Universität zu Köln

Sauerland, Stefan ORCID: 0000-0003-1048-796X, Brockhaus, Anne Catharina, Fujita-Rohwerder, Naomi and Saad, Stefano (2014). Approaches to assessing the benefits and harms of medical devices for application in surgery. Langenbecks Arch. Surg., 399 (3). S. 279 - 286. NEW YORK: SPRINGER. ISSN 1435-2451

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Abstract

The surgical community and the medical device industry enjoy a fruitful cooperation for the benefit of patients, but during the last years several high-risk products have led to problems and scandals, thus highlighting the need for reforms in European CE marking requirements. In October 2013, the European Parliament voted on a draft regulation on medical devices that intends to replace the current directives in 2014. This article offers guidance to surgeons on how to select and assess medical devices for clinical use. Examples include artificial sphincters, surgical meshes, as well as single-incision and robot-assisted surgery. It is important that surgeons have a basic understanding of the requirements for CE marking of new medical devices. Because device performance rather than effectiveness is required for European market entry, surgeons (and their patients) are often left with the burden of using potentially harmful devices. In addition, potential problems concerning the safety or effectiveness of approved devices are concealed by the lack of data transparency. Because regulatory reforms were blocked at the European level, many member states will now seek other ways of restricting the use of medical devices with unknown effectiveness. One interesting model in this regard is to link the reimbursement of new medical devices to the conduct of clinical trials. Surgeons should develop a structured multidisciplinary approach to innovation management in their hospitals before using a new high-risk device. The key question is how to strike the right balance between innovation and safety.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Sauerland, Stefan UNSPECIFIED orcid.org/0000-0003-1048-796X UNSPECIFIED Brockhaus, Anne Catharina UNSPECIFIED UNSPECIFIED UNSPECIFIED Fujita-Rohwerder, Naomi UNSPECIFIED UNSPECIFIED UNSPECIFIED Saad, Stefano UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-444562
DOI:	10.1007/s00423-014-1173-y
Journal or Publication Title:	Langenbecks Arch. Surg.
Volume:	399
Number:	3
Page Range:	S. 279 - 286
Date:	2014
Publisher:	SPRINGER
Place of Publication:	NEW YORK
ISSN:	1435-2451
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language MAGNETIC ANAL-SPHINCTER; IDEAL FRAMEWORK; SINGLE-INCISION; TECHNOLOGIES; METAANALYSIS; MANAGEMENT; COVERAGE; REGISTRY; CLOSURE; VACUUM Multiple languages Surgery Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/44456