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Approaches to assessing the benefits and harms of medical devices for application in surgery

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Abstract

Background

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.

Purpose

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.

Conclusions

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.

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Acknowledgments

The authors thank Natalie McGauran for editorial support.

Conflicts of interest

None

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Authors and Affiliations

  1. Institute for Quality and Efficiency in Health Care (IQWiG), Im Mediapark 8, 50670, Cologne, Germany

    Stefan Sauerland, Anne Catharina Brockhaus & Naomi Fujita-Rohwerder

  2. Institute for Research in Operative Medicine (IFOM), University of Witten/Herdecke, Cologne, Germany

    Stefan Sauerland

  3. Institute for Health Economics and Clinical Epidemiology, University of Cologne, Cologne, Germany

    Anne Catharina Brockhaus

  4. Department of General Surgery, Clinic Gummersbach, Academic Hospital University of Cologne, Cologne, Germany

    Stefano Saad

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  1. Stefan Sauerland
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  2. Anne Catharina Brockhaus
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Correspondence to Stefan Sauerland.

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Sauerland, S., Brockhaus, A.C., Fujita-Rohwerder, N. et al. Approaches to assessing the benefits and harms of medical devices for application in surgery. Langenbecks Arch Surg 399, 279–285 (2014). https://doi.org/10.1007/s00423-014-1173-y

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