Editorial
Copyright ©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Orthop. Mar 18, 2016; 7(3): 162-166
Published online Mar 18, 2016. doi: 10.5312/wjo.v7.i3.162
New regulations for medical devices: Rationale, advances and impact on research and patient care
Gerold Labek, Harald Schöffl, Christian Ioan Stoica
Gerold Labek, Department of Orthopaedic Surgery, Medical University of Innsbruck, 6020 Innsbruck, Austria
Harald Schöffl, Department for Trauma Surgery, General Hospital Linz, 4020 Linz, Austria
Christian Ioan Stoica, Clinica Fiosor de Foc, 060274 Bucharest, Romania
Author contributions: Labek G drafted, finalised and submitted the manuscript, carried out the literature review, contributed to the perspective of elective orthopaedic surgery, know-how from international register collaboration and as expert to regulators’ working groups; Schöffl H provided content related to trauma surgery and implants and provided a critical review of the draft and final article; Stoica CI contributed through his experience as the Head of the Romanian Arthroplasty Register to the perspective from a national level and conducted a critical review of the draft and final article.
Conflict-of-interest statement: The authors have no conflict of interests.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Gerold Labek, MD, Department of Orthopaedic Surgery, Medical University of Innsbruck, Innrain 52, 6020 Innsbruck, Austria. gerold.labek@i-med.ac.at
Telephone: +43-512-50481600 Fax: +43-512-50422701
Received: May 25, 2015
Peer-review started: May 27, 2015
First decision: June 26, 2015
Revised: December 7, 2015
Accepted: December 18, 2015
Article in press: December 21, 2015
Published online: March 18, 2016
Processing time: 288 Days and 23.5 Hours
Abstract

A series of events relating to inferior medical devices has brought about changes in the legal requirements regarding quality control on the part of regulators. Apart from clinical studies, register and routine data will play an essential role in this context. To ensure adequate use of these data, adapted methodologies are required as register data in fact represent a new scientific entity. For the interpretation of register and routine data several limitations of published data should be taken into account. In many cases essential parameters of study cohorts - such as age, comorbidities, the patients’ risk profiles or the hospital profile - are not presented. Required data and evaluation procedures differ significantly, for example, between hip and spine implants. A “one fits for all” methodology is quite unlikely to exist and vigorous efforts will be required to develop suitable standards in the next future. The new legislation will affect all high-risk products, besides joint implants also contact lenses, cardiac pacemakers or stents, for example, the new regulations can markedly enhance product quality monitoring. Register data and clinical studies should not be considered as competitors, they complement each other when used responsibly. In the future follow-up studies should increasingly focus on specific questions, while global follow-up investigations regarding product complication rates and surgical methods will increasingly be covered by registers.

Keywords: Arthroplasty; Outcome; Research; Medical device; Regulation

Core tip: In the next few years new worldwide regulations as well as the availability of register data will lead to a shift in scientific focuses. The interpretation of register and routine data will be associated with new methodological challenges. Monocenter follow-up studies will become less attractive. Publications based on large data sets from registers will continue to gain influence and cover general issues; clinical studies should focus on specific questions.