Regulatory Requirements For Medical Devices And Vascular Ageing: An Overview.

The development and use of medical devices are subject to regulations and approval activities to enter the market. These are mandatory for manufacturers and have important implications for all involved professionals. In fact, the innovation process, starting from a clinical need, includes the identification of a solution and its implementation, and requires taking into account crucial aspects according to regulatory requirements in each phase. These include exemplary validation or risk management. The aim of this work is to provide an overview of some key aspects of regulation and their implementation in medical devices for vascular ageing assessment. In particular, regulatory scenarios in Europe, Australia and the United States of America are described and examples of marketed medical devices for vascular ageing assessment are provided. Strong and active links among industry, research, clinical experts and governments adds value for the community, requiring the ability to communicate between different skills and backgrounds: this multidisciplinary and multi-partner collaboration can speed up the innovation process and can increase the system's efficiency related to both social and ethical impact.

Differentiation of self and trait anxiety: A cross-cultural perspective.

Cultural differences are likely to affect the ability to deal with anxiety. We investigated this issue among four cultural groups-Germans and Italians (Europeans living in South Tyrol, Italy), Jews and Arabs (Israelis)-in terms of their levels of differentiation of self, trait anxiety and somatic symptoms. We also examined the relationship of differentiation of self to trait anxiety and somatic symptoms. The sample consisted of 824 students: 387 Israelis (mean age 23.6) and 437 Europeans (mean age 22.3). Israeli participants reported lower levels of trait anxiety than European students. Jewish students reported lower trait anxiety than Arab students (mean difference = -.14, p < .009), while there was no difference between German and Italian students (mean difference = .03, p > .99). Jews reported a significantly lower level of emotional cutoff than Arabs (mean difference = -.45, p < .001), and Germans reported a significantly lower level of emotional reactivity than Italians (mean difference = .29, p < .001). Emotional reactivity and I-position predicted all participants' trait anxiety. On the whole, results point to the importance of examining differentiation of self when trying to reduce trait anxiety, as well as some important cultural differences.

'Fighting for care': parents' perspectives of children's palliative care in South Tyrol, Italy.

BACKGROUND: Children's palliative care in Italy develops comparatively slowly. Recent legislation is enabling, but foundational research exploring parental experiences and perceptions is lacking. AIM: To investigate the experiences and perceptions of parents in South Tyrol, Italy regarding caring for a child with a life-threatening or life-limiting illness. DESIGN: A mixed qualitative design incorporated both an online survey and parent interviews. Using purposive sampling, 13 parents undertook 9 interviews and 7 parents completed the survey. RESULTS: The authors highlight a major parental theme describing difficult relationships with health services requiring them to 'fight the system' for services. DISCUSSION: The authors raise a disturbing possibility that such 'fighting the system' is now so widely recognised worldwide that it cannot be considered to be accidental. CONCLUSION: The authors recommend the establishment of a specialist, dedicated paediatric palliative care service in South Tyrol with the international recognised values and operating standards that would render such parental 'fighting' unnecessary.