Materiovigilance – basic concepts and legislative framework

personАвтори: E. Grigorov, H. Lebanova, I. Getov


Medical devices (MD) safety for patients and medical specialists in the handling and use of medical devices is a serious problem in the European Union (EU), which takes more and more attention. Recent studies indicate the growing number of incidents associated with MD, which are reported by health professionals and manufacturers and which resulted in different types of corrective actions. Safety is defined as an act to avoid unnecessary or potential harm to patients and medical professionals associated with health in the use of different classes of medical devices. EU/European Economic Area cooperation is necessary from legislative point of view to improve the unified system of vigilance and stimulate greater activity by medical professionals. Efforts to improve patient safety depend on establishing effective and consistent policies, legislative framework and programs across Europe. The aim of the present study is to assess the importance of materiovigilance for the safe use of medical devices and its implementing into practice and education. Patient safety is an important part of the EU policy agenda. That is why in many documents are spelled out the obligations of all participants in the processes of production, distribution and use of medical devices. European Commission aims to facilitate and support the work and activities of Member States through pro-active work with different stakeholders: the World Health Organization, Council of Europe and European associations of patients, pharmacists, physicians, nurses, dentists, manufacturers and hospitals as active members in this overall process of ensuring the safe use of medical devices.

Етикети: ,