scholarly journals Model-Based System, Safety and Security Co-Engineering Method and Toolchain for Medical Devices Design

2019 ◽  
Author(s):  
Marc Sango ◽  
Jean Godot ◽  
Antonio Gonzalez ◽  
Ricardo Ruiz Nolasco
Keyword(s):  
Medical Device ◽  
Systems Engineering ◽  
Medical Devices ◽  
Specific Reference ◽  
Reference Architecture ◽  
Security Risk ◽  
Domain Specific ◽  
Model Based ◽  
Healthcare Model ◽  
Device Use

The increasing complexity of the medical regulatory environment and the inherent complexity of medical devices, especially due to the increased use of connected devices and embedded control software, impose adoption of new methods and tools for the system design, safety and security analyses. In this paper, we propose a method and an associated toolchain to couple model-based system engineering and safety/security analyses at the design phase of medical devices. The method is compliant with ANSI/AAMI/ISO TIR57 safety and security guidance, and compatible with INCOSE Biomedical-Healthcare Model-Based Systems Engineering works. The toolchain is based on a system architecture modelling tool and supports medical device domain specific reference architecture, as well as tools for safety and security risk analyses. The proposed method and toolchain are illustrated by considering a RGB’s TOF-CUFF monitor device analyzed in the scope of the AQUAS project as a medical device use case.

scholarly journals Towards a Domain-Specific Approach Enabling Tool-Supported Model-Based Systems Engineering of Complex Industrial Internet-of-Things Applications

Systems ◽  
2021 ◽  
Vol 9 (2) ◽  
pp. 21
Author(s):  
Christoph Binder ◽  
Christian Neureiter ◽  
Arndt Lüder
Keyword(s):  
Internet Of Things ◽  
Systems Engineering ◽  
Industry 4.0 ◽  
Manufacturing Systems ◽  
Major Change ◽  
Reference Architecture ◽  
Architecture Model ◽  
Domain Specific ◽  
Model Based ◽  
Model Based Systems Engineering

Contemporary manufacturing systems are undergoing a major change promoted by emerging technologies such as Cyber-physical Systems (CPS) or the Internet of Things (IoT). This trend, nowadays widely known by the term “Industry 4.0”, leads to a new kind of automated production. However, the rising number of dynamically interconnected elements in industrial production lines results in such a system being transformed into a complex System of Systems (SoS). Due to the increasing complexity and the challenges accompanied by this change, conventional engineering methods using generic principles reach their limits when developing this type of systems. With varying approaches only trying to find a solution for small-scaled areas of this problem statement, the need for a holistic methodology becomes more and more obvious. Having recognized this issue, one of the most promising approaches has been introduced with the Reference Architecture Model Industry 4.0 (RAMI 4.0). However, in the current point of view, this domain-specific architecture framework is missing specifications to address all aspects of such a critical infrastructure. Thus, this paper introduces a comprehensive modeling approach utilizing methods applied in Model-Based Systems Engineering (MBSE) and including domain-specific particularities as well as architectural concepts with the goal to enable mutual engineering of current and future industrial systems. The resulting artifacts, a domain-specific language (DSL), an architecture definition and a development process, are thereby consolidated in a ready to use software framework, whose applicability was evaluated by a real-world case study.

scholarly journals Medical Device Integration Model Based on the Internet of Things

2015 ◽  
Vol 9 (1) ◽  
pp. 256-261 ◽  
Author(s):  
Aiyu Hao ◽  
Ling Wang
Keyword(s):  
Information System ◽  
Internet Of Things ◽  
Medical Device ◽  
Medical Devices ◽  
Medical Information ◽  
Medical Information System ◽  
The Internet ◽  
Model Based ◽  
Device Integration ◽  
The Internet Of Things

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

scholarly journals An Analysis of FDA Adverse Event Reporting Data for Trends in Medical Device Use Error

2020 ◽  
Vol 9 (1) ◽  
pp. 130-134
Author(s):  
Benjamin M. Knisely ◽  
Camille Levine ◽  
Kush C. Kharod ◽  
Monifa Vaughn-Cooke
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Medical Device ◽  
Medical Devices ◽  
Product Life Cycle ◽  
Risk Mitigation ◽  
Adverse Event Reporting ◽  
Mitigation Strategies ◽  
Event Reporting ◽  
Device Use

Humans can contribute to error at all stages of the medical device product life-cycle. Use error associated with medical devices can result in catastrophic consequences for end users and inefficient use of healthcare system resources. Industry-wide statistics about medical device use error has the potential to aid in identifying opportunities for human factors intervention, however publicly available statistics are sparse. The Food and Drug Administration (FDA) requires medical device manufactures, importers, and device user facilities to track and report adverse events for post-market surveillance through medical device reports (MDRs). This data is available in an online database: Manufacturer and User Facility Experience (MAUDE). This study provides a comprehensive evaluation of use error adverse events in MAUDE (2010-2018) based on device class, device operator, and event outcome, to address the lack of industry-wide statistics on medical device use error. Results indicate that use error is significantly represented in adverse event reporting, constituting 28.1% of reports labeled with device problem codes. Events associated with patient device operators were predominately associated with diabetes-related medical devices, while provider operators were associated with a wider array of devices. Additionally, it was found that most use error reports were attributed to issues with device output; using the device in accordance with manufacturer expectations; and physically activating, positioning, or separating device components. This work demonstrates the viability of using MAUDE to attain industry wide statistics on medical device use error for later integration in industry-wide or device-specific risk mitigation strategies.

Use of Medical Devices in Hospice for Symptom Management

2016 ◽  
Vol 33 (10) ◽  
pp. 929-934 ◽  
Author(s):  
Nidhi Shah ◽  
Peter Homel ◽  
Jennifer Breznay
Keyword(s):  
End Of Life ◽  
Medical Device ◽  
Medical Devices ◽  
Symptom Management ◽  
Hospice Care ◽  
The United States ◽  
Patient Controlled Analgesia ◽  
Sampling Weights ◽  
Hospice Patients ◽  
Device Use

Background: Home health services in the United States(US) have been on a rise. Hospice patients cope with diverse physical and pain symptoms; medical devices are used for symptom management to improve their quality-of-care at end-of-life. Objective: Using the National Home and Hospice Care Survey (NHHCS), the study summarizes medical device use for symptom management and tracks various demographic variables for home hospice patients. Methods: A cross-sectional analysis of data using the 2007 NHHCS was conducted. There were 4733 hospice discharges which corresponded to 2,505,011 individuals in US with sampling weights. The data was analyzed using chi square tests and confounding factors adjusted with logistic regression. Results: Eighty-nine percent of hospice discharges were evaluated for pain at first assessment. The regression model for pain at first assessment was significantly associated with use of patient controlled analgesia (OR = 1.82, 95% CI = 1.28, 2.59) and urinary catheters (OR = 1.16, 95% CI = 1.02, 1.33). Patient with dyspnea were associated with significant use of oxygen (OR = 3.00, 95% CI = 2.64, 3.40) and metered dose inhaler (OR = 2.43, 95% CI = 1.92, 3.07). There was negligible use of total parenteral nutrition (TPN) noted in the study. Conclusion: In conclusion, the study highlights medical device use in home hospice care for end-of-life symptom management. It noted the significant use of IV infusion pumps and patient controlled analgesia. Conversely, there is little use of TPN or CPAP in patients with anorexia or dyspnea. While missing data on critical symptom evaluations regrettably raises questions about the validity of the study, the NHHCS serves as an important reservoir of data on the growing population of home hospice patients.

Using SysML to Elicit a Value Model in Multi-Stakeholder Value-Driven System Design

2014 ◽  
Author(s):  
Douglas Broadwell ◽  
Christiaan J. J. Paredis
Keyword(s):  
System Design ◽  
Systems Engineering ◽  
Essential Elements ◽  
Value Network ◽  
Domain Specific ◽  
Model Based ◽  
A Value ◽  
System Properties ◽  
Multi Stakeholder ◽  
Value Model

In recent years, a formal, mathematically rigorous, value-based approach to system design has been proposed within the systems engineering community. This approach stands in contrast to the traditional requirements based approach to system design because of its foundations in decision theory. One of the crucial first steps in the value-based approach is the elicitation of information about all the elements that influence a design or acquisition decisions, namely, all actors, system properties and behavior, preferences, and concerns. This elicitation step requires a formalized, model-based method for capturing these elements of the value network, the basis of the decision maker’s value function. In this paper, we examine previous work in the area of elicitation in system design and define a set of elements necessary to effectively elicit a meaningful value network. We then consider a domain-specific profile as an extension of SysML to formally capture the essential elements of a value network. To illustrate the modeling approach, the profile is applied to a case study of the design of a heads-up display system (iHUD) in order to test the depth of the profile as well as to show the value of the model-based approach in the elicitation process.

Using Domain Specific Languages to Capture Design Synthesis Knowledge for Model-Based Systems Engineering

2009 ◽  
Author(s):  
Aleksandr A. Kerzhner ◽  
Christiaan J. J. Paredis
Keyword(s):  
Systems Engineering ◽  
Design Synthesis ◽  
System Architectures ◽  
Computer Tools ◽  
Domain Specific ◽  
Model Based ◽  
Functional Specification ◽  
Management Group ◽  
Computational Synthesis ◽  
Model Based Systems Engineering

Design synthesis is a fundamental engineering task that involves the generation of a structural specification from a desired functional specification. Although the use of computer tools is common throughout the design process, design synthesis is often a task left to the designer. Formally capturing design synthesis knowledge in models and applying computational synthesis may result in better exploration of the design space and eliminate repetitive design tasks. In this paper, a graph-based framework for capturing and combining design synthesis knowledge is presented for scenarios involving the composition of well defined components into larger systems. This approach fits in the context of Model-Based Systems Engineering where a variety of formal models are used to represent knowledge about a system. This approach uses the Systems Modeling Language developed by The Object Management Group (OMG SysML™) to define both models of possible components and possible system architectures. The framework is illustrated by combining it with an evolutionary algorithm and applying it to an example problem of hydraulic circuit synthesis.

Medical Device Education among Australian Registered Nurses: A Comparison of Agency and Hospital Nurses

1995 ◽  
Vol 11 (3) ◽  
pp. 585-594 ◽  
Author(s):  
Edwina A. McConnell ◽  
Jan Fletcher ◽  
Jutta H. Nissen
Keyword(s):  
Registered Nurses ◽  
Medical Device ◽  
Medical Devices ◽  
Hospital Nurses ◽  
Patient Harm ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Device Use

AbstractA cross-sectional survey was used to compare the medical device education of 142 agency- and 443 hospital-employed Australian registered nurses. The two groups differed significantly on descriptive characteristics and on what they had learned about medical devices. Potential negative aspects of device use were nurse stress and patient harm, with a significantly larger proportion of hospital nurses indicating their use of any medical device had made them feel stress. Fear of harming the patient and being unsure of how to use the device caused stress in the majority of nurses. The incidence of patient harm was approximately 10% for each group.

Sign in / Sign up

Export Citation Format

Share Document