Do not recommend, prescribe or use cough.
Do not routinely use steroids and bronchodilators in infants presenting with bronchiolitis.
Duration: Do not routinely prolong IV antibiotics to treat severe infections, but consider switching to the oral form as soon as the clinical condition has improved.
Do not routinely use antibiotics in children with acute otitis media when self-resolution is expected.
Do not prescribe antibiotics for neonates without clinical signs of sepsis.
Do not routinely continue hospitalization in well-appearing febrile infants once bacterial cultures have been confirmed negative for 24 to 36 hours if adequate outpatient follow-up can be assured.
Do not continue antibiotic therapy for suspected neonatal sepsis >36-48 hours without clear suspicion of bacterial infection.
Do not perform screening panels (IgE tests) for food allergies without a history consistent with a specific food allergy.
Do not request urine culture in febrile children older than 2 months with respiratory tract infection.
Do not routinely prescribe acid blockers and motility agents in infants with GER.
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.
