• Harri Sievänen and Petri Pommelin.
• National Agency for Medicines, Medical Devices Department, PO Box 55, FIN-00301 Helsinki, Finland.
• Technol Health Care. 2003 Jan 1; 11 (4): 275-81.

AbstractThe quality of the notifications issued within the European Medical Device Vigilance system were retrospectively reviewed and the adequacy of the recommended guidelines evaluated. The study material comprised all 589 vigilance notifications the Finnish competent authority received from manufacturers and other national competent authorities during 1997, 1999, and 2001. The number of vigilance reports, particularly the reports issued by national competent authorities, has increased from 82 in 1997 up 166 in 2001 while the proportion of reports with demonstrated bearing on health risk has decreased from about 40% down to 20% during the last five years. The number of manufacturers' reports has also increased from 28 in 1997 up to 98 in 2001 while the information given in the reports have become somewhat more incoherent. The time needed to close a device-related incident has increased, too. It is obvious that the present vigilance guidelines provide adequate guidance for both the manufacturers and competent authorities to manage vigilance cases efficiently and appropriately. It is crucial that all pertinent parties should adopt the recommended procedures and act accordingly. The vigilance system underpinned with high quality notifications only assures the continuous enhancement of patient safety, the bottom line.

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