1st EFORT European Consensus “Medical& Scientific Research Requirements for the Clinical Introduction of Artificial Joint Arthroplasty Devices”: Background, Delphi Methodology& Consensus process
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1st EFORT European Consensus “Medical& Scientific Research Requirements for the Clinical Introduction of Artificial Joint Arthroplasty Devices” : Background, Delphi Methodology& Consensus process. / Grupp, Thomas M.; Rusch, Sabine; Massin, Philippe; Blom, Ashley; Garcia-Rey, Eduardo; Cristofolini, Luca; Janssen, Dennis; Grimm, Bernd; Giurea, Alexander; Jäger, Marcus; Siccardi, Francesco; Overgaard, Søren.
In: EFORT Open Reviews, Vol. 8, No. 7, 2023, p. 499-508.Research output: Contribution to journal › Review › Research › peer-review
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TY - JOUR
T1 - 1st EFORT European Consensus “Medical& Scientific Research Requirements for the Clinical Introduction of Artificial Joint Arthroplasty Devices”
T2 - Background, Delphi Methodology& Consensus process
AU - Grupp, Thomas M.
AU - Rusch, Sabine
AU - Massin, Philippe
AU - Blom, Ashley
AU - Garcia-Rey, Eduardo
AU - Cristofolini, Luca
AU - Janssen, Dennis
AU - Grimm, Bernd
AU - Giurea, Alexander
AU - Jäger, Marcus
AU - Siccardi, Francesco
AU - Overgaard, Søren
N1 - Publisher Copyright: © 2023 the author(s)
PY - 2023
Y1 - 2023
N2 - The objectives of the 1st EFORT European Consensus on ‘Medical and Scientific Research Requirements for the Clinical Introduction of Artificial Joint Arthroplasty Devices’ were foremost to focus on patient safety by establishing performance requirements for medical devices. The 1st EFORT European Consensus applied an a priori-defined, modified Delphi methodology to produce unbiased, high-quality recommendation statements, confirmed by consensus voting of a European expert panel. Intended key outcomes are practical guidelines justified by the current stage of knowledge and based on a broad European Expert Consensus, to maintain innovation and optimisation of orthopaedic devices within the boundaries of MDR 2017/745. Twenty-one main research areas of relevance were defined relying on input from the EFORT IPSI WG1 ‘Introduction of Innovation’ recommendations and a related survey. A modified Delphi approach with a preparatory literature review and work in small groups were used to prepare answers to the research questions in the form of 32 draft Consensus statements. A Consensus Conference in a hybrid format, on-site in the Carl Gustav Carus University of Dresden was organised to further refine the draft statements and define consensus within the complete group of participants by final voting, intended to further quantify expert opinion knowledge. The modified Delphi approach provides practical guidelines for hands-on orientation for orthopaedic surgeons, research institutes and laboratories, orthopaedic device manufacturers, patient representatives, Notified Bodies, National Institutes and authorities. For the first time, initiated by the EFORT IPSI (WG1 ‘Introduction of Innovation’), knowledge of all related stakeholders was combined in the 1st EFORT European Consensus to develop guidelines and result in a comprehensive set of recommendations.
AB - The objectives of the 1st EFORT European Consensus on ‘Medical and Scientific Research Requirements for the Clinical Introduction of Artificial Joint Arthroplasty Devices’ were foremost to focus on patient safety by establishing performance requirements for medical devices. The 1st EFORT European Consensus applied an a priori-defined, modified Delphi methodology to produce unbiased, high-quality recommendation statements, confirmed by consensus voting of a European expert panel. Intended key outcomes are practical guidelines justified by the current stage of knowledge and based on a broad European Expert Consensus, to maintain innovation and optimisation of orthopaedic devices within the boundaries of MDR 2017/745. Twenty-one main research areas of relevance were defined relying on input from the EFORT IPSI WG1 ‘Introduction of Innovation’ recommendations and a related survey. A modified Delphi approach with a preparatory literature review and work in small groups were used to prepare answers to the research questions in the form of 32 draft Consensus statements. A Consensus Conference in a hybrid format, on-site in the Carl Gustav Carus University of Dresden was organised to further refine the draft statements and define consensus within the complete group of participants by final voting, intended to further quantify expert opinion knowledge. The modified Delphi approach provides practical guidelines for hands-on orientation for orthopaedic surgeons, research institutes and laboratories, orthopaedic device manufacturers, patient representatives, Notified Bodies, National Institutes and authorities. For the first time, initiated by the EFORT IPSI (WG1 ‘Introduction of Innovation’), knowledge of all related stakeholders was combined in the 1st EFORT European Consensus to develop guidelines and result in a comprehensive set of recommendations.
KW - 1st EFORT European Consensus
KW - arthroplasty device registration
KW - medical device regulation
KW - methodology and process description
KW - modified Delphi approach
U2 - 10.1530/EOR-23-0054
DO - 10.1530/EOR-23-0054
M3 - Review
C2 - 37395678
AN - SCOPUS:85167802764
VL - 8
SP - 499
EP - 508
JO - EFORT Open Reviews
JF - EFORT Open Reviews
SN - 2396-7544
IS - 7
ER -
ID: 370566368