Danish users begin medical device reporting scheme:
This article was originally published in Clinica
Professional users of medical devices in hospitals in Denmark are now required to report medical device incidents to the regulatory agency following the enforcement of the Patient Safety Act on January 1 2004. This anonymous system will also apply to large clinics as of January 1 2005 and eventually to the primary care sector after its use by the professionals has been evaluated. According to the Danish medical device industry association, Medicoindustrien, all reports concerning the failure of devices have to be sent directly to the Medicines Agency, while incidents in which devices appear to have played a more incidental role must be reported to the National Board of Health, with a copy to the Medicines Agency.