Unsafe Devices Research Articles

A novel management scheme for power grid demand response based on blockchain

The smart grid optimizes traditional power grids and provides more intelligent services for end users and utilities. However, due to the large number of unsafe devices in the smart grid, there are corresponding risks when implementing relevant solutions on these devices. Therefore, in this article, a security demand response management scheme based on blockchain is proposed to safely make energy trading decisions, thereby realizing the management of the overall load of users in the power grid. In this scheme, the miner node is the verifier. These nodes are responsible for verifying energy transactions in the smart grid (SG) and adding corresponding blocks to the blockchain. Successful energy transactions only occur in blocks in the blockchain. Here, the proposed method is validated through experiments on electric vehicles. The experimental results demonstrate the effectiveness of the proposed scheme in demand response management.

Defending Against Identity Threats Using Risk-Based Authentication

Abstract Defending against identity-based threats, which have predominantly increased in the era of remote access and working, requires non-conventional, dynamic, intelligent, and strategic means of authenticating and authorizing. This paper aims at devising detailed risk-scoring algorithms for five real-time use cases to make identity security adaptive and risk-based. Zero-trust principles are incorporated by collecting sign-in logs and analyzing them continually to check for any anomalies, making it a dynamic approach. Users are categorized as risky and non-risky based on the calculated risk scores. While many adaptive security mechanisms have been proposed, they confine identities only to users. This paper also considers devices as having an identity and categorizes them as safe or unsafe devices. Further, results are displayed on a dashboard, making it easy for security administrators to analyze and make wise decisions like multifactor authentication, mitigation, or any other access control decisions as such.

Cross Deep Learning Method for Effectively Detecting the Propagation of IoT Botnet.

In recent times, organisations in a variety of businesses, such as healthcare, education, and others, have been using the Internet of Things (IoT) to produce more competent and improved services. The widespread use of IoT devices makes our lives easier. On the other hand, the IoT devices that we use suffer vulnerabilities that may impact our lives. These unsafe devices accelerate and ease cybersecurity attacks, specifically when using a botnet. Moreover, restrictions on IoT device resources, such as limitations in power consumption and the central processing unit and memory, intensify this issue because they limit the security techniques that can be used to protect IoT devices. Fortunately, botnets go through different stages before they can start attacks, and they can be detected in the early stage. This research paper proposes a framework focusing on detecting an IoT botnet in the early stage. An empirical experiment was conducted to investigate the behaviour of the early stage of the botnet, and then a baseline machine learning model was implemented for early detection. Furthermore, the authors developed an effective detection method, namely, Cross CNN_LSTM, to detect the IoT botnet based on using fusion deep learning models of a convolutional neural network (CNN) and long short-term memory (LSTM). According to the conducted experiments, the results show that the suggested model is accurate and outperforms some of the state-of-the-art methods, and it achieves 99.7 accuracy. Finally, the authors developed a kill chain model to prevent IoT botnet attacks in the early stage.

Roundtable Discussion: How the AAMI COVID-19 Response Team Responded to Crisis.

Roundtable Discussion: How the AAMI COVID-19 Response Team Responded to Crisis.

Effects of the Medical Device User Fee and Modernization Act on Fda Review Times for Medical Devices

In the United States, the safety and efficacy of medical devices are regulated by the US Food and Drug Administration (FDA), which must successfully navigate a crucial tradeoff between speed and safety in approving applications for new devices. Although a shorter (and potentially less thorough) approval process could benefit patients by resulting in quicker access to potentially life-saving therapies, the potential benefits could be outweighed if a shorter approval process allows more unsafe devices to enter the market. In 2002, Congress passed the Medical Device User Fee and Modernization Act (MDUFA), with the aim of pushing the FDA toward the speed side of the tradeoff. The MDUFA levied large user fees on manufacturers of medical devices in exchange for the promise of shorter review times by the FDA. Whether the Act has resulted in shorter review times is unclear. We conducted a regression analysis using data on FDA review times for devices seeking approval between 1991 and 2012 to address this question. During the pre-MDUFA era (1991–2002), review times for new devices fell by 8% annually for device applications submitted for approval under the more stringent process of premarket approval and fell by 4.5% annually for devices submitted under the less stringent premarket notification, or 501(k), process. These trends continued during the initial MDUFA era (2003–2008), as well as during the initial period after the law's reauthorization (2008–2012). Our results suggest that, for the years studied, the MDUFA was associated with a smaller annual decline in review times and does not appear to have achieved its intended goal of reducing review times for medical devices.

A low-cost and calibration-free gaze estimator for soft biometrics: An explorative study

Soft biometric systems have spread among recent years, both for powering classical biometrics, as well as stand alone solutions with several application scopes ranging from digital signage to human-robot interaction. Among all, in the recent years emerged the possibility to consider as a soft biometrics also the temporal evolution of the human gaze and some recent works in the literature explored this exciting research line by using expensive and (perhaps) unsafe devices which require user cooperation to be calibrated. This work is instead the first attempt to perform biometric identification of individuals on the basis of data acquired by a low-cost, non-invasive, safe and calibration-free gaze estimation framework consisting of two main components conveniently combined and performing user’s head pose estimation and eyes’ pupil localization on data acquired by a RGB-D device. The experimental evidence of the feasibility of using the proposed framework as soft-biometrics is given on a set of users watching three benchmark heterogeneous videos in an unconstrained environment.

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

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.

What is the Best Way to Supervise the Quality of Medical Devices? Searching for a Balance Between ex-ante and ex-post Regulation

This article discusses the legal remedies available for Competent Authorities, patients and healthcare professionals to prevent harmful incidents involving medical devices. It outlines a theoretical framework for ex-ante and ex-post regulation of medical devices. It then focuses on certain aspects of ex-post regulation. Participation by Competent Authorities with a supervisory role, healthcare professionals and patients in ex-post regulatory legal processes is analysed in the light of the current European Union legal framework and the revised framework proposed by the European Commission. It also discusses whether the proposed new legal framework enables the Competent Authorities, patients and healthcare professionals to prevent the harm caused by unsafe medical devices. Ex-ante regulation might prevent the entrance on the market of unsafe devices whereas ex-post regulation might dismiss the unsafe devices. The contribution concludes by suggesting a number of improvements to the supervisory system of medical devices in Europe.

Safe Human-Robot Cooperation in an Industrial Environment

The standard EN ISO10218 is fostering the implementation of hybrid production systems, i.e., production systems characterized by a close relationship among human operators and robots in cooperative tasks. Human-robot hybrid systems could have a big economic benefit in small and medium sized production, even if this new paradigm introduces mandatory, challenging safety aspects. Among various requirements for collaborative workspaces, safety-assurance involves two different application layers; the algorithms enabling safe space-sharing between humans and robots and the enabling technologies allowing acquisition data from sensor fusion and environmental data analysing. This paper addresses both the problems: a collision avoidance strategy allowing on-line re-planning of robot motion and a safe network of unsafe devices as a suggested infrastructure for functional safety achievement.

Detection of RF unsafe devices using a parallel transmission MR system

The permanent presence of devices (pacemakers) inside a patient, or the need to use other devices (catheters), for diagnosis and treatment, usually represents a contraindication for a magnetic resonance examination. To help overcome this problem, a novel and noninvasive magnetic resonance system-based concept is proposed to detect potentially unsafe radio frequency (RF) conditions of such devices to ensure patient safety. This concept makes use of parallel transmit technology by monitoring currents in individual RF transmit coil elements during RF transmission using suitable current sensors. For interventional devices, current changes can be directly measured, whereas for implanted devices, the use of reference signals is proposed, which cannot be measured in the patient. Coupling of unsafe devices to transmit coils led to detectable current changes in the elements because of energy absorption into the device. The concept was successfully tested on interventional and implantable devices and turned out to be so sensitive that even very weak RF coupling to these devices was detectable. In this study, basic feasibility to detect RF unsafe conditions was successfully demonstrated. In the future, RF patient safety may be improved in the presence of implanted devices, as well as during interventions using this concept.

A reply

We would like to thank Drs Willcox and Turner for their interest in our paper [1]. We are pleased that our publication raised a number of discussion points and we welcome the opportunity to comment. We agree that the risk of transmission of infection from endoscopes is probably low. However, current guidelines suggest that single-use devices should be used where possible (although only if the performance is equivalent) [2, 3]. In addition, the Department of Health bulletin states that endoscopes should be cleaned before and after each use [3]. Consequently, the single-use Ambu aScope is likely to have a shorter ready-to-use time than a re-usable device. This is especially relevant when delay in securing the airway increases the risk to patients, i.e. the Plan B of the Difficult Airway Society guidelines [4]. Furthermore, the single-use fibrescope may be useful in locations remote from the main theatre complex where the fibrescope is infrequently used and an endoscope reprocessing unit may not be readily available. Provision and maintenance of re-usable fibrescopes in such remote locations may be prohibitively expensive. Lastly, the National Creutzfeldt-Jakob Disease Surveillance Unit provides fibrescopes only for established cases of vCJD. The lack of a suction port of the aScope may impair the operator’s ability to clear secretions and blood in the airway. However, the suction channel of the LF-GP Olympus re-usable scope used in our study is only 1.5 mm. Cautious use of external suction, accessing the airway thorough the mouth with either a soft or rigid suction catheter, is likely to provide much better clearance than the limited suction force from the re-usable fibrescope. There are limitations to extrapolating data from any study into clinical practice. Manikin studies have an established place in the evaluation process of an airway device [5, 6]. This is recognised by the Airway Device Evaluation Project Team (ADEPT) [7]. There are number of reasons why no newly introduced device should be used on patients before manikin evaluation is completed. Firstly, the findings of a manikin study can exclude unsafe devices from being used on patients [8, 9] and highlight the design features that require further evaluation on patients [10]. Secondly, they allow for the device to be tested by a large number of clinicians and not only by a small number of researchers and experts. Thirdly, the manikin study design allows for levels of simulation that are likely to be considered unethical if conducted on patients (i.e. crossover study design and simulation of a difficult airway). Although, in our institution, manikin studies go through the same rigorous review as the patient studies (Research and Development and Ethics Committee review), they are still likely to be faster than patient studies in providing initial evidence regarding the safety and usefulness of an untested device. Furthermore, data on historical controls that are required for obtaining level 3b evidence stated in the ADEPT article [7] may not be available for every device currently on the market. Our study was designed to provide evidence on the ease of use and manoeuvrabity of the Ambu aScope when used by a large number of anaesthetists in a manikin set to simulate difficult fiberscope placement. Although this single-use device has a number of potential applications and advantages, the clinical usefulness of the aScope remains to be established.

The Roundup

The Roundup

Inflatable Jumping castles: advocacy in action

The use of inflatable jumping castles has directly led to the death and injury of children. In 2007 a child was killed in Budapest, with five others seriously injured when...

Needlestick injuries among health care workers: Occupational hazard or avoidable hazard?

SummaryOBJECTIVES: The objective of this study was to describe the mechanisms and preventability of occupational percutaneous blood exposure of healthcare workers through needlestick injuries and to discuss rational strategies for prevention. METHODS: To calculate the preventability, we surveyed in a first step the number and kind of needlestick injuries and in a second step the reasons for the injuries and the working conditions of the healthcare workers. Both data sets were collected in independent anonymous questionnaire covering occupational blood exposure among healthcare workers in a German university hospital. RESULTS: Needlestick injuries were caused through unsafe procedures, difficult working conditions and unsafe devices. On average, 50.3% (n = 492/978) of all needlestick injuries could have been avoided by the use of safety devices, whereas only 15.2% could have been prevented by organizational measures. In our study, 31.5% (n = 503/1598) of participant healthcare workers had sustained at least one needlestick injury in the past twelve months. The rate of underreporting was about 75%. After introduction of safety devices, 91.8% of the healthcare workers reported being satisfied with the anti-needlestick devices and 83.4% believed that safety devices would increase the safety of the work environment. CONCLUSIONS: Occupational exposure to blood is a common problem among healthcare workers. The introduction of safety devises is one of the main starting points for avoidance of needlestick injuries, and acceptance among healthcare workers is high. Further targets for preventive measures, such as training in safe working routines, are necessary for improvement of safe work conditions.

Monitoring Device Safety in Interventional Cardiology

ObjectiveA variety of postmarketing surveillance strategies to monitor the safety of medical devices have been supported by the U.S. Food and Drug Administration, but there are few systems to automate surveillance. Our objective was to develop a system to perform real-time monitoring of safety data using a variety of process control techniques. DesignThe Web-based Data Extraction and Longitudinal Time Analysis (DELTA) system imports clinical data in real-time from an electronic database and generates alerts for potentially unsafe devices or procedures. The statistical techniques used are statistical process control (SPC), logistic regression (LR), and Bayesian updating statistics (BUS). MeasurementsWe selected in-patient mortality following implantation of the Cypher drug-eluting coronary stent to evaluate our system. Data from the University of Michigan Consortium Bare-Metal Stent Study was used to calculate the event rate alerting boundaries. Data analysis was performed on local catheterization data from Brigham and Women's Hospital from July 1, 2003, shortly after the Cypher release, to December 31, 2004, including 2,270 cases with 27 observed deaths. ResultsThe single-stratum SPC had alerts in months 4 and 10. The multistrata SPC had alerts in months 5, 10, and 18 in the moderate-risk stratum, and months 1, 4, 7, and 10 in the high-risk stratum. The only cumulative alerts were in the first month for the high-risk stratum of the multistrata SPC. The LR method showed no monthly or cumulative alerts. The BUS method showed an alert in the first month for the high-risk stratum. ConclusionThe system performed adequately within the Brigham and Women's Hospital Intranet environment based on the design goals. All three cumulative methods agreed that the overall observed event rates were not significantly higher for the new medical device than for a closely related medical device and were consistent with the observation that the initial concerns about this device dissipated as more data accumulated.

Percutaneous blood exposure among Danish doctors: exposure mechanisms and strategies for prevention.

The objective of this study was to describe the mechanisms of percutaneous blood exposure (PCE) among doctors and discuss rational strategies for prevention. Data were obtained as part of a nation-wide questionnaire survey of occupational blood exposure among hospital employed doctors in Denmark. The doctors were asked to describe their most recent PCE, if any, within the previous 3 months. Detailed information on the instruments, procedures, circumstances and mechanisms that caused the PCE was obtained. Of 9375 doctors, 6256 (67%) responded, and 6005 questionnaires were eligible for analysis. Of 971 described PCE the majority were caused by suture needles (n = 483), i.v.-catheter-stylets (n = 94), injection needles (n = 75), phlebotomy needles (n = 53), scalpels (n = 45), arterial blood sample needles (n = 41) and bone fragments (n = 23). Inattentiveness was the most common cause, contributing to 30.5% of all PCE. Use of fingers rather than instruments was a major cause of injury in surgical specialities and was a contributing cause of 36.9% PCE on suture needles. Common contributing causes when fingers were used (n = 199) were poor space in (30.2%) or view of (18.6%) the operation field. It was often argued that instruments were not practical to use or might harm the tissue. Of 689 PCE in surgical specialties, 17.4% were inflicted by colleagues. Up to 53.3% of PCE on hollow-bore needles could be attributed to unsafe routines like recapping only, but other mechanisms like sudden patient movements and 'acute situation' were common, especially in the case of PCE on i.v.-catheter-stylets. It is concluded that the exposure mechanisms of PCE reflect both unsafe routines, difficult working conditions and unsafe devices. Education in safer working routines are needed in all specialties. Introduction of safer devices should have a high priority in surgical specialties, and should be considered in non-surgical specialties too.

Federal regulation and the practicing surgeon

The benefits of the Medical Device Act of 1976 are few and the liabilities to patients and the medical community are many. The Act will probably remove unsafe devices from the marketplace. If problems develop with a device, the hazard warning system similar to that used for drugs may be helpful. Greater responsibility will be placed on the manufacturer of medical devices for repair, replacement, or refund to the patient or hospital for defective devices. The Act probably will not increase the reliability of products. There will be fewer new devices in the future because of markedly increased costs of development and bureaucratic approval. Devices currently available and all future devices will be more expensive to patients, insurance carriers, and government. The availability of special order or custom-made devices for specific patients will decrease. The Act discourages clinical investigation because of the increased costs, time required, and risk imposed on the investigational surgical practitioner. Surgeons will be required to notify all patients concerning a potential problem with a device, which may cause unnecessary anxiety. The surgical practitioner in small institutions will not have use of investigational devices because of the restrictions imposed by the proposed regulations and the authority of the Secretary of the FDA to limit the use of investigational devices to specific centers and surgeons. The innovative small manufacturer who has produced so many of the new technology devices will generally disappear from the marketplace because of an inability to meet the regulatory restrictions due to limited capital and resources. The proposed regulations will put voluntary standards and certification organizations under federal control. There will be a large increase in time and costs to institutions for the activities of institutional review boards. Importantly, these regulations will not improve the scientific data base nor significantly decrease the risk of new devices. These regulations will put more lawyers to work at the expense of the clinician, his patients, and the American public.