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Safe use of medical devices in Dutch hospitals.

Porte, P.J. Safe use of medical devices in Dutch hospitals.: , 2019. 72 p. Proefschrift van de Vrije Universiteit Amsterdam
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Awareness of the importance of patient safety started to increase in the nineties, after
revolutionary research emphasised the importance of the safety of patients in hospitals. The
emphasis on patient safety is also increasing in the medical device field, a fast-developing and
changing environment. This growing attention is especially visible in the increased number of
medical device regulations at the European and national level. The Dutch regulations, defined in more detail as the ‘Covenant safe application of medical devices’, describe guidelines that
hospitals must comply with in the field of the safe use of medical devices. The guidelines in this
covenant facilitate the safe implantation, use and disposal of medical devices. One of these
guidelines is the obligation that all staff should be proficient to use medical devices, as ‘human
involvement’ causes from 70% to 87% of adverse medical device events (AMDEs), although
studies suggest they are typically multifactorial in origin.
In this thesis we focus on the Dutch context, in which regulations became more extensive after
implementation of the ‘Covenant safe application of medical devices in hospitals’ in 2011. The
aim of this thesis is to explore the current safe use of medical devices and possible solutions to
improve it by answering the following two research questions.
1) To what extent is the safety of patients in the Netherlands threatened by medical
devices, and what are possible solutions to improve the safe use of medical devices?
2) How do Dutch hospitals apply proficiency testing to improve the safe use of medical
devices, and what is the attitude of healthcare staff towards proficiency testing?