Dear Colleague,
We are all horrified at the events unfolding in Ukraine. The European Academy of Paediatrics has already made a statement about protecting children during the war in Ukraine. Now, we are considering how best we can further, and most effectively, support the health and welfare of those children.
The Ukrainian Paediatric health system faces a huge burden, taking care of casualties of war whilst continuing to care for those children with complex chronic disease, including cancer, chronic respiratory problems, epilepsy, and many other conditions. Some of those children remain in Ukraine, but potentially without access to medical help and supplies, whilst others are refugees crossing into Europe.
The EAP wants to coordinate the help for these children, who are already being offered a range of support by many different countries. We would like to collate a list of hospitals in Europe that would be able to take Ukrainian paediatric patients with complicated, rare, or chronic diseases and treat them according to their needs.
We believe that National Bodies are in the best position to determine what can be done internally, but that the EAP can assist in collating what resources are available and how they can be accessed. Additional information (rules on Visa requirements, COVID regulations, availability of translators for example) may also be very valuable.
Being aware that each country has different approach to admitting paediatric patients from Ukraine, we offer you two ways of which you can choose for medical institutions in your country to be approached:
In both cases contact data will be available only through closed access system to whom access would be granted to project team members, EAP EC and participating Ukrainian doctors. It would not be publicly available. Interested parties would contact national coordinator or available contact person in institution directly or via EAP project team.
Therefore, we kindly ask you or to complete questionnaire about national coordinator or forward the Link 2 to questionnaire to medical institutions in your country interested in admitting Ukrainian paediatric patients with complex chronic diseases.
We are in touch with the Ukrainian Paediatric Societies and using them to help us direct care to the most appropriate providers.
We suspect that there are other areas where you can offer expertise – for example EuSEMs series of short webinars (prepared for Myanmar) setting out a number of obstetric, paediatric and trauma related scenarios, helping inexperienced staff undertake emergency procedures and care. Please, feel free to share such information with us, so we can share it with Ukrainian colleagues.
Due to the urgency of the situation, we would kindly ask you to provide us with answers no later than Tuesday 17th of April 2022. Still, all answers sent even after April 17th will be incorporated in this database.
We are aware that this will take a lot of time and effort from you, especially for bigger countries, but are also aware of the situation in Ukraine and need of those children. This is the moment when EAP must join forces and use our full capacities to help Ukrainian children.
For all your questions please feel free to contact Ivan Bambir (ivan_bambir@hotmail.com), Loraine Lugasi (llugasi@paragong.com) or Yannis Trimithiotis (yiannis@projectsquared.com.cy).
Yours sincerely,
|
Adamos Hadjipanayis EAP President |
Ivan Bambir YEAP Chair |
New ways to test high-risk medical devices.
Manufacturers of medical devices need to test their products before being allowed to market them. Specifically, they require clinical data showing their medical device is safe and efficient. In this context, the EU-funded CORE-MD project will translate expert scientific and clinical evidence on study designs for evaluating high-risk medical devices into advice for EU regulators. The project will propose how new trial designs can contribute and suggest ways to aggregate real-world data from medical device registries.
It will also conduct multidisciplinary workshops to propose a hierarchy of levels of evidence from clinical investigations, as well as educational and training objectives for all stakeholders, to build expertise in regulatory science in Europe. CORE–MD will translate expert scientific and clinical evidence on study designs for evaluating high-risk medical devices into advice for EU regulators, to achieve an appropriate balance between innovation, safety, and effectiveness. A unique collaboration between medical associations, regulatory agencies, notified bodies, academic institutions, patients’ groups, and health technology assessment agencies, will systematically review methodologies for the clinical investigation of high-risk medical devices, recommend how new trial designs can contribute, and advise on methods for aggregating real-world data from medical device registries with experience from clinical practice The consortium is led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, and involves all 33 specialist medical associations that are members of the Biomedical Alliance in Europe.
