Original scientific paper
https://doi.org/10.3325/cmj.2023.64.265
Analysis of health care professionals’ incident reports on medical devices in Croatia
Antonela Šimunović
orcid.org/0000-0002-4567-4522
; Croatian Agency for Medicinal Products and Medical Devices, Zagreb, Croatia
*
Krunoslav Kranjčec
; Croatian Agency for Medicinal Products and Medical Devices, Zagreb, Croatia
Marija Pekas
; Croatian Agency for Medicinal Products and Medical Devices, Zagreb, Croatia
Siniša Tomić
; Croatian Agency for Medicinal Products and Medical Devices, Zagreb, Croatia
* Corresponding author.
Abstract
Aim To assess the quantity and quality of incident reports
on medical devices by health care professionals from 2012
to 2021 and evaluate the effect of reporting on manufacturers’ post-market surveillance.
Methods Eighty-five incident reports were scored according to a self-developed evaluation system, and categorized
as excellent, good, medium, qualified, and unqualified. The
completeness of data in critical fields was assessed. For
each report, the type and city of the reporter, and medical
device risk class were extracted to calculate the frequency of report occurrence per risk class and outcomes for reportable reports.
Results The number of reports received from health care
professionals was low; the highest number of reports in a
year was 17. The majority of reports were deemed as unqualified (61.18%) and only 4.71% as excellent. Still, 67.65%
of incident reports importantly affected the manufacturer’s post-market surveillance, either as added information
that contributes to risk monitoring or directly triggering a
field safety corrective action.
Conclusion The number of total reports and reports per
year shows extensive underreporting in Croatia, and the
quality of the provided reports is insufficient
Keywords
Hrčak ID:
331841
URI
Publication date:
31.8.2023.
Visits: 594 *