Application of ISO 13485:2003 in Biomedical Engineering: a Systematic Review

Introduction: Quality is the foremost objective of healthcare organisms and it is frequently the subject ofintense discourse because of not only the citizens-patients’ requirements but health administrations andprofessionals’ goals and aims as well.Objectives: The aim of the present study is to show the significance of quality system ISO 13485:2003 andmodern tendencies round this in the international reality and in our country.Method: An online, systematic peer-reviewed search in Medline, Pubmed and the Cochrane Database withmeta-analysis of the search results was conducted. The retrieved studies were then screened to meet certaininclusion criteria, i.e. relevance, significant meanings in correspondence with this paper’s objectives and ofinterest to an international health-professional readership.Results: The present study constitutes a theoretical approach of quality in healthcare environment, as well as apresentation and description of the ways and processes for quality measurement and quality of health careservices improvement. Initially, quality is conceptually determined as a general idea, but mainly focusing onhealth sector and the providing services. Acute importance is given on quality measurement methods and tools,as well as on the administrative processes that can be applied to continuously improve and ensure an adequatelevel of quality. An important part of this study is the delineation of quality system of ISO 13485:2003, as this isinternationally and domestically applied in the field of Biomedical Engineering.Conclusion: Given the need for implementation of the prevalent European and National legislation, in order toensure the safe distribution of medical equipment and the prevention of possible adverse incidents, the presentstudy was realized

Cardiovascular Disease and Chronic Inflammation in End Stage Kidney Disease

Background: Chronic Kidney Disease (CKD) is one of the most severe diseases worldwide. In patients affected by CKD, a progressive destruction of the nephrons is observed not only in structuralbut also in functional level. Atherosclerosis is a progressive disease of large and medium-sized arteries. It is characterized by the deposition of lipids and fibrous elements and is a common complication of the uremic syndrome because of the coexistence of a wide range of risk factors. High blood pressure, anaemia, insulin resistance, inflammation, high oxidative stress are some of the most common factors that cause cardiovascular disease and atherogenesis in patients suffering from End Stage Kidney Disease (ESRD). At the same time, the inflammatory process constitutes a common element in the apparition and development of CKD. A wide range of possible causes can justify the development of inflammation under uremic conditions. Such causes are oxidative stress, oxidation, coexistentpathological conditions as well as factors that are due to renal clearance techniques. Patients in ESRD and coronary disease usually show increased acute phase products. Pre-inflammatory cytokines, such as IL-6 and TNF-a, and acute phase reactants, such as CRP and fibrinogen, are closely related. The treatment of chronic inflammation in CKD is of high importance for the development ofthe disease as well as for the treatment of cardiovascular morbidity.Conclusions: The treatment factors focus on the use of renin-angiotensic system inhibitors, acetylsalicylic acid, statins and anti-oxidant treatment in order to prevent the action of inflammatorycytokines that have the ability to activate the mechanisms of inflammation

Predictors of anxiety and depressive symptoms among Greek nurses

Introduction: The increasing needs of an aging population and the shortage of nursing personnel have a negative impact on the workload of nurses increasing the risk of developing anxiety and depressive symptoms. This research aims to evaluate the strength of occupational and demographic characteristics in predicting anxiety and depression among nurses. Methods: In this cross-sectional study, a sample of 164 Greek nurses from three hospitals employed full-time participated. Anxiety and depression were measured using the validated Greek versions of the State-Trait Anxiety Inventory – State and Trait Y forms and the Centre for Epidemiological Studies Depression scale, respectively. The statistical analysis of the data was performed using the statistical program SPSS version 19.0. The statistical significance level was set up at 0.05. Results: Younger nurses, unmarried, those without children, those with less work experience, and working in the general medical units were more vulnerable. The average number of patients per nurse during the day shift may not predict anxiety or depression scores. Strong positive correlation between state and trait anxiety (r [162] = 0.77, p < 0.001), state anxiety and depression (r [162] = 0.62, p < 0.001), and trait anxiety and depression (r [162] = 0.63, p < 0.001) was revealed. Conclusion: Anxiety and depression are prevalent among nurses. Demographic and working characteristics are strong predictors of anxiety and depression among nurses. Nursing managers should emphasize emotional interventions (cognitive behavioral therapy, training on emotional intelligence, strengthening coping skills, and development of high resilience) in supporting nurses at higher risk

Anxiety, insomnia and family support in nurses, two years after the onset of the pandemic crisis

Introduction: The Covid-19 pandemic continues to cause serious physical and mental problems for health professionals, particularly nurses. Aim: To estimate the prevalence of anxiety and insomnia and to evaluate their possible association with family support received by nurses two years after the onset of the pandemic. Materials and methods: In total, the study participants were 404 nurses (335 females and 69 males) with a mean age of 42.88 (SD = 10.9) years and a mean of 17.96 (SD = 12) years working as nurses. Nurses from five tertiary hospitals in Athens constituted the study population who completed the questionnaires State-Trait Anxiety Inventory (STAI), Athens Insomnia Scale (AIS) and Family Support Scale (FSS), in the months of November and December 2021. Regarding demographic and occupational characteristics, gender, age and years of experience as nurses were recorded. Results: 60.1% of the nurses showed abnormal scores in state anxiety, with 46.8% in trait anxiety, and 61.4% showed insomnia. Women showed higher scores on the two subscales of anxiety and the insomnia scale compared to men (p 0.05). Positive correlations (p < 0.01) were found between the State Anxiety Inventory, Trait Anxiety Inventory and AIS, while all of them showed a high negative correlation with FSS (p < 0.01). Age showed a negative correlation with Trait Anxiety Inventory (p < 0.05). As shown by the mediation analysis, the relationship between state anxiety and insomnia was mediated by trait anxiety, whereas state anxiety appeared to be dependent on family support. Conclusions: Nurses continue to experience high levels of anxiety and insomnia and feel less supported by their families than in the first year of the pandemic. Insomnia appears to be dependent on state anxiety, with a significant indirect effect of trait anxiety, while family support seems to affect state anxiety

Fatigue and Quality of Life after Pulmonary Rehabilitation Program

BACKGROUND. Fatigue and poor quality of life can play an important role in chronic obstructive disease and treatment outcomes. The aim of this study was to examine the levels of fatigue and quality of life (QoL) among chronic obstructive pulmonary disease patients before and after a pulmonary rehabilitation program. METHODS. In this experimental study, 31 chronic obstructive pulmonary disease patients at a large hospital of Athens were randomly followed a pulmonary rehabilitation program and completed two questionnaires pre- and post-intervention:the Fatigue Assessment Scale designed for measuring fatigue and the Missoula -Vitas Quality of Life Index-15 designed for measuring QoL. Statistical analysis of the data was performed via the Statistical Program SPSS version 19.0.The statistical significance was set up at 0.05. RESULTS. The results showed decreased levels of fatigue after the completion of the Pulmonary Rehabilitation Program compared to pre -intervention. Moreover, although QoL did not seem to change after the intervention, however the dimension "Transcendent" seemed to be increased for the majority of the participants. After the participation in the rehabilitation program a statistically significant and negative correlation was observed between mental fatigue and total score of quality of life (r= -0.436, p=0.014 <0.05) as well as between physical fatigue and the dimensions of "Interpersonal" (r= -0.470 p=0.008),"Well-Being" (r= -0.615, p=0.000), "Transcendent" (r= -0.636, p=0.000) and total score of QoL (r= -0.543, p=0.002). CONCLUSIONS. A pulmonary rehabilitation program seems to be a successful and innovative clinical prevention program leading to a lower level of fatigue for those patients who suffer from chronic obstructive pulmonary disease

Physical therapists’ perceptions about patients with incomplete post-traumatic paraplegia adherence to recommended home exercises: a qualitative study

Background: The overall purpose of physical therapy for patients with spinal cord injury is to improve health-related quality of life. However, poor adherence is a problem in physical therapy and may have negative impact on outcomes.Objectives: To explore the physical therapists’ perspectives about patients with incomplete post-traumatic paraplegia adherence to recommended home exercises.Methods: A qualitative content analysis was conducted. Data were collected in a convenience sample using semi-structured interviews. Thirteen registered physical therapists in Athens area participated in the study.Results: Five categories emerged from the data: (1) reasons to recommend home exercise by the physical therapist; (2) obstacles to recommend home exercise by the physical therapist; (3) methods addressing these obstacles; (4) the family's role in the adherence to recommended home exercise; and (5) the impact of financial crisis in adherence to recommended home exercise. All participants found the recommended home exercises essential to rehabilitation and health maintenance, and they value their benefits. They also expressed the obstacles that need to be faced during rehabilitation process in order to promote adherence.Conclusion: Physical therapists should take into account the different obstacles that may prevent patients with incomplete post-traumatic paraplegia adherence to recommended home exercises. These involve the patients and their families, while, financial crisis has also an impact in adherence. In order to overcome these obstacles and increase adherence, communication with patient and family while taking into account the individual's needs, capacities, and resources are essential.</p

Are Burnout Syndrome and Depression Predictors for Aggressive Behavior Among Mental Health Care Professionals?

This study aims to examine the possible relation between depression and burnout as predictors to aggressive behaviors among mental healthcare professionals. For the purposes of this study 72 mental health care professionals were recruited and were evaluated in three questionnaires which were provided to them online. Firstly regarding depression, the Center for Epidemiologic Studies Depression Scale (CES-D) was administered, secondly, concerning burnout, Maslach Burnout Inventory (MBI) was applied and finally, regarding aggression, the Aggression Questionnaire (GAQ) was employed. Statistical data analysis was performed using the IBM SPSS Statistics Version 19. The level of statistical significance was set at up at 0.05. The results showed that depression is considered to be a statistically significant predictor of aggressive behaviors. However, burnout was not found to be a statistically significant predictor of aggression. In addition, a statistically significant relationship was found between burnout and depression. It seems to be of essential importance for mental healthcare professionals to be provided with support and assistance in order to diminish the potential high-stress levels and in that way to overcome depression and burnout of those who work in mental health settings

Anxiety and Depression in Patients with Permanent Atrial Fibrillation: Prevalence and Associated Factors

Atrial fibrillation (AF) is an important public health problem that is increasing at an alarming rate, worldwide. The most common type is permanent AF followed by the paroxysmal and persistent AF. Purpose. This study was aimed at exploring anxiety and depression and the associated factors in patients with permanent AF. Materials and Methods. The sample of the study included 170 AF patients. Data collection was performed by the method of interview using the “Hospital Anxiety and Depression Scale” (HADS) to assess anxiety and depression and a questionnaire including patients’ characteristics. Results. 70% of the participants were men, and 32.4% were above 70 years old. Furthermore, 34.9% of the patients had high levels of anxiety, and 20.2% had high levels of depression. Anxiety levels were statistically significantly associated with gender p=0.022, age p=0.022, educational level p=0.025, years having the disease p=0.005, and relations with nursing staff p=0.040. Depression levels were statistically significantly associated with age p=0.037, degree of information of the state of health p<0.001, years having the disease p<0.001, and relations with medical staff p=0.041. Conclusions. Patients’ characteristics are associated with anxiety and depression and need to be evaluated when treating this frequently encountered arrhythmia

The Effect of Fatigue and Pain Self- Efficacy on Health-Related Quality of Life Among Patients with Multiple Sclerosis

Health-related quality of life is a major issue among patients with Multiple sclerosis (MS). To explore the effect of fatigue and pain self-efficacy on health-related quality of life among patients with MS. Between March and May 2018, 85 MS patients from a large Hospital of Athens region completed the questionnaires: a) Missoula-VITAS Quality of Life Index-15, which examines 5 dimensions of quality of life, b) Pain Self Efficacy Questionnaire which measures the pain self-efficacy that an individual perceives, c) Fatigue Assessment Scale (FAS) which measures fatigue, d) a questionnaire about the sociodemographic elements. Statistical analysis was performed using the IBM SPSS Statistics version 21. The significance level was set up to 0.001. Fatigue might predict the dimension of quality of life "Function" while Pain Self-Efficacy might, also, predict the dimension of quality of life "Interpersonal". A strong correlation was found between the dimensions of quality of life "Well-being" and "Transcendent" and between "Interpersonal" and Pain Self-Efficacy. The total score of fatigue was strongly correlated with Physical Fatigue and very strongly correlated with Mental Fatigue. Fatigue and Pain Self-Efficacy are important predictors of the dimensions of quality of life among patients with MS. Pain in MS has to be taken into serious consideration in every patient with MS

A cross-sectional study for the impact of coping strategies on mental health disorders among psychiatric nurses

Several studies report that psychiatric nursing is a highly stressful occupation. The ways that nurses use in order to deal with stressful situations have a serious effect on their psychological mood and their health status. The purpose of this study was to investigate the coping strategies in predicting of depression and anxiety among mental health nurses working in public psychiatric hospitals. A descriptive, cross-sectional study was conducted in Athens, Greece from April to May 2017. A questionnaire consisting of the socio-demographic and work-related characteristics, the Patient Health Questionnaire-2, the Generalized Anxiety Disorder-2, and the 38-items Ways of Coping Questionnaire - Greek version, was completed by a total of 110 mental health nurses. Univariate and multivariate analyses were performed using the logistic regression model. Coping strategies focused on the problem (positive re-evaluation, positive approach, problem solving, and seeking social support) were the most commonly used by the mental health nurses. Strategies focused on emotion (prayer/daydream, prayer, avoidance/escape, resignation, and denial) were positively associated with depression and anxiety outcomes. Also, the coping skills of problem solving (Adjusted Odds Ratio, AOR=0.402), and seeking social support (AOR=3.719) were significant predictors only for elevated anxiety symptoms. The results from the study demonstrated the importance of coping behaviours in mental health problems of psychiatric nurses