When a Californian company founded by a U.S. veteran wounded in Afghanistan sought to register a new medical device this year, it turned to Europe before the United States. The European approvals system had long been quicker, the company said, but the introduction of new rules is changing all that.
 “Now it has flipped,” said Bill Colone, CEO of San Clemente-based Spinal Singularity, which hopes to launch a ‘smart’ catheter for men with spinal injuries or disease early next year after squeezing in its application under the old European rules.
Colone is part of a chorus of industry voices warning that a switch to stricter European rules governing medical devices, due to come into force a year from now, will slow or even halt the release of products in Europe that could transform patients’ lives.
Defenders of the regulations say they will not significantly complicate the process and are vital to prevent problems like rupturing silicone breast implants and debris from all-metal hip implants damaging tissue and bones.
Many patient advocates say the new rules do not go far enough to reform a European system in which a top U.S. official suggested in 2011 patients may be “guinea pigs” here. The comment drew a sharp response from the European Union, which still firmly rejects that characterization.
That transatlantic spat, and the subsequent evolution of medical device certification around the world, are part of a wider global struggle by governments to attract businesses seeking light-touch regulation without scaring off their voters.
The new medical devices rules agreed by the European Union in 2017 will tighten control of devices before they come to market, improve transparency and strengthen surveillance by national authorities, a European Commission spokesperson said.
The new system changes less than some proposals – which envisaged regulation by a public body, along U.S. lines, replacing the existing practice of certification by profit-making private firms.
But players in medical technology – which ranges from surgical implants to scans – say it is too burdensome and is being built too slowly, risking not only hampering innovation but also harming patients by interrupting supplies.
“Immediate action is needed now to avoid severe disruption of product supply to patients and hospitals,” seven European Associations said in a joint statement last week.
All 55,000 devices certified under the old directives have to be re-certified along with other products such as reusable scalpels, nasal saline sprays and dental imaging software.
The industry says there are not enough Notified Bodies – the private firms charged with certifying the safety of devices ranging from bandages to pacemakers, and that manufacturers may have to take products off the market or delay new launches.
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The IHF World Hospital Congress is a unique global forum that brings together leaders of hospitals, health services, and healthcare organizations to discuss key drivers of national and international policy, management, financial trends and solutions. The 44th edition of the World Hospital Congress will take place on 2 to 5 November, 2020 at the Palau de Congressos de Catalunya in Barcelona. Professionals from the health sector interested in sharing their work to the international healthcare community are now invited to submit their abstracts.
The International Hospital Federation and La Unió Catalana d’Hospitals, organizers of the congress, invite leaders and professionals from hospitals, health services, and healthcare organizations to submit abstracts for an opportunity to showcase their best practices, innovations, projects, programs and researches to over a thousand peers from around the world.
The congress will tackle the overarching theme “People on board, transforming healthcare”.
“The demands of the society and industry have forced healthcare to transform in ways we wouldn’t have imagined before. And now that transformations are very well in motion, there is so much for us to understand and implement,” said Prof. Antoni Trilla, Chair of the Scientific Committee of the World Hospital Congress.
Those interested to present their work through an oral presentation or as a poster can submit abstracts online under the following sub-themes:
DIGITAL AND TECHNOLOGY DRIVEN TRANSFORMATIONS
· Artificial Intelligence for smart health and care
· Big accurate data: how it helps us
· How is digital health transforming the way health systems are run and healthcare is delivered
· Glocalization: new actors, new rules, global healthcare invaders in the local healthcare set
TOWARDS AN INTEGRATED CONCEPT OF HEALTH AND CARE SERVICES MODEL: VALUE DRIVEN TRANSFORMATIONS
· Enabling the flexibility of organizations to adapt quickly to changes, addressing accelerated innovation adoption
· Key results that really matter: patients outcomes as the driver for better healthcare
· Health and care sustainability supported by applied research and innovation adoption
· Global Healthcare, global mobility, global access: towards a liquid borderless healthcare system
PEOPLE AT THE CENTER OF HEALTHCARE SYSTEM TRANSFORMATIONS
· How to put citizens at the center of health and care
· Humanistic centered care
· Professionals leading transformations: the strength of professionals to promote transformation
· From health management to ethical leadership
Deadline of submission is on 31 January 2020. For more details and to submit your abstracts, go to https://worldhospitalcongress.org/2020-call-for-papers-and-posters. https://www.ihf-fih.org/ https://www.uch.cat/ Email: Mylene.dayola@ihf-fih.org

The European Society of Radiology (ESR) has renewed its initiatives to harmonize medical training for radiologists across Europe. Following advocacy on the part of the radiology community, in close coordination with the European Union of Medical Specialists (UEMS), after the modernization of the Professional Qualifications Directive in 2013, the current political climate offers new opportunities for adapting the legal framework regulating the free movement of doctors and recognition of professional qualifications.
 
Considering the ongoing evaluation of the Professional Qualifications Directive, the ESR brings again to the attention of the European Commission its twofold request to change Annex V, Section 5.1.3. in order to safeguard the highest standards of medical training and patient care throughout Europe.

Once again, the ESR has joined forces with the UEMS, the authority on medical education in Europe, demonstrating its continuous commitment to collaborating with partner organizations on the harmonization of medical education.
 
In an official letter submitted to the European Commission, the ESR strongly urges the European Commission to adopt a delegated act to increase the minimum years of training for radiologists from four to five years, in full compliance with the European Training Curriculum for Radiology that was developed to further harmonize radiology education throughout Europe.

Growing training needs and the introduction of digital solutions in medical imaging require equally high standards of training that can only be met by implementing a full-fledged five-year radiology training.
 
In addition, the ESR calls on the Member States and the European Commission to change the name of the discipline from “Diagnostic Radiology” to “Radiology”, reflecting the profession’s current practice comprising both diagnostic and interventional procedures.

As Member States hold the competence to unilaterally enter the name of a profession into Annex V, individual Member States are strongly encouraged to unilaterally enter “Radiology” as the name of the discipline as a first step towards harmonization. Nevertheless, the ESR believes that an EU-wide solution is needed and therefore urges the Member States and the European Commission to enter into dialogue in the interest of the free movement of radiologists in Europe.
 
The ESR supports a multi-layered approach, simultaneously launching initiatives at national and EU levels, to strengthen the voice of radiology in the debate. Therefore, the ESR counts on the national radiological societies to be the messenger of the unified radiology position towards national Ministries of Health and health authorities.

Only a coordinated approach involving the ESR and its institutional members can lead to the highest standards and a true harmonization of radiology training and enhance the mobility of the radiology profession in Europe.

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