European regulators have turned the world of in vitro diagnostics (IVDs) upside down with new legislation that will come into effect at the end of this year. The new EU legislation gives manufacturers five years to meet strict standards. That may not be enough time.
New policy recommendations on preventing occupational exposure to cytotoxic drugs were launched in the European Parliament on 26 April 2016, an important new initiative designed to protect healthcare professionals working across the EU.
Bracco Imaging S.p.A., a global leading company in the diagnostic imaging business, today announced the approval of the use of MultiHance® (gadobenate dimeglumine) in Magnetic Resonance Imaging (MRI) of the whole body in adults and paediatric patients (> 2 years). The approval was obtained through a Mutual Recognition Procedure, with the Medicines and Healthcare products Regulatory Agency…
The U.S. Food and Drug Administration (FDA) has granted Siemens Healthcare Diagnostics Inc. (Siemens) an Emergency Use Authorization (EUA) for its real-time PCR Zika Virus assay, the VERSANT® Zika RNA 1.0 Assay (kPCR) Kit. With respect to Zika in vitro diagnostic tests, FDA has been authorized to issue EUAs to allow for use of unapproved medical products or unapproved uses of approved medical…
Patients and clinicians need greater regulatory transparency to make informed decisions about treatment Medical devices approved first in the European Union (EU) are associated with a greater rate of safety issues, finds a study published by The BMJ.
Around the world, especially in developing nations, counterfeit medicines are a real problem. Until now, in many countries there hasn't been a standard protocol to conduct investigations and pursue prosecution. New research, led by Michigan State University, is providing the foundation to apply criminology theory to preventing the production and sale of fake and substandard medicines.
COCIR welcomes the adoption of the European Data Protection Regulation (DPR). However, in order for the Regulation to deliver on its objectives, it is crucial that EU Member States move rapidly towards a harmonised interpretation and enforcement of its provisions. This will pave the way for growth, innovation and a data-driven healthcare sector.
Juries in criminal cases typically decide if someone is guilty, then a judge determines a suitable level of punishment. New research confirms that these two separate assessments of guilt and punishment – though related - are calculated in different parts of the brain. In fact, researchers found that they can disrupt and change one decision without affecting the other.
Noting a paradigm shift among consumers who are seeking greater control over their own healthcare, AACC issued a position statement today on direct-to-consumer laboratory testing, which allows people to order medical tests directly from a lab without having to work with their healthcare provider. The statement emphasizes direct-to-consumer test results must be accurate and easily understood—an…
The proposed EU draft IVD regulation looks set to have major implications for IVD manufacturers and laboratory-developed tests (LDTs). Replacing a current system that is inflexible, unresponsive and does not effectively protect patients, the new regulation will apply directly to all 28 EU countries and govern the manufacture and marketing of in vitro diagnostic devices (IVDs).
Leading infectious diseases experts have released new guidance for healthcare facilities looking to establish precautions for visitors of patients with infectious diseases. The guidance looks to reduce the potential for healthcare visitors in spreading dangerous bacteria within the healthcare facility and community. The recommendations are published online in Infection Control & Hospital…
The ‘Robert Koch’ plane for medical evacuations (MedEvac) is the winged equivalent of a German hospital isolation ward. Within it, medics with viral haemorrhagic fever while working on the Ebola outbreak in West Africa, receive intensive medical care during any stages of the disease, while being evacuated. Report: Anja Behringer
ECR 2015 evoked Shakespeare´s repertoire as delegates were asked to ponder the ethical implications of incidental findings in large population imaging studies in Vienna. Report: Mélisande Rouger
Every European knows how differences can boost cultural diversity and open unexpected perspectives – but, when it comes to having a homogeneous standard of care, they can become an absolute nightmare.
Where some decry the commoditisation of radiology, Gabriel Krestin MD, sees an opportunity to redefine the profession, for radiologists to rise up from basement reading rooms to consult as equals with other medical specialists in multi-disciplinary conferences focused on patient care. ‘If we are going to think about the future, we should not be looking in a rear view mirror. We need to be open…
Sermo, the social network for doctors, announced the results of a poll of 2,238 doctors on the contentious issue of whether obese individuals should be considered disabled. An overwhelming majority of doctors, 88 percent, disagreed with a new ruling from the European Union under which employers will be required to protect obese workers and provide them with special parking spaces, larger seats…
Last October the Association of the German Diagnostics Industry (VDGH) warned that the proposed EU regulation on in vitro diagnostic medical devices will increase production costs. Simultaneously with the Brussels proposal publication, the German Federal Ministry of Health presented a draft fees regulation that includes significant increases and several new fees, inter alia the minimum fee for…
Patients are no longer content to be passive recipients of medical care, and are instead taking a more active role in their treatment, says Kathy Oliver, Chair co-director of the International Brain Tumour Alliance (IBTA). Report: Frank Swain
Two years ago, following John Dalli’s resignation as Commissioner for Health and Consumer Affairs, Tonio Borg was appointed to that role by the Council of the European Commission.
Treat a proficiency testing (PT) sample just like a patient sample. But don't. That has been the message labs have struggled with and in some cases lost their CLIA certificates over.
The survival of premature newborns in England is 30% higher in specialist units treating large numbers of neonates, reveals an analysis of national data published in the online journal BMJ Open.
Although nosocomial infections and medical accidents have declined, over 750 hospitals with the highest number of such cases now face penalties – amounting to an estimated $330 million a year – issued by Medicare.
It was long overdue: Seven years after the arrival of the USA’s Image Wisely and Image Gently Campaigns, a European campaign for greater radiation protection in diagnostic and interventional imaging has arrived.
For the first time, the right of patients in Europe to seek healthcare in another Member State, and be reimbursed for it, is clearly established thanks to the EU Directive on Patients’ Rights in Cross-Border Healthcare. EPF organised a three-day regional conference to enable Patient leaders to understand the details of this legislation and its transposition at national level.
A one-day course on Infection Prevention and Control (20 November. 9.30 a.m. - 6.00 p.m.) will focus on a vital issue at the Medica Education Conference 2013.