The Spanish society of Electromedicine and Clinical Engineering (SEEIC) stresses the need to strengthen the monitoring mechanisms.

-This document provides guidelines for the inclusion of the surveillance requirements established by the Royal Decrees 1591 / 2009, 1616 / 2009 and 1662 / 2000 in the quality of health care systems

Madrid, February 2012.- from the Spanish society of Electromedicine and Clinical Engineering (SEEIC) insist on the need to strengthen the monitoring mechanisms. In this line, they have developed a guide for surveillance of health technologies, specifically for the treatment of incidents and corrective actions. The purpose of this document is to become an element rather than assist the professional in your day to day work ”, says Jesus Manzanares Pedroche, President of the SEEIC.

The guide provides guidelines for the inclusion of the surveillance requirements established by the Royal Decrees 1591 / 2009, 1616 / 2009 and 1662 / 2000 in the quality systems of health centres, taking a broader scope of medical devices, including all the technologies in this sector.

The surveillance system is the notification of adverse incidents arising from the use of medical devices, their registration and evaluation, the adoption of appropriate measures in order to protection of health and the transmission of such measures to stakeholders.

For the preparation of this document – says Jesus Manzanares, and so it is of great practical utility, included with the participation of numerous experts in the sector ”.

Contents of the Guide

The guide is composed of several chapters including regulatory requirements, which States the obligation, by the economic agents involved (manufacturers, importers and distributors) and professional users, communicate any adverse incident which occurs with a medical device. In this sense, explains what should be reported, who must be notified and where the incident should be reported.

Also, establishing the requirements of suppliers and users, as well as the treatment of incidents and corrective actions of security in the market.

The guide is complemented by a large index of annexed documents, which include models of procedure, forms, list of points of contact, etc.

Present and future of the SEEIC

The Spanish society of Electromedicine and Clinical Engineering (SEEIC) is a national institution for scientific and technical character acting, among others, with the goal of being the partner to promote, before the public and private agencies, management and professional standardization of standards and requirements necessary for the correct application of the electromedical equipment.

It’s a pioneer in Spain society, whose members carry out their activity in companies, health centres and other organizations and institutions related with electromédica technology.

The challenges of this scientific society aimed at short-term towards implementing underway of the certificates of professionalism throughout the country, and the definition of evidence itself by the competent administration until now formally absent, to respond to a training and regulation of the sector of the Electromedicine and clinical engineering in Spain and the consolidation of the relevant professional categories within public and private of the country hospitals, and companies in the sector, with a very direct condition in continuous improvement of healthcare quality and safety in the implementation and use of systems and electro-medical equipment.

On the other hand, in line with its objective to collaborate in the preparation of professionals who carry out tasks related to the electromedical equipment, the company has own training programmes covering different technical and managerial issues related to their area of responsibility.