How to increase efficiency with the certification of process compliance

Certification as well as self-assessment of safety-critical systems is an expensive and time-consuming activity due to the necessity of providing numerous deliverables. These deliverables can be process-related or product-related. Process-related deliverables are aimed at showing compliance with normative documents (e.g., safety standards), which impose specific requirements on the development process (e.g., reference models for the safety life-cycles). In this lecture, we limit our attention to process-related deliverables and we propose a solution aimed at reducing time and cost related to their provision. Our solution consists of the combination of three approaches: the safety-oriented process line engineering approach, the process-based argumentation line approach, and the model driven certification-oriented approach. More specifically, we define how these three approaches are combined and which techniques, tools and guidelines should be used to implement the resulting approach. Then, via small-sized but realistic process-fragments, we illustrate it. Finally, we present a roadmap for future research directions.Universidad de Málaga. Campus de Excelencia Internacional Andalucía Tech

AMASS: A Large-Scale European Project to Improve the Assurance and Certification of Cyber-Physical Systems

Most safety-critical systems must undergo assurance and certification processes. The associated activities can be complex and labour-intensive, thus practitioners need suitable means to execute them. The activities are further becoming more challenging as a result of the evolution of the systems towards cyber-physical ones, as these systems have new assurance and certification needs. The AMASS project (Architecture-driven, Multi-concern and Seamless Assurance and Certification of Cyber-Physical Systems) tackled these issues by creating and consolidating the de-facto European-wide open tool platform, ecosystem, and self-sustainable community for assurance and certification of cyber-physical systems. The project defined a novel holistic approach for architecture-driven assurance, multi-concern assurance, seamless interoperability, and cross- and intra-domain reuse of assurance assets. AMASS results were applied in 11 industrial case studies to demonstrate the reduction of effort in assurance and certification, the reduction of (re)certification cost, the reduction of assurance and certification risks, and the increase in technology harmonisation and interoperability.The research leading to this paper has received funding from the AMASS project (H2020-ECSEL grant agreement no 692474; Spain’s MINECO ref. PCIN-2015-262; Sweden’s Vinnova) and the Ramon y Cajal Program (Spain’s MICINN ref. RYC-2017-22836; EC’s European Social Fund). We are also grateful to all the AMASS partners. Their work and results are summarised in this paper

Architecture-driven, Multi-concern and Seamless Assurance and Certification of Cyber-Physical Systems.

Unlike practices in electrical and mechanical equipment engineering, Cyber-Physical Systems (CPS) do not have a set of standardized and harmonized practices for assurance and certification that ensures safe, secure and reliable operation with typical software and hardware architectures. This paper presents a recent initiative called AMASS (Architecture-driven, Multi-concern and Seamless Assurance and Certification of Cyber-Physical Systems) to promote harmonization, reuse and automation of labour-intensive certification-oriented activities via using model-based approaches and incremental techniques. AMASS will develop an integrated and holistic approach, a supporting tool ecosystem and a self-sustainable community for assurance and certification of CPS. The approach will be driven by architectural decisions (fully compatible with standards, e.g. AUTOSAR and IMA), including multiple assurance concerns such as safety, security and reliability. AMASS will support seamless interoperability between assurance/certification and engineering activities along with third-party activities (external assessments, supplier assurance). The ultimate aim is to lower certification costs in face of rapidly changing product features and market needs.This project has received funding from the Electronic Component Systems for European Leadership Joint Undertaking under grant agreement No 692474. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and Spain, Czech Republic, Germany, Sweden, Austria, Italy, United Kingdom, Franc

Nursing students’ experience of risk assessment, prevention and management: a systematic review

Introduction:  As a fundamental dimension of quality, the patient safety and healthcare workers safety in the healthcare environment depend on the ability of each healthcare workers (whether administrators or technicians) to reduce the probability of error. This review focused on nursing students. The aim was to assess level and determinants of knowledge about risk assessment, risk prevention and risk management of nursing students. Methods: A systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Two reviewers searched the bibliographic databases Pubmed, Scopus and Cinahl to collect all the available articles in English and Italian issued between 2015 and August 2019. To obtain an exhaustive string search, the following keywords were combined through Boolean operators AND and OR: Clinical Risk Assessment, Nursing Education, Nursing Student*, Patient Safety. The authors assessed the quality of the evidence by using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) method.  Results: Twelve papers are included. Although the literature on the nursing student's error is limited, their frequencies are worrying. Some authors have created a model of prevention of clinical error based on three level. However, the majority of nursing students don’t felt confident with a patient safety. Many authors shown that patient safety education was delivery by lecture, laboratory or simulation sessions. Conclusions: This review underlines the need to revise the nursing curriculum on patient safety and the need to think what educational methodology is the better for the student to create a safe care. &nbsp

FGF2 and ET1 promote human fetal striatal neuroblasts survival in hypoxic conditions

Fetal striatal transplantation emerged as a new strategy to promote reparative responses in Huntington’s disease (HD) patients1. Mechanisms that support neuroblasts survival and replenishment of damaged cells within the HD brain in hypoxia remain to be elucidated. This study investigated how human fetal striatal neuroblasts (HSP cells) respond to hypoxia, using the hypoxia-mimetic agent cobalt chloride (CoCl2)2. We analyzed CoCl2 effect on hypoxia-related proteins, such as HIF-1α and VEGF, and on a neuroprotective factor, such as Seladin-1. Moreover, we evaluated FGF2 (50 ng/ml) and ET1 (100 nM) proliferative/survival effects in HSP cells in normoxic and hypoxic conditions. These growth factors could be important mediators under pathological conditions for striatal neuroblasts function and response to hypoxia. Dose-response experiments with increasing concentration of CoCl2 (50-750 um) showed an increase of HSP cell proliferation at 24-48h, with maximal effects observed at 400 um, while cell survival was impaired at 72h. Hypoxia increased protein expressions of HIF-1α and VEGF, whereas decreased Seladin-1 levels. FGF2 and ET1 significantly stimulated HSP cells proliferation both in normoxic and hypoxic condition, counteracting the apoptotic CoCl2 effect at 72h. FGF2 and ET1 neuroprotective effect was abolished by the selective inhibition of their receptors (FGFR1, ETA and ETB). In particular, ET1 stimulated HSP cells survival through ETA receptor in normoxic condition and through ETB receptor during hypoxia. Our results support the idea that FGF2 and ET1 promote neurogenesis and survival of HSP cells, through receptor-mediated mechanisms, when grafted into the hypoxic HD brain

Effect of short-term aerobic exercise on cardiovascular remodelling in post-menopause women

It is well known that menopause is associated with an increase of cardiovascular (CV) risk factors, including changes on metabolic profile, body composition, haemdynamic loads and cardiovascular remodelling. The latter starts with an increase of arterial elastance and early concentric left ventricular remodeling, manifested by an increment of the relative wall thickness. We investigated morphological and functional effects of short-term aerobic exercise at moderate intensity without diet restriction on cardiovascular apparatus in post-menopause women. Seventy-six post-menopausal healthy sedentary postwomen (56± 4 yrs) underwent clinical history, physician and anthropometric exam, 12-lead electrocardiography. Echocardiography was used to assess LV geometry and systolic and diastolic functions. Relative diastolic wall thickness (RWT), midwall fractional shortening (MFS) and arterial elastance (AE) were calculated to evaluate the LV concentric remodeling, the intrinsic systolic function and the vascular load, respectively. Data were collected before and after 14 weeks of moderate aerobic exercise training (four time per week). After the intervention program, systolic and diastolic arterial pressure, heart rate and hip circumference were significantly decreased (P = 0,01; P = 0,00; P = 0,00; P = 0,01, respectively). Left ventricular mass/height 2.7, ejection fraction and MFS were higher (p< 0,00; P= 0,00; P =0,00), while relative wall thickness (RWT) and AE were lower (P<0,03;P=0,00). Mitral E wave and E/A were higher (P = 0,001; P<0,0001). Left ventricular mass/height 2.7 was correlated to BMI (P = 0,04), WC (P = 0,034) and waist/hip ratio (P = 0,007). In post-menopause women aerobic exercise improves CV function (concentric remodelling, diastolic and systolic function) acting both on haemodynamic factors and body composition. Our data underline the role of non pharmacological interventions in the CV disease prevention

Tumor Necrosis Factor α Influences Phenotypic Plasticity and Promotes Epigenetic Changes in Human Basal Forebrain Cholinergic Neuroblasts.

TNFα is the main proinflammatory cytokine implicated in the pathogenesis of neurodegenerative disorders, but it also modulates physiological functions in both the developing and adult brain. In this study, we investigated a potential direct role of TNFα in determining phenotypic changes of a recently established cellular model of human basal forebrain cholinergic neuroblasts isolated from the nucleus basalis of Meynert (hfNBMs). Exposing hfNBMs to TNFα reduced the expression of immature markers, such as nestin and β-tubulin III, and inhibited primary cilium formation. On the contrary, TNFα increased the expression of TNFα receptor TNFR2 and the mature neuron marker MAP2, also promoting neurite elongation. Moreover, TNFα affected nerve growth factor receptor expression. We also found that TNFα induced the expression of DNA-methylation enzymes and, accordingly, downregulated genes involved in neuronal development through epigenetic mechanisms, as demonstrated by methylome analysis. In summary, TNFα showed a dual role on hfNBMs phenotypic plasticity, exerting a negative influence on neurogenesis despite a positive effect on differentiation, through mechanisms that remain to be elucidated. Our results help to clarify the complexity of TNFα effects in human neurons and suggest that manipulation of TNFα signaling could provide a potential therapeutic approach against neurodegenerative disorders

Estudo retrospectivo de tumor venéreo transmissível em cães (Canis lupus familiaris) na região de Garça, São Paulo, Brasil

O objetivo do trabalho foi realizar um estudo retrospectivo do Tumor Venéreo Transmissível (TVT) em cães na região de Garça - São Paulo (SP), no período de 2012 a 2016, por meio de estudo das variáveis existentes. Foram analisados os dados das fichas clínico-cirúrgicas de clínicas veterinárias da região, do período de janeiro de 2012 a julho de 2016. As variáveis incluíram sexo, idade, raça, massa corpórea, cães submetidos ou não à contracepção cirúrgica, acesso livre à rua, exames laboratoriais sanguíneos, localização e tamanho do TVT, e o tipo e a duração do tratamento. Foram diagnosticados 20 cães com TVT, 80% fêmeas e 20% machos, com maior incidência em cães com idade acima de seis anos, sem raça definida (SRD), com massa corpórea entre nove e 15 kg, não submetidos à contracepção cirúrgica e com acesso livre à rua. Todos os cães apresentaram leucocitose e linfocitose. Nos machos, o TVT foi observado somente no prepúcio (20%); e nas fêmeas a região mais acometida foi a vaginal (45%). TVTs com tamanho entre 1 e 3 cm foram os mais incidentes (50%). O protocolo de tratamento mais usado foi o sulfato de vincristina a cada sete dias (60%) com uma média de 3,7 ± 1,5 aplicações, seguido da associação com doxiciclina em casos positivos de erliquiose. Concluiu-se que as cadelas adultas não castradas, da raça SRD de porte médio, e com acesso livre à rua foram as que apresentaram maior incidência do TVT e o protocolo de tratamento foi com sulfato de vincristina

Current trends on subtotal petrosectomy with cochlear implantation in recalcitrant chronic middle ear disorders

Objective. To establish the safety and effectiveness of subtotal petrosectomy with cochlear implantation in patients affected by chronic middle ear disorders to refractory to previous surgical treatments. Methods. A multicentre, retrospective study was conducted on patients affected by recalcitrant chronic middle ear disorders who underwent cochlear implantation in combi-nation with subtotal petrosectomy. Patients’ details were collected from databases of 11 Italian tertiary referral centres. Additionally, a review of the most updated literature was carried out. Results. 55 patients were included with a mean follow-up time of 44 months. Cholestea-toma was the most common middle ear recurrent pathology and 50.9% of patients had an open cavity. 80% of patients underwent a single stage surgery. One case of explantation for device failure was reported among the 7 patients with post-operative complications. Conclusions. Subtotal petrosectomy with cochlear implantation is a benchmark for management of patients with recalcitrant chronic middle ear disorders. A single stage procedure is the most recommended strategy. Optimal follow-up is still debated. Further studies are required to investigate the role of this surgery in paediatric patients. © Società Italiana di Otorinolaringoiatria e Chirurgia Cervico-Facciale

Current trends on subtotal petrosectomy with cochlear implantation in recalcitrant chronic middle ear disorders

Objective. To establish the safety and effectiveness of subtotal petrosectomy with cochlear implantation in patients affected by chronic middle ear disorders to refractory to previous surgical treatments. Methods. A multicentre, retrospective study was conducted on patients affected by recalcitrant chronic middle ear disorders who underwent cochlear implantation in combi-nation with subtotal petrosectomy. Patients’ details were collected from databases of 11 Italian tertiary referral centres. Additionally, a review of the most updated literature was carried out. Results. 55 patients were included with a mean follow-up time of 44 months. Cholestea-toma was the most common middle ear recurrent pathology and 50.9% of patients had an open cavity. 80% of patients underwent a single stage surgery. One case of explantation for device failure was reported among the 7 patients with post-operative complications. Conclusions. Subtotal petrosectomy with cochlear implantation is a benchmark for management of patients with recalcitrant chronic middle ear disorders. A single stage procedure is the most recommended strategy. Optimal follow-up is still debated. Further studies are required to investigate the role of this surgery in paediatric patients