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Zentralbl Chir. 2012 Aug;137(4):380-4. doi: 10.1055/s-0031-1271549. Epub 2011 Jul 7.

[Clinical trials with medical devices: lack of quality illustrated for faecal incontinence].

[Article in German]

Author information

1
Universität zu Lübeck, Universitätsklinikum Schleswig Holstein, Campus Lübeck, Institut für Medizinische Biometrie und Statistik. Reinhard.Vonthein@imbs.uniluebeck.de

Abstract

BACKGROUND:

Medical devices must be safe and functioning states the law. Treatments with medical devices need not be efficacious to be allowed. We investigated special requirements and problems arising from the law.

METHODS:

The market for medical devices is contrasted with that for drugs. The requirements of relevant laws are discussed. Finally, published clinical studies on anal incontinence are analysed with respect to their methodological quality.

RESULTS:

Clinical trials of medical devices for treat-ing anal incontinence are of poor methodological quality thus preventing evaluation of the devices' utility.

CONCLUSION:

Large, high quality clinical studies of the efficacy of medical devices for treating anal incontinence are urgently needed. Only such studies enable health technology assessment and comprehensible decisions on reimbursement by health insurance.

PMID:
21739411
DOI:
10.1055/s-0031-1271549
[Indexed for MEDLINE]

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