Monitoring Device Safety in Interventional Cardiology

OpenAIRE

Matheny, Michael E.; Ohno-Machado, Lucila; Resnic, Frederic S.

2006-01-01

Objective: A variety of postmarketing surveillance strategies to monitor the safety of medical devices have been supported by the U.S. Food and Drug Administration, but there are few systems to automate surveillance. Our objective was to develop a system to perform real-time monitoring of safety data using a variety of process control techniques.

Safety considerations in the design of the fusion engineering device

International Nuclear Information System (INIS)

Barrett, R.J.

1983-01-01

Safety considerations play a significant role in the design of a near-term Fusion Engineering Device (FED). For the safety of the general public and the plant workers, the radiation environment caused by the reacting plasma and the potential release of tritium fuel are the dominant considerations. The U.S. Department of Energy (DOE) regulations and guidelines for radiation protection have been reviewed and are being applied to the device design. Direct radiation protection is provided by the device shield and the reactor building walls. Radiation from the activated device components and the tritium fuel is to be controlled with shielding, contamination control, and ventilation. The potential release of tritium from the plant has influenced the selection of reactor building and plant designs and specifications. The safety of the plant workers is affected primarily by the radiation from the activated device components and from plasma chamber debris. The highly activated device components make it necessary to design many of the maintenance activities in the reactor building for totally remote operation. The hot cell facility has evolved as a totally remote maintenance facility due to the high radiation levels of the device components. Safety considerations have had substantial impacts on the design of FED. Several examples of safety-related design impacts are discussed in the paper. Feasible solutions have been identified for all outstanding safety-related items, and additional optimization of these solutions is anticipated in future design studies

Flexible Organic Electronics in Biology: Materials and Devices.

Science.gov (United States)

Liao, Caizhi; Zhang, Meng; Yao, Mei Yu; Hua, Tao; Li, Li; Yan, Feng

2015-12-09

At the convergence of organic electronics and biology, organic bioelectronics attracts great scientific interest. The potential applications of organic semiconductors to reversibly transmit biological signals or stimulate biological tissues inspires many research groups to explore the use of organic electronics in biological systems. Considering the surfaces of movable living tissues being arbitrarily curved at physiological environments, the flexibility of organic bioelectronic devices is of paramount importance in enabling stable and reliable performances by improving the contact and interaction of the devices with biological systems. Significant advances in flexible organic bio-electronics have been achieved in the areas of flexible organic thin film transistors (OTFTs), polymer electrodes, smart textiles, organic electrochemical ion pumps (OEIPs), ion bipolar junction transistors (IBJTs) and chemiresistors. This review will firstly discuss the materials used in flexible organic bioelectronics, which is followed by an overview on various types of flexible organic bioelectronic devices. The versatility of flexible organic bioelectronics promises a bright future for this emerging area. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Nanoplasmonic and Microfluidic Devices for Biological Sensing

KAUST Repository

Perozziello, G.; Giugni, Andrea; Allione, Marco; Torre, Bruno; Das, Gobind; Coluccio, M. L.; Marini, Monica; Tirinato, Luca; Moretti, Manola; Limongi, Tania; Candeloro, P.; Di Fabrizio, Enzo M.

2017-01-01

In this chapter we report about recent advances on the development and application of 2D and 3D plasmonic nanostructures used for sensing of biological samples by Raman spectroscopy at unprecedented resolution of analysis. Besides, we explain how the integration of these nanodevices in a microfluidic apparatus can simplify the analysis of biological samples. In the first part we introduce and motivate the convenience of using nanoplasmonic enhancers and Raman spectroscopy for biological sensing, describing the phenomena and the current approaches to fabricate nanoplasmonic structures. In the second part, we explain how specific multi-element devices produce the optimal enhancement of the Raman scattering. We report cases where biological sensing of DNA was performed at few molecules level with nanometer spatial resolutions. Finally, we show an example of microfluidic device integrating plasmonic nanodevices to sort and drive biological samples, like living cells, towards the optical probe in order to obtain optimal conditions of analysis.

Nanoplasmonic and Microfluidic Devices for Biological Sensing

KAUST Repository

Perozziello, G.

2017-02-16

In this chapter we report about recent advances on the development and application of 2D and 3D plasmonic nanostructures used for sensing of biological samples by Raman spectroscopy at unprecedented resolution of analysis. Besides, we explain how the integration of these nanodevices in a microfluidic apparatus can simplify the analysis of biological samples. In the first part we introduce and motivate the convenience of using nanoplasmonic enhancers and Raman spectroscopy for biological sensing, describing the phenomena and the current approaches to fabricate nanoplasmonic structures. In the second part, we explain how specific multi-element devices produce the optimal enhancement of the Raman scattering. We report cases where biological sensing of DNA was performed at few molecules level with nanometer spatial resolutions. Finally, we show an example of microfluidic device integrating plasmonic nanodevices to sort and drive biological samples, like living cells, towards the optical probe in order to obtain optimal conditions of analysis.

Push Off 2000 : new oilfield safety device catching on

Energy Technology Data Exchange (ETDEWEB)

Mowers, J.

2006-12-15

Fuel gas scrubbers use production gas to operate oil batteries, well separators, dehydrators, compressors, and pneumatic and pressure controls. Once an internal float gets stuck, production is stopped. The Push Off 2000 is a new safety device for fuel gas scrubbers which allows operators to easily dislodge a stuck internal float by activating the tool, which is mounted on top of the vessel. The device was developed after an operator suffered burns from a flash explosion that occurred after using a hammer to strike the fuel gas scrubber. The hammer method is the usual method of dealing with stuck internal floats, and can also jeopardize the integrity of the vessel, releasing gas or liquid hydrocarbons into the environment. The Push Off 2000 is expected to reduce costly facility downtime and increase revenue generating production time. Over 50 oil and gas companies have the Push Off 2000 device installed on fuel gas scrubber units at their facilities, and have recognized the safety and economic merits of the tool. The patented device has been approved by the Alberta Boilers Safety Association, the British Columbia Boiler and Elevator Safety Branch, and the Saskatchewan Boiler and Pressure Vessel Safety Unit. 1 fig.

[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").

Functionality of road safety devices – identification and analysis of factors

Directory of Open Access Journals (Sweden)

Jeliński Łukasz

2017-01-01

Full Text Available Road safety devices are designed to protect road users from the risk of injury or death. The principal type of restraint is the safety barrier. Deployed on sites with the highest risk of run-off-road accidents, safety barriers are mostly found on bridges, flyovers, central reservations, and on road edges which have fixed obstacles next to them. If properly designed and installed, safety barriers just as other road safety devices, should meet a number of functional features. This report analyses factors which may deteriorate functionality, ways to prevent this from happening and the thresholds for loss of road safety device functionality.

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

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

Science.gov (United States)

2005-01-01

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

The safety of non-incineration waste disposal devices in four hospitals of Tehran.

Science.gov (United States)

Farshad, Aliasghar; Gholami, Hamid; Farzadkia, Mahdi; Mirkazemi, Roksana; Kermani, Majid

2014-01-01

The safe management of hospital waste is a challenge in many developing countries. The aim of this study was to compare volatile organic compounds (VOCs) emissions and the microbial disinfectant safety in non-incineration waste disposal devices. VOC emissions and microbial infections were measured in four non-incineration waste disposal devices including: autoclave with and without a shredder, dry heat system, and hydroclave. Using NIOSH and US EPA-TO14 guidelines, the concentration and potential risk of VOCs in emitted gases from four devices were assessed. ProSpore2 biological indicators were used to assess the microbial analysis of waste residue. There was a significant difference in the type and concentration of VOCs and microbial infection of residues in the four devices. Emissions from the autoclave with a shredder had the highest concentration of benzene, ethyl benzene, xylene, and BTEX, and emissions from the hydroclave had the highest concentration of toluene. The highest level of microbial infection was observed in the residues of the autoclave without a shredder. There is an increased need for proper regulation and control of non-incinerator devices and for monitoring and proper handling of these devices in developing countries.

CFD Analysis of the Safety Injection Tank and Fluidic Device

Energy Technology Data Exchange (ETDEWEB)

Cho, Jai Oan; Nietiadi, Yohanes Setiawan; Lee, Jeong Ik [KAIST, Daejeon (Korea, Republic of); Addad, Yacine [KUSTAR, Abu Dhabi (United Arab Emirates)

2016-05-15

One of the most important components in the ECCS is the safety injection tank (SIT). Inside the SIT, a fluidic device is installed, which passively controls the mass flow of the safety injection and eliminates the need for low pressure safety injection pumps. As more passive safety mechanisms are being pursued, it has become more important to understand flow structure and the loss mechanism within the fluidic device. Current computational fluid dynamics (CFD) calculations have had limited success in predicting the fluid flow accurately. This study proposes to find a more exact result using CFD and more realistic modeling to predict the performance during accident scenarios more accurately. The safety injection tank with fluidic device was analyzed thoroughly using CFD. The preliminary calculation used 60,000 meshes for the initial test calculation. The results fit the experimental results surprisingly despite its coarse grid. Nonetheless, the mesh resolution was increased to capture the vortex in the fluidic device precisely. Once a detailed CFD computation is finished, a small-scale experiment will be conducted for the given conditions. Using the experimental results and the CFD model, physical models can be improved to fit the results more accurately.

Safety and feasibility research of CIPT-Ⅱ irradiation device

International Nuclear Information System (INIS)

Zhang Zhihua; Mi Xiangmiao; Li Rundong

2014-01-01

CITP-Ⅱ irradiation device, which is specially designed for fusion tritium breeder research, works in a thermal neutron reactor. With lithium orthosilicate as the breeder, the safety analysis was done to work out the device's influence on physical parameters of the reactor and get the breeder's temperature distribution and thermo-technical features in the n-γ field. The stiffness and strength were checked, and also the safety characters of the device were assessed. The feasibility of gap gas regulating the temperature and gas refueling the breeder was demonstrated. The calculation and analysis results provide data for comprehensive performance assessment. (authors)

The design study of the JT-60SU device. No.8. Nuclear shielding and safety design

Energy Technology Data Exchange (ETDEWEB)

Miya, Naoyuki; Kikuchi, Mitsuru; Ushigusa, Kenkichi [Japan Atomic Energy Research Inst., Naka, Ibaraki (Japan). Naka Fusion Research Establishment] [and others

1998-03-01

Results of nuclear shielding design study and safety analysis for the steady-state tokamak device JT-60SU are described. D-T operation (option) for two years is adopted in addition to ten years operation using deuterium. Design work has been done in accordance with general laws for radioisotopes handling in Japan as a guideline of safety evaluation, which is applied to the operation of present JT-60U device. Optimization of the shielding design for the device structure including vacuum vessel has been presented to meet with allowable limits of biological shielding determined in advance. It is shown that JT-60SU can be operated safely in the present JT-60 experimental building. It is planed to use 100g/year of tritium in D-T operation phase. A concept of multiple -barrier system is applied to the facility design to prevent propagation of tritium, in which the torus hall and the tritium removal room provide the tertiary confinement. From the design of atmosphere detritiation system for accidental tritium release, it is shown that tritium concentration level can be reduced to the allowable level after two weeks with reasonable compact size components. Safety assessment related to activation of coolant/air, and atmospheric tritium effluents are discussed. (author)

Design of Hack-Resistant Diabetes Devices and Disclosure of Their Cyber Safety.

Science.gov (United States)

Sackner-Bernstein, Jonathan

2017-03-01

The focus of the medical device industry and regulatory bodies on cyber security parallels that in other industries, primarily on risk assessment and user education as well as the recognition and response to infiltration. However, transparency of the safety of marketed devices is lacking and developers are not embracing optimal design practices with new devices. Achieving cyber safe diabetes devices: To improve understanding of cyber safety by clinicians and patients, and inform decision making on use practices of medical devices requires disclosure by device manufacturers of the results of their cyber security testing. Furthermore, developers should immediately shift their design processes to deliver better cyber safety, exemplified by use of state of the art encryption, secure operating systems, and memory protections from malware.

Comparing non-safety with safety device sharps injury incidence data from two different occupational surveillance systems.

Science.gov (United States)

Mitchell, A H; Parker, G B; Kanamori, H; Rutala, W A; Weber, D J

2017-06-01

The United States Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard as amended by the Needlestick Safety and Prevention Act requiring the use of safety-engineered medical devices to prevent needlesticks and sharps injuries has been in place since 2001. Injury changes over time include differences between those from non-safety compared with safety-engineered medical devices. This research compares two US occupational incident surveillance systems to determine whether these data can be generalized to other facilities and other countries either with legislation in place or considering developing national policies for the prevention of sharps injuries among healthcare personnel. Copyright © 2017 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

Silica diatom shells tailored with Au nanoparticles enable sensitive analysis of molecules for biological, safety and environment applications

KAUST Repository

Onesto, V.; Villani, M.; Coluccio, M. L.; Majewska, R.; Alabastri, A.; Battista, E.; Schirato, A.; Calestani, D.; Coppedé , N.; Cesarelli, M.; Amato, F.; Di Fabrizio, Enzo M.; Gentile, F.

2018-01-01

Diatom shells are a natural, theoretically unlimited material composed of silicon dioxide, with regular patterns of pores penetrating through their surface. For their characteristics, diatom shells show promise to be used as low cost, highly efficient drug carriers, sensor devices or other micro-devices. Here, we demonstrate diatom shells functionalized with gold nanoparticles for the harvesting and detection of biological analytes (bovine serum albumin—BSA) and chemical pollutants (mineral oil) in low abundance ranges, for applications in bioengineering, medicine, safety, and pollution monitoring.

Silica diatom shells tailored with Au nanoparticles enable sensitive analysis of molecules for biological, safety and environment applications

KAUST Repository

Onesto, V.

2018-04-19

Diatom shells are a natural, theoretically unlimited material composed of silicon dioxide, with regular patterns of pores penetrating through their surface. For their characteristics, diatom shells show promise to be used as low cost, highly efficient drug carriers, sensor devices or other micro-devices. Here, we demonstrate diatom shells functionalized with gold nanoparticles for the harvesting and detection of biological analytes (bovine serum albumin—BSA) and chemical pollutants (mineral oil) in low abundance ranges, for applications in bioengineering, medicine, safety, and pollution monitoring.

Cell biology apps for Apple devices.

Science.gov (United States)

Stark, Louisa A

2012-01-01

Apps for touch-pad devices hold promise for guiding and supporting learning. Students may use them in the classroom or on their own for didactic instruction, just-in-time learning, or review. Since Apple touch-pad devices (i.e., iPad and iPhone) have a substantial share of the touch-pad device market (Campbell, 2012), this Feature will explore cell biology apps available from the App Store. My review includes iPad and iPhone apps available in June 2012, but does not include courses, lectures, podcasts, audiobooks, texts, or other books. I rated each app on a five-point scale (1 star = lowest; 5 stars = highest) for educational and production values; I also provide an overall score.

A safety control device for detecting undesirable conditions

Energy Technology Data Exchange (ETDEWEB)

1974-09-26

The invention relates to safety control devices. It deals with a device adapted to transmit a warning signal and to the detection of an undesirable condition in an associated apparatus, said device comprising switching means comprising transistors mounted in a reaction path, feeding means for opening the switching means whenever an undesirable condition has been detected by sensors, whereby an oscillator is caused to stop oscillating, and an outlet device controlled by the oscillator stoppage. This can be applied to the supervision of nuclear reactor.

The safety of non-incineration waste disposal devices in four hospitals of Tehran

Science.gov (United States)

Farshad, Aliasghar; Gholami, Hamid; Farzadkia, Mahdi; Mirkazemi, Roksana; Kermani, Majid

2014-01-01

Background: The safe management of hospital waste is a challenge in many developing countries. Objectives: The aim of this study was to compare volatile organic compounds (VOCs) emissions and the microbial disinfectant safety in non-incineration waste disposal devices. Methods: VOC emissions and microbial infections were measured in four non-incineration waste disposal devices including: autoclave with and without a shredder, dry heat system, and hydroclave. Using NIOSH and US EPA-TO14 guidelines, the concentration and potential risk of VOCs in emitted gases from four devices were assessed. ProSpore2 biological indicators were used to assess the microbial analysis of waste residue. Results: There was a significant difference in the type and concentration of VOCs and microbial infection of residues in the four devices. Emissions from the autoclave with a shredder had the highest concentration of benzene, ethyl benzene, xylene, and BTEX, and emissions from the hydroclave had the highest concentration of toluene. The highest level of microbial infection was observed in the residues of the autoclave without a shredder. Conclusions: There is an increased need for proper regulation and control of non-incinerator devices and for monitoring and proper handling of these devices in developing countries. PMID:25000113

The biological basis of plutonium safety standards

International Nuclear Information System (INIS)

Mole, R.H.

1976-01-01

Since no radiation injury or cancer in man can, as yet, be directly attributed to Pu, all safety standards for Pu must be determined by reference to other safety standards, development of which is discussed. A system of safety standards must be based on links with real damage, such as the requirement for 226 Ra in bone. The type of biological information required for making standards realistic is considered in relation to Pu and Ra in bone. Also considered are the possible effects of Pu in soft tissue such as bone marrow. Not only dose, but also the number of cells exposed to the dose are important biologically and cellular aspects are examined. Since there is no positive evidence of Pu toxicity relevant information on other α emitters must be examined. The observed effectiveness of Ra, daughters of 222 Ra and 232 Th in causing mutations and cancer, is surveyed. Reference is made to the necessity of improving the ICRP system, currently based on the critical organ concept, by recognising the need for summation of risks in other organs where exposure to Pu is concerned. Improved biological understanding particularly that of hereditary damage, in recent years leads to less pessimistic thinking on the effects of ionizing radiations. The immediate need appears to be for consistency in safety standards. (U.K.)

Use of digital computing devices in systems important to safety

International Nuclear Information System (INIS)

1986-01-01

The incorporation of digital computing devices in systems important to safety now is progressing fast in several countries, including Canada, France, Federal Republic of Germany, Japan, USA. There are now reactors with microprocessors in some trip systems. The major functions of those systems are: reactor trip initiation, display, monitoring, testing, re-calibration of detectors. The benefits of moving to a fully computerized shut-down system should be improved reliability, greater flexibility, better man-machine interface, improved testing, higher reactor output and lower overall cost. With the introduction of computer devices in systems important to safety, plant availability and safety are improved because disturbances are treated before they lead to safety action, in this way helping the operator to avoid errors. The Meeting presentations were divided into sessions devoted to the following topics: Needs for the use of digital devices (DCD) in safety important systems (SIS) (5 papers); Problems raised by the integration SIS in the NPP control (7 papers); Description and presentation of DCD of SIS (6 papers); Results of experiences in engineering, manufacture, qualification operation of DCD hardware and software (5 papers). A separate abstract was prepared for each of these papers

Nanofluidic device for continuous multiparameter quality assurance of biologics.

Science.gov (United States)

Ko, Sung Hee; Chandra, Divya; Ouyang, Wei; Kwon, Taehong; Karande, Pankaj; Han, Jongyoon

2017-08-01

Process analytical technology (PAT) is critical for the manufacture of high-quality biologics as it enables continuous, real-time and on-line/at-line monitoring during biomanufacturing processes. The conventional analytical tools currently used have many restrictions to realizing the PAT of current and future biomanufacturing. Here we describe a nanofluidic device for the continuous monitoring of biologics' purity and bioactivity with high sensitivity, resolution and speed. Periodic and angled nanofilter arrays served as the molecular sieve structures to conduct a continuous size-based analysis of biologics. A multiparameter quality monitoring of three separate commercial biologic samples within 50 minutes has been demonstrated, with 20 µl of sample consumption, inclusive of dead volume in the reservoirs. Additionally, a proof-of-concept prototype system, which integrates an on-line sample-preparation system and the nanofluidic device, was demonstrated for at-line monitoring. Thus, the system is ideal for on-site monitoring, and the real-time quality assurance of biologics throughout the biomanufacturing processes.

Safety Features of Material and Personnel Movement Devices. Module SH-25. Safety and Health.

Science.gov (United States)

Center for Occupational Research and Development, Inc., Waco, TX.

This student module on safety features of material and personnel movement devices is one of 50 modules concerned with job safety and health. This module covers safe conditions and operating practices for conveyors, elevators, escalators, moving walks, manlifts, forklifts, and motorized hand trucks. Following the introduction, 10 objectives (each…

FAST and SAFE Passive Safety Devices for Sodium-cooled Fast Reactor

Energy Technology Data Exchange (ETDEWEB)

Hartanto, Donny; Kim, Chihyung; Kim, In-Hyung; Kim, Yonghee [KAIST, Daejeon (Korea, Republic of)

2015-05-15

The major factor is the impact of the neutron spectral hardening. The second factor that affects the CVR is reduced capture by the coolant when the coolant voiding occurs. To improve the CVR, many ideas and concepts have been proposed, which include introduction of an internal blanket, spectrum softening, or increasing the neutron leakage. These ideas may reduce the CVR, but they deteriorate the neutron economy. Another potential solution is to adopt a passive safety injection device such as the ARC (autonomous reactivity control) system, which is still under development. In this paper, two new concepts of passive safety devices are proposed. The devices are called FAST (Floating Absorber for Safety at Transient) and SAFE (Static Absorber Feedback Equipment). Their purpose is to enhance the negative reactivity feedback originating from the coolant in fast reactors. SAFE is derived to balance the positive reactivity feedback due to sodium coolant temperature increases. It has been demonstrated that SAFE allows a low-leakage SFR to achieve a self-shutdown and self-controllability even though the generic coolant temperature coefficient is quite positive and the coolant void reactivity can be largely managed by the new FAST device. It is concluded that both FAST and SAFE devices will improve substantially the fast reactor safety and they deserve more detailed investigations.

Safety work with MRI devices in medicine

International Nuclear Information System (INIS)

Zivkovic, D.; Hrnjak, M.

1999-01-01

This paper gives the basis of biological effects of physical factors which could affect personnel working on MRI devices and patients, and corresponding protection measures. Medical personnel working with MRI devices and patients could be exposed to static magnetic field, time varying fields and radiofrequency radiation, danger from electric current and chemical matters, and there is a high risk from moving metal objects which could wound the persons near-by. The protection from static magnetic field could be ensured by increasing the distance from the source. If MRI device is put in Faradays cage it could be corresponding protection of radiofrequency radiation. (author)

Effect of electronic device use on pedestrian safety : a literature review.

Science.gov (United States)

2016-04-01

This literature review on the effect of electronic device use on pedestrian safety is part of a research project sponsored by the Office of Behavioral Safety Research in the National Highway Traffic Safety Administration (NHTSA). An extensive literat...

78 FR 29392 - Embedded Digital Devices in Safety-Related Systems, Systems Important to Safety, and Items Relied...

Science.gov (United States)

2013-05-20

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0098] Embedded Digital Devices in Safety-Related Systems, Systems Important to Safety, and Items Relied on for Safety AGENCY: Nuclear Regulatory Commission. ACTION... (NRC) is issuing for public comment Draft Regulatory Issue Summary (RIS) 2013-XX, ``Embedded Digital...

Biologics in pediatric psoriasis - efficacy and safety.

Science.gov (United States)

Dogra, Sunil; Mahajan, Rahul

2018-01-01

Childhood psoriasis is a special situation that is a management challenge for the treating dermatologist. As is the situation with traditional systemic agents, which are commonly used in managing severe psoriasis in children, the biologics are being increasingly used in the recalcitrant disease despite limited data on long term safety. Areas covered: We performed an extensive literature search to collect evidence-based data on the use of biologics in pediatric psoriasis. The relevant literature published from 2000 to September 2017 was obtained from PubMed, using the MeSH words 'biologics', 'biologic response modifiers' and 'treatment of pediatric/childhood psoriasis'. All clinical trials, randomized double-blind or single-blind controlled trials, open-label studies, retrospective studies, reviews, case reports and letters concerning the use of biologics in pediatric psoriasis were screened. Articles covering the use of biologics in pediatric psoriasis were screened and reference lists in the selected articles were scrutinized to identify other relevant articles that had not been found in the initial search. Articles without relevant information about biologics in general (e.g. its mechanism of action, pharmacokinetics and adverse effects) and its use in psoriasis in particular were excluded. We screened 427 articles and finally selected 41 relevant articles. Expert opinion: The available literature on the use of biologics such as anti-tumor necrosis factor (TNF)-α agents, and anti-IL-12/23 agents like ustekinumab suggests that these are effective and safe in managing severe pediatric psoriasis although there is an urgent need to generate more safety data. Dermatologists must be careful about the potential adverse effects of the biologics before administering them to children with psoriasis. It is likely that with rapidly evolving scenario of biologics in psoriasis, these will prove to be very useful molecules particularly in managing severe and recalcitrant

A microfluidic dialysis device for complex biological mixture SERS analysis

KAUST Repository

Perozziello, Gerardo; Candeloro, Patrizio; Gentile, Francesco T.; Coluccio, Maria Laura; Tallerico, Marco; De Grazia, Antonio; Nicastri, Annalisa; Perri, Angela Mena; Parrotta, Elvira; Pardeo, Francesca; Catalano, Rossella; Cuda, Giovanni; Di Fabrizio, Enzo M.

2015-01-01

In this paper, we present a microfluidic device fabricated with a simple and inexpensive process allowing rapid filtering of peptides from a complex mixture. The polymer microfluidic device can be used for sample preparation in biological

Safety of Magnetic Resonance Imaging in Patients with Cardiac Devices.

Science.gov (United States)

Nazarian, Saman; Hansford, Rozann; Rahsepar, Amir A; Weltin, Valeria; McVeigh, Diana; Gucuk Ipek, Esra; Kwan, Alan; Berger, Ronald D; Calkins, Hugh; Lardo, Albert C; Kraut, Michael A; Kamel, Ihab R; Zimmerman, Stefan L; Halperin, Henry R

2017-12-28

Patients who have pacemakers or defibrillators are often denied the opportunity to undergo magnetic resonance imaging (MRI) because of safety concerns, unless the devices meet certain criteria specified by the Food and Drug Administration (termed "MRI-conditional" devices). We performed a prospective, nonrandomized study to assess the safety of MRI at a magnetic field strength of 1.5 Tesla in 1509 patients who had a pacemaker (58%) or an implantable cardioverter-defibrillator (42%) that was not considered to be MRI-conditional (termed a "legacy" device). Overall, the patients underwent 2103 thoracic and nonthoracic MRI examinations that were deemed to be clinically necessary. The pacing mode was changed to asynchronous mode for pacing-dependent patients and to demand mode for other patients. Tachyarrhythmia functions were disabled. Outcome assessments included adverse events and changes in the variables that indicate lead and generator function and interaction with surrounding tissue (device parameters). No long-term clinically significant adverse events were reported. In nine MRI examinations (0.4%; 95% confidence interval, 0.2 to 0.7), the patient's device reset to a backup mode. The reset was transient in eight of the nine examinations. In one case, a pacemaker with less than 1 month left of battery life reset to ventricular inhibited pacing and could not be reprogrammed; the device was subsequently replaced. The most common notable change in device parameters (>50% change from baseline) immediately after MRI was a decrease in P-wave amplitude, which occurred in 1% of the patients. At long-term follow-up (results of which were available for 63% of the patients), the most common notable changes from baseline were decreases in P-wave amplitude (in 4% of the patients), increases in atrial capture threshold (4%), increases in right ventricular capture threshold (4%), and increases in left ventricular capture threshold (3%). The observed changes in lead parameters

Safety and effectiveness considerations for clinical studies of visual prosthetic devices

Science.gov (United States)

Cohen, Ethan D.

2007-03-01

With the advent of new designs of visual prostheses for the blind, FDA is faced with developing guidance for evaluating their engineering, safety and patient performance. Visual prostheses are considered significant risk medical devices, and their use in human clinical trials must be approved by FDA under an investigation device exemption (IDE). This paper contains a series of test topics and design issues that sponsors should consider in order to assess the safety and efficacy of their device. The IDE application includes a series of pre-clinical and clinical data sections. The pre-clinical section documents laboratory, animal and bench top performance tests of visual prostheses safety and reliability to support a human clinical trial. The materials used in constructing the implant should be biocompatible, sterile, corrosion resistant, and able to withstand any forces exerted on it during normal patient use. The clinical data section is composed of items related to patient-related evaluation of device performance. This section documents the implantation procedure, trial design, statistical analysis and how visual performance is assessed. Similar to cochlear implants, a visual prosthesis is expected to last in the body for many years, and good pre-clinical and clinical testing will help ensure its safety, durability and effectiveness.

NASA safety standard for lifting devices and equipment

Science.gov (United States)

1990-09-01

NASA's minimum safety requirements are established for the design, testing, inspection, maintenance, certification, and use of overhead and gantry cranes (including top running monorail, underhung, and jib cranes), mobile cranes, derrick hoists, and special hoist supported personnel lifting devices (these do not include elevators, ground supported personnel lifts, or powered platforms). Minimum requirements are also addressed for the testing, inspection, and use of Hydra-sets, hooks, and slings. Safety standards are thoroughly detailed.

Autonomous booster device of a safety valve

International Nuclear Information System (INIS)

Namand, H.

1983-01-01

The invention concerns an autonomous booster device of a protection safety valve of a pressure vessel. The valve comprises a hollow structure, a seat connected with a mobile flap forming one piece with a stem and a calibration spring bearing on the stem and on the valve structure to maintain the flap bearing on the seat. The stem of the flap is prolongated in a box forming one piece with the valve structure and receives an added push of a spring. The box acts as a pressure device of which the piston can exercise on the stem a push opposite to and larger than the spring one. The feeding device of the pressure box is finally described in detail [fr

Sources and basic threats of biological safety

International Nuclear Information System (INIS)

Nazarova, O.D.

2010-01-01

Full text: Biological safety of any state is connected with development of its public protection against biological weapons and opportunity to prevent bio terrorist attacks. That's why in modern social-economic and geo-political conditions, the problem of biological safety strengthening become significant, which is connected with migration process globalization, development of bio-technology and dramatically increased risk of pathogenic germ infections proliferation, which can be used as biological weapon. Despite of undertaken efforts by world community on full prohibition of biological weapon, its proliferation in the world still takes place. Biology revolution during second and third millennium lead to development not only biotechnology but new achievements in medicine, agriculture and other fields of economy, but also created scientific and research preconditions for development of advanced biological means of mass destruction, that make it more attractive for achieving superiority and assigned targets: low developments costs, opportunity to create it by one small laboratory with two-three high qualified specialists bio technologists; tremendous impact effect: one substance gram can contain from one till one hundreds quintillions (10"1"8 - 10"2"0) active pathogen molecules and in case if they belong to amplificated RNA and DNA, each molecule getting to organism, will multiply and contaminate environment (the last one is its principal difference from chemical weapon); bypass of organism immunological barriers and specific vaccinations; unusual clinic finding, hard diagnosis; weakness of traditional medications and treatment methods; lack of material destruction; opportunity of tight-lipped developments; opportunity of tight-lipped application; opportunity of delayed effect; opportunity of selective influence on specific population (by use of genetic, climatic and cultural specifications of race, nations and nationalities). Above mentioned specifications create

Health and safety manual

International Nuclear Information System (INIS)

1980-02-01

The manual consists of the following chapters: general policies and administration; the Environmental Health and Safety Department; the Medical Services Department: biological hazards; chemical safety; confined space entry; cryogenic safety; electrical safety; emergency plans; engineering and construction; evacuations, trenching, and shoring; fire safety; gases, flammable and compressed; guarding, mechanical; ladders and scaffolds, work surfaces; laser safety; materials handling and storage; noise; personal protective equipment; pressure safety; radiation safety, ionizing and non-ionizing; sanitation; seismic safety; training, environmental health and safety; tools, power and hand-operated; traffic and transportation; and warning signs and devices

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).

Double network bacterial cellulose hydrogel to build a biology-device interface

Science.gov (United States)

Shi, Zhijun; Li, Ying; Chen, Xiuli; Han, Hongwei; Yang, Guang

2013-12-01

Establishing a biology-device interface might enable the interaction between microelectronics and biotechnology. In this study, electroactive hydrogels have been produced using bacterial cellulose (BC) and conducting polymer (CP) deposited on the BC hydrogel surface to cover the BC fibers. The structures of these composites thus have double networks, one of which is a layer of electroactive hydrogels combined with BC and CP. The electroconductivity provides the composites with capabilities for voltage and current response, and the BC hydrogel layer provides good biocompatibility, biodegradability, bioadhesion and mass transport properties. Such a system might allow selective biological functions such as molecular recognition and specific catalysis and also for probing the detailed genetic and molecular mechanisms of life. A BC-CP composite hydrogel could then lead to a biology-device interface. Cyclic voltammetry and electrochemical impedance spectroscopy (EIS) are used here to study the composite hydrogels' electroactive property. BC-PAni and BC-PPy respond to voltage changes. This provides a mechanism to amplify electrochemical signals for analysis or detection. BC hydrogels were found to be able to support the growth, spreading and migration of human normal skin fibroblasts without causing any cytotoxic effect on the cells in the cell culture. These double network BC-CP hydrogels are biphasic Janus hydrogels which integrate electroactivity with biocompatibility, and might provide a biology-device interface to produce implantable devices for personalized and regenerative medicine.

Safety device for nuclear reactors

International Nuclear Information System (INIS)

Gruhl, H.

1974-01-01

The safety device is used to capture fragments of the lid of a pressure vessel when this vessel ruptures. It consists of a catcher structure attached to the concrete vessel, which is open at the top, and surrounding the pressure vessel. The catcher structure in this case may be designed as a ring installed very close to the concrete vessel, as a closure plate or may be made of transverse beams arranged parallel to each other. It is anchored either rigidly or elastically to the concrete vessel by means of springs or to the foundation by means of steel stretching members. (DG) [de

MRI with cardiac pacing devices – Safety in clinical practice

Energy Technology Data Exchange (ETDEWEB)

Kaasalainen, Touko, E-mail: touko.kaasalainen@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Department of Physics, University of Helsinki (Finland); Pakarinen, Sami, E-mail: sami.pakarinen@hus.fi [HUS Department of Cardiology, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Kivistö, Sari, E-mail: sari.kivisto@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Holmström, Miia, E-mail: miia.holmstrom@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Hänninen, Helena, E-mail: helena.hanninen@hus.fi [HUS Department of Cardiology, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Peltonen, Juha, E-mail: juha.peltonen@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Department of Biomedical Engineering and Computational Science, School of Science, Aalto University, Helsinki (Finland); Lauerma, Kirsi, E-mail: kirsi.lauerma@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Sipilä, Outi, E-mail: outi.sipila@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland)

2014-08-15

Objectives: The aim of this study was to introduce a single centre “real life” experience of performing MRI examinations in clinical practice on patients with cardiac pacemaker systems. Additionally, we aimed to evaluate the safety of using a dedicated safety protocol for these patients. Materials and methods: We used a 1.5 T MRI scanner to conduct 68 MRI scans of different body regions in patients with pacing systems. Of the cardiac devices, 32% were MR-conditional, whereas the remaining 68% were MR-unsafe. We recorded the functional parameters of the devices prior, immediately after, and approximately one month after the MRI scanning, and compared the device parameters to the baseline values. Results: All MRI examinations were completed safely, and each device could be interrogated normally following the MRI. We observed no changes in the programmed parameters of the devices. For most of the participants, the distributions of the immediate and one-month changes in the device parameters were within 20% of the baseline values, although some changes approached clinically important thresholds. Furthermore, we observed no differences in the variable changes between MR-conditional and MR-unsafe pacing systems, or between scans of the thorax area and other scanned areas. Conclusion: MRI in patients with MR-conditional pacing systems and selected MR-unsafe systems could be performed safely under strict conditions in this study.

An examination of safety reports involving electronic flight bags and portable electronic devices

Science.gov (United States)

2014-06-01

The purpose of this research was to develop a better understanding of safety considerations with the use of Electronic Flight Bags (EFBs) and Portable Electronic Devices (PEDs) by examining safety reports from Aviation Safety Reporting System (ASRS),...

The Role of Patient Safety in the Device Purchasing Process

National Research Council Canada - National Science Library

Johnson, Todd R; Zhang, Jiajie; Patel, Vimla L; Keselman, Alla; Tang, Xiaozhou; Brixey, Juliana J; Paige, Danielle; Turley, James P

2005-01-01

To examine how patient safety considerations are incorporated into medical device purchase decisions, individuals involved in recent infusion pump purchasing decisions at three different health care...

Safety considerations in the design of the Fusion Engineering Device

International Nuclear Information System (INIS)

Barrett, R.J.

1983-01-01

The US Department of Energy (DOE) regulations and guidelines for radiation protection have been reviewed and are being applied to the device design. Direct radiation protection is provided by the device shield and the reactor building walls. Radiation from the activated device components and the tritium fuel is to be controlled with shielding, contamination control, and ventilation. The potential release of tritium from the plant has influenced the selection of reactor building and plant designs and specifications. The safety of the plant workers is affected primarily by the radiation from the activated device components and from plasma chamber debris

Motorcycle safety device investigation: A case study on airbags

Indian Academy of Sciences (India)

analysis methods for research evaluation of rider crash protective devices fitted to ... The safety evaluation is then based on simulation of the 200 impact types. ... with recording of ISO 13232 car-front impact tests to evaluate the qualitative.

Synthetic biology and occupational risk.

Science.gov (United States)

Howard, John; Murashov, Vladimir; Schulte, Paul

2017-03-01

Synthetic biology is an emerging interdisciplinary field of biotechnology that involves applying the principles of engineering and chemical design to biological systems. Biosafety professionals have done an excellent job in addressing research laboratory safety as synthetic biology and gene editing have emerged from the larger field of biotechnology. Despite these efforts, risks posed by synthetic biology are of increasing concern as research procedures scale up to industrial processes in the larger bioeconomy. A greater number and variety of workers will be exposed to commercial synthetic biology risks in the future, including risks to a variety of workers from the use of lentiviral vectors as gene transfer devices. There is a need to review and enhance current protection measures in the field of synthetic biology, whether in experimental laboratories where new advances are being researched, in health care settings where treatments using viral vectors as gene delivery systems are increasingly being used, or in the industrial bioeconomy. Enhanced worker protection measures should include increased injury and illness surveillance of the synthetic biology workforce; proactive risk assessment and management of synthetic biology products; research on the relative effectiveness of extrinsic and intrinsic biocontainment methods; specific safety guidance for synthetic biology industrial processes; determination of appropriate medical mitigation measures for lentiviral vector exposure incidents; and greater awareness and involvement in synthetic biology safety by the general occupational safety and health community as well as by government occupational safety and health research and regulatory agencies.

Universal Safety Distance Alert Device for Road Vehicles

Directory of Open Access Journals (Sweden)

Matic Virant

2016-04-01

Full Text Available Driving with too short of a safety distance is a common problem in road traffic, often with traffic accidents as a consequence. Research has identified a lack of vehicle-mountable devices for alerting the drivers of trailing vehicles about keeping a sufficient safe distance. The principal requirements for such a device were defined. A conceptual study was performed in order to select the components for the integration of the device. Based on the results of this study, a working prototype of a flexible, self-contained device was designed, built and tested. The device is intended to be mounted on the rear of a vehicle. It uses radar as the primary distance sensor, assisted with a GPS receiver for velocity measurement. A Raspberry Pi single-board computer is used for data acquisition and processing. The alerts are shown on an LED-matrix display mounted on the rear of the host vehicle. The device software is written in Python and provides automatic operation without requiring any user intervention. The tests have shown that the device is usable on almost any motor vehicle and performs reliably in simulated and real traffic. The open issues and possibilities for future improvements are presented in the Discussion.

H+-type and OH- -type biological protonic semiconductors and complementary devices.

Science.gov (United States)

Deng, Yingxin; Josberger, Erik; Jin, Jungho; Roudsari, Anita Fadavi; Rousdari, Anita Fadavi; Helms, Brett A; Zhong, Chao; Anantram, M P; Rolandi, Marco

2013-10-03

Proton conduction is essential in biological systems. Oxidative phosphorylation in mitochondria, proton pumping in bacteriorhodopsin, and uncoupling membrane potentials by the antibiotic Gramicidin are examples. In these systems, H(+) hop along chains of hydrogen bonds between water molecules and hydrophilic residues - proton wires. These wires also support the transport of OH(-) as proton holes. Discriminating between H(+) and OH(-) transport has been elusive. Here, H(+) and OH(-) transport is achieved in polysaccharide- based proton wires and devices. A H(+)- OH(-) junction with rectifying behaviour and H(+)-type and OH(-)-type complementary field effect transistors are demonstrated. We describe these devices with a model that relates H(+) and OH(-) to electron and hole transport in semiconductors. In turn, the model developed for these devices may provide additional insights into proton conduction in biological systems.

Condition Monitoring and Fault Diagnosis for an Antifalling Safety Device

Directory of Open Access Journals (Sweden)

Guangxiang Yang

2015-01-01

Full Text Available There is a constant need for the safe operation and reliability of antifalling safety device (AFSD of an elevator. This paper reports an experimental study on rotation speed and catching torque monitoring and fault diagnosis of an antifalling safety device in a construction elevator. Denoising the signal using wavelet transform is presented in this paper. Based on the denoising effects for several types of wavelets, the sym8 wavelet basis, which introduces the high order approximation and an adaptive threshold, is employed for denoising the signal. The experimental result shows a maximum data error reduction of 7.5% is obtained and SNRs (signal-to-noise ratio of rotation speed and catching torque are improved for 3.9% and 6.4%, respectively.

Strategy on biological evaluation for biodegradable/absorbable materials and medical devices.

Science.gov (United States)

Liu, Chenghu; Luo, Hongyu; Wan, Min; Hou, Li; Wang, Xin; Shi, Yanping

2018-01-01

During the last two decades, biodegradable/absorbable materials which have many benefits over conventional implants are being sought in clinical practices. However, to date, it still remains obscure for us to perform full physic-chemical characterization and biological risk assessment for these materials and related devices due to their complex design and coherent processing. In this review, based on the art of knowledge for biodegradable/absorbable materials and biological risk assessment, we demonstrated some promising strategies to establish and improve the current biological evaluation systems for these biodegradable/absorbable materials and related medical devices.

H+-type and OH−-type biological protonic semiconductors and complementary devices

Science.gov (United States)

Deng, Yingxin; Josberger, Erik; Jin, Jungho; Rousdari, Anita Fadavi; Helms, Brett A.; Zhong, Chao; Anantram, M. P.; Rolandi, Marco

2013-01-01

Proton conduction is essential in biological systems. Oxidative phosphorylation in mitochondria, proton pumping in bacteriorhodopsin, and uncoupling membrane potentials by the antibiotic Gramicidin are examples. In these systems, H+ hop along chains of hydrogen bonds between water molecules and hydrophilic residues – proton wires. These wires also support the transport of OH− as proton holes. Discriminating between H+ and OH− transport has been elusive. Here, H+ and OH− transport is achieved in polysaccharide- based proton wires and devices. A H+- OH− junction with rectifying behaviour and H+-type and OH−-type complementary field effect transistors are demonstrated. We describe these devices with a model that relates H+ and OH− to electron and hole transport in semiconductors. In turn, the model developed for these devices may provide additional insights into proton conduction in biological systems. PMID:24089083

Magnetic resonance: safety measures and biological effects

International Nuclear Information System (INIS)

Gordillo, I.; Lafuente, J.; Fernandez, C.; Barbero, M.J.; Cascon, E.

1997-01-01

The biological effects of electromagnetic fields is currently a subject of great controversy. For this reason, magnetic resonance imaging (MRI) and spectroscopy are constantly under investigation. The source of the risk in MRI is associated with the three types of electromagnetic radiation to which the patient is exposed: the static magnetic field, variable (gradient) magnetic fields and radiofrequency fields. Each is capable of producing significant biological effects when employed at sufficient intensity. Patients exposed to risk sources are those situated within the lines of force of the magnetic field, ellipsoid lines that are arranged around the magnet, representing the strength of the surrounding field. To date, at the intensity normally utilized in MRI(<2T) and respecting the field limit recommendations established by the US Food and Drug Administration (FDA) for clinical use of this technique no adverse secondary biological effects have been reported. The known biological effects and other possible secondary effects are reviewed, and the recommended safety measures are discussed. (Author)

Thermo-fluidic devices and materials inspired from mass and energy transport phenomena in biological system

Institute of Scientific and Technical Information of China (English)

Jian XIAO; Jing LIU

2009-01-01

Mass and energy transport consists of one of the most significant physiological processes in nature, which guarantees many amazing biological phenomena and activ-ities. Borrowing such idea, many state-of-the-art thermo-fluidic devices and materials such as artificial kidneys, carrier erythrocyte, blood substitutes and so on have been successfully invented. Besides, new emerging technologies are still being developed. This paper is dedicated to present-ing a relatively complete review of the typical devices and materials in clinical use inspired by biological mass and energy transport mechanisms. Particularly, these artificial thermo-fluidic devices and materials will be categorized into organ transplantation, drug delivery, nutrient transport, micro operation, and power supply. Potential approaches for innovating conventional technologies were discussed, corresponding biological phenomena and physical mechan-isms were interpreted, future promising mass-and-energy-transport-based bionic devices were suggested, and prospects along this direction were pointed out. It is expected that many artificial devices based on biological mass and energy transport principle will appear to better improve vari-ous fields related to human life in the near future.

Thermal-Responsive Polymers for Enhancing Safety of Electrochemical Storage Devices.

Science.gov (United States)

Yang, Hui; Leow, Wan Ru; Chen, Xiaodong

2018-03-01

Thermal runway constitutes the most pressing safety issue in lithium-ion batteries and supercapacitors of large-scale and high-power density due to risks of fire or explosion. However, traditional strategies for averting thermal runaway do not enable the charging-discharging rate to change according to temperature or the original performance to resume when the device is cooled to room temperature. To efficiently control thermal runaway, thermal-responsive polymers provide a feasible and reversible strategy due to their ability to sense and subsequently act according to a predetermined sequence when triggered by heat. Herein, recent research progress on the use of thermal-responsive polymers to enhance the thermal safety of electrochemical storage devices is reviewed. First, a brief discussion is provided on the methods of preventing thermal runaway in electrochemical storage devices. Subsequently, a short review is provided on the different types of thermal-responsive polymers that can efficiently avoid thermal runaway, such as phase change polymers, polymers with sol-gel transitions, and polymers with positive temperature coefficients. The results represent the important development of thermal-responsive polymers toward the prevention of thermal runaway in next-generation smart electrochemical storage devices. © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Software used to size the safety devices

CERN Multimedia

CERN. Geneva

2016-01-01

To avoid mistakes during the calculation, CEA/SBT has decided to write a software that take into account all the situations it is possible to encountered (subcritical state, supercritical state, …). The goal is to permit to the engineer in charge of a cryostat manufacturing to perform this calculation; he is the only person able to do the accidental analysis which is fundamental for the sizing of the safety device. The software performed will be presented.

Factors affecting the utilization of safety devices by commercial ...

African Journals Online (AJOL)

Background: Motorcycle crashes are common causes of morbidity and mortality for both riders and passengers. To prevent and reduce the severity of injuries sustained through road traffic accidents (RTA) many countries enforce the use of safety devices while riding. Certain factors including non-enforcement of the existing ...

Biological and haematological safety profile of oral amodiaquine ...

African Journals Online (AJOL)

Biological and haematological safety profile of oral amodiaquine and chloroquine in healthy volunteers with or without Plasmodium falciparum infection in northeast Tanzania. JJ Massaga, JP Lusingu, R Makunde, HM Malebo, MM Chile, JA Akida, MM Lemnge, AM Rønn, TG Theander, IC Bygbjerg, AY Kitua ...

Design and construction of safety devices utilizing methods of measurement and control engineering

Energy Technology Data Exchange (ETDEWEB)

Greiner, B; Weidlich, S

1982-08-01

This article considers a proposed concept for the design and construction of measurement and control devices for the safety of chemical plants with the aim of preventing danger to persons and the environment and damage. Such measurement and control devices are generally employed when primary measures adopted for plant safety, such as safety valves, collection vessels, etc. are not applicable or insufficient by themselves. The concept regards the new sheet no. 3 of the VDI/VDE code draft 2180 ''Safety of chemical engineering plant'' and proposes a further subdivision of class A into safety classes A0, A1, and A2. Overall, it is possible, on the basis of the measures for raising the availability of measurement and control equipment which are presented in this article, to make selection appropriate to the potential danger involved. The proposed procedure should not, however, be regarded as a rigid scheme but rather as leading to a systematic view and supporting decisions resting on sound operating experience.

Biological samples positioning device for irradiations on a radial channel at the nuclear research reactor

International Nuclear Information System (INIS)

Rodriguez Gual, Maritza; Mas Milian, Felix; Deppman, Airton; Pinto Coelho, Paulo Rogerio

2010-01-01

For the demand of an experimental device for biological samples positioning system for irradiations on a radial channel at the nuclear research reactor in operation was constructed and started up a device for the place and remove of the biological samples from the irradiation channels without interrupting the operation of the reactor. The economical valuations are effected comparing with another type of device with the same functions. This work formed part of an international project between Cuba and Brazil that undertook the study of the induced damages by various types of ionizing radiation in DNA molecules. Was experimentally tested the proposed solution, which demonstrates the practical validity of the device. As a result of the work, the experimental device for biological samples irradiations are installed and operating in the radial beam hole No3(BH3) for more than five years at the IEA-R1 Brazilian research reactor according to the solicited requirements the device. The designed device increases considerably the type of studies can be conducted in this reactor. Its practical application in research taking place in that facility, in the field of radiobiology and dosimetry, and so on is immediate

Semiconductor Devices Inspired By and Integrated With Biology

Energy Technology Data Exchange (ETDEWEB)

Rogers, John [University of Illinois

2012-04-25

Biology is curved, soft and elastic; silicon wafers are not. Semiconductor technologies that can bridge this gap in form and mechanics will create new opportunities in devices that adopt biologically inspired designs or require intimate integration with the human body. This talk describes the development of ideas for electronics that offer the performance of state-of-the-art, wafer- based systems but with the mechanical properties of a rubber band. We explain the underlying materials science and mechanics of these approaches, and illustrate their use in (1) bio- integrated, ‘tissue-like’ electronics with unique capabilities for mapping cardiac and neural electrophysiology, and (2) bio-inspired, ‘eyeball’ cameras with exceptional imaging properties enabled by curvilinear, Petzval designs.

Safety, efficacy, and drug survival of biologics and biosimilars for moderate-to-severe plaque psoriasis

DEFF Research Database (Denmark)

Egeberg, A; Ottosen, M B; Gniadecki, R

2018-01-01

BACKGROUND: Real-life data on newer biologic and biosimilar agents for moderate-to-severe psoriasis are lacking. OBJECTIVES: To examine safety, efficacy, and time to discontinuation (drug survival) of biologics (adalimumab, etanercept, infliximab, secukinumab, and ustekinumab) and compare origina...... the long-term safety of novel biologics for psoriasis. This article is protected by copyright. All rights reserved....

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.

10 CFR 32.101 - Schedule B-prototype tests for luminous safety devices for use in aircraft.

Science.gov (United States)

2010-01-01

....101 Schedule B—prototype tests for luminous safety devices for use in aircraft. An applicant for a... 10 Energy 1 2010-01-01 2010-01-01 false Schedule B-prototype tests for luminous safety devices for use in aircraft. 32.101 Section 32.101 Energy NUCLEAR REGULATORY COMMISSION SPECIFIC DOMESTIC LICENSES...

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 ...

Modified laminar flow biological safety cabinet.

Science.gov (United States)

McGarrity, G J; Coriell, L L

1974-10-01

Tests are reported on a modified laminar flow biological safety cabinet in which the return air plenum that conducts air from the work area to the high efficiency particulate air filters is under negative pressure. Freon gas released inside the cabinet could not be detected outside by a freon gas detection method capable of detecting 10(-6) cc/s. When T3 bacteriophage was aerosolized 5 cm outside the front opening in 11 tests, no phage could be detected inside the cabinet with the motor-filter unit in operation. An average of 2.8 x 10(5) plaque-forming units (PFU)/ft(3) (ca. 0.028 m(3)) were detected with the motor-filter unit not in operation, a penetration of 0.0%. Aerosolization 5 cm inside the cabinet yielded an average of 10 PFU/ft(3) outside the cabinet with the motor-filter unit in operation and an average of 4.1 x 10(5) PFU/ft(3) with the motor-filter unit not in operation, a penetration of 0.002%. These values are the same order of effectiveness as the positive-pressure laminar flow biological safety cabinets previously tested. The advantages of the negative-pressure return plenum design include: (i) assurance that if cracks or leaks develop in the plenum it will not lead to discharge of contaminated air into the laboratory; and (ii) the price is lower due to reduced manufacturing costs.

Practices and exploration on competition of molecular biological detection technology among students in food quality and safety major.

Science.gov (United States)

Chang, Yaning; Peng, Yuke; Li, Pengfei; Zhuang, Yingping

2017-07-08

With the increasing importance in the application of the molecular biological detection technology in the field of food safety, strengthening education in molecular biology experimental techniques is more necessary for the culture of the students in food quality and safety major. However, molecular biology experiments are not always in curricula of Food quality and safety Majors. This paper introduced a project "competition of molecular biological detection technology for food safety among undergraduate sophomore students in food quality and safety major", students participating in this project needed to learn the fundamental molecular biology experimental techniques such as the principles of molecular biology experiments and genome extraction, PCR and agarose gel electrophoresis analysis, and then design the experiments in groups to identify the meat species in pork and beef products using molecular biological methods. The students should complete the experimental report after basic experiments, write essays and make a presentation after the end of the designed experiments. This project aims to provide another way for food quality and safety majors to improve their knowledge of molecular biology, especially experimental technology, and enhances them to understand the scientific research activities as well as give them a chance to learn how to write a professional thesis. In addition, in line with the principle of an open laboratory, the project is also open to students in other majors in East China University of Science and Technology, in order to enhance students in other majors to understand the fields of molecular biology and food safety. © 2017 by The International Union of Biochemistry and Molecular Biology, 45(4):343-350, 2017. © 2017 The International Union of Biochemistry and Molecular Biology.

MedWatch Safety Alerts for Human Medical Products

Data.gov (United States)

U.S. Department of Health & Human Services — MedWatch alerts provide timely new safety information on human drugs, medical devices, vaccines and other biologics, dietary supplements, and cosmetics. The alerts...

Safety, security, and serving the public interest in synthetic biology.

Science.gov (United States)

Gronvall, Gigi Kwik

2018-03-21

This article describes what may be done by scientists and by the biotechnology industry, generally, to address the safety and security challenges in synthetic biology. Given the technical expertise requirements for developing sound policy options, as well as the importance of these issues to the future of the industry, scientists who work in synthetic biology should be informed about these challenges and get involved in shaping policies relevant to the field.

Regulatory Experience of the Embedded Digital Devices for Safety I and C Systems on Nuclear Power Plants

Energy Technology Data Exchange (ETDEWEB)

Kim, Y. M.; Lee, H. K.; Park, H. S. [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

2016-10-15

Conventional I and C(Instrumentation and Control) systems are tend to becoming unavailable and being replaced by smart equipment. These smart equipment is usually called embedded digital devices (EDDs) or industrial digital devices of limited functionality. Usually, some of these devices are found embedded in plant equipment such as sensing instrumentation, motors, pumps, actuators and breakers. They typically have a micro-processor, RAM, communication interface, a power source, etc. The U.S. Nuclear Regulatory Commission (US NRC) is concerning that these EDDs might exist in procured equipment used in safety systems without the devices having been explicitly identified in procurement documentation. This paper addresses the regulatory experiences of KINS of the EDDs for safety I and C systems and the future works for them. In this paper, we showed regulatory experiences of EDDs which used for safety grade equipment. EDDs might exist in safety grade procured equipment without explicit identification. Undetected defects of EDDs might be the potential safety concerns. EDDs should meet certain specific requirements in order to be selected and used in safety I and C system. We have plan to develop technical positions for identification and qualifying them. The technical position will address, but may not be limited to, quality and reliability, CCFs via software errors, EMC, and CGID for EDDs.

Book review: Safety of Biologics Therapy

Directory of Open Access Journals (Sweden)

Robak T

2017-01-01

Full Text Available Tadeusz Robak Department of Hematology, Medical University of Lodz and Copernicus Memorial Hospital, Lodz, PolandSafety of Biologics Therapy: Monoclonal Antibodies, Cytokines, Fusion Proteins, Hormones, Enzymes, Coagulation Proteins, Vaccines, Botulinum Toxins (Cham, Switzerland: Springer International Publishing; 2016 by Brian A Baldo from the Molecular Immunology Unit, Kolling Institute of Medical Research, Royal North Shore Hospital of Sydney, and the Department of Medicine, University of Sydney, Australia, is a book that belongs on the shelf of everyone in the field of biologic therapies research and clinical practice. In writing this book, the author’s intention was to produce an up-to-date text book on approved biologic therapies, as far as that is possible in this time of rapidly evolving developments in biotherapeutic research and the introduction of new and novel agents for clinical use.The monograph comprises 610 pages in 13 chapters, each including a summary and further reading suggestions. All chapters include a discussion of basic and clinical material. Well-designed, comprehensive tables and color figures are present throughout the book. The book itself examines the biologic products that have regulatory approval in the USA and/or European Union and that show every indication of remaining important therapies. It covers in great detail all the latest work on peptide hormones and enzymes, monoclonal antibodies, fusion proteins, and cytokine therapies. Beyond that, it also presents the latest information on blood coagulation proteins, vaccines, botulinum neurotoxins, and biosimilars. 

Permitting product liability litigation for FDA-approved drugs and devices promotes patient safety.

Science.gov (United States)

Kesselheim, A S

2010-06-01

In 2008 and 2009, the Supreme Court reviewed the question of whether patients injured by dangerous prescription drugs or medical devices can bring tort lawsuits against pharmaceutical and device manufacturers. The Court ruled that claims against device manufacturers were preempted while claims against pharmaceutical manufacturers were not. The threat of product liability lawsuits promotes patient safety by encouraging manufacturers to take greater responsibility in providing clear warnings about known adverse effects of their products.

Research Devices Maintenance Programs and Safety Network Infrastructures in Nuclear Malaysia

International Nuclear Information System (INIS)

Zainudin Jaafar; Muhammad Zahidee Taat; Ishak Mansor

2015-01-01

Instrumentation and Automation Center (PIA) is responsible in carrying out maintenance work for building safety infrastructure and area for nuclear scientific and research work. Care cycle and nuclear scientific tools starting from the preparation of specifications until devices disposal- to get the maximum output from devices therefore PIA has introduced Effective and Comprehensive Maintenance Plan under Management/ Trust/ Development/ Science Fund budgets and also user, Asset Management, caring and handling of the devices. This paper also discussed more on case study related to using and handling so that it can be guidance and standard when its involving mishandling, improper maintenance, inadequacy of supervision and others including improvement suggestion programs. (author)

Utilization of ocular safety devices among Sawmill workers in Nigeria

African Journals Online (AJOL)

Objective: The study was carried out to assess the use of eye safety devices in sawmill workers in Nigeria. Methods: A cross-sectional study of sawmill workers was carried out using pretested questionnaires. Ocular examination was done on site with a pen torch, portable hand-held slit lamp bio-microscope and direct ...

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...

78 FR 35284 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Science.gov (United States)

2013-06-12

... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2013-M-0036... Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY...

76 FR 31965 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Science.gov (United States)

2011-06-02

... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2011-M-0034... Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY...

Passive safety device and internal short tested method for energy storage cells and systems

Science.gov (United States)

Keyser, Matthew; Darcy, Eric; Long, Dirk; Pesaran, Ahmad

2015-09-22

A passive safety device for an energy storage cell for positioning between two electrically conductive layers of the energy storage cell. The safety device also comprising a separator and a non-conductive layer. A first electrically conductive material is provided on the non-conductive layer. A first opening is formed through the separator between the first electrically conductive material and one of the electrically conductive layers of the energy storage device. A second electrically conductive material is provided adjacent the first electrically conductive material on the non-conductive layer, wherein a space is formed on the non-conductive layer between the first and second electrically conductive materials. A second opening is formed through the non-conductive layer between the second electrically conductive material and another of the electrically conductive layers of the energy storage device. The first and second electrically conductive materials combine and exit at least partially through the first and second openings to connect the two electrically conductive layers of the energy storage device at a predetermined temperature.

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...

41 CFR 102-34.250 - Do Federal employees in Government motor vehicles have to use all safety devices and follow all...

Science.gov (United States)

2010-07-01

... safety devices and follow all safety guidelines? Yes, Federal employees in Government motor vehicles have... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Do Federal employees in Government motor vehicles have to use all safety devices and follow all safety guidelines? 102-34.250 Section...

77 FR 35745 - Highway Safety Programs; Conforming Products List of Screening Devices To Measure Alcohol in...

Science.gov (United States)

2012-06-14

..., battery powered device with a semiconductor sensor. (2) Alcohol Countermeasure Systems Corp., submitted...-0062] Highway Safety Programs; Conforming Products List of Screening Devices To Measure Alcohol in... Screening Devices to Measure Alcohol in Bodily Fluids dated, March 31, 2008 (73 FR 16956). DATES: Effective...

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.

Practices and Exploration on Competition of Molecular Biological Detection Technology among Students in Food Quality and Safety Major

Science.gov (United States)

Chang, Yaning; Peng, Yuke; Li, Pengfei; Zhuang, Yingping

2017-01-01

With the increasing importance in the application of the molecular biological detection technology in the field of food safety, strengthening education in molecular biology experimental techniques is more necessary for the culture of the students in food quality and safety major. However, molecular biology experiments are not always in curricula…

Synthetic biology devices and circuits for RNA-based 'smart vaccines': a propositional review.

Science.gov (United States)

Andries, Oliwia; Kitada, Tasuku; Bodner, Katie; Sanders, Niek N; Weiss, Ron

2015-02-01

Nucleic acid vaccines have been gaining attention as an alternative to the standard attenuated pathogen or protein based vaccine. However, an unrealized advantage of using such DNA or RNA based vaccination modalities is the ability to program within these nucleic acids regulatory devices that would provide an immunologist with the power to control the production of antigens and adjuvants in a desirable manner by administering small molecule drugs as chemical triggers. Advances in synthetic biology have resulted in the creation of highly predictable and modular genetic parts and devices that can be composed into synthetic gene circuits with complex behaviors. With the recent advent of modified RNA gene delivery methods and developments in the RNA replicon platform, we foresee a future in which mammalian synthetic biologists will create genetic circuits encoded exclusively on RNA. Here, we review the current repertoire of devices used in RNA synthetic biology and propose how programmable 'smart vaccines' will revolutionize the field of RNA vaccination.

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.

A Synthetic Biology Project - Developing a single-molecule device for screening drug-target interactions.

Science.gov (United States)

Firman, Keith; Evans, Luke; Youell, James

2012-07-16

This review describes a European-funded project in the area of Synthetic Biology. The project seeks to demonstrate the application of engineering techniques and methodologies to the design and construction of a biosensor for detecting drug-target interactions at the single-molecule level. Production of the proteins required for the system followed the principle of previously described "bioparts" concepts (a system where a database of biological parts - promoters, genes, terminators, linking tags and cleavage sequences - is used to construct novel gene assemblies) and cassette-type assembly of gene expression systems (the concept of linking different "bioparts" to produce functional "cassettes"), but problems were quickly identified with these approaches. DNA substrates for the device were also constructed using a cassette-system. Finally, micro-engineering was used to build a magnetoresistive Magnetic Tweezer device for detection of single molecule DNA modifying enzymes (motors), while the possibility of constructing a Hall Effect version of this device was explored. The device is currently being used to study helicases from Plasmodium as potential targets for anti-malarial drugs, but we also suggest other potential uses for the device. Copyright © 2012 Federation of European Biochemical Societies. Published by Elsevier B.V. All rights reserved.

Safety catching device for pipes in missile shielding cylinders of nuclear power plants

International Nuclear Information System (INIS)

Hering, S.; Doll, B.

1976-01-01

The safety catching device consists of a steel wire passed in U-shape around the pipe to be caught and supported by two anchor ties embedded in the concrete of the missile shielding cylinder. This flexible catching device is to cause the energy released in case of a pipe rupture to be absorbed and no dangerous bending shesses to be transferred to the walls of the missile shielding cylinder. (UWI) [de

Safety evaluation of stamp type digital microneedle devices in hairless mice.

Science.gov (United States)

Park, Kui Young; Jang, Woo Sun; Lim, Yun Young; Ahn, Joo Hee; Lee, Sang Jin; Kim, Chan Woong; Kim, Sung Eun; Kim, Beom Joon; Kim, Myeung Nam

2013-02-01

Microneedles provide a minimally invasive means to transport molecules into the skin. A number of specific strategies have been employed to use microneedles for transdermal delivery. The purpose of this study was to investigate the safety of two new digital microneedle devices (Digital Hand® and Digital Pro®; Bomtech Electronics Co., Ltd., Seoul, Korea) for the perforation of skin in skin-hairless-1 mice. This device replaces conventional needles and is designed specifically for intradermal delivery. We used two newly developed digital microneedle devices to perforate the skin of skin-hairless-1 mice. We conducted a comparative study of the two digital microneedle devices and DTS® (Disk type-microneedle Therapy System; DTS lab., Seoul, Korea). To evaluate skin stability, we performed visual and dermatoscopic inspections, measurements of transepidermal water loss, and biopsies. The two novel digital microneedle devices did not induce significant abnormalities of the skin on visual or dermatoscopic inspection, regardless of needle size (0.25~2.0 mm). No significant histopathological changes, such as inflammatory cell infiltration, desquamation of the stratum corneum, or disruption of the basal layer, were observed. The digital microneedle devices and microneedle therapy system produced similar results on measures of skin stability. These two novel digital microneedle devices are safe transdermal drug delivery systems.

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.

ACCIDENT WITH NEEDLESTICK: KNOWLEDGE AND USE OF SAFETY DEVICE

Directory of Open Access Journals (Sweden)

Sandra Maria Souza da Silva

2016-07-01

Full Text Available Health workers engaged in labour activities in environments surrounded the occupational hazards. Identify knowledge and use of safety devide for preventing accidents with sharp objects between nurses and nurse technicians, workers of the Intensive Care Unit, Emergency and Surgical Block, during the month of may 2015. Exploratory study, quantitative, developed in a teaching hospital in in Recife-PE. The data collection was conducted using a questionnaire prepared by the research authors. The results were submitted to descriptive statistical analysis, being evidenced that, although data indicate high rate of respondents know and use products with referencing safety devices to prevent accidents, cite gloves and masks as representatives of those materials, which requires clarification in discussion of the study. It is necessary to guide and clarify as to such mechanisms, through the permanent education, and training among workers.

Devices for overcoming biological barriers: the use of physical forces to disrupt the barriers.

Science.gov (United States)

Mitragotri, Samir

2013-01-01

Overcoming biological barriers including skin, mucosal membranes, blood brain barrier as well as cell and nuclear membrane constitutes a key hurdle in the field of drug delivery. While these barriers serve the natural protective function in the body, they limit delivery of drugs into the body. A variety of methods have been developed to overcome these barriers including formulations, targeting peptides and device-based technologies. This review focuses on the use of physical methods including acoustic devices, electric devices, high-pressure devices, microneedles and optical devices for disrupting various barriers in the body including skin and other membranes. A summary of the working principles of these devices and their ability to enhance drug delivery is presented. Copyright © 2012. Published by Elsevier B.V.

Leaving patients to their own devices? Smart technology, safety and therapeutic relationships.

Science.gov (United States)

Ho, Anita; Quick, Oliver

2018-03-06

This debate article explores how smart technologies may create a double-edged sword for patient safety and effective therapeutic relationships. Increasing utilization of health monitoring devices by patients will likely become an important aspect of self-care and preventive medicine. It may also help to enhance accurate symptom reports, diagnoses, and prompt referral to specialist care where appropriate. However, the development, marketing, and use of such technology raise significant ethical implications for therapeutic relationships and patient safety. Drawing on lessons learned from other direct-to-consumer health products such as genetic testing, this article explores how smart technology can also pose regulatory challenges and encourage overutilization of healthcare services. In order for smart technology to promote safer care and effective therapeutic encounters, the technology and its utilization must be safe. This article argues for unified regulatory guidelines and better education for both healthcare providers and patients regarding the benefits and risks of these devices.

A microfluidic dialysis device for complex biological mixture SERS analysis

KAUST Repository

Perozziello, Gerardo

2015-08-01

In this paper, we present a microfluidic device fabricated with a simple and inexpensive process allowing rapid filtering of peptides from a complex mixture. The polymer microfluidic device can be used for sample preparation in biological applications. The device is fabricated by micromilling and solvent assisted bonding, in which a microdialysis membrane (cut-off of 12-14 kDa) is sandwiched in between an upper and a bottom microfluidic chamber. An external frame connects the microfluidic device to external tubes, microvalves and syringe pumps. Bonding strength and interface sealing are pneumatically tested. Microfluidic protocols are also described by using the presented device to filter a sample composed of specific peptides (MW 1553.73 Da, at a concentration of 1.0 ng/μl) derived from the BRCA1 protein, a tumor-suppressor molecule which plays a pivotal role in the development of breast cancer, and albumin (MW 66.5 kDa, at a concentration of 35 μg/μl), the most represented protein in human plasma. The filtered samples coming out from the microfluidic device were subsequently deposited on a SERS (surface enhanced Raman scattering) substrate for further analysis by Raman spectroscopy. By using this approach, we were able to sort the small peptides from the bigger and highly concentrated protein albumin and to detect them by using a label-free technique at a resolution down to 1.0 ng/μl.

Synthetic biology devices for in vitro and in vivo diagnostics.

Science.gov (United States)

Slomovic, Shimyn; Pardee, Keith; Collins, James J

2015-11-24

There is a growing need to enhance our capabilities in medical and environmental diagnostics. Synthetic biologists have begun to focus their biomolecular engineering approaches toward this goal, offering promising results that could lead to the development of new classes of inexpensive, rapidly deployable diagnostics. Many conventional diagnostics rely on antibody-based platforms that, although exquisitely sensitive, are slow and costly to generate and cannot readily confront rapidly emerging pathogens or be applied to orphan diseases. Synthetic biology, with its rational and short design-to-production cycles, has the potential to overcome many of these limitations. Synthetic biology devices, such as engineered gene circuits, bring new capabilities to molecular diagnostics, expanding the molecular detection palette, creating dynamic sensors, and untethering reactions from laboratory equipment. The field is also beginning to move toward in vivo diagnostics, which could provide near real-time surveillance of multiple pathological conditions. Here, we describe current efforts in synthetic biology, focusing on the translation of promising technologies into pragmatic diagnostic tools and platforms.

Materials for electrochemical device safety

Science.gov (United States)

Vissers, Daniel R.; Amine, Khalil; Thackeray, Michael M.; Kahaian, Arthur J.; Johnson, Christopher S.

2015-04-07

An electrochemical device includes a thermally-triggered intumescent material or a gas-triggered intumescent material. Such devices prevent or minimize short circuits in a device that could lead to thermal run-away. Such devices may include batteries or supercapacitors.

Toxicity of Biologically Active Peptides and Future Safety Aspects: An Update.

Science.gov (United States)

Khan, Fazlullah; Niaz, Kamal; Abdollahi, Mohammad

2018-02-18

Peptides are fragments of proteins with significant biological activities. These peptides are encoded in the protein sequence. Initially, such peptides are inactive in their parental form, unless proteolytic enzymes are released. These peptides then exhibit various functions and play a therapeutic role in the body. Besides the therapeutic and physiological activities of peptides, the main purpose of this study was to highlight the safety aspects of peptides. We performed an organized search of available literature using PubMed, Google Scholar, Medline, EMBASE, Reaxys and Scopus databases. All the relevant citations including research and review articles about the toxicity of biologically active peptides were evaluated and gathered in this study. Biological peptides are widely used in the daily routine ranging from food production to the cosmetics industry and also they have a beneficial role in the treatment and prevention of different diseases. These peptides are manufactured by both chemical and biotechnological techniques, which show negligible toxicity, however, some naturally occurring peptides and enzymes may induce high toxicity. Depending upon the demand and expected use in the food or pharmaceutical industry, we need different approaches to acertain the safety of these peptides preferentially through in silico methods. Intestinal wall disruption, erythrocytes and lymphocytes toxicity, free radical production, enzymopathic and immunopathic tissue damage and cytotoxicity due to the consumption of peptides are the main problems in the biological system that lead to various complicated disorders. Therefore, before considering biologically active peptides for food production and for therapeutic purpose, it is first necessary to evaluate the immunogenicity and toxicities of peptides. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Self-assembling hybrid diamond–biological quantum devices

International Nuclear Information System (INIS)

Albrecht, A; B Plenio, M; Koplovitz, G; Yochelis, S; Paltiel, Y; Retzker, A; Nevo, Y; Shoseyov, O; Jelezko, F; Porath, D

2014-01-01

The realization of scalable arrangements of nitrogen vacancy (NV) centers in diamond remains a key challenge on the way towards efficient quantum information processing, quantum simulation and quantum sensing applications. Although technologies based on implanting NV-centers in bulk diamond crystals or hybrid device approaches have been developed, they are limited by the achievable spatial resolution and by the intricate technological complexities involved in achieving scalability. We propose and demonstrate a novel approach for creating an arrangement of NV-centers, based on the self-assembling capabilities of biological systems and their beneficial nanometer spatial resolution. Here, a self-assembled protein structure serves as a structural scaffold for surface functionalized nanodiamonds, in this way allowing for the controlled creation of NV-structures on the nanoscale and providing a new avenue towards bridging the bio–nano interface. One-, two- as well as three-dimensional structures are within the scope of biological structural assembling techniques. We realized experimentally the formation of regular structures by interconnecting nanodiamonds using biological protein scaffolds. Based on the achievable NV-center distances of 11 nm, we evaluate the expected dipolar coupling interaction with neighboring NV-centers as well as the expected decoherence time. Moreover, by exploiting these couplings, we provide a detailed theoretical analysis on the viability of multiqubit quantum operations, suggest the possibility of individual addressing based on the random distribution of the NV intrinsic symmetry axes and address the challenges posed by decoherence and imperfect couplings. We then demonstrate in the last part that our scheme allows for the high-fidelity creation of entanglement, cluster states and quantum simulation applications. (papers)

Self-assembling hybrid diamond-biological quantum devices

Science.gov (United States)

Albrecht, A.; Koplovitz, G.; Retzker, A.; Jelezko, F.; Yochelis, S.; Porath, D.; Nevo, Y.; Shoseyov, O.; Paltiel, Y.; Plenio, M. B.

2014-09-01

The realization of scalable arrangements of nitrogen vacancy (NV) centers in diamond remains a key challenge on the way towards efficient quantum information processing, quantum simulation and quantum sensing applications. Although technologies based on implanting NV-centers in bulk diamond crystals or hybrid device approaches have been developed, they are limited by the achievable spatial resolution and by the intricate technological complexities involved in achieving scalability. We propose and demonstrate a novel approach for creating an arrangement of NV-centers, based on the self-assembling capabilities of biological systems and their beneficial nanometer spatial resolution. Here, a self-assembled protein structure serves as a structural scaffold for surface functionalized nanodiamonds, in this way allowing for the controlled creation of NV-structures on the nanoscale and providing a new avenue towards bridging the bio-nano interface. One-, two- as well as three-dimensional structures are within the scope of biological structural assembling techniques. We realized experimentally the formation of regular structures by interconnecting nanodiamonds using biological protein scaffolds. Based on the achievable NV-center distances of 11 nm, we evaluate the expected dipolar coupling interaction with neighboring NV-centers as well as the expected decoherence time. Moreover, by exploiting these couplings, we provide a detailed theoretical analysis on the viability of multiqubit quantum operations, suggest the possibility of individual addressing based on the random distribution of the NV intrinsic symmetry axes and address the challenges posed by decoherence and imperfect couplings. We then demonstrate in the last part that our scheme allows for the high-fidelity creation of entanglement, cluster states and quantum simulation applications.

Economic benefits of safety-engineered sharp devices in Belgium - a budget impact model.

Science.gov (United States)

Hanmore, Emma; Maclaine, Grant; Garin, Fiona; Alonso, Alexander; Leroy, Nicolas; Ruff, Lewis

2013-11-25

Measures to protect healthcare workers where there is risk of injury or infection from medical sharps became mandatory in the European Union (EU) from May 2013. Our research objective was to estimate the net budget impact of introducing safety-engineered devices (SEDs) for prevention of needlestick injuries (NSIs) in a Belgian hospital. A 5-year incidence-based budget impact model was developed from the hospital inpatient perspective, comparing costs and outcomes with SEDs and prior-used conventional (non-safety) devices. The model accounts for device acquisition costs and costs of NSI management in 4 areas of application where SEDs are currently used: blood collection, infusion, injection and diabetes insulin administration. Model input data were sourced from the Institut National d'Assurance Maladie-Invalidité, published studies, clinical guidelines and market research. Costs are discounted at 3%. For a 420-bed hospital, 100% substitution of conventional devices by SEDs is estimated to decrease the cumulative 5-year incidence of NSIs from 310 to 75, and those associated with exposure to blood-borne viral diseases from 60 to 15. Cost savings from managing fewer NSIs more than offset increased device acquisition costs, yielding estimated 5-year overall savings of €51,710. The direction of these results is robust to a range of sensitivity and model scenario analyses. The model was most sensitive to variation in the acquisition costs of SEDs, rates of NSI associated with conventional devices, and the acquisition costs of conventional devices. NSIs are a significant potential risk with the use of sharp devices. The incidence of NSIs and the costs associated with their management can be reduced through the adoption of safer work practices, including investment in SEDs. For a Belgian hospital, the budget impact model reports that the incremental acquisition costs of SEDs are offset by the savings from fewer NSIs. The availability of more robust data for NSI reduction

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...

The efficacy and safety of a novel posterior scleral reinforcement device in rabbits

Energy Technology Data Exchange (ETDEWEB)

Yuan, Yongguang; Zong, Yao; Zheng, Qishan [State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou (China); Qian, Garrett [University of New South Wales (Australia); Qian, Xiaobin; Li, Yujie; Shao, Wanwen [State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou (China); Gao, Qianying, E-mail: gaoqy@mail.sysu.edu.cn [State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou (China)

2016-05-01

Purpose: To evaluate the efficacy and safety of posterior scleral reinforcement (PSR) device for myopia suppression in rabbits' eyes. Methods: PSR surgery was performed on the normal 12 8-week-old New Zealand white rabbits' right eyes. To determine efficacy of the device, ophthalmic examination would be taken at pre-operation and post-operation (1 week, 1 month, 3 months, 6 months, and 1 year), such as A-ultrasound, diopter and B-ultrasound. Evaluation of safety were based on the following indicators: intraocular pressure (IOP), slit lamp, fundus photography, fundus fluorescein angiography and pathological examination after surgery. The efficacy and safety of PSR device were evaluated by comparison (treated eyes and contralateral eyes) of pre and post-operation. Results: The novel PSR device could significantly shorten axial length (preoperative axial length: 16.36 ± 0.14 mm, postoperative 1 week, 1 month, 3 months, 6 months and 1 year axial lengths: 15.03 ± 0.28 mm, 15.23 ± 0.32 mm, 15.39 ± 0.31 mm, 15.45 ± 0.22 mm and 15.45 ± 0.22 mm; P = 0.00037 < 0.001) in the treated eyes (right eyes) after surgery. At different postoperative time points, the B-ultrasound images showed that the PSR located in appropriate position and supported the posterior sclera very well. At the same time, IOP of treated eyes kept a relatively stable level (preoperative IOP: 12.56 ± 2.01 mmHg, postoperative IOP: ranging from 11.33 ± 1.23 mmHg to 13.44 ± 2.19 mmHg, P > 0.05) post-operation 1 year. During observation period, there was no significant inflammatory reaction and complications such as anterior chamber flare, empyema, endophthalmitis, vitreous hemorrhage, retina detachment and retinal choroid neovascularization by slit lamp, fundus photography and fundus fluorescein angiography. In addition, there were no pathologic changes be found by comparison treated eyes group and contralateral group eyes based on pathological examinations. Conclusions: In vivo study

Inherent Risk or Risky Decision? Coach's Failure to Use Safety Device an Assumed Risk

Science.gov (United States)

Dodds, Mark A.; Bochicchio, Kristi Schoepfer

2013-01-01

The court examined whether a coach's failure to implement a safety device during pitching practice enhanced the risk to the athlete or resulted in a suboptimal playing condition, in the context of the assumption of risk doctrine.

Cardiovascular safety of biologic therapies for the treatment of RA.

Science.gov (United States)

Greenberg, Jeffrey D; Furer, Victoria; Farkouh, Michael E

2011-11-15

Cardiovascular disease represents a major source of extra-articular comorbidity in patients with rheumatoid arthritis (RA). A combination of traditional cardiovascular risk factors and RA-related factors accounts for the excess risk in RA. Among RA-related factors, chronic systemic inflammation has been implicated in the pathogenesis and progression of atherosclerosis. A growing body of evidence--mainly derived from observational databases and registries--suggests that specific RA therapies, including methotrexate and anti-TNF biologic agents, can reduce the risk of future cardiovascular events in patients with RA. The cardiovascular profile of other biologic therapies for the treatment of RA has not been adequately studied, including of investigational drugs that improve systemic inflammation but alter traditional cardiovascular risk factors. In the absence of large clinical trials adequately powered to detect differences in cardiovascular events between biologic drugs in RA, deriving firm conclusions on cardiovascular safety is challenging. Nevertheless, observational research using large registries has emerged as a promising approach to study the cardiovascular risk of emerging RA biologic therapies.

Low power digital communication in implantable devices using volume conduction of biological tissues.

Science.gov (United States)

Yao, Ning; Lee, Heung-No; Sclabassi, R J; Sun, Mingui

2006-01-01

This work investigates the data communication problem of implantable devices using fundamental theories in communications. We utilize the volume conduction property of biological tissues to establish a digital communications link. Data obtained through animal experiments are used to analyze the time and frequency response of the volume conduction channel as well as to characterize the biological signals and noises present in the system. A low power bandwidth efficient channel-coded modulation scheme is proposed to conserve battery power and reduce the health risks associated.

Wheeled mobility device transportation safety in fixed route and demand-responsive public transit vehicles within the United States.

Science.gov (United States)

Frost, Karen L; van Roosmalen, Linda; Bertocci, Gina; Cross, Douglas J

2012-01-01

An overview of the current status of wheelchair transportation safety in fixed route and demand-responsive, non-rail, public transportation vehicles within the US is presented. A description of each mode of transportation is provided, followed by a discussion of the primary issues affecting safety, accessibility, and usability. Technologies such as lifts, ramps, securement systems, and occupant restraint systems, along with regulations and voluntary industry standards have been implemented with the intent of improving safety and accessibility for individuals who travel while seated in their wheeled mobility device (e.g., wheelchair or scooter). However, across both fixed route and demand-responsive transit systems a myriad of factors such as nonuse and misuse of safety systems, oversized wheeled mobility devices, vehicle space constraints, and inadequate vehicle operator training may place wheeled mobility device (WhMD) users at risk of injury even under non-impact driving conditions. Since WhMD-related incidents also often occur during the boarding and alighting process, the frequency of these events, along with factors associated with these events are described for each transit mode. Recommendations for improving WhMD transportation are discussed given the current state of

Combining biologic and phototherapy treatments for psoriasis: safety, efficacy, and patient acceptability

Directory of Open Access Journals (Sweden)

Farahnik B

2016-07-01

Full Text Available Benjamin Farahnik,1 Viraat Patel,2 Kourosh Beroukhim,3 Tian Hao Zhu,4 Michael Abrouk,2 Mio Nakamura,5 Rasnik Singh,3 Kristina Lee,5 Tina Bhutani,5 John Koo5 1University of Vermont College of Medicine, Burlington, VT; 2School of Medicine, University of California, Irvine, 3David Geffen School of Medicine, University of California, Los Angeles, 4University of Southern California Keck School of Medicine, Los Angeles, 5Department of Dermatology, Psoriasis and Skin Treatment Center, University of California, San Francisco, CA, USA Background: The efficacy and safety of biologic and phototherapy in treating moderate-to-severe psoriasis is well known. However, some patients may not respond well to biologic agents or phototherapy on their own and may require combination therapy. Skillfully combining a biologic agent and phototherapy may provide an additive improvement without much increase in risks.Objective: To summarize the current state of evidence for the efficacy and safety of combining biologics with phototherapy in the treatment of moderate-to-severe plaque psoriasis.Methods: We conducted an extensive search on Pubmed database for English language literature that evaluated the use of a combination of biologic and phototherapy for the treatment of moderate-to-severe psoriasis through January 2016. The search included the following keywords: psoriasis, etanercept, adalimumab, infliximab, ustekinumab, biologics, phototherapy, and combination therapy.Results: The primary literature included randomized controlled trials, a head-to-head study, open-label controlled and uncontrolled trials, case series, and case reports. Etanercept was used in over half of the reported cases, but other biologic agents used included ustekinumab, adalimumab, and infliximab. The vast majority of phototherapy was narrowband ultraviolet B (NBUVB radiation. Most cases reported enhanced improvement with combination therapy. Serious adverse events throughout the study duration

Safety, efficacy, and performance of implanted recycled cardiac rhythm management (CRM) devices in underprivileged patients.

Science.gov (United States)

Hasan, Reema; Ghanbari, Hamid; Feldman, Dustin; Menesses, Daniel; Rivas, Daniel; Zakhem, Nicole C; Duarte, Carlos; Machado, Christian

2011-06-01

Patients in underdeveloped nations have limited access to life-saving medical technology including cardiac rhythm management (CRM) devices. We evaluated alternative means to provide such technology to this patient population while assessing the safety and efficacy of such a practice. Patients in the United States with clinical indications for extraction of CRM devices were consented. Antemortem CRM devices were cleaned and sterilized following a protocol established at our institution. Surveillance in vitro cultures were performed for quality assurance. The functional status of pulse generators was tested with a pacing system analyzer to confirm at least 70% battery life. Most generators were transported, in person, to an implanting institution in Nicaragua. Recipients with a Class I indication for CRM implantation, and meeting economical criteria set forth, were consented for implantation of a recycled device. Between 2003 and 2009, implantation was performed in 17 patients with an average age of 42.1 ± 20.3 years. Of the 17 patients, nine were male and eight were female. Mean follow-up was 68 ± 38 months. Device evaluation occurred prior to discharge, 4 weeks post implantation, and every 6 months thereafter. There were three deaths during the follow-up period secondary to myocardial infarction, stroke, and heart failure. Hematoma formation occurred in one patient. No infections, early battery depletion, or device malfunction were identified during follow-up. Our case series is the longest follow-up of recipients of recycled antemortem CRM devices. Our findings support the feasibility and safety of this alternative acquisition of life-saving technology. ©2011, The Authors. Journal compilation ©2011 Wiley Periodicals, Inc.

Guidelines on the safety of light-based home-use hair removal devices from the European Society for Laser Dermatology

DEFF Research Database (Denmark)

Town, Graham; Ash, C; Dierickx, C

2012-01-01

. These guidelines provide a definition of light-based home-use technology, to inform healthcare professionals about home-use light-based technology and encourage manufacturers wishing to sell in Europe to adopt 'best practice'. The review presents the current status on standards and regulation issues and considers...... home-use safety issues, encompassing human, device and electrical safety, given risks to the eyes and skin from optical radiation both to the consumer and persons in the vicinity. Proposed technical measurement methodology is considered with focus on recognized critical parameters for the safe use...... of light-based hair removal technology including recording the technical performance and safety claims of a range of home-use hair removal devices. The literature review emphasizes potential adverse incidents and safety aspects of treating cosmetic conditions, such as unwanted hair growth. Although some...

A novel melittin nano-liposome exerted excellent anti-hepatocellular carcinoma efficacy with better biological safety

Directory of Open Access Journals (Sweden)

Jie Mao

2017-03-01

Full Text Available Abstract Melittin is the main effective component of bee venom and has extensive biological functions; however, serious side effects have restricted its clinical application. Preclinical and clinical studies showed that the main adverse events were allergic reaction and pain at the administration site. To decrease the toxicity, we prepared melittin nano-liposomes by encapsulating melittin with poloxamer 188 and explored the inhibitory activities on liver cancer together with biological safety. Here, we showed that melittin nano-liposomes significantly inhibited the survival of hepatocellular carcinoma (HCC cells in vitro and prominently suppressed the growth of subcutaneous and orthotopic HCC transplantation tumors in vivo. It was important that it induced less inflammation and allergy in mice compared with melittin. Overall, melittin nano-liposomes would have a better application in HCC therapy due to its significant anti-tumor activity and better biological safety.

A novel melittin nano-liposome exerted excellent anti-hepatocellular carcinoma efficacy with better biological safety.

Science.gov (United States)

Mao, Jie; Liu, Shujun; Ai, Min; Wang, Zhuo; Wang, Duowei; Li, Xianjing; Hu, Kaiyong; Gao, Xinghua; Yang, Yong

2017-03-20

Melittin is the main effective component of bee venom and has extensive biological functions; however, serious side effects have restricted its clinical application. Preclinical and clinical studies showed that the main adverse events were allergic reaction and pain at the administration site. To decrease the toxicity, we prepared melittin nano-liposomes by encapsulating melittin with poloxamer 188 and explored the inhibitory activities on liver cancer together with biological safety. Here, we showed that melittin nano-liposomes significantly inhibited the survival of hepatocellular carcinoma (HCC) cells in vitro and prominently suppressed the growth of subcutaneous and orthotopic HCC transplantation tumors in vivo. It was important that it induced less inflammation and allergy in mice compared with melittin. Overall, melittin nano-liposomes would have a better application in HCC therapy due to its significant anti-tumor activity and better biological safety.

Micro- and nanofluidic systems in devices for biological, medical and environmental research

Science.gov (United States)

Evstrapov, A. A.

2017-11-01

The use of micro- and nanofluidic systems in modern analytical instruments allow you to implement a number of unique opportunities and achieve ultra-high measurement sensitivity. The possibility of manipulation of the individual biological objects (cells, bacteria, viruses, proteins, nucleic acids) in a liquid medium caused the development of devices on microchip platform for methods: chromatographic and electrophoretic analyzes; polymerase chain reaction; sequencing of nucleic acids; immunoassay; cytometric studies. Development of micro and nano fabrication technologies, materials science, surface chemistry, analytical chemistry, cell engineering have led to the creation of a unique systems such as “lab-on-a-chip”, “human-on-a-chip” and other. This article discusses common in microfluidics materials and methods of making functional structures. Examples of integration of nanoscale structures in microfluidic devices for the implementation of new features and improve the technical characteristics of devices and systems are shown.

76 FR 23255 - Federal Motor Vehicle Safety Standards; Lamps, Reflective Devices, and Associated Equipment

Science.gov (United States)

2011-04-26

... petitions for reconsideration from Harley-Davidson Motor Company (January 18, 2008) and Ford Motor Company... [Docket No. NHTSA-2007-28322] Federal Motor Vehicle Safety Standards; Lamps, Reflective Devices, and... part, the petitions for reconsideration of the December 4, 2007, final rule reorganizing Federal Motor...

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

Safety motion increase of trains by improvement diagnostics process devices of railway automation

Directory of Open Access Journals (Sweden)

B.M.Bondarenko

2012-12-01

Full Text Available The complex use of methods of nondestructive check for the automated diagnostics electromagnetic relays of railway automation the first class reliability is offered. The methods determination of their mechanical parameters are resulted, that allows to exclude a human factor from the control, promote reliability of devices railway automation and safety motion of railway transport.

Off-label biologic regimens in psoriasis: a systematic review of efficacy and safety of dose escalation, reduction, and interrupted biologic therapy.

Directory of Open Access Journals (Sweden)

Elizabeth A Brezinski

Full Text Available OBJECTIVES: While off-label dosing of biologic treatments may be necessary in selected psoriasis patients, no systematic review exists to date that synthesizes the efficacy and safety of these off-label dosing regimens. The aim of this systematic review is to evaluate efficacy and safety of off-label dosing regimens (dose escalation, dose reduction, and interrupted treatment with etanercept, adalimumab, infliximab, ustekinumab, and alefacept for psoriasis treatment. DATA SOURCES AND STUDY SELECTION: We searched OVID Medline from January 1, 1990 through August 1, 2011 for prospective clinical trials that studied biologic therapy for psoriasis treatment in adults. Individual articles were screened for studies that examined escalated, reduced, or interrupted therapy with etanercept, adalimumab, infliximab, ustekinumab, or alefacept. DATA SYNTHESIS: A total of 23 articles with 12,617 patients matched the inclusion and exclusion criteria for the systematic review. Data were examined for primary and secondary efficacy outcomes and adverse events including infections, malignancies, cardiovascular events, and anti-drug antibodies. The preponderance of data suggests that continuous treatment with anti-TNF agents and anti-IL12/23 agent was necessary for maintenance of disease control. Among non-responders, dose escalation with etanercept, adalimumab, ustekinumab, and alefacept typically resulted in greater efficacy than standard dosing. Dose reduction with etanercept and alefacept resulted in reduced efficacy. Withdrawal of the examined biologics led to an increase in disease activity; efficacy from retreatment did not result in equivalent initial response rates for most biologics. Safety data on off-label dosing regimens are limited. CONCLUSION: Dose escalation in non-responders generally resulted in increased efficacy in the examined biologics used to treat moderate-to-severe psoriasis. Continuous treatment with anti-TNF agents and anti-IL12/23 agent

Biological evaluation of devices used for reducing entrainment and impingement losses at thermal power plants

International Nuclear Information System (INIS)

Cada, G.F.; Szluha, A.T.

1978-01-01

A preliminary survey of fish protection devices either in use or proposed for water intake structures was conducted for the purpose of assessing their potential for reducing impingement and entrainment. All the designs examined can be divided into two basic categories: behavioral screening systems and physical screening systems. The behavioral screening devices rely upon the ability of fish to sense artificial stimuli and respond by swimming away from hazardous areas. These systems are of little or no value in protecting planktonic fish eggs, larvae, and disoriented, heat-shocked, or lethargic adult fishes. Many of the physical screening devices, on the other hand, require the impingement of organisms against a screen before they can be removed from the intake system, thus subjecting survival. Some of the designs incorporate both behavioral and physical sceening concepts. Six devices were selected for further consideration based on their potential or demonstrated effectiveness in reducing impingement and entrainment losses at a variety of intake situations. The structures evaluated were modified vertical traveling screens, louvers, angled vertical traveling screens, horizontal traveling screens, center-flow screens, and wedge-wire screens. Since some of these intake structures represent new concepts, few laboratory or in situ biological studies have been carried out. For others, actual reductions in fish losses have been demonstrated. The design features and status of biological testing is discussed for each device, and an evaluation of their fish protection potential is presented

Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies.

Science.gov (United States)

Ponce, Rafael; Abad, Leslie; Amaravadi, Lakshmi; Gelzleichter, Thomas; Gore, Elizabeth; Green, James; Gupta, Shalini; Herzyk, Danuta; Hurst, Christopher; Ivens, Inge A; Kawabata, Thomas; Maier, Curtis; Mounho, Barbara; Rup, Bonita; Shankar, Gopi; Smith, Holly; Thomas, Peter; Wierda, Dan

2009-07-01

An evaluation of potential antibody formation to biologic therapeutics during the course of nonclinical safety studies and its impact on the toxicity profile is expected under current regulatory guidance and is accepted standard practice. However, approaches for incorporating this information in the interpretation of nonclinical safety studies are not clearly established. Described here are the immunological basis of anti-drug antibody formation to biopharmaceuticals (immunogenicity) in laboratory animals, and approaches for generating and interpreting immunogenicity data from nonclinical safety studies of biotechnology-derived therapeutics to support their progression to clinical evaluation. We subscribe that immunogenicity testing strategies should be adapted to the specific needs of each therapeutic development program, and data generated from such analyses should be integrated with available clinical and anatomic pathology, pharmacokinetic, and pharmacodynamic data to properly interpret nonclinical studies.

An overview of review guidelines for HDL programmable devices in nuclear safety systems

International Nuclear Information System (INIS)

Komanduri, Raghavan; Srivani, L.; Thirugnana Murthy, D.

2013-01-01

HDL programmable devices viz. CPLDs and FPGAs are increasingly being used to implement digital designs in the I and C systems performing safety functions of nuclear power plants. Synthesizable RTL descriptions manually written in HDLs are the first step in developing industry standard large scale digital designs. The reliability of the implementation is determined by the methodologies followed by the designer during development. Very few guidelines on HPD design practices, specific to nuclear industry are available. This paper presents an overview of the existing guidelines such as IEC 62566 and U.S. NRC's 'Review guidelines for FPGAs in nuclear power plant safety systems'. (author)

Multiwire proportional chambers in the devices for molecular biology constructed at JINR

Energy Technology Data Exchange (ETDEWEB)

Anisimov, Y S; Chernenko, S P; Ivanov, A B; Peshekhonov, V D; Skvaril, J; Zanevsky, Y V [Joint Inst. for Nuclear Research, Dubna (USSR). Lab. of High Energy; Kheiker, D M [Joint Inst. for Nuclear Research, Dubna (USSR). Lab. of High Energy; AN SSSR, Moscow. Inst. Kristallografii)

1980-10-01

The automation of measuring processes in molecular biology is a current problem. In order to solve this problem, conventionally used methods should be changed for an up-to-date technique which allows the processes of data measurement and analysis to be automated. Toward this end two-coordinate proportional chambers (MWPCs) are coming widely into use. The use of MWPCs in devices for radiochromatography and x-ray diffractrometry is discussed in this paper. A new device consisting of proportional chambers has been constructed for an automated analysis of thin layer radiochromatograms. The device enables one to localize radioactive zones (labelled with /sup 3/H, /sup 14/C, /sup 32/P), to identify radionuclides and to measure their activities. The device has a high sensitivity (5 pCi for tritium), a small dead time, good space resolution (in the case of /sup 3/H zones spaced 1-2 mm apart are separated) and high reproducibility. For x-ray diffractometry of single crystals, a high counting rate device has been constructed on the basis of a MWPC with a total number of channels amounting to 350 x 200 = 70,000. The dead time of the device is about 0.6 ..mu..s which allows to detect 3 x 10/sup 5/ events/s at counting losses of no more than 20%. The quantum efficiency (Cu K..cap alpha..) is about 73%. The X and Y space resolution (fwhm) is equal to 1 mm and 1.7 mm, respectively.

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

Radiation Safety of Electromagnetic Waves

International Nuclear Information System (INIS)

Hussein, A.Z.

2009-01-01

The wide spread of Electromagnetic Waves (EMW) through the power lines, multimedia, communications, devices, appliances, etc., are well known. The probable health hazards associated with EMW and the radiation safety criteria are to be reviewed. However, the principles of the regulatory safety are based on radiation protection procedure, intervention to combat the relevant risk and to mitigate consequences. The oscillating electric magnetic fields (EMF) of the electromagnetic radiation (EMR) induce electrical hazards. The extremely high power EMR can cause fire hazards and explosions of pyrotechnic (Rad Haz). Biological hazards of EMF result as dielectric heat, severe burn, as well as the hazards of eyes. Shielding is among the technical protective measures against EMR hazards. Others are limitation of time of exposure and separation distance apart of the EMR source. Understanding and safe handling of the EMR sources are required to feel safety.

Evolution of approaches to viral safety issues for biological products.

Science.gov (United States)

Lubiniecki, Anthony S

2011-01-01

CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December 1-3, 2010 Guest Editors: Arifa Khan (Bethesda, MD), Patricia Hughes (Bethesda, MD) and Michael Wiebe (San Francisco, CA) Approaches to viral safety issues for biological products have evolved during the past 50+ years. The first cell culture products (viral vaccines) relied largely on the use of in vitro and in vivo virus screening assays that were based upon infectivity of adventitious viral agents. The use of Cohn fractionation and pasteurization by manufacturers of plasma derivatives introduced the concepts that purification and treatment with physical and chemical agents could greatly reduce the risk of viral contamination of human albumin and immunoglobulin products. But the limitations of such approaches became clear for thermolabile products that were removed early in fractionation such as antihemophilic factors, which transmitted hepatitis viruses and HIV-1 to some product recipients. These successes and limitations were taken into account by the early developers of recombinant DNA (rDNA)-derived cell culture products and by regulatory agencies, leading to the utilization of cloning technology to reduce/eliminate contamination due to human viruses and purification technologies to physically remove and inactivate adventitious and endogenous viruses, along with cell banking and cell bank characterization for adventitious and endogenous viruses, viral screening of biological raw materials, and testing of cell culture harvests, to ensure virus safety. Later development and incorporation of nanofiltration technology in the manufacturing process provided additional assurance of viral clearance for safety of biotechnology products. These measures have proven very effective at preventing iatrogenic infection of recipients of biotechnology products; however, viral contamination of production cell cultures has

Computational biology

DEFF Research Database (Denmark)

Hartmann, Lars Røeboe; Jones, Neil; Simonsen, Jakob Grue

2011-01-01

Computation via biological devices has been the subject of close scrutiny since von Neumann’s early work some 60 years ago. In spite of the many relevant works in this field, the notion of programming biological devices seems to be, at best, ill-defined. While many devices are claimed or proved t...

A novel safety device with metal counter meshing gears discriminator directly driven by axial flux permanent magnet micromotors based on MEMS technology

Science.gov (United States)

Zhang, Weiping; Chen, Wenyuan; Zhao, Xiaolin; Li, Shengyong; Jiang, Yong

2005-08-01

In a novel safety device based on MEMS technology for high consequence systems, the discriminator consists of two groups of metal counter meshing gears and two pawl/ratchet wheel mechanisms. Each group of counter meshing gears is onepiece and driven directly by an axial flux permanent magnet micromotor respectively. The energy-coupling element is an optical shutter with two collimators and a coupler wheel. The safety device's probability is less than 1/106. It is fabricated by combination of an LiGA-like process and precision mechanical engineering. The device has simple structure, few dynamic problems, high strength and strong reliability.

Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Final rule.

Science.gov (United States)

2010-09-29

The Food and Drug Administration (FDA) is amending its regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND). The final rule codifies the agency's expectations for timely review, evaluation, and submission of relevant and useful safety information and implements internationally harmonized definitions and reporting standards. The revisions will improve the utility of IND safety reports, reduce the number of reports that do not contribute in a meaningful way to the developing safety profile of the drug, expedite FDA's review of critical safety information, better protect human subjects enrolled in clinical trials, subject bioavailability and bioequivalence studies to safety reporting requirements, promote a consistent approach to safety reporting internationally, and enable the agency to better protect and promote public health.

Biological effects and physical safety aspects of NMR imaging and in vivo spectroscopy

Energy Technology Data Exchange (ETDEWEB)

Tenforde, T.S.; Budinger, T.F.

1985-08-01

An assessment is made of the biological effects and physical hazards of static and time-varying fields associated with the NMR devices that are being used for clinical imaging and in vivo spectroscopy. A summary is given of the current state of knowledge concerning the mechanisms of interaction and the bioeffects of these fields. Additional topics that are discussed include: (1) physical effects on pacemakers and metallic implants such as aneurysm clips, (2) human health studies related to the effects of exposure to nonionizing electromagnetic radiation, and (3) extant guidelines for limiting exposure of patients and medical personnel to the fields produced by NMR devices. On the basis of information available at the present time, it is concluded that the fields associated with the current generation of NMR devices do not pose a significant health risk in themselves. However, rigorous guidelines must be followed to avoid the physical interaction of these fields with metallic implants and medical electronic devices. 476 refs., 5 figs., 2 tabs.

Biological effects and physical safety aspects of NMR imaging and in vivo spectroscopy

International Nuclear Information System (INIS)

Tenforde, T.S.; Budinger, T.F.

1985-08-01

An assessment is made of the biological effects and physical hazards of static and time-varying fields associated with the NMR devices that are being used for clinical imaging and in vivo spectroscopy. A summary is given of the current state of knowledge concerning the mechanisms of interaction and the bioeffects of these fields. Additional topics that are discussed include: (1) physical effects on pacemakers and metallic implants such as aneurysm clips, (2) human health studies related to the effects of exposure to nonionizing electromagnetic radiation, and (3) extant guidelines for limiting exposure of patients and medical personnel to the fields produced by NMR devices. On the basis of information available at the present time, it is concluded that the fields associated with the current generation of NMR devices do not pose a significant health risk in themselves. However, rigorous guidelines must be followed to avoid the physical interaction of these fields with metallic implants and medical electronic devices. 476 refs., 5 figs., 2 tabs

"We can't get along without each other": Qualitative interviews with physicians about device industry representatives, conflict of interest and patient safety.

Directory of Open Access Journals (Sweden)

Anna R Gagliardi

Full Text Available Physician relationships with device industry representatives have not been previously assessed. This study explored interactions with device industry representatives among physicians who use implantable cardiovascular and orthopedic devices to identify whether conflict of interest (COI is a concern and how it is managed.A descriptive qualitative approach was used. Physicians who implant orthopedic and cardiovascular devices were identified in publicly available directories and web sites, and interviewed about their relationships with device industry representatives. Sampling was concurrent with data collection and analysis. Data were analyzed and discussed using constant comparative technique by all members of the research team.Twenty-two physicians (10 cardiovascular, 12 orthopedic were interviewed. Ten distinct representative roles were identified: purchasing, training, trouble-shooting, supplying devices, assisting with device assembly and insertion, supporting operating room staff, mitigating liability, conveying information about recalls, and providing direct and indirect financial support. Participants recognized the potential for COI but representatives were present for the majority of implantations. Participants revealed a tension between physicians and representatives that was characterized as "symbiotic", but required physicians to be vigilant about COI and patient safety, particularly because representatives varied regarding disclosure of device defects. They described a concurrent tension between hospitals, whose policies and business practices were focused on cost-control, and physicians who were required to comply with those policies and use particular devices despite concerns about their safety and effectiveness.Given the potential for COI and threats to patient safety, further research is needed to establish the clinical implications of the role of, and relationship with device industry representatives; and whether and how

Device for removing hydrogen gas from the safety containment vessel of a nuclear reactor

International Nuclear Information System (INIS)

Stiefel, M.

1983-01-01

The safe processing of all concentrations of gas mixtures should be possible with such a device using a thermal recombiner of compact construction. A recombiner consisting of a metal case and diverter sheets situated in it is heated by induction. The incoming pipe for the gas mixture enriched with hydrogen and the outgoing pipe for the gas mixture with low hydrogen content are connected together by a three way valve. The third connection to the safety valve takes the larger port of the gas mixture with low hydrogen content back to the safety containment vessel. Sufficient amount of the gas mixture with low hydrogen content is taken via the three way valve to the safety containment vessel to ensure that the hydrogen content of the gas mixture taken to the recombiner remains below the 4% by volume limit. (orig./PW)

Development and application of a micro-digestion device for biological samples

International Nuclear Information System (INIS)

Bohlen, A. von; Klockenkaemper, R.; Messerschmidt, J.; Alt, F.

2000-01-01

The analytical characterization of small amounts of a sample is of increasing importance for various research projects in biology, biochemistry and medicine. Reliable determinations of minor and trace elements in microsamples can be performed by total reflection x-ray fluorescence analysis (TXRF). This microanalytical method is suitable for direct multielement analyses of a tiny amount of a liquid or solid sample. Instead of a direct analysis, however, a complete digestion or mineralisation of the sample material prior to analysis can be recommendable. It can be advantageous for a favorable presentation, for a preconcentration and/or homogenization of the material and particularly for an accurate quantification. Unfortunately, commercially available digestion devices are optimized for amounts of 50 to 400 mg of a sample. For smaller amounts, a microdigestion device was constructed and adapted to an equipment of high pressure ashing, which is commercially available. Digestions of very different microsamples between some μg and some mg were carried out, followed by quantitative determinations of a lot of elements. Besides, different Standard Reference Materials (SRM) were analyzed. The homogeneity of these materials could be investigated by comparing the results found for microsamples with those obtained for samples of 200 mg, the latter after digestion in a conventional device. (author)

Endovenous mechanochemical ablation of great saphenous vein incompetence using the ClariVein device: a safety study

NARCIS (Netherlands)

Eekeren, R. van; Boersma, D.; Elias, S.; Holewijn, S.; Werson, D.A.; Vries, J.P. de; Reijnen, M.M.P.J.

2011-01-01

PURPOSE: To evaluate the feasibility and safety of endovenous mechanochemical ablation (MOCA) for the treatment of great saphenous vein (GSV) incompetence. METHODS: The newly developed ClariVein device uses a technique that combines mechanical endothelial damage using a rotating wire with the

Biological in situ Dose Painting for Image-Guided Radiation Therapy Using Drug-Loaded Implantable Devices

International Nuclear Information System (INIS)

Cormack, Robert A.; Sridhar, Srinivas; Suh, W. Warren; D'Amico, Anthony V.; Makrigiorgos, G. Mike

2010-01-01

Purpose: Implantable devices routinely used for increasing spatial accuracy in modern image-guided radiation treatments (IGRT), such as fiducials or brachytherapy spacers, encompass the potential for in situ release of biologically active drugs, providing an opportunity to enhance the therapeutic ratio. We model this new approach for two types of treatment. Methods and Materials: Radiopaque fiducials used in IGRT, or prostate brachytherapy spacers ('eluters'), were assumed to be loaded with radiosensitizer for in situ drug slow release. An analytic function describing the concentration of radiosensitizer versus distance from eluters, depending on diffusion-elimination properties of the drug in tissue, was developed. Tumor coverage by the drug was modeled for tumors typical of lung stereotactic body radiation therapy treatments for various eluter dimensions and drug properties. Six prostate 125 I brachytherapy cases were analyzed by assuming implantation of drug-loaded spacers. Radiosensitizer-induced subvolume boost was simulated from which biologically effective doses for typical radiosensitizers were calculated in one example. Results: Drug distributions from three-dimensional arrangements of drug eluters versus eluter size and drug properties were tabulated. Four radiosensitizer-loaded fiducials provide adequate radiosensitization for ∼4-cm-diameter lung tumors, thus potentially boosting biologically equivalent doses in centrally located stereotactic body treated lesions. Similarly, multiple drug-loaded spacers provide prostate brachytherapy with flexible shaping of 'biologically equivalent doses' to fit requirements difficult to meet by using radiation alone, e.g., boosting a high-risk region juxtaposed to the urethra while respecting normal tissue tolerance of both the urethra and the rectum. Conclusions: Drug loading of implantable devices routinely used in IGRT provides new opportunities for therapy modulation via biological in situ dose painting.

Reactor safety device

International Nuclear Information System (INIS)

Okada, Yasumasa.

1987-01-01

Purpose: To scram control rods by processing signals from a plurality of temperature detectors and generating abnormal temperature warning upon occurrence of abnormal temperature in a nuclear reactor. Constitution: A temperature sensor comprising a plurality of reactors each having a magnetic body as the magnetic core having a curie point different from each other and corresponding to the abnormal temperature against which reactor core fuels have to be protected is disposed in an identical instrumentation well near the reactor core fuel outlet/inlet of a reactor. A temperature detection device actuated upon detection of an abnormal temperature by the abrupt reduction of the reactance of each of the reactors is disposed. An OR circuit and an AND circuit for conducting OR and AND operations for each of the abnormal temperature detection signals from the temperature detection device are disposed. The output from the OR circuit is used as the abnormal temperature warning signal, while the output from the AND circuit is utilized as a signal for actuating the scram operation of control rod drive mechanisms. Accordingly, it is possible to improve the reliability of the reactor scram system, particularly, improve the reliability under a high temperature atmosphere. (Kamimura, M.)

Hearing Tests on Mobile Devices: Evaluation of the Reference Sound Level by Means of Biological Calibration.

Science.gov (United States)

Masalski, Marcin; Kipiński, Lech; Grysiński, Tomasz; Kręcicki, Tomasz

2016-05-30

Hearing tests carried out in home setting by means of mobile devices require previous calibration of the reference sound level. Mobile devices with bundled headphones create a possibility of applying the predefined level for a particular model as an alternative to calibrating each device separately. The objective of this study was to determine the reference sound level for sets composed of a mobile device and bundled headphones. Reference sound levels for Android-based mobile devices were determined using an open access mobile phone app by means of biological calibration, that is, in relation to the normal-hearing threshold. The examinations were conducted in 2 groups: an uncontrolled and a controlled one. In the uncontrolled group, the fully automated self-measurements were carried out in home conditions by 18- to 35-year-old subjects, without prior hearing problems, recruited online. Calibration was conducted as a preliminary step in preparation for further examination. In the controlled group, audiologist-assisted examinations were performed in a sound booth, on normal-hearing subjects verified through pure-tone audiometry, recruited offline from among the workers and patients of the clinic. In both the groups, the reference sound levels were determined on a subject's mobile device using the Bekesy audiometry. The reference sound levels were compared between the groups. Intramodel and intermodel analyses were carried out as well. In the uncontrolled group, 8988 calibrations were conducted on 8620 different devices representing 2040 models. In the controlled group, 158 calibrations (test and retest) were conducted on 79 devices representing 50 models. Result analysis was performed for 10 most frequently used models in both the groups. The difference in reference sound levels between uncontrolled and controlled groups was 1.50 dB (SD 4.42). The mean SD of the reference sound level determined for devices within the same model was 4.03 dB (95% CI 3

Laboratory Safety in the Biology Lab.

Science.gov (United States)

Ritch, Donna; Rank, Jane

2001-01-01

Reports on a research project to determine if students possess and comprehend basic safety knowledge. Shows a significant increase in the amount of safety knowledge gained when students are exposed to various topics in laboratory safety and are held accountable for learning the information as required in a laboratory safety course. (Author/MM)

Determination of the dynamical behaviour of biological materials during impact using a pendulum device

Science.gov (United States)

Van Zeebroeck, M.; Tijskens, E.; Van Liedekerke, P.; Deli, V.; De Baerdemaeker, J.; Ramon, H.

2003-09-01

A pendulum device has been developed to measure contact force, displacement and displacement rate of an impactor during its impact on the sample. Displacement, classically measured by double integration of an accelerometer, was determined in an alternative way using a more accurate incremental optical encoder. The parameters of the Kuwabara-Kono contact force model for impact of spheres have been estimated using an optimization method, taking the experimentally measured displacement, displacement rate and contact force into account. The accuracy of the method was verified using a rubber ball. Contact force parameters for the Kuwabara-Kono model have been estimated with success for three biological materials, i.e., apples, tomatoes and potatoes. The variability in the parameter estimations for the biological materials was quite high and can be explained by geometric differences (radius of curvature) and by biological variation of mechanical tissue properties.

Safety and effectiveness of repeat arterial closure using the AngioSeal device in patients with hepatic malignancy.

Science.gov (United States)

Hieb, Robert A; Neisen, Melissa J; Hohenwalter, Eric J; Molnar, Jim A; Rilling, William S

2008-12-01

To retrospectively evaluate the safety and effectiveness of the use of the AngioSeal device for repeat arterial closure in patients with hepatic malignancy. A retrospective analysis of patients with hepatic malignancy who had undergone repeated arterial closure with the AngioSeal device was performed. All charts for patients undergoing transarterial chemoembolization or TheraSphere radioembolization were reviewed for the method of hemostasis and the number of arterial closures. A total of 53 patients (58.5% men, 41.5% women; mean age, 58.7 years) had repeat AngioSeal arterial puncture closure after chemoembolization or TheraSphere treatment. Percutaneous closure of the common femoral artery with the AngioSeal device was performed in accordance with the manufacturer's recommendations. The patients were examined for complications on follow-up. Effectiveness was defined by the ability to obtain satisfactory hemostasis. Safety was assessed by the absence of groin complications and by vessel patency on follow-up angiograms of the puncture site obtained at subsequent liver-directed therapy sessions. Fifty-three patients in this study group had a total of 203 common femoral artery punctures. There were a total of 161 closures with the AngioSeal device (79.3%): 58 (36%) single closures and 103 (64.0%) repeat closures. Of the 161 attempts at AngioSeal closure, there was one closure failure in the single-puncture group, yielding a success rate of 98.3%; and one closure failure in the repeat-puncture group, yielding a success rate of 99%. In these two patients, hemostasis was achieved with traditional manual compression without the need for any other device, and no complications were noted. The overall success rate of AngioSeal device closure was 98.7%. The repeat use of the AngioSeal closure device is safe and effective in patients with hepatic malignancy undergoing regional oncologic interventional procedures.

Sharps injuries in UK health care: a review of injury rates, viral transmission and potential efficacy of safety devices.

Science.gov (United States)

Elder, Alexander; Paterson, Caron

2006-12-01

To review the literature on sharps injuries and occupational bloodborne virus transmission in health care in the UK and the worldwide evidence for injury prevention of sharps safety devices. Literature review by online database and Internet resource search. Twenty-four relevant publications were identified regarding UK reported sharps injury rates. UK studies showed as much as a 10-fold difference between injuries reported through standard reporting systems (0.78-5.15 per 100 person-years) and rates estimated from retrospective questionnaires of clinical populations (30-284 per 100 person-years). National surveillance data from England, Wales and Northern Ireland gives a rate of 1.43 known hepatitis C virus or human immunodeficiency virus (HIV) transmissions to health care workers per annum. When extrapolated, this suggests an approximate rate of 0.009 such viral transmissions per 1000 hospital beds per annum. Risk of infection from sources with no risk factors is extremely small (less than one in one million for HIV transmission based on Scottish data). Thirty-one studies on the efficacy of sharps safety devices showed evidence of a reduction in injuries, with the greatest reductions achieved by blunt suture needles and safety cannulae. Although injuries remain common, confirmed viral transmission in the UK has been relatively rare. The degree of under-reporting of sharps injuries may be as much as 10-fold. Safety-engineered devices are likely to be effective at injury reduction.

Regulatory Anatomy: How "Safety Logics" Structure European Transplant Medicine.

Science.gov (United States)

Hoeyer, Klaus

2015-07-01

This article proposes the term "safety logics" to understand attempts within the European Union (EU) to harmonize member state legislation to ensure a safe and stable supply of human biological material for transplants and transfusions. With safety logics, I refer to assemblages of discourses, legal documents, technological devices, organizational structures, and work practices aimed at minimizing risk. I use this term to reorient the analytical attention with respect to safety regulation. Instead of evaluating whether safety is achieved, the point is to explore the types of "safety" produced through these logics as well as to consider the sometimes unintended consequences of such safety work. In fact, the EU rules have been giving rise to complaints from practitioners finding the directives problematic and inadequate. In this article, I explore the problems practitioners face and why they arise. In short, I expose the regulatory anatomy of the policy landscape.

Recommended safety procedures for the selection and use of demonstration-type gas discharge devices in schools

International Nuclear Information System (INIS)

1979-01-01

A 1972 survey of 30 Ottawa secondary schools revealed a total of 347 actual or potential X-ray sources available in these schools. More than half of these sources were gas discharge tubes. Some gas discharge tubes, in particular the cold cathode type, can emit X-rays at significantly high levels. Unless such tubes are used carefully, and with regard for good radiation safety practices, they can result in exposures to students that are in excess of the maximum levels recommended by the International Commission on Radiological Protection. Several cases of the recommended dose being exceeded were found in the classes surveyed. This document has been prepared to assist science teachers and others using demonstration-type gas discharge devices to select and use such devices so as to present negligible risk to themselves and students. Useful information on safety procedures to be followed when performing demonstrations or experiments is included. (J.T.A.)

A microfluidic device for continuous manipulation of biological cells using dielectrophoresis.

Science.gov (United States)

Das, Debanjan; Biswas, Karabi; Das, Soumen

2014-06-01

The present study demonstrates the design, simulation, fabrication and testing of a label-free continuous manipulation and separation micro-device of particles/biological cells suspended on medium based on conventional dielectrophoresis. The current dielectrophoretic device uses three planner electrodes to generate non-uniform electric field and induces both p-DEP and n-DEP force simultaneously depending on the dielectric properties of the particles and thus influencing at least two types of particles at a time. Numerical simulations were performed to predict the distribution of non-uniform electric field, DEP force and particle trajectories. The device is fabricated utilizing the advantage of bonding between PDMS and SU8 polymer. The p-DEP particles move away from the center of the streamline, while the n-DEP particles will follow the central streamline along the channel length. Dielectrophoretic effects were initially tested using polystyrene beads followed by manipulation of HeLa cells. In the experiment, it was observed that polystyrene beads in DI water always response as n-DEP up to 1MHz frequency, whereas HeLa cells in PBS medium response as n-DEP up to 400kHz frequency and then it experiences p-DEP up to 1MHz. Further, the microscopic observations of DEP responses of HeLa cells were verified by performing trapping experiment at static condition. Copyright © 2013 IPEM. Published by Elsevier Ltd. All rights reserved.

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...

30 CFR 77.808 - Disconnecting devices.

Science.gov (United States)

2010-07-01

... Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS, SURFACE COAL MINES AND SURFACE WORK AREAS OF UNDERGROUND COAL MINES Surface High-Voltage Distribution § 77.808 Disconnecting devices. Disconnecting devices shall be installed at the...

Nuclear reactor safety protection device

International Nuclear Information System (INIS)

Okido, Fumiyasu; Noguchi, Atomi; Matsumiya, Shoichi; Furusato, Ken-ichiro; Arita, Setsuo.

1994-01-01

The device of the present invention extremely reduces a probability of causing unnecessary scram of a nuclear reactor. That is, four control devices receive signals from each of four sensors and output four trip signals respectively in a quardruplicated control device. Each of the trip signals and each of trip signals via a delay circuit are inputted to a logical sum element. The output of the logical sum circuit is inputted to a decision of majority circuit. The decision of majority circuit controls a scram pilot valve which conducts scram of the reactor by way of a solenoid coils. With such procedures, even if surge noises of a short pulse width are mixed to the sensor signals and short trip signals are outputted, there is no worry that the scram pilot valve is actuated. Accordingly, factors of lowering nuclear plant operation efficiency due to erroneous reactor scram can be reduced. (I.S.)

Estimating Safety Effects of Green-Man Countdown Devices at Signalized Pedestrian Crosswalk Based on Cellular Automata

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Chen Chai

2017-01-01

Full Text Available Safety effects of Green-Man Countdown Device (GMCD at signalized pedestrian crosswalks are evaluated. Pedestrian behavior at GMCD and non-GMCD crosswalks is observed and analyzed. A microsimulation model is developed based on field observations to estimate safety performance. Simulation outputs allow analysts to assess the impacts of GMCD at various conditions with different geometric layout, traffic and pedestrian volumes, and the green time. According to simulation results, it is found that the safety impact of GMCD is affected by traffic condition as well as different time duration within green-man signal phase. In general, GMCD increases average walking velocity, especially during the last few seconds. The installation of GMCD improves safety performance generally, especially at more crowded crossings. Conflict severity is increased during last 10 s after GMCD installation. Findings from this study suggest that the current practice, which is to install GMCD at more crowded crosswalks or near the school zone, is effective. Moreover, at crosswalks with GMCD, longer all red signal phase is suggested to improve pedestrian safety during intergreen period.

A simple method of fabricating mask-free microfluidic devices for biological analysis.

KAUST Repository

Yi, Xin

2010-09-07

We report a simple, low-cost, rapid, and mask-free method to fabricate two-dimensional (2D) and three-dimensional (3D) microfluidic chip for biological analysis researches. In this fabrication process, a laser system is used to cut through paper to form intricate patterns and differently configured channels for specific purposes. Bonded with cyanoacrylate-based resin, the prepared paper sheet is sandwiched between glass slides (hydrophilic) or polymer-based plates (hydrophobic) to obtain a multilayer structure. In order to examine the chip\\'s biocompatibility and applicability, protein concentration was measured while DNA capillary electrophoresis was carried out, and both of them show positive results. With the utilization of direct laser cutting and one-step gas-sacrificing techniques, the whole fabrication processes for complicated 2D and 3D microfluidic devices are shorten into several minutes which make it a good alternative of poly(dimethylsiloxane) microfluidic chips used in biological analysis researches.

Hydrodynamics of Safety Injection Tank with Fluidic Device in Recent Regulation

International Nuclear Information System (INIS)

Bang, Young Seok; Yoo, Seung Hun

2016-01-01

Safety Injection Tank (SIT) with Fluidic Device (FD) has been used in several APR1400 nuclear power plants. It was designed to provide a longer passive safety injection than the existing accumulator to improve the safety for Large Break Loss-of-Coolant Accident (LBLOCA) by changing the injected flow through the FD and the standpipe of the SIT. As a result, high flow injection phase and the subsequent low flow one can be achieved as longer than the existing accumulator. The present paper discusses the major concerns related to SIT hydrodynamics and the directions to resolution recently concerned. Modeling of SIT/FD by total hydraulic resistances, potential of nitrogen intrusion, and effect of initial pressure of SIT testing are included. Based on the discussion, a table of the important phenomena of the SIT/FD was proposed with the relevancy of the calculation models applied. The present paper discussed the SIT hydrodynamics including the modeling of SIT/FD by total hydraulic resistances, potential of nitrogen intrusion, and effect of initial pressure of SIT testing. Also a table of the important phenomena of the SIT/FD was proposed with the relevancy of the calculation models applied. The following conclusions are obtained uncertainty due to the assumption of the total Kfactor as constant for high flow, transition phase, and low flow phase should be considered and nitrogen intrusion phenomena during the transition phase should be considered with a conservatism, especially considering the current situation of nonmeasuring the standpipe level

Hydrodynamics of Safety Injection Tank with Fluidic Device in Recent Regulation

Energy Technology Data Exchange (ETDEWEB)

Bang, Young Seok; Yoo, Seung Hun [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

2016-10-15

Safety Injection Tank (SIT) with Fluidic Device (FD) has been used in several APR1400 nuclear power plants. It was designed to provide a longer passive safety injection than the existing accumulator to improve the safety for Large Break Loss-of-Coolant Accident (LBLOCA) by changing the injected flow through the FD and the standpipe of the SIT. As a result, high flow injection phase and the subsequent low flow one can be achieved as longer than the existing accumulator. The present paper discusses the major concerns related to SIT hydrodynamics and the directions to resolution recently concerned. Modeling of SIT/FD by total hydraulic resistances, potential of nitrogen intrusion, and effect of initial pressure of SIT testing are included. Based on the discussion, a table of the important phenomena of the SIT/FD was proposed with the relevancy of the calculation models applied. The present paper discussed the SIT hydrodynamics including the modeling of SIT/FD by total hydraulic resistances, potential of nitrogen intrusion, and effect of initial pressure of SIT testing. Also a table of the important phenomena of the SIT/FD was proposed with the relevancy of the calculation models applied. The following conclusions are obtained uncertainty due to the assumption of the total Kfactor as constant for high flow, transition phase, and low flow phase should be considered and nitrogen intrusion phenomena during the transition phase should be considered with a conservatism, especially considering the current situation of nonmeasuring the standpipe level.

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.

Biologic agents therapy for Saudi children with rheumatic diseases: indications and safety.

Science.gov (United States)

Al-Mayouf, Sulaiman M; Alenazi, Abdullatif; AlJasser, Hind

2016-06-01

To report the indications and safety of biologic agents in childhood rheumatic diseases at a tertiary hospital. Children with rheumatic diseases treated with biologic agents at King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia, from January 2001 to December 2011 were included. All patients were reviewed for: demographic characteristics, diagnosis, concomitant treatment and indications of using biologic agents, age at start of therapy and side effects during the treatment period. In all, 134 children (89 female) with various rheumatic diseases were treated with biologic agents. Mean age at starting biologic treatment was 9.3 (4.25-14) years and mean therapy duration was 14.7 (3-88) months. Juvenile idiopathic arthritis (JIA) was the most frequent diagnosis (70.1%) followed by systemic lupus erythematosus (12.7%) and vasculitis (4.5%). All patients received concomitant therapy (corticosteroids and disease-modifying antirheumatic drugs). In total, 273 treatments with biologic agents were used, (95 etanercept, 52 rituximab, 47 adalimumab, 37 infliximab, 23 anakinra, 10 tocilizumab and nine abatacept). Therapy was switched to another agent in 57 (42.5%) patients, mainly because of inefficacy (89.4%) or adverse event (10.6%). A total of 95 (34.8%) adverse events were notified; of these, the most frequent were infusion-related reactions (33.7%) followed by infections (24.2%) and autoantibody positivity (10.6%). One patient developed macrophage activation syndrome. Biologic agents were used in children with a range of rheumatic diseases. Of these, the most frequent was JIA. Off-label use of biologic agents in our cohort is common. These agents seem safe. However, they may associated with various adverse events. Sequential therapy seems well tolerated. However, this should be carefully balanced and considered on an individual basis. © 2014 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd.

A systematic review of light-based home-use devices for hair removal and considerations on human safety

DEFF Research Database (Denmark)

Thaysen-Petersen, D; Bjerring, P; Dierickx, C

2012-01-01

To systematically review and evaluate the efficacy and human safety of currently available home-based optical hair removal devices. Methods A comprehensive Pub Med literature search was conducted which systematically identified publications of relevance. Prospective clinical trials were included whether controlled......, uncontrolled or randomized and with a sample size of at least 10 individuals. Results We identified a total of seven studies: one controlled (CT) and six uncontrolled trials (UCTs). No randomized controlled trials (RCT) were recognized. The best evidence was found for IPL (intense pulsed light) (three devices...

Improving Patient Safety with X-Ray and Anesthesia Machine Ventilator Synchronization: A Medical Device Interoperability Case Study

Science.gov (United States)

Arney, David; Goldman, Julian M.; Whitehead, Susan F.; Lee, Insup

When a x-ray image is needed during surgery, clinicians may stop the anesthesia machine ventilator while the exposure is made. If the ventilator is not restarted promptly, the patient may experience severe complications. This paper explores the interconnection of a ventilator and simulated x-ray into a prototype plug-and-play medical device system. This work assists ongoing interoperability framework development standards efforts to develop functional and non-functional requirements and illustrates the potential patient safety benefits of interoperable medical device systems by implementing a solution to a clinical use case requiring interoperability.

Accidentes percutáneos con riesgo biológico, producidos por dispositivos de seguridad en la Comunidad de Madrid Percutaneous injuries with biological risk caused by security devices in Madrid Community

Directory of Open Access Journals (Sweden)

María Clemente Yélamos

2012-06-01

Full Text Available Desde la implantación en 2006, de procedimientos seguros y un Sistema de Vigilancia de Accidentes Biológicos en el ámbito sanitario de la Comunidad de Madrid, se viene observando un aumento de los accidentes percutáneos relacionados con la utilización de Dispositivos de Seguridad. Con la finalidad de estudiar los factores contribuyentes a la producción de accidentes con estos nuevos dispositivos, se realiza un estudio descriptivo longitudinal prospectivo de los accidentes notificados a lo largo de 6 meses (2010-2011. Se incluyen 378 accidentes, el 86% afectó a mujeres, siendo la tasa de incidencia en enfermería de 14,3 y entre facultativos de 3,1 (accidentes por mil. Las agujas subcutáneas fueron las más implicadas (25,7%. En el 6,6% de los accidentes se había inactivado intencionadamente su mecanismo de seguridad y solo un 2,6% podría imputarse a un fallo del dispositivo. Entre los factores externos que han podido contribuir destacan "apremio de tiempo/ritmo de trabajo elevado" (46,5% y "realizar la maniobra con posturas incómodas" (31,5%. Las intervenciones para prevenir Accidentes Biológicos deben ser específicas para cada categoría profesional y área de trabajo. Se debe seguir apostando por la introducción de Dispositivos de Seguridad, identificar los factores contribuyentes e implementar acciones individualizadas que minimicen los riesgos.Since the implementation in 2006 of security procedures and a surveillance system of biological accidents in Madrid public health services, an increase of percutaneus accidents related to the use of safety devices has been observed. With the purpose of studying the external factors to the production of accidents with these new devices, there is realized a prospective, longitudinal and descriptive study of the accidents happened throughout six months (2010-2011. 378 accidents are included, 86% happened in women, the incidence rate being 14.3 accidents per thousand in nurses, and 3.1 in

Extraglottic airway devices: technology update

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Sharma B

2017-08-01

Full Text Available Bimla Sharma, Chand Sahai, Jayashree Sood Department of Anaesthesiology, Pain and Perioperative Medicine, Sir Ganga Ram Hospital, New Delhi, India Abstract: Extraglottic airway devices (EADs have revolutionized the field of airway management. The invention of the laryngeal mask airway was a game changer, and since then, there have been several innovations to improve the EADs in design, functionality, safety and construction material. These have ranged from changes in the shape of the mask, number of cuffs and material used, like rubber, polyvinylchloride and latex. Phthalates, which were added to the construction material in order to increase device flexibility, were later omitted when this chemical was found to have serious adverse reproductive outcomes. The various designs brought out by numerous companies manufacturing EADs resulted in the addition of several devices to the airway market. These airway devices were put to use, many of them with inadequate or no evidence base regarding their efficacy and safety. To reduce the possibility of compromising the safety of the patient, the Difficult Airway Society (DAS formed the Airway Device Evaluation Project Team (ADEPT to strengthen the evidence base for airway equipment and vet the new extraglottic devices. A preuse careful analysis of the design and structure may help in better understanding of the functionality of a particular device. In the meantime, the search for the ideal EAD continues. Keywords: extraglottic airway devices, laryngeal mask airway, other extraglottic airway devices, safety, technology update

Toward a treaty on safety and cost-effectiveness of pharmaceuticals and medical devices: enhancing an endangered global public good

Directory of Open Access Journals (Sweden)

Faunce Thomas

2006-03-01

Full Text Available Abstract • Expert evaluations of the safety, efficacy and cost-effectiveness of pharmaceutical and medical devices, prior to marketing approval or reimbursement listing, collectively represent a globally important public good. The scientific processes involved play a major role in protecting the public from product risks such as unintended or adverse events, sub-standard production and unnecessary burdens on individual and governmental healthcare budgets. • Most States now have an increasing policy interest in this area, though institutional arrangements, particularly in the area of cost-effectiveness analysis of medical devices, are not uniformly advanced and are fragile in the face of opposing multinational industry pressure to recoup investment and maintain profit margins. • This paper examines the possibility, in this context, of States commencing negotiations toward bilateral trade agreement provisions, and ultimately perhaps a multilateral Treaty, on safety, efficacy and cost-effectiveness analysis of pharmaceuticals and medical devices. Such obligations may robustly facilitate a conceptually interlinked, but endangered, global public good, without compromising the capacity of intellectual property laws to facilitate local product innovations.

Safety analysis of an irradiation device for 99Mo production in RA-3 reactor

International Nuclear Information System (INIS)

Lerner, Ana Maria; Madariaga, Marcelo; Waldman, Ricardo

2000-01-01

The Argentine RA-3 research reactor (5 MW) has been converted to LEU fuel more than nine years ago. Since then, it has been operating with LEU fuel, which has been designed and fabricated at the National Atomic Energy Commission (CNEA). The Nuclear Regulatory Authority (ARN) is the institution in charge of the installation safety control. It is under this framework that the ARN has elaborated a neutronic calculation model for the RA-3 core, paying special attention to the device presently used for the irradiation of (HEU) 235 U targets required to obtain 9 '9Mo as a fission product. A regulatory analysis of results is carried out in the framework of ARN standards for fixed experiments. For such purpose, calculated reactivity values associated with such device are compared with recently measured values at the installation. Finally, and according to guidelines established in the first part of this work, a calculation model for a new device proposed by CNEA for the irradiation of metallic (LEU) uranium targets and still at its design stage, is here analysed. (author)

An experimental study of the flow characteristics of fluidic device in a passive safety injection tank

International Nuclear Information System (INIS)

Cho, Seok; Song, Chul Hwa; Won, Suon Yeon; Min, Kyong Ho; Chung, Moon Ki

1998-01-01

It is considered to adopt passive safety injection tank (SIT) as a enhanced safety feature in KNGR. Passive SIT employs a vortex chamber as a fluidic device, which control injection flow rate passively by the variation of flow resistance produced by vortex intensity within the vortex chamber. To investigate the flow characteristics of the vortex chamber many tests have been carried out by using small-scale test facility. In this report the effects of geometric parameters of vortex chamber on discharge flow characteristics and the velocity measurement result of flow field, measured by PIV, are presented and discussed. (author). 25 refs., 11 tabs., 31 figs

Biological Agents

Science.gov (United States)

... E-Tools Safety and Health Topics / Biological Agents Biological Agents This page requires that javascript be enabled ... 202) 693-2300 if additional assistance is required. Biological Agents Menu Overview In Focus: Ebola Frederick A. ...

Chitosan to Connect Biology to Electronics: Fabricating the Bio-Device Interface and Communicating Across This Interface

Directory of Open Access Journals (Sweden)

Eunkyoung Kim

2014-12-01

Full Text Available Individually, advances in microelectronics and biology transformed the way we live our lives. However, there remain few examples in which biology and electronics have been interfaced to create synergistic capabilities. We believe there are two major challenges to the integration of biological components into microelectronic systems: (i assembly of the biological components at an electrode address, and (ii communication between the assembled biological components and the underlying electrode. Chitosan possesses a unique combination of properties to meet these challenges and serve as an effective bio-device interface material. For assembly, chitosan’s pH-responsive film-forming properties allow it to “recognize” electrode-imposed signals and respond by self-assembling as a stable hydrogel film through a cathodic electrodeposition mechanism. A separate anodic electrodeposition mechanism was recently reported and this also allows chitosan hydrogel films to be assembled at an electrode address. Protein-based biofunctionality can be conferred to electrodeposited films through a variety of physical, chemical and biological methods. For communication, we are investigating redox-active catechol-modified chitosan films as an interface to bridge redox-based communication between biology and an electrode. Despite significant progress over the last decade, many questions still remain which warrants even deeper study of chitosan’s structure, properties, and functions.

Development of technique for laser welding of biological tissues using laser welding device and nanocomposite solder.

Science.gov (United States)

Gerasimenko, A; Ichcitidze, L; Podgaetsky, V; Ryabkin, D; Pyankov, E; Saveliev, M; Selishchev, S

2015-08-01

The laser device for welding of biological tissues has been developed involving quality control and temperature stabilization of weld seam. Laser nanocomposite solder applied onto a wound to be weld has been used. Physicochemical properties of the nanocomposite solder have been elucidated. The nature of the tissue-organizing nanoscaffold has been analyzed at the site of biotissue welding.

Safety and efficacy of a low-cost glaucoma drainage device for refractory childhood glaucoma.

Science.gov (United States)

Kaushik, Sushmita; Kataria, Pankaj; Raj, Srishti; Pandav, Surinder Singh; Ram, Jagat

2017-12-01

To evaluate the safety and efficacy of a low-cost glaucoma drainage device (GDD), Aurolab aqueous drainage implant (AADI), similar in design to the Baerveldt glaucoma implant (BGI), in refractory childhood glaucoma. This prospective interventional study was conducted in a tertiary care postgraduate teaching institute. Children aged glaucoma valve implant in children. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

e-Biologics: Fabrication of Sustainable Electronics with "Green" Biological Materials.

Science.gov (United States)

Lovley, Derek R

2017-06-27

The growing ubiquity of electronic devices is increasingly consuming substantial energy and rare resources for materials fabrication, as well as creating expansive volumes of toxic waste. This is not sustainable. Electronic biological materials (e-biologics) that are produced with microbes, or designed with microbial components as the guide for synthesis, are a potential green solution. Some e-biologics can be fabricated from renewable feedstocks with relatively low energy inputs, often while avoiding the harsh chemicals used for synthesizing more traditional electronic materials. Several are completely free of toxic components, can be readily recycled, and offer unique features not found in traditional electronic materials in terms of size, performance, and opportunities for diverse functionalization. An appropriate investment in the concerted multidisciplinary collaborative research required to identify and characterize e-biologics and to engineer materials and devices based on e-biologics could be rewarded with a new "green age" of sustainable electronic materials and devices. Copyright © 2017 Lovley.

Biological effects of electromagnetic fields and recently updated safety guidelines for strong static magnetic fields

International Nuclear Information System (INIS)

Yamaguchi-Sekino, Sachiko; Sekino, Masaki; Ueno, Shoogo

2011-01-01

Humans are exposed daily to artificial and naturally occurring magnetic fields that originate from many different sources. We review recent studies that examine the biological effects of and medical applications involving electromagnetic fields, review the properties of static and pulsed electromagnetic fields that affect biological systems, describe the use of a pulsed electromagnetic field in combination with an anticancer agent as an example of a medical application that incorporates an electromagnetic field, and discuss the recently updated safety guidelines for static electromagnetic fields. The most notable modifications to the 2009 International Commission on Non-Ionizing Radiation Protection guidelines are the increased exposure limits, especially for those who work with or near electromagnetic fields (occupational exposure limits). The recommended increases in exposure were determined using recent scientific evidence obtained from animal and human studies. Several studies since the 1994 publication of the guidelines have examined the effects on humans after exposure to high static electromagnetic fields (up to 9.4 tesla), but additional research is needed to ascertain further the safety of strong electromagnetic fields. (author)

Development of a safety case for the use of current limiting devices to manage short circuit currents on electrical distribution networks. Final report

Energy Technology Data Exchange (ETDEWEB)

NONE

2004-07-01

The original objective of this study was to review the safety issues associated with the use of current limiting devices and to write a risk assessment in accordance with good practice. But, when legislative procedures became apparent, the scope was changed to include involvement with the HSE, the DTI and Ofgem. It turned out that it would have been very difficult to write a safety case that would satisfy all of the agencies, or a risk assessment that would cover all applications. The scope of the study was therefore changed to focus on how the existing barriers should be tackled and the implications of the existing legislation. The approach to the study is described; it included reviews of background information and literature, questionnaires to manufacturers, a review of the reliability and hazards of the devices, and a review of UK safety legislation. The Final Report describes all this and includes discussion on the consequences of failure of fault current limiting devices, control measures which could be used to minimise risk, and recommendations for a way forward.

Microfluidic Organ/Body-on-a-Chip Devices at the Convergence of Biology and Microengineering

Directory of Open Access Journals (Sweden)

Ana Rubina Perestrelo

2015-12-01

Full Text Available Recent advances in biomedical technologies are mostly related to the convergence of biology with microengineering. For instance, microfluidic devices are now commonly found in most research centers, clinics and hospitals, contributing to more accurate studies and therapies as powerful tools for drug delivery, monitoring of specific analytes, and medical diagnostics. Most remarkably, integration of cellularized constructs within microengineered platforms has enabled the recapitulation of the physiological and pathological conditions of complex tissues and organs. The so-called “organ-on-a-chip” technology, which represents a new avenue in the field of advanced in vitro models, with the potential to revolutionize current approaches to drug screening and toxicology studies. This review aims to highlight recent advances of microfluidic-based devices towards a body-on-a-chip concept, exploring their technology and broad applications in the biomedical field.

Microfluidic Organ/Body-on-a-Chip Devices at the Convergence of Biology and Microengineering

Science.gov (United States)

Perestrelo, Ana Rubina; Águas, Ana C. P.; Rainer, Alberto; Forte, Giancarlo

2015-01-01

Recent advances in biomedical technologies are mostly related to the convergence of biology with microengineering. For instance, microfluidic devices are now commonly found in most research centers, clinics and hospitals, contributing to more accurate studies and therapies as powerful tools for drug delivery, monitoring of specific analytes, and medical diagnostics. Most remarkably, integration of cellularized constructs within microengineered platforms has enabled the recapitulation of the physiological and pathological conditions of complex tissues and organs. The so-called “organ-on-a-chip” technology, which represents a new avenue in the field of advanced in vitro models, with the potential to revolutionize current approaches to drug screening and toxicology studies. This review aims to highlight recent advances of microfluidic-based devices towards a body-on-a-chip concept, exploring their technology and broad applications in the biomedical field. PMID:26690442

Reactor safety

International Nuclear Information System (INIS)

Butz, H.P.; Heuser, F.W.; May, H.

1985-01-01

The paper comprises an introduction into nuclear physics bases, the safety concept generally speaking, safety devices of pwr type reactors, accident analysis, external influences, probabilistic safety assessment and risk studies. It further describes operational experience, licensing procedures under the Atomic Energy Law, research in reactor safety and the nuclear fuel cycle. (DG) [de

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.

Use of FPGA and CPLD in nuclear reactor safety systems and its regulatory review requirements for reactor safety

International Nuclear Information System (INIS)

Roy, Suvadip; Biswas, Animesh; Pradhan, S.K.

2015-01-01

Field Programmable Gate Arrays (FPGA) and Complex Programmable Logic Devices (CPLD) is being used widely in safety critical and safety related systems in nuclear power plans like in trip logic units, Engineered Safety Feature (ESF) actuation decision logic and neutronic signal processing for their reprogrammability feature and compact design. These HDL Programmable devices (HPD) are complex devices consisting of both hardware and software which is used to implement the logic on the FPGA. It is observed that these Programmable devices suffer from various modes of failure and the major failures in these devices are due to Single Event Upset (SEU), where a highly energetic ionizing radiation may lead to device failure which can even occur in radiologically benign environment. Other failures can occur during steps of developing the hardware using software tools like during Synthesis and placement and routing of the desired hardware. Here a study on use of such devices in Nuclear Reactors, study on mode of failures of these devices, way to tackle such failure and development of review guidelines for review of such devices used in safety critical and safety related systems with special emphasis on choice of software tools, way to mitigate effects of SEU and simulation and hardware testing results to be reviewed by regulatory body during design safety review is done. (author)

IINFLUENCE OF FREEZING AND PROLONGED STORAGE OF EXPRESSED BREAST MILK ON ITS NUTRITIVE, BIOLOGICAL VALUES AND MICROBIOLOGICAL SAFETY

Directory of Open Access Journals (Sweden)

O. L. Lukoyanova

2011-01-01

Full Text Available Evaluation of prolonged storage of breast milk safety for nutrition of newborns remains actual problem of modern nutritiology. Objectives: to evaluate an influence of freezing and prolonged storage of expressed breast milk on its nutritive, biological values and microbiological safety. Methods: samples of expressed breast milk (native samples and after 1 and 3 months of storage in containers Philips AVENT in t -18°С were analyzed; levels of secretory IgA, lysozyme, transforming growth factor (TGF β1, potassium, calcium, magnesium, pH, buffer capacity and bacterial cells were detected. Results: there is no statistically significant influence of low temperature and prolonged storage of expressed breast milk on levels of secretory IgA, lysozyme, TGF β1 and bacterial cells. Potassium and calcium levels significantly decreased (on about 10% and 20% accordingly, pH increased, and buffer capacity of milk lowered after freezing during 3 months. Conclusion: children’s feeding with native and expressed breast milk defrosted after 3 months of storage is equal in nutritive and biological values and microbiological safety.

Efficacy and Safety Data of Subsequent Entry Biologics Pertinent to Nephrology Practice: A Systematic Review

Directory of Open Access Journals (Sweden)

Judith Genevieve Marin

2014-12-01

Full Text Available Background: Subsequent entry biologics (SEBs may soon be a reality in Canadian nephrology practice. Understanding the worldwide experience with these agents will be valuable to Canadian clinicians. Objectives: To compare the efficacy and safety data between SEBs used in nephrology practice and their reference biologic. Design: Systematic review. Sources of information: Ovid MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Database of Abstracts of Review of Effects, Cochrane Central Register of Controlled Trials. Patients: Adult patients with chronic kidney disease (CKD. Methods: Our systematic review follows the process outlined by Cochrane Reviews. For efficacy data, all randomized controlled trials (RCTs, quasi-RCTs and observational trials in nephrology practice were included. For safety data, case series, case reports, review articles in nephrology practice and pharmacovigilance programs were included as well. Results: Only epoetin SEBs trials were published in the literature. Ten studies involving three different epoetin SEBs (epoetin zeta, HX575 and epoetin theta were included. The mean epoetin dose used did not differ significantly between the SEBs and the reference product. For epoetin zeta and epoetin theta, the mean hemoglobin levels achieved in the studies were similar between the SEBs and the reference epoetin. The HX 575 studies reported a mean absolute change in hemoglobin within the predefined equivalence margin, when compared with the reference biologic. In terms of safety data, 2 cases of pure-red-cell aplasia were linked to the subcutaneous administration of HX 575. Otherwise, the rate of adverse drug reactions was similar when epoetin SEBs were compared with the reference biologic. Limitations: Our analysis is limited by the paucity of information available on SEB use in nephrology with the exception of epoetin SEBs. Methodological flaw was found in one of the epoetin zeta studies which accounted for 45% of pooled

Reactor protecting device

International Nuclear Information System (INIS)

Ono, Hiroshi; Kasuga, Hajime; Kasuga, Hiroshi.

1984-01-01

Purpose: To reduce the recycling flowrate thereby decrease the neutron flux level before the reactor shutdown upon generation of abnormality such as increase in the neutron flux, by setting the safety level lower than the value for generating the reaction scram signal. Constitution: A netron flux safety level setter and an instruction signal generator are disposed between a neutron flux detector and a recycling flowrate control device. A neutron flux safety level lower than the level for generating a reactor scram signal and higher that the level for the ordinary operation is set and, if the detection level for the neutron flux in the reactor core arrives at the safety level, a neutron flux decreasing instruction signal is outputted from the instruction signal generator to the recycling flowrate control device to thereby decrease the recycling flowrate and decrease the neutron flux without reaching the reactor shutdown, whereby the thermal safety of the fuel rod can be maintained and the reactor operation performance can be improved. (Moriyama, K.)

Safety analysis and evaluation of the next fusion device

International Nuclear Information System (INIS)

Kobayashi, Shigetada; Honda, Tsutomu; Ohmura, Hiroshi; Kawai, Masayoshi; Shimizu, Takeshi; Yamaoka, Mitsuaki; Nakahara, Katsuhiko; Seki, Yasushi.

1988-12-01

As a part of safety evaluation, a probabilistic risk assessment (PRA) has been attempted for the Next Fusion Device system. Among the various events related to safety, a number of representative events have been selected for assessment, from the events in normal operation state, repair and maintenance state and accidental state. In the first chapter, in order to conduct the probabilistic risk assessment of the whole Fusion Experimental Reactor (FER), the data base required for the analysis was investigated in 1.1, the results on the failure mode and effects analysis (FMEA), accident sequence, radioactive inventory leakage flow path, event tree analysis (ETA) and fault tree analysis (FTA) were summarized in 1.2 to 1.5, respectively. Based on these results, accident initiating events were evaluated in 1.6, and overall risk was assessed in 1.7 and the tasks for the future were summarized in 1.8. It is important to analyze and evaluate various events during normal operations, repair and maintenance and accidents. However, due to the large uncertainties in the modeling of phenomena or the data base, there are many events for which realistic analyses are difficult. Three such events were selected and studied in chapter two. In 2.1, the temperature rise in the reactor structure after the Loss-of-Coolant-Accident caused by the decay heat under various heat removal conditions were investigated. In 2.2, the radiation dose of personnel during repair and maintenance period caused by the release of activated dust were estimated. Lastly, in 2.3 tritium behavior in the stainless steel first wall and graphite armour were studied. (author)

Operating room fire prevention: creating an electrosurgical unit fire safety device.

Science.gov (United States)

Culp, William C; Kimbrough, Bradly A; Luna, Sarah; Maguddayao, Aris J

2014-08-01

To reduce the incidence of surgical fires. Operating room fires represent a potentially life-threatening hazard and are triggered by the electrosurgical unit (ESU) pencil. Carbon dioxide is a fire suppressant and is a routinely used medical gas. We hypothesize that a shroud of protective carbon dioxide covering the tip of the ESU pencil displaces oxygen, thereby preventing fire ignition. Using 3-dimensional modeling techniques, a polymer sleeve was created and attached to an ESU pencil. This sleeve was connected to a carbon dioxide source and directed the gas through multiple precisely angled ports, generating a cone of fire-suppressive carbon dioxide surrounding the active pencil tip. This device was evaluated in a flammability test chamber containing 21%, 50%, and 100% oxygen with sustained ESU activation. The sleeve was tested with and without carbon dioxide (control) until a fuel was ignited or 30 seconds elapsed. Time to ignition was measured by high-speed videography. Fires were ignited with each control trial (15/15 trials). The control group median ± SD ignition time in 21% oxygen was 3.0 ± 2.4 seconds, in 50% oxygen was 0.1 ± 1.8 seconds, and in 100% oxygen was 0.03 ± 0.1 seconds. No fire was observed when the fire safety device was used in all concentrations of oxygen (0/15 trials; P fire ignition was 76% to 100%. A sleeve creating a cone of protective carbon dioxide gas enshrouding the sparks from an ESU pencil effectively prevents fire in a high-flammability model. Clinical application of this device may reduce the incidence of operating room fires.

33 CFR 159.95 - Safety.

Science.gov (United States)

2010-07-01

... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Safety. 159.95 Section 159.95... SANITATION DEVICES Design, Construction, and Testing § 159.95 Safety. (a) Each device must— (1) Be free of... explosion or over pressurization as a result of an accumulation of gases; and (3) Meet all other safety...

Hearing Tests Based on Biologically Calibrated Mobile Devices: Comparison With Pure-Tone Audiometry.

Science.gov (United States)

Masalski, Marcin; Grysiński, Tomasz; Kręcicki, Tomasz

2018-01-10

Hearing screening tests based on pure-tone audiometry may be conducted on mobile devices, provided that the devices are specially calibrated for the purpose. Calibration consists of determining the reference sound level and can be performed in relation to the hearing threshold of normal-hearing persons. In the case of devices provided by the manufacturer, together with bundled headphones, the reference sound level can be calculated once for all devices of the same model. This study aimed to compare the hearing threshold measured by a mobile device that was calibrated using a model-specific, biologically determined reference sound level with the hearing threshold obtained in pure-tone audiometry. Trial participants were recruited offline using face-to-face prompting from among Otolaryngology Clinic patients, who own Android-based mobile devices with bundled headphones. The hearing threshold was obtained on a mobile device by means of an open access app, Hearing Test, with incorporated model-specific reference sound levels. These reference sound levels were previously determined in uncontrolled conditions in relation to the hearing threshold of normal-hearing persons. An audiologist-assisted self-measurement was conducted by the participants in a sound booth, and it involved determining the lowest audible sound generated by the device within the frequency range of 250 Hz to 8 kHz. The results were compared with pure-tone audiometry. A total of 70 subjects, 34 men and 36 women, aged 18-71 years (mean 36, standard deviation [SD] 11) participated in the trial. The hearing threshold obtained on mobile devices was significantly different from the one determined by pure-tone audiometry with a mean difference of 2.6 dB (95% CI 2.0-3.1) and SD of 8.3 dB (95% CI 7.9-8.7). The number of differences not greater than 10 dB reached 89% (95% CI 88-91), whereas the mean absolute difference was obtained at 6.5 dB (95% CI 6.2-6.9). Sensitivity and specificity for a mobile

'The Closer'-percutaneous vascular suture device: evaluation of safety and performance in neuroangiography

International Nuclear Information System (INIS)

Henk, Christine B.; Grampp, Stephan; Heimberger, Karl; Czerny, Christian; Schindler, Erwin; Mostbeck, Gerhard H.

2003-01-01

Objective: To evaluate the use of the suture mediated vascular closure device concerning practicability and safety in clinical angiography practice. Material and methods: One hundred and seventeen patients (59 female, 58 male, mean age 40.9±13.4) underwent percutaneous closure of common femoral arterial puncture sites following diagnostic neuroangiography using the suture device 'the Closer' (Perclose Inc., Redwood City, CA, USA). Primary success, early problems (within 24 h) and late complications were evaluated. Complications were graded as minor and severe with or without need of surgical intervention and categorized by type. Parameters such as age, gender, sheath size and number of previous arterial punctures were evaluated with respect to complications. Results: Percutaneous closure was primary successful in 85% (100/117). The overall complication rate was 32% (28% mild n=35, 4% severe n=6, which needed surgical intervention). All but one problem occurred within the first 24 h after the suture. Additional manual compression was necessary in 32 cases (25%). There was no significant difference in age and gender between the groups with and without complications. Sheath size was significantly larger (P<0.01) and numbers of preceding angiograms were significantly higher (P<0.01) in the complications group compared with uncomplicated cases. Conclusion: The evaluated percutaneous vascular suture device is useful in clinical practice but limitations concerning patient selection seem to emerge in order to avoid complications

Nuclear criticality safety and time reactivity enhancement aspects of energy amplifier system devices

Energy Technology Data Exchange (ETDEWEB)

Siciliano, F [ENEA, Centro Ricerche Trisaia, Rotondelle, Matera (Italy). Direzione INFO

1995-12-01

As far as the Rubbia`s and colleagues proposal of innovating Energy Amplifier system (E.A.s.) device driven by a particle beam accelerator is concerned, four basic topics are comprised in the present paper: (1) A short outline of the nuclear aspects of Th-U and U-Pu fuel cycles regarding their general breeding and efficiency features. (2) The needed nuclear criticality control requirements have been studied in terms of safety regulating parameters on the basis of the ThO2 mixed oxides selected as fuel kind for the E.A.s. device technology development. Particular attention is devoted to time evolution of neutron multiplication factor since delayed development of the 233U buildup and so system reactivity are expected in the Th-U cycle. (3) Code E.A.s. device irradiation and post-irradiation modelling for determining higher actinides buildup, fission products formation and fuel consumption trends as function of time, system enrichment degree and flux level parameters. (4) The confirmation, on the basis of the same specific power irradiation, of expected actinides waste obtainment cleaner than the one deriving from the U-Pu cycle utilization. For this end, a model comparison of equivalent enriched fissile nuclides in both cycles has been devised as having, within the range of 0-700 days, ten irradiation periods of about 53 MW/ton specific power and equivalent cooling time post-irradiation periods.

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.

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

Microfluidic devices for biological applications

CSIR Research Space (South Africa)

Potgieter, S

2010-01-01

Full Text Available Microfluidics is a multi-disciplinary field that deals with the behaviour, control and manipulation of fluids constrained to sub-millilitre volumes. It is proving to be a useful tool for biological studies, affording advantages such as reduced cost...

Safety of mechanical chest compression devices AutoPulse and LUCAS in cardiac arrest: a randomized clinical trial for non-inferiority

NARCIS (Netherlands)

Koster, Rudolph W.; Beenen, Ludo F.; van der Boom, Esther B.; Spijkerboer, Anje M.; Tepaske, Robert; van der Wal, Allart C.; Beesems, Stefanie G.; Tijssen, Jan G.

2017-01-01

Aims Mechanical chest compression (CC) during cardiopulmonary resuscitation (CPR) with AutoPulse or LUCAS devices has not improved survival from cardiac arrest. Cohort studies suggest risk of excess damage. We studied safety of mechanical CC and determined possible excess damage compared with manual

Radiation emitting devices act

International Nuclear Information System (INIS)

1970-01-01

This Act, entitled the Radiation Emitting Devices Act, is concerned with the sale and importation of radiation emitting devices. Laws relating to the sale, lease or import, labelling, advertising, packaging, safety standards and inspection of these devices are listed as well as penalties for any person who is convicted of breaking these laws

Safety catching device for pipe lines in missile shielding cylinders of nuclear power plants

International Nuclear Information System (INIS)

Hering, S.; Doll, B.

1975-01-01

The safety catching device for pipes in the missile shielding cylinders consists of a flexible steel cable surrounding the pipe in a distance in U-shape. The arrester cable - which works as a spring and is freely movable in all directions - is attached to the cylinder wall. For this, the ends of the cable are primarily fastened to anchor boxes which are then inserted in a stay tube with the same axis as the cable ends. The anchor boxes are fastened to the outer wall of the missile shielding cylinder by anchor bolts and holding plates. (DG/AK) [de

An open prospective study evaluating efficacy and safety of a new medical device for rectal application of activated carbon in the treatment of chronic, uncomplicated perianal fistulas

DEFF Research Database (Denmark)

Zawadzki, Antoni; Johnson, Louis Banka; Bohe, Måns

2017-01-01

PURPOSE: It has been proposed that biological/chemical substances in the intestine might play a role in the occurrence and deterioration of perianal fistulas. Elimination of such unidentified factors from the lower gastrointestinal tract might offer a new strategy for the management of anal...... fistulas. The aim of this study was to evaluate the clinical effects on non-Crohn's disease perianal fistula healing, and the safety and tolerability of a new medical device that applies high-purity, high-activity granular activated carbon locally into the rectum twice daily of patients with perianal...... fistulas without any concomitant medication. METHODS: An open, single-arm, prospective study with active treatment for 8 weeks and an optional follow-up until week 24 ( ClinicalTrial.gov identifier NCT01462747) among patients with chronic, uncomplicated perianal fistulas scheduled for surgery was conducted...

The risk of a safety-critical event associated with mobile device use in specific driving contexts.

Science.gov (United States)

Fitch, Gregory M; Hanowski, Richard J; Guo, Feng

2015-01-01

We explored drivers' mobile device use and its associated risk of a safety-critical event (SCE) in specific driving contexts. Our premise was that the SCE risk associated with mobile device use increases when the driving task becomes demanding. Data from naturalistic driving studies involving commercial motor vehicle drivers and light vehicle drivers were partitioned into subsets representative of specific driving contexts. The subsets were generated using data set attributes that included level of service and relation to junction. These attributes were selected based on exogenous factors known to alter driving task demands. The subsets were analyzed using a case-cohort approach, which was selected to complement previous investigations of mobile device SCE risk using naturalistic driving data. Both commercial motor vehicle and light vehicle drivers varied as to how much they conversed on a mobile device but did not vary their engagement in visual-manual subtasks. Furthermore, commercial motor vehicle drivers conversed less frequently as the driving task demands increased, whereas light vehicle drivers did not. The risk of an SCE associated with mobile device use was dependent on the subtask performed and the driving context. Only visual-manual subtasks were associated with an increased SCE risk, whereas conversing was associated with a decreased risk in some driving contexts. Drivers' engagement in mobile device subtasks varies by driving context. The SCE risk associated with mobile device use is dependent on the types of subtasks performed and the driving context. The findings of this exploratory study can be applied to the design of driver-vehicle interfaces that mitigate distraction by preventing visual-manual subtasks while driving.

CIRSE Vascular Closure Device Registry

NARCIS (Netherlands)

Reekers, Jim A.; Müller-Hülsbeck, Stefan; Libicher, Martin; Atar, Eli; Trentmann, Jens; Goffette, Pierre; Borggrefe, Jan; Zeleňák, Kamil; Hooijboer, Pieter; Belli, Anna-Maria

2011-01-01

Vascular closure devices are routinely used after many vascular interventional radiology procedures. However, there have been no major multicenter studies to assess the safety and effectiveness of the routine use of closure devices in interventional radiology. The CIRSE registry of closure devices

Fast reactor recharging device

International Nuclear Information System (INIS)

Artemiev, L.N.; Kurilkin, V.V.

1979-01-01

Disclosure is made of a device for recharging a fast-neutron reactor, intended for the transfer of fuel assemblies and rods of the control and safety system, having profiled heads to be gripped on the outside. The device comprises storage drums whose compartments for rods of the control and safety system are identical to compartments for fuel assemblies. In order to store and transport rods of the control and safety system from the storage drums to the recharging mechanism provision is made for sleeve-type holders. When placed in such a holder, the dimensions of a rod of the control and safety system are equal to those of a fuel assembly. To join a holder to a rod of the control and safety system, on the open end of each holder there is mounted a collet, whereas on the surface of each rod of the control and safety system, close to its head, there is provided an encircling groove to interact with the collet. The grip of the recharging mechanism is provided with a stop interacting with the collet in order to open the latter and withdraw the safety and control system rod from its holder

Traffic sounds and cycling safety : the use of electronic devices by cyclists and the quietness of hybrid and electric cars.

NARCIS (Netherlands)

Stelling-Konczak, A. Hagenzieker, M.P. & Wee, B. van

2015-01-01

The growing popularity of electric devices and the increasing number of hybrid and electric cars have recently raised concerns about the use of auditory signals by vulnerable road users. This paper consolidates current knowledge about the two trends in relation to cycling safety. Both a literature

Safety-related control air systems

International Nuclear Information System (INIS)

Anon.

1977-01-01

This Standard applies to those portions of the control air system that furnish air required to support, control, or operate systems or portions of systems that are safety related in nuclear power plants. This Standard relates only to the air supply system(s) for safety-related air operated devices and does not apply to the safety-related air operated device or to air operated actuators for such devices. The objectives of this Standard are to provide (1) minimum system design requirements for equipment, piping, instruments, controls, and wiring that constitute the air supply system; and (2) the system and component testing and maintenance requirements

[Side effects of biologic therapies in psoriasis].

Science.gov (United States)

Altenburg, A; Augustin, M; Zouboulis, C C

2018-04-01

The introduction of biologics has revolutionized the treatment of moderate to severe plaque psoriasis. Due to the continuous expansion of biological therapies for psoriasis, it is particularly important to acknowledge efficacy and safety of the compounds not only in clinical trials but also in long-term registry-based observational studies. Typical side effects and significant risks of antipsoriatic biologic therapies considering psoriatic control groups are presented. A selective literature search was conducted in PubMed and long-term safety studies of the psoriasis registries PsoBest, PSOLAR and BADBIR were evaluated. To assess the long-term safety of biologics, the evaluation of the course of large patient cohorts in long-term registries is of particular medical importance. Newer biologic drugs seem to exhibit a better safety profile than older ones.

New biological deodrization device using dried activated sludge. Kanso odei wo mochiita shinki seibutsu dasshu sochi no kaihatsu

Energy Technology Data Exchange (ETDEWEB)

Hatakeyama, S.; Nagayasu, K.; Suwa, T.; Hayashitani, M.; Ito, H.; Habata, K.; Kitakaze, T. (Kawasaki Heavy Industries, Ltd., Tokyo (Japan))

1993-10-20

The new biological deodorization device was developed using dried activated sludge as deodorant. Activated sludge obtained from a waste water treatment plant was dried at room temperature to protect from extinction of microorganisms in it before its charge into the device, and washed by water only as required. Offensive odor substances were oxidation-decomposed by microorganism after their adsorption into sludge surfaces, while microorganisms survived for a long time while getting such substances as nutritive sources. As basic deodorization characteristics were studied with the experimental device and artificial odor gases, more than 99% of 200 and 2,000 ppm H2S were removed at space velocities of 400/h and 33/h, respectively, together with nine typical offensive odor substances. As the result of demonstration tests with the small test device installed in a public waste water treatment plant, a high deodorizing efficiency was retained for 10 months or more, and its running cost was as low as 75% of that of current systems because of only one necessary washing every month. 3 refs., 14 figs., 12 tabs.

Developments of radiation safety requirements for the management of radiation devices

International Nuclear Information System (INIS)

Lee, Hee Seock; Choi, Jin Ho; Cheong, Yuon Young

2002-03-01

The approach of the risk-informed regulatory options was studied to develop the radiation safety requirements for the managements for radiation devices. The task analysis, exposure, accident scenario development, risk analysis, and systematic approach for regulatory options was considered in full, based on the NRC report, 'NUREG/CR-6642', and the translation of its core part was conducted for ongoing research. In this methodology, the diamond tree that includes human factors, etc, additionally with normal event tree, was used. According to the analysis results of this approach, the risk analysis and the development of regulatory options were applied for the electron linear accelerators and the qualitative results were obtained. Because the field user groups were participated in this study could contribute to the basis establishment of the risk-informed regulation policy through securing consensus and inducing particle interests. It will make an important role of establishing the detail plan of ongoing research

Developments of radiation safety requirements for the management of radiation devices

Energy Technology Data Exchange (ETDEWEB)

Lee, Hee Seock [Pohang Accelerator Lab, Pohang (Korea, Republic of); Choi, Jin Ho [Gachun University of Medicine and science, Incheon (Korea, Republic of); Cheong, Yuon Young [Asan Medical Center, Seoul (Korea, Republic of)] (and others)

2002-03-15

The approach of the risk-informed regulatory options was studied to develop the radiation safety requirements for the managements for radiation devices. The task analysis, exposure, accident scenario development, risk analysis, and systematic approach for regulatory options was considered in full, based on the NRC report, 'NUREG/CR-6642', and the translation of its core part was conducted for ongoing research. In this methodology, the diamond tree that includes human factors, etc, additionally with normal event tree, was used. According to the analysis results of this approach, the risk analysis and the development of regulatory options were applied for the electron linear accelerators and the qualitative results were obtained. Because the field user groups were participated in this study could contribute to the basis establishment of the risk-informed regulation policy through securing consensus and inducing particle interests. It will make an important role of establishing the detail plan of ongoing research.

Organic light-emitting devices (OLEDs) and OLED-based chemical and biological sensors: an overview

International Nuclear Information System (INIS)

Shinar, Joseph; Shinar, Ruth

2008-01-01

The basic photophysics, transport properties, state of the art, and challenges in OLED science and technology, and the major developments in structurally integrated OLED-based luminescent chemical and biological sensors are reviewed briefly. The dramatic advances in OLED performance have resulted in devices with projected continuous operating lifetimes of ∼2 x 10 5 h (∼23 yr) at ∼150 Cd m -2 (the typical brightness of a computer monitor or TV). Consequently, commercial products incorporating OLEDs, e.g., cell phones, MP3 players, and, most recently, OLED TVs, are rapidly proliferating. The progress in elucidating the photophysics and transport properties, occurring in tandem with the development of OLEDs, has been no less dramatic. It has resulted in a detailed understanding of the dynamics of trapped and mobile negative and positive polarons (to which the electrons and holes, respectively, relax upon injection), and of singlet and triplet excitons. It has also yielded a detailed understanding of the spin dynamics of polarons and triplet excitons, which affects their overall dynamics significantly. Despite the aforementioned progress, there are outstanding challenges in OLED science and technology, notably in improving the efficiency of the devices and their stability at high brightness (>1000 Cd m -2 ). One of the most recent emerging OLED-based technologies is that of structurally integrated photoluminescence-based chemical and biological sensors. This sensor platform, pioneered by the authors, yields uniquely simple and potentially very low-cost sensor (micro)arrays. The second part of this review describes the recent developments in implementing this platform for gas phase oxygen, dissolved oxygen (DO), anthrax lethal factor, and hydrazine sensors, and for a DO, glucose, lactate, and ethanol multianalyte sensor. (topical review)

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...

Controlled power delivery for super-resolution imaging of biological samples using digital micromirror device

Science.gov (United States)

Valiya Peedikakkal, Liyana; Cadby, Ashley

2017-02-01

Localization based super resolution images of a biological sample is generally achieved by using high power laser illumination with long exposure time which unfortunately increases photo-toxicity of a sample, making super resolution microscopy, in general, incompatible with live cell imaging. Furthermore, the limitation of photobleaching reduces the ability to acquire time lapse images of live biological cells using fluorescence microscopy. Digital Light Processing (DLP) technology can deliver light at grey scale levels by flickering digital micromirrors at around 290 Hz enabling highly controlled power delivery to samples. In this work, Digital Micromirror Device (DMD) is implemented in an inverse Schiefspiegler telescope setup to control the power and pattern of illumination for super resolution microscopy. We can achieve spatial and temporal patterning of illumination by controlling the DMD pixel by pixel. The DMD allows us to control the power and spatial extent of the laser illumination. We have used this to show that we can reduce the power delivered to the sample to allow for longer time imaging in one area while achieving sub-diffraction STORM imaging in another using higher power densities.

A novel mechanical design of broken rope protection device for enhancing the safety performances of overhead manned equipment in coal mine

Directory of Open Access Journals (Sweden)

Xiaoguang Zhang

2015-08-01

Full Text Available A novel mechanical design of the broken rope protection device is proposed to enhance the safety performances of the overhead manned equipment. According to the operating characteristics and functional requirements of the overhead manned equipment, a three-dimensional mechanical model of the broken rope protection device was redesigned. Based on the known parameters of the mechanical model, the stress and strength of the main components are readjusted using the statics characteristics of finite element analysis. To ensure the reliability of the control system of the broken rope protection device, the process of people’s falling, the response performance of the tension sensor, and the signal extraction of the broken rope are analyzed under different loading and unloading speeds. The working principle of the broken rope protection device is expounded in detail. The experimental results showed that better effect is obtained by the new broken rope protection device, which is characterized by good durability, low investment, and high reliability.

Assessment of radiation safety awareness and attitude toward biological effect of radiation for employees in nuclear workplace

International Nuclear Information System (INIS)

Youngchuay, U.; Jetawattana, S.; Toeypho, V.; Eso, J.

2016-01-01

This study demonstrated a potential relevance of data pertaining to the interaction of awareness in radiation biology and their attitude towards radiation hazards. The obtained information is useful in ascertaining the effectiveness of the ongoing radiation safety program and will be further used to determine the relationships between the radiation effective dose and cytogenetic approach in these groups of workers. (author)

30 CFR 75.208 - Warning devices.

Science.gov (United States)

2010-07-01

... Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Roof Support § 75.208 Warning devices. Except during the..., or a physical barrier shall be installed to impede travel beyond permanent support. ...

Comparison of the efficacy and safety of thrombectomy devices in acute stroke : a network meta-analysis of randomized trials.

Science.gov (United States)

Saber, Hamidreza; Rajah, Gary B; Kherallah, Riyad Y; Jadhav, Ashutosh P; Narayanan, Sandra

2017-12-15

Mechanical thrombectomy (MT) is increasingly used for large-vessel occlusions (LVO), but randomized clinical trial (RCT) level data with regard to differences in clinical outcomes of MT devices are limited. We conducted a network meta-analysis (NMA) that enables comparison of modern MT devices (Trevo, Solitaire, Aspiration) and strategies (stent retriever vs aspiration) across trials. Relevant RCTs were identified by a systematic review. The efficacy outcome was 90-day functional independence (modified Rankin Scale (mRS) score 0-2). Safety outcomes were 90-day catastrophic outcome (mRS 5-6) and symptomatic intracranial hemorrhage (sICH). Fixed-effect Bayesian NMA was performed to calculate risk estimates and the rank probabilities. In a NMA of six relevant RCTs (SWIFT, TREVO2, EXTEND-IA, SWIFT-PRIME, REVASCAT, THERAPY; total of 871 patients, 472 Solitaire vs medical-only, 108 Aspiration vs medical-only, 178 Trevo vs Merci, and 113 Solitaire vs Merci) with medical-only arm as the reference, Trevo had the greatest functional independence (OR 4.14, 95% credible interval (CrI) 1.41-11.80; top rank probability 92%) followed by Solitaire (OR 2.55, 95% CrI 1.75-3.74; top rank probability 72%). Solitaire and Aspiration devices had the greatest top rank probability with respect to low sICH and catastrophic outcomes (76% and 91%, respectively), but without significant differences between each other. In a separate network of seven RCTs (MR-CLEAN, ESCAPE, EXTEND-IA, SWIFT-PRIME, REVASCAT, THERAPY, ASTER; 1737 patients), first-line stent retriever was associated with a higher top rank probability of functional independence than aspiration (95% vs 54%), with comparable safety outcomes. These findings suggest that Trevo and Solitaire devices are associated with a greater likelihood of functional independence whereas Solitaire and Aspiration devices appear to be safer. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights

MICROBIOLOGICAL SAFETY BIBLIOGRAPHY

Science.gov (United States)

More than a thousand articles on biological safety in infectious disease laboratories are listed for the use of supervisors responsible for the safety of laboratory personnel. An author index is included.

Device for increasing the safety in the environment of nuclear facilities in case of containment failure

International Nuclear Information System (INIS)

Morlock, G.; Wiesemes, J.; Bachner, D.

1978-01-01

In order to increase the safety in the environment of nuclear facilities, e.g. in case of containment failure, with respect to released radioactive material new or existing facilities are covered with ground. The ground material has got a consistency very much reducing the permeability for liquids and gases. In addition irrigation devices for keeping the ground wet and/or intermediate layers of films pervious to water, e.g. perforated sheets, may be provided. Additionally the ground is protected against frost. Especially suited for ground material is clay. (DG) [de

Licensing of simple digital devices

International Nuclear Information System (INIS)

Jackson, T. W.

2008-01-01

The inability to guarantee error-free software gave rise to the potential for common-cause failure of digital safety systems in nuclear power plants. To address this vulnerability, the U. S. Nuclear Regulatory Commission (NRC) required a quality software development process and a defense-in-depth and diversity analysis for digital safety systems. As a result of recent interim [NRC] staff guidance in the digital instrumentation and control (I and C) area, licensing of simple digital devices decreases some regulatory burden with respect to demonstrating a quality software development process and defense-in-depth and diversity analysis. This paper defines simple digital devices and addresses the interim staff guidance that applies to such devices. The paper also highlights the technical aspects that affect the licensing of such devices and incorporates licensing experience in the U.S. to date. (authors)

Synthetic biology: programming cells for biomedical applications.

Science.gov (United States)

Hörner, Maximilian; Reischmann, Nadine; Weber, Wilfried

2012-01-01

The emerging field of synthetic biology is a novel biological discipline at the interface between traditional biology, chemistry, and engineering sciences. Synthetic biology aims at the rational design of complex synthetic biological devices and systems with desired properties by combining compatible, modular biological parts in a systematic manner. While the first engineered systems were mainly proof-of-principle studies to demonstrate the power of the modular engineering approach of synthetic biology, subsequent systems focus on applications in the health, environmental, and energy sectors. This review describes recent approaches for biomedical applications that were developed along the synthetic biology design hierarchy, at the level of individual parts, of devices, and of complex multicellular systems. It describes how synthetic biological parts can be used for the synthesis of drug-delivery tools, how synthetic biological devices can facilitate the discovery of novel drugs, and how multicellular synthetic ecosystems can give insight into population dynamics of parasites and hosts. These examples demonstrate how this new discipline could contribute to novel solutions in the biopharmaceutical industry.

Organic light-emitting devices (OLEDs) and OLED-based chemical and biological sensors: an overview

Energy Technology Data Exchange (ETDEWEB)

Shinar, Joseph [Ames Laboratory-USDOE and Department of Physics and Astronomy, Iowa State University, Ames, IA 50011 (United States); Shinar, Ruth [Microelectronics Research Center, Iowa State University, Ames, IA 50011 (United States)

2008-07-07

The basic photophysics, transport properties, state of the art, and challenges in OLED science and technology, and the major developments in structurally integrated OLED-based luminescent chemical and biological sensors are reviewed briefly. The dramatic advances in OLED performance have resulted in devices with projected continuous operating lifetimes of {approx}2 x 10{sup 5} h ({approx}23 yr) at {approx}150 Cd m{sup -2} (the typical brightness of a computer monitor or TV). Consequently, commercial products incorporating OLEDs, e.g., cell phones, MP3 players, and, most recently, OLED TVs, are rapidly proliferating. The progress in elucidating the photophysics and transport properties, occurring in tandem with the development of OLEDs, has been no less dramatic. It has resulted in a detailed understanding of the dynamics of trapped and mobile negative and positive polarons (to which the electrons and holes, respectively, relax upon injection), and of singlet and triplet excitons. It has also yielded a detailed understanding of the spin dynamics of polarons and triplet excitons, which affects their overall dynamics significantly. Despite the aforementioned progress, there are outstanding challenges in OLED science and technology, notably in improving the efficiency of the devices and their stability at high brightness (>1000 Cd m{sup -2}). One of the most recent emerging OLED-based technologies is that of structurally integrated photoluminescence-based chemical and biological sensors. This sensor platform, pioneered by the authors, yields uniquely simple and potentially very low-cost sensor (micro)arrays. The second part of this review describes the recent developments in implementing this platform for gas phase oxygen, dissolved oxygen (DO), anthrax lethal factor, and hydrazine sensors, and for a DO, glucose, lactate, and ethanol multianalyte sensor. (topical review)

Rumble devices for road traffic safety

CSIR Research Space (South Africa)

Jobson, AJ

1973-01-01

Full Text Available on the approaches to hazardous curves or intersections. City and town engineers had little to report on rumble installations but showed a keen interest in their potential usefulness. Each type of rumble device has certain merits and these are discussed...

30 CFR 57.9311 - Anchoring stationary sizing devices.

Science.gov (United States)

2010-07-01

... NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-UNDERGROUND METAL AND NONMETAL MINES Loading, Hauling, and Dumping Safety Devices, Provisions, and Procedures for Roadways, Railroads, and Loading and...

Eat-by-light fiber-optic and micro-optic devices for food quality and safety assessment

Science.gov (United States)

Mignani, A. G.; Ciaccheri, L.; Cucci, C.; Mencaglia, A. A.; Cimato, A.; Attilio, C.; Thienpont, H.; Ottevaere, H.; Paolesse, R.; Mastroianni, M.; Monti, D.; Buonocore, G.; Del Nobile, A.; Mentana, A.; Grimaldi, M. F.; Dall'Asta, C.; Faccini, A.; Galaverna, G.; Dossena, A.

2007-06-01

A selection is presented of fiber-optic and micro-optic devices that have been designed and tested for guaranteeing the quality and safety of typical foods, such as extra virgin olive oil, beer, and milk. Scattered colorimetry is used to authenticate various types of extra virgin olive oil and beer, while a fiber-optic-based device for UV-VIS-NIR absorption spectroscopy is exploited in order to obtain the hyperspectral optical signature of olive oil. This is done not only for authentication purposes, but also so as to correlate the spectral data with the content of fatty acids, which are important nutritional factors. A micro-optic sensor for the detection of olive oil aroma that is capable of distinguishing different ageing levels of extra virgin olive oil is also presented. It shows effective potential for acting as a smart cap of bottled olive oil in order to achieve a non-destructive olfactory perception of oil ageing. Lastly, a compact portable fluorometer for the rapid monitoring of the carcinogenic M1 aflatoxin in milk, is experimented.

Eat-by-light: fiber-optic and micro-optic devices for food safety and quality assessment

Science.gov (United States)

Mignani, A. G.; Ciaccheri, L.; Cucci, C.; Mencaglia, A. A.; Cimato, A.; Attilio, C.; Thienpont, H.; Ottevaere, H.; Paolesse, R.; Mastroianni, M.; Monti, D.; Buonocore, G.; Del Nobile, A.; Mentana, A.; Dall'Asta, C.; Faccini, A.; Galaverna, G.; Dossena, A.

2007-07-01

A selection of fiber-optic and micro-optic devices is presented designed and tested for monitoring the quality and safety of typical foods, namely the extra virgin olive oil, the beer, and the milk. Scattered colorimetry is used for the authentication of various types of extra virgin olive oil and beer, while a fiber-optic-based device for UV-VIS-NIR absorption spectroscopy is exploited in order to obtain the hyperspectral optical signature of olive oil. This is done not only for authentication purposes, but also so as to correlate the spectral data with the content of fatty acids that are important nutritional factors. A micro-optic sensor for the detection of olive oil aroma is presented. It is capable of distinguishing different ageing levels of extra virgin olive oil. It shows effective potential for acting as a smart cap of bottled olive oil in order to achieve a non-destructive olfactory perception of oil ageing. Lastly, a compact portable fluorometer is experimented for the rapid monitoring of the carcinogenic M1 aflatoxin in milk.

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...

[Biological agents].

Science.gov (United States)

Amano, Koichi

2009-03-01

There are two types of biological agents for the treatment of rheumatoid arthritis (RA); monoclonal antibodies and recombinant proteins. Among the latter, etanercept, a recombinant fusion protein of soluble TNF receptor and IgG was approved in 2005 in Japan. The post-marketing surveillance of 13,894 RA patients revealed the efficacy and safety profiles of etanercept in the Japanese population, as well as overseas studies. Abatacept, a recombinant fusion protein of CTLA4 and IgG, is another biological agent for RA. Two clinical trials disclosed the efficacy of abatacept for difficult-to-treat patients: the AIM for MTX-resistant cases and the ATTAIN for patients who are resistant to anti-TNF. The ATTEST trial suggested abatacept might have more acceptable safety profile than infliximab. These biologics are also promising for the treatment of RA for not only relieving clinical symptoms and signs but retarding structural damage.

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.

An Overview of Biofield Devices

Science.gov (United States)

Muehsam, David; Chevalier, Gaétan; Barsotti, Tiffany

2015-01-01

Advances in biophysics, biology, functional genomics, neuroscience, psychology, psychoneuroimmunology, and other fields suggest the existence of a subtle system of “biofield” interactions that organize biological processes from the subatomic, atomic, molecular, cellular, and organismic to the interpersonal and cosmic levels. Biofield interactions may bring about regulation of biochemical, cellular, and neurological processes through means related to electromagnetism, quantum fields, and perhaps other means of modulating biological activity and information flow. The biofield paradigm, in contrast to a reductionist, chemistry-centered viewpoint, emphasizes the informational content of biological processes; biofield interactions are thought to operate in part via low-energy or “subtle” processes such as weak, nonthermal electromagnetic fields (EMFs) or processes potentially related to consciousness and nonlocality. Biofield interactions may also operate through or be reflected in more well-understood informational processes found in electroencephalographic (EEG) and electrocardiographic (ECG) data. Recent advances have led to the development of a wide variety of therapeutic and diagnostic biofield devices, defined as physical instruments best understood from the viewpoint of a biofield paradigm. Here, we provide a broad overview of biofield devices, with emphasis on those devices for which solid, peer-reviewed evidence exists. A subset of these devices, such as those based upon EEG- and ECG-based heart rate variability, function via mechanisms that are well understood and are widely employed in clinical settings. Other device modalities, such a gas discharge visualization and biophoton emission, appear to operate through incompletely understood mechanisms and have unclear clinical significance. Device modes of operation include EMF-light, EMF-heat, EMF-nonthermal, electrical current, vibration and sound, physical and mechanical, intentionality and nonlocality

[Knowledge and adherence to bio-safety measures and biological accidents by nursing students during their clinical practice].

Science.gov (United States)

Merino-de la Hoz, Felicitas; Durá-Ros, María Jesús; Rodríguez-Martín, Elías; González-Gómez, Silvia; Mariano López-López, Luis; Abajas-Bustillo, Rebeca; de la Horra-Gutiérrez, Inmaculada

2010-01-01

To identify the degree of knowledge and performance of bio-safety measures by nursing students and knowing the type of biological accidents suffered during their clinical practice. A cross-sectional study was conducted on the students of three Nursing courses held in May of 2008. Data was collected by an anonymous self-administered questionnaire, with a return of 54%. A total of 97% of students seemed to know the standard biosafety measures, and all of them (100%) stated that those measures must be applied to every patient. However, the reality of clinical practice shows that biosafety measures are only partially applied. An average of 60.2% implement the personal hygiene measures, 66.1% use physical barriers, and 44% use sharp materials safely. Around 32.25% of the students have suffered some biological accident, with a greater incidence in the second year: administering injections (24%), drawing blood samples with Venojet needles (18%) and recapping used needles (17%). The high level of knowledge shown by the students on standard precautions is not always shown in clinical practice. There are significant deficiencies in student safety practices: recapping of used needles continues to be one of the most common risk practices carried out. Copyright (c) 2009 Elsevier España, S.L. All rights reserved.

30 CFR 57.9306 - Warning devices for restricted clearances.

Science.gov (United States)

2010-07-01

... AND NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-UNDERGROUND METAL AND NONMETAL MINES Loading, Hauling, and Dumping Safety Devices, Provisions, and Procedures for Roadways, Railroads, and...

Safety-related control air systems - approved 1977

International Nuclear Information System (INIS)

Anon.

1978-01-01

This standard applies to those portions of the control air system that furnish air required to support, control, or operate systems or portions of systems that are safety related in nuclear power plants. This standard relates only to the air supply system(s) for safety-related air operated devices and does not apply to the safety-related air operated device or to air operated actuators for such devices. The objectives of this standard are to provide (1) minimum system design requirements for equipment, piping, instruments, controls, and wiring that constitute the air supply system; and (2) the system and component testing and maintenance requirements

Patent foramen ovale closure using a bioabsorbable closure device: safety and efficacy at 6-month follow-up.

Science.gov (United States)

Van den Branden, Ben J; Post, Martijn C; Plokker, Herbert W; ten Berg, Jurriën M; Suttorp, Maarten J

2010-09-01

The aim of this study was to assess the mid-term safety and efficacy of percutaneous patent foramen ovale (PFO) closure using a bioabsorbable device (BioSTAR, NMT Medical, Boston, Massachusetts). Closure of PFO in patients with cryptogenic stroke has proven to be safe and effective using different types of permanent devices. All consecutive patients who underwent percutaneous PFO closure with the bioabsorbable closure device between November 2007 and January 2009 were included. Residual shunt was assessed using contrast transthoracic echocardiography. Sixty-two patients (55% women, mean age 47.7 ± 11.8 years) underwent PFO closure. The in-hospital complications were a surgical device retrieval in 2 patients (3.2%), device reposition in 1 (1.6%), and a minimal groin hematoma in 6 patients (9.7%). The short-term complications at 1-month follow-up (n = 60) were a transient ischemic attack in the presence of a residual shunt in 1 patient and new supraventricular tachycardia in 7 patients (11.3%). At 6-month follow-up (n = 60), 1 patient without residual shunt developed a transient ischemic attack and 1 developed atrial fibrillation. A mild or moderate residual shunt was noted in 51.7%, 33.9%, and 23.7% after 1-day, 1-month, and 6-month follow-up, respectively. A large shunt was present in 8.3%, 3.4%, and 0% after 1-day, 1-month, and 6-month follow-up. Closure of PFO using the bioabsorbable device is associated with a low complication rate and a low recurrence rate of embolic events. However, a relatively high percentage of mild or moderate residual shunting is still present at 6-month follow-up. Copyright © 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

The Safety of Using High Frequency, Low Intensity Ultrasound to Enhance Thrombolysis

International Nuclear Information System (INIS)

Soltani, Azita

2006-01-01

The EKOS Ultrasound Infusion Systems (EKOS Corporation, Bothell, WA) use high frequency, low intensity ultrasound to accelerate thrombolysis by enhancing clot permeability and lytic drug penetration into thrombus. These systems are designed to provide efficacious catheter-directed treatment for the management of stroke, peripheral arterial occlusion and deep vein thrombosis. The in vitro and in vivo results of investigating the stability of therapeutic and diagnostic compounds used in combination with EKOS devices, the potential for adverse biological effects and the clot fragmentation confirmed the safety of EKOS ultrasound infusion systems in thrombolysis treatment

Ontology-supported research on vaccine efficacy, safety and integrative biological networks.

Science.gov (United States)

He, Yongqun

2014-07-01

While vaccine efficacy and safety research has dramatically progressed with the methods of in silico prediction and data mining, many challenges still exist. A formal ontology is a human- and computer-interpretable set of terms and relations that represent entities in a specific domain and how these terms relate to each other. Several community-based ontologies (including Vaccine Ontology, Ontology of Adverse Events and Ontology of Vaccine Adverse Events) have been developed to support vaccine and adverse event representation, classification, data integration, literature mining of host-vaccine interaction networks, and analysis of vaccine adverse events. The author further proposes minimal vaccine information standards and their ontology representations, ontology-based linked open vaccine data and meta-analysis, an integrative One Network ('OneNet') Theory of Life, and ontology-based approaches to study and apply the OneNet theory. In the Big Data era, these proposed strategies provide a novel framework for advanced data integration and analysis of fundamental biological networks including vaccine immune mechanisms.

Biological Responses to Materials

Science.gov (United States)

Anderson, James M.

2001-08-01

All materials intended for application in humans as biomaterials, medical devices, or prostheses undergo tissue responses when implanted into living tissue. This review first describes fundamental aspects of tissue responses to materials, which are commonly described as the tissue response continuum. These actions involve fundamental aspects of tissue responses including injury, inflammatory and wound healing responses, foreign body reactions, and fibrous encapsulation of the biomaterial, medical device, or prosthesis. The second part of this review describes the in vivo evaluation of tissue responses to biomaterials, medical devices, and prostheses to determine intended performance characteristics and safety or biocompatibility considerations. While fundamental aspects of tissue responses to materials are important from research and development perspectives, the in vivo evaluation of tissue responses to these materials is important for performance, safety, and regulatory reasons.

Treating moderate to severe psoriasis - best use of biologics.

LENUS (Irish Health Repository)

Lynch, Maeve

2014-02-01

This review focuses on the efficacy, safety and best use of biologic agents in moderate-to-severe psoriasis. Recommendations from two recent guidelines are summarised. The NICE Guidelines 2012 provide recommendations on best practice for prescribing biologics. The German S3 Guidelines are based on a systematic review of published studies and report the efficacy of biologics and guidelines for treatment. Data on the safety of biologics are available for up to 5 years in psoriasis and are on the whole reassuring. Registry data is evolving and will provide data on safety to help inform long-term monitoring of patients with psoriasis on biologics agents. New anti-interleukin-17 (IL17) and anti-IL17RA biologics are in Phase 3 clinical trials and may prove to be more effective than existing biologics.

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.

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...

Biological agents in polyarticular juvenile idiopathic arthritis

DEFF Research Database (Denmark)

Amarilyo, Gil; Tarp, Simon; Foeldvari, Ivan

2016-01-01

BACKGROUND AND OBJECTIVE: Although various biological agents are in use for polyarticular juvenile idiopathic arthritis (pJIA), head-to-head trials comparing the efficacy and safety among them are lacking. We aimed to compare the efficacy and safety of biological agents in pJIA using all currently...

3D printing functional materials and devices (Conference Presentation)

Science.gov (United States)

McAlpine, Michael C.

2017-05-01

The development of methods for interfacing high performance functional devices with biology could impact regenerative medicine, smart prosthetics, and human-machine interfaces. Indeed, the ability to three-dimensionally interweave biological and functional materials could enable the creation of devices possessing unique geometries, properties, and functionalities. Yet, most high quality functional materials are two dimensional, hard and brittle, and require high crystallization temperatures for maximal performance. These properties render the corresponding devices incompatible with biology, which is three-dimensional, soft, stretchable, and temperature sensitive. We overcome these dichotomies by: 1) using 3D printing and scanning for customized, interwoven, anatomically accurate device architectures; 2) employing nanotechnology as an enabling route for overcoming mechanical discrepancies while retaining high performance; and 3) 3D printing a range of soft and nanoscale materials to enable the integration of a diverse palette of high quality functional nanomaterials with biology. 3D printing is a multi-scale platform, allowing for the incorporation of functional nanoscale inks, the printing of microscale features, and ultimately the creation of macroscale devices. This three-dimensional blending of functional materials and `living' platforms may enable next-generation 3D printed devices.

Safety Evakuation Of Triga-2000 Reactor Operation Viewed From Safety Culture

International Nuclear Information System (INIS)

Karliana, Itjeu

2001-01-01

The safety evaluation activities of TRIGA-2000 operation viewed from safety culture performed by questioners data collected from the operators and supervisor site of TRIGA-2000 P3TN, Bandung. There are 9 activity aspects surveyed, for instant to avail the policy of safety from their chairman, safety management, education and training, emergency aids planning, safety consultancy, accident information, safety analysis, safety devices, safety and occupational health. The surveying undertaken by filling the questioner that containing of 9 activity aspects and 20 samples of employees. The safety evaluation results' of the operation personnel in TRIGA-2000 P3TN are good implemented by both the operators and supervisors should be improve and attention need to provide the equipment's. The education and training especially for safety refreshment must be performing

Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microbial Pathogen Nucleic Acids in Cerebrospinal Fluid. Final order.

Science.gov (United States)

2017-10-20

The Food and Drug Administration (FDA or we) is classifying the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid into class II (special controls). The special controls that will apply to the device type are identified in this order and will be part of the codified language for the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid’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.

Safety in the Utilization and Modification of Research Reactors. Specific Safety Guide

Energy Technology Data Exchange (ETDEWEB)

NONE

2012-07-15

This Safety Guide is a revision of Safety Series No. 35-G2 on safety in the utilization and modification of research reactors. It provides recommendations on meeting the requirements for the categorization, safety assessment and approval of research reactor experiments and modification projects. Specific safety considerations in different phases of utilization and modification projects are covered, including the pre-implementation, implementation and post-implementation phases. Guidance is also provided on the operational safety of experiments, including in the handling, dismantling, post-irradiation examination and disposal of experimental devices. Examples of the application of the safety categorization process for experiments and modification projects and of the content of the safety analysis report for an experiment are also provided. Contents: 1. Introduction; 2. Management system for the utilization and modification of a research reactor; 3. Categorization, safety assessment and approval of an experiment or modification; 4. Safety considerations for the design of an experiment or modification; 5. Pre-implementation phase of a modification or utilization project; 6. Implementation phase of a modification or utilization project; 7. Post-implementation phase of a utilization or modification project; 8. Operational safety of experiments at a research reactor; 9. Safety considerations in the handling, dismantling, post-irradiation examination and disposal of experimental devices; 10. Safety aspects of out-of-reactor-core installations; Annex I: Example of a checklist for the categorization of an experiment or modification at a research reactor; Annex II: Example of the content of the safety analysis report for an experiment at a research reactor; Annex III: Examples of reasons for a modification at a research reactor.

Safety in the Utilization and Modification of Research Reactors. Specific Safety Guide

International Nuclear Information System (INIS)

2012-01-01

This Safety Guide is a revision of Safety Series No. 35-G2 on safety in the utilization and modification of research reactors. It provides recommendations on meeting the requirements for the categorization, safety assessment and approval of research reactor experiments and modification projects. Specific safety considerations in different phases of utilization and modification projects are covered, including the pre-implementation, implementation and post-implementation phases. Guidance is also provided on the operational safety of experiments, including in the handling, dismantling, post-irradiation examination and disposal of experimental devices. Examples of the application of the safety categorization process for experiments and modification projects and of the content of the safety analysis report for an experiment are also provided. Contents: 1. Introduction; 2. Management system for the utilization and modification of a research reactor; 3. Categorization, safety assessment and approval of an experiment or modification; 4. Safety considerations for the design of an experiment or modification; 5. Pre-implementation phase of a modification or utilization project; 6. Implementation phase of a modification or utilization project; 7. Post-implementation phase of a utilization or modification project; 8. Operational safety of experiments at a research reactor; 9. Safety considerations in the handling, dismantling, post-irradiation examination and disposal of experimental devices; 10. Safety aspects of out-of-reactor-core installations; Annex I: Example of a checklist for the categorization of an experiment or modification at a research reactor; Annex II: Example of the content of the safety analysis report for an experiment at a research reactor; Annex III: Examples of reasons for a modification at a research reactor.

Ultra-thin titanium nanolayers for plasmon-assisted enhancement of bioluminescence of chloroplast in biological light emitting devices

Energy Technology Data Exchange (ETDEWEB)

Hsun Su, Yen [Department of Materials Science and Engineering, National Cheng Kung University, Tainan 70101, Taiwan (China); Advanced Optoelectronic Technology Center, National Cheng Kung University, Tainan 70101, Taiwan (China); Hsu, Chia-Yun; Chang, Chung-Chien [Science and Technology of Accelerator Light Source, Hsinchu 300, Taiwan (China); Department of Materials Science and Engineering, National Chiao Tung University, Hsinchu 300, Taiwan (China); Tu, Sheng-Lung; Shen, Yun-Hwei [Department of Resource Engineering, National Cheng Kung University, Tainan 70101, Taiwan (China)

2013-08-05

Ultra-thin titanium films were deposited via ultra-high vacuum ion beam sputter deposition. Since the asymmetric electric field of the metal foil plane matches the B-band absorption of chlorophyll a, the ultra-thin titanium nanolayers were able to generate surface plasmon resonance, thus enhancing the photoluminescence of chlorophyll a. Because the density of the states of plasmon resonance increases, the enhancement of photoluminescence also rises. Due to the biocompatibility and inexpensiveness of titanium, it can be utilized to enhance the bioluminescence of chloroplast in biological light emitting devices, bio-laser, and biophotonics.

Safety and efficacy of cervical laminoplasty using a piezosurgery device compared with a high-speed drill.

Science.gov (United States)

Li, Kunpeng; Zhang, Wen; Li, Bin; Xu, Hui; Li, Zhong; Luo, Dawei; Zhang, Jingtao; Ma, Jinzhu

2016-09-01

Piezosurgery is a relatively new osteotomy technique using microvibrations of scalpels at ultrasonic frequencies to perform safe and effective osteotomies without damage to adjacent soft tissue, which is widely used in spinal, oral, and maxillofacial surgery. We hypothesized that such a device could also be useful in cervical laminoplasty. The purpose of this study was to compare the safety and efficacy of a piezosurgery device with those of a highspeed drill in cervical laminoplasty. A prospectively randomized clinical study was designed. Forty-two consecutive patients were enrolled in the study. All patients underwent modified expansive open-door laminoplasty and were randomly divided into 2 groups according to the instrument for transection of the lamina, using high-speed drill (drill group) or piezosurgery device (piezosurgery group). The operation time, intraoperative blood loss, and postoperative drainage were recorded. Japanese Orthopedic Association (JOA) score and visual analogue scale (VAS) as clinical assessments were quantified. No significant difference was observed in the operation time between the 2 groups. In the piezosurgery group, there were less loss of the intraoperative blood and postoperative drainage compared with the drill group. However, clinical results (VAS and JOA scores) showed no significant difference between both groups during the all follow-up periods. The piezosurgery is a useful instrument and at least as safe and efficacious as the conventional high-speed drill in cervical laminoplasty.

The Development of Computer Code for Safety Injection Tank (SIT) with Fluidic Device(FD) Blowdown Test

International Nuclear Information System (INIS)

Lee, Joo Hee; Kim, Tae Han; Choi, Hae Yun; Lee, Kwang Won; Chung, Chang Kyu

2007-01-01

Safety Injection Tanks (SITs) with the Fluidic Device (FD) of APR1400 provides a means of rapid reflooding of the core following a large break Loss Of Coolant Accident (LOCA), and keeping it covered until flow from the Safety Injection Pump (SIP) becomes available. A passive FD can provide two operation stages of a safety water injection into the RCS and allow more effective use of borated water in case of LOCA. Once a large break LOCA occurs, the system will deliver a high flow rate of cooling water for a certain period of time, and thereafter, the flow rate is reduced to a lower flow rate. The conventional computer code 'TURTLE' used to simulate the blowdown of OPR1000 SIT can not be directly applied to simulate a blowdown process of the SIT with FD. A new computer code is needed to be developed for the blowdown test evaluation of the APR1400 SIT with FD. Korea Power Engineering Company (KOPEC) has developed a new computer code to analyze the characteristics of the SIT with FD and validated the code through the comparison of the calculation results with the test results obtained by Ulchin 5 and 6 units pre-operational test and VAlve Performance Evaluation Rig (VAPER) tests performed by The Korea Atomic Energy Research Institute (KAERI)

Mammalian synthetic biology for studying the cell.

Science.gov (United States)

Mathur, Melina; Xiang, Joy S; Smolke, Christina D

2017-01-02

Synthetic biology is advancing the design of genetic devices that enable the study of cellular and molecular biology in mammalian cells. These genetic devices use diverse regulatory mechanisms to both examine cellular processes and achieve precise and dynamic control of cellular phenotype. Synthetic biology tools provide novel functionality to complement the examination of natural cell systems, including engineered molecules with specific activities and model systems that mimic complex regulatory processes. Continued development of quantitative standards and computational tools will expand capacities to probe cellular mechanisms with genetic devices to achieve a more comprehensive understanding of the cell. In this study, we review synthetic biology tools that are being applied to effectively investigate diverse cellular processes, regulatory networks, and multicellular interactions. We also discuss current challenges and future developments in the field that may transform the types of investigation possible in cell biology. © 2017 Mathur et al.

The inverted cup device for blood transfer on malaria RDTs: ease of use, acceptability and safety in routine use by health workers in Nigeria.

Science.gov (United States)

Incardona, Sandra; Mwancha-Kwasa, Magoma; Rees-Channer, Roxanne R; Albertini, Audrey; Havumaki, Joshua; Chiodini, Peter; Oyibo, Wellington; Gonzalez, Iveth J

2018-01-15

Malaria rapid diagnostic tests (RDTs) are becoming widely adopted for case management at community level. However, reports and anecdotal observations indicate that the blood transfer step poses a significant challenge to many users. This study sought to evaluate the inverted cup device in the hands of health workers in everyday clinical practice, in comparison with the plastic pipette, and to determine the volume accuracy of the device made of a lower-cost plastic. The volume accuracy of inverted cup devices made of two plastics, PMMA and SBC, was compared by transferring blood 150 times onto filter paper and comparing the blood spot areas with those produced by 20 reference transfers with a calibrated micropipette. The ease of use, safety and acceptability of the inverted cup device and the pipette were evaluated by 50 health workers in Nigeria. Observations were recorded on pre-designed questionnaires, by the health workers themselves and by trained observers. Focus group discussions were also conducted. The volume accuracy assessment showed that the device made from the low-cost material (SBC) delivered a more accurate volume (mean 5.4 μL, SD 0.48 μL, range 4.5-7.0 μL) than the PMMA device (mean 5.9 μL, SD 0.48 μL, range 4.9-7.2 μL). The observational evaluation demonstrated that the inverted cup device performed better than the pipette in all aspects, e.g. higher proportions of health workers achieved successful blood collection (96%, vs. 66%), transfer of the required blood volume (90%, vs. 58%), and blood deposit without any loss (95%, vs. 50%). Majority of health workers also considered it' very easy' to use (81%),'very appropriate' for everyday use (78%), and 50% of them reported that it was their preferred BTD. The good volume accuracy and high acceptability of the inverted cup device shown in this study, along with observed ease of use and safety in hands of health workers, further strengthens prior findings which demonstrated its higher

Components for containment enclosures. Part 4: Ventilation and gas-cleaning systems such as filters, traps, safety and regulation valves, control and protection devices

International Nuclear Information System (INIS)

2001-01-01

ISO 11933 consists of the following parts, under the general title Components for containment enclosures: Part 1: Glove/bag ports, bungs for glove/bag ports, enclosure rings and interchangeable units; Part 2: Gloves, welded bags, gaiters for remote-handling tongs and for manipulators; Part 3: Transfer systems such as plain doors, airlock chambers, double door transfer systems, leaktight connections for waste drums; Part 4: Ventilation and gas-cleaning systems such as filters, traps, safety and regulation valves, control and protection devices; Part 5: Penetrations for electrical and fluid circuits. This part of ISO 11933 specifies the design criteria and the characteristics of various components used for ventilation and gas-cleaning in containment enclosures. These components are either directly fixed to the containment enclosure wall, or used in the environment of a shielded or unshielded containment enclosure or line of such enclosures. They can be used alone or in conjunction with other mechanical components, including those specified in ISO 11933-1 and ISO 11933-3. This part of ISO 11933 is applicable to: filtering devices, including high-efficiency particulate air (HEPA) filters and iodine traps; safety valves and pressure regulators; systems ensuring the mechanical protection of containment enclosures; control and pressure-measurement devices

Review of the ethnobotany, chemistry, biological activity and safety of the botanical dietary supplement Morinda citrifolia (noni).

Science.gov (United States)

Pawlus, Alison D; Kinghorn, Douglas A

2007-12-01

Morinda citrifolia, commonly called noni, has a long history as a medicinal plant and its use as a botanical dietary supplement has grown tremendously in recent years. This has prompted a concomitant increase in research on the phytochemical constituents and biological activity of noni. A relatively large number of scientific publications on noni have been published in recent years, including a number of review articles. The goals of this review are to provide an updated categorization of the phytochemical constituents found in noni and to provide perspective for its extensive utilization as a major botanical dietary supplement. Included herein are a comprehensive list of known ethnobotanical uses and common names of M. citrifolia, a brief summary of relevant biological studies and a discussion of the safety of noni as a supplement.

Expediting Clinician Adoption of Safety Practices: The UCSF Venous Access Patient Safety Interdisciplinary Education Project

National Research Council Canada - National Science Library

Donaldson, Nancy E; Plank, Rosemary K; Williamson, Ann; Pearl, Jeffrey; Kellogg, Jerry; Ryder, Marcia

2005-01-01

...) Venous Access Device (VAD) Patient Safety Interdisciplinary Education Project was to develop a 30-hour/one clinical academic unit VAD patient safety course with the aim of expediting clinician adoption of critical concepts...

Neutronic, thermal-hydraulics and safety calculations of a Miniplate Irradiation Device (MID) of dispersion type fuel elements

International Nuclear Information System (INIS)

Domingos, Douglas Borges

2010-01-01

Neutronic, thermal-hydraulics and accident analysis calculations were developed to estimate the safety of a Miniplate Irradiation Device (MID) to be placed in the IEA-R1 reactor core. The irradiation device is used to receive miniplates of U 3 O 8 -Al and U 3 Si 2 - Al dispersion fuels, LEU type (19.75 % 235 U) with uranium densities of, respectively, 3.2 gU/cm 3 and 4.8 gU/cm 3 . The fuel miniplates will be irradiated to nominal 235 U burnup levels of 50% and 80%, in order to qualify the above high-density dispersion fuels to be used in the Brazilian Multipurpose Reactor (RMB), now in the conception phase. For the neutronic calculation, the computer codes CITATION and 2DB were utilized. The computer code FLOW was used to calculate the coolant flow rate in the irradiation device, allowing the determination of the fuel miniplate temperatures with the computer model MTRCR-IEA-R1. A postulated Loss of Coolant Accident (LOCA) was analyzed with the computer codes LOSS and TEMPLOCA, allowing the calculation of the fuel miniplate temperatures after the reactor pool draining. The calculations showed that the irradiation should occur without adverse consequences in the IEA-R1 reactor. (author)

[Occupational risks among public safety and security forces].

Science.gov (United States)

Candura, S M; Verni, P; Minelli, C M; Rosso, G L; Cappelli, M I; Strambi, S; Martellosio, V

2006-01-01

The present paper tries to identify the occupational risk factors (physical, chemical, biological, psychological), variable depending on jobs and tasks, to which the heterogeneous public safety/security workers are exposed. The fight against criminality and public order maintenance imply (sometimes fatal) traumatic risks, and expose to psychophysical and sensorial tiring, unfavourable macro- and microclimatic conditions, the risk of baropathy (air navigation, underwater activities), noise (generated by firearms and several other sources), vibrations and shakings (automatic weapons, transport vehicles), the risk of electric injury, ionizing (X and gamma rays) and non-inonizing (ultraviolet rays, microwaves and radiofrequencies, electromagnetic fields) radiations. Chemical hazards include carbon monoxide and other combustion products (fires, urban traffic), substances released in chemical accidents, tear gases, lead (firing grounds, metal works, environmental pollution), solvents, lubrificants and cutting oils (mechanic repair and maintenance), laboratory materials and reagents, irritant and/or sensitizing agents contained in gloves. The main biological risks are tetanus, blood-borne diseases (viral hepatitis, AIDS), aerogenous diseases (e.g., tuberculosis, Legionnaire's disease, epidemic cerebrospinal meningitis), dog- or horse-transmitted zoonosis. Finally, emotional, psychosomatic and behavioural stress-related disorders (e.g., burn-out syndrome, post-traumatic stress disorder) are typically frequent. The presence of numerous and diversified hazards among public safety/security forces imposes the adoption of occupational medicine measures, including risk assessment, health education, technical and environmental prevention, personal protective devices, sanitary surveillance and biological monitoring, clinical interventions (diagnosis, therapy and rehabilitation of occupational accidents and illnesses), prompt medico-legal evaluation of occupational

Radiation Safety in Industrial Radiography. Specific Safety Guide

International Nuclear Information System (INIS)

2011-01-01

This Safety Guide provides recommendations for ensuring radiation safety in industrial radiography used in non-destructive testing. This includes industrial radiography work that utilizes X ray and gamma sources, both in shielded facilities that have effective engineering controls and in outside shielded facilities using mobile sources. Contents: 1. Introduction; 2. Duties and responsibilities; 3. Safety assessment; 4. Radiation protection programme; 5. Training and qualification; 6. Individual monitoring of workers; 7. Workplace monitoring; 8. Control of radioactive sources; 9. Safety of industrial radiography sources and exposure devices; 10. Radiography in shielded enclosures; 11. Site radiography; 12. Transport of radioactive sources; 13. Emergency preparedness and response; Appendix: IAEA categorization of radioactive sources; Annex I: Example safety assessment; Annex II: Overview of industrial radiography sources and equipment; Annex III: Examples of accidents in industrial radiography.

Development of Network Protocol for the Integrated Safety System

Energy Technology Data Exchange (ETDEWEB)

Park, S. W.; Baek, J. I.; Lee, S. H.; Park, C. S.; Park, K. H.; Shin, J. M. [Hannam Univ., Daejeon (Korea, Republic of)

2007-06-15

Communication devices in the safety system of nuclear power plants are distinguished from those developed for commercial purposes in terms of a strict requirement of safety. The concept of safety covers the determinability, the reliability, and the separation/isolation to prevent the undesirable interactions among devices. The safety also requires that these properties be never proof less. Most of the current commercialized communication products rarely have the safety properties. Moreover, they can be neither verified nor validated to satisfy the safety property of implementation process. This research proposes the novel architecture and protocol of a data communication network for the safety system in nuclear power plants.

Development of Network Protocol for the Integrated Safety System

International Nuclear Information System (INIS)

Park, S. W.; Baek, J. I.; Lee, S. H.; Park, C. S.; Park, K. H.; Shin, J. M.

2007-06-01

Communication devices in the safety system of nuclear power plants are distinguished from those developed for commercial purposes in terms of a strict requirement of safety. The concept of safety covers the determinability, the reliability, and the separation/isolation to prevent the undesirable interactions among devices. The safety also requires that these properties be never proof less. Most of the current commercialized communication products rarely have the safety properties. Moreover, they can be neither verified nor validated to satisfy the safety property of implementation process. This research proposes the novel architecture and protocol of a data communication network for the safety system in nuclear power plants

Risks of carcinogenesis from electromagnetic radiation of mobile telephony devices.

Science.gov (United States)

Yakymenko, I; Sidorik, E

2010-07-01

Intensive implementation of mobile telephony technology in everyday human life during last two decades has given a possibility for epidemiological estimation of long-term effects of chronic exposure of human organism to low-intensive microwave (MW) radiation. Latest epidemiological data reveal a significant increase in risk of development of some types of tumors in chronic (over 10 years) users of mobile phone. It was detected a significant increase in incidence of brain tumors (glioma, acoustic neuroma, meningioma), parotid gland tumor, seminoma in long-term users of mobile phone, especially in cases of ipsilateral use (case-control odds ratios from 1.3 up to 6.1). Two epidemiological studies have indicated a significant increase of cancer incidence in people living close to the mobile telephony base station as compared with the population from distant area. These data raise a question of adequacy of modern safety limits of electromagnetic radiation (EMR) exposure for humans. For today the limits were based solely on the conception of thermal mechanism of biological effects of RF/MW radiation. Meantime the latest experimental data indicate the significant metabolic changes in living cell under the low-intensive (non-thermal) EMR exposure. Among reproducible biological effects of low-intensive MWs are reactive oxygen species overproduction, heat shock proteins expression, DNA damages, apoptosis. The lack of generally accepted mechanism of biological effects of low-intensive non-ionizing radiation doesn't permit to disregard the obvious epidemiological and experimental data of its biological activity. Practical steps must be done for reasonable limitation of excessive EMR exposure, along with the implementation of new safety limits of mobile telephony devices radiation, and new technological decisions, which would take out the source of radiation from human brain.

Synergistic Synthetic Biology: Units in Concert

Science.gov (United States)

Trosset, Jean-Yves; Carbonell, Pablo

2013-01-01

Synthetic biology aims at translating the methods and strategies from engineering into biology in order to streamline the design and construction of biological devices through standardized parts. Modular synthetic biology devices are designed by means of an adequate elimination of cross-talk that makes circuits orthogonal and specific. To that end, synthetic constructs need to be adequately optimized through in silico modeling by choosing the right complement of genetic parts and by experimental tuning through directed evolution and craftsmanship. In this review, we consider an additional and complementary tool available to the synthetic biologist for innovative design and successful construction of desired circuit functionalities: biological synergies. Synergy is a prevalent emergent property in biological systems that arises from the concerted action of multiple factors producing an amplification or cancelation effect compared with individual actions alone. Synergies appear in domains as diverse as those involved in chemical and protein activity, polypharmacology, and metabolic pathway complementarity. In conventional synthetic biology designs, synergistic cross-talk between parts and modules is generally attenuated in order to verify their orthogonality. Synergistic interactions, however, can induce emergent behavior that might prove useful for synthetic biology applications, like in functional circuit design, multi-drug treatment, or in sensing and delivery devices. Synergistic design principles are therefore complementary to those coming from orthogonal design and may provide added value to synthetic biology applications. The appropriate modeling, characterization, and design of synergies between biological parts and units will allow the discovery of yet unforeseeable, novel synthetic biology applications. PMID:25022769

Synergistic Synthetic Biology: Units in Concert

International Nuclear Information System (INIS)

Trosset, Jean-Yves; Carbonell, Pablo

2013-01-01

Synthetic biology aims at translating the methods and strategies from engineering into biology in order to streamline the design and construction of biological devices through standardized parts. Modular synthetic biology devices are designed by means of an adequate elimination of cross-talk that makes circuits orthogonal and specific. To that end, synthetic constructs need to be adequately optimized through in silico modeling by choosing the right complement of genetic parts and by experimental tuning through directed evolution and craftsmanship. In this review, we consider an additional and complementary tool available to the synthetic biologist for innovative design and successful construction of desired circuit functionalities: biological synergies. Synergy is a prevalent emergent property in biological systems that arises from the concerted action of multiple factors producing an amplification or cancelation effect compared with individual actions alone. Synergies appear in domains as diverse as those involved in chemical and protein activity, polypharmacology, and metabolic pathway complementarity. In conventional synthetic biology designs, synergistic cross-talk between parts and modules is generally attenuated in order to verify their orthogonality. Synergistic interactions, however, can induce emergent behavior that might prove useful for synthetic biology applications, like in functional circuit design, multi-drug treatment, or in sensing and delivery devices. Synergistic design principles are therefore complementary to those coming from orthogonal design and may provide added value to synthetic biology applications. The appropriate modeling, characterization, and design of synergies between biological parts and units will allow the discovery of yet unforeseeable, novel synthetic biology applications.

Device for analyzing a solution

International Nuclear Information System (INIS)

Marchand, Joseph.

1978-01-01

The device enables a solution containing an antigen to be analyzed by the radio-immunology technique without coming up against the problems of antigen-antibody complex and free antigen separation. This device, for analyzing a solution containing a biological compound capable of reacting with an antagonistic compound specific of the biological compound, features a tube closed at its bottom end and a component set and immobilized in the bottom of the tube so as to leave a capacity between the bottom of the tube and its lower end. The component has a large developed surface and is so shaped that it allows the solution to be analyzed to have access to the bottom of the tube; it is made of a material having some elastic deformation and able to take up a given quantity of the biological compound or of the antagonistic compound specific of the biological compound [fr

The first symposium of Research Center for Radiation Safety, NIRS. Perspective of future studies of radiation safety

International Nuclear Information System (INIS)

Shimo, Michikuni

2002-03-01

This paper summarizes presentations given in the title symposium, held at the Conference Room of National Institute of Radiological Sciences (NIRS) on November 29 and 30, 2001. Contained are Introductory remarks: Basic presentations concerning exposure dose in man; Environmental levels of radiation and radioactivity, environmental radon level and exposure dose, and radiation levels in the specific environment (like in the aircraft): Special lecture (biological effects given by space environment) concerning various needs for studies of radiation safety; Requirement for open investigations, from the view of utilization, research and development of atomic energy, from the clinical aspect, and from the epidemiological aspect: Special lecture (safety in utilization of atomic energy and radiation-Activities of Nuclear Safety Commission of Japan) concerning present state and perspective of studies of radiation safety; Safety of radiation and studies of biological effects of radiation-perspective, and radiation protection and radiation safety studies: Studies in the Research Center for Radiation Safety; Summary of studies in the center, studies of the biological effects of neutron beam, carcinogenesis by radiation and living environmental factors-complicated effects, and studies of hereditary effects: Panel discussion (future direction of studies of radiation safety for the purpose of the center's direction): and concluding remarks. (N.I.)

30 CFR 75.320 - Air quality detectors and measurement devices.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Air quality detectors and measurement devices... COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Ventilation § 75.320 Air quality detectors and measurement devices. (a) Tests for methane shall be made by a qualified person with...

Evolution of atherectomy devices.

Science.gov (United States)

Al Khoury, G; Chaer, R

2011-08-01

Percutaneous atherectomy provides an alternative approach to the endovascular treatment of peripheral atherosclerotic occlusive disease beyond angioplasty and stenting, and has the theoretical advantage of lesion debulking and minimizing barotrauma to the vessel wall. Atherectomy has evolved greatly during the last decade, with currently four FDA approved devices for the treatment of peripheral arterial disease. Several reports have focused on the initial technical success rates, and demonstrated the safety and short as well as mid-term efficacy of atherectomy devices. This article will review the evolution of current atherectomy devices and the associated literature.

Innovative safety ideas for fusion experimental machines

International Nuclear Information System (INIS)

Brereton, S.J.; Gouge, M.; Piet, S.J.; Merrill, B.J.; Holland, D.F.; Sze, D.K.

1990-01-01

Throughout the early stages of design of fusion experimental devices, such as ITER, safety experts have worked with designers to incorporate safety features into the design. Recent efforts have focused on passive safety features. Although designs of near-term fusion machines may appear consistent with expected regulatory requirements, the safety characteristics can potentially be more attractive. Here, a variety of suggestions that appear promising in terms of improving safety are given. These include new concepts, innovative technologies, further support of past concepts, and possible modification to operating scenarios. Some technical discussion on the feasibility of the proposals is provided. The ideas are generally conceptual at this stage and require further assessment and development work. However, each has the potential for enhancing the safety of experimental devices. 33 refs., 6 figs., 9 tabs

Feasibility and Safety of Endovascular Stripping of Totally Implantable Venous Access Devices

International Nuclear Information System (INIS)

Heye, Sam; Maleux, Geert; Goossens, G. A.; Vaninbroukx, Johan; Jerôme, M.; Stas, M.

2012-01-01

Purpose: To evaluate the safety and feasibility of percutaneous stripping of totally implantable venous access devices (TIVAD) in case of catheter-related sleeve and to report a technique to free the catheter tip from vessel wall adherence. Materials and Methods: A total of 37 stripping procedures in 35 patients (14 men, 40%, and 21 women, 60%, mean age 53 ± 14 years) were reviewed. Totally implantable venous access devices were implanted because of malignancy in most cases (85.7%). Catheter-related sleeve was confirmed as cause of persistent catheter dysfunction despite instillation of thrombolytics. A technique to mobilize the catheter tip from the vessel wall was used when stripping with the snare catheter was impossible. Technical success, complication rate, and outcome were noted. Results: A total of 55.9% (n = 19) of the 34 technically successful procedures (91.9%) could be done with the snare catheter. In 15 cases (44.1%), additional maneuvers to free the TIVAD’s tip from the vessel wall were needed. Success rate was not significantly lower before (72.4%) than after (96.7%) implementation of the new technique (P = 0.09). No complications were observed. Follow-up was available in 67.6% of cases. Recurrent catheter dysfunction was found in 17 TIVADs (78.3%) at a mean of 137.7 days and a median of 105 days. Conclusions: Stripping of TIVADs is technically feasible and safe, with an overall success rate of 91.9%. Additional endovascular techniques to mobilize the distal catheter tip from the wall of the superior vena cava or right atrium to allow encircling the TIVAD tip with the snare catheter may be needed in 44.1% of cases.

Healthcare Provider Attitudes of Safety of Intrauterine Devices in the Postpartum Period.

Science.gov (United States)

Rauh-Benoit, Lisa A; Tepper, Naomi K; Zapata, Lauren B; Whiteman, Maura K; Curtis, Kathryn M; Mandel, Michele G; Marchbanks, Polly A; Jamieson, Denise J

2017-07-01

Immediate postpartum intrauterine devices (IUDs) have been underutilized in the United States despite their known safety. Understanding how providers' attitudes contribute to underutilization is important in improving access. Our objective was to examine healthcare providers' perceptions of the safety of immediate postpartum IUDs before publication of United States contraceptive guidelines. We analyzed survey data collected from December 2009 to March 2010 from 635 office-based physicians and 1368 Title X clinic providers (overall response rate of 64.8%). Providers were asked how safe they thought copper and levonorgestrel (LNG) IUDs were in postpartum women (very safe, safe, unsafe, very unsafe, and unsure). Multivariable logistic regression was used to calculate adjusted odds ratios (aORs) and 95% confidence intervals (95% CIs) for characteristics associated with considering immediate and delayed postpartum IUDs to be safe. Less than 40% of respondents considered immediate or delayed IUD insertion to be safe. Providers with postpartum IUD insertion to be safe compared with unsafe/unsure (aOR 0.18, 95% CI 0.04-0.84 for copper IUD and aOR 0.17, 95% CI 0.04-0.81 for LNG-IUD). Providers without training in postpartum or interval copper IUD insertion had decreased odds of considering immediate postpartum copper IUD insertion (aOR 0.40, 95% CI 0.16-0.79) and delayed postpartum insertion for both IUD types to be safe (aOR 0.34, 95% CI 0.18-0.66 for copper IUD and aOR 0.41, 95% CI 0.21-0.77 for LNG-IUD). Before United States contraceptive guidelines, a majority of providers perceived immediate postpartum IUDs to be unsafe.

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.

Efficiency and safety of bipolar vessel and tissue sealing in visceral surgery.

Science.gov (United States)

Overhaus, Marcus; Schaefer, Nico; Walgenbach, Klaus; Hirner, Andreas; Szyrach, Mara Natascha; Tolba, René Hany

2012-11-01

The aim of this study was to analyze the efficiency and safety of the bipolar tissue/vessel sealing and cutting device EnSeal(™) in comparison to the conventional clamp and ligation technique in visceral surgery. In an acute animal model, a part of the small bowel, a part of the colon and the kidneys were resected either with the conventional clamp and ligation technique or with EnSeal(™). Operation time, blood loss and blood parameters as well as the lateral thermal spread were evaluated. Small bowel, colon and kidney resection time with the EnSeal(™) device was shorter compared to the conventional clamp and ligation technique (small bowel: EnSeal(™): 4.7 ± 1.0 min vs. con: 35.1 ± 2.3 min; colon: EnSeal(™): 7.0 ± 1.4 min vs. con: 16.3 ± 1.5 min, kidney: EnSeal(™): 5.7 ± 1.3 min vs. con: 16.7 ± 3.7 min, p surgery with EnSeal(™) can be performed more efficiently in a shorter time, with significantly less blood loss, minimal thermal damage and without changes of blood parameters, indicating biological safety and integrity.

47 CFR 95.1125 - RF safety.

Science.gov (United States)

2010-10-01

... 47 Telecommunication 5 2010-10-01 2010-10-01 false RF safety. 95.1125 Section 95.1125 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO SERVICES Wireless Medical Telemetry Service (WMTS) General Provisions § 95.1125 RF safety. Portable devices...

ACED devices and SECAF supports for the control of structure, pipe network and equipment behaviour at seismic movements in order to enhance the safety margin

International Nuclear Information System (INIS)

Serban, Viorel; Prisecaru, I.; Cretu, D.; Moldoveanu, T.

2002-01-01

In order to enhance the safety margin of structure, pipe networks and equipment associated to the existing NPPs, the classic consolidation solutions are very expensive and many times, impossible to be implemented. Structures, pipe networks, systems and equipment have geometries imposed by the basic construction requirements, operating and safety requirements and their modifications is not always possible. In order to enhance the strength capacity of (new or old) structures, systems and equipment mechanical devices with controlled elasticity and damping (ACED) have been designed, constructed and experimented. These devices are capable to support very large static loads over which dynamic loads (shock, vibration and seismic movements) overlap (which are damped). To increase the strength capacity of (new or existing) pipe networks and equipment connecting with pipes, SECAF supports that allow displacements from thermal expansions with low reaction force have been designed, constructed and experimented. SECAF supports are capable elastically to take permanent loads over which shocks, vibrations and seismic movements (which are damp) overlap. ACED devices and SECAF supports can be used to rehabilitate the existing NPPs with law financial costs and an increase of their strength capacity up to 100% under seismic movements, shocks and vibrations. ACED devices and SECAF supports do not require maintenance, are not affected by presence of a radiation field and their estimated service-life is similar to the NPPs

Research on condensed matter and atomic physics using major experimental facilities and devices: Physics, chemistry, biology. Reports on results. Vol. 3. 4. Chemistry. 5. Biology. 6. Development of methods and instruments

International Nuclear Information System (INIS)

1993-01-01

This report in three volumes substantiates the contents of the programme survey published in September 1989. The progress reports cover the following research areas: Vol. I, (1). Atomic and molecular physics - free atoms, molecules, macromolecules, clusters, matrix-isolated atoms and molecules. (2) Physics and chemistry of surfaces and interfaces - epitaxy, surface structure, adsorption, electrical, magnetic, and optical properties, thin films, synthetic layer structure. Vol. II, (3). Solid-state physics, and materials science -structural research, lattice dynamics, magnetic structure and dynamics, electronic states; load; spin and pulse density fluctuations; diffusion and internal motion, defects, unordered systems and liquids. Vol. III, (4). Chemistry - bonding and structure, kinetics and reaction mechanisms, polymer research, analysis and synthesis. (5). Biology, - structure and dynamics of biological macromolecules, membrane and cell biology. (6) Development of methods and instruments - neutron sources, synchrotron sources, special accelerators, research with interlinked systems and devices. (orig.) [de

Medical devices; immunology and microbiology devices; classification of nucleic acid-based devices for the detection of Mycobacterium tuberculosis complex and the genetic mutations associated with antibiotic resistance. Final order.

Science.gov (United States)

2014-10-22

The Food and Drug Administration (FDA) is classifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens devices into class II (special controls). The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.

Safety implications of a graphite oxidation accident in the compact ignition tokamak device

International Nuclear Information System (INIS)

Merrill, B.J.; O'Brien, M.H.

1989-01-01

This paper addresses the possible safety consequences of an air ingress accident for the Compact Ignition Tokamak (CIT) device. An experimental program was undertaken to determine oxidation rates of four nuclear grade graphites in air at temperatures ranging from 800 to 1800 C and flow velocities from 3 to 7 m/s. On the basis of these test results, an analytic model was developed to assess the extent of first wall/divertor protective tile oxidation and the amount of energy released from this oxidation. For CIT, a significant restriction to vacuum vessel air inflow will be provided by the air seals and walls of the surrounding test cells. Under these conditions, the graphite oxidation reaction inside the vacuum vessel will become oxygen starved within minutes of the onset of this event. Since significant oxidation rates were not achieved, the heat release did not elevate structural temperatures to levels of concern with regard to activated material release. 7 refs., 9 figs

[Prevention of medical device-related adverse events in hospitals: Specifying the recommendations of the German Coalition for Patient Safety (APS) for users and operators of anaesthesia equipment].

Science.gov (United States)

Bohnet-Joschko, Sabine; Zippel, Claus; Siebert, Hartmut

2015-01-01

The use and organisation of medical technology has an important role to play for patient and user safety in anaesthesia. Specification of the recommendations of the German Coalition for Patient Safety (APS) for users and operators of anaesthesia equipment, explore opportunities and challenges for the safe use and organisation of anaesthesia devices. We conducted a literature search in Medline/PubMed for studies dealing with the APS recommendations for the prevention of medical device-related risks in the context of anaesthesia. In addition, we performed an internet search for reports and recommendations focusing on the use and organisation of medical devices in anaesthesia. Identified studies were grouped and assigned to the recommendations. The division into users and operators was maintained. Instruction and training in anaesthesia machines is sometimes of minor importance. Failure to perform functional testing seems to be a common cause of critical incidents in anaesthesia. There is a potential for reporting to the federal authority. Starting points for the safe operation of anaesthetic devices can be identified, in particular, at the interface of staff, organisation, and (anaesthesia) technology. The APS recommendations provide valuable information on promoting the safe use of medical devices and organisation in anaesthesia. The focus will be on risks relating to the application as well as on principles and materials for the safe operation of anaesthesia equipment. Copyright © 2015. Published by Elsevier GmbH.

Psoriasis : implications of biologics

NARCIS (Netherlands)

Lecluse, L.L.A.

2010-01-01

Since the end of 2004 several specific immunomodulating therapies: ‘biologic response modifiers’ or ‘biologics’ have been registered for moderate to severe psoriasis in Europe. This thesis is considering the implications of the introduction of the biologics for psoriasis patients, focusing on safety

Safety in the Internet

Directory of Open Access Journals (Sweden)

Semenko T.V.

2016-11-01

Full Text Available the modern world is the world of computer technology, and the children living in this world feel comfortable in it, they master the computer, mobile devices, new-fangled gadgets easily and use them skillfully. However, their knowledge of the safety in the Internet lags behind their ability to develop new devices. The number of the Internet users is increased every year, so the problem of children safety in the Internet is very urgent. It is necessary for parents, educators and teachers to conduct explanatory conversations and activities for explanation and consolidation the rules of “The Safe Internet”.

Assisting the older driver : intersection design and in-car devices to improve the safety of the older driver. Proefschrift Rijksuniversiteit Groningen RUG, Groningen.

NARCIS (Netherlands)

Davidse, R.J.

2007-01-01

In this thesis, the main focus was on assistive devices that may improve and prolong the safe mobility of older drivers. Older drivers form a group of road users that is getting more and more attention in road safety research and policy. An important reason for this growing interest is the increase

A Wii-controlled safety device for electric chainsaws

Directory of Open Access Journals (Sweden)

R. Gubiani

2013-09-01

Full Text Available Forestry continues to represent one of the most hazardous economic sectors of human activity, and historically, the operation of chainsaws has mainly been restricted to professional lumberjacks. In recent years, because of low cost, chainsaws have become popular among unprofessionals, e.g. for cutting firewood and trimming trees. Serious or lethal lesions due to the use of chainsaws or electric chainsaws are often observed by traumatologists or forensic pathologists. Such serious accidents often occur during occupational activities and are essentially due to kickback or uncorrected use of the tool, or when the operator falls down losing the control of the implement. A new device in order to stop a cutting chain was developed and adapted to an electric chainsaw. The device is based on a Wiimote controller (Nintendo™, including two accelerometers and two gyroscopes for detecting rotation and inclination. A Bluetooth wireless technology is used to transfer data to a portable computer. The data collected about linear and angular acceleration are filtered by an algorithm, based on the Euclid norm, capable to distinguishing between normal movements and dangerous chainsaw movements. The result show a good answer to device and when happen a dangerous situation an alarm signal is sent back to the implement in order to stop the cutting chain. The device show a correct behavior in tested dangerous situations and is envisaged to extend to combustion engine chainsaws, as well as to other portable equipment used in agriculture and forestry operations and for this objectives were patented.

Methods for open innovation on a genome-design platform associating scientific, commercial, and educational communities in synthetic biology.

Science.gov (United States)

Toyoda, Tetsuro

2011-01-01

Synthetic biology requires both engineering efficiency and compliance with safety guidelines and ethics. Focusing on the rational construction of biological systems based on engineering principles, synthetic biology depends on a genome-design platform to explore the combinations of multiple biological components or BIO bricks for quickly producing innovative devices. This chapter explains the differences among various platform models and details a methodology for promoting open innovation within the scope of the statutory exemption of patent laws. The detailed platform adopts a centralized evaluation model (CEM), computer-aided design (CAD) bricks, and a freemium model. It is also important for the platform to support the legal aspects of copyrights as well as patent and safety guidelines because intellectual work including DNA sequences designed rationally by human intelligence is basically copyrightable. An informational platform with high traceability, transparency, auditability, and security is required for copyright proof, safety compliance, and incentive management for open innovation in synthetic biology. GenoCon, which we have organized and explained here, is a competition-styled, open-innovation method involving worldwide participants from scientific, commercial, and educational communities that aims to improve the designs of genomic sequences that confer a desired function on an organism. Using only a Web browser, a participating contributor proposes a design expressed with CAD bricks that generate a relevant DNA sequence, which is then experimentally and intensively evaluated by the GenoCon organizers. The CAD bricks that comprise programs and databases as a Semantic Web are developed, executed, shared, reused, and well stocked on the secure Semantic Web platform called the Scientists' Networking System or SciNetS/SciNeS, based on which a CEM research center for synthetic biology and open innovation should be established. Copyright © 2011 Elsevier Inc

Texas curve margin of safety.

Science.gov (United States)

2013-01-01

This software can be used to assist with the assessment of margin of safety for a horizontal curve. It is intended for use by engineers and technicians responsible for safety analysis or management of rural highway pavement or traffic control devices...

30 CFR 57.19006 - Automatic hoist braking devices.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Automatic hoist braking devices. 57.19006 Section 57.19006 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND... Hoisting Hoists § 57.19006 Automatic hoist braking devices. Automatic hoists shall be provided with devices...

30 CFR 56.19006 - Automatic hoist braking devices.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Automatic hoist braking devices. 56.19006 Section 56.19006 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND... Hoisting Hoists § 56.19006 Automatic hoist braking devices. Automatic hoists shall be provided with devices...

Overview of Robotic Devices for Nursing Care Project.

Science.gov (United States)

Hirukawa, Hirohisa

2017-01-01

METI/AMED are conducting a project on the development and deployment of robotic devices for nursing care to enhance the autonomy of elderly persons and assist care givers. An evaluation protocol is presented and the devices developed in the project are introduced. The devices consist of transfer assist devices (wearable/non-wearable), walking assist devices (outdoor/indoor), safety surveillance sensors (nursing home/private home), bath lift and toilet assist.

Cybersecurity for Connected Diabetes Devices.

Science.gov (United States)

Klonoff, David C

2015-04-16

Diabetes devices are increasingly connected wirelessly to each other and to data-displaying reader devices. Threats to the accurate flow of information and commands may compromise the function of these devices and put their users at risk of health complications. Sound cybersecurity of connected diabetes devices is necessary to maintain confidentiality, integrity, and availability of the data and commands. Diabetes devices can be hacked by unauthorized agents and also by patients themselves to extract data that are not automatically provided by product software. Unauthorized access to connected diabetes devices has been simulated and could happen in reality. A cybersecurity standard designed specifically for connected diabetes devices will improve the safety of these products and increase confidence of users that the products will be secure. © 2015 Diabetes Technology Society.

Streamline-based microfluidic device

Science.gov (United States)

Tai, Yu-Chong (Inventor); Zheng, Siyang (Inventor); Kasdan, Harvey (Inventor)

2013-01-01

The present invention provides a streamline-based device and a method for using the device for continuous separation of particles including cells in biological fluids. The device includes a main microchannel and an array of side microchannels disposed on a substrate. The main microchannel has a plurality of stagnation points with a predetermined geometric design, for example, each of the stagnation points has a predetermined distance from the upstream edge of each of the side microchannels. The particles are separated and collected in the side microchannels.

Occupational Health and Safety: reflection on potential risks and the safety handling of nanomaterials

Directory of Open Access Journals (Sweden)

Guilherme Frederico Bernardo Lenz e Silva

2013-11-01

Full Text Available Every day the nanotechnology, that refers to a field whose theme is the control of matter on an atomic and molecular scale working with nanometric structures (<100 nm, is more present in the development of products and industrial processes. The particle manipulation of nanometric structures has created opportunities in the development of new products and materials. However, synthesis, handling, storage, stabilization and the incorporation of these materials, with nanometric dimensions, demand a new perspective of analysis and evaluation of old manufacturing processes, procedures and industrial devices, in order to guarantee collective and individual protection to workers and society. With the increasing of scale and production of nanoestrutuctured materials, a big part of labour community starts to be in contact with different nanomaterials (forms and ways. In this work the main aspects and involved risks of manufacture, storage, synthesis, stabilization and incorporation of nanomaterials on new products are evaluated in order to reduce, decrease and eliminate chemical, physical and biological risks for the employees. A bibliographic review was conducted about risk, safety and nanotechnology based on available English literature focusing safety and environmental agencies from different countries such as USA, Canada, EU (France, UK, Germany, Den-mark, Australia and Japan.

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.

Connecting Biology to Electronics: Molecular Communication via Redox Modality.

Science.gov (United States)

Liu, Yi; Li, Jinyang; Tschirhart, Tanya; Terrell, Jessica L; Kim, Eunkyoung; Tsao, Chen-Yu; Kelly, Deanna L; Bentley, William E; Payne, Gregory F

2017-12-01

Biology and electronics are both expert at for accessing, analyzing, and responding to information. Biology uses ions, small molecules, and macromolecules to receive, analyze, store, and transmit information, whereas electronic devices receive input in the form of electromagnetic radiation, process the information using electrons, and then transmit output as electromagnetic waves. Generating the capabilities to connect biology-electronic modalities offers exciting opportunities to shape the future of biosensors, point-of-care medicine, and wearable/implantable devices. Redox reactions offer unique opportunities for bio-device communication that spans the molecular modalities of biology and electrical modality of devices. Here, an approach to search for redox information through an interactive electrochemical probing that is analogous to sonar is adopted. The capabilities of this approach to access global chemical information as well as information of specific redox-active chemical entities are illustrated using recent examples. An example of the use of synthetic biology to recognize external molecular information, process this information through intracellular signal transduction pathways, and generate output responses that can be detected by electrical modalities is also provided. Finally, exciting results in the use of redox reactions to actuate biology are provided to illustrate that synthetic biology offers the potential to guide biological response through electrical cues. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

78 FR 27442 - Coal Mine Dust Sampling Devices; Correction

Science.gov (United States)

2013-05-10

... DEPARTMENT OF LABOR Mine Safety and Health Administration Coal Mine Dust Sampling Devices; Correction AGENCY: Mine Safety and Health Administration, Labor. ACTION: Notice; correction. SUMMARY: On April 30, 2013, Mine Safety and Health Administration (MSHA) published a notice in the Federal Register...

Safety, effectiveness and acceptability of the PrePex device for adult male circumcision in Kenya.

Directory of Open Access Journals (Sweden)

Paul J Feldblum

Full Text Available To assess the safety, effectiveness and acceptability of the PrePex device for adult medical male circumcision (MMC in routine service delivery in Kenya.We enrolled 427 men ages 18-49 at one fixed and two outreach clinics. Procedures were performed by trained clinical officers and nurses. The first 50 enrollees were scheduled for six follow-up visits, and remaining men were followed at Days 7 and 42. We recorded adverse events (AEs and time to complete healing, and interviewed men about acceptability and pain.Placement and removal procedures each averaged between 3 and 4 minutes. Self-reported pain was minimal during placement but was fleetingly intense during removal. The rate of moderate/severe AEs was 5.9% overall (95% confidence interval [CI] 3.8%-8.5%, all of which resolved without sequelae. AEs included 5 device displacements, 2 spontaneous foreskin detachments, and 9 cases of insufficient foreskin removal. Surgical completion of MMC was required for 9 men (2.1%. Among the closely monitored first 50 participants, the probability of complete healing by Day 42 was 0.44 (95% CI 0.30-0.58, and 0.90 by Day 56. A large majority of men was favorable about their MMC procedure and would recommend PrePex to friends and family.The PrePex device was effective for MMC in Kenya, and well-accepted. The AE rate was higher than reported for surgical procedures there, or in previous PrePex studies. Healing time is longer than following surgical circumcision. Provider experience and clearer counseling on post-placement and post-removal care should lead to lower AE rates.ClinicalTrials.gov NCT01711411.

TH-C-18C-01: MRI Safety

Energy Technology Data Exchange (ETDEWEB)

Pooley, R [Mayo Clinic, Jacksonville, FL (United States); Bernstein, M; Shu, Y; Gorny, K; Felmlee, J [Mayo Clinic, Rochester, MN (United States); Panda, A [Mayo Clinic, Arizona, Scottsdale, AZ (United States)

2014-06-15

Clinical diagnostic medical physicists may be responsible for implementing and maintaining a comprehensive MR safety program. Accrediting bodies including the ACR, IAC, Radsite and The Joint Commission each include aspects of MR Safety into their imaging accreditation programs; MIPPA regulations further raise the significance of non-compliance. In addition, The Joint Commission recently announced New and Revised Diagnostic Imaging Standards for accredited health care organizations which include aspects of MR Safety. Hospitals and clinics look to the physicist to understand guidelines, regulations and accreditation requirements related to MR safety. The clinical medical physicist plays a significant role in a clinical practice by understanding the physical basis for the risks and acting as a facilitator to successfully implement a safety program that provides well-planned siting, allows for the safe scanning of certain implanted devices, and helps radiologists manage specific patient exams. The MRI scanning of specific devices will be discussed including cardiac pacemakers and neurostimulators such as deep brain stimulators. Furthermore for sites involved in MR guided interventional procedures, the MR physicist plays an essential role to establish safe practices. Creating a framework for a safe MRI practice includes the review of actual safety incidents or close calls to determine methods for prevention in the future. Learning Objectives: Understand the requirements and recommendations related to MR safety from accrediting bodies and federal regulations. Understand the Medical Physicist's roles to ensure MR Safety. Identify best practices for dealing with implanted devices, including pacemakers and deep brain stimulators. Review aspects of MR safety involved in an MR guided interventional environment. Understand the important MR safety aspects in actual safety incidents or near misses.

Safety and performance of a novel embolic deflection device in patients undergoing transcatheter aortic valve replacement: results from the DEFLECT I study.

Science.gov (United States)

Baumbach, Andreas; Mullen, Michael; Brickman, Adam M; Aggarwal, Suneil K; Pietras, Cody G; Forrest, John K; Hildick-Smith, David; Meller, Stephanie M; Gambone, Louise; den Heijer, Peter; Margolis, Pauliina; Voros, Szilard; Lansky, Alexandra J

2015-05-01

This study aimed to evaluate the safety and performance of the TriGuard™ Embolic Deflection Device (EDD), a nitinol mesh filter positioned in the aortic arch across all three major cerebral artery take-offs to deflect emboli away from the cerebral circulation, in patients undergoing transcatheter aortic valve replacement (TAVR). The prospective, multicentre DEFLECT I study (NCT01448421) enrolled 37 consecutive subjects undergoing TAVR with the TriGuard EDD. Subjects underwent clinical and cognitive follow-up to 30 days; cerebral diffusion-weighted magnetic resonance imaging (DW-MRI) was performed pre-procedure and at 4±2 days post procedure. The device performed as intended with successful cerebral coverage in 80% (28/35) of cases. The primary safety endpoint (in-hospital EDD device- or EDD procedure-related cardiovascular mortality, major stroke disability, life-threatening bleeding, distal embolisation, major vascular complications, or need for acute cardiac surgery) occurred in 8.1% of subjects (VARC-defined two life-threatening bleeds and one vascular complication). The presence of new cerebral ischaemic lesions on post-procedure DW-MRI (n=28) was similar to historical controls (82% vs. 76%, p=NS). However, an exploratory analysis found that per-patient total lesion volume was 34% lower than reported historical data (0.2 vs. 0.3 cm3), and 89% lower in patients with complete (n=17) versus incomplete (n=10) cerebral vessel coverage (0.05 vs. 0.45 cm3, p=0.016). Use of the first-generation TriGuard EDD during TAVR is safe, and device performance was successful in 80% of cases during the highest embolic-risk portions of the TAVR procedure. The potential of the TriGuard EDD to reduce total cerebral ischaemic burden merits further randomised investigation.

Intrauterine Morcellator Devices: The Icon of Hysteroscopic Future or Merely a Marketing Image? A Systematic Review Regarding Safety, Efficacy, Advantages, and Contraindications.

Science.gov (United States)

Noventa, Marco; Ancona, Emanuele; Quaranta, Michela; Vitagliano, Amerigo; Cosmi, Erich; D'Antona, Donato; Gizzo, Salvatore

2015-10-01

The aim of this study was to analyze all available evidence regarding the use of intrauterine morcellator (IUM), for treatment of the most prevalent intrauterine benign lesions, compared to both traditional resectoscopy and conventional outpatient operative hysteroscopy in terms of safety, efficacy, contraindications, perioperative complications, operating time, and estimated learning curve. We reported data regarding a total of 1185 patients. Concerning polypectomy and myomectomy procedures, IUM systems demonstrated a better outcome in terms of operative time and fluid deficit compared to standard surgical procedures. Complication rates in the inpatient setting were as follows: 0.02% for IUM using Truclear 8.0 (Smith & Nephew Endoscopy, Andover, Massachusetts) and 0.4% for resectoscopic hysteroscopy. No complications were described using Versapoint devices. Office polipectomy reported a total complication rate of 10.1% using Versapoint device (Ethicon Women's Health and Urology, Somerville, New Jersey) and 1.6% using Truclear 5.0 (Smith & Nephew Endoscopy). The reported recurrence rate after polypectomy was 9.8% using Versapoint device and 2.6% using Truclear 8.0. Finally, the reported intraoperative and postoperative complication rate of IUM related to removal of placental remnants using Truclear 8.0 and MyoSure (Hologic, Marlborough, Massachusetts) was 12.3%. The available evidence allows us to consider IUM devices as a safe, effective, and cost-effective tool for the removal of intrauterine lesions such as polyps, myomas (type 0 and type 1), and placental remnants. Evidence regarding Truclear 5.0 suggests that it may represent the best choice for office hysteroscopy. Further studies are needed to confirm the available evidence and to validate the long-term safety of IUM in procedures for which current data are not exhaustive (placental remnants removal). © The Author(s) 2015.

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.

Plant synthetic biology.

Science.gov (United States)

Liu, Wusheng; Stewart, C Neal

2015-05-01

Plant synthetic biology is an emerging field that combines engineering principles with plant biology toward the design and production of new devices. This emerging field should play an important role in future agriculture for traditional crop improvement, but also in enabling novel bioproduction in plants. In this review we discuss the design cycles of synthetic biology as well as key engineering principles, genetic parts, and computational tools that can be utilized in plant synthetic biology. Some pioneering examples are offered as a demonstration of how synthetic biology can be used to modify plants for specific purposes. These include synthetic sensors, synthetic metabolic pathways, and synthetic genomes. We also speculate about the future of synthetic biology of plants. Copyright © 2015 Elsevier Ltd. All rights reserved.

Safeguards of basic protection devices, high-protection devices, full-protection devices and school X-ray devices. Guideline for manufacturer and evaluating experts, rev. 1.0; Sicherheitsvorrichtungen von Basisschutzgeraeten, Hochschutzgeraeten, Vollschutzgeraeten und Schulroentgeneinrichtungen. Anforderungen fuer die Bauartpruefung nach der Roentgenverordnung. Leitfaden fuer Hersteller und Gutachter Rev. 1.0

Energy Technology Data Exchange (ETDEWEB)

Dombrowski, Harald; Grottker, Ulrich; Pullner, Bjoern; Roettger, Annette; Zwiener, Roland

2017-07-15

This report describes the PTB requirements for engineered safeguards of basic-protection devices, high-protection devices, full-protection devices and school X-ray devices within the framework of type tests according to the German X-ray Ordinance. It contains detailed requirements for the hard- and software to ensure the required safety level. Especially manufacturers and evaluators of such X-ray tube assemblies are addressed.

21 CFR 610.11 - General safety.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false General safety. 610.11 Section 610.11 Food and... GENERAL BIOLOGICAL PRODUCTS STANDARDS General Provisions § 610.11 General safety. A general safety test... for administration to humans. The general safety test is required in addition to other specific tests...

Synaptic electronics: materials, devices and applications.

Science.gov (United States)

Kuzum, Duygu; Yu, Shimeng; Wong, H-S Philip

2013-09-27

In this paper, the recent progress of synaptic electronics is reviewed. The basics of biological synaptic plasticity and learning are described. The material properties and electrical switching characteristics of a variety of synaptic devices are discussed, with a focus on the use of synaptic devices for neuromorphic or brain-inspired computing. Performance metrics desirable for large-scale implementations of synaptic devices are illustrated. A review of recent work on targeted computing applications with synaptic devices is presented.

Synaptic electronics: materials, devices and applications

International Nuclear Information System (INIS)

Kuzum, Duygu; Yu, Shimeng; Philip Wong, H-S

2013-01-01

In this paper, the recent progress of synaptic electronics is reviewed. The basics of biological synaptic plasticity and learning are described. The material properties and electrical switching characteristics of a variety of synaptic devices are discussed, with a focus on the use of synaptic devices for neuromorphic or brain-inspired computing. Performance metrics desirable for large-scale implementations of synaptic devices are illustrated. A review of recent work on targeted computing applications with synaptic devices is presented. (topical review)

Device and method for treating cells

NARCIS (Netherlands)

2010-01-01

The present invention relates to a device for treating biological cells in an object, the device comprising: - a single winding coil element; - an electrical generator connected to the single winding coil element, the single winding being configured to be positioned essentially around the object;

Biological effects of radiation human health and safety

International Nuclear Information System (INIS)

1977-05-01

The biological hazards of nuclear energy usage are a growing source of public concern. The medical profession may well be expected to contribute to public debate on the issue. This document, therefore, attempts a balanced review of the known and suspected human biological consequences of exposure to different types of ionizing radiation, emphasizing in particular the nuclear industry

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.

Fast-acting nuclear reactor control device

International Nuclear Information System (INIS)

Kotlyar, O.M.; West, P.B.

1993-01-01

A fast-acting nuclear reactor control device is described for controlling a safety control rod within the core of a nuclear reactor, the reactor controlled by a reactor control system, the device comprising: a safety control rod drive shaft and an electromagnetic clutch co-axial with the drive shaft operatively connected to the safety control rod for driving and positioning the safety control rod within or without the reactor core during reactor operation, the safety rod being oriented in a substantially vertical position to allow the rod to fall into the reactor core under the influence of gravity during shutdown of the reactor; the safety control rod drive shaft further operatively connected to a hydraulic pump such that operation of the drive shaft simultaneously drives and positions the safety control rod and operates the hydraulic pump such that a hydraulic fluid is forced into an accumulator, filling the accumulator with oil for the storage and supply of primary potential energy for safety control rod insertion such that the release of potential energy in the accumulator causes hydraulic fluid to flow through the hydraulic pump, converting the hydraulic pump to a hydraulic motor having speed and power capable of full length insertion and high speed driving of the safety control rod into the reactor core; a solenoid valve interposed between the hydraulic pump and the accumulator, said solenoid valve being a normally open valve, actuated to close when the safety control rod is out of the reactor during reactor operation; and further wherein said solenoid opens in response to a signal from the reactor control system calling for shutdown of the reactor and rapid insertion of the safety control rod into the reactor core, such that the opening of the solenoid releases the potential energy in the accumulator to place the safety control rod in a safe shutdown position

Radiation Safety in Industrial Radiography. Specific Safety Guide (Spanish Edition)

International Nuclear Information System (INIS)

2013-01-01

This Safety Guide provides recommendations for ensuring radiation safety in industrial radiography used in non-destructive testing. This includes industrial radiography work that utilizes X ray and gamma sources, both in shielded facilities that have effective engineering controls and in outside shielded facilities using mobile sources. Contents: 1. Introduction; 2. Duties and responsibilities; 3. Safety assessment; 4. Radiation protection programme; 5. Training and qualification; 6. Individual monitoring of workers; 7. Workplace monitoring; 8. Control of radioactive sources; 9. Safety of industrial radiography sources and exposure devices; 10. Radiography in shielded enclosures; 11. Site radiography; 12. Transport of radioactive sources; 13. Emergency preparedness and response; Appendix: IAEA categorization of radioactive sources; Annex I: Example safety assessment; Annex II: Overview of industrial radiography sources and equipment; Annex III: Examples of accidents in industrial radiography

Radiation Safety in Industrial Radiography. Specific Safety Guide (French Edition)

International Nuclear Information System (INIS)

2013-01-01

This Safety Guide provides recommendations for ensuring radiation safety in industrial radiography used in non-destructive testing. This includes industrial radiography work that utilizes X ray and gamma sources, both in … shielded facilities that have effective engineering controls and in outside shielded facilities using mobile sources. Contents: 1. Introduction; 2. Duties and responsibilities; 3. Safety assessment; 4. Radiation protection programme; 5. Training and qualification; 6. Individual monitoring of workers; 7. Workplace monitoring; 8. Control of radioactive sources; 9. Safety of industrial radiography sources and exposure devices; 10. Radiography in shielded enclosures; 11. Site radiography; 12. Transport of radioactive sources; 13. Emergency preparedness and response; Appendix: IAEA categorization of radioactive sources; Annex I: Example safety assessment; Annex II: Overview of industrial radiography sources and equipment; Annex III: Examples of accidents in industrial radiography

Radiation Safety in Industrial Radiography. Specific Safety Guide (Arabic Edition)

International Nuclear Information System (INIS)

2012-01-01

This Safety Guide provides recommendations for ensuring radiation safety in industrial radiography used in non-destructive testing. This includes industrial radiography work that utilizes X ray and gamma sources, both in shielded facilities that have effective engineering controls and outside shielded facilities using mobile sources. Contents: 1. Introduction; 2. Duties and responsibilities; 3. Safety assessment; 4. Radiation protection programme; 5. Training and qualification; 6. Individual monitoring of workers; 7. Workplace monitoring; 8. Control of radioactive sources; 9. Safety of industrial radiography sources and exposure devices; 10. Radiography in shielded enclosures; 11. Site radiography; 12. Transport of radioactive sources; 13. Emergency preparedness and response; Appendix: IAEA categorization of radioactive sources; Annex I: Example safety assessment; Annex II: Overview of industrial radiography sources and equipment; Annex III: Examples of accidents in industrial radiography.

Are needle-free injections a useful alternative for growth hormone therapy in children? Safety and pharmacokinetics of growth hormone delivered by a new needle-free injection device compared to a fine gauge needle.

NARCIS (Netherlands)

Dorr, H.G.; Zabransky, S.; Keller, E.; Otten, B.J.; Partsch, C.J.; Nyman, L.; Gillespie, B.K.; Lester, N.R.; Wilson, A.M.; Hyren, C.; Kuijck, M.A. van; Schuld, P.; Schoenfeld, S.L.

2003-01-01

The clinical safety, use and pharmacokinetics of a new needle-free device for delivery of growth hormone (GH) were compared with those of conventional needle injection devices. In an open-label, randomized, 4-period crossover study, 18 healthy adults received single subcutaneous injections of

Radiation safety in X-ray facilities

International Nuclear Information System (INIS)

2001-09-01

The guide specifies the radiation safety requirements for structural shielding and other safety arrangements used in X-ray facilities in medical and veterinary X-ray activities and in industry, research and education. The guide is also applicable to premises in which X-ray equipment intended for radiation therapy and operating at a voltage of less than 25 kV is used. The guide applies to new X-ray facilities in which X-ray equipment that has been used elsewhere is transferred. The radiation safety requirements for radiation therapy X-ray devices operating at a voltage exceeding 25 kV, and for the premices in which such devices are used, are set out in Guide ST 2.2

Radiation safety in X-ray facilities

Energy Technology Data Exchange (ETDEWEB)

NONE

2001-09-01

The guide specifies the radiation safety requirements for structural shielding and other safety arrangements used in X-ray facilities in medical and veterinary X-ray activities and in industry, research and education. The guide is also applicable to premises in which X-ray equipment intended for radiation therapy and operating at a voltage of less than 25 kV is used. The guide applies to new X-ray facilities in which X-ray equipment that has been used elsewhere is transferred. The radiation safety requirements for radiation therapy X-ray devices operating at a voltage exceeding 25 kV, and for the premices in which such devices are used, are set out in Guide ST 2.2.

Developing optimal input design strategies in cancer systems biology with applications to microfluidic device engineering.

Science.gov (United States)

Menolascina, Filippo; Bellomo, Domenico; Maiwald, Thomas; Bevilacqua, Vitoantonio; Ciminelli, Caterina; Paradiso, Angelo; Tommasi, Stefania

2009-10-15

Mechanistic models are becoming more and more popular in Systems Biology; identification and control of models underlying biochemical pathways of interest in oncology is a primary goal in this field. Unfortunately the scarce availability of data still limits our understanding of the intrinsic characteristics of complex pathologies like cancer: acquiring information for a system understanding of complex reaction networks is time consuming and expensive. Stimulus response experiments (SRE) have been used to gain a deeper insight into the details of biochemical mechanisms underlying cell life and functioning. Optimisation of the input time-profile, however, still remains a major area of research due to the complexity of the problem and its relevance for the task of information retrieval in systems biology-related experiments. We have addressed the problem of quantifying the information associated to an experiment using the Fisher Information Matrix and we have proposed an optimal experimental design strategy based on evolutionary algorithm to cope with the problem of information gathering in Systems Biology. On the basis of the theoretical results obtained in the field of control systems theory, we have studied the dynamical properties of the signals to be used in cell stimulation. The results of this study have been used to develop a microfluidic device for the automation of the process of cell stimulation for system identification. We have applied the proposed approach to the Epidermal Growth Factor Receptor pathway and we observed that it minimises the amount of parametric uncertainty associated to the identified model. A statistical framework based on Monte-Carlo estimations of the uncertainty ellipsoid confirmed the superiority of optimally designed experiments over canonical inputs. The proposed approach can be easily extended to multiobjective formulations that can also take advantage of identifiability analysis. Moreover, the availability of fully automated

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.

[Measures for counteracting of biological terrorism in the Russian Federation].

Science.gov (United States)

Onishchenko, G G

2005-01-01

The article deals with topicality of the problem of ensuring biological safety in Russia. The necessity of a unified state policy aimed at the realization of the concept of biological safety is grounded. In particular, the expediency of the state support of research programs is emphasized. The organizational and practical measures, carried out by the Ministry of Health and Social Development in this field, are analyzed. The list of prospective measures for the organization of effective state regulation in the field of ensuring the biological safety of the country is given.

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.

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.

Sealing devices

International Nuclear Information System (INIS)

Coulson, R.A.

1980-01-01

A sealing device for minimising the leakage of toxic or radioactive contaminated environments through a biological shield along an opening through which a flexible component moves that penetrates the shield. The sealing device comprises an outer tubular member which extends over a length not less than the maximum longitudinal movement of the component along the opening. An inner sealing block is located intermediate the length of the component by connectors and is positioned in the bore of the outer tubular member to slide in the bore and effect a seal over the entire longitudinal movement of the component. The cross-section of the device may be circular and the block may be of polytetrafluoroethylene or of nylon impregnated with molybdenum or may be metallic. A number of the sealing devices may be combined into an assembly for a plurality of adjacent longitudinally movable components, each adapted to sustain a tensile load, providing the various drives of a master-slave manipulator. (author)

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.

Activity of safety review for the facilities using nuclear material (2). Safety review results and maintenance experiences for hot laboratories

International Nuclear Information System (INIS)

Amagai, Tomio; Fujishima, Tadatsune; Mizukoshi, Yasutaka; Sakamoto, Naoki; Ohmori, Tsuyoshi

2009-01-01

In the site of O-arai Research and Development Center of Japan Atomic Energy Agency (JAEA), five hot laboratories for post-irradiation examination and development of plutonium fuels are operated more than 30 years. A safety review method for preventive maintenance on these hot laboratories includes test facilities and devices are established in 2003. After that, the safety review of these facilities and devices are done and taken the necessary maintenance based on the results in each year. In 2008, 372 test facilities and devices in these hot laboratories were checked and reviewed by this method. As a results of the safety review, repair issues of 38 facilities of above 372 facilities were resolved. This report shows the review results and maintenance experiences based on the results. (author)

ALARA issues arising for safety and security of radiation sources and security screening devices - Summary and recommendations of the 12. European ALARA network workshop

International Nuclear Information System (INIS)

Shaw, P.; Crouail, P.; Drouet, F.

2010-01-01

The 12. European ALARA Network (EAN) workshop on 'ALARA issues arising for safety and security of radiation sources and security screening devices' took place in Vienna (Austria) in October 2009. The aim of that workshop was to consider how the implementation of ALARA3, in terms of planned and emergency situations, involving worker and public doses, is affected by the introduction of security-related measures. In the case of new equipment and procedures, there was also the question of whether exposures arising from security screening devices can be justified and optimised. This workshop consisted of invited oral presentations, which highlighted the main issues, and half of the programme was devoted to discussions within working groups on specific topics. During their discussions, the working groups identified recommendations dealing with the following topics: the implementation of the Code of Conduct and HASS4 - ensuring ALARA; balancing security and safety - how to achieve an optimum solution; the management of an emergency exposure situation from an ALARA perspective; the justification and optimisation of the use of security devices. The objective of this paper is to present the main conclusions and recommendations produced during the workshop. Individual presentations (papers and slides) as well as the reports from the working groups are available to download on the EAN web site (http://www.eu-alara.net). (authors)

Review of Wearable Device Technology and Its Applications to the Mining Industry

Directory of Open Access Journals (Sweden)

Mokhinabonu Mardonova

2018-03-01

Full Text Available This paper reviews current trends in wearable device technology, and provides an overview of its prevalent and potential deployments in the mining industry. This review includes the classification of wearable devices with some examples of their utilization in various industrial fields as well as the features of sensors used in wearable devices. Existing applications of wearable device technology to the mining industry are reviewed. In addition, a wearable safety management system for miners and other possible applications are proposed. The findings of this review show that by introducing wearable device technology to mining sites, the safety of mining operations can be enhanced. Therefore, wearable devices should be further used in the mining industry.

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.

Safety and efficiency of emergency department interrogation of cardiac devices.

Science.gov (United States)

Neuenschwander, James F; Peacock, W Frank; Migeed, Madgy; Hunter, Sara A; Daughtery, John C; McCleese, Ian C; Hiestand, Brian C

2016-12-01

Patients with implanted cardiac devices may wait extended periods for interrogation in emergency departments (EDs). Our purpose was to determine if device interrogation could be done safely and faster by ED staff. Prospective randomized, standard therapy controlled, trial of ED staff device interrogation vs. standard process (SP), with 30-day follow-up. Eligibility criteria: ED presentation with a self-report of a potential device related complaint, with signed informed consent. SP interrogation was by company representative or hospital employee. Of 60 patients, 42 (70%) were male, all were white, with a median (interquartile range) age of 71 (64 to 82) years. No patient was lost to follow up. Of all patients, 32 (53%) were enrolled during business hours. The overall median (interquartile range) ED vs. SP time to interrogation was 98.5 (40 to 260) vs. 166.5 (64 to 412) minutes (P=0.013). While ED and SP interrogation times were similar during business hours, 102 (59 to 138) vs. 105 (64 to 172) minutes (P=0.62), ED interrogation times were shorter vs. SP during non-business hours; 97 (60 to 126) vs. 225 (144 to 412) minutes, P=0.002, respectively. There was no difference in ED length of stay between the ED and SP interrogation, 249 (153 to 390) vs. 246 (143 to 333) minutes (P=0.71), regardless of time of presentation. No patient in any cohort suffered an unplanned medical contact or post-discharge adverse device related event. ED staff cardiac device interrogations are faster, and with similar 30-day outcomes, as compared to SP.

Design and construction of engineering test device of a multi-purpose radwaste incineration system

International Nuclear Information System (INIS)

Wang Peiyi; Zhou Lianquan; Ma Mingxie; Qiu Mingcai; Yang Liguo; Li Xiaohai; Zhang Xiaobin; Lu Xiaowu; Dong Jingling; Wang Xujin; Li Chuanlian; Yang Baomin

2002-01-01

The author describes designs of main un-standard devices, monitoring system and safety system, as well as construction of the engineering system devices for a multi-purpose radwaste incineration system. Un-standard devices include waste crusher, pyrolysis furnace, incinerator furnace, cool stream dilution device and bag filter, etc. The monitoring system mainly includes industrial controlled computer, supported by conventional electrical equipment and instruments. Designs of system safety takes account of containment of radioactive materials fire-prevention, explosion prevention, anti-corrosion, redundance and reservation, emergency system, controlling and electric safety system, etc. Results show that main technological system remains good airtight with leakage ratio at 0.67%

Short time efficacy and safety of focused monopolar radiofrequency device for labial laxity improvement-noninvasive labia tissue tightening. A prospective cohort study.

Science.gov (United States)

Fistonić, Ivan; Sorta Bilajac Turina, Iva; Fistonić, Nikola; Marton, Ingrid

2016-03-01

To evaluate safety and efficacy of focused monopolar radio frequency (RF) device for non-invasive labia tissue tightening and improvement of labial laxity. This prospective cohort study participants were 17 female subjects aged between 27 and 56 years with lax skin at the labia area. All subjects received four consecutive treatments at 7-day intervals with RF device (Exilis Protege IntimaR, BTL Industries Inc., Boston, MA). The primary efficacy outcome measure was defined as one or more point improvement on 1-4 scale for vulva appearance determined by three blinded evaluators. Digital photographs were taken at the baseline and 1 month after the last treatment. Sexual gratification was assessed with Female Sexual Functioning Index (FSFI) and patient discomfort by Visual Analogue Scale (VAS). An average 2.9 (of maximum 4) points improvement rate in vulvar appearance was observed (P RF device for non-invasive labia tissue tightening. The treatment is effective and safe with high patient satisfaction. © 2016 Wiley Periodicals, Inc.

Guide On Safety Tests

Energy Technology Data Exchange (ETDEWEB)

NONE

1987-05-15

This book tells US important things to do safety tests, which includes basic caution for experiment treatment of used materials such as ignition substance inflammables, explosive substance and toxic substance, handling of used equipment like inflammable device, machine, high pressure device, high pressure gas, and high energy device, first aid such as addiction by drug, flame, radiation exposure, and heart massage treatment of waste in laboratory like cautions on general treatment, handling of inorganic waste, organic waste and waste treatment with disposal facilities.

Guide On Safety Tests

International Nuclear Information System (INIS)

1987-05-01

This book tells US important things to do safety tests, which includes basic caution for experiment treatment of used materials such as ignition substance inflammables, explosive substance and toxic substance, handling of used equipment like inflammable device, machine, high pressure device, high pressure gas, and high energy device, first aid such as addiction by drug, flame, radiation exposure, and heart massage treatment of waste in laboratory like cautions on general treatment, handling of inorganic waste, organic waste and waste treatment with disposal facilities.

Consumers' Use of Personal Electronic Devices in the Kitchen.

Science.gov (United States)

Lando, Amy M; Bazaco, Michael C; Chen, Yi

2018-02-23

Smartphones, tablets, and other personal electronic devices have become ubiquitous in Americans' daily lives. These devices are used by people throughout the day, including while preparing food. For example, a device may be used to look at recipes and therefore be touched multiple times during food preparation. Previous research has indicated that cell phones can harbor bacteria, including opportunistic human pathogens such as Staphylococcus and Klebsiella spp. This investigation was conducted with data from the 2016 Food Safety Survey (FSS) and from subsequent focus groups to determine the frequency with which consumers use personal electronic devices in the kitchen while preparing food, the types of devices used, and hand washing behaviors after handling these devices. The 2016 FSS is the seventh wave of a repeated cross-sectional survey conducted by the U.S. Food and Drug Administration in collaboration with the U.S. Department of Agriculture. The goal of the FSS is to evaluate U.S. adult consumer attitudes, behaviors, and knowledge about food safety. The FSS included 4,169 adults that were contacted using a dual-frame (land line and cell phone interviews) random-digit-dial sampling process. The personal electronics module was the first of three food safety topics discussed by each of eight consumer focus groups, which were convened in four U.S. cities in fall 2016. Results from the 2016 FSS revealed that of those individuals who use personal electronic devices while cooking, only about one third reported washing hands after touching the device and before continuing cooking. This proportion is significantly lower than that for self-reported hand washing behaviors after touching risky food products such as raw eggs, meat, chicken, or fish. Results from the focus groups highlight the varied usage of these devices during food preparation and the related strategies consumers are using to incorporate personal electric devices into their cooking routines.

Device for sealing and shielding a nuclear fuel storage tank

International Nuclear Information System (INIS)

Masaki, Gengo.

1975-01-01

Object: To provide a shield device for opening and closing a great opening in a relay-storage-tank within a hot cell for temporarily storing a nuclear fuel, in which the device is simplified in construction and which can perform the opening and closing operation in simple, positive and quick manner. Structure: A biological shield is positioned upwardly of an opening of a nuclear fuel storage tank to render an actuator inoperative. A sealing plate, which is pivotally supported by a plurality of support rod devices from the biological shield for parallel movement with respect to the biological shield, comes in contact with a resilient seal disposed along the entire peripheral edge of the opening to form an air-tight seal therebetween. In order to release the opening, the actuator is first actuated and the end of the sealing plate is horizontally pressed by a piston rod thereof. Then, the sealing plate is moved along the line depicted by the end of the support rod in the support rod devices and as a consequence, the plate is moved away from the resilient seal in the peripheral edge of the opening. When a driving device is actuated to travel the plate along the aforesaid line while maintaining the condition as described, the biological device moves along the guide. (Kamimura, M.)

FDA Regulation of Follow-On Biologics

Science.gov (United States)

2009-02-24

opening a pathway for the approval of follow-on biologics. A biologic is a preparation, such as a drug or a vaccine , that is made from living...2006 Drug Trend Report, April 2006, p. 38. C Biologic vs. Follow-on Biologic A biologic is a preparation, such as a drug or a vaccine , that is...doc9496/s1695.pdf. 19 Thijs J. Giezen, Aukje K. Mantel-Teeuwisse, and Sabine M. J. M. Straus, et al., “Safety-related regulatory actions for biologicals

Safety, efficacy, and usage compliance of home-use device utilizing RF and light energies for treating periorbital wrinkles.

Science.gov (United States)

Gold, Michael H; Biron, Julie; Levi, Liora; Sensing, Whitney

2017-03-01

The aging process is often associated with undesirable effects on facial skin such as skin redundancy, reduction of elasticity, and increased wrinkling. Radiofrequency (RF) and light-emitting diodes (LEDs) are widely used, clinically proven technologies for skin rejuvenation. This study aimed to evaluate the safety, efficacy, and usage compliance of the home-use device, utilizing RF and LED energies, for self-treatment of periorbital wrinkles and improvement of skin appearance. Thirty-three subjects performed 21 treatment sessions every other day, over 6 weeks on the periorbital areas. In addition, two maintenance treatments were conducted 1 and 2 months following treatment end. Each subject served as his/her own control, comparing results before treatment, and 3 months following treatment end. Thirty subjects completed the study. A blinded, independent photographs assessment of three dermatologists demonstrated an average reduction of 1.49 Fitzpatrick scores (P Skin Tightening (HST) device offers a safe and effective in-home noninvasive technique to improve the appearance of age-related periorbital wrinkles. © 2016 Wiley Periodicals, Inc.

Wood-Derived Materials for Green Electronics, Biological Devices, and Energy Applications.

Science.gov (United States)

Zhu, Hongli; Luo, Wei; Ciesielski, Peter N; Fang, Zhiqiang; Zhu, J Y; Henriksson, Gunnar; Himmel, Michael E; Hu, Liangbing

2016-08-24

goal of this study is to review the fundamental structures and chemistries of wood and wood-derived materials, which are essential for a wide range of existing and new enabling technologies. The scope of the review covers multiscale materials and assemblies of cellulose, hemicellulose, and lignin as well as other biomaterials derived from wood, in regard to their major emerging applications. Structure-properties-application relationships will be investigated in detail. Understanding the fundamental properties of these structures is crucial for designing and manufacturing products for emerging applications. Today, a more holistic understanding of the interplay between the structure, chemistry, and performance of wood and wood-derived materials is advancing historical applications of these materials. This new level of understanding also enables a myriad of new and exciting applications, which motivate this review. There are excellent reviews already on the classical topic of woody materials, and some recent reviews also cover new understanding of these materials as well as potential applications. This review will focus on the uniqueness of woody materials for three critical applications: green electronics, biological devices, and energy storage and bioenergy.

Wood-Derived Materials for Green Electronics, Biological Devices, and Energy Applications

Energy Technology Data Exchange (ETDEWEB)

Zhu, Hongli; Luo, Wei; Ciesielski, Peter N.; Fang, Zhiqiang; Zhu, J. Y.; Henriksson, Gunnar; Himmel, Michael E.; Hu, Liangbing

2016-08-24

goal of this study is to review the fundamental structures and chemistries of wood and wood-derived materials, which are essential for a wide range of existing and new enabling technologies. The scope of the review covers multiscale materials and assemblies of cellulose, hemicellulose, and lignin as well as other biomaterials derived from wood, in regard to their major emerging applications. Structure-properties-application relationships will be investigated in detail. Understanding the fundamental properties of these structures is crucial for designing and manufacturing products for emerging applications. Today, a more holistic understanding of the interplay between the structure, chemistry, and performance of wood and wood-derived materials is advancing historical applications of these materials. This new level of understanding also enables a myriad of new and exciting applications, which motivate this review. There are excellent reviews already on the classical topic of woody materials, and some recent reviews also cover new understanding of these materials as well as potential applications. This review will focus on the uniqueness of woody materials for three critical applications: green electronics, biological devices, and energy storage and bioenergy.

Bacterial spores as possible contaminants of biomedical materials and devices. [Bacillus anthracis, clostridium botulinum, C. perfringens, C. tetani

Energy Technology Data Exchange (ETDEWEB)

Grecz, N; Kang, T

1973-01-01

Destruction of spores on biomedical devices in drugs, and biologicals is essential for prevention of infection of patients with pathogenic sporeformers. Of particular concern are Clostridium tetani, C. perfringens, C. botulinum, Bacillus anthracis and other sporeforming pathogens. Spores are ubiquitous in nature and contamination of biomedical devices varies depending on manufacturing process, handling, raw materials and other variables. In the last 20 years the number of cases per year of specific notifiable diseases in the United States was as follows: tetanus, 120 to 500 cases, botulism, 7 to 47 cases, and anthrax, 2 to 10 cases. Gas gangrene is caused by a mixed flora consisting predominantly of sporeformers. C botulinum, which usually acts as saprophytic agent of food poisoning, may also initiate pathogenic processes; there are nine cases on record in the United States of botulism wound infections almost half of which ended in death. The spores of these organisms are distinguished by high radiation resistance and their erradication often requires severe radiation treatments. Representative bacterial spores in various suspending media show D/sub 10/ values (dose necessary to destroy 90 percent of a given population) ranging from approximately 0.1 to 0.4 Mrad. Some viruses show D/sub 10/ values up to greater than 1 Mrad. The D/sub 10/-values of spores vary depending on physical, chemical and biological factors. This variability is important in evaluation and selection of biological indicator organisms. Radiation sterilization of biomedical devices and biomedical materials must provide safety from infectious microorganisms including radiation resistant spores and viruses.

Safety Assessment of Wearing the AN/PVS-14 Monocular Night Vision Device (MNVD) and AN/AVS-6 Aviators' Night Vision Imaging System (ANVIS) During 5-Ton and HMMWV Night Driving

National Research Council Canada - National Science Library

Redden, Elizabeth

2002-01-01

.... The Communications-Electronics Command Directorate for Safety Risk Management, Fort Monmouth, New Jersey, will use the results of the assessment to determine the suitability of both devices for driving...

EFSA Panel on Biological Hazards (BIOHAZ); Scientific Opinion on the maintenance of the list of QPS biological agents intentionally added to food and feed (2011 update)

DEFF Research Database (Denmark)

Hald, Tine

) assessment was developed by EFSA for its own use to provide a generic risk assessment approach applicable across EFSA’s scientific Panels, for biological agents notified for intentional use in the whole food chain. The safety of unambiguously defined biological agents at the highest taxonomic unit......EFSA is requested to assess the safety of a broad range of biological agents (including microorganisms and viruses) in the context of notifications for market authorisation as sources of food and feed additives, enzymes and plant protection products. The qualified presumption of safety (QPS...

Qualified Presumption of Safety (QPS) is a generic risk assessment approach applied by the European Food Safety Authority (EFSA)

DEFF Research Database (Denmark)

Leuschner, R. G. K.; Robinson, T. P.; Hugas, M.

2010-01-01

Qualified Presumption of Safety (QPS) is a generic risk assessment approach applied by the European Food Safety Authority (EFSA) to notified biological agents aiming at simplifying risk assessments across different scientific Panels and Units. The aim of this review is to outline the implementation...... and value of the QPS assessment for EFSA and to explain its principles such as the unambiguous identity of a taxonomic unit, the body of knowledge including potential safety concerns and how these considerations lead to a list of biological agents recommended for QPS which EFSA keeps updated through...

Safety valve opening and closing operation monitor

International Nuclear Information System (INIS)

Kodama, Kunio; Takeshima, Ikuo; Takahashi, Kiyokazu.

1981-01-01

Purpose: To enable the detection of the closing of a safety valve when the internal pressure in a BWR type reactor is a value which will close the safety valve, by inputting signals from a pressure detecting device mounted directly at a reactor vessel and a safety valve discharge pressure detecting device to an AND logic circuit. Constitution: A safety valve monitor is formed of a pressure switch mounted at a reactor pressure vessel, a pressure switch mounted at the exhaust pipe of the escape safety valve and a logic circuit and the lide. When the input pressure of the safety valve is raised so that the valve and the pressure switch mounted at the exhaust pipe are operated, an alarm is indicated, and the operation of the pressure switch mounted at a pressure vessel is eliminated. If the safety valve is not reclosed when the vessel pressure is decreased lower than the pressure at which it is to be reclosed after the safety valve is operated, an alarm is generated by the logic circuit since both the pressure switches are operated. (Sekiya, K.)

Formalising Java safety -- An overview

NARCIS (Netherlands)

Hartel, Pieter H.; Domingo-Ferrer, J; Chan, D.; Watson, A.

We review the existing literature on Java safety, emphasizing formal approaches, and the impact of Java safety on small footprint devices such as smart cards. The conclusion is that while a lot of good work has been done, a more concerted effort is needed to build a coherent set of machine readable

[Establishment of Quality Control System of Nucleic Acid Detection for Ebola Virus in Sierra Leone-China Friendship Biological Safety Laboratory].

Science.gov (United States)

Wang, Qin; Zhang, Yong; Nie, Kai; Wang, Huanyu; Du, Haijun; Song, Jingdong; Xiao, Kang; Lei, Wenwen; Guo, Jianqiang; Wei, Hejiang; Cai, Kun; Wang, Yanhai; Wu, Jiang; Gerald, Bangura; Kamara, Idrissa Laybohr; Liang, Mifang; Wu, Guizhen; Dong, Xiaoping

2016-03-01

The quality control process throughout the Ebola virus nucleic acid detection in Sierra Leone-China Friendship Biological Safety Laboratory (SLE-CHN Biosafety Lab) was described in detail, in order to comprehensively display the scientific, rigorous, accurate and efficient practice in detection of Ebola virus of first batch detection team in SLE-CHN Biosafety Lab. Firstly, the key points of laboratory quality control system was described, including the managements and organizing, quality control documents and information management, instrument, reagents and supplies, assessment, facilities design and space allocation, laboratory maintenance and biosecurity. Secondly, the application of quality control methods in the whole process of the Ebola virus detection, including before the test, during the test and after the test, was analyzed. The excellent and professional laboratory staffs, the implementation of humanized management are the cornerstone of the success; High-level biological safety protection is the premise for effective quality control and completion of Ebola virus detection tasks. And professional logistics is prerequisite for launching the laboratory diagnosis of Ebola virus. The establishment and running of SLE-CHN Biosafety Lab has landmark significance for the friendship between Sierra Leone and China, and the lab becomes the most important base for Ebola virus laboratory testing in Sierra Leone.

Volume 8 No. 4 2008 December 2008 427 THE USE OF SAFETY ...

African Journals Online (AJOL)

the knowledge and use of safety devices and methods attached to the proper application of the ... farmers aware of the high risk due to inadequate education, training and safety devices in ..... delivery in Southwestern Nigeria. Ph. D Thesis.

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).

NeuroChip: a microfluidic electrophysiological device for genetic and chemical biology screening of Caenorhabditis elegans adult and larvae.

Directory of Open Access Journals (Sweden)

Chunxiao Hu

Full Text Available Genetic and chemical biology screens of C. elegans have been of enormous benefit in providing fundamental insight into neural function and neuroactive drugs. Recently the exploitation of microfluidic devices has added greater power to this experimental approach providing more discrete and higher throughput phenotypic analysis of neural systems. Here we make a significant addition to this repertoire through the design of a semi-automated microfluidic device, NeuroChip, which has been optimised for selecting worms based on the electrophysiological features of the pharyngeal neural network. We demonstrate this device has the capability to sort mutant from wild-type worms based on high definition extracellular electrophysiological recordings. NeuroChip resolves discrete differences in excitatory, inhibitory and neuromodulatory components of the neural network from individual animals. Worms may be fed into the device consecutively from a reservoir and recovered unharmed. It combines microfluidics with integrated electrode recording for sequential trapping, restraining, recording, releasing and recovering of C. elegans. Thus mutant worms may be selected, recovered and propagated enabling mutagenesis screens based on an electrophysiological phenotype. Drugs may be rapidly applied during the recording thus permitting compound screening. For toxicology, this analysis can provide a precise description of sub-lethal effects on neural function. The chamber has been modified to accommodate L2 larval stages showing applicability for small size nematodes including parasitic species which otherwise are not tractable to this experimental approach. We also combine NeuroChip with optogenetics for targeted interrogation of the function of the neural circuit. NeuroChip thus adds a new tool for exploitation of C. elegans and has applications in neurogenetics, drug discovery and neurotoxicology.

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...

Monitor for safety engineering facility

International Nuclear Information System (INIS)

Sato, Akira; Kaneda, Mitsunori.

1982-01-01

Purpose: To improve the reactor safety and decrease misoperation upon periodical inspection by instantly obtaining the judgement for the stand-by states in engineering safety facilities of a nuclear power plant. Constitution: Process inputs representing the states of valves, pumps, flowrates or the likes of the facility are gathered into an input device and inputted to a status monitor. The status of the facility inputted to the input device are judged for each of the inputs in a judging section and recognized as a present system stand-by pattern of the system (Valve) to be inspected. While on the other hand, a normal system stand-by pattern previously stored in a memory unit is read out by an instruction from an operator console and judged by comparison with the system stand-by pattern in a comparison section. The results are displayed on a display device. Upon periodical inspection, inspection procedures stored in the memory unit are displayed on the display device by the instruction from the operator console. (Seki, T.)

X-ray safety at the Los Alamos National Laboratory

International Nuclear Information System (INIS)

Gutierrez, J.A.

1986-11-01

An organized and structured safety program for x-ray generating devices was initiated in October, 1979. An X-ray Device Control Office was established to manage the program that currently oversees the activities of 201 x-ray generating devices and to provide SOP reviews, perform shielding calculations, and provide training for both the operators and health physics x-ray device surveyors. The new program also establishes controls for procurement of new equipment, requires the writing of Standard Operating Procedures, requires training for operators and provides routine and non-routine safety inspections of x-ray generating devices. Prior to this program going into effect, the Laboratory had recorded nine documented x-ray related exposure accidents. Since then, there have been none. Program elements and experiences of interest to other x-ray device users are discussed. 3 refs

Norms concerning the programmable automatic control devices

International Nuclear Information System (INIS)

Fourmentraux, G.

1995-01-01

This presentation is a report of the studies carried out by the Work Group on Functioning Safety of Programmable Automatic Control Devices and by the Group for Prevention Studies (GEP) from the CEA. The objective of these groups is to evaluate the methods which could be used to estimate the functioning safety of control and instrumentation systems involved in the Important Elements for Safety (EIS) of the Basic Nuclear Installations (INB) of the CEA, and also to carry out a qualification of automatic control devices. Norms, protocols and tools for the evaluation are presented. The problem comprises two aspects: the evaluation of fault avoidance techniques and the evaluation of fault control techniques used during the conceiving. For the fault avoidance techniques, the quality assurance organization, the environment tests, and the software quality plans are considered. For the fault control techniques, the different available tools and fault injection models are analysed. The results of an analysis carried out with the DEF.I tool from the National Institute for Research and Safety (INRS) are reported. (J.S.). 23 refs

Bioanalysis in microfluidic devices.

Science.gov (United States)

Khandurina, Julia; Guttman, András

2002-01-18

Microfabricated bioanalytical devices (also referred to as laboratory-on-a-chip or micro-TAS) offer highly efficient platforms for simultaneous analysis of a large number of biologically important molecules, possessing great potential for genome, proteome and metabolome studies. Development and implementation of microfluidic-based bioanalytical tools involves both established and evolving technologies, including microlithography, micromachining, micro-electromechanical systems technology and nanotechnology. This article provides an overview of the latest developments in the key device subject areas and the basic interdisciplinary technologies. Important aspects of DNA and protein analysis, interfacing issues and system integration are all thoroughly discussed, along with applications for this novel "synergized" technology in high-throughput separations of biologically important molecules. This review also gives a better understanding of how to utilize these technologies as well as to provide appropriate technical solutions to problems perceived as being more fundamental.

Reactor power control device

International Nuclear Information System (INIS)

Ishii, Yoshihiko; Arita, Setsuo; Miyamoto, Yoshiyuki; Fukazawa, Yukihisa; Ishii, Kazuhiko

1998-01-01

The present invention provides a reactor power control device capable of enhancing an operation efficiency while keeping high reliability and safety in a BWR type nuclear power plant. Namely, the device of the present invention comprises (1) a means for inputting a set value of a generator power and a set value of a reactor power, (2) a means for controlling the reactor power to either smaller one of the reactor power corresponding to the set value of the generator power and the set value of the reactor power. With such procedures, even if the nuclear power plant is set so as to operate it to make the reactor power 100%, when the generator power reaches the upper limit, the reactor power is controlled with a preference given to the upper limit value of the generator power. Accordingly, safety and reliability are not deteriorated. The operation efficiency of the plant can be improved. (I.S.)

Tritium radioluminescent devices, Health and Safety Manual

Energy Technology Data Exchange (ETDEWEB)

Traub, R.J.; Jensen, G.A.

1995-06-01

This document consolidates available information on the properties of tritium, including its environmental chemistry, its health physics, and safe practices in using tritium-activated RL lighting. It also summarizes relevant government regulations on RL lighting. Chapters are divided into a single-column part, which provides an overview of the topic for readers simply requiring guidance on the safety of tritium RL lighting, and a dual-column part for readers requiring more technical and detailed information.

Tritium radioluminescent devices, Health and Safety Manual

International Nuclear Information System (INIS)

Traub, R.J.; Jensen, G.A.

1995-06-01

This document consolidates available information on the properties of tritium, including its environmental chemistry, its health physics, and safe practices in using tritium-activated RL lighting. It also summarizes relevant government regulations on RL lighting. Chapters are divided into a single-column part, which provides an overview of the topic for readers simply requiring guidance on the safety of tritium RL lighting, and a dual-column part for readers requiring more technical and detailed information

Usage, biological activity, and safety of selected botanical dietary supplements consumed in the United States

Directory of Open Access Journals (Sweden)

P. Annécie Benatrehina

2018-04-01

Full Text Available In view of the continuous growth of the botanical dietary supplement industry and the increased popularity of lesser known or exotic botanicals, recent findings are described on the phytochemical composition and biological activities of five selected fruits consumed in the United States, namely, açaí, noni, mangosteen, black chokeberry, and maqui berry. A review of the ethnomedicinal uses of these plants has revealed some similarities ranging from wound-healing to the treatment of fever and infectious diseases. Laboratory studies on açaí have shown both its antioxidant and anti-inflammatory activities in vitro, and more importantly, its neuroprotective properties in animals. Anthraquinones and iridoid glucosides isolated from noni fruit induce the phase II enzyme quinone reductase (QR, and noni fruit juice exhibited antitumor and antidiabetic activities in certain animal models. Antitumorigenic effects of mangosteen in animal xenograft models of human cancers have been attributed to its xanthone content, and pure α-mangostin was shown to display antineoplastic activity in mice despite a reported low oral bioavailability. Work on the less extensively investigated black chokeberry and maqui berry has focused on recent isolation studies and has resulted in the identification of bioactive secondary metabolites with QR-inducing and hydroxyl-radical scavenging properties. On the basis of the safety studies and toxicity case reports described herein, these fruits may be generally considered as safe. However, cases of adulteration found in a commercialized açaí product and some conflicting results from mangosteen safety studies warrant further investigation on the safety of these marketed botanical dietary supplements. Keywords: Açaí, Noni, Mangosteen, Black chokeberry, Maqui berry

Reliability evaluation programmable logic devices

International Nuclear Information System (INIS)

Srivani, L.; Murali, N.; Thirugnana Murthy, D.; Satya Murty, S.A.V.

2014-01-01

Programmable Logic Devices (PLD) are widely used as basic building modules in high integrity systems, considering their robust features such as gate density, performance, speed etc. PLDs are used to implement digital design such as bus interface logic, control logic, sequencing logic, glue logic etc. Due to semiconductor evolution, new PLDs with state-of-the-art features are arriving to the market. Since these devices are reliable as per the manufacturer's specification, they were used in the design of safety systems. But due to their reduced market life, the availability of performance data is limited. So evaluating the PLD before deploying in a safety system is very important. This paper presents a survey on the use of PLDs in the nuclear domain and the steps involved in the evaluation of PLD using Quantitative Accelerated Life Testing. (author)

Electronic cigarette devices and oro-facial trauma (Literature review)

Science.gov (United States)

Ghazali, A. F.; Ismail, A. F.; Daud, A.

2017-08-01

Detrimental effects of cigarette smoking have been well described and recognized globally. With recent advancement of technology, electronic cigarette has been introduced and gained its popularity and became a global trend, especially among young adults. However, the safety of the electronic devices remains debatable. This paper aimed to compile and review the reported cases of oro-facial trauma related to the usage of electronic cigarette devices. A literature search was conducted using PubMed/Medline in December 2016. The search terms used were a combination of “oral trauma”, “dental trauma”, “oral injury” and “electronic cigarette”. The search included all abstract published from the inception of the database until December 2016. Abstract that was written in English, case report, letter to editors, clinical and human studies were included for analysis. All selected abstract were searched for full articles. A total of 8 articles were included for review. All of the articles were published in 2016 with mostly case reports. The sample size of the studies ranged from 1 to 15 patients. Seven of the included articles are from United States of America and one from Mexico. Our review concluded that the use of electronic cigarette devices posed not only a safety concern but also that the devices were mostly unregulated. There should be a recognized authority body to regulate the safety and standard of the electronic devices.

Safety and effectiveness of the INVATEC MO.MA proximal cerebral protection device during carotid artery stenting: results from the ARMOUR pivotal trial.

Science.gov (United States)

Ansel, Gary M; Hopkins, L Nelson; Jaff, Michael R; Rubino, Paolo; Bacharach, J Michael; Scheinert, Dierk; Myla, Subbarao; Das, Tony; Cremonesi, Alberto

2010-07-01

The multicenter ARMOUR (ProximAl PRotection with the MO.MA Device DUring CaRotid Stenting) trial evaluated the 30-day safety and effectiveness of the MO.MA Proximal Cerebral Protection Device (Invatec, Roncadelle, Italy) utilized to treat high surgical risk patients undergoing carotid artery stenting (CAS). Distal embolic protection devices (EPD) have been traditionally utilized during CAS. The MO.MA device acts as a balloon occlusion "endovascular clamping" system to achieve cerebral protection prior to crossing the carotid stenosis. This prospective registry enrolled 262 subjects, 37 roll-in and 225 pivotal subjects evaluated with intention to treat (ITT) from September 2007 to February 2009. Subjects underwent CAS using the MO.MA device. The primary endpoint, myocardial infarction, stroke, or death through 30 days (30-day major adverse cardiac and cerebrovascular events [MACCE]) was compared to a performance goal of 13% derived from trials utilizing distal EPD. For the ITT population, the mean age was 74.7 years with 66.7% of the cohort being male. Symptomatic patients comprised 15.1% and 28.9% were octogenarians. Device success was 98.2% and procedural success was 93.2%. The 30-day MACCE rate was 2.7% [95% CI (1.0-5.8%)] with a 30-day major stroke rate of 0.9%. No symptomatic patient suffered a stroke during this trial. The ARMOUR trial demonstrated that the MO.MA(R) Proximal Cerebral Protection Device is safe and effective for high surgical risk patients undergoing CAS. The absence of stroke in symptomatic patients is the lowest rate reported in any independently adjudicated prospective multicenter registry trial to date. (c) 2010 Wiley-Liss, Inc.

Adapting to Biology: Maintaining Container-Closure System Compatibility with the Therapeutic Biologic Revolution.

Science.gov (United States)

Degrazio, Dominick

Many pharmaceutical companies are transitioning their research and development drug product pipeline from traditional small-molecule injectables to the dimension of evolving therapeutic biologics. Important concerns associated with this changeover are becoming forefront, as challenges develop of varying complexity uncommon with the synthesis and production of traditional drugs. Therefore, alternative measures must be established that aim to preserve the efficacy and functionality of a biologic that might not be implemented for small molecules. Conserving protein stability is relative to perpetuating a net equilibrium of both intrinsic and extrinsic factors. Key to sustaining this balance is the ability of container-closure systems to maintain their compatibility with the ever-changing dynamics of therapeutic biologics. Failure to recognize and adjust the material properties of packaging components to support compatibility with therapeutic biologics can compromise patient safety, drug productivity, and biological stability. This review will examine the differences between small-molecule drugs and therapeutic biologics, lay a basic foundation for understanding the stability of therapeutic biologics, and demonstrate potential sources of container-closure systems' incompatibilities with therapeutic biologics at a mechanistic level. Many pharmaceutical companies are transitioning their research and development drug product pipeline from traditional small-molecule injectables to recombinantly derived therapeutic biologics. Concerns associated with this transformation are becoming prominent, as therapeutic biologics are uncharacteristic to small-molecule drugs. Maintaining the stability of a therapeutic biologic is a combination of balancing intrinsic factors and external elements within the biologic's microenvironment. An important aspect of this balance is relegated to the overall compatibility of primary, parenteral container-closure systems with therapeutic biologics

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...

Biological safety of nasal thallium-201 administration. A preclinical study for olfacto-scintigraphy

International Nuclear Information System (INIS)

Washiyama, Kohshin; Shiga, Hideaki; Hirota, Kyoko

2011-01-01

Nasal administration of thallium-201 ( 201 Tl) has previously been shown to be useful for the assessment of olfactory nerve connectivity in vivo. We assessed the biological effects of nasal 201 Tl administration in mice to determine its safety before conducting clinical trials on humans. 201 Tl uptake was evaluated in normal mice (n=5) in vivo by using a high-resolution gamma camera and radiography 15 min, 1, 2 and 9 d after administration of 201 TlCl to the right side of the nasal cavity (10 μl 201 TlCl per nostril, 74 MBq/ml). Murine olfactory epithelial thickness (n=5) was measured 9 d following nasal administration of 201 TlCl. We assessed the odor detection ability of normal mice (n=8) following nasal administration of 201 TlCl to both sides of the nasal cavity, by observing cycloheximide solution avoidance behavior. We subsequently administrated 201 TlCl (n=4) or saline (n=4) to both nostrils to assess the odor detection ability of mice following bilateral olfactory nerve transection. 201 Tl uptake by the nasal cavity decreased immediately following nasal administration of 201 Tl in normal mice. Nasal administration of 201 Tl did not affect the olfactory epithelial thickness or the odor detection ability of normal mice. Recovery of odor detection ability following olfactory nerve transection was not significantly different between mice nasally administered with 201 Tl, and mice administered with saline. Thus, nasal administration of 201 Tl for the diagnosis of traumatic olfactory impairment did not produce harmful biological effects in vivo. (author)

Patterns of use and impact of standardised MedDRA query analyses on the safety evaluation and review of new drug and biologics license applications.

Directory of Open Access Journals (Sweden)

Lin-Chau Chang

Full Text Available Standardised MedDRA Queries (SMQs have been developed since the early 2000's and used by academia, industry, public health, and government sectors for detecting safety signals in adverse event safety databases. The purpose of the present study is to characterize how SMQs are used and the impact in safety analyses for New Drug Application (NDA and Biologics License Application (BLA submissions to the United States Food and Drug Administration (USFDA.We used the PharmaPendium database to capture SMQ use in Summary Basis of Approvals (SBoAs of drugs and biologics approved by the USFDA. Characteristics of the drugs and the SMQ use were employed to evaluate the role of SMQ safety analyses in regulatory decisions and the veracity of signals they revealed.A comprehensive search of the SBoAs yielded 184 regulatory submissions approved from 2006 to 2015. Search strategies more frequently utilized restrictive searches with "narrow terms" to enhance specificity over strategies using "broad terms" to increase sensitivity, while some involved modification of search terms. A majority (59% of 1290 searches used descriptive statistics, however inferential statistics were utilized in 35% of them. Commentary from reviewers and supervisory staff suggested that a small, yet notable percentage (18% of 1290 searches supported regulatory decisions. The searches with regulatory impact were found in 73 submissions (40% of the submissions investigated. Most searches (75% of 227 searches with regulatory implications described how the searches were confirmed, indicating prudence in the decision-making process.SMQs have an increasing role in the presentation and review of safety analysis for NDAs/BLAs and their regulatory reviews. This study suggests that SMQs are best used for screening process, with descriptive statistics, description of SMQ modifications, and systematic verification of cases which is crucial for drawing regulatory conclusions.

Patterns of use and impact of standardised MedDRA query analyses on the safety evaluation and review of new drug and biologics license applications.

Science.gov (United States)

Chang, Lin-Chau; Mahmood, Riaz; Qureshi, Samina; Breder, Christopher D

2017-01-01

Standardised MedDRA Queries (SMQs) have been developed since the early 2000's and used by academia, industry, public health, and government sectors for detecting safety signals in adverse event safety databases. The purpose of the present study is to characterize how SMQs are used and the impact in safety analyses for New Drug Application (NDA) and Biologics License Application (BLA) submissions to the United States Food and Drug Administration (USFDA). We used the PharmaPendium database to capture SMQ use in Summary Basis of Approvals (SBoAs) of drugs and biologics approved by the USFDA. Characteristics of the drugs and the SMQ use were employed to evaluate the role of SMQ safety analyses in regulatory decisions and the veracity of signals they revealed. A comprehensive search of the SBoAs yielded 184 regulatory submissions approved from 2006 to 2015. Search strategies more frequently utilized restrictive searches with "narrow terms" to enhance specificity over strategies using "broad terms" to increase sensitivity, while some involved modification of search terms. A majority (59%) of 1290 searches used descriptive statistics, however inferential statistics were utilized in 35% of them. Commentary from reviewers and supervisory staff suggested that a small, yet notable percentage (18%) of 1290 searches supported regulatory decisions. The searches with regulatory impact were found in 73 submissions (40% of the submissions investigated). Most searches (75% of 227 searches) with regulatory implications described how the searches were confirmed, indicating prudence in the decision-making process. SMQs have an increasing role in the presentation and review of safety analysis for NDAs/BLAs and their regulatory reviews. This study suggests that SMQs are best used for screening process, with descriptive statistics, description of SMQ modifications, and systematic verification of cases which is crucial for drawing regulatory conclusions.

30 CFR 90.206 - Approved sampling devices; equivalent concentrations.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved sampling devices; equivalent... LABOR COAL MINE SAFETY AND HEALTH MANDATORY HEALTH STANDARDS-COAL MINERS WHO HAVE EVIDENCE OF THE DEVELOPMENT OF PNEUMOCONIOSIS Sampling Procedures § 90.206 Approved sampling devices; equivalent...

Environmental contamination by cyclophosphamide preparation: Comparison of conventional manual production in biological safety cabinet and robot-assisted production by APOTECAchemo.

Science.gov (United States)

Schierl, Rudolf; Masini, Carla; Groeneveld, Svenja; Fischer, Elke; Böhlandt, Antje; Rosini, Valeria; Paolucci, Demis

2016-02-01

The aim of this study was to compare environmental contamination of cyclophosphamide (CP) during 1 week of drug compounding by conventional manual procedure in a biological safety cabinet (BSC) with laminar airflow and a new robotic drug preparation system (APOTECAchemo). During four consecutive days, similar numbers of infusion bags with cyclophosphamide were prepared with both techniques in a cross-over design. Wipe samples (49 for BSC, 50 for APOTECAchemo) were taken at several locations (gloves, infusion bags, trays, BSC-benches, floor) in the pharmacy and analyzed for CP concentrations by GC-MSMS (LOD 0.2 ng/sample). The detection rate was 70% in the BSC versus 15% in APOTECAchemo. During manual preparation of admixtures using BSC contamination with CP was below 0.001 ng/cm(2) at most locations, but significant on gloves (0.0004-0.0967 ng/cm(2)) and the majority (70%) of infusion bags (preparation by APOTECAchemo, gloves (1 of 8: 0.0007 ng/cm(2)) and infusion bags (3 of 20: 0.0005, 0.0019, 0.0094 ng/cm(2)) were considerably less contaminated. Residual contamination was found on the surfaces under the dosing device in the compounding area (0.0293-0.1603 ng/cm(2)) inside the robotic system. Compared to outcomes of other studies, our results underline good manufacturing procedures in this pharmacy with low contamination for both techniques (BSC and APOTECAchemo). Comparison of both preparation procedures validated that contamination of infusion bags was much lower by using the robotic system. © The Author(s) 2014.

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.

Laboratory Safety Manual for Alabama Schools. Bulletin 1975. No. 20.

Science.gov (United States)

Alabama State Dept. of Education, Montgomery.

This document presents the Alabama State Department of Education guidelines for science laboratory safety, equipment, storage, chemical safety, rocket safety, electrical safety, safety with radioisotopes, and safety with biologicals. Also included is a brief bibliography, a teacher's checklist, a listing of laser facts and regulations, and a…

Models for synthetic biology.

Science.gov (United States)

Kaznessis, Yiannis N

2007-11-06

Synthetic biological engineering is emerging from biology as a distinct discipline based on quantification. The technologies propelling synthetic biology are not new, nor is the concept of designing novel biological molecules. What is new is the emphasis on system behavior. The objective is the design and construction of new biological devices and systems to deliver useful applications. Numerous synthetic gene circuits have been created in the past decade, including bistable switches, oscillators, and logic gates, and possible applications abound, including biofuels, detectors for biochemical and chemical weapons, disease diagnosis, and gene therapies. More than fifty years after the discovery of the molecular structure of DNA, molecular biology is mature enough for real quantification that is useful for biological engineering applications, similar to the revolution in modeling in chemistry in the 1950s. With the excitement that synthetic biology is generating, the engineering and biological science communities appear remarkably willing to cross disciplinary boundaries toward a common goal.

1994 Baseline biological studies for the Device Assembly Facility at the Nevada Test Site

Energy Technology Data Exchange (ETDEWEB)

Townsend, Y.E. [ed.; Woodward, B.D.; Hunter, R.B.; Greger, P.D.; Saethre, M.B.

1995-02-01

This report describes environmental work performed at the Device Assembly Facility (DAF) in 1994 by the Basic Environmental Monitoring and Compliance Program (BECAMP). The DAF is located near the Mojave-Great Basin desert transition zone 27 km north of Mercury. The area immediately around the DAF building complex is a gentle slope cut by 1 to 3 m deep arroyos, and occupied by transitional vegetation. In 1994, construction activities were largely limited to work inside the perimeter fence. The DAF was still in a preoperational mode in 1994, and no nuclear materials were present. The DAF facilities were being occupied so there was water in the sewage settling pond, and the roads and lights were in use. Sampling activities in 1994 represent the first year in the proposed monitoring scheme. The proposed biological monitoring plan gives detailed experimental protocols. Plant, lizard, tortoise, small mammal, and bird surveys were performed in 1994. The authors briefly outline procedures employed in 1994. Studies performed on each taxon are reviewed separately then summarized in a concluding section.

Industrial Personal Computer based Display for Nuclear Safety System

International Nuclear Information System (INIS)

Kim, Ji Hyeon; Kim, Aram; Jo, Jung Hee; Kim, Ki Beom; Cheon, Sung Hyun; Cho, Joo Hyun; Sohn, Se Do; Baek, Seung Min

2014-01-01

The safety display of nuclear system has been classified as important to safety (SIL:Safety Integrity Level 3). These days the regulatory agencies are imposing more strict safety requirements for digital safety display system. To satisfy these requirements, it is necessary to develop a safety-critical (SIL 4) grade safety display system. This paper proposes industrial personal computer based safety display system with safety grade operating system and safety grade display methods. The description consists of three parts, the background, the safety requirements and the proposed safety display system design. The hardware platform is designed using commercially available off-the-shelf processor board with back plane bus. The operating system is customized for nuclear safety display application. The display unit is designed adopting two improvement features, i.e., one is to provide two separate processors for main computer and display device using serial communication, and the other is to use Digital Visual Interface between main computer and display device. In this case the main computer uses minimized graphic functions for safety display. The display design is at the conceptual phase, and there are several open areas to be concreted for a solid system. The main purpose of this paper is to describe and suggest a methodology to develop a safety-critical display system and the descriptions are focused on the safety requirement point of view

Industrial Personal Computer based Display for Nuclear Safety System

Energy Technology Data Exchange (ETDEWEB)

Kim, Ji Hyeon; Kim, Aram; Jo, Jung Hee; Kim, Ki Beom; Cheon, Sung Hyun; Cho, Joo Hyun; Sohn, Se Do; Baek, Seung Min [KEPCO, Youngin (Korea, Republic of)

2014-08-15

The safety display of nuclear system has been classified as important to safety (SIL:Safety Integrity Level 3). These days the regulatory agencies are imposing more strict safety requirements for digital safety display system. To satisfy these requirements, it is necessary to develop a safety-critical (SIL 4) grade safety display system. This paper proposes industrial personal computer based safety display system with safety grade operating system and safety grade display methods. The description consists of three parts, the background, the safety requirements and the proposed safety display system design. The hardware platform is designed using commercially available off-the-shelf processor board with back plane bus. The operating system is customized for nuclear safety display application. The display unit is designed adopting two improvement features, i.e., one is to provide two separate processors for main computer and display device using serial communication, and the other is to use Digital Visual Interface between main computer and display device. In this case the main computer uses minimized graphic functions for safety display. The display design is at the conceptual phase, and there are several open areas to be concreted for a solid system. The main purpose of this paper is to describe and suggest a methodology to develop a safety-critical display system and the descriptions are focused on the safety requirement point of view.

Medical Devices; Immunology and Microbiology Devices; Classification of the Assayed Quality Control Material for Clinical Microbiology Assays. Final order.

Science.gov (United States)

2017-07-27

The Food and Drug Administration (FDA, Agency, or we) is classifying the assayed quality control material for clinical microbiology assays 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 assayed quality control material for clinical microbiology assays' classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device.

Hydrogen Safety Issues Compared to Safety Issues with Methane and Propane

International Nuclear Information System (INIS)

Green, Michael A.

2005-01-01

The hydrogen economy is not possible if the safety standards currently applied to liquid hydrogen and hydrogen gas by many laboratories are applied to devices that use either liquid or gaseous hydrogen. Methane and propane are commonly used by ordinary people without the special training. This report asks, 'How is hydrogen different from flammable gasses that are commonly being used all over the world?' This report compares the properties of hydrogen, methane and propane and how these properties may relate to safety when they are used in both the liquid and gaseous state. Through such an analysis, sensible safety standards for the large-scale (or even small-scale) use of liquid and gaseous hydrogen systems can be developed. This paper is meant to promote discussion of issues related to hydrogen safety so that engineers designing equipment can factor sensible safety standards into their designs

Hydrogen Safety Issues Compared to Safety Issues with Methane andPropane

Energy Technology Data Exchange (ETDEWEB)

Green, Michael A.

2005-08-20

The hydrogen economy is not possible if the safety standards currently applied to liquid hydrogen and hydrogen gas by many laboratories are applied to devices that use either liquid or gaseous hydrogen. Methane and propane are commonly used by ordinary people without the special training. This report asks, 'How is hydrogen different from flammable gasses that are commonly being used all over the world?' This report compares the properties of hydrogen, methane and propane and how these properties may relate to safety when they are used in both the liquid and gaseous state. Through such an analysis, sensible safety standards for the large-scale (or even small-scale) use of liquid and gaseous hydrogen systems can be developed. This paper is meant to promote discussion of issues related to hydrogen safety so that engineers designing equipment can factor sensible safety standards into their designs.

A 3D printed microfluidic perfusion device for multicellular spheroid cultures.

Science.gov (United States)

Ong, Louis Jun Ye; Islam, Anik; DasGupta, Ramanuj; Iyer, Narayanan Gopalakkrishna; Leo, Hwa Liang; Toh, Yi-Chin

2017-09-11

The advent of 3D printing technologies promises to make microfluidic organ-on-chip technologies more accessible for the biological research community. To date, hydrogel-encapsulated cells have been successfully incorporated into 3D printed microfluidic devices. However, there is currently no 3D printed microfluidic device that can support multicellular spheroid culture, which facilitates extensive cell-cell contacts important for recapitulating many multicellular functional biological structures. Here, we report a first instance of fabricating a 3D printed microfluidic cell culture device capable of directly immobilizing and maintaining the viability and functionality of 3D multicellular spheroids. We evaluated the feasibility of two common 3D printing technologies i.e. stereolithography (SLA) and PolyJet printing, and found that SLA could prototype a device comprising of cell immobilizing micro-structures that were housed within a microfluidic network with higher fidelity. We have also implemented a pump-free perfusion system, relying on gravity-driven flow to perform medium perfusion in order to reduce the complexity and footprint of the device setup, thereby improving its adaptability into a standard biological laboratory. Finally, we demonstrated the biological performance of the 3D printed device by performing pump-free perfusion cultures of patient-derived parental and metastatic oral squamous cell carcinoma tumor and liver cell (HepG2) spheroids with good cell viability and functionality. This paper presents a proof-of-concept in simplifying and integrating the prototyping and operation of a microfluidic spheroid culture device, which will facilitate its applications in various drug efficacy, metabolism and toxicity studies.

78 FR 35173 - Physical Medicine Devices; Reclassification of Stair-Climbing Wheelchairs

Science.gov (United States)

2013-06-12

... necessary to assure the safety and effectiveness of the device. II. Regulatory History of the Device On... petitioner's own history of use, the petitioner's own preclinical testing, and the development of relevant... inclined planes (forward, backward, and lateral); [cir] Demonstration of the ability of the device to...

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 ...

Carbon nanostructure-based field-effect transistors for label-free chemical/biological sensors.

Science.gov (United States)

Hu, PingAn; Zhang, Jia; Li, Le; Wang, Zhenlong; O'Neill, William; Estrela, Pedro

2010-01-01

Over the past decade, electrical detection of chemical and biological species using novel nanostructure-based devices has attracted significant attention for chemical, genomics, biomedical diagnostics, and drug discovery applications. The use of nanostructured devices in chemical/biological sensors in place of conventional sensing technologies has advantages of high sensitivity, low decreased energy consumption and potentially highly miniaturized integration. Owing to their particular structure, excellent electrical properties and high chemical stability, carbon nanotube and graphene based electrical devices have been widely developed for high performance label-free chemical/biological sensors. Here, we review the latest developments of carbon nanostructure-based transistor sensors in ultrasensitive detection of chemical/biological entities, such as poisonous gases, nucleic acids, proteins and cells.

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...

Microfluidic chip-capillary electrophoresis devices

CERN Document Server

Fung, Ying Sing; Du, Fuying; Guo, Wenpeng; Ma, Tongmei; Nie, Zhou; Sun, Hui; Wu, Ruige; Zhao, Wenfeng

2015-01-01

Capillary electrophoresis (CE) and microfluidic chip (MC) devices are relatively mature technologies, but this book demonstrates how they can be integrated into a single, revolutionary device that can provide on-site analysis of samples when laboratory services are unavailable. By introducing the combination of CE and MC technology, Microfluidic Chip-Capillary Electrophoresis Devices broadens the scope of chemical analysis, particularly in the biomedical, food, and environmental sciences. The book gives an overview of the development of MC and CE technology as well as technology that now allows for the fabrication of MC-CE devices. It describes the operating principles that make integration possible and illustrates some achievements already made by the application of MC-CE devices in hospitals, clinics, food safety, and environmental research. The authors envision further applications for private and public use once the proof-of-concept stage has been passed and obstacles to increased commercialization are ad...

Biologic and Conventional Systemic Therapies Show Similar Safety and Efficacy in Elderly and Adult Patients With Moderate to Severe Psoriasis.

Science.gov (United States)

Garber, Caren; Plotnikova, Natalia; Au, Shiu-chung; Sorensen, Eric P; Gottlieb, Alice

2015-08-01

Despite the aging population, few studies have documented the treatment of geriatric psoriasis. The purpose of this study is to compare the efficacy, safety, and prescribing patterns of biologics and conventional systemic medications in elderly versus adult psoriasis. All patient visits coded for psoriasis or psoriatic arthritis (ICD-9 696.1 or 696.0) at the Tufts Medical Center General Dermatology Clinic from January 1, 2008, to March 1, 2015 were included in this retrospective cohort study. The outcome measure used was the validated simple-measure for assessing psoriasis activity (S-MAPA), the product of the physician's global assessment and the body surface area. 194 patients who underwent 278 treatment courses were included in the study. 48 patients were included in the elderly cohort (≥ 65 years old) and 146 in the adult cohort (18-64 years old). There was no significant difference in S-MAPA improvement at 12 weeks between the two cohorts when treated with biologics (42.92% improvement in adults, 48.77% in elderly; P=0.498) or conventional systemics (43.96% and 51.82%, respectively; P=0.448). Within the elderly cohort, there was no significant difference in efficacy of biologics versus conventional systemics at any time point. Topical prescription rates were significantly higher in the elderly cohort ( P=0.004) while biologic prescription rates were significantly lower ( P=0.014) despite the same baseline S-MAPA in both age groups. For both biologics and conventional systemics, there was no statistically significant intergroup difference in the rate of adverse events ( P=0.322 for biologics; P=0.581 for conventional systemics) or infection ( P=0.753 for biologics; P=0.828 for conventional systemics). Within the elderly cohort, there was a higher rate of adverse events with conventional systemic treatment than with biologic treatment ( P=0.033). This study provides preliminary evidence to suggest that biologic and conventional systemic therapies are similarly

Vehicle Battery Safety Roadmap Guidance

Energy Technology Data Exchange (ETDEWEB)

Doughty, D. H.

2012-10-01

The safety of electrified vehicles with high capacity energy storage devices creates challenges that must be met to assure commercial acceptance of EVs and HEVs. High performance vehicular traction energy storage systems must be intrinsically tolerant of abusive conditions: overcharge, short circuit, crush, fire exposure, overdischarge, and mechanical shock and vibration. Fail-safe responses to these conditions must be designed into the system, at the materials and the system level, through selection of materials and safety devices that will further reduce the probability of single cell failure and preclude propagation of failure to adjacent cells. One of the most important objectives of DOE's Office of Vehicle Technologies is to support the development of lithium ion batteries that are safe and abuse tolerant in electric drive vehicles. This Roadmap analyzes battery safety and failure modes of state-of-the-art cells and batteries and makes recommendations on future investments that would further DOE's mission.

APR1400 Fluidic Device Sensitivity Test

International Nuclear Information System (INIS)

Choi, Nam Hyun; Chu, In Cheol; Min, Kyong Ho; Song, Chul Hwa

2005-12-01

In the safety injection tank at the emergency core cooling system of APR1400, a new safety design feature, passive fluidic device is equipped which includes no active driving system. It is essential to evaluate the new design feature with various experiments. For this reason, three categories of sensitivity tests have been performed in the present study. As the first sensitivity experiment, the effect of the height of the stand pipe was investigated. The second sensitivity test was conducted with removing the insert plate gasket to examine its effect. The effect of the expansion of the control nozzle width was ascertained from the third sensitivity test. The results of each test showed that the passive fluidic device which will be equipped in the SIT tank of APR1400 has great integrity and repeatability

Safety strategy and safety analysis of nuclear power plants

International Nuclear Information System (INIS)

Franzen, L.F.

1976-01-01

The safety strategy for nuclear power plants is characterized by the fact that the high level of safety was attained not as a result of experience, but on the basis of preventive accident analyses and the finding derived from such analyses. Although, in these accident analyses, the deterministic approach is predominant, it is supplemented by reliability analyses. The accidents analyzed in nuclear licensing procedures cover a wide spectrum from minor incidents to the design basis accidents which determine the design of the safety devices. The initial and boundary conditions, which are essentail for accident analyses, and the determination of the loads occurring in various states during regular operation and in accidents flow into the design of the individual systems and components. The inevitable residual risk and its origins are discussed. (orig.) [de

Medical devices, electronic health records and assuring patient safety : Future challenges?

NARCIS (Netherlands)

Kalkman, Cor J.

2015-01-01

The patient safety movement was triggered by publications showing that modern health care is more unsafe than road travel and that more patients are killed annually by avoidable adverse events than by breast cancer [1]. As a result, an urgent need to improve patient safety has dominated

Efficiency and safety of percuSurge distal protection device in acute ...

African Journals Online (AJOL)

user

2011-04-25

Apr 25, 2011 ... myocardial infarction. The long-term effects of the distal protection device are still in controversy. The enhanced myocardial efficacy and recovery by aspiration of liberated debris (EMERALD) trial failed to show the effectiveness of the distal protection device in patients with AMI (Yamada and Topol, 2000).

Telemetry System of Biological Parameters

Directory of Open Access Journals (Sweden)

Jan Spisak

2005-01-01

Full Text Available The mobile telemetry system of biological parameters serves for reading and wireless data transfer of measured values of selected biological parameters to an outlying computer. It concerns basically long time monitoring of vital function of car pilot.The goal of this projects is to propose mobile telemetry system for reading, wireless transfer and processing of biological parameters of car pilot during physical and psychical stress. It has to be made with respect to minimal consumption, weight and maximal device mobility. This system has to eliminate signal noise, which is created by biological artifacts and disturbances during the data transfer.

Reactor control device

International Nuclear Information System (INIS)

Fukami, Haruo; Morimoto, Yoshinori.

1981-01-01

Purpose: To operate a reactor always with safety operation while eliminating the danger of tripping. Constitution: In a reactor control device adapted to detect the process variants of a reactor, control a control rod drive controlling system based on the detected signal to thereby control the driving the control rods, control the reactor power and control the electric power generated from an electric generator by the output from the reactor, detection means is provided for the detection of the electric power from said electric generator, and a compensation device is provided for outputting control rod driving compensation signals to the control rod driving controlling system in accordance with the amount of variation in the detected value. (Seki, T.)

Synthetic biology of polyketide synthases

DEFF Research Database (Denmark)

Yuzawa, Satoshi; Backman, Tyler W.H.; Keasling, Jay D.

2018-01-01

). The modules are composed of enzymatic domains that share sequence and functional similarity across all known PKSs. We have used the nomenclature of synthetic biology to classify the enzymatic domains and modules as parts and devices, respectively, and have generated detailed lists of both. In addition, we...... realize the potential that synthetic biology approaches bring to this class of molecules....

Safety Education in Driving. 2nd Revision.

Science.gov (United States)

Ohio State Univ., Columbus. Vocational Instructional Materials Lab.

Intended for driving instruction students, this publication contains instructional materials for safety education. It contains six sections on facts and figures; defensive driving; safety devices; restraints; emergency situations; and other highway users. Each section consists of reading material followed by an activity or activities. A total of…

Automatic shadowing device for electron microscopy

Energy Technology Data Exchange (ETDEWEB)

Bishop, F W; Bogitch, S

1960-01-01

For the past ten years in the laboratory of the Department of Nuclear Medicine and Radiation Biology at the University of California, and before that at Rochester, New York, every evaporation was done with the aid of an automatic shadowing device. For several months the automatic shadowing device has been available at the Atomic Bomb Casualty Commission (ABCC) Hiroshima, Japan with the modifications described. 1 reference.

Plasma position and shape control device for thermonuclear device

International Nuclear Information System (INIS)

Takeuchi, Kazuhiro; Abe, Mitsushi; Kinoshita, Shigemi.

1993-01-01

A plasma position and shape control system is constituted with a measuring device, a quenching probability calculation section and a control calculation section. A quenching probability is calculated in the quenching probability calculation section by using a measuring data on temperature, electric current and magnetic field of superconductive coils, based on a margin upto a limit value. The control calculation section selects a control method which decreases applied voltage or current instruction value as the quenching probability of the coils is higher. Since the quenching probability of the superconductive coils can be forecast and a state of low quenching danger can be selected, the safety of the device is improved. When the quenching danger is allowed to a predetermined value, a wide operation region can be provided. (N.H.)

Control device for a nuclear reactor with a multitude of control rods, extending into the reactor core from above, with linear drive mechanisms and additional gripper devices

International Nuclear Information System (INIS)

Bevilacqua, F.

1979-01-01

The components of the additional gripper devices with magnetically operated finger-shaped latches are separated from the also magnetically operated latches of the linear drive mechanisms in order to avoid common-mode failures when fast shutdown is required. Only part of the safety rods are held by the additional gripping devices in the withdrawn position. There is provided for recording elements indicating positively which one of the safety locks is gearing with the control rods. At the upper end of each control rod there is a coupling head held by electromagnetically operated locking devices in the withdrawn position, if control power is available. (DG) [de

Evaluation of Automated Flagger Assistance Devices

Science.gov (United States)

2018-02-01

Automated flagger assistance devices (AFADs) are designed to improve worker safety by replacing flaggers who are typically located near traffic approaching a work zone. In this study, a new AFAD developed by the Missouri Department of Transportation ...

Safety code 19: recommended safety procedures for the selection, installation and use of x-ray diffraction equipment

International Nuclear Information System (INIS)

1984-01-01

This document is one of a series of Safety Codes prepared by the Radiation Protection Bureau to set out requirements for the safe use of radiation emitting devices. The equipment and installation guidelines and safety procedures detailed in this Code are primarily for the instruction and guidance of persons employed in Federal Public Service Departments and Agencies, as well as those coming under the jurisdiction of the Canada Labour Code. This Safety Code is also intended to assist other users of X-ray diffraction equipment to select safe equipment and to install and use it so that the radiation hazard to the operator and other persons in its vicinity is negligible. It should be noted that facilities under provincial jurisdiction may be subject to requirements specified under provincial statutes. This Code supersedes Safety Code RPD-SC-7, entitled 'Requirements For Non-Medical X-Ray Equipment, Use and Installation', insofar as X-ray diffraction equipment is concerned, and it is intended to complement X-ray equipment design, construction and performance standards promulgated under the Radiation Emitting Devices Act

Review of safety reports involving electronic flight bags

Science.gov (United States)

2009-04-27

Electronic Flight Bags (EFBs) are a relatively new device used by pilots. Even so, 37 safety-related events involving EFBs were identified from the public online Aviation Safety Reporting System (ASRS) database as of June 2008. In addition, two accid...

Evaluation of safety requirements of erbium laser equipment used in dentistry

International Nuclear Information System (INIS)

Braga, Flavio Hamilton

2002-01-01

The erbium laser (Er:YAG) has been used in several therapeutic processes. Erbium lasers, however, operate with energies capable to produce lesions in biological tissues. Aiming the safe use, the commercialization of therapeutic laser equipment is controlled in Brazil, where the equipment should comply with quality and safety requirement prescribed in technical regulations. The objective of this work is to evaluate the quality and safety requirements of a commercial therapeutic erbium laser according to Brazilian regulations, and to discuss a risk control program intended to minimize the accidental exposition at dangerous laser radiation levels. It was verified that the analyzed laser can produce lesions in the skin and eyes, when exposed to laser radiation at distances smaller than 80 cm by 10 s or more. In these conditions, the use of protection glasses is recommended to the personnel that have access to the laser operation ambient. It was verified that the user's training and the presence of a target indicator are fundamental to avoid damages in the skin and buccal cavity. It was also verified that the knowledge and the correct use of the equipment safety devices, and the application of technical and administrative measures is efficient to minimize the risk of dangerous expositions to the laser radiation. (author)

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

Integrated microfluidic device for single-cell trapping and spectroscopy

KAUST Repository

Liberale, Carlo

2013-02-13

Optofluidic microsystems are key components towards lab-on-a-chip devices for manipulation and analysis of biological specimens. In particular, the integration of optical tweezers (OT) in these devices allows stable sample trapping, while making available mechanical, chemical and spectroscopic analyses.

Integrated microfluidic device for single-cell trapping and spectroscopy

KAUST Repository

Liberale, Carlo; Cojoc, G.; Bragheri, F.; Minzioni, P.; Perozziello, G.; La Rocca, R.; Ferrara, L.; Rajamanickam, V.; Di Fabrizio, Enzo M.; Cristiani, I.

2013-01-01

Optofluidic microsystems are key components towards lab-on-a-chip devices for manipulation and analysis of biological specimens. In particular, the integration of optical tweezers (OT) in these devices allows stable sample trapping, while making available mechanical, chemical and spectroscopic analyses.

Report by the work-group on 'safety of medical devices emitting ionizing radiations'. Articulation of radiation protection requirements of the 97/43/Euratom directive and IAEA recommendations with the essential requirements of the 93/42/CEE directive related to medical devices used in external radiotherapy

International Nuclear Information System (INIS)

2010-01-01

As some dysfunctions and events had been reported in 2007 and 2008 in field of radiotherapy, this report aims at clarifying the articulation between the different European regulations concerning medical devices emitting ionizing radiations and radiation protection. The authors report a survey with device manufacturers, and analyze the content of the different regulations and recommendations. Then, the authors recommend and propose a set of actions related to the IAEA requirements and recommendations, to CE marking requirements, and to new radiation protection and safety requirements present in the Euratom directive

Medical Devices; Obstetrical and Gynecological Devices; Classification of the Pressure Wedge for the Reduction of Cesarean Delivery. Final order.

Science.gov (United States)

2017-12-28

The Food and Drug Administration (FDA or we) is classifying the pressure wedge for the reduction of cesarean delivery 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 pressure wedge for the reduction of cesarean delivery'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.

Safety flywheel

Energy Technology Data Exchange (ETDEWEB)

Schneider, R.T.

1977-01-17

The patent application relates to an inertial energy storage device employing a safety flywheel which is made of flexible material such as a twisted rope ring. The rigidity required for such a device is achieved through centrifugal forces inherent in such a device when it is operating. A small number of the strands of the rope ring have a tensile strength that is lower than the vast majority of the strands of the rope ring whereby should any of these strands fail, they will begin to whiplash allowing such a failure to be detected and braked before a catastrophic failure occurs. This is accomplished by the inclusion of glass tubes located around the periphery of the flywheel. The tubes are in communication with a braking fluid reservoir. The flywheel and glass tubes are enclosed within a vacuum-tight housing.

76 FR 67020 - Railroad Safety Advisory Committee; Notice of Meeting

Science.gov (United States)

2011-10-28

... Device Distraction, Critical Incident, Track Safety Standards, Dark Territory, Passenger Safety, and... requisite range of views and expertise necessary to discharge its responsibilities. See the RSAC Web site...

Microfluidic Devices in Advanced Caenorhabditis elegans Research

Directory of Open Access Journals (Sweden)

Muniesh Muthaiyan Shanmugam

2016-08-01

Full Text Available The study of model organisms is very important in view of their potential for application to human therapeutic uses. One such model organism is the nematode worm, Caenorhabditis elegans. As a nematode, C. elegans have ~65% similarity with human disease genes and, therefore, studies on C. elegans can be translated to human, as well as, C. elegans can be used in the study of different types of parasitic worms that infect other living organisms. In the past decade, many efforts have been undertaken to establish interdisciplinary research collaborations between biologists, physicists and engineers in order to develop microfluidic devices to study the biology of C. elegans. Microfluidic devices with the power to manipulate and detect bio-samples, regents or biomolecules in micro-scale environments can well fulfill the requirement to handle worms under proper laboratory conditions, thereby significantly increasing research productivity and knowledge. The recent development of different kinds of microfluidic devices with ultra-high throughput platforms has enabled researchers to carry out worm population studies. Microfluidic devices primarily comprises of chambers, channels and valves, wherein worms can be cultured, immobilized, imaged, etc. Microfluidic devices have been adapted to study various worm behaviors, including that deepen our understanding of neuromuscular connectivity and functions. This review will provide a clear account of the vital involvement of microfluidic devices in worm biology.

Effect of Smaller Left Ventricular Capture Threshold Safety Margins to Improve Device Longevity in Recipients of Cardiac Resynchronization-Defibrillation Therapy.

Science.gov (United States)

Steinhaus, Daniel A; Waks, Jonathan W; Collins, Robert; Kleckner, Karen; Kramer, Daniel B; Zimetbaum, Peter J

2015-07-01

Device longevity in cardiac resynchronization therapy (CRT) is affected by the pacing capture threshold (PCT) and programmed pacing amplitude of the left ventricular (LV) pacing lead. The aims of this study were to evaluate the stability of LV pacing thresholds in a nationwide sample of CRT defibrillator recipients and to determine potential longevity improvements associated with a decrease in the LV safety margin while maintaining effective delivery of CRT. CRT defibrillator patients in the Medtronic CareLink database were eligible for inclusion. LV PCT stability was evaluated using ≥2 measurements over a 14-day period. Separately, a random sample of 7,250 patients with programmed right atrial and right ventricular amplitudes ≤2.5 V, LV thresholds ≤ 2.5 V, and LV pacing ≥90% were evaluated to estimate theoretical battery longevity improvement using LV safety margins of 0.5 and 1.5 V. Threshold stability analysis in 43,256 patients demonstrated LV PCT stability of 1 V had the greatest increases in battery life (mean increase 0.86 years, 95% confidence interval 0.85 to 0.87). In conclusion, nearly all CRT defibrillator patients had LV PCT stability <1.0 V. Decreasing the LV safety margin from 1.5 to 0.5 V provided consistent delivery of CRT for most patients and significantly improved battery longevity. Copyright © 2015 Elsevier Inc. All rights reserved.

Pre-market clinical evaluations of innovative high-risk medical devices in Europe.

Science.gov (United States)

Hulstaert, Frank; Neyt, Mattias; Vinck, Imgard; Stordeur, Sabine; Huić, Mirjana; Sauerland, Stefan; Kuijpers, Marja R; Abrishami, Payam; Vondeling, Hindrik; Flamion, Bruno; Garattini, Silvio; Pavlovic, Mira; van Brabandt, Hans

2012-07-01

High-quality clinical evidence is most often lacking when novel high-risk devices enter the European market. At the same time, a randomized controlled trial (RCT) is often initiated as a requirement for obtaining market access in the US. Should coverage in Europe be postponed until RCT data are available? We studied the premarket clinical evaluation of innovative high-risk medical devices in Europe compared with the US, and with medicines, where appropriate. The literature and regulatory documents were checked. Representatives from industry, Competent Authorities, Notified Bodies, Ethics Committees, and HTA agencies were consulted. We also discuss patient safety and the transparency of information. In contrast to the US, there is no requirement in Europe to demonstrate the clinical efficacy of high-risk devices in the premarket phase. Patients in Europe can thus have earlier access to a potentially lifesaving device, but at the risk of insufficiently documented efficacy and safety. Variations in the stringency of clinical reviews, both at the level of Notified Bodies and Competent Authorities, do not guarantee patient safety. We tried to document the design of premarket trials in Europe and number of patients exposed, but failed as this information is not made public. Furthermore, the Helsinki Declaration is not followed with respect to the registration and publication of premarket trials. For innovative high-risk devices, new EU legislation should require the premarket demonstration of clinical efficacy and safety, using an RCT if possible, and a transparent clinical review, preferably centralized.

Can we use IEC 61850 for safety related functions?

Directory of Open Access Journals (Sweden)

Luca Rocca

2016-08-01

Full Text Available Safety is an essential issue for processes that present high risk for human beings and environment. An acceptable level of risk is obtained both with actions on the process itself (risk reduction and with the use of special safety systems that switch the process into safe mode when a fault or an abnormal operation mode happens. These safety systems are today based on digital devices that communicate through digital networks. The IEC 61508 series specifies the safety requirements of all the devices that are involved in a safety function, including the communication network. Also electrical generation and distribution systems are processes that may have a significant level of risk, so the criteria stated by the IEC 61508 applies. Starting from this consideration, the paper analyzes the safety requirement for the communication network and compare them with the services of the communication protocol IEC 61850 that represents the most used protocol for automation of electrical plants. The goal of this job is to demonstrate that, from the technical point of view, IEC 61850 can be used for implementing safety-related functions, even if a formal safety certification is still missing.

[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.

Safety philosophy in Plowshare

Energy Technology Data Exchange (ETDEWEB)

Thalgott, R H [Nevada Operations Office, U.S. Atomic Energy Commission (United States)

1969-07-01

A nuclear device can be detonated safely when it can ascertained that the detonation can be accomplished without injury to people, either directly or indirectly, and without unacceptable damage to the ecological system and natural or man made structures. This philosophy has its origin in the nuclear weapons testing program dating back to the first detonation in 1945 and applies without reservation to PIowshare projects. This paper therefore will outline the mechanics employed by government in implementing this safety philosophy. The talk will describe those type of actions taken by safety oriented organizations and committees to assure that necessary and desirable safety reviews are conducted. (author)

Safety philosophy in Plowshare

International Nuclear Information System (INIS)

Thalgott, R.H.

1969-01-01

A nuclear device can be detonated safely when it can ascertained that the detonation can be accomplished without injury to people, either directly or indirectly, and without unacceptable damage to the ecological system and natural or man made structures. This philosophy has its origin in the nuclear weapons testing program dating back to the first detonation in 1945 and applies without reservation to PIowshare projects. This paper therefore will outline the mechanics employed by government in implementing this safety philosophy. The talk will describe those type of actions taken by safety oriented organizations and committees to assure that necessary and desirable safety reviews are conducted. (author)

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...

Clinician-Driven Design of VitalPAD–An Intelligent Monitoring and Communication Device to Improve Patient Safety in the Intensive Care Unit

Science.gov (United States)

Flohr, Luisa; Beaudry, Shaylene; Johnson, K Taneille; West, Nicholas; Burns, Catherine M; Ansermino, J Mark; Dumont, Guy A; Wensley, David; Skippen, Peter

2018-01-01

The pediatric intensive care unit (ICU) is a complex environment, in which a multidisciplinary team of clinicians (registered nurses, respiratory therapists, and physicians) continually observe and evaluate patient information. Data are provided by multiple, and often physically separated sources, cognitive workload is high, and team communication can be challenging. Our aim is to combine information from multiple monitoring and therapeutic devices in a mobile application, the VitalPAD, to improve the efficiency of clinical decision-making, communication, and thereby patient safety. We observed individual ICU clinicians, multidisciplinary rounds, and handover procedures for 54 h to identify data needs, workflow, and existing cognitive aid use and limitations. A prototype was developed using an iterative participatory design approach; usability testing, including general and task-specific feedback, was obtained from 15 clinicians. Features included map overviews of the ICU showing clinician assignment, patient status, and respiratory support; patient vital signs; a photo-documentation option for arterial blood gas results; and team communication and reminder functions. Clinicians reported the prototype to be an intuitive display of vital parameters and relevant alerts and reminders, as well as a user-friendly communication tool. Future work includes implementation of a prototype, which will be evaluated under simulation and real-world conditions, with the aim of providing ICU staff with a monitoring device that will improve their daily work, communication, and decision-making capacity. Mobile monitoring of vital signs and therapy parameters might help improve patient safety in wards with single-patient rooms and likely has applications in many acute and critical care settings. PMID:29552425

Subcutaneous Photovoltaic Infrared Energy Harvesting for Bio-Implantable Devices.

Science.gov (United States)

Moon, Eunseong; Blaauw, David; Phillips, Jamie D

2017-05-01

Wireless biomedical implantable devices on the mm-scale enable a wide range of applications for human health, safety, and identification, though energy harvesting and power generation are still looming challenges that impede their widespread application. Energy scavenging approaches to power biomedical implants have included thermal [1-3], kinetic [4-6], radio-frequency [7-11] and radiative sources [12-14]. However, the achievement of efficient energy scavenging for biomedical implants at the mm-scale has been elusive. Here we show that photovoltaic cells at the mm-scale can achieve a power conversion efficiency of more than 17 % for silicon and 31 % for GaAs under 1.06 μW/mm 2 infrared irradiation at 850 nm. Finally, these photovoltaic cells demonstrate highly efficient energy harvesting through biological tissue from ambient sunlight, or irradiation from infrared sources such as used in present-day surveillance systems, by utilizing the near infrared (NIR) transparency window between the 650 nm and 950 nm wavelength range [15-17].

Handheld multi-channel LAPS device as a transducer platform for possible biological and chemical multi-sensor applications

International Nuclear Information System (INIS)

Wagner, Torsten; Molina, Roberto; Yoshinobu, Tatsuo; Kloock, Joachim P.; Biselli, Manfred; Canzoneri, Michelangelo; Schnitzler, Thomas; Schoening, Michael J.

2007-01-01

The light-addressable potentiometric sensor is a promising technology platform for multi-sensor applications and lab-on-chip devices. However, many prior LAPS developments suffer from their lack in terms of non-portability, insufficient robustness, complicate handling, etc. Hence, portable and robust LAPS-based measurement devices have been investigated by the authors recently. In this work, a 'chip card'-based light-addressable potentiometric sensor system is presented. The utilisation of ordinary 'chip cards' allows an easy handling of different sensor chips for a wide range of possible applications. The integration of the electronic and the mechanical set-up into a single reader unit results in a compact design with the benefits of portability and low required space. In addition, the presented work includes a new multi-frequency measurement procedure, based on an FFT algorithm, which enables the simultaneous real-time measurement of up to 16 sensor spots. The comparison between the former batch-LAPS and the new FFT-based LAPS set-up will be presented. The immobilisation of biological cells (CHO: Chinese hamster ovary) demonstrates the possibility to record their metabolic activity with 16 measurement spots on the same chip. Furthermore, a Cd 2+ -selective chalcogenide-glass layer together with a pH-sensitive Ta 2 O 5 layer validates the use of the LAPS for chemical multi-sensor applications

30 CFR 90.204 - Approved sampling devices; maintenance and calibration.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved sampling devices; maintenance and... LABOR COAL MINE SAFETY AND HEALTH MANDATORY HEALTH STANDARDS-COAL MINERS WHO HAVE EVIDENCE OF THE DEVELOPMENT OF PNEUMOCONIOSIS Sampling Procedures § 90.204 Approved sampling devices; maintenance and...

Safety as experienced by patients themselves: a Finnish survey of the most recent period of care.

Science.gov (United States)

Sahlström, Merja; Partanen, Pirjo; Turunen, Hannele

2014-06-01

We examined patients' experiences of patient safety and participation in promoting safe care during their most recent care period. A survey of patients (N = 175) revealed that treatment, medication, and device safety were mostly experienced as very good or excellent, but responses varied by age and experience. Patients ages 66-75 were most critical of treatment and medication safety. Device safety was rated the worst aspect of safety. Twenty percent of respondents had experienced errors at some time during their care. Patients who had experienced errors and those who were treated at inpatient wards versus a day surgery unit were most critical towards patient participation. Open and transparent error management involving patients is needed to promote treatment, medication, and especially device safety. © 2014 Wiley Periodicals, Inc.

75 FR 74128 - Manual on Uniform Traffic Control Devices (MUTCD) Compliance Dates

Science.gov (United States)

2010-11-30

... existing non-compliant devices based on what it believes to be a reasonable balance of the safety benefits... public works agencies, that State and local governments must balance with highway safety and traffic... service life of sign sheeting materials. \\7\\ D. Ripley. Quantifying the Safety Benefits of Traffic Control...

Effects of open-air temperature on air temperature inside biological safety cabinet.

Science.gov (United States)

Umemura, Masayuki; Shigeno, Katsuro; Yamamura, Keiko; Osada, Takashi; Soda, Midori; Yamada, Kiyofumi; Ando, Yuichi; Wakiya, Yoshifumi

2011-02-14

In Japan, biological safety cabinets (BSCs) are normally used by medical staff while handling antineoplastic agents. We have also set up a class II B2 BSC at the Division of Chemotherapy for Outpatients. The air temperature inside this BSC, however, decreases in winter. We assumed that this decrease is caused by the intake of open-air. Therefore, we investigated the effects of low open-air temperature on the BSC temperature and the time of admixtures of antineoplastic agents. The studies were conducted from January 1 to March 31, 2008. The outdoor air temperature was measured in the shade near the intake nozzle of the BSC and was compared with the BSC temperature. The correlation between the outdoor air temperature and the BSC temperature, the dissolution time of cyclophosphamide (CPA) and gemcitabine (GEM), and accurate weight measurement of epirubicin (EPI) solution were investigated for low and normal BSC temperatures. The BSC temperature was correlated with the open-air temperature for open-air temperatures of 5-20°C (p air is drawn from outdoors. We showed that the BSC temperature affects the dissolution rate of antineoplastic agents. Further, we suggested that the BSC temperature drop might delay the affair of the admixtures of antineoplastic agents and increase the waiting time of outpatients for chemotherapy.

Safety and effectiveness of tacrolimus add-on therapy for rheumatoid arthritis patients without an adequate response to biological disease-modifying anti-rheumatic drugs (DMARDs): Post-marketing surveillance in Japan.

Science.gov (United States)

Takeuchi, Tsutomu; Ishida, Kota; Shiraki, Katsuhisa; Yoshiyasu, Takashi

2018-01-01

Post-marketing surveillance (PMS) was conducted to assess the safety and effectiveness of tacrolimus (TAC) add-on therapy for patients with rheumatoid arthritis (RA) and an inadequate response to biological disease-modifying anti-rheumatic drugs (DMARDs). Patients with RA from 180 medical sites across Japan were registered centrally with an electronic investigation system. The observational period was 24 weeks from the first day of TAC administration concomitantly with biological DMARDs. Safety and effectiveness populations included 624 and 566 patients, respectively. Patients were predominantly female (81.1%), with a mean age of 61.9 years. Overall, 125 adverse drug reactions (ADRs) occurred in 94 patients (15.1%), and 15 serious ADRs occurred in 11 patients (1.8%). These incidences were lower compared with previously reported incidences after TAC treatment in PMS, and all of the observed ADRs were already known. A statistically significant improvement was observed in the primary effectiveness variable of Simplified Disease Activity Index after TAC treatment; 62.7% of patients achieved remission or low disease activity at week 24. TAC is well tolerated and effective when used as an add-on to biological DMARDs in Japanese patients with RA who do not achieve an adequate response to biological DMARDs in a real-world clinical setting.

A clinical comparison of safety and efficacy in phacoemulsification with versus without ophthalmic viscoelastic device.

Science.gov (United States)

Kugu, Suleyman; Erdogan, Gurkan; Sahin Sevim, M; Ozerturk, Yusuf

2015-03-01

To evaluate in a comparative manner the safety and efficacy of 1.0% sodium-Hyaluronate used during capsulorhexis and intraocular lens (IOL) implantation in phacoemulsification surgery. 1.0% sodium-Hyaluronate, which is commonly used as one of the ophthalmic viscoelastic devices, was compared to intraocular irrigating solution, which can bring up these effects. In addition, the effect of both methods on occurring corneal endothelial cell (CEC) loss was investigated. Each group comprised 19 eyes. The mean preoperative CEC density was 2525.68 ± 181.85 in Group H and 2514.16 ± 174.59 in Group V; no statistically significant difference was found between the groups (p > 0.05). Preoperative and postoperative first and twelfth week CEC densities were 2438.21 ± 198.12 (p  0.05). Although it was found that there was no statistically difference in terms of preventing CEC loss between 1.0% sodium-Hyaluronate and the irrigation method during phacoemulsification, it was observed clinically that 1.0% sodium-hyaluronate can make the procedure easy, safer, very helpful, especially for understanding phacoemulsification.

Improving signal to noise in labeled biological specimens using energy-filtered TEM of sections with a drift correction strategy and a direct detection device.

Science.gov (United States)

Ramachandra, Ranjan; Bouwer, James C; Mackey, Mason R; Bushong, Eric; Peltier, Steven T; Xuong, Nguyen-Huu; Ellisman, Mark H

2014-06-01

Energy filtered transmission electron microscopy techniques are regularly used to build elemental maps of spatially distributed nanoparticles in materials and biological specimens. When working with thick biological sections, electron energy loss spectroscopy techniques involving core-loss electrons often require exposures exceeding several minutes to provide sufficient signal to noise. Image quality with these long exposures is often compromised by specimen drift, which results in blurring and reduced resolution. To mitigate drift artifacts, a series of short exposure images can be acquired, aligned, and merged to form a single image. For samples where the target elements have extremely low signal yields, the use of charge coupled device (CCD)-based detectors for this purpose can be problematic. At short acquisition times, the images produced by CCDs can be noisy and may contain fixed pattern artifacts that impact subsequent correlative alignment. Here we report on the use of direct electron detection devices (DDD's) to increase the signal to noise as compared with CCD's. A 3× improvement in signal is reported with a DDD versus a comparably formatted CCD, with equivalent dose on each detector. With the fast rolling-readout design of the DDD, the duty cycle provides a major benefit, as there is no dead time between successive frames.

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...

Co-design in synthetic biology: a system-level analysis of the development of an environmental sensing device.

Science.gov (United States)

Ball, David A; Lux, Matthew W; Graef, Russell R; Peterson, Matthew W; Valenti, Jane D; Dileo, John; Peccoud, Jean

2010-01-01

The concept of co-design is common in engineering, where it is necessary, for example, to determine the optimal partitioning between hardware and software of the implementation of a system features. Here we propose to adapt co-design methodologies for synthetic biology. As a test case, we have designed an environmental sensing device that detects the presence of three chemicals, and returns an output only if at least two of the three chemicals are present. We show that the logical operations can be implemented in three different design domains: (1) the transcriptional domain using synthetically designed hybrid promoters, (2) the protein domain using bi-molecular fluorescence complementation, and (3) the fluorescence domain using spectral unmixing and relying on electronic processing. We discuss how these heterogeneous design strategies could be formalized to develop co-design algorithms capable of identifying optimal designs meeting user specifications.

Experience With Laser Safety In The USA--A Review

Science.gov (United States)

Sliney, David H.

1986-10-01

Following several research programs in the 1960's aimed at studying the adverse biological effects of lasers and other optical radiation sources, laser occupational exposure limits were set and general safety standards were developed. Today, the experience from laser accidents and the development of new lasers and new applications have altered the format of the exposure limits and the safety procedures. It is critically important to distinguish between different biological injury mechanisms. The biological effects of ultraviolet radiation upon the skin and eye are additive over a period of at least one workday, and require different safety procedures. The scattered UV irradiance from excimer lasers may be quite hazardous, depending upon wavelength and action spectra. Since laser technology is young, the exposure of an individual in natural sunlight must be studied to evaluate the potential for chronic effects. The safety measures necessary in the use of lasers depend upon a hazard evaluation. The appropriate control measures and alternate means of enclosure, baffling, and operational control measures are presented. Present laser safety standards are explained briefly. Eye protective techniques and eyewear are considered for a variety of sources. The optical properties of enclosure materials are also discussed.

Organizational Culture and Safety

Science.gov (United States)

Adams, Catherine A.

2003-01-01

'..only a fool perseveres in error.' Cicero. Humans will break the most advanced technological devices and override safety and security systems if they are given the latitude. Within the workplace, the operator may be just one of several factors in causing accidents or making risky decisions. Other variables considered for their involvement in the negative and often catastrophic outcomes include the organizational context and culture. Many organizations have constructed and implemented safety programs to be assimilated into their culture to assure employee commitment and understanding of the importance of everyday safety. The purpose of this paper is to examine literature on organizational safety cultures and programs that attempt to combat vulnerability, risk taking behavior and decisions and identify the role of training in attempting to mitigate unsafe acts.

Advanced molecular devices based on light-driven molecular motors

NARCIS (Netherlands)

Chen, Jiawen

2015-01-01

Nature has provided a large collection of molecular machines and devices that are among the most amazing nanostructures on this planet. These machines are able to operate complex biological processes which are of great importance in our organisms. Inspired by these natural devices, artificial

Highway Safety, Economic Behavior, and Driving Environment

OpenAIRE

Keeler, Theodore E.

1991-01-01

Economic analysis has enhanced our understanding of the efficacy of highway safety regulations. Specifically, a consumer-theoretic literature has developed on drivers' responses to regulations, based on ideas first set forth by Lester lave and W. E. Weber (1970) and more fully thought out by Sam Peltzman (1975). Meanwhile, an empirical literature has also developed, testing hypotheses relating to the effects on safety of speed limits, safety-device regulations, and alcohol policies, among oth...

Establishing a national biological laboratory safety and security monitoring program.

Science.gov (United States)

Blaine, James W

2012-12-01

The growing concern over the potential use of biological agents as weapons and the continuing work of the Biological Weapons Convention has promoted an interest in establishing national biological laboratory biosafety and biosecurity monitoring programs. The challenges and issues that should be considered by governments, or organizations, embarking on the creation of a biological laboratory biosafety and biosecurity monitoring program are discussed in this article. The discussion focuses on the following questions: Is there critical infrastructure support available? What should be the program focus? Who should be monitored? Who should do the monitoring? How extensive should the monitoring be? What standards and requirements should be used? What are the consequences if a laboratory does not meet the requirements or is not willing to comply? Would the program achieve the results intended? What are the program costs? The success of a monitoring program can depend on how the government, or organization, responds to these questions.

30 CFR 90.205 - Approved sampling devices; operation; air flowrate.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved sampling devices; operation; air... LABOR COAL MINE SAFETY AND HEALTH MANDATORY HEALTH STANDARDS-COAL MINERS WHO HAVE EVIDENCE OF THE DEVELOPMENT OF PNEUMOCONIOSIS Sampling Procedures § 90.205 Approved sampling devices; operation; air flowrate...

Act to keep patients safe: device-related adverse event reporting.

Science.gov (United States)

Schoem, Scott R; Shah, Udayan K

2010-05-01

Primum non nocere- "Above all do no harm." Since the first year of medical school, we have all heard and spoken this dictum countless times. Translating this dictum into action may present challenges in our daily practice. Every day, clinicians must distinguish between scientific evidence, clinical experience, and marketing claims by industry vendors of improved efficacy and safety regarding medical devices. Adverse event reporting and device failure notification are generally laid out well in hospital practice settings. Reporting beyond the local level takes on a new dimension for most surgeons. Perceived stigma from peers and corporations, lack of confidentiality, and cynicism regarding protective actions for patients should not limit one from "raising the alarm" when concerns arise about device safety or performance. This commentary aims to explain the process for reporting device-related adverse events. Copyright 2010 American Academy of Otolaryngology-Head and Neck Surgery Foundation. Published by Mosby, Inc. All rights reserved.

Efficacy and Safety of REVIVE SE Thrombectomy Device for Acute Ischemic Stroke: River JAPAN (Reperfuse Ischemic Vessels with Endovascular Recanalization Device in Japan).

Science.gov (United States)

Sakai, Nobuyuki; Ota, Shinzo; Matsumoto, Yasushi; Kondo, Rei; Satow, Tetsu; Kubo, Michiya; Tsumoto, Tomoyuki; Enomoto, Yukiko; Kataoka, Taketo; Imamura, Hirotoshi; Todo, Kenichi; Hayakawa, Mikito; Yamagami, Hiroshi; Toyoda, Kazunori; Ito, Yasushi; Sugiu, Kenji; Matsumaru, Yuji; Yoshimura, Shinichi

2018-04-15

REVIVE SE (REVIVE) is a closed-ended, self-expanding stent retriever used in the RIVER JAPAN study. We present our early experience with REVIVE for revascularization of acute ischemic stroke (AIS) in patients who have failed or are ineligible for intravenous recombinant tissue plasminogen activator treatment. This prospective, single-arm, non-randomized, multicenter registry study followed up patients undergoing mechanical thrombectomy with REVIVE for 90 days. The primary endpoint was a post-procedure Thrombolysis in Cerebral Infarction (TICI) score ≥2a. Secondary endpoints were clot migration/embolization; recanalization without symptomatic intracranial hemorrhage (ICH) at 24 h; symptomatic ICH; good neurological outcome (modified Rankin Scale score ≤2 National Institute of Health Stroke Scale (NIHSS) score decrease ≥10) at day 90; device- or procedure-related serious adverse events (SAEs) and mortality at day 90. To confirm non-inferiority of REVIVE, results were compared with historical data of the Merci Retriever. About 49 patients were enrolled (median age 73 years; males 46.9%; middle cerebral artery (MCA) occlusion 83.7%; median NIHSS score 17). A post-procedure TICI score ≥2a was observed in 73.5% (36/49, 95% confidence interval [CI] 58.9-85.1) of patients. No post-procedural clot migration/embolization events occurred. Successful recanalization without symptomatic ICH was observed in 62.5% (30/48, 95% CI 47.4-76.0). The good neurological outcome was achieved in 66.7% (32/48) patients. Symptomatic ICH and device- or procedure-related SAEs were reported in 6.3% and 12.2% of patients, respectively. Two deaths were reported. REVIVE demonstrated equivalent efficacy and safety as the Merci Retriever. Results suggest that REVIVE is effective and safe in recanalizing occluded intracranial arteries in AIS.

Silk-polypyrrole biocompatible actuator performance under biologically relevant conditions

Science.gov (United States)

Hagler, Jo'elen; Peterson, Ben; Murphy, Amanda; Leger, Janelle

Biocompatible actuators that are capable of controlled movement and can function under biologically relevant conditions are of significant interest in biomedical fields. Previously, we have demonstrated that a composite material of silk biopolymer and the conducting polymer polypyrrole (PPy) can be formed into a bilayer device that can bend under applied voltage. Further, these silk-PPy composites can generate forces comparable to human muscle (>0.1 MPa) making them ideal candidates for interfacing with biological tissues. Here silk-PPy composite films are tested for performance under biologically relevant conditions including exposure to a complex protein serum and biologically relevant temperatures. Free-end bending actuation performance, current response, force generation and, mass degradation were investigated . Preliminary results show that when exposed to proteins and biologically relevant temperatures, these silk-PPy composites show minimal degradation and are able to generate forces and conduct currents comparable to devices tested under standard conditions. NSF.

New-generation bar adsorptive microextraction (BAμE) devices for a better eco-user-friendly analytical approach-Application for the determination of antidepressant pharmaceuticals in biological fluids.

Science.gov (United States)

Ide, A H; Nogueira, J M F

2018-05-10

The present contribution aims to design new-generation bar adsorptive microextraction (BAμE) devices that promote an innovative and much better user-friendly analytical approach. The novel BAμE devices were lab-made prepared having smaller dimensions by using flexible nylon-based supports (7.5 × 1.0 mm) coated with convenient sorbents (≈ 0.5 mg). This novel advance allows effective microextraction and back-extraction ('only single liquid desorption step') stages as well as interfacing enhancement with the instrumental systems dedicated for routine analysis. To evaluate the achievements of these improvements, four antidepressant agents (bupropion, citalopram, amitriptyline and trazodone) were used as model compounds in aqueous media combined with liquid chromatography (LC) systems. By using an N-vinylpyrrolidone based-polymer phase good selectivity and efficiency were obtained. Assays performed on 25 mL spiked aqueous samples, yielded average recoveries in between 67.8 ± 12.4% (bupropion) and 88.3 ± 12.1% (citalopram), under optimized experimental conditions. The analytical performance also showed convenient precision (RSD  0.9820). The application of the proposed analytical approach on biological fluids showed negligible matrix effects by using the standard addition methodology. From the data obtained, the new-generation BAμE devices presented herein provide an innovative and robust analytical cycle, are simple to prepare, cost-effective, user-friendly and compatible with the current LC autosampler systems. Furthermore, the novel devices were designed to be disposable and used together with negligible amounts of organic solvents (100 μL) during back-extraction, in compliance with the green analytical chemistry principles. In short, the new-generation BAμE devices showed to be an eco-user-friendly approach for trace analysis of priority compounds in biological fluids and a versatile alternative over other well-stablished sorption

Spike-Timing Dependent Plasticity in Unipolar Silicon Oxide RRAM Devices.

Science.gov (United States)

Zarudnyi, Konstantin; Mehonic, Adnan; Montesi, Luca; Buckwell, Mark; Hudziak, Stephen; Kenyon, Anthony J

2018-01-01

Resistance switching, or Resistive RAM (RRAM) devices show considerable potential for application in hardware spiking neural networks (neuro-inspired computing) by mimicking some of the behavior of biological synapses, and hence enabling non-von Neumann computer architectures. Spike-timing dependent plasticity (STDP) is one such behavior, and one example of several classes of plasticity that are being examined with the aim of finding suitable algorithms for application in many computing tasks such as coincidence detection, classification and image recognition. In previous work we have demonstrated that the neuromorphic capabilities of silicon-rich silicon oxide (SiO x ) resistance switching devices extend beyond plasticity to include thresholding, spiking, and integration. We previously demonstrated such behaviors in devices operated in the unipolar mode, opening up the question of whether we could add plasticity to the list of features exhibited by our devices. Here we demonstrate clear STDP in unipolar devices. Significantly, we show that the response of our devices is broadly similar to that of biological synapses. This work further reinforces the potential of simple two-terminal RRAM devices to mimic neuronal functionality in hardware spiking neural networks.

Regulator Loss Functions and Hierarchical Modeling for Safety Decision Making.

Science.gov (United States)

Hatfield, Laura A; Baugh, Christine M; Azzone, Vanessa; Normand, Sharon-Lise T

2017-07-01

Regulators must act to protect the public when evidence indicates safety problems with medical devices. This requires complex tradeoffs among risks and benefits, which conventional safety surveillance methods do not incorporate. To combine explicit regulator loss functions with statistical evidence on medical device safety signals to improve decision making. In the Hospital Cost and Utilization Project National Inpatient Sample, we select pediatric inpatient admissions and identify adverse medical device events (AMDEs). We fit hierarchical Bayesian models to the annual hospital-level AMDE rates, accounting for patient and hospital characteristics. These models produce expected AMDE rates (a safety target), against which we compare the observed rates in a test year to compute a safety signal. We specify a set of loss functions that quantify the costs and benefits of each action as a function of the safety signal. We integrate the loss functions over the posterior distribution of the safety signal to obtain the posterior (Bayes) risk; the preferred action has the smallest Bayes risk. Using simulation and an analysis of AMDE data, we compare our minimum-risk decisions to a conventional Z score approach for classifying safety signals. The 2 rules produced different actions for nearly half of hospitals (45%). In the simulation, decisions that minimize Bayes risk outperform Z score-based decisions, even when the loss functions or hierarchical models are misspecified. Our method is sensitive to the choice of loss functions; eliciting quantitative inputs to the loss functions from regulators is challenging. A decision-theoretic approach to acting on safety signals is potentially promising but requires careful specification of loss functions in consultation with subject matter experts.

SafeNet: a methodology for integrating general-purpose unsafe devices in safe-robot rehabilitation systems.

Science.gov (United States)

Vicentini, Federico; Pedrocchi, Nicola; Malosio, Matteo; Molinari Tosatti, Lorenzo

2014-09-01

Robot-assisted neurorehabilitation often involves networked systems of sensors ("sensory rooms") and powerful devices in physical interaction with weak users. Safety is unquestionably a primary concern. Some lightweight robot platforms and devices designed on purpose include safety properties using redundant sensors or intrinsic safety design (e.g. compliance and backdrivability, limited exchange of energy). Nonetheless, the entire "sensory room" shall be required to be fail-safe and safely monitored as a system at large. Yet, sensor capabilities and control algorithms used in functional therapies require, in general, frequent updates or re-configurations, making a safety-grade release of such devices hardly sustainable in cost-effectiveness and development time. As such, promising integrated platforms for human-in-the-loop therapies could not find clinical application and manufacturing support because of lacking in the maintenance of global fail-safe properties. Under the general context of cross-machinery safety standards, the paper presents a methodology called SafeNet for helping in extending the safety rate of Human Robot Interaction (HRI) systems using unsafe components, including sensors and controllers. SafeNet considers, in fact, the robotic system as a device at large and applies the principles of functional safety (as in ISO 13489-1) through a set of architectural procedures and implementation rules. The enabled capability of monitoring a network of unsafe devices through redundant computational nodes, allows the usage of any custom sensors and algorithms, usually planned and assembled at therapy planning-time rather than at platform design-time. A case study is presented with an actual implementation of the proposed methodology. A specific architectural solution is applied to an example of robot-assisted upper-limb rehabilitation with online motion tracking. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Integrated Biological Control