann, Annette; Nell, Martin
Smoking bans are gaining widespread support in the European Union and other countries. The vast majority of these bans are partial bans given that smoking is still permitted in certain places. This article investigates the role of partial smoking bans in coping with externalities caused by the secondhand smoking problem. Although it is widely known that Pigouvian taxation is superior to a perfect ban, this result does not necessarily carry over to a partial ban because taxes cannot (easily) be differentiated according to location. We show that under an easy and intuitive condition, (1) enacting a partial smoking ban alone always improves social welfare (a) in an unregulated society and (b) even in a regulated society if externalities can be eliminated, and (2) it is ensured that a combination of Pigouvian tax and a partial smoking ban leads to a higher social optimum than implementing corrective Pigouvian taxation alone.
... 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...
Calcagnini, G; Mattei, E; Censi, F; Triventi, M; Lo Sterzo, R; Marchetta, E; Bartolini, P
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.
... 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...
... 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...
According to what I call the 'argument from public bads', if a researcher deceived subjects in the past, there is a chance that subjects will discount the information that a subsequent researcher provides, thus compromising the validity of the subsequent researcher's experiment. While this argument is taken to justify an existing informal ban on explicit deception in experimental economics, it can also apply to implicit deception, yet implicit deception is not banned and is sometimes used in experimental economics. Thus, experimental economists are being inconsistent when they appeal to the argument from public bads to justify banning explicit deception but not implicit deception. Copyright © 2015 Elsevier Ltd. All rights reserved.
The "Game of Decisions" is presented to encourage students to consider the consequences of banning books and/or ideas. The game involves story writing, creating probability graphs, writing a letter protesting censorship from a chosen historical period, and examining a controversial science issue. Three thesis statements for generating group…
Full Text Available The Securities and Exchange Commission’s 2008 emergency order introduced a shorting ban of some 800 financials traded in the US. This paper provides an empirical analysis of the options market around the ban period. Using transaction level data from OPRA (The Options Price Reporting Authority, we study the options volume, spreads, pricing measures and option trade volume informativeness during the ban. We also consider the put–call parity relationship. While mostly statistically significant, economic magnitudes of our results suggest that the impact of the ban on the equity options market was likely not as dramatic as initially thought.
Marvell, Thomas B
A 1994 federal law bans possession of handguns by persons under 18 years of age. Also in 1994, 11 states passed their own juvenile gun possession bans. Eighteen states had previously passed bans, 15 of them between 1975 and 1993. These laws were intended to reduce homicides, but arguments can be made that they have no effect on or that they even increase the homicide rate. This paper estimates the laws' impacts on various crime measures, primarily juvenile gun homicide victimizations and suic...
.... 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...
...] 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...
Hall, Jill; Bond, Christine; Kinnear, Moira; McKinstry, Brian
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
Ellaway, Rachel H; Fink, Patricia; Graves, Lisa; Campbell, Alanna
Although many medical learners and teachers are using mobile technologies within medical education, there has been little evidence presented describing how they use mobile devices across a whole curriculum. The Northern Ontario School of Medicine (NOSM) introduced a new mobile device program in 2010. Incoming undergraduate medical learners received a laptop and an iPad and learners entering year three of the four-year program received a laptop and an iPhone. A survey was sent to all learners to gather information on their use of and attitudes toward these devices. A combination of quantitative and qualitative methods was used to analyze the data and to generate a series of themes that synthesized student behaviors, perceptions and attitudes. Context and learner autonomy were found to be important factors with learners using multiple devices for different purposes and adopting strategic approaches to learning using these devices. The expectation that school-issued devices would be regularly and enthusiastically used to replace more traditional study media was not reflected in practice. Learners' approaches to using mobile devices are heterogeneous as is the extent to which they use them. Learners adapt their use of mobile devices to the learning cultures and contexts they find themselves in.
Advancing medical device innovation through collaboration and coordination of structured data capture pilots: Report from the Medical Device Epidemiology Network (MDEpiNet) Specific, Measurable, Achievable, Results-Oriented, Time Bound (SMART) Think Tank.
Reed, Terrie L; Drozda, Joseph P; Baskin, Kevin M; Tcheng, James; Conway, Karen; Wilson, Natalia; Marinac-Dabic, Danica; Heise, Theodore; Krucoff, Mitchell W
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.
Tabei, Masae; Kudo, Hisaaki; Katsumura, Yosuke
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.)
Whipple, Elizabeth C; Allgood, Kacy L; Larue, Elizabeth M
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.
Casson, Alexander J; Rodriguez-Villegas, Esther
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.
Hinrichs, Saba; Dickerson, Terry; Clarkson, John
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.
Tom Coupe; Olena Gnezdilova
We use panel data on advertising expenditures to check the influence of tobacco advertising bans on the advertising industry. We find no clear evidence of a negative effect of tobacco bans on total per capita advertising expenditures.
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.
Zhang Tongcheng; Liu Qingfang; Zhong Hongliang; Mi Zhisu; Wang Chunlei; Jiang Jianping
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
...] 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...
... 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...
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
Hiilamo, Heikki; Glantz, Stanton
We sought to evaluate changes in countries' enacting advertising bans after the effect of ratifying the WHO Framework Convention on Tobacco Control (FCTC). We compared adoption of advertising bans on five areas (TV and radio, print media, billboards, point-of-sale, sponsorship) in countries that did versus did not ratify the FCTC, accounting for years since the ratification of the Convention. On average, passage of complete advertising bans accelerated after FCTC ratification. The development was strongest among lower middle-income countries. Lack of state capacity was associated with lower likelihood of countries implementing complete advertising bans. Implementation of complete advertising bans slowed after 2007. Implementation of FCTC Article 13 was followed by increased progress towards complete advertising bans, but progress is incomplete, especially among low-income countries. Low-income countries need comprehensive support to implement FCTC as part of a broad effort to reinvigorate progress on global implementation of the FCTC. Enforcing complete bans requires constant monitoring and attacking of tobacco industry efforts to circumvent them. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
... 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...
... 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...
Núñez, C.; Castro, D.
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.
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 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...
Gulácsi, L; Dávid, T; Dózsa, Cs
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.
Since 1 February this year, under the EU's Biocidal Products Directive, it has been illegal to sell or use water treatment systems that use elemental copper, a practice employed historically by a significant number of UK healthcare facilities to combat Legionella. Alan Lester, managing director of specialist supplier of 'environmentally-friendly' water treatment systems, Advanced Hydro, says the ban has caused 'a storm of giant proportion,' with advocates of copper ion-based treatment systems arguing that this disinfection method dates back 3,000 years to Egyptian times, making it an 'undoubtedly proven' technology. Here he explains why the ban came into force, considers why the UK's Health and Safety Executive (HSE) is seeking a derogation, looks at the ban's likely impact, and gives a personal viewpoint on the 'pros and cons' of some of the alternative treatment technologies, including a titanium dioxide-based system marketed by Advanced Hydro itself in the UK.
Full Text Available This paper examines the impacts of the l998 ban on Oman fish exports to the EU markets and ensuing the internationalization of Oman fish companies. The ban raises two concerns that the paper intends to answer: (i how firms have responded to surmount the ban, and (ii which strategies are more effective in the process of internationalization. The paper distinguishes three sets of actions: during the ban and immediate actions; short term actions; and long term actions. Besides government support for the implementation of international norms of quality and safety control, firms have responded individually to the EU ban. The actions subsequently undertaken by firms in response to the ban were selected: identification of new markets (alternatives; implementation of the required regulations and needed support to continue exporting to traditional European markets (competence; and long term business and marketing strategies (strategic thinking. These actions or steps represent the internationalization process or approach followed by the fisheries firms in Oman. All these actions have been undertaken after the EU ban, which leads to the conclusion that the ban has indeed worked as a driving force to internationalize, i.e. to develop the requisites of international markets.
... 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...
Gao, Zan; Detyniecki, Marcin; Chen, Ming-Yu; Wu, Wen; Hauptmann, Alexander G; Wactlar, Howard D
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%.
Lansdowne, Krystal; Scully, Christopher G; Galeotti, Loriano; Schwartz, Suzanne; Marcozzi, David; Strauss, David G
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.
Rogers, Kipp D.
In "Mobile Learning Devices," the author helps educators confront and overcome their fears and doubts about using mobile learning devices (MLDs) such as cell phones, personal digital assistants, MP3 players, handheld games, digital audio players, and laptops in classrooms. School policies that ban such tools are outdated, the author suggests;…
... 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 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...
Triani, Gerry; Doe, Simon
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
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.
... 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? ...
Agray, N.; Hoek, van der W.; Vink, de E.P.; Dunin-Keplicz, B.; Nawarecki, E.
This paper reports on two case-studies of applying BAN logic to industrial strength security protocols. These studies demonstrate the flexibility of the BAN language, as it caters for the addition of appropriate constructs and rules. We argue that, although a semantical foundation of the formalism
...] 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...
Kasparick, Martin; Schmitz, Malte; Andersen, Björn; Rockstroh, Max; Franke, Stefan; Schlichting, Stefan; Golatowski, Frank; Timmermann, Dirk
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.
Miller, Peter; Curtis, Ashlee; Palmer, Darren; Warren, Ian; McFarlane, Emma
Alcohol-related harm in and around licensed venues is associated with substantial costs. Many interventions have been introduced in an effort to combat these harms, and one such intervention is known as patron banning. Patron banning involves prohibiting patrons who have been violent or disorderly in a licensed venue in an attempt to reduce alcohol-related harm. It can be implemented by the venue, by members of police, or by liquor accords. This study aimed to obtain key informant perspectives on the benefits of patron banning as well as on the effectiveness of patron banning in reducing alcohol-related harm. Thirty-six key informants provided perspectives on patron banning through in-depth interviews that were part of a larger study. Key informants were supportive of patron banning for reducing alcohol-related harm, noting that it had many benefits including increased venue safety, general risk management, and deterrence of antisocial behavior. Although processes for banning were not always consistent, identification scanners were generally recognized as a way to ensure that patron banning was enforced. Key informants viewed patron banning as an effective measure for increasing patron safety and reducing alcohol-related harms.
Roberts, Neil; Rees, Michael
Mobile devices are increasingly used by students in university lectures. This has resulted in controversy and the banning of mobile devices in some lectures. Although there has been some research into how students use laptop computers in lectures, there has been little investigation into the wider use of mobile devices. This study was designed to…
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.
Shah Anuja; Goyal R
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 ...
Zippel, Claus; Bohnet-Joschko, Sabine
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.
Yamazaki, Asumi; Liu, Peter; Cheng, Wei-Chung; Badano, Aldo
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
Goldman, Julian M
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...
de Ana, F J; Umstead, K A; Phillips, G J; Conner, C P
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.
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
Ghaffari, Roozbeh; Kim, Dae-Hyeong
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.
Grocott, Patricia; Weir, Heather; Ram, Mala Bridgelal
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.
Wong, Kathie A; Hodgson, Luke; Garas, George; Malietzis, George; Markar, Sheraz; Rao, Christopher; von Segesser, Ludwig K; Athanasiou, Thanos
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.
In the summer of 2014, the European Court of Human Rights ruled that the French 2010 law banning face-covering clothing in public spaces, the so-called burqa ban, did not violate the right to freedom of religion. Due to the ‘wide margin of appreciation’, the Court deemed the ban proportionate...... to the French state’s legitimate aim with the ban of preserving the conditions of ‘living together’. The paper analyses and provides an internal criticism of the Court’s justification for this judgement focusing on the aim of living together and the right to freedom of religion. The Court’s justification...
Tobacco advertising bans have become commonplace in developed nations but are less prevalent in developing countries. The importance of advertising bans as part of comprehensive tobacco control strategies has been emphasised by the Framework Convention on Tobacco Control which calls for comprehensive bans on tobacco advertising. The empirical literature suggests that comprehensive advertising bans have played a role in reducing consumption in developed countries but that limited policies have not. This paper extends this analysis to include 30 developing countries and finds that bans do play an important role in reducing tobacco consumption in these countries. It finds that both comprehensive as well as limited policies are effective in reducing consumption although comprehensive bans have a far greater impact than limited ones. Furthermore, it finds that advertising bans may be even more effective in the developing world than they are in the developed world.
Matthew C. Farrelly; William N. Evans; Edward Montgomery
In recent years there has been a heightened public concern over the potentially harmful effects of environmental tobacco smoke (ETS). In response, smoking has been banned on many jobs. Using data from the 1991 and 1993 National Health Interview Survey and smoking supplements to the September 1992 and May 1993 Current Population Survey, we investigate whether these workplace policies reduce smoking prevalence and smoking intensity among workers. Our estimates suggest that workplace bans reduce...
Blagec, Kathrin; Jungwirth, David; Haluza, Daniela; Samwald, Matthias
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.
McCartt, Anne T.; Kidd, David G.; Teoh, Eric R.
Almost all U.S. states have laws limiting drivers’ cellphone use. The evidence suggests that all-driver bans on hand-held phone conversations have resulted in long-term reductions in hand-held phone use, and drivers in ban states reported higher rates of hands-free phone use and lower overall phone use compared with drivers in non-ban states. Bans on all phone use by teenage drivers have not been shown to reduce their phone use. The effects of texting bans on the rates of drivers’ texting are unknown. With regard to the effects of bans on crashes, 11 peer-reviewed papers or technical reports of all-driver hand-held phone bans and texting bans were reviewed. Some were single-state studies examining crash measures before and after a state ban; other national or multi-state studies compared crashes in states with and without bans over time. The results varied widely. The lack of appropriate controls and other challenges in conducting strong evaluations limited the findings of some studies. Thus, despite the proliferation of laws limiting drivers’ cellphone use, it is unclear whether they are having the desired effects on safety. Priorities for future research are suggested. PMID:24776230
.... 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...
Cheelo, Chilala; Nzala, Selestine; Zulu, Joseph M
In 2010 the government of the republic of Zambia stopped training traditional birth attendants and forbade them from conducting home deliveries as they were viewed as contributing to maternal mortality. This study explored positive and negative maternal health related experiences and effects of the ban in a rural district of Kazungula. This was a phenomenological study and data were collected through focus group discussions as well as in-depth interviews with trained traditional birth attendants (tTBAs) and key informant interviews with six female traditional leaders that were selected one from each of the six zones. All 22 trained tTBAs from three clinic catchment areas were included in the study. Content analysis was used to analyse the data after coding it using NVIVO 8 software. Home deliveries have continued despite the community and tTBAs being aware of the ban. The ban has had both negative and positive effects on the community. Positive effects include early detection and management of pregnancy complications, enhanced HIV/AIDS prevention and better management of post-natal conditions, reduced criticisms of tTBAs from the community in case of birth complications, and quick response at health facilities in case of an emergency. Negatives effects of the ban include increased work load on the part of health workers, high cost for lodging at health facilities and traveling to health facilities, as well as tTBAs feeling neglected, loss of respect and recognition by the community. Countries should design their approach to banning tTBAs differently depending on contextual factors. Further, it is important to consider adopting a step wise approach when implementing the ban as the process of banning tTBAs may trigger several negative effects.
Min, Hery Michelle
This Note examines New York City's Sugary Drinks Portion Cap Rule (Soda Ban), which was originally set to become effective March 12, 2013. The New York County Supreme Court's decision in New York Statewide Coalition of Hispanic Chambers of Commerce v. New York City Department of Health and Mental Hygiene suspended the Soda Ban on March 11, 2013. The First Department of the Appellate Division of New York State Supreme Court affirmed the suspension on July 30, 2013. However, the complex economic policy and constitutional issues arising from the proposed Soda Ban deserve as much attention as the ultimate result of the legal challenge to the ban. Both courts struck down the Soda Ban on the grounds that it violated the separation of powers doctrine. The lower court further held that the Soda Ban was arbitrary and capricious. This Note does not focus solely on the holdings of the two courts, but takes a broader approach in analyzing the issues involved in the Soda Ban. By comparing and contrasting tobacco products with sugary beverages, this Note explains why the public seems to find the Soda Ban less appealing than tobacco regulations. Specifically, this Note addresses how the failed attempts of numerous states and cities to implement soda taxes demonstrate the complexity of policies geared toward curbing obesity; how fundamental values, such as health, fairness, efficiency, and autonomy factor into obesity policies; and the fact that legislatures and courts are struggling to determine the scope of public health law intervention. The Note explores how the Soda Ban, despite its judicial suspension, could represent a stepping-stone in combating the obesity epidemic.
Pfeiffer, Jonas H; Kasparick, Martin; Strathen, Benjamin; Dietz, Christian; Dingler, Max E; Lueth, Tim C; Timmermann, Dirk; Radermacher, Klaus; Golatowski, Frank
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).
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.
Khan, Yasser; Ostfeld, Aminy E; Lochner, Claire M; Pierre, Adrien; Arias, Ana C
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.
A survey of international efforts from the partial test-ban Treaty (in atmosphere, in outer space and under water) in 1963 to the Soviet-USA negotiations on verification measures for the threshold test-ban Treaty is given. As was the case in the bilateral and trilateral negotiations, the question of adequate verification procedures has remained one of the major problems in the multilateral considerations on a comprehensive test ban. Over the years, a number of proposals have been made in order to solve the issue, in particular by Sweden and by the Soviet Union. In 1988, the four experimental data centres, situated in Canberra, Moscow, Stockholm and Washington, carried out separate and joint experiments in analysis methodology. Communication techniques between the four international data centres and a number of national seismological stations were also tested. In addition, a global data-gathering experiment was conducted, resulting in the creation of an initial research data base at the experimental data centre in Canberra. Further technical experiments are planned for 1989, an in 1990 a large-scale experiment in data exchange and analysis, involving up to a hundred seismological stations globally and lasting several months, is foreseen
Williams, Rebecca S; Ribisl, Kurt M
Most Internet cigarette sales have violated taxation and youth access laws, leading to landmark 2005 agreements with credit card companies, PayPal, and private shippers (United Parcel Service, Federal Express, DHL) to cease participation in these transactions. Despite their promise at the time, loopholes allowed for check payment and U.S. Postal Service (USPS) shipping. This study assessed actual vendor compliance with the payment and shipping bans using a purchase survey. In late 2007 and early 2008, an adult buyer attempted to order cigarettes from the 97 most popular Internet cigarette vendors (ICVs) using banned payment and shipping methods. When banned payment or shipping methods were unavailable, purchases were attempted with alternate methods (e.g., checks, e-checks, USPS). Twenty-seven of 100 orders were placed with (banned) credit cards; 23 were successfully received. Seventy-one orders were placed with checks (60 successfully received). Four orders were delivered using banned shippers; 79 of 83 successfully received orders were delivered by the USPS. About a quarter of ICVs violated the payment ban, others adapted by accepting checks. Most vendors complied with the shipping ban, perhaps because USPS was an easy substitute shipping option. Better enforcement of the bans is needed; the 2009 Prevent All Cigarette Trafficking Act closed the USPS loophole by making cigarettes nonmailable material; evaluation of enforcement efforts and adaptations by vendors are needed. These sorts of bans are a promising approach to controlling the sale of restricted goods online.
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
A growing body of evidence has linked consumption of trans fatty acids to cardiovascular disease. To promote public health, numerous state and local governments in the United States have banned the use of artificial trans fats in restaurant foods, and additional bans may follow. Although these policies may have a positive impact on human health, they open the door to excessive government control over food, which could restrict dietary choices, interfere with cultural, ethnic, and religious traditions, and exacerbate socioeconomic inequalities. These slippery slope concerns cannot be dismissed as far-fetched, because the social and political pressures are place to induce additional food regulations. To protect human freedom and other values, policies that significantly restrict food choices, such as bans on types of food, should be adopted only when they are supported by substantial scientific evidence, and when policies that impose fewer restrictions on freedom, such as educational campaigns and product labeling, are likely to be ineffective. PMID:20229412
Boruff, Jill T.; Storie, Dale
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
Boruff, Jill T; Storie, Dale
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.
Chuah, Agnes S. F.; Leong, Alisius D.; Cummings, Christopher L.; Ho, Shirley S.
The future of nano-food largely hinges on public perceptions and willingness to accept this novel technology. The present study utilizes the scientific literacy model and psychometric paradigm as the key theoretical frameworks to examine the factors influencing public support for labeling and banning of nano-food in Singapore. Using data collected from a nationally representative survey of 1001 respondents, the findings demonstrated that attitudes toward technology, preference for natural product, science knowledge, and risk perception were found to substantially affect public support for both labeling and banning of nano-food. Conversely, attention to food safety news on traditional media and attention to nano-news on new media were only associated with public support for labeling of nano-food. Similarly, benefit perception was only significantly associated with public support for banning of nano-food. Theoretically, these findings support the growing body of literature that argues for the significant role played by predispositions, media use, science knowledge, and risk and benefit perceptions on attitude formation toward nano-food. It serves as the pioneering piece to address the aspect of banning in the field of nano-food. Practically, insights drawn from this study could aid relevant stakeholders in enlisting effecting strategies to convey the benefits of nano-food while mitigating the risk perceptions among the public.
Siamak Aram; Rouzbeh A. Shirvani; Eros G. Pasero; Mohamd F. Chouikha
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...
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.
... 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...
Moultrie, James; Sutcliffe, Laura Francesca Rose; Maier, Anja
. 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...
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
...] 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...
Delnevo, Cristine D; Hrywna, Mary
Following the passage of the Family Smoking Prevention and Tobacco Control Act in 2009, flavoured cigarettes, including clove cigarettes, were banned based on the rationale that such cigarettes appealed to youth. However, the ban on characterising flavours was not extended to cigars. This study reviewed industry documents from Kretek International, the parent company behind Djarum clove cigars, to document the changes in their marketing and production strategies following the flavour ban on cigarettes. To assess sales trends following the ban, data for clove cigar sales in the USA from 2009 to 2012 were analysed using Nielsen's Convenience Track retail scanner database. Additionally, data on tobacco imports to the USA from Indonesia were obtained from the USDA Foreign Agricultural Service's Global Agricultural Trade System for the years 2008-2012. In anticipation of Food and Drug Administration's (FDA) flavour ban on cigarettes and recognising the regulatory advantages of cigars, Kretek International began developing Djarum clove cigars in 2007. Immediately following the flavour ban, sales of this product increased by more than 1400% between 2009 and 2012. During this same period, tobacco imports to the USA from Indonesia, a leader in clove tobacco production, shifted from cigarettes to almost exclusively cigars. Kretek International, like other tobacco manufacturers, manipulated its products following the Family Smoking Prevention and Tobacco Control Act as a way to capitalise on regulatory loopholes and replace its now banned clove cigarettes. As a result, consumption of the company's Djarum clove cigars increased exponentially in recent years. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
Scott, John Anthony
Describes recent cases of high school book banning illustrating patterns of censorship in the United States. The author examines reasons for book banning, the motivations behind this kind of censorship, and the ideological orientation of groups responsible for it. A bibliography of information on censorship is included. (AM)
Stephanie K. Kolar
Full Text Available Objectives: Electronic cigarette (e-cigarette use is increasing in the U.S. Although marketed as a safer alternative for cigarettes, initial evidence suggests that e-cigarettes may pose a secondhand exposure risk. The current study explored the prevalence and correlates of support for e-cigarette bans. Methods: A sample of 265 current/former smokers completed a cross-sectional telephone survey from June–September 2014; 45% Black, 31% White, 21% Hispanic. Items assessed support for home and workplace bans for cigarettes and e-cigarettes and associated risk perceptions. Results: Most participants were aware of e-cigarettes (99%. Results demonstrated less support for complete e-cigarette bans in homes and workplaces compared to cigarettes. Support for complete e-cigarette bans was strongest among older, higher income, married respondents, and former smokers. Complete e-cigarette bans were most strongly endorsed when perceptions of addictiveness and health risks were high. While both e-cigarette lifetime and never-users strongly supported cigarette smoking bans, endorsement for e-cigarette bans varied by lifetime use and intentions to use e-cigarettes. Conclusions: Support for indoor e-cigarette bans is relatively low among individuals with a smoking history. Support for e-cigarette bans may change as evidence regarding their use emerges. These findings have implications for public health policy.
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...
Vicedo-Cabrera, Ana M; Röösli, Martin; Radovanovic, Dragana; Grize, Leticia; Witassek, Fabienne; Schindler, Christian; Perez, Laura
Smoking bans are considered one of the most effective policies to reduce population exposure to tobacco smoke and prevent adverse health outcomes. However, evidence on the effect of contextual variables on the effectiveness of smoking bans is still lacking. The patchwork of cantonal smoke-free laws in Switzerland was used as a quasi-experimental setting to assess changes after their introduction in: hospitalisations and mortality due to cardiorespiratory diseases in adults; total hospitalisations and hospitalisations due to respiratory disorders in children; and the modifying effects of contextual factors and the effectiveness of the laws. Using hospital and mortality registry data for residents in Switzerland (2005-2012), we conducted canton-specific interrupted time-series analyses followed by random effects meta-analyses to obtain nationwide smoking ban estimates by subgroups of age, sex and causes of hospitalisation or death. Heterogeneity of the impact caused by strictness of the ban and other smoking-related characteristics of the cantons was explored through meta-regression. Total hospitalisation rates due to cardiovascular and respiratory diseases did not significantly change after the introduction of the ban. Post-ban changes were detected in ischaemic heart disease hospitalisations, with a 2.5% reduction (95% confidence interval [CI)] -6.2 to 1.3%) for all ages and 5.5% (95% CI -10.8 to -0.2%) in adults 35-64 years old. Total mortality due to respiratory diseases decreased by 8.2% (95% CI -15.2 to -0.6%) over all ages, and chronic obstructive pulmonary disease mortality decreased by 14.0% (95% CI -22.3 to -4.5%) in adults ≥65 years old. Cardiovascular mortality did not change after the introduction of the ban, but there was an indication of post-ban reductions in mortality due to hypertensive disorders (-5.4%, 95% CI -12.6 to 2.3%), and congestive heart failure (-6.0%, 95% CI -14.5 to 3.4%). No benefits were observed for hospitalisations due to
Wolozny Gomez Robelo, Daniel Andre
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...
Full Text Available This paper aims to examine the process through which a total ban on asbestos was achieved in Japan. We reconstructed the process, analyzed the roles of involved parties/events, and drew lessons from the Japanese experience of achieving the ban. In Japan, a bill to phase out asbestos was proposed in 1992 but rejected without deliberation. Wide support for such a ban subsequently grew, however, largely due to the actions of trade unions and civil societies in establishing a coalition, raising awareness, organizing asbestos victims and their families, and propagating information on international developments. A governmental decision towards a ban was made in 2002 based on several national and international factors. A huge asbestos scandal in 2005 preponed the achievement of a total ban and led to the establishment of comprehensive measures to tackle asbestos issues. However, challenges remain for the elimination of asbestos-related diseases.
Schmettow, M.; Schnittker, R.; Schraagen, J.M.
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
Parry, Charles; Burnhams, Nadine Harker; London, Leslie
Evidence from burden of disease and economic costing studies amply indicate that the public health burden from hazardous and harmful use of alcohol in South Africa warrants drastic action. Evidence that banning alcohol advertising is likely to be an effective intervention is reflected in WHO strategy documents on non-communicable diseases and harmful use of alcohol. Studies on young people furthermore support arguments refuting the claim that advertising only influences brand choice. Given the weakness of relying on industry self-regulation, the government is considering legislation to ban alcohol advertising, resulting in heated debate. Tobacco control and studies investigating the effect of alcohol advertising bans on consumption and alcohol-related deaths point to the effectiveness of such action - ideally supplemented by other policy interventions. Arguments against an advertising ban include possible communication sector job losses, but these are likely to have been exaggerated. Banning alcohol advertising will necessitate greater scrutiny of digital media, satellite television and merchandising to reduce the likelihood of subverting the ban.
Ito, Hitoshi; Ishigaki, Isao
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)
Hunter, Tim B; Yoshino, Mark T; Dzioba, Robert B; Light, Rick A; Berger, William G
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
Costa Monteiro, E.; Leon, L. F.
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.
Schleich, Joachim; Ehrhart, Karl-Martin; Hoppe, Christian; Seifert, Stefan
Admitting banking in emissions trading systems reduces overall compliance costs by allowing for inter-temporal flexibility: cost savings can be traded over time. However, unless individual EU Member States (MS) decide differently, the transfer of unused allowances from the period of 2005-2007 into the first commitment period under the Kyoto Protocol, i.e. 2008-2012, will be prohibited. In this paper, we first explore the implications of such a ban on banking when initial emission targets are lenient. This analysis is based on a simulation which was recently carried out in Germany with companies and with a student control group. The findings suggest that a EU-wide ban on banking would lead to efficiency losses in addition to those losses which arise from the lack of inter-temporal flexibility. Second, we use simple game-theoretic considerations to argue that, under reasonable assumptions, such a EU-wide ban on banking will be the equilibrium outcome. Thus, to avoid a possible prisoners' dilemma, MS should have co-ordinated their banking decisions
Girling, Alan; Young, Terry; Brown, Celia; Lilford, Richard
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.
... 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...
Morgenstern, M; Wiborg, G; Hanewinkel, R
The purpose of this study was to measure students' attitudes towards a total smoking ban in schools and towards impositions in cases of violation. Cross-sectional survey of 1 738 students of 12 public schools in Schleswig-Holstein (grades 7-13, age 11-20 years). Data were collected by means of written questionnaires administered during class time. The following variables were assessed: attitude towards smoking ban, attitude towards impositions, age, sex, citizenship, perceived school climate, current smoking, lifetime smoking; for smokers, and additionally, the "Heaviness of Smoking Index". 76.5% of all students agreed with a total smoking ban, 66.4% agreed with the punishment of violations. Higher acceptance rates were found among girls, young students (11-15 years of age), for never-smokers, and for students who feel comfortable at school. Acceptance of the smoking ban is closely related to current smoking status: 93% of the non-smoking students, but only 14% of the daily smoking students agreed with the regulations. Refusal of the ban increased with increasing physical dependence. The intensification of the smoking ban in public schools meets approval by the majority of students. Smoking students should be more strongly involved in the implementation process, e.g., by supplemental cessation programmes.
Leary, James F.
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.
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...
He, Longjun; Ming, Xing; Xu, Lang; Liu, Qian
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.
Martelli, N; van den Brink, H; Denies, F; Dervaux, B; Germe, A F; Prognon, P; Pineau, J
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.
In 2003 an executive order was issued banning industrially produced trans-fatty acids above a low level in food items in Denmark. To date, only a few other countries have followed Denmark’s example. The way health consequences of trans fats were translated by the different actors enabled the crea......In 2003 an executive order was issued banning industrially produced trans-fatty acids above a low level in food items in Denmark. To date, only a few other countries have followed Denmark’s example. The way health consequences of trans fats were translated by the different actors enabled...
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
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.
Ferguson, John E; Redish, A David
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.
Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M
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.
...] 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...
Prichard, Ivanka; Dobbinson, Suzanne; Wilson, Carlene; Hutchinson, Amanda D; Rayner, Joanne; Makin, Jen
The causal link between ultraviolet radiation from solarium use and skin cancer is well established. In 2012 and 2013, state governments across Australia announced plans to ban commercial solarium use from 31 December 2014. The present study examined the responses of solarium and non-solarium users to the ban on commercial solariums in Australia. Participants (n = 488; 388 females, 100 males; mean age = 26.02, s.d. = 9.95) completed an online questionnaire during the summer prior to the ban relating to solarium usage and their opinions about the ban. Overall, 49% (n = 237) of participants were aware of the impending ban; 17% (n = 83) had used a solarium at some point in their life. The response to the solarium ban was positive; however, some current solarium users intended post-ban to use privately owned sunbeds and or spend a greater amount of time sun-tanning. These findings indicate a high level of public support for the solarium ban, which has removed a risky source of ultraviolet radiation in Australia. SO WHAT? Further steps are now needed to monitor the tanning behaviours of previous solarium users post-ban and their access to private sunbed use and other potentially dangerous methods of tanning (e.g. tanning injections).
Choy, Courtney C; Cartmel, Brenda; Clare, Rachel A; Ferrucci, Leah M
Indoor tanning is a known risk factor for skin cancer and is especially dangerous for adolescents. Some states have passed indoor tanning bans for minors, but business compliance with the bans is not well understood. Thus far, studies have assessed ban compliance in one or two states at a time. This study aimed to assess compliance with indoor tanning bans for minors and knowledge of dangers and benefits of tanning among indoor tanning businesses. Female research assistants posing as minors telephoned a convenience sample of 412 businesses in 14 states with tanning bans for minors under age 17 or 18. We evaluated differences in compliance by census region and years since ban was implemented and differences in reported dangers and benefits by compliance. Most (80.1%) businesses told the "minor" caller she could not use the tanning facilities. Businesses in the south and in states with more recent bans were less compliant. Among those (n = 368) that completed the full interview, 52.2% identified burning and 20.1% mentioned skin cancer as potential dangers. However, 21.7% said dangers were no worse than the sun and 10.3% denied any dangers. Stated benefits included vitamin D (27.7%), social/cosmetic (27.2%), and treats skin diseases (26.4%), with only 4.9% reporting no benefits. While most businesses followed the indoor tanning ban when a minor called, one-fifth did not. Many stated inaccurate health claims. Additional enforcement or education might increase compliance with indoor tanning bans and action is needed to prevent businesses from stating false health information.
Deng, Yong-Yuan; Chen, Chin-Ling; Tsaur, Woei-Jiunn; Tang, Yung-Wen; Chen, Jung-Hsuan
As sensor networks and cloud computation technologies have rapidly developed over recent years, many services and applications integrating these technologies into daily life have come together as an Internet of Things (IoT). At the same time, aging populations have increased the need for expanded and more efficient elderly care services. Fortunately, elderly people can now wear sensing devices which relay data to a personal wireless device, forming a body area network (BAN). These personal wireless devices collect and integrate patients' personal physiological data, and then transmit the data to the backend of the network for related diagnostics. However, a great deal of the information transmitted by such systems is sensitive data, and must therefore be subject to stringent security protocols. Protecting this data from unauthorized access is thus an important issue in IoT-related research. In regard to a cloud healthcare environment, scholars have proposed a secure mechanism to protect sensitive patient information. Their schemes provide a general architecture; however, these previous schemes still have some vulnerability, and thus cannot guarantee complete security. This paper proposes a secure and lightweight body-sensor network based on the Internet of Things for cloud healthcare environments, in order to address the vulnerabilities discovered in previous schemes. The proposed authentication mechanism is applied to a medical reader to provide a more comprehensive architecture while also providing mutual authentication, and guaranteeing data integrity, user untraceability, and forward and backward secrecy, in addition to being resistant to replay attack.
Zhang, Fei; Hackworth, Steven A; Liu, Xiaoyu; Chen, Haiyan; Sclabassi, Robert J; Sun, Mingui
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.
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.
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.
Abouk, Rahi; Adams, Scott
Many states have banned electronic cigarette sales to minors under the rationale that using e-cigarettes leads to smoking traditional combustion cigarettes. Such sales bans would be counterproductive, however, if e-cigarettes and traditional cigarettes are substitutes, as bans might push teenagers back to smoking the more dangerous combustion cigarettes. We provide evidence that these sales bans reduce the incidence of smoking conventional cigarettes among high school seniors. Moreover, we provide evidence suggesting that sales bans reduced e-cigarette usage as well. This evidence suggests that not only are e-cigarettes and smoking regular cigarettes positively related and not substitutes for young people, banning retail sales to minors is an effective policy tool in reducing tobacco use. Copyright © 2017 Elsevier B.V. All rights reserved.
Sleath, Betsy; Carpenter, Delesha M; Ayala, Guadalupe X; Williams, Dennis; Davis, Stephanie; Tudor, Gail; Yeatts, Karin; Gillette, Chris
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.
Kibriya, Nabil; Hall, Rebecca; Powell, Steven; How, Thien; McWilliams, Richard G.
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
... 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...
India has sought a nuclear-test ban for the last 42 years bur is now unable to sign the Comprehensive Test ban Treaty (CTBT) when it is in its final form and moved to block its transmittal from the Conference on Disarmament to the UN General assembly. The negotiating mandate for the CTBT required it to effectively contribute to the process of disarmament. It is towards this end that India proposed amendments. Nuclear disarmament is fundamental for India's strategic and security interests. The only viable solution to India's security concerns related to nuclear weapons is in pursuing total elimination of nuclear weapons from national arsenals
...] 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...
Howard, Jason J
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.
Sachin C. Deorukhkar
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.
Römer, GertWillem R.B.E.; Stuyt, Harry J.A.
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
...] 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...
Moqeem, Aasia; Baig, Mirza; Gholamhosseini, Hamid; Mirza, Farhaan; Lindén, Maria
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.
Banke imajo, kot osrednje finančne institucije, veliko zaslug za hiter razvoj informacijske tehnologije. Če je bila še pred približno 15 leti tehnologija bank skrita pred očmi javnosti, je danes preko elektronskega bančništva povezana s komitenti bank, saj se je v zadnjem desetletju elektronsko bančništvo izkazalo za eno najbolj dobičkonosnih spletnih storitev. Spletno bančništvo je del elektronskega bančništva in omogoča opravljanje bančnih poslov preko interneta ob vseh urah dneva, hkrat...
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.)
Foo, Jong Yong Abdiel; Tan, Xin Ji Alan
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.
Voss, Thaddaeus J; Subbian, Vignesh; Beyette, Fred R
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.
Soliman, Y.S.; Beshir, W.B.; Abdel-Fattah, A.A.; Abdel-Rehim, F.
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.
Howarth, Nicholas A.A.; Rosenow, Jan
Much academic attention has been directed at analysing energy efficiency investments through the lens of ‘behavioural failure’. These studies have challenged the neoclassical framing of regulation which emphasises the efficiency benefits of price based policy, underpinned by the notion of rational individual self-mastery. The increasing use of a regulatory ban on electric lamps in many countries is one of the most recent and high profile flash points in this dialectic of ‘freedom-versus-the-state’ in the public policy discourse. This paper interrogates this debate through a study of electric lamp diffusion in Germany. It is argued that neoclassical theory and equilibrium analysis is inadequate as a tool for policy analysis as it takes the formation of market institutions, such as existing regulations, for granted. Further still, it may be prone to encourage idealistic debates around such grand narratives which may in practice simply serve those who benefit most from the status quo. Instead we argue for an evolutionary approach which we suggest offers a more pragmatic framing tool which focuses on the formation of market institutions in light of shifting social norms and political goals—in our case, progress towards energy efficiency and environmental goals. - Highlights: • Empirical data on the ban of incandescent lamps in Germany is presented. • The political debate on the ban is positioned within key bodies of theory. • Discourse was found to have positively influenced diffusion of efficient lighting. • Tools for the reframing of political debate are proposed for policy makers
Hannig, Jürgen; Siekmeier, Rüdiger
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
Treaty on limitation of underground nuclear weapon tests and treaty on world banning of nuclear tests contribute to and accompany the process of nuclear disarmament. Test ban in three (Moscow treaty of 1963) as well as the Threshold Test Ban up to 1991 was controlled only with national means. But since 1991 nuclear test threshold of 150 kt has been measured with hydrodynamic and tele seismic methods and checked by the inspection. Distinctive feature of this control is that control is that it is bilateral. This conforms to Treaty on limitation of underground nuclear weapon tests signed by two countries - USA and USSR. The inspection at the place of tests requires monitoring of the test site of the party conducting a test and geological information of rock in the area of explosion. In the treaty of the World Nuclear Test Ban the following ways of international control are provided for: - seismologic measurements; - radionuclide measurements; - hydro-acoustics measurements; - infra-sound measurements; - inspection at the place of the tests conduction
The conclusion of a comprehensive nuclear test ban is of critical importance for the future of arms limitation and disarmament. As the 1980 report of the Secretary-General concluded, a comprehensive nuclear test ban is regarded as the first and most urgent step towards the cessation of the nuclear arms race and, in particular, of its qualitative aspects. It could serve as an important measure for the non-proliferation of nuclear weapons, both vertical and horizontal. It would have a major arms limitation impact in that it would make it difficult, if not impossible, to develop new designs of nuclear weapons and would also place constraints on the modification of existing weapon designs. The permanent cessation of all nuclear-weapon tests has long been sought by the world community and its achievement would be an event of great international significance
Perkins, Richard; Neumayer, Eric
We examine the determinants governing both countries' enactment of smoking bans in public places and their ability to successfully put these bans into effect. Using a large sample (N = 99-184) of low-, middle- and high-income countries, econometric techniques are used to estimate the influence of several variables on cross-national variations in the adoption and compliance of second-hand smoke laws (2010). We find similarities in the determinants of adoption and compliance. Yet more notable are the differences, with several political economy factors which have a statistically significant influence on countries' level of compliance with existing smoke-free laws in public places found not to consistently influence their propensity to adopt bans in the first place. Possible explanations for this discrepancy are that governments are motivated to adopt smoking bans for reasons other than protecting the health of their citizens and that the real costs of smoking bans are predominantly borne at the compliance stage. More effort needs to be made to ensure that governments realize their existing policy commitments through effective enforcement of bans.
Bruzzi, M S; Linehan, J H
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.
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.
Kim, Do-Hyun; Kim, Moon S.; Hwang, Jeeseong
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.
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.
Reino, Luís; Figueira, Rui; Beja, Pedro; Araújo, Miguel B; Capinha, César; Strubbe, Diederik
Wildlife trade is a major pathway for introduction of invasive species worldwide. However, how exactly wildlife trade influences invasion risk, beyond the transportation of individuals to novel areas, remains unknown. We analyze the global trade network of wild-caught birds from 1995 to 2011 as reported by CITES (Convention on International Trade in Endangered Species of Wild Fauna and Flora). We found that before the European Union ban on imports of wild-caught birds, declared in 2005, invasion risk was closely associated with numbers of imported birds, diversity of import sources, and degree of network centrality of importer countries. After the ban, fluxes of global bird trade declined sharply. However, new trade routes emerged, primarily toward the Nearctic, Afrotropical, and Indo-Malay regions. Although regional bans can curtail invasion risk globally, to be fully effective and prevent rerouting of trade flows, bans should be global.
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
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
Full Text Available This study examines the effects of China’s 2008 trading ban regulation on the insider trading of large shareholders in China’s A-share market. It finds no evidence of insider trading during the ban period (one month before the announcement of a financial report, due to high regulation risk. However, the ban only constrains the profitability of insider trades during the ban period, while trades outside it remain highly profitable. Informed insider trading before the ban period is 2.83 times more profitable than uninformed trading. The regulation has changed insider trading patterns, but has been ineffective in preventing insider trading by large shareholders due to rigid administrative supervision and a lack of civil litigation and flexible market monitoring. This study enhances understanding of large shareholders’ trading behavior and has important implications for regulators.
Hyde James N
Full Text Available Abstract Background We quantified the air quality benefits of a smoke-free workplace law in Boston Massachusetts, U.S.A., by measuring air pollution from secondhand smoke (SHS in 7 pubs before and after the law, comparing actual ventilation practices to engineering society (ASHRAE recommendations, and assessing SHS levels using health and comfort indices. Methods We performed real-time measurements of respirable particle (RSP air pollution and particulate polycyclic aromatic hydrocarbons (PPAH, in 7 pubs and outdoors in a model-based design yielding air exchange rates for RSP removal. We also assessed ventilation rates from carbon dioxide concentrations. We compared RSP air pollution to the federal Air Quality Index (AQI and the National Ambient Air Quality Standard (NAAQS to assess health risks, and assessed odor and irritation levels using published SHS-RSP thresholds. Results Pre-smoking-ban RSP levels in 6 pubs (one pub with a non-SHS air quality problem was excluded averaged 179 μg/m3, 23 times higher than post-ban levels, which averaged 7.7 μg/m3, exceeding the NAAQS for fine particle pollution (PM2.5 by nearly 4-fold. Pre-smoking ban levels of fine particle air pollution in all 7 of the pubs were in the Unhealthy to Hazardous range of the AQI. In the same 6 pubs, pre-ban indoor carcinogenic PPAH averaged 61.7 ng/m3, nearly 10 times higher than post-ban levels of 6.32 ng/m3. Post-ban particulate air pollution levels were in the Good AQI range, except for 1 venue with a defective gas-fired deep-fat fryer, while post-ban carcinogen levels in all 7 pubs were lower than outdoors. Conclusion During smoking, although pub ventilation rates per occupant were within ASHRAE design parameters for the control of carbon dioxide levels for the number of occupants present, they failed to control SHS carcinogens or RSP. Nonsmokers' SHS odor and irritation sensory thresholds were massively exceeded. Post-ban air pollution measurements showed 90% to 95
Repace, James L; Hyde, James N; Brugge, Doug
We quantified the air quality benefits of a smoke-free workplace law in Boston Massachusetts, U.S.A., by measuring air pollution from secondhand smoke (SHS) in 7 pubs before and after the law, comparing actual ventilation practices to engineering society (ASHRAE) recommendations, and assessing SHS levels using health and comfort indices. We performed real-time measurements of respirable particle (RSP) air pollution and particulate polycyclic aromatic hydrocarbons (PPAH), in 7 pubs and outdoors in a model-based design yielding air exchange rates for RSP removal. We also assessed ventilation rates from carbon dioxide concentrations. We compared RSP air pollution to the federal Air Quality Index (AQI) and the National Ambient Air Quality Standard (NAAQS) to assess health risks, and assessed odor and irritation levels using published SHS-RSP thresholds. Pre-smoking-ban RSP levels in 6 pubs (one pub with a non-SHS air quality problem was excluded) averaged 179 microg/m3, 23 times higher than post-ban levels, which averaged 7.7 microg/m3, exceeding the NAAQS for fine particle pollution (PM2.5) by nearly 4-fold. Pre-smoking ban levels of fine particle air pollution in all 7 of the pubs were in the Unhealthy to Hazardous range of the AQI. In the same 6 pubs, pre-ban indoor carcinogenic PPAH averaged 61.7 ng/m3, nearly 10 times higher than post-ban levels of 6.32 ng/m3. Post-ban particulate air pollution levels were in the Good AQI range, except for 1 venue with a defective gas-fired deep-fat fryer, while post-ban carcinogen levels in all 7 pubs were lower than outdoors. During smoking, although pub ventilation rates per occupant were within ASHRAE design parameters for the control of carbon dioxide levels for the number of occupants present, they failed to control SHS carcinogens or RSP. Nonsmokers' SHS odor and irritation sensory thresholds were massively exceeded. Post-ban air pollution measurements showed 90% to 95% reductions in PPAH and RSP respectively, differing
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.
Lingg, Myriam; Wyss, Kaspar; Durán-Arenas, Luis
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
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 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...
Abrous-Anane, S; Benhassine, S; Lopez, S; Cristina, K; Mazeron, J-J
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.
Coyer, Fiona M; Stotts, Nancy A; Blackman, Virginia Schmied
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.
Full Text Available As millions of immigrants moved to Hong Kong (HK from China in the recent decades, large amount of residential housings were built in the early years and a substantial proportion of those buildings used asbestos-containing materials (ACMs. Since the number of new cases of ARDs diagnosed has increased year by year since 1990’s, the remarkable increase of incidences had drawn the attention of the public and most importantly the HK government. It became one of the trigger points leading to asbestos ban in HK history. Comparatively, non-governmental organizations (NGOs, labor unions and patients’ self-help organizations demonstrated a more aggressive and proactive attitude than the HK government and have played a key role in the development of asbestos banning policy in HK. After numerous petitions and meetings with the government representatives by those parties in the past decade, the HK government eventually changed its attitude and started to consider terminating the endless threat from asbestos by amending the policy, and the new clause of legislation for banning of all forms of asbestos was enacted on 4 April 2014. Other than the restriction of asbestos use, the compensation system about ARDs has also made some great moves by the effort of those parties as well. Based on the experience we learnt through the years, efforts from different stakeholders including patients’ self-help organizations, NGOs, legislative councilors, and media power are absolutely essential to the success of progression and development in today’s asbestos banning in HK.
Hanus, Josef; Nosek, Tomas; Zahora, Jiri; Bezrouk, Ales; Masin, Vladimir
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.
Billaux, Mathilde; Borget, Isabelle; Prognon, Patrice; Pineau, Judith; Martelli, Nicolas
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
... banned its use regardless of the nature of the conflict or the status of the leader. The United States should eliminate the assassination ban. As potentially one of the most effective and efficient means for combating and deterring aggression from rogue states and terrorists, assassination or at least the credible threat of assassination, should be an option available to the United States.
A full work area smoking ban reduced the current smoking rate by 9.6 percentage points among males and the average daily consumption among smokers by 24 percent relative to no smoking ban. Secondhand smoke showed a dramatic decrease of 88 percent from the sample mean among males. The public anti-smoking campaign did not show any significant impact on smoking behavior.
Yue, Lilly Q; Campbell, Gregory; Lu, Nelson; Xu, Yunling; Zuckerman, Bram
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.
A resolution calling for a ban on genetic engineering of human reproductive cells has been signed by leaders of almost every major church group in the United States. Some of the religious leaders, while not certain that a total moratorium should be placed on altering germline cells, signed the statement in order to stimulate public debate on the issue. Legislation has recently been introduced in Congress to set up a committee to monitor genetic engineering and its human applications, but author Jeremy Rifkin, the impetus behind the church leaders' resolution, argues that such tampering threatens the gene pool and should be banned altogether.
"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...
Markiewicz, Katarzyna; van Til, Janine Astrid; Steuten, Lotte Maria Gertruda; IJzerman, Maarten Joost
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
... 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...
Full Text Available BACKGROUND: Many countries have introduced legislations for public smoking bans to reduce the harmful effects of exposure to tobacco smoke. Smoking bans cause significant reductions in admissions for acute coronary syndromes but their impact on respiratory diseases is unclear. In Geneva, Switzerland, two popular votes led to a stepwise implementation of a state smoking ban in public places, with a temporary suspension. This study evaluated the effect of this smoking ban on hospitalisations for acute respiratory and cardiovascular diseases. METHODS: This before and after intervention study was conducted at the University Hospitals of Geneva, Switzerland, across 4 periods with different smoking legislations. It included 5,345 patients with a first hospitalisation for acute coronary syndrome, ischemic stroke, acute exacerbation of chronic obstructive pulmonary disease, pneumonia and acute asthma. The main outcomes were the incidence rate ratios (IRR of admissions for each diagnosis after the final ban compared to the pre-ban period and adjusted for age, gender, season, influenza epidemic and secular trend. RESULTS: Hospitalisations for acute exacerbation of chronic obstructive pulmonary disease significantly decreased over the 4 periods and were lowest after the final ban (IRR=0.54 [95%CI: 0.42-0.68]. We observed a trend in reduced admissions for acute coronary syndromes (IRR=0.90 [95%CI: 0.80-1.00]. Admissions for ischemic stroke, asthma and pneumonia did not significantly change. CONCLUSIONS: A legislative smoking ban was followed by a strong decrease in hospitalisations for acute exacerbation of chronic obstructive pulmonary disease and a trend for reduced admissions for acute coronary syndrome. Smoking bans are likely to be very beneficial for patients with chronic obstructive pulmonary disease.
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.
Full Text Available As sensor networks and cloud computation technologies have rapidly developed over recent years, many services and applications integrating these technologies into daily life have come together as an Internet of Things (IoT. At the same time, aging populations have increased the need for expanded and more efficient elderly care services. Fortunately, elderly people can now wear sensing devices which relay data to a personal wireless device, forming a body area network (BAN. These personal wireless devices collect and integrate patients’ personal physiological data, and then transmit the data to the backend of the network for related diagnostics. However, a great deal of the information transmitted by such systems is sensitive data, and must therefore be subject to stringent security protocols. Protecting this data from unauthorized access is thus an important issue in IoT-related research. In regard to a cloud healthcare environment, scholars have proposed a secure mechanism to protect sensitive patient information. Their schemes provide a general architecture; however, these previous schemes still have some vulnerability, and thus cannot guarantee complete security. This paper proposes a secure and lightweight body-sensor network based on the Internet of Things for cloud healthcare environments, in order to address the vulnerabilities discovered in previous schemes. The proposed authentication mechanism is applied to a medical reader to provide a more comprehensive architecture while also providing mutual authentication, and guaranteeing data integrity, user untraceability, and forward and backward secrecy, in addition to being resistant to replay attack.
Hussain, Abrar; Mohan, Anjana; Sathiyasekaran, B W C
Smoking has become an important global problem that poses serious health hazards. Today even teenagers have got trapped by this addictive habit. To curb this menace, the Government of Tamilnadu has proposed a ban on smoking in public places by introducing the Bill "Tamilnadu Prohibition of Smoking and Spitting 2002". A study was conducted in the month of February, 2003 to find out the response to this proposed ban among health providers. One hundred and twenty-seven hospital employees were studied using a one page questionnaire. The prevalence of smoking was found to be 12.6% (95% CI 6.9 to 18.3). The response of the study group to the proposed ban was recorded by asking them about their awareness, acceptability and their personal opinion about the ban. It was found that 94% of the smokers and 83% of the non-smokers were aware of the proposed ban and 50% of the smokers and 69% of non-smokers wanted the ban to be implemented. It was also found that 43.8% of the smokers and 52.3% of the non-smokers were confident that the ban on smoking in public places will be effective. They were also of the opinion that awareness had to be increased and the penalties had to be implemented strictly. Further studies on other population groups may have to be taken upto know about the impact of this important Act after it comes into effect.
... through the ETC Pass-through Clause contained in Banning's TO Tariff; (3) accept revisions to Appendix I to Banning's TO Tariff to reflect Banning's revised TRBAA, forcasted calendar year 2012 ETC costs... lieu of paper using the ``eFiling'' link at http://www.ferc.gov . Persons unable to file electronically...
Phelps, Megan; Scott, Karen M.; Chauffeté-Manillier, Martine; Lenne, Frédéric; Le Jeunne, Claire
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…
Bashir, R.; Afroze, B.; Zulfiqar, H. F.; Saleem, R.; Saleem, F.; Aslam, F.; Naz, S.
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)
Huang, Kaiyong; Chen, Hailian; Liao, Jing; Nong, Guangmin; Yang, Li; Winickoff, Jonathan P; Zhang, Zhiyong; Abdullah, Abu S
(1) BACKGROUND: The home environment is a major source of Environmental Tobacco Smoke (ETS) exposure among children especially in early childhood. ETS exposure is an important health risk among children and can cause severe and chronic diseases, such as asthma, bronchitis, and premature death. However, ETS exposure at home has often been neglected in the Chinese families. Identification of factors that facilitate or otherwise hamper the adoption of home smoking ban will help in the design and implementation of evidence-based intervention programs. This study identifies factors correlated with home smoking bans in Chinese families with children. (2) METHODS: A cross-sectional survey of parents living in Nanning city, Guangxi Province, China with at least one smoker and a child in the household was conducted between September, 2013 and January, 2014. A Chi-square test was used to compare categorical variables differences between the parents who had home smoking bans and those with no home smoking ban. Multiple logistic regression analyses were used to identify factors correlated with home smoking bans. (3) RESULTS: 969 completed questionnaires were collected with a response rate of 92.29% (969/1050). Of the respondents (n = 969), 14.34% had complete home smoking bans. Factors that were associated with home smoking bans were: having no other smokers in the family (OR = 2.173), attaining education up to high school (OR = 2.471), believing that paternal smoking would increase the risk of lower respiratory tract illnesses (OR = 2.755), perceiving the fact that smoking cigarettes in the presence of the child will hurt the child's health (OR = 1.547), believing that adopting a no smoking policy at home is very important (OR = 2.816), and being confident to prevent others to smoke at home (OR = 1.950). Additionally, parents who perceived difficulty in adopting a no smoking policy at home would not have a home smoking ban (OR = 0.523). (4) CONCLUSIONS: A home smoking ban is
Full Text Available (1 Background: The home environment is a major source of Environmental Tobacco Smoke (ETS exposure among children especially in early childhood. ETS exposure is an important health risk among children and can cause severe and chronic diseases, such as asthma, bronchitis, and premature death. However, ETS exposure at home has often been neglected in the Chinese families. Identification of factors that facilitate or otherwise hamper the adoption of home smoking ban will help in the design and implementation of evidence-based intervention programs. This study identifies factors correlated with home smoking bans in Chinese families with children. (2 Methods: A cross-sectional survey of parents living in Nanning city, Guangxi Province, China with at least one smoker and a child in the household was conducted between September, 2013 and January, 2014. A Chi-square test was used to compare categorical variables differences between the parents who had home smoking bans and those with no home smoking ban. Multiple logistic regression analyses were used to identify factors correlated with home smoking bans. (3 Results: 969 completed questionnaires were collected with a response rate of 92.29% (969/1050. Of the respondents (n = 969, 14.34% had complete home smoking bans. Factors that were associated with home smoking bans were: having no other smokers in the family (OR = 2.173, attaining education up to high school (OR = 2.471, believing that paternal smoking would increase the risk of lower respiratory tract illnesses (OR = 2.755, perceiving the fact that smoking cigarettes in the presence of the child will hurt the child’s health (OR = 1.547, believing that adopting a no smoking policy at home is very important (OR = 2.816, and being confident to prevent others to smoke at home (OR = 1.950. Additionally, parents who perceived difficulty in adopting a no smoking policy at home would not have a home smoking ban (OR = 0.523. (4 Conclusions: A home smoking
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.
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)
Doruk, Sibel; Çelik, Deniz; İnönü Köseoğlu, Handan; Etikan, Ilker; Çetin, İlhan
We aimed to evaluate the knowledge and perspective of employees/employers in the catering sector in our city regarding the smoking ban, as well as to determine the changes in the number of customers and income after the bans implementation. In this two phased cross-sectional study 337 and 310 adults were evaluated respectively. Before the smoking ban was implemented we visited 84 workplaces in city center, after 18 months later 97 workplaces were visited in the same region. In both phases, the participants' opinions about the necessity/applicability of the ban were evaluated. In the second phase, they were also asked whether they had any changes in their income. In both phases, participants' general characteristics were similar. When all participants were evaluated, we determined that their knowledge and belief in the necessity/applicability of the ban did not change over time. It was determined that non-smokers more strongly believed in the necessity/applicability of the ban. Thirty-eight participants were included in both phases; 44.7% of them reported a decrease in the number of customers, and 60% of employers reported an increase in their income. The smokers were less convinced about the applicability/necessity of this ban than non-smokers. According to our results it could be said that smoking can also adversely affect implementation of the related ban. Employers should be informed that the ban will not affect their income.
Nkaku R. Kisaalita
Full Text Available Drug ‘doping’ and the use of banned performance enhancing products (PEPs remains an issue in virtually all competitive sports despite penal consequences and known health risks. The lines distinguishing “fair” and “unfair” performance enhancement have become increasingly blurred. Few studies have explored how attitudes towards legal performance enhancers (drugs/substances, diet, and equipment modifications may influence motivations to use banned PEPs. In the present study, 68 competitive cyclists completed a survey examining the importance of choosing banned and non-banned PEPs using World Anti-Doping Agency (WADA and Union Cycliste Internationale (UCI criteria. Results showed that over 60 percent of cyclists used non-banned PEPs while 8 percent used banned PEPs. Health was overall the most important factor in choosing a PEP while apprehension by a doping agency was least important. Mixed- model ANOVA analyses revealed that motivations to use banned PEPs were complex, as the importance of health, violating the sprit of the sport, performance improvement, and getting caught were differentially influenced by PEP legality (p 0.05. Our findings illustrate the multifactorial nature of PEP use/doping attitudes and highlight the unique role that “legal” performance enhancement may plays in influencing banned and/or unethical sports behaviors.
Ryu, Gyeong Suk; Lee, Yu Jeung
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
The position of Environment Canada in banning the export of PCB waste to the United States was defended as falling within their jurisdiction under provisions of the the Canadian Environmental Protection Act. The United States had previously banned the import of Canadian PCBs, but when it reversed its decision Environment Canada posted an Interim Order, upholding the ban. The decision to do so was based on protection of the large investment that was made to develop the Canadian PCB incineration facility in Swan Lake, Alberta. Canada also had an obligation under the Basel Convention to reduce it cross boundary movement of hazardous waste and provide adequate destruction facilities in Canada. Legal implications of PCB exports and the uncertainty of continuing access to American facilities were also cited as reasons for issuing the Interim Order
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.
Ruhdel, I W
For the second time the European Commission has postponed the sales ban on cosmetics products that have been developed and tested in animal experiments now until 2002. In the meantime the Commission wants to adopt the Seventh Amendment of the EU Cosmetics Directive. In its draft the Commission proposes to scrap the sales ban and replace it with an animal testing ban. This change would avoid possible conflicts with the WTO, however, from the animal welfare point of view would result in animal testing moving into third countries instead of avoiding them. This is because cosmetics products tested on animals outside the EU could be sold in the EU without any restrictions. As a consequence this measure would take the pressure from authorities and industry to further develop and adopt alternative methods. Other proposed measures are not acceptable from the animal welfare point of view, e.g. because they contradict Directive 86/609 and would result in a delay of the application of validated alternative methods. The Deutscher Tierschutzbund therefore still demands an immediate and complete sales ban in connection with an animal testing ban within the EU.
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)
Teixeira, Marie B
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
...] 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...
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
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.
In 2005 the SCC decided that there would be a total smoking ban in all restaurants and satellite cafeterias on the CERN site, except for the designated area in Restaurant No.1. Unfortunately, it seems that this ban is often over-looked, resulting in an unhealthy and unpleasant environment for the users and staff of these facilities. You are asked to respect this ban and are reminded that smoking is only permitted in the room in Restaurant 1 specially installed for this purpose. The CSR Restaurant Monitoring Committee
Ronquillo, Jay G; Zuckerman, Diana M
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
Noon, Christian; Holub, Joseph; Winer, Eliot
Performing high quality 3D visualizations on mobile devices, while tantalizingly close in many areas, is still a quite difficult task. This is especially true for 3D volume rendering of digital medical images. Allowing this would empower medical personnel a powerful tool to diagnose and treat patients and train the next generation of physicians. This research focuses on performing real time volume rendering of digital medical images on iOS devices using custom developed GPU shaders for orthogonal texture slicing. An interactive volume renderer was designed and developed with several new features including dynamic modification of render resolutions, an incremental render loop, a shader-based clipping algorithm to support OpenGL ES 2.0, and an internal backface culling algorithm for properly sorting rendered geometry with alpha blending. The application was developed using several application programming interfaces (APIs) such as OpenSceneGraph (OSG) as the primary graphics renderer coupled with iOS Cocoa Touch for user interaction, and DCMTK for DICOM I/O. The developed application rendered volume datasets over 450 slices up to 50-60 frames per second, depending on the specific model of the iOS device. All rendering is done locally on the device so no Internet connection is required.
... devices operating in the 608-614 MHz band. For a wireless medical telemetry device operating within the... 47 Telecommunication 5 2010-10-01 2010-10-01 false Specific requirements for wireless medical telemetry devices operating in the 608-614 MHz band. 95.1119 Section 95.1119 Telecommunication FEDERAL...
He, Yanyun; Shang, Ce; Huang, Jidong; Cheng, Kai-Wen; Chaloupka, Frank J
Since Iceland became the first country to impose a ban on point-of-sale (POS) tobacco product displays in 2001, 20 countries have implemented POS display bans as of 2016. This study examined the effect that POS display bans have on smoking prevalence. Data were sourced from Euromonitor International and the WHO MPOWER package for 2007-2014 from 77 countries worldwide. generalised linear models with country and year fixed effects were estimated to analyse the effect of POS display bans on smoking prevalence. Having a POS display ban reduced overall adult daily smoking, male smoking and female smoking by about 7%, 6% and 9%, respectively. Having a POS display ban is likely to reduce smoking prevalence and generate public health benefits. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
DeMott, R.P.; Gauthier, T.D.; Wiersema, J.M.; Crenson, G. [ENVIRON International, Tampa, FL (USA)
Polycyclic aromatic hydrocarbon (PAH) concentrations were measured in stream sediments collected before and after a municipal ban on the use of coal-tar-based pavement sealers in Austin, Texas. Samples were collected in October 2005, prior to the ban, and again in April, 2008, approximately 2 years after the ban. Differences in total PAH concentrations between samples collected before and after the ban show no net change in PAH levels in Austin stream sediments. Results of hydrocarbon fingerprinting reveal subtle differences in PAH profiles that appear to reflect the effects of weathering rather than a change in PAH sources.
Salloum, Ramzi G; Nakkash, Rima T; Myers, Allison E; Wood, Kathryn A; Ribisl, Kurt M
The objective of this study was to conduct an audit of point-of-sale (POS) tobacco advertising and assess compliance with an advertising ban in a large district of Beirut, Lebanon. The audit was conducted 3 months following the ban on tobacco advertising. Trained students observed all tobacco retail outlets (n = 100) and entered data into a web-based form using iPad(®) technology. Presence of tobacco advertisements was assessed to determine compliance with the national advertising ban. Among the 100 tobacco retail outlets, 62% had tobacco advertisements, including 7% with a tobacco brand logo as part of the main exterior store sign. POS tobacco advertising is widespread in Beirut despite the national advertising ban. These findings point to an urgent need for the enforcement of the advertisement ban with tobacco retail outlets in Lebanon.
Paukštė, Ernesta; Liutkutė, Vaida; Stelemėkas, Mindaugas; Goštautaitė Midttun, Nijolė; Veryga, Aurelijus
In response to the dramatic increase in alcohol-related problems in Lithuania, policy measures, including alcohol advertising and availability restrictions combined with taxation increase, were implemented in 2007-08. Simultaneously, a full alcohol advertising ban was adopted to take effect from 1 January 2012. Therefore, the alcohol industry responded with extensive lobbying aiming to revoke this ban, and ultimately they succeeded at the end of December 2011. To document and analyse actions of stakeholders and events during the alcohol advertising ban cancellation process in Lithuania. Policy analysis includes a development of event time-line, description of key stakeholders' actions and a review of policy context. The alcohol industry in Lithuania used similar tactics as the tobacco industry globally, such as creating strong and diverse opposing groups. The industry successfully exerted pressure to change alcohol control legislation, while non-governmental organizations had the important role of a watchdog, blunting industry's efforts. Unequal power distribution made it difficult to withstand combined local and international lobbying to cancel the ban. Given the global nature of the alcohol industry, there is a need for international regulation to limit the influence of vested interests on national lawmaking. © 2014 Society for the Study of Addiction.
Arney, David; Plourde, Jeffrey; Goldman, Julian M
We give an overview of OpenICE, an open source implementation of the ASTM standard F2761 for the Integrated Clinical Environment (ICE) that leverages medical device interoperability, together with an analysis of the clinical and non-functional requirements and community process that inspired its design.
Full Text Available The article deals with the formation and operation of the D-collection (a special collection of banned prints in the National and University Library (NUL. The functioning of the collection was constantly faced with different complications caused either by legislation or by librarians themselves, due to a too strict adherence to some unwritten rules ("better one more then one less". In the 50-years period, a unique collection of at that tirne banned prints was formed,complemented by over 17000 articles indexed from different periodicals.
Kusche, Kristopher P
The academic medical center is faced with the unique challenge of meeting the multi-faceted needs of both a modern healthcare organization and an academic institution, The need for security to protect patient information must be balanced by the academic freedoms expected in the college setting. The Albany Medical Center, consisting of the Albany Medical College and the Albany Medical Center Hospital, was challenged with implementing a solution that would preserve the availability, integrity and confidentiality of business, patient and research data stored on mobile devices. To solve this problem, Albany Medical Center implemented a mobile encryption suite across the enterprise. Such an implementation comes with complexities, from performance across multiple generations of computers and operating systems, to diversity of application use mode and end user adoption, all of which requires thoughtful policy and standards creation, understanding of regulations, and a willingness and ability to work through such diverse needs.
Bero Lisa A
Full Text Available Abstract Background In January 1998, the California state legislature extended a workplace smoking ban to bars. The purpose of this study was to explore the conditions that facilitate or hinder compliance with a smoking ban in bars. Methods We studied the implementation of the smoking ban in bars by interviewing three sets of policy participants: bar employers responsible for complying with the law; local government officials responsible for enforcing the law; and tobacco control activists who facilitated implementation. We transcribed the interviews and did a qualitative analysis of the text. Results The conditions that facilitated bar owners' compliance with a smoking ban in bars included: if the cost to comply was minimal; if the bars with which they were in competition were in compliance with the smoking ban; and if there was authoritative, consistent, coordinated, and uniform enforcement. Conversely, the conditions that hindered compliance included: if the law had minimal sanctions; if competing bars in the area allowed smoking; and if enforcement was delayed or inadequate. Conclusion Many local enforcers wished to forfeit their local discretion and believed the workplace smoking ban in bars would be best implemented by a state agency. The potential implication of this study is that, given the complex nature of local politics, smoking bans in bars are best implemented at a broader provincial or national level.
Montini, Theresa; Bero, Lisa A
In January 1998, the California state legislature extended a workplace smoking ban to bars. The purpose of this study was to explore the conditions that facilitate or hinder compliance with a smoking ban in bars. We studied the implementation of the smoking ban in bars by interviewing three sets of policy participants: bar employers responsible for complying with the law; local government officials responsible for enforcing the law; and tobacco control activists who facilitated implementation. We transcribed the interviews and did a qualitative analysis of the text. The conditions that facilitated bar owners' compliance with a smoking ban in bars included: if the cost to comply was minimal; if the bars with which they were in competition were in compliance with the smoking ban; and if there was authoritative, consistent, coordinated, and uniform enforcement. Conversely, the conditions that hindered compliance included: if the law had minimal sanctions; if competing bars in the area allowed smoking; and if enforcement was delayed or inadequate. Many local enforcers wished to forfeit their local discretion and believed the workplace smoking ban in bars would be best implemented by a state agency. The potential implication of this study is that, given the complex nature of local politics, smoking bans in bars are best implemented at a broader provincial or national level.
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; name and place of business of manufacturer, packer or distributor. 801.1 Section 801.1 Food and Drugs FOOD AND DRUG ADMINISTRATION... § 801.1 Medical devices; name and place of business of manufacturer, packer or distributor. (a) The...
Full Text Available Lesley J Burgess, Marli TerblancheTREAD Research/Cardiology Unit, Department of Internal Medicine, Tygerberg Hospital and University of Stellenbosch, Parow, South AfricaAbstract: Numerous factors contribute to the declining pharmaceutical industry on the one hand and the rapidly growing generic industry together with the growing importance of medical devices and biologicals on the other. It is clear that the pharmaceutical industry is going to undergo a change in the next decade in order to meet the current challenges facing it and ultimately sustain its profitability and growth. This paper aims to identify a number of fairly obvious trends that are likely to have a significant impact on the product development pipeline in the next decade. It is more than clear that the current production pipeline for pharmaceutical, biotechnology and medical device industries is no longer sustainable and that urgent interventions are required in order to maintain its current level of profitability.Keywords: pharmaceutical industry, personalized medicine, trends, generics, biotechnology
Mehta, Rashi I; Mehta, Rupal I
Hydrophilic polymers are ubiquitously applied as surface coatings on catheters and intravascular medical technologies. Recent clinical literature has heightened awareness on the complication of hydrophilic polymer embolism, the phenomenon wherein polymer coating layers separate from catheter and device surfaces, and may be affiliated with a range of unanticipated adverse reactions. Significant system barriers have limited and delayed reporting on this iatrogenic complication, the full effects of which remain underrecognized by healthcare providers and manufacturers of various branded devices. In 2015, the United States Food and Drug Administration acknowledged rising clinical concerns and stated that the agency would work with stakeholders to further evaluate gaps that exist in current national and international device standards for coated intravascular medical technologies. The present article reviews current knowledge on this complication as well as factors that played a role in delaying detection and dissemination of information and new knowledge once hazards and clinical risks were identified. Furthermore, organ-specific effects and adverse reaction patterns are summarized, along with implications for device manufacturing, safety assurance, and regulation. Qualitative and quantitative particulate testing are needed to optimize coated intravascular device technologies. Moreover, general enhanced processes for medical device surveillance are required for timely adverse event management and to ensure patient safety.
This study provided information about compliance to the smoking ban in Beirut. The advertising sector's compliance would hopefully decrease the tobacco industry’s influence on the public. Further studies aiming at understanding the underlying factors behind the lack of compliance to the indoor smoking ban and finding effective solutions in a politically unstable country with weak rule of law like Lebanon are crucial and can serve as an example for similar developing countries.
Trippoli, Sabrina; Caccese, Erminia; Marinai, Claudio; Messori, Andrea
In the acute ischemic stroke, endovascular devices have shown promising clinical results and are also likely to represent value for money, as several modeling studies have shown. Pharmacoeconomic evaluations in this field, however, have little impact on the procurement of these devices. The present study explored how complex pharmacoeconomic models that evaluate effectiveness and cost can be incorporated into the in-hospital procurement of thrombectomy devices. As regards clinical modeling, we extracted outcomes at three months from randomized trials conducted for four thrombectomy devices, and we projected long-term results using standard Markov modeling. In estimating QALYs, the same model was run for the four devices. As regards economic modeling, we firstly estimated for each device the net monetary benefit (NMB) per patient (threshold = $60,000 per QALY); then, we simulated a competitive tender across the four products by determining the tender-based score (on a 0-to-100 scale). Prices of individual devices were obtained from manufacturers. Extensive sensitivity testing was applied to our analyses. For the four devices (Solitaire, Trevo, Penumbra, Solumbra), QALYs were 1.86, 1.52, 1,79, 1.35, NMB was $101,824, $83,546, $101,923, $69,440, and tender-based scores were 99.70, 43.43, 100, 0, respectively. Sensitivity analysis confirmed findings from base-case. Our results indicate that, in the field of thrombectomy devices, incorporating the typical tools of cost-effectiveness into the processes of tenders and procurement is feasible. Bridging the methodology of cost-effectiveness with the every-day practice of in-hospital procurement can contribute to maximizing the health returns that are generated by in-hospital expenditures for medical devices. Copyright © 2018 Elsevier B.V. All rights reserved.
Chopra, Amitabh M; Mehta, Monik; Bismuth, Jean; Shapiro, Maksim; Fishbein, Michael C; Bridges, Alina G; Vinters, Harry V
Over the past three decades, lubricious (hydrophobic and/or hydrophilic) polymer-coated devices have been increasingly adopted by interventional physicians and vascular surgeons to access and treat a wider range of clinical presentations. Recent clinical literature highlights the presence of polymer coating emboli within the anatomy - a result of coating separation from an intravascular device - and associates it with a range of adverse clinical sequelae. The 2015 U.S. Food and Drug Administration safety communication titled "Lubricious Coating Separation from Intravascular Medical Devices" acknowledges these concerns and concludes that it will work with stakeholders to develop nonclinical test methodologies, establish performance criteria, and identify gaps in current national and international device standards for coating integrity performance. Despite this communication and multiple case reports from interventional physicians, pathologists, dermatologists and other involved physician specialties, polymer coating embolism remains clinically underrecognized. This article consolidates the available literature on polymer coating embolism (1986-2016) and highlights the following relevant information for the physician: (a) the history and elusive nature of polymer coating embolism; (b) potential incidence rates of this phenomenon; (c) reported histologic findings and clinical effects of polymer emboli in the anatomy; (d) the importance of the collaborative clinician-pathologist partnership to report polymer embolism findings; and (e) the importance to study particulate release from intravascular devices so as to further understand and potentially evolve coated interventional technologies. Preliminary research on coatings highlights the potential of using iterations of coatings on medical devices that attain the desired therapeutic result and mitigate or eliminate particulates altogether. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.
Minardi, Valentina; Gorini, Giuseppe; Carreras, Giulia; Masocco, Maria; Ferrante, Gianluigi; Possenti, Valentina; Quarchioni, Elisa; Spizzichino, Lorenzo; Galeone, Daniela; Vasselli, Stefania; Salmaso, Stefania
The aim of this paper is to report compliance with the smoking ban and the spread of smoke-free homes after 3-8 years since the Italian smoking ban implementation, according to the ongoing Italian surveillance system for behavioural risk factors (PASSI). PASSI is based on representative annual samples of the Italian population aged 18-69 years. We considered questions on smoking habits, self-reported compliance with the ban, and on smoke-free homes of 176,236 interviews conducted in 2008-2012. Ninety percent of respondents in 2012 reported that the smoking ban was enforced in hospitality premises (HPs), with a significant 3% increase from 2008. Similarly, 91.3% in 2012 reported a high compliance in workplaces other than HPs, with a significant 5% increase. Perception of compliance did not change among smokers and non-smokers. Seventy-eight percent of respondents in 2012 reported smoke-free homes, with a significant increase from 2008 to 2012. The high compliance with the ban that is still increasing even after 8 years since its implementation may partially have caused the concurrent increase in smoke-free homes.
Wang, Man Ping; Wang, Xin; Lam, Tai Hing; Viswanath, Kasisomayajula; Chan, Sophia S
Tobacco endgame policies are increasingly advocated to end tobacco use. This study investigated public support for a total ban on tobacco sales, use and possession in Hong Kong. A telephone survey was conducted among 1537 randomly selected residents in 2012 to assess their support for a total ban on tobacco sales, usage and possession. Information on sociodemographic characteristics, smoking, and second hand smoke exposure were collected. Logistic regression was used to investigate factors associated with support for a total ban. Most of the never smokers (75.3%), ex-smokers (63.9%), and nearly half of current smokers (48.9%) backed some form of a total ban on tobacco. A total ban on tobacco sales was the most popular option among the three groups, with over half (64.8%) of all respondents supporting a ban within 10 years. Current smoking and higher educational attainment were associated with less support for a total ban on tobacco sales. Among current smokers, having quit intentions and attempts to quit were associated with support for a total ban. A total ban on tobacco sales was supported by most respondents. Ex-smokers and current smokers also voiced substantial support, although less than never smokers. A total ban on tobacco sales before 2022 should be the goal as it is supported by most of the respondents. Interim tobacco control measures, such as tax increases, expansion of smoking cessation services and plain packaging should be implemented to help current smokers quit and reduce smoking initiation before implementation of the ban. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
The FDA Compliance Program Guidance Manual provides a system for issuing and filing program plans and instructions directed to Food and Drug Administration Field operations for project implementation. Section IV provides those chapters of the Compliance Program Guidance Manual which pertain to the areas of medical and radiological devices. Some of the areas of coverage include laser and sunlamp standards inspections, compliance testing of various radiation-emitting products such as television receivers and microwave ovens, emergency response planning and policy, premarket approval and device manufacturers inspections, device problem reporting, sterilization of devices, and consumer education programs on medical and radiological devices
This article justifies classifying the TI-Nspire CAS Touchpad as a mobile device for grades 8-16 mathematics classrooms equipped with a Navigator system. The 2010 Horizon Report: K-12 indicates virtually every secondary school aged child has some sort of mobile device. Yet, many school policies ban the use of mobile devices, preventing students…
Vreugdenburg, T D; Willis, C D; Mundy, L; Hiller, J E
While research investigating direct-to-consumer advertising of therapeutic goods in Australia has historically focused on prescription medicines, recent action taken by regulators against companies promoting medical devices has placed the industry into the spotlight. Despite the need to effectively regulate direct-to-consumer advertising of medical devices due to its potential harms, inadequacies in the current regulatory system have been noted. Under the present system, devices with a questionable evidence base may enter the Australian marketplace without an evaluation of their effectiveness, and regulators are reliant on industry self-regulation and consumer complaints to draw attention to cases of advertising misconduct. Although some successes in the present system have been observed, we argue that the outlined inadequacies continue to enable the promotion of medical devices to consumers without thorough or sufficient examination of evidence. © 2011 The Authors; Internal Medicine Journal © 2011 Royal Australasian College of Physicians.
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0066] Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Molecular and Clinical Genetics Panel of the Medical Devices Advisory...
King, Marissa; Bearman, Peter S
The pharmaceutical industry spends roughly 15 billion dollars annually on detailing - providing gifts, information, samples, trips, honoraria and other inducements - to physicians in order to encourage them to prescribe their drugs. In response, several states in the United States adopted policies that restrict detailing. Some states banned gifts from pharmaceutical companies to doctors, other states simply required physicians to disclose the gifts they receive, while most states allowed unrestricted detailing. We exploit this geographic variation to examine the relationship between gift regulation and the diffusion of four newly marketed medications. Using a dataset that captures 189 million psychotropic prescriptions written between 2005 and 2009, we find that uptake of new costly medications was significantly lower in states with marketing regulation than in areas that allowed unrestricted pharmaceutical marketing. In states with gift bans, we observed reductions in market shares ranging from 39% to 83%. Policies banning or restricting gifts were associated with the largest reductions in uptake. Disclosure policies were associated with a significantly smaller reduction in prescribing than gift bans and gift restrictions. In states that ban gift-giving, peer influence substituted for pharmaceutical detailing when a relatively beneficial drug came to market and provided a less biased channel for physicians to learn about new medications. Our work suggests that policies banning or limiting gifts from pharmaceutical representatives to doctors are likely to be more effective than disclosure policies alone. Copyright © 2016 Elsevier Ltd. All rights reserved.
De Schoenmaker, Sofie; Van Cauwenberge, Philippe; Vander Bauwhede, Heidi
To examine whether the nationwide smoking ban, imposed in 2007, had an impact on the profitability of Belgian restaurants. Objective financial reporting data on 1613 restaurants were analysed with return on assets as the outcome measure. The data were collected from the Belfirst database and cover the period 2004-2009. To assess the impact of the smoking ban, a differences-in-differences estimation method was used, with bars serving as the control group. The regression model was estimated, while controlling for firm-specific characteristics and unobserved firm-level heterogeneity. The variable of interest is the interaction between the smoking ban dummy and the dummy for the treatment group. The coefficient of this variable is insignificant. The adoption of the nationwide smoking ban did not affect the profitability of Belgian restaurants.
Tarricone, Rosanna; Torbica, Aleksandra; Drummond, Michael
Assessing medical devices (MDs) raises challenges which require us to reflect on whether current methods are adequate. Major features of devices are: (i) device-operator interaction can generate learning curve effects; (ii) incremental nature of innovation needs to be addressed by careful identification of the alternatives for comparative and incremental cost-effectiveness analysis; and (iii) broader organizational impact in terms of training and infrastructure, coupled with dynamic pricing, requires a more flexible approach to costing. The objective of the MedtecHTA project was to investigate improvements in HTA methods to allow for more comprehensive evaluation of MDs. It consisted of several work packages concerning (i) the available evidence on the currently adopted approaches for regulation and HTA of medical devices; (ii) the geographical variation in access to MDs; (iii) the development of methodological frameworks for conducting comparative effectiveness research and economic evaluation of MDs; and (iv) the organizational impact of MDs. This introductory paper summarizes the main results of the project and draws out the main overarching themes. This supplement represents a comprehensive report of all the main findings of the MedtecHTA project, and it is intended to be the main source for researchers and policy makers wanting information on the project. © 2017 The Authors. Health Economics published by John Wiley & Sons, Ltd. © 2017 The Authors. Health Economics Published by John Wiley & Sons, Ltd.
Yuksel, Mustafa; Dogac, Asuman
Medical devices are essential to the practice of modern healthcare services. Their benefits will increase if clinical software applications can seamlessly acquire the medical device data. The need to represent medical device observations in a format that can be consumable by clinical applications has already been recognized by the industry. Yet, the solutions proposed involve bilateral mappings from the ISO/IEEE 11073 Domain Information Model (DIM) to specific message or document standards. Considering that there are many different types of clinical applications such as the electronic health record and the personal health record systems, the clinical workflows, and the clinical decision support systems each conforming to different standard interfaces, detailing a mapping mechanism for every one of them introduces significant work and, thus, limits the potential health benefits of medical devices. In this paper, to facilitate the interoperability of clinical applications and the medical device data, we use the ISO/IEEE 11073 DIM to derive an HL7 v3 Refined Message Information Model (RMIM) of the medical device domain from the HL7 v3 Reference Information Mode (RIM). This makes it possible to trace the medical device data back to a standard common denominator, that is, HL7 v3 RIM from which all the other medical domains under HL7 v3 are derived. Hence, once the medical device data are obtained in the RMIM format, it can easily be transformed into HL7-based standard interfaces through XML transformations because these interfaces all have their building blocks from the same RIM. To demonstrate this, we provide the mappings from the developed RMIM to some of the widely used HL7 v3-based standard interfaces.
Prajapati, S.; Mackie, T. R.; Jeraj, R.
Open-Source Medical Devices (OSMD) was initiated with the goal of facilitating medical research by developing medical technologies including both hardware and software on an open-source platform. Our first project was to develop an integrated imaging and radiotherapy device for small animals that includes computed tomography (CT), positron emission tomography (PET) and radiation therapy (RT) modalities for which technical specifications were defined in the first OSMD conference held in Madison, Wisconsin, USA in December 2011. This paper specifically focuses on the development of a small animal RT (micro-RT) system by designing a binary micro multileaf collimator (bmMLC) and a small animal treatment planning system (SATPS) to enable intensity modulated RT (IMRT). Both hardware and software projects are currently under development and their current progresses are described. After the development, both bmMLC and TPS will be validated and commissioned for a micro-RT system. Both hardware design and software development will be open-sourced after completion.
... requirements for medical devices held by the Strategic National Stockpile. 801.128 Section 801.128 Food and... requirements for medical devices held by the Strategic National Stockpile. (a) The appropriate FDA Center... Strategic National Stockpile. (b)(1)(i) A Strategic National Stockpile official or any entity that...
Law, Sabrina P; Oron, Assaf P; Kemna, Mariska S; Albers, Erin L; McMullan, D Michael; Chen, Jonathan M; Law, Yuk M
Ventricular assist devices have gained popularity in the management of refractory heart failure in children listed for heart transplantation. Our primary aim was to compare the composite endpoint of all-cause pretransplant mortality and loss of transplant eligibility in children who were treated with a ventricular assist device versus a medically managed cohort. This was a retrospective cohort analysis. Data were obtained from the Scientific Registry of Transplant Recipients. The at-risk population (n = 1,380) was less than 18 years old, either on a ventricular assist device (605 cases) or an equivalent-severity, intensively medically treated group (referred to as MED, 775 cases). None. The impact of ventricular assist devices was estimated via Cox proportional hazards regression (hazard ratio), dichotomizing 1-year outcomes to "poor" (22%: 193 deaths, 114 too sick) versus all others (940 successful transplants, 41 too healthy, 90 censored), while adjusting for conventional risk factors. Among children 0-12 months old, ventricular assist device was associated with a higher risk of poor outcomes (hazard ratio, 2.1; 95% CI, 1.5-3.0; p comparative study of ventricular assist devices versus medical therapy in children. Age is a significant modulator of waitlist outcomes for children with end-stage heart failure supported by ventricular assist device, with the impact of ventricular assist devices being more beneficial in adolescents.
Barbour, Nita H.
Maintains that corporal punishment should be banned from every school as a means of classroom discipline, and presents teachers and administrators with workable alternatives to disciplining children. (BB)
In the 'Regulations for the State Evaluation and Registration of Medical Equipment' force (Hereinafter Rules) set forth in Chapter VII, Articles 79 and 86, the monitoring activity as one of the programs necessary for evaluating the safety and effectiveness of medical monitoring equipment. In the years 2008 and 2011 were approved and implemented by the Center for State Control of Medical Equipment (CCEEM) Regulations and -1.1 ER and ER-1 that support and regulatory requirements 'Control and monitoring of pacemakers and implantable defibrillators' and 'Assessment, recording and control after market surgical silicone implants,' which are specific to these products and have provided a useful result for the performance of the activity. Given the number and diversity of high-risk medical devices as implantable or sustain human life that are brought into our National Health System (SNS), a regulation establishing control over the behavior becomes necessary safety and effectiveness of this equipment during use, which provide inputs to risk management. The objective of this regulation is to establish the regulatory requirements for tracking medical equipment introduced in the NHS. The provisions of this Regulation is aimed at health institutions, to CECMED as manufacturers, suppliers, distributors and importers of medical equipment.
Full Text Available Towards the realization of smart building applications, buildings are increasingly instrumented with diverse sensors and actuators. These sensors generate large volumes of data which can be analyzed for optimizing building operations. Many building energy management tasks such as energy forecasting, disaggregation, among others require complex analytics leveraging collected sensor data. While several standalone and cloud-based systems for archiving, sharing and visualizing sensor data have emerged, their support for analyzing sensor data streams is primitive and limited to rule-based actions based on thresholds and simple aggregation functions. We develop OpenBAN, an open source sensor data analytics middleware for buildings, to make analytics an integral component of modern smart building applications. OpenBAN provides a framework of extensible sensor data processing elements for identifying various building context, which different applications can leverage. We validate the capabilities of OpenBAN by developing three representative real-world applications which are deployed in our test-bed buildings: (i household energy disaggregation, (ii detection of sprinkler usage from water meter data, and (iii electricity demand forecasting. We also provide a preliminary system performance of OpenBAN when deployed in the cloud and locally.
Galán, Iñaki; Simón, Lorena; Boldo, Elena; Ortiz, Cristina; Medrano, María José; Fernández-Cuenca, Rafael; Linares, Cristina; Pastor-Barriuso, Roberto
To evaluate the impact of 2 smoking bans enacted in 2006 (partial ban) and 2011 (comprehensive ban) on hospitalizations for cardiovascular disease in the Spanish adult population. The study was performed in 14 provinces in Spain. Hospital admission records were collected for acute myocardial infarction (AMI), ischemic heart disease (IHD), and cerebrovascular disease (CVD) in patients aged ≥ 18 years from 2003 through 2012. We estimated immediate and 1-year effects with segmented-linear models. The coefficients for each province were combined using random-effects multivariate meta-analysis models. Overall, changes in admission rates immediately following the implementation of the partial ban and 1 year later were -1.8% and +1.2% for AMI, +0.1 and +0.4% for IHD, and +1.0% and +2.8% for CVD (P>.05). After the comprehensive ban, immediate changes were -2.3% for AMI, -2.6% for IHD, and -0.8% for CVD (P>.05), only to return to precomprehensive ban values 1 year later. For patients aged ≥ 65 years of age, immediate changes associated with the comprehensive ban were -5.0%, -3.9%, and -2.3% for AMI, IHD, and CVD, respectively (P<.05). Again, the 1-year changes were not statistically significant. In Spain, smoking bans failed to significantly reduce hospitalizations for AMI, IHD, or CVD among patients ≥ 18 years of age. In the population aged ≥ 65 years, hospital admissions due to these diseases showed significant decreases immediately after the implementation of the comprehensive ban, but these reductions disappeared at the 1-year evaluation. Copyright © 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.
... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Restrictions on use for further manufacture of medical devices. 610.42 Section 610.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... for Communicable Disease Agents § 610.42 Restrictions on use for further manufacture of medical...
Safitri Zen, Irina; Ahamad, Rahmalan; Gopal Rampal, Krishna; Omar, Wahid
Malaysia has partially banned the use of asbestos. The prohibition of asbestos building materials in schools, clinics, and hospitals built by government started in 1999. Since 2005, prohibition has also been applied to all government buildings. However, asbestos construction materials such as roof and ceiling tiles are still sold in the market. There are no acts or regulations prohibiting the use of asbestos in private buildings in Malaysia. Asbestos was first used for industrial purposes in Malaysia in the 1960s and the first regulations related to asbestos have been around since the 1980s. Non-governmental organizations have been pushing the government to impose a total ban since the 1980s. Asbestos is still used in the manufacturing sector under the "control use" concept. The study found difficulties in established and validated medical record data on asbestos-related diseases. This paper reviews existing asbestos-related regulations and guidelines in Malaysia and discusses the urgency for a total ban in the use of asbestos in building materials in the country. In the meanwhile, stricter enforcement of occupational safety and health regulations related to the use and exposure of asbestos among workers in the manufacturing, construction, maintenance, and demolition sectors has been in place.
Godlonton, Susan; Okeke, Edward N.
Informal health providers ranging from drug vendors to traditional healers account for a large fraction of health care provision in developing countries. They are, however, largely unlicensed and unregulated leading to concern that they provide ineffective and, in some cases, even harmful care. A new and controversial policy tool that has been proposed to alter household health seeking behavior is an outright ban on these informal providers. The theoretical effects of such a ban are ambiguous. In this paper, we study the effect of a ban on informal (traditional) birth attendants imposed by the Malawi government in 2007. To measure the effect of the ban, we use a difference-in-difference strategy exploiting variation across time and space in the intensity of exposure to the ban. Our most conservative estimates suggest that the ban decreased use of traditional attendants by about 15 percentage points. Approximately three quarters of this decline can be attributed to an increase in use of the formal sector and the remainder is accounted for by an increase in relative/friend-attended births. Despite the rather large shift from the informal to the formal sector, we do not find any evidence of a statistically significant reduction in newborn mortality on average. The results are robust to a triple difference specification using young children as a control group. We examine several explanations for this result and find evidence consistent with quality of formal care acting as a constraint on improvements in newborn health. PMID:26681821
Jerome Adda; Francesca Cornaglia
This paper evaluates the effect of excise taxes and bans on smoking in public places on the exposure to tobacco smoke of non-smokers. We use a novel way of quantifying passive smoking: we use data on cotinine concentration- a metabolite of nicotine- measured in a large population of non-smokers over time. Exploiting state and time variation across US states, we reach two important conclusions. First, excise taxes have a significant effect on passive smoking. Second, smoking bans have on avera...
Jérôme Adda; Francesca Cornaglia
This paper evaluates the effect of excise taxes and bans on smoking in public places on the exposure to tobacco smoke of non-smokers. We use a novel way of quantifying passive smoking: we use data on cotinine concentration- a metabolite of nicotine- measured in a large population of non-smokers over time. Exploiting state and time variation across US states, we reach two important conclusions. First, excise taxes have a significant effect on passive smoking. Second, smoking bans have on avera...
S. V. Seraphimov
Full Text Available Introduction. The problem of limited accessibility and quality of ophthalmic medical care remains one of the leading ones in the national healthcare. This article presents results of the survey conducted among ophthalmologists about the effect of large-scale equipment of all medical institutions in the Leningrad Region with modern ophthalmologic devices over the recent years.Objective is to determine the contribution of the health care modernization program to equipping the medical institutions of the Leningrad Region with modern ophthalmologic medical devices, and to identify the main areas for improving the ophthalmologic care for residents of the Leningrad region with cataracts.Materials and methods. According to a specially developed questionnaire, 105 ophthalmologists from the Leningrad Region were interviewed. The survey was conducted among physicians working both in out-patient medical facilities and in medical facilities with in-patient modalities.Results. The results of the study confirmed positive changes that occurred in recent years as a result of equipping medical institutions with modern medical devices. Almost two-thirds (59.9% of respondents noted that equipping with modern medical devices had a significant impact on the quality of the medical and diagnostic measures carried out in healthcare facilities of the region.Conclusions. The equipment had a significant impact on the diagnosis and treatment of all kinds of diseases of the eye and its appendages, especially such eye disease which is so common among the population of the Leningrad Region as cataracts (75.0 per 100 ophthalmologists surveyed. At the same time, in spite of these efforts, the standard for equipping ophthalmologic departments in individual medical institutions has not been fully provided. Only every fifth (20.9% ophthalmologist noted during the survey that the list of available ophthalmic devices was sufficient, and that they all worked properly.
Lwo, Lwun-syin Laurence; Yuan, You-Shi
Corporal punishment (CP) has been officially banned since December 2006 in Taiwan. It would be useful to explore the perceptions and concerns of elementary school teachers on the issue of banning CP and on alternative methods of discipline in 2008, two years since the ban took effect. In this study, 323 teachers were stratified randomly and drawn…
Recent years, China medical devices industry has been a sunrise industry with widely-ranged products, high-tech innovation, and booming market demands. But with the globalization of market economy, China industry is still in the inferior position of competition. How to promote the industrial structure transition, increase scientific and technological level, speed up the updating of products, enhance the international competitiveness is one of the major tasks to maintain the healthy development of industry. This article makes a study on current situation of China medical devices industry, analyses the new opportunities, challenges and restriction factors, provides the countermeasures of strengthening industry competitiveness as well.
Carter, Owen B J; Phan, Tina; Mills, Brennen W
To assess the impact of the Western Australian tobacco point-of-sale display ban on spontaneous purchase behaviours. Daily adult smokers (n=402) observed purchasing cigarettes were recruited via exit interviews either 2 months before or after the implementation of the display ban. Smokers were asked if they had intended to purchase cigarettes before entering the store to assess spontaneous purchase behaviours. Whether smokers had noticed the displays before their purchase and the extent to which this influenced their purchase decision was also assessed via non-prompting questions. When compared with before the ban, fewer smokers after the ban noticed the displays (27.1% vs 1.1%, pmaking spontaneous purchases (28.2% vs 19.8%, ppurchase decisions (free recall 5.0% vs 1.1%, ppurchasers were more likely than planned purchasers to suggest the displays influenced their purchase decisions (free recall 9.7% vs 3.2%, ppurchasers nominating the influence of displays fell substantially (free recall 9.7% vs 5.6%, p=NS; cued recall 40.0% vs 11.1%, ppurchasers (free recall 3.2% vs 0.0%, pmaking spontaneous tobacco purchases after implementation of the Western Australian tobacco display ban and between a fivefold and sixfold reduction in the proportion suggesting displays influenced their decision to purchase cigarettes. These data are consistent with previous research suggesting tobacco displays encourage spontaneous purchases and their removal corresponds to reductions in the same. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Paterson, Mary; Kinnear, Moira; Bond, Christine; McKinstry, Brian
Many patients experience difficulties adhering to medication regimes. For people who forget or get confused about medication, there are products to help them such as multi-compartment medication devices (MMDs). Some of these, known as electronic MMDs (eMMDs), use audible and/or visual signals to prompt the patient when to take medication, dispense medications, give instructions to the patient, and contact a caregiver (mobile Internet or text to a carer) as needed. To systematically review the literature on the use of eMMDs, to determine what evidence for their effectiveness is available. A comprehensive literature search of 10 databases, plus an Internet search and hand searching was conducted, using the MeSH terms reminder systems/patient compliance/medication adherence. There were no date restrictions. Inclusion criteria were patients in any community setting, in any country and with no restrictions of age, gender, ethnicity or medical condition, using an eMMD. Peer-reviewed quantitative or qualitative studies of any design were included. Of 805 abstracts identified and 99 full text papers retrieved, six met the inclusion criteria. Five of the studies reported adherence to medication regimes; one reported design factors to improve adherence. Adherence varied by the context of the reminders, the target group and usability of the devices. The studies were small scale and only one was a well conducted randomised controlled trial. Overall methodological quality of the studies was poor. Although positive effects on adherence were reported further, rigorously conducted, studies are needed to inform the use of eMMDs. © 2016 Royal Pharmaceutical Society.
Egardt, Jenny; Nilsson, Per; Dahllöf, Ingela
Antifouling paints are widely used to avoid organisms settling on boat hulls. The active ingredients in the paints have differed over the years where lead, TBT, irgarol and diuron have been deemed too harmful to non-target organisms and subsequently been banned within the EU. Most of these compounds however are persistent in the environment and can cause problems long after they are deposited. We have examined if present-day and banned substances used in antifouling paints can be found in sediments in a national park on the Swedish west coast. Sampled locations include waterways, natural harbours and small marinas for leisure crafts to investigate if number of visiting boats affect the concentration of antifouling compounds in sediments. Few significant differences were found when comparing the different locations types, suggesting that overall boat presence is more important than specific mooring sites, however, several banned antifouling compounds were found in the surface sediments. Copyright © 2017 Elsevier Ltd. All rights reserved.
Brent D. Kerger
Full Text Available Abstract Background Negative news media reports regarding potential health hazards of implanted medical devices and pharmaceuticals can lead to a ‘negative halo effect,’ a phenomenon whereby judgments about a product or product type can be unconsciously altered even though the scientific support is tenuous. To determine how a ‘negative halo effect’ may impact the rates of use and/or explantation of medical products, we analyzed the occurrence of such an effect on three implanted medical devices and one drug: 1 intrauterine contraceptive devices (IUDs; 2 silicone gel-filled breast implants (SGBI; 3 metal-on-metal hip implants (MoM; and 4 the drug Tysabri. Methods Data on IUD use from 1965 to 2008 were gathered from the Department of Health and Human Services Vital and Health Statistics and peer-reviewed publications. Data regarding SGBI implant and explantation rates from 1989 to 2012 were obtained from the Institute of Medicine and the American Society of Plastic Surgeons. MoM implant and explantation data were extracted from the England and Wales National Joint Registry and peer-reviewed publications. Tysabri patient data were reported by Elan Corporation or Biogen Idec Inc. Data trends for all products were compared with historical recall or withdrawal events and discussed in the context of public perceptions following such events. Results We found that common factors altered public risk perceptions and patterns of continued use. First, a negative halo effect may be driven by continuing patient anxiety despite positive clinical outcomes. Second, negative reports about one product can spill over to affect the use of dissimilar products in the same category. Third, a negative halo effect on an entire category of medical devices can be sustained regardless of the scientific findings pertaining to safety. Fourth, recovery of a product’s safety reputation and prevalent use may take decades in the U.S., even while these products may
Vincent, Christopher James; Li, Yunqiu; Blandford, Ann
Manufacturers of interactive medical devices, such as infusion pumps, need to ensure that devices minimise the risk of unintended harm during use. However, development teams face challenges in incorporating Human Factors. The aim of the research reported here was to better understand the constraints under which medical device design and development take place. We report the results of a qualitative study based on 19 semi-structured interviews with professionals involved in the design, development and deployment of interactive medical devices. A thematic analysis was conducted. Multiple barriers to designing for safety and usability were identified. In particular, we identified barriers to communication both between the development organisation and the intended users and between different teams within the development organisation. We propose the use of mediating representations. Artefacts such as personas and scenarios, known to provide integration across multiple perspectives, are an essential component of designing for safety and usability. Copyright © 2013 Elsevier Ltd and The Ergonomics Society. All rights reserved.
Busdicker, Mike; Upendra, Priyanka
This article discusses the role of healthcare technology management (HTM) in medical device cybersecurity and outlines concepts that are applicable to HTM professionals at a healthcare delivery organization or at an integrated delivery network, regardless of size. It provides direction for HTM professionals who are unfamiliar with the security aspects of managing healthcare technologies but are familiar with standards from The Joint Commission (TJC). It provides a useful set of recommendations, including relevant references for incorporating good security practices into HTM practice. Recommendations for policies, procedures, and processes referencing TJC standards are easily applicable to HTM departments with limited resources and to those with no resource concerns. The authors outline processes from their organization as well as best practices learned through information sharing at AAMI, National Health Information Sharing and Analysis Center (NH-ISAC), and Medical Device Innovation, Safety, and Security Consortium (MDISS) conferences and workshops.
Buczkowski, T.; Janusek, D.; Zavala-Fernandez, H.; Skrok, M.; Kania, M.; Liebert, A.
Health aspects of the use of radiating devices, like mobile phones, are still a public concern. Stand-alone electrocardiographic systems and those built-in, more sophisticated, medical devices have become a standard tool used in everyday medical practice. GSM mobile phones might be a potential source of electromagnetic interference (EMI) which may affect reliability of medical appliances. Risk of such event is particularly high in places remote from GSM base stations in which the signal received by GSM mobile phone is weak. In such locations an increase in power of transmitted radio signal is necessary to enhance quality of the communication. In consequence, the risk of interference of electronic devices increases because of the high level of EMI. In the present paper the spatial, temporal, and spectral characteristics of the interference have been examined. The influence of GSM mobile phone on multilead ECG recordings was studied. It was observed that the electrocardiographic system was vulnerable to the interference generated by the GSM mobile phone working with maximum transmit power and in DTX mode when the device was placed in a distance shorter than 7.5 cm from the ECG electrode located on the surface of the chest. Negligible EMI was encountered at any longer distance.
Verdonk-Kleinjan, Wendy M I; Knibbe, Ronald A; Tan, Frans E S; Willemsen, Marc C; de Groot, Henk N; de Vries, Hein
A workplace-smoking ban in the Netherlands was introduced on January 1, 2004. Before the ban male and low educated employees were at higher risk for exposure to environmental tobacco smoke (ETS). Effective implementation of the ban should result not only in an overall decline of exposure, but also in the disappearance of systematic differences in exposure between subgroups of employees. Data from a Dutch continuous Internet survey were used. From July 2003 through June 2005, 200 respondents were randomly selected each week. The sample consisted of 11,291 non-smoking, working respondents, aged 16-65 years. ETS exposure decreased among all employees and among subgroups at higher risk before the ban. However, also after the ban, males and low educated employees were still most likely to be exposed to ETS. The workplace-smoking ban was effective in reducing ETS exposure among employees. However, after the ban still 52.2% of non-smoking workers reported to be exposed. We did not find the expected stronger effect among employees who were at higher risk. Both before and after implementation of the ban, males and lower educated employees were about two times more likely to be exposed to ETS.
Ramasamy, A; Hill, A M; Clasper, J C
The improvised explosive device (IED), in all its forms, has become the most significant threat to troops operating in Afghanistan and Iraq. These devices range from rudimentary home made explosives to sophisticated weapon systems containing high-grade explosives. Within this broad definition they may be classified as roadside explosives and blast mines, explosive formed pojectile (EFP) devices and suicide bombings. Each of these groups causeinjury through a number of different mechanisms and can result in vastly different injury profiles. The "Global War on Terror" has meant that incidents which were previously exclusively seen in conflict areas, can occur anywhere, and clinicians who are involved in emergency trauma care may be required to manage casualties from similar terrorist attacks. An understanding of the types of devices and their pathophysiological effects is necessary to allow proper planning of mass casualty events and to allow appropriate management of the complex poly-trauma casualties they invariably cause. The aim of this review article is to firstly describe the physics and injury profile from these different devices and secondly to present the current clinical evidence that underpins their medical management.
Zoë M. McLaren
Full Text Available Background: Maternal mortality remains a major health challenge facing developing countries, with pre-eclampsia accounting for up to 17% of maternal deaths. Diagnosis requires skilled health providers and devices that are appropriate for low-resource settings. This study presents the first cost-effectiveness analysis of multiple medical devices used to diagnose pre-eclampsia in low- and middle-income countries (LMICs. Methods: Blood pressure and proteinuria measurement devices, identified from compendia for LMICs, were included. We developed a decision tree framework to assess the cost-effectiveness of each device using parameter values that reflect the general standard of care based on a survey of relevant literature and expert opinion. We examined the sensitivity of our results using one-way and second-order probabilistic multivariate analyses. Results: Because the disability-adjusted life years (DALYs averted for each device were very similar, the results were influenced by the per-use cost ranking. The most cost-effective device combination was a semi-automatic blood pressure measurement device and visually read urine strip test with the lowest combined per-use cost of $0.2004 and an incremental cost effectiveness ratio of $93.6 per DALY gained relative to a baseline with no access to diagnostic devices. When access to treatment is limited, it is more cost-effective to improve access to treatment than to increase testing rates or diagnostic device sensitivity. Conclusions: Our findings were not sensitive to changes in device sensitivity, however they were sensitive to changes in the testing rate and treatment rate. Furthermore, our results suggest that simple devices are more cost-effective than complex devices. The results underscore the desirability of two design features for LMICs: ease of use and accuracy without calibration. Our findings have important implications for policy makers, health economists, health care providers and
Yap, Wai Teng; Foo, Soo Leong; Lee, Teck Kheng
The effects of the sterilization process have been studied on medical grade thermoplastic polyetheretherketone (PEEK). For a reusable medical device, material reliability is an important parameter to decide its lifetime, as it will be subjected to the continuous steam sterilization process. A spring nature, clip component was selected out of a newly designed medical device (patented) to perform this reliability study. This clip component was sterilized for a predetermined number of cycles (2, 4, 6, 8, 10, 20…100) at 121 °C for 30 min. A significant decrease of ~20% in the compression force of the spring was observed after 30 cycles, and a ~6% decrease in the lateral dimension of the clip was observed after 50 cycles. No further significant change in the compression force or dimension was observed for the subsequent sterilization cycles. Vickers hardness and differential scanning calorimetry (DSC) techniques were used to characterize the effects of sterilization. DSC results exhibited no significant change in the degree of cure and melting behavior of PEEK before and after the sterilization. Hardness measurement exhibited an increase of ~49% in hardness after just 20 cycles. When an unsterilized sample was heated for repetitive cycles without the presence of moisture (121 °C, 10 and 20 cycles), only ~7% of the maximum change in hardness was observed. PMID:29466289
Kumar, Amit; Yap, Wai Teng; Foo, Soo Leong; Lee, Teck Kheng
The effects of the sterilization process have been studied on medical grade thermoplastic polyetheretherketone (PEEK). For a reusable medical device, material reliability is an important parameter to decide its lifetime, as it will be subjected to the continuous steam sterilization process. A spring nature, clip component was selected out of a newly designed medical device (patented) to perform this reliability study. This clip component was sterilized for a predetermined number of cycles (2, 4, 6, 8, 10, 20…100) at 121 °C for 30 min. A significant decrease of ~20% in the compression force of the spring was observed after 30 cycles, and a ~6% decrease in the lateral dimension of the clip was observed after 50 cycles. No further significant change in the compression force or dimension was observed for the subsequent sterilization cycles. Vickers hardness and differential scanning calorimetry (DSC) techniques were used to characterize the effects of sterilization. DSC results exhibited no significant change in the degree of cure and melting behavior of PEEK before and after the sterilization. Hardness measurement exhibited an increase of ~49% in hardness after just 20 cycles. When an unsterilized sample was heated for repetitive cycles without the presence of moisture (121 °C, 10 and 20 cycles), only ~7% of the maximum change in hardness was observed.
Kent, Brian D
The implementation of workplace smoking bans has contributed to a significant reduction in the incidence of acute coronary syndrome admissions, but their influence on adult acute pulmonary disease admissions is unclear. We sought to assess the impact of a national smoking ban on nationwide admissions of individuals of working age with acute pulmonary illness.
Goodman, S.L.; Mengelt, T.J.; Ali, M.; Ulfig, R.M.; Martens, R.M.; Kelly, T.F.; Kostrna, S.L.P.; Kostrna, M.S.; Carmichael, W.J.
Full text: As medical technology advances towards microsurgical and minimally invasive techniques, there is a drive to produce ever-smaller devices that demand higher material performance and hence enhanced nano and micro-scale control of material structure. These devices are made from stainless steel alloys, Nitinol, titanium, CoCrMo, and non-metals such as pyrolytic carbon and silicon. These applications are made possible due to suitable physical and mechanical properties, good corrosion resistance in biological environments, reasonable biocompatibility, and good manufacturability. With respect to the metals, the nano-structure and composition of the material surface, typically an oxide, is especially critical since biological responses and corrosion occur at the material-environment interface. Thus, there is an increasing need to understand the 3-D structure and composition of metallic biomaterials at the atomic scale. Three-dimensional atom probe microscopy can uniquely provide such atomic-level structural information. In the present study several of these medical device materials were examined. These include a 316L stainless steel alloy which is widely used in implanted spinal fixation devices, bone screws, cardiovascular and neurological stents, a cast CoCrMo acetabular hip cup of a Cormet metal-on-metal Hip Resurfacing System (Corin Group, Cirencester, England) that was rejected for clinical use, Nitinol wires specimens such as are used for stents and guide wires, and low temperature pyrolytic carbon as used in clinical heart valve prosthetics. (author)
... use, existing scientific research data to determine pediatric effectiveness based on a similar course... research data, and C. The methods to overcome the pitfalls and data gaps, including statistical approaches... announcing a public workshop entitled ``Using Scientific Research Data to Support Pediatric Medical Device...
Full Text Available Abstrak-Standar keuangan adalah salah satu standar yang dinilai dalam instrumen BAN-PT, yaitu pada standar 6.1. Pengelolaan keuangan sebuah perguruan tinggi harus memenuhi standar tersebut. Untuk dapat mengetahui seberapa besar tingkat pemenuhan standar diperlukan penilaian. Sistem informasi keuangan yang dikembangkan dalam penelitian ini digunakan untuk memasukkan data transaksi keuangan, mencatatnya dalam sistem akuntansi, dan melaporkannya. Laporan-laporan yang disajikan berbentuk tabel dan grafik yang menyatakan kinerja keuangan dan diukur sesuai dengan standar 6.1. BAN-PT. Sistem informasi keuangan ini, juga terintegrasi dengan SISFOKAMPUS 4.1 yang merupakan sistem informasi akademik open source yang berbasis web. Hasil dari penelitian ini adalah sistem informasi keuangan dengan fungsi khusus yaitu menilai kinerja keuangan yang sesuai dengan standar 6.1. BAN-PT yang dapat digunakan untuk melakukan audit internal. Kata kunci: Standar 6.1. BAN-PT, Sistem Informasi Keuangan, SISFOKAMPUS 4.1.
Foley, Kristie L; Proescholdbell, Scott; Herndon Malek, Sally; Johnson, Jana
Despite the national trend that 90% of prisons have smoke-free indoors policies, compliance and enforcement remain barriers to policy success. Key informant interviews about policy compliance and enforcement were conducted with 10 staff and inmates at two North Carolina prison facilities, one with a complete ban (indoors and outdoors) and one with a partial ban (indoors only). Communication of the tobacco bans was consistent and well understood in both facilities. Barriers to compliance and enforcement, especially in the complete ban facility, included policy ''buy in,'' the emerging black market for cigarettes, staff support, and access to nicotine replacement therapy. Despite these barriers, most informants reported that implementation and enforcement of complete bans is possible with adequate communication about the policy and access to cessation therapy.
This Order made by the Ministers of Health and Social Security, Agriculture and Labour amends a previous Decree of 23 April 1969 in particular concerning the classification of medical or dental radiodiagnostic devices subject to approval. The technical conditions to be complied with for such devices and facilities have also been amended. Finally, it is provided that, as regards facilities with heavy equipment subject to licensing (Act of 31 December 1970), approval is subject to compliance with the licensing conditions and is requested together with the application for a licence. (NEA) [fr
Overbye, Marie Birch; Elbe, Anne-Marie; Knudsen, Mette Lykke
Today the main doping deterrence strategy is to ban athletes from sport if caught. This study examines whether Danish elite athletes perceive the ban as a deterrent and how they evaluate social, self-imposed and financial sanctions compared with the ban. Questionnaires were emailed to elite...... athletes from 40 sports (N = 645; response rate, 43%). Results showed that 78% of athletes regarded the ban as a deterrent. Older male athletes, however, did so to a lesser degree. Seventy-seven per cent, regardless of gender, age, sport type and previous experience of doping testing, viewed social...... sanctions as a greater deterrent than the ban. Many also considered self-imposed sanctions (54%) and financial consequences (47%) a greater deterrent. Four per cent considered neither the ban nor the presented alternatives a deterrent. The findings indicate that the ban from sport deters doping...
The pharmaceutical sector is one of the main markets in the European Union. The consumption of medicines is high and steadily increasing. However, the pharmaceutical market is subject to a wider range of restrictions than almost any other sector. The restrictions mainly apply to information provision and advertising practice within the community. One of the main features in pharmaceutical regulation is the ban on direct-to-consumer advertising (DTCA) of prescription medicines. However, an abolition of the ban is controversial in the European Community, especially as the pharmaceutical industry keeps pleading for its ability to use the highly effective marketing strategy of DTCA to promote prescription medicines to the general public. Such advertising is only allowed in two jurisdictions in the world, New Zealand and the United States. In both systems the impact of DTCA on the consumer and the economy has been subject to research. The outcome of these studies is outlined in this article. Since the European Commission has provided a new proposal to amend the current information practice regarding prescription medicines in 2008 (European Commission, Proposal for a Directive of the European Parliament and of the Council Amending, as Regards Information to the General Public on Medicinal Products Subject to Medical Prescription, Directive 2001/83/EC on the Community Code Relating to Medicinal Products for Human Use, COM/2008/0663 final) it is time to examine different options to regulate the provision of information and discuss the need for a ban of DTCA.
Callinan, Joanne E
BACKGROUND: Smoking bans have been implemented in a variety of settings, as well as being part of policy in many jurisdictions to protect the public and employees from the harmful effects of secondhand smoke (SHS). They also offer the potential to influence social norms and smoking behaviour of those populations they affect. OBJECTIVES: To assess the extent to which legislation-based smoking bans or restrictions reduce exposure to SHS, help people who smoke to reduce tobacco consumption or lower smoking prevalence and affect the health of those in areas which have a ban or restriction in place. SEARCH STRATEGY: We searched the Cochrane Tobacco Addiction Group Specialised Register, MEDLINE, EMBASE, PsycINFO, CINAHL, Conference Paper Index, and reference lists and bibliographies of included studies. We also checked websites of various organisations. Date of most recent search; July 1st 2009. SELECTION CRITERIA: We considered studies that reported legislative smoking bans and restrictions affecting populations. The minimum standard was having a ban explicitly in the study and a minimum of six months follow-up for measures of smoking behaviour. We included randomized controlled trials, quasi-experimental studies (i.e. non-randomized controlled studies), controlled before and after studies, interrupted-time series as defined by the Cochrane Effective Practice and Organization of Care Group, and uncontrolled pre- and post-ban data. DATA COLLECTION AND ANALYSIS: Characteristics and content of the interventions, participants, outcomes and methods of the included studies were extracted by one author and checked by a second. Because of heterogeneity in the design and content of the studies, we did not attempt a meta-analysis. We evaluated the studies using qualitative narrative synthesis. MAIN RESULTS: There were 50 studies included in this review. Thirty-one studies reported exposure to secondhand smoke (SHS) with 19 studies measuring it using biomarkers. There was
Shang, Ce; Huang, Jidong; Cheng, Kai-Wen; Li, Qing; Chaloupka, Frank J
Point-of-sale (POS) tobacco advertising has been linked to youth smoking susceptibility and experimental smoking. However, there is limited evidence of the association between POS advertising bans and youth smoking participation. This study aims to examine how such bans are associated with current smoking, daily smoking, and regular smoking (≥ 1 cigarettes per day) participation among youth. one to two waves (primarily one wave) of the Global Youth Tobacco Survey were conducted in 130 countries between 2007 and 2011. These surveys were linked to the WHO "MPOWER" data using country and year identifiers to analyze the association between POS advertising bans (a dichotomous measure of the existence of such bans) and smoking participation in the past month. Weighted logistic regressions were employed to analyze this association while controlling for age, gender, parents' smoking status, 6 MPOWER policy scores, and GDP per capita. We find that in countries with POS advertising bans, current smoking (OR = 0.73, p ≤ 0.1), daily smoking (OR = 0.70, p ≤ 0.1), and regular smoking (OR = 0.75, p ≤ 0.05) participation in the past month is significantly lower, suggesting that POS promotion bans can potentially reduce youth smoking. This study provides evidence to support the implementation of POS promotion regulations by the US FDA and implementation of the WHO FCTC guidelines regarding restrictions on tobacco POS promotion.
Rashid-Doubell, F; Mohamed, S; Elmusharaf, K; O'Neill, C S
The aims of this study were to describe the experiences of senior students using mobile devices in a clinical setting while learning and interacting with clinical teachers, patients and each other, and to identify challenges that facilitated or impeded the use of such devices in the hospital. Interpretative phenomenology was chosen to guide our enquiry. Semi-structured interviews were conducted to examine the experiences of five senior medical students using mobile devices in the clinical setting. Senior medical students at an international medical school in the Middle East. Three main themes emerged from the data analysis: learning; professional identity and transitioning from student to doctor. The findings showed that using mobile devices in the clinical area as a learning tool was not a formalised process. Rather, it was opportunistic learning at the bedside and on occasion a source of distraction from clinical teaching. Students needed to negotiate relationships between themselves, the clinical teacher and patients in order to ensure that they maintained an acceptable professional image. Participants experienced and negotiated the change from student to doctor making them mindful of using their devices at the bedside. Mobile devices are part of daily life for a medical student and there is a need to adapt medical education in the clinical setting, to allow the students to use their devices in a sensitive manner. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
Full Text Available 2014 marked the centenary of Cumann na mBan, the Irish Republican women’s organisation. While a number of recent publications have dealt with the first decade of Cumann na mBan, its existence in the second half of the 20th century has largely been neglected by academics. However, women played an integral part in the Republican struggle and many of these women held influential positions in the Irish Republican Movement. With this in mind, the article will discuss the role of Cumann na mBan within the so-called Provisional Republican Movement between 1969 and 1986. Based on 25 Oral History interviews with former members of the women’s organisation, the membership structure of the organisation and its activities will be discussed. In particular, the role of women in the Irish Republican Movement will be examined along with a number of other factors which have hitherto been largely underplayed in the historiography of women activists in the Irish Republican Movement. This will provide students and academics with literature for further in-depth research on Cumann na mBan. In essence, the aim of the article is to introduce Cumann na mBan into the historiography of the recent conflict in the North of Ireland.
Kwon, L; Long, K D; Wan, Y; Yu, H; Cunningham, B T
We review the recent development of mobile detection instruments used for medical diagnostics, and consider the relative advantages of approaches that utilize the internal sensing capabilities of commercially available mobile communication devices (such as smartphones and tablet computers) compared to those that utilize a custom external sensor module. In this review, we focus specifically upon mobile medical diagnostic platforms that are being developed to serve the need in global health, personalized medicine, and point-of-care diagnostics. Copyright © 2016 Elsevier Inc. All rights reserved.
... Contact Person) no later than September 5, 2012. No commercial or promotional material will be permitted... develop and implement a comprehensive medical device postmarket surveillance strategy to collect, analyze... implementing this strategy, FDA is holding a public meeting to discuss the current and future state of medical...
Full Text Available The implementation of an effective quality management system has always been considered a principal method for a manufacturer to maintain and improve its product and service quality. Globally many regulatory authorities incorporate quality management system as one of the mandatory requirements for the regulatory control of high-risk medical devices. The present study aims to analyze the GMP enforcement experience in Taiwan between 1998 and 2013. It describes the regulatory implementation of medical device GMP requirement and initiatives taken to assist small and medium-sized enterprises in compliance with the regulatory requirement. Based on statistical data collected by the competent authority and industry research institutes, the present paper reports the growth of Taiwan local medical device industry after the enforcement of GMP regulation. Transition in the production, technologies, and number of employees of Taiwan medical device industry between 1998 and 2013 provides the competent authorities around the world with an empirical foundation for further policy development.
Björnsdóttir, U S; Gizurarson, S; Sabale, U
Asthma requires individually tailored and careful management to control and prevent symptoms and exacerbations. Selection of the most appropriate treatment is dependent on both the choice of drugs and inhaler device; however, financial pressures may result in patients being switched to alternative medications and devices in an attempt to reduce costs. This review aimed to examine the published literature in order to ascertain whether switching a patient's asthma medications or device negatively impacts clinical and economic outcomes. A literature search of MEDLINE (2001-13 September 2011) was conducted to identify English-language articles focused on the direct impact of switching medications and inhaler devices and switching from fixed-dose combination to monocomponent therapy via separate inhalers in patients with asthma; the indirect impacts of switching were also assessed. Evidence showed that non-consented switching of medications and inhalers in patients with asthma can be associated with a range of negative outcomes, at both individual and organisational levels. Factors that reduce adherence may lead to compromised symptom control resulting in increased healthcare resource utilisation and poorer patient quality of life. The consequences of a non-consented switch should be weighed carefully against arguments supporting an inhaler switch without the patient's consent for non-medical/budgetary reasons, such as potential reductions in initial acquisition costs, which may be associated with subsequent additional healthcare needs. Given the increasing pressure for reduced costs and efficient allocation of limited healthcare resources, an additional investment in ensuring high medication adherence may lead to greater savings due to a potentially decreased demand for healthcare services. In contrast, savings achieved in acquisition costs may result in a greater net loss due to increased healthcare consumption caused by decreased asthma control. © 2013 The Authors
Inoue, Susumu; Kodjebacheva, Gergana; Scherrer, Tammy; Rice, Gary; Grigorian, Matthew; Blankenship, Jeremy; Onwuzurike, Nkechi
Adherence to hydroxyurea (HU) is a significant modifying factor in sickle cell vaso-occlusive pain. We conducted a study using an electronic medication container-monitor-reminder device (GlowCap™) to track adherence and determine whether use of this device affected rates of HU adherence. Subjects were regular attendees to our clinic. They were given a 37-item questionnaire and were asked to use a GlowCap containing HU. When the device cap is opened, it makes a remote "medication taken" record. The device also provides usage reminder in the form of lights and alarm sounds if the cap opening is delayed. Nineteen subjects participated in the survey, and 17 in the intervention phase. Of the 17, 12 had reliable adherence data. Seventeen caregivers of patients and two patients completed the survey. Two most common barriers to adherence identified were lack of reminders and absence of medicine home delivery. The intervention component of this study, which used both the electronic (GlowCap) method and medication possession ratio showed that the median adherence rate for the 12 patients evaluated was 85 %. The GlowCap device accurately kept a record of adherence rates. This device may be an effective tool for increasing HU medication adherence.
Boes, Stefan; Marti, Joachim; Maclean, Johanna Catherine
In this paper, we exploit the progressive implementation of smoking bans in public venues at the state level in Switzerland to evaluate both the direct effects on smoking and the potential unintended consequences of these legislations on consumer behaviors as measured by visiting restaurants/bars and discos ('going out'). Our results indicate that public venue smoking bans in Switzerland reduce smoking rates, but the findings do not emerge until 1 year following the ban. This pattern of results is consistent with delays in ban enforcement on the part of business owners, difficulties in changing addictive behaviors such as smoking, and/or learning on the part of smokers. We find evidence that smoking bans influence going-out behavior and there is substantial heterogeneity across venue and consumer characteristics. Copyright © 2014 John Wiley & Sons, Ltd.
... labeling or advertising of the device. (d) If such voluntary action is not taken, the Commissioner may take... FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES BANNED DEVICES General Provisions § 895.25 Labeling. (a) If the Commissioner determines that the...
Metal oxide semiconductor (MOS) integrated circuits, with the benefits of low power consumption, represent the state of the art technology for implantable medical devices. Three significant sources of radiation are classified as having the ability to damage or alter the behavior of implantable electronics; Secondary neutron cosmic radiation, alpha particle radiation from the device packaging and therapeutic doses(up to 70 Gγ) of high energy radiation used in radiation oncology. The effects of alpha particle radiation from the packaging may be eliminated by the use of polyimide or silicone rubber die coatings. The relatively low incidence of therapeutic radiation incident on an implantable device and the use of die coating leaves cosmic radiation induced secondary neutron single event upset (SEU) as the main pervasive ionising radiation threat to the reliability of implantable devices. A theoretical model which predicts the susceptibility of a RAM cell to secondary neutron cosmic radiation induced SEU is presented. The model correlates well within the statistical uncertainty associated with both the theoretical and field estimate. The predicted Soft Error Rate (SER) is 4.8 x l0 -12 upsets/(bit hr) compared to an observed upset rate of 8.5 x 10 -12 upsets/(bit hr) from 20 upsets collected over a total of 284672 device days. The predicted upset rate may increase by up to 20% when consideration is given to patients flying in aircraft The upset rate is also consistent with the expected geographical variations of the secondary cosmic ray neutron flux, although insufficient upsets precluded a statistically significant test. This is the first clinical data set obtained indicating the effects of cosmic radiation on implantable devices. Importantly, it may be used to predict the susceptibility of future to the implantable device designs to the effects of cosmic radiation
.... Written by an experienced industry professional, this practical book provides a complete guide to the ISO 13485 standard certification for medical device manufacturing in terms of quality control...
Polisena, Julie; Gagliardi, Anna; Urbach, David; Clifford, Tammy; Fiander, Michelle
Medical devices have improved the treatment of many medical conditions. Despite their benefit, the use of devices can lead to unintended incidents, potentially resulting in unnecessary harm, injury or complications to the patient, a complaint, loss or damage. Devices are used in hospitals on a routine basis. Research to date, however, has been primarily limited to describing incidents rates, so the optimal design of a hospital-based surveillance system remains unclear. Our research objectives were twofold: i) to explore factors that influence device-related incident recognition, reporting and resolution and ii) to investigate interventions or strategies to improve the recognition, reporting and resolution of medical device-related incidents. We searched the bibliographic databases: MEDLINE, Embase, the Cochrane Central Register of Controlled Trials and PsycINFO database. Grey literature (literature that is not commercially available) was searched for studies on factors that influence incident recognition, reporting and resolution published and interventions or strategies for their improvement from 2003 to 2014. Although we focused on medical devices, other health technologies were eligible for inclusion. Thirty studies were included in our systematic review, but most studies were concentrated on other health technologies. The study findings indicate that fear of punishment, uncertainty of what should be reported and how incident reports will be used and time constraints to incident reporting are common barriers to incident recognition and reporting. Relevant studies on the resolution of medical errors were not found. Strategies to improve error reporting include the use of an electronic error reporting system, increased training and feedback to frontline clinicians about the reported error. The available evidence on factors influencing medical device-related incident recognition, reporting and resolution by healthcare professionals can inform data collection and
Miguel-Cruz, Antonio; Rios-Rincón, Adriana; Haugan, Gregory L
To determine what factors have a significant influence on the performance of medical device maintenance outsourcing, and to determine how the performance of external governance structures differs depending on whether a hospital is private or public. This was a longitudinal study of 590 maintenance transactions at 20 hospitals in Bogotá, Colombia, involving 764 medical devices and 72 maintenance service providers. Maintenance performance data (i.e., turn-around time in hours; TAT) for the service providers (either in-house or outsourced) were primarily collected over a 20-month period, from December 2009-August 2011, by means of a monitoring procedure; then, a hazards model was run. The availability of specific repair parts, in-stock, in the city in which the medical devices were located, had a positive impact on the performance of both internal and external governance structures. Online service also had a positive impact on both, with a stronger positive impact on the performance of internal governance than on that of external governance. For transactions governed by external structures, better performance was seen in private hospitals than in public ones. In public health institutions, internal governance showed better performance than external governance. Both internal and external governance structures showed better performance in private healthcare institutions than in public ones. In public health institutions, internal governance shows better performance than external governance; this suggests that healthcare managers should reconsider the trend to eliminate in-house maintenance service staff in public healthcare institutions.
Proctor, Robert N
The cigarette is the deadliest artefact in the history of human civilisation. Most of the richer countries of the globe, however, are making progress in reducing both smoking rates and overall consumption. Many different methods have been proposed to steepen this downward slope, including increased taxation, bans on advertising, promotion of cessation, and expansion of smoke-free spaces. One option that deserves more attention is the enactment of local or national bans on the sale of cigarett...
The objective of this guide is to focus on the political issues in the test ban debate in the conference of Disarmament, and to produce a guide providing diplomats, researchers, and the interested public with background information. Such a complex negotiating process requires a selection of proposals, comments and technical details. The criterion from selecting material was based upon the importance for present negotiations. The first part of this guide provides a historical perspective on the arguments used for and against nuclear testing, and on the record of negotiating activities on this subject. The second part examines the test ban debate in the Conference on Disarmament during the past ten years. Figs
Meng, Chuizhou; Gall, Oren Z; Irazoqui, Pedro P
We present a high-energy local power supply based on a flexible and solid-state supercapacitor for miniature wireless implantable medical devices. Wireless radio-frequency (RF) powering recharges the supercapacitor through an antenna with an RF rectifier. A power management circuit for the super-capacitive system includes a boost converter to increase the breakdown voltage required for powering device circuits, and a parallel conventional capacitor as an intermediate power source to deliver current spikes during high current transients (e.g., wireless data transmission). The supercapacitor has an extremely high area capacitance of ~1.3 mF/mm(2), and is in the novel form of a 100 μm-thick thin film with the merit of mechanical flexibility and a tailorable size down to 1 mm(2) to meet various clinical dimension requirements. We experimentally demonstrate that after fully recharging the capacitor with an external RF powering source, the supercapacitor-based local power supply runs a full system for electromyogram (EMG) recording that consumes ~670 μW with wireless-data-transmission functionality for a period of ~1 s in the absence of additional RF powering. Since the quality of wireless powering for implantable devices is sensitive to the position of those devices within the RF electromagnetic field, this high-energy local power supply plays a crucial role in providing continuous and reliable power for medical device operations.
... wireless medical telemetry devices operating in the 1395-1400 and 1427-1432 MHz bands. Due to the critical... 47 Telecommunication 5 2010-10-01 2010-10-01 false Specific requirements for wireless medical telemetry devices operating in the 1395-1400 and 1427-1432 MHz bands. 95.1121 Section 95.1121...
Critics of the Food & Drug Administration's ban on off-label promotion often claim that it violates the First Amendment because it suppresses pharmaceutical manufacturers' truthful speech about their legal--and beneficial--products. Characterizing the ban on off-label promotion in this way has more than rhetorical significance. Bans on truthful, non-misleading speech elicit special skepticism because of the belief that they "usually rest solely on the offensive assumption that the public will respond 'irrationally' to the truth." The legislative history of the provisions of the Food Drug and Cosmetic Act that underlie the ban on off-label promotion, however, reveals that Congress was concerned that physicians were responding rationally to false and misleading promotional claims. In this Article, I explore the doctrinal questions raised by conceiving of the ban on off-label promotion not as a ban on "truthful speech to physicians" but instead as a prophylaxis against false and misleading pharmaceutical promotion. I review the evidence that false and misleading claims were commonplace before the ban's adoption and persist today, along with the enforcement challenges the FDA confronted at that time and would confront were the ban lifted, and conclude the government likely could develop the factual record necessary to establish that Congress' rejection of an after-the-fact case-by-case approach to combating false and misleading prescription drug promotion is constitutional.
Patel, Vishal; Lee, Henry; Taylor, Dave; Aggarwal, Rajesh; Kinross, James; Darzi, Ara
Medical infusion devices are an integral component within the delivery of healthcare management. The aim of this study was to develop a training simulation in the virtual world of Second Life for the management of adverse events associated with infusion devices. Forty nurses were subsequently recruited to participate within the simulation and assess its feasibility.
Tran, Phong A; Hocking, Dianna M; O'Connor, Andrea J
Bacterial infection associated with medical devices remains a challenge to modern medicine as more patients are being implanted with medical devices that provide surfaces and environment for bacteria colonization. In particular, bacteria are commonly found to adhere more preferably to hydrophobic materials and many of which are used to make medical devices. Bacteria are also becoming increasingly resistant to common antibiotic treatments as a result of misuse and abuse of antibiotics. There is an urgent need to find alternatives to antibiotics in the prevention and treatment of device-associated infections world-wide. Silver nanoparticles have emerged as a promising non-drug antimicrobial agent which has shown effectiveness against a wide range of both Gram-negative and Gram-positive pathogen. However, for silver nanoparticles to be clinically useful, they must be properly incorporated into medical device materials whose wetting properties could be detrimental to not only the incorporation of the hydrophilic Ag nanoparticles but also the release of active Ag ions. This study aimed at impregnating the hydrophobic polycaprolactone (PCL) polymer, which is a FDA-approved polymeric medical device material, with hydrophilic silver nanoparticles. Furthermore, a novel approach was employed to uniformly, incorporate silver nanoparticles into the PCL matrix in situ and to improve the release of Ag ions from the matrix so as to enhance antimicrobial efficacy. Copyright © 2014. Published by Elsevier B.V.
Konkani, Avinash; Oakley, Barbara; Bauld, Thomas J
Increasing noise in hospital environments, especially in intensive care units (ICUs) and operating rooms (ORs), has created a formidable challenge for both patients and hospital staff. A major contributing factor for the increasing noise levels in these environments is the number of false alarms generated by medical devices. This study focuses on discovering best practices for reducing the number of false clinical alarms in order to increase patient safety and provide a quiet environment for both work and healing. The researchers reviewed Pub Med, Web of Knowledge and Google Scholar sources to obtain original journal research and review articles published through January 2012. This review includes 27 critically important journal articles that address different aspects of medical device alarms management, including the audibility, identification, urgency mapping, and response time of nursing staff and different solutions to such problems. With current technology, the easiest and most direct method for reducing false alarms is to individualize alarm settings for each patient's condition. Promoting an institutional culture change that emphasizes the importance of individualization of alarms is therefore an important goal. Future research should also focus on the development of smart alarms.
Mokwunye Idongesit U.; Babalola Folaranmi D.; Asogwa Uche E.; Idris Ndagi; Aderolu Ismail A.; Mokwunye Francis C.; Idrisu Mohammed
This study investigated the compliance of marketers of agrochemicals with the approved and banned cocoa pesticides in selected cocoa producing states of southwest Nigeria. Primary data was collected through the use of structured questionnaire administered to randomly selected agrochemical marketers. All the marketers (100%) were aware of the recently banned cocoa pesticides, however, majority still have the pesticides in stock. About 70.6% of the marketers ...
... Device Quality Systems Regulation (QSR) to the regulated industry, particularly small businesses. DATES... registration fee will be used to offset expenses of hosting the event including continental breakfast, lunch... interest in the topics discussed from small medical device manufacturers in the Dallas District area. This...
Donovan, Aine; Kaplan, Aaron V
The past fifty years has witnessed dramatic progress in the understanding and treatment of patients suffering from cardiovascular disease leading to symptomatic relief and impressive increases in longevity. These advances have been due in large part to the development, study and implementation of new technology. Within interventional cardiology in particular, these advances have been driven by the availability of new technology in the form of medical devices. Successful device development efforts require close collaboration among basic scientist, clinician-inventors/entrepreneurs, clinician-investigators and corporations. Though the role of the clinician is central to this process, these activities present important conflicts-of-interest (COIs). The purpose of this paper is to 1) characterize these conflicts, 2) provide a context from which to approach their management and 3) recommend management strategies. Copyright © 2012 Elsevier Inc. All rights reserved.
Elton-Marshall, Tara; Leatherdale, Scott T; Driezen, Pete; Azagba, Sunday; Burkhalter, Robin
To examine youth exposure to smoking in cars following 7 provincial bans on smoking in cars with children in Canada. Repeated cross-sectional data from the 2004-2012 Youth Smoking Survey (n=91,800) were examined. Using a quasi-experimental design, contrasts of the interaction of survey year and province included in the logistic regression analyses were used to test whether exposure significantly declined pre-post implementation of a ban on smoking in cars relative to control provinces not implementing a ban. Exposure across all provinces declined from 26.5% in 2004 to 18.2% of youth in 2012. Exposure declined significantly from pre to post implementation of a ban on smoking in cars with children in Ontario at time 1 post ban (Pre-Ban=20.4% T1post=10.3%, OR=0.45), time 2 post ban (12.1%, OR=0.61) and time 3 post ban (11.6%, OR=0.58) relative to control provinces that did not implement a ban. In British Columbia exposure to smoking in cars declined significantly at pre-post ban time 3 compared to the control group (Pre-Ban=21.2%, T3post=9.6%, OR=0.51). No other provinces had a significant change in exposure pre-post ban relative to the control provinces. Although rates declined, significant differences were only found in Ontario relative to control provinces in the immediate and long term. Copyright © 2015 Elsevier Inc. All rights reserved.
..., FDA- 2012-M-0965, FDA-2012-M-0968, FDA-2012-M-1011, and FDA-2012-M-1013] Medical Devices; Availability.... Glucose Monitoring System (TGMS). P000008/S017, FDA-2012-M-1013.. Allergan, Inc..... LAP-BAND \\TM\\ February 16, 2011. Adjustable Gastric Banding System. P100049, FDA-2012-M-0893....... Torax Medical, Inc...
Ransford, Benjamin; Molina-Markham, Andres; Stewart, Quinn; Fu, Kevin; Kramer, Daniel Bruce; Baker, Matthew Charles; Reynolds, Matthew R.
Background: Medical devices increasingly depend on computing functions such as wireless communication and Internet connectivity for software-based control of therapies and network-based transmission of patients’ stored medical information. These computing capabilities introduce security and privacy risks, yet little is known about the prevalence of such risks within the clinical setting. Methods: We used three comprehensive, publicly available databases maintained by the Food and Drug Admini...
Kelly, Janet; Matthews, Ben
of the product. We present a case study that documents how we worked with pre-users of two different types of medical technologies: hearing aids and insulin injection devices. Pre-users are people who do not currently use these products, but who are in a life situation for which these technologies may...
Bouchard, Maryse; Kohler, Jillian C; Orbinski, James; Howard, Andrew
Globally, injuries cause approximately as many deaths per year as HIV/AIDS, tuberculosis and malaria combined, and 90% of injury deaths occur in low- and middle- income countries. Given not all injuries kill, the disability burden, particularly from orthopaedic injuries, is much higher but is poorly measured at present. The orthopaedic services and orthopaedic medical devices needed to manage the injury burden are frequently unavailable in these countries. Corruption is known to be a major barrier to access of health care, but its effects on access to orthopaedic services is still unknown. A qualitative case study of 45 open-ended interviews was conducted to investigate the access to orthopaedic health services and orthopaedic medical devices in Uganda. Participants included orthopaedic surgeons, related healthcare professionals, industry and government representatives, and patients. Participants' experiences in accessing orthopaedic medical devices were explored. Thematic analysis was used to analyze and code the transcripts. Analysis of the interview data identified poor leadership in government and corruption as major barriers to access of orthopaedic care and orthopaedic medical devices. Corruption was perceived to occur at the worker, hospital and government levels in the forms of misappropriation of funds, theft of equipment, resale of drugs and medical devices, fraud and absenteeism. Other barriers elicited included insufficient health infrastructure and human resources, and high costs of orthopaedic equipment and poverty. This study identified perceived corruption as a significant barrier to access of orthopaedic care and orthopaedic medical devices in Uganda. As the burden of injury continues to grow, the need to combat corruption and ensure access to orthopaedic services is imperative. Anti-corruption strategies such as transparency and accountability measures, codes of conduct, whistleblower protection, and higher wages and benefits for workers could be
Full Text Available Abstract Background Globally, injuries cause approximately as many deaths per year as HIV/AIDS, tuberculosis and malaria combined, and 90% of injury deaths occur in low- and middle- income countries. Given not all injuries kill, the disability burden, particularly from orthopaedic injuries, is much higher but is poorly measured at present. The orthopaedic services and orthopaedic medical devices needed to manage the injury burden are frequently unavailable in these countries. Corruption is known to be a major barrier to access of health care, but its effects on access to orthopaedic services is still unknown. Methods A qualitative case study of 45 open-ended interviews was conducted to investigate the access to orthopaedic health services and orthopaedic medical devices in Uganda. Participants included orthopaedic surgeons, related healthcare professionals, industry and government representatives, and patients. Participants’ experiences in accessing orthopaedic medical devices were explored. Thematic analysis was used to analyze and code the transcripts. Results Analysis of the interview data identified poor leadership in government and corruption as major barriers to access of orthopaedic care and orthopaedic medical devices. Corruption was perceived to occur at the worker, hospital and government levels in the forms of misappropriation of funds, theft of equipment, resale of drugs and medical devices, fraud and absenteeism. Other barriers elicited included insufficient health infrastructure and human resources, and high costs of orthopaedic equipment and poverty. Conclusions This study identified perceived corruption as a significant barrier to access of orthopaedic care and orthopaedic medical devices in Uganda. As the burden of injury continues to grow, the need to combat corruption and ensure access to orthopaedic services is imperative. Anti-corruption strategies such as transparency and accountability measures, codes of conduct
Background Globally, injuries cause approximately as many deaths per year as HIV/AIDS, tuberculosis and malaria combined, and 90% of injury deaths occur in low- and middle- income countries. Given not all injuries kill, the disability burden, particularly from orthopaedic injuries, is much higher but is poorly measured at present. The orthopaedic services and orthopaedic medical devices needed to manage the injury burden are frequently unavailable in these countries. Corruption is known to be a major barrier to access of health care, but its effects on access to orthopaedic services is still unknown. Methods A qualitative case study of 45 open-ended interviews was conducted to investigate the access to orthopaedic health services and orthopaedic medical devices in Uganda. Participants included orthopaedic surgeons, related healthcare professionals, industry and government representatives, and patients. Participants’ experiences in accessing orthopaedic medical devices were explored. Thematic analysis was used to analyze and code the transcripts. Results Analysis of the interview data identified poor leadership in government and corruption as major barriers to access of orthopaedic care and orthopaedic medical devices. Corruption was perceived to occur at the worker, hospital and government levels in the forms of misappropriation of funds, theft of equipment, resale of drugs and medical devices, fraud and absenteeism. Other barriers elicited included insufficient health infrastructure and human resources, and high costs of orthopaedic equipment and poverty. Conclusions This study identified perceived corruption as a significant barrier to access of orthopaedic care and orthopaedic medical devices in Uganda. As the burden of injury continues to grow, the need to combat corruption and ensure access to orthopaedic services is imperative. Anti-corruption strategies such as transparency and accountability measures, codes of conduct, whistleblower protection, and higher
Monnette, Alisha; Zhang, Yichen; Shao, Hui; Shi, Lizheng
As medication adherence continues to be a prevalent issue in today's society, the methods used to monitor medication-taking behaviors are constantly being re-evaluated and compared in search of the 'gold standard' measure. Our review aimed to assess the current literature surrounding the correlation between self-reported questionnaires (SRQs) and electronic monitoring devices to determine if these measures produce similar results. We performed a literature search from 2009 to 2017 using PubMed, PubMed In-Process and Non-Indexed, EMBASE, Ovid MEDLINE, and Ovid MEDLINE In-Process. A keyword search using the terms 'patient compliance', 'treatment compliance', 'medication adherence', 'drug monitoring', 'drug therapy', 'electronic', 'digital', 'computer', 'monitor', 'monitoring', 'drug', 'pharmaceutical preparations', 'compliance', and 'medications' was done to capture all articles. We included articles measuring adherence using both monitoring devices and SRQs. Thirty-five articles were included in this review. The average difference in measured adherence rates between the two measures was 9.2% (range -66.3 to 61.5). A majority (62.7%) of articles reported moderate (n = 12; 27.9%), high (n = 5, 11.6%), or significant (n = 10, 23.3%) correlations between SRQs and monitoring devices. Results from our review are consistent with previous studies, as we found that many of our studies produced moderate to high correlation between both SRQs and monitoring devices [Farmer, Clin Ther 21(6):1074-90 (1999), IMS Institute for Healthcare Informatics. Avoidable costs in US health care (2012), Patel et al., Respirology 18(3):546-52 (2013), Siracusa et al., J Cyst Fibros 14(5):621-6 (2015), Smith et al., Int J Cardiol 145(1):122-3 (2010)]. Our findings demonstrate that self-reported adherence produces comparable results to electronic monitoring devices. As there is not yet a 'gold standard' measure for monitoring patient adherence, SRQs and Medication Event Monitoring Systems
Kegler, Michelle C.; Haardörfer, Regine; Bundy, Lucja T.; Escoffery, Cam; Berg, Carla J.; Fernandez, Maria; Williams, Rebecca; Hovell, Mel
Understanding who establishes partial home smoking bans, what these bans cover, and whether they are an intermediate step in going smoke-free would help to inform smoke-free home interventions. Participants were recruited from United Way of Greater Atlanta's 2-1-1 contact center. Data were collected at baseline, 3 and 6 months via telephone…
Polívková, A.; Hubáček, Tomáš; Staszek, M.; Švorčík, V.; Siegel, J.
Roč. 18, č. 2 (2017), č. článku 419. E-ISSN 1422-0067 Institutional support: RVO:60077344 Keywords : antimicrobials * medical devices * nanostructures * polymers * modification Subject RIV: JJ - Other Materials OBOR OECD: Materials engineering Impact factor: 3.226, year: 2016
Hulstaert, F.; Neyt, M.; Vinck, I.
data are available? We studied the premarket clinical evaluation of innovative high-risk medical devices in Europe compared with the US, and with medicines, where appropriate. Methods: The literature and regulatory documents were checked. Representatives from industry, Competent Authorities, Notified...... of premarket trials in Europe and number of patients exposed, but failed as this information is not made public. Furthermore, the Helsinki Declaration is not followed with respect to the registration and publication of premarket trials. Conclusions: For innovative high-risk devices, new EU legislation should...
Risiken und Nebenwirkungen der Integration medizinischer Software in klinische IT-Strukturen – Erlanger Memorandum [Software as a medical device – side effects when applying the new European regulation on medical devices for IT products
Full Text Available [english] European medical device regulations have been altered to cover pure software applications as well. They now may be classified as a medical device if used for medical diagnostics and/or medical treatment. Slowly, these regulations are being implemented into national law of the EEC member states, for example into the German MPG (Medical Product Law.For some software applications such as Picture Archiving and Communication systems (PACS a classification as medical device is – at least for parts of it – routine today, ruling e.g. the quality of medical monitor screens for assessment of x-ray pictures. For software applications such as patient data management systems (PDMS, electronic health records (EHR, laboratory information systems and similar systems this was not the case so far. This paper deals with the consequences which may arise if a PDMS used on intensive care units or even an EHR is now classified as a medical device, e.g. because it is able to deliver intelligent composite views on laboratory data, medical data, and treatment information to support diagnostic assessment or treatment advice.Modern clinical information systems, PDMS and EHR support the user with medical information and clinical decision support (CDSS. So there is doubt that they are used for diagnostics and/or treatment. Medical device regulations distinguish between medical product classes I (low risk, II and III (high risk of medical devices according to potential risks for the patient. IF CDSS functions e.g. as modules of a PDMS use vital sign values in the decision algorithms, the PDMS may even be classified as class II medical product, similar to e.g. intravenous pumps. If decision rules of a decision support-system are defined by IT-administrators working for a hospital itself it could even become manufacturer of the medical device.The authors discuss implications and demonstrate difficulties which arise for manufacturers as well as for hospitals or the
Rozema, A D; Mathijssen, J J P; Jansen, M W J; van Oers, J A M
Although increasing numbers of countries are implementing outdoor school ground smoking bans at secondary schools, less attention is paid to the post-implementation period even though sustainability of a policy is essential for long-term effectiveness. Therefore, this study assesses the level of sustainability and examines perceived barriers/facilitators related to the sustainability of an outdoor school ground smoking ban at secondary schools. A mixed-method design was used with a sequential explanatory approach. In phase I, 438 online surveys were conducted and in phase II, 15 semi-structured interviews were obtained from directors of relevant schools. ANOVA (phase I) and a thematic approach (phase II) were used to analyze data. Level of sustainability of an outdoor school ground smoking ban was high at the 48% Dutch schools with an outdoor smoking ban. Furthermore, school size was significantly associated with sustainability. The perceived barriers/facilitators fell into three categories: (i) smoking ban implementation factors (side-effects, enforcement, communication, guidelines and collaboration), (ii) school factors (physical environment, school culture, education type and school policy) and (iii) community environment factors (legislation and social environment). Internationally, the spread of outdoor school ground smoking bans could be further promoted. Once implemented, the ban has become 'normal' practice and investments tend to endure. Moreover, involvement of all staff is important for sustainability as they function as role models, have an interrelationship with students, and share responsibility for enforcement. These findings are promising for the sustainability of future tobacco control initiatives to further protect against the morbidity/mortality associated with smoking. © The Author 2017. Published by Oxford University Press on behalf of the European Public Health Association.
Pashkov, Vitalii; Harkusha, Andrii; Bytiak, Oleksii
Chosen European foreign policy vector for Ukraine establishes its obligation to enforce the process of adaptation of the EU law regulations in the internal legal policy. The approximation of Ukrainian law to the European Union (EU) "acquis communautaire" is not only the instrument for deepening our economic cooperation with the European Union, but also the important measure to enhance further development of Ukraine in general. National legislation, which regulate advertising and promotion of medical devices (MD), is not an exception. Some key points on legal regulation of abovementioned sphere is a base of this study. Ukrainian legislation, European Union`s Law Acts, EU's member-states law, WHO Acts and Recommendations, European Medical Technology Industry Association (EUCOMED) Acts. Article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. In accordance with Ukrainian legislation, there is no special law that concerns advertising on MD in Ukraine, this sphere is regulated by general law that named ≪About advertisement≫, but it doesn't take into account even main characteristics of such a special object as medical devices (MD). Moreover, the law ≪About advertisement≫ contain discrepancies in terms that are used, these contradictions, in our opinion, must be eliminated by appropriate law reforms. The advertising and promotion of MD in EU is regulated by a combination of EU and national legislation of EU Member States, national advertising and promotion of MD are not harmonized with the EU MDD for now, resulting in a fragmented legal landscape that differs from one EU Member State to the other. Practice of adopting different codes and guides that regulate advertising, including advertising of MD, is widespread in EU and EU Member States and thus must be used in Ukraine with appropriate reformation of national law.
Katzis, Konstantinos; Jones, Richard W; Despotou, George
Modern Implantable Medical Devices (IMDs), implement capabilities that have contributed significantly to patient outcomes, as well as quality of life. The ever increasing connectivity of IMD's does raise security concerns though there are instances where implemented security measures might impact on patient safety. The paper discusses challenges of addressing both of these attributes in parallel.
Full Text Available OBJECTIVE: To determine what factors have a significant influence on the performance of medical device maintenance outsourcing, and to determine how the performance of external governance structures differs depending on whether a hospital is private or public. METHODS: This was a longitudinal study of 590 maintenance transactions at 20 hospitals in Bogotá, Colombia, involving 764 medical devices and 72 maintenance service providers. Maintenance performance data (i.e., turn-around time in hours; TAT for the service providers (either in-house or outsourced were primarily collected over a 20-month period, from December 2009-August 2011, by means of a monitoring procedure; then, a hazards model was run. RESULTS: The availability of specific repair parts, in-stock, in the city in which the medical devices were located, had a positive impact on the performance of both internal and external governance structures. Online service also had a positive impact on both, with a stronger positive impact on the performance of internal governance than on that of external governance. For transactions governed by external structures, better performance was seen in private hospitals than in public ones. In public health institutions, internal governance showed better performance than external governance. Both internal and external governance structures showed better performance in private healthcare institutions than in public ones. CONCLUSIONS: In public health institutions, internal governance shows better performance than external governance; this suggests that healthcare managers should reconsider the trend to eliminate in-house maintenance service staff in public healthcare institutions.
Full Text Available In 2009, asbestos was finally banned in Korea, about 70 years after the first opening of asbestos mines under Japanese control. After having presented the history of asbestos industry, together with its regulations and health effects over time, we constructed narrative analyses of how the asbestos issue under the prevailing risk system was managed by whom and for what purpose, to provide context for the change. We could identify five different phases: laissez-faire, politico-technical, economic–managerial, health-oriented cultural, and human rights-based post-cultural risk systems. The changes leading to the asbestos ban evolved over different phases, and each phase change was necessary to reach the final ban, in that, without resolving the previous issues by examining different categories of potential alternatives, either the final ban was not possible or, even if instituted, could not be sustained. An asbestos ban could be introduced when all the alternatives to these issues, including legitimate political windows, economic rationalizations, health risk protections, and human rights sensitivities, were available. We think the alternatives that we had were not in perfect shape, but in more or less loosely connected forms, and hence we had to know how to build solidarities between different stakeholders to compensate for the imperfections.
Hajdu, Tamás; Hajdu, Gábor
In 2012, smoking restrictions were extended to hospitality venues in Hungary. Women working in bars and restaurants were primarily affected by the intervention. In this research, we analyze the effect of this smoking ban on the outcomes of their pregnancies. Using individual live birth, fetal loss, and infant mortality registry data, we examine the probability of live birth, indicators of health at birth, and the probability of death in the first year of life. We apply a difference-in-differences framework and show that the smoking ban has improved health at birth. We observed birth weight to increase by 56 g (95% CI: 4.2 to 106.8) and gestation length by 0.19 weeks (95% CI: 0.02 to 0.36). Due to the ban, the probability of being born with very low and low birth weight has decreased by 1.2 and 2.2 percentage points, respectively (95% CI: -0.2 to -2.2 and 0.06 to -4.4), and we see a 0.9 percentage points reduction in the chance of being born very preterm (95% CI: -0.03 to -1.9). We also observe a decrease in the probability of being born with a low Ponderal index (decrease of 4.1 percentage points, 95% CI: -0.7 to -7.5). Performing a series of robustness and placebo tests, we provide evidence that supports the causal interpretation of our results. We also show that the ban was more beneficial for newborns of parents with low educational attainment and at the bottom of the fetal health endowment distribution. Copyright © 2018 Elsevier B.V. All rights reserved.
Fagan, M E; DeFries, R S; Sesnie, S E; Arroyo, J P; Soto, C; Walker, W; Chazdon, R L; Sanchun, A
Forest protection policies potentially reduce deforestation and re-direct agricultural expansion to already-cleared areas. Using satellite imagery, we assessed whether deforestation for conversion to pasture and cropland decreased in the lowlands of northern Costa Rica following the 1996 ban on forest clearing, despite a tripling of area under pineapple cultivation in the last decade. We observed that following the ban, mature forest loss decreased from 2.2% to 1.2% per year, and the proportion of pineapple and other export-oriented cropland derived from mature forest declined from 16.4% to 1.9%. The post-ban expansion of pineapples and other crops largely replaced pasture, exotic and native tree plantations, and secondary forests. Overall, there was a small net gain in forest cover due to a shifting mosaic of regrowth and clearing in pastures, but cropland expansion decreased reforestation rates. We conclude that forest protection efforts in northern Costa Rica have likely slowed mature forest loss and succeeded in re-directing expansion of cropland to areas outside mature forest. Our results suggest that deforestation bans may protect mature forests better than older forest regrowth and may restrict clearing for large-scale crops more effectively than clearing for pasture. (letter)
Jones, K; Wakefield, M; Turnbull, D A
To determine compliance with a voluntary code of practice (VCP) for restricting smoking in restaurants and to canvass the attitudes of restaurateurs towards tougher smoking restrictions. Cross-sectional survey conducted in 1996 using a telephone questionnaire. Metropolitan restaurants and cafes in Adelaide, South Australia. 276 (86.8%) of a sample of randomly selected owners and managers. Restaurant non-smoking policies, reported and anticipated change in business, and restaurateurs' attitudes towards smoking restrictions. 26.8% of restaurants had a total smoking ban; 40.6% restricted smoking some other way; and 32.6% permitted unrestricted smoking. Only 15.1% of restaurants with a ban or restrictions had used the VCP to guide the development of their policy, and only half of these were complying with it. Although 78.4% of those with bans and 84.4% of those with restrictions reported that their non-smoking policy had been associated with either no change or a gain in business, only 33.3% of those allowing unrestricted smoking expected that this would be the case, if they were to limit smoking. A total of 50.4% of restaurateurs, including 45.3% of those with no restrictions, agreed that the government should ban smoking in all restaurants. The VCP made an insignificant contribution to adoption of non-smoking policies, and compliance with the code was poor. Despite concerns about loss of business, there was considerable support for legislation which would ban smoking in all dining establishments.
Li, Bin; He, Meng-qiao; Cao, Jian-wen
In this paper, the SWOT analysis method is used to find out the internal strength, weakness, exterior opportunities and threats of the present medical devices' procurements in hospitals and some strategic considerations are suggested as "one direction, two expansions, three changes and four countermeasures".
Traditionally medical devices companies manage business compliance with anti-corruption and anti-fraud rules in a document-oriented way that does not always yield optimal results for the company. As a result, compliance issues are not optimally managed by the companies. Now that medical devices companies become ever more internationally active, they must also take into account the international dimensions of business compliance. This article intends to provide U.S. medical devices companies with activities in Europe with an insight in business compliance risks in the European Union (EU) and the risks related to U.S. statutes that may be applicable to a U.S. company's activities overseas. The article proposes a process-oriented and IT-supported way of structuring an international business compliance program, resulting in increased effectiveness of the program and increased competitiveness and risk management of the company as well as a high degree of acceptance of the procedures by the company's employees.
Roohpour, Nima; Moshaverinia, Alireza; Wasikiewicz, Jaroslaw M; Paul, Deepen; Vadgama, Pankaj; Wilks, Mark; Millar, Michael
Polyurethanes have been widely used in medicine for coating and packaging implantable and other medical devices. Polyether-urethanes, in particular, have superior mechanical properties and are biocompatible, but in common with other medical materials they are susceptible to microbial film formation. In this study, polyether-urethane was end-capped with silver lactate and silver sulfadiazine functional groups to produce a bacterially resistant polymer without sacrificing the useful mechanical properties of the polyether-polyurethane. The silver ions were covalently incorporated into the polymer during chain extension of the prepolymer. The functionalized polymers were structurally characterized by light scattering, electron microscopy, NMR, FTIR and Raman spectroscopy. Mechanical properties, hydrophilicity, in vitro stability and antibacterial action of polymers were also investigated. Results indicate that both silver salts were successfully incorporated into the polymer structure without significant effect on mechanical properties, whilst conferring acceptable bacterial resistance.
Capacci, Sara; Mazzocchi, Mario; Shankar, Bhavani
This paper estimates the effect of the 2005 vending machine ban in French secondary schools on nutrient intakes and on the frequency of morning snacking at school. Using data before and after the ban, and exploiting the discontinuity associated with the age-dependent exposure to the ban, we specify a difference-in-differences regression…
Coughlin, Steven S; Anderson, Jennifer; Smith, Selina A
Secondhand smoke, which is also referred to as environmental tobacco smoke and passive smoke, is a known human carcinogen. Secondhand smoke also causes disease and premature death in nonsmoking adults and children. We summarize studies of secondhand smoke in public places before and after smoking bans, as well as studies of cardiovascular and respiratory disease before and after such bans. To protect the public from the harmful effects of secondhand smoke, smoke-free legislation is an effective public health measure. Smoking bans in public places, which have been implemented in many jurisdictions across the U.S. and in other countries, have the potential to influence social norms and reduce smoking behavior. Through legislative smoking bans for reducing secondhand smoke exposure and smoking prevalence, opportunities exist to protect the health of Georgians and other Americans and to reduce health care costs. These opportunities include increasing the comprehensiveness of smoking bans in public places and ensuring adequate funding to quit line services.
Bang, Ye Jin; Kim, Jaeyoung; Lee, Won Jin
The purpose of this study was to examine the proportion of paraquat use among farmers and to describe their epidemiologic characteristics after the paraquat ban in 2012. We interviewed 249 farmers in Korea in 2014. Approximately 20% of the farmers reported using paraquat in 2014. Farmers with longer farming experience, longer pesticide application years, and upland farming reported an increased risk of paraquat use although the trend was not statistically significant. The majority of the farmers used preexisting paraquat (85.7%), but some farmers purchased it illegally (14.3%). Farmers who used paraquat perceived paraquat as a dangerous chemical; however, they disagreed with the necessity of the paraquat ban.
Muhammad Ainul Yaqin
Full Text Available Abstrak- Standar sarana dan prasarana adalah salah satu standar yang dinilai dalam instrumen BAN-PT, yaitu pada standar 6.2. Pengelolaan sarana dan prasarana sebuah perguruan tinggi harus memenuhi standar tersebut. Untuk dapat mengetahui seberapa besar tingkat pemenuhan standar diperlukan penilaian. Sistem informasi sarana dan prasarana yang dikembangkan dalam penelitian ini digunakan untuk memasukkan data-data usulan pengadaan, penerimaan, distribusi, penggunaan, pemeliharaan, dan pemusnahan. Laporan-laporan yang disajikan berbentuk tabel dan grafik yang menyatakan kinerja keuangan dan diukur sesuai dengan standar 6.2. BAN-PT. Sistem informasi sarana dan prasarana ini, juga terintegrasi dengan SISFOKAMPUS 4.1 yang merupakan sistem informasi akademik open source yang berbasis web. Hasil dari penelitian ini adalah sistem informasi sarana dan prasarana dengan fungsi khusus yaitu menilai kinerja keuangan yang sesuai dengan standar 6.1. BAN-PT yang dapat digunakan untuk melakukan audit internal. Kata kunci : standar 6.2. BAN-PT, Sistem Informasi Sarana dan Prasarana, SISFOKAMPUS 4.1.
... format so that patients, caregivers, and healthcare providers may access and utilize device labeling as... labeling, and what they would want in a standard version of device labeling. Key findings from the survey... survey with the National Family Caregivers Association (NFCA) on medical device labeling to elicit home...
He, Longjun; Ming, Xing; Liu, Qian
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. However, for direct interactive 3D visualization, which plays an important role in radiological diagnosis, the mobile device cannot provide a satisfactory quality of experience for radiologists. This paper developed a medical system that can get medical images from the picture archiving and communication system on the mobile device over the wireless network. In the proposed application, the mobile device got patient information and medical images through a proxy server connecting to the PACS server. Meanwhile, the proxy server integrated a range of 3D visualization techniques, including maximum intensity projection, multi-planar reconstruction and direct volume rendering, to providing shape, brightness, depth and location information generated from the original sectional images for radiologists. Furthermore, an algorithm that changes remote render parameters automatically to adapt to the network status was employed to improve the quality of experience. Finally, performance issues regarding the remote 3D visualization of the medical images over the wireless network of the proposed application were also discussed. The results demonstrated that this proposed medical application could provide a smooth interactive experience in the WLAN and 3G networks.
Maak, Travis G; Wylie, James D
Medical device regulation is a controversial topic in both the United States and the European Union. Many physicians and innovators in the United States cite a restrictive US FDA regulatory process as the reason for earlier and more rapid clinical advances in Europe. The FDA approval process mandates that a device be proved efficacious compared with a control or be substantially equivalent to a predicate device, whereas the European Union approval process mandates that the device perform its intended function. Stringent, peer-reviewed safety data have not been reported. However, after recent high-profile device failures, political pressure in both the United States and the European Union has favored more restrictive approval processes. Substantial reforms of the European Union process within the next 5 to 10 years will result in a more stringent approach to device regulation, similar to that of the FDA. Changes in the FDA regulatory process have been suggested but are not imminent.
The Comprehensive Nuclear-Test-Ban Treaty (CTBT) was opened for signature in September 1996. In March 1997, the Preparatory Commission for the Comprehensive Nuclear-Test-Ban Treaty Organization started work in Vienna, Austria. This film depicts the Commission's activities in establishing the Treaty's verification regime to monitor adherence to the global ban on nuclear explosions. It presents the challenging work at some of the global monitoring facilities, and at the International Data Centre in Vienna, where the data generated by the facilities are received, processed and analysed
Lapo Filistrucchi; Andrea Mangani; Luigi Luini
We analyse the effects of the advertising ban on French public television, which came into effect on the 5th of January 2009. The ban forbids commercial advertising on public TV in the time slot 20.00-6.00. By using a difference-in-difference approach we show that advertising which was previously broadcasted on public TV in the time slot 20.00-6.00 did not switch to private channels in the same time slot (nor did the price per second in that time slot on private channels rise). Rather adverti...
Mauser, Stanislas; Burgert, Oliver
There are several intra-operative use cases which require the surgeon to interact with medical devices. We used the Leap Motion Controller as input device and implemented two use-cases: 2D-Interaction (e.g. advancing EPR data) and selection of a value (e.g. room illumination brightness). The gesture detection was successful and we mapped its output to several devices and systems.
Kim, Hyeong Gyun [Dept. of Radiological Science, Far East University, Eumsung (Korea, Republic of); Yoon, Jae Ho [Jukwang Precision Co., Ltd., Gumi (Korea, Republic of); Choi, Seong Dae [Dept. of Mechanical system engineering, Kumoh Institute of Technology, Gumi (Korea, Republic of)
There is a progressive development in the medical imaging technology, especially of descriptive capability for anatomical structure of human body thanks to advancement of information technology and medical devices. But however maintenance of correct posture is essential for the medical imaging checkup on the shoulder joint requiring rotation of the upper limb due to the complexity of human body. In the cases of MRI examination, long duration and fixed posture are critical, as failure to comply with them leads to minimal possibility of reproducibility only with the efforts of the examiner and will of the patient. Thus, this study aimed to develop an auxiliary device that enables rotation of the upper limb as well as fixing it at quantitative angles for medical imaging examination capable of providing diagnostic values. An auxiliary device has been developed based on the results of precedent studies, by designing a 3D model with the CATIA software, an engineering application, and producing it with the 3D printer. The printer is Objet350 Connex from Stratasys, and acrylonitrile- butadiene-styrene(ABS) is used as the material of the device. Dimensions are 120 X 150 X 190 mm, with the inner diameter of the handle being 125.9 mm. The auxiliary device has 4 components including the body (outside), handle (inside), fixture terminal and the connection part. The body and handle have the gap of 2.1 mm for smooth rotation, while the 360 degree of scales have been etched on the handle so that the angle required for observation may be recorded per patient for traceability and dual examination.
Kim, Hyeong Gyun; Yoon, Jae Ho; Choi, Seong Dae
There is a progressive development in the medical imaging technology, especially of descriptive capability for anatomical structure of human body thanks to advancement of information technology and medical devices. But however maintenance of correct posture is essential for the medical imaging checkup on the shoulder joint requiring rotation of the upper limb due to the complexity of human body. In the cases of MRI examination, long duration and fixed posture are critical, as failure to comply with them leads to minimal possibility of reproducibility only with the efforts of the examiner and will of the patient. Thus, this study aimed to develop an auxiliary device that enables rotation of the upper limb as well as fixing it at quantitative angles for medical imaging examination capable of providing diagnostic values. An auxiliary device has been developed based on the results of precedent studies, by designing a 3D model with the CATIA software, an engineering application, and producing it with the 3D printer. The printer is Objet350 Connex from Stratasys, and acrylonitrile- butadiene-styrene(ABS) is used as the material of the device. Dimensions are 120 X 150 X 190 mm, with the inner diameter of the handle being 125.9 mm. The auxiliary device has 4 components including the body (outside), handle (inside), fixture terminal and the connection part. The body and handle have the gap of 2.1 mm for smooth rotation, while the 360 degree of scales have been etched on the handle so that the angle required for observation may be recorded per patient for traceability and dual examination
The worldwide need for rapid expansion and diversification of medical devices and the corresponding requirements in industry pose arduous challenges for educators to train undergraduate biomedical engineering (BME) students. Preparing BME students for working in the research and development (R&D) in medical device industry is not easily accomplished by adopting traditional pedagogical methods. Even with the inclusion of the design and development elements in capstone projects, medical device industry may be still experience a gap in fulfilling their needs in R&D. This paper proposes a new model based on interdisciplinary project-based learning (IDPBL) to address the requirements of building the necessary skill sets in academia for carrying out R&D in medical device industry. The proposed model incorporates IDPBL modules distributed in a stepwise fashion through the four years of a typical BME program. The proposed model involves buy-in and collaboration from faculty as well as students. The implementation of the proposed design in an undergraduate BME program is still in process. However, a variant of the proposed IDPBL method has been attempted at a limited scale at the postgraduate level and has shown some success. Extrapolating the previous results, the adoption of the IDPBL to BME training seems to suggest promising outcomes. Despite numerous implementation challenges, with continued efforts, the proposed IDPBL will be valuable n academia for skill sets building for medical device R&D.
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0495] Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Documents; Availability AGENCY: Food and Drug Administration, HHS. ACTION...
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0495] Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of Comment Period AGENCY: Food and Drug...
Rajkumar, Sarah; Stolz, Daiana; Hammer, Jürg; Moeller, Alexander; Bauer, Georg F; Huynh, Cong Khanh; Röösli, Martin
The aim of this study was to examine the effect of a smoking ban on lung function, fractional exhaled nitric oxide, and respiratory symptoms in nonsmoking hospitality workers. Secondhand smoke exposure at the workplace, spirometry, and fractional exhaled nitric oxide were measured in 92 nonsmoking hospitality workers before as well as twice after a smoking ban. At baseline, secondhand smoke-exposed hospitality workers had lung function values significantly below the population average. After the smoking ban, the covariate-adjusted odds ratio for cough was 0.59 (95% confidence interval, 0.36 to 0.93) and for chronic bronchitis 0.75 (95% confidence interval, 0.55 to 1.02) compared with the preban period. The below-average lung function before the smoking ban indicates chronic damages from long-term exposure. Respiratory symptoms such as cough decreased within 12 months after the ban.
Drozda, Joseph P; Roach, James; Forsyth, Thomas; Helmering, Paul; Dummitt, Benjamin; Tcheng, James E
The US Food and Drug Administration (FDA) has recognized the need to improve the tracking of medical device safety and performance, with implementation of Unique Device Identifiers (UDIs) in electronic health information as a key strategy. The FDA funded a demonstration by Mercy Health wherein prototype UDIs were incorporated into its electronic information systems. This report describes the demonstration's informatics architecture. Prototype UDIs for coronary stents were created and implemented across a series of information systems, resulting in UDI-associated data flow from manufacture through point of use to long-term follow-up, with barcode scanning linking clinical data with UDI-associated device attributes. A reference database containing device attributes and the UDI Research and Surveillance Database (UDIR) containing the linked clinical and device information were created, enabling longitudinal assessment of device performance. The demonstration included many stakeholders: multiple Mercy departments, manufacturers, health system partners, the FDA, professional societies, the National Cardiovascular Data Registry, and information system vendors. The resulting system of systems is described in detail, including entities, functions, linkage between the UDIR and proprietary systems using UDIs as the index key, data flow, roles and responsibilities of actors, and the UDIR data model. The demonstration provided proof of concept that UDIs can be incorporated into provider and enterprise electronic information systems and used as the index key to combine device and clinical data in a database useful for device evaluation. Keys to success and challenges to achieving this goal were identified. Fundamental informatics principles were central to accomplishing the system of systems model. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: email@example.com
Full Text Available Beverley D GlassSchool of Pharmacy and Molecular Sciences, James Cook University, Townsville, QLD, AustraliaAbstract: The World Health Organization has reported that counterfeit medicines potentially make up more than 50% of the global drug market, with a significant proportion of these fake products being encountered in developing countries. This occurrence is attributed to a lack of effective regulation and a weak enforcement capacity existing in these countries, with an increase in this trade resulting from the growing size and sophistication of drug counterfeiters. In addition, due to both cost and lack of availability of medicines, consumers in developing countries are more likely to seek out these inexpensive options. The World Health Organization is mindful of the impact of counterfeit drugs on consumer confidence in health care systems, health professionals, the supply chain, and genuine suppliers of medicines and medical devices. Antibiotics, antituberculosis drugs, and antimalarial and antiretroviral drugs are frequently targeted, with reports of 60% of the anti-infective drugs in Asia and Africa containing active pharmaceutical ingredients outside their pharmacopoeial limits. This has obvious public health implications of increasing drug resistance and negating all the efforts that have already gone into the provision of medicines to treat these life threatening conditions in the developing world. This review, while focusing on counterfeit medicines and medical devices in developing countries, will present information on their impact and how these issues can be addressed by regulation and control of the supply chain using technology appropriate to the developing world. The complexity of the problem will also be highlighted in terms of the definition of counterfeit and substandard medicines, including gray pharmaceuticals. Although this issue presents as a global public health problem, outcomes in developing countries where counterfeit
Steffensen, Søren Langer; Merete H., Vestergaard,; Jensen, Minna Grønning
Bacterial colonization and biofilm formation on medical devices constitute major challenges in clinical long-term use of e.g. catheters due to the risk of (re)infection of patients, which would result in additional use of antibiotics risking bacterial resistance development. The aim of the present...... in the range of 1–20 mg/mL. Devices containing 25% (w/w) hydrogel and loaded with ciprofloxacin displayed a strong antibacterial effect against Staphylococcus aureus bacterial colonization and subsequent biofilm formation on the device material was inhibited for 29 days. In conclusion, the hydrogel...
Zheng, Caixian; Zheng, Kun; Shen, Yunming; Wu, Yunyun
The content related to the quality during life-cycle in operation of medical device includes daily use, repair volume, preventive maintenance, quality control and adverse event monitoring. In view of this, the article aims at discussion on the quality evaluation method of medical devices during their life cycle in operation based on the Analytic Hierarchy Process (AHP). The presented method is proved to be effective by evaluating patient monitors as example. The method presented in can promote and guide the device quality control work, and it can provide valuable inputs to decisions about purchase of new device.
Children and adolescents are particularly vulnerable to the harmful effects of alcohol, with heavy drinking risking impaired brain development and future alcohol dependence. Advertisements increase expectancies about alcohol, leading to a greater likelihood of drinking. A systematic review of 13 longitudinal studies of over 38,000 young people found convincing evidence of an impact of media exposure and alcohol advertising on subsequent alcohol use, including initiation of drinking and heavier drinking among existing drinkers. All European countries, with the exception of the UK, have a ban on one or more types of advertising. Since self-regulation is reported as failing to prevent marketing which has an impact on younger people, and since advertising commonly crosses country borders, there is an argument to approximate advertising rules across Europe banning alcohol advertising targeted at young people, a highly cost-effective measure to reduce harmful alcohol use, and one supported by European citizens and case law.
Kramer, Daniel B; Baker, Matthew; Ransford, Benjamin; Molina-Markham, Andres; Stewart, Quinn; Fu, Kevin; Reynolds, Matthew R
Medical devices increasingly depend on computing functions such as wireless communication and Internet connectivity for software-based control of therapies and network-based transmission of patients' stored medical information. These computing capabilities introduce security and privacy risks, yet little is known about the prevalence of such risks within the clinical setting. We used three comprehensive, publicly available databases maintained by the Food and Drug Administration (FDA) to evaluate recalls and adverse events related to security and privacy risks of medical devices. Review of weekly enforcement reports identified 1,845 recalls; 605 (32.8%) of these included computers, 35 (1.9%) stored patient data, and 31 (1.7%) were capable of wireless communication. Searches of databases specific to recalls and adverse events identified only one event with a specific connection to security or privacy. Software-related recalls were relatively common, and most (81.8%) mentioned the possibility of upgrades, though only half of these provided specific instructions for the update mechanism. Our review of recalls and adverse events from federal government databases reveals sharp inconsistencies with databases at individual providers with respect to security and privacy risks. Recalls related to software may increase security risks because of unprotected update and correction mechanisms. To detect signals of security and privacy problems that adversely affect public health, federal postmarket surveillance strategies should rethink how to effectively and efficiently collect data on security and privacy problems in devices that increasingly depend on computing systems susceptible to malware.
Kao, Audiey C; Braddock, Clarence; Clay, Maria; Elliott, Donna; Epstein, Scott K; Filstead, William; Hotze, Tim; May, Win; Reenan, Jennifer
To determine the effect of educational interventions on medical students' attitudes toward pharmaceutical industry marketing practices and whether restrictive medical school policies governing medicine-industry interactions are associated with student support for banning such interactions. Prospective cohort study involving the graduating classes of 2009 (intervention, n=474) and 2010 (control, n=459) at four U.S. medical schools. Intervention students experienced a former pharmaceutical representative's presentation, faculty debate, and a Web-based course. Both groups completed baseline and follow-up attitude surveys about pharmaceutical marketing. A total of 482 students (51.6%) completed both surveys. In regression analyses, intervention students were more likely than control students to think that physicians are strongly or moderately influenced by pharmaceutical marketing (OR, 2.29; 95% CI, 1.46-3.59) and believed they would be more likely to prescribe a company's drug if they accepted that company's gifts and food (OR, 1.68; 95% CI, 1.12-2.52). Intervention students were more likely to support banning interactions between pharmaceutical representatives and students (OR, 4.82; 95% CI, 3.02-7.68) and with physicians (OR, 6.88; 95% CI, 4.04-11.70). Students from schools with more restrictive policies were more likely to support banning interactions between pharmaceutical representatives and students (OR, 1.99; 95% CI, 1.26-3.16) and with physicians (OR, 3.44; 95% CI, 2.05-5.79). Education about pharmaceutical marketing practices and more restrictive policies governing medicine-industry interactions seem to increase medical students' skepticism about the appropriateness of such marketing practices and disapproval of pharmaceutical representatives in the learning environment.
Górski, A; Letkiewicz, S
In the past years, it has become increasingly apparent that ghostwriting may erode the public trust in medical science and scientific publishing. It is estimated that approximately 10% of articles published in reputed journals are ghostwritten, and this rate may be even higher in some medical specialties. Although this practice is rather universally condemned, the propriety of participation of professional writers in producing papers remains an open question. Although some believe this practice should also be banned, others argue that such stringent policy would increase nonpublication and rather encourage disclosure; but should medical writers be included as authors on the final version of manuscripts? These and other questions should be solved to maintain the high scientific and ethical standards of medical communication and public trust in medicine. Copyright © 2010 Elsevier Inc. All rights reserved.
Viriyachaiyo, V; Lim, A
Thailand is internationally renowned for its stringent tobacco control measures. In Thailand, a regulation banning smoking in air-conditioned hotel lobbies was issued in late 2006, causing substantial apprehension within the hospitality industry. A survey of tourists' attitudes toward the ban was conducted. A cross-sectional survey of 5550 travellers staying in various hotels in Bangkok, Surat Thani, Phuket, Krabi and Songkhla provinces, October 2005 to December 2006. Travellers aged 15 years or older with a check-in duration of at least one day and willing to complete the questionnaire were requested by hotel staff to fill in the 5-minute questionnaire at check-in or later at their convenience. Secondhand cigarette smoke was recognised as harmful to health by 89.7% of respondents. 47.8% of travellers were aware of the Thai regulation banning smoking in air-conditioned restaurants. 80.9% of the respondents agreed with the ban, particularly female non-smokers. 38.6% of survey respondents indicated that they would be more likely to visit Thailand again because of the regulation, 53.4% that the regulation would not affect their decision and 7.9% that they would be less likely to visit Thailand again. Banning smoking in air-conditioned hotel lobbies in Thailand is widely supported by tourists. Enforcement of the regulation is more likely to attract tourists than dissuade them from holidaying in Thailand.
Are pupils in the United Kingdom using mobile devices to help their learning? If so, what are they using and why? This article is based on research carried out by questionnaire, observation and pupil interviews at two English academies. One of the academies provides mobile devices for the pupils, and the other bans the use of mobile devices. The…
Núñez-Beltrán, Arianna; López-Romero, Everardo; Cuéllar-Cruz, Mayra
Adhesion is the first step for Candida species to form biofilms on medical devices implanted in the human host. Both the physicochemical nature of the biomaterial and cell wall proteins (CWP) of the pathogen play a determinant role in the process. While it is true that some CWP have been identified in vitro, little is known about the CWP of pathogenic species of Candida involved in adhesion. On this background, we considered it important to investigate the potential role of CWP of C. albicans, C. glabrata, C. krusei and C. parapsilosis in adhesion to different medical devices. Our results indicate that the four species strongly adher to polyvinyl chloride (PVC) devices, followed by polyurethane and finally by silicone. It was interesting to identify fructose-bisphosphate aldolase (Fba1) and enolase 1 (Eno1) as the CWP involved in adhesion of C. albicans, C. glabrata and C. krusei to PVC devices whereas phosphoglycerate kinase (Pgk) and Eno1 allow C. parapsilosis to adher to silicone-made implants. Results presented here suggest that these CWP participate in the initial event of adhesion and are probably followed by other proteins that covalently bind to the biomaterial thus providing conditions for biofilm formation and eventually the onset of infection. Copyright © 2017 Elsevier Ltd. All rights reserved.
Langer, Lissy; Huppmann, Daniel; Holz, Franziska
The upheaval in global crude oil markets and the boom in shale oil production in North America brought scrutiny on the US export ban for crude oil from 1975. The ban was eventually lifted in early 2016. This paper examines the shifts of global trade flows and strategic refinery investments in a spatial, game-theoretic partial equilibrium model. We consider detailed oil supply chain infrastructure with multiple crude oil types, distinct oil products, as well as specific refinery configurations and modes of transport. Prices, quantities produced and consumed, as well as infrastructure and refining capacity investments are endogenous to the model. We compare two scenarios: an insulated US crude oil market, and a counter-factual with lifted export restrictions. We find a significant expansion of US sweet crude exports with the lift of the export ban. In the US refinery sector, more (imported) heavy sour crude is transformed. Countries importing US sweet crude gain from higher product output, while avoiding costly refinery investments. Producers of heavy sour crude (e.g. the Middle East) are incentivised to climb up the value chain to defend their market share and maintain their dominant position. - Highlights: • We study the impacts of lifting the US crude ban on global oil flows and investments. • We find massive expansion of US sweet crude oil exports. • We analyze the resulting welfare effects for US producers, refiners and consumers. • We indicate the changes on global trade patterns. • We conclude that lifting the ban is the right policy for the US and the global economy.
Lee, Seung Youl; Kim, Jae Ryang; Lee, Jun Ho; Park, Chang Won [Division of Medical Device Research, National Institute of Food and Drug Safety Evaluation, Mnistry of Food and Drug Safety (Korea, Republic of)
Due to recent population aging, the number of check-up for senior citizens has increased steadily. According to this trend, the market size of dental X-ray equipment and the number of approval and review for these devices have simultaneously increased. The technical document of medical device is required for approval and review for medical device, and medical device companies needs to have work comprehension and expertise, as the document needs to include the overall contents such as performances, test criteria, etc.. Yet, since most of domestic manufacturers or importers of medical devices are small businesses, it is difficult for them to recruit professional manpower for approval of medical devices, and submission of inaccurate technical documents has increased. These problems lead to delay of the approval process and to difficulties in quick entering into the market. Especially, the Ministry of Food and Drug safety (MFDS) standards of a dental extra-oral X-ray equipment, a dental intra-oral X-ray equipment, an arm-type computed tomography, and a portable X-ray system have been recently enacted or not. this guideline of dental X-ray equipment adjusting revised standards was developed to help relative companies and reviewers. For this study, first, the methods to write technical document have been reviewed with revised international and domestic regulations and system. Second, the domestic and foreign market status of each item has been surveyed and analyzed. Third, the contents of technical documents already approved by MFDS have been analyzed to select the correct example, test items, criteria, and methods. Finally, the guideline has been developed based on international and domestic regulation, through close review of a consultative body composed of academic, industrial, research institute and government experts.
Lee, Seung Youl; Kim, Jae Ryang; Lee, Jun Ho; Park, Chang Won
Due to recent population aging, the number of check-up for senior citizens has increased steadily. According to this trend, the market size of dental X-ray equipment and the number of approval and review for these devices have simultaneously increased. The technical document of medical device is required for approval and review for medical device, and medical device companies needs to have work comprehension and expertise, as the document needs to include the overall contents such as performances, test criteria, etc.. Yet, since most of domestic manufacturers or importers of medical devices are small businesses, it is difficult for them to recruit professional manpower for approval of medical devices, and submission of inaccurate technical documents has increased. These problems lead to delay of the approval process and to difficulties in quick entering into the market. Especially, the Ministry of Food and Drug safety (MFDS) standards of a dental extra-oral X-ray equipment, a dental intra-oral X-ray equipment, an arm-type computed tomography, and a portable X-ray system have been recently enacted or not. this guideline of dental X-ray equipment adjusting revised standards was developed to help relative companies and reviewers. For this study, first, the methods to write technical document have been reviewed with revised international and domestic regulations and system. Second, the domestic and foreign market status of each item has been surveyed and analyzed. Third, the contents of technical documents already approved by MFDS have been analyzed to select the correct example, test items, criteria, and methods. Finally, the guideline has been developed based on international and domestic regulation, through close review of a consultative body composed of academic, industrial, research institute and government experts
Employing narrative ways of inquiry, this study interrogated how a reform action--legal banning corporal punishment in schools, which was intentionally introduced into Taiwanese society by advocates as a social movement strategy at a time when the incidence rate of school corporal punishment was high--could contribute to ending educators' use of…
Kennedy, Ryan David; Behm, Ilan; Craig, Lorraine; Thompson, Mary E; Fong, Geoffrey T; Guignard, Romain; Beck, Francois
On January 1, 2008, the French government implemented a national ban on indoor smoking in hospitality venues. Survey results indicate the indoor ban has been successful at dramatically reducing indoor smoking; however, there are reports of an increased number of outdoor hospitality spaces (patios) where smoking can take place. This study sought to understand if the indoor ban simply moved smoking to the outdoors, and to assess levels of support for smoking restrictions in outdoor hospitality settings after the smoke-free law. Telephone interviews were conducted among 1067 adult smokers before and after the 2008 indoor ban as part of the International Tobacco Control (ITC) France Survey. Among other topics, this survey measures how the smoking ban has influenced smoking behaviour relevant to outdoor sections of hospitality venues. In addition, 414 non-smoking adults and 164 respondents who had quit smoking between waves were also asked about support for outdoor smoking restrictions. Reported smoking outdoors at cafés/pubs/bars increased from 33.6% of smokers at Wave 1 to 75.9% at Wave 2. At restaurants, smoking outdoors increased from 28.9% to 59.0%. There was also an increase in reported non-smoking for both visits to cafés/pubs/bars, and restaurants from 13.4% to 24.7%, and 30.4% to 40.8% respectively. The majority of smokers (74.5%), non-smokers (89.4%) and quitters (74.0%) support a partial or complete ban on smoking in outdoor areas of restaurants. The indoor smoking ban moved smoking to outdoor spaces; however, the ban is also associated with increased non-smoking behaviour. The majority of respondents support outdoor smoking restrictions in patio environments.
Brown, Ashley; Sweeting, Helen; Logan, Greig; Demou, Evangelia; Hunt, Kate
In jurisdictions permitting prisoner smoking, rates are high (c75%), with smoking embedded in prison culture, leading to secondhand smoke exposures among staff and prisoners and challenges for smoking cessation. Momentum is building to ban smoking in prisons, but research on staff and prisoner views is lacking. We address this gap, providing evidence on staff and prisoner views throughout all Scottish prisons. Data were collected prior to announcement of a (November 2018) prison smoking ban throughout Scotland. Mixed methods were used: surveys of staff (online, N=1,271, ~27%) and prisoners (questionnaire, N=2,512, ~34%); 17 focus groups and two paired interviews with staff in 14 prisons. Staff were more positive than prisoners about bans and increased smoking restrictions, although prisoner views were more favourable should e-cigarettes be permitted. Non-smokers were more positive than smokers. Whilst 74% staff and 22% prisoners agreed bans were a good idea, both groups acknowledged implementation and enforcement challenges. Staff views were influenced by beliefs about: acceptability of the policy in principle; and whether/how bans could be achieved. Although some voiced doubts about smoke-free policies, staff likened a ban to other operational challenges. Staff raised concerns around needs for appropriate measures, resources and support, adequate lead-in time, and effective communication prior to a ban. We recommend that regular and open opportunities for dialogue within and between different stakeholder groups are created when preparing for prison smoking bans, and that specific measures to address staff and prisoner concerns are incorporated into plans to create and maintain smoke-free environments. To our knowledge, this study is the first to research staff and prisoner views across a whole prison system prior to implementation of smoke-free policies. The results highlight potential challenges and suggest measures which might help to maximise the success of
Cruz, B.L. da; Brito, E.B.; Gomes, A.S.
Ordinance 453/98 of the Ministry of Health establishes that medical X-ray equipment should be monitored by tests that prove its efficiency. This practice is called quality control (QC), and two important tests jointly evaluate the operation of the collimation and alignment systems of the central axis of the X-ray beam. The low supply and the high cost generate allegations of difficulties in the periodic realization of the tests. The aim of this work is to design, make and evaluate the performance of a handmade device for the mentioned tests, using low cost materials. Once built, the device had its performance evaluated and compared with the traditionally marketed device. The handmade device proved to be fit in its functions. It is possible to make a device that tests X-ray medical equipment, using the radiology technologist himself as the test runner. Radiation protection is promoted and legislation with no real financial burden
Wallace, Sean; Clark, Marcia; White, Jonathan
The last decade has seen the introduction of new technology which has transformed many aspects of our culture, commerce, communication and education. This study examined how medical teachers and learners are using mobile computing devices such as the iPhone in medical education and practice, and how they envision them being used in the future. Semistructured interviews were conducted with medical students, residents and faculty to examine participants' attitudes about the current and future use of mobile computing devices in medical education and practice. A thematic approach was used to summarise ideas and concepts expressed, and to develop an online survey. A mixed methods approach was used to integrate qualitative and quantitative findings. Medical students, residents and faculty at a large Canadian medical school in 2011. Interviews were conducted with 18 participants (10 students, 7 residents and 1 faculty member). Only 213 participants responded to the online survey (76 students, 65 residents and 41 faculty members). Over 85% of participants reported using a mobile-computing device. The main uses described for mobile devices related to information management, communication and time management. Advantages identified were portability, flexibility, access to multimedia and the ability to look up information quickly. Challenges identified included: superficial learning, not understanding how to find good learning resources, distraction, inappropriate use and concerns about access and privacy. Both medical students and physicians expressed the view that the use of these devices in medical education and practice will increase in the future. This new technology offers the potential to enhance learning and patient care, but also has potential problems associated with its use. It is important for leadership in medical schools and healthcare organisations to set the agenda in this rapidly developing area to maximise the benefits of this powerful new technology while
... technical data, software, or information) that are subject to license application requirements of another... IRANIAN TRANSACTIONS REGULATIONS Licenses, Authorizations and Statements of Licensing Policy § 560.533 Brokering sales of agricultural commodities, medicine, and medical devices. (a) General license for...
Nair, S; Schensul, J J; Bilgi, S; Kadam, V; D'Mello, S; Donta, B
The Maharashtra government has banned the production, sale, distribution and storage of gutka, and pan masala in the Maharashtra State due to the increasing burden of cancer and reproductive health problems attributable to the use of these products. In view of this, it is important to understand the way producers', sellers' and users' are adapting to the ban. During the two months following the ban (July 19 th through Sept 30, 2012), a research team studying smokeless tobacco use and promotion in a low income community of Mumbai conducted rapid surveillance to assess the impact of the ban in the study community. Assessment involved documenting new points of sale, informal observations of tobacco use, and interviews with thirteen shop owners and eight gutka users'. Overall changes in accessibility, availability, patterns of use of tobacco products, perception of ban, social norms and surveillance activities were assessed. Tobacco companies were marketing new products that resembled gutka, under similar brand logos. Surveillance, financial and social cost of selling gutka or using it in public have had an immediate effect on reducing local supply, demand and use and increasing stigma associated with its use. There was an increased recognition of ill-effects of gutka on cancer among sellers' but not overall. To reduce the overall consumption of tobacco in the community, it is critical to include programs that create awareness about effects of smokeless tobacco on health and sustain surveillance levels. This would maintain requirements of the ban, and sustain limits on accessibility, availability and use of these products in the community and other similar communities.
Martin, Jennifer L; Barnett, Julie
It is well established that considering users is an important aspect of medical device development. However it is also well established that there are numerous barriers to successfully conducting user research and integrating the results into product development. It is not sufficient to simply conduct user research, it must also be effectively integrated into product development. A case study of the development of a new medical imaging device was conducted to examine in detail how users were involved in a medical device development project. Two user research studies were conducted: a requirements elicitation interview study and an early prototype evaluation using contextual inquiry. A descriptive in situ approach was taken to investigate how these studies contributed to the product development process and how the results of this work influenced the development of the technology. Data was collected qualitatively through interviews with the development team, participant observation at development meetings and document analysis. The focus was on investigating the barriers that exist to prevent user data from being integrated into product development. A number of individual, organisational and system barriers were identified that functioned to prevent the results of the user research being fully integrated into development. The user and technological aspects of development were seen as separate work streams during development. The expectations of the developers were that user research would collect requirements for the appearance of the device, rather than challenge its fundamental concept. The manner that the user data was communicated to the development team was not effective in conveying the significance or breadth of the findings. There are a range of informal and formal organisational processes that can affect the uptake of user data during medical device development. Adopting formal decision making processes may assist manufacturers to take a more integrated and
Martin Jennifer L
Full Text Available Abstract Background It is well established that considering users is an important aspect of medical device development. However it is also well established that there are numerous barriers to successfully conducting user research and integrating the results into product development. It is not sufficient to simply conduct user research, it must also be effectively integrated into product development. Methods A case study of the development of a new medical imaging device was conducted to examine in detail how users were involved in a medical device development project. Two user research studies were conducted: a requirements elicitation interview study and an early prototype evaluation using contextual inquiry. A descriptive in situ approach was taken to investigate how these studies contributed to the product development process and how the results of this work influenced the development of the technology. Data was collected qualitatively through interviews with the development team, participant observation at development meetings and document analysis. The focus was on investigating the barriers that exist to prevent user data from being integrated into product development. Results A number of individual, organisational and system barriers were identified that functioned to prevent the results of the user research being fully integrated into development. The user and technological aspects of development were seen as separate work streams during development. The expectations of the developers were that user research would collect requirements for the appearance of the device, rather than challenge its fundamental concept. The manner that the user data was communicated to the development team was not effective in conveying the significance or breadth of the findings. Conclusion There are a range of informal and formal organisational processes that can affect the uptake of user data during medical device development. Adopting formal decision
Jones, E.D.; Banks, W.W.; Altenbach, T.J.; Fischer, L.E. [Lawrence Livermore National Lab., CA (United States)
This report describes a preliminary application of an analysis approach for assessing relative risks in the use of radiation- emitting medical devices. Results are presented on human-initiated actions and failure modes that are most likely to occur in the use of the Gamma Knife, a gamma irradiation therapy device. This effort represents an initial step in a US Nuclear Regulatory Commission (NRC) plan to evaluate the potential role of risk analysis in regulating the use of nuclear medical devices. For this preliminary application of risk assessment, the focus was to develop a basic process using existing techniques for identifying the most likely risk contributors and their relative importance. The approach taken developed relative risk rankings and profiles that incorporated the type and quality of data available and could present results in an easily understood form. This work was performed by the Lawrence Livermore National Laboratory for the NRC.
Jones, E.D.; Banks, W.W.; Altenbach, T.J.; Fischer, L.E.
This report describes a preliminary application of an analysis approach for assessing relative risks in the use of radiation- emitting medical devices. Results are presented on human-initiated actions and failure modes that are most likely to occur in the use of the Gamma Knife, a gamma irradiation therapy device. This effort represents an initial step in a US Nuclear Regulatory Commission (NRC) plan to evaluate the potential role of risk analysis in regulating the use of nuclear medical devices. For this preliminary application of risk assessment, the focus was to develop a basic process using existing techniques for identifying the most likely risk contributors and their relative importance. The approach taken developed relative risk rankings and profiles that incorporated the type and quality of data available and could present results in an easily understood form. This work was performed by the Lawrence Livermore National Laboratory for the NRC
Weaver, J. D.; Gutierrez, E. J.; Nagaraja, S.; Stafford, P. R.; Sivan, S.; Di Prima, M.
Processing of nitinol medical devices has evolved over the years as manufacturers have identified methods of reducing surface defects such as inclusions. One recent method proposes to soak nitinol medical devices in a 6% sodium hypochlorite (NaClO) solution as a means of identifying surface inclusions. Devices with surface inclusions could in theory then be removed from production because inclusions would interact with NaClO to form a visible black material on the nitinol surface. To understand the effects of an NaClO soak on performance, we compared as-received and NaClO-soaked nitinol wires with two different surface finishes (black oxide and electropolished). Pitting corrosion susceptibility was equivalent between the as-received and NaClO-soaked groups for both surface finishes. Nickel ion release increased in the NaClO-soaked group for black oxide nitinol, but was equivalent for electropolished nitinol. Fatigue testing revealed a lower fatigue life for NaClO-soaked black oxide nitinol at all alternating strains. With the exception of 0.83% alternating strain, NaClO-soaked and as-received electropolished nitinol had similar average fatigue life, but the NaClO-soaked group showed higher variability. NaClO-soaked electropolished nitinol had specimens with the lowest number of cycles to fracture for all alternating strains tested with the exception of the highest alternating strain 1.2%. The NaClO treatment identified only one specimen with surface inclusions and caused readily identifiable surface damage to the black oxide nitinol. Damage from the NaClO soak to electropolished nitinol surface also appears to have occurred and is likely the cause of the increased variability of the fatigue results. Overall, the NaClO soak appears to not lead to an improvement in nitinol performance and seems to be damaging to the nitinol surface in ways that may not be detectable with a simple visual inspection for black material on the nitinol surface.