Fundamental Use of Surgical Energy (FUSE): An Essential Educational Program for Operating Room Safety

PubMed Central

Jones, Stephanie B; Munro, Malcolm G; Feldman, Liane S; Robinson, Thomas N; Brunt, L Michael; Schwaitzberg, Steven D; Jones, Daniel B; Fuchshuber, Pascal R

2017-01-01

Operating room (OR) safety has become a major concern in patient safety since the 1990s. Improvement of team communication and behavior is a popular target for safety programming at the institutional level. Despite these efforts, essential safety gaps remain in the OR and procedure rooms. A prime example is the use of energy-based devices in ORs and procedural areas. The lack of fundamental understanding of energy device function, design, and application contributes to avoidable injury and harm at a rate of approximately 1 to 2 per 1000 patients in the US. Hundreds of OR fires occur each year in the US, some causing severe injury and even death. Most of these fires are associated with the use of energy-based surgical devices. In response to this safety issue, the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) developed the Fundamental Use of Surgical Energy (FUSE) program. This program includes a standardized curriculum targeted to surgeons, other physicians, and allied health care professionals and a psychometrically designed and validated certification test. A successful FUSE certification documents acquisition of the basic knowledge needed to safely use energy-based devices in the OR. By design FUSE fills a void in the curriculum and competency assessment for surgeons and other procedural specialists in the use of energy-based devices in patients. PMID:28241913

Extraglottic airway devices: technology update.

PubMed

Sharma, Bimla; Sahai, Chand; Sood, Jayashree

2017-01-01

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.

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

PubMed

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.

Operating manual-based usability evaluation of medical devices: an effective patient safety screening method.

PubMed

Turley, James P; Johnson, Todd R; Smith, Danielle Paige; Zhang, Jaijie; Brixey, Juliana J

2006-04-01

Use of medical devices often directly contributes to medical errors. Because it is difficult or impossible to change the design of existing devices, the best opportunity for improving medical device safety is during the purchasing process. However, most hospital personnel are not familiar with the usability evaluation methods designed to identify aspects of a user interface that do not support intuitive and safe use. A review of medical device operating manuals is proposed as a more practical method of usability evaluation. Operating manuals for five volumetric infusion pumps from three manufacturers were selected for this study (January-April 2003). Each manual's safety message content was evaluated to determine whether the message indicated a device design characteristic that violated known usability principles (heuristics) or indicated a violation of an affordance of the device. "Minimize memory load," with 65 violations, was the heuristic violated most frequently across pumps. Variations between pumps, including the frequency and severity of violations for each, were noted. Results suggest that manual review can provide a proxy for heuristic evaluation of the actual medical device. This method, intended to be a component of prepurchasing evaluation, can complement more formal usability evaluation methods and be used to select a subset of devices for more extensive and formal testing.

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

DTIC Science & Technology

2005-01-01

have the potential to become solid tools for manufacturers, purchasers, and consumers to evaluate patient safety issues in various health related...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

Design of a reusable kinetic energy absorber for an astronaut safety tether to be used during extravehicular activities on the Space Station

NASA Technical Reports Server (NTRS)

Borthwick, Dawn E.; Cronch, Daniel F.; Nixon, Glen R.

1991-01-01

The goal of this project is to design a reusable safety device for a waist tether which will absorb the kinetic energy of an astronaut drifting away from the Space Station. The safety device must limit the tension of the tether line in order to prevent damage to the astronaut's space suit or to the structure of the spacecraft. The tether currently used on shuttle missions must be replaced after the safety feature has been developed. A reusable tether for the Space Station would eliminate the need for replacement tethers, conserving space and mass. This report presents background information, scope and limitations, methods of research and development, alternative designs, a final design solution and its evaluation, and recommendations for further work.

Advanced Design Features of APR1400 and Realization in Shin Kori Construction Project

DOE Office of Scientific and Technical Information (OSTI.GOV)

OH, S.J.; Park, K.C.; Kim, H.G.

2006-07-01

APR1400 adopted several advanced design features. To ensure their proper operation as a part of ShinKori 3,4 project, both experimental and analytical work are continuing. In this paper, work on the advanced design features related to enhanced safety is examined. APR1400 safety injection system consists of four independent trains which include four safety injection pump and tanks. A passive flow regulating device called fluidic device is installed in the safety injection tanks. Separate effect tests including a full scale fluidic device tests have been conducted. Integral system tests are in progress. Combination of these work with the analytical work usingmore » RELAP5/Mod3 would ensure the proper operation of the new safety injection systems. To mitigate severe accidents, hydrogen mitigation system using PARs and igniters is adopted. Also, active injection system and the streamlined insulation design are adopted to enhance the in-vessel retention capability with the external cooling of RPV strategy. Analytic work with supporting experiments is performed. We are certain that these preparatory work would help the successful adaptation of ADF in ShinKori project. (authors)« less

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

PubMed

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

2014-05-01

Manufacturers of interactive medical devices, such as infusion pumps, need to ensure that devices minimise the risk of unintended harm during use. However, development teams face challenges in incorporating Human Factors. The aim of the research reported here was to better understand the constraints under which medical device design and development take place. We report the results of a qualitative study based on 19 semi-structured interviews with professionals involved in the design, development and deployment of interactive medical devices. A thematic analysis was conducted. Multiple barriers to designing for safety and usability were identified. In particular, we identified barriers to communication both between the development organisation and the intended users and between different teams within the development organisation. We propose the use of mediating representations. Artefacts such as personas and scenarios, known to provide integration across multiple perspectives, are an essential component of designing for safety and usability. Copyright © 2013 Elsevier Ltd and The Ergonomics Society. All rights reserved.

Designing Crane Controls with Applied Mechanical and Electrical Safety Features

NASA Technical Reports Server (NTRS)

Lytle, Bradford P.; Walczak, Thomas A.

2002-01-01

The use of overhead traveling bridge cranes in many varied applications is common practice. In particular, the use of cranes in the nuclear, military, commercial, aerospace, and other industries can involve safety critical situations. Considerations for Human Injury or Casualty, Loss of Assets, Endangering the Environment, or Economic Reduction must be addressed. Traditionally, in order to achieve additional safety in these applications, mechanical systems have been augmented with a variety of devices. These devices assure that a mechanical component failure shall reduce the risk of a catastrophic loss of the correct and/or safe load carrying capability. ASME NOG-1-1998, (Rules for Construction of Overhead and Gantry Cranes, Top Running Bridge, and Multiple Girder), provides design standards for cranes in safety critical areas. Over and above the minimum safety requirements of todays design standards, users struggle with obtaining a higher degree of reliability through more precise functional specifications while attempting to provide "smart" safety systems. Electrical control systems also may be equipped with protective devices similar to the mechanical design features. Demands for improvement of the cranes "control system" is often recognized, but difficult to quantify for this traditionally "mechanically" oriented market. Finite details for each operation must be examined and understood. As an example, load drift (or small motions) at close tolerances can be unacceptable (and considered critical). To meet these high functional demands encoders and other devices are independently added to control systems to provide motion and velocity feedback to the control drive. This paper will examine the implementation of Programmable Electronic Systems (PES). PES is a term this paper will use to describe any control system utilizing any programmable electronic device such as Programmable Logic Controllers (PLC), or an Adjustable Frequency Drive (AID) 'smart' programmable motion controller. Therefore the use of the term Programmable Electronic Systems (PES) is an encompassing description for a large spectrum of programmable electronic control devices.

Soft robotic devices for hand rehabilitation and assistance: a narrative review.

PubMed

Chu, Chia-Ye; Patterson, Rita M

2018-02-17

The debilitating effects on hand function from a number of a neurologic disorders has given rise to the development of rehabilitative robotic devices aimed at restoring hand function in these patients. To combat the shortcomings of previous traditional robotics, soft robotics are rapidly emerging as an alternative due to their inherent safety, less complex designs, and increased potential for portability and efficacy. While several groups have begun designing devices, there are few devices that have progressed enough to provide clinical evidence of their design's therapeutic abilities. Therefore, a global review of devices that have been previously attempted could facilitate the development of new and improved devices in the next step towards obtaining clinical proof of the rehabilitative effects of soft robotics in hand dysfunction. A literature search was performed in SportDiscus, Pubmed, Scopus, and Web of Science for articles related to the design of soft robotic devices for hand rehabilitation. A framework of the key design elements of the devices was developed to ease the comparison of the various approaches to building them. This framework includes an analysis of the trends in portability, safety features, user intent detection methods, actuation systems, total DOF, number of independent actuators, device weight, evaluation metrics, and modes of rehabilitation. In this study, a total of 62 articles representing 44 unique devices were identified and summarized according to the framework we developed to compare different design aspects. By far, the most common type of device was that which used a pneumatic actuator to guide finger flexion/extension. However, the remainder of our framework elements yielded more heterogeneous results. Consequently, those results are summarized and the advantages and disadvantages of many design choices as well as their rationales were highlighted. The past 3 years has seen a rapid increase in the development of soft robotic devices for hand rehabilitative applications. These mostly preclinical research prototypes display a wide range of technical solutions which have been highlighted in the framework developed in this analysis. More work needs to be done in actuator design, safety, and implementation in order for these devices to progress to clinical trials. It is our goal that this review will guide future developers through the various design considerations in order to develop better devices for patients with hand impairments.

Apollo Spacecraft and Saturn V Launch Vehicle Pyrotechnics/Explosive Devices

NASA Technical Reports Server (NTRS)

Interbartolo, Michael

2009-01-01

The Apollo Mission employs more than 210 pyrotechnic devices per mission.These devices are either automatic of commanded from the Apollo spacecraft systems. All devices require high reliability and safety and most are classified as either crew safety critical or mission critical. Pyrotechnic devices have a wide variety of applications including: launch escape tower separation, separation rocket ignition, parachute deployment and release and electrical circuit opening and closing. This viewgraph presentation identifies critical performance, design requirements and safety measures used to ensure quality, reliability and performance of Apollo pyrotechnic/explosive devices. The major components and functions of a typical Apollo pyrotechnic/explosive device are listed and described (initiators, cartridge assemblies, detonators, core charges). The presentation also identifies the major locations and uses for the devices on: the Command and Service Module, Lunar Module and all stages of the launch vehicle.

49 CFR Appendix B to Part 236 - Risk Assessment Criteria

Code of Federal Regulations, 2010 CFR

2010-10-01

... results of the application of safety design principles as noted in Appendix C to this part. The MTTHE is... fault/failure analysis must be based on the assessment of the design and implementation of all safety... associated device drivers, as well as historical performance data, analytical methods and experimental safety...

49 CFR Appendix B to Part 236 - Risk Assessment Criteria

Code of Federal Regulations, 2013 CFR

2013-10-01

... results of the application of safety design principles as noted in Appendix C to this part. The MTTHE is... fault/failure analysis must be based on the assessment of the design and implementation of all safety... associated device drivers, as well as historical performance data, analytical methods and experimental safety...

29 CFR 1910.68 - Manlifts.

Code of Federal Regulations, 2012 CFR

2012-07-01

... floor to floor. (6) Rated speed. Rated speed is the speed for which the device is designed and installed... purpose of this section is to provide reasonable safety for life and limb. (3) Design requirements. All... meet the design requirements of the “American National Safety Standard for Manlifts ANSI A90.1-1969...

29 CFR 1910.68 - Manlifts.

Code of Federal Regulations, 2011 CFR

2011-07-01

... floor to floor. (6) Rated speed. Rated speed is the speed for which the device is designed and installed... purpose of this section is to provide reasonable safety for life and limb. (3) Design requirements. All... meet the design requirements of the “American National Safety Standard for Manlifts ANSI A90.1-1969...

Design of a novel telerehabilitation system with a force-sensing mechanism.

PubMed

Zhang, Songyuan; Guo, Shuxiang; Gao, Baofeng; Hirata, Hideyuki; Ishihara, Hidenori

2015-05-19

Many stroke patients are expected to rehabilitate at home, which limits their access to proper rehabilitation equipment, treatment, or assessment by therapists. We have developed a novel telerehabilitation system that incorporates a human-upper-limb-like device and an exoskeleton device. The system is designed to provide the feeling of real therapist-patient contact via telerehabilitation. We applied the principle of a series elastic actuator to both the master and slave devices. On the master side, the therapist can operate the device in a rehabilitation center. When performing passive training, the master device can detect the therapist's motion while controlling the deflection of elastic elements to near-zero, and the patient can receive the motion via the exoskeleton device. When performing active training, the design of the force-sensing mechanism in the master device can detect the assisting force added by the therapist. The force-sensing mechanism also allows force detection with an angle sensor. Patients' safety is guaranteed by monitoring the motor's current from the exoskeleton device. To compensate for any possible time delay or data loss, a torque-limiter mechanism was also designed in the exoskeleton device for patients' safety. Finally, we successfully performed a system performance test for passive training with transmission control protocol/internet protocol communication.

Design of a Novel Telerehabilitation System with a Force-Sensing Mechanism

PubMed Central

Zhang, Songyuan; Guo, Shuxiang; Gao, Baofeng; Hirata, Hideyuki; Ishihara, Hidenori

2015-01-01

Many stroke patients are expected to rehabilitate at home, which limits their access to proper rehabilitation equipment, treatment, or assessment by therapists. We have developed a novel telerehabilitation system that incorporates a human-upper-limb-like device and an exoskeleton device. The system is designed to provide the feeling of real therapist–patient contact via telerehabilitation. We applied the principle of a series elastic actuator to both the master and slave devices. On the master side, the therapist can operate the device in a rehabilitation center. When performing passive training, the master device can detect the therapist’s motion while controlling the deflection of elastic elements to near-zero, and the patient can receive the motion via the exoskeleton device. When performing active training, the design of the force-sensing mechanism in the master device can detect the assisting force added by the therapist. The force-sensing mechanism also allows force detection with an angle sensor. Patients’ safety is guaranteed by monitoring the motor’s current from the exoskeleton device. To compensate for any possible time delay or data loss, a torque-limiter mechanism was also designed in the exoskeleton device for patients’ safety. Finally, we successfully performed a system performance test for passive training with transmission control protocol/internet protocol communication. PMID:25996511

24 CFR 3280.302 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... any device or other means designed to transfer home anchoring loads to the ground. Anchoring equipment... means a specific anchoring assembly device designed to transfer home anchoring loads to the ground... DEVELOPMENT MANUFACTURED HOME CONSTRUCTION AND SAFETY STANDARDS Body and Frame Construction Requirements...

The development of neural stimulators: a review of preclinical safety and efficacy studies.

PubMed

Shepherd, Robert K; Villalobos, Joel; Burns, Owen; Nayagam, David

2018-05-14

Given the rapid expansion of the field of neural stimulation and the rigorous regulatory approval requirements required before these devices can be applied clinically, it is important that there is clarity around conducting preclinical safety and efficacy studies required for the development of this technology. The present review examines basic design principles associated with the development of a safe neural stimulator and describes the suite of preclinical safety studies that need to be considered when taking a device to clinical trial. Neural stimulators are active implantable devices that provide therapeutic intervention, sensory feedback or improved motor control via electrical stimulation of neural or neuro-muscular tissue in response to trauma or disease. Because of their complexity, regulatory bodies classify these devices in the highest risk category (Class III), and they are therefore required to go through a rigorous regulatory approval process before progressing to market. The successful development of these devices is achieved through close collaboration across disciplines including engineers, scientists and a surgical/clinical team, and the adherence to clear design principles. Preclinical studies form one of several key components in the development pathway from concept to product release of neural stimulators. Importantly, these studies provide iterative feedback in order to optimise the final design of the device. Key components of any preclinical evaluation include: in vitro studies that are focussed on device reliability and include accelerated testing under highly controlled environments; in vivo studies using animal models of the disease or injury in order to assess safety and, given an appropriate animal model, the efficacy of the technology under both passive and electrically active conditions; and human cadaver and ex vivo studies designed to ensure the device's form factor conforms to human anatomy, to optimise the surgical approach and to develop any specialist surgical tooling required. The pipeline from concept to commercialisation of these devices is long and expensive; careful attention to both device design and its preclinical evaluation will have significant impact on the duration and cost associated with taking a device through to commercialisation. Carefully controlled in vitro and in vivo studies together with ex vivo and human cadaver trials are key components of a thorough preclinical evaluation of any new neural stimulator. © 2018 IOP Publishing Ltd.

10 CFR 32.53 - Luminous safety devices for use in aircraft: Requirements for license to manufacture, assemble...

Code of Federal Regulations, 2014 CFR

2014-01-01

... maximum quantity of tritium or promethium-147 in each device; (2) Details of construction and design; (3... information, including experimental studies and tests, required by the Commission to facilitate a... direct physical contact by any person with it; (3) The device is so designed that it cannot easily be...

10 CFR 32.53 - Luminous safety devices for use in aircraft: Requirements for license to manufacture, assemble...

Code of Federal Regulations, 2013 CFR

2013-01-01

... maximum quantity of tritium or promethium-147 in each device; (2) Details of construction and design; (3... information, including experimental studies and tests, required by the Commission to facilitate a... direct physical contact by any person with it; (3) The device is so designed that it cannot easily be...

14 CFR 437.55 - Hazard analysis.

Code of Federal Regulations, 2014 CFR

2014-01-01

... TRANSPORTATION LICENSING EXPERIMENTAL PERMITS Safety Requirements § 437.55 Hazard analysis. (a) A permittee must...) Design inadequacies; or (vi) Procedural deficiencies. (2) Determine the likelihood of occurrence and... include one or more of the following: (i) Designing for minimum risk, (ii) Incorporating safety devices...

14 CFR 437.55 - Hazard analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... TRANSPORTATION LICENSING EXPERIMENTAL PERMITS Safety Requirements § 437.55 Hazard analysis. (a) A permittee must...) Design inadequacies; or (vi) Procedural deficiencies. (2) Determine the likelihood of occurrence and... include one or more of the following: (i) Designing for minimum risk, (ii) Incorporating safety devices...

14 CFR 437.55 - Hazard analysis.

Code of Federal Regulations, 2011 CFR

2011-01-01

... TRANSPORTATION LICENSING EXPERIMENTAL PERMITS Safety Requirements § 437.55 Hazard analysis. (a) A permittee must...) Design inadequacies; or (vi) Procedural deficiencies. (2) Determine the likelihood of occurrence and... include one or more of the following: (i) Designing for minimum risk, (ii) Incorporating safety devices...

NASA safety standard for lifting devices and equipment

NASA Astrophysics Data System (ADS)

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.

NASA safety standard for lifting devices and equipment

NASA Technical Reports Server (NTRS)

1990-01-01

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.

Innovative Design to Prevent Reversal of Roller Blood Pump Rotation in the Event of Electromechanical Failure: An Easy Solution to a Devastating Problem

PubMed Central

Skoletsky, Jennifer S.; White, Brian T.; Austin, Jon W.

2007-01-01

Abstract: Despite the advanced technologies of battery back-up for heart-lung consoles and the availability of system-wide generators, electromechanical failure is still occurring. Several heartlung machine manufacturers still provide unsafe handcranking devices to use in the case of an emergency while using a roller blood pump. A new design has been engineered to eliminate safety and quality issues for the perfusionist and the patient when the need for handcranking presents itself. A ratchet-style handcranking device was fabricated by means of a steel plate with adjustable pins. The adjustable pins allow for use with different models of the Cobe, Stockert, and Jostra heart-lung consoles, which contain roller pumps with 180° roller heads. Additional modifications such as a 1:2 transmission and fluorescent markers are also used in the design. This innovative design is an improvement in safety compared with the current handcrank provided by Cobe, Stockert, and Jostra. With this modified handcranking device, accidental reverse rotation of the roller pump head cannot occur. Fluorescent markers will improve visualization of the pump head in low-light situations. The ergonomic design improves efficiency by reducing fatigue. Most importantly, a “safe” safety device will replace the current design provided by these manufacturers, thus improving the quality of care by health care providers. PMID:17672191

Patient Safety Threat - Syringe Reuse

MedlinePlus

... Fingerstick Devices Clinical Reminder: Insulin Pens Publications Infection Control Assessment of Ambulatory Surgical Centers Meetings Insurance Stakeholders Meeting – December 2011 Ambulatory Surgical Centers – October 2010 Safety by Design – May 2010 Sticking with Safety – May 2010 Injection ...

Protection and Safety.

ERIC Educational Resources Information Center

American School Board Journal, 1964

1964-01-01

Several aspects of school safety and protection are presented for school administrators and architects. Among those topics discussed are--(1) life safety, (2) vandalism controlled through proper design, (3) personal protective devices, and (4) fire alarm systems. Another critical factor in providing a complete school safety program is proper…

Mutual interferences and design principles for mechatronic devices in magnetic resonance imaging.

PubMed

Yu, Ningbo; Gassert, Roger; Riener, Robert

2011-07-01

Robotic and mechatronic devices that work compatibly with magnetic resonance imaging (MRI) are applied in diagnostic MRI, image-guided surgery, neurorehabilitation and neuroscience. MRI-compatible mechatronic systems must address the challenges imposed by the scanner's electromagnetic fields. We have developed objective quantitative evaluation criteria for device characteristics needed to formulate design guidelines that ensure MRI-compatibility based on safety, device functionality and image quality. The mutual interferences between an MRI system and mechatronic devices working in its vicinity are modeled and tested. For each interference, the involved components are listed, and a numerical measure for "MRI-compatibility" is proposed. These interferences are categorized into an MRI-compatibility matrix, with each element representing possible interactions between one part of the mechatronic system and one component of the electromagnetic fields. Based on this formulation, design principles for MRI-compatible mechatronic systems are proposed. Furthermore, test methods are developed to examine whether a mechatronic device indeed works without interferences within an MRI system. Finally, the proposed MRI-compatibility criteria and design guidelines have been applied to an actual design process that has been validated by the test procedures. Objective and quantitative MRI-compatibility measures for mechatronic and robotic devices have been established. Applying the proposed design principles, potential problems in safety, device functionality and image quality can be considered in the design phase to ensure that the mechatronic system will fulfill the MRI-compatibility criteria. New guidelines and test procedures for MRI instrument compatibility provide a rational basis for design and evaluation of mechatronic devices in various MRI applications. Designers can apply these criteria and use the tests, so that MRI-compatibility results can accrue to build an experiential database.

Further Development of a Robotic-Assisted Transfer Device

PubMed Central

Burkman, Jessica; Grindle, Garrett; Wang, Hongwu; Kelleher, Annmarie

2017-01-01

Background: The task of performing transfers, such as from a wheelchair to a bed, has a high risk of injury to both the caregiver and the person being transferred. Although mechanical transfer devices can reduce these risks, these devices are not meant for use in the community and they still place strain on the caregiver when used. Purpose: The aim of this study is to describe feedback gathered from focus groups of potential users of the Robotic-Assisted Transfer Device (RATD) and describe design changes aimed at preparing the device for the next step in the development process. Method: The RATD was transferred to a newer electric-powered wheelchair (EPW), key components were redesigned, and the control program was updated to increase the safety of the device. Two focus groups, one consisting of people with disabilities and the other consisting of clinicians and caregivers, were conducted to gather feedback from potential users. Results: Error checking, safety zones, a motor brake, and a new track helped increase the safety of the device. Sixty-three percent of the people with disabilities and 83% of caregivers surveyed said they would use the device. Conclusions: The results from the focus groups were positive and the design changes were successful, but more development is needed before the RATD can be marketed. PMID:29339890

30 CFR 56.9307 - Design, installation, and maintenance of railroads.

Code of Federal Regulations, 2010 CFR

2010-07-01

... railroads. 56.9307 Section 56.9307 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF... MINES Loading, Hauling, and Dumping Safety Devices, Provisions, and Procedures for Roadways, Railroads, and Loading and Dumping Sites § 56.9307 Design, installation, and maintenance of railroads. Roadbeds...

77 FR 11199 - Visual-Manual NHTSA Driver Distraction Guidelines for In-Vehicle Electronic Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-24

...The National Highway Traffic Safety Administration (NHTSA) is concerned about the effects of distraction due to drivers' use of electronic devices on motor vehicle safety. Consequently, NHTSA is issuing nonbinding, voluntary NHTSA Driver Distraction Guidelines (NHTSA Guidelines) to promote safety by discouraging the introduction of excessively distracting devices in vehicles. This notice details the contents of the first phase of the NHTSA Driver Distraction Guidelines. These NHTSA Guidelines cover original equipment in-vehicle device secondary tasks (communications, entertainment, information gathering, and navigation tasks not required to drive are considered secondary tasks) performed by the driver through visual-manual means (meaning the driver looking at a device, manipulating a device-related control with the driver's hand, and watching for visual feedback). The proposed NHTSA Guidelines list certain secondary, non-driving related tasks that, based on NHTSA's research, are believed by the agency to interfere inherently with a driver's ability to safely control the vehicle. The Guidelines recommend that those in-vehicle devices be designed so that they cannot be used by the driver to perform such tasks while the driver is driving. For all other secondary, non-driving-related visual-manual tasks, the NHTSA Guidelines specify a test method for measuring the impact of task performance on driving safety while driving and time-based acceptance criteria for assessing whether a task interferes too much with driver attention to be suitable to perform while driving. If a task does not meet the acceptance criteria, the NHTSA Guidelines recommend that in- vehicle devices be designed so that the task cannot be performed by the driver while driving. In addition to identifying inherently distracting tasks and providing a means for measuring and evaluating the level of distraction associated with other non-driving-related tasks, the NHTSA Guidelines contain several design recommendations for in-vehicle devices in order to minimize their potential for distraction. NHTSA seeks comments on these NHTSA Guidelines and any suggestions for how to improve them so as to better enhance motor vehicle safety.

Reducing RF-related heating of cardiac pacemaker leads in MRI: implementation and experimental verification of practical design changes.

PubMed

Nordbeck, Peter; Fidler, Florian; Friedrich, Michael T; Weiss, Ingo; Warmuth, Marcus; Gensler, Daniel; Herold, Volker; Geistert, Wolfgang; Jakob, Peter M; Ertl, Georg; Ritter, Oliver; Ladd, Mark E; Bauer, Wolfgang R; Quick, Harald H

2012-12-01

There are serious concerns regarding safety when performing magnetic resonance imaging in patients with implanted conductive medical devices, such as cardiac pacemakers, and associated leads, as severe incidents have occurred in the past. In this study, several approaches for altering an implant's lead design were systematically developed and evaluated to enhance the safety of implanted medical devices in a magnetic resonance imaging environment. The individual impact of each design change on radiofrequency heating was then systematically investigated in functional lead prototypes at 1.5 T. Radiofrequency-induced heating could be successfully reduced by three basic changes in conventional pacemaker lead design: (1) increasing the lead tip area, (2) increasing the lead conductor resistance, and (3) increasing outer lead insulation conductivity. The findings show that radiofrequency energy pickup in magnetic resonance imaging can be reduced and, therefore, patient safety can be improved with dedicated construction changes according to a "safe by design" strategy. Incorporation of the described alterations into implantable medical devices such as pacemaker leads can be used to help achieve favorable risk-benefit-ratios when performing magnetic resonance imaging in the respective patient group. Copyright © 2012 Wiley Periodicals, Inc.

Pediatric cardiovascular safety: challenges in drug and device development and clinical application.

PubMed

Bates, Katherine E; Vetter, Victoria L; Li, Jennifer S; Cummins, Susan; Aguel, Fernando; Almond, Christopher; Dubin, Anne M; Elia, Josephine; Finkle, John; Hausner, Elizabeth A; Joseph, Francesca; Karkowsky, Abraham M; Killeen, Matthew; Lemacks, Jodi; Mathis, Lisa; McMahon, Ann W; Pinnow, Ellen; Rodriguez, Ignacio; Stockbridge, Norman L; Stockwell, Margaret; Tassinari, Melissa; Krucoff, Mitchell W

2012-10-01

Development of pediatric medications and devices is complicated by differences in pediatric physiology and pathophysiology (both compared with adults and within the pediatric age range), small patient populations, and practical and ethical challenges to designing clinical trials. This article summarizes the discussions that occurred at a Cardiac Safety Research Consortium-sponsored Think Tank convened on December 10, 2010, where members from academia, industry, and regulatory agencies discussed important issues regarding pediatric cardiovascular safety of medications and cardiovascular devices. Pediatric drug and device development may use adult data but often requires additional preclinical and clinical testing to characterize effects on cardiac function and development. Challenges in preclinical trials include identifying appropriate animal models, clinically relevant efficacy end points, and methods to monitor cardiovascular safety. Pediatric clinical trials have different ethical concerns from adult trials, including consideration of the subjects' families. Clinical trial design in pediatrics should assess risks and benefits as well as incorporate input from families. Postmarketing surveillance, mandated by federal law, plays an important role in both drug and device safety assessment and becomes crucial in the pediatric population because of the limitations of premarketing pediatric studies. Solutions for this wide array of issues will require collaboration between academia, industry, and government as well as creativity in pediatric study design. Formation of various epidemiologic tools including registries to describe outcomes of pediatric cardiac disease and its treatment as well as cardiac effects of noncardiovascular medications, should inform preclinical and clinical development and improve benefit-risk assessments for the patients. The discussions in this article summarize areas of emerging consensus and other areas in which consensus remains elusive and provide suggestions for additional research to further our knowledge and understanding of this topic. Copyright © 2012 Mosby, Inc. All rights reserved.

29 CFR 1910.27 - Fixed ladders.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR OCCUPATIONAL SAFETY AND HEALTH STANDARDS Walking-Working Surfaces § 1910.27 Fixed ladders. (a) Design... fraction thereof, except that, where no cage, well, or ladder safety device is provided, landing platforms...

Regulatory science based approach in development of novel medical devices.

PubMed

Sakuma, Ichiro

2015-08-01

For development rational evaluation method for medical devices' safety and efficacy, regulatory science studies are important. Studies on regulatory affairs related to a medical device under development should be conducted as well as its technological development. Clinical performance of a medical device is influenced by performance of the device, medical doctors' skill, pathological condition of a patient, and so on. Thus it is sometimes difficult to demonstrate superiority of the device in terms of clinical outcome although its efficacy as a medical device is accepted. Setting of appropriate end points is required to evaluate a medical device appropriately. Risk assessment and risk management are the basis of medical device safety assurance. In case of medical device software, there are difficulties in identifying the risk due to its complexity of user environment and different design and manufacturing procedure compared with conventional hardware based medical devices. Recent technological advancement such as information and communication technologies (ICT) for medical devices and wireless network has raised new issue on risk management: cybersecurity. We have to watch closely the progress of safety standard development.

42 CFR 84.70 - Self-contained breathing apparatus; description.

Code of Federal Regulations, 2013 CFR

2013-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Self..., including all completely assembled, portable, self-contained devices designed for use as respiratory...

42 CFR 84.70 - Self-contained breathing apparatus; description.

Code of Federal Regulations, 2014 CFR

2014-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Self..., including all completely assembled, portable, self-contained devices designed for use as respiratory...

42 CFR 84.70 - Self-contained breathing apparatus; description.

Code of Federal Regulations, 2012 CFR

2012-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Self..., including all completely assembled, portable, self-contained devices designed for use as respiratory...

Effect of current federal regulations on handgun safety features.

PubMed

Milne, John S; Hargarten, Stephen W; Kellermann, Arthur L; Wintemute, Garen J

2003-01-01

In the late 1960s, the Bureau of Alcohol, Tobacco, and Firearms implemented the "factoring criteria," a set of minimum size and safety standards required for any handgun imported into the United States. These standards, however, were not applied to guns manufactured domestically. We determine whether extending the factoring criteria to all handguns sold in the United States, as has been proposed in Congress, would increase the likelihood that safety devices would be included in new handgun designs. Imported and domestic handgun models produced in 1996 were examined to determine the prevalence of 4 passively acting safety devices on pistols and 1 passive safety device on revolvers. Domestic models were also scored against the factoring criteria. Compared with domestic pistol models, imported pistols were more likely to include a firing pin block (odds ratio [OR] 2.43; 95% confidence interval [CI] 1.54 to 3.85) and a loaded chamber indicator (OR 1.59; 95% CI 0.98 to 2.56). Domestic pistol models that already met the factoring criteria were more likely to include a loaded chamber indicator (OR 12.05; 95% CI 2.74 to 53.02), a grip safety (OR 24.12; 95% CI 7.8 to 74.33), and a firing pin block (OR 4.92; 95% CI 2.35 to 10.29) than domestic models that did not meet the criteria. Although pistol models that meet the factoring criteria are more likely to contain safety devices than those that do not, the net effect is modest. Thus, the factoring criteria alone are insufficient to ensure consistent incorporation of safety features into new handgun designs.

Lithium Ion Battery Design and Safety

NASA Technical Reports Server (NTRS)

Au, George; Locke, Laura

2001-01-01

This viewgraph presentation makes several recommendations to ensure the safe and effective design of Lithium ion cell batteries. Large lithium ion cells require pressure switches and small cells require pressure disconnects and other safety devices with the ability to instantly interrupt flow. Other suggestions include specifications for batteries and battery chargers.

33 CFR 159.97 - Safety: inspected vessels.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 33 Navigation and Navigable Waters 2 2011-07-01 2011-07-01 false Safety: inspected vessels. 159.97 Section 159.97 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) POLLUTION MARINE SANITATION DEVICES Design, Construction, and Testing § 159.97 Safety: inspected vessels...

Development of fluorescence based handheld imaging devices for food safety inspection

NASA Astrophysics Data System (ADS)

Lee, Hoyoung; Kim, Moon S.; Chao, Kuanglin; Lefcourt, Alan M.; Chan, Diane E.

2013-05-01

For sanitation inspection in food processing environment, fluorescence imaging can be a very useful method because many organic materials reveal unique fluorescence emissions when excited by UV or violet radiation. Although some fluorescence-based automated inspection instrumentation has been developed for food products, there remains a need for devices that can assist on-site inspectors performing visual sanitation inspection of the surfaces of food processing/handling equipment. This paper reports the development of an inexpensive handheld imaging device designed to visualize fluorescence emissions and intended to help detect the presence of fecal contaminants, organic residues, and bacterial biofilms at multispectral fluorescence emission bands. The device consists of a miniature camera, multispectral (interference) filters, and high power LED illumination. With WiFi communication, live inspection images from the device can be displayed on smartphone or tablet devices. This imaging device could be a useful tool for assessing the effectiveness of sanitation procedures and for helping processors to minimize food safety risks or determine potential problem areas. This paper presents the design and development including evaluation and optimization of the hardware components of the imaging devices.

Design of a Fatigue Detection System for High-Speed Trains Based on Driver Vigilance Using a Wireless Wearable EEG.

PubMed

Zhang, Xiaoliang; Li, Jiali; Liu, Yugang; Zhang, Zutao; Wang, Zhuojun; Luo, Dianyuan; Zhou, Xiang; Zhu, Miankuan; Salman, Waleed; Hu, Guangdi; Wang, Chunbai

2017-03-01

The vigilance of the driver is important for railway safety, despite not being included in the safety management system (SMS) for high-speed train safety. In this paper, a novel fatigue detection system for high-speed train safety based on monitoring train driver vigilance using a wireless wearable electroencephalograph (EEG) is presented. This system is designed to detect whether the driver is drowsiness. The proposed system consists of three main parts: (1) a wireless wearable EEG collection; (2) train driver vigilance detection; and (3) early warning device for train driver. In the first part, an 8-channel wireless wearable brain-computer interface (BCI) device acquires the locomotive driver's brain EEG signal comfortably under high-speed train-driving conditions. The recorded data are transmitted to a personal computer (PC) via Bluetooth. In the second step, a support vector machine (SVM) classification algorithm is implemented to determine the vigilance level using the Fast Fourier transform (FFT) to extract the EEG power spectrum density (PSD). In addition, an early warning device begins to work if fatigue is detected. The simulation and test results demonstrate the feasibility of the proposed fatigue detection system for high-speed train safety.

Unintentional and undetermined firearm related deaths: a preventable death analysis for three safety devices

PubMed Central

Vernick, J; O'Brien, M; Hepburn, L; Johnson, S; Webster, D; Hargarten, S

2003-01-01

Objective: To determine the proportion of unintentional and undetermined firearm related deaths preventable by three safety devices: personalization devices, loaded chamber indicators (LCIs), and magazine safeties. A personalized gun will operate only for an authorized user, a LCI indicates when the gun contains ammunition, and a magazine safety prevents the gun from firing when the ammunition magazine is removed. Design: Information about all unintentional and undetermined firearm deaths from 1991–98 was obtained from the Office of the Chief Medical Examiner for Maryland, and from the Wisconsin Firearm Injury Reporting System for Milwaukee. Data regarding the victim, shooter, weapon, and circumstances were abstracted. Coding rules to classify each death as preventable, possibly preventable, or not preventable by each of the three safety devices were also applied. Results: There were a total of 117 firearm related deaths in our sample, 95 (81%) involving handguns. Forty three deaths (37%) were classified as preventable by a personalized gun, 23 (20%) by a LCI, and five (4%) by a magazine safety. Overall, 52 deaths (44%) were preventable by at least one safety device. Deaths involving children 0–17 (relative risk (RR) 3.3, 95% confidence interval (CI) 2.1 to 5.1) and handguns (RR 8.1, 95% CI 1.2 to 53.5) were more likely to be preventable. Projecting the findings to the entire United States, an estimated 442 deaths might have been prevented in 2000 had all guns been equipped with these safety devices. Conclusion: Incorporating safety devices into firearms is an important injury intervention, with the potential to save hundreds of lives each year. PMID:14693889

Light Augmentation Device: A New Surgical Tool for Improved Laparoscopic Visibility and Transillumination: Proof-of-Concept Study.

PubMed

Asti, Emanuele; Nebbia, Fabio; Sironi, Andrea; Bottino, Vincenzo; Bonitta, Gianluca; Bonavina, Luigi

2016-12-01

The light augmentation device (LAD ® ) is a new disposable tool designed to improve observation by transillumination in laparoscopic surgery. It can be introduced into the abdomen through an 11-12 mm port as a supplementary light source. The miniaturized design allows the surgeon to pick up the device with an endograsper and to place it under direct vision where needed. This proof-of-concept study demonstrated safety and efficacy of the device in the animal model.

33 CFR 159.129 - Safety: Ignition prevention test.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 33 Navigation and Navigable Waters 2 2011-07-01 2011-07-01 false Safety: Ignition prevention test. 159.129 Section 159.129 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) POLLUTION MARINE SANITATION DEVICES Design, Construction, and Testing § 159.129 Safety: Ignition...

Model-Driven Safety Analysis of Closed-Loop Medical Systems

PubMed Central

Pajic, Miroslav; Mangharam, Rahul; Sokolsky, Oleg; Arney, David; Goldman, Julian; Lee, Insup

2013-01-01

In modern hospitals, patients are treated using a wide array of medical devices that are increasingly interacting with each other over the network, thus offering a perfect example of a cyber-physical system. We study the safety of a medical device system for the physiologic closed-loop control of drug infusion. The main contribution of the paper is the verification approach for the safety properties of closed-loop medical device systems. We demonstrate, using a case study, that the approach can be applied to a system of clinical importance. Our method combines simulation-based analysis of a detailed model of the system that contains continuous patient dynamics with model checking of a more abstract timed automata model. We show that the relationship between the two models preserves the crucial aspect of the timing behavior that ensures the conservativeness of the safety analysis. We also describe system design that can provide open-loop safety under network failure. PMID:24177176

Model-Driven Safety Analysis of Closed-Loop Medical Systems.

PubMed

Pajic, Miroslav; Mangharam, Rahul; Sokolsky, Oleg; Arney, David; Goldman, Julian; Lee, Insup

2012-10-26

In modern hospitals, patients are treated using a wide array of medical devices that are increasingly interacting with each other over the network, thus offering a perfect example of a cyber-physical system. We study the safety of a medical device system for the physiologic closed-loop control of drug infusion. The main contribution of the paper is the verification approach for the safety properties of closed-loop medical device systems. We demonstrate, using a case study, that the approach can be applied to a system of clinical importance. Our method combines simulation-based analysis of a detailed model of the system that contains continuous patient dynamics with model checking of a more abstract timed automata model. We show that the relationship between the two models preserves the crucial aspect of the timing behavior that ensures the conservativeness of the safety analysis. We also describe system design that can provide open-loop safety under network failure.

Evaluation of Automated Flagger Assistance Devices

DOT National Transportation Integrated Search

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 ...

Effectiveness of Existing Eye Safety Legislation in Arizona.

ERIC Educational Resources Information Center

Gillaspy, Roy Eugene

This study was designed to ascertain the current practices of eye safety in Arizona high school industrial education laboratories, including the enforcement of eye safety legislation, use of eye protection devices, how the eye ware meets the American National Standards Institute specifications, and the teachers' interpretations of the existing eye…

Portable oxygen subsystem. [design analysis and performance tests

NASA Technical Reports Server (NTRS)

1975-01-01

The concept and design of a portable oxygen device for use in the space shuttle orbiter is presented. Hardware fabrication and acceptance tests (i.e., breadboard models) are outlined and discussed. Optimization of the system (for weight, volume, safety, costs) is discussed. The device is of the rebreather type, and provides a revitalized breathing gas supply to a crewman for denitrogenization and emergency activities. Engineering drawings and photographs of the device are shown.

Safety and Efficacy of the BrainPort V100 Device in Individuals Blinded by Traumatic Injury

DTIC Science & Technology

2015-10-01

within the next quarter. 15 . SUBJECT TERMS BrainPort, V100, V200, blindness, visual impairment, assistive device, assistive technology, visual aid, non...2. Keywords 4 3. Accomplishments 4 4. Impact 10 5 . Changes/Problems 10 6. Products 10 7. Participants & Other...design were finalized during the 4 th quarter. The headset frame design (plastic and silicone components) was completed and device hardware 5 and

49 CFR 232.613 - End-of-train devices.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., DEPARTMENT OF TRANSPORTATION BRAKE SYSTEM SAFETY STANDARDS FOR FREIGHT AND OTHER NON-PASSENGER TRAINS AND EQUIPMENT; END-OF-TRAIN DEVICES Electronically Controlled Pneumatic (ECP) Braking Systems § 232.613 End-of... equipped with an ECP brake system unless that train is equipped with a functioning ECP-EOT device designed...

Modeling of endoluminal and interstitial ultrasound hyperthermia and thermal ablation: applications to device design, feedback control, and treatment planning

PubMed Central

Prakash, Punit; Salgaonkar, Vasant A.; Diederich, Chris J.

2014-01-01

Endoluminal and catheter-based ultrasound applicators are currently under development and are in clinical use for minimally invasive hyperthermia and thermal ablation of various tissue targets. Computational models play a critical role in in device design and optimization, assessment of therapeutic feasibility and safety, devising treatment monitoring and feedback control strategies, and performing patient-specific treatment planning with this technology. The critical aspects of theoretical modeling, applied specifically to endoluminal and interstitial ultrasound thermotherapy, are reviewed. Principles and practical techniques for modeling acoustic energy deposition, bioheat transfer, thermal tissue damage, and dynamic changes in the physical and physiological state of tissue are reviewed. The integration of these models and applications of simulation techniques in identification of device design parameters, development of real time feedback-control platforms, assessing the quality and safety of treatment delivery strategies, and optimization of inverse treatment plans are presented. PMID:23738697

An Evaluation Tool for Agricultural Health and Safety Mobile Applications.

PubMed

Reyes, Iris; Ellis, Tammy; Yoder, Aaron; Keifer, Matthew C

2016-01-01

As the use of mobile devices and their software applications, or apps, becomes ubiquitous, use amongst agricultural working populations is expanding as well. The smart device paired with a well-designed app has potential for improving workplace health and safety in the hands of those who can act upon the information provided. Many apps designed to assess workplace hazards and implementation of worker protections already exist. However, the abundance and diversity of such applications also presents challenges regarding evaluation practices and assignation of value. This is particularly true in the agricultural workspace, as there is currently little information on the value of these apps for agricultural safety and health. This project proposes a framework for developing and evaluating apps that have potential usefulness in agricultural health and safety. The evaluation framework is easily transferable, with little modification for evaluation of apps in several agriculture-specific areas.

49 CFR 232.405 - Design and performance standards for two-way end-of-train devices.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 4 2012-10-01 2012-10-01 false Design and performance standards for two-way end-of-train devices. 232.405 Section 232.405 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION BRAKE SYSTEM SAFETY STANDARDS FOR FREIGHT AND OTHER NON-PASSENGER TRAINS...

49 CFR 232.403 - Design standards for one-way end-of-train devices.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 4 2012-10-01 2012-10-01 false Design standards for one-way end-of-train devices. 232.403 Section 232.403 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION BRAKE SYSTEM SAFETY STANDARDS FOR FREIGHT AND OTHER NON-PASSENGER TRAINS AND EQUIPMENT; EN...

9 CFR 592.5 - Designation of official certificates, memoranda, marks, other identifications, and devices for...

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Designation of official certificates, memoranda, marks, other identifications, and devices for purposes of the Agricultural Marketing Act. 592.5 Section 592.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY...

9 CFR 592.5 - Designation of official certificates, memoranda, marks, other identifications, and devices for...

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Designation of official certificates, memoranda, marks, other identifications, and devices for purposes of the Agricultural Marketing Act. 592.5 Section 592.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY...

9 CFR 592.5 - Designation of official certificates, memoranda, marks, other identifications, and devices for...

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Designation of official certificates, memoranda, marks, other identifications, and devices for purposes of the Agricultural Marketing Act. 592.5 Section 592.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY...

10 CFR 830.3 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-01-01

.... Critical assembly means special nuclear devices designed and used to sustain nuclear reactions, which may... reaction becomes self-sustaining. Design features means the design features of a nuclear facility specified..., or the environment, including (1) Physical, design, structural, and engineering features; (2) Safety...

10 CFR 830.3 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-01-01

.... Critical assembly means special nuclear devices designed and used to sustain nuclear reactions, which may... reaction becomes self-sustaining. Design features means the design features of a nuclear facility specified..., or the environment, including (1) Physical, design, structural, and engineering features; (2) Safety...

Intelligent behaviors through vehicle-to-vehicle and vehicle-to-infrastructure communication

NASA Astrophysics Data System (ADS)

Garcia, Richard D.; Sturgeon, Purser; Brown, Mike

2012-06-01

The last decade has seen a significant increase in intelligent safety devices on private automobiles. These devices have both increased and augmented the situational awareness of the driver and in some cases provided automated vehicle responses. To date almost all intelligent safety devices have relied on data directly perceived by the vehicle. This constraint has a direct impact on the types of solutions available to the vehicle. In an effort to improve the safety options available to a vehicle, numerous research laboratories and government agencies are investing time and resources into connecting vehicles to each other and to infrastructure-based devices. This work details several efforts in both the commercial vehicle and the private auto industries to increase vehicle safety and driver situational awareness through vehicle-to-vehicle and vehicle-to-infrastructure communication. It will specifically discuss intelligent behaviors being designed to automatically disable non-compliant vehicles, warn tractor trailer vehicles of unsafe lane maneuvers such as lane changes, passing, and merging, and alert drivers to non-line-of-sight emergencies.

Development and evaluation of devices designed to minimize deer-vehicle collisions.

DOT National Transportation Integrated Search

2007-07-02

This project was funded by Georgia Department of Transportation (GDOT) through the : Governors Office of Highway Safety and the National Highway Traffic Safety Administration. : The study was a collaborative research project initiated in 2004 and ...

Bumpers: Traffic Safety Tips

DOT National Transportation Integrated Search

1996-01-01

This fact sheet, NHTSA Facts: Summer 1996, discusses automobile bumpers. It notes that a car bumper is not a safety device to prevent or reduce injuries to people in the car. Instead, it is designed to protect the hood, trunk, grille, parking lights,...

Understanding safety-critical interactions with a home medical device through Distributed Cognition.

PubMed

Rajkomar, Atish; Mayer, Astrid; Blandford, Ann

2015-08-01

As healthcare shifts from the hospital to the home, it is becoming increasingly important to understand how patients interact with home medical devices, to inform the safe and patient-friendly design of these devices. Distributed Cognition (DCog) has been a useful theoretical framework for understanding situated interactions in the healthcare domain. However, it has not previously been applied to study interactions with home medical devices. In this study, DCog was applied to understand renal patients' interactions with Home Hemodialysis Technology (HHT), as an example of a home medical device. Data was gathered through ethnographic observations and interviews with 19 renal patients and interviews with seven professionals. Data was analyzed through the principles summarized in the Distributed Cognition for Teamwork methodology. In this paper we focus on the analysis of system activities, information flows, social structures, physical layouts, and artefacts. By explicitly considering different ways in which cognitive processes are distributed, the DCog approach helped to understand patients' interaction strategies, and pointed to design opportunities that could improve patients' experiences of using HHT. The findings highlight the need to design HHT taking into consideration likely scenarios of use in the home and of the broader home context. A setting such as home hemodialysis has the characteristics of a complex and safety-critical socio-technical system, and a DCog approach effectively helps to understand how safety is achieved or compromised in such a system. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Current challenges for clinical trials of cardiovascular medical devices.

PubMed

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.

Design of a Fatigue Detection System for High-Speed Trains Based on Driver Vigilance Using a Wireless Wearable EEG

PubMed Central

Zhang, Xiaoliang; Li, Jiali; Liu, Yugang; Zhang, Zutao; Wang, Zhuojun; Luo, Dianyuan; Zhou, Xiang; Zhu, Miankuan; Salman, Waleed; Hu, Guangdi; Wang, Chunbai

2017-01-01

The vigilance of the driver is important for railway safety, despite not being included in the safety management system (SMS) for high-speed train safety. In this paper, a novel fatigue detection system for high-speed train safety based on monitoring train driver vigilance using a wireless wearable electroencephalograph (EEG) is presented. This system is designed to detect whether the driver is drowsiness. The proposed system consists of three main parts: (1) a wireless wearable EEG collection; (2) train driver vigilance detection; and (3) early warning device for train driver. In the first part, an 8-channel wireless wearable brain-computer interface (BCI) device acquires the locomotive driver’s brain EEG signal comfortably under high-speed train-driving conditions. The recorded data are transmitted to a personal computer (PC) via Bluetooth. In the second step, a support vector machine (SVM) classification algorithm is implemented to determine the vigilance level using the Fast Fourier transform (FFT) to extract the EEG power spectrum density (PSD). In addition, an early warning device begins to work if fatigue is detected. The simulation and test results demonstrate the feasibility of the proposed fatigue detection system for high-speed train safety. PMID:28257073

Comparison of the EZ-Cap recapper with the Mayo recapper for the prevention of needlesticks.

PubMed

Dewhirst, Chad A; Hung, Joseph C

2008-09-01

The purpose of this project was the development of a device that improves the design of our current capping block, the Mayo recapper. The major challenges for design and improvement included creating a device that is simple to use and can be applied throughout our department. We wanted a recapper device that increased safety and minimized the potential for needlesticks. Simplicity was another important factor, along with versatility and low cost. A new recapper, called EZ-Cap, was developed, and a comparison study was conducted to evaluate the pros and cons of the EZ-Cap recapper and the Mayo recapper. Nuclear medicine technologists (n = 10) in our department used each device when administering patient injections. At the conclusion of their patient injection rotation, they recorded on a survey sheet the pros and cons of each device. The results of this survey were used to evaluate the effectiveness, comfort level during use, and safety of each recapping device. We used a 2-level scoring system to help determine which device was more favorable. The first level focused on comfort and convenience and was given a score of +1 or -1. The second level focused on safety and was given a score of +2 or -2. Because we believed that safety was a high priority for our capping blocks, this level received a higher score than the first level. The Mayo recapper was the device preferred by 9 of 10 technologists surveyed. The EZ-Cap recapper had several technical issues that made it difficult to use and that could potentially lead to safety concerns. According to our scoring system, the Mayo recapper received a score of +9 for its pros and -4 for its cons. By comparison, the EZ-Cap recapper received a score of +7 for its pros and -16 for its cons. Our results show that the Mayo recapper was the device of choice because its pros outweighed its cons. However, we will continually improve the effectiveness of the Mayo recapper to prevent needlesticks.

76 FR 70150 - Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-10

... proof of principle and initial clinical safety data before the device design is finalized. This draft... to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm.... Early feasibility studies allow for early clinical evaluation of devices to provide proof of principle...

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

PubMed

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

2014-11-01

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

A History of the Sonocare CST-100: The First FDA-approved HIFU Device

NASA Astrophysics Data System (ADS)

Muratore, Robert

2006-05-01

The Sonocare CST-100 Therapeutic Ultrasound System, designed for the treatment of glaucoma, was developed in the 1980s and became the first high intensity focused ultrasound (HIFU) device to receive Food and Drug Administration approval. The system arose from studies done by F.L. Lizzi, Eng.Sc.D., of Riverside Research Institute and D.J. Coleman, M.D., of Cornell Medical Center/New York Hospital on the safety of ultrasound diagnosis of the eye. As safety limits were probed, therapeutic regimes were discovered. Optimization of operational parameters, clinical experience, and engineering design came together through a spin-off company, Sonocare, Inc., formed to produce and market the ophthalmic device. Various precedents were set during the approval process, including the acceptance by the FDA of radiation momentum imparted to an absorber as a measure of acoustic power. Many devices were sold, but the laser industry, grandfathered into the therapeutic field, eventually out-marketed Sonocare. The CST-100 remains as a model of elegant industrial design, and existing units are used daily in HIFU laboratory experiments.

Strength characteristics of sealer devices at design stage

NASA Astrophysics Data System (ADS)

Butov, V. G.; Golubeva, K. A.; Nikulchikov, V. K.; Yashchuk, A. A.

2016-09-01

The paper deals with strength characteristics of several sealer devices used to seal the inner cavity of an oil pipeline during the replacement of a pipeline section. Construction calculations revealed the stresses related to the pressurized rubber-cord sealing element rupture resulted from an emergency situation. It was concluded that it is necessary to test the operating parameters before applying the sealers. Estimation of the safety factor of existing sealer devices designs was conducted and recommendations for its increase were proposed.

2014 Summer Series - Kristin Yvonne Rozier - No More Helicopter Parenting: Intelligent Autonomous Unmanned Aerial Vehicle

NASA Image and Video Library

2014-06-10

Safety is NASA's top priority! The search for innovative new ways to validate and verify is vital for the development of safety-critical systems. Such techniques have been successfully used to assure systems for air traffic control, airplane separation assurance, autopilots, logic designs, medical devices, and other functions that ensure human safety.

The Home Inventory of Dangers and Safety Precautions--2: Addressing Critical Needs for Prescriptive Assessment Devices in Child Maltreatment and in Healthcare.

ERIC Educational Resources Information Center

Tymchuk, Alexander J.; Lang, Cathy M.; Doylniuk, Chrystina A.; Berney-Ficklin, Karen; Spitz, Rebecca

1999-01-01

Describes a study involving 29 low-income parents with learning difficulties that validated a prescriptive home-danger and safety-precaution instrument containing 14 epidemiological categories to be used in the design and evaluation of family-tailored injury prevention and safety interventions. (Author/CR)

Seat Belts: Are They the Best Solution to the Real Problem?

ERIC Educational Resources Information Center

Comeau, Lee F.

1985-01-01

More children are killed outside their school buses than inside. To solve this problem, we should improve bus design, provide driver training programs for all school bus drivers, utilize the latest safety devices available, and improve ridership safety curriculum. (MLF)

A revolutionary design change to improve stapler safety.

PubMed

Arteaga-González, Iván J

2013-01-01

Postoperative staple line leaks and bleeding are the most common reasons for complications in surgical procedures that involve organ resection, such as sleeve gastrectomy. Increasing the safety of these operations requires improving the instruments (endostaplers or endocutters) used for stapling and sectioning the tissues. We present a new prototype stapler for marketing in resection surgery, especially designed for the sleeve gastrectomy. We suggest that the medical instrument industry creates devices in which the channel along which the knife blade runs is located asymmetrically. This would allow more staples to be placed on the side of the gastric remnant, thus improving the sealing and hemostasis of the suture line and reducing the number of complications for patients as a result. The application of new concepts in medical surgical devices can improve the safety of the procedures in our patients.

Assurance Cases for Medical Devices

DTIC Science & Technology

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

Crashworthiness Design of the Shear Bolts for Light Collision Safety Devices

NASA Astrophysics Data System (ADS)

Kim, Jin Sung; Huh, Hoon; Kwon, Tae Soo

This paper introduces the jig set for the crash test and the crash test results of shear bolts which are designed to fail at train crash conditions. The tension and shear bolts are attached to Light Collision Safety Devices(LCSD) as a mechanical fuse when tension and shear bolts reach their failure load designed. The kinetic energy due to the crash is absorbed by the secondary energy absorbing device after LCSD are detached from the main body by the fracture of shear bolts. A single shear bolt was designed to fail at the load of 250 kN. The jig set designed to convert a compressive loading to a shear loading was installed to the high speed crash tester for dynamic shear tests. Two strain gauges were attached at the parallel section of the jig set to measure the load responses acting on the shear bolts. Crash tests were performed with a carrier whose mass was 250 kg and the initial speed of the carrier was 9 m/sec. From the quasi-static and dynamic experiments as well as the numerical analysis, the capacity of the shear bolts were accurately predicted for the crashworthiness design.

Optical design applications for enhanced illumination performance

NASA Astrophysics Data System (ADS)

Gilray, Carl; Lewin, Ian

1995-08-01

Nonimaging optical design techniques have been applied in the illumination industry for many years. Recently however, powerful software has been developed which allows accurate simulation and optimization of illumination devices. Wide experience has been obtained in using such design techniques for practical situations. These include automotive lighting where safety is of greatest importance, commercial lighting systems designed for energy efficiency, and numerous specialized applications. This presentation will discuss the performance requirements of a variety of illumination devices. It will further cover design methodology and present a variety of examples of practical applications for enhanced system performance.

Safety assessment in plant layout design using indexing approach: implementing inherent safety perspective. Part 1 - guideword applicability and method description.

PubMed

Tugnoli, Alessandro; Khan, Faisal; Amyotte, Paul; Cozzani, Valerio

2008-12-15

Layout planning plays a key role in the inherent safety performance of process plants since this design feature controls the possibility of accidental chain-events and the magnitude of possible consequences. A lack of suitable methods to promote the effective implementation of inherent safety in layout design calls for the development of new techniques and methods. In the present paper, a safety assessment approach suitable for layout design in the critical early phase is proposed. The concept of inherent safety is implemented within this safety assessment; the approach is based on an integrated assessment of inherent safety guideword applicability within the constraints typically present in layout design. Application of these guidewords is evaluated along with unit hazards and control devices to quantitatively map the safety performance of different layout options. Moreover, the economic aspects related to safety and inherent safety are evaluated by the method. Specific sub-indices are developed within the integrated safety assessment system to analyze and quantify the hazard related to domino effects. The proposed approach is quick in application, auditable and shares a common framework applicable in other phases of the design lifecycle (e.g. process design). The present work is divided in two parts: Part 1 (current paper) presents the application of inherent safety guidelines in layout design and the index method for safety assessment; Part 2 (accompanying paper) describes the domino hazard sub-index and demonstrates the proposed approach with a case study, thus evidencing the introduction of inherent safety features in layout design.

46 CFR 56.50-20 - Pressure relief piping.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING PIPING SYSTEMS AND... authorized by the Marine Safety Center. (b) Discharge lines (reproduces 122.6.2(d)). Discharge lines from pressure-relieving safety devices shall be designed to facilitate drainage. (c) Stop valves. Stop valves...

46 CFR 56.50-20 - Pressure relief piping.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING PIPING SYSTEMS AND... authorized by the Marine Safety Center. (b) Discharge lines (reproduces 122.6.2(d)). Discharge lines from pressure-relieving safety devices shall be designed to facilitate drainage. (c) Stop valves. Stop valves...

OPERATING PARAMETERS TO MINIMIZE EMISSIONS DURING ROTARY KILN EMERGENCY SAFETY VENT OPENINGS

EPA Science Inventory

Certain designs of hazardous waste incinerator systems include emergency safety vents (ESVs). ESVs (also called dump stacks, vent stacks, emergency by-pass stacks, thermal relief valves, and pressure relief valves) are regarded as true emergency devices. Their purpose is to vent ...

75 FR 60863 - Safety Advisory 2010-02

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-01

... equipped, railroads should ensure that the circuit plan shows the actual interconnection and the designed... detection device (or equivalent) is programmed or equipped to provide the appropriate designed pre-emption... circuit and as designed. By conducting comprehensive periodic joint inspections, the railroad and State...

Magnetic resonance imaging in patients with cardiac pacemakers: era of "MR Conditional" designs.

PubMed

Shinbane, Jerold S; Colletti, Patrick M; Shellock, Frank G

2011-10-27

Advances in cardiac device technology have led to the first generation of magnetic resonance imaging (MRI) conditional devices, providing more diagnostic imaging options for patients with these devices, but also new controversies. Prior studies of pacemakers in patients undergoing MRI procedures have provided groundwork for design improvements. Factors related to magnetic field interactions and transfer of electromagnetic energy led to specific design changes. Ferromagnetic content was minimized. Reed switches were modified. Leads were redesigned to reduce induced currents/heating. Circuitry filters and shielding were implemented to impede or limit the transfer of certain unwanted electromagnetic effects. Prospective multicenter clinical trials to assess the safety and efficacy of the first generation of MR conditional cardiac pacemakers demonstrated no significant alterations in pacing parameters compared to controls. There were no reported complications through the one month visit including no arrhythmias, electrical reset, inhibition of generator output, or adverse sensations. The safe implementation of these new technologies requires an understanding of the well-defined patient and MR system conditions. Although scanning a patient with an MR conditional device following the strictly defined patient and MR system conditions appears straightforward, issues related to patients with pre-existing devices remain complex. Until MR conditional devices are the routine platform for all of these devices, there will still be challenging decisions regarding imaging patients with pre-existing devices where MRI is required to diagnose and manage a potentially life threatening or serious scenario. A range of other devices including ICDs, biventricular devices, and implantable physiologic monitors as well as guidance of medical procedures using MRI technology will require further biomedical device design changes and testing. The development and implementation of cardiac MR conditional devices will continue to require the expertise and collaboration of multiple disciplines and will need to prove safety, effectiveness, and cost effectiveness in patient care.

Magnetic resonance imaging in patients with cardiac pacemakers: era of "MR Conditional" designs

PubMed Central

2011-01-01

Advances in cardiac device technology have led to the first generation of magnetic resonance imaging (MRI) conditional devices, providing more diagnostic imaging options for patients with these devices, but also new controversies. Prior studies of pacemakers in patients undergoing MRI procedures have provided groundwork for design improvements. Factors related to magnetic field interactions and transfer of electromagnetic energy led to specific design changes. Ferromagnetic content was minimized. Reed switches were modified. Leads were redesigned to reduce induced currents/heating. Circuitry filters and shielding were implemented to impede or limit the transfer of certain unwanted electromagnetic effects. Prospective multicenter clinical trials to assess the safety and efficacy of the first generation of MR conditional cardiac pacemakers demonstrated no significant alterations in pacing parameters compared to controls. There were no reported complications through the one month visit including no arrhythmias, electrical reset, inhibition of generator output, or adverse sensations. The safe implementation of these new technologies requires an understanding of the well-defined patient and MR system conditions. Although scanning a patient with an MR conditional device following the strictly defined patient and MR system conditions appears straightforward, issues related to patients with pre-existing devices remain complex. Until MR conditional devices are the routine platform for all of these devices, there will still be challenging decisions regarding imaging patients with pre-existing devices where MRI is required to diagnose and manage a potentially life threatening or serious scenario. A range of other devices including ICDs, biventricular devices, and implantable physiologic monitors as well as guidance of medical procedures using MRI technology will require further biomedical device design changes and testing. The development and implementation of cardiac MR conditional devices will continue to require the expertise and collaboration of multiple disciplines and will need to prove safety, effectiveness, and cost effectiveness in patient care. PMID:22032338

Eye Safety. Mississippi Industrial Arts.

ERIC Educational Resources Information Center

Mississippi State Dept. of Education, Jackson. Div. of Vocational and Technical Education.

This manual is designed to help industrial arts teachers eliminate student eye injuries within industrial arts programs. Presented first is Mississippi eye safety law. Following a discussion of eye protection equipment, illustrations of eye protection devices are provided. Guidelines are set forth for selecting shade numbers for welding filters.…

Remote biomonitoring of temperatures in mothers and newborns: design, development and testing of a wearable sensor device in a tertiary-care hospital in southern India.

PubMed

Mony, Prem K; Thankachan, Prashanth; Bhat, Swarnarekha; Rao, Suman; Washington, Maryann; Antony, Sumi; Thomas, Annamma; Nagarajarao, Sheela C; Rao, Hiteshwar; Amrutur, Bharadwaj

2018-04-01

Newer technologies such as wearables, sensors, mobile telephony and computing offer opportunities to monitor vital physiological parameters and tackle healthcare problems, thereby improving access and quality of care. We describe the design, development and testing of a wearable sensor device for remote biomonitoring of body temperatures in mothers and newborns in southern India. Based on client needs and technological requirements, a wearable sensor device was designed and developed using principles of 'social innovation' design. The device underwent multiple iterations in product design and engineering based on user feedback, and then following preclinical testing, a techno-feasibility study and clinical trial were undertaken in a tertiary-care teaching hospital in Bangalore, India. Clinical trial phases I and IIa for evaluation of safety and efficacy were undertaken in the following sequence: 7 healthy adult volunteers; 18 healthy mothers; 3 healthy babies; 10 stable babies in the neonatal care intensive unit and 1 baby with morbidities. Time-stamped skin temperature readings obtained at 5 min intervals over a 1-hour period from the device secured on upper arms of mothers and abdomen of neonates were compared against readings from thermometers used routinely in clinical practice. Devices were comfortably secured on to adults and neonates, and data were efficiently transmitted via the gateway device for secure storage and retrieval for analysis. The mean skin temperatures in mothers were lower than the axillary temperatures by 2°C; and in newborns, there was a precision of -0.5°C relative to axillary measurements. While occasional minimal adverse events were noted in healthy volunteers, no adverse events were noted in mothers or neonates. This proof-of-concept study shows that this device is promising in terms of feasibility, safety and accuracy (with appropriate calibration) with potential for further refinements in device accuracy and pursuit of further phases of clinical research for improved maternal and neonatal health.

78 FR 25308 - Proposed Collection; Comment Request; Coal Mine Dust Sampling Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-30

...; Coal Mine Dust Sampling Devices AGENCY: Mine Safety and Health Administration, Labor. ACTION: 60-Day.... Background Continuous Personal Dust Monitors (CPDMs) determine the concentration of respirable dust in coal mines. CPDMs must be designed and constructed for coal miners to wear and operate without impeding their...

Recommendations for yield-to-bus traffic control devices and bus pullout bays design characteristics.

DOT National Transportation Integrated Search

2013-04-01

Traffic control devices such as roadside signs and pavement markings are used to promote highway safety and efficiency for all road users. A bus pullout bay is a special geometric roadway feature that allows transit buses to stop outside the travel l...

Development of non-keyboard input device checklists through assessments.

PubMed

Woods, Valerie; Hastings, Sarah; Buckle, Peter; Haslam, Roger

2003-11-01

An assessment of non-keyboard input devices (NKID) was conducted to identify factors for good design in relation to operation, performance and comfort. Twenty-seven NKID users, working in health and safety, evaluated eight devices that included mice, trackballs and a joystick mouse. The factors considered important for good design were: (1) comfortable hand and finger position, (2) adequate control, (3) intuitive and easy to use, (4) ease of device, button and trackball movement, (5) good interaction with software, (6) provision of suitable accessories. Mice were rated more favourably than trackballs or the joystick mouse. The design of the standard 2-button mouse (D4) was considered most desirable to use; the 3-button mouse (D1) and 3-button curved mouse (D8) were also favoured. Assessment data and comments were drawn together with previously published research to produce useful tools for NKID purchasing (i.e. Device Purchasing Checklist) and assessment (i.e. Device Assessment Checklist).

Photobiomodulation therapy for androgenetic alopecia: A clinician's guide to home-use devices cleared by the Federal Drug Administration.

PubMed

Dodd, Erin M; Winter, Margo A; Hordinsky, Maria K; Sadick, Neil S; Farah, Ronda S

2018-06-01

The market for home-use photobiomodulation devices to treat androgenetic alopecia has rapidly expanded, and the Food and Drug Administration (FDA) has recently cleared many devices for this purpose. Patients increasingly seek the advice of dermatologists regarding the safety and efficacy of these hair loss treatments. The purpose of this guide was threefold: (1) to identify all home-use photobiomodulation therapy devices with FDA-clearance for treatment of androgenetic alopecia; (2) to review device design, features and existing clinical evidence; and (3) to discuss practical considerations of photobiomodulation therapy, including patient suitability, treatment goals, safety, and device selection. A search of the FDA 510(k) Premarket Notification database was conducted using product code "OAP" to identify all home-use devices that are FDA-cleared to treat androgenetic alopecia. Thirteen commercially available devices were identified and compared. Devices varied in shape, wavelength, light sources, technical features, price, and level of clinical evidence. To date, there are no head-to-head studies comparing the efficacy of these devices. Photobiomodulation therapy devices have an excellent safety profile and mounting evidence supporting their efficacy. However, long-term, high quality studies comparing these devices in diverse populations are lacking. As these devices become increasingly popular, dermatologists should be familiar with this treatment modality to add to their therapeutic armamentarium. AGA, androgenetic alopecia; FDA, Food and Drug Administration; IEC, International Electrotechnical Commission; LED, light-emitting diode; PBMT, photobiomodulation therapy.

Injury prevention counselling to improve safety practices by parents in Mexico.

PubMed Central

Mock, Charles; Arreola-Risa, Carlos; Trevino-Perez, Rodolfo; Almazan-Saavedra, Victoria; Zozaya-Paz, Jaime E.; Gonzalez-Solis, Reynaldo; Simpson, Kate; Rodriguez-Romo, Laura; Hernandez-Torre, Martin H.

2003-01-01

OBJECTIVES: To evaluate the effectiveness of educational counselling programmes aimed at increasing parents' practice of childhood safety in Monterrey, Mexico, and to provide information aimed at helping to improve the effectiveness of future efforts in this field. METHODS: Three different counselling programmes were designed to meet the needs of the upper, middle and lower socioeconomic strata. Evaluation involved the use of baseline questionnaires on parents' existing safety-related practices for intervention and control groups and the administration of corresponding questionnaires after the programmes had been carried out. FINDINGS: Data were obtained on 1124 children before counselling took place and on 625 after it had been given. Overall safety scores (% safe responses) increased from 54% and 65% for the lower and upper socioeconomic strata, respectively, before counselling to 62% and 73% after counselling (P <0.001 for all groups). Improvements occurred both for activities that required caution and for activities that required the use of safety-related devices (e.g. helmets, car seats). However, scores for the use of such devices remained suboptimal even after counselling and there were wide discrepancies between the socioeconomic strata. The post-counselling scores for the use of safety-related devices were 55%, 38% and 19% for the upper, middle and lower socioeconomic strata, respectively. CONCLUSIONS: Brief educational interventions targeting parents' practice of childhood safety improved safe behaviours. Increased attention should be given to specific safety-related devices and to the safety of pedestrians. Educational efforts should be combined with other strategies for injury prevention, such as the use of legislation and the improvement of environmental conditions. PMID:14576891

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

PubMed Central

Lehoux, Pascale; Ducey, Ariel; Easty, Anthony; Ross, Sue; Bell, Chaim; Trbovich, Patricia

2017-01-01

Objectives 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. Design 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. Results 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. Conclusions 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 hospitals do and should govern interaction with representatives, or support their staff in this regard. PMID:28358886

Kinetic energy recovery systems in motor vehicles

NASA Astrophysics Data System (ADS)

Śliwiński, C.

2016-09-01

The article draws attention to the increasing environmental pollution caused by the development of vehicle transport and motorization. Different types of design solutions used in vehicles for the reduction of fuel consumption, and thereby emission of toxic gasses into the atmosphere, were specified. Historical design solutions concerning energy recovery devices in mechanical vehicles which used flywheels to accumulate kinetic energy were shown. Developmental tendencies in the area of vehicle manufacturing in the form of hybrid electric and electric devices were discussed. Furthermore, designs of energy recovery devices with electrical energy storage from the vehicle braking and shock absorbing systems were presented. A mechanical energy storing device using a flywheel operating under vacuum was presented, as were advantages and disadvantages of both systems, the limitations they impose on individual constructions and safety issues. The paper also discusses a design concept of an energy recovery device in mechanical vehicles which uses torsion springs as the main components of energy accumulation during braking. The desirability of a cooperation of both the mechanical- and electrical energy recovery devices was indicated.

Distraction and Pedestrian Safety: How Talking on the Phone, Texting, and Listening to Music Impact Crossing the Street

PubMed Central

Schwebel, David C.; Stavrinos, Despina; Byington, Katherine W.; Davis, Tiffany; O’Neal, Elizabeth E.; de Jong, Desiree

2011-01-01

As use of handheld multimedia devices has exploded globally, safety experts have begun to consider the impact of distraction while talking, text-messaging, or listening to music on traffic safety. This study was designed to test how talking on the phone, texting, and listening to music may influence pedestrian safety. 138 college students crossed an interactive, semi-immersive virtual pedestrian street. They were randomly assigned to one of four groups: crossing while talking on the phone, crossing while texting, crossing while listening to a personal music device, or crossing while undistracted. Participants distracted by music or texting were more likely to be hit by a vehicle in the virtual pedestrian environment than were undistracted participants. Participants in all three distracted groups were more likely to look away from the street environment (and look toward other places, such as their telephone or music device) than were undistracted participants. Findings were maintained after controlling for demographics, walking frequency, and media use frequency. Distraction from multimedia devices has a small but meaningful impact on college students’ pedestrian safety. Future research should consider the cognitive demands of pedestrian safety, and how those processes may be impacted by distraction. Policymakers might consider ways to protect distracted pedestrians from harm and to reduce the number of individuals crossing streets while distracted. PMID:22269509

Distraction and pedestrian safety: how talking on the phone, texting, and listening to music impact crossing the street.

PubMed

Schwebel, David C; Stavrinos, Despina; Byington, Katherine W; Davis, Tiffany; O'Neal, Elizabeth E; de Jong, Desiree

2012-03-01

As use of handheld multimedia devices has exploded globally, safety experts have begun to consider the impact of distraction while talking, text-messaging, or listening to music on traffic safety. This study was designed to test how talking on the phone, texting, and listening to music may influence pedestrian safety. 138 college students crossed an interactive, semi-immersive virtual pedestrian street. They were randomly assigned to one of four groups: crossing while talking on the phone, crossing while texting, crossing while listening to a personal music device, or crossing while undistracted. Participants distracted by music or texting were more likely to be hit by a vehicle in the virtual pedestrian environment than were undistracted participants. Participants in all three distracted groups were more likely to look away from the street environment (and look toward other places, such as their telephone or music device) than were undistracted participants. Findings were maintained after controlling for demographics, walking frequency, and media use frequency. Distraction from multimedia devices has a small but meaningful impact on college students' pedestrian safety. Future research should consider the cognitive demands of pedestrian safety, and how those processes may be impacted by distraction. Policymakers might consider ways to protect distracted pedestrians from harm and to reduce the number of individuals crossing streets while distracted. Copyright © 2011 Elsevier Ltd. All rights reserved.

77 FR 35471 - National Environmental Policy Act Implementation

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-13

... designed to promote transportation safety, security, accessibility, communication or operational efficiency... surface treatments or pavement markings, small passenger shelters, railroad warning devices, train control...

Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines.

PubMed

Pane, Josep; Coloma, Preciosa M; Verhamme, Katia M C; Sturkenboom, Miriam C J M; Rebollo, Irene

2017-01-01

Recent safety issues involving non-active implantable medical devices (NAIMDs) have highlighted the need for better pre-market and post-market evaluation. Some stakeholders have argued that certain features of medicine safety evaluation should also be applied to medical devices. Our objectives were to compare the current processes and methodologies for the assessment of NAIMD safety profiles with those for medicines, identify potential gaps, and make recommendations for the adoption of new methodologies for the ongoing benefit-risk monitoring of these devices throughout their entire life cycle. A literature review served to examine the current tools for the safety evaluation of NAIMDs and those for medicines. We searched MEDLINE using these two categories. We supplemented this search with Google searches using the same key terms used in the MEDLINE search. Using a comparative approach, we summarized the new product design, development cycle (preclinical and clinical phases), and post-market phases for NAIMDs and drugs. We also evaluated and compared the respective processes to integrate and assess safety data during the life cycle of the products, including signal detection, signal management, and subsequent potential regulatory actions. The search identified a gap in NAIMD safety signal generation: no global program exists that collects and analyzes adverse events and product quality issues. Data sources in real-world settings, such as electronic health records, need to be effectively identified and explored as additional sources of safety information, particularly in some areas such as the EU and USA where there are plans to implement the unique device identifier (UDI). The UDI and other initiatives will enable more robust follow-up and assessment of long-term patient outcomes. The safety evaluation system for NAIMDs differs in many ways from those for drugs, but both systems face analogous challenges with respect to monitoring real-world usage. Certain features of the drug safety evaluation process could, if adopted and adapted for NAIMDs, lead to better and more systematic evaluations of the latter.

Structural Statics Analysis and Optimization Design of Regulating Device for Air Conveyer Outlet in Coal Mine

NASA Astrophysics Data System (ADS)

Gong, Xiaoyan; Li, Ying; Zhang, Yongqiang

2018-06-01

In view of the enlargement of fully mechanized face excavation and long distance driving, gas emission and dust production increase greatly. However, the current ventilation device direction angle, caliber and front-back distance cannot change dynamically at any time, resulting in the serious accumulation in the dead zone. In this paper, a new device were proposed that can solve above problems. Finite element ANSYS software were used to simulate and optimize the structural safety of the control device' key components. The optimization results showed that the equivalent stress decreases by 49%; after the optimization of deformation and mass are 0.829mm and 0.548kg, which were 21% and 10% lower than before.The quality, safety, reliability and cost of the control device reach the expected standards perfectly, which can meet the requirements of safe ventilation and down-dusting of fully mechanized face.

46 CFR 154.476 - Cargo transfer devices and means.

Code of Federal Regulations, 2010 CFR

2010-10-01

... of cargo transfer, such as another pump or gas pressurization. (b) If cargo is transferred by gas... SAFETY STANDARDS FOR SELF-PROPELLED VESSELS CARRYING BULK LIQUEFIED GASES Design, Construction and Equipment Support System § 154.476 Cargo transfer devices and means. (a) If a cargo pump in a cargo tank is...

Drug-device trials for infectious diseases: CDRH perspective.

PubMed

Meier, Kristen L; Gitterman, Steven

2011-05-01

Assessing the performance of new diagnostic tests for infectious diseases has traditionally focused on comparing the new assay against a reference standard such as culture. In this paper, we suggest that clinical trial designs with both a diagnostic and therapeutic component may be necessary to evaluate the safety and effectiveness of nonmicrobiologically based assays, with a specific emphasis on the test/marker-stratified design. General design challenges for trials of infectious diseases that simultaneously study both diagnostic and therapeutic components (eg, both devices and drugs) are also discussed.

Defense Small Business Innovation Research (SBIR) Program. Program Solicitation 90.1. FY-1990

DTIC Science & Technology

1989-10-01

Electronics Assemble and Test A90-125 Guided-Wave TeO2 Optical Devices A90-126 Acceleration Sensing Module for Munition Safety Systems A90-127 Electromagnetic...package containing all drawings and process information, complete operating manuals. A90-125 Guided-Wave TeO2 Optical Devices OBJECTIVE: This exploratory...bandwidth and efficiency of these devices. PHASE I: Phase one would consist of the design of several breadboard TeO2 AO devices each having TBWP of

Alerts and Notices (Devices)

MedlinePlus

... Medical Devices Medical Device Safety Safety Communications Safety Communications Share Tweet Linkedin Pin it More sharing options ... Older safety communications are listed below. Older Safety Communications 2016 Safety Communications 2015 Safety Communications 2014 Safety ...

42 CFR 84.126 - Canister bench tests; minimum requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Gas Masks... canisters designated as providing respiratory protection against gases, ammonia, organic vapors, carbon...

42 CFR 84.126 - Canister bench tests; minimum requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Gas Masks... canisters designated as providing respiratory protection against gases, ammonia, organic vapors, carbon...

42 CFR 84.126 - Canister bench tests; minimum requirements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Gas Masks... canisters designated as providing respiratory protection against gases, ammonia, organic vapors, carbon...

42 CFR 84.126 - Canister bench tests; minimum requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Gas Masks... canisters designated as providing respiratory protection against gases, ammonia, organic vapors, carbon...

42 CFR 84.126 - Canister bench tests; minimum requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Gas Masks... canisters designated as providing respiratory protection against gases, ammonia, organic vapors, carbon...

Blood transfer devices for malaria rapid diagnostic tests: evaluation of accuracy, safety and ease of use.

PubMed

Hopkins, Heidi; Oyibo, Wellington; Luchavez, Jennifer; Mationg, Mary Lorraine; Asiimwe, Caroline; Albertini, Audrey; González, Iveth J; Gatton, Michelle L; Bell, David

2011-02-08

Malaria rapid diagnostic tests (RDTs) are increasingly used by remote health personnel with minimal training in laboratory techniques. RDTs must, therefore, be as simple, safe and reliable as possible. Transfer of blood from the patient to the RDT is critical to safety and accuracy, and poses a significant challenge to many users. Blood transfer devices were evaluated for accuracy and precision of volume transferred, safety and ease of use, to identify the most appropriate devices for use with RDTs in routine clinical care. Five devices, a loop, straw-pipette, calibrated pipette, glass capillary tube, and a new inverted cup device, were evaluated in Nigeria, the Philippines and Uganda. The 227 participating health workers used each device to transfer blood from a simulated finger-prick site to filter paper. For each transfer, the number of attempts required to collect and deposit blood and any spilling of blood during transfer were recorded. Perceptions of ease of use and safety of each device were recorded for each participant. Blood volume transferred was calculated from the area of blood spots deposited on filter paper. The overall mean volumes transferred by devices differed significantly from the target volume of 5 microliters (p < 0.001). The inverted cup (4.6 microliters) most closely approximated the target volume. The glass capillary was excluded from volume analysis as the estimation method used is not compatible with this device. The calibrated pipette accounted for the largest proportion of blood exposures (23/225, 10%); exposures ranged from 2% to 6% for the other four devices. The inverted cup was considered easiest to use in blood collection (206/226, 91%); the straw-pipette and calibrated pipette were rated lowest (143/225 [64%] and 135/225 [60%] respectively). Overall, the inverted cup was the most preferred device (72%, 163/227), followed by the loop (61%, 138/227). The performance of blood transfer devices varied in this evaluation of accuracy, blood safety, ease of use, and user preference. The inverted cup design achieved the highest overall performance, while the loop also performed well. These findings have relevance for any point-of-care diagnostics that require blood sampling.

Systems, methods and apparatus for quiesence of autonomic safety devices with self action

NASA Technical Reports Server (NTRS)

Hinchey, Michael G. (Inventor); Sterritt, Roy (Inventor)

2011-01-01

Systems, methods and apparatus are provided through which in some embodiments an autonomic environmental safety device may be quiesced. In at least one embodiment, a method for managing an autonomic safety device, such as a smoke detector, based on functioning state and operating status of the autonomic safety device includes processing received signals from the autonomic safety device to obtain an analysis of the condition of the autonomic safety device, generating one or more stay-awake signals based on the functioning status and the operating state of the autonomic safety device, transmitting the stay-awake signal, transmitting self health/urgency data, and transmitting environment health/urgency data. A quiesce component of an autonomic safety device can render the autonomic safety device inactive for a specific amount of time or until a challenging situation has passed.

Hydrogen Safety Issues Compared to Safety Issues with Methane and Propane

NASA Astrophysics Data System (ADS)

Green, M. A.

2006-04-01

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

DOE Office of Scientific and Technical Information (OSTI.GOV)

Green, Michael A.

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 standardsmore » 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.« less

Remote biomonitoring of temperatures in mothers and newborns: design, development and testing of a wearable sensor device in a tertiary-care hospital in southern India

PubMed Central

Mony, Prem K; Thankachan, Prashanth; Bhat, Swarnarekha; Rao, Suman; Washington, Maryann; Antony, Sumi; Thomas, Annamma; Nagarajarao, Sheela C; Rao, Hiteshwar; Amrutur, Bharadwaj

2018-01-01

Objective Newer technologies such as wearables, sensors, mobile telephony and computing offer opportunities to monitor vital physiological parameters and tackle healthcare problems, thereby improving access and quality of care. We describe the design, development and testing of a wearable sensor device for remote biomonitoring of body temperatures in mothers and newborns in southern India. Methods Based on client needs and technological requirements, a wearable sensor device was designed and developed using principles of ‘social innovation’ design. The device underwent multiple iterations in product design and engineering based on user feedback, and then following preclinical testing, a techno-feasibility study and clinical trial were undertaken in a tertiary-care teaching hospital in Bangalore, India. Clinical trial phases I and IIa for evaluation of safety and efficacy were undertaken in the following sequence: 7 healthy adult volunteers; 18 healthy mothers; 3 healthy babies; 10 stable babies in the neonatal care intensive unit and 1 baby with morbidities. Time-stamped skin temperature readings obtained at 5 min intervals over a 1-hour period from the device secured on upper arms of mothers and abdomen of neonates were compared against readings from thermometers used routinely in clinical practice. Results Devices were comfortably secured on to adults and neonates, and data were efficiently transmitted via the gateway device for secure storage and retrieval for analysis. The mean skin temperatures in mothers were lower than the axillary temperatures by 2°C; and in newborns, there was a precision of –0.5°C relative to axillary measurements. While occasional minimal adverse events were noted in healthy volunteers, no adverse events were noted in mothers or neonates. Conclusions This proof-of-concept study shows that this device is promising in terms of feasibility, safety and accuracy (with appropriate calibration) with potential for further refinements in device accuracy and pursuit of further phases of clinical research for improved maternal and neonatal health. PMID:29670758

Study on high reliability safety valve for railway vehicle

NASA Astrophysics Data System (ADS)

Zhang, Xuan; Chen, Ruikun; Zhang, Shixi; Xu, BuDu

2017-09-01

Now, the realization of most of the functions of the railway vehicles rely on compressed air, so the demand for compressed air is growing higher and higher. This safety valve is a protection device for pressure limitation and pressure relief in an air supply system of railway vehicles. I am going to introduce the structure, operating principle, research and development process of the safety valve designed by our company in this document.

Risk-based requirements management framework with applications to assurance cases

NASA Astrophysics Data System (ADS)

Feng, D.; Eyster, C.

The current regulatory approach for assuring device safety primarily focuses on compliance with prescriptive safety regulations and relevant safety standards. This approach, however, does not always lead to a safe system design even though safety regulations and standards have been met. In the medical device industry, several high profile recalls involving infusion pumps have prompted the regulatory agency to reconsider how device safety should be managed, reviewed and approved. An assurance case has been cited as a promising tool to address this growing concern. Assurance cases have been used in safety-critical systems for some time. Most assurance cases, if not all, in literature today are developed in an ad hoc fashion, independent from risk management and requirement development. An assurance case is a resource-intensive endeavor that requires additional effort and documentation from equipment manufacturers. Without a well-organized requirements infrastructure in place, such “ additional effort” can be substantial, to the point where the cost of adoption outweighs the benefit of adoption. In this paper, the authors present a Risk-Based Requirements and Assurance Management (RBRAM) methodology. The RBRAM is an elaborate framework that combines Risk-Based Requirements Management (RBRM) with assurance case methods. Such an integrated framework can help manufacturers leverage an existing risk management to present a comprehensive assurance case with minimal additional effort while providing a supplementary means to reexamine the integrity of the system design in terms of the mission objective. Although the example used is from the medical industry, the authors believe that the RBRAM methodology underlines the fundamental principle of risk management, and offers a simple, yet effective framework applicable to aerospace industry, perhaps, to any industry.

Software Safety Assurance of Programmable Logic

NASA Technical Reports Server (NTRS)

Berens, Kalynnda

2002-01-01

Programmable Logic (PLC, FPGA, ASIC) devices are hybrids - hardware devices that are designed and programmed like software. As such, they fall in an assurance gray area. Programmable Logic is usually tested and verified as hardware, and the software aspects are ignored, potentially leading to safety or mission success concerns. The objective of this proposal is to first determine where and how Programmable Logic (PL) is used within NASA and document the current methods of assurance. Once that is known, raise awareness of the PL software aspects within the NASA engineering community and provide guidance for the use and assurance of PL form a software perspective.

42 CFR 84.40 - Quality control plans; filing requirements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Quality... proposed quality control plan which shall be designed to assure the quality of respiratory protection...

42 CFR 84.40 - Quality control plans; filing requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Quality... proposed quality control plan which shall be designed to assure the quality of respiratory protection...

42 CFR 84.40 - Quality control plans; filing requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Quality... proposed quality control plan which shall be designed to assure the quality of respiratory protection...

42 CFR 84.40 - Quality control plans; filing requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Quality... proposed quality control plan which shall be designed to assure the quality of respiratory protection...

42 CFR 84.40 - Quality control plans; filing requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Quality... proposed quality control plan which shall be designed to assure the quality of respiratory protection...

Spinoff 2009

NASA Technical Reports Server (NTRS)

2009-01-01

Topics covered include: Image-Capture Devices Extend Medicine's Reach; Medical Devices Assess, Treat Balance Disorders; NASA Bioreactors Advance Disease Treatments; Robotics Algorithms Provide Nutritional Guidelines; "Anti-Gravity" Treadmills Speed Rehabilitation; Crew Management Processes Revitalize Patient Care; Hubble Systems Optimize Hospital Schedules; Web-based Programs Assess Cognitive Fitness; Electrolyte Concentrates Treat Dehydration; Tools Lighten Designs, Maintain Structural Integrity; Insulating Foams Save Money, Increase Safety; Polyimide Resins Resist Extreme Temperatures; Sensors Locate Radio Interference; Surface Operations Systems Improve Airport Efficiency; Nontoxic Resins Advance Aerospace Manufacturing; Sensors Provide Early Warning of Biological Threats; Robot Saves Soldier's Lives Overseas (MarcBot); Apollo-Era Life Raft Saves Hundreds of Sailors; Circuits Enhance Scientific Instruments and Safety Devices; Tough Textiles Protect Payloads and Public Safety Officers; Forecasting Tools Point to Fishing Hotspots; Air Purifiers Eliminate Pathogens, Preserve Food; Fabrics Protect Sensitive Skin from UV Rays; Phase Change Fabrics Control Temperature; Tiny Devices Project Sharp, Colorful Images; Star-Mapping Tools Enable Tracking of Endangered Animals; Nanofiber Filters Eliminate Contaminants; Modeling Innovations Advance Wind Energy Industry; Thermal Insulation Strips Conserve Energy; Satellite Respondent Buoys Identify Ocean Debris; Mobile Instruments Measure Atmospheric Pollutants; Cloud Imagers Offer New Details on Earth's Health; Antennas Lower Cost of Satellite Access; Feature Detection Systems Enhance Satellite Imagery; Chlorophyll Meters Aid Plant Nutrient Management; Telemetry Boards Interpret Rocket, Airplane Engine Data; Programs Automate Complex Operations Monitoring; Software Tools Streamline Project Management; Modeling Languages Refine Vehicle Design; Radio Relays Improve Wireless Products; Advanced Sensors Boost Optical Communication, Imaging; Tensile Fabrics Enhance Architecture Around the World; Robust Light Filters Support Powerful Imaging Devices; Thermoelectric Devices Cool, Power Electronics; Innovative Tools Advance Revolutionary Weld Technique; Methods Reduce Cost, Enhance Quality of Nanotubes; Gauging Systems Monitor Cryogenic Liquids; Voltage Sensors Monitor Harmful Static; and Compact Instruments Measure Heat Potential.

Design and Development of a Clinical Risk Management Tool Using Radio Frequency Identification (RFID)

PubMed Central

Pourasghar, Faramarz; Tabrizi, Jafar Sadegh; Yarifard, Khadijeh

2016-01-01

Background: Patient safety is one of the most important elements of quality of healthcare. It means preventing any harm to the patients during medical care process. Objective: This paper introduces a cost-effective tool in which the Radio Frequency Identification (RFID) technology is used to identify medical errors in hospital. Methods: The proposed clinical error management system (CEMS) is consisted of a reader device, a transfer/receiver device, a database and managing software. The reader device works using radio waves and is wireless. The reader sends and receives data to/from the database via the transfer/receiver device which is connected to the computer via USB port. The database contains data about patients’ medication orders. Results: The CEMS has the ability to identify the clinical errors before they occur and then warns the care-giver with voice and visual messages to prevent the error. This device reduces the errors and thus improves the patient safety. Conclusion: A new tool including software and hardware was developed in this study. Application of this tool in clinical settings can help the nurses prevent medical errors. It can also be a useful tool for clinical risk management. Using this device can improve the patient safety to a considerable extent and thus improve the quality of healthcare. PMID:27147802

Design and Development of a Clinical Risk Management Tool Using Radio Frequency Identification (RFID).

PubMed

Pourasghar, Faramarz; Tabrizi, Jafar Sadegh; Yarifard, Khadijeh

2016-04-01

Patient safety is one of the most important elements of quality of healthcare. It means preventing any harm to the patients during medical care process. This paper introduces a cost-effective tool in which the Radio Frequency Identification (RFID) technology is used to identify medical errors in hospital. The proposed clinical error management system (CEMS) is consisted of a reader device, a transfer/receiver device, a database and managing software. The reader device works using radio waves and is wireless. The reader sends and receives data to/from the database via the transfer/receiver device which is connected to the computer via USB port. The database contains data about patients' medication orders. The CEMS has the ability to identify the clinical errors before they occur and then warns the care-giver with voice and visual messages to prevent the error. This device reduces the errors and thus improves the patient safety. A new tool including software and hardware was developed in this study. Application of this tool in clinical settings can help the nurses prevent medical errors. It can also be a useful tool for clinical risk management. Using this device can improve the patient safety to a considerable extent and thus improve the quality of healthcare.

Engineering Design Challenges in a Science Curriculum

ERIC Educational Resources Information Center

Eisenkraft, Arthur

2011-01-01

Create a light and sound show to entertain friends. Design an improved safety device for a car. Develop a 2-3 minute voice-over for a sports clip explaining the physics involved in the sport. Modify the design of a roller coaster to meet the needs of a specific group of riders. Design an appliance package for a family limited by the power and…

Safety by design: effects of operating room floor marking on the position of surgical devices to promote clean air flow compliance and minimise infection risks.

PubMed

de Korne, Dirk F; van Wijngaarden, Jeroen D H; van Rooij, Jeroen; Wauben, Linda S G L; Hiddema, U Frans; Klazinga, Niek S

2012-09-01

To evaluate the use of floor marking on the positioning of surgical devices within the clean air flow in an operating room (OR) to minimise infection risk. Laminar flow clean air systems are important in preventing infection in ORs but, for optimal results, surgical devices must be correctly positioned. The authors evaluated floor marking in four ORs at an eye hospital using time series analysis. Through observations during 829 surgeries over a 20-month period, the positions of surgical devices were determined. Eight semistructured interviews with surgical staff were conducted to assess user experiences and team dynamics. Before marking, the instrument table was positioned completely within the laminar flow in only 6.1% of the cases. This increased to 36.1% and finally 53.8%. Mayo stands were increasingly positioned within the laminar flow: from 74.2% to 84.7%. The surgical lamp decreasingly obstructed flow: from 41.8% to 28.7%. At T3 (20 months), however, in 48.6% of the applicable cases the lamp was positioned in the flow again. Discussions and site visits between airside operators and surgical staff resulted in increasing awareness of specific risk areas in the OR. OR floor markings facilitated and stimulated safety awareness and resulted in significantly increased compliance with the positioning of surgical devices in the clean air flow. Safety and quality approaches in hospital care, therefore, should include a human factors approach that focuses on system design in addition to teaching clinical and non-technical skills.

A Smartphone-Based Driver Safety Monitoring System Using Data Fusion

PubMed Central

Lee, Boon-Giin; Chung, Wan-Young

2012-01-01

This paper proposes a method for monitoring driver safety levels using a data fusion approach based on several discrete data types: eye features, bio-signal variation, in-vehicle temperature, and vehicle speed. The driver safety monitoring system was developed in practice in the form of an application for an Android-based smartphone device, where measuring safety-related data requires no extra monetary expenditure or equipment. Moreover, the system provides high resolution and flexibility. The safety monitoring process involves the fusion of attributes gathered from different sensors, including video, electrocardiography, photoplethysmography, temperature, and a three-axis accelerometer, that are assigned as input variables to an inference analysis framework. A Fuzzy Bayesian framework is designed to indicate the driver’s capability level and is updated continuously in real-time. The sensory data are transmitted via Bluetooth communication to the smartphone device. A fake incoming call warning service alerts the driver if his or her safety level is suspiciously compromised. Realistic testing of the system demonstrates the practical benefits of multiple features and their fusion in providing a more authentic and effective driver safety monitoring. PMID:23247416

46 CFR 98.25-15 - Markings.

Code of Federal Regulations, 2010 CFR

2010-10-01

... safety relief valves, liquid level gaging devices and pressure gages shall be labeled to designate whether they terminate in the vapor or liquid space. Labels of noncorrosive material may be attached to...

46 CFR 98.25-15 - Markings.

Code of Federal Regulations, 2013 CFR

2013-10-01

... safety relief valves, liquid level gaging devices and pressure gages shall be labeled to designate whether they terminate in the vapor or liquid space. Labels of noncorrosive material may be attached to...

30 CFR 75.808 - Disconnecting devices.

Code of Federal Regulations, 2010 CFR

2010-07-01

... MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Underground High-Voltage Distribution § 75.808... branch lines in high-voltage circuits and equipped or designed in such a manner that it can be determined...

46 CFR 98.25-15 - Markings.

Code of Federal Regulations, 2014 CFR

2014-10-01

... safety relief valves, liquid level gaging devices and pressure gages shall be labeled to designate whether they terminate in the vapor or liquid space. Labels of noncorrosive material may be attached to...

46 CFR 98.25-15 - Markings.

Code of Federal Regulations, 2012 CFR

2012-10-01

... safety relief valves, liquid level gaging devices and pressure gages shall be labeled to designate whether they terminate in the vapor or liquid space. Labels of noncorrosive material may be attached to...

46 CFR 98.25-15 - Markings.

Code of Federal Regulations, 2011 CFR

2011-10-01

... safety relief valves, liquid level gaging devices and pressure gages shall be labeled to designate whether they terminate in the vapor or liquid space. Labels of noncorrosive material may be attached to...

The safety and reliability of the S and A mechanism designed for the NASA/LSPE program

NASA Technical Reports Server (NTRS)

Montesi, L. J.

1973-01-01

Under contract to the Manned Spacecraft Center, NASA/Houston, NOL developed a number of explosive charges for use in studying the surface of the moon during Apollo 17 activities. The charges were part of the Lunar Seismic Profiling Experiment (LSPE). When the Safety and Arming Device used in the previous ALSEP experiments was found unsuitable for use with the new explosive packages, NOL also designed the Safety and Arming Mechanism, and the safety and reliability tests conducted are described. The results of the test program indicate that the detonation transfer probability between the armed explosive components exceeds 0.9999, and is less than 0.0001 when the explosive components are in the safe position.

Design and Verification of a Shape Memory Polymer Peripheral Occlusion Device

PubMed Central

Landsman, Todd L.; Bush, Ruth L.; Glowczwski, Alan; Horn, John; Jessen, Staci L.; Ungchusri, Ethan; Diguette, Katelin; Smith, Harrison R.; Hasan, Sayyeda M.; Nash, Daniel; Clubb, Fred J.; Maitland, Duncan J.

2017-01-01

Shape memory polymer foams have been previously investigated for their safety and efficacy in treating a porcine aneurysm model. Their biocompatibility, rapid thrombus formation, and ability for endovascular catheter-based delivery to a variety of vascular beds makes these foams ideal candidates for use in numerous embolic applications, particularly within the peripheral vasculature. This study sought to investigate the material properties, safety, and efficacy of a shape memory polymer peripheral embolization device in vitro. The material characteristics of the device were analyzed to show tunability of the glass transition temperature (Tg) and the expansion rate of the polymer to ensure adequate time to deliver the device through a catheter prior to excessive foam expansion. Mechanical analysis and flow migration studies were performed to ensure minimal risk of vessel perforation and undesired thromboembolism upon device deployment. The efficacy of the device was verified by performing blood flow studies that established affinity for thrombus formation and blood penetration throughout the foam and by delivery of the device in an ultrasound phantom that demonstrated flow stagnation and diversion of flow to collateral pathways. PMID:27419615

Design and verification of a shape memory polymer peripheral occlusion device.

PubMed

Landsman, Todd L; Bush, Ruth L; Glowczwski, Alan; Horn, John; Jessen, Staci L; Ungchusri, Ethan; Diguette, Katelin; Smith, Harrison R; Hasan, Sayyeda M; Nash, Daniel; Clubb, Fred J; Maitland, Duncan J

2016-10-01

Shape memory polymer foams have been previously investigated for their safety and efficacy in treating a porcine aneurysm model. Their biocompatibility, rapid thrombus formation, and ability for endovascular catheter-based delivery to a variety of vascular beds makes these foams ideal candidates for use in numerous embolic applications, particularly within the peripheral vasculature. This study sought to investigate the material properties, safety, and efficacy of a shape memory polymer peripheral embolization device in vitro. The material characteristics of the device were analyzed to show tunability of the glass transition temperature (Tg) and the expansion rate of the polymer to ensure adequate time to deliver the device through a catheter prior to excessive foam expansion. Mechanical analysis and flow migration studies were performed to ensure minimal risk of vessel perforation and undesired thromboembolism upon device deployment. The efficacy of the device was verified by performing blood flow studies that established affinity for thrombus formation and blood penetration throughout the foam and by delivery of the device in an ultrasound phantom that demonstrated flow stagnation and diversion of flow to collateral pathways. Copyright © 2016 Elsevier Ltd. All rights reserved.

Image-Directed Fine-needle Aspiration Biopsy of the Thyroid with Safety-engineered Devices

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sibbitt, Randy R., E-mail: THESIBB2@aol.com; Palmer, Dennis J., E-mail: lyonscreek@aol.com; Sibbitt, Wilmer L., E-mail: wsibbitt@salud.unm.edu

2011-10-15

Purpose: The purpose of the present study was to integrate safety-engineered devices into outpatient fine-needle aspiration (FNA) biopsy of the thyroid in an interventional radiology practice. Materials and Methods: The practice center is a tertiary referral center for image-directed FNA thyroid biopsies in difficult patients referred by the primary care physician, endocrinologist, or otolaryngologist. As a departmental quality of care and safety improvement program, we instituted integration of safety devices into our thyroid biopsy procedures and determined the effect on outcome (procedural pain, diagnostic biopsies, inadequate samples, complications, needlesticks to operator, and physician satisfaction) before institution of safety devices (54more » patients) and after institution of safety device implementation (56 patients). Safety devices included a patient safety technology-the mechanical aspirating syringe (reciprocating procedure device), and a health care worker safety technology (antineedlestick safety needle). Results: FNA of thyroid could be readily performed with the safety devices. Safety-engineered devices resulted in a 49% reduction in procedural pain scores (P < 0.0001), a 56% reduction in significant pain (P < 0.002), a 21% increase in operator satisfaction (P < 0.0001), and a 5% increase in diagnostic specimens (P = 0.5). No needlesticks to health care workers or patient injuries occurred during the study. Conclusions: Safety-engineered devices to improve both patient and health care worker safety can be successfully integrated into diagnostic FNA of the thyroid while maintaining outcomes and improving safety.« less

Usability test of a hand exoskeleton for activities of daily living: an example of user-centered design.

PubMed

Almenara, Maria; Cempini, Marco; Gómez, Cristina; Cortese, Mario; Martín, Cristina; Medina, Josep; Vitiello, Nicola; Opisso, Eloy

2017-01-01

(1) To assess a robotic device (Handexos) during the design process with regard to usability, end user satisfaction and safety, (2) to determine whether Handexos can improve the activities of daily living (ADLs) of spinal cord injury (SCI) patients and stroke patients with upper-limb dysfunction. During a 2-year development stage of the device, a total of 37 participants (aged 22-68), 28 clinicians (experts) and nine patients with SCI or stroke (end users) were included in a user-centered design process featuring usability tests. They performed five grasps wearing the device. The assessments were obtained at the end of the session by filling out a questionnaire and making suggestions. The experts' opinion was that the modified device was an improvement over the preliminary version, although this was not reflected in the scores. Whereas end user scores for comfort, grasp, performance and safety were above the sufficiency threshold, the scores for year 2 were lower than those for year 1. The findings demonstrate that although Handexos meets the initial functional requirements and underlines the potential for assisting SCI and post-stroke subjects in ADLs, several aspects such as mechanical complexity and low adaptability to different hand sizes need to be further addressed. Implications for Rehabilitation Wearable robotics devices could improve the activities of daily living in patients with spinal cord injury or stroke. They could be a tool for rehabilitation of the upper limb. Further usability tests to improve this type of tools are recommended.

49 CFR 192.150 - Passage of internal inspection devices.

Code of Federal Regulations, 2011 CFR

2011-10-01

...) of this section, each new transmission line and each replacement of line pipe, valve, fitting, or other line component in a transmission line must be designed and constructed to accommodate the passage... TRANSPORTATION OF NATURAL AND OTHER GAS BY PIPELINE: MINIMUM FEDERAL SAFETY STANDARDS Design of Pipeline...

49 CFR 192.150 - Passage of internal inspection devices.

Code of Federal Regulations, 2014 CFR

2014-10-01

...) of this section, each new transmission line and each replacement of line pipe, valve, fitting, or other line component in a transmission line must be designed and constructed to accommodate the passage... TRANSPORTATION OF NATURAL AND OTHER GAS BY PIPELINE: MINIMUM FEDERAL SAFETY STANDARDS Design of Pipeline...

49 CFR 192.150 - Passage of internal inspection devices.

Code of Federal Regulations, 2013 CFR

2013-10-01

...) of this section, each new transmission line and each replacement of line pipe, valve, fitting, or other line component in a transmission line must be designed and constructed to accommodate the passage... TRANSPORTATION OF NATURAL AND OTHER GAS BY PIPELINE: MINIMUM FEDERAL SAFETY STANDARDS Design of Pipeline...

49 CFR 192.150 - Passage of internal inspection devices.

Code of Federal Regulations, 2012 CFR

2012-10-01

...) of this section, each new transmission line and each replacement of line pipe, valve, fitting, or other line component in a transmission line must be designed and constructed to accommodate the passage... TRANSPORTATION OF NATURAL AND OTHER GAS BY PIPELINE: MINIMUM FEDERAL SAFETY STANDARDS Design of Pipeline...

49 CFR Appendix A to Part 209 - Statement of Agency Policy Concerning Enforcement of the Federal Railroad Safety Laws

Code of Federal Regulations, 2013 CFR

2013-10-01

... exercise of jurisdiction. In this context, the presence of intrusion detection devices to alert one or both... about sufficient intrusion detection and related safety measures designed to avoid a collision between...). By “general railroad system of transportation,” FRA refers to the network of standard gage track over...

49 CFR Appendix A to Part 209 - Statement of Agency Policy Concerning Enforcement of the Federal Railroad Safety Laws

Code of Federal Regulations, 2014 CFR

2014-10-01

... exercise of jurisdiction. In this context, the presence of intrusion detection devices to alert one or both... about sufficient intrusion detection and related safety measures designed to avoid a collision between...). By “general railroad system of transportation,” FRA refers to the network of standard gage track over...

49 CFR Appendix A to Part 209 - Statement of Agency Policy Concerning Enforcement of the Federal Railroad Safety Laws

Code of Federal Regulations, 2012 CFR

2012-10-01

... exercise of jurisdiction. In this context, the presence of intrusion detection devices to alert one or both... about sufficient intrusion detection and related safety measures designed to avoid a collision between...). By “general railroad system of transportation,” FRA refers to the network of standard gage track over...

Tracking down a solution: exploring the acceptability and value of wearable GPS devices for older persons, individuals with a disability and their support persons.

PubMed

Williamson, Brittany; Aplin, Tammy; de Jonge, Desleigh; Goyne, Matthew

2017-11-01

To explore the acceptability and value of three wearable GPS devices for older persons and individuals with a disability and safety concerns when accessing the community. This pilot study explored six wearers' and their support persons' experience of using three different wearable GPS devices (a pendant, watch, and mini GPS phone), each for a two-week period. Participants identified safety as the main value of using a wearable GPS device. The acceptability and value of these devices was strongly influenced by device features, ease of use, cost, appearance, the reliability of the GPS coordinates, the wearer's health condition and the users familiarity with technology. Overall, participants indicated that they preferred the pendant. Wearable GPS devices are potentially useful in providing individuals who have safety concerns with reassurance and access to assistance as required. To ensure successful utilization, future device design and device selection should consider the user's familiarity with technology and their health condition. This study also revealed that not all wearable GPS devices provide continuous location tracking. It is therefore critical to ensure that the device's location tracking functions address the wearer's requirements and reason for using the device. Implications for Rehabilitation The acceptability and usability of wearable GPS devices is strongly influenced by the device features, ease of use, cost, appearance, the reliability of the device to provide accurate and timely GPS coordinates, as well as the health condition of the wearer and their familiarity with technology. Wearable GPS devices need to be simple to use and support and training is essential to ensure they are successfully utilized. Not all wearable GPS devices provide continuous location tracking and accuracy of location is impacted by line of sight to satellites. Therefore, care needs to be taken when choosing a suitable device, to ensure that the device's location tracking features are based on the wearer's requirements and value behind using the device.

Fibre optic strain sensor: examples of applications

NASA Astrophysics Data System (ADS)

Kruszewski, J.; Beblowska, M.; Wrzosek, P.

2006-03-01

Construction of strain sensor for application in safety systems has been presented. The device consists of sensor's head and source and detector units. The head is made of polymer fiber bends. Designed sensor could be mounted in monitoring place (e.g. under a floor) and controlled by PC unit or could be used as a portable device for a valuable object protection.

Practice of Regulatory Science (Development of Medical Devices).

PubMed

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.

Material selection for climbing hardware using the example of a belay device

NASA Astrophysics Data System (ADS)

Semenov, E.; Schwanitz, S.; Odenwald, S.

2017-03-01

The aim of the research project was to design a novel climbing belay device. The present article describes the details of the therefor performed material selection. Literature research on the materials used in commercially available belay devices revealed a lack of definite information. Thus, a pilot x-ray fluorescence (XRF) test was performed on a small sample of common aluminium belay devices. It revealed the use of a variety of different alloy systems. The selection process continued by compiling a thorough list of constraints and objectives for this safety related piece of sports equipment. Different material options including non-aluminium-materials were discussed. The final material choice was a high strength aluminium alloy with a T6 thermal treatment. The device was designed and calculated by use of CAD and FEM software respectively, aiming to reduce weight. After manufacturing the strength, usability and friction properties of the device have been successfully tested.

46 CFR 38.05-5 - Markings-TB/ALL.

Code of Federal Regulations, 2014 CFR

2014-10-01

..., except safety relief valves, liquid level gaging devices, and pressure gages, shall be labeled to designate whether they terminate in the vapor or liquid space. Labels of corrosion-resistant material may be...

46 CFR 38.05-5 - Markings-TB/ALL.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., except safety relief valves, liquid level gaging devices, and pressure gages, shall be labeled to designate whether they terminate in the vapor or liquid space. Labels of corrosion-resistant material may be...

46 CFR 38.05-5 - Markings-TB/ALL.

Code of Federal Regulations, 2013 CFR

2013-10-01

..., except safety relief valves, liquid level gaging devices, and pressure gages, shall be labeled to designate whether they terminate in the vapor or liquid space. Labels of corrosion-resistant material may be...

46 CFR 38.05-5 - Markings-TB/ALL.

Code of Federal Regulations, 2012 CFR

2012-10-01

..., except safety relief valves, liquid level gaging devices, and pressure gages, shall be labeled to designate whether they terminate in the vapor or liquid space. Labels of corrosion-resistant material may be...

46 CFR 38.05-5 - Markings-TB/ALL.

Code of Federal Regulations, 2011 CFR

2011-10-01

..., except safety relief valves, liquid level gaging devices, and pressure gages, shall be labeled to designate whether they terminate in the vapor or liquid space. Labels of corrosion-resistant material may be...

40 CFR 63.1041 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-07-01

... foam- or liquid-filled continuous seal that is mounted between the wall of the separator and the... safety device is designed to remain in a closed position during normal operations and open only when the...

40 CFR 63.1041 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-07-01

... foam- or liquid-filled continuous seal that is mounted between the wall of the separator and the... safety device is designed to remain in a closed position during normal operations and open only when the...

40 CFR 63.1041 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-07-01

... foam- or liquid-filled continuous seal that is mounted between the wall of the separator and the... safety device is designed to remain in a closed position during normal operations and open only when the...

40 CFR 63.1041 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... foam- or liquid-filled continuous seal that is mounted between the wall of the separator and the... safety device is designed to remain in a closed position during normal operations and open only when the...

40 CFR 63.1041 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... foam- or liquid-filled continuous seal that is mounted between the wall of the separator and the... safety device is designed to remain in a closed position during normal operations and open only when the...

Mitigating Motion Base Safety Issues: The NASA LaRC CMF Implementation

NASA Technical Reports Server (NTRS)

Bryant, Richard B., Jr.; Grupton, Lawrence E.; Martinez, Debbie; Carrelli, David J.

2005-01-01

The NASA Langley Research Center (LaRC), Cockpit Motion Facility (CMF) motion base design has taken advantage of inherent hydraulic characteristics to implement safety features using hardware solutions only. Motion system safety has always been a concern and its implementation is addressed differently by each organization. Some approaches rely heavily on software safety features. Software which performs safety functions is subject to more scrutiny making its approval, modification, and development time consuming and expensive. The NASA LaRC's CMF motion system is used for research and, as such, requires that the software be updated or modified frequently. The CMF's customers need the ability to update the simulation software frequently without the associated cost incurred with safety critical software. This paper describes the CMF engineering team's approach to achieving motion base safety by designing and implementing all safety features in hardware, resulting in applications software (including motion cueing and actuator dynamic control) being completely independent of the safety devices. This allows the CMF safety systems to remain intact and unaffected by frequent research system modifications.

Design and adaptation of a novel supercritical extraction facility for operation in a glove box for recovery of radioactive elements

NASA Astrophysics Data System (ADS)

Kumar, V. Suresh; Kumar, R.; Sivaraman, N.; Ravisankar, G.; Vasudeva Rao, P. R.

2010-09-01

The design and development of a novel supercritical extraction experimental facility adapted for safe operation in a glove box for the recovery of radioactive elements from waste is described. The apparatus incorporates a high pressure extraction vessel, reciprocating pumps for delivering supercritical fluid and reagent, a back pressure regulator, and a collection chamber. All these components of the system have been specially designed for glove box adaptation and made modular to facilitate their replacement. Confinement of these materials must be ensured in a glove box to protect the operator and prevent contamination to the work area. Since handling of radioactive materials under high pressure (30 MPa) and temperature (up to 333 K) is involved in this process, the apparatus needs elaborate safety features in the design of the equipment, as well as modification of a standard glove box to accommodate the system. As a special safety feature to contain accidental leakage of carbon dioxide from the extraction vessel, a safety vessel has been specially designed and placed inside the glove box. The extraction vessel was enclosed in the safety vessel. The safety vessel was also incorporated with pressure sensing and controlling device.

On Demand Internal Short Circuit Device Enables Verification of Safer, Higher Performing Battery Designs

DOE Office of Scientific and Technical Information (OSTI.GOV)

Darcy, Eric; Keyser, Matthew

The Internal Short Circuit (ISC) device enables critical battery safety verification. With the aluminum interstitial heat sink between the cells, normal trigger cells cannot be driven into thermal runaway without excessive temperature bias of adjacent cells. With an implantable, on-demand ISC device, thermal runaway tests show that the conductive heat sinks protected adjacent cells from propagation. High heat dissipation and structural support of Al heat sinks show high promise for safer, higher performing batteries.

23 CFR 630.1004 - Definitions and explanation of terms.

Code of Federal Regulations, 2010 CFR

2010-04-01

... of the work zone design on worker safety. The number of worker fatalities and injuries at a given... activities. A work zone is typically marked by signs, channelizing devices, barriers, pavement markings, and...

23 CFR 630.1004 - Definitions and explanation of terms.

Code of Federal Regulations, 2011 CFR

2011-04-01

... of the work zone design on worker safety. The number of worker fatalities and injuries at a given... activities. A work zone is typically marked by signs, channelizing devices, barriers, pavement markings, and...

23 CFR 630.1004 - Definitions and explanation of terms.

Code of Federal Regulations, 2012 CFR

2012-04-01

... of the work zone design on worker safety. The number of worker fatalities and injuries at a given... activities. A work zone is typically marked by signs, channelizing devices, barriers, pavement markings, and...

23 CFR 630.1004 - Definitions and explanation of terms.

Code of Federal Regulations, 2014 CFR

2014-04-01

... of the work zone design on worker safety. The number of worker fatalities and injuries at a given... activities. A work zone is typically marked by signs, channelizing devices, barriers, pavement markings, and...

23 CFR 630.1004 - Definitions and explanation of terms.

Code of Federal Regulations, 2013 CFR

2013-04-01

... of the work zone design on worker safety. The number of worker fatalities and injuries at a given... activities. A work zone is typically marked by signs, channelizing devices, barriers, pavement markings, and...

40 CFR 265.1081 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-07-01

... complete contact with it) inside a tank that has a fixed roof. Liquid-mounted seal means a foam or liquid... fluctuations. A safety device is designed to remain in a closed position during normal operations and open only...

40 CFR 265.1081 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... complete contact with it) inside a tank that has a fixed roof. Liquid-mounted seal means a foam or liquid... fluctuations. A safety device is designed to remain in a closed position during normal operations and open only...

40 CFR 265.1081 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-07-01

... complete contact with it) inside a tank that has a fixed roof. Liquid-mounted seal means a foam or liquid... fluctuations. A safety device is designed to remain in a closed position during normal operations and open only...

40 CFR 265.1081 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... complete contact with it) inside a tank that has a fixed roof. Liquid-mounted seal means a foam or liquid... fluctuations. A safety device is designed to remain in a closed position during normal operations and open only...

40 CFR 265.1081 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-07-01

... complete contact with it) inside a tank that has a fixed roof. Liquid-mounted seal means a foam or liquid... fluctuations. A safety device is designed to remain in a closed position during normal operations and open only...

Multi-modal vehicle display design and analysis

DOT National Transportation Integrated Search

2004-10-01

It is now evident from anecdotal evidence and preliminary research that distractions can : hinder the task of operating a vehicle, and consequently reduce driver safety. However with : increasing wireless connectivity and the mobility of office devic...

Colossal Tooling Design: 3D Simulation for Ergonomic Analysis

NASA Technical Reports Server (NTRS)

Hunter, Steve L.; Dischinger, Charles; Thomas, Robert E.; Babai, Majid

2003-01-01

The application of high-level 3D simulation software to the design phase of colossal mandrel tooling for composite aerospace fuel tanks was accomplished to discover and resolve safety and human engineering problems. The analyses were conducted to determine safety, ergonomic and human engineering aspects of the disassembly process of the fuel tank composite shell mandrel. Three-dimensional graphics high-level software, incorporating various ergonomic analysis algorithms, was utilized to determine if the process was within safety and health boundaries for the workers carrying out these tasks. In addition, the graphical software was extremely helpful in the identification of material handling equipment and devices for the mandrel tooling assembly/disassembly process.

A knee-mounted biomechanical energy harvester with enhanced efficiency and safety

NASA Astrophysics Data System (ADS)

Chen, Chao; Chau, Li Yin; Liao, Wei-Hsin

2017-06-01

Energy harvesting is becoming a major limiting issue for many portable devices. When undertaking any activity, the human body generates a significant amount of biomechanical energy, which can be collected by means of a portable energy harvester. This energy provides a method of powering portable devices such as prosthetic limbs. In this paper, a knee-mounted energy harvester with enhanced efficiency and safety is proposed and developed to convert mechanical energy into electricity during human motion. This device can change the bi-directional knee input into uni-directional rotation for an electromagnetic generator using a specially designed transmission system. Without the constraint of induced impact on the human body, this device can harvest biomechanical energy from both knee flexion and extension, improving the harvesting efficiency over previous single-direction energy harvesters. It can also provide protection from device malfunction, and increase the safety of current biomechanical energy harvesters. A highly compact and light prototype is developed taking into account human kinematics. The biomechanical energy harvesting system is also modeled and analyzed. The prototype is tested under different conditions including walking, running and climbing stairs, to evaluate the energy harvesting performance and effect on the human gait. The experimental results show that the prototype can harvest an average power of 3.6 W at 1.5 m s-1 walking speed, which is promising for portable electronic devices.

9 CFR 592.5 - Designation of official certificates, memoranda, marks, other identifications, and devices for...

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Designation of official certificates... Section 592.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... class, quality, quantity, or condition specified in this part or any symbol, stamp, label, or seal...

9 CFR 592.5 - Designation of official certificates, memoranda, marks, other identifications, and devices for...

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Designation of official certificates... Section 592.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... class, quality, quantity, or condition specified in this part or any symbol, stamp, label, or seal...

42 CFR 84.1148 - Tests for respirators designed for respiratory protection against more than one type of...

Code of Federal Regulations, 2010 CFR

2010-10-01

... Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Dust, Fume, and Mist; Pesticide... 42 Public Health 1 2010-10-01 2010-10-01 false Tests for respirators designed for respiratory...

42 CFR 84.1148 - Tests for respirators designed for respiratory protection against more than one type of...

Code of Federal Regulations, 2013 CFR

2013-10-01

... Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Dust, Fume, and Mist; Pesticide... 42 Public Health 1 2013-10-01 2013-10-01 false Tests for respirators designed for respiratory...

42 CFR 84.1148 - Tests for respirators designed for respiratory protection against more than one type of...

Code of Federal Regulations, 2012 CFR

2012-10-01

... Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Dust, Fume, and Mist; Pesticide... 42 Public Health 1 2012-10-01 2012-10-01 false Tests for respirators designed for respiratory...

42 CFR 84.1151 - DOP filter test; respirators designed as respiratory protection against dusts, fumes, and mists...

Code of Federal Regulations, 2013 CFR

2013-10-01

... Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Dust, Fume, and Mist; Pesticide... 42 Public Health 1 2013-10-01 2013-10-01 false DOP filter test; respirators designed as...

42 CFR 84.1151 - DOP filter test; respirators designed as respiratory protection against dusts, fumes, and mists...

Code of Federal Regulations, 2014 CFR

2014-10-01

... Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Dust, Fume, and Mist; Pesticide... 42 Public Health 1 2014-10-01 2014-10-01 false DOP filter test; respirators designed as...

42 CFR 84.1148 - Tests for respirators designed for respiratory protection against more than one type of...

Code of Federal Regulations, 2011 CFR

2011-10-01

... Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Dust, Fume, and Mist; Pesticide... 42 Public Health 1 2011-10-01 2011-10-01 false Tests for respirators designed for respiratory...

42 CFR 84.1151 - DOP filter test; respirators designed as respiratory protection against dusts, fumes, and mists...

Code of Federal Regulations, 2012 CFR

2012-10-01

... Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Dust, Fume, and Mist; Pesticide... 42 Public Health 1 2012-10-01 2012-10-01 false DOP filter test; respirators designed as...

42 CFR 84.1151 - DOP filter test; respirators designed as respiratory protection against dusts, fumes, and mists...

Code of Federal Regulations, 2010 CFR

2010-10-01

... Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Dust, Fume, and Mist; Pesticide... 42 Public Health 1 2010-10-01 2010-10-01 false DOP filter test; respirators designed as...

42 CFR 84.1151 - DOP filter test; respirators designed as respiratory protection against dusts, fumes, and mists...

Code of Federal Regulations, 2011 CFR

2011-10-01

... Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Dust, Fume, and Mist; Pesticide... 42 Public Health 1 2011-10-01 2011-10-01 false DOP filter test; respirators designed as...

42 CFR 84.1148 - Tests for respirators designed for respiratory protection against more than one type of...

Code of Federal Regulations, 2014 CFR

2014-10-01

... Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Dust, Fume, and Mist; Pesticide... 42 Public Health 1 2014-10-01 2014-10-01 false Tests for respirators designed for respiratory...

Report of an exploratory study: Safety and liability considerations for photovoltaic modules/panels

NASA Technical Reports Server (NTRS)

Weinstein, A. S.; Meeker, D. G.

1981-01-01

An overview of legal issues as they apply to design, manufacture and use of photovoltaic module/array devices is provided and a methodology is suggested for use of the design stage of these products to minimize or eliminate perceived hazards. Questions are posed to stimulate consideration of this area.

BESAFE II: Accident safety analysis code for MFE reactor designs

NASA Astrophysics Data System (ADS)

Sevigny, Lawrence Michael

The viability of controlled thermonuclear fusion as an alternative energy source hinges on its desirability from an economic and an environmental and safety standpoint. It is the latter which is the focus of this thesis. For magnetic fusion energy (MFE) devices, the safety concerns equate to a design's behavior during a worst-case accident scenario which is the loss of coolant accident (LOCA). In this dissertation, we examine the behavior of MFE devices during a LOCA and how this behavior relates to the safety characteristics of the machine; in particular the acute, whole-body, early dose. In doing so, we have produced an accident safety code, BESAFE II, now available to the fusion reactor design community. The Appendix constitutes the User's Manual for BESAFE II. The theory behind early dose calculations including the mobilization of activation products is presented in Chapter 2. Since mobilization of activation products is a strong function of temperature, it becomes necessary to calculate the thermal response of a design during a LOCA in order to determine the fraction of the activation products which are mobilized and thus become the source for the dose. The code BESAFE II is designed to determine the temperature history of each region of a design and determine the resulting mobilization of activation products at each point in time during the LOCA. The BESAFE II methodology is discussed in Chapter 4, followed by demonstrations of its use for two reference design cases: a PCA-Li tokamak and a SiC-He tokamak. Of these two cases, it is shown that the SiC-He tokamak is a better design from an accident safety standpoint than the PCA-Li tokamak. It is also found that doses derived from temperature-dependent mobilization data are different than those predicted using set mobilization categories such as those that involve Piet fractions. This demonstrates the need for more experimental data on fusion materials. The possibility for future improvements and modifications to BESAFE II is discussed in Chapter 6, for example, by adding additional environmental indices such as a waste disposal index. The biggest improvement to BESAFE II would be an increase in the database of activation product mobilization for a larger spectrum of fusion reactor materials. The ultimate goal we have is for BESAFE II to become part of a systems design program which would include economic factors and allow both safety and the cost of electricity to influence design.

49 CFR 393.71 - Coupling devices and towing methods, driveaway-towaway operations.

Code of Federal Regulations, 2013 CFR

2013-10-01

... chains or cables are used as the safety device for that vehicle, at least two safety chains or cables... safety chains or cables are used as the safety device, the required strength shall be the combined strength of the combination of chains and cables. (ii) If chains or cables are used as the safety device...

49 CFR 393.71 - Coupling devices and towing methods, driveaway-towaway operations.

Code of Federal Regulations, 2014 CFR

2014-10-01

... chains or cables are used as the safety device for that vehicle, at least two safety chains or cables... safety chains or cables are used as the safety device, the required strength shall be the combined strength of the combination of chains and cables. (ii) If chains or cables are used as the safety device...

A new method for overhead drilling.

PubMed

Rempel, David; Star, Demetra; Barr, Alan; Gibbons, Billy; Janowitz, Ira

2009-12-01

In the construction sector, overhead drilling into concrete or metal ceilings is a strenuous task associated with shoulder, neck and back musculoskeletal disorders due to the large applied forces and awkward arm postures. Two intervention devices, an inverted drill press and a foot lever design, were developed then compared to the usual method by construction workers performing their normal overhead drilling activities (n = 14). While the intervention devices were rated as less fatiguing than the usual method, their ratings on usability measures were worse than the usual method. The study demonstrates that the intervention devices can reduce fatigue; however, additional modifications are necessary in order to improve usability and productivity. Devices designed to improve workplace safety may need to undergo several rounds of field testing and modification prior to implementation.

Cybersecurity for Connected Diabetes Devices

PubMed Central

Klonoff, David C.

2015-01-01

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. PMID:25883162

Cybersecurity for Connected Diabetes Devices.

PubMed

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.

Teaching biomedical design through a university-industry partnership.

PubMed

Khuon, Lunal; Zum, Karl R; Zurn, Jane B; Herrera, Gerald M

2016-08-01

This paper describes a course that, as a result of a university-industry partnership, emphasizes bringing industry experts into the classroom to teach biomedical design. Full-time faculty and industry engineers and entrepreneurs teach the senior technical elective course, Biomedical System Design. This hands-on senior course in biomedical system design places varied but connected emphasis on understanding the biological signal source, electronics design, safety, patient use, medical device qualifications, and good manufacturing practices.

Electrical safety Q&A. A reference guide for the clinical engineer.

PubMed

2005-02-01

This guide, which ECRI developed to answer the electrical safety questions most frequently asked by member hospitals, features practical advice for addressing electrical safety concerns in the healthcare environment. Questions addressed include: STANDARDS AND APPROVALS: What electrical safety standards apply? How do NFPA 99 and IEC 60601-1 differ? What organizations approve medical devices? LEAKAGE CURRENT LIMITS AND TESTING: How are leakage current limits established? What limits apply to equipment used in the hospital? And how should the limits be applied in special cases, such as the use of PCs in the patient care area or equipment used in the clinical laboratory? ISOLATED POWER: What are its advantages and disadvantages, and is isolated power needed in the operating room? Other topics addressed include double insulation, ground-fault circuit interrupters (GFCIs), and requirements for medical devices used in the home. Supplementary articles discuss acceptable alternatives to UL listing, the use of Hospital Grade plugs, the limitations of leakage current testing of devices connected to isolated power systems, and the debate about whether to designate ORs as wet locations. Experienced clinical engineers should find this guide to be a handy reference, while those new to the field should find it to be a helpful educational resource.

Biosensors for Real-Time Monitoring of Radiation-Induced Biologic Effects in Space

NASA Technical Reports Server (NTRS)

Baker, James R., Jr.; Balogh, Lajos; Majoros, Istvan; Keszler, Balazs; Myc, Andrzej; Kukowska-Latallo, Jolanta; Norris, Theodore; delaIglesia, Felix; Beeson, Nicholas W. (Compiler)

2002-01-01

This proposal seeks to develop cellular biosensors based on dendritic polymers. Nanoscale polymer structures less than 20 nm in diameter will be used as the basis of the sensor/actuators. The structures will be designed to target into specific cells of an astronaut and be able to monitor health issues such as the exposure to radiation or infectious agents. Multiple components can be assembled on the polymers including target directors, analytical devices (such as molecular probes), magnetic particles and metals, and imaging agents. The design and assembly of these devices has been pioneered at the Center for Biologic Nanotechnology in the University of Michigan. These molecules would also be able to administer therapeutics in response to the needs of the astronaut, and act as actuators to remotely manipulate an astronaut as necessary to ensure their safety. The reporting will be accomplished either through fluorescence signal monitoring, with the use of multispectral analysis for signal interpretation, or through functional MRI. These nanosensors coupled to NEMS devices could facilitate the success and increase the safety of extended space flight.

Medical cyber-physical systems: A survey.

PubMed

Dey, Nilanjan; Ashour, Amira S; Shi, Fuqian; Fong, Simon James; Tavares, João Manuel R S

2018-03-10

Medical cyber-physical systems (MCPS) are healthcare critical integration of a network of medical devices. These systems are progressively used in hospitals to achieve a continuous high-quality healthcare. The MCPS design faces numerous challenges, including inoperability, security/privacy, and high assurance in the system software. In the current work, the infrastructure of the cyber-physical systems (CPS) are reviewed and discussed. This article enriched the researches of the networked Medical Device (MD) systems to increase the efficiency and safety of the healthcare. It also can assist the specialists of medical device to overcome crucial issues related to medical devices, and the challenges facing the design of the medical device's network. The concept of the social networking and its security along with the concept of the wireless sensor networks (WSNs) are addressed. Afterward, the CPS systems and platforms have been established, where more focus was directed toward CPS-based healthcare. The big data framework of CPSs is also included.

A RFID specific participatory design approach to support design and implementation of real-time location systems in the operating room.

PubMed

Guédon, A C P; Wauben, L S G L; de Korne, D F; Overvelde, M; Dankelman, J; van den Dobbelsteen, J J

2015-01-01

Information technology, such as real-time location (RTL) systems using Radio Frequency IDentification (RFID) may contribute to overcome patient safety issues and high costs in healthcare. The aim of this work is to study if a RFID specific Participatory Design (PD) approach supports the design and the implementation of RTL systems in the Operating Room (OR). A RFID specific PD approach was used to design and implement two RFID based modules. The Device Module monitors the safety status of OR devices and the Patient Module tracks the patients' locations during their hospital stay. The PD principles 'multidisciplinary team', 'participation users (active involvement)' and 'early adopters' were used to include users from the RFID company, the university and the hospital. The design and implementation process consisted of two 'structured cycles' ('iterations'). The effectiveness of this approach was assessed by the acceptance in terms of level of use, continuity of the project and purchase. The Device Module included eight strategic and twelve tactical actions and the Patient Module included six strategic and twelve tactical actions. Both modules are now used on a daily basis and are purchased by the hospitals for continued use. The RFID specific PD approach was effective in guiding and supporting the design and implementation process of RFID technology in the OR. The multidisciplinary teams and their active participation provided insights in the social and the organizational context of the hospitals making it possible to better fit the technology to the hospitals' (future) needs.

49 CFR 229.93 - Safety cut-off device.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 4 2011-10-01 2011-10-01 false Safety cut-off device. 229.93 Section 229.93 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION... Equipment § 229.93 Safety cut-off device. The fuel line shall have a safety cut-off device that— (a) Is...

49 CFR 229.93 - Safety cut-off device.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 4 2010-10-01 2010-10-01 false Safety cut-off device. 229.93 Section 229.93 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION... Equipment § 229.93 Safety cut-off device. The fuel line shall have a safety cut-off device that— (a) Is...

78 FR 69943 - Anthropomorphic Test Devices; Q3s 3-Year-Old Child Side Impact Test Dummy, Incorporation by...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-21

... design and by July 2007 Build Level C was released. b. Developments In 2007, the Occupant Safety Research... reference a parts list, a set of design drawings, and a ``Procedures for Assembly, Disassembly and Inspection (PADI)'' document, to ensure that all Q3s dummies are the same in their design and construction.\\2...

A variable stiffness transverse mode shape memory alloy actuator as a minimally invasive organ positioner

NASA Astrophysics Data System (ADS)

Anderson, W.; Eshghinejad, A.; Azadegan, R.; Cooper, C.; Elahinia, M.

2013-09-01

Smart materials have gained a great deal of attention in recent years because of their unique actuation properties. Actuators are needed in the medical field where space is limited. Presented within this work is an organ positioner used to position the esophagus away from the left atrium to avoid the development of an esophageal fistula during atrial fibrillation (afib) ablation procedures. Within this work, a subroutine was implemented into the finite element framework to predict the midspan load capacity of a near equiatomic NiTi specimen in both the super elastic and shape memory regimes. The purpose of the simulations and experimental results was to develop a design envelope for the organ positioning device. The transverse loading experiments were conducted at several different temperatures leading to the ability to design a variable stiffness actuator. This is essential because the actuator must not be too stiff to injure the organ it is positioning. Extended further, geometric perturbations were applied in the virtual model and the entire design envelope was developed. Further, nitinol was tested for safety in the radio-frequency environment (to ensure that local heating will not occur in the ablation environment). With the safety of the device confirmed, a primitive prototype was manufactured and successfully tested in a cadaver. The design of the final device is also presented. The contribution of this work is the presentation of a new type of positoning device for medical purposes (NiTiBOP). In the process a comprehensive model for transverse actuation of an SMA actuator was developed and experimentally verified.

A Detection Device for the Signs of Human Life in Accident

NASA Astrophysics Data System (ADS)

Ning, Li; Ruilan, Zhang; Jian, Liu; Ruirui, Cheng; Yuhong, Diao

2017-12-01

A detection device for the signs of human life in accidents is a device used in emergency situations, such as the crash site. the scene of natural disasters, the battlefield ruins. it designed to detect the life signs of the distress under the injured ambulance vital signs devices. The device can on human vital signs, including pulse, respiration physiological signals to make rapid and accurate response. After some calculations, and after contrast to normal human physiological parameters given warning signals, in order for them to make timely ambulance judgment. In this case the device is required to do gymnastics convenience, ease of movement, power and detection of small flexible easy realization. This device has the maximum protection of the wounded safety significance.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Physical device safety is typically implemented locally using embedded controllers, while operations safety is primarily performed in control centers. Safe operations can be enhanced by correct design of device-level control algorithms, and protocols, procedures and operator training at the control-room level, but all can fail. Moreover, these elements exchange data and issue commands via vulnerable communication layers. In order to secure these gaps and enhance operational safety, we believe monitoring of command sequences must be combined with an awareness of physical device limitations and automata models that capture safety mechanisms. One way of doing this is by leveraging specification-based intrusionmore » detection to monitor for physical constraint violations. The method can also verify that physical infrastructure state is consistent with monitoring information and control commands exchanged between field devices and control centers. This additional security layer enhances protection from both outsider attacks and insider mistakes. We implemented specification-based SCADA command analyzers using physical constraint algorithms directly in the Bro framework and Broccoli APIs for three separate scenarios: a water heater, an automated distribution system, and an over-current protection scheme. To accomplish this, we added low-level analyzers capable of examining control system-specific protocol packets for both Modbus TCP and DNP3, and also higher-level analyzers able to interpret device command and data streams within the context of each device's physical capabilities and present operational state. Thus the software that we are making available includes the Bro/Broccoli scripts for these three scenarios, as well as simulators, written in C, of those scenarios that generate sample traffic that is monitored by the Bro/Broccoli scripts. In addition, we have also implemented systems to directly pull cyber-physical information from the OSIsoft PI historian system. We have included the Python scripts used to perform that monitoring.« less

Seven Experiment Designs Addressing Problems of Safety and Capacity on Two-Lane Rural Highways : Volume 6. Experimental Design for Comparative Evaluation of Warning-Advisory and Regulatory Traffic Control Devices

DOT National Transportation Integrated Search

2006-04-14

This report presents the results of the national evaluation of the South Lake Tahoe coordinated Transit System (CTS) Project. The CTS Project involved combining transit services offered by private and public sector stakeholders in South Lake Tahoe in...

9 CFR 354.2 - Designation of official certificates, memoranda, marks, other identifications, and devices for...

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Designation of official certificates... Section 354.2 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... means any symbol, stamp, label, or seal indicating that the product has been officially inspected and/or...

9 CFR 354.2 - Designation of official certificates, memoranda, marks, other identifications, and devices for...

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Designation of official certificates... Section 354.2 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... means any symbol, stamp, label, or seal indicating that the product has been officially inspected and/or...

36 CFR 1192.23 - Mobility aid accessibility.

Code of Federal Regulations, 2010 CFR

2010-07-01

... subpart shall provide a level-change mechanism or boarding device (e.g., lift or ramp) complying with... 22 feet in length or less. (b) Vehicle lift—(1) Design load. The design load of the lift shall be at... upon which the lift depends for support of the load, shall have a safety factor of at least six, based...

36 CFR 1192.23 - Mobility aid accessibility.

Code of Federal Regulations, 2011 CFR

2011-07-01

... subpart shall provide a level-change mechanism or boarding device (e.g., lift or ramp) complying with... 22 feet in length or less. (b) Vehicle lift—(1) Design load. The design load of the lift shall be at... upon which the lift depends for support of the load, shall have a safety factor of at least six, based...

21 CFR 882.1440 - Neuropsychiatric interpretive electroencephalograph assessment aid.

Code of Federal Regulations, 2014 CFR

2014-04-01

... described in detail in the software requirements specification and software design specification... the device, hardware and software, must be fully characterized and must demonstrate a reasonable assurance of safety and effectiveness. (i) Hardware specifications must be provided. Appropriate...

Formal verification of software-based medical devices considering medical guidelines.

PubMed

Daw, Zamira; Cleaveland, Rance; Vetter, Marcus

2014-01-01

Software-based devices have increasingly become an important part of several clinical scenarios. Due to their critical impact on human life, medical devices have very strict safety requirements. It is therefore necessary to apply verification methods to ensure that the safety requirements are met. Verification of software-based devices is commonly limited to the verification of their internal elements without considering the interaction that these elements have with other devices as well as the application environment in which they are used. Medical guidelines define clinical procedures, which contain the necessary information to completely verify medical devices. The objective of this work was to incorporate medical guidelines into the verification process in order to increase the reliability of the software-based medical devices. Medical devices are developed using the model-driven method deterministic models for signal processing of embedded systems (DMOSES). This method uses unified modeling language (UML) models as a basis for the development of medical devices. The UML activity diagram is used to describe medical guidelines as workflows. The functionality of the medical devices is abstracted as a set of actions that is modeled within these workflows. In this paper, the UML models are verified using the UPPAAL model-checker. For this purpose, a formalization approach for the UML models using timed automaton (TA) is presented. A set of requirements is verified by the proposed approach for the navigation-guided biopsy. This shows the capability for identifying errors or optimization points both in the workflow and in the system design of the navigation device. In addition to the above, an open source eclipse plug-in was developed for the automated transformation of UML models into TA models that are automatically verified using UPPAAL. The proposed method enables developers to model medical devices and their clinical environment using clinical workflows as one UML diagram. Additionally, the system design can be formally verified automatically.

US Food and Drug Administration Clearance of Moderate-Risk Otolaryngologic Devices via the 510(k) Process, 1997-2016.

PubMed

Rathi, Vinay K; Gadkaree, Shekhar K; Ross, Joseph S; Kozin, Elliott D; Sethi, Rosh K; Naunheim, Matthew R; Puram, Sidharth V; Gray, Stacey T

2017-10-01

Objective The US Food and Drug Administration (FDA) clears moderate-risk devices via the 510(k) process based on substantial equivalence to previously cleared devices; evidence of safety and effectiveness is not required. We characterized the premarket evidence supporting FDA clearance of otolaryngologic devices. Study Design Retrospective cross-sectional analysis. Setting Publicly available FDA documents. Subjects and Methods Recently cleared (1997-2016) moderate-risk otolaryngologic devices were categorized by type (diagnostic/therapeutic), subspecialty, implantable designation (yes/no), and recall history (yes/no). Supporting evidence was categorized by type (clinical/nonclinical/none; nonclinical and clinical mutually inclusive) and public availability of nonclinical and clinical performance data (available/not provided/not applicable). Results Between 1997 and 2016, the FDA cleared 377 moderate-risk otolaryngologic devices. The majority were therapeutic (n = 240/377 [63.7%]) and otologic (n = 311/377 [82.5%]); roughly one-third (n = 121/377 [32.1%]) were implantable. Few (n = 10/377 [2.7%]) devices were subject to recall. FDA documents summarizing premarket evidence were accessible for two-thirds (n = 247/377 [65.5%]) of devices. Among these devices, one-quarter (n = 66/247 [26.7%]) were supported by clinical evidence. The majority (n = 177/247 [71.7%]) were supported by nonclinical evidence, although nearly one-quarter (n = 58/247 [23.5%]) were cleared without supporting evidence. Therapeutic devices were more often cleared without supporting evidence (therapeutic: n = 53/170 [31.2%]; diagnostic: n = 5/77 [6.5%]; P < .0001). Nonclinical and clinical performance data were rarely available (nonclinical: n = 49/247 [19.8%]; clinical: n = 32/247 [13.0%]) within public summaries. Conclusion The FDA cleared most moderate-risk otolaryngologic devices for marketing via the 510(k) process without clinical evidence of safety and effectiveness. Otolaryngologists should be aware of limitations in premarket evidence when considering the adoption of new devices into clinical practice.

Electrical safety device

DOEpatents

White, David B.

1991-01-01

An electrical safety device for use in power tools that is designed to automatically discontinue operation of the power tool upon physical contact of the tool with a concealed conductive material. A step down transformer is used to supply the operating power for a disconnect relay and a reset relay. When physical contact is made between the power tool and the conductive material, an electrical circuit through the disconnect relay is completed and the operation of the power tool is automatically interrupted. Once the contact between the tool and conductive material is broken, the power tool can be quickly and easily reactivated by a reset push button activating the reset relay. A remote reset is provided for convenience and efficiency of operation.

Evaluating the Performance of the NASA LaRC CMF Motion Base Safety Devices

NASA Technical Reports Server (NTRS)

Gupton, Lawrence E.; Bryant, Richard B., Jr.; Carrelli, David J.

2006-01-01

This paper describes the initial measured performance results of the previously documented NASA Langley Research Center (LaRC) Cockpit Motion Facility (CMF) motion base hardware safety devices. These safety systems are required to prevent excessive accelerations that could injure personnel and damage simulator cockpits or the motion base structure. Excessive accelerations may be caused by erroneous commands or hardware failures driving an actuator to the end of its travel at high velocity, stepping a servo valve, or instantly reversing servo direction. Such commands may result from single order failures of electrical or hydraulic components within the control system itself, or from aggressive or improper cueing commands from the host simulation computer. The safety systems must mitigate these high acceleration events while minimizing the negative performance impacts. The system accomplishes this by controlling the rate of change of valve signals to limit excessive commanded accelerations. It also aids hydraulic cushion performance by limiting valve command authority as the actuator approaches its end of travel. The design takes advantage of inherent motion base hydraulic characteristics to implement all safety features using hardware only solutions.

Medina® Embolization Device for the Treatment of Intracranial Aneurysms: Safety and Angiographic Effectiveness at 6 Months.

PubMed

Sourour, Nader-Antoine; Vande Perre, Saskia; Maria, Federico Di; Papagiannaki, Chrysanthi; Gabrieli, Joseph; Pistocchi, Silvia; Bartolini, Bruno; Degos, Vincent; Carpentier, Alexandre; Chiras, Jacques; Clarençon, Frédéric

2018-02-01

The Medina Embolization Device (MED) is a new concept device that combines the design of a detachable coil and the one of an intrasaccular flow disruption device. To evaluate the feasibility, safety, and 6- to 9-mo effectiveness of this new device for the treatment of intracranial wide-necked aneurysms. Twelve patients (10 females, mean age = 56 yr) with 13 wide-necked intracranial aneurysms (3 ruptured; 10 unruptured) were treated by means of the MED from January 2015 to October 2015. In 15% of the cases, MEDs were used in a standalone fashion; in 85% of the cases, additional regular coils were used. Adjunctive compliant balloon was used in 4 of 13 cases (31%). Procedure-related complications were systematically recorded; discharge and 6- to 9-mo follow-up modified Rankin Scale was assessed. Angiographic follow-up was performed with a mean delay of 5.5 ± 1.7 mo. Occlusion rate was evaluated in postprocedure and at midterm follow-up using the Roy-Raymond scale. The deployment of the MED was feasible in all cases. No perforation was recorded. One case of thromboembolic complication was observed in a ruptured anterior communicating artery aneurysm, without any clinical consequence at follow-up. Grade A occlusion rate was 61.5% in postprocedure and 83% at 6-mo follow-up. Two cases (17%) of recanalization were documented angiographically. The MED is a new generation device combining the design of a detachable coil and an intrasaccular flow disruption device. According to our early experience, this device is safe and provides a satisfactory occlusion rate at angiographic follow-up of 6 mo. Copyright © 2017 by the Congress of Neurological Surgeons

Designing DNA nanodevices for compatibility with the immune system of higher organisms

NASA Astrophysics Data System (ADS)

Surana, Sunaina; Shenoy, Avinash R.; Krishnan, Yamuna

2015-09-01

DNA is proving to be a powerful scaffold to construct molecularly precise designer DNA devices. Recent trends reveal their ever-increasing deployment within living systems as delivery devices that not only probe but also program and re-program a cell, or even whole organisms. Given that DNA is highly immunogenic, we outline the molecular, cellular and organismal response pathways that designer nucleic acid nanodevices are likely to elicit in living systems. We address safety issues applicable when such designer DNA nanodevices interact with the immune system. In light of this, we discuss possible molecular programming strategies that could be integrated with such designer nucleic acid scaffolds to either evade or stimulate the host response with a view to optimizing and widening their applications in higher organisms.

The Airfloat HL project. [design analysis of airships and lift devices for materials handling

NASA Technical Reports Server (NTRS)

Mowforth, E.

1975-01-01

A design study is described for a large low-cost rigid airship intended primarily for the movement of large indivisible loads (cargo) between industrial sites. A survey of the ship and its overall performance is followed by accounts of the operational procedures for the above function and for an alternative application to unit module transfer between fixed terminals. A final section indicates the estimated costs of construction and operation. Safety factors are also considered. Lifting devices such as winches, hoists are shown and described, and airship configurations are also shown.

Measuring Tyre Rolling Noise at the Contact Patch

NASA Astrophysics Data System (ADS)

Kozak, P.; Matuszkova, R.; Radimsky, M.; Kudrna, J.

2017-06-01

This paper deals with noise generated by road traffic. A focus is concentrated solely on one of its sources related to tyre/road interaction referred as rolling noise. The paper states brief overview of various approaches and methods used to measure this particular source of road traffic noise. On the basis of literature reviews, a unique device has been designed. Development of the measuring device and possibilities of its usage are described in detail in this paper. Obtained results of noise measurements can then be used to design measures that increase safety and a lead to better comfort on the road.

Safety Assessment of Multi Purpose Small Payload Rack(MSPR)

NASA Astrophysics Data System (ADS)

Mizutani, Yoshinobu; Takada, Satomi; Murata, Kosei; Ozawa, Daisaku; Kobayashi, Ryoji; Nakamura, Yasuhiro

2010-09-01

We are reporting summary of preliminary safety assessment for Multi Purpose Small Payload Rack(MSPR), which is one of the micro gravity experiment facilities that are being developed for the 2nd phase JEM utilization(JEM: Japanese Experiment Module) that will be launched on H-II Transfer Vehicle(HTV) 2nd flight in 2011. MSPR is used for multi-purpose micro-g experiment providing experimental spaces and work stations. MSPR has three experimental spaces; first, there is a space called Work Volume(WV) with capacity volume of approximately 350 litters, in which multiple resources including electricity, communication, and moving image functions can be used. Within this space, installation of devices can be done by simple, prompt attachment by Velcro and pins with high degree of flexibility. Second, there is Small Experiment Area(SEA), with capacity volume of approximately 70 litters, in which electricity, communication, and moving image functions can also be used in the same way as WV. These spaces protect experiment devices and specimens from contingent loads by the crewmembers. Third, there is Work Bench with area of 0.5 square meters, on which can be used for maintenance, inspection and data operations of installed devices, etc. This bench can be stored in the rack during contingency. Chamber for Combustion Experiment(CCE) that is planned to be installed in WV is a pressure-resistant experimental container that can be used to seal hazardous materials from combustion experiments. This CCE has double sealing design in chamber itself, which resist gas leakage under normal the temperature and pressure. Electricity, communication, moving image function can be used in the same way as WV. JAXA Phase 2 Safety Review Panel(SRP) has been held in April, 2010. For safety analysis of MSPR, hazards were identified based on Fault Tree Analysis methodology and then these hazards were classified into either eight ISS standard-type hazards or eight unique-type hazards that requires special controls based on ISS common safety assessment methodology. Safety evaluation results are reported in the Safety Assessment Report(SAR) 1). Regarding structural failure, unique hazards are especially evaluated considering not only the tolerance for launch load but also load by crewmembers or orbital loads. Regarding electrical shock, electricity design up to secondary power is evaluated in unique hazard from a view point of Electrical design suitable for high voltage(32VDC or more) circuit. Regarding rupture/leakage of pressure system, hazards of fuel supply line, waste line for combustion gas, and pressure system including CCE are evaluated. Also evaluation for contamination due to hazardous gas leakage from CCE is conducted. External propagation of fire from CCE is also evaluated. In this report, we will show the overview of the result of safety assessment and future plan toward critical design phase activity.

Assessment of truck driver distraction problem and research needs

DOT National Transportation Integrated Search

2005-05-01

The issue of driver distraction associated with the use of in-vehicle devices in heavy vehicles was explored through interviews with truck drivers and safety regulators. In order to characterize some of the interface designs and better understand the...

23 CFR 630.1002 - Purpose.

Code of Federal Regulations, 2010 CFR

2010-04-01

... mobility of road users and highway workers. These safety and mobility impacts are exacerbated by an aging... prescribes standards for the design, application, installation, and maintenance of traffic control devices for highway and street construction, maintenance operation, and utility work. In addition to the...

Use of positive protection in work zones : transportation synthesis.

DOT National Transportation Integrated Search

2017-05-01

The MnDOT Office of Traffic, Safety and Technology is developing a manual on the use of temporary barriers, truck-mounted attenuators and other types of positive protection devices as guidance for designers, construction workers and contractors. To s...

Advanced Measurement Systems Available to PIWG Members

NASA Technical Reports Server (NTRS)

Anderson, Robert; Lei, Jih-Fen (Technical Monitor)

2002-01-01

It was developed advanced measurement technologies to meet NASA goals: reduce design cycle time, reduce emission, reduce testing time, increase safety. The technology are saving money. This technology are available now for technology transfer: optical diagnostics, the film technology and MEMS devices.

Presenting hazard warning information to drivers using an advanced traveler information system

DOT National Transportation Integrated Search

1997-02-01

Although Advanced Traveler Information System (ATIS) devices have the potential to improve travel safety, efficiency, and comfort, they represent a new frontier in ground transportation. In order to realize this potential, they must be designed in a ...

Predictors of nurses' acceptance of an intravenous catheter safety device.

PubMed

Rivers, Dianna Lipp; Aday, Lu Ann; Frankowski, Ralph F; Felknor, Sarah; White, Donna; Nichols, Brenda

2003-01-01

It is important to determine the factors that predict whether nurses accept and use a new intravenous (IV) safety device because there are approximately 800,000 needlesticks per year with the risk of contracting a life-threatening bloodborne disease such as HIV or hepatitis C. To determine the predictors of nurses' acceptance of the Protectiv Plus IV catheter safety needle device at a teaching hospital in Texas. A one-time cross-sectional survey of nurses (N = 742) was conducted using a 34-item questionnaire. A framework was developed identifying organizational and individual predictors of acceptance. The three principal dimensions of acceptance were (a) satisfaction with the device, (b) extent to which the device is always used, and (c) nurse recommendations over other safety devices. Measurements included developing summary subscales for the variables of safety climate and acceptance. Descriptive statistics and multiple linear and logistic regression models were computed. The findings showed widespread acceptance of the device. Nurses who had adequate training and a positive institutional safety climate were more accepting (p

Design and development of a low-cost biphasic charge-balanced functional electric stimulator and its clinical validation.

PubMed

Shendkar, Chandrashekhar; Lenka, Prasanna K; Biswas, Abhishek; Kumar, Ratnesh; Mahadevappa, Manjunatha

2015-10-01

Functional electric stimulators that produce near-ideal, charge-balanced biphasic stimulation waveforms with interphase delay are considered safer and more efficacious than conventional stimulators. An indigenously designed, low-cost, portable FES device named InStim is developed. It features a charge-balanced biphasic single channel. The authors present the complete design, mathematical analysis of the circuit and the clinical evaluation of the device. The developed circuit was tested on stroke patients affected by foot drop problems. It was tested both under laboratory conditions and in clinical settings. The key building blocks of this circuit are low dropout regulators, a DC-DC voltage booster and a single high-power current source OP-Amp with current-limiting capabilities. This allows the device to deliver high-voltage, constant current, biphasic pulses without the use of a bulky step-up transformer. The advantages of the proposed design over the currently existing devices include improved safety features (zero DC current, current-limiting mechanism and safe pulses), waveform morphology that causes less muscle fatigue, cost-effectiveness and compact power-efficient circuit design with minimal components. The device is also capable of producing appropriate ankle dorsiflexion in patients having foot drop problems of various Medical Research Council scale grades.

Role of preliminary registry data in development of a clinical trial for an innovative device: a small but integral piece of a health policy initiative

PubMed Central

Ricci, Donald R.; de Vries, Joost; Blanc, Raphael

2017-01-01

ABSTRACT Establishing a national health policy at a macro level involves the integration of a series of health initiatives across a spectrum of activities, including clinical care. Evaluation of the safety and efficacy of a new medical device ultimately evolves to testing in humans. The pathway to a formal prospective clinical trial includes a stepwise appreciation of pre-clinical data and detailed analysis of data obtained from preliminary registries, where information about appropriate patient selection and use of the device is obtained. Evaluation of procedural and follow-up efficacy and safety data in a preliminary series of cases, chosen to simulate published data, allows the design and conduct of clinical trials that are required to verify preliminary observations, closing the loop on one aspect of modifying health policy decisions. PMID:28321285

Electromagnetic pulse-induced current measurement device

NASA Astrophysics Data System (ADS)

Gandhi, Om P.; Chen, Jin Y.

1991-08-01

To develop safety guidelines for exposure to high fields associated with an electromagnetic pulse (EMP), it is necessary to devise techniques that would measure the peak current induced in the human body. The main focus of this project was to design, fabricate, and test a portable, self-contained stand-on device that would measure and hold the peak current and the integrated change Q. The design specifications of the EMP-Induced Current Measurement Device are as follows: rise time of the current pulse, 5 ns; peak current, 20-600 A; charge Q, 0-20 microcoulombs. The device uses a stand-on parallel-plate bilayer sensor and fast high-frequency circuit that are well-shielded against spurious responses to high incident fields. Since the polarity of the incident peak electric field of the EMP may be either positive or negative, the induced peak current can also be positive or negative. Therefore, the device is designed to respond to either of these polarities and measure and hold both the peak current and the integrated charge which are simultaneously displayed on two separate 3-1/2 digit displays. The prototype device has been preliminarily tested with the EMP's generated at the Air Force Weapons Laboratory (ALECS facility) at Kirtland AFB, New Mexico.

78 FR 24817 - Visual-Manual NHTSA Driver Distraction Guidelines for In-Vehicle Electronic Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-26

...The National Highway Traffic Safety Administration (NHTSA) is concerned about the effects of distraction on motor vehicle safety due to drivers' use of electronic devices. Consequently, NHTSA is issuing nonbinding, voluntary Driver Distraction Guidelines (NHTSA Guidelines) to promote safety by discouraging the introduction of excessively distracting devices in vehicles. This notice announces the issuance of the final version of the first phase of the NHTSA Guidelines. This first phase applies to original equipment (OE) in-vehicle electronic devices used by the driver to perform secondary tasks (communications, entertainment, information gathering, navigation tasks, etc. are considered secondary tasks) through visual-manual means (i.e., the driver looks at a device, manipulates a device-related control with his or her hand, and/or watches for visual feedback). The NHTSA Guidelines list certain secondary tasks believed by the agency to interfere inherently with a driver's ability to safely control the vehicle. The NHTSA Guidelines recommend that in-vehicle devices be designed so that they cannot be used by the driver to perform these inherently distracting secondary tasks while driving. For all other visual-manual secondary tasks, the NHTSA Guidelines specify a test method for measuring eye glance behavior during those tasks. Eye glance metrics are compared to acceptance criteria to evaluate whether a task interferes too much with driver attention, rendering it unsuitable for a driver to perform while driving. If a task does not meet the acceptance criteria, the NHTSA Guidelines recommend that the task be made inaccessible for performance by the driver while driving. In addition, the NHTSA Guidelines contain several recommendations to limit and reduce the potential for distraction associated with the use of OE in-vehicle electronic devices.

FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012.

PubMed

Rome, Benjamin N; Kramer, Daniel B; Kesselheim, Aaron S

The US Food and Drug Administration (FDA) evaluates high-risk medical devices such as cardiac implantable electronic devices (CIEDs), including pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy devices, via the premarket approval (PMA) process, during which manufacturers submit clinical data demonstrating safety and effectiveness. Subsequent changes to approved high-risk devices are implemented via "supplements," which may not require additional clinical testing. To characterize the prevalence and characteristics of changes to CIEDs made through the PMA supplement process. Using the FDA's PMA database, we reviewed all CIEDs approved as original PMAs or supplements from 1979 through 2012. For each supplement, we collected the date approved, type of supplement (panel-track, 180-day, real-time, special, and 30-day notice), and the nature of the changes. We calculated the number of supplements approved per PMA and analyzed trends relating to different supplement regulatory categories over time. For supplements approved via the 180-day regulatory pathway, which often involve significant design changes, from 2010-2012, we identified how often additional clinical data were collected. From 1979-2012, the FDA approved 77 original and 5829 supplement PMA applications for CIEDs, with a median of 50 supplements per original PMA (interquartile range [IQR], 23-87). Excluding manufacturing changes that do not alter device design, the number of supplements approved each year was stable around a mean (SD) of 2.6 (0.9) supplements per PMA per year. Premarket approvals remained active via successive supplements over a median period of 15 years (IQR, 8-20), and 79% of the 77 original PMAs approved during our study period were the subject of at least 1 supplement in 2012. Thirty-seven percent of approved supplements involved a change to the device's design. Among 180-day supplements approved from 2010-2012, 23% (15/64) included new clinical data to support safety and effectiveness. Many CIED models currently used by clinicians were approved via the PMA supplement process, not as original PMAs. Most new device models are deemed safe and effective without requiring new clinical data, reinforcing the importance of rigorous postapproval surveillance of these devices.

The Role of Patient Safety in the Device Purchasing Process

DTIC Science & Technology

2005-05-01

Juliana J. Brixey, Danielle Paige, James P. Turley Abstract To examine how patient safety considerations are incorporated into medical device...Despite the general awareness of patient safety, its importance, and its role in medical device comparisons and purchasing decisions, this study...into the medical device purchasing process. We presently have a set of guidelines in development to help hospitals better emphasize patient safety

Stakeholder challenges in purchasing medical devices for patient safety.

PubMed

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.

Second Insulin Pump Safety Meeting: Summary Report

PubMed Central

Zhang, Yi; Jones, Paul L.; Klonoff, David C.

2010-01-01

Diabetes Technology Society facilitated a second meeting of insulin pump experts at Mills-Peninsula Health Services, San Mateo, California on November 4, 2009, at the request of the Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories. The first such meeting was held in Bethesda, Maryland, on November 12, 2008. The group of physicians, nurses, diabetes educators, and engineers from across the United States discussed safety issues in insulin pump therapy and recommended adjustments to current insulin pump design and use to enhance overall safety. The meeting discussed safety issues in the context of pump operation; software; hardware; physical structure; electrical, biological, and chemical considerations; use; and environment from engineering, medical, nursing, and pump/user perspectives. There was consensus among meeting participants that insulin pump designs have made great progress in improving the quality of life of people with diabetes, but much more remains to be done. PMID:20307411

Ensuring Patient Safety by using Colored Petri Net Simulation in the Design of Heterogeneous, Multi-Vendor, Integrated, Life-Critical Wireless (802.x) Patient Care Device Networks.

PubMed

Sloane, Elliot; Gehlot, Vijay

2005-01-01

Hospitals and manufacturers are designing and deploying the IEEE 802.x wireless technologies in medical devices to promote patient mobility and flexible facility use. There is little information, however, on the reliability or ultimate safety of connecting multiple wireless life-critical medical devices from multiple vendors using commercial 802.11a, 802.11b, 802.11g or pre-802.11n devices. It is believed that 802.11-type devices can introduce unintended life-threatening risks unless delivery of critical patient alarms to central monitoring systems and/or clinical personnel is assured by proper use of 802.11e Quality of Service (QoS) methods. Petri net tools can be used to simulate all possible states and transitions between devices and/or systems in a wireless device network, and can identify failure modes in advance. Colored Petri Net (CPN) tools are ideal, in fact, as they allow tracking and controlling each message in a network based on pre-selected criteria. This paper describes a research project using CPN to simulate and validate alarm integrity in a small multi-modality wireless patient monitoring system. A 20-monitor wireless patient monitoring network is created in two versions: one with non-prioritized 802.x CSM protocols and the second with simulated Quality of Service (QoS) capabilities similar to 802.11e (i.e., the second network allows message priority management.) In the standard 802.x network, dangerous heart arrhythmia and pulse oximetry alarms could not be reliably and rapidly communicated, but the second network's QoS priority management reduced that risk significantly.

Lithium-ion batteries for hearing aid applications. II. Pulse discharge and safety tests

NASA Astrophysics Data System (ADS)

Passerini, S.; Coustier, F.; Owens, B. B.

Rechargeable lithium-ion batteries were designed to meet the power requirements of hearing aid devices (HADs). The batteries were designed in a 312-button cell size, compatible with existing hearing aids. The batteries were tested to evaluate the design and the electrochemical performance, as they relate to a typical hearing aid application. The present report covers the pulse capabilities, cycle life and preliminary safety tests. The results are compared with other battery chemistries: secondary lithium-alloy and nickel-metal hydride batteries and primary Zn-air batteries. The cell AC impedance was stable over the frequency range between 1 and 50 kHz, ranging between 5 Ω at the higher frequency and 12 Ω at the lower extreme. Pulse tests were consistent with these values, as the cells were capable of providing a series of 100 mA pulses of 10-s duration. The safety tests suggest that the design is intrinsically safe with respect to the most common types of abuse conditions.

On-Demand Cell Internal Short Circuit Device

NASA Technical Reports Server (NTRS)

Darcy, Eric; Keyser, Matthew

2014-01-01

A device implantable in Li-ion cells that can generate a hard internal short circuit on-demand by exposing the cell to 60?C has been demonstrated to be valuable for expanding our understanding of cell responses. The device provides a negligible impact to cell performance and enables the instigation of the 4 general categories of cell internal shorts to determine relative severity and cell design susceptibility. Tests with a 18650 cell design indicates that the anode active material short to the aluminum cathode current collector tends to be more catastrophic than the 3 other types of internal shorts. Advanced safety features (such as shutdown separators) to prevent or mitigate the severity of cell internal shorts can be verified with this device. The hard short success rate achieved to date in 18650 cells is about 80%, which is sufficient for using these cells in battery assemblies for field-failure-relevant, cell-cell thermal runaway propagation verification tests

Wheelchair-mounted robotic arm to hold and move a communication device - final design.

PubMed

Barrett, Graham; Kurley, Kyle; Brauchie, Casey; Morton, Scott; Barrett, Steven

2015-01-01

At the 51st Rocky Mountain Bioengineering Symposium we presented a preliminary design for a robotic arm to assist an individual living within an assistive technology smart home. The individual controls much of their environment with a Dynavox Maestro communication device. However, the device obstructs the individual’s line of site when navigating about the smart home. A robotic arm was developed to move the communication device in and out of the user’s field of view as desired. The robotic arm is controlled by a conveniently mounted jelly switch. The jelly switch sends control signals to a four state (up, off, down, off) single-axis robotic arm interfaced to a DC motor by high power electronic relays. This paper describes the system, control circuitry, and multiple safety features. The arm will be delivered for use later in 2015.

Who left the defibrillator on?

PubMed

Gosbee, John

2004-05-01

Two related scenarios involving defibrillator devices reveal how inadvertent hazardous design can go unnoticed until engineers or patient safety personnel use human factors engineering (HFE) analysis. The first adverse event, in which the device was inadvertently turned off while being used to externally pace the patient's heart, resulted in an increased length of stay. The second scenario describes a similar close call and the useless acts of sanctioning the nurse and firing the engineer technician. Feedback to the end user about a device's status is an important design issue. It does not take much expertise to detect when there are problems with "dialogue" from the device to the person (that is, feedback). Many HFE issues have been cited in emergency care areas, and many medical devices--not just defibrillators--do not have readable and understandable feedback to the end user or the kind of automation that would make the wrong action harder to accomplish. All the interactions of multifunction devices with end users in a hectic, noisy, and dynamic environment need to be usability tested and validated. Nurses and engineering personnel can be trained to more easily see HFE design issues--and not dismiss them as individual failings or "someone else's job." Medical device companies are starting to follow the guidelines and regulations that should help prevent adverse events. The defibrillator's design problems had successfully masqueraded as "expected" glitches with hospital electrical utilities, personnel shortcomings, and personality problems. Adverse events related to seemingly simple devices can be prevented with HFE analysis.

FemCap with removal strap: ease of removal, safety and acceptability.

PubMed

Mauck, Christine K; Weiner, Debra H; Creinin, Mitchell D; Archer, David F; Schwartz, Jill L; Pymar, Helen C; Ballagh, Susan A; Henry, Deborah M; Callahan, Marianne M

2006-01-01

FemCap is a silicone-rubber barrier contraceptive approved for marketing in the United States. To address reported problems with removal and dislodgment, the device's developer added a strap to the device and increased the height of the brim. This trial assessed whether the new design reduced removal difficulties and had any effects on dislodgment, genital pain/discomfort, safety, and acceptability. Women used the strapped device for 8 weeks with follow-up visits at 2 and 8 weeks. Outcome measures were obtained through diary cards, questionnaires, and naked eye examination. Data from these 120 women were compared with data from 419 women who used the unstrapped FemCap in a previous contraceptive effectiveness study. The strapped device was not significantly easier for users to remove than the unstrapped device. Similar odds of dislodgment and cervical/vaginal irritation were seen with the two devices. Both female and male participants were significantly more likely to report pain/discomfort with use of the strapped device. Female users of the strapped device were significantly more likely to say they disliked their device. In six weeks, two pregnancies were observed, but pregnancy was not an endpoint in the study and no conclusions should be drawn regarding pregnancy rates. The modifications to the FemCap did not significantly improve the ease of device removal and appears to have resulted in significantly more female and male partner pain/discomfort and decreased acceptability, compared with the unstrapped device.

49 CFR 178.255-8 - Safety devices.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 3 2011-10-01 2011-10-01 false Safety devices. 178.255-8 Section 178.255-8 Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY... Portable Tanks § 178.255-8 Safety devices. (a) See § 173.315(i) of this subchapter. (b) [Reserved] [Amdt...

49 CFR 178.255-8 - Safety devices.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 2 2010-10-01 2010-10-01 false Safety devices. 178.255-8 Section 178.255-8 Transportation Other Regulations Relating to Transportation PIPELINE AND HAZARDOUS MATERIALS SAFETY... Specifications for Portable Tanks § 178.255-8 Safety devices. (a) See § 173.315(i) of this subchapter. (b...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-15

... reasonable assurance of safety and effectiveness of the device. A hemorrhoid prevention pressure wedge... provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its...

Manufacturer evaluations of endograft modifications.

PubMed

Waninger, Matthew S; Whirley, Robert G; Smith, Louis J; Wolf, Ben S

2013-03-01

The motivation to modify the design of a vascular device can arise from a number of sources. Clinical experience with the unmodified device could suggest new design modifications to improve device performance or clinical outcomes. Similarly, clinical success with a device often suggests modifications that could broaden the applicability of the device to enable treatment of different or more advanced disease states. As a specific example, both of these scenarios have arisen during the last decade in the evolution of endovascular grafts for the treatment of abdominal aortic aneurysms, with modifications enabling the treatment of patients with shorter infrarenal necks, more angulated anatomy, and smaller access vessels. These modifications have been made by manufacturers and additionally by physicians who create branched and fenestrated devices. The experience to date with the use of fenestrated devices and the development of chimney, snorkel, and periscope techniques suggests that modifications to off-the-shelf devices may provide some clinical benefit. This experience provides additional motivation for manufacturers to develop devices to address the clinical needs not met with their current product lines. For manufacturers, the device development process includes an assessment of the new device design to determine the appropriate evaluation strategy to support the safety and effectiveness of the modified device. This report provides a high-level overview of the process generally followed by device manufacturers to evaluate a proposed device modification before market release, in accordance with local country regulations and recognized international standards such as the International Organization of Standardization (ISO) standards for endovascular grafts (ISO 25539 Part 1). Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.

Augmented paper maps: Exploring the design space of a mixed reality system

NASA Astrophysics Data System (ADS)

Paelke, Volker; Sester, Monika

Paper maps and mobile electronic devices have complementary strengths and shortcomings in outdoor use. In many scenarios, like small craft sailing or cross-country trekking, a complete replacement of maps is neither useful nor desirable. Paper maps are fail-safe, relatively cheap, offer superior resolution and provide large scale overview. In uses like open-water sailing it is therefore mandatory to carry adequate maps/charts. GPS based mobile devices, on the other hand, offer useful features like automatic positioning and plotting, real-time information update and dynamic adaptation to user requirements. While paper maps are now commonly used in combination with mobile GPS devices, there is no meaningful integration between the two, and the combined use leads to a number of interaction problems and potential safety issues. In this paper we explore the design space of augmented paper maps in which maps are augmented with additional functionality through a mobile device to achieve a meaningful integration between device and map that combines their respective strengths.

Safety syringes and anti-needlestick devices in orthopaedic surgery.

PubMed

Sibbitt, Wilmer L; Band, Philip A; Kettwich, Lawrence G; Sibbitt, Cristina R; Sibbitt, Lori J; Bankhurst, Arthur D

2011-09-07

The American Academy of Orthopaedic Surgery (AAOS), The Joint Commission, the Occupational Safety and Health Administration (OSHA), and the Needlestick Safety and Prevention Act encourage the integration of safety-engineered devices to prevent needlestick injuries to health-care workers and patients. We hypothesized that safety syringes and needles could be used in outpatient orthopaedic injection and aspiration procedures. The study investigated the orthopaedic uses and procedural idiosyncrasies of safety-engineered devices, including (1) four safety needles (Eclipse, SafetyGlide, SurGuard, and Magellan), (2) a mechanical safety syringe (RPD), (3) two automatic retractable syringes (Integra, VanishPoint), (4) three manual retractable syringes (Procedur-SF, Baksnap, Invirosnap), and (5) three shielded syringes (Safety-Lok, Monoject, and Digitally Activated Shielded [DAS] Syringe). The devices were first tested ex vivo, and then 1300 devices were used for 425 subjects undergoing outpatient arthrocentesis, intra-articular injections, local anesthesia, aspiration biopsy, and ultrasound-guided procedures. During the clinical observation, there were no accidental needlesticks (0 needlesticks per 1300 devices). Safety needles could be successfully used on a Luer syringe but were limited to ≤1.5 in (≤3.81 cm) in length and the shield could interfere with sonography. The mechanical safety syringes functioned well in all orthopaedic procedures. Automatic retractable syringes were too small for arthrocentesis of the knee, and the plunger blew out and prematurely collapsed with high-pressure injections. The manual retractable syringes and shielded syringes could be used with conventional needles for most orthopaedic procedures. The most effective and reliable safety devices for orthopaedic syringe procedures are shielded safety needles, mechanical syringes, manual retractable syringes, and shielded syringes, but not automatic retractable syringes. Even when adopting safety-engineered devices for an orthopaedic clinic, conventional syringes larger than 20 mL and conventional needles longer than 1.5 in (3.8 cm) are necessary.

Spine device clinical trials: design and sponsorship.

PubMed

Cher, Daniel J; Capobianco, Robyn A

2015-05-01

Multicenter prospective randomized clinical trials represent the best evidence to support the safety and effectiveness of medical devices. Industry sponsorship of multicenter clinical trials is purported to lead to bias. To determine what proportion of spine device-related trials are industry-sponsored and the effect of industry sponsorship on trial design. Analysis of data from a publicly available clinical trials database. Clinical trials of spine devices registered on ClinicalTrials.gov, a publicly accessible trial database, were evaluated in terms of design, number and location of study centers, and sample size. The relationship between trial design characteristics and study sponsorship was evaluated using logistic regression and general linear models. One thousand six hundred thrity-eight studies were retrieved from ClinicalTrials.gov using the search term "spine." Of the 367 trials that focused on spine surgery, 200 (54.5%) specifically studied devices for spine surgery and 167 (45.5%) focused on other issues related to spine surgery. Compared with nondevice trials, device trials were far more likely to be sponsored by the industry (74% vs. 22.2%, odds ratio (OR) 9.9 [95% confidence interval 6.1-16.3]). Industry-sponsored device trials were more likely multicenter (80% vs. 29%, OR 9.8 [4.8-21.1]) and had approximately four times as many participating study centers (p<.0001) and larger sample sizes. There were very few US-based multicenter randomized trials of spine devices not sponsored by the industry. Most device-related spine research is industry-sponsored. Multicenter trials are more likely to be industry-sponsored. These findings suggest that previously published studies showing larger effect sizes in industry-sponsored vs. nonindustry-sponsored studies may be biased as a result of failure to take into account the marked differences in design and purpose. Copyright © 2015 Elsevier Inc. All rights reserved.

Li4 Ti5 O12 Anode: Structural Design from Material to Electrode and the Construction of Energy Storage Devices.

PubMed

Chen, Zhijie; Li, Honsen; Wu, Langyuan; Lu, Xiaoxia; Zhang, Xiaogang

2018-03-01

Spinel Li 4 Ti 5 O 12 , known as a zero-strain material, is capable to be a competent anode material for promising applications in state-of-art electrochemical energy storage devices (EESDs). Compared with commercial graphite, spinel Li 4 Ti 5 O 12 offers a high operating potential of ∼1.55 V vs Li/Li + , negligible volume expansion during Li + intercalation process and excellent thermal stability, leading to high safety and favorable cyclability. Despite the merits of Li 4 Ti 5 O 12 been presented, there still remains the issue of Li 4 Ti 5 O 12 suffering from poor electronic conductivity, manifesting disadvantageous rate performance. Typically, a material modification process of Li 4 Ti 5 O 12 will be proposed to overcome such an issue. However, the previous reports have made few investigations and achievements to analyze the subsequent processes after a material modification process. In this review, we attempt to put considerable interest in complete device design and assembly process with its material structure design (or modification process), electrode structure design and device construction design. Moreover, we have systematically concluded a series of representative design schemes, which can be divided into three major categories involving: (1) nanostructures design, conductive material coating process and doping process on material level; (2) self-supporting or flexible electrode structure design on electrode level; (3) rational assembling of lithium ion full cell or lithium ion capacitor on device level. We believe that these rational designs can give an advanced performance for Li 4 Ti 5 O 12 -based energy storage device and deliver a deep inspiration. © 2018 The Chemical Society of Japan & Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.

Automatic safety rod for reactors. [LMFBR

DOEpatents

Germer, J.H.

1982-03-23

An automatic safety rod for a nuclear reactor containing neutron absorbing material and designed to be inserted into a reactor core after a loss-of-flow. Actuation is based upon either a sudden decrease in core pressure drop or the pressure drop decreases below a predetermined minimum value. The automatic control rod includes a pressure regulating device whereby a controlled decrease in operating pressure due to reduced coolant flow does not cause the rod to drop into the core.

Automatic safety rod for reactors

DOEpatents

Germer, John H.

1988-01-01

An automatic safety rod for a nuclear reactor containing neutron absorbing material and designed to be inserted into a reactor core after a loss-of-core flow. Actuation is based upon either a sudden decrease in core pressure drop or the pressure drop decreases below a predetermined minimum value. The automatic control rod includes a pressure regulating device whereby a controlled decrease in operating pressure due to reduced coolant flow does not cause the rod to drop into the core.

10 CFR 40.5 - Communications.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Communications. 40.5 Section 40.5 Energy NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF SOURCE MATERIAL General Provisions § 40.5 Communications. (a... Administrators. (ii) Health and safety design review of sealed sources and devices and approval, for licensing...

49 CFR 214.509 - Required visual illumination and reflective devices for new on-track roadway maintenance machines.

Code of Federal Regulations, 2010 CFR

2010-10-01

... activated by the application of the machine braking system, and designed to be visible for a distance of 300... TRANSPORTATION RAILROAD WORKPLACE SAFETY On-Track Roadway Maintenance Machines and Hi-Rail Vehicles § 214.509...

Evaluation of advanced high rate Li-SOCl2 cells

NASA Technical Reports Server (NTRS)

Deligiannis, F.; Ang, V.; Dawson, S.; Frank, H.; Subbarao, S.

1986-01-01

Under NASA sponsorship, JPL is developing advanced, high rate Li-SOCl2 cells for future space missions. As part of this effort, Li-SOCl2 cells of various designs were examined for performance and safety. The cells differed from one another in several aspects, such as: nature of carbon cathode, catalysts, cell configuration, case polarity, and safety devices. Performance evaluation included constant-current discharge over a range of currents and temperatures. Abuse-testing consisted of shortcircuiting, charging, and over-discharge. Energy densities greater than 300 Wh/Kg at the C/2 rate were found for some designs. A cell design featuring a high-surface-area carbon cathode was found to deliver nearly 500 Wh/Kg at moderate discharge rates. Temperature influenced the performance significantly.

[Implementation of safety devices: biological accident prevention].

PubMed

Catalán Gómez, M Teresa; Sol Vidiella, Josep; Castellà Castellà, Manel; Castells Bo, Carolina; Losada Pla, Nuria; Espuny, Javier Lluís

2010-04-01

Accidental exposures to blood and biological material were the most frequent and potentially serious accidents in healthcare workers, reported in the Prevention of Occupational Risks Unit within 2002. Evaluate the biological percutaneous accidents decrease after a progressive introduction of safety devices. Biological accidents produced between 2.002 and 2.006 were analyzed and reported by the injured healthcare workers to the Level 2b Hospital Prevention of Occupational Risk Unit with 238 beds and 750 employees. The key of the study was the safety devices (peripheral i.v. catheter, needleless i.v. access device and capillary blood collection lancet). Within 2002, 54 percutaneous biological accidents were registered and 19 in 2006, that represents a 64.8% decreased. There has been no safety devices accident reported involving these material. Accidents registered during the implantation period occurred because safety devices were not used at that time. Safety devices have proven to be effective in reducing needle stick percutaneous accidents, so that they are a good choice in the primary prevention of biological accidents contact.

Preliminary findings on the safety of 1.5 and 3 Tesla magnetic resonance imaging in cardiac pacemaker patients.

PubMed

van Dijk, Vincent F; Delnoy, Peter Paul H M; Smit, Jaap Jan J; Ramdat Misier, R Anand; Elvan, Arif; van Es, H Wouter; Rensing, Benno J W M; Raciti, Giovanni; Boersma, Lucas V A

2017-07-01

Modern pacemakers are designed to allow patients to undergo magnetic resonance imaging (MRI) under a set of specific conditions. Aim of this study is to provide confirmatory evidence of safety and performance of a new pacing system (ImageReady™, Boston Scientific) in patients undergoing 1.5 and 3T MRI. Two prospective, nonrandomized, single-arm studies were designed to provide confirmatory data of no impact of MRI on device function, lead parameters, and patient conditions in subjects implanted with the system undergoing a clinically non-indicated 1.5T and 3T MRI, respectively. Device measurements were done within 1 hour before and after the scan and at 1 month follow-up. Thirty-two subjects underwent MRI visit (17 subjects with 1.5T MRI and 15 subjects with 3T MRI). There were no unanticipated adverse effects related to the pacemaker. Device measurements taken pre- and post-MRI scan did not show any clinical relevant change that could indicate an effect of the MRI on the device or at the lead-tissue interface (RV threshold change: 0.01 ± 0.13 V, P = 0.60; RA threshold change: 0.01 ± 0.11 V, P = 0.53; R wave change: -0.44 ± 1.73 mV, P = 0.36; R wave change: 0.12 ± 1.67 mV, P = 0.73), with data confirmed at 1-month follow-up visit. The study documented safety of the pacing system in the 1.5T and 3T MRI environment by showing no adverse events related to device or MRI scan. Additional data are required to cover the more complex scenarios involving different diagnostic needs, conditions of use, clinical conditions, and new emerging technologies. © 2017 Wiley Periodicals, Inc.

Improving bicycle safety: The role of paediatricians and family physicians

PubMed Central

LeBlanc, John C; Huybers, Sherry

2004-01-01

Cycling is a complex activity requiring motor, sensory and cognitive skills that develop at different rates from childhood to adolescence. While children can successfully ride a two-wheeled bicycle at age five or six, judgment of road hazards are poor at that age and matures slowly until adult-like judgment is reached in early adolescence. Safe cycling depends on the care, skills and judgment of cyclists and motorists; roadway design that promotes safe coexistence of bicycles and motor vehicles; and the use of safety devices, including bicycle helmets, lights and reflective tape. Whereas, research into optimal roadway design and educational programs for drivers to improve road safety has yielded contradictory results, the benefits of bicycle helmet use and programs to enhance their use have been clearly shown. This paper has the following objectives for paediatricians and family physicians: To understand the relationship between bicycle safety and children’s motor and cognitive skills.To understand the effectiveness and limitations of strategies to improve bicycle safety.To describe activities to promote bicycle safety that physicians can undertake in clinical settings and in the community. PMID:19657515

Effects and Satisfaction of Medical Device Safety Information Reporting System Using Electronic Medical Record.

PubMed

Jang, Hye Jung; Choi, Young Deuk; Kim, Nam Hyun

2017-04-01

This paper describes an evaluation study on the effectiveness of developing an in-hospital medical device safety information reporting system for managing safety information, including adverse incident data related to medical devices, following the enactment of the Medical Device Act in Korea. Medical device safety information reports were analyzed for 190 cases that took place prior to the application of a medical device safety information reporting system and during a period when the reporting system was used. Also, questionnaires were used to measure the effectiveness of the medical device safety information reporting system. The analysis was based on the questionnaire responses of 15 reporters who submitted reports in both the pre- and post-reporting system periods. Sixty-two reports were submitted in paper form, but after the system was set up, this number more than doubled to 128 reports in electronic form. In terms of itemized reporting, a total of 45 items were reported. Before the system was used, 23 items had been reported, but this increased to 32 items after the system was put to use. All survey variables of satisfaction received a mean of over 3 points, while positive attitude , potential benefits , and positive benefits all exceeded 4 points, each receiving 4.20, 4.20, and 4.13, respectively. Among the variables, time-consuming and decision-making had the lowest mean values, each receiving 3.53. Satisfaction was found to be high for system quality and user satisfaction , but relatively low for time-consuming and decision-making . We were able to verify that effective reporting and monitoring of adverse incidents and the safety of medical devices can be implemented through the establishment of an in-hospital medical device safety information reporting system that can enhance patient safety and medical device risk management.

Technology and active agency of older adults living in service house environment.

PubMed

Sallinen, Merja; Hentonen, Outi; Kärki, Anne

2015-01-01

The purpose of the study was to explore whether or not the assistive and safety technology that is currently used in service house environment supports the active agency of the elderly residents. Twelve purposively chosen elderly residents were interviewed. The data were analyzed by theory-driven content analysis using the modalities of the agency-model as a theoretical frame. The technological devices and systems partially support the active agency of the residents. Deterioration of their functioning seems to limit the use of devices as well as complicate their learning on how to use these systems. The respondents had only few insights of the possibilities that this technology could offer to them in their daily life and they were not expecting their functioning to improve in the future. The homeliness and intimacy of the environment was highly appreciated. Although the attitude towards technology was, in general, reserved, technology was seen as one possibility to support active agency. The current technologies seem to be designed from the needs of the organization and not from the needs of the residents. In the future, more emphasis needs to be put on designing individualized devices in cooperation with the users. Implications for Rehabilitation To support independence, autonomy and active agency of the older adults, the technological solutions must be based on perceived needs of the individual and the design should be adaptable to the functional limitations one has. Nursing staff's knowledge about assistive devices and technologies need to be updated on regular bases in order to be able to recommend appropriate devices for the elderly. Taking into account the fact that many older adults have mild to moderate memory problems as well as difficulties with vision and hearing, more attention needs to be paid to didactics, i.e. how the introduction and guidance of the use of new technologies, assistive devices or safety systems is best done with them.

Influence of Steering Control Devices Mounted in Cars for the Disabled on Passive Safety

NASA Astrophysics Data System (ADS)

Masiá, J.; Eixerés, B.; Dols, J. F.; Colomina, F. J.

2009-11-01

The purpose of this research is to analyze the influence of steering control devices for disabled people on passive safety. It is based on the advances made in the modelling and simulation of the driver position and in the suit verification test. The influence of these devices is studied through airbag deployment and/or its influence on driver safety. We characterize the different adaptations that are used in adapted cars that can be found mounted in vehicles in order to generating models that are verified by experimental test. A three dimensional design software package was used to develop the model. The simulations were generated using a dynamic simulation program employing LSDYNA finite elements. This program plots the geometry and assigns materials. The airbag is shaped, meshed and folded just as it is mounted in current vehicles. The thermodynamic model of expansion of gases is assigned and the contact interfaces are defined. Static tests were carried out on deployment of the airbag to contrast with and to validate the computational models and to measure the behaviour of the airbag when there are steering adaptations mounted in the vehicle.

Design and Optimization of a Hybrid-Driven Waist Rehabilitation Robot

PubMed Central

Zi, Bin; Yin, Guangcai; Zhang, Dan

2016-01-01

In this paper a waist rehabilitation robot driven by cables and pneumatic artificial muscles (PAMs) has been conceptualized and designed. In the process of mechanism design, the human body structure, the waist movement characteristics, and the actuators’ driving characteristics are the main considerable factors to make the hybrid-driven waist rehabilitation robot (HWRR) cost-effective, safe, flexible, and well-adapted. A variety of sensors are chosen to measure the position and orientation of the recovery patient to ensure patient safety at the same time as the structure design. According to the structure specialty and function, the HWRR is divided into two independent parallel robots: the waist twist device and the lower limb traction device. Then these two devices are analyzed and evaluated, respectively. Considering the characters of the human body in the HWRR, the inverse kinematics and statics are studied when the waist and the lower limb are considered as a spring and link, respectively. Based on the inverse kinematics and statics, the effect of the contraction parameter of the PAM is considered in the optimization of the waist twist device, and the lower limb traction device is optimized using particle swarm optimization (PSO) to minimize the global conditioning number over the feasible workspace. As a result of the optimization, an optimal rehabilitation robot design is obtained and the condition number of the Jacobian matrix over the feasible workspace is also calculated. PMID:27983626

Design and Optimization of a Hybrid-Driven Waist Rehabilitation Robot.

PubMed

Zi, Bin; Yin, Guangcai; Zhang, Dan

2016-12-14

In this paper a waist rehabilitation robot driven by cables and pneumatic artificial muscles (PAMs) has been conceptualized and designed. In the process of mechanism design, the human body structure, the waist movement characteristics, and the actuators' driving characteristics are the main considerable factors to make the hybrid-driven waist rehabilitation robot (HWRR) cost-effective, safe, flexible, and well-adapted. A variety of sensors are chosen to measure the position and orientation of the recovery patient to ensure patient safety at the same time as the structure design. According to the structure specialty and function, the HWRR is divided into two independent parallel robots: the waist twist device and the lower limb traction device. Then these two devices are analyzed and evaluated, respectively. Considering the characters of the human body in the HWRR, the inverse kinematics and statics are studied when the waist and the lower limb are considered as a spring and link, respectively. Based on the inverse kinematics and statics, the effect of the contraction parameter of the PAM is considered in the optimization of the waist twist device, and the lower limb traction device is optimized using particle swarm optimization (PSO) to minimize the global conditioning number over the feasible workspace. As a result of the optimization, an optimal rehabilitation robot design is obtained and the condition number of the Jacobian matrix over the feasible workspace is also calculated.

FY2017 Updates to the SAS4A/SASSYS-1 Safety Analysis Code

DOE Office of Scientific and Technical Information (OSTI.GOV)

Fanning, T. H.

The SAS4A/SASSYS-1 safety analysis software is used to perform deterministic analysis of anticipated events as well as design-basis and beyond-design-basis accidents for advanced fast reactors. It plays a central role in the analysis of U.S. DOE conceptual designs, proposed test and demonstration reactors, and in domestic and international collaborations. This report summarizes the code development activities that have taken place during FY2017. Extensions to the void and cladding reactivity feedback models have been implemented, and Control System capabilities have been improved through a new virtual data acquisition system for plant state variables and an additional Block Signal for a variablemore » lag compensator to represent reactivity feedback for novel shutdown devices. Current code development and maintenance needs are also summarized in three key areas: software quality assurance, modeling improvements, and maintenance of related tools. With ongoing support, SAS4A/SASSYS-1 can continue to fulfill its growing role in fast reactor safety analysis and help solidify DOE’s leadership role in fast reactor safety both domestically and in international collaborations.« less

Design of integrated laser initiator

NASA Astrophysics Data System (ADS)

Cao, Chunqiang; He, Aifeng; Jing, Bo; Ma, Yue

2018-03-01

This paper analyzes the design principle of integrated laser detonator, introduces the design method of integrated laser Detonators. Based on the integrated laser detonator, structure, laser energy -exchange device, circuit design and the energetic material properties and the charge parameters, developed a high level of integration Antistatic ability Small size of the integrated laser prototype Detonator. The laser detonator prototype antistatic ability of 25 kV. The research of this paper can solve the key design of laser detonator miniaturization and integration of weapons and equipment, satisfy the electromagnetic safety and micro weapons development of explosive demand.

46 CFR 151.50-30 - Compressed gases.

Code of Federal Regulations, 2011 CFR

2011-10-01

... BULK LIQUID HAZARDOUS MATERIAL CARGOES Special Requirements § 151.50-30 Compressed gases. (a) All tank inlet and outlet connections, except safety relief valves, liquid level gauging devices, and pressure gauges shall be marked to designate whether they terminate in the vapor or liquid space. Labels, when...

46 CFR 151.50-30 - Compressed gases.

Code of Federal Regulations, 2014 CFR

2014-10-01

... BULK LIQUID HAZARDOUS MATERIAL CARGOES Special Requirements § 151.50-30 Compressed gases. (a) All tank inlet and outlet connections, except safety relief valves, liquid level gauging devices, and pressure gauges shall be marked to designate whether they terminate in the vapor or liquid space. Labels, when...

46 CFR 151.50-30 - Compressed gases.

Code of Federal Regulations, 2012 CFR

2012-10-01

... BULK LIQUID HAZARDOUS MATERIAL CARGOES Special Requirements § 151.50-30 Compressed gases. (a) All tank inlet and outlet connections, except safety relief valves, liquid level gauging devices, and pressure gauges shall be marked to designate whether they terminate in the vapor or liquid space. Labels, when...

46 CFR 151.50-30 - Compressed gases.

Code of Federal Regulations, 2013 CFR

2013-10-01

... BULK LIQUID HAZARDOUS MATERIAL CARGOES Special Requirements § 151.50-30 Compressed gases. (a) All tank inlet and outlet connections, except safety relief valves, liquid level gauging devices, and pressure gauges shall be marked to designate whether they terminate in the vapor or liquid space. Labels, when...

46 CFR 151.50-30 - Compressed gases.

Code of Federal Regulations, 2010 CFR

2010-10-01

... BULK LIQUID HAZARDOUS MATERIAL CARGOES Special Requirements § 151.50-30 Compressed gases. (a) All tank inlet and outlet connections, except safety relief valves, liquid level gauging devices, and pressure gauges shall be marked to designate whether they terminate in the vapor or liquid space. Labels, when...

10 CFR 830.3 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 4 2013-01-01 2013-01-01 false Definitions. 830.3 Section 830.3 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT § 830.3 Definitions. (a) The following definitions apply to this part.... Critical assembly means special nuclear devices designed and used to sustain nuclear reactions, which may...

Radiology Technician (AFSC 90370).

ERIC Educational Resources Information Center

Sobczak, James

This five-volume student text is designed for use by Air Force personnel enrolled in a self-study extension course for radiology technicians. Covered in the individual volumes are radiographic fundamentals (x-ray production; primary beams; exposure devices; film, film holders, and darkrooms; control of film quality; and environmental safety);…

Analysis of roadside safety devices for use on very high-speed roadways.

DOT National Transportation Integrated Search

2009-09-01

The Texas Department of Transportation (TxDOT) is embarking on a multi-decade effort to expand : the states transportation system. TxDOT has expressed an interest in using very high design speeds (above : 80 mph) for some of these facilities to pr...

Evaluation of a new pediatric intraosseous needle insertion device for low-resource settings.

PubMed

Kalechstein, Sara; Permual, Ahiliyia; Cameron, Blair M; Pemberton, Julia; Hollaar, Gwen; Duffy, Deirdre; Cameron, Brian H

2012-05-01

The Near Needle Holder (NNH) (Near Manufacturing, Camrose, Alberta, Canada) is a reusable tool to introduce a standard hollow needle for pediatric intraosseous (IO) infusion. We compared the NNH to the Cook Dieckmann (Cook Critical Care, Bloomington, IN) manual IO needle in a simulation setting. Study subjects were 32 physicians, nurses, and medical students participating in a trauma course in Guyana. After watching a training video and practicing under supervision, subjects were observed inserting each device into a pediatric leg model using a randomized crossover design. Outcome measures were time to successful insertion, technical complications, ease of use, and safety of each device. The mean time for IO insertion (32 ± 13 seconds) was similar for both devices (P = .92). Subjects rated the NNH device equivalent in ease of use to the Cook IO needle but slightly lower in perceived safety to the user. After training, all subjects successfully inserted the NNH IO device in a simulation environment, and most rated it as easy to use and safe. The NNH is a significant advance because IO needles are often not available in emergency departments in developing countries. Further studies are needed to evaluate clinical effectiveness of the NNH. Copyright © 2012 Elsevier Inc. All rights reserved.

PARTICIPATORY DESIGN OF PEDIATRIC UPPER LIMB PROSTHESES: QUALITATIVE METHODS AND PROTOTYPING.

PubMed

Sims, Tara; Cranny, Andy; Metcalf, Cheryl; Chappell, Paul; Donovan-Hall, Maggie

2017-01-01

The study aims to develop an understanding of the views of children and adolescents, parents, and professionals on upper limb prosthetic devices to develop and improve device design. Previous research has found that children are dissatisfied with prostheses but has relied heavily on parent proxy reports and quantitative measures (such as questionnaires) to explore their views. Thirty-four participants (eight children aged 8-15 years with upper limb difference, nine parents, eight prosthetists, and nine occupational therapists) contributed to the development of new devices through the BRIDGE methodology of participatory design, using focus groups and interviews. The study identified areas for improving prostheses from the perspective of children and adolescents, developed prototypes based on these and gained feedback on the prototypes from the children and other stakeholders (parents and professionals) of paediatric upper limb prostheses. Future device development needs to focus on ease of use, versatility, appearance, and safety. This study has demonstrated that children and adolescents can and should be involved as equal partners in the development of daily living equipment and that rapid prototyping (three-dimensional printing or additive manufacturing), used within a participatory design framework, can be a useful tool for facilitating this.

Printable Fabrication of Nanocoral-Structured Electrodes for High-Performance Flexible and Planar Supercapacitor with Artistic Design.

PubMed

Lin, Yuanjing; Gao, Yuan; Fan, Zhiyong

2017-11-01

Planar supercapacitors with high flexibility, desirable operation safety, and high performance are considered as attractive candidates to serve as energy-storage devices for portable and wearable electronics. Here, a scalable and printable technique is adopted to construct novel and unique hierarchical nanocoral structures as the interdigitated electrodes on flexible substrates. The as-fabricated flexible all-solid-state planar supercapacitors with nanocoral structures achieve areal capacitance up to 52.9 mF cm -2 , which is 2.5 times that of devices without nanocoral structures, and this figure-of-merit is among the highest in the literature for the same category of devices. More interestingly, due to utilization of the inkjet-printing technique, excellent versatility on electrode-pattern artistic design is achieved. Particularly, working supercapacitors with artistically designed patterns are demonstrated. Meanwhile, the high scalability of such a printable method is also demonstrated by fabrication of large-sized artistic supercapacitors serving as energy-storage devices in a wearable self-powered system as a proof of concept. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

30 CFR 77.808 - Disconnecting devices.

Code of Federal Regulations, 2010 CFR

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...

Characterization of Commercial Li-ion Cells in Pouch Format

NASA Technical Reports Server (NTRS)

Jeevarajan, Judith

2014-01-01

The li-ion pouch design cells exhibit similar behavior under off-nominal conditions as those in metal cans that do not have the internal safety devices. Safety should be well characterized before batteries are designed. Some of the li-ion pouch cell designs studied in this program reacted most violently to overcharge conditions at the medium rates but were tolerant to overcharge at very low rates. Some pouch cell designs have higher tolerance to vacuum exposures than some others. A comparison of the pouch material itself does not show a correlation between this tolerance and the number of layers or composition of the pouch indicating that this is a property of the electrode stack design inside the pouch. Reduced pressure (8 to 10 psi) test environments show that the extent of capacity degradation under reduced pressure environments is much less than that observed under vacuum conditions. Lithium-ion Pouch format cells are not necessarily true polymer cells.

Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure: Rationale and Design of the Randomized Trial to REDUCE Elevated Left Atrial Pressure in Heart Failure (REDUCE LAP-HF I).

PubMed

Feldman, Ted; Komtebedde, Jan; Burkhoff, Daniel; Massaro, Joseph; Maurer, Mathew S; Leon, Martin B; Kaye, David; Silvestry, Frank E; Cleland, John G F; Kitzman, Dalane; Kubo, Spencer H; Van Veldhuisen, Dirk J; Kleber, Franz; Trochu, Jean-Noël; Auricchio, Angelo; Gustafsson, Finn; Hasenfuβ, Gerd; Ponikowski, Piotr; Filippatos, Gerasimos; Mauri, Laura; Shah, Sanjiv J

2016-07-01

Heart failure with preserved ejection fraction (HFpEF), a major public health problem with high morbidity and mortality rates, remains difficult to manage because of a lack of effective treatment options. Although HFpEF is a heterogeneous clinical syndrome, elevated left atrial pressure-either at rest or with exertion-is a common factor among all forms of HFpEF and one of the primary reasons for dyspnea and exercise intolerance in these patients. On the basis of clinical experience with congenital interatrial shunts in mitral stenosis, it has been hypothesized that the creation of a left-to-right interatrial shunt to decompress the left atrium (without compromising left ventricular filling or forward cardiac output) is a rational, nonpharmacological strategy for alleviating symptoms in patients with HFpEF. A novel transcatheter interatrial shunt device has been developed and evaluated in patients with HFpEF in single-arm, nonblinded clinical trials. These studies have demonstrated the safety and potential efficacy of the device. However, a randomized, placebo-controlled evaluation of the device is required to further evaluate its safety and efficacy in patients with HFpEF. In this article, we give the rationale for a therapeutic transcatheter interatrial shunt device in HFpEF, and we describe the design of REDUCE Elevated Left Atrial Pressure in Heart Failure (REDUCE LAP-HF I), the first randomized controlled trial of a device-based therapy to reduce left atrial pressure in HFpEF. URL: http://www.clinicaltrials.gov. Unique identifier: NCT02600234. © 2016 American Heart Association, Inc.

Study of Damped Set-Back Pins for S and A Mechanisms.

DTIC Science & Technology

1976-11-01

arm device for artillery munitions. This damped set-back pin assembly is one of two safety features on a S and A device used in the M739 PD/XM587 ET...The damped set-back pin study program was for the design, testing, fabrication, and delivery and damped set-back pin assemblies for use in a safe and...fuzes for a rotating projectile. A pin, porous disc, return spring, floating O-ring, and sleeve comprise the selected damped set-back pin assembly

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

PubMed

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").

Implementing AORN recommended practices for MIS: Part II.

PubMed

Morton, Paula J

2012-10-01

This article focuses on the equipment and workplace safety aspects of the revised AORN "Recommended practices for minimally invasive surgery." A multidisciplinary team that includes the perioperative nurse should be established to discuss aspects of the development and design of new construction or renovation (eg, room access, ergonomics, low-lighting, OR integration, hybrid OR considerations, design development). Equipment safety considerations during minimally invasive surgical procedures include using active electrode monitoring; verifying the properties of distention media; using smoke evacuation systems; reducing equipment, electrical, thermal, and fire hazards; performing routine safety checks on insufflation accessories; and minimizing the risk of ergonomic injuries to staff members. Additional considerations include using video recording devices, nonmagnetic equipment during magnetic resonance imaging, and fluid containment methods for fluid management. Copyright © 2012 AORN, Inc. Published by Elsevier Inc. All rights reserved.

Design and testing of a self-actuated shut down system for the protection of liquid metal fast breeder reactors (LMFBRs)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Josephson, J.; Sowa, E.S.

1977-04-01

The design and testing of a simple and reliable Self-Actuated Shutdown System (SASS) for the protection of Liquid Metal Fast Breeder Reactors (LMFBRs) is described. A ferromagnetic Curie temperature permanent magnet holding device has been selected for the design of the Self-Actuated Shutdown System in order to enhance the safety of liquid metal cooled fast reactors (LMFBRs). The self-actuated, self-contained device operates such that accident conditions, resulting in increased coolant temperature or neutron flux reduce the magnetic holding force suspending a neutron absorber above the core by raising the temperature of the trigger mechanism above the Curie point. Neutron absorbermore » material is then inserted into the core, under gravity, terminating the accident. Two possible design variations of the selected concept are presented.« less

Agricultural Machinery - Equipment. Agricultural Cooperative Training. Vocational Agricluture. Revised.

ERIC Educational Resources Information Center

Sandlin, David, Comp.; And Others

Designed for students enrolled in the Agricultural Cooperative Part-Time Training Program, this course of study contains 12 units on agricultural machinery mechanics. Units include (examples of unit topics in parentheses): introduction (agricultural mechanics as an occupation; safety--shop and equipment; use of holding devices, jacks, lifts, and…

30 CFR 75.1107-12 - Inerting of mine atmosphere prohibited.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Inerting of mine atmosphere prohibited. 75.1107-12 Section 75.1107-12 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... atmosphere prohibited. No fire suppression device designed to control fire by total flooding shall be...

30 CFR 75.1107-12 - Inerting of mine atmosphere prohibited.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Inerting of mine atmosphere prohibited. 75.1107-12 Section 75.1107-12 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... atmosphere prohibited. No fire suppression device designed to control fire by total flooding shall be...

30 CFR 75.1107-12 - Inerting of mine atmosphere prohibited.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Inerting of mine atmosphere prohibited. 75.1107-12 Section 75.1107-12 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... atmosphere prohibited. No fire suppression device designed to control fire by total flooding shall be...

30 CFR 75.1107-12 - Inerting of mine atmosphere prohibited.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Inerting of mine atmosphere prohibited. 75.1107-12 Section 75.1107-12 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... atmosphere prohibited. No fire suppression device designed to control fire by total flooding shall be...

30 CFR 75.1107-12 - Inerting of mine atmosphere prohibited.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Inerting of mine atmosphere prohibited. 75.1107-12 Section 75.1107-12 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... atmosphere prohibited. No fire suppression device designed to control fire by total flooding shall be...

Battery Safety Basics

ERIC Educational Resources Information Center

Roy, Ken

2010-01-01

Batteries commonly used in flashlights and other household devices produce hydrogen gas as a product of zinc electrode corrosion. The amount of gas produced is affected by the batteries' design and charge rate. Dangerous levels of hydrogen gas can be released if battery types are mixed, batteries are damaged, batteries are of different ages, or…

42 CFR 84.1142 - Isoamyl acetate tightness test; respirators designed for respiratory protection against dusts...

Code of Federal Regulations, 2013 CFR

2013-10-01

....1142 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Dust, Fume, and... 42 Public Health 1 2013-10-01 2013-10-01 false Isoamyl acetate tightness test; respirators...

42 CFR 84.1142 - Isoamyl acetate tightness test; respirators designed for respiratory protection against dusts...

Code of Federal Regulations, 2012 CFR

2012-10-01

....1142 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Dust, Fume, and... 42 Public Health 1 2012-10-01 2012-10-01 false Isoamyl acetate tightness test; respirators...

42 CFR 84.1142 - Isoamyl acetate tightness test; respirators designed for respiratory protection against dusts...

Code of Federal Regulations, 2011 CFR

2011-10-01

....1142 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Dust, Fume, and... 42 Public Health 1 2011-10-01 2011-10-01 false Isoamyl acetate tightness test; respirators...

42 CFR 84.1142 - Isoamyl acetate tightness test; respirators designed for respiratory protection against dusts...

Code of Federal Regulations, 2014 CFR

2014-10-01

....1142 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Dust, Fume, and... 42 Public Health 1 2014-10-01 2014-10-01 false Isoamyl acetate tightness test; respirators...

42 CFR 84.1142 - Isoamyl acetate tightness test; respirators designed for respiratory protection against dusts...

Code of Federal Regulations, 2010 CFR

2010-10-01

....1142 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Dust, Fume, and... 42 Public Health 1 2010-10-01 2010-10-01 false Isoamyl acetate tightness test; respirators...

Recommendations for yield-to-bus traffic control devices and bus pullout bays design characteristics : [research summary].

DOT National Transportation Integrated Search

2013-04-01

Bus pullout bays are being installed increasingly : on Floridas roads as a safety factor and so that : stopped buses do not impede traffic. In Florida, : state law requires car drivers to yield to buses : when a bus needs to reenter the roadway af...

Optical spectroscopy for food and beverages control

NASA Astrophysics Data System (ADS)

Mignani, Anna Grazia; Ciaccheri, Leonardo; Mencaglia, Andrea Azelio

2011-08-01

A selection of spectroscopy-based, fiber optic and micro-optic devices is presented. They have been designed and tested for monitoring the quality and safety of typical foodstuffs. The VIS-NIR spectra, considered as product fingerprints, allowed to discriminating the geographic region of production and to detecting nutritional and nutraceutic indicators.

30 CFR 57.6502 - Safety fuse.

Code of Federal Regulations, 2011 CFR

2011-07-01

... least the minimum burning time for a particular size round, as specified in the following table: Table E... blasthole detonates. (d) Fuse shall be cut and capped in dry locations. (e) Blasting caps shall be crimped... with devices designed for that purpose. Carbide lights, liquefied petroleum gas torches, and cigarette...

30 CFR 57.6502 - Safety fuse.

Code of Federal Regulations, 2014 CFR

2014-07-01

... least the minimum burning time for a particular size round, as specified in the following table: Table E... blasthole detonates. (d) Fuse shall be cut and capped in dry locations. (e) Blasting caps shall be crimped... with devices designed for that purpose. Carbide lights, liquefied petroleum gas torches, and cigarette...

30 CFR 57.6502 - Safety fuse.

Code of Federal Regulations, 2013 CFR

2013-07-01

... least the minimum burning time for a particular size round, as specified in the following table: Table E... blasthole detonates. (d) Fuse shall be cut and capped in dry locations. (e) Blasting caps shall be crimped... with devices designed for that purpose. Carbide lights, liquefied petroleum gas torches, and cigarette...

30 CFR 57.6502 - Safety fuse.

Code of Federal Regulations, 2012 CFR

2012-07-01

... least the minimum burning time for a particular size round, as specified in the following table: Table E... blasthole detonates. (d) Fuse shall be cut and capped in dry locations. (e) Blasting caps shall be crimped... with devices designed for that purpose. Carbide lights, liquefied petroleum gas torches, and cigarette...

System principles, mathematical models and methods to ensure high reliability of safety systems

NASA Astrophysics Data System (ADS)

Zaslavskyi, V.

2017-04-01

Modern safety and security systems are composed of a large number of various components designed for detection, localization, tracking, collecting, and processing of information from the systems of monitoring, telemetry, control, etc. They are required to be highly reliable in a view to correctly perform data aggregation, processing and analysis for subsequent decision making support. On design and construction phases of the manufacturing of such systems a various types of components (elements, devices, and subsystems) are considered and used to ensure high reliability of signals detection, noise isolation, and erroneous commands reduction. When generating design solutions for highly reliable systems a number of restrictions and conditions such as types of components and various constrains on resources should be considered. Various types of components perform identical functions; however, they are implemented using diverse principles, approaches and have distinct technical and economic indicators such as cost or power consumption. The systematic use of different component types increases the probability of tasks performing and eliminates the common cause failure. We consider type-variety principle as an engineering principle of system analysis, mathematical models based on this principle, and algorithms for solving optimization problems of highly reliable safety and security systems design. Mathematical models are formalized in a class of two-level discrete optimization problems of large dimension. The proposed approach, mathematical models, algorithms can be used for problem solving of optimal redundancy on the basis of a variety of methods and control devices for fault and defects detection in technical systems, telecommunication networks, and energy systems.

SOLITAIRE™ with the intention for thrombectomy (SWIFT) trial: design of a randomized, controlled, multicenter study comparing the SOLITAIRE™ Flow Restoration device and the MERCI Retriever in acute ischaemic stroke.

PubMed

Saver, J L; Jahan, R; Levy, E I; Jovin, T G; Baxter, B; Nogueira, R; Clark, W; Budzik, R; Zaidat, O O

2014-07-01

Self-expanding stent retrievers are a promising new device class designed for rapid flow restoration in acute cerebral ischaemia. The SOLITAIRE™ Flow Restoration device (SOLITAIRE) has shown high rates of recanalization in preclinical models and in uncontrolled clinical series. (1) To demonstrate non-inferiority of SOLITAIRE compared with a legally marketed device, the MERCI Retrieval System®; (2) To demonstrate safety, feasibility, and efficacy of SOLITAIRE in subjects requiring mechanical thrombectomy diagnosed with acute ischaemic stroke. DESIGN : Multicenter, randomized, prospective, controlled trial with blinded primary end-point ascertainment. Key entry criteria include: age 22-85; National Institute of Health Stroke Scale (NIHSS) ≥8 and <30; clinical and imaging findings consistent with acute ischaemic stroke; patient ineligible or failed intravenous tissue plasminogen activator; accessible occlusion in M1 or M2 middle cerebral artery, internal carotid artery, basilar artery, or vertebral artery; and patient able to be treated within 8 h of onset. Sites first participate in a roll-in phase, treating two patients with the SOLITAIRE device, before proceeding to the randomized phase. In patients unresponsive to the initially assigned therapy, after the angiographic component of the primary end-point is ascertained (reperfusion with the initial assigned device), rescue therapy with other reperfusion techniques is permitted. The primary efficacy end-point is successful recanalization with the assigned study device (no use of rescue therapy) and with no symptomatic intracranial haemorrhage. Successful recanalization is defined as achieving Thrombolysis In Myocardial Ischemia 2 or 3 flow in all treatable vessels. The primary safety end-point is the incidence of device-related and procedure-related serious adverse events. A major secondary efficacy end-point is time to achieve initial recanalization. Additional secondary end-points include clinical outcomes at 90 days and radiologic haemorrhagic transformation. © 2012 The Authors. International Journal of Stroke © 2012 World Stroke Organization.

Design, Fabrication, and In Vitro Testing of an Anti-biofouling Glaucoma Micro-shunt.

PubMed

Harake, Ryan S; Ding, Yuzhe; Brown, J David; Pan, Tingrui

2015-10-01

Glaucoma, one of the leading causes of irreversible blindness, is a progressive neurodegenerative disease. Chronic elevated intraocular pressure (IOP), a prime risk factor for glaucoma, can be treated by aqueous shunts, implantable devices, which reduce IOP in glaucoma patients by providing alternative aqueous outflow pathways. Although initially effective at delaying glaucoma progression, contemporary aqueous shunts often lead to numerous complications and only 50% of implanted devices remain functional after 5 years. In this work, we introduce a novel micro-device which provides an innovative platform for IOP reduction in glaucoma patients. The device design features an array of parallel micro-channels to provide precision aqueous outflow resistance control. Additionally, the device's microfluidic channels are composed of a unique combination of polyethylene glycol materials in order to provide enhanced biocompatibility and resistance to problematic channel clogging from biofouling of aqueous proteins. The microfabrication process employed to produce the devices results in additional advantages such as enhanced device uniformity and increased manufacturing throughput. Surface characterization experimental results show the device's surfaces exhibit significantly less non-specific protein adsorption compared to traditional implant materials. Results of in vitro flow experiments verify the device's ability to provide aqueous resistance control, continuous long-term stability through 10-day protein flow testing, and safety from risk of infection due to bacterial ingression.

Flight Simulator Evaluation of Display Media Devices for Synthetic Vision Concepts

NASA Technical Reports Server (NTRS)

Arthur, J. J., III; Williams, Steven P.; Prinzel, Lawrence J., III; Kramer, Lynda J.; Bailey, Randall E.

2004-01-01

The Synthetic Vision Systems (SVS) Project of the National Aeronautics and Space Administration's (NASA) Aviation Safety Program (AvSP) is striving to eliminate poor visibility as a causal factor in aircraft accidents as well as enhance operational capabilities of all aircraft. To accomplish these safety and capacity improvements, the SVS concept is designed to provide a clear view of the world around the aircraft through the display of computer-generated imagery derived from an onboard database of terrain, obstacle, and airport information. Display media devices with which to implement SVS technology that have been evaluated so far within the Project include fixed field of view head up displays and head down Primary Flight Displays with pilot-selectable field of view. A simulation experiment was conducted comparing these display devices to a fixed field of view, unlimited field of regard, full color Helmet-Mounted Display system. Subject pilots flew a visual circling maneuver in IMC at a terrain-challenged airport. The data collected for this experiment is compared to past SVS research studies.

76 FR 69321 - Petition to Modify an Exemption of a Previously Approved Antitheft Device; Porsche

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-08

... DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration Petition to Modify an Exemption of a Previously Approved Antitheft Device; Porsche AGENCY: National Highway Traffic Safety... previously approved antitheft device. SUMMARY: On May 25, 1989, the National Highway Traffic Safety...

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

PubMed Central

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

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

PubMed

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

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.

Travel health: a survey of life jacket designs currently in use on commercial aircraft.

PubMed

Bauer, Irmgard L

2002-01-01

Although any travel harbors potential health problems, travel across water poses the additional risk of involuntary contact with water in the event of an emergency. Studies suggest that fatal boat-related accidents have occurred due to the passengers' inability to don their life jackets. With the dramatic increase of long-haul flights, it was decided to investigate if potential safety hazards can be identified leading to similar problems in relation to the life jackets provided onboard aircraft. It was assumed that the variety of designs combined with a possible lack of attention paid to safety instructions could represent such a problem. Safety instruction cards in passengers' seat pockets usually depict the life jacket model used on a particular aircraft. Ninety-eight such safety cards from 53 airlines were analyzed and categorized to identify the range and variety of designs currently in use. Twelve different categories of life jacket models could be distinguished with some airlines using more than one model. It was also found that not all cards show a clear depiction of the models used, the cards of two airlines show two different designs on the same cards, and two other companies chose to change the model halfway through the pictured donning procedure. There is a wide variety of life jacket designs in use with the safety cards not always giving accurate instructions. This variety also has implications for the safety demonstration at the beginning of a flight. Further research is recommended into a range of topics, one being the quality and content of these instructions, and also into other personal floating devices provided for the safety of travelers in the event of an emergency over water.

77 FR 35747 - Highway Safety Programs; Conforming Products List of Evidential Breath Alcohol Measurement Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-14

...-0061] Highway Safety Programs; Conforming Products List of Evidential Breath Alcohol Measurement... Evidential Breath Alcohol Measurement Devices dated, September 17, 1993 (58 FR 48705). DATES: Effective Date... Safety Administration (NHTSA) published the Standards for Devices to Measure Breath Alcohol (38 FR 30459...

14 CFR 29.1413 - Safety belts: passenger warning device.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 1 2013-01-01 2013-01-01 false Safety belts: passenger warning device. 29.1413 Section 29.1413 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF....1413 Safety belts: passenger warning device. (a) If there are means to indicate to the passengers when...

18 CFR 12.42 - Warning and safety devices.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 18 Conservation of Power and Water Resources 1 2012-04-01 2012-04-01 false Warning and safety devices. 12.42 Section 12.42 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... PROJECT WORKS Other Responsibilities of Applicant or Licensee § 12.42 Warning and safety devices. To the...

14 CFR 29.1413 - Safety belts: passenger warning device.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 1 2012-01-01 2012-01-01 false Safety belts: passenger warning device. 29.1413 Section 29.1413 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF....1413 Safety belts: passenger warning device. (a) If there are means to indicate to the passengers when...

14 CFR 29.1413 - Safety belts: passenger warning device.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Safety belts: passenger warning device. 29.1413 Section 29.1413 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF....1413 Safety belts: passenger warning device. (a) If there are means to indicate to the passengers when...

18 CFR 12.42 - Warning and safety devices.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 18 Conservation of Power and Water Resources 1 2013-04-01 2013-04-01 false Warning and safety devices. 12.42 Section 12.42 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... PROJECT WORKS Other Responsibilities of Applicant or Licensee § 12.42 Warning and safety devices. To the...

18 CFR 12.42 - Warning and safety devices.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Warning and safety devices. 12.42 Section 12.42 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... PROJECT WORKS Other Responsibilities of Applicant or Licensee § 12.42 Warning and safety devices. To the...

14 CFR 29.1413 - Safety belts: passenger warning device.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Safety belts: passenger warning device. 29.1413 Section 29.1413 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF....1413 Safety belts: passenger warning device. (a) If there are means to indicate to the passengers when...

14 CFR 29.1413 - Safety belts: passenger warning device.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 1 2014-01-01 2014-01-01 false Safety belts: passenger warning device. 29.1413 Section 29.1413 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF....1413 Safety belts: passenger warning device. (a) If there are means to indicate to the passengers when...

18 CFR 12.42 - Warning and safety devices.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 18 Conservation of Power and Water Resources 1 2014-04-01 2014-04-01 false Warning and safety devices. 12.42 Section 12.42 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... PROJECT WORKS Other Responsibilities of Applicant or Licensee § 12.42 Warning and safety devices. To the...

18 CFR 12.42 - Warning and safety devices.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 18 Conservation of Power and Water Resources 1 2011-04-01 2011-04-01 false Warning and safety devices. 12.42 Section 12.42 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... PROJECT WORKS Other Responsibilities of Applicant or Licensee § 12.42 Warning and safety devices. To the...

33 CFR 159.127 - Safety coliform count: Recirculating devices.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Safety coliform count....127 Safety coliform count: Recirculating devices. Thirty-eight of forty samples of flush fluid from a recirculating device must have less than 240 fecal coliform bacteria per 100 milliliters. These samples must be...

10 CFR 32.31 - Certain industrial devices containing byproduct material: Safety criteria.

Code of Federal Regulations, 2014 CFR

2014-01-01

... Certain industrial devices containing byproduct material: Safety criteria. (a) An applicant for a license... 10 Energy 1 2014-01-01 2014-01-01 false Certain industrial devices containing byproduct material: Safety criteria. 32.31 Section 32.31 Energy NUCLEAR REGULATORY COMMISSION SPECIFIC DOMESTIC LICENSES TO...

10 CFR 32.31 - Certain industrial devices containing byproduct material: Safety criteria.

Code of Federal Regulations, 2013 CFR

2013-01-01

... Certain industrial devices containing byproduct material: Safety criteria. (a) An applicant for a license... 10 Energy 1 2013-01-01 2013-01-01 false Certain industrial devices containing byproduct material: Safety criteria. 32.31 Section 32.31 Energy NUCLEAR REGULATORY COMMISSION SPECIFIC DOMESTIC LICENSES TO...

Ultimately Reliable Pyrotechnic Systems

NASA Technical Reports Server (NTRS)

Scott, John H.; Hinkel, Todd

2015-01-01

This paper presents the methods by which NASA has designed, built, tested, and certified pyrotechnic devices for high reliability operation in extreme environments and illustrates the potential applications in the oil and gas industry. NASA's extremely successful application of pyrotechnics is built upon documented procedures and test methods that have been maintained and developed since the Apollo Program. Standards are managed and rigorously enforced for performance margins, redundancy, lot sampling, and personnel safety. The pyrotechnics utilized in spacecraft include such devices as small initiators and detonators with the power of a shotgun shell, detonating cord systems for explosive energy transfer across many feet, precision linear shaped charges for breaking structural membranes, and booster charges to actuate valves and pistons. NASA's pyrotechnics program is one of the more successful in the history of Human Spaceflight. No pyrotechnic device developed in accordance with NASA's Human Spaceflight standards has ever failed in flight use. NASA's pyrotechnic initiators work reliably in temperatures as low as -420 F. Each of the 135 Space Shuttle flights fired 102 of these initiators, some setting off multiple pyrotechnic devices, with never a failure. The recent landing on Mars of the Opportunity rover fired 174 of NASA's pyrotechnic initiators to complete the famous '7 minutes of terror.' Even after traveling through extreme radiation and thermal environments on the way to Mars, every one of them worked. These initiators have fired on the surface of Titan. NASA's design controls, procedures, and processes produce the most reliable pyrotechnics in the world. Application of pyrotechnics designed and procured in this manner could enable the energy industry's emergency equipment, such as shutoff valves and deep-sea blowout preventers, to be left in place for years in extreme environments and still be relied upon to function when needed, thus greatly enhancing safety and operational availability.

Safety of capsule endoscopy using human body communication in patients with cardiac devices.

PubMed

Chung, Joo Won; Hwang, Hye Jin; Chung, Moon Jae; Park, Jeong Youp; Pak, Hui-Nam; Song, Si Young

2012-06-01

The MiroCam (IntroMedic, Ltd., Seoul, Korea) is a small-bowel capsule endoscope that uses human body communication to transmit data. The potential interactions between cardiac devices and the capsule endoscope are causes for concern, but no data are available for this matter. This clinical study was designed to evaluate the potential influence of the MiroCam capsules on cardiac devices. Patients with cardiac pacemakers or implantable cardiac defibrillators referred for evaluation of small bowel disease were prospectively enrolled in this study. Before capsule endoscopy, a cardiologist checked baseline electrocardiograms and functions of the cardiac devices. Cardiac rhythms were continuously monitored by 24-h telemetry during capsule endoscopy in the hospital. After completion of procedures, functions of the cardiac devices were checked again for interference. Images from the capsule endoscopy were reviewed and analyzed for technical problems. Six patients, three with pacemakers and three with implantable cardiac defibrillators, were included in the study. We identified no disturbances in the cardiac devices and no arrhythmias detected on telemetry monitoring during capsule endoscopy. No significant changes in the programmed parameters of the cardiac devices were noted after capsule endoscopy. There were no imaging disturbances from the cardiac devices on capsule endoscopy. Capsule endoscopy using human body communication to transmit data was safely performed in patients with cardiac pacemakers or implantable cardiac defibrillators. Images from the capsule endoscopy were not affected by cardiac devices. A further large-scale study is required to confirm the safety of capsule endoscopy with various types of cardiac devices.

Thermic sealing in femoral catheterisation: First experience with the Secure Device.

PubMed

Sacherer, Michael; Kolesnik, Ewald; von Lewinski, Friederike; Verheyen, Nicolas; Brandner, Karin; Wallner, Markus; Eaton, Deborah M; Luha, Olev; Zweiker, Robert; von Lewinski, Dirk

2018-04-03

Devices currently used to achieve hemostasis of the femoral artery following percutaneous cardiac catheterization are associated with vascular complications and remnants of artificial materials are retained at the puncture site. The SECURE arterial closure device induces hemostasis by utilizing thermal energy, which causes collagen shrinking and swelling. In comparison to established devices, it has the advantage of leaving no foreign material in the body following closing. This study was designed to evaluate the efficacy and safety of the SECURE device to close the puncture site following percutaneous cardiac catheterization. The SECURE device was evaluated in a prospective non-randomized single-centre trial with patients undergoing 6 F invasive cardiac procedures. A total of 67 patients were enrolled and the device was utilized in 63 patients. 50 diagnostic and 13 interventional cases were evaluated. Femoral artery puncture closure was performed immediately after completion of the procedure. Time to hemostasis (TTH), time to ambulation (TTA) and data regarding short-term and 30-day clinical follow-up were recorded. Mean TTH was 4:30 ± 2:15 min in the overall observational group. A subpopulation of patients receiving anticoagulants had a TTH of 4:53 ± 1:43 min. There were two access site complications (hematoma > 5 cm). No major adverse events were identified during hospitalization or at the 30 day follow-up. The new SECURE device demonstrates that it is feasible in diagnostic and interventional cardiac catheterization. With respect to safety, the SECURE device was non-inferior to other closure devices as tested in the ISAR closure trial.

Powered off-road wheelchair for the transportation of tetraplegics along mountain trails.

PubMed

Antonelli, Michele Gabrio; Alleva, Stefano; Beomonte Zobel, Pierluigi; Durante, Francesco; Raparelli, Terenziano

2017-12-08

For off-road mobility, some manual or power assisted devices were conceived to be self-driven by paraplegics while for tetraplegics non power-assisted devices were conceived. These devices require one or more conductors who are subjected to a high physical demand thus potentially creating: precarious safety condition for the user an elevated physical demand of conductors could reduce the care and the attention to give to the user; the time of the outdoor adventure experience of the user could be limited. To address these issues, an innovative user-centered power assisted off-road wheelchair for the transportation of tetraplegics along mountain trails was developed. The device, structured like a trike, is driven by two healthy conductors; the user is placed in the middle of the frame. A movable seat provides for the transfer from the standard to the off-road wheelchair. An electrical motor, powered by a battery pack, provides for the actuation. All the design and prototype aspects, the control system and experimental tests are detailed. The prototype satisfies mechanical, safety and duration requirements. No physical demand while using the device and for the transfer of the user to the device was identified. Fun and engaging tests were carried out and all the participants were involved. Implications for Rehabilitation The device has the potential to enhance the quality of life of tetraplegics in terms of new life experiences. The device revealed the real possibility of a full recreational experience, an enhanced participation and a better social integration of tetraplegics.

Prospective randomized evaluation of the watchman left atrial appendage closure device in patients with atrial fibrillation versus long-term warfarin therapy: The PREVAIL trial.

PubMed

Belgaid, Djouhar Roufeida; Khan, Zara; Zaidi, Mariam; Hobbs, Adrian

2016-09-15

Assessing the safety and effectiveness of left atrial appendage (LAA) (pouch found in the upper chambers of the heart) occlusion, using the Watchman device compared to long term warfarin therapy (drug that reduces clot formation), in preventing the risk of stroke in patients with atrial fibrillation (most common type of irregular heart beat). 90% of strokes in atrial fibrillation arise from clots forming in this pouch. By mechanically blocking it using the device less clots are suggested to be formed. This is an alternative to taking warfarin especially in patients who cannot take it. 50 sites in the United States enrolled 407 participants. After being randomly allocated, the device group had 269 participants and warfarin group (comparator)had 138 participants. Patients with atrial fibrillation and at high risk of stroke were randomly allocated a group after they were deemed eligible. Patients in the device group had to take warfarin and aspirin for 45days till the complete closure of the LAA. The oral anticoagulant was followed by dual antiplatelet therapy until 6months and then ASA. Patients in the warfarin group have to take it for life and were continually monitored. The study ran for 26months. The trial assessed the rate of adverse events using three endpoints: The PREVAIL trial was not designed to show superiority, but non-inferiority. It met the safety endpoint and one efficacy endpoint for the watchman device compared to long term warfarin for overall efficacy of the device. The results established that LAA occlusion is not worse than warfarin intake for the prevention of stroke more than 1week after randomization. Compared to previous trials, the safety of the device has also improved. LAA occlusion is a reasonable alternative to chronic warfarin therapy in stroke prevention for patients with atrial fibrillation. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Evaluating the implementation of health and safety innovations under a regulatory context: a collective case study of Ontario's safer needle regulation.

PubMed

Chambers, Andrea; Mustard, Cameron A; Breslin, Curtis; Holness, Linn; Nichol, Kathryn

2013-01-22

Implementation effectiveness models have identified important factors that can promote the successful implementation of an innovation; however, these models have been examined within contexts where innovations are adopted voluntarily and often ignore the socio-political and environmental context. In the field of occupational health and safety, there are circumstances where organizations must adopt innovations to comply with a regulatory standard. Examining how the external environment can facilitate or challenge an organization's change process may add to our understanding of implementation effectiveness. The objective of this study is to describe implementation facilitators and barriers in the context of a regulation designed to promote the uptake of safer engineered medical devices in healthcare. The proposed study will focus on Ontario's safer needle regulation (2007) which requires healthcare organizations to transition to the use of safer engineered medical devices for the prevention of needlestick injuries. A collective case study design will be used to learn from the experiences of three acute care hospitals in the province of Ontario, Canada. Interviews with management and front-line healthcare workers and analysis of supporting documents will be used to describe the implementation experience and examine issues associated with the integration of these devices. The data collection and analysis process will be influenced by a conceptual framework that draws from implementation science and the occupational health and safety literature. The focus of this study in addition to the methodology creates a unique opportunity to contribute to the field of implementation science. First, the study will explore implementation experiences under circumstances where regulatory pressures are influencing the organization's change process. Second, the timing of this study provides an opportunity to focus on issues that arise during later stages of implementation, a phase during the implementation cycle that has been understudied. This study also provides the opportunity to examine the relevance and utility of current implementation science models in the field of occupational health where the adoption of an innovation is meant to enhance the health and safety of workers. Previous work has tended to focus almost exclusively on innovations that are designed to enhance an organization's productivity or competitive advantage.

Strategies to improve electrode positioning and safety in cochlear implants.

PubMed

Rebscher, S J; Heilmann, M; Bruszewski, W; Talbot, N H; Snyder, R L; Merzenich, M M

1999-03-01

An injection-molded internal supporting rib has been produced to control the flexibility of silicone rubber encapsulated electrodes designed to electrically stimulate the auditory nerve in human subjects with severe to profound hearing loss. The rib molding dies, and molds for silicone rubber encapsulation of the electrode, were designed and machined using AutoCad and MasterCam software packages in a PC environment. After molding, the prototype plastic ribs were iteratively modified based on observations of the performance of the rib/silicone composite insert in a clear plastic model of the human scala tympani cavity. The rib-based electrodes were reliably inserted farther into these models, required less insertion force and were positioned closer to the target auditory neural elements than currently available cochlear implant electrodes. With further design improvements the injection-molded rib may also function to accurately support metal stimulating contacts and wire leads during assembly to significantly increase the manufacturing efficiency of these devices. This method to reliably control the mechanical properties of miniature implantable devices with multiple electrical leads may be valuable in other areas of biomedical device design.

Sensor-Based Assistive Devices for Visually-Impaired People: Current Status, Challenges, and Future Directions

PubMed Central

Elmannai, Wafa; Elleithy, Khaled

2017-01-01

The World Health Organization (WHO) reported that there are 285 million visually-impaired people worldwide. Among these individuals, there are 39 million who are totally blind. There have been several systems designed to support visually-impaired people and to improve the quality of their lives. Unfortunately, most of these systems are limited in their capabilities. In this paper, we present a comparative survey of the wearable and portable assistive devices for visually-impaired people in order to show the progress in assistive technology for this group of people. Thus, the contribution of this literature survey is to discuss in detail the most significant devices that are presented in the literature to assist this population and highlight the improvements, advantages, disadvantages, and accuracy. Our aim is to address and present most of the issues of these systems to pave the way for other researchers to design devices that ensure safety and independent mobility to visually-impaired people. PMID:28287451

A Laboratory Experimental Study: An FBG-PVC Tube Integrated Device for Monitoring the Slip Surface of Landslides.

PubMed

Wang, Kai; Zhang, Shaojie; Chen, Jiang; Teng, Pengxiao; Wei, Fangqiang; Chen, Qiao

2017-10-30

A new detection device was designed by integrating fiber Bragg grating (FBG) and polyvinyl chloride (PVC) tube in order to monitor the slip surface of a landslide. Using this new FBG-based device, a corresponding slope model with a pre-set slip surface was designed, and seven tests with different soil properties were carried out in laboratory conditions. The FBG sensing fibers were fixed on the PVC tube to measure strain distributions of PVC tube at different elevation. Test results indicated that the PVC tube could keep deformation compatible with soil mass. The new device was able to monitor slip surface location before sliding occurrence, and the location of monitored slip surface was about 1-2 cm above the pre-set slip surface, which basically agreed with presupposition results. The monitoring results are expected to be used to pre-estimate landslide volume and provide a beneficial option for evaluating the potential impact of landslides on shipping safety in the Three Gorges area.

[Testing system design and analysis for the execution units of anti-thrombotic device].

PubMed

Li, Zhelong; Cui, Haipo; Shang, Kun; Liao, Yuehua; Zhou, Xun

2015-02-01

In an anti-thrombotic pressure circulatory device, relays and solenoid valves serve as core execution units. Thus the therapeutic efficacy and patient safety of the device will directly depend on their performance. A new type of testing system for relays and solenoid valves used in the anti-thrombotic device has been developed, which can test action response time and fatigue performance of relay and solenoid valve. PC, data acquisition card and test platform are used in this testing system based on human-computer interaction testing modules. The testing objectives are realized by using the virtual instrument technology, the high-speed data acquisition technology and reasonable software design. The two sets of the system made by relay and solenoid valve are tested. The results proved the universality and reliability of the testing system so that these relays and solenoid valves could be accurately used in the antithrombotic pressure circulatory equipment. The newly-developed testing system has a bright future in the aspects of promotion and application prospect.

A Laboratory Experimental Study: An FBG-PVC Tube Integrated Device for Monitoring the Slip Surface of Landslides

PubMed Central

Zhang, Shaojie; Chen, Jiang; Teng, Pengxiao; Wei, Fangqiang; Chen, Qiao

2017-01-01

A new detection device was designed by integrating fiber Bragg grating (FBG) and polyvinyl chloride (PVC) tube in order to monitor the slip surface of a landslide. Using this new FBG-based device, a corresponding slope model with a pre-set slip surface was designed, and seven tests with different soil properties were carried out in laboratory conditions. The FBG sensing fibers were fixed on the PVC tube to measure strain distributions of PVC tube at different elevation. Test results indicated that the PVC tube could keep deformation compatible with soil mass. The new device was able to monitor slip surface location before sliding occurrence, and the location of monitored slip surface was about 1–2 cm above the pre-set slip surface, which basically agreed with presupposition results. The monitoring results are expected to be used to pre-estimate landslide volume and provide a beneficial option for evaluating the potential impact of landslides on shipping safety in the Three Gorges area. PMID:29084157

[Field 4. Environmental safety practice in the intensive care unit. French-speaking Society of Intensive Care. French Society of Anesthesia and Resuscitation].

PubMed

Fougère, S; Beydon, L; Saulnier, F

2008-10-01

Medical devices are known to carry risks from design to scrap. Accident reports in ICU show that medical device account for only 20% of accidents. Formation of users and providing a postmarketing incident reporting are thus essential in health institutions. Clinical and engineering departments should cooperate to produce and secure procedures which should be applied during the lifetime of each clinical device. Several points should be especially fulfilled: close cooperation between clinical departments and biomedical engineering departments with available technicians, computer-based inventory of all devices, evaluation of specifications required before purchasing a new device, education of users on utilisation and maintenance, technical follow-up of devices and keeping maintenance and repair logs, ability to provide users with replacement devices, provision of check-lists before use, forging criteria to decide when device should be discarded. These principles are simple and should be considered as mandatory in order to improve medical device related security.

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

DOT National Transportation Integrated Search

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...

Generic Safety Requirements for Developing Safe Insulin Pump Software

PubMed Central

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

2011-01-01

Background The authors previously introduced a highly abstract generic insulin infusion pump (GIIP) model that identified common features and hazards shared by most insulin pumps on the market. The aim of this article is to extend our previous work on the GIIP model by articulating safety requirements that address the identified GIIP hazards. These safety requirements can be validated by manufacturers, and may ultimately serve as a safety reference for insulin pump software. Together, these two publications can serve as a basis for discussing insulin pump safety in the diabetes community. Methods In our previous work, we established a generic insulin pump architecture that abstracts functions common to many insulin pumps currently on the market and near-future pump designs. We then carried out a preliminary hazard analysis based on this architecture that included consultations with many domain experts. Further consultation with domain experts resulted in the safety requirements used in the modeling work presented in this article. Results Generic safety requirements for the GIIP model are presented, as appropriate, in parameterized format to accommodate clinical practices or specific insulin pump criteria important to safe device performance. Conclusions We believe that there is considerable value in having the diabetes, academic, and manufacturing communities consider and discuss these generic safety requirements. We hope that the communities will extend and revise them, make them more representative and comprehensive, experiment with them, and use them as a means for assessing the safety of insulin pump software designs. One potential use of these requirements is to integrate them into model-based engineering (MBE) software development methods. We believe, based on our experiences, that implementing safety requirements using MBE methods holds promise in reducing design/implementation flaws in insulin pump development and evolutionary processes, therefore improving overall safety of insulin pump software. PMID:22226258

46 CFR 58.16-15 - Valves and safety relief devices.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 2 2013-10-01 2013-10-01 false Valves and safety relief devices. 58.16-15 Section 58.16-15 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING MAIN AND... and safety relief devices. (a) Each cylinder shall have a manually operated screw-down shutoff valve...

46 CFR 58.16-15 - Valves and safety relief devices.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 2 2011-10-01 2011-10-01 false Valves and safety relief devices. 58.16-15 Section 58.16-15 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING MAIN AND... and safety relief devices. (a) Each cylinder shall have a manually operated screw-down shutoff valve...

46 CFR 58.16-15 - Valves and safety relief devices.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 2 2012-10-01 2012-10-01 false Valves and safety relief devices. 58.16-15 Section 58.16-15 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING MAIN AND... and safety relief devices. (a) Each cylinder shall have a manually operated screw-down shutoff valve...

46 CFR 58.16-15 - Valves and safety relief devices.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 2 2014-10-01 2014-10-01 false Valves and safety relief devices. 58.16-15 Section 58.16-15 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING MAIN AND... and safety relief devices. (a) Each cylinder shall have a manually operated screw-down shutoff valve...

77 FR 10559 - Agency Information Collection Activities: Proposed collection; comments requested: Certification...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-22

... Secure Gun Storage or Safety Devices ACTION: 60-Day notice of information collection. The Department of...) Title of the Form/Collection: Certification of Secure Gun Storage or Safety Devices. (3) Agency form... gun storage or safety devices. (5) An estimate of the total number of respondents and the amount of...

75 FR 21567 - Federal Motor Vehicle Safety Standard No. 108; Lamp, Reflective Devices and Associated Equipment...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-26

... Federal Motor Vehicle Safety Standard No. 108; Lamp, Reflective Devices and Associated Equipment; Denial... Motor Vehicle Safety Standard (FMVSS) No. 108; Lamps, reflective devices, and associated equipment... physical filaments in the lamp. Specifically, BMW requested that paragraph S10.17.1.1.2 \\4\\ of the...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-20

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0098] Embedded Digital Devices in Safety-Related Systems... (NRC) is issuing for public comment Draft Regulatory Issue Summary (RIS) 2013-XX, ``Embedded Digital... requirements for the quality and reliability of basic components with embedded digital devices. DATES: Submit...

SAFETY ON UNTRUSTED NETWORK DEVICES (SOUND)

DTIC Science & Technology

2017-10-10

in the Cyber & Communication Technologies Group , but not on the SOUND project, would review the code, design and perform attacks against a live...3.5 Red Team As part of our testing , we planned to conduct Red Team assessments. In these assessments, a group of engineers from BAE who worked...developed under the DARPA CRASH program and SOUND were designed to be companion projects. SAFE focused on the processor and the host, SOUND focused on

Unintentional and undetermined firearm related deaths: a preventable death analysis for three safety devices.

PubMed

Vernick, J S; O'Brien, M; Hepburn, L M; Johnson, S B; Webster, D W; Hargarten, S W

2003-12-01

To determine the proportion of unintentional and undetermined firearm related deaths preventable by three safety devices: personalization devices, loaded chamber indicators (LCIs), and magazine safeties. A personalized gun will operate only for an authorized user, a LCI indicates when the gun contains ammunition, and a magazine safety prevents the gun from firing when the ammunition magazine is removed. Information about all unintentional and undetermined firearm deaths from 1991-98 was obtained from the Office of the Chief Medical Examiner for Maryland, and from the Wisconsin Firearm Injury Reporting System for Milwaukee. Data regarding the victim, shooter, weapon, and circumstances were abstracted. Coding rules to classify each death as preventable, possibly preventable, or not preventable by each of the three safety devices were also applied. There were a total of 117 firearm related deaths in our sample, 95 (81%) involving handguns. Forty three deaths (37%) were classified as preventable by a personalized gun, 23 (20%) by a LCI, and five (4%) by a magazine safety. Overall, 52 deaths (44%) were preventable by at least one safety device. Deaths involving children 0-17 (relative risk (RR) 3.3, 95% confidence interval (CI) 2.1 to 5.1) and handguns (RR 8.1, 95% CI 1.2 to 53.5) were more likely to be preventable. Projecting the findings to the entire United States, an estimated 442 deaths might have been prevented in 2000 had all guns been equipped with these safety devices. Incorporating safety devices into firearms is an important injury intervention, with the potential to save hundreds of lives each year.

Building quality mHealth for low resource settings.

PubMed

Ettinger, Kate Michi; Pharaoh, Hamilton; Buckman, Reymound Yaw; Conradie, Hoffie; Karlen, Walter

In low- and middle-income countries (LMIC), community health care workers (CHCW) are the primary point of care for millions of people. Mobile phone health applications (mHealth app) are the preferred technology platform to deliver clinical support to CHCW. In LMIC, limited regulatory oversight exists to guide quality and safety for medical devices, including mHealth. During the development of a mHealth app to assist CHCW with patient assessment and clinical diagnosis in rural South Africa, we applied human-centred design (HCD) and a bioethics consultation. The HCD approach enabled us to develop a mHealth app that responded to the needs and capacities of CHCW. The bioethics consultation prompted early consideration of safety concerns, social implications of our mHealth app and our technology's impact on the CHCW-patient relationship. In this study, we found that combining a HCD approach with bioethics consultation improved the design quality and reduced safety concerns for our mHealth app.

30 CFR 57.9311 - Anchoring stationary sizing devices.

Code of Federal Regulations, 2010 CFR

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...

MRI-conditional pacemakers: current perspectives.

PubMed

Ferreira, António M; Costa, Francisco; Tralhão, António; Marques, Hugo; Cardim, Nuno; Adragão, Pedro

2014-01-01

Use of both magnetic resonance imaging (MRI) and pacing devices has undergone remarkable growth in recent years, and it is estimated that the majority of patients with pacemakers will need an MRI during their lifetime. These investigations will generally be denied due to the potentially dangerous interactions between cardiac devices and the magnetic fields and radio frequency energy used in MRI. Despite the increasing reports of uneventful scanning in selected patients with conventional pacemakers under close surveillance, MRI is still contraindicated in those circumstances and cannot be considered a routine procedure. These limitations prompted a series of modifications in generator and lead engineering, designed to minimize interactions that could compromise device function and patient safety. The resulting MRI-conditional pacemakers were first introduced in 2008 and the clinical experience gathered so far supports their safety in the MRI environment if certain conditions are fulfilled. With this technology, new questions and controversies arise regarding patient selection, clinical impact, and cost-effectiveness. In this review, we discuss the potential risks of MRI in patients with electronic cardiac devices and present updated information regarding the features of MRI-conditional pacemakers and the clinical experience with currently available models. Finally, we provide some guidance on how to scan patients who have these devices and discuss future directions in the field.

33 CFR 183.710 - Start-in-gear protection required.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Start-in-gear protection required... (CONTINUED) BOATING SAFETY BOATS AND ASSOCIATED EQUIPMENT Start-in-Gear Protection § 183.710 Start-in-gear... starting must have a built-in start-in-gear protection device. (2) Outboard motors designed for remote...

42 CFR 84.1141 - Isoamyl acetate tightness test; dust, fume, and mist respirators designed for respiratory...

Code of Federal Regulations, 2013 CFR

2013-10-01

... Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Dust, Fume, and Mist... 42 Public Health 1 2013-10-01 2013-10-01 false Isoamyl acetate tightness test; dust, fume, and...

42 CFR 84.1141 - Isoamyl acetate tightness test; dust, fume, and mist respirators designed for respiratory...

Code of Federal Regulations, 2010 CFR

2010-10-01

... Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Dust, Fume, and Mist... 42 Public Health 1 2010-10-01 2010-10-01 false Isoamyl acetate tightness test; dust, fume, and...

42 CFR 84.1141 - Isoamyl acetate tightness test; dust, fume, and mist respirators designed for respiratory...

Code of Federal Regulations, 2014 CFR

2014-10-01

... Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Dust, Fume, and Mist... 42 Public Health 1 2014-10-01 2014-10-01 false Isoamyl acetate tightness test; dust, fume, and...

42 CFR 84.1141 - Isoamyl acetate tightness test; dust, fume, and mist respirators designed for respiratory...

Code of Federal Regulations, 2012 CFR

2012-10-01

... Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Dust, Fume, and Mist... 42 Public Health 1 2012-10-01 2012-10-01 false Isoamyl acetate tightness test; dust, fume, and...

42 CFR 84.1141 - Isoamyl acetate tightness test; dust, fume, and mist respirators designed for respiratory...

Code of Federal Regulations, 2011 CFR

2011-10-01

... Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Dust, Fume, and Mist... 42 Public Health 1 2011-10-01 2011-10-01 false Isoamyl acetate tightness test; dust, fume, and...

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

DOT National Transportation Integrated Search

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),...

Critical Current Test of Liquid Hydrogen Cooled HTC Superconductors under External Magnetic Field

NASA Astrophysics Data System (ADS)

Shirai, Yasuyuki; Shiotsu, Masahiro; Tatsumoto, Hideki; Kobayashi, Hiroaki; Naruo, Yoshihiro; Nonaka, Satoshi; Inatani, Yoshifumi

High-Tc (HTC) superconductors including MgB2 will show excellent properties under temperature of Liquid Hydrogen (LH2:20K), which has large latent heat and low viscosity coefficient. In order to design and fabricate the LH2 cooled superconducting energy devices, we must clear the cooling property of LH2 for superconductors, the cooling system and safety design of LH2 cooled superconducting devices and electro-magnetic property evaluation of superconductors (BSCCO, REBCO and MgB2) and their magnets cooled by LH2. As the first step of the study, an experimental setup which can be used for investigating heat transfer characteristics of LH2 in a pool and also in forced flow (circulation loop with a pump), and also for evaluation of electro-magnetic properties of LH2 cooled superconductors under external magnetic field (up to 7 T). In this paper, we will show a short sketch of the experimental set-up, practical experiences in safety operation of liquid hydrogen cooling system and example test results of critical current evaluation of HTC superconductors cooled by LH2.

Adaptive Transcutaneous Power Transfer to Implantable Devices: A State of the Art Review

PubMed Central

Bocan, Kara N.; Sejdić, Ervin

2016-01-01

Wireless energy transfer is a broad research area that has recently become applicable to implantable medical devices. Wireless powering of and communication with implanted devices is possible through wireless transcutaneous energy transfer. However, designing wireless transcutaneous systems is complicated due to the variability of the environment. The focus of this review is on strategies to sense and adapt to environmental variations in wireless transcutaneous systems. Adaptive systems provide the ability to maintain performance in the face of both unpredictability (variation from expected parameters) and variability (changes over time). Current strategies in adaptive (or tunable) systems include sensing relevant metrics to evaluate the function of the system in its environment and adjusting control parameters according to sensed values through the use of tunable components. Some challenges of applying adaptive designs to implantable devices are challenges common to all implantable devices, including size and power reduction on the implant, efficiency of power transfer and safety related to energy absorption in tissue. Challenges specifically associated with adaptation include choosing relevant and accessible parameters to sense and adjust, minimizing the tuning time and complexity of control, utilizing feedback from the implanted device and coordinating adaptation at the transmitter and receiver. PMID:26999154

Adaptive Transcutaneous Power Transfer to Implantable Devices: A State of the Art Review.

PubMed

Bocan, Kara N; Sejdić, Ervin

2016-03-18

Wireless energy transfer is a broad research area that has recently become applicable to implantable medical devices. Wireless powering of and communication with implanted devices is possible through wireless transcutaneous energy transfer. However, designing wireless transcutaneous systems is complicated due to the variability of the environment. The focus of this review is on strategies to sense and adapt to environmental variations in wireless transcutaneous systems. Adaptive systems provide the ability to maintain performance in the face of both unpredictability (variation from expected parameters) and variability (changes over time). Current strategies in adaptive (or tunable) systems include sensing relevant metrics to evaluate the function of the system in its environment and adjusting control parameters according to sensed values through the use of tunable components. Some challenges of applying adaptive designs to implantable devices are challenges common to all implantable devices, including size and power reduction on the implant, efficiency of power transfer and safety related to energy absorption in tissue. Challenges specifically associated with adaptation include choosing relevant and accessible parameters to sense and adjust, minimizing the tuning time and complexity of control, utilizing feedback from the implanted device and coordinating adaptation at the transmitter and receiver.

A framework of medical equipment management system for in-house clinical engineering department.

PubMed

Chien, Chia-Hung; Huang, Yi-You; Chong, Fok-Ching

2010-01-01

Medical equipment management is an important issue for safety and cost in modern hospital operation. In addition, the use of an efficient information system effectively promotes the managing performance. In this study, we designed a framework of medical equipment management system used for in-house clinical engineering department. The system was web-based, and it integrated clinical engineering and hospital information system components. Through related information application, it efficiently improved the operation management of medical devices immediately and continuously. This system has run in the National Taiwan University Hospital. The results showed only few examples in the error analysis of medical equipment by the maintenance sub-system. The information can be used to improve work quality, to reduce the maintenance cost, and to promote the safety of medical device used in patients and clinical staffs.

Design and simulation of printed spiral coil used in wireless power transmission systems for implant medical devices.

PubMed

Wu, Wei; Fang, Qiang

2011-01-01

Printed Spiral Coil (PSC) is a coil antenna for near-field wireless power transmission to the next generation implant medical devices. PSC for implant medical device should be power efficient and low electromagnetic radiation to human tissues. We utilized a physical model of printed spiral coil and applied our algorithm to design PSC operating at 13.56 MHz. Numerical and electromagnetic simulation of power transfer efficiency of PSC in air medium is 77.5% and 71.1%, respectively. The simulation results show that the printed spiral coil which is optimized for air will keep 15.2% power transfer efficiency in human subcutaneous tissues. In addition, the Specific Absorption Ratio (SAR) for this coil antenna in subcutaneous at 13.56 MHz is below 1.6 W/Kg, which suggests this coil is implantable safe based on IEEE C95.1 safety guideline.

10 CFR 32.74 - Manufacture and distribution of sources or devices containing byproduct material for medical use.

Code of Federal Regulations, 2013 CFR

2013-01-01

... accidents; (iv) For devices containing byproduct material, the radiation profile of a prototype device; (v... source or device pertinent to an evaluation of its radiation safety, including: (i) The byproduct...) Instructions for handling and storing the source or device from the radiation safety standpoint; these...

10 CFR 32.74 - Manufacture and distribution of sources or devices containing byproduct material for medical use.

Code of Federal Regulations, 2014 CFR

2014-01-01

... accidents; (iv) For devices containing byproduct material, the radiation profile of a prototype device; (v... source or device pertinent to an evaluation of its radiation safety, including: (i) The byproduct...) Instructions for handling and storing the source or device from the radiation safety standpoint; these...

Stimulating Patient Engagement in Medical Device Development in Kidney Disease: A Report of a Kidney Health Initiative Workshop.

PubMed

Hurst, Frank P; Chianchiano, Dolph; Upchurch, Linda; Fisher, Benjamin R; Flythe, Jennifer E; Castillo Lee, Celeste; Hill, Terri; Neuland, Carolyn Y

2017-10-01

New technologies challenge current dialysis treatment paradigms as devices become smaller, more portable, and increasingly used outside the dialysis clinic. It is unclear how patients will view this care transition, and it will be important to consider patient and care partner perspectives during all aspects of development for novel dialysis therapies, from design and clinical trials to regulatory approval. To gain insight into this area, the Kidney Health Initiative, a public-private partnership between the American Society of Nephrology, the US Food and Drug Administration, and nearly 80 member organizations and companies dedicated to enhancing patient safety and fostering innovation in kidney disease, convened a workshop of patients, care partners, and other kidney community stakeholders. The workshop included background presentations followed by focused small group discussions in 3 areas (device design, clinical trials, and regulatory approval). Participants explored how to involve patients throughout the life cycle of a medical device, including discussions of how patients can influence device design, assist in the planning and implementation of clinical trials, and provide input to affect regulatory decisions. Patients were engaged in the workshop discussion and interested in sharing their perspectives, but they recommended additional efforts around education, communication, and outreach in these areas. Published by Elsevier Inc.

Safety evaluation of a leadless transcatheter pacemaker for magnetic resonance imaging use.

PubMed

Soejima, Kyoko; Edmonson, Jonathan; Ellingson, Michael L; Herberg, Ben; Wiklund, Craig; Zhao, Jing

2016-10-01

Increased magnetic resonance imaging (MRI) adoption and demand are driving the need for device patients to have safe access to MRI. The aim of this study was to address the interactions of MRI with the Micra transcatheter pacemaker system. A strategy was developed to evaluate potential MRI risks including device heating, unintended cardiac stimulation, force, torque, vibration, and device malfunction. Assessment of MRI-induced device heating was conducted using a phantom containing gelled saline, and Monte Carlo simulations incorporating these results were conducted to simulate numerous combinations of human body models, position locations in the MRI scanner bore, and a variety of coil designs. Lastly, a patient with a Micra pacemaker who underwent a clinically indicated MRI scan is presented. Compared to traditional MRI conditional pacemakers, the overall risk with Micra was greatly reduced because of the small size of the device and the absence of a lead. The modeling results predicted that the nonperfused temperature rise of the device would be less than 0.4°C at 1.5 T and 0.5°C at 3 T and that the risk of device heating with multiple device implants was not increased as compared with a single device. The clinical case study revealed no MRI-related complications. The MRI safety assessment tests conducted for the Micra pacemaker demonstrate that patients with a single device or multiple devices can safely undergo MRI scans in both 1.5- and 3-T MRI scanners. No MRI-related complications were observed in a patient implanted with a Micra pacemaker undergoing a clinically indicated scan. Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Trial of a novel endoscopic tattooing biopsy forceps on animal model

PubMed Central

Si, Jian-Min; Sun, Lei-Min; Fan, Yu-Jing; Wang, Liang-Jing

2005-01-01

AIM: To tattoo gastric mucosa with a novel medical device which could be used to monitor and follow-up gastric mucosal lesions. METHODS: Combining endoscopic biopsy with sclerotherapy injection, we designed a new device that could perform biopsy and injection simultaneously. We performed endoscopies on a pig by using a novel endoscope tattoo biopsy forceps for 15 mo. At the same time, we used two-step method combining sclerotherapy injection needle with endoscopic biopsy. The acuity, inflammation and duration of endoscopy were compared between two methods. RESULTS: Compared with the old two-step method, although the inflammation induced by our new device was similar, the duration of procedure was markedly decreased and the acuity of tattooing was better than the old two-step method. All characteristics of the novel device complied with national safety guidelines. Follow-up gastroscopy after 15 mo showed the stained site with injection of 1:100 0.5 mL of India ink was still markedly visible with little inflammatory reaction. CONCLUSION: Endoscopic tattooing biopsy forceps can be widely used in monitoring precancerous lesions. Its safety and effectiveness has been established in animals. PMID:15793881

Connected cane: Tactile button input for controlling gestures of iOS voiceover embedded in a white cane.

PubMed

Batterman, Jared M; Martin, Vincent F; Yeung, Derek; Walker, Bruce N

2018-01-01

Accessibility of assistive consumer devices is an emerging research area with potential to benefit both users with and without visual impairments. In this article, we discuss the research and evaluation of using a tactile button interface to control an iOS device's native VoiceOver Gesture navigations (Apple Accessibility, 2014). This research effort identified potential safety and accessibility issues for users trying to interact and control their touchscreen mobile iOS devices while traveling independently. Furthermore, this article discusses the participatory design process in creating a solution that aims to solve issues in utilizing a tactile button interface in a novel device. The overall goal of this study is to enable visually impaired white cane users to access their mobile iOS device's capabilities navigation aids more safely and efficiently on the go.

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

PubMed Central

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

2018-01-01

A large number of medications and medical devices removed from the market by the US Food and Drug Administration over the past 4 decades specifically posed greater health risks to women. This article reviews the historical background of sex and gender in clinical research policy and describes several approved drugs and devices targeted for use in women that have caused major morbidity and mortality. The intended population for the medications and devices, population affected, approval process, and the basic and legal actions taken against the medication/drug company are also discussed. It is recognized that women are still at risk for harm from unsafe medications and devices, and continued improvements in legislation that promotes inclusion of sex and gender into the design and analysis of research will improve safety for both men and women. PMID:28069260

30 CFR 75.1107-7 - Water spray devices; capacity; water supply; minimum requirements.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Water spray devices; capacity; water supply; minimum requirements. 75.1107-7 Section 75.1107-7 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Fire Protection Fire Suppression Devices and...

30 CFR 75.1107-7 - Water spray devices; capacity; water supply; minimum requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Water spray devices; capacity; water supply; minimum requirements. 75.1107-7 Section 75.1107-7 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Fire Protection Fire Suppression Devices and...

30 CFR 75.1107-7 - Water spray devices; capacity; water supply; minimum requirements.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Water spray devices; capacity; water supply; minimum requirements. 75.1107-7 Section 75.1107-7 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Fire Protection Fire Suppression Devices and...

30 CFR 75.1107-7 - Water spray devices; capacity; water supply; minimum requirements.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Water spray devices; capacity; water supply; minimum requirements. 75.1107-7 Section 75.1107-7 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Fire Protection Fire Suppression Devices and...

Design of a mechanical system in gait rehabilitation with progressive addition of weight

NASA Astrophysics Data System (ADS)

Braidot, Ariel A. A.; Aleman, Guillermo L.

2011-12-01

In this paper we designed and developed a mechanical device for gait rehabilitation based on the application of "partial body weight reduction therapy". An evaluation of the characteristics of devices based on this therapy currently available on the market was carried out obtaining information of the different mechanisms used in it. The device was designed to adapt to different height and weight of patients and to be used with additional equipment in gait rehabilitation, for example, treadmills, elliptical trainers and vertical scalers. It was envisaged to be used by patients with asymmetry in the lower extremities capabilities. We developed a stable structure in steel ASTM A36 which does not depend on the building conditions of the installation site. RamAdvanse software was used to calculate structural stability. A winch with automatic brake mechanism was used to raise/lower the patient, who was tied to a comfortable harness which provided safety to the patient and therapist. It was possible to quantify precisely, using counterweights, the weight borne by the patient during therapy. We obtained a small-sized and ergonomic low-cost prototype, with similar features to those currently considered cutting-edge devices.

Knowledge, attitudes, beliefs, values, preferences, and feasibility in relation to the use of injection safety devices in healthcare settings: a systematic review.

PubMed

Tarabay, Rami; El Rassi, Rola; Dakik, Abeer; Harb, Alain; Ballout, Rami A; Diab, Batoul; Khamassi, Selma; Akl, Elie A

2016-07-13

Adopting technologies such as injection safety devices in healthcare settings can enhance injection safety. Developing guidelines for appropriate adoption of such technologies need to consider factors beyond evidence for their health effects. The objective of this study is to systematically review the published literature for evidence among healthcare workers and patients about knowledge, attitudes, beliefs, values, preferences, and feasibility in relation to the use of injection safety devices in healthcare settings. We included both qualitative and quantitative studies conducted with the general public, patients, and healthcare workers, administrators, or policy makers. We searched MEDLINE, EMBASE, CINHAL and CENTRAL. We used a duplicate and independent approach to title and abstract screening, full text screening, data abstraction and risk of bias assessment. Out of a total of 6568 identified citations, we judged fourteen studies as eligible for this systematic review. All these studies were surveys, conducted with healthcare workers in high-income countries. We did not identify any qualitative study, or a study of the general public, patients, healthcare administrators or policy makers. We did not identify any study assessing knowledge, or values assigned to outcomes relevant to injection safety devices. Each of the included studies suffered from methodological limitations, which lowers our confidence in their findings. Based on the findings of six studies, the injection safety devices were generally perceived as easy to use and as an improvement compared with conventional syringes. Some of these studies reported few technical problems while using the devices. In three studies assessing perceived safety, the majority of participants judged the devices as safe. Two studies reported positive perceptions of healthcare workers regarding patient tolerance of these injection safety devices. One study found that less than half the nurses felt comfortable using the insulin pens. Findings from four studies assessing preference and satisfaction were not consistent. This systematic review identified evidence that injection safety devices are generally perceived as easy to use, safe, and tolerated by patients. There were few reports of technical problems while using the devices and some discomfort by nurses using the insulin pens.

Suggestion of Design Evaluation Plan based on Star Life Cycle to introduce the Information Minimalism Concept of KOREA Nuclear Plant

NASA Astrophysics Data System (ADS)

Jang, Gwi-sook; Lee, Seung-min; Park, Gee-yong

2018-01-01

The design of Korea Nuclear Power Plant (NPP) main control rooms (MCR) has been changed to be fully digitalized. Five or six display devices are assigned to each operator in NPP MCR to provide the information of safety parameter and plant status, and various control functions by connecting computerized control devices. Under this circumstance, the distributed displays can induce a dispersion of the operators' attention and increase the workload while conducting monitoring and control tasks efficiently. In addition, to support human operators to reduce their workload and increase the performance, the concepts of the ecological interface design (EID) and the operator-centered design were applied to the design HMI display. However these designs are applied to a limited set of screens and did not differ largely from the traditional HMI design in that the layout of the information is somewhere similar to P&IDs. In this paper, we propose a design evaluation plan based on star life cycle to introduce the information minimalism concept for designing an HMI display.

Home delivery of an injury prevention kit for children in four French cities: a controlled randomized trial

PubMed Central

Sznajder, M; Leduc, S; Janvrin, M; Bonnin, M; Aegerter, P; Baudier, F; Chevallier, B; Macarthur, C

2003-01-01

Objectives: Home delivery of counselling and safety devices to prevent child injuries could help parents to adopt safe behaviour. The aim of this study was to test a safety kit designed and used in Quebec (Canada). Design and subjects: One hundred families from four towns in the Paris suburbs were visited at home by nurses or doctors when their child reached 6–9 months. Selection criteria were: primipara, medical problem, psychological, and/or socioeconomic difficulties. Interventions: During the first visit, 50 families (group 1) received counselling and a kit including preventive devices and pamphlets about indoor injuries and ways to avoid them. The other 50 families (group 2) received counselling but not the kit. A second home visit was made 6–8 weeks later. Main outcome measures: The number of safety improvements was calculated 6–8 weeks after a first home visit. Perceived usefulness of the kit was collected from families and from interviewers. Results: Between the first and the second visits, safety improvement was significantly higher in the group with the kit. This was mainly related to the risk of fall (p<0.02), fire and burns (p<0.001), poisoning (p<0.01), and suffocation (p<0.001). For improvement related to devices provided in the kit, the difference between the groups was significant: 64.4% improvement in group 1 versus 41.2% in group 2 (p<0.01). The relative risk (RR) of safety improvement between groups was 1.56 (95% confidence interval (CI) 1.35 to 1.80). Even for improvements not related to the kit the difference remained significant: 31.2% in group 1 versus 20.2% in group 2 (p<0.05); RR = 1.54 (95% CI 1.22 to 1.93). Conclusion: Routine home visits by social services offer a good opportunity to tackle child injury prevention. Free delivery of prevention kits and counselling allow families to modify their behaviour and homes so as to reduce risks. PMID:12966017

FDA working to ensure the safety of medical devices used in the pediatric population.

PubMed

Flack, Marilyn Neder; Gross, Thomas P; Reid, Joy Samuels; Mills, Thalia T; Francis, Jacqueline

2012-12-01

Special initiatives exist in FDA's Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research, and the Center for Biologics Evaluation and Research to ensure the safety and effectiveness of medical products used in the vulnerable pediatric population. This article focuses on the special programs, projects, and special studies implemented by CDRH to ensure this safety and effectiveness in devices used in pediatric patients throughout the devices' total product life-cycles. Pediatricians play a major role in keeping medical devices safe for use in children by reporting device problems to FDA. Published by Elsevier Inc.

Packaging - Materials review

NASA Astrophysics Data System (ADS)

Herrmann, Matthias

2014-06-01

Nowadays, a large number of different electrochemical energy storage systems are known. In the last two decades the development was strongly driven by a continuously growing market of portable electronic devices (e.g. cellular phones, lap top computers, camcorders, cameras, tools). Current intensive efforts are under way to develop systems for automotive industry within the framework of electrically propelled mobility (e.g. hybrid electric vehicles, plug-in hybrid electric vehicles, full electric vehicles) and also for the energy storage market (e.g. electrical grid stability, renewable energies). Besides the different systems (cell chemistries), electrochemical cells and batteries were developed and are offered in many shapes, sizes and designs, in order to meet performance and design requirements of the widespread applications. Proper packaging is thereby one important technological step for designing optimum, reliable and safe batteries for operation. In this contribution, current packaging approaches of cells and batteries together with the corresponding materials are discussed. The focus is laid on rechargeable systems for industrial applications (i.e. alkaline systems, lithium-ion, lead-acid). In principle, four different cell types (shapes) can be identified - button, cylindrical, prismatic and pouch. Cell size can be either in accordance with international (e.g. International Electrotechnical Commission, IEC) or other standards or can meet application-specific dimensions. Since cell housing or container, terminals and, if necessary, safety installations as inactive (non-reactive) materials reduce energy density of the battery, the development of low-weight packages is a challenging task. In addition to that, other requirements have to be fulfilled: mechanical stability and durability, sealing (e.g. high permeation barrier against humidity for lithium-ion technology), high packing efficiency, possible installation of safety devices (current interrupt device, valve, etc.), chemical inertness, cost issues, and others. Finally, proper cell design has to be considered for effective thermal management (i.e. cooling and heating) of battery packs.

Complying with the Occupational Safety and Health Administration's Bloodborne Pathogens Standard: implementing needleless systems and intravenous safety devices.

PubMed

Marini, Michelle A; Giangregorio, Maeve; Kraskinski, Joanna C

2004-03-01

Preventing the transmission of bloodborne pathogens to healthcare workers has been a mission and a challenge of the healthcare industry for over 20 years. The development of the Occupational Safety and Health Administration Bloodborne Pathogens Standard in 1991 and the passing of the Needlestick Safety Act in 2000 mandated hospitals to develop an Exposure Control Plan to protect workers from these pathogens. Children's Hospital Boston began implementation of a needleless system in 1993. Employees readily accepted these systems into practice, because they were convenient and easy to use. A marked decrease in exposures to bloodborne pathogens naturally followed, which is consistent with the national data. The transition to intravenous (i.v.) safety devices at Children's Hospital began in 2000 and proved to be more of a challenge. First, the clinicians must choose a safety product, which requires developing and implementing a trial plan with potential catheters. This selection process is especially difficult in pediatrics where successful placement of the smallest-gauge catheter, no. 24, is imperative. After choosing an i.v. safety product, successful transition is dependent upon the thoroughness of i.v. safety device training and a commitment by the clinicians to the use of these products. Although the number of needlestick injuries and subsequent transmission of bloodborne pathogens have been further reduced with the use of i.v. safety devices, needlestick injuries still occur. This results from a lack of familiarity with the engineering of the device and therefore poor technique or a failure to activate the safety mechanism. Staff resistance due to loss of expertise with the new device and patient care concerns are additional barriers to the use of these new products. Addressing these obstacles and providing adequate training for all clinicians were required for successful implementation of these i.v. safety devices.

Compressed Natural Gas Vehicle Maintenance Facility Modification Handbook

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kelly, K.; Melendez, M.; Gonzales, J.

To ensure the safety of personnel and facilities, vehicle maintenance facilities are required by law and by guidelines of the National Fire Protection Association (NFPA) and the International Fire Code (IFC) to exhibit certain design features. They are also required to be fitted with certain fire protection equipment and devices because of the potential for fire or explosion in the event of fuel leakage or spills. All fuels have an explosion or fire potential if specific conditions are present. This handbook covers the primary elements that must be considered when developing a CNG vehicle maintenance facility design that will protectmore » against the ignition of natural gas releases. It also discusses specific protocols and training needed to ensure safety.« less

Overview of the 2016 U.S. Food and Drug Administration Circulatory System Devices Advisory Panel Meeting on the Absorb Bioresorbable Vascular Scaffold System.

PubMed

Steinvil, Arie; Rogers, Toby; Torguson, Rebecca; Waksman, Ron

2016-09-12

This study aims to describe the discussions and recommendations made during the U.S. Food and Drug Administration (FDA) Circulatory System Device Panel pre-market approval application for the Absorb Bioresorbable Vascular Scaffold (BVS) System. The Absorb BVS System is a first-of-its-kind fully bioresorbable percutaneous coronary intervention technology. The absorb BVS was studied in the ABSORB III (A Clinical Evaluation of Absorb BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de Novo Native Coronary Artery Lesions) trial, the pivotal U.S. investigational device exemption trial. Observational report of the FDA Circulatory System Device Panel pre-market approval application meeting held on March 15, 2016. The U.S. FDA Circulatory System Device Panel members reviewed the ABSROB III trial outcomes and additional post hoc analyses presented by the sponsor and the FDA. The ABSORB III trial met the primary endpoint of noninferiority of Absorb BVS compared with the control, XIENCE drug-eluting stent, for target lesion failure at 1 year. Although a higher numerical trend for adverse outcomes was reported for the Absorb BVS, there were no statistical differences between Absorb BVS and XIENCE for any safety or effectiveness components for target lesion failure or for the secondary pre-specified outcomes. Panel members raised concerns with regard to the ABSORB III results and post hoc analyses focusing mainly on the noninferiority design of the trial, the apparent safety issues of the Absorb BVS in small vessels, the mismatch of visually versus intravascular imaging assessed vessel size found in ABSORB III and its implications on the adequate device labeling, the safety of Absorb BVS in specific patient and lesion subsets, and the post-approval commitments of the sponsor. Following panel discussions and the evidence presented, the panel voted for approval of the device. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Incorporating patient-preference evidence into regulatory decision making.

PubMed

Ho, Martin P; Gonzalez, Juan Marcos; Lerner, Herbert P; Neuland, Carolyn Y; Whang, Joyce M; McMurry-Heath, Michelle; Hauber, A Brett; Irony, Telba

2015-10-01

Patients have a unique role in deciding what treatments should be available for them and regulatory agencies should take their preferences into account when making treatment approval decisions. This is the first study designed to obtain quantitative patient-preference evidence to inform regulatory approval decisions by the Food and Drug Administration Center for Devices and Radiological Health. Five-hundred and forty United States adults with body mass index (BMI) ≥ 30 kg/m(2) evaluated tradeoffs among effectiveness, safety, and other attributes of weight-loss devices in a scientific survey. Discrete-choice experiments were used to quantify the importance of safety, effectiveness, and other attributes of weight-loss devices to obese respondents. A tool based on these measures is being used to inform benefit-risk assessments for premarket approval of medical devices. Respondent choices yielded preference scores indicating their relative value for attributes of weight-loss devices in this study. We developed a tool to estimate the minimum weight loss acceptable by a patient to receive a device with a given risk profile and the maximum mortality risk tolerable in exchange for a given weight loss. For example, to accept a device with 0.01 % mortality risk, a risk tolerant patient will require about 10 % total body weight loss lasting 5 years. Patient preference evidence was used make regulatory decision making more patient-centered. In addition, we captured the heterogeneity of patient preferences allowing market approval of effective devices for risk tolerant patients. CDRH is using the study tool to define minimum clinical effectiveness to evaluate new weight-loss devices. The methods presented can be applied to a wide variety of medical products. This study supports the ongoing development of a guidance document on incorporating patient preferences into medical-device premarket approval decisions.

78 FR 1162 - Cardiovascular Devices; Reclassification of External Cardiac Compressor

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-08

... safety and electromagnetic compatibility; For devices containing software, software verification... electromagnetic compatibility; For devices containing software, software verification, validation, and hazard... electrical components, appropriate analysis and testing must validate electrical safety and electromagnetic...

Effects of transit bus interior configuration on performance of wheeled mobility users during simulated boarding and disembarking.

PubMed

D'Souza, Clive; Paquet, Victor; Lenker, James A; Steinfeld, Edward

2017-07-01

The emergence of low-floor bus designs and related regulatory standards in the U.S. have resulted in substantial improvements in public transit accessibility. However, passengers using wheeled mobility devices still experience safety concerns and inefficiencies in boarding, disembarking, and interior circulation on low-floor buses. This study investigates effects of low-floor bus interior configuration and passenger crowding on boarding and disembarking efficiency and safety. Users of manual wheelchairs (n = 18), powered wheelchairs (n = 21) and electric scooters (n = 9) simulated boarding and disembarking in three interior layout configurations at low and high passenger crowding conditions on a full-scale laboratory mock-up of a low-floor bus. Dependent measures comprised task times and critical incidents during access ramp use, fare payment, and movement to and from the doorway and wheeled mobility securement area. Individual times for unassisted boarding ranged from 15.2 to 245.3 s and for disembarking ranged from 9.1 to 164.6 s across layout and passenger crowding conditions. Nonparametric analysis of variance showed significant differences and interactions across vehicle design conditions, passenger load and mobility device type on user performance. The configuration having electronic on-board fare payment, rear-bus entrance doorways and adjacent device securement areas demonstrated greatest efficiency and safety. High passenger load adversely impacted efficiency and frequency of critical incidents during on-board circulation across all three layouts. Findings have broader implications for improving transit system efficiency and quality of service across the spectrum of transit users. Copyright © 2017 Elsevier Ltd. All rights reserved.

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

PubMed

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.

Taguchi Based Performance and Reliability Improvement of an Ion Chamber Amplifier for Enhanced Nuclear Reactor Safety

NASA Astrophysics Data System (ADS)

Kulkarni, R. D.; Agarwal, Vivek

2008-08-01

An ion chamber amplifier (ICA) is used as a safety device for neutronic power (flux) measurement in regulation and protection systems of nuclear reactors. Therefore, performance reliability of an ICA is an important issue. Appropriate quality engineering is essential to achieve a robust design and performance of the ICA circuit. It is observed that the low input bias current operational amplifiers used in the input stage of the ICA circuit are the most critical devices for proper functioning of the ICA. They are very sensitive to the gamma radiation present in their close vicinity. Therefore, the response of the ICA deteriorates with exposure to gamma radiation resulting in a decrease in the overall reliability, unless desired performance is ensured under all conditions. This paper presents a performance enhancement scheme for an ICA operated in the nuclear environment. The Taguchi method, which is a proven technique for reliability enhancement, has been used in this work. It is demonstrated that if a statistical, optimal design approach, like the Taguchi method is used, the cost of high quality and reliability may be brought down drastically. The complete methodology and statistical calculations involved are presented, as are the experimental and simulation results to arrive at a robust design of the ICA.

Medical Device Safety

MedlinePlus

... Cooling and Heating Systems and HX2™ Temperature Management Systems Due to Revised Cleaning Instructions 05/07/18 More Medical Device Recalls Recent Medical Device Safety Communications FDA analyses and recommendations for patients and health care providers about ongoing ...

Safety and Efficacy of Microinvasive Glaucoma Surgery

PubMed Central

Chen, David Z.

2017-01-01

Microinvasive glaucoma surgery (MIGS) is emerging as a new therapeutic option for glaucoma patients who wish to reduce their medication burden and avoid the postoperative complications of conventional glaucoma filtration surgery. These devices differ in terms of their efficacy and safety profile. Schlemm's canal devices have the most favorable safety profile at the compromise of modest efficacy, while subconjunctival and suprachoroidal devices are potentially more effective at lowering the intraocular pressure at the expense of a higher rate of complications. This review consolidates the latest evidence on the efficacy and safety of the MIGS devices in clinical use and provides an overview on upcoming devices which would likely also become viable treatment options in the near future. These clinical data would assist a glaucoma surgeon in selecting the most appropriate MIGS device for each patient based on the glaucoma severity and patient expectations. PMID:28512578

The strain capacitor: A novel energy storage device

DOE Office of Scientific and Technical Information (OSTI.GOV)

Deb Shuvra, Pranoy; McNamara, Shamus, E-mail: shamus.mcnamara@louisville.edu

2014-12-15

A novel electromechanical energy storage device is reported that has the potential to have high energy densities. It can efficiently store both mechanical strain energy and electrical energy in the form of an electric field between the electrodes of a strain-mismatched bilayer capacitor. When the charged device is discharged, both the electrical and mechanical energy are extracted in an electrical form. The charge-voltage profile of the device is suitable for energy storage applications since a larger portion of the stored energy can be extracted at higher voltage levels compared to a normal capacitor. Its unique features include the potential formore » long lifetime, safety, portability, wide operating temperature range, and environment friendliness. The device can be designed to operate over varied operating voltage ranges by selecting appropriate materials and by changing the dimensions of the device. In this paper a finite element model of the device is developed to verify and demonstrate the potential of the device as an energy storage element. This device has the potential to replace conventional energy storage devices.« less

Spinoff 2011

NASA Technical Reports Server (NTRS)

2012-01-01

Topics include: Bioreactors Drive Advances in Tissue Engineering; Tooling Techniques Enhance Medical Imaging; Ventilator Technologies Sustain Critically Injured Patients; Protein Innovations Advance Drug Treatments, Skin Care; Mass Analyzers Facilitate Research on Addiction; Frameworks Coordinate Scientific Data Management; Cameras Improve Navigation for Pilots, Drivers; Integrated Design Tools Reduce Risk, Cost; Advisory Systems Save Time, Fuel for Airlines; Modeling Programs Increase Aircraft Design Safety; Fly-by-Wire Systems Enable Safer, More Efficient Flight; Modified Fittings Enhance Industrial Safety; Simulation Tools Model Icing for Aircraft Design; Information Systems Coordinate Emergency Management; Imaging Systems Provide Maps for U.S. Soldiers; High-Pressure Systems Suppress Fires in Seconds; Alloy-Enhanced Fans Maintain Fresh Air in Tunnels; Control Algorithms Charge Batteries Faster; Software Programs Derive Measurements from Photographs; Retrofits Convert Gas Vehicles into Hybrids; NASA Missions Inspire Online Video Games; Monitors Track Vital Signs for Fitness and Safety; Thermal Components Boost Performance of HVAC Systems; World Wind Tools Reveal Environmental Change; Analyzers Measure Greenhouse Gasses, Airborne Pollutants; Remediation Technologies Eliminate Contaminants; Receivers Gather Data for Climate, Weather Prediction; Coating Processes Boost Performance of Solar Cells; Analyzers Provide Water Security in Space and on Earth; Catalyst Substrates Remove Contaminants, Produce Fuel; Rocket Engine Innovations Advance Clean Energy; Technologies Render Views of Earth for Virtual Navigation; Content Platforms Meet Data Storage, Retrieval Needs; Tools Ensure Reliability of Critical Software; Electronic Handbooks Simplify Process Management; Software Innovations Speed Scientific Computing; Controller Chips Preserve Microprocessor Function; Nanotube Production Devices Expand Research Capabilities; Custom Machines Advance Composite Manufacturing; Polyimide Foams Offer Superior Insulation; Beam Steering Devices Reduce Payload Weight; Models Support Energy-Saving Microwave Technologies; Materials Advance Chemical Propulsion Technology; and High-Temperature Coatings Offer Energy Savings.

Effects Of Rapid Crushing On Composites

NASA Technical Reports Server (NTRS)

Farley, Gary L.

1990-01-01

Experimental study described in NASA technical memorandum performed to determine whether crash energy-absorption capabilities of graphite/epoxy and Kevlar/epoxy composite materials are functions of speed of crushing. Additional objective to develop understanding of mechanisms of crushing. Technology applied to enhancement of safety and crashworthiness of automobiles, design of energy-absorbing devices in machinery, and problems involving explosions and impacts.

Fabrication of Solid-State Gas Sensors by Drawing: An Undergraduate and High School Introduction to Functional Nanomaterials and Chemical Detection

ERIC Educational Resources Information Center

Smith, Merry K.; Martin-Peralta, Daphnie G.; Pivak, Polina A.; Mirica, Katherine A.

2017-01-01

Carbon nanomaterials have promising utility in chemical sensing including applications in preserving occupational safety, monitoring of environmental pollution, and human health. While recent advances in device fabrication and molecular design of functional materials have enabled rapid fabrication of chemical sensors from carbon nanomaterials,…

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

NASA Astrophysics Data System (ADS)

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

NASA Astrophysics Data System (ADS)

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.

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

ERIC Educational Resources Information Center

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…

Could changes in the wheelchair delivery system improve safety?

PubMed Central

Kirby, R L; Coughlan, S G; Christie, M

1995-01-01

Despite emerging evidence about the high incidence and severity of wheelchair-related injuries, regulations governing wheelchair safety are almost nonexistent in Canada. The authors believe that, to improve wheelchair safety, a concerted effort by government, manufacturers, purchasing groups, users and clinicians is needed. Health Canada's Health Protection Branch should treat wheelchairs as medical devices (as defined in the Food and Drugs Act 1985) and improve its injury-reporting network. Manufacturers should give a higher priority to safety in wheelchair design, improve their educational materials and formalize postmarketing surveillance. Purchasing groups should try to ensure that they do not stifle innovation in wheelchair design by setting unrealistic reimbursement ceilings and should use their market power more effectively. Users should obtain their wheelchairs in specialized settings, heed safety warnings and make more effective use of litigation when such action is warranted. Clinicians should ensure that patients are equipped with the most appropriate wheelchair for their needs, that they are given adequate training in safe wheelchair use and that they understand the dangers involved. Rapid changes in wheelchair technology and emerging evidence about the high incidence and severity of injuries related to wheelchair use suggest that such changes are needed in the wheelchair delivery system. PMID:7489551

Titanium-based, fenestrated, in-plane microneedles for passive ocular drug delivery.

PubMed

Khandan, Omid; Famili, Amin; Kahook, Malik Y; Rao, Masaru P

2012-01-01

Drug delivery to the eye remains a key challenge, due to limitations inherent to prevailing delivery techniques. For example, while topical delivery offers simplicity and safety, its efficacy is often limited by poor bioavailability, due to natural transport barriers and clearance mechanisms. Similarly, while intravitreal injections performed across the ocular tunic provide means for circumventing such limitations, non-negligible potential for retinal detachment and other complications adversely affects safety. Herein, we discuss our initial efforts to address these limitations through development of titanium-based microneedles (MNs) which seek to provide a safer, simpler, and more efficacious means of ocular drug delivery. Devices with in-plane geometry and through-thickness fenestrations that serve as drug reservoirs for passive delivery via diffusive transport from fast-dissolving coatings are demonstrated. Details regarding device design, fabrication, and mechanical testing are presented, as are results from preliminary coating characterization and insertion testing in ex vivo rabbit cornea.

Development and Application of Fiber Bragg Grating Clinometer

NASA Astrophysics Data System (ADS)

Guo, Xin; Li, Wen; Wang, Wentao; Feng, Xiaoyu

2017-06-01

Using FBG (fiber bragg grating) technology in clinometers can solve the technological problem facing by wireless transmission devices like big data transfer volume and poor stability, which has been receiving more and more attention. This paper discusses a new clinometer that is designed and transformed based on upgrading current clinometers, installing fiber grating strain gauges and fiber thermometers, and carrying out studies on such aspects as equipment upgrading, on-site setting, and data acquisition and analysis. In addition, it brings up the method of calculating displacement change based on wavelength change; this method is used in safety monitoring of the right side slope of Longyong Expressway ZK56+860 ~ ZK56+940 Section. Data shows that the device is operating well with a higher accuracy, and the slope is currently in a steady state. The equipment improvement and the method together provide reference data for safety analysis of the side slope.

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

Federal Register 2010, 2011, 2012, 2013, 2014

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...

Ethical issues associated with the introduction of new surgical devices, or just because we can, doesn't mean we should.

PubMed

Ross, Sue; Robert, Magali; Harvey, Marie-Andrée; Farrell, Scott; Schulz, Jane; Wilkie, David; Lovatsis, Danny; Epp, Annette; Easton, Bill; McMillan, Barry; Schachter, Joyce; Gupta, Chander; Weijer, Charles

2008-06-01

Surgical devices are often marketed before there is good evidence of their safety and effectiveness. Our paper discusses the ethical issues associated with the early marketing and use of new surgical devices from the perspectives of the six groups most concerned. Health Canada, which is responsible for licensing new surgical devices, should amend their requirements to include rigorous clinical trials that provide data on effectiveness and safety for each new product before it is marketed. Industry should comply with all Health Canada requirements to obtain licenses for new products. Until Health Canada requires effectiveness and safety data, industry should cooperate with physicians in appropriate studies before releasing new products and should make balanced presentations of all the available evidence. Surgeons should, before using a new surgical device, assess the evidence on its effectiveness and safety and ensure they are properly trained and competent in using the device. Surgeons should provide their patients with an evaluation of the available evidence and inform them about possible complications and the surgeon's level of experience with the new device. Patients, who should be given an honest evaluation of the available evidence, possible complications, and the surgeon's experience, should be encouraged to evaluate the evidence and information to their own satisfaction to ensure that fully informed consent is given. Health institutions, responsible for regulating practice within their walls, should review new devices for safety, effectiveness, and economic impacts, before allowing their use. They should also limit the use of new surgical devices to surgeons trained and competent in the new technology. Professional societies should provide guidance on the early adoption of new surgical devices and technologies. We urge all those involved in the development, licensing, and use of new surgical devices to aim for higher ethical standards to protect the health and safety of patients requiring surgery. The lowest acceptable ethical standard would require device manufacturers to provide surgeons with accurate and timely information on the efficacy and safety of their products, allowing surgeons and patients to evaluate the evidence (and the significance of information not yet available) before surgery.

Safety status system for operating room devices.

PubMed

Guédon, Annetje C P; Wauben, Linda S G L; Overvelde, Marlies; Blok, Joleen H; van der Elst, Maarten; Dankelman, Jenny; van den Dobbelsteen, John J

2014-01-01

Since the increase of the number of technological aids in the operating room (OR), equipment-related incidents have come to be a common kind of adverse events. This underlines the importance of adequate equipment management to improve the safety in the OR. A system was developed to monitor the safety status (periodic maintenance and registered malfunctions) of OR devices and to facilitate the notification of malfunctions. The objective was to assess whether the system is suitable for use in an busy OR setting and to analyse its effect on the notification of malfunctions. The system checks automatically the safety status of OR devices through constant communication with the technical facility management system, informs the OR staff real-time and facilitates notification of malfunctions. The system was tested for a pilot period of six months in four ORs of a Dutch teaching hospital and 17 users were interviewed on the usability of the system. The users provided positive feedback on the usability. For 86.6% of total time, the localisation of OR devices was accurate. 62 malfunctions of OR devices were reported, an increase of 12 notifications compared to the previous year. The safety status system was suitable for an OR complex, both from a usability and technical point of view, and an increase of reported malfunctions was observed. The system eases monitoring the safety status of equipment and is a promising tool to improve the safety related to OR devices.

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

PubMed

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

2017-01-01

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

Noninvasive and continuous blood pressure measurement via superficial temporal artery tonometry.

PubMed

Canning, Julia; Helbert, Kendall; Iashin, Grigoriy; Matthews, Jonathan; Yang, Jason; Delano, Margaret K; Sodini, Charles G; Quan Zhang

2016-08-01

The measurement of blood pressure is an important cardiovascular health assessment, yet the current set of methodologies is limited in resolution, repeatability, accuracy, simplicity, and safety. This paper presents the design and prototype implementation of a novel and easy-to-use medical device for noninvasive and continuous blood pressure monitoring through tonometry at the superficial temporal artery (STA). The device features a stable form factor inspired by over-ear headphones that adjusts easily from person to person using a combination prismatic and rotational joint. A stepper motor and pressure sensor, built into the device, apply a controlled force to flatten the artery and measure the wearer's blood pressure. The design is fully wireless, using Bluetooth communication to connect to a custom control and monitoring interface on the user's laptop that allows for easy calibration and real-time measurement. Preliminary testing of the device showed a percentage error from a blood pressure cuff mean arterial pressure measurement of 7.7% (7.0 mmHg). This was also compared to a Nexfin vascular unloading device, which showed a percentage error from the blood pressure cuff of 7.3% (6.6 mmHg).

75 FR 16391 - Limiting the Use of Wireless Communication Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-01

... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration 49 CFR Parts 383, 384... Communication Devices AGENCY: Federal Motor Carrier Safety Administration, DOT. ACTION: Notice of proposed rulemaking; request for comments. SUMMARY: The Federal Motor Carrier Safety Administration (FMCSA) proposes...

Commercial vehicle (CV) retrofit safety device (RSD) kits project.

DOT National Transportation Integrated Search

2014-07-01

Retrofit Safety Device (RSD) kits were developed and deployed on commercial vehicles as part of the U.S. DOT Connected Vehicle Safety Pilot to gain insight into the unique aspects of deploying connected vehicle technology in a commercial vehicle envi...

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

PubMed

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 accuracy as compared with other BTDs in a laboratory setting. Altogether, these studies suggest that the inverted cup device should replace other types of devices for use in day-to-day malaria diagnosis with RDTs.

Technology assessment of medical devices at the Center for Devices and Radiological Health.

PubMed

Kessler, L; Richter, K

1998-09-25

We reviewed the Food and Drug Administration's regulatory process for medical devices and described the issues that arise in assessing device safety and effectiveness during the postmarket period. The Center for Devices and Radiological Health (CDRH), an organization within the Food and Drug Administration, has the legal authority and responsibility for ensuring that medical devices marketed in the United States are both reasonably safe and effective for their intended use. This is an enormous challenge given the diversity of medical devices and the large number of different types of devices on the market. Many scientific and regulatory activities are necessary to ensure device safety and effectiveness, including technology assessment, albeit in a manner quite different from that of conventional technology assessment. The basic approach taken at the CDRH to ensure device safety and effectiveness is to develop an understanding of the way in which a medical device works and how it will perform in clinical situations.

Biomechanics of injury prediction for anthropomorphic manikins - preliminary design considerations

DOE Office of Scientific and Technical Information (OSTI.GOV)

Engin, A.E.

1996-12-31

The anthropomorphic manikins are used in automobile safety research as well as in aerospace related applications. There is now a strong need to advance the biomechanics knowledge to determine appropriate criteria for injury likelihood prediction as functions of manikin-measured responses. In this paper, three regions of a manikin, namely, the head, knee joint, and lumbar spine are taken as examples to introduce preliminary design considerations for injury prediction by means of responses of theoretical models and strategically placed sensing devices.

Three dimensional design, simulation and optimization of a novel, universal diabetic foot offloading orthosis

NASA Astrophysics Data System (ADS)

Sukumar, Chand; Ramachandran, K. I.

2016-09-01

Leg amputation is a major consequence of aggregated foot ulceration in diabetic patients. A common sense based treatment approach for diabetic foot ulceration is foot offloading where the patient is required to wear a foot offloading orthosis during the entire treatment course. Removable walker is an excellent foot offloading modality compared to the golden standard solution - total contact cast and felt padding. Commercially available foot offloaders are generally customized with huge cost and less patient compliance. This work suggests an optimized 3D model of a new type light weight removable foot offloading orthosis for diabetic patients. The device has simple adjustable features which make this suitable for wide range of patients with weight of 35 to 74 kg and height of 137 to 180 cm. Foot plate of this orthosis is unisexual, with a size adjustability of (US size) 6 to 10. Materials like Aluminum alloy 6061-T6, Acrylonitrile Butadiene Styrene (ABS) and Polyurethane acted as the key player in reducing weight of the device to 0.804 kg. Static analysis of this device indicated that maximum stress developed in this device under a load of 1000 N is only 37.8 MPa, with a small deflection of 0.150 cm and factor of safety of 3.28, keeping the safety limits, whereas dynamic analysis results assures the load bearing capacity of this device. Thus, the proposed device can be safely used as an orthosis for offloading diabetic ulcerated foot.

Magnetostatics Analysis, Design, and Construction of a Loudspeaker

NASA Astrophysics Data System (ADS)

Galeriu, Calin

2010-11-01

Making a loudspeaker is a very rewarding hands-on activity that can be used to teach about electro-magnetism and sound waves. Several loudspeaker designs have been described in this magazine.1-4 The simplest loudspeaker4 has only a magnet, a coil, and three plastic cups. The simpler devices3,4 require a powerful amplified output, e.g., from a boom box. The more complex devices1,2 can operate using the smaller electric current from a CD player earphone output. Unfortunately, the procedure to make a more efficient loudspeaker is lengthy and less recommended to some high school students, involving a hot glue gun, a safety razor, five-minute epoxy, etc. Our loudspeaker, a variation of Heller's,2 is both simple in construction and efficient in operation. An analysis of the magnetic field distribution helped us in the design of this loudspeaker.

A household LOC device for online monitoring bacterial pathogens in drinking water with green design concept.

PubMed

Zhao, Xinyan; Dong, Tao

2013-01-01

Bacterial waterborne pathogens often threaten the water safety of the drinking water system. In order to protect the health of home users, a household lab-on-a-chip (LOC) device was developed for online monitoring bacterial pathogens in drinking water, which are in accord with green design concept. The chip integrated counter-flow micromixers, a T-junction droplet generator and time-delay channels (TD-Cs), which can mix water sample and reactants into droplets in air flow and incubate the droplets in the LOC for about 18 hours before observation. The detection module was simplified into a transparent observation chamber, from which the home users can evaluate the qualitative result by naked eyes. The liquid waste generated by the LOC system was sterilized and absorbed by quicklime powders. No secondary pollution was found. The preliminary test of the prototype system met its design requirements.

16 CFR 1500.88 - Exemptions from lead limits under section 101 of the Consumer Product Safety Improvement Act for...

Code of Federal Regulations, 2010 CFR

2010-01-01

... 101 of the Consumer Product Safety Improvement Act for certain electronic devices. 1500.88 Section... from lead limits under section 101 of the Consumer Product Safety Improvement Act for certain electronic devices. (a) The Consumer Product Safety Improvement Act (CPSIA) provides for specific lead limits...

49 CFR 393.71 - Coupling devices and towing methods, driveaway-towaway operations.

Code of Federal Regulations, 2012 CFR

2012-10-01

... the tow-bar fails or becomes disconnected. When safety chains or cables are used as the safety device for that vehicle, at least two safety chains or cables meeting the requirements of paragraph (h)(10...-bars required in the table of paragraph (h)(1) of this section. If safety chains or cables are used as...

49 CFR 393.71 - Coupling devices and towing methods, driveaway-towaway operations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... the tow-bar fails or becomes disconnected. When safety chains or cables are used as the safety device for that vehicle, at least two safety chains or cables meeting the requirements of paragraph (h)(10...-bars required in the table of paragraph (h)(1) of this section. If safety chains or cables are used as...

49 CFR 393.71 - Coupling devices and towing methods, driveaway-towaway operations.

Code of Federal Regulations, 2011 CFR

2011-10-01

... the tow-bar fails or becomes disconnected. When safety chains or cables are used as the safety device for that vehicle, at least two safety chains or cables meeting the requirements of paragraph (h)(10...-bars required in the table of paragraph (h)(1) of this section. If safety chains or cables are used as...

The role of the Pharmaceuticals and Medical Devices Agency and healthcare professionals in post-marketing safety.

PubMed

Mori, Kazuhiko; Watanabe, Meguru; Horiuchi, Naoya; Tamura, Atsushi; Kutsumi, Hiromu

2014-04-01

The development of drugs and medical devices is necessary for medical progress; however, safety measures need to be put in place to protect the health of the population. In order to ensure the safety of drugs and medical devices, it is important to determine measures for appropriate management of risks at any time during the development phase, the regulatory review and the post-marketing phase. Adverse events detected in clinical trials are limited due to the restricted numbers of patients enrolled in the trials. Therefore, it is almost impossible to predict rare serious adverse events during the post-marketing phase. The revised Pharmaceutical Affairs Act was established in Japan in November 20, 2013. The new act focuses on increased safety of drugs and medical devices. The Pharmaceuticals and Medical Devices Agency (PMDA) is the regulatory authority in Japan that promotes safety measures from the development phase through to the post-marketing phase. In the post-marketing phase, the PMDA collects information from the medical product companies and healthcare professionals, as well as instructing and advising them with regard to post-marketing safety measures for each drug and medical device. Since Japan has a national health insurance system, a new drug or a medical device is available throughout the country when the drug price or medical fee is listed in the National Health Insurance price list. Healthcare professionals in medical institutions must learn about the drugs and medical devices they handle, and should make an effort to maintain patient safety. The PMDA medi-navi is a very useful electronic mail delivery service that provides critical information for protecting patients from health hazards caused by adverse events. The 'risk management plan' is also important as it contains important information about safety profile and post-marketing measures of a new drug.

78 FR 27442 - Coal Mine Dust Sampling Devices; Correction

Federal Register 2010, 2011, 2012, 2013, 2014

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...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-04

...: General Requirements for Safety-- Collateral Standard: Electromagnetic Compatibility--Requirements and... electromagnetic compatibility and electrical safety. Firms are now exempt from 510(k) requirements for vertical... Equipment--Part 1-2: General Requirements for Safety--Collateral Standard: Electromagnetic Compatibility...

Nanotechnology and textiles engineered by carbon nanotubes for the realization of advanced personal protective equipments

DOE Office of Scientific and Technical Information (OSTI.GOV)

Andretta, Antonio, E-mail: Antonio-Andretta@klopman.com; Terranova, Maria Letizia; Lavecchia, Teresa

2014-06-19

Carbon nanotubes (CNT) and CNT-based active materials have been used to assemble the gas sensing unit of innovative platforms able to detect toxic atmospheres developing in confined workplaces. The main goal of the project was to realize a full-featured, operator-friendly safety detection and monitoring system based on multifunctional textiles nanotechnologies. The fabricated sensing platform consists of a multiple gas detector coupled with a specifically designed telecommunication infrastructure. The portable device, totally integrated in the workwear, offers several advantages over the conventional safety tools employed in industrial work activities.

Nanotechnology and textiles engineered by carbon nanotubes for the realization of advanced personal protective equipments

NASA Astrophysics Data System (ADS)

Andretta, Antonio; Terranova, Maria Letizia; Lavecchia, Teresa; Gay, Stefano; Picano, Alfredo; Mascioletti, Alessandro; Stirpe, Daniele; Cucchiella, Cristian; Pascucci, Eddy; Dugnani, Giovanni; Gatti, Davide; Laria, Giuseppe; Codenotti, Barbara; Maldini, Giorgio; Roth, Siegmar; Passeri, Daniele; Rossi, Marco; Tamburri, Emanuela

2014-06-01

Carbon nanotubes (CNT) and CNT-based active materials have been used to assemble the gas sensing unit of innovative platforms able to detect toxic atmospheres developing in confined workplaces. The main goal of the project was to realize a full-featured, operator-friendly safety detection and monitoring system based on multifunctional textiles nanotechnologies. The fabricated sensing platform consists of a multiple gas detector coupled with a specifically designed telecommunication infrastructure. The portable device, totally integrated in the workwear, offers several advantages over the conventional safety tools employed in industrial work activities.

Clinical Evaluation of a Safety-device to Prevent Urinary Catheter Inflation Related Injuries.

PubMed

Davis, Niall F; Cunnane, Eoghan M; Mooney, Rory O'C; Forde, James C; Walsh, Michael T

2018-05-01

To evaluate the feasibility of a novel "safety-valve" device for preventing catheter related urethral trauma during urethral catheterization (UC). To assess the opinions of clinicians on the performance of the safety-valve device. A validated prototype "safety-valve" device for preventing catheter balloon inflation related urethral injuries was prospectively piloted in male patients requiring UC in a tertiary referral teaching hospital (n = 100). The device allows fluid in the catheter system to decant through an activated safety threshold pressure valve if the catheter anchoring balloon is misplaced. Users evaluated the "safety-valve" with an anonymous questionnaire. The primary outcome measurement was prevention of anchoring balloon inflation in the urethra. Secondary outcome measurement was successful inflation of urinary catheter anchoring balloon in the bladder. Patient age was 76 ± 12 years and American Society of Anaesthesiologists grade was 3 ± 1.4. The "safety-valve" was utilized by 34 clinicians and activated in 7% (n = 7/100) patients during attempted UC, indicating that the catheter anchoring balloon was incorrectly positioned in the patient's urethra. In these 7 cases, the catheter was successfully manipulated into the urinary bladder and inflated. 31 of 34 (91%) clinicians completed the questionnaire. Ten percent (n = 3/31) of respondents had previously inflated a urinary catheter anchoring balloon in the urethra and 100% (n = 31) felt that a safety mechanism for preventing balloon inflation in the urethra should be compulsory for all UCs. The safety-valve device piloted in this clinical study offers an effective solution for preventing catheter balloon inflation related urethral injuries. Copyright © 2018 Elsevier Inc. All rights reserved.

Design and finite element analysis of micro punch CNC machine modeling for medical devices

NASA Astrophysics Data System (ADS)

Pranoto, Sigiet Haryo; Mahardika, Muslim

2018-03-01

Research on micromanufacturing has been conducted. Miniaturization and weight reduction of various industrial products continue to be developed, machines with high accuracy and good quality of machining results are needed recently. This research includes design and simulation of Micro Punch CNC Machine using Abaqus with pneumatic system. This article concern of modeling simulation of punching miniplate titanium with 0.6 MPa of pressure and 500 µm of thickness. This study explaining von misses stress, safety factor and displacement analysis while the machine had the load of punching. The result gives the reaction forced of punching is 0.5 MPa on punch tip and maximum displacement is 3.237 × 10-1 mm. The safety factor is over than 12, and considered it safe for manufacturing process.

The NASA Aerospace Battery Safety Handbook

NASA Technical Reports Server (NTRS)

Halpert, Gerald; Subbarao, Surampudi; Rowlette, John J.

1986-01-01

This handbook has been written for the purpose of acquainting those involved with batteries with the information necessary for the safe handling, storage, and disposal of these energy storage devices. Included in the document is a discussion of the cell and battery design considerations and the role of the components within a cell. The cell and battery hazards are related to user- and/or manufacturer-induced causes. The Johnson Space Center (JSC) Payload Safety Guidelines for battery use in Shuttle applications are also provided. The electrochemical systems are divided into zinc anode and lithium anode primaries, secondary cells, and fuel cells. Each system is briefly described, typical applications are given, advantages and disadvantages are tabulated, and most importantly, safety hazards associated with its use are given.

Criticality Safety Evaluation for the TACS at DAF

DOE Office of Scientific and Technical Information (OSTI.GOV)

Percher, C. M.; Heinrichs, D. P.

2011-06-10

Hands-on experimental training in the physical behavior of multiplying systems is one of ten key areas of training required for practitioners to become qualified in the discipline of criticality safety as identified in DOE-STD-1135-99, Guidance for Nuclear Criticality Safety Engineer Training and Qualification. This document is a criticality safety evaluation of the training activities and operations associated with HS-3201-P, Nuclear Criticality 4-Day Training Course (Practical). This course was designed to also address the training needs of nuclear criticality safety professionals under the auspices of the NNSA Nuclear Criticality Safety Program1. The hands-on, or laboratory, portion of the course will utilizemore » the Training Assembly for Criticality Safety (TACS) and will be conducted in the Device Assembly Facility (DAF) at the Nevada Nuclear Security Site (NNSS). The training activities will be conducted by Lawrence Livermore National Laboratory following the requirements of an Integrated Work Sheet (IWS) and associated Safety Plan. Students will be allowed to handle the fissile material under the supervision of an LLNL Certified Fissile Material Handler.« less

Pyrotechnic whistle technology enhancements to law enforcement applications

NASA Astrophysics Data System (ADS)

Domanico, Joseph A.; Thomas, Terry E.

1998-12-01

In the past several years, there has been increasing interest in acoustic technology for less-than-lethal applications. Pyrotechnic whistles have been under study at the Edgewood Research, Development and engineering Center for several years for similar applications. Improvements in safety and handling, combined with increased levels of acoustic output, make the properly designed pyrotechnic whistle a valuable addition (read augmentation) to some current device designs. Either alone or in combination with other distraction effects, such as multiple concussion, strobing pyrotechnic, or microstarts, the pyrotechnic whistle family of devices provide a high level of target reaction with a minimum of collateral damage. This paper will summarize the recent research and development efforts in pyrotechnic whistle compositions, and the capabilities for the application of pyrotechnic whistles for typical law enforcement applications.

Safety Standard for Hydrogen and Hydrogen Systems: Guidelines for Hydrogen System Design, Materials Selection, Operations, Storage and Transportation. Revision

NASA Technical Reports Server (NTRS)

1997-01-01

The NASA Safety Standard, which establishes a uniform process for hydrogen system design, materials selection, operation, storage, and transportation, is presented. The guidelines include suggestions for safely storing, handling, and using hydrogen in gaseous (GH2), liquid (LH2), or slush (SLH2) form whether used as a propellant or non-propellant. The handbook contains 9 chapters detailing properties and hazards, facility design, design of components, materials compatibility, detection, and transportation. Chapter 10 serves as a reference and the appendices contained therein include: assessment examples; scaling laws, explosions, blast effects, and fragmentation; codes, standards, and NASA directives; and relief devices along with a list of tables and figures, abbreviations, a glossary and an index for ease of use. The intent of the handbook is to provide enough information that it can be used alone, but at the same time, reference data sources that can provide much more detail if required.

Value Proposition of Department of Defense Domestic Technology Transfer

DTIC Science & Technology

2010-01-15

Directorate NASA Langley Research Center and Boundary Layer Research, Inc., Everett, WA CRADA/PLA Complete Trivalent Chromium Pretreatment Naval Air...Dynamics Directorate NASA Langley Research Center and Boundary Layer Research, Inc., Everett, WA CRADA/PLA Trivalent Chromium Processes Naval Air...Warfare Systems Center, Pacific Various CRADA On-Hold Safety Welding Cart Air Force Training Device Design and Engineering Center Spika Welding

Inter-Vehicular Ad Hoc Networks: From the Ground Truth to Algorithm Design and Testbed Architecture

ERIC Educational Resources Information Center

Giordano, Eugenio

2011-01-01

Many of the devices we interact with on a daily basis are currently equipped with wireless connectivity. Soon this will be extended to the vehicles we drive/ride every day. Wirelessly connected vehicles will form a new kind of network that will enable a wide set of innovative applications ranging from enhanced safety to entertainment. To…

[Study on the application of pyroelectric infrared sensor to safety protection system].

PubMed

Wang, Song-de; Zhang, Shuan-ji; Zhu, Xiao-long; Yang, Jie-hui

2006-11-01

Using the infrared ray of human body, which is received and magnified by pyroelectric infrared sensor to form a certain voltage control signal, and using the control signal to trigger a voice recording-reproducing circuit, a pyroelectric infrared detector voice device with auto-control function designed. The circuit adopted new pyroelectric infrared detector assembly and voice recording-reproducing assembly. When someone is present in the detectable range of the pyroelectric infrared detector, first, the pyroelectric infrared sensor will transform the incepted radiation energy to a electric signal, which is then magnified and compared by an inside circuit, and an output control signal, touches off the voice recording-reproducing assembly with the reproducer sending out a beforehand transcribed caution voice to wise the man who does not know well the surrounding condition that the frontage is a danger zone and should not be approched. With the design of integrated structures, the distance-warning device has the advantages of strong anti-jamming ability, low temperature resistance, working stability and use-convenience, and it can be suitably installed and used in several locations which may endanger person safety, such as substation, high voltage switch panel, electric transformer, etc.

21 CFR 814.82 - Postapproval requirements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... periodic reporting on the safety, effectiveness, and reliability of the device for its intended use. FDA... a device and in the advertising of any restricted device of warnings, hazards, or precautions... extent required for the medical welfare of the individual, to determine the safety or effectiveness of...

The Need to Apply Medical Device Informatics in Developing Standards for Safe Interoperable Medical Systems.

PubMed

Weininger, Sandy; Jaffe, Michael B; Goldman, Julian M

2017-01-01

Medical device and health information technology systems are increasingly interdependent with users demanding increased interoperability. Related safety standards must be developed taking into account these systems' perspective. In this article, we describe the current development of medical device standards and the need for these standards to address medical device informatics. Medical device information should be gathered from a broad range of clinical scenarios to lay the foundation for safe medical device interoperability. Five clinical examples show how medical device informatics principles, if applied in the development of medical device standards, could help facilitate the development of safe interoperable medical device systems. These examples illustrate the clinical implications of the failure to capture important signals and device attributes. We provide recommendations relating to the coordination between historically separate standards development groups, some of which focus on safety and effectiveness and others focus on health informatics. We identify the need for a shared understanding among stakeholders and describe organizational structures to promote cooperation such that device-to-device interactions and related safety information are considered during standards development.

The Need to Apply Medical Device Informatics in Developing Standards for Safe Interoperable Medical Systems

PubMed Central

Weininger, Sandy; Jaffe, Michael B.; Goldman, Julian M

2016-01-01

Medical device and health information technology systems are increasingly interdependent with users demanding increased interoperability. Related safety standards must be developed taking into account this systems perspective. In this article we describe the current development of medical device standards and the need for these standards to address medical device informatics. Medical device information should be gathered from a broad range of clinical scenarios to lay the foundation for safe medical device interoperability. Five clinical examples show how medical device informatics principles, if applied in the development of medical device standards, could help facilitate the development of safe interoperable medical device systems. These examples illustrate the clinical implications of the failure to capture important signals and device attributes. We provide recommendations relating to the coordination between historically separate standards development groups; some which focus on safety and effectiveness, and others that focus on health informatics. We identify the need for a shared understanding among stakeholders and describe organizational structures to promote cooperation such that device-to-device interactions and related safety information are considered during standards development. PMID:27584685

A glucose meter evaluation co-designed with both health professional and consumer input.

PubMed

Thompson, Harmony; Chan, Huan; Logan, Florence J; Heenan, Helen F; Taylor, Lynne; Murray, Chris; Florkowski, Christopher M; Frampton, Christopher M A; Lunt, Helen

2013-11-22

Health consumer's input into assessment of medical device safety is traditionally given either as part of study outcome (trial participants) or during post marketing surveillance. Direct consumer input into the methodological design of device assessment is less common. We discuss the difference in requirements for assessment of a measuring device from the consumer and clinician perspectives, using the example of hand held glucose meters. Around 80,000 New Zealanders with diabetes recently changed their glucose meter system, to enable ongoing access to PHARMAC subsidised meters and strips. Consumers were most interested in a direct comparison of their 'old' meter system (Accu-Chek Performa) with their 'new' meter system (CareSens brand, including the CareSens N POP), rather than comparisons against a laboratory standard. This direct comparison of meter/strip systems showed that the CareSens N POP meter read around 0.6 mmol/L higher than the Performa system. Whilst this difference is unlikely to result in major errors in clinical decision making such as major insulin dosing errors, this information is nevertheless of interest to consumers who switched meters so that they could maintain access to PHARMAC subsidised meters and strips. We recommend that when practical, the consumer perspective be incorporated into study design related to medical device assessment.

Non-ablative hyperthermic mesenchymal regeneration: a proposed mechanism of action based on the Vivev model

NASA Astrophysics Data System (ADS)

Vos, Jeffrey A.; Livengood, Ryan H.; Jessop, Morris; Coad, James E.

2011-03-01

Novel non-ablative hyperthermic medical devices are currently being developed, in association with cryogen surface cooling, to rejuvenate tissues without collagen scarring. These devices have been designed to remodel skin, manage urinary stress incontinence, and more recently, treat vaginal laxity. In contrast to the thermal injury and reparative healing associated with higher energy ablation systems, these lower energy non-ablative systems are designed to subtly modify the collagen, stimulate the fibroblasts, and maintain a functional tissue architecture that subsequently promotes tissue rejuvenation and restoration. While these devices have primarily relied on clinical outcome questionnaires and satisfaction surveys to establish efficacy, a physiologic explanation for the induced tissue changes and tightening has not been well documented. Recent histology studies, using the Viveve ovine vaginal treatment model, have identified changes that propose both a mechanism of action and a tissue remodeling timeline for such non-ablative hyperthermic devices. The Viveve model results are consistent with subtle connective tissue changes leading to fibroblast stimulation and subsequent collagen replacement and augmentation. Unlike tissue ablation devices that cause thermal necrosis, these non-ablative devices renew the targeted tissue without dense collagenous scarring over a period of 3 or more months. The spectrum of histologic findings, as illustrated in the Viveve ovine vaginal model, further support the previously documented safety and efficacy profiles for low-dose non-ablative hyperthermic devices that rejuvenate and tighten submucosal tissues.

A study of medical device regulation management model in Asia.

PubMed

Wu, Yi-Hui; Li, Fong-An; Fan, Yin-Ting; Tu, Pei-Weng

2016-06-01

With the aging of the post-war baby boomer generation, the increasing demands for healthcare are driving the growth of medical industry and development of new products in order to meet the immense needs from the aging population. However, medical devices are designed to maintain the health and safety of people, therefore, medical devices are undergoing rigorous management by competent health authorities in all countries. In recent years, Asian countries have been reforming their regulations and standards for medical devices with substantial changes. The study is a summary of the framework of medical device regulations in Asian countries, including Asian Harmonization Working Party (AHWP), Japan, China, Taiwan, South Korea, India and Singapore. Expert commentary: Asian countries are constantly reforming their medical device regulations. The emergence of brand-new technology and quality management issues arose by global manufacturing have imposed difficulties in harmonizing and reaching consensus between countries. The third-party conformity assessment system for medical devices can reduce the costs for competent health authorities and shorten the review time, which could facilitate the feasibility of harmonization of medical device regulations.

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

PubMed

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.

Selection of wires and circuit protective devices for STS Orbiter vehicle payload electrical circuits

NASA Technical Reports Server (NTRS)

Gaston, Darilyn M.

1991-01-01

Electrical designers of Orbiter payloads face the challenge of determining proper circuit protection/wire size parameters to satisfy Orbiter engineering and safety requirements. This document is the result of a program undertaken to review test data from all available aerospace sources and perform additional testing to eliminate extrapolation errors. The resulting compilation of data was used to develop guidelines for the selection of wire sizes and circuit protection ratings. The purpose is to provide guidance to the engineering to ensure a design which meets Orbiter standards and which should be applicable to any aerospace design.

Development of a Portable 3CCD Camera System for Multispectral Imaging of Biological Samples

PubMed Central

Lee, Hoyoung; Park, Soo Hyun; Noh, Sang Ha; Lim, Jongguk; Kim, Moon S.

2014-01-01

Recent studies have suggested the need for imaging devices capable of multispectral imaging beyond the visible region, to allow for quality and safety evaluations of agricultural commodities. Conventional multispectral imaging devices lack flexibility in spectral waveband selectivity for such applications. In this paper, a recently developed portable 3CCD camera with significant improvements over existing imaging devices is presented. A beam-splitter prism assembly for 3CCD was designed to accommodate three interference filters that can be easily changed for application-specific multispectral waveband selection in the 400 to 1000 nm region. We also designed and integrated electronic components on printed circuit boards with firmware programming, enabling parallel processing, synchronization, and independent control of the three CCD sensors, to ensure the transfer of data without significant delay or data loss due to buffering. The system can stream 30 frames (3-waveband images in each frame) per second. The potential utility of the 3CCD camera system was demonstrated in the laboratory for detecting defect spots on apples. PMID:25350510

Designing the modern pump: engineering aspects of continuous subcutaneous insulin infusion software.

PubMed

Welsh, John B; Vargas, Steven; Williams, Gary; Moberg, Sheldon

2010-06-01

Insulin delivery systems attracted the efforts of biological, mechanical, electrical, and software engineers well before they were commercially viable. The introduction of the first commercial insulin pump in 1983 represents an enduring milestone in the history of diabetes management. Since then, pumps have become much more than motorized syringes and have assumed a central role in diabetes management by housing data on insulin delivery and glucose readings, assisting in bolus estimation, and interfacing smoothly with humans and compatible devices. Ensuring the integrity of the embedded software that controls these devices is critical to patient safety and regulatory compliance. As pumps and related devices evolve, software engineers will face challenges and opportunities in designing pumps that are safe, reliable, and feature-rich. The pumps and related systems must also satisfy end users, healthcare providers, and regulatory authorities. In particular, pumps that are combined with glucose sensors and appropriate algorithms will provide the basis for increasingly safe and precise automated insulin delivery-essential steps to developing a fully closed-loop system.

75 FR 17511 - Coal Mine Dust Sampling Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-06

... Part III Department of Labor Mine Safety and Health Adminisration 30 CFR Parts 18, 74, and 75 Coal Mine Dust Sampling Devices; High-Voltage Continuous Mining Machine Standard for Underground Coal Mines...-AB61 Coal Mine Dust Sampling Devices AGENCY: Mine Safety and Health Administration, Labor. ACTION...

Incremental Revisions across the Life Span of Ophthalmic Devices after Initial Food and Drug Administration Premarket Approval, 1979-2015.

PubMed

Gopal, Anand D; Rathi, Vinay K; Teng, Christopher C; Del Priore, Lucian; Ross, Joseph S

2017-08-01

To characterize the frequency, nature, and regulatory mechanisms by which ophthalmic devices are iteratively modified after initial Food and Drug Administration (FDA) Premarket Approval (PMA). Retrospective cross-sectional analysis using publicly available FDA data. Ophthalmic devices initially approved via the FDA's PMA pathway between January 1, 1979 and December 31, 2015. We used the FDA's PMA Database to identify and characterize initial approvals and subsequent postmarket modifications to Class III ophthalmic devices. The FDA Recalls Database was used to identify associated safety events. Median iterated life span (timespan across which modifications occurred after initial PMA) and median number of supplements approved per device, by device type, and overall, stratified by regulatory pathway and modification type. Between 1979 and 2015, the FDA approved 168 original ophthalmic devices via the PMA pathway and 2813 subsequent modifications. More than one third (n = 64; 38%) of original approvals were intraocular lenses. Overall, devices underwent a median of 11 postmarket modifications (interquartile range [IQR], 3-24.8) across a median 10.0-year iterated life span (IQR, 4.1-16.7). The majority of devices (n = 144; 86%) underwent more than 1 postapproval modification, including more than 1 design modification (n = 84; 50%). The median number of changes altering device design or labeling was 3.5 (IQR, 1-9). Although manufacturing alterations (n = 834 of 2813; 30%) were the most frequent type of revision, changes involving device design (n = 667; 24%) and labeling (n = 417; 15%) were common. Recalled devices underwent more frequent postapproval modifications per year (median, 1.4; IQR, 0.7-2.3; mean, 1.5; 95% confidence interval, 1.1-1.9) in the period preceding recall than did nonrecalled devices (median, 0.5; IQR, 0.2-1.1; mean, 0.8; 95% confidence interval, 0.7-1.0) across their market approval period (P < 0.001). Most ophthalmic devices approved via the FDA's PMA pathway have undergone extensive revisions, including serial design and labeling changes, since their initial approvals, often without supporting clinical data. Ophthalmologists should take into consideration that cumulative revisions may render the clinical evidence that supported an original FDA approval less relevant to newer device models. Copyright © 2017 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Discovering Innovation at the Intersection of Undergraduate Medical Education, Human Factors, and Collaboration: The Development of a Nasogastric Tube Safety Pack.

PubMed

Taylor, Natalie; Bamford, Thomas; Haindl, Cornelia; Cracknell, Alison

2016-04-01

Significant deficiencies exist in the knowledge and skills of medical students and residents around health care quality and safety. The theory and practice of quality and safety should be embedded into undergraduate medical practice so that health care professionals are capable of developing interventions and innovations to effectively anticipate and mitigate errors. Since 2011, Leeds Medical School in the United Kingdom has used case study examples of nasogastric (NG) tube patient safety incidents within the undergraduate patient safety curriculum. In 2012, a medical undergraduate student approached a clinician with an innovative idea after undertaking an NG tubes root cause analysis case study. Simultaneously, a separate local project demonstrated low compliance (11.6%) with the United Kingdom's National Patient Safety Agency NG tubes guideline for use of the correct method to check tube position. These separate endeavors led to interdisciplinary collaboration between a medical student, health care professionals, researchers, and industry to develop the Initial Placement Nasogastric Tube Safety Pack. Human factors engineering was used to inform pack design to allow guideline recommendations to be accessible and easy to follow. A timeline of product development, mapped against key human factors and medical device design principles used throughout the process, is presented. The safety pack has since been launched in five UK National Health Service (NHS) hospitals, and the pack has been introduced into health care professional staff training for NG tubes. A mixed-methods evaluation is currently under way in five NHS organizations.

30 CFR 250.801 - Subsurface safety devices.

Code of Federal Regulations, 2010 CFR

2010-07-01

... conditions, hydrate formation, or paraffins, an alternate setting depth of the subsurface safety device may... conditions such as permafrost, unstable bottom conditions, hydrate formations, and paraffins. (g) Subsurface...

Identifying User Needs and the Participative Design Process

NASA Astrophysics Data System (ADS)

Meiland, Franka; Dröes, Rose-Marie; Sävenstedt, Stefan; Bergvall-Kåreborn, Birgitta; Andersson, Anna-Lena

As the number of persons with dementia increases and also the demands on care and support at home, additional solutions to support persons with dementia are needed. The COGKNOW project aims to develop an integrated, user-driven cognitive prosthetic device to help persons with dementia. The project focuses on support in the areas of memory, social contact, daily living activities and feelings of safety. The design process is user-participatory and consists of iterative cycles at three test sites across Europe. In the first cycle persons with dementia and their carers (n = 17) actively participated in the developmental process. Based on their priorities of needs and solutions, on their disabilities and after discussion between the team, a top four list of Information and Communication Technology (ICT) solutions was made and now serves as the basis for development: in the area of remembering - day and time orientation support, find mobile service and reminding service, in the area of social contact - telephone support by picture dialling, in the area of daily activities - media control support through a music playback and radio function, and finally, in the area of safety - a warning service to indicate when the front door is open and an emergency contact service to enhance feelings of safety. The results of this first project phase show that, in general, the people with mild dementia as well as their carers were able to express and prioritize their (unmet) needs, and the kind of technological assistance they preferred in the selected areas. In next phases it will be tested if the user-participatory design and multidisciplinary approach employed in the COGKNOW project result in a user-friendly, useful device that positively impacts the autonomy and quality of life of persons with dementia and their carers.

49 CFR 179.103-4 - Safety relief devices and pressure regulators.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 3 2013-10-01 2013-10-01 false Safety relief devices and pressure regulators. 179...) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) SPECIFICATIONS FOR TANK CARS Specifications for Pressure Tank Car Tanks (Classes DOT-105, 109, 112, 114 and 120...

49 CFR 179.103-4 - Safety relief devices and pressure regulators.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 3 2014-10-01 2014-10-01 false Safety relief devices and pressure regulators. 179...) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) SPECIFICATIONS FOR TANK CARS Specifications for Pressure Tank Car Tanks (Classes DOT-105, 109, 112, 114 and 120...

49 CFR 179.103-4 - Safety relief devices and pressure regulators.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 2 2010-10-01 2010-10-01 false Safety relief devices and pressure regulators. 179... HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION HAZARDOUS MATERIALS REGULATIONS SPECIFICATIONS FOR TANK CARS Specifications for Pressure Tank Car Tanks (Classes DOT-105, 109, 112, 114 and 120...

49 CFR 179.103-4 - Safety relief devices and pressure regulators.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 3 2011-10-01 2011-10-01 false Safety relief devices and pressure regulators. 179...) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) SPECIFICATIONS FOR TANK CARS Specifications for Pressure Tank Car Tanks (Classes DOT-105, 109, 112, 114 and 120...

78 FR 14015 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Patient Transport

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-04

... for Safety--Collateral Standard: Electromagnetic Compatibility--Requirements and Tests,'' and ASME A18.1 ``Safety Standard for Platform Lifts and Stairway Chair Lifts'') must validate electromagnetic...: Electromagnetic Compatibility--Requirements and Tests,'' and ASME A18.1 ``Safety Standard for Platform Lifts and...

Innovative Designs for the Smart ICU.

PubMed

Halpern, Neil A

2014-03-01

Successfully designing a new ICU requires clarity of vision and purpose and the recognition that the patient room is the core of the ICU experience for patients, staff, and visitors. The ICU can be conceptualized into three components: the patient room, central areas, and universal support services. Each patient room should be designed for single patient use and be similarly configured and equipped. The design of the room should focus upon functionality, ease of use, healing, safety, infection control, communications, and connectivity. All aspects of the room, including its infrastructure; zones for work, care, and visiting; environment, medical devices, and approaches to privacy; logistics; and waste management, are important elements in the design process. Since most medical devices used at the ICU bedside are really sophisticated computers, the ICU needs to be capable of supporting the full scope of medical informatics. The patient rooms, the central ICU areas (central stations, corridors, supply rooms, pharmacy, laboratory, staff lounge, visitor waiting room, on-call suite, conference rooms, and offices), and the universal support services (infection prevention, finishings and flooring, staff communications, signage and wayfinding, security, and fire and safety) work best when fully interwoven. This coordination helps establish efficient and safe patient throughput and care and fosters physical and social cohesiveness within the ICU. A balanced approach to centralized and decentralized monitoring and logistics also offers great flexibility. Synchronization of the universal support services in the ICU with the hospital's existing systems maintains unity of purpose and continuity across the enterprise and avoids unnecessary duplication of efforts. Copyright © 2014 The American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

30 CFR 57.14132 - Horns and backup alarms for surface equipment.

Code of Federal Regulations, 2010 CFR

2010-07-01

... NONMETAL MINES Machinery and Equipment Safety Devices and Maintenance Requirements § 57.14132 Horns and backup alarms for surface equipment. (a) Manually-operated horns or other audible warning devices provided on self-propelled mobile equipment as a safety device shall be maintained in a functional...

30 CFR 75.1107-13 - Approval of other fire suppression devices.

Code of Federal Regulations, 2010 CFR

2010-07-01

... COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Fire Protection Fire Suppression Devices and Fire-Resistant Hydraulic Fluids on Underground Equipment § 75.1107-13 Approval of... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approval of other fire suppression devices. 75...

46 CFR 98.25-40 - Valves, fittings, and accessories.

Code of Federal Regulations, 2013 CFR

2013-10-01

... located at the highest practical point. The thermometer well shall terminate in the liquid space and be... and discharge liquid and vapor shut-off valves, safety relief valves, liquid level gaging devices... to the tanks, except safety devices and liquid level gaging devices, shall have manually operated...

46 CFR 98.25-40 - Valves, fittings, and accessories.

Code of Federal Regulations, 2012 CFR

2012-10-01

... located at the highest practical point. The thermometer well shall terminate in the liquid space and be... and discharge liquid and vapor shut-off valves, safety relief valves, liquid level gaging devices... to the tanks, except safety devices and liquid level gaging devices, shall have manually operated...

46 CFR 98.25-40 - Valves, fittings, and accessories.

Code of Federal Regulations, 2011 CFR

2011-10-01

... located at the highest practical point. The thermometer well shall terminate in the liquid space and be... and discharge liquid and vapor shut-off valves, safety relief valves, liquid level gaging devices... to the tanks, except safety devices and liquid level gaging devices, shall have manually operated...

46 CFR 98.25-40 - Valves, fittings, and accessories.

Code of Federal Regulations, 2014 CFR

2014-10-01

... located at the highest practical point. The thermometer well shall terminate in the liquid space and be... and discharge liquid and vapor shut-off valves, safety relief valves, liquid level gaging devices... to the tanks, except safety devices and liquid level gaging devices, shall have manually operated...

49 CFR 392.9 - Inspection of cargo, cargo securement devices and systems.

Code of Federal Regulations, 2010 CFR

2010-10-01

...) FEDERAL MOTOR CARRIER SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS DRIVING OF COMMERCIAL MOTOR VEHICLES General § 392.9 Inspection of cargo, cargo securement devices... drives that commercial motor vehicle; (2) Inspect the cargo and the devices used to secure the cargo...

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

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false Schedule B-prototype tests for luminous safety devices for... thermometer. (d) Shock test. The device shall be dropped upon a concrete or iron surface in a 3-foot free gravitational fall, or shall be subjected to equivalent treatment in a test device simulating such a free fall...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-23

... Mitigation measures Excessive laser power Electrical safety and electromagnetic compatibility (EMC... should validate electromagnetic compatibility (EMC), electrical safety, and battery characteristics; (4...

Evaluation of Human and Anthropomorphic Test Device Finite Element Models under Spaceflight Loading Conditions

NASA Technical Reports Server (NTRS)

Putnam, Jacob P.; Untaroiu, Costin; Somers. Jeffrey

2014-01-01

In an effort to develop occupant protection standards for future multipurpose crew vehicles, the National Aeronautics and Space Administration (NASA) has looked to evaluate the test device for human occupant restraint with the modification kit (THOR-K) anthropomorphic test device (ATD) in relevant impact test scenarios. With the allowance and support of the National Highway Traffic Safety Administration, NASA has performed a series of sled impact tests on the latest developed THOR-K ATD. These tests were performed to match test conditions from human volunteer data previously collected by the U.S. Air Force. The objective of this study was to evaluate the THOR-K finite element (FE) model and the Total HUman Model for Safety (THUMS) FE model with respect to the tests performed. These models were evaluated in spinal and frontal impacts against kinematic and kinetic data recorded in ATD and human testing. Methods: The FE simulations were developed based on recorded pretest ATD/human position and sled acceleration pulses measured during testing. Predicted responses by both human and ATD models were compared to test data recorded under the same impact conditions. The kinematic responses of the models were quantitatively evaluated using the ISO-metric curve rating system. In addition, ATD injury criteria and human stress/strain data were calculated to evaluate the risk of injury predicted by the ATD and human model, respectively. Results: Preliminary results show well-correlated response between both FE models and their physical counterparts. In addition, predicted ATD injury criteria and human model stress/strain values are shown to positively relate. Kinematic comparison between human and ATD models indicates promising biofidelic response, although a slightly stiffer response is observed within the ATD. Conclusion: As a compliment to ATD testing, numerical simulation provides efficient means to assess vehicle safety throughout the design process and further improve the design of physical ATDs. The assessment of the THOR-K and THUMS FE models in a spaceflight testing condition is an essential first step to implementing these models in the computational evaluation of spacecraft occupant safety. Promising results suggest future use of these models in the aerospace field.

Innovation design of medical equipment based on TRIZ.

PubMed

Gao, Changqing; Guo, Leiming; Gao, Fenglan; Yang, Bo

2015-01-01

Medical equipment is closely related to personal health and safety, and this can be of concern to the equipment user. Furthermore, there is much competition among medical equipment manufacturers. Innovative design is the key to success for those enterprises. The design of medical equipment usually covers vastly different domains of knowledge. The application of modern design methodology in medical equipment and technology invention is an urgent requirement. TRIZ (Russian abbreviation of what can be translated as `theory of inventive problem solving') was born in Russia, which contain some problem-solving methods developed by patent analysis around the world, including Conflict Matrix, Substance Field Analysis, Standard Solution, Effects, etc. TRIZ is an inventive methodology for problems solving. As an Engineering example, infusion system is analyzed and re-designed by TRIZ. The innovative idea is generated to liberate the caretaker from the infusion bag watching out. The research in this paper shows the process of the application of TRIZ in medical device inventions. It is proved that TRIZ is an inventive methodology for problems solving and can be used widely in medical device development.

Using human factors engineering to improve patient safety in the cardiovascular operating room.

PubMed

Gurses, Ayse P; Martinez, Elizabeth A; Bauer, Laura; Kim, George; Lubomski, Lisa H; Marsteller, Jill A; Pennathur, Priyadarshini R; Goeschel, Chris; Pronovost, Peter J; Thompson, David

2012-01-01

Despite significant medical advances, cardiac surgery remains a high risk procedure. Sub-optimal work system design characteristics can contribute to the risks associated with cardiac surgery. However, hazards due to work system characteristics have not been identified in the cardiovascular operating room (CVOR) in sufficient detail to guide improvement efforts. The purpose of this study was to identify and categorize hazards (anything that has the potential to cause a preventable adverse patient safety event) in the CVOR. An interdisciplinary research team used prospective hazard identification methods including direct observations, contextual inquiry, and photographing to collect data in 5 hospitals for a total 22 cardiac surgeries. We performed thematic analysis of the qualitative data guided by a work system model. 60 categories of hazards such as practice variations, high workload, non-compliance with evidence-based guidelines, not including clinicians' in medical device purchasing decisions were found. Results indicated that hazards are common in cardiac surgery and should be eliminated or mitigated to improve patient safety. To improve patient safety in the CVOR, efforts should focus on creating a culture of safety, increasing compliance with evidence based infection control practices, improving communication and teamwork, and designing better tools and technologies through partnership among all stakeholders.

Occupational hazards and safety measures amongst the paint factory workers in lagos, Nigeria.

PubMed

Awodele, Olufunsho; Popoola, Temidayo D; Ogbudu, Bawo S; Akinyede, Akin; Coker, Herbert A B; Akintonwa, Alade

2014-06-01

The manufacture of paint involves a variety of processes that present with medical hazards. Safety initiatives are hence introduced to limit hazard exposures and promote workplace safety. This aim of this study is to assess the use of available control measures/initiatives in selected paint factories in Lagos West Senatorial District, Nigeria. A total of 400 randomly selected paint factory workers were involved in the study. A well-structured World Health Organization standard questionnaire was designed and distributed to the workers to elicit information on awareness to occupational hazards, use of personal protective devices, and commonly experienced adverse symptoms. Urine samples were obtained from 50 workers randomly selected from these 400 participants, and the concentrations of the heavy metals (lead, cadmium, arsenic, and chromium) were determined using atomic absorption spectroscopy. The results show that 72.5% of the respondents are aware of the hazards associated with their jobs; 30% have had formal training on hazards and safety measures; 40% do not use personal protective devices, and 90% of the respondents reported symptoms relating to hazard exposure. There was a statistically significant (p < 0.05) increase in the mean heavy metal concentrations in the urine samples obtained from paint factory workers as compared with nonfactory workers. The need to develop effective frameworks that will initiate the integration and ensure implementation of safety regulations in paint factories is evident. Where these exist, there is a need to promote adherence to these practice guidelines.

Fast-acting nuclear reactor control device

DOEpatents

Kotlyar, Oleg M.; West, Phillip B.

1993-01-01

A fast-acting nuclear reactor control device for moving and positioning a fety control rod to desired positions within the core of the reactor between a run position in which the safety control rod is outside the reactor core, and a shutdown position in which the rod is fully inserted in the reactor core. The device employs a hydraulic pump/motor, an electric gear motor, and solenoid valve to drive the safety control rod into the reactor core through the entire stroke of the safety control rod. An overrunning clutch allows the safety control rod to freely travel toward a safe position in the event of a partial drive system failure.

77 FR 26045 - Agency Information Collection Activities; Proposed Collection; Comments Requested: Certification...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-02

... Secure Gun Storage or Safety Devices ACTION: 30-Day Notice of information collection. The Department of... approved collection. (2) Title of the Form/Collection: Certification of Secure Gun Storage or Safety... to the availability of secure gun storage or safety devices. (5) An estimate of the total number of...

30 CFR 75.1714-2 - Self-rescue devices; use and location requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... requirements. 75.1714-2 Section 75.1714-2 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Miscellaneous... paragraph (c), (d), (e), or (f) of this section, self-rescue devices shall be worn or carried at all times...

Understanding the C-pulse device and its potential to treat heart failure.

PubMed

Sales, Virna L; McCarthy, Patrick M

2010-03-01

The Sunshine Heart C-Pulse (C-Pulse; Sunshine Heart Inc., Tustin, CA) device is an extra-aortic implantable counterpulsation pump designed as a non-blood contacting ambulatory heart assist device, which may provide relief from symptoms for class II-III congestive heart failure patients. It has a comparable hemodynamic augmentation to intra-aortic balloon counterpulsation devices. The C-Pulse cuff is implanted through a median sternotomy, secured around the ascending aorta, and pneumatically driven by an external system controller. Pre-clinical studies in the acute pig model, and initial temporary clinical studies in patients undergoing off-pump coronary bypass surgery have shown substantial increase in diastolic perfusion of the coronary vessels, which translated to a favorable improvement in ventricular function. A U.S. prospective multi-center trial to evaluate the safety and efficacy of the C-Pulse in class III patients with moderate heart failure is now in progress.

Study on light and thermal energy of illumination device for plant factory design

NASA Astrophysics Data System (ADS)

Yoshida, A.; Moriuchi, K.; Ueda, Y.; Kinoshita, S.

2018-01-01

To investigate the effect of illumination devices on the yield of crops cultivated in a plant factory, it is necessary to measure the actual cultivation environmental factors related to the plant growth and understand the distribution ratio of light and thermal energy to the electrical energy injected into the illumination device. Based on cultivation results, we found that light intensity greatly affected the growth of plant weight. Regarding the selection of illumination device, its spectral components also affected the morphological change. Lighting experiments using a high frequency (Hf) fluorescent lamp and a light emitting diode (LED) bulb were performed. A certain difference was found in the distribution ratio of light energy to electrical energy between Hf and LED. It was showed that by placing the safety equipment or internal circuits outside the cultivated site, the air conditioning load could be reduced.

Micro Electromechanical Systems (MEMS) Based Microfluidic Devices for Biomedical Applications

PubMed Central

Ashraf, Muhammad Waseem; Tayyaba, Shahzadi; Afzulpurkar, Nitin

2011-01-01

Micro Electromechanical Systems (MEMS) based microfluidic devices have gained popularity in biomedicine field over the last few years. In this paper, a comprehensive overview of microfluidic devices such as micropumps and microneedles has been presented for biomedical applications. The aim of this paper is to present the major features and issues related to micropumps and microneedles, e.g., working principles, actuation methods, fabrication techniques, construction, performance parameters, failure analysis, testing, safety issues, applications, commercialization issues and future prospects. Based on the actuation mechanisms, the micropumps are classified into two main types, i.e., mechanical and non-mechanical micropumps. Microneedles can be categorized according to their structure, fabrication process, material, overall shape, tip shape, size, array density and application. The presented literature review on micropumps and microneedles will provide comprehensive information for researchers working on design and development of microfluidic devices for biomedical applications. PMID:21747700

Lasers and laser-like devices: part one.

PubMed

Stewart, Nicholas; Lim, Adrian C; Lowe, Patricia M; Goodman, Greg

2013-08-01

Lasers have been used in dermatology for nearly 50 years. Through their selective targeting of skin chromophores they have become the preferred treatment for many skin conditions, including vascular malformations, photorejuvenation and acne scars. The technology and design of lasers continue to evolve, allowing greater control of laser parameters and resulting in increased safety and efficacy for patients. Innovations have allowed the range of conditions and the skin types amenable to treatment, in both general and cosmetic dermatology, to expand over the last decade. Integrated skin cooling and laser beam fractionation, for example, have improved safety, patient tolerance and decreased downtime. Furthermore, the availability and affordability of quality devices continues to increase, allowing clinicians not only to access laser therapies more readily but also to develop their personal experience in this field. As a result, most Australian dermatologists now have access to laser therapies, either in their own practice or within referable proximity, and practical knowledge of these technologies is increasingly required and expected by patients. Non-laser energy devices utilising intense pulsed light, plasma, radiofrequency, ultrasound and cryolipolysis contribute to the modern laser practitioners' armamentarium and will also be discussed. © 2013 The Authors. Australasian Journal of Dermatology © 2013 The Australasian College of Dermatologists.

30 CFR 75.1101-10 - Water sprinkler systems; fire warning devices at belt drives.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Water sprinkler systems; fire warning devices..., DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Fire Protection § 75.1101-10 Water sprinkler systems; fire warning devices at belt drives. Each water sprinkler...

30 CFR 75.1101-10 - Water sprinkler systems; fire warning devices at belt drives.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Water sprinkler systems; fire warning devices..., DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Fire Protection § 75.1101-10 Water sprinkler systems; fire warning devices at belt drives. Each water sprinkler...

30 CFR 75.1101-10 - Water sprinkler systems; fire warning devices at belt drives.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Water sprinkler systems; fire warning devices..., DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Fire Protection § 75.1101-10 Water sprinkler systems; fire warning devices at belt drives. Each water sprinkler...

30 CFR 75.1101-10 - Water sprinkler systems; fire warning devices at belt drives.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Water sprinkler systems; fire warning devices..., DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Fire Protection § 75.1101-10 Water sprinkler systems; fire warning devices at belt drives. Each water sprinkler...

30 CFR 75.1101-10 - Water sprinkler systems; fire warning devices at belt drives.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Water sprinkler systems; fire warning devices..., DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Fire Protection § 75.1101-10 Water sprinkler systems; fire warning devices at belt drives. Each water sprinkler...

Magnetic-adhesive based valves for microfluidic devices used in low-resource settings.

PubMed

Harper, Jason C; Andrews, Jenna M; Ben, Candice; Hunt, Andrew C; Murton, Jaclyn K; Carson, Bryan D; Bachand, George D; Lovchik, Julie A; Arndt, William D; Finley, Melissa R; Edwards, Thayne L

2016-10-18

Since the introduction of micro total analytical systems (μTASs), significant advances have been made toward development of lab-on-a-chip platforms capable of performing complex biological assays that can revolutionize public health, among other applications. However, use of these platforms in low-resource environments (e.g. developing countries) has yet to be realized as the majority of technologies used to control microfluidic flow rely on off-device hardware with non-negligible size, cost, power requirements and skill/training to operate. In this paper we describe a magnetic-adhesive based valve that is simple to construct and operate, and can be used to control fluid flow and store reagents within a microfluidic device. The design consists of a port connecting two chambers on different planes in the device that is closed by a neodymium disk magnet seated on a thin ring of adhesive. Bringing an external magnet into contact with the outer surface of the device unseats and displaces the valve magnet from the adhesive ring, exposing the port. Using this configuration, we demonstrate on-device reagent storage and on-demand transport and reaction of contents between chambers. This design requires no power or external instrumentation to operate, is extremely low cost ($0.20 materials cost per valve), can be used by individuals with no technical training, and requires only a hand-held magnet to actuate. Additionally, valve actuation does not compromise the integrity of the completely sealed microfluidic device, increasing safety for the operator when toxic or harmful substances are contained within. This valve concept has the potential to simplify design of μTASs, facilitating development of lab-on-a-chip systems that may be practical for use in point-of-care and low-resource settings.

Demonstration Advanced Avionics System (DAAS)

NASA Technical Reports Server (NTRS)

1982-01-01

The feasibility of developing an integrated avionics system suitable for general aviation was determined. A design of reliable integrated avionics which provides expanded functional capability that significantly enhances the utility and safety of general aviation at a cost commensurate with the general aviation market was developed. The use of a data bus, microprocessors, electronic displays and data entry devices, and improved function capabilities were emphasized. An avionics system capable of evaluating the most critical and promising elements of an integrated system was designed, built and flight tested in a twin engine general aviation aircraft.

Appraisal of evidence base for introduction of new implants in hip and knee replacement: a systematic review of five widely used device technologies

PubMed Central

Nieuwenhuijse, Marc J; Nelissen, R G H H; Schoones, J W

2014-01-01

Objective To determine the evidence of effectiveness and safety for introduction of five recent and ostensibly high value implantable devices in major joint replacement to illustrate the need for change and inform guidance on evidence based introduction of new implants into healthcare. Design Systematic review of clinical trials, comparative observational studies, and registries for comparative effectiveness and safety of five implantable device innovations. Data sources PubMed (Medline), Embase, Web of Science, Cochrane, CINAHL, reference lists of articles, annual reports of major registries, summaries of safety and effectiveness for pre-market application and mandated post-market studies at the US Food and Drug Administration. Study selection The five selected innovations comprised three in total hip replacement (ceramic-on-ceramic bearings, modular femoral necks, and uncemented monoblock cups) and two in total knee replacement (high flexion knee replacement and gender specific knee replacement). All clinical studies of primary total hip or knee replacement for symptomatic osteoarthritis in adults that compared at least one of the clinical outcomes of interest (patient centred outcomes or complications, or both) in the new implant group and control implant group were considered. Data searching, abstraction, and analysis were independently performed and confirmed by at least two authors. Quantitative data syntheses were performed when feasible. Results After assessment of 10 557 search hits, 118 studies (94 unique study cohorts) met the inclusion criteria and reported data related to 15 384 implants in 13 164 patients. Comparative evidence per device innovation varied from four low to moderate quality retrospective studies (modular femoral necks) to 56 studies of varying quality including seven high quality (randomised) studies (high flexion knee replacement). None of the five device innovations was found to improve functional or patient reported outcomes. National registries reported two to 12 year follow-up for revision occurrence related to more than 200 000 of these implants. Reported comparative data with well established alternative devices (over 1 200 000 implants) did not show improved device survival. Moreover, we found higher revision occurrence associated with modular femoral necks (hazard ratio 1.9) and ceramic-on-ceramic bearings (hazard ratio 1.0-1.6) in hip replacement and with high flexion knee implants (hazard ratio 1.0-1.8). Conclusion We did not find convincing high quality evidence supporting the use of five substantial, well known, and already implemented device innovations in orthopaedics. Moreover, existing devices may be safer to use in total hip or knee replacement. Improved regulation and professional society oversight are necessary to prevent patients from being further exposed to these and future innovations introduced without proper evidence of improved clinical efficacy and safety. PMID:25208953