Application of the Medical Device Directive to Software: Methodological Challenges

被引：1

作者：

Pelayo, Sylvia ^{[1
]}

Da Costa, Sabrina Bras ^{[1
,2
]}

Leroy, Nicolas ^{[1
]}

Loiseau, Severine ^{[1
]}

MacKeon, Damien ^{[2
]}

Trancard, Delphine ^{[2
]}

Beuscart-Zephir, Marie-Catherine ^{[1
]}

机构：

[1] CHRU Lille, CIC IT Lille, EVALAB, Batiment Hippoerate,150-154 Rue Doeteur Yersin, F-59120 Loos, France

[2] Univ Montpellier 3, InterPsy ETIC EA 4432, F-57006 Metz 1, France

来源：

MEDINFO 2013: PROCEEDINGS OF THE 14TH WORLD CONGRESS ON MEDICAL AND HEALTH INFORMATICS, PTS 1 AND 2 | 2013年 / 192卷

关键词：

Patient Safety; Risk Management; Human Engineering; Standards; Evaluation Studies;

D O I：

10.3233/978-1-61499-289-9-437

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

The European Union (EU) adopted the revised Medical Device Directive (MDD) in 2010. A major change is that software for certain purposes is now considered a medical device (MD) and thus is subject to the same regulation as MDs. That means the integration of a usability engineering process with its documentation in a usability file is now mandatory. This paper presents a case study, performed in particular conditions, to (i) illustrate the adopted user-centered approach to be compliant with the ergonomic-essential requirement and (ii) discuss the methodological challenges associated even under such favorable conditions. The results raise the question about whether software regulation is feasible. We conclude that there is a need to think about recommendations for how regulation could be implemented with support for manufacturers, with minimal impact on innovation, and with rigorous but not too rigid evaluation procedures.

引用

页码：437 / 441

页数：5

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