Abstract

Abstract Newsmedia have regularly reported about acts of terrorism that involved members of the same family, but also about instances where one sibling becomes a terrorist, whereas the other becomes a successful, law-abiding citizen. The question is, then, to what extent family circumstances and individual risk factors impact on pathways towards these shared or divergent outcomes. To date, studies on the family characteristics of terrorist suspects have been hampered by a lack of empirical data, small sample sizes and non-representative samples. Using register data on individuals suspected of a terrorist offense in the Netherlands and their family members, the present study examines the demographic and socio-economic characteristics of the families, as well as criminal, employment and education careers of individual family members (parents and brothers/sisters). We compare these characteristics with those of two control groups: suspects of non-terrorist offenses and a matched sample from the population. We also compared the terrorist suspects with matched siblings who were not suspected of a terrorist offence. We will end with a discussion of both risk and protective factors that are present within these families and that can put members of the same family on different pathways.

Highlights

  • Medical devices play an increasingly important role in healthcare worldwide

  • Collaboration between all stakeholders is needed to develop a more proactive safety evaluation process. This new process should incorporate real-world data to develop a risk assessment model that is suitable for all medical devices

  • A medical device is defined as ‘‘any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease, replacement or modification of the anatomy or of a physiological process, and control of conception’’

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Summary

Introduction

Medical devices play an increasingly important role in healthcare worldwide. A medical device is defined as ‘‘any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease, replacement or modification of the anatomy or of a physiological process, and control of conception’’. The amount of mandatory data that needs to be analyzed as part of a medical device post-market surveillance (PMS) system has grown exponentially in recent times This is a consequence of increasingly demanding and complex regulatory requirements from Health Authorities, aimed at a better understanding of the medical device safety evaluation. Regardless of the challenges associated with the use of medical devices, recent safety issues have led to health authorities questioning the rigor of the current medical device legislation and its ability to rapidly identify new safety issues or monitor known problems in order to protect patients (or its users) This concern further grew after the medical problems that arose when poly implant prosthesis (PIP) breast implants were discovered in patients. Article 90 of the new EU regulation states that the European Commission shall put in place systems and processes to actively monitor medical device safety signals

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