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[Harm related to medical device use - legal and organisational risks].

Authors
  • Hölscher, U M
Type
Published Article
Journal
Gesundheitswesen (Bundesverband der Ärzte des Öffentlichen Gesundheitsdienstes (Germany))
Publication Date
Dec 01, 2014
Volume
76
Issue
12
Pages
807–812
Identifiers
DOI: 10.1055/s-0034-1372616
PMID: 24824355
Source
Medline
License
Unknown

Abstract

The effectiveness of the risk management systems established by medical device manufacturers and health-care facilities is clearly mitigated by European and national legal provisions. Laws, regulations and authorities prevent the systematic exchange of much safety-relevant information. The obligation to report adverse events is suspended for many relevant risks associated with medical device use. Reporting into the vigilance system is of little avail for users. Reporting even may endanger the information provider. The federal fragmentation of the German vigilance system poses a risk for patients. Risk management in health-care facilities without risk policy is dangerously incomplete.

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