Ensuring Safety and Quality of Tissues in Italy: Application of European Directives

Three European Directives published in 2004 and 2006 require Member States to take a series of regulatory actions to ensure appropriate quality and safety of tissues and cells. These directives define responsibilities to inspect and certify centers, to put vigilance systems in place and to publish information on certified centers and their activities. A European-funded project led by the Italian National Transplant Centre has supported Member States in the development of common guidelines for inspection, tools for vigilance, and training for inspectors. In Italy, inspections are conducted every 2 years at each tissue bank, and a vigilance system has been launched. Information on Italian centers and their activity is published in the Eurocet Registry.     

Living Organ Donation by Minors: An Analysis of the Regulations in European Union Member States

Living organ donation (LD) is an increasingly established practice. Whereas in the United States and Canada LD by minors has occasionally been reported, LD by minors seems to be largely absent in the European Union (EU). It is currently unclear whether this is the result of a different legal approach. This study is the first to systematically analyze the regulations of EU member states, Norway, and Iceland toward LD by minors. Relevant regulations were identified by searching government websites, translated, compared, and sent for verification to national legal experts. We identified five countries where LD by minors is allowed. In two of these (Belgium and the United Kingdom), some minors may be deemed sufficiently mature to make an autonomous decision regarding LD. In contrast, in the three other countries (Luxembourg, Norway, and Sweden), LD by minors is only allowed subject to parental permission and the assent (or absence of objection) of the donor. Where allowed, regulations differ significantly with regard to the substantive and procedural safeguards in place. In view of the controversial nature of the procedure, as illustrated by recent reports and surveys, we argue for a very cautious approach and greater harmonization in countries where LD by minors is allowed.     

Bone Development: Overview of Bone Cells and Signaling

Vertebrates evolved elaborating a structure made up of more than 200 bones and cartilages articulated with one another to form the skeleton, through which locomotion, organ protection, lodging of hematopoiesis, and mineral homeostasis are allowed. Skeletogenesis starts at the fetal stage, along with marrow hematopoiesis, and evolves postnatally through modeling and remodeling processes that permit skeletal mass buildup. Preservation of skeletal mass is then implemented by balanced remodeling, which ensures continuous renovation of the tissue to allow its mechanical, structural, and metabolic properties to remain unaltered until ageing or diseases disrupt this equilibrium. Skeletal homeostasis is fulfilled by specialized bone cells in association with systemic and local regulators. Herein I review landmark discoveries that shed light on the intricate mesh connecting bone cells among themselves and with other systems, thus representing the cellular basis of normal and abnormal bone development and homeostasis.     

Disability policy of the European Union: The supranational level

During recent years disability policy at the European level has changed from a formerly disregarded branch of traditional social policy into a modern policy formation which comprises not only social protection and labour market integration, but also equal rights and non-discrimination. In the light of this evolution, against the background of an ongoing research project the paper explores these questions: what kind of a political body is the European Union (EU)? What kind of impact does it have on disability policy? How did EU disability policy evolve? What are the relations between social policy and equal rights policy? Do different welfare regimes operate at the EU level? The article presents results of a systematic analysis of disability related policy documents of the EU covering the period from 1958 until 2005. The documentary analysis shows that from the late 1970s up to the middle of the 1990s EU disability policy has centred around labour market integration. During the last decade, however, the equal rights approach has got more and more dominant. The paper concludes with suggestions for further research.     

Re: Prevalence of erectile dysfunction in the European Union

Dear Sir,Erectile dysfunction (ED) is a worldwide problem whose prevalence is projected to rise sharply due to increasing age in Europe and North America and to population growth in other continents, especially Asia [Giuliano F. Eur Urol 2002; 1 (Supp l):Sl].The recent development,     

Epidemic Threats to the European Union: Expert Views on Six Virus Groups

In recent years, several animal disease epidemics have occurred within the European Union (EU). At the 4th Annual Meeting of the EPIZONE network (7–10 June 2010, St. Malo, France), an interactive session was run to elicit the opinions of delegates on a pre‐defined list of epidemic threats to the EU. Responses from over 190 delegates, to questions relating to impact and likelihood, were used to rank six virus groups with respect to their perceived threat now (2010) and in 2020. The combined opinions of all delegates suggested that, from the pre‐selected list of virus groups, foot‐and‐mouth disease and influenza are currently of most concern. Delegates thought that influenza would be less of a threat and zoonotic arboviruses would be more of a threat in 2020. Although the virus group rankings should not be taken as definitive, the results could be used in conjunction with experimental and field data, by scientists, policy‐makers and stakeholders when assessing and managing risks associated with these virus groups.     

磁感应热疗用镍-铜热籽对L-929细胞及兔肌肉组织的影响

目的探讨磁感应热疗用镍-铜热籽体外升温特性以及对细胞与组织的影响。方法测量感应热籽在离体兔肝组织内升温特性;通过细胞毒性试验（MTT试验）评价该治疗热籽浸提液体外细胞毒性;溶血试验评价其有无溶血作用;兔体内肌肉埋植试验来评价其材料的组织毒性。结果实验中所用的铁磁热籽在离体兔肝内具有良好的升温效果;细胞毒性试验结果显示镀金热籽对L-929细胞毒性为1级,属对细胞无毒性范畴;溶血试验中镀金热籽的溶血率3．25％（〈5％）,表明实验用热籽无溶血作用;各期体内埋植试验反映了材料在肌肉组织中不同的炎性反应。结论自制的镀金镍-铜热籽在感应加温交变磁场中可升温到适合的温度,对L-929细胞毒性为1级,无溶血作用。     

The prevalence of cystic fibrosis in the European Union

This study combined a variety of methods to determine the prevalence of cystic fibrosis in the European Union. The results of literature reviews, surveys, and registry analyses revealed a mean prevalence of 0.737/10,000 in the 27 EU countries, which is similar to the value of 0.797 in the United States, and only one outlier, namely the Republic of Ireland at 2.98.     

The regulation of xenotransplantation in Germany and in the European Union

Since the middle of the 1990, xenotransplantation has been the object of regulatory work. In this context, the point of main emphasis is the issue of protection of the individual and the general public against the risks of xenotransplantation, especially against the risks of infection associated with xenotransplantation. International organizations, such as the WHO and the Council of Europe have issued a series of publications dealing with xenotransplantation (inter alia, [ 1 - 3 ] below), which, however, are not legally binding. Yet, there are legally binding provisions at EU level. First the general regulations on medicinal products are applied [ 4 - 6 ]. Provisions specifically relating to xenogeneic medicinal products are included in Part IV Annex I of Directive 2001/83/EC [ 4 ] and in Directive 2001/20/EC [ 5 ]. In addition, the document entitled “Points to Consider on Xenogeneic Cell Therapy Medicinal Products” [ 7 ] by the EMEA comprises basic considerations on the development and evaluation of xenogeneic cell therapy medicinal products. Regulation (EC) No 1394/2007 on advanced therapy medicinal products [ 8 ] which entered into force at the end of 2007, will soon introduce further specific provisions concerning the authorisation, supervision, and pharmacovigilance of xenogeneic medicinal products as well. For the purpose of adjustment to the gain in scientific knowledge and harmonization of the regulatory framework, currently various Community rules are being further developed and/or elaborated. Moreover, a Committee on Advanced Therapies is to be established at the EMEA. In Germany, the legal framework of xenotransplantation is substantially determined by Community rules, particularly by ordinances and directives. Ordinances directly apply to all member states and thus they have the force of law. However, directives first have to be incorporated into national law, which, as far as the above‐mentioned directives are concerned, was substantially effected in the German Medicinal Products Act [ 9 ] and in the German GCP‐Ordinance [ 10 ]. Moreover, in the context of xenotransplantation further provisions are relevant, inter alia, provisions of the genetic engineering legislation, of the animal welfare legislation, the professional standards and the code of professional conduct of physicians and of the protection against infection legislation.     

Burn mass casualty incidents in Europe: A European response plan within the European Union Civil Protection Mechanism

BackgroundBurn care is centralized in highly specialized burn centers in Europe. These centers are of limited capacity and may be overwhelmed by a sudden surge in case of a burn mass casualty incident. Prior incidents in Europe and abroad have sustained high standards of care through well-orchestrated responses to share the burden of care in several burn centers. A burn mass casualty incident in Romania in 2015 sparked an initiative to strengthen the existing EU mechanisms. This paper aims to provide insight into developing a response plan for burn mass casualties within the EU Civil Protection Mechanism.MethodsThe European Burns Association drafted medical guidelines for burn mass casualty incidents based on a literature review and an in-depth analysis of the Romanian incident. An online questionnaire surveyed European burn centers and EU States for burn mass casualty preparedness.ResultsThe Romanian burn mass casualty in 2015 highlighted the lack of a burn-specific mechanism, leading to the late onset of international transfers. In Europe, 71% of respondents had existing mass casualty response plans, though only 35% reported having a burn-specific plan. A burns response plan for burn mass casualties was developed and adopted as a Commission staff working document in preparation for further implementation. The plan builds on the existing Union Civil Protection Mechanism framework and the standards of the WHO Emergency Medical Teams initiative to provide 1) burn assessment teams for specialized in-hospital triage of patients, 2) specialized burn care across European burn centers, and 3) medevac capacities from participating states.ConclusionThe European burn mass casualty response plan could enable the delivery of high-level burn care in the face of an overwhelming incident in an affected European country. Further steps for integration and implementation of the plan within the Union Civil Protection Mechanism framework are needed.     

The Helsinki Declaration on Patient Safety in Anesthesiology: a way forward with the European Board and the European Society of Anesthesiology

Anesthesiology, which includes anaesthesia, perioperative care, intensive care medicine, emergency medicine and pain therapy, is acknowledged as the leading medical specialty in addressing issues of patient safety, but there is still a long way to go. Several factors pose hazards in Anesthesiology, like increasingly older and sicker patients, more complex surgical interventions, more pressure on throughput, as well as new drugs and devices. To better design educational and research strategies to improve patient safety, the European Board of Anesthesiology (EBA) and the European Society of Anesthesiology (ESA) have produced a blueprint for patient safety in Anesthesiology. This document, to be known as the Helsinki Declaration on Patient Safety in Anesthesiology, was endorsed together with the World Health Organization (WHO), the World Federation of Societies of Anesthesiologists (WFSA), and the European Patients' Federation (EPF) at the Euroanaesthesia meeting in Helsinki in June 2010. It was signed by several Presidents of National Anesthesiology Societies as well as other stakeholders. The Helsinki Declaration on Patient Safety in Anesthesiology represents a shared European view of what is necessary to improve patient safety, recommending practical steps that all anesthesiologists can include in their own clinical practice. The Italian Society of Anaesthesia, Analgesia, Reanimation and Intensive Care (SIAARTI) is looking forward to continuing work on "patient safety" issues in Europe, and to cooperating with the ESA in the best interest of European patients.