Process of designing robust, dependable, safe and secure software for medical devices: Point of care testing device as a case study

This article has been made available through the Brunel Open Access Publishing Fund.Copyright © 2013 Sivanesan Tulasidas et al. This paper presents a holistic methodology for the design of medical device software, which encompasses of a new way of eliciting requirements, system design process, security design guideline, cloud architecture design, combinatorial testing process and agile project management. The paper uses point of care diagnostics as a case study where the software and hardware must be robust, reliable to provide accurate diagnosis of diseases. As software and software intensive systems are becoming increasingly complex, the impact of failures can lead to significant property damage, or damage to the environment. Within the medical diagnostic device software domain such failures can result in misdiagnosis leading to clinical complications and in some cases death. Software faults can arise due to the interaction among the software, the hardware, third party software and the operating environment. Unanticipated environmental changes and latent coding errors lead to operation faults despite of the fact that usually a significant effort has been expended in the design, verification and validation of the software system. It is becoming increasingly more apparent that one needs to adopt different approaches, which will guarantee that a complex software system meets all safety, security, and reliability requirements, in addition to complying with standards such as IEC 62304. There are many initiatives taken to develop safety and security critical systems, at different development phases and in different contexts, ranging from infrastructure design to device design. Different approaches are implemented to design error free software for safety critical systems. By adopting the strategies and processes presented in this paper one can overcome the challenges in developing error free software for medical devices (or safety critical systems).Brunel Open Access Publishing Fund

Secure expandable communication framework for POCT system development and deployment

This thesis was submitted for the award of Doctor of Philosophy and was awarded by Brunel University LondonHealth-care delivery in developing countries has many challenges because they do not have enough resources for meeting the healthcare needs and they lack testing lab infras- tructures in communities. It has been proven that Point-Of-Care (POC) testing can be considered as one of the ways to resolve the crisis in healthcare delivery in these com- munities. The POC testing is a mission critical processes in which the patient conduct tests outside of laboratory environment and it needs a secure communication system of architecture support which the research refers as POCT system Almost every ten years there will be a new radio access technology (RAT) is released in the wireless communication system evolution which is primarily driven by the 3GPP standards organisation. It is challenging to develop a predictable communication sys- tem in an environment of frequent changes originated by the 3GPP and the wireless operators. The scalable and expandable network architecture is needed for cost-effective network management, deployment and operation of the POC devices. Security mecha- nisms are necessary to address the specific threats associated with POCT system. Se- curity mechanisms are necessary to address the specific threats associated with POCT system.The POCT system communication must provide secure storage and secure com- munication to maintain patient data privacy and security. The Federal Drug Admin- istration (FDA) reports the leading causes of defects and system failures in medical devices are caused by gaps between the requirements, implementation and testing. The research was conducted, and technical research contributions are made to resolve the issues and challenges related to the POCT system. A communication protocol implemented at the application level, independent of radio access technologies. A new methodology was created by combining Easy Approach to Requirement Specifications (EARS) methodology and Use Case Maps (UCM) model which is a new approach and it addresses the concerns raised by the FDA. Secure cloud architecture was created which is a new way of data storage and security algorithms models were designed to address the security threats in the POCT system. The security algorithms, secure cloud architecture and the communication protocol coexist together to provide Radio access technology Independent Secure and Expandable (RISE) POCT system. These are the contributions to new knowledge that came out of the research. The research was conducted with a team of experts who are the subject matter experts in the areas such as microfluidics, bio-medical, mechanical engineering and medicine

Housing developments for electric factory, Bangalore, India

Call number: LD2668 .T4 1967 T91

Security Framework for Managing Data Security within Point of Care Tests

Point of Care (PoC) devices and systems can be categorized into three broad classes (CAT 1, CAT 2, and CAT 3) based on the context of operation and usage. In this paper, the categories are defined to address certain usage models of the PoC device. PoC devices that are used for PoC testing and diagnostic applications are defined CAT 1 devices; PoC devices that are used for patient monitoring are defined as CAT 2 devices (PoCM); PoC devices that are used for as interfacing with other devices are defined as CAT 3 devices (PoCI). The PoCI devices provide an interface gateway for collecting and aggregating data from other medical devices. In all categories, data security is an important aspect. This paper presents a security framework concept, which is applicable for all of the classes of PoC operation. It outlines the concepts and security framework for preventing security challenges in unauthorized access to data, unintended data flow, and data tampering during communication between system entities, the user, and the PoC system. The security framework includes secure layering of basic PoC system architecture, protection of PoC devices in the context of application and network. Developing the security framework is taken into account of a thread model of the PoC system. A proposal for a low-level protocol is discussed. This protocol is independent of communications technologies, and it is elaborated in relation to providing security. An algorithm that can be used to overcome the threat challenges has been shown using the elements in the protocol. The paper further discusses the vulnerability scanning process for the PoC system interconnected network. The paper also presents a four-step process of authentication and authorization framework for providing the security for the PoC system. Finally, the paper concludes with the machine to machine (M2M) security viewpoint and discusses the key stakeholders within an actual deployment of the PoC system and its security challenges

Requirements for Point of Care Devices using Use Case Maps

Point of Care (PoC) testing (diagnosis) is a method for bringing medical laboratories to a patient’s home to conduct diagnostic tests so that the patient does not need to go to the doctor or laboratory in person. PoC testing reduces the burden on expensive laboratory setups and provides management of patient care in cost effective manner. The design and development of the PoC device and the associated infrastructure must be done with extreme rigor, as the PoC system meets the definition of a mission critical or safety critical system. Requirements creation and management are the key processes for ensuring that a highly reliable and low defect PoC system is developed since accurate PoC testing-based diagnosis is an essential process improvement for remote patient care management. It is important that the requirements be specified accurately, completely and without any ambiguity so that the PoC device can be designed and developed with minimal errors. This provides physicians a vehicle to diagnose patients with drastically increased reliability. This paper explains how Use Case Maps (UCM), a modeling technique, can help to sufficiently model requirement specifications for a PoC system development. It illustrates PoC functional requirements and security requirements in terms of the UCM representation. DOI: 10.17762/ijritcc2321-8169.150616

Combined convective and microwave drying of grapes

The potential of dielectric heating with microwaves at 2450 MHz for drying grapes into raisins was studied. Feasibility studies in a conventional microwave oven were successful. A new microwave drying system equipped with specialized instrumentation and data acquisition components and permitting full control of microwave power levels and duration of application was then developed and used for detailed experimental work.It was found that when the grapes were dipped in surfactants, as is common practice in the raisin industry, microwave drying was not only faster than convective drying but also had a much lower specific energy requirement. However, it was also possible to obtain raisins of adequate quality without dippings. Good quality light coloured raisins were obtained without sulphur dioxide fumigation. Thus, microwave drying has potential in reducing both the quantity of chemicals entering at this point in the food chain and the energy consumed for food preservation.The shrinkage and density of grapes were found to be linearly related to moisture content; initial size and method of drying had no influence. (Abstract shortened by UMI.

A study on biofilm production and antifungal drug resistance among Candida species from vulvovaginal and bloodstream infections

Sanyuktha Tulasidas,1 Pooja Rao,2 Sevitha Bhat,2 Radhakrishna Manipura1 1Department of Microbiology, Kasturba Medical College, Manipal Academy of Higher Education, Mangalore, Manipal, India; 2Department of Microbiology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal McGill Center for Infectious Diseases, Mangalore, Manipal, India Introduction: Candida species, one among the opportunistic fungi, has become a common pathogen causing vaginal thrush and nosocomial bloodstream infections (BSIs). This study aims to evaluate the prevalence and antifungal susceptibility of various Candida species and slime production by Candida species in BSIs and vulvovaginal candidiasis (VVC). Materials and methods: A total of 176 samples were collected for a period of 1 year. Antifungal susceptibility testing and biofilm production testing were performed by the Kirby-Bauer method and crystal violet assay, respectively. Results: Out of 176 samples, 74 (42%) were from BSIs and 102 (58%) were from VVC. The biofilm production was comparatively high in blood isolates, 55 (74%), than cervical isolates, 45 (44%). Increase in the trends of non-albicans Candida (NAC) species was seen in our setup. Good susceptibility rates were seen among Candida species, 82.38% to voriconazole and an increasing resistance pattern of 26.13% to fluconazole. Conclusion: Speciation of Candida becomes important as the prevalence of NAC is increasing. Antifungal susceptibility testing by the disk diffusion method is cost effective and should be adopted in routine testing as there is an increasing azole resistance, especially in invasive NAC infections. In this study, there was no correlation of antifungal drugs with the biofilm production. Keywords: biofilm, Candida, azoles, vulvovaginal, bloodstream infection