Software Safety Research Articles

Safety and feasibility of novel technology fusing echocardiography and fluoroscopy images during MitraClip interventions

The EchoNavigator (EN) software (Philips Healthcare, Best, The Netherlands) enables real-time fusion of echocardiography and fluoroscopy by co-registration of the echocardiography probe on the x-ray image. We aimed to evaluate the feasibility and safety of this novel software during MitraClip procedures. Twenty-one patients were treated with the support of EchoNavigator software (EN+ patients). The primary (safety) endpoint was the total radiation dose. Secondary endpoints were fluoroscopy and total procedure time. The measurements were compared to those of 21 patients treated immediately before the installation of EchoNavigator (EN- patients). More MitraClips (45 vs. 36) were implanted in the EN+ group, mirroring more complex interventions in this group. In EN+ patients, radiation dose (Gy/cm2) was similar compared to EN- patients (146.5±123.6 vs.146.8±134.1, p=0.9). Total procedure time (minutes) was similar in the EN+ group compared to EN- patients (136.2±50.2 vs. 125.7±51.2, p=0.5). The main benefit of the EchoNavigator is the automated real-time fusion of echocardiography and fluoroscopy, leading to easier catheter manipulation. The use of EchoNavigator software was feasible and safe in all study patients. Further studies are necessary to confirm the benefits of using this software.

A DEVELOPMENT FRAMEWORK FOR SOFTWARE SECURITY IN NUCLEAR SAFETY SYSTEMS: INTEGRATING SECURE DEVELOPMENT AND SYSTEM SECURITY ACTIVITIES

The protection of nuclear safety software is essential in that a failure can result in significant economic loss and physical damage to the public. However, software security has often been ignored in nuclear safety software development. To enforce security considerations, nuclear regulator commission recently issued and revised the security regulations for nuclear computer-based systems. It is a great challenge for nuclear developers to comply with the security requirements. However, there is still no clear software development process regarding security activities. This paper proposes an integrated development process suitable for the secure development requirements and system security requirements described by various regulatory bodies. It provides a three-stage framework with eight security activities as the software development process. Detailed descriptions are useful for software developers and licensees to understand the regulatory requirements and to establish a detailed activity plan for software design and engineering.

A SOFTWARE RELIABILITY ESTIMATION METHOD TO NUCLEAR SAFETY SOFTWARE

A method for estimating software reliability for nuclear safety software is proposed in this paper. This method is based on the software reliability growth model (SRGM), where the behavior of software failure is assumed to follow a non-homogeneous Poisson process. Two types of modeling schemes based on a particular underlying method are proposed in order to more precisely estimate and predict the number of software defects based on very rare software failure data. The Bayesian statistical inference is employed to estimate the model parameters by incorporating software test cases as a covariate into the model. It was identified that these models are capable of reasonably estimating the remaining number of software defects which directly affects the reactor trip functions. The software reliability might be estimated from these modeling equations, and one approach of obtaining software reliability value is proposed in this paper.

Research on Software Hazard Classification

The detection and prevention of hazard is the focus of software safety. It helps safety personnel to eliminate hazard and find unknown hazard through the research on the classification of software hazard. The current situation of software hazard and concepts are first introduced in this paper. And then software hazard classification is presented from three aspects which based on the structure, system and process. This paper provides a new good way to solve software safety testing and testing requirements analysis from the angle of reuse and efficiency.

Safety Analysis of Software Requirements: Model and Process

Since lots of software hazards are caused by incompleteness or omissions of requirements, safety analysis of software requirements becomes more and more important. However, there are no systematic researches and exposition on the scope and the requirements of safety analysis. Safety analysts often get confused about how to take a complete analysis of software safety requirements. In this paper, referring to the software V&V model, an analysis model is proposed to specify the scope of software requirements safety analysis. Then, a process framework of safety analysis is determined to verify those analysis requirements derived from the analysis model. Relevant software safety analysis techniques which may be used in the analysis process framework were classified. Finally, the analysis model and process were applied to the landing gear control system.

Software Safety Testing based on STPA

Software safety testing is important to critical software in Avionics; however, the safety test requirements are usually not clear during system-level testing. Considering software safety engineering and software test theory, this paper researches software safety testing based on STPA. It proposes a software safety test framework which includes 4 phases: software safety test planning, software safety test design, software safety test implementation and software safety test assessment; then to obtain software safety test requirements in safety testing, it introduces a method of software safety test requirements elicitation based on STPA, and an example is given to explain how to put it into use.

Research on Elicitation of Safety Testing Requirements for Airborne Software

Software safety testing requirements elicitation method was put forward based on the safety-critical software including safety testing requirements classification, safety testing requirements decomposition and the finishing of elicitation sources in order to get more perfect software safety testing requirements. And it was compared with the safety testing requirements of current test methods. Finally the elicited testing requirements were applied in certain engine control software, and was validated more sufficiently.

Development of a Visualization System for Safety Analyst

The AASHTO software Safety Analyst is a state-of-the-art tool with significant capabilities and advanced analytical methods for comprehensive analysis and management of highway safety. However, this tool does not provide visualization capabilities. To address that limitation, this study proposes a visualization system for Safety Analyst that provides graphical displays, including location and color-coded information for each module. In addition, the system generates charts, which have various degrees of resolution and aggregation; tables; and a report summarizing safety performance measures. The system can use Google Maps or ESRI ArcGIS to generate the graphical displays. The advantage of using Google Maps is its simplicity; in contrast, the ArcGIS display provides additional modeling and computing capabilities of the GIS framework. All displays are very intuitive and can be customized according to user needs. Because the user can see the locations of every specific site, the displays facilitate analysis as well as the decision-making process. The visualization system interacts with Safety Analyst so that the user can access all tools and data throughout the entire modeling and analysis process.

Code Search API, Base of Parallel Code Refactoring System For Safety Standards Compliance

New technologies of multi-core and massively parallel processors are becoming common parts of today’s desktop computers. These state-of-the-art technologies allow programming of parallel applications and systems, however, creating parallel applications puts higher demands on programmers’ skills,projectmaintenanceandmodificationofexistingsourcecodes.Program flaws entered on source codes could have fatal consequences, specifically in aviation or medicine systems, due to possible fatal impacts in case of systems failure. This paper describes the current status of aviation and medicine software safety standards, points out the common requirements of all these standards, specially the requirement for reliability. Reliability can be easily achieved using design patterns with verified reliable source code modules. In our research, we propose system for implementation of concurrency and synchronization design patterns into existing code. We have created parallel source code search API which is described in this paper, and which is planned to be used in our parallel code refactoring system for safety standards compliance. ThisAPI enables us to define appropriate places in source codes for introduction of parallel design patterns into existing parallel source codes. In next design iteration, the proposed system will provide suggestions of refactoring operations of found source codes, based on static code analysis and formal description of parallel design patterns.

The Integration of the Risk Management Process with the Lifecycle of Medical Device Software

The application of software in the Medical Device (MD) domain has become central to the improvement of diagnoses and treatments. The new European regulations that specifically address software as an important component of MD, require complex procedures to make software compliant with safety requirements, introducing thereby new challenges in the qualification and classification of MD software as well as in the performance of risk management activities. Under this perspective, the aim of this paper is to propose an integrated framework that combines the activities to be carried out by the manufacturer to develop safe software within the development lifecycle based on the regulatory requirements reported in US and European regulations as well as in the relevant standards and guidelines. A comparative analysis was carried out to identify the main issues related to the application of the current new regulations. In addition, standards and guidelines recently released to harmonise procedures for the validation of MD software have been used to define the risk management activities to be carried out by the manufacturer during the software development process. This paper highlights the main issues related to the qualification and classification of MD software, providing an analysis of the different regulations applied in Europe and the US. A model that integrates the risk management process within the software development lifecycle has been proposed too. It is based on regulatory requirements and considers software risk analysis as a central input to be managed by the manufacturer already at the initial stages of the software design, in order to prevent MD failures. Relevant changes in the process of MD development have been introduced with the recognition of software being an important component of MDs as stated in regulations and standards. This implies the performance of highly iterative processes that have to integrate the risk management in the framework of software development. It also makes it necessary to involve both medical and software engineering competences to safeguard patient and user safety.

Supervisory Controller Synthesis for Safe Software Adaptation

Today's software systems need to adapt their behavior due to the changes in their operational environments and user requirements. To this end, an adaptive software performs a sequence of adaptations at runtime. Correctness of the behavior of an adaptive software system during dynamic adaptation is an important challenge along the way to realize correct adaptive systems. In this research, we model adaptation as a supervisory control problem and synthesize a controller that guides the behavior of a software system during adaptation. The system during adaptation is modeled using a graph transition system and properties to be enforced are specified using an automaton. To ensure correctness, we then synthesize a controller that imposes constraints on the system during adaptation.

Session details: Approaches to software safety and security

Session details: Approaches to software safety and security

Implementing smart pump technology in a pediatric intensive care unit: A cost-effective approach

ObjectiveTo analyze the cost effectiveness of implementing smart infusion pump technology in a pediatric intensive care unit (PICU). Material and methodsAn observational, prospective, intervention study with analytical components was carried out. A drug library was developed and integrated into the Carefusion Alaris Guardrails® infusion systems. A systematic analysis of all the data stored on the devices during use was performed by the data processing program Guardrails® CQI v4.1 Event Reporter. Intercepted errors were classified in terms of their potential severity and probability of causing an adverse effect (PAE) had they reached the patient. Knowing the estimated cost of a preventable adverse effect (AE), we analyzed costs saved and the profit/cost ratio resulting from the implementation process. ResultsCompliance with the drug library was 92% and during the study period 92 infusion-related programming errors were intercepted, leading to a saving of 172,279 euros by preventing AEs. This means that 2.15 euros would be obtained for each euro invested in hiring a pharmacist to implement this technology. DiscussionThe high percentage of use of safety software in our study compared to others allowed for the interception of 92 errors. The estimation of the potential impact of these errors is based on clinical judgment. The cost saved might be underestimated because the cost of an AE is usually higher in pediatrics, indirect and intangible costs were not considered and pharmacists involved do not spend the whole day on this task. ConclusionsSmart pumps have shown to be profitable in a PICU because they have the ability to intercept potentially serious medication errors and reduce costs associated with such errors.

Analysis for Floor Slabs of Wall-Slab System

The structure of Wall-slab is composed of slab and shear wall, and only in the outer wall part are the shear wall connected by a coupling beam. The floor and shear wall can bear vertical force and horizontal lateral force together. While under the situation of irregular bearing form shear wall and irregular partition loads, tablet computing becomes an urgent problem. Aiming at this problem, the model which is one layer of floor of Wall system has been used for analysis through the Safe software. In the condition of different thickness of slabs, exploratory results can get about the slab deformations, stresses and reinforcement ratios. The paragraph provides the basis to determine the optimal thickness of plate.

Using smart pumps to understand and evaluate clinician practice patterns to ensure patient safety.

Safety software installed on intravenous (IV) infusion pumps has been shown to positively impact the quality of patient care through avoidance of medication errors. The data derived from the use of smart pumps are often overlooked, although these data provide helpful insight into the delivery of quality patient care. The objectives of this report are to describe the value of implementing IV infusion safety software and analyzing the data and reports generated by this system. Based on experience at the Carolinas HealthCare System (CHS), executive score cards provide an aggregate view of compliance rate, number of alerts, overrides, and edits. The report of serious errors averted (ie, critical catches) supplies the location, date, and time of the critical catch, thereby enabling management to pinpoint the end-user for educational purposes. By examining the number of critical catches, a return on investment may be calculated. Assuming 3,328 of these events each year, an estimated cost avoidance would be $29,120,000 per year for CHS. Other reports allow benchmarking between institutions. A review of the data about medication safety across CHS has helped garner support for a medication safety officer position with the goal of ultimately creating a safer environment for the patient.

Impact of implementing smart infusion pumps in a pediatric intensive care unit

The impact of smart infusion pumps on the interception of errors in the programming of i.v. drug administrations on a pediatric intensive care unit (PICU) is investigated. A prospective observational intervention study was conducted in the PICU of a hospital in Madrid, Spain, to estimate the patient safety benefits resulting from the implementation of smart pump technology (Alaris System, CareFusion, San Diego, CA). A systematic analysis of data stored by the devices during the designated study period (January 2010-June 2011) was conducted using the system software (Guardrails CQI Event Reporter, CareFusion). The severity of intercepted errors was independently classified by a group of four clinical pharmacists and a group of four intensive care pediatricians; analyses of intragroup and intergroup agreement in perceptions of severity were performed. During the 17-month study period, the overall rate of user compliance with the safety software was 78%. The use of smart pump technology resulted in the interception of 92 programming errors, 84% of which involved analgesics, antiinfectives, inotropes, and sedatives. About 97% of the errors resulted from user programming of doses or infusion rates above the hard limits defined in the smart pump drug library. The potential consequences of the intercepted errors were considered to be of moderate, serious, or catastrophic severity in 49% of cases. The use of smart pumps in a PICU improved patient safety by enabling the interception of infusion programming errors that posed the potential for severe injury to pediatric patients.

OSEK OS 기반 ACC/LKS 통합제어기 구현

Abstract This paper implements an integrated vehicle chassis system of ACC(Adaptive Cruise Control) and LKS(Lane Keeping System) based on OSEK OS to vehicle operating system and analyzes its performance through experiments. In recent years active safety and advanced driver assistance system has discussed to improve safety of vehicle. Among the rest, We integrate ACC that controls longitudinal velocity of vehicle and LKS that assists a vehicle in maintaing its driving lane, then implement integrated control system in vehicle. Implemented control system uses OSEK/VDX proposed standard, which is aiming at reusability and safety of software for vehicle and removal hardware dependence of application software. Redesigned control system based on OSEK OS, which is supported by OSEK/VDX, can manage real-time task, process interrupt and manage shared resource. We show by results performed EILS(ECU-In-the-Loop Simulation) that OSEK OS-based integrated controller of ACC and LKS is equivalent conventional integrated controller of ACC and LKS.

Welcome to the new Journal of Software Engineering Research and Development (JSERD)

© A m Editorial Research is shared with the world through the publication of scientific papers in conferences and journals. Between these two, journals are the traditional means for archival publication of research results across a broad range of disciplines. So it is in software engineering. Despite the important role that our conferences serve in furthering our field, journals still serve the role of disseminating and archiving more complete and mature results. Providing this avenue is crucial, given how software is present in human life more than ever. As a result, our community has the great responsibility to invent, develop, and deploy new techniques that assist developers everywhere in creating high-quality, safe, and secure software through productive and economicallyfeasible processes. Only by ‘seeing the research through’, that is, pushing it further so we understand the full ramifications of our inventions, can we guarantee that what we propose actually helps make the world a better place. As such, journal publications are as important as ever. One might question the need for another journal. After all, our community already has quite a few existing journals. Some of these, however, experience backlogs that lead to a long delay between the original submission and eventual publication. Others are specialized, focusing on one or at best a handful of specific subareas. JSERD emerged in this context as the result of extensive discussions in the Special Software Engineering Committee (CEES) of the Brazilian Computing Society (SBC) that lead to the recognition of the need for a broad software engineering journal that promotes rapid publication. JSERD is this journal, and is based on four major principles.

On Implied Defect in Elevator Control Software which Causes the Lift Car suddenly Reverse its Direction

An implied defect in one of the elevator control software is analyzed and modified. This defect would cause the elevator keep running up and down unbreakably between the next layer and previous layer of the target layer. The modification of the control software without adding physical parts was proposed. Three software design patterns to improve the safety of the elevator control software were discussed. The methods are validated to be reliable and feasible.

Case studies in process safety: Lessons learned from software-related accidents

Software and automation can play a significant role with respect to safety in the chemical process and energy production industries. Because computing systems are increasingly used to control critical functions, software may directly contribute to an accident. On the other hand, software can also be used as part of the hazard control strategy to reduce risks, and computing systems can provide valuable information to help make safety decisions. The importance of including software as part of an organization's efforts to analyze and manage hazards and risks seems clear, but for many organizations software is not effectively incorporated into process safety efforts. This article reviews lessons learned from accidents and incidents to illustrate the potential for a software-related accident even when process safety management tools and techniques are used. This discussion is intended to provide insights to help improve process safety and software safety efforts. © 2013 American Institute of Chemical Engineers Process Saf Prog 33: 124–130, 2014