No recomendar, prescribir o usar medicamentos para la tos en niños.
No usar habitualmente corticoides ni broncodilatadores en niños con bronquiolitis aguda.
No prolongar rutinariamente la antibioterapia intravenosa en el tratamiento de infecciones graves, sino considerar el cambio a vía oral tan pronto como mejore su estado clínico.
No usar rutinariamente antibióticos en niños con otitis media aguda cuando se espera una resolución espontánea.
No prescribir antibióticos en neonatos sin signos clínicos de sepsis.
No mantener hospitalizados a lactantes febriles con buen estado general si los cultivos bacterianos son negativos a las 24-36 horas, si se puede asegurar un seguimiento ambulatorio adecuado.
No mantener tratamiento antibiótico por sospecha de sepsis neonatal más de 36-48 horas si no existe una sospecha clara de infección bacteriana.
No llevar a cabo cribado para alergias alimentarias (pruebas de IgE) sin una historia clínica que sea compatible con una alergia alimentaria específica.
No solicitar cultivo de orina en niños febriles mayores de 2 meses con infección del tracto respiratorio.
No prescribir de forma rutinaria antiácidos ni procinéticos en lactantes con reflujo gastroesofágico.
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.
