WorldWideScience

Sample records for biomaterials medical devices

  1. Regulatory affairs for biomaterials and medical devices

    CERN Document Server

    Amato, Stephen F; Amato, B

    2015-01-01

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

  2. Biomaterials and medical devices a perspective from an emerging country

    CERN Document Server

    Hermawan, Hendra

    2016-01-01

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

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

    Science.gov (United States)

    Vienken, Jörg

    2012-06-01

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

  4. Handbook of materials for medical devices

    National Research Council Canada - National Science Library

    Davis, J. R

    2003-01-01

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

  5. Discovery and Development of Synthetic and Natural Biomaterials for Protein Therapeutics and Medical Device Applications

    Science.gov (United States)

    Keefe, Andrew J.

    Controlling nonspecific protein interactions is important for applications from medical devices to protein therapeutics. The presented work is a compilation of efforts aimed at using zwitterionic (ionic yet charge neutral) polymers to modify and stabilize the surface of sensitive biomedical and biological materials. Traditionally, when modifying the surface of a material, the stability of the underlying substrate. The materials modified in this dissertation are unique due to their unconventional amorphous characteristics which provide additional challenges. These are poly(dimethyl siloxane) (PDMS) rubber, and proteins. These materials may seem dissimilar, but both have amorphous surfaces, that do not respond well to chemical modification. PDMS is a biomaterial extensively used in medical device manufacturing, but experiences unacceptably high levels of non-specific protein fouling when used with biological samples. To reduce protein fouling, surface modification is often needed. Unfortunately conventional surface modification methods, such as Poly(ethylene glycol) (PEG) coatings, do not work for PDMS due to its amorphous state. Herein, we demonstrate how a superhydrophilic zwitterionic material, poly(carboxybetaine methacrylate) (pCBMA), can provide a highly stable nonfouling coating with long term stability due to the sharp the contrast in hydrophobicity between pCBMA and PDMS. Biological materials, such as proteins, also require stabilization to improve shelf life, circulation time, and bioactivity. Conjugation of proteins with PEG is often used to increase protein stability, but has a detrimental effect on bioactivity. Here we have shown that pCBMA conjugation improves stability in a similar fashion to PEG, but also retains, or even improves, binding affinity due to enhanced protein-substrate hydrophobic interactions. Recognizing that pCBMA chemically resembles the combination of lysine (K) and glutamic acid (E) amino acids, we have shown how zwitterionic

  6. Design for Additive Bio-Manufacturing: From Patient-Specific Medical Devices to Rationally Designed Meta-Biomaterials.

    Science.gov (United States)

    Zadpoor, Amir A

    2017-07-25

    Recent advances in additive manufacturing (AM) techniques in terms of accuracy, reliability, the range of processable materials, and commercial availability have made them promising candidates for production of functional parts including those used in the biomedical industry. The complexity-for-free feature offered by AM means that very complex designs become feasible to manufacture, while batch-size-indifference enables fabrication of fully patient-specific medical devices. Design for AM (DfAM) approaches aim to fully utilize those features for development of medical devices with substantially enhanced performance and biomaterials with unprecedented combinations of favorable properties that originate from complex geometrical designs at the micro-scale. This paper reviews the most important approaches in DfAM particularly those applicable to additive bio-manufacturing including image-based design pipelines, parametric and non-parametric designs, metamaterials, rational and computationally enabled design, topology optimization, and bio-inspired design. Areas with limited research have been identified and suggestions have been made for future research. The paper concludes with a brief discussion on the practical aspects of DfAM and the potential of combining AM with subtractive and formative manufacturing processes in so-called hybrid manufacturing processes.

  7. Design for Additive Bio-Manufacturing: From Patient-Specific Medical Devices to Rationally Designed Meta-Biomaterials

    Directory of Open Access Journals (Sweden)

    Amir A. Zadpoor

    2017-07-01

    Full Text Available Recent advances in additive manufacturing (AM techniques in terms of accuracy, reliability, the range of processable materials, and commercial availability have made them promising candidates for production of functional parts including those used in the biomedical industry. The complexity-for-free feature offered by AM means that very complex designs become feasible to manufacture, while batch-size-indifference enables fabrication of fully patient-specific medical devices. Design for AM (DfAM approaches aim to fully utilize those features for development of medical devices with substantially enhanced performance and biomaterials with unprecedented combinations of favorable properties that originate from complex geometrical designs at the micro-scale. This paper reviews the most important approaches in DfAM particularly those applicable to additive bio-manufacturing including image-based design pipelines, parametric and non-parametric designs, metamaterials, rational and computationally enabled design, topology optimization, and bio-inspired design. Areas with limited research have been identified and suggestions have been made for future research. The paper concludes with a brief discussion on the practical aspects of DfAM and the potential of combining AM with subtractive and formative manufacturing processes in so-called hybrid manufacturing processes.

  8. Surface modification of biomaterials and biomedical devices using additive manufacturing.

    Science.gov (United States)

    Bose, Susmita; Robertson, Samuel Ford; Bandyopadhyay, Amit

    2018-01-15

    The demand for synthetic biomaterials in medical devices, pharmaceutical products and, tissue replacement applications are growing steadily due to aging population worldwide. The use for patient matched devices is also increasing due to availability and integration of new technologies. Applications of additive manufacturing (AM) or 3D printing (3DP) in biomaterials have also increased significantly over the past decade towards traditional as well as innovative next generation Class I, II and III devices. In this review, we have focused our attention towards the use of AM in surface modified biomaterials to enhance their in vitro and in vivo performances. Specifically, we have discussed the use of AM to deliberately modify the surfaces of different classes of biomaterials with spatial specificity in a single manufacturing process as well as commented on the future outlook towards surface modification using AM. It is widely understood that the success of implanted medical devices depends largely on favorable material-tissue interactions. Additive manufacturing has gained traction as a viable and unique approach to engineered biomaterials, for both bulk and surface properties that improve implant outcomes. This review explores how additive manufacturing techniques have been and can be used to augment the surfaces of biomedical devices for direct clinical applications. Copyright © 2017 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.

  9. Building blocks of Collagen based biomaterial devices

    Indian Academy of Sciences (India)

    First page Back Continue Last page Overview Graphics. Building blocks of Collagen based biomaterial devices. Collagen as a protein. Collagen in tissues and organs. Stabilizing and cross linking agents. Immunogenicity. Hosts (drugs). Controlled release mechanisms of hosts. Biodegradability, workability into devices ...

  10. Medical applications for biomaterials in Bolivia

    CERN Document Server

    Arias, Susan

    2015-01-01

    This book investigates the potential medical benefits natural biomaterials can offer in developing countries by analyzing the case of Bolivia. The book explores the medical and health related applications of Bolivian commodities: quinoa, barley, sugarcane, corn, sorghum and sunflower seeds. This book helps readers better understand some of the key health concerns facing countries like Bolivia and how naturally derived biomaterials and therapeutics could help substantially alleviate many of their problems.

  11. Toward biomaterial-based implantable photonic devices

    Directory of Open Access Journals (Sweden)

    Humar Matjaž

    2017-03-01

    Full Text Available Optical technologies are essential for the rapid and efficient delivery of health care to patients. Efforts have begun to implement these technologies in miniature devices that are implantable in patients for continuous or chronic uses. In this review, we discuss guidelines for biomaterials suitable for use in vivo. Basic optical functions such as focusing, reflection, and diffraction have been realized with biopolymers. Biocompatible optical fibers can deliver sensing or therapeutic-inducing light into tissues and enable optical communications with implanted photonic devices. Wirelessly powered, light-emitting diodes (LEDs and miniature lasers made of biocompatible materials may offer new approaches in optical sensing and therapy. Advances in biotechnologies, such as optogenetics, enable more sophisticated photonic devices with a high level of integration with neurological or physiological circuits. With further innovations and translational development, implantable photonic devices offer a pathway to improve health monitoring, diagnostics, and light-activated therapies.

  12. Novel Biomaterials Used in Medical 3D Printing Techniques

    Directory of Open Access Journals (Sweden)

    Karthik Tappa

    2018-02-01

    Full Text Available The success of an implant depends on the type of biomaterial used for its fabrication. An ideal implant material should be biocompatible, inert, mechanically durable, and easily moldable. The ability to build patient specific implants incorporated with bioactive drugs, cells, and proteins has made 3D printing technology revolutionary in medical and pharmaceutical fields. A vast variety of biomaterials are currently being used in medical 3D printing, including metals, ceramics, polymers, and composites. With continuous research and progress in biomaterials used in 3D printing, there has been a rapid growth in applications of 3D printing in manufacturing customized implants, prostheses, drug delivery devices, and 3D scaffolds for tissue engineering and regenerative medicine. The current review focuses on the novel biomaterials used in variety of 3D printing technologies for clinical applications. Most common types of medical 3D printing technologies, including fused deposition modeling, extrusion based bioprinting, inkjet, and polyjet printing techniques, their clinical applications, different types of biomaterials currently used by researchers, and key limitations are discussed in detail.

  13. Novel Biomaterials Used in Medical 3D Printing Techniques.

    Science.gov (United States)

    Tappa, Karthik; Jammalamadaka, Udayabhanu

    2018-02-07

    The success of an implant depends on the type of biomaterial used for its fabrication. An ideal implant material should be biocompatible, inert, mechanically durable, and easily moldable. The ability to build patient specific implants incorporated with bioactive drugs, cells, and proteins has made 3D printing technology revolutionary in medical and pharmaceutical fields. A vast variety of biomaterials are currently being used in medical 3D printing, including metals, ceramics, polymers, and composites. With continuous research and progress in biomaterials used in 3D printing, there has been a rapid growth in applications of 3D printing in manufacturing customized implants, prostheses, drug delivery devices, and 3D scaffolds for tissue engineering and regenerative medicine. The current review focuses on the novel biomaterials used in variety of 3D printing technologies for clinical applications. Most common types of medical 3D printing technologies, including fused deposition modeling, extrusion based bioprinting, inkjet, and polyjet printing techniques, their clinical applications, different types of biomaterials currently used by researchers, and key limitations are discussed in detail.

  14. Medical Devices

    NARCIS (Netherlands)

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

    2004-01-01

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

  15. Medical devices regulations, standards and practices

    CERN Document Server

    Ramakrishna, Seeram; Wang, Charlene

    2015-01-01

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

  16. Bio-tribocorrosion in biomaterials and medical implants

    CERN Document Server

    Yan, Yu

    2013-01-01

    During their service life, most biomaterials and medical implants are vulnerable to tribological damage. In addition, the environments in which they are placed are often corrosive. The combination of triobology, corrosion and the biological environment has been named 'bio-tribocorrosion'. Understanding this complex phenomenon is critical to improving the design and service life of medical implants. This important book reviews recent key research in this area. After an introduction to the topography of bio-tribocorrosion, Part one discusses different types of tribocorrosion including fatigue-corrosion, fretting-corrosion, wear-corrosion and abrasion-corrosion. The book also discusses the prediction of wear in medical devices. Part two looks at biological effects on tribocorrosion processes, including how proteins interact with material surfaces and the evolution of surface changes due to bio-tribocorrosion resulting from biofilms and passive films. Part three reviews the issue of bio-tribocorrosion in clinical...

  17. Logic of Biomaterial devices from CLRI for wound management

    Indian Academy of Sciences (India)

    First page Back Continue Last page Overview Graphics. Logic of Biomaterial devices from CLRI for wound management. Designing of biodegradable scaffolds. Designing the scaffold. Host drugs and growth factors. Design controlled drug release only to the wound area (based on pH differentials). Smartness is built in ...

  18. Novel Biomaterials Used in Medical 3D Printing Techniques

    OpenAIRE

    Karthik Tappa; Udayabhanu Jammalamadaka

    2018-01-01

    The success of an implant depends on the type of biomaterial used for its fabrication. An ideal implant material should be biocompatible, inert, mechanically durable, and easily moldable. The ability to build patient specific implants incorporated with bioactive drugs, cells, and proteins has made 3D printing technology revolutionary in medical and pharmaceutical fields. A vast variety of biomaterials are currently being used in medical 3D printing, including metals, ceramics, polymers, and c...

  19. Marine Structural Biomaterials in Medical Biomimicry.

    Science.gov (United States)

    Green, David W; Lee, Jong-Min; Jung, Han-Sung

    2015-10-01

    Marine biomaterials display properties, behaviors, and functions that have not been artificially matched in relation to their hierarchical construction, crack-stopping properties, growth adaptation, and energy efficiency. The discovery and understanding of such features that are characteristic of natural biomaterials can be used to manufacture more energy-efficient and lightweight materials. However, a more detailed understanding of the design of natural biomaterials with good performance and the mechanism of their design is required. Far-reaching biomolecular characterization of biomaterials and biostructures from the ocean world is possible with sophisticated analytical methods, such as whole-genome RNA-seq, and de novo transcriptome sequencing and mass spectrophotometry-based sequencing. In combination with detailed material characterization, the elements in newly discovered biomaterials and their properties can be reconstituted into biomimetic or bio-inspired materials. A major aim of harnessing marine biomaterials is their translation into biomimetic counterparts. To achieve full translation, the genome, proteome, and hierarchical material characteristics, and their profiles in space and time, have to be associated to allow for smooth biomimetic translation. In this article, we highlight the novel science of marine biomimicry from a materials perspective. We focus on areas of material design and fabrication that have excelled in marine biological models, such as embedded interfaces, chiral organization, and the use of specialized composite material-on-material designs. Our emphasis is primarily on key materials with high value in healthcare in which we evaluate their future prospects. Marine biomaterials are among the most exquisite and powerful aspects in materials science today.

  20. Biomaterials

    NARCIS (Netherlands)

    Van Mourik, P.; Van Dam, J.; Picken, S.J.; Ursem, B.

    2013-01-01

    The metabolic pathways of living organisms produce biomaterials. Hence, in principle biomaterials are fully sustainable. This does not mean that their processing and application have no impact on the environment, e.g. the recycling of natural rubber remains a problem. Biomaterials are applied in a

  1. Biomaterials

    CERN Document Server

    Migonney , Véronique

    2014-01-01

    Discovered in the 20th century, biomaterials have contributed to many of the incredible scientific and technological advancements made in recent decades. This book introduces and details the tenets of biomaterials, their relevance in a various fields, practical applications of their products, and potential advancements of the years to come. A comprehensive resource, the text covers the reasons that certain properties of biomaterials contribute to specific applications, and students and researchers will appreciate this exhaustive textbook.

  2. Medical Device Safety

    Science.gov (United States)

    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 ...

  3. Implantable electronic medical devices

    CERN Document Server

    Fitzpatrick, Dennis

    2014-01-01

    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

  4. Implantable Medical Devices

    Science.gov (United States)

    ... 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 ...

  5. Characterization of biomaterials

    CERN Document Server

    Jaffe, M; Tolias, P; Arinzeh, T

    2012-01-01

    Biomaterials and medical devices must be rigorously tested in the laboratory before they can be implanted. Testing requires the right analytical techniques. Characterization of biomaterials reviews the latest methods for analyzing the structure, properties and behaviour of biomaterials. Beginning with an introduction to microscopy techniques for analyzing the phase nature and morphology of biomaterials, Characterization of biomaterials goes on to discuss scattering techniques for structural analysis, quantitative assays for measuring cell adhesion, motility and differentiation, and the evaluation of cell infiltration and tissue formation using bioreactors. Further topics considered include studying molecular-scale protein-surface interactions in biomaterials, analysis of the cellular genome and abnormalities, and the use of microarrays to measure cellular changes induced by biomaterials. Finally, the book concludes by outlining standards and methods for assessing the safety and biocompatibility of biomaterial...

  6. Medical device development.

    Science.gov (United States)

    Panescu, Dorin

    2009-01-01

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

  7. An overview of development and status of fiber-reinforced composites as dental and medical biomaterials.

    Science.gov (United States)

    Vallittu, Pekka K

    2018-01-01

    Fibr-reinforced composites (FRC) have been used successfully for decades in many fields of science and engineering applications. Benefits of FRCs relate to physical properties of FRCs and versatile production methods, which can be utilized. Conventional hand lamination of prefabricated FRC prepregs is utilized still most commonly in fabrication of dental FRC devices but CAD-CAM systems are to be come for use in certain production steps of dental constructions and medical FRC implants. Although metals, ceramics and particulate filler resin composites have successfully been used as dental and medical biomaterials for decades, devices made out of these materials do not meet all clinical requirements. Only little attention has been paid to FRCs as dental materials and majority of the research in dental field has been focusing on particulate filler resin composites and in medical biomaterial research to biodegradable polymers. This is paradoxical because FRCs can potentially resolve many of the problems related to traditional isotropic dental and medical materials. This overview reviews the rationale and status of using biostable glass FRC in applications from restorative and prosthetic dentistry to cranial surgery. The overview highlights also the critical material based factors and clinical requirement for the succesfull use of FRCs in dental reconstructions.

  8. MDR (Medical Device Reporting)

    Data.gov (United States)

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

  9. The application of radiation technology in the field of medical biomaterials

    International Nuclear Information System (INIS)

    Jin Huanyu; An Yan; Yin Hua

    2011-01-01

    The radiation technology has been applied extensively in the fields of biological engineering, tissue engineering, medical industry and so on. It also plays an important role in the sterilization and modification of biomaterials. This work reviews the development of irradiation technology and absorbed doses for the sterilization and modification of medical biomaterials. (authors)

  10. A Medical Delivery Device

    DEFF Research Database (Denmark)

    2010-01-01

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

  11. Engineering mechanical gradients in next generation biomaterials - Lessons learned from medical textile design.

    Science.gov (United States)

    Ng, Joanna L; Collins, Ciara E; Knothe Tate, Melissa L

    2017-07-01

    Nonwoven and textile membranes have been applied both externally and internally to prescribe boundary conditions for medical conditions as diverse as oedema and tissue defects. Incorporation of mechanical gradients in next generation medical membrane design offers great potential to enhance function in a dynamic, physiological context. Yet the gradient properties and resulting mechanical performance of current membranes are not well described. To bridge this knowledge gap, we tested and compared the mechanical properties of bounding membranes used in both external (compression sleeves for oedema, exercise bands) and internal (surgical membranes) physiological contexts. We showed that anisotropic compression garment textiles, isotropic exercise bands and surgical membranes exhibit similar ranges of resistance to tension under physiologic strains. However, their mechanical gradients and resulting stress-strain relationships show differences in work capacity and energy expenditure. Exercise bands' moduli of elasticity and respective thicknesses allow for controlled, incremental increases in loading to facilitate healing as injured tissues return to normal structure and function. In contrast, the gradients intrinsic to compression sleeve design exhibit gaps in the middle range (1-5N) of physiological strains and also inconsistencies along the length of the sleeve, resulting in less than optimal performance of these devices. These current shortcomings in compression textile and garment design may be addressed in the future through implementation of novel approaches. For example, patterns, fibre compositions, and fibre anisotropy can be incorporated into biomaterial design to achieve seamless mechanical gradients in structure and resulting dynamic function, which would be particularly useful in physiological contexts. These concepts can be applied further to biomaterial design to deliver pressure gradients during movement of oedematous limbs (compression garments) and

  12. Preventing medical device recalls

    CERN Document Server

    Raheja, Dev

    2014-01-01

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

  13. Case outsourcing medical device reprocessing.

    Science.gov (United States)

    Haley, Deborah

    2004-04-01

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

  14. Biomaterials Evaluation: Conceptual Refinements and Practical Reforms.

    Science.gov (United States)

    Masaeli, Reza; Zandsalimi, Kavosh; Tayebi, Lobat

    2018-01-01

    Regarding the widespread and ever-increasing applications of biomaterials in different medical fields, their accurate assessment is of great importance. Hence the safety and efficacy of biomaterials is confirmed only through the evaluation process, the way it is done has direct effects on public health. Although every biomaterial undergoes rigorous premarket evaluation, the regulatory agencies receive a considerable number of complications and adverse event reports annually. The main factors that challenge the process of biomaterials evaluation are dissimilar regulations, asynchrony of biomaterials evaluation and biomaterials development, inherent biases of postmarketing data, and cost and timing issues. Several pieces of evidence indicate that current medical device regulations need to be improved so that they can be used more effectively in the evaluation of biomaterials. This article provides suggested conceptual refinements and practical reforms to increase the efficiency and effectiveness of the existing regulations. The main focus of the article is on strategies for evaluating biomaterials in US, and then in EU.

  15. Power Approaches for Implantable Medical Devices

    Directory of Open Access Journals (Sweden)

    Achraf Ben Amar

    2015-11-01

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

  16. Designing protein-based biomaterials for medical applications.

    Science.gov (United States)

    Gagner, Jennifer E; Kim, Wookhyun; Chaikof, Elliot L

    2014-04-01

    Biomaterials produced by nature have been honed through billions of years, evolving exquisitely precise structure-function relationships that scientists strive to emulate. Advances in genetic engineering have facilitated extensive investigations to determine how changes in even a single peptide within a protein sequence can produce biomaterials with unique thermal, mechanical and biological properties. Elastin, a naturally occurring protein polymer, serves as a model protein to determine the relationship between specific structural elements and desirable material characteristics. The modular, repetitive nature of the protein facilitates the formation of well-defined secondary structures with the ability to self-assemble into complex three-dimensional architectures on a variety of length scales. Furthermore, many opportunities exist to incorporate other protein-based motifs and inorganic materials into recombinant protein-based materials, extending the range and usefulness of these materials in potential biomedical applications. Elastin-like polypeptides (ELPs) can be assembled into 3-D architectures with precise control over payload encapsulation, mechanical and thermal properties, as well as unique functionalization opportunities through both genetic and enzymatic means. An overview of current protein-based materials, their properties and uses in biomedicine will be provided, with a focus on the advantages of ELPs. Applications of these biomaterials as imaging and therapeutic delivery agents will be discussed. Finally, broader implications and future directions of these materials as diagnostic and therapeutic systems will be explored. Copyright © 2013 Elsevier Ltd. All rights reserved.

  17. Engineering of biomaterials

    CERN Document Server

    dos Santos, Venina; Savaris, Michele

    2017-01-01

    This book focuses on biomaterials of different forms used for medical implants. The authors introduce the characteristics and properties of biomaterials and then dedicate special chapters to metallic, ceramic, polymeric and composite biomaterials. Case studies on sterilization methods by biomaterials are also presented. Finally, the authors describe the degradation and effects of biomaterials in living tissue.

  18. Human Factors and Medical Devices

    International Nuclear Information System (INIS)

    Dick Sawyer

    1998-01-01

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

  19. Surgical tools and medical devices

    CERN Document Server

    Jackson, Mark

    2016-01-01

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

  20. Oscillatory device for use with linear tribometer, for tribological evaluation of biomaterials

    Science.gov (United States)

    Athayde, J. N.; Siqueira, C. J. M.; Kuromoto, N. K.; Cambraia, H. N.

    2017-07-01

    Orthopedic implants still have limitations regarding their durability, despite being in use for over fifty years. Particles arising from wear due to the relative motion of their surfaces remain responsible for aseptic failure. This paper presents a device to be coupled with a reciprocal linear tribometer to reproduce the ex vivo wear of biomaterials, allowing the measurement of force and coefficient of friction. The device consists of a structure connected to the tribometer that transforms its reciprocal linear motion into one that is oscillatory for the mechanical assembly that contains the samples to test the desired biomaterials. The tribological pair used for testing consisted of Ultra High Molecular Weight Polyethylene (UHMWPE) in conjunction with the austenitic stainless steel AISI 316L in dry lubrication. The results showed that the values of the coefficient of friction in the linear mode and oscillatory mode and the UHMWPE life curve in the oscillatory mode were consistent with those cited in the literature for tests in a dry lubrication environment. Moreover, the UHMWPE sample life curve showed a reduction in the wear rate that can be explained by the preponderance of a wear mechanism over the others. The volumetric wear showed an increase with the number of cycles.

  1. Body Implanted Medical Device Communications

    Science.gov (United States)

    Yazdandoost, Kamya Yekeh; Kohno, Ryuji

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

  2. Medical device market in China.

    Science.gov (United States)

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

    2015-06-01

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

  3. Medical devices and human engineering

    CERN Document Server

    Bronzino, Joseph D

    2014-01-01

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

  4. Radiation sterilization of medical devices

    International Nuclear Information System (INIS)

    Kaluska, I.; Stuglik, Z.

    1996-01-01

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

  5. Assurance Cases for Medical Devices

    Science.gov (United States)

    2011-04-28

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

  6. Inspiration and application in the evolution of biomaterials

    OpenAIRE

    Huebsch, Nathaniel; Mooney, David J.

    2009-01-01

    Biomaterials, traditionally defined as materials used in medical devices, have been used since antiquity, but recently their degree of sophistication has increased significantly. Biomaterials made today are routinely information rich and incorporate biologically active components derived from nature. In the future, biomaterials will assume an even greater role in medicine and will find use in a wide variety of non-medical applications through biologically inspired design and incorporation of ...

  7. Inspiration and application in the evolution of biomaterials.

    Science.gov (United States)

    Huebsch, Nathaniel; Mooney, David J

    2009-11-26

    Biomaterials, traditionally defined as materials used in medical devices, have been used since antiquity, but recently their degree of sophistication has increased significantly. Biomaterials made today are routinely information rich and incorporate biologically active components derived from nature. In the future, biomaterials will assume an even greater role in medicine and will find use in a wide variety of non-medical applications through biologically inspired design and incorporation of dynamic behaviour.

  8. MEDIC: medical embedded device for individualized care.

    Science.gov (United States)

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

    2008-02-01

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

  9. [Consideration of Mobile Medical Device Regulation].

    Science.gov (United States)

    Peng, Liang; Yang, Pengfei; He, Weigang

    2015-07-01

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

  10. The Biological Responses to Magnesium-Based Biodegradable Medical Devices

    Directory of Open Access Journals (Sweden)

    Lumei Liu

    2017-11-01

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

  11. Metrological Reliability of Medical Devices

    Science.gov (United States)

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

    2015-02-01

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

  12. Innate Immunity and Biomaterials at the Nexus: Friends or Foes

    OpenAIRE

    Christo, Susan N.; Diener, Kerrilyn R.; Bachhuka, Akash; Vasilev, Krasimir; Hayball, John D.

    2015-01-01

    Biomaterial implants are an established part of medical practice, encompassing a broad range of devices that widely differ in function and structural composition. However, one common property amongst biomaterials is the induction of the foreign body response: an acute sterile inflammatory reaction which overlaps with tissue vascularisation and remodelling and ultimately fibrotic encapsulation of the biomaterial to prevent further interaction with host tissue. Severity and clinical manifestati...

  13. [Medical Devices Law for pain therapists].

    Science.gov (United States)

    Regner, M; Sabatowski, R

    2016-08-01

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

  14. On the nature of biomaterials.

    Science.gov (United States)

    Williams, David F

    2009-10-01

    The situations in which biomaterials are currently used are vastly different to those of just a decade ago. Although implantable medical devices are still immensely important, medical technologies now encompass a range of drug and gene delivery systems, tissue engineering and cell therapies, organ printing and cell patterning, nanotechnology based imaging and diagnostic systems and microelectronic devices. These technologies still encompass metals, ceramics and synthetic polymers, but also biopolymers, self assembled systems, nanoparticles, carbon nanotubes and quantum dots. These changes imply that our original concepts of biomaterials and our expectations of their performance also have to change. This Leading Opinion Paper addresses these issues. It concludes that many substances which hitherto we may not have thought of as biomaterials should now be considered as such so that, alongside the traditional structural biomaterials, we have substances that have been engineered to perform functions within health care where their performance is directly controlled by interactions with tissues and tissue components. These include engineered tissues, cells, organs and even viruses. This essay develops the arguments for a radically different definition of a biomaterial.

  15. Medical device software: defining key terms.

    Science.gov (United States)

    Pashkov, Vitalii; Gutorova, Nataliya; Harkusha, Andrii

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

  16. 21 CFR 892.2040 - Medical image hardcopy device.

    Science.gov (United States)

    2010-04-01

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

  17. Classification and evaluation of medical devices

    Directory of Open Access Journals (Sweden)

    Edina Vranić

    2003-05-01

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

  18. Medical device reliability and associated areas

    National Research Council Canada - National Science Library

    Dhillon, Balbir S

    2000-01-01

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

  19. Class 1 devices case studies in medical devices design

    CERN Document Server

    Ogrodnik, Peter J

    2014-01-01

    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...

  20. A novel method for improving chest tube insertion skills among medical interns. Using biomaterial-covered mannequin

    Directory of Open Access Journals (Sweden)

    Ozgur Tatli

    2017-10-01

    Full Text Available Objectives: To develop a low-cost biomaterial-covered chest tube simulation model and assess its possible usefulness for developing the chest tube insertion skills among medical interns. Methods: This mannequin-based interventional study was performed in a University hospital setting. We included 63 physicians performing emergency medicine internship at the Faculty of Medicine, Karadeniz Technical University, Trabzon, Turkey, between January 2015 and March 2015. A dummy was prepared for training simulation using a display mannequin. Medical interns received instruction concerning pneumothorax and the chest tube procedure. A total of 63 medical interns participating in this interventional study were asked to insert a chest tube in a biomaterial-covered mannequin. A senior trainee scored their performance using a check list and the mean of the total scores was calculated (21 items; total score, 42. Results: The mean procedural score was 40.9 ± 1.3 of a possible 42. The maximum score of 42 was achieved by 39.7% of the medical interns, while another 33.3% achieved a score of 41. Of the participants, 85% succeeded in inserting the tube via an appropriate technique, achieving a score of 40 or more. Conclusion: Our results indicated that this model could be useful for effective training of medical interns for chest tube insertion, which is an important skill in emergency medicine. This biomaterial-covered model is inexpensive and its use can potentially be widened to improve training methods without significant financial demand.

  1. A novel method for improving chest tube insertion skills among medical interns. Using biomaterial-covered mannequin.

    Science.gov (United States)

    Tatli, Ozgur; Turkmen, Suha; Imamoglu, Melih; Karaca, Yunus; Cicek, Mustafa; Yadigaroglu, Metin; Bayrak, Selen T; Asik, Olgun; Topbas, Murat; Turedi, Suleyman

    2017-10-01

    To develop a low-cost biomaterial-covered chest tube simulation model and assess its possible usefulness for developing the chest tube insertion skills among medical interns. Methods: This mannequin-based interventional study was performed in a University hospital setting. We included 63 physicians performing emergency medicine internship at the Faculty of Medicine, Karadeniz Technical University, Trabzon, Turkey, between January 2015 and March 2015. A dummy was prepared for training simulation using a display mannequin. Medical interns received instruction concerning pneumothorax and the chest tube procedure. A total of 63 medical interns participating in this interventional study were asked to insert a chest tube in a biomaterial-covered mannequin. A senior trainee scored their performance using a check list and the mean of the total scores was calculated (21 items; total score, 42). Results: The mean procedural score was 40.9 ± 1.3 of a possible 42. The maximum score of 42 was achieved by 39.7% of the medical interns, while another 33.3% achieved a score of 41. Of the participants, 85% succeeded in inserting the tube via an appropriate technique, achieving a score of 40 or more. Conclusion: Our results indicated that this model could be useful for effective training of medical interns for chest tube insertion, which is an important skill in emergency medicine. This biomaterial-covered model is inexpensive and its use can potentially be widened to improve training methods without significant financial demand.

  2. Anti-malware software and medical devices.

    Science.gov (United States)

    2010-10-01

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

  3. 77 FR 72924 - Taxable Medical Devices

    Science.gov (United States)

    2012-12-07

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

  4. INTERFACE ELECTRONIC MEDICAL CARD ON MOBILE DEVICE

    Directory of Open Access Journals (Sweden)

    Y. L. Nechyporenko

    2013-05-01

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

  5. Contextual inquiry for medical device design

    CERN Document Server

    Privitera, Mary Beth

    2015-01-01

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

  6. Engineering Biomaterials to Integrate and Heal: The Biocompatibility Paradigm Shifts

    Science.gov (United States)

    Bryers, James D.; Giachelli, Cecilia M.; Ratner, Buddy D.

    2012-01-01

    This article focuses on one of the major failure routes of implanted medical devices, the foreign body reaction (FBR)—that is, the phagocytic attack and encapsulation by the body of the so-called “biocompatible” biomaterials comprising the devices. We then review strategies currently under development that might lead to biomaterial constructs that will harmoniously heal and integrate into the body. We discuss in detail emerging strategies to inhibit the FBR by engineering biomaterials that elicit more biologically pertinent responses. PMID:22592568

  7. Mobile medical device connectivity: real world solutions.

    Science.gov (United States)

    Pettus, Dan

    2004-01-01

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

  8. Biomaterials for MEMS

    CERN Document Server

    Chiao, Mu

    2011-01-01

    This book serves as a guide for practicing engineers, researchers, and students interested in MEMS devices that use biomaterials and biomedical applications. It is also suitable for engineers and researchers interested in MEMS and its applications but who do not have the necessary background in biomaterials.Biomaterials for MEMS highlights important features and issues of biomaterials that have been used in MEMS and biomedical areas. Hence this book is an essential guide for MEMS engineers or researchers who are trained in engineering institutes that do not provide the background or knowledge

  9. Home Healthcare Medical Devices: A Checklist

    Science.gov (United States)

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

  10. BIOANALYTICAL STANDARDIZING FOR SEROLOGICAL DIAGNOSTIC MEDICAL DEVICES

    OpenAIRE

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

    2015-01-01

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

  11. Medical device-related pressure ulcers

    Directory of Open Access Journals (Sweden)

    Black JM

    2016-08-01

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

  12. Use of mobile devices for medical imaging.

    Science.gov (United States)

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

    2014-12-01

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

  13. Medical simulator with injection device

    NARCIS (Netherlands)

    2011-01-01

    medical simulator 611 comprises a vessel 609 representing a simulated blood vessel. The vessel comprises a simulated vessel wall capable of being punctured by an electrically conductive injection needle 503. The vessel wall comprises a first electrically conductive layer for closing an electric

  14. 2010 Panel on the Biomaterials Grand Challenges

    Science.gov (United States)

    Reichert, William “Monty”; Ratner, Buddy D.; Anderson, James; Coury, Art; Hoffman, Allan S.; Laurencin, Cato T.; Tirrell, David

    2014-01-01

    In 2009, the National Academy for Engineering issued the Grand Challenges for Engineering in the 21st Century comprised of 14 technical challenges that must be addressed to build a healthy, profitable, sustainable, and secure global community (http://www.engineeringchallenges.org). Although crucial, none of the NEA Grand Challenges adequately addressed the challenges that face the biomaterials community. In response to the NAE Grand Challenges, Monty Reichert of Duke University organized a panel entitled Grand Challenges in Biomaterials at the at the 2010 Society for Biomaterials Annual Meeting in Seattle. Six members of the National Academies—Buddy Ratner, James Anderson, Allan Hoffman, Art Coury, Cato Laurencin, and David Tirrell—were asked to propose a grand challenge to the audience that, if met, would significantly impact the future of biomaterials and medical devices. Successfully meeting these challenges will speed the 60-plus year transition from commodity, off-the-shelf biomaterials to bioengineered chemistries, and biomaterial devices that will significantly advance our ability to address patient needs and also to create new market opportunities. PMID:21171147

  15. Handheld Diagnostic Device Delivers Quick Medical Readings

    Science.gov (United States)

    2014-01-01

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

  16. 78 FR 18233 - Medical Devices; Technical Amendment

    Science.gov (United States)

    2013-03-26

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

  17. Medical ice slurry production device

    Science.gov (United States)

    Kasza, Kenneth E [Palos Park, IL; Oras, John [Des Plaines, IL; Son, HyunJin [Naperville, IL

    2008-06-24

    The present invention relates to an apparatus for producing sterile ice slurries for medical cooling applications. The apparatus is capable of producing highly loaded slurries suitable for delivery to targeted internal organs of a patient, such as the brain, heart, lungs, stomach, kidneys, pancreas, and others, through medical size diameter tubing. The ice slurry production apparatus includes a slurry production reservoir adapted to contain a volume of a saline solution. A flexible membrane crystallization surface is provided within the slurry production reservoir. The crystallization surface is chilled to a temperature below a freezing point of the saline solution within the reservoir such that ice particles form on the crystallization surface. A deflector in the form of a reciprocating member is provided for periodically distorting the crystallization surface and dislodging the ice particles which form on the crystallization surface. Using reservoir mixing the slurry is conditioned for easy pumping directly out of the production reservoir via medical tubing or delivery through other means such as squeeze bottles, squeeze bags, hypodermic syringes, manual hand delivery, and the like.

  18. Titanium-Based Biomaterials for Preventing Stress Shielding between Implant Devices and Bone

    Directory of Open Access Journals (Sweden)

    M. Niinomi

    2011-01-01

    Full Text Available β-type titanium alloys with low Young's modulus are required to inhibit bone atrophy and enhance bone remodeling for implants used to substitute failed hard tissue. At the same time, these titanium alloys are required to have high static and dynamic strength. On the other hand, metallic biomaterials with variable Young's modulus are required to satisfy the needs of both patients and surgeons, namely, low and high Young's moduli, respectively. In this paper, we have discussed effective methods to improve the static and dynamic strength while maintaining low Young's modulus for β-type titanium alloys used in biomedical applications. Then, the advantage of low Young's modulus of β-type titanium alloys in biomedical applications has been discussed from the perspective of inhibiting bone atrophy and enhancing bone remodeling. Further, we have discussed the development of β-type titanium alloys with a self-adjusting Young's modulus for use in removable implants.

  19. Infection resistance of degradable versus non-degradable biomaterials : An assessment of the potential mechanisms

    NARCIS (Netherlands)

    Daghighi, Seyedmojtaba; Sjollema, Jelmer; van der Mei, Henny C.; Busscher, Henk J.; Rochford, Edward T. J.

    Extended life expectancy and medical development has led to an increased reliance on biomaterial implants and devices to support or restore human anatomy and function. However, the presence of an implanted biomaterial results in an increased susceptibility to infection. Due to the severity of the

  20. Medical instruments and devices principles and practices

    CERN Document Server

    Schreiner, Steven; Peterson, Donald R

    2015-01-01

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

  1. International Standards for Radiation Sterilization of Medical Devices

    International Nuclear Information System (INIS)

    Miller, A.

    2007-01-01

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

  2. Biomaterials science an introduction to materials in medicine

    CERN Document Server

    Ratner, Buddy D; Lemons, Jack E; Yaszemski, Michael J; Yaszemski, Michael

    2004-01-01

    The second edition of this bestselling title provides the most up-to-date comprehensive review of all aspects of biomaterials science by providing a balanced, insightful approach to learning biomaterials. This reference integrates a historical perspective of materials engineering principles with biological interactions of biomaterials. Also provided within are regulatory and ethical issues in addition to future directions of the field, and a state-of-the-art update of medical and biotechnological applications. All aspects of biomaterials science are thoroughly addressed, from tissue engineering to cochlear prostheses and drug delivery systems. Over 80 contributors from academia, government and industry detail the principles of cell biology, immunology, and pathology. Focus within pertains to the clinical uses of biomaterials as components in implants, devices, and artificial organs. This reference also touches upon their uses in biotechnology as well as the characterization of the physical, chemical, biochemi...

  3. Modelling degradation of bioresorbable polymeric medical devices

    CERN Document Server

    Pan, J

    2015-01-01

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

  4. Biomaterials for artificial organs

    CERN Document Server

    Lysaght, Michael J

    2010-01-01

    The worldwide demand for organ transplants far exceeds available donor organs. Consequently some patients die whilst waiting for a transplant. Synthetic alternatives are therefore imperative to improve the quality of, and in some cases, save people's lives. Advances in biomaterials have generated a range of materials and devices for use either outside the body or through implantation to replace or assist functions which may have been lost through disease or injury. Biomaterials for artificial organs reviews the latest developments in biomaterials and investigates how they can be used to improve the quality and efficiency of artificial organs. Part one discusses commodity biomaterials including membranes for oxygenators and plasmafilters, titanium and cobalt chromium alloys for hips and knees, polymeric joint-bearing surfaces for total joint replacements, biomaterials for pacemakers, defibrillators and neurostimulators and mechanical and bioprosthetic heart valves. Part two goes on to investigate advanced and ...

  5. Biomaterials and their applications

    Science.gov (United States)

    Sharma, Anu; Sharma, Gayatri

    2018-05-01

    There is a growing demand for novel biomaterials for the replacement and repairing of soft and hard tissues such as bones, cartilage and blood vessels, decaying teeth, arthritic hips, injured tissues or even entire organs. The main aim of biomaterial research is to find the appropriate combination of chemical and physical properties matched with tissues replaced in the host. It improves the quality of life. On increasing number of people each year with increasing demands on these materials with higher expectations related to quality of life arising from an aging population. Now a day there is an ever-increasing search for novel biomaterials as the material requirements for complex biomedical devices increases with time. Many materials such as metals, ceramics, polymers, and glasses are being investigated as biomaterials. They are very useful in various fields due to their excellent bioactivity and biocompatibility. This paper includes various eco-friendly biomaterials and their application in various fields.

  6. Medical applications for pharmacists using mobile devices.

    Science.gov (United States)

    Aungst, Timothy Dy

    2013-01-01

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

  7. 77 FR 6028 - Taxable Medical Devices

    Science.gov (United States)

    2012-02-07

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

  8. Electronic medical devices: a primer for pathologists.

    Science.gov (United States)

    Weitzman, James B

    2003-07-01

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

  9. Medical devices for the anesthetist: current perspectives

    Directory of Open Access Journals (Sweden)

    Ingrande J

    2014-03-01

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

  10. Value-based purchasing of medical devices.

    Science.gov (United States)

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

    2012-04-01

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

  11. Identification of proteins involved in the adhesionof Candida species to different medical devices.

    Science.gov (United States)

    Núñez-Beltrán, Arianna; López-Romero, Everardo; Cuéllar-Cruz, Mayra

    2017-06-01

    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.

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

    Science.gov (United States)

    Cao, Shaoping; Yin, Chunguang; Zhao, Zhenying

    2013-03-01

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

  13. BIOANALYTICAL STANDARDIZING FOR SEROLOGICAL DIAGNOSTIC MEDICAL DEVICES

    Directory of Open Access Journals (Sweden)

    A. Yu. Galkin

    2015-04-01

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

  14. Open-source hardware for medical devices.

    Science.gov (United States)

    Niezen, Gerrit; Eslambolchilar, Parisa; Thimbleby, Harold

    2016-04-01

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

  15. Innate Immunity and Biomaterials at the Nexus: Friends or Foes.

    Science.gov (United States)

    Christo, Susan N; Diener, Kerrilyn R; Bachhuka, Akash; Vasilev, Krasimir; Hayball, John D

    2015-01-01

    Biomaterial implants are an established part of medical practice, encompassing a broad range of devices that widely differ in function and structural composition. However, one common property amongst biomaterials is the induction of the foreign body response: an acute sterile inflammatory reaction which overlaps with tissue vascularisation and remodelling and ultimately fibrotic encapsulation of the biomaterial to prevent further interaction with host tissue. Severity and clinical manifestation of the biomaterial-induced foreign body response are different for each biomaterial, with cases of incompatibility often associated with loss of function. However, unravelling the mechanisms that progress to the formation of the fibrotic capsule highlights the tightly intertwined nature of immunological responses to a seemingly noncanonical "antigen." In this review, we detail the pathways associated with the foreign body response and describe possible mechanisms of immune involvement that can be targeted. We also discuss methods of modulating the immune response by altering the physiochemical surface properties of the biomaterial prior to implantation. Developments in these areas are reliant on reproducible and effective animal models and may allow a "combined" immunomodulatory approach of adapting surface properties of biomaterials, as well as treating key immune pathways to ultimately reduce the negative consequences of biomaterial implantation.

  16. Innate Immunity and Biomaterials at the Nexus: Friends or Foes

    Directory of Open Access Journals (Sweden)

    Susan N. Christo

    2015-01-01

    Full Text Available Biomaterial implants are an established part of medical practice, encompassing a broad range of devices that widely differ in function and structural composition. However, one common property amongst biomaterials is the induction of the foreign body response: an acute sterile inflammatory reaction which overlaps with tissue vascularisation and remodelling and ultimately fibrotic encapsulation of the biomaterial to prevent further interaction with host tissue. Severity and clinical manifestation of the biomaterial-induced foreign body response are different for each biomaterial, with cases of incompatibility often associated with loss of function. However, unravelling the mechanisms that progress to the formation of the fibrotic capsule highlights the tightly intertwined nature of immunological responses to a seemingly noncanonical “antigen.” In this review, we detail the pathways associated with the foreign body response and describe possible mechanisms of immune involvement that can be targeted. We also discuss methods of modulating the immune response by altering the physiochemical surface properties of the biomaterial prior to implantation. Developments in these areas are reliant on reproducible and effective animal models and may allow a “combined” immunomodulatory approach of adapting surface properties of biomaterials, as well as treating key immune pathways to ultimately reduce the negative consequences of biomaterial implantation.

  17. 78 FR 68853 - International Medical Device Regulators Forum; Medical Device Single Audit Program International...

    Science.gov (United States)

    2013-11-15

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

  18. Bio-based hyperbranched polyurethane/Fe3O4 nanocomposites: smart antibacterial biomaterials for biomedical devices and implants

    International Nuclear Information System (INIS)

    Das, Beauty; Karak, Niranjan; Mandal, Manabendra; Upadhyay, Aadesh; Chattopadhyay, Pronobesh

    2013-01-01

    The fabrication of a smart magnetically controllable bio-based polymeric nanocomposite (NC) has immense potential in the biomedical domain. In this context, magneto-thermoresponsive sunflower oil modified hyperbranched polyurethane (HBPU)/Fe 3 O 4 NCs with different wt.% of magnetic nanoparticles (Fe 3 O 4 ) were prepared by an in situ polymerization technique. Fourier-transform infrared, x-ray diffraction, vibrating sample magnetometer, scanning electron microscope, transmission electron microscope, thermal analysis and differential scanning calorimetric were used to analyze various physico-chemical structural attributes of the prepared NC. The results showed good interfacial interactions between HBPU and well-dispersed superparamagnetic Fe 3 O 4 , with an average diameter of 7.65 nm. The incorporation of Fe 3 O 4 in HBPU significantly improved the thermo-mechanical properties along with the shape-memory behavior, antibacterial activity, biocompatibility as well as biodegradability in comparison to the pristine system. The cytocompatibility of the degraded products of the NC was also verified by in vitro hemolytic activity and MTT assay. In addition, the in vivo biocompatibility and non-immunological behavior, as tested in Wistar rats after subcutaneous implantation, show promising signs for the NC to be used as antibacterial biomaterial for biomedical device and implant applications. (paper)

  19. Biomaterials a basic introduction

    CERN Document Server

    Chen, Qizhi

    2014-01-01

    Part IBiomaterials ScienceBiomaterials Science and EngineeringLearning ObjectivesMaterials Science and EngineeringMultilevels of Structure and Categorization of MaterialsFour Categories of MaterialsDefinitions of Biomaterials, Biomedical Materials, and Biological MaterialsBiocompatibilityChapter HighlightsActivitiesSimple Questions in ClassProblems and ExercisesBibliographyToxicity and CorrosionLearning ObjectivesElements in the BodyBiological Roles and Toxicities of Trace ElementsSelection of Metallic Elements in Medical-Grade AlloysCorrosion of MetalsEnvironment inside the BodyMinimization of Toxicity of Metal ImplantsChapter HighlightsLaboratory Practice 1Simple Questions in ClassProblems and ExercisesAdvanced Topic: Biological Roles of Alloying ElementsBibliographyMechanical Properties of BiomaterialsLearning ObjectivesRole of Implant BiomaterialsMechanical Properties of General ImportanceHardnessElasticity: Resilience and StrechabilityMechanical Properties Terms Used in the Medical CommunityFailureEssent...

  20. Implantable Medical Devices; Networking Security Survey

    OpenAIRE

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

    2016-01-01

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

  1. Initiatives in the Australian Medical Devices Industry

    International Nuclear Information System (INIS)

    Whelan, Luke

    2005-01-01

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

  2. Stretchable bioelectronics for medical devices and systems

    CERN Document Server

    Ghaffari, Roozbeh; Kim, Dae-Hyeong

    2016-01-01

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

  3. Prospects of radiation sterilization of medical devices

    International Nuclear Information System (INIS)

    Hosobuchi, Kazunari

    1992-01-01

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

  4. Implantable Medical Devices; Networking Security Survey

    Directory of Open Access Journals (Sweden)

    Siamak Aram

    2016-08-01

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

  5. FUNCTIONAL BIOMATERIALS: Design of Novel Biomaterials

    Science.gov (United States)

    Sakiyama-Elbert, Se; Hubbell, Ja

    2001-08-01

    The field of biomaterials has recently been focused on the design of intelligent materials. Toward this goal, materials have been developed that can provide specific bioactive signals to control the biological environment around them during the process of materials integration and wound healing. In addition, materials have been developed that can respond to changes in their environment, such as a change in pH or cell-associated enzymatic activity. In designing such novel biomaterials, researchers have sought not merely to create bio-inert materials, but rather materials that can respond to the cellular environment around them to improve device integration and tissue regeneration.

  6. 78 FR 21129 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2013-04-09

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

  7. Hacking medical devices a review - biomed 2013.

    Science.gov (United States)

    Frenger, Paul

    2013-01-01

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

  8. 76 FR 7220 - Medical Device Innovation Initiative; Request for Comments

    Science.gov (United States)

    2011-02-09

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

  9. Medical applications of superconducting quantum interference devices

    International Nuclear Information System (INIS)

    Uehara, Gen

    2011-01-01

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

  10. Design controls for the medical device industry

    CERN Document Server

    Teixeira, Marie B

    2013-01-01

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

  11. Practical design control implementation for medical devices

    CERN Document Server

    Justiniano, Jose

    2003-01-01

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

  12. Analytical Chemistry in the Regulatory Science of Medical Devices.

    Science.gov (United States)

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

    2018-06-12

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

  13. 77 FR 18829 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2012-03-28

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

  14. 76 FR 71983 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2011-11-21

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

  15. 75 FR 57968 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2010-09-23

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

  16. 78 FR 26786 - Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-05-08

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

  17. 76 FR 48871 - Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-08-09

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

  18. 76 FR 55398 - Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of...

    Science.gov (United States)

    2011-09-07

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

  19. A Radially Organized Multipatterned Device as a Diagnostic Tool for the Screening of Topographies in Tissue Engineering Biomaterials

    NARCIS (Netherlands)

    Babo, P.S.; Klymov, A.; Riet, J. te; Reis, R.L.; Jansen, J.A.; Gomes, M.E.; Walboomers, X.F.

    2016-01-01

    Micro- and nanotextured biomaterial surfaces have been widely studied for their capacity to drive the regeneration of organized tissues. Nanotopographical features in the shape of groove-ridge patterns aim at mimicking the extracellular matrix organization. However, to date, a wide array of groove

  20. Security and privacy for implantable medical devices

    CERN Document Server

    Carrara, Sandro

    2014-01-01

     This book presents a systematic approach to analyzing the challenging engineering problems posed by the need for security and privacy in implantable medical devices (IMD).  It describes in detail new issues termed as lightweight security, due to the associated constraints on metrics such as available power, energy, computing ability, area, execution time, and memory requirements. Coverage includes vulnerabilities and defense across multiple levels, with basic abstractions of cryptographic services and primitives such as public key cryptography, block ciphers and digital signatures. Experts from engineering introduce to some IMD systems that have  recently been proposed and developed. Experts from Computer Security and Cryptography present new research, which shows vulnerabilities in existing IMDs and proposes solutions. Experts from Privacy Technology and Policy will discuss the societal, legal and ethical challenges surrounding IMD security as well as technological solutions that build on the latest in C...

  1. On the impact of medical device regulations on software architecture

    DEFF Research Database (Denmark)

    Hansen, Klaus Marius; Manikas, Konstantinos

    2016-01-01

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

  2. Smart biomaterials

    CERN Document Server

    Ebara, Mitsuhiro; Narain, Ravin; Idota, Naokazu; Kim, Young-Jin; Hoffman, John M; Uto, Koichiro; Aoyagi, Takao

    2014-01-01

    This book surveys smart biomaterials, exploring the properties, mechanics and characterization of hydrogels, particles, assemblies, surfaces, fibers and conjugates. Reviews applications such as drug delivery, tissue engineering, bioseparation and more.

  3. 78 FR 68714 - Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug

    Science.gov (United States)

    2013-11-15

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

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

    Science.gov (United States)

    Raths, David

    2009-02-01

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

  5. Legislative aspects of the development of medical devices.

    Science.gov (United States)

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

    2015-09-01

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

  6. An update on mobile phones interference with medical devices

    International Nuclear Information System (INIS)

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

    2013-01-01

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

  7. An update on mobile phones interference with medical devices.

    Science.gov (United States)

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

    2013-10-01

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

  8. Biomaterials and therapeutic applications

    Science.gov (United States)

    Ferraro, Angelo

    2016-03-01

    A number of organic and inorganic, synthetic or natural derived materials have been classified as not harmful for the human body and are appropriate for medical applications. These materials are usually named biomaterials since they are suitable for introduction into living human tissues of prosthesis, as well as for drug delivery, diagnosis, therapies, tissue regeneration and many other clinical applications. Recently, nanomaterials and bioabsorbable polymers have greatly enlarged the fields of application of biomaterials attracting much more the attention of the biomedical community. In this review paper I am going to discuss the most recent advances in the use of magnetic nanoparticles and biodegradable materials as new biomedical tools.

  9. Real-time in vivo detection of biomaterial-induced reactive oxygen species

    OpenAIRE

    Liu, Wendy F.; Ma, Minglin; Bratlie, Kaitlin M.; Dang, Tram T.; Langer, Robert; Anderson, Daniel G.

    2010-01-01

    The non-specific host response to implanted biomaterials is often a key challenge of medical device design. To evaluate biocompatibility, measuring the release of reactive oxygen species (ROS) produced by inflammatory cells in response to biomaterial surfaces is a well-established method. However, the detection of ROS in response to materials implanted in vivo has not yet been demonstrated. Here, we develop a bioluminescence whole animal imaging approach to observe ROS released in response to...

  10. Analysis of medical device materials with the local electrode atom probe

    International Nuclear Information System (INIS)

    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.

    2004-01-01

    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)

  11. Bone substitute biomaterials

    CERN Document Server

    Mallick, K

    2014-01-01

    Bone substitute biomaterials are fundamental to the biomedical sector, and have recently benefitted from extensive research and technological advances aimed at minimizing failure rates and reducing the need for further surgery. This book reviews these developments, with a particular focus on the desirable properties for bone substitute materials and their potential to encourage bone repair and regeneration. Part I covers the principles of bone substitute biomaterials for medical applications. One chapter reviews the quantification of bone mechanics at the whole-bone, micro-scale, and non-scale levels, while others discuss biomineralization, osteoductivization, materials to fill bone defects, and bioresorbable materials. Part II focuses on biomaterials as scaffolds and implants, including multi-functional scaffolds, bioceramics, and titanium-based foams. Finally, Part III reviews further materials with the potential to encourage bone repair and regeneration, including cartilage grafts, chitosan, inorganic poly...

  12. Role of Plasma Fibronectin in the Foreign Body Response to Biomaterials

    OpenAIRE

    Keselowsky, Benjamin G.; Bridges, Amanda W.; Burns, Kellie L.; Tate, Ciara C.; Babensee, Julia E.; LaPlaca, Michelle C.; García, Andrés J.

    2007-01-01

    Host responses to biomaterials control the biological performance of implanted medical devices. Upon implantation, synthetic materials adsorb biomolecules which trigger an inflammatory cascade comprising coagulation, leukocyte recruitment/adhesion, and foreign body reaction. The foreign body reaction and ensuing fibrous encapsulation severely limit the in vivo performance of numerous biomedical devices. While it is well established that plasma fibrinogen and secreted cytokines modulate leukoc...

  13. Wettability and surface free energy of polarised ceramic biomaterials

    International Nuclear Information System (INIS)

    Nakamura, Miho; Hori, Naoko; Namba, Saki; Yamashita, Kimihiro; Toyama, Takeshi; Nishimiya, Nobuyuki

    2015-01-01

    The surface modification of ceramic biomaterials used for medical devices is expected to improve osteoconductivity through control of the interfaces between the materials and living tissues. Polarisation treatment induced surface charges on hydroxyapatite, β-tricalcium phosphate, carbonate-substituted hydroxyapatite and yttria-stabilized zirconia regardless of the differences in the carrier ions participating in the polarisation. Characterization of the surfaces revealed that the wettability of the polarised ceramic biomaterials was improved through the increase in the surface free energies compared with conventional ceramic surfaces. (note)

  14. 78 FR 15878 - Taxable Medical Devices; Correction

    Science.gov (United States)

    2013-03-13

    ...--MANUFATURERS AND RETAILERS EXCISE TAXES 0 Paragraph 1. The authority citation for part 48 continues to read in... device. * * * * * (b) * * * (2) * * * A device will be considered to be of a type that is generally..., the mobile x-ray systems are not devices that are of a type that are generally purchased by the...

  15. 77 FR 69488 - Medical Devices; Custom Devices; Request for Comments

    Science.gov (United States)

    2012-11-19

    ... strategy and policy for the custom device exemption criteria in the FD&C Act amended by FDASIA. FDA is... States in finished form through labeling or advertising by the manufacturer, importer, or distributor for...

  16. Cybersecurity and the Medical Device Product Development Lifecycle.

    Science.gov (United States)

    Jones, Richard W; Katzis, Konstantinos

    2017-01-01

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

  17. Towards sustainable design for single-use medical devices.

    Science.gov (United States)

    Hanson, Jacob J; Hitchcock, Robert W

    2009-01-01

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

  18. Model-based engineering for medical-device software.

    Science.gov (United States)

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

    2010-01-01

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

  19. Cybersecurity and medical devices: A practical guide for cardiac electrophysiologists

    Science.gov (United States)

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

    2017-01-01

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

  20. Medical Device Integration Model Based on the Internet of Things

    Science.gov (United States)

    Hao, Aiyu; Wang, Ling

    2015-01-01

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

  1. 78 FR 12329 - Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements; Draft...

    Science.gov (United States)

    2013-02-22

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

  2. Biomaterials surface science

    CERN Document Server

    Taubert, Andreas; Rodriguez-Cabello, José Carlos

    2013-01-01

    The book provides an overview of the highly interdisciplinary field of surface science in the context of biological and biomedical applications. The covered topics range from micro- and nanostructuring for imparting functionality in a top-down manner to the bottom-up fabrication of gradient surfaces by self-assembly, from interfaces between biomaterials and living matter to smart, stimuli-responsive surfaces, and from cell and surface mechanics to the elucidation of cell-chip interactions in biomedical devices.

  3. Product-based Safety Certification for Medical Devices Embedded Software.

    Science.gov (United States)

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

    2015-01-01

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

  4. Practice of Regulatory Science (Development of Medical Devices).

    Science.gov (United States)

    Niimi, Shingo

    2017-01-01

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

  5. 75 FR 68200 - Medical Devices; Radiology Devices; Reclassification of Full-Field Digital Mammography System

    Science.gov (United States)

    2010-11-05

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

  6. 77 FR 14272 - Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological...

    Science.gov (United States)

    2012-03-09

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

  7. A concept ideation framework for medical device design.

    Science.gov (United States)

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

    2015-06-01

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

  8. Biological biomaterials

    Energy Technology Data Exchange (ETDEWEB)

    Jorge-Herrero, E. [Servicio de Cirugia Experimental. Clinica Puerta de Hierro, Madrid (Spain)

    1997-05-01

    There are a number of situations in which substances of biological origin are employed as biomaterials. Most of them are macromolecules derived from isolated connective tissue or the connective tissue itself in membrane form, in both cases, the tissue can be used in its natural form or be chemically treated. In other cases, certain blood vessels can be chemically pretreated and used as vascular prostheses. Proteins such as albumin, collagen and fibrinogen are employed to coat vascular prostheses. Certain polysaccharides have also been tested for use in controlled drug release systems. Likewise, a number of tissues, such as dura mater, bovine pericardium, procine valves and human valves, are used in the preparation of cardiac prostheses. We also use veins from animals or humans in arterial replacement. In none of these cases are the tissues employed dissimilar to the native tissues as they have been chemically modified, becoming a new bio material with different physical and biochemical properties. In short, we find that natural products are being utilized as biomaterials and must be considered as such; thus, it is necessary to study both their chemicobiological and physicomechanical properties. In the present report, we review the current applications, problems and future prospects of some of these biological biomaterials. (Author) 84 refs.

  9. Hybrid laser technology and doped biomaterials

    Czech Academy of Sciences Publication Activity Database

    Jelínek, Miroslav; Zemek, Josef; Remsa, Jan; Mikšovský, Jan; Kocourek, Tomáš; Písařík, Petr; Trávníčková, Martina; Filová, Elena; Bačáková, Lucie

    2017-01-01

    Roč. 417, Sep (2017), s. 73-83 ISSN 0169-4332 R&D Projects: GA ČR(CZ) GA15-05864S Institutional support: RVO:68378271 ; RVO:67985823 Keywords : hybrid PLD * Cr: DLC * Ti: DLC. comparison of properties * in vitro tests Subject RIV: BM - Solid Matter Physics ; Magnetism; EI - Biotechnology ; Bionics (FGU-C) OBOR OECD: Condensed matter physics (including formerly solid state physics, supercond.); Biomaterials (as related to medical implants, devices, sensors) (FGU-C) Impact factor: 3.387, year: 2016

  10. Making Medical Devices Safer at Home

    Science.gov (United States)

    ... things found in a home environment, such as pet hair, well water or temperature variations. Other challenges include the user's and the caregiver's physical and emotional health. People taking medications that affect their alertness or ...

  11. #DDOD Use Case: Consolidated reporting of medical device recalls

    Data.gov (United States)

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

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

    Science.gov (United States)

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

    2011-07-01

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

  13. Development of Implantable Medical Devices: From an Engineering Perspective

    Directory of Open Access Journals (Sweden)

    Yeun-Ho Joung

    2013-09-01

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

  14. 21 CFR 892.2010 - Medical image storage device.

    Science.gov (United States)

    2010-04-01

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

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

    Science.gov (United States)

    Jayabalan, M

    1995-07-01

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

  16. Biomaterials. The Behavior of Stainless Steel as a Biomaterial

    Directory of Open Access Journals (Sweden)

    Sanda VISAN

    2011-06-01

    Full Text Available The biomaterials belong to the broad range of biocompatible chemical substances (sometimes even an element, which can be used for a period of time to treat or replace a tissue, organ or function of the human body. These materials bring many advantages in the diagnosis, prevention and medical therapy, reducing downtime for patients, restoring their biological functions, improving hospital management. The market in Romania sells a wide range of biomaterials for dental, cardiovascular medicine, renal, etc. Scientific research contributes to the discovery of new biomaterials or testing known biomaterials, for finding new applications. The paper exemplifies this contribution by presenting the testing of passive stainless steel behaviour in albumin solution using technique of cyclic voltammetry. It was shown that passivation contribute to increased stability of stainless steel implants to corrosive body fluids.

  17. A comparative study of the refractive index of silk protein thin films towards biomaterial based optical devices

    Science.gov (United States)

    Bucciarelli, A.; Mulloni, V.; Maniglio, D.; Pal, R. K.; Yadavalli, V. K.; Motta, A.; Quaranta, A.

    2018-04-01

    Over the last two decades, silk fibroin has been exploited as a versatile optical material in biological applications due to a combination of unique properties. Recently, protocols have been developed to produce a silk fibroin negative tone resist that is UV crosslinkable, thereby allowing micro and nanoscale patterning of the protein using traditional photolithographic tools. The same protocol has been applied to the silk protein sericin to develop a sericin resist. Despite the immense potential of these biomaterials to develop micro optical patterns on silicon and glass surfaces, as well as self-standing components, their refractive indexes are not well characterized. In this work, optimizing a method to obtain extremely smooth, thin films, the refractive index (RI) of fibroin and sericin proteins and resists were characterized using ellipsometry. The parameters of the Sellmeier and Cauchy dispersion laws have been determined to obtain the RI over a large wavelength range. A complete morphological study of the films has been conducted. In addition, the effect of solvent on the optical properties of silk fibroin and sericin thin films are reported, with differences in values explained by examining the change in the protein secondary structure.

  18. Medical device integration using mobile telecommunications infrastructure.

    Science.gov (United States)

    Moorman, Bridget A; Cockle, Richard A

    2013-01-01

    Financial pressures, an aging population, and a rising number of patients with chronic diseases, have encouraged the use of remote monitoring technologies. This usually entails at least one physiological parameter measurement for a clinician. Mobile telecommunication technologies lend themselves to this functionality, and in some cases, avoid some of the issues encountered with device integration. Moreover, the inherent characteristics of the mobile telecommunications infrastructure allow a coupling of business and clinical functions that were not possible before. Table I compares and contrasts some key aspect of device integration in and out of a healthcare facility. An HTM professional may be part of the team that acquires and/or manages a system using a mobile telecommunications technology. It is important for HTM professionals to ensure the data is in a standard format so that the interfaces across this system don't become brittle and break easily if one part changes. Moreover, the security and safety considerations of the system and the data should be a primary consideration in and y purchase, with attention given to the proper environmental and encryption mechanisms. Clinical engineers and other HTM professionals are unique in that they understand the patient/clinician/device interface and the need to ensure its safety and effectiveness regardless of geographical environment.

  19. Medical device problem reporting for the betterment of healthcare.

    Science.gov (United States)

    1998-08-01

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

  20. Medical device risk management and its economic impact

    Directory of Open Access Journals (Sweden)

    Katerina Krsteva Jakimovska

    2013-10-01

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

  1. Implantable photonic devices for improved medical treatments

    Science.gov (United States)

    Sheinman, Victor; Rudnitsky, Arkady; Toichuev, Rakhmanbek; Eshiev, Abdyrakhman; Abdullaeva, Svetlana; Egemkulov, Talantbek; Zalevsky, Zeev

    2014-10-01

    An evolving area of biomedical research is related to the creation of implantable units that provide various possibilities for imaging, measurement, and the monitoring of a wide range of diseases and intrabody phototherapy. The units can be autonomic or built-in in some kind of clinically applicable implants. Because of specific working conditions in the live body, such implants must have a number of features requiring further development. This topic can cause wide interest among developers of optical, mechanical, and electronic solutions in biomedicine. We introduce preliminary clinical trials obtained with an implantable pill and devices that we have developed. The pill and devices are capable of applying in-body phototherapy, low-level laser therapy, blue light (450 nm) for sterilization, and controlled injection of chemicals. The pill is also capable of communicating with an external control box, including the transmission of images from inside the patient's body. In this work, our pill was utilized for illumination of the sinus-carotid zone in dog and red light influence on arterial pressure and heart rate was demonstrated. Intrabody liver tissue laser ablation and nanoparticle-assisted laser ablation was investigated. Sterilization effect of intrabody blue light illumination was applied during a maxillofacial phlegmon treatment.

  2. The medical physics of ventricular assist devices

    International Nuclear Information System (INIS)

    Wood, Houston G; Throckmorton, Amy L; Untaroiu, Alexandrina; Song Xinwei

    2005-01-01

    Millions of patients, from infants to adults, are diagnosed with congestive heart failure each year all over the world. A limited number of donor hearts available for these patients results in a tremendous demand for alternative, supplemental circulatory support in the form of artificial heart pumps or ventricular assist devices (VADs). The development procedure for such a device requires careful consideration of biophysical factors, such as biocompatibility, haemolysis, thrombosis, implantability, physiologic control feasibility and pump performance. Conventional pump design equations based on Newton's law and computational fluid dynamics (CFD) are readily used for the initial design of VADs. In particular, CFD can be employed to predict the pressure-flow performance, hydraulic efficiencies, flow profile through the pump, stress levels and biophysical factors, such as possible blood cell damage. These computational flow simulations may involve comprehensive steady and transient flow analyses. The transient simulations involve time-varying boundary conditions and virtual modelling of the impeller rotation in the blood pumps. After prototype manufacture, laser flow measurements with sophisticated optics and mock circulatory flow loop testing assist with validation of pump design and identification of irregular flow patterns for optimization. Additionally, acute and chronic animal implants illustrate the blood pump's ability to support life physiologically. These extensive design techniques, coupled with fundamental principles of physics, ensure a reliable and effective VAD for thousands of heart failure patients each year

  3. 75 FR 61507 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Science.gov (United States)

    2010-10-05

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

  4. Design considerations for medical devices in the home environment.

    Science.gov (United States)

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

    2010-01-01

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

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

    Science.gov (United States)

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

    2007-04-01

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

  6. Security Belt for Wireless Implantable Medical Devices.

    Science.gov (United States)

    Kulaç, Selman

    2017-09-19

    In this study, a new protective design compatible with existing non-secure systems was proposed, since it is focused on the secure communication of wireless IMD systems in all transmissions. This new protector is an external wearable device and appears to be a belt fitted around for the patients IMD implanted. However, in order to provide effective full duplex transmissions and physical layer security, some sophisticated transceiver antennas have been placed on the belt. In this approach, beam-focused multi-antennas in optimal positions on the belt are randomly switched when transmissions to the IMD are performed and multi-jammer switching with MRC combining or majority-rule based receiving techniques are applied when transmissions from the IMD are carried out. This approach can also reduce the power consumption of the IMDs and contribute to the prolongation of the IMD's battery life.

  7. Medical device for applying therapeutic radiation

    International Nuclear Information System (INIS)

    Tokita, K.M.; Haller, B.L.

    1986-01-01

    A device is described for applying therapeutic radiation from a preselected radiation source to a predetermined portion of a body comprising, in combination: a body member having: an external peripheral surface; a first end surface; and a second end surface spaced from the first end surface; the body member further comprising: at least first internal walls defining a first radiation source receiving channel means spaced a preselected distance from the peripheral surface, and having: a first portion extending from the second end surface to regions adjacent the first end surface; and a second portion extending from the first portion at the first end surface to the second end surface; and, the channel means communicating with regions external the body member at the second surface whereby the radiation source of a preselected intensity inserted at least along a preselected portion of the channel means is applied to the predetermined area of the body requiring therapeutic radiation treatment

  8. A review of the clinical implications of anti-infective biomaterials and infection-resistant surfaces.

    Science.gov (United States)

    Campoccia, Davide; Montanaro, Lucio; Arciola, Carla Renata

    2013-11-01

    Infection is currently regarded as the most severe and devastating complication associated to the use of biomaterials. The important social, clinical and economic impacts of implant-related infections are promoting the efforts to obviate these severe diseases. In this context, the development of anti-infective biomaterials and of infection-resistant surfaces is being regarded as the main strategy to prevent the establishment of implant colonisation and biofilm formation by bacteria. In this review, the attention is focused on the biomaterial-associated infections, from which the need for anti-infective biomaterials originates. Biomaterial-associated infections differ markedly for epidemiology, aetiology and severity, depending mainly on the anatomic site, on the time of biomaterial application, and on the depth of the tissues harbouring the prosthesis. Here, the diversity and complexity of the different scenarios where medical devices are currently utilised are explored, providing an overview of the emblematic applicative fields and of the requirements for anti-infective biomaterials. © 2013 Elsevier Ltd. All rights reserved.

  9. 76 FR 14414 - Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-03-16

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

  10. 76 FR 22322 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

    Science.gov (United States)

    2011-04-21

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

  11. 77 FR 19534 - Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological...

    Science.gov (United States)

    2012-04-02

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

  12. 76 FR 16292 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

    Science.gov (United States)

    2011-03-23

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

  13. 75 FR 70112 - Medical Devices; General and Plastic Surgery Devices; Classification of Non-Powered Suction...

    Science.gov (United States)

    2010-11-17

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

  14. 75 FR 68972 - Medical Devices; General and Plastic Surgery Devices; Classification of Tissue Adhesive With...

    Science.gov (United States)

    2010-11-10

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

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

    Science.gov (United States)

    Bachmor, T; Schöchlin, J; Bolz, A

    2002-01-01

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

  16. Stakeholder challenges in purchasing medical devices for patient safety.

    Science.gov (United States)

    Hinrichs, Saba; Dickerson, Terry; Clarkson, John

    2013-03-01

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

  17. Collagen based Biomaterials from CLRI: An Inspiration from the ...

    Indian Academy of Sciences (India)

    Collagen-based Smart Biomaterials · Smart materials: As smart people see them · Some Biomaterials based on Collagen in Human Health care · Questions of Value to this presentation ... Collagen based biomaterials · COLLAGEN IN VISION CARE · Slide 57 · Bandage lens: A smart device · Work at CLRI: In summary.

  18. Developing medical device software in compliance with regulations.

    Science.gov (United States)

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

    2015-08-01

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

  19. Pricing and reimbursement of drugs and medical devices in Hungary.

    Science.gov (United States)

    Gulácsi, L; Dávid, T; Dózsa, Cs

    2002-01-01

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

  20. Current status of the regulation for medical devices

    OpenAIRE

    Shah Anuja; Goyal R

    2008-01-01

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

  1. Recent Nanotechnology Approaches for Prevention and Treatment of Biofilm-Associated Infections on Medical Devices

    Directory of Open Access Journals (Sweden)

    Mohankandhasamy Ramasamy

    2016-01-01

    Full Text Available Bacterial colonization in the form of biofilms on surfaces causes persistent infections and is an issue of considerable concern to healthcare providers. There is an urgent need for novel antimicrobial or antibiofilm surfaces and biomedical devices that provide protection against biofilm formation and planktonic pathogens, including antibiotic resistant strains. In this context, recent developments in the material science and engineering fields and steady progress in the nanotechnology field have created opportunities to design new biomaterials and surfaces with anti-infective, antifouling, bactericidal, and antibiofilm properties. Here we review a number of the recently developed nanotechnology-based biomaterials and explain underlying strategies used to make antibiofilm surfaces.

  2. Recent Nanotechnology Approaches for Prevention and Treatment of Biofilm-Associated Infections on Medical Devices.

    Science.gov (United States)

    Ramasamy, Mohankandhasamy; Lee, Jintae

    2016-01-01

    Bacterial colonization in the form of biofilms on surfaces causes persistent infections and is an issue of considerable concern to healthcare providers. There is an urgent need for novel antimicrobial or antibiofilm surfaces and biomedical devices that provide protection against biofilm formation and planktonic pathogens, including antibiotic resistant strains. In this context, recent developments in the material science and engineering fields and steady progress in the nanotechnology field have created opportunities to design new biomaterials and surfaces with anti-infective, antifouling, bactericidal, and antibiofilm properties. Here we review a number of the recently developed nanotechnology-based biomaterials and explain underlying strategies used to make antibiofilm surfaces.

  3. Medical Devices Assess, Treat Balance Disorders

    Science.gov (United States)

    2009-01-01

    series of dynamic protocols to isolate and assess balance function deficiencies. The technology was based on Nashner s novel, engineering-inspired concept of balance as an adaptable collaboration between multiple sensory and motor systems. CDP proved useful not only for examining astronauts, but for anyone suffering from balance problems. Today, CDP is the standard medical tool for objectively evaluating balance control.

  4. Bioinspired phospholipid polymer biomaterials for making high performance artificial organs

    Directory of Open Access Journals (Sweden)

    K Ishihara

    2000-01-01

    Full Text Available Novel polymer biomaterials, which can be used in contact with blood, are prepared with strong inspiration from the surface structure of biomembrane. That is, the polymers with a phospholipid polar group in the side chain, 2-methacrylooyloxyethyl phosphorylcholine (MPC polymers were synthesized. The MPC polymers can inhibit surface-induced clot formation effectively, when they are in contact with blood even in the absence of an anticoagulant. This phenomenon was due to the reduction of plasma protein and suppression of denaturation of adsorbed proteins, that is the MPC polymers interact with blood components very mildly. As the molecular structure of the MPC polymer was easily designed by changing the monomer units and their composition, it could be applied to surface modification of artificial organs and biomedical devices for improving blood and tissue compatibility. Thus, the MPC polymers are useful polymer biomaterials for manufacturing high performance artificial organs and biomedical devices to provide safe medical treatments.

  5. Low power signal processing electronics for wearable medical devices.

    Science.gov (United States)

    Casson, Alexander J; Rodriguez-Villegas, Esther

    2010-01-01

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

  6. Radiation produced biomaterials

    International Nuclear Information System (INIS)

    Rosiak, J.M.

    1998-01-01

    Medical advances that have prolonged the average life span have generated increased need for new materials that can be used as tissue and organ replacements, drug delivery systems and/or components of devices related to therapy and diagnosis. The first man-made plastic used as surgical implant was celluloid, applied for cranial defect repair. However, the first users applied commercial materials with no regard for their purity, biostability and post-operative interaction with the organism. Thus, these materials evoked a strong tissue reaction and were unacceptable. The first polymer which gained acceptance for man-made plastic was poly(methyl methacrylate). But the first polymer of choice, precursor of the broad class of materials known today as hydrogels, was poly(hydroxyethyl methacrylate) synthesized in the fifties by Wichterle and Lim. HEMA and its various combinations with other, both hydrophilic and hydrophobic, polymers are till now the most often used hydrogels for medical purposes. In the early fifties, the pioneers of the radiation chemistry of polymers began some experiments with radiation crosslinking, also with hydrophilic polymers. However, hydrogels were analyzed mainly from the point of view of phenomena associated with mechanism of reactions, topology of network, and relations between radiation parameters of the processes. Fundamental monographs on radiation polymer physics and chemistry written by Charlesby (1960) and Chapiro (1962) proceed from this time. The noticeable interest in application of radiation to obtain hydrogels for biomedical purposes began in the late sixties as a result of the papers and patents published by Japanese and American scientists. Among others, the team of the Takasaki Radiation Chemistry Research Establishment headed by Kaetsu as well as Hoffman and his colleagues from the Center of Bioengineering, University of Washington have created the base for spreading interest in the field of biomaterials formed by means of

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

    Science.gov (United States)

    Matsuoka, Atsuko

    2012-01-01

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

  8. 78 FR 16684 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2013-03-18

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

  9. 77 FR 20642 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2012-04-05

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

  10. 75 FR 47606 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2010-08-06

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

  11. 76 FR 14415 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2011-03-16

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

  12. 76 FR 62419 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2011-10-07

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

  13. 75 FR 49940 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2010-08-16

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

  14. 78 FR 30928 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2013-05-23

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

  15. 76 FR 39882 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2011-07-07

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

  16. Risk evaluation of medical and industrial radiation devices

    International Nuclear Information System (INIS)

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

    1994-03-01

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

  17. Integrin-directed modulation of macrophage responses to biomaterials.

    Science.gov (United States)

    Zaveri, Toral D; Lewis, Jamal S; Dolgova, Natalia V; Clare-Salzler, Michael J; Keselowsky, Benjamin G

    2014-04-01

    Macrophages are the primary mediator of chronic inflammatory responses to implanted biomaterials, in cases when the material is either in particulate or bulk form. Chronic inflammation limits the performance and functional life of numerous implanted medical devices, and modulating macrophage interactions with biomaterials to mitigate this response would be beneficial. The integrin family of cell surface receptors mediates cell adhesion through binding to adhesive proteins nonspecifically adsorbed onto biomaterial surfaces. In this work, the roles of integrin Mac-1 (αMβ2) and RGD-binding integrins were investigated using model systems for both particulate and bulk biomaterials. Specifically, the macrophage functions of phagocytosis and inflammatory cytokine secretion in response to a model particulate material, polystyrene microparticles were investigated. Opsonizing proteins modulated microparticle uptake, and integrin Mac-1 and RGD-binding integrins were found to control microparticle uptake in an opsonin-dependent manner. The presence of adsorbed endotoxin did not affect microparticle uptake levels, but was required for the production of inflammatory cytokines in response to microparticles. Furthermore, it was demonstrated that integrin Mac-1 and RGD-binding integrins influence the in vivo foreign body response to a bulk biomaterial, subcutaneously implanted polyethylene terephthalate. A thinner foreign body capsule was formed when integrin Mac-1 was absent (~30% thinner) or when RGD-binding integrins were blocked by controlled release of a blocking peptide (~45% thinner). These findings indicate integrin Mac-1 and RGD-binding integrins are involved and may serve as therapeutic targets to mitigate macrophage inflammatory responses to both particulate and bulk biomaterials. Copyright © 2014 Elsevier Ltd. All rights reserved.

  18. 76 FR 71982 - Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices...

    Science.gov (United States)

    2011-11-21

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

  19. Remote Access: A Vision for Mobile Medical Devices

    Directory of Open Access Journals (Sweden)

    Herbert Ernst

    2005-11-01

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

  20. Optical tests for using smartphones inside medical devices

    Science.gov (United States)

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

    2018-02-01

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

  1. Medical devices of the head, neck, and spine.

    Science.gov (United States)

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

    2004-01-01

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

  2. French Sizing of Medical Devices is not Fit for Purpose

    International Nuclear Information System (INIS)

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

    2013-01-01

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

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

    Science.gov (United States)

    Hojo, Taisuke

    2017-01-01

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

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

    Science.gov (United States)

    Kusche, Kristopher P

    2009-01-01

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

  5. Image Quality Characteristics of Handheld Display Devices for Medical Imaging

    Science.gov (United States)

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

    2013-01-01

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

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

    Science.gov (United States)

    Haghi, Mostafa; Thurow, Kerstin; Stoll, Regina

    2017-01-01

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

  7. Feasibility of energy harvesting techniques for wearable medical devices.

    Science.gov (United States)

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

    2014-01-01

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

  8. 31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

    Science.gov (United States)

    2010-07-01

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

  9. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Science.gov (United States)

    2010-07-01

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

  10. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Science.gov (United States)

    2010-07-01

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

  11. Biomaterials and Magnetic fields for Cancer Therapy

    Science.gov (United States)

    Ramachandran, Narayanan; Mazuruk, Konstanty

    2003-01-01

    The field of biomaterials has emerged as an important topic in the purview of NASA s new vision of research activities in the Microgravity Research Division. Although this area has an extensive track record in the medical field as borne out by the routine use of polymeric sutures, implant devices, and prosthetics, novel applications such as tissue engineering, artificial heart valves and controlled drug delivery are beginning to be developed. Besides the medical field, biomaterials and bio-inspired technologies are finding use in a host of emerging interdisciplinary fields such as self-healing and self-assembling structures, biosensors, fuel systems etc. The field of magnetic fluid technology has several potential applications in medicine. One of the emerging fields is the area of controlled drug delivery, which has seen its evolution from the basic oral delivery system to pulmonary to transdermal to direct inoculations. In cancer treatment by chemotherapy for example, targeted and controlled drug delivery has received vast scrutiny and substantial research and development effort, due to the high potency of the drugs involved and the resulting requirement to keep the exposure of the drugs to surrounding healthy tissue to a minimum. The use of magnetic particles in conjunction with a static magnetic field allows smart targeting and retention of the particles at a desired site within the body with the material transport provided by blood perfusion. Once so located, the therapeutical aspect (radiation, chemotherapy, hyperthermia, etc.) of the treatment, now highly localized, can be implemented.

  12. Research on dose setting for radiation sterilization of medical device

    International Nuclear Information System (INIS)

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

    2002-01-01

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

  13. A model of user engagement in medical device development.

    Science.gov (United States)

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

    2007-01-01

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

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

    Science.gov (United States)

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

    2013-12-01

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

  15. Management information system of medical equipment using mobile devices

    Science.gov (United States)

    Núñez, C.; Castro, D.

    2011-09-01

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

  16. Additive Manufacturing for Robust and Affordable Medical Devices

    OpenAIRE

    Wolozny Gomez Robelo, Daniel Andre

    2016-01-01

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

  17. 76 FR 65200 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of...

    Science.gov (United States)

    2011-10-20

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

  18. Wireless energy transfer platform for medical sensors and implantable devices.

    Science.gov (United States)

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

    2009-01-01

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

  19. Towards automated assistance for operating home medical devices.

    Science.gov (United States)

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

    2010-01-01

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

  20. Dosimetric studies for gamma radiation validation of medical devices

    International Nuclear Information System (INIS)

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

    2013-01-01

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

  1. Innovating transformative medical devices and growing the local medical device manufacturing sector

    CSIR Research Space (South Africa)

    Bunn, Tony

    2017-01-01

    Full Text Available . The 4IR is marked by emerging technology breakthroughs in a number of fields, including robotics, genomics, biosensors and wearables, AI, the internet of things, quantum computing, big data predictive analytics, 3D printing/additive manufacturing... of personalized prosthetics and products • Personalized devices and technologies for precision medicine Secure Airway Clamp for safer Anaesthesia MANDIBULAR IMPLANTS PATIENT 2 PATIENT 1 PATIENT 3 PATIENT CT SCAN 3D PRINTED TITANIUM IMPLANT PROPOSED...

  2. El Centro de Cardioestimuladores del Uruguay. CCC Medical Devices

    Directory of Open Access Journals (Sweden)

    Pablo Darscht

    2011-05-01

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

  3. Campaign to gather medical devices containing radium: results

    International Nuclear Information System (INIS)

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

    2002-01-01

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

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

    Science.gov (United States)

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

    2018-03-01

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

  5. APPLICATIONS OF BIOTECHNOLOGY IN DEVELOPMENT OF BIOMATERIALS: NANOTECHNOLOGY AND BIOFILMS

    Energy Technology Data Exchange (ETDEWEB)

    Brigmon, R.; Berry, T.; Narayan, R.

    2010-11-29

    Biotechnology is the application of biological techniques to develop new tools and products for medicine and industry. Due to various properties including chemical stability, biocompatibility, and specific activity, e.g. antimicrobial properties, many new and novel materials are being investigated for use in biosensing, drug delivery, hemodialysis, and other medical applications. Many of these materials are less than 100 nanometers in size. Nanotechnology is the engineering discipline encompassing designing, producing, testing, and using structures and devices less than 100 nanometers. One of the challenges associated with biomaterials is microbial contamination that can lead to infections. In recent work we have examined the functionalization of nanoporous biomaterials and antimicrobial activities of nanocrystalline diamond materials. In vitro testing has revealed little antimicrobial activity against Pseudomonas fluorescens bacteria and associated biofilm formation that enhances recalcitrance to antimicrobial agents including disinfectants and antibiotics. Laser scanning confocal microscopy studies further demonstrated properties and characteristics of the material with regard to biofilm formation.

  6. Monitoring of Vital Signs with Flexible and Wearable Medical Devices.

    Science.gov (United States)

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

    2016-06-01

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

  7. Improvised explosive devices: pathophysiology, injury profiles and current medical management.

    Science.gov (United States)

    Ramasamy, A; Hill, A M; Clasper, J C

    2009-12-01

    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.

  8. Regulation E 69-14. Monitoring requirements for medical devices

    International Nuclear Information System (INIS)

    2015-01-01

    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.

  9. Polymeric biomaterials structure and function, v.1

    CERN Document Server

    Dumitriu, Severian

    2013-01-01

    Biomaterials have had a major impact on the practice of contemporary medicine and patient care. Growing into a major interdisciplinary effort involving chemists, biologists, engineers, and physicians, biomaterials development has enabled the creation of high-quality devices, implants, and drug carriers with greater biocompatibility and biofunctionality. The fast-paced research and increasing interest in finding new and improved biocompatible or biodegradable polymers has provided a wealth of new information, transforming this edition of Polymeric Biomaterials into a two-volume set. This volume

  10. The effects of cosmic radiation on implantable medical devices

    International Nuclear Information System (INIS)

    Bradley, P.

    1996-01-01

    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

  11. Designing Biomaterials for 3D Printing.

    Science.gov (United States)

    Guvendiren, Murat; Molde, Joseph; Soares, Rosane M D; Kohn, Joachim

    2016-10-10

    Three-dimensional (3D) printing is becoming an increasingly common technique to fabricate scaffolds and devices for tissue engineering applications. This is due to the potential of 3D printing to provide patient-specific designs, high structural complexity, rapid on-demand fabrication at a low-cost. One of the major bottlenecks that limits the widespread acceptance of 3D printing in biomanufacturing is the lack of diversity in "biomaterial inks". Printability of a biomaterial is determined by the printing technique. Although a wide range of biomaterial inks including polymers, ceramics, hydrogels and composites have been developed, the field is still struggling with processing of these materials into self-supporting devices with tunable mechanics, degradation, and bioactivity. This review aims to highlight the past and recent advances in biomaterial ink development and design considerations moving forward. A brief overview of 3D printing technologies focusing on ink design parameters is also included.

  12. Medical devices made into weapons by prisoners: an unrecognized risk.

    Science.gov (United States)

    Hayden, J W; Laney, C; Kellermann, A L

    1995-12-01

    The alteration of a knee immobilizer into a sharp weapon by a prisoner prompted us to survey neighboring penal institutions to determine the frequency of such events. We mailed a nine-item survey to all detention facilities in Tennessee, Arkansas, and Mississippi. A second survey was sent to nonresponding institutions 6 weeks after the initial mailing. The Regional Medical Center at Memphis, the designated facility for evaluation and treatment of prisoners from the county jail and state penitentiary. Survey respondents included 25 state penitentiaries, 31 county jails, 1 state minimum-security facility, 1 state maximum-security facility, 1 work-release center, 1 county detention center for drunken-driving offenders, and 1 federal penitentiary. Of the 81 institutions surveyed, 77% responded to one of the two mailings. Forty percent responded in the affirmative when asked whether stolen or unauthorized medical equipment from outside their institutions had been discovered among inmates. When respondents were questioned as to whether medical equipment, prescribed or not, had been used or altered in a criminal manner, 34% responded "yes." Medications and medical appliances were listed in the responses. A survey of 81 local and neighboring penal institutions in a three-state area revealed that the illicit use of medicine and medical devices by prisoners is a legitimate safety concern of prison personnel and health care workers when medical care for inmates must be sought outside the security of their institutions. The modification of medical equipment into weapons by incarcerated patients, although clearly recognized as a security and safety problem by police authorities, appears to be unappreciated by health care workers providing episodic care to inmates.

  13. Properties and processing technologies of polymers for medical devices; Proprieta' e tecnologie di lavorazione dei polimeri utilizzati nei dispositivi medici

    Energy Technology Data Exchange (ETDEWEB)

    Salernitano, E [ENEA, Divisione Nuovi Materiali, Centro Ricerche Casaccia, Rome (Italy)

    2000-07-01

    The variety of biomaterials applications in medical devices for substitution or functional integration of organs and tissues has remarkably grown. This has allowed an increased survival of patients affected by traumatic or pathologic events. Biomaterials growing variety and improvement were remarkable and constant over the last twenty years; this fact yielded important clinical effects in every medical area, especially in orthopaedics, cardiovascular surgery and dentistry. Performances of medical materials are evaluated according to their bio functionality and biocompatibility. These concepts are strongly connected: bio functionality refers to devices physical and mechanical properties which allow to perform a specific function. Several transformation methods and different processing technologies allow to obtain products having different physico-chemical and mechanical properties. Among them, chemical and physical stability, biocompatibility, possibility to undergo sterilisation process, control of gases and moisture permeability, control of biodegradation products, wear and fatigue resistance and toughness are the most relevant. Most of research efforts are devoted to improve reliability and last of biomaterials already used thanks to their bio functionality and biocompatibility. Expected developments of medial devices are associated with the design of bio artificial organs, where biomaterials act as a scaffold for the three-dimensional cells growth. [Italian] Il numero delle applicazioni dei biomateriali in dispositivi medici che sostituiscono od integrino dal punto di vista funzionale organi o tessuti e' cresciuto notevolmente. Questo ha portato ad un aumento della sopravvivenza dei pazienti colpiti da eventi patologici o traumatici. La crescita ed il perfezionamento dei biomateriali e' stata, infatti, nell'ultimo ventennio considerevole e costante ed ha avuto importanti ricadute cliniche in tutte le discipline mediche ed in particolare in ortopedia, in

  14. Microgel Mechanics in Biomaterial Design

    OpenAIRE

    Saxena, Shalini; Hansen, Caroline E.; Lyon, L. Andrew

    2014-01-01

    Conspectus The field of polymeric biomaterials has received much attention in recent years due to its potential for enhancing the biocompatibility of systems and devices applied to drug delivery and tissue engineering. Such applications continually push the definition of biocompatibility from relatively straightforward issues such as cytotoxicity to significantly more complex processes such as reducing foreign body responses or even promoting/recapitulating natural body functions. Hydrogels a...

  15. 78 FR 66941 - Design Considerations for Pivotal Clinical Investigations for Medical Devices; Guidance for...

    Science.gov (United States)

    2013-11-07

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

  16. 78 FR 35940 - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft...

    Science.gov (United States)

    2013-06-14

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

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

    Science.gov (United States)

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

  18. Effects of Sterilization Cycles on PEEK for Medical Device Application

    Science.gov (United States)

    Yap, Wai Teng; Foo, Soo Leong; Lee, Teck Kheng

    2018-01-01

    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

  19. Effects of Sterilization Cycles on PEEK for Medical Device Application.

    Science.gov (United States)

    Kumar, Amit; Yap, Wai Teng; Foo, Soo Leong; Lee, Teck Kheng

    2018-02-21

    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.

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

    Science.gov (United States)

    Degaspari, John

    2011-07-01

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

  1. Biomaterials in orthopaedics

    Science.gov (United States)

    Navarro, M; Michiardi, A; Castaño, O; Planell, J.A

    2008-01-01

    At present, strong requirements in orthopaedics are still to be met, both in bone and joint substitution and in the repair and regeneration of bone defects. In this framework, tremendous advances in the biomaterials field have been made in the last 50 years where materials intended for biomedical purposes have evolved through three different generations, namely first generation (bioinert materials), second generation (bioactive and biodegradable materials) and third generation (materials designed to stimulate specific responses at the molecular level). In this review, the evolution of different metals, ceramics and polymers most commonly used in orthopaedic applications is discussed, as well as the different approaches used to fulfil the challenges faced by this medical field. PMID:18667387

  2. Navigating conflicts of interest for the medical device entrepreneur.

    Science.gov (United States)

    Donovan, Aine; Kaplan, Aaron V

    2012-01-01

    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.

  3. Modeling and Data Needs of Atmospheric Pressure Gas Plasma and Biomaterial Interaction

    International Nuclear Information System (INIS)

    Sakiyama, Yukinori; Graves, David B.

    2009-01-01

    Non-thermal atmospheric pressure plasmas have received considerable attention recently. One promising application of non-thermal plasma devices appears to be biomaterial and biomedical treatment. Various biological and medical effects of non-thermal plasmas have been observed by a variety of investigators, including bacteria sterilization, cell apoptosis, and blood coagulation, among others. The mechanisms of the plasma-biomaterial interaction are however only poorly understood. A central scientific challenge is therefore how to answer the question: 'What plasma-generated agents are responsible for the observed biological effects?' Our modeling efforts are motivated by this question. In this paper, we review our modeling results of the plasma needle discharge. Then, we address data needs for further modeling and understanding of plasma-biomaterial interaction

  4. 78 FR 33849 - Battery-Powered Medical Devices Workshop: Challenges and Opportunities; Public Workshop; Request...

    Science.gov (United States)

    2013-06-05

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

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

    Science.gov (United States)

    2005-01-01

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

  6. 77 FR 8260 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device...

    Science.gov (United States)

    2012-02-14

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

  7. 42 CFR 410.36 - Medical supplies, appliances, and devices: Scope.

    Science.gov (United States)

    2010-10-01

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

  8. Establishment Of Dose Correlation During Dose Mapping On Medical Devices

    International Nuclear Information System (INIS)

    Ruzalina Baharin; Hasan Sham; Ahsanulkhaliqin Abdul Wahab

    2014-01-01

    This paper explains the work done during product dose mapping in order to get the correlation between doses at MINTec-Sinagama plant. Product used was medical devices in aluminium tubes packaged in cardboard kegs packaging with average weight of 12 kg per carton. 12 cartons were loaded in every one tote to give 0.2 g/ cm 3 of density. Ceric cerous dosimeters were placed at specific locations as indicated in SP14: Product Dose Mapping, QMS of MINTec-Sinagama around three planes. Three processes were made at different days as a three replicates to show the reproducibility of measurements. (author)

  9. Challenges to validation of a complex nonsterile medical device tray.

    Science.gov (United States)

    Prince, Daniel; Mastej, Jozef; Hoverman, Isabel; Chatterjee, Raja; Easton, Diana; Behzad, Daniela

    2014-01-01

    Validation by steam sterilization of reusable medical devices requires careful attention to many parameters that directly influence whether or not complete sterilization occurs. Complex implant/instrument tray systems have a variety of configurations and components. Geobacillus stearothermophilus biological indicators (BIs) are used in overkill cycles to to simulate worst case conditions and are intended to provide substantial sterilization assurance. Survival of G. stearothermophilus spores was linked to steam access and size of load in the chamber. By a small and reproducible margin, it was determined that placement of the trays in a rigid container into minimally loaded chambers were more difficult to completely sterilize than maximally loaded chambers.

  10. Development of bacterially resistant polyurethane for coating medical devices

    International Nuclear Information System (INIS)

    Roohpour, Nima; Moshaverinia, Alireza; Wasikiewicz, Jaroslaw M; Paul, Deepen; Vadgama, Pankaj; Wilks, Mark; Millar, Michael

    2012-01-01

    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.

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

    Science.gov (United States)

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

  12. The future of the pharmaceutical, biological and medical device industry

    Directory of Open Access Journals (Sweden)

    Burgess LJ

    2011-09-01

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

  13. Reducing hospital noise: a review of medical device alarm management.

    Science.gov (United States)

    Konkani, Avinash; Oakley, Barbara; Bauld, Thomas J

    2012-01-01

    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.

  14. 75 FR 1395 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Science.gov (United States)

    2010-01-11

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

  15. 76 FR 42713 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Science.gov (United States)

    2011-07-19

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

  16. Biomaterials for cardiac regeneration

    CERN Document Server

    Ruel, Marc

    2015-01-01

    This book offers readers a comprehensive biomaterials-based approach to achieving clinically successful, functionally integrated vasculogenesis and myogenesis in the heart. Coverage is multidisciplinary, including the role of extracellular matrices in cardiac development, whole-heart tissue engineering, imaging the mechanisms and effects of biomaterial-based cardiac regeneration, and autologous bioengineered heart valves. Bringing current knowledge together into a single volume, this book provides a compendium to students and new researchers in the field and constitutes a platform to allow for future developments and collaborative approaches in biomaterials-based regenerative medicine, even beyond cardiac applications. This book also: Provides a valuable overview of the engineering of biomaterials for cardiac regeneration, including coverage of combined biomaterials and stem cells, as well as extracellular matrices Presents readers with multidisciplinary coverage of biomaterials for cardiac repair, including ...

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

    Science.gov (United States)

    Wang, Lanming

    2012-11-01

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

  18. Biomaterials and their applications

    CERN Document Server

    Reza Rezaie, Hamid; Öchsner, Andreas

    2015-01-01

    This short book presents an overview of different types of biomaterial such as bio ceramics, bio polymers, metals and bio composites, while especially focusing on nano biomaterials and their applications in different tissues. It provides a compact introduction to nano materials for drug delivery systems, tissue engineering and implants, while also reviewing essential trends in the biomaterial field over the last few decades and the latest developments.

  19. Advertising of medical devices: foreign experience and Ukrainian practice.

    Science.gov (United States)

    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.

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

    Science.gov (United States)

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

    2017-04-01

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

  1. Tracking of Drug Release and Material Fate for Naturally Derived Omega-3 Fatty Acid Biomaterials.

    Science.gov (United States)

    Faucher, Keith M; Artzi, Natalie; Beck, Moshe; Beckerman, Rita; Moodie, Geoff; Albergo, Theresa; Conroy, Suzanne; Dale, Alicia; Corbeil, Scott; Martakos, Paul; Edelman, Elazer R

    2016-03-01

    In vitro and in vivo studies were conducted on omega-3 fatty acid-derived biomaterials to determine their utility as an implantable material for adhesion prevention following soft tissue hernia repair and as a means to allow for the local delivery of antimicrobial or antibiofilm agents. Naturally derived biomaterials offer several advantages over synthetic materials in the field of medical device development. These advantages include enhanced biocompatibility, elimination of risks posed by the presence of toxic catalysts and chemical crosslinking agents, and derivation from renewable resources. Omega-3 fatty acids are readily available from fish and plant sources and can be used to create implantable biomaterials either as a stand-alone device or as a device coating that can be utilized in local drug delivery applications. In-depth characterization of material erosion degradation over time using non-destructive imaging and chemical characterization techniques provided mechanistic insight into material structure: function relationship. This in turn guided rational tailoring of the material based on varying fatty acid composition to control material residence time and hence drug release. These studies demonstrate the utility of omega-3 fatty acid derived biomaterials as an absorbable material for soft tissue hernia repair and drug delivery applications.

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

    Science.gov (United States)

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

    2018-02-23

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

  3. An introduction to biomaterials

    CERN Document Server

    Hollinger, Jeffrey O

    2011-01-01

    Consensus Definitions, Fundamental Concepts, and a Standardized Approach to Applied Biomaterials Sciences, J.O. HollingerBiology, Biomechanics, Biomaterial Interactions: Wound Healing BiologyCutaneous Wound Pathobiology: Raison d'etre for Tissue Engineering, L.K. Macri and R.A.F. ClarkOsseous Wound Healing, A. Nawab, M. Wong, D. Kwak, L. Schutte, A. Sharma, and J.O. HollingerBiology, Biomechanics, Biomaterial Interactions: Cellular MechanicsCell and Tissue Mechanobiology, W. Guo, P. Alvarez, and Y. WangBiology, Biomechanics, Biomaterial Interactions: Materials-Host InteractionsCell-Material In

  4. Adherence ability of Staphylococcus epidermidis on prosthetic biomaterials: an in vitro study

    Directory of Open Access Journals (Sweden)

    Shida T

    2013-10-01

    Full Text Available Takayuki Shida,1 Hironobu Koseki,1 Itaru Yoda,1 Hidehiko Horiuchi,1 Hideyuki Sakoda,2 Makoto Osaki11Department of Orthopedic Surgery, Graduate School of Medicine, Nagasaki University, Nagasaki, Japan; 2Division of Medical Devices, National Institute of Health Sciences, Tokyo, JapanAbstract: Bacterial adhesion to the surface of biomaterials is an essential step in the pathogenesis of implant-related infections. In this in vitro research, we evaluated the ability of Staphylococcus epidermidis to adhere to the surface of solid biomaterials, including oxidized zirconium-niobium alloy (Oxinium, cobalt-chromium-molybdenum alloy, titanium alloy, commercially pure titanium, and stainless steel, and performed a biomaterial-to-biomaterial comparison. The test specimens were physically analyzed to quantitatively determine the viable adherent density of the S. epidermidis strain RP62A (American Type Culture Collection [ATCC] 35984. Field emission scanning electron microscope and laser microscope examination revealed a featureless, smooth surface in all specimens (average roughness <10 nm. The amounts of S. epidermidis that adhered to the biomaterial were significantly lower for Oxinium and the cobalt-chromium-molybdenum alloy than for commercially pure titanium. These results suggest that Oxinium and cobalt-chromium-molybdenum alloy are less susceptible to bacterial adherence and are less inclined to infection than other materials of a similar degree of smoothness.Keyword: bacterial adhesion, implant, infection, surface character

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

    International Nuclear Information System (INIS)

    Tabei, Masae; Kudo, Hisaaki; Katsumura, Yosuke

    2004-01-01

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

  6. System theory in medical diagnostic devices: an overview.

    Science.gov (United States)

    Baura, Gail D

    2006-01-01

    Medical diagnostics refers to testing conducted either in vitro or in vivo to provide critical health care information for risk assessment, early diagnosis, treatment, or disease management. Typical in vivo diagnostic tests include the computed tomography scan, magnetic resonance imaging, and blood pressure screening. Typical in vitro diagnostic tests include cholesterol, Papanicolaou smear, and conventional glucose monitoring tests. Historically, devices associated with both types of diagnostics have used heuristic curve fitting during signal analysis. However, since the early 1990s, a few enterprising engineers and physicians have used system theory to improve their core processing for feature detection and system identification. Current applications include automated Pap smear screening for detection of cervical cancer and diagnosis of Alzheimer's disease. Future applications, such as disease prediction before symptom onset and drug treatment customization, have been catalyzed by the Human Genome Project.

  7. Energy efficiency improvement of medical electric tools and devices

    Directory of Open Access Journals (Sweden)

    Meshkov Aleksandr S.

    2014-01-01

    Full Text Available With the ever-increasing volume of applications of various kinds of electric drives in all spheres of human activity, the issues in improving the efficiency of the electromechanical converters of electric energy, one of the most important components of the electric drive (ED, are becoming increasingly important. Such issues include reducing their weight and size, improving the functional characteristics of these devices to increase their operational life and reducing the cost of manufacture. Taking full advantage of these opportunities relates to the AC and DC single-phase commutator motor (SCM, which is widely used in regulated and high-speed motor drives in medical electric hand tools. The SCM is used in machinery where the load torque has a hyperbolic dependence on the rotational speed and the need to work with a large motor overload due to the “soft” mechanical characteristics of such motors.

  8. [New medical device hospital assessment: what kind of clinical data?].

    Science.gov (United States)

    Beaussier, H; Junot, H; Lancrenon, S; Faure, P

    2012-01-01

    Since 2003, the AP-HP medical devices committee (CODIMS) assess the therapeutic relevance of innovated medical device (MD) for the French AP-HP hospitals' group. To accomplish this task, the CODIMS asks manufacturers to bring out clinical arguments to justify the use of their MD in hospital. This work analyses retrospectively after 8years, all assessed MD until March 2011 and the scientific quality of the clinical data submitted by manufacturers to the CODIMS to purchase their MD. All MD were classed according to their certification's level (I, IIa, IIb, III, DMIA). The quality of available clinical studies (CS) provided by manufacturers for each case was assessed and classed according to five clinical relevance levels based on the evidence-based medecine standards (1-2: high methodology; 3-5: low methodology). One hundred and three MD files (80 % of class IIb and III MD) were analysed by the CODIMS (630CS). Our results highlight the lack of relevance of files that are provided to assess innovated MD: 29 files without any CS; concerning class IIb (32DMS, 221CS) and III (50, 342CS) MD, only 6 % of CS presented a correct clinical relevance level. And the situation did not get better during this assessment period. The CODIMS deplore the poor clinical relevance of files provided to assess MD (wrong comparator, inappropriate ends-points, insufficient follow-up to assess long-term security, small population studied). Future legislative developments for MD assessment are expected to improve this situation. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

  9. Improving risk assessment of color additives in medical device polymers.

    Science.gov (United States)

    Chandrasekar, Vaishnavi; Janes, Dustin W; Forrey, Christopher; Saylor, David M; Bajaj, Akhil; Duncan, Timothy V; Zheng, Jiwen; Riaz Ahmed, Kausar B; Casey, Brendan J

    2018-01-01

    Many polymeric medical device materials contain color additives which could lead to adverse health effects. The potential health risk of color additives may be assessed by comparing the amount of color additive released over time to levels deemed to be safe based on available toxicity data. We propose a conservative model for exposure that requires only the diffusion coefficient of the additive in the polymer matrix, D, to be specified. The model is applied here using a model polymer (poly(ether-block-amide), PEBAX 2533) and color additive (quinizarin blue) system. Sorption experiments performed in an aqueous dispersion of quinizarin blue (QB) into neat PEBAX yielded a diffusivity D = 4.8 × 10 -10 cm 2  s -1 , and solubility S = 0.32 wt %. On the basis of these measurements, we validated the model by comparing predictions to the leaching profile of QB from a PEBAX matrix into physiologically representative media. Toxicity data are not available to estimate a safe level of exposure to QB, as a result, we used a Threshold of Toxicological Concern (TTC) value for QB of 90 µg/adult/day. Because only 30% of the QB is released in the first day of leaching for our film thickness and calculated D, we demonstrate that a device may contain significantly more color additive than the TTC value without giving rise to a toxicological concern. The findings suggest that an initial screening-level risk assessment of color additives and other potentially toxic compounds found in device polymers can be improved. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 310-319, 2018. © 2017 Wiley Periodicals, Inc.

  10. Smart Radiation Therapy Biomaterials.

    Science.gov (United States)

    Ngwa, Wilfred; Boateng, Francis; Kumar, Rajiv; Irvine, Darrell J; Formenti, Silvia; Ngoma, Twalib; Herskind, Carsten; Veldwijk, Marlon R; Hildenbrand, Georg Lars; Hausmann, Michael; Wenz, Frederik; Hesser, Juergen

    2017-03-01

    Radiation therapy (RT) is a crucial component of cancer care, used in the treatment of over 50% of cancer patients. Patients undergoing image guided RT or brachytherapy routinely have inert RT biomaterials implanted into their tumors. The single function of these RT biomaterials is to ensure geometric accuracy during treatment. Recent studies have proposed that the inert biomaterials could be upgraded to "smart" RT biomaterials, designed to do more than 1 function. Such smart biomaterials include next-generation fiducial markers, brachytherapy spacers, and balloon applicators, designed to respond to stimuli and perform additional desirable functions like controlled delivery of therapy-enhancing payloads directly into the tumor subvolume while minimizing normal tissue toxicities. More broadly, smart RT biomaterials may include functionalized nanoparticles that can be activated to boost RT efficacy. This work reviews the rationale for smart RT biomaterials, the state of the art in this emerging cross-disciplinary research area, challenges and opportunities for further research and development, and a purview of potential clinical applications. Applications covered include using smart RT biomaterials for boosting cancer therapy with minimal side effects, combining RT with immunotherapy or chemotherapy, reducing treatment time or health care costs, and other incipient applications. Copyright © 2016 Elsevier Inc. All rights reserved.

  11. 21 CFR 801.122 - Medical devices for processing, repacking, or manufacturing.

    Science.gov (United States)

    2010-04-01

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

  12. 78 FR 27971 - Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-05-13

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

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

    Science.gov (United States)

    Brand, Darren

    2012-12-01

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

  14. 21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.

    Science.gov (United States)

    2010-04-01

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

  15. Counterfeit drugs and medical devices in developing countries

    Directory of Open Access Journals (Sweden)

    Glass BD

    2014-03-01

    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

  16. Sodium Hypochlorite Treatment and Nitinol Performance for Medical Devices

    Science.gov (United States)

    Weaver, J. D.; Gutierrez, E. J.; Nagaraja, S.; Stafford, P. R.; Sivan, S.; Di Prima, M.

    2017-09-01

    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.

  17. FY1995 biodegradable medical devices with molecular piston function; 1995 nendo bunshi piston kino wo yusuru iryoyo tainai bunkaisei soshi

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-03-01

    The design of biodegradable medical devices with molecular piston function is examined by utilizing the structure of polyrotaxane. A polyrotaxane in which {beta}-cyclodextrins ({beta}-CDs) are threaded onto a block-copolymer of poly(ethylene glycol) (PEG) and poly(propylene glycol) (PPG) is synthesized, and its molecular dynamics is evaluated in terms of the movement of {beta}-CDs along the copolymer. Also, polyrotaxanes in which {alpha}-cyclodextrins ({alpha}-CDs) are threaded onto a PEG chain capped with biodegradable peptide moieties are synthesized, and their degradation characteristics concerning {alpha}-CD release behavior are clarified. Cellular response to these polyrotaxanes is examined as a bioactive molecule. The polyrotaxane composed of {beta}-CDs and the block-copolymer was synthesized, and both assembled and dispersed states of {alpha}-CDs were characterized along the copolymer in response to external stimulus (temperature). Further, the polyrotaxane composed of {alpha}-CDs and PEG were synthesize, and their facility as a drug carrier was evaluated in terms of the release of {alpha}-CDs triggered by the hydrolysis of terminal peptides. Also, these biodegradable polyrotaxanes were found to enhance the fluidity of plasma membranes and to regulate cellular activation (cytoplasmic calcium increase). Thus, the polyrotaxanes were concluded to be promising as novel biomaterials aiming for medical micromachines and polymeric drug carriers. (NEDO)

  18. 77 FR 4252 - Additional Spectrum for the Medical Device Radiocommunication Service

    Science.gov (United States)

    2012-01-27

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

  19. Additive Manufacturing of Biomaterials, Tissues, and Organs.

    Science.gov (United States)

    Zadpoor, Amir A; Malda, Jos

    2017-01-01

    The introduction of additive manufacturing (AM), often referred to as three-dimensional (3D) printing, has initiated what some believe to be a manufacturing revolution, and has expedited the development of the field of biofabrication. Moreover, recent advances in AM have facilitated further development of patient-specific healthcare solutions. Customization of many healthcare products and services, such as implants, drug delivery devices, medical instruments, prosthetics, and in vitro models, would have been extremely challenging-if not impossible-without AM technologies. The current special issue of the Annals of Biomedical Engineering presents the latest trends in application of AM techniques to healthcare-related areas of research. As a prelude to this special issue, we review here the most important areas of biomedical research and clinical practice that have benefited from recent developments in additive manufacturing techniques. This editorial, therefore, aims to sketch the research landscape within which the other contributions of the special issue can be better understood and positioned. In what follows, we briefly review the application of additive manufacturing techniques in studies addressing biomaterials, (re)generation of tissues and organs, disease models, drug delivery systems, implants, medical instruments, prosthetics, orthotics, and AM objects used for medical visualization and communication.

  20. Design for additive bio-manufacturing : From patient-specific medical devices to rationally designed meta-biomaterials

    NARCIS (Netherlands)

    Zadpoor, A.A.

    2017-01-01

    Recent advances in additive manufacturing (AM) techniques in terms of accuracy, reliability, the range of processable materials, and commercial availability have made them promising candidates for production of functional parts including those used in the biomedical industry. The

  1. 77 FR 32644 - Medical Devices; Exemption From Premarket Notification: Wheelchair Elevator

    Science.gov (United States)

    2012-06-01

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

  2. Health Care: Reprocessed Medical Single-Use Devices in DoD

    National Research Council Canada - National Science Library

    2002-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Cvetković Mihajlo

    2014-01-01

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

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

    Science.gov (United States)

    Wen, Jing; Xiao, Jiangyi; Wang, Aijun

    2018-02-08

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

  5. Nanotechnology in medicine: nanofilm biomaterials.

    Science.gov (United States)

    Van Tassel, Paul R

    2013-12-13

    By interrogating nature at the length scale of important biological molecules (proteins, DNA), nanotechnology offers great promise to biomedicine. We review here our recent work on nanofilm biomaterials: "nanoscopically" thin, functional, polymer-based films serving as biocompatible interfaces. In one thrust, films containing carbon nanotubes are shown to be highly antimicrobial and, thus, to be promising as biomedical device materials inherently resistive to microbial infection. In another thrust, strategies are developed toward films of independently controllable bioactivity and mechanical rigidity - two key variables governing typical biological responses.

  6. 75 FR 18219 - Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and...

    Science.gov (United States)

    2010-04-09

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

  7. 77 FR 38177 - TRICARE; Off-Label Uses of Devices; Partial List of Examples of Unproven Drugs, Devices, Medical...

    Science.gov (United States)

    2012-06-27

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

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

    National Research Council Canada - National Science Library

    Abuhav, Itay

    2012-01-01

    .... 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...

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

    Science.gov (United States)

    Keller, James P

    2010-04-01

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

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

    National Research Council Canada - National Science Library

    Goldman, Julian M

    2008-01-01

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

  11. New biomaterials obtained with ionizing radiations

    International Nuclear Information System (INIS)

    Gaussens, G.

    1982-01-01

    In present-day surgery and medicine use is increasingly made of materials foreign to the organism in order to remedy a physiological defect either temporarily or permanently. These materials, known as ''biomaterials'', take widely varying forms: plastics, metals, cements, ceramics, etc. Biomaterials can be classified in accordance with their function: (a) Devices designed to be fully implanted in the human body in order to replace an anatomical structure, either temporarily or permanently, such as articular, vascular, mammary and osteosynthetic prostheses, etc.; (b) Devices having prolonged contact with mucous tissues, such as intra-uterine devices, contact lenses, etc.; (c) Extracorporeal devices designed to treat blood such as artificial kidneys, blood oxygenators, etc.; and (d) Biomaterials can also be taken to mean chemically inert, implantable materials designed to produce a continuous discharge of substances containing pharmacologically active molecules, such as contraceptive devices or ocular devices (for treating glaucoma). The two most important criteria for a biomaterial are those of biological compatibility and biological functionality. Techniques using ionizing radiation as an energy source provide an excellent tool for synthesizing or modifying the properties of plastics. The properties of polymers can be improved, new polymers can be synthesized without chemical additives (often the cause of incompatibility with tissue or blood) and without increased temperature, and polymerization can be induced in the solid state using deep-frozen monomers. Also, radiation-induced modifications in polymers can be applied to semi-finished or finished products. Examples are also given of marketed biomaterials that have been produced using radiation chemistry techniques

  12. Optimize Use of Space Research and Technology for Medical Devices

    Science.gov (United States)

    Minnifield, Nona K.

    2012-01-01

    systems, and cutting-edge component technologies to conduct a wide range of scientific observations and measurements. These technologies are also considered for practical applications that benefit society in remarkable ways. At NASA Goddard, the technology transfer initiative promotes matching technologies from Earth and space science needs to targeted industry sectors. This requires clear knowledge of industry needs and priorities and social demands. The process entails matching mature technologies where there are known innovation challenges and good opportunities for matching technology needs. This requires creative thinking and takes commitment of time and resources. Additionally, we also look at applications for known hot industry or societal needs. Doing so has given us occasion to host discussions with representatives from industry, academia, government organizations, and societal special interest groups about the application of NASA Goddard technologies for devices used in medical monitoring and detection tools. As a result, partnerships have been established. Innovation transpired when new products were enabled because of NASA Goddard research and technology programs.

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

    Directory of Open Access Journals (Sweden)

    Lydia Royeen

    2015-10-01

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

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

    Science.gov (United States)

    Smith, Colleen

    2015-01-01

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

  15. Biofilm and Dental Biomaterials

    Directory of Open Access Journals (Sweden)

    Marit Øilo

    2015-05-01

    Full Text Available All treatment involving the use of biomaterials in the body can affect the host in positive or negative ways. The microbiological environment in the oral cavity is affected by the composition and shape of the biomaterials used for oral restorations. This may impair the patients’ oral health and sometimes their general health as well. Many factors determine the composition of the microbiota and the formation of biofilm in relation to biomaterials such as, surface roughness, surface energy and chemical composition, This paper aims to give an overview of the scientific literature regarding the association between the chemical, mechanical and physical properties of dental biomaterials and oral biofilm formation, with emphasis on current research and future perspectives.

  16. Biomaterials in Artificial Organs.

    Science.gov (United States)

    Kambic, Helen E.; And Others

    1986-01-01

    Biomaterials are substances or combinations of substances that can be used in a system that treats, augments, or replaces any tissue, organ, or body function. The nature and role of these substances, particularly in the cadiovascular system, are discussed. (JN)

  17. [Biomaterials in bone repair].

    Science.gov (United States)

    Puska, Mervi; Aho, Allan J; Vallittu, Pekka K

    2013-01-01

    In orthopedics, traumatology, and craniofacial surgery, biomaterials should meet the clinical demands of bone that include shape, size and anatomical location of the defect, as well as the physiological load-bearing stresses. Biomaterials are metals, ceramics, plastics or materials of biological origin. In the treatment of large defects, metallic endoprostheses or bone grafts are employed, whereas ceramics in the case of small defects. Plastics are employed on the artificial joint surfaces, in the treatment of vertebral compression fractures, and as biodegradable screws and plates. Porosity, bioactivity, and identical biomechanics to bone are fundamental for achieving a durable, well-bonded, interface between biomaterial and bone. In the case of severe bone treatments, biomaterials should also imply an option to add biologically active substances.

  18. Designer biomaterials for mechanobiology

    Science.gov (United States)

    Li, Linqing; Eyckmans, Jeroen; Chen, Christopher S.

    2017-12-01

    Biomaterials engineered with specific bioactive ligands, tunable mechanical properties and complex architecture have emerged as powerful tools to probe cell sensing and response to physical properties of their material surroundings, and ultimately provide designer approaches to control cell function.

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

    Science.gov (United States)

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

    2015-01-01

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

  20. Biomaterials for Tissue Engineering

    Science.gov (United States)

    Lee, Esther J.; Kasper, F. Kurtis; Mikos, Antonios G.

    2013-01-01

    Biomaterials serve as an integral component of tissue engineering. They are designed to provide architectural framework reminiscent of native extracellular matrix in order to encourage cell growth and eventual tissue regeneration. Bone and cartilage represent two distinct tissues with varying compositional and mechanical properties. Despite these differences, both meet at the osteochondral interface. This article presents an overview of current biomaterials employed in bone and cartilage applications, discusses some design considerations, and alludes to future prospects within this field of research. PMID:23820768

  1. Safety problems with the use of medical equipment/devices

    NARCIS (Netherlands)

    Rademakers, C.

    2009-01-01

    In the past decennia medical technology has rapidly developed. Nowadays it plays an important role in all medical fields. It introduced technologic solutions for many medical problems and it definitely increased the possibilities in the medical field to increase the quality of life. However with

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

    Science.gov (United States)

    Blessing, Melissa M; Lin, Peter T

    2018-05-01

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

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

    Directory of Open Access Journals (Sweden)

    Muniz Janaína Barbosa

    2003-01-01

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

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

    Science.gov (United States)

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

    2014-11-01

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

  5. Fiber bundle probes for interconnecting miniaturized medical imaging devices

    Science.gov (United States)

    Zamora, Vanessa; Hofmann, Jens; Marx, Sebastian; Herter, Jonas; Nguyen, Dennis; Arndt-Staufenbiel, Norbert; Schröder, Henning

    2017-02-01

    Miniaturization of medical imaging devices will significantly improve the workflow of physicians in hospitals. Photonic integrated circuit (PIC) technologies offer a high level of miniaturization. However, they need fiber optic interconnection solutions for their functional integration. As part of European funded project (InSPECT) we investigate fiber bundle probes (FBPs) to be used as multi-mode (MM) to single-mode (SM) interconnections for PIC modules. The FBP consists of a set of four or seven SM fibers hexagonally distributed and assembled into a holder that defines a multicore connection. Such a connection can be used to connect MM fibers, while each SM fiber is attached to the PIC module. The manufacturing of these probes is explored by using well-established fiber fusion, epoxy adhesive, innovative adhesive and polishing techniques in order to achieve reliable, low-cost and reproducible samples. An innovative hydrofluoric acid-free fiber etching technology has been recently investigated. The preliminary results show that the reduction of the fiber diameter shows a linear behavior as a function of etching time. Different etch rate values from 0.55 μm/min to 2.3 μm/min were found. Several FBPs with three different type of fibers have been optically interrogated at wavelengths of 630nm and 1550nm. Optical losses are found of approx. 35dB at 1550nm for FBPs composed by 80μm fibers. Although FBPs present moderate optical losses, they might be integrated using different optical fibers, covering a broad spectral range required for imaging applications. Finally, we show the use of FBPs as promising MM-to-SM interconnects for real-world interfacing to PIC's.

  6. 21 CFR 801.125 - Medical devices for use in teaching, law enforcement, research, and analysis.

    Science.gov (United States)

    2010-04-01

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

  7. 76 FR 18227 - Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2011-04-01

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

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

    International Nuclear Information System (INIS)

    Eidenberger, R.Reiner

    2000-01-01

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

  9. 77 FR 32642 - Medical Devices; Exemption From Premarket Notification: Powered Patient Transport

    Science.gov (United States)

    2012-06-01

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

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

    NARCIS (Netherlands)

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

    2007-01-01

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

  11. 78 FR 56719 - Challenging Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of...

    Science.gov (United States)

    2013-09-13

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

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

    NARCIS (Netherlands)

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

    2017-01-01

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

  13. Medical Devices; General Hospital and Personal Use Devices; Classification of the Ultraviolet Radiation Chamber Disinfection Device. Final order.

    Science.gov (United States)

    2015-11-20

    The Food and Drug Administration (FDA or the Agency) is classifying the ultraviolet (UV) radiation chamber disinfection device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the UV radiation chamber disinfection device classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

  14. Applications of biomaterials in corneal wound healing

    Directory of Open Access Journals (Sweden)

    I-Lun Tsai

    2015-04-01

    Full Text Available Disease affecting the cornea is a common cause of blindness worldwide. To date, the amniotic membrane (AM is the most widely used clinical method for cornea regeneration. However, donor-dependent differences in the AM may result in variable clinical outcomes. To overcome this issue, biomaterials are currently under investigation for corneal regeneration in vitro and in vivo. In this article, we highlight the recent advances in hydrogels, bioengineered prosthetic devices, contact lenses, and drug delivery systems for corneal regeneration. In clinical studies, the therapeutic effects of biomaterials, including fibrin and collagen-based hydrogels and silicone contact lenses, have been demonstrated in damaged cornea. The combination of cells and biomaterials may provide potential treatment in corneal wound healing in the future.

  15. 77 FR 3781 - Pediatric Medical Devices; Public Workshop; Reopening of Comment Period

    Science.gov (United States)

    2012-01-25

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

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

    Science.gov (United States)

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

    2017-01-01

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

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

    Science.gov (United States)

    2017-10-01

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

  18. Stepping into the omics era: Opportunities and challenges for biomaterials science and engineering☆

    Science.gov (United States)

    Rabitz, Herschel; Welsh, William J.; Kohn, Joachim; de Boer, Jan

    2016-01-01

    The research paradigm in biomaterials science and engineering is evolving from using low-throughput and iterative experimental designs towards high-throughput experimental designs for materials optimization and the evaluation of materials properties. Computational science plays an important role in this transition. With the emergence of the omics approach in the biomaterials field, referred to as materiomics, high-throughput approaches hold the promise of tackling the complexity of materials and understanding correlations between material properties and their effects on complex biological systems. The intrinsic complexity of biological systems is an important factor that is often oversimplified when characterizing biological responses to materials and establishing property-activity relationships. Indeed, in vitro tests designed to predict in vivo performance of a given biomaterial are largely lacking as we are not able to capture the biological complexity of whole tissues in an in vitro model. In this opinion paper, we explain how we reached our opinion that converging genomics and materiomics into a new field would enable a significant acceleration of the development of new and improved medical devices. The use of computational modeling to correlate high-throughput gene expression profiling with high throughput combinatorial material design strategies would add power to the analysis of biological effects induced by material properties. We believe that this extra layer of complexity on top of high-throughput material experimentation is necessary to tackle the biological complexity and further advance the biomaterials field. PMID:26876875

  19. 76 FR 36548 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-06-22

    ... information related to the humanitarian device exemption for the Berlin Heart EXCOR Pediatric Ventricular Assist Device (VAD) sponsored by Berlin Heart, Inc. The Berlin Heart EXCOR Pediatric VAD device is a..., please contact AnnMarie Williams, Conference Management Staff, at 301-796-5966, at least 7 days in...

  20. Wear Characteristics of Metallic Biomaterials: A Review

    Science.gov (United States)

    Hussein, Mohamed A.; Mohammed, Abdul Samad; Al-Aqeeli, Naser

    2015-01-01

    Metals are extensively used in a variety of applications in the medical field for internal support and biological tissue replacements, such as joint replacements, dental roots, orthopedic fixation, and stents. The metals and alloys that are primarily used in biomedical applications are stainless steels, Co alloys, and Ti alloys. The service period of a metallic biomaterial is determined by its abrasion and wear resistance. A reduction in the wear resistance of the implant results in the release of incompatible metal ions into the body that loosen the implant. In addition, several reactions may occur because of the deposition of wear debris in tissue. Therefore, developing biomaterials with high wear resistance is critical to ensuring a long life for the biomaterial. The aim of this work is to review the current state of knowledge of the wear of metallic biomaterials and how wear is affected by the material properties and conditions in terms of the type of alloys developed and fabrication processes. We also present a brief evaluation of various experimental test techniques and wear characterization techniques that are used to determine the tribological performance of metallic biomaterials.

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

    Science.gov (United States)

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

    2013-12-01

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

  2. Viscoelasticity of biomaterials

    International Nuclear Information System (INIS)

    Glasser, W.G.; Hatakeyama, H.

    1992-01-01

    Viscoelasticity of Biomaterials is divided into three sections. The first offers a materials design lesson on the architectural arrangement of biopolymers in collagen. Included also are reviews on solution properties of polysacchardies, chiral and liquid crystalline solution characteristics of cellulose derivatives, and viscoelastic properties of wood and wood fiber reinforced thermoplastics. The second section, Biogels and Gelation, discusses the molecular arrangements of highly hydrated biomaterials such as mucus, gums, skinlike tissue, and silk fibroin. The physical effects that result from the transition from a liquid to a solid state are the subject of the third section, which focuses on relaxation phenomena. Gel formation, the conformation of domain structures, and motional aspects of complex biomaterials are described in terms of recent experimental advances in various fields. A relevant chapter on the effects of ionizing radiation on connective tissue is abstracted separately

  3. Advanced biomaterials and biodevices

    CERN Document Server

    Tiwari, Ashutosh

    2014-01-01

    Biomaterials are the fastest-growing emerging field of  biodevices. Design and development of biomaterials play a significant role in the diagnosis, treatment, and prevention of diseases. Recently, a variety of scaffolds/carriers have been evaluated for tissue regeneration, drug delivery, sensing and imaging.  Liposomes and microspheres have been developed for sustained delivery. Several anti-cancer drugs have been successfully formulated using biomaterial. The targeting of drugs to certain physiological sites has emerged as a promising tool in the treatment with improved drug bioavailability and reduction of dosing frequency. Biodevices-based targeting of drugs may improve the therapeutic success by limiting the adverse drug effects and resulting in more patient compliance and attaining a higher adherence level. Advanced biodevices hold merit as a drug carrier with high carrier capacity, feasibility of incorporation of both hydrophilic and hydrophobic substances, high stability, as well as the feasibility...

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

    Science.gov (United States)

    Zippel, Claus; Bohnet-Joschko, Sabine

    2017-08-01

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

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

    Science.gov (United States)

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

    2018-01-01

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

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

    Science.gov (United States)

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

    2017-01-01

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

  7. Current challenges for clinical trials of cardiovascular medical devices.

    Science.gov (United States)

    Zannad, Faiez; Stough, Wendy Gattis; Piña, Ileana L; Mehran, Roxana; Abraham, William T; Anker, Stefan D; De Ferrari, Gaetano M; Farb, Andrew; Geller, Nancy L; Kieval, Robert S; Linde, Cecilia; Redberg, Rita F; Stein, Kenneth; Vincent, Alphons; Woehrle, Holger; Pocock, Stuart J

    2014-07-15

    Several features of cardiovascular devices raise considerations for clinical trial conduct. Prospective, randomized, controlled trials remain the highest quality evidence for safety and effectiveness assessments, but, for instance, blinding may be challenging. In order to avoid bias and not confound data interpretation, the use of objective endpoints and blinding patients, study staff, core labs, and clinical endpoint committees to treatment assignment are helpful approaches. Anticipation of potential bias should be considered and planned for prospectively in a cardiovascular device trial. Prospective, single-arm studies (often referred to as registry studies) can provide additional data in some cases. They are subject to selection bias even when carefully designed; thus, they are generally not acceptable as the sole basis for pre-market approval of high risk cardiovascular devices. However, they complement the evidence base and fill the gaps unanswered by randomized trials. Registry studies present device safety and effectiveness in day-to-day clinical practice settings and detect rare adverse events in the post-market period. No single research design will be appropriate for every cardiovascular device or target patient population. The type of trial, appropriate control group, and optimal length of follow-up will depend on the specific device, its potential clinical benefits, the target patient population and the existence (or lack) of effective therapies, and its anticipated risks. Continued efforts on the part of investigators, the device industry, and government regulators are needed to reach the optimal approach for evaluating the safety and performance of innovative devices for the treatment of cardiovascular disease. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

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

    CERN Document Server

    Abuhav, Itay

    2011-01-01

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

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

    Science.gov (United States)

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

    2012-01-01

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

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

    Science.gov (United States)

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

    2012-03-01

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

  11. Safety evaluation in the development of medical devices and combination products

    CERN Document Server

    Gad, Shayne C

    2008-01-01

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

  12. Medical devices; neurological devices; classification of the transcutaneous electrical nerve stimulator to treat headache. Final order.

    Science.gov (United States)

    2014-07-03

    The Food and Drug Administration (FDA) is classifying the transcutaneous electrical nerve stimulator to treat headache into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the transcutaneous electrical nerve stimulator to treat headache classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

  13. Medical devices; neurological devices; classification of the transcranial magnetic stimulator for headache. Final order.

    Science.gov (United States)

    2014-07-08

    The Food and Drug Administration (FDA) is classifying the transcranial magnetic stimulator for headache into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the transcranial magnetic stimulator for headache classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

  14. Medical Devices; Neurological Devices; Classification of the External Vagal Nerve Stimulator for Headache. Final order.

    Science.gov (United States)

    2017-12-27

    The Food and Drug Administration (FDA or we) is classifying the external vagal nerve stimulator for headache into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the external vagal nerve stimulator for headache's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

  15. Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Organophosphate Test System. Final order.

    Science.gov (United States)

    2017-10-18

    The Food and Drug Administration (FDA or we) is classifying the organophosphate test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the organophosphate test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

  16. Medical Devices; Obstetrical and Gynecological Devices; Classification of the Fetal Head Elevator. Final order.

    Science.gov (United States)

    2017-12-19

    The Food and Drug Administration (FDA or we) is classifying the fetal head elevator into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the fetal head elevator's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

  17. Medical Devices; Hematology and Pathology Devices; Classification of a Cervical Intraepithelial Neoplasia Test System. Final order.

    Science.gov (United States)

    2018-01-03

    The Food and Drug Administration (FDA or we) is classifying the cervical intraepithelial neoplasia (CIN) test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the CIN test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

  18. Biomaterials for tissue engineering: summary

    Science.gov (United States)

    Christenson, L.; Mikos, A. G.; Gibbons, D. F.; Picciolo, G. L.; McIntire, L. V. (Principal Investigator)

    1997-01-01

    This article summarizes presentations and discussion at the workshop "Enabling Biomaterial Technology for Tissue Engineering," which was held during the Fifth World Biomaterials Congress in May 1996. Presentations covered the areas of material substrate architecture, barrier effects, and cellular response, including analysis of biomaterials challenges involved in producing specific tissue-engineered products.

  19. Biomaterials modification by ion beam

    International Nuclear Information System (INIS)

    Zhang Tonghe; Yi Zhongzhen; Zhang Xu; Wu Yuguang

    2001-01-01

    Ion beam technology is one of best ways for the modification of biomaterials. The results of ion beam modification of biomaterials are given. The method and results of improved biocompatibility are indicated by ion beam technology. The future development of ion beam modification of biomaterials is discussed

  20. 76 FR 34845 - Medical Devices; Ear, Nose, and Throat Devices; Classification of the Wireless Air-Conduction...

    Science.gov (United States)

    2011-06-15

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

  1. Properties and processing technologies of polymers for medical devices; Proprieta' e tecnologie di lavorazione dei polimeri utilizzati nei dispositivi medici

    Energy Technology Data Exchange (ETDEWEB)

    Salernitano, E. [ENEA, Divisione Nuovi Materiali, Centro Ricerche Casaccia, Rome (Italy)

    2000-07-01

    The variety of biomaterials applications in medical devices for substitution or functional integration of organs and tissues has remarkably grown. This has allowed an increased survival of patients affected by traumatic or pathologic events. Biomaterials growing variety and improvement were remarkable and constant over the last twenty years; this fact yielded important clinical effects in every medical area, especially in orthopaedics, cardiovascular surgery and dentistry. Performances of medical materials are evaluated according to their bio functionality and biocompatibility. These concepts are strongly connected: bio functionality refers to devices physical and mechanical properties which allow to perform a specific function. Several transformation methods and different processing technologies allow to obtain products having different physico-chemical and mechanical properties. Among them, chemical and physical stability, biocompatibility, possibility to undergo sterilisation process, control of gases and moisture permeability, control of biodegradation products, wear and fatigue resistance and toughness are the most relevant. Most of research efforts are devoted to improve reliability and last of biomaterials already used thanks to their bio functionality and biocompatibility. Expected developments of medial devices are associated with the design of bio artificial organs, where biomaterials act as a scaffold for the three-dimensional cells growth. [Italian] Il numero delle applicazioni dei biomateriali in dispositivi medici che sostituiscono od integrino dal punto di vista funzionale organi o tessuti e' cresciuto notevolmente. Questo ha portato ad un aumento della sopravvivenza dei pazienti colpiti da eventi patologici o traumatici. La crescita ed il perfezionamento dei biomateriali e' stata, infatti, nell'ultimo ventennio considerevole e costante ed ha avuto importanti ricadute cliniche in tutte le discipline mediche ed in particolare in

  2. Prodrugs as self-assembled hydrogels: a new paradigm for biomaterials.

    Science.gov (United States)

    Vemula, Praveen Kumar; Wiradharma, Nikken; Ankrum, James A; Miranda, Oscar R; John, George; Karp, Jeffrey M

    2013-12-01

    Prodrug-based self-assembled hydrogels represent a new class of active biomaterials that can be harnessed for medical applications, in particular the design of stimuli responsive drug delivery devices. In this approach, a promoiety is chemically conjugated to a known-drug to generate an amphiphilic prodrug that is capable of forming self-assembled hydrogels. Prodrug-based self-assembled hydrogels are advantageous as they alter the solubility of the drug, enhance drug loading, and eliminate the use of harmful excipients. In addition, self-assembled prodrug hydrogels can be designed to undergo controlled drug release or tailored degradation in response to biological cues. Herein we review the development of prodrug-based self-assembled hydrogels as an emerging class of biomaterials that overcome several common limitations encountered in conventional drug delivery. Published by Elsevier Ltd.

  3. Corrosion behaviour of electropolished AISI 316L austenitic biomaterial in physiological solution

    Science.gov (United States)

    Zatkalíková, V.; Markovičová, L.; Škorvanová, M.

    2017-11-01

    Due to suitable mechanical properties, satisfactory corrosion resistance and relatively low cost, austenitic stainless steels are important biomaterials for manufacture of implants and various medical instruments and devices. Their corrosion properties and biocompatibility are significantly affected by protective passive surface film quality, which depends on used mechanical and chemical surface treatment. This article deals with corrosion resistance of AISI 316L stainless steel, which is the most widely used Cr-Ni-Mo austenitic biomaterial. Corrosion behaviour of five various surfaces (original, electropolished, three surfaces with combined treatment finished by electropolishing) is evaluated on the bases of cyclic potentiodynamic polarization tests performed in physiological solution at the temperature of 37± 0.5 °C.

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

    Science.gov (United States)

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

    2018-02-23

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

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

    Science.gov (United States)

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

    2012-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Maresova P

    2015-10-01

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

  7. Silk-based biomaterials.

    Science.gov (United States)

    Altman, Gregory H; Diaz, Frank; Jakuba, Caroline; Calabro, Tara; Horan, Rebecca L; Chen, Jingsong; Lu, Helen; Richmond, John; Kaplan, David L

    2003-02-01

    Silk from the silkworm, Bombyx mori, has been used as biomedical suture material for centuries. The unique mechanical properties of these fibers provided important clinical repair options for many applications. During the past 20 years, some biocompatibility problems have been reported for silkworm silk; however, contamination from residual sericin (glue-like proteins) was the likely cause. More recent studies with well-defined silkworm silk fibers and films suggest that the core silk fibroin fibers exhibit comparable biocompatibility in vitro and in vivo with other commonly used biomaterials such as polylactic acid and collagen. Furthermore, the unique mechanical properties of the silk fibers, the diversity of side chain chemistries for 'decoration' with growth and adhesion factors, and the ability to genetically tailor the protein provide additional rationale for the exploration of this family of fibrous proteins for biomaterial applications. For example, in designing scaffolds for tissue engineering these properties are particularly relevant and recent results with bone and ligament formation in vitro support the potential role for this biomaterial in future applications. To date, studies with silks to address biomaterial and matrix scaffold needs have focused on silkworm silk. With the diversity of silk-like fibrous proteins from spiders and insects, a range of native or bioengineered variants can be expected for application to a diverse set of clinical needs.

  8. Electrophoretic deposition of biomaterials

    Science.gov (United States)

    Boccaccini, A. R.; Keim, S.; Ma, R.; Li, Y.; Zhitomirsky, I.

    2010-01-01

    Electrophoretic deposition (EPD) is attracting increasing attention as an effective technique for the processing of biomaterials, specifically bioactive coatings and biomedical nanostructures. The well-known advantages of EPD for the production of a wide range of microstructures and nanostructures as well as unique and complex material combinations are being exploited, starting from well-dispersed suspensions of biomaterials in particulate form (microsized and nanoscale particles, nanotubes, nanoplatelets). EPD of biological entities such as enzymes, bacteria and cells is also being investigated. The review presents a comprehensive summary and discussion of relevant recent work on EPD describing the specific application of the technique in the processing of several biomaterials, focusing on (i) conventional bioactive (inorganic) coatings, e.g. hydroxyapatite or bioactive glass coatings on orthopaedic implants, and (ii) biomedical nanostructures, including biopolymer–ceramic nanocomposites, carbon nanotube coatings, tissue engineering scaffolds, deposition of proteins and other biological entities for sensors and advanced functional coatings. It is the intention to inform the reader on how EPD has become an important tool in advanced biomaterials processing, as a convenient alternative to conventional methods, and to present the potential of the technique to manipulate and control the deposition of a range of nanomaterials of interest in the biomedical and biotechnology fields. PMID:20504802

  9. EPR analysis of biomaterials

    International Nuclear Information System (INIS)

    Sukhodub, L.

    2001-01-01

    There is the review of electron spin resonance application for paramagnetic individual investigation in biomaterials. Especially the bone tissue and tooth enamel can be taken into account. The material composition (e.g. Mn 2+ and Cr 3+ ions) can be measured, also after irradiation (X, γ radiations) when paramagnetic signal appears as a result of physical radiation effects

  10. Hot topics in biomaterials

    CERN Document Server

    Alton, Eric W; Griesenbach, Uta

    2014-01-01

    The expert coverage of the eight chapters in this book reflects the diverse nature of the field of biomaterials science and encompasses contributions from a wide range of fields, highlighting key classes of novel materials and exploring the underlying science and potential applications.

  11. 78 FR 49272 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-08-13

    ... into two types: (1) Devices that provide automatic chest compressions at a fixed compression rate and... circuit is comprised of multiple device types, including, but not limited to, an oxygenator, blood pump... submit a brief statement of the general nature of the evidence or arguments they wish to present, the...

  12. 76 FR 44489 - Medical Devices; Neurological Devices; Classification of Repetitive Transcranial Magnetic...

    Science.gov (United States)

    2011-07-26

    ... is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient... premarket notification, prior to marketing the device, which contains information about the rTMS system they... significant effect on the human environment. Thus, neither an environmental assessment nor an environmental...

  13. 78 FR 14013 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Wheelchair Elevator

    Science.gov (United States)

    2013-03-04

    ... Elevator AGENCY: Food and Drug Administration, HHS. ACTION: Final order. SUMMARY: The Food and Drug... requirements for wheelchair elevator devices commonly known as inclined platform lifts and vertical platform... wheelchair elevators, class II devices, from premarket notification and establishes conditions for exemption...

  14. Medical devices; exemption from premarket notification; class II devices; wheelchair elevator. Final order.

    Science.gov (United States)

    2013-03-04

    The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from premarket notification requirements for wheelchair elevator devices commonly known as inclined platform lifts and vertical platform lifts. These devices are used to provide a means for a person with a mobility impairment caused by injury or other disease to move from one level to another, usually in a wheelchair. This order exempts wheelchair elevators, class II devices, from premarket notification and establishes conditions for exemption for this device that will provide a reasonable assurance of the safety and effectiveness of the device without submission of a premarket notification (510(k)). This exemption from 510(k), subject to these conditions, is immediately in effect for wheelchair elevators. All other devices classified under FDA's wheelchair elevator regulations, including attendant-operated stair climbing devices for wheelchairs and portable platform lifts, continue to require submission of 510(k)s. FDA is publishing this order in accordance with the section of the Food, Drug, and Cosmetic Act (the FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k).

  15. Medical devices; immunology and microbiology devices; classification of John Cunningham Virus serological reagents. Final order.

    Science.gov (United States)

    2014-01-23

    The Food and Drug Administration (FDA) is classifying John Cunningham Virus (JCV) serological reagents into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

  16. 76 FR 21237 - Medical Devices; Obstetrical and Gynecological Devices; Classification of the Hemorrhoid...

    Science.gov (United States)

    2011-04-15

    ... type of device must submit to FDA a premarket notification, prior to marketing the device, which... directs agencies to assess all costs and benefits of available regulatory alternatives and, when... economic, environmental, public health and safety, and other advantages; distributive impacts; and equity...

  17. 76 FR 43119 - Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound...

    Science.gov (United States)

    2011-07-20

    ... type of device must submit to FDA a premarket notification, prior to marketing the device, which... Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory... (including potential economic, environmental, public health and safety, and other advantages; distributive...

  18. Payments by US pharmaceutical and medical device manufacturers to US medical journal editors: retrospective observational study

    Science.gov (United States)

    Bell, Chaim M; Matelski, John J; Detsky, Allan S; Cram, Peter

    2017-01-01

    Objective To estimate financial payments from industry to US journal editors. Design Retrospective observational study. Setting 52 influential (high impact factor for their specialty) US medical journals from 26 specialties and US Open Payments database, 2014. Participants 713 editors at the associate level and above identified from each journal’s online masthead. Main outcome measures All general payments (eg, personal income) and research related payments from pharmaceutical and medical device manufacturers to eligible physicians in 2014. Percentages of editors receiving payments and the magnitude of such payments were compared across journals and by specialty. Journal websites were also reviewed to determine if conflict of interest policies for editors were readily accessible. Results Of 713 eligible editors, 361 (50.6%) received some (>$0) general payments in 2014, and 139 (19.5%) received research payments. The median general payment was $11 (£8; €9) (interquartile range $0-2923) and the median research payment was $0 ($0-0). The mean general payment was $28 136 (SD $415 045), and the mean research payment was $37 963 (SD $175 239). The highest median general payments were received by journal editors from endocrinology ($7207, $0-85 816), cardiology ($2664, $0-12 912), gastroenterology ($696, $0-20 002), rheumatology ($515, $0-14 280), and urology ($480, $90-669). For high impact general medicine journals, median payments were $0 ($0-14). A review of the 52 journal websites revealed that editor conflict of interest policies were readily accessible (ie, within five minutes) for 17/52 (32.7%) of journals. Conclusions Industry payments to journal editors are common and often large, particularly for certain subspecialties. Journals should consider the potential impact of such payments on public trust in published research. PMID:29074628

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

    Science.gov (United States)

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

    2015-06-01

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

  20. The development of peptide-based interfacial biomaterials for generating biological functionality on the surface of bioinert materials.

    Science.gov (United States)

    Meyers, Steven R; Khoo, Xiaojuan; Huang, Xin; Walsh, Elisabeth B; Grinstaff, Mark W; Kenan, Daniel J

    2009-01-01

    Biomaterials used in implants have traditionally been selected based on their mechanical properties, chemical stability, and biocompatibility. However, the durability and clinical efficacy of implantable biomedical devices remain limited in part due to the absence of appropriate biological interactions at the implant interface and the lack of integration into adjacent tissues. Herein, we describe a robust peptide-based coating technology capable of modifying the surface of existing biomaterials and medical devices through the non-covalent binding of modular biofunctional peptides. These peptides contain at least one material binding sequence and at least one biologically active sequence and thus are termed, "Interfacial Biomaterials" (IFBMs). IFBMs can simultaneously bind the biomaterial surface while endowing it with desired biological functionalities at the interface between the material and biological realms. We demonstrate the capabilities of model IFBMs to convert native polystyrene, a bioinert surface, into a bioactive surface that can support a range of cell activities. We further distinguish between simple cell attachment with insufficient integrin interactions, which in some cases can adversely impact downstream biology, versus biologically appropriate adhesion, cell spreading, and cell survival mediated by IFBMs. Moreover, we show that we can use the coating technology to create spatially resolved patterns of fluorophores and cells on substrates and that these patterns retain their borders in culture.

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

    DEFF Research Database (Denmark)

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

    2016-01-01

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

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

    National Research Council Canada - National Science Library

    Shunmugaperumal, Tamilvanan

    2010-01-01

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

  3. [Precautions of physical performance requirements and test methods during product standard drafting process of medical devices].

    Science.gov (United States)

    Song, Jin-Zi; Wan, Min; Xu, Hui; Yao, Xiu-Jun; Zhang, Bo; Wang, Jin-Hong

    2009-09-01

    The major idea of this article is to discuss standardization and normalization for the product standard of medical devices. Analyze the problem related to the physical performance requirements and test methods during product standard drafting process and make corresponding suggestions.

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

    International Nuclear Information System (INIS)

    Triani, Gerry; Doe, Simon

    2005-01-01

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

  5. 77 FR 125 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification...

    Science.gov (United States)

    2012-01-03

    ... organization. These 16 Panels have largely been the driving force for CDRH's internal organizational structure...). The draft guidance, when finalized, will represent the Agency's current thinking on medical device...

  6. 78 FR 21612 - Medical Device Classification Product Codes; Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-04-11

    ... driving force for CDRH's internal organizational structure as well. These Panels were established with the... guidance represents the Agency's current thinking on medical device classification product codes. It does...

  7. 75 FR 20854 - Medical Device Use in the Home Environment: Implications for the Safe and Effective Use of...

    Science.gov (United States)

    2010-04-21

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

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

    Science.gov (United States)

    2010-10-01

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

  9. Role of plasma fibronectin in the foreign body response to biomaterials.

    Science.gov (United States)

    Keselowsky, Benjamin G; Bridges, Amanda W; Burns, Kellie L; Tate, Ciara C; Babensee, Julia E; LaPlaca, Michelle C; García, Andrés J

    2007-09-01

    Host responses to biomaterials control the biological performance of implanted medical devices. Upon implantation, synthetic materials adsorb biomolecules, which trigger an inflammatory cascade comprising coagulation, leukocyte recruitment/adhesion, and foreign body reaction. The foreign body reaction and ensuing fibrous encapsulation severely limit the in vivo performance of numerous biomedical devices. While it is well established that plasma fibrinogen and secreted cytokines modulate leukocyte recruitment and maturation into foreign body giant cells, mediators of chronic inflammation and fibrous encapsulation of implanted biomaterials remain poorly understood. Using plasma fibronectin (pFN) conditional knock-out mice, we demonstrate that pFN modulates the foreign body response to polyethylene terephthalate disks implanted subcutaneously. Fibrous collagenous capsules were two-fold thicker in mice depleted of pFN compared to controls. In contrast, deletion of pFN did not alter acute leukocyte recruitment to the biomaterial, indicating that pFN modulates chronic fibrotic responses. The number of foreign body giant cells associated with the implant was three times higher in the absence of pFN while macrophage numbers were not different, suggesting that pFN regulates the formation of biomaterial-associated foreign body giant cells. Interestingly, cellular FN (cFN) was present in the capsules of both normal and pFN-depleted mice, suggesting that cFN could not compensate for the loss of pFN. These results implicate pFN in the host response to implanted materials and identify a potential target for therapeutic intervention to enhance the biological performance of biomedical devices.

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

    Science.gov (United States)

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

    2011-05-01

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

  11. Applications of carbon nanotubes-based biomaterials in biomedical nanotechnology.

    Science.gov (United States)

    Polizu, Stefania; Savadogo, Oumarou; Poulin, Philippe; Yahia, L'Hocine

    2006-07-01

    One of the facets of nanotechnology applications is the immense opportunities they offer for new developments in medicine and health sciences. Carbon nanotubes (CNTs) have particularly attracted attention for designing new monitoring systems for environment and living cells as well as nanosensors. Carbon nanotubes-based biomaterials are also employed as support for active prosthesis or functional matrices in reparation of parts of the human body. These nanostructures are studied as molecular-level building blocks for the complex and miniaturized medical device, and substrate for stimulation of cellular growth. The CNTs are cylindrical shaped with caged molecules which can act as nanoscale containers for molecular species, well required for biomolecular recognition and drug delivery systems. Endowed with very large aspect ratios, an excellent electrical conductivity and inertness along with mechanical robustness, nanotubes found enormous applications in molecular electronics and bioelectronics. The ballistic electrical behaviour of SWNTs conjugated with functionalization promotes a large variety of biosensors for individual molecules. Actuative response of CNTs is considered very promising feature for nanodevices, micro-robots and artificial muscles. An description of CNTs based biomaterials is attempted in this review, in order to point out their enormous potential for biomedical nanotechnology and nanobiotechnology.

  12. Advancing biomaterials of human origin for tissue engineering

    OpenAIRE

    Chen, Fa-Ming; Liu, Xiaohua

    2015-01-01

    Biomaterials have played an increasingly prominent role in the success of biomedical devices and in the development of tissue engineering, which seeks to unlock the regenerative potential innate to human tissues/organs in a state of deterioration and to restore or reestablish normal bodily function. Advances in our understanding of regenerative biomaterials and their roles in new tissue formation can potentially open a new frontier in the fast-growing field of regenerative medicine. Taking in...

  13. Graded/Gradient Porous Biomaterials

    Directory of Open Access Journals (Sweden)

    Xigeng Miao

    2009-12-01

    Full Text Available Biomaterials include bioceramics, biometals, biopolymers and biocomposites and they play important roles in the replacement and regeneration of human tissues. However, dense bioceramics and dense biometals pose the problem of stress shielding due to their high Young’s moduli compared to those of bones. On the other hand, porous biomaterials exhibit the potential of bone ingrowth, which will depend on porous parameters such as pore size, pore interconnectivity, and porosity. Unfortunately, a highly porous biomaterial results in poor mechanical properties. To optimise the mechanical and the biological properties, porous biomaterials with graded/gradient porosity, pores size, and/or composition have been developed. Graded/gradient porous biomaterials have many advantages over graded/gradient dense biomaterials and uniform or homogenous porous biomaterials. The internal pore surfaces of graded/gradient porous biomaterials can be modified with organic, inorganic, or biological coatings and the internal pores themselves can also be filled with biocompatible and biodegradable materials or living cells. However, graded/gradient porous biomaterials are generally more difficult to fabricate than uniform or homogenous porous biomaterials. With the development of cost-effective processing techniques, graded/gradient porous biomaterials can find wide applications in bone defect filling, implant fixation, bone replacement, drug delivery, and tissue engineering.

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

    Science.gov (United States)

    Bruzzi, M S; Linehan, J H

    2013-09-01

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

  15. 75 FR 17143 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Science.gov (United States)

    2010-04-05

    ... 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...

  16. 75 FR 44267 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Science.gov (United States)

    2010-07-28

    ... 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...

  17. Virtual worlds are an innovative tool for medical device training in a simulated environment.

    Science.gov (United States)

    Patel, Vishal; Lee, Henry; Taylor, Dave; Aggarwal, Rajesh; Kinross, James; Darzi, Ara

    2012-01-01

    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.

  18. 77 FR 26769 - Educational Forum on Medical Device Reporting, Complaint Files, and Recalls, Corrections, and...

    Science.gov (United States)

    2012-05-07

    ... 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...

  19. 76 FR 20840 - Medical Devices; General and Plastic Surgery Devices; Classification of the Low Level Laser...

    Science.gov (United States)

    2011-04-14

    ... looking directly at the laser beam and the wearing of appropriate laser safety eyewear by both the user...). The special control for this device is the FDA guidance document entitled ``Guidance for Industry and...

  20. 78 FR 25747 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2013-05-02

    ... Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD... as catheters, cannulae or hollow needles. Chronic hemodialysis catheters are soft, blunt-tipped...

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

    OpenAIRE

    Haghi, Mostafa; Thurow, Kerstin; Stoll, Regina

    2017-01-01

    Objectives 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 a...

  2. A Sensor Middleware for integration of heterogeneous medical devices.

    Science.gov (United States)

    Brito, M; Vale, L; Carvalho, P; Henriques, J

    2010-01-01

    In this paper, the architecture of a modular, service-oriented, Sensor Middleware for data acquisition and processing is presented. The described solution was developed with the purpose of solving two increasingly relevant problems in the context of modern pHealth systems: i) to aggregate a number of heterogeneous, off-the-shelf, devices from which clinical measurements can be acquired and ii) to provide access and integration with an 802.15.4 network of wearable sensors. The modular nature of the Middleware provides the means to easily integrate pre-processing algorithms into processing pipelines, as well as new drivers for adding support for new sensor devices or communication technologies. Tests performed with both real and artificially generated data streams show that the presented solution is suitable for use both in a Windows PC or a Windows Mobile PDA with minimal overhead.

  3. Enabling Medical Device Interoperability for the Integrated Clinical Environment

    Science.gov (United States)

    2016-12-01

    context. For instance, part of the data logger demo at NIH included a scenario in which the patient received an overdose from a PCA pump . The device...data shows the patient’s physiologic response, the log from a PCA pump would show that the dose request button was pressed, but only the video could...databases including Microsoft Access  vcd (IEEE-1364) – Value Change Dump – a waveform storage format defined by the Institute of Electrical and

  4. Implantable Glucose BioFuel Cells for Medical Devices

    International Nuclear Information System (INIS)

    Cinquin, P; Martin, D K; Cosnier, S; Belgacem, N; Cosnier, M L; Dal Molin, R

    2013-01-01

    An Implantable BioFuel Cell (IBFC) is a device that produces power only from the chemicals that are naturally occurring inside the body. We have been working on two approaches to creating an IBFC. The first approach is to use chemicals such as glucose and oxygen to provide the fuel for an enzymatic IBFC. The second approach is to use electrolytes such as sodium to provide the fuel for a biomimetic IBFC

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

    Directory of Open Access Journals (Sweden)

    Howard JJ

    2014-11-01

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

  6. Bioresorption and degradation of biomaterials.

    Science.gov (United States)

    Das, Debarun; Zhang, Ziyang; Winkler, Thomas; Mour, Meenakshi; Gunter, Christina; Morlock, Michael; Machens, Hans-Gunther; Schilling, Arndt F

    2012-01-01

    The human body is a composite structure, completely constructed of biodegradable materials. This allows the cells of the body to remove and replace old or defective tissue with new material. Consequently, artificial resorbable biomaterials have been developed for application in regenerative medicine. We discuss here advantages and disadvantages of these bioresorbable materials for medical applications and give an overview of typically used metals, ceramics and polymers. Methods for the quantification of bioresorption in vitro and in vivo are described. The next challenge will be to better understand the interface between cell and material and to use this knowledge for the design of “intelligent” materials that can instruct the cells to build specific tissue geometries and degrade in the process.

  7. 78 FR 950 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2013-01-07

    ..., 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...

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

    NARCIS (Netherlands)

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

    2016-01-01

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

  9. 77 FR 52742 - Public Meeting-Strengthening the National Medical Device Postmarket Surveillance System; Request...

    Science.gov (United States)

    2012-08-30

    ... 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...

  10. 21 CFR 610.42 - Restrictions on use for further manufacture of medical devices.

    Science.gov (United States)

    2010-04-01

    ... 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...

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

    Science.gov (United States)

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

    2013-01-01

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

  12. Payments by US pharmaceutical and medical device manufacturers to US medical journal editors: retrospective observational study.

    Science.gov (United States)

    Liu, Jessica J; Bell, Chaim M; Matelski, John J; Detsky, Allan S; Cram, Peter

    2017-10-26

    Objective  To estimate financial payments from industry to US journal editors. Design  Retrospective observational study. Setting  52 influential (high impact factor for their specialty) US medical journals from 26 specialties and US Open Payments database, 2014. Participants  713 editors at the associate level and above identified from each journal's online masthead. Main outcome measures  All general payments (eg, personal income) and research related payments from pharmaceutical and medical device manufacturers to eligible physicians in 2014. Percentages of editors receiving payments and the magnitude of such payments were compared across journals and by specialty. Journal websites were also reviewed to determine if conflict of interest policies for editors were readily accessible. Results  Of 713 eligible editors, 361 (50.6%) received some (>$0) general payments in 2014, and 139 (19.5%) received research payments. The median general payment was $11 (£8; €9) (interquartile range $0-2923) and the median research payment was $0 ($0-0). The mean general payment was $28 136 (SD $415 045), and the mean research payment was $37 963 (SD $175 239). The highest median general payments were received by journal editors from endocrinology ($7207, $0-85 816), cardiology ($2664, $0-12 912), gastroenterology ($696, $0-20 002), rheumatology ($515, $0-14 280), and urology ($480, $90-669). For high impact general medicine journals, median payments were $0 ($0-14). A review of the 52 journal websites revealed that editor conflict of interest policies were readily accessible (ie, within five minutes) for 17/52 (32.7%) of journals. Conclusions  Industry payments to journal editors are common and often large, particularly for certain subspecialties. Journals should consider the potential impact of such payments on public trust in published research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a

  13. Protective device for organs exposed to medical X-radiation

    International Nuclear Information System (INIS)

    Zimmer, K.

    1978-01-01

    The protective device for male or female gonads consists of a protective screen made of hard lead coated with silicon caoutchouc, a flexible supporting arm, and a base plate on which the supporting arm for the protective screen is monted. The protective screen has got the shape of a dish resp. a pear-shaped contour for male resp. female persons. The base may be arranged on a Bucky table between the legs of the person to be examined by means of suction cups. (DG) [de

  14. Biomaterials and bone mechanotransduction

    Science.gov (United States)

    Sikavitsas, V. I.; Temenoff, J. S.; Mikos, A. G.; McIntire, L. V. (Principal Investigator)

    2001-01-01

    Bone is an extremely complex tissue that provides many essential functions in the body. Bone tissue engineering holds great promise in providing strategies that will result in complete regeneration of bone and restoration of its function. Currently, such strategies include the transplantation of highly porous scaffolds seeded with cells. Prior to transplantation the seeded cells are cultured in vitro in order for the cells to proliferate, differentiate and generate extracellular matrix. Factors that can affect cellular function include the cell-biomaterial interaction, as well as the biochemical and the mechanical environment. To optimize culture conditions, good understanding of these parameters is necessary. The new developments in bone biology, bone cell mechanotransduction, and cell-surface interactions are reviewed here to demonstrate that bone mechanotransduction is strongly influenced by the biomaterial properties.

  15. Medical device innovation and the value analysis process.

    Science.gov (United States)

    Krantz, Heidi; Strain, Barbara; Torzewski, Jane

    2017-09-01

    Heidi A. Krantz, RN, BSN is the Director of Value Analysis at Johns Hopkins Bayview Medical Center in the Johns Hopkins Health System. Barbara Strain, MA, CVAHP is the Director of Value Management at the University of Virginia Health System. Jane Torzewski RN, MAN, MBA is a Senior Category Manager for the Mayo Clinic Physician Preference Contracting team. She previously was a Senior Clinical Value Analyst on the Mayo Clinic Value Analysis team. Copyright © 2018. Published by Elsevier Inc.

  16. EXPERIENCES IN THE AIR SPINNING TO MANUFACTURE MEDICAL DEVICES

    Directory of Open Access Journals (Sweden)

    MARSAL Feliu

    2015-05-01

    Full Text Available The work aims to determine, with scientific rigor, differences in key parameters of the yarns produced by conventional ring spinning systems, open-end and air spinning and its interrelation with the main parameters of those products that are intended for medical-sanitary sector. The experiences have been made in a Spanish company from short fibers sector that has three spinning systems, with tradition and prestige in world market, validating the results in Innotex Center laboratories of the Polytechnic University of Catalonia. Considering the results, it shows that the technology of manufacture of yarns by air is suitable for yarn, woven fabrics and knitting, structures to textile medical-sanitary application, by specific properties as well as enhanced competitiveness, due to the high production rate and shortened spinning process. The viscose yarns manufactured by air mass are more mass regular. The new DR parameter clearly indicates a better look of the finished fabric when we work with yarns produced by air technology.The significant reduction of the hairiness means less formation of loose fibres by friction, very important in the application of these yarns in the manufacture of textile structures for medical-sanitary use. Also no-table increase of about 15% in the absorption capacity of the fluids, especially water, from the yarns made by air. In the functionalization of fabrics obtained from spun yarn by air will need to apply a permanent smoothing.

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

    Science.gov (United States)

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

    2007-01-01

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

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

    Science.gov (United States)

    2005-07-01

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

  19. Integration of human factors and ergonomics during medical device design and development: it's all about communication.

    Science.gov (United States)

    Vincent, Christopher James; Li, Yunqiu; Blandford, Ann

    2014-05-01

    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.

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

    Science.gov (United States)

    Gittard, Shaun D; Narayan, Roger J

    2010-01-01

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

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

    Science.gov (United States)

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

    2016-05-01

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

  2. Comparison of Transplant Waitlist Outcomes for Pediatric Candidates Supported by Ventricular Assist Devices Versus Medical Therapy.

    Science.gov (United States)

    Law, Sabrina P; Oron, Assaf P; Kemna, Mariska S; Albers, Erin L; McMullan, D Michael; Chen, Jonathan M; Law, Yuk M

    2018-05-01

    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.

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

    Science.gov (United States)

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

    2014-02-01

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

  4. Perspectives of the Si3N4-TiN ceramic composite as a biomaterial and manufacturing of complex-shaped implantable devices by electrical discharge machining (EDM).

    Science.gov (United States)

    Bucciotti, Francesco; Mazzocchi, Mauro; Bellosi, Alida

    2010-01-01

    In this work we investigated the suitability of electroconductive silicon nitride/titanium nitride composite for biomedical implantable devices with particular attention on the processing route that allows the net-shaping of complex components by electrical discharge machining (EDM). The composite, constituted mainly of a beta-Si3N4, dispersed TiN grains and a glassy grain boundary phase, exhibited a low density and high hardness, strength and toughness. Bulk, surface characteristics and properties of the Si3N4-TiN composite were analyzed. After the EDM process, the microstructure of the machined surface was examined. The obtained results showed that the Si3N4-TiN ceramic composite together with the EDM manufacturing process might potentially play a key role in implantable load-bearing prosthesis applications.

  5. 78 FR 28733 - Medical Devices; General Hospital and Personal Use Monitoring Devices; Classification of the...

    Science.gov (United States)

    2013-05-16

    ... through intrabody communication to an external recorder which records the date and time of ingestion as... prior to marketing the device, which contains information about the ingestible event marker they intend... environment. Therefore, neither an environmental assessment nor an environmental impact statement is required...

  6. 76 FR 6551 - Medical Devices; General and Plastic Surgery Devices; Classification of Contact Cooling System...

    Science.gov (United States)

    2011-02-07

    ... (classes) of devices, depending on the regulatory controls needed to provide reasonable assurance of their... addressed by adequate bench testing demonstrating that the feedback controls for temperature/ cooling are functional and do maintain target temperature within the stated value. Proper function of mechanical controls...

  7. 77 FR 16925 - Medical Devices; Neurological Devices; Classification of the Near Infrared Brain Hematoma Detector

    Science.gov (United States)

    2012-03-23

    ... notification, prior to marketing the device, which contains information about the NIR Brain Hematoma Detector...), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct..., environmental, public health and safety, and other advantages; distributive impacts; and equity). The Agency...

  8. 77 FR 8117 - Medical Devices; Cardiovascular Devices; Classification of the Endovascular Suturing System

    Science.gov (United States)

    2012-02-14

    ... premarket notification, prior to marketing the device, which contains information about the endovascular...), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct..., environmental, public health and safety, and other advantages; distributive impacts; and equity). The Agency...

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

    Science.gov (United States)

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

    2012-11-01

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

  10. Biomaterials in light amplification

    Science.gov (United States)

    Mysliwiec, Jaroslaw; Cyprych, Konrad; Sznitko, Lech; Miniewicz, Andrzej

    2017-03-01

    Biologically produced or inspired materials can serve as optical gain media, i.e. they can exhibit the phenomenon of light amplification. Some of these materials, under suitable dye-doping and optical pumping conditions, show lasing phenomena. The emerging branch of research focused on obtaining lasing action in highly disordered and highly light scattering materials, i.e. research on random lasing, is perfectly suited for biological materials. The use of biomaterials in light amplification has been extensively reported in the literature. In this review we attempt to report on progress in the development of biologically derived systems able to show the phenomena of light amplification and random lasing together with the contribution of our group to this field. The rich world of biopolymers modified with molecular aggregates and nanocrystals, and self-organized at the nanoscale, offers a multitude of possibilities for tailoring luminescent and light scattering properties that are not easily replicated in conventional organic or inorganic materials. Of particular importance and interest are light amplification and lasing, or random lasing studies in biological cells and tissues. In this review we will describe nucleic acids and their complexes employed as gain media due to their favorable optical properties and ease of manipulation. We will report on research conducted on various biomaterials showing structural analogy to nucleic acids such as fluorescent proteins, gelatins in which the first distributed feedback laser was realized, and also amyloids or silks, which, due to their dye-doped fiber-like structure, allow for light amplification. Other materials that were investigated in that respect include polysaccharides, like starch exhibiting favorable photostability in comparison to other biomaterials, and chitosan, which forms photonic crystals or cellulose. Light amplification and random lasing was not only observed in processed biomaterials but also in living

  11. New biomaterials for orthopedic implants

    Directory of Open Access Journals (Sweden)

    Ong KL

    2015-09-01

    Full Text Available Kevin L Ong, Brian Min Yun, Joshua B WhiteExponent, Inc., Philadelphia, PA, USAAbstract: With the increasing use of orthopedic implants worldwide, there continues to be great interest in the development of novel technologies to further improve the effective clinical performance of contemporary treatment modalities and devices. Continuing research interest also exists in developing novel bulk biomaterials (eg, polycarbonate urethanes, silicon or novel formulations of existing but less widely used biomaterials (eg, polyaryletherketones, polyetheretherketone. There is also growing focus on customizing the material properties of bioabsorbables and composite materials with fillers such as bioactive ceramics. In terms of tissue engineering, more recent developments have focused on basic engineering and biological fundamentals to use cells, signaling factors, and the scaffold material itself to better restore tissue and organ structure and function. There has also been recent controversy with the use of injectables as a nonsurgical approach to treat joint disorders, but more attention is being directed toward the development of newer formulations with different molecular weights. The industry has also continuously sought to improve coatings to supplement the function of existing implants, with the goal of improving their osseointegrative qualities and incorporating antimicrobial properties. These include the use of bone morphogenetic protein, bisphosphonates, calcium phosphate, silicon nitride, and iodine. Due to the widespread use of bone graft materials, recent developments in synthetic graft materials have explored further development of bioactive glass, ceramic materials, and porous titanium particles. This review article provides an overview of ongoing efforts in the above research areas.Keywords: coatings, scaffolds, bioabsorbables, bone graft, injectables

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

    Science.gov (United States)

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

    2016-10-17

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

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

    Science.gov (United States)

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

    2018-02-23

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

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

    Science.gov (United States)

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

    2013-09-01

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

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

    International Nuclear Information System (INIS)

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

    2016-01-01

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

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

    Science.gov (United States)

    Kraft, Marc

    2008-09-03

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

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

    International Nuclear Information System (INIS)

    Ito, Hitoshi; Ishigaki, Isao

    1986-01-01

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

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

    Science.gov (United States)

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

    2015-08-01

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

  19. A new approach to the rationale discovery of polymeric biomaterials

    Science.gov (United States)

    Kohn, Joachim; Welsh, William J.; Knight, Doyle

    2007-01-01

    This paper attempts to illustrate both the need for new approaches to biomaterials discovery as well as the significant promise inherent in the use of combinatorial and computational design strategies. The key observation of this Leading Opinion Paper is that the biomaterials community has been slow to embrace advanced biomaterials discovery tools such as combinatorial methods, high throughput experimentation, and computational modeling in spite of the significant promise shown by these discovery tools in materials science, medicinal chemistry and the pharmaceutical industry. It seems that the complexity of living cells and their interactions with biomaterials has been a conceptual as well as a practical barrier to the use of advanced discovery tools in biomaterials science. However, with the continued increase in computer power, the goal of predicting the biological response of cells in contact with biomaterials surfaces is within reach. Once combinatorial synthesis, high throughput experimentation, and computational modeling are integrated into the biomaterials discovery process, a significant acceleration is possible in the pace of development of improved medical implants, tissue regeneration scaffolds, and gene/drug delivery systems. PMID:17644176

  20. Medical Device Regulation: A Comparison of the United States and the European Union.

    Science.gov (United States)

    Maak, Travis G; Wylie, James D

    2016-08-01

    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.

  1. 77 FR 7589 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-02-13

    ... ongoing randomized clinical trial, ``Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis'' (SAMMPRIS), published in the New England Journal of Medicine (2011;365...-0923. FDA intends to make background material available to the public no later than 2 business days...

  2. 76 FR 63928 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-10-14

    ..., releasing the Sensor. Electronics Unit (Interrogator) and database--The Electronics Unit contains hardware... transmitted from the electronics unit, and presents the data for review by medical professionals. FDA intends... person on or before November 30, 2011. Oral presentations from the public will be scheduled between...

  3. Review of biomaterials for electronics and photonics

    Science.gov (United States)

    Ouchen, Fahima; Rau, Ileana; Kajzar, François; Heckman, Emily; Grote, James G.

    2018-03-01

    Much work has been done developing and utilizing biomaterials over the last decade. Biomaterials not only includes deoxyribonucleic acid (DNA), but nucleobases and silk. These materials are abundant, inexpensive, non-fossil fuel-based and green. Researchers have demonstrated their potential to enhance the performance of organic and inorganic electronic and photonic devices, such as light emitting diodes, thin film transistors, capacitors, electromagnetic interference shielding and electro-optic modulators. Starting around the year 2000, with only a hand full of researchers, including researchers at the Air Force Research Laboratory (AFRL) and researchers at the Chitose Institute of Technology (CIST), it has grown into a large US, Asia and European consortium, producing over 3400 papers, three books, many book chapters and multiple patents. Presented here is a short overview of the progress in this exciting field of nano bio-engineering.

  4. 47 CFR 95.1119 - Specific requirements for wireless medical telemetry devices operating in the 608-614 MHz band.

    Science.gov (United States)

    2010-10-01

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

  5. Synthetic diamond devices for medical dosimetry applied to radiotherapy

    International Nuclear Information System (INIS)

    Descamps, C.

    2007-06-01

    The aim of this thesis, lead in the framework of an integrated European project entitled M.A.E.S.T.R.O. for ' Methods and Advanced Equipment for Simulation and Treatment in Radio Oncology', was to develop and test synthetic diamond detector in clinical environment for new modalities used in radiotherapy. Diamond is a good candidate for the detection of high energy beams in medical fields. It can be used for passive dosimetry, as thermoluminescent dosimeters or for active dosimetry as ionisation chambers. These two applications are presented here. Concerning the thermoluminescence, several impurities or dopants (boron, phosphorus, and nitrogen) have been incorporated in the diamond films during growth, in order to modify the material dosimetric properties and a detailed study of nitrogen-containing films is proposed. The second part presents the results obtained in active dosimetry. Two guide lines were followed: the measurement set-up optimisation and the material modification. The first dosimetric studies under radiotherapy beams concerning nitrogen-containing polycrystalline diamond as well as high purity single crystal diamond are conclusive. The detectors behaviours are in agreement with the recommendations of the International Atomic Energy Agency (IAEA). (author)

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

    Science.gov (United States)

    Foo, Jong Yong Abdiel; Tan, Xin Ji Alan

    2017-06-01

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

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

    Science.gov (United States)

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

    2014-12-01

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

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

    Science.gov (United States)

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

    2018-01-01

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

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

    Science.gov (United States)

    Ferguson, John E; Redish, A David

    2011-07-01

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

  10. Medical Device Innovation in the Era of the Affordable Care Act: The End of Sexy.

    Science.gov (United States)

    Mattke, Soeren; Liu, Hangsheng; Orr, Patrick

    2016-06-20

    In this article, the authors explore why medical device innovation has traditionally been geared so thoroughly toward improving performance, with little regard to cost. They argue that the changing incentives in the health care sector and the move to value-based payment models, accelerated by the implementation of the Affordable Care Act, will force device manufacturers to redirect investments from the spectacular toward the prudent, which they dub "the end of sexy." The authors explore consequences for manufacturers, investors, and policymakers.

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

    Directory of Open Access Journals (Sweden)

    Sachin C. Deorukhkar

    2016-01-01

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

  12. [Study on restriction factors and countermeasures of influence of China medical devices competitiveness].

    Science.gov (United States)

    Zhang, Zhijun

    2012-07-01

    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.

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

    International Nuclear Information System (INIS)

    Ishizeki, Chuichi

    1985-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Rockstroh Max

    2015-09-01

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

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

    Science.gov (United States)

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

    2015-01-01

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

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

    Science.gov (United States)

    Mehta, Rashi I; Mehta, Rupal I

    2018-03-19

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

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

    Science.gov (United States)

    Howard, Jason J

    2014-01-01

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

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

    Science.gov (United States)

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

    2014-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Sangita Revdiwala

    2012-01-01

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

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

    Science.gov (United States)

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

    2018-01-01

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

  1. Sustained prevention of biofilm formation on a novel silicone matrix suitable for medical devices

    DEFF Research Database (Denmark)

    Steffensen, Søren Langer; Merete H., Vestergaard,; Jensen, Minna Grønning

    2015-01-01

    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...

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

    Science.gov (United States)

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

    2018-03-01

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

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

    Science.gov (United States)

    2016-10-01

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

  4. Security and Privacy Qualities of Medical Devices: An Analysis of FDA Postmarket Surveillance

    OpenAIRE

    Ransford, Benjamin; Molina-Markham, Andres; Stewart, Quinn; Fu, Kevin; Kramer, Daniel Bruce; Baker, Matthew Charles; Reynolds, Matthew R.

    2012-01-01

    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...

  5. Biomaterials: An Introduction for Librarians.

    Science.gov (United States)

    Bush, Renee B.

    1996-01-01

    Contains an overview of biomaterials, an interdisciplinary field in which research combines medicine, biological sciences, physical sciences, and engineering. Biomaterials are substances which improve quality of life by augmenting or replacing bodily tissues or functions. Highlights problems associated with collection development and literature…

  6. Stepping into the omics era: Opportunities and challenges for biomaterials science and engineering.

    Science.gov (United States)

    Groen, Nathalie; Guvendiren, Murat; Rabitz, Herschel; Welsh, William J; Kohn, Joachim; de Boer, Jan

    2016-04-01

    The research paradigm in biomaterials science and engineering is evolving from using low-throughput and iterative experimental designs towards high-throughput experimental designs for materials optimization and the evaluation of materials properties. Computational science plays an important role in this transition. With the emergence of the omics approach in the biomaterials field, referred to as materiomics, high-throughput approaches hold the promise of tackling the complexity of materials and understanding correlations between material properties and their effects on complex biological systems. The intrinsic complexity of biological systems is an important factor that is often oversimplified when characterizing biological responses to materials and establishing property-activity relationships. Indeed, in vitro tests designed to predict in vivo performance of a given biomaterial are largely lacking as we are not able to capture the biological complexity of whole tissues in an in vitro model. In this opinion paper, we explain how we reached our opinion that converging genomics and materiomics into a new field would enable a significant acceleration of the development of new and improved medical devices. The use of computational modeling to correlate high-throughput gene expression profiling with high throughput combinatorial material design strategies would add power to the analysis of biological effects induced by material properties. We believe that this extra layer of complexity on top of high-throughput material experimentation is necessary to tackle the biological complexity and further advance the biomaterials field. In this opinion paper, we postulate that converging genomics and materiomics into a new field would enable a significant acceleration of the development of new and improved medical devices. The use of computational modeling to correlate high-throughput gene expression profiling with high throughput combinatorial material design strategies would

  7. New Models for Patient-specific Evaluation of the Effect of Biomaterials on Macrophages

    NARCIS (Netherlands)

    N. Grotenhuis (Nienke)

    2017-01-01

    markdownabstractBiomaterials are often used in many fields of medicine to restore or replace tissue. These biomaterials always elicit a reaction of the immune system, called the foreign body reaction, which can lead to complications in patients and failure of the device. Macrophages are key players

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

    Science.gov (United States)

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

    2014-03-01

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

  9. Biomaterial associated impairment of local neutrophil function.

    Science.gov (United States)

    Kaplan, S S; Basford, R E; Kormos, R L; Hardesty, R L; Simmons, R L; Mora, E M; Cardona, M; Griffith, B L

    1990-01-01

    The effect of biomaterials on neutrophil function was studied in vitro to determine if these materials activated neutrophils and to determine the subsequent response of these neutrophils to further stimulation. Two biomaterials--polyurethane, a commonly used substance, and Velcro pile (used in the Jarvik 7 heart)--were evaluated. Two control substances, polyethylene and serum-coated polystyrene, were used for comparison. Neutrophil superoxide release was measured following incubation with these materials for 10, 30, and 120 min in the absence of additional stimulation and after stimulation with formylmethionylleucylphenylalanine (fMLP) or phorbol myristate acetate (PMA). The authors observed that the incubation of neutrophils on both polyurethane and Velcro resulted in substantially increased superoxide release that was greater after the 10 min than after the 30 or 120 min association. These activated neutrophils exhibited a poor additional response to fMLP but responded well to PMA. The effect of implantation of the Novacor left ventricular assist device on peripheral blood neutrophil function was also evaluated. The peripheral blood neutrophils exhibited normal superoxide release and chemotaxis. These studies suggest that biomaterials may have a profound local effect on neutrophils, which may predispose the patient to periprosthetic infection, but that the reactivity of circulating neutrophils is unimpaired.

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

    Science.gov (United States)

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

    2010-08-01

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

  11. Taking transition into account: designing with pre-users of medical devices

    DEFF Research Database (Denmark)

    Kelly, Janet; Matthews, Ben

    2010-01-01

    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...

  12. 75 FR 6401 - Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of...

    Science.gov (United States)

    2010-02-09

    ... Biologics Evaluation and Research (HFM-17), Food and Drug Administration, suite 200N, 1401 Rockville Pike... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-M-0513] Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Summaries...

  13. 76 FR 45826 - Medical Device User Fee Rates for Fiscal Year 2012

    Science.gov (United States)

    2011-08-01

    ... paper check: All paper checks must be in U.S. currency from a U.S. bank and made payable to the Food and... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0542] Medical Device User Fee Rates for Fiscal Year 2012 AGENCY: Food and Drug Administration, HHS. ACTION...

  14. 75 FR 15439 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Science.gov (United States)

    2010-03-29

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...

  15. 78 FR 15957 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Science.gov (United States)

    2013-03-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...

  16. 77 FR 10537 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Science.gov (United States)

    2012-02-22

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...

  17. 78 FR 41069 - Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-07-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0743] Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  18. 76 FR 47210 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2011-08-04

    ... placed on the Internet. Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period.......... Chestnut Medical Pipeline embolization device.... April 6, 2011. Technologies, Inc. P100034 FDA-2011-M-0295... Scientific Corp ION paclitaxel-eluting coronary April 22, 2011. stent system (monorail and over- the-wire...

  19. 75 FR 391 - Medical Device Quality System Regulation Educational Forum on Risk Management Through the Product...

    Science.gov (United States)

    2010-01-05

    ...] Medical Device Quality System Regulation Educational Forum on Risk Management Through the Product Life... on Risk Management through the Product Life Cycle.'' This public workshop is intended to provide... discussed at the workshop: (1) Standards and guidance, (2) risk management in design, (3) risk management in...

  20. Risk assessment of medical devices: evaluation of microbiological and toxicological safety

    International Nuclear Information System (INIS)

    Dorpema, J.W.

    1995-01-01

    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)

  1. 78 FR 17415 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2013-03-21

    ... its decision. The regulations provide that FDA publish a quarterly list of available safety and..., FDA-2012-M-1183, and FDA-2012-M-1184] Medical Devices; Availability of Safety and Effectiveness.... SUMMARY: The Food and Drug Administration (FDA) is publishing a list of premarket approval applications...

  2. 77 FR 60704 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2012-10-04

    ... regulations provide that FDA publish a quarterly list of available safety and effectiveness summaries of PMA...-0638] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval... Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This...

  3. 76 FR 7222 - Medical Device Innovation Initiative; Public Meeting; Request for Comments

    Science.gov (United States)

    2011-02-09

    ... public meeting will be provided on a space-available basis beginning at 7 a.m. Non-U.S. citizens are... The United States is the global leader in medical device innovation and CDRH is committed to assuring... public health. CDRH is responsible for advancing public health and facilitating innovation to help bring...

  4. 76 FR 14028 - Center for Devices and Radiological Health 510(k) Implementation: Online Repository of Medical...

    Science.gov (United States)

    2011-03-15

    ... could facilitate patient access to information on what types of devices are available for their medical... input from the public on what they would want and need in labeling and how they would want to access it. CDRH is also interested in learning more about how patients, consumers, and caregivers acquire and use...

  5. Early assessment of medical devices in development for company decision making : An exploration of best practices

    NARCIS (Netherlands)

    Markiewicz, Katarzyna; Van Til, Janine; IJzerman, Maarten

    2017-01-01

    To improve successful development and clinical use of medical technologies, it is suggested that manufacturers should start collecting evidence on devices effectiveness and eficiency early in their development. The aim of this study was to explore whether and how Dutch manufacturers perform an early

  6. OpenICE medical device interoperability platform overview and requirement analysis.

    Science.gov (United States)

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

    2018-02-23

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

  7. [Introduction of Quality Management System Audit in Medical Device Single Audit Program].

    Science.gov (United States)

    Wen, Jing; Xiao, Jiangyi; Wang, Aijun

    2018-01-30

    The audit of the quality management system in the medical device single audit program covers the requirements of several national regulatory authorities, which has a very important reference value. This paper briefly described the procedures and contents of this audit. Some enlightenment on supervision and inspection are discussed in China, for reference by the regulatory authorities and auditing organizations.

  8. Application of Dielectric, Ferroelectric and Piezoelectric Thin Film Devices in Mobile Communication and Medical Systems

    NARCIS (Netherlands)

    Klee, M.; Beelen, D.; Keurl, W.; Kiewitt, R.; Kumar, B.; Mauczok, R.; Reimann, K.; Renders, Ch.; Roest, A.; Roozeboom, F.; Steeneken, P.G.; Tiggelman, M.P.J.; Vanhelmont, F.; Wunnicke, O.; Lok, P.; Neumann, K.; Fraser, J.; Schmitz, G.

    2007-01-01

    Dielectric, ferroelectric and piezoelectric thin films are getting more and more attention for next generation mobile communication and medical systems. Thin film technologies based on dielectric, ferroelectric and piezoelectric thin films enable System-in-Package (SiP) devices, resulting in optimal

  9. 31 CFR 560.533 - Brokering sales of agricultural commodities, medicine, and medical devices.

    Science.gov (United States)

    2010-07-01

    ... 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...

  10. The Challenges of Balancing Safety and Security in Implantable Medical Devices.

    Science.gov (United States)

    Katzis, Konstantinos; Jones, Richard W; Despotou, George

    2016-01-01

    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.

  11. Linking the Regulatory and Reimbursement Processes for Medical Devices : The Need for Integrated Assessments

    NARCIS (Netherlands)

    Ciani, Oriana; Wilcher, Britni; van Giessen, Anoukh; Taylor, Rod S.

    2017-01-01

    Much criticism has been directed at the licencing requirements for medical devices (MDs) as they often result in a lack of robust evidence to inform health technology assessment (HTA) decisions. To better understand the current international decisional framework on MD technologies, we undertook

  12. [The SWOT analysis and strategic considerations for the present medical devices' procurement].

    Science.gov (United States)

    Li, Bin; He, Meng-qiao; Cao, Jian-wen

    2006-05-01

    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".

  13. Antimicrobial treatment of polymeric medical devices by silver nanomaterials and related technology

    Czech Academy of Sciences Publication Activity Database

    Polívková, A.; Hubáček, Tomáš; Staszek, M.; Švorčík, V.; Siegel, J.

    2017-01-01

    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

  14. Do we have to Include HCI Issues in Clinical Trials of Medical Devices?

    DEFF Research Database (Denmark)

    Nielsen, Lene; Christensen, Lars Rune; Sabers, Anne

    2017-01-01

    Digital devices play an important role in medical treatment and will in the future play a larger role in connection to cures of health-related issues. Traditionally medicine has been tested by clinical double blind, randomized trials to document the efficacy and safety profile. When it comes to t...

  15. 75 FR 51829 - Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and...

    Science.gov (United States)

    2010-08-23

    ... hotel at 301-977-8900 or refer to their Web page at: www.gaithersburg.hilton.com . Contact Person: Daya... provide public comments, time permitting. If you need special accommodations due to a disability, please... refer to the meeting registration Web page at http://www.fda.gov/MedicalDevices/NewsEvents/Workshops...

  16. 76 FR 67463 - Pediatric Medical Devices; Public Workshop; Request for Comments

    Science.gov (United States)

    2011-11-01

    ... 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...

  17. 78 FR 69694 - Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity...

    Science.gov (United States)

    2013-11-20

    ...] Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity and... Administration (FDA) is announcing a public workshop entitled ``Changing Regulatory and Reimbursement Paradigms... information on the AGA Web site. If you need special accommodations due to a disability, please contact...

  18. High-Confidence Medical Devices: Cyber-Physical Systems for 21st Century Health Care

    Data.gov (United States)

    Networking and Information Technology Research and Development, Executive Office of the President — The U.S. market for medical devices is the largest in the world. At an estimated $83 billion in 2006, this market represents nearly half the global total and is...

  19. CSIR research, development and innovation initiatives for the medical device and diagnostic industry

    CSIR Research Space (South Africa)

    Vilakazi, Busisiwe

    2017-10-01

    Full Text Available This presentation is focused on development and innovation initiatives in the medical device and diagnostic industry. It is presented by Dr Busisiwe Vilakasi at The 6th CSIR Conference: Ideas that work for industrial development, 5-6 October 2017...

  20. Semi-confined compression of microfabricated polymerized biomaterial constructs

    International Nuclear Information System (INIS)

    Moraes, Christopher; Likhitpanichkul, Morakot; Simmons, Craig A; Sun, Yu; Zhao, Ruogang

    2011-01-01

    Mechanical forces are critical parameters in engineering functional tissue because of their established influence on cellular behaviour. However, identifying ideal combinations of mechanical, biomaterial and chemical stimuli to obtain a desired cellular response requires high-throughput screening technologies, which may be realized through microfabricated systems. This paper reports on the development and characterization of a MEMS device for semi-confined biomaterial compression. An array of these devices would enable studies involving mechanical deformation of three-dimensional biomaterials, an important parameter in creating physiologically relevant microenvironments in vitro. The described device has the ability to simultaneously apply a range of compressive mechanical stimuli to multiple polymerized hydrogel microconstructs. Local micromechanical strains generated within the semi-confined hydrogel cylinders are characterized and compared with those produced in current micro- and macroscale technologies. In contrast to previous work generating unconfined compression in microfabricated devices, the semi-confined compression model used in this work generates uniform regions of strain within the central portion of each hydrogel, demonstrated here to range from 20% to 45% across the array. The uniform strains achieved simplify experimental analysis and improve the utility of the compression platform. Furthermore, the system is compatible with a wide variety of polymerizable biomaterials, enhancing device versatility and usability in tissue engineering and fundamental cell biology studies

  1. Biomaterials-based electronics: polymers and interfaces for biology and medicine.

    Science.gov (United States)

    Muskovich, Meredith; Bettinger, Christopher J

    2012-05-01

    Advanced polymeric biomaterials continue to serve as a cornerstone for new medical technologies and therapies. The vast majority of these materials, both natural and synthetic, interact with biological matter in the absence of direct electronic communication. However, biological systems have evolved to synthesize and utilize naturally-derived materials for the generation and modulation of electrical potentials, voltage gradients, and ion flows. Bioelectric phenomena can be translated into potent signaling cues for intra- and inter-cellular communication. These cues can serve as a gateway to link synthetic devices with biological systems. This progress report will provide an update on advances in the application of electronically active biomaterials for use in organic electronics and bio-interfaces. Specific focus will be granted to covering technologies where natural and synthetic biological materials serve as integral components such as thin film electronics, in vitro cell culture models, and implantable medical devices. Future perspectives and emerging challenges will also be highlighted. Copyright © 2012 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  2. Relative risk analysis in regulating the use of radiation-emitting medical devices. A preliminary application

    Energy Technology Data Exchange (ETDEWEB)

    Jones, E.D.; Banks, W.W.; Altenbach, T.J.; Fischer, L.E. [Lawrence Livermore National Lab., CA (United States)

    1995-09-01

    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.

  3. Relative risk analysis in regulating the use of radiation-emitting medical devices. A preliminary application

    International Nuclear Information System (INIS)

    Jones, E.D.; Banks, W.W.; Altenbach, T.J.; Fischer, L.E.

    1995-09-01

    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

  4. Simulation of leakage current measurement on medical devices using helmholtz coil configuration with different current flow

    Science.gov (United States)

    Sutanto, E.; Chandra, F.; Dinata, R.

    2017-05-01

    Leakage current measurement which can follow IEC standard for medical device is one of many challenges to be answered. The IEC 60601-1 has defined that the limit for a leakage current for Medical Device can be as low as 10 µA and as high as 500 µA, depending on which type of contact (applied part) connected to the patient. Most people are using ELCB (Earth-leakage circuit breaker) for safety purpose as this is the most common and available safety device in market. One type of ELCB devices is RCD (Residual Current Device) and this RCD type can measure the leakage current directly. This work will show the possibility on how Helmholtz Coil Configuration can be made to be like the RCD. The possibility is explored by comparing the magnetic field formula from each device, then it proceeds with a simulation using software EJS (Easy Java Simulation). The simulation will make sure the concept of magnetic field current cancellation follows the RCD concept. Finally, the possibility of increasing the measurement’s sensitivity is also analyzed. The sensitivity is needed to see the possibility on reaching the minimum leakage current limit defined by IEC, 0.01mA.

  5. Simulation of leakage current measurement on medical devices using helmholtz coil configuration with different current flow

    International Nuclear Information System (INIS)

    Sutanto, E; Chandra, F; Dinata, R

    2017-01-01

    Leakage current measurement which can follow IEC standard for medical device is one of many challenges to be answered. The IEC 60601-1 has defined that the limit for a leakage current for Medical Device can be as low as 10 µA and as high as 500 µA, depending on which type of contact (applied part) connected to the patient. Most people are using ELCB (Earth-leakage circuit breaker) for safety purpose as this is the most common and available safety device in market. One type of ELCB devices is RCD (Residual Current Device) and this RCD type can measure the leakage current directly. This work will show the possibility on how Helmholtz Coil Configuration can be made to be like the RCD. The possibility is explored by comparing the magnetic field formula from each device, then it proceeds with a simulation using software EJS (Easy Java Simulation). The simulation will make sure the concept of magnetic field current cancellation follows the RCD concept. Finally, the possibility of increasing the measurement’s sensitivity is also analyzed. The sensitivity is needed to see the possibility on reaching the minimum leakage current limit defined by IEC, 0.01mA. (paper)

  6. Trends in biomaterials

    CERN Document Server

    Kothiyal, G P

    2016-01-01

    Biomaterials research requires the union of materials scientists, engineers, biologists, biomedical doctors, and surgeons. Societal implications have invoked tremendous interest in this area of research in recent years. What started as a search for strong and durable implant materials has now led to path-breaking developments in tissue engineering, targeted drug delivery, and tissue scaffolds. Viable applications of mesoporous structures, polymer biocomposites, and fibers (synthetic and natural) in the areas of clinical orthopedics, controlled drug delivery, tissue engineering, orthodontics, etc., have emerged as relatively recent concepts. This book presents recent results related to both materials aspects and implant issues. The focus is on structural, magnetic, antibacterial, bioactivity/compatibility, mechanical, and other related properties and the implication of these results on biomedical applications. The book discusses technical problems faced by the surgeon during implant fixation in total hip repla...

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

    Science.gov (United States)

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

    2016-12-01

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

  8. Cost effectiveness of medical devices to diagnose pre-eclampsia in low-resource settings

    Directory of Open Access Journals (Sweden)

    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

  9. Mechanics of additively manufactured biomaterials.

    Science.gov (United States)

    Zadpoor, Amir A

    2017-06-01

    Additive manufacturing (3D printing) has found many applications in healthcare including fabrication of biomaterials as well as bioprinting of tissues and organs. Additively manufactured (AM) biomaterials may possess arbitrarily complex micro-architectures that give rise to novel mechanical, physical, and biological properties. The mechanical behavior of such porous biomaterials including their quasi-static mechanical properties and fatigue resistance is not yet well understood. It is particularly important to understand the relationship between the designed micro-architecture (topology) and the resulting mechanical properties. The current special issue is dedicated to understanding the mechanical behavior of AM biomaterials. Although various types of AM biomaterials are represented in the special issue, the primary focus is on AM porous metallic biomaterials. As a prelude to this special issue, this editorial reviews some of the latest findings in the mechanical behavior of AM porous metallic biomaterials so as to describe the current state-of-the-art and set the stage for the other studies appearing in the issue. Some areas that are important for future research are also briefly mentioned. Copyright © 2017 Elsevier Ltd. All rights reserved.

  10. Potential negative consequences of non-consented switch of inhaled medications and devices in asthma patients.

    Science.gov (United States)

    Björnsdóttir, U S; Gizurarson, S; Sabale, U

    2013-09-01

    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

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

    Science.gov (United States)

    Hannig, Jürgen; Siekmeier, Rüdiger

    2015-01-01

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

  12. Current disparities in the prices of medical materials between Japan and the United States: further investigation of cardiovascular medical devices.

    Science.gov (United States)

    Yasunaga, Hideo; Ide, Hiroo; Imamura, Tomoaki

    2007-02-01

    Prices of medical devices in Japan were previously reported to be 2 to 4 times higher than those in the United States in 1996 and 1997. However, such data are out of date. We previously compared the market prices in early 2005 between Japan and the US for 16 items in 10 categories of medical materials, and showed that price differences still existed for all these items. However, the number of items investigated was small for each category, and generalization of the results might have been limited. The present study conducted a further investigation into price information for multiple items for each category, focusing on 5 cardiovascular devices. The US market price information was obtained from interviews of a healthcare provider network and 2 different group-purchasing organizations. We could obtain price information on 19 items in 5 categories. We substituted the Japanese reimbursement prices for the Japanese market prices. The price ratio (Japanese reimbursement price / US market price)was 2.0-3.5 for coronary stents, 5.9-6.8 for percutaneous transluminal coronary angioplasty catheters, 2.2-3.5 for pacemakers, 1.6-2.5 for mechanical valves, and 3.4-4.7 for oxygenators. The price disparities for cardiovascular devices between Japan and the US were reconfirmed. Japan's healthcare system should establish group-purchasing organizations, promote centers of clinical excellence, and abolish regulation of parallel imports and protectionism under the Japanese Pharmaceutical Affairs Law.

  13. Biomaterials for tissue engineering applications.

    Science.gov (United States)

    Keane, Timothy J; Badylak, Stephen F

    2014-06-01

    With advancements in biological and engineering sciences, the definition of an ideal biomaterial has evolved over the past 50 years from a substance that is inert to one that has select bioinductive properties and integrates well with adjacent host tissue. Biomaterials are a fundamental component of tissue engineering, which aims to replace diseased, damaged, or missing tissue with reconstructed functional tissue. Most biomaterials are less than satisfactory for pediatric patients because the scaffold must adapt to the growth and development of the surrounding tissues and organs over time. The pediatric community, therefore, provides a distinct challenge for the tissue engineering community. Copyright © 2014. Published by Elsevier Inc.

  14. Effect of Winemaking on the Composition of Red Wine as a Source of Polyphenols for Anti-Infective Biomaterials

    Directory of Open Access Journals (Sweden)

    Arianna Di Lorenzo

    2016-04-01

    Full Text Available Biomaterials releasing bactericides have currently become tools for thwarting medical device-associated infections. The ideal anti-infective biomaterial must counteract infection while safeguarding eukaryotic cell integrity. Red wine is a widely consumed beverage to which many biological properties are ascribed, including protective effects against oral infections and related bone (osteoarthritis, osteomyelitis, periprosthetic joint infections and cardiovascular diseases. In this study, fifteen red wine samples derived from grapes native to the Oltrepò Pavese region (Italy, obtained from the winemaking processes of “Bonarda dell’Oltrepò Pavese” red wine, were analyzed alongside three samples obtained from marc pressing. Total polyphenol and monomeric anthocyanin contents were determined and metabolite profiling was conducted by means of a chromatographic analysis. Antibacterial activity of wine samples was evaluated against Streptococcus mutans, responsible for dental caries, Streptococcus salivarius, and Streptococcus pyogenes, two oral bacterial pathogens. Results highlighted the winemaking stages in which samples exhibit the highest content of polyphenols and the greatest antibacterial activity. Considering the global need for new weapons against bacterial infections and alternatives to conventional antibiotics, as well as the favorable bioactivities of polyphenols, results point to red wine as a source of antibacterial substances for developing new anti-infective biomaterials and coatings for biomedical devices.

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

    Science.gov (United States)

    Noon, Christian; Holub, Joseph; Winer, Eliot

    2013-03-01

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

  16. Influence of Mobile Phones on the Quality of ECG Signal Acquired by Medical Devices

    Science.gov (United States)

    Buczkowski, T.; Janusek, D.; Zavala-Fernandez, H.; Skrok, M.; Kania, M.; Liebert, A.

    2013-10-01

    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.

  17. Integrating the results of user research into medical device development: insights from a case study.

    Science.gov (United States)

    Martin, Jennifer L; Barnett, Julie

    2012-07-19

    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

  18. Study on 3D printer production of auxiliary device for upper limb for medical imaging test

    Energy Technology Data Exchange (ETDEWEB)

    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)

    2015-12-15

    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.

  19. Integrating the results of user research into medical device development: insights from a case study

    Directory of Open Access Journals (Sweden)

    Martin Jennifer L

    2012-07-01

    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

  20. Study on 3D printer production of auxiliary device for upper limb for medical imaging test

    International Nuclear Information System (INIS)

    Kim, Hyeong Gyun; Yoon, Jae Ho; Choi, Seong Dae

    2015-01-01

    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