Actualités
EFORT Updates 03/2021
EFORT Updates 03/2021
Rolle, December 2021
www.efort.org
EFORT's Activities in 2021 – a Retrospect from the EFORT President
Presidential Editorial
Almost six months have passed since the 2021 Virtual General Assembly.
Despite the difficulties, we are facing due to the ongoing COVID-19
pandemic and the reduced working hours of our Head Office, many
activities are ongoing. Even though most meetings are online and virtual,
we are optimistic for the year to come. The planning of the Congress in
Lisbon 2022 is at full speed. The theme of the congress is "Modern
Patient Needs – Challenges and Solutions in O&T". We are indeed looking forward to a
face-to-face meeting. Apart from this major event, I would like to take the opportunity to
share some information on other ongoing activities.
Medical Device Regulation (MDR)
An important milestone on EU level is the Medical Device Regulation (MDR). Due to the
pandemic there has been a delay of one year. But on 26 May 2021, the previous directive
was replaced by a new regulation. The MDR will have effects on both surgeons, patients and
industry. Patient safety is at center stage and backward and forward traceability by means
of fully integrated Unique Device and Product Identifiers (UDI and UPI) are followed closely.
The creation of a European database on medical devices (EUDAMED) is one of the key
aspects of the new rules on medical devices and in vitro diagnostic medical devices.
EUDAMED will provide a living picture of the lifecycle of medical devices that are made
available in the European Union (EU). It will integrate different electronic systems to collate
and process information about medical devices and related companies (e.g. manufacturers).
In doing so, EUDAMED aims to enhance overall transparency, including better access to
information for the public and healthcare professionals as well as enhanced coordination
between the different Member States in the EU. EFORT continues to closely follow this
development.
Meetings
EFORT Fora Programme
EFORT has participated in several FORA, some face to face and some in hybrid format. This
fall, FORA have been organized together with several national societies, DKOU (Germany),
BOA (UK), HAOST (Greece), SECOT (Spain), SOFCOT (France) and TOTBID (Turkey).
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EFORT Updates 03/2021
Rolle, December 2021
www.efort.org
EFORT Session at the FEMECOT
EFORT has also organized a session at the FEMECOT (Mexican Orthopaedic and Trauma
Federation) with virtual participation of several invited scientific presentations. I would like
to thank all participants for their most valuable contributions on behalf of EFORT.
Meetings with National Societies
In November, the EFORT board has had virtual meetings with the national societies. This is an important activity enabling exchange of knowledge and perspectives in dialogue. Not unexpectedly, the effects of the COVID-19 pandemic on O&T have been vividly discussed. It is clear that there have been severe effects not only on elective surgery, but also on resident training. These effects will be carefully followed.
IPSSI
The Implant and Patient Safety Initiative (IPSI) has been upgraded to The Implant, Patient
and Staff Safety Initiative (IPSSI). This has been a natural step in light of the pandemic as
well as a need to focus on sustainable working life in Orthopaedics and Traumatology.
EFORT thus supports the European Medical Organisation on Violence Against Health
professionals and as part of the IPSSI, is about the create another working group looking
into this.
Cobalt toxicity
A working group on Cobalt toxicity has been initiated under the IPSSI umbrella. In order to
raise awareness of this issue a webinar is planned on this topic on January 31, 2022. The
title of the webinar is "Relevance of metal carcinogenicity for orthopeadics – controversies
and concerns".
Whitebook
The Whitebook is in final administrative preparation and I would like to express my
appreciation for the great work done by the three co-editors Per Kjaersgaard-Andersen and
Jan Verhaar, EFORT Past Presidents as well as David Limb, the current EFORT Second Vice President.
info EFORT
EFORT Updates 03/2021
Rolle, December 2021
www.efort.org
CORE-MD
CORE-MD, the collaboration between the European Heart Association and EFORT, financed
by Horizon 2020, is ongoing. To enable this EFORT has hired a new Policy & Public Health
Officer from October.
EFORT Open Reviews (EOR)
As of January 2022, EOR (2021 Impact Factor is 4,618) will have a new publisher since our previous contract reached an end. Bioscientifica Ltd will be the new publisher. All content will remain freely available and fully searchable. EOR offers a unique opportunity to take advantage of a gold mine of knowledge. It clearly represents one of EFORTS prime products and I would like to thank the Editor in Chief Pierre Hoffmeyer, the entire editorial team and all authors for their valuable work and tireless efforts when materializing the EOR, our leading journal in O&T.
Education
EFORT Webinars
During the fall, three interesting EFORT webinars were given with replays available. The
topics are: "The Periprosthetic Fractures of the Femur (Hip): Diagnosis and Treatment",
"Total Hip Replacement and Lumbar Spine" and "3D Printed Reconstructions in Complex
Pelvic Revisions and Oncology Surgery".
Bioskills courses
Updating of basic ethical principles in Bioskills courses is in progress in the Ethics
committee. This is important in order to maintain trust and set up minimal requirement
levels discussions and input from different parts of Europe.
Basic Science and Research Online course
The Education Committee is in the final phase of completing the 2nd Edition of the Basic Science and Research Online course. An application for CME accreditation is in progress.
On behalf of the EFORT Board
Prof. Dr. Li Felländer-Tsai EFORT President 2021/2022
EFORT Updates 03/2021
Rolle, December 2021
www.efort.org
23rd EFORT Congress in Lisbon, Portugal from 22 to 24 June 2022
Key dates:
Notification for Abstract Acceptance Status Monday 31 JANUARY 2022
Registration Presenting Authors Closes Monday 28 FEBRUARY 2022 | 23:59 CET
Early Registration Deadline
Tuesday 15 MARCH 2022 | 23:59 CET
Advanced Scientific Programme Online Tuesday 15 MARCH 2022
For more information, visit the official website https://congress.efort.org/
EFORT Implant, Patient and Staff Safety Initiative (IPSSI)
EFORT recommendations for off-label use, mix & match and mismatch in hip and knee arthroplasty
Keith Tucker, Klaus-Peter Günther, Per Kjaersgaard-Andersen, Jörg Lützner, Jan Philippe Kretzer, Rob G.H.H. Nelissen, Toni Lange, Luigi Zagra
During this era, when orthopaedic surgeons are being increasingly regulated and litigated
against, most will agree that there are occasions when surgeons have to tread carefully between what they think is best for a patient and what is deemed 'correct' by regulators and lawyers. For the majority of the time most surgeons will practice evidence-based medicine, but patients are unique and there are times when standard techniques maybe not the best option for a patient. Most surgeons have the capacity to adapt their practice when they think it is necessary and go 'off-label'. EFORT consider these issues extremely important; they are all about patient safety, which is why they commissioned this appraisal in order to evaluate all aspects of these practices and to produce guidance for the benefit of patients, surgeons, manufacturers and regulators.
In this article we will attempt to clarify and suggest recommendations around the issues of
off-label, including discussing the mixing and matching of implants from different
EFORT Updates 03/2021
Rolle, December 2021
www.efort.org
manufacturers in total joint arthroplasty ("mix & match") and commenting on 'mismatch'.
The commentary and conclusions we have made are based on an extensive literature review
and consensus meetings. We have reached out to the specialist groups that represent the
surgeons who we hope will eventually be guided by our conclusions, and have taken careful
note of their opinions.
→For more information, please read the full article enclosed.
CORE-MD
The CORE-MD initiative, its potential impact on Orthopaedic practice.
Rob GHH Nelissen, Per Kjaersgaard-Andersen
Total hip and knee arthroplasties (THA and TKA) are considered highly effective treatments
for symptomatic osteoarthritis to reduce pain and improve functionality for the patients,
while lasting to function for decades. Outcome is basically determined by four factors:
fixation of the implant within the bone, liner wear, implant infection and patient reported
outcome scores (PRO). The first two outcome measures are seemingly easy to measure:
loosening of the implant with revision as end-point being a surrogate for this migrating or
loosened implant. Metrics for migrating implants like RSA (roentgen-stereographic analysis)
can only be done prospective although CT measures for implant migration are being developed as is AI (machine learning) techniques. As is obvious, evidence is needed when introducing new implants to be used in patients.
Despite the discussion on the importance of evidence-based medicine and phased implant
introduction for decades, still discussion exists which scientific methods to be used for new
orthopaedic implants. The latter creates is not only confusing for stakeholders like
orthopaedic surgeons and their patients, but also for Notified Bodies, regulators but also
industry, since different, often not transparent, advice is given. For that matter, which
metrics have to be used to evaluate new implants compared to which gold standard (e.g.
the one with 10 year follow-up and a mean 95% survival or mean 5% revision) with which
methodology (e.g. randomised controlled trials, non-inferiority trials, nested trials within
national registries etc) still is in need of a framework to be used when new, innovative
orthopaedic medical devices come to the market, with the aim to create more benefit than
EFORT Updates 03/2021
Rolle, December 2021
www.efort.org
risk for the patient. As for the multitude of orthopaedic articles on the value of PROs,
although of importance in the patient-physician communication its place as one of the
important tools and how to use it and which one to use in implant evaluation needs
guidance for correct interpretation as well.
These two basic aspects, when interpreting the value of new implants for patients, seem
obvious. However, how to implement them in a transparent and evidence-based way, so all
stakeholders, including regulators, can easily use them, is the challenge the CORE-MD
consortium has taken up this task in close collaboration between the European Society of
Cardiology, Biomed Alliance and EFORT.
Application Expert Panel Members – Call from the EU Commission
How to apply?
All the relevant information can be found on the expert panel page with call. Interested candidates are invited to submit their application through the following website:
https://ec.europa.eu/health/md_expertpanels/application_en
Please note that the work of the expert panels shall comply with principles of high levels of expertise, independence, impartiality and objectivity, commitment, transparency and confidentiality.
News from the Biomedical Alliance
Artificial Intelligence & healthcare: a match made in heaven?
AI & Healthcare: a match made in heaven? The use of Artificial Intelligence in healthcare is
significantly increasing, with promising new developments that are transforming healthcare.
AI has enormous potential to enhance patient care and facilitate health research, but there
are also challenges and risks ahead
EFORT Updates 03/2021
Rolle, December 2021
www.efort.org
The BioMed Alliance organised an online discussion on the future of healthcare and the
integration of AI in clinical practice and health research. At the occasion of the BioMed
Alliance General Assembly, a series of interesting speakers shared their experience and
knowledge on the use of AI and the regulatory framework that intends to facilitate the
development and use of AI technologies, while mitigating risks. There were discussions on
practical case studies, protecting public interest, the ownership of data, the role of clinicians
in the deployment of AI in health and the involvement of patients. There was also time for
questions and reflection on what the future will look like, and how we can ensure that
clinicians, healthcare professionals and patients are part of the transition.
CORE-MD project: survey on education in regulatory affairs
BioMed Alliance recently conducted a survey that will allow us to get a better overview of
education in regulatory affairs!
As part of our work on the CORE-MD project we ran a short questionnaire on education in
regulatory affairs. This questionnaire assessed what sort of training or education exists to
inform healthcare professionals about regulatory affairs, and particularly in relation to the
EU Medical Devices Regulation. With this survey we aim to identify educational needs
relevant to the assessment of high-risk medical devices.
This project has received funding from the European Union's Horizon 2020 research and
innovation programme under grant agreement No 965246.
→More information at https://www.biomedeurope.org/news/biomed-updates.html
EFORT Updates 03/2021
Rolle, December 2021
www.efort.org
Season's Greetings
Season's Greetings and a Happy New Year 2022 also from the entire Head Office Team. Thank you all for your valuable support during this challenging year!
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