A second chance, a second opportunity in life is what most organ-transplant receivers say they have been given. As human beings, we know our time is finite, yet thanks to science, technology, and years of research, we can now battle some fatal conditions. Nevertheless, there are certain risks involved.
According to the Spanish Association of Cardiology, there has been an increasing number of urgent transplants and medical devices to support said transplants in the last years. To improve patient safety and reinforce vigilance, the Spanish Authority built a new database: RENACER.
What purpose does it serve? RENACER (Registro Nacional de Dispositivos de Asistencia Circulatoria y Respiratoria) is a database created by the Spanish Agency of Medicine and Sanitary Devices (AEMS), where circulatory and respiratory assistance devices used with transplants will be registered. This will facilitate the analysis of the devices’ safety and efficacy over their lifespan.
María Jesús Lamas, head of AEMPS, said on RENACER’s presentation (September 28, 2021) that the main interest of registering these devices is the safety generated around them. It is clear then that it is not just a counting matter, but rather an effort to compile data so that both we and future generations can make informed decisions towards progress in the Medical Devices Realm.
Finally, since this database has come to life thanks to the collaboration between six entities (SEC, SECCE, SEMICYUC, SECPCC, SEDAR, and SECIP) the variables taken into consideration and measured cover a wide range of niches of information and have been approved by several Scientific Communities. Special attention (meaning more information is retrieved) is given to patients who use more than a device, and there are two different sections for each procedure and device involved. The first one is compulsory, and the physician is in charge of filling it in. The second one is voluntary and will reflect any extra information that could be useful in the future but could not be measured within strict parameters. The purpose for this process is that safer, better, and more efficient healthcare coverage can be provided to those who need it.
Are you a manufacturer producing medical devices assisting in transplant surgeries? Do you wish to market your device on the EU market? Obelis experts with more than 30 years of regulator expertise will gladly help you.
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Silvia Zarzuela Martín
Regulatory Affairs Department
24.11.2021
References:
AEMPS. (2021). Presentación del Registro RENACER. Retrieved on 24/11/2021 from https://www.infosalus.com/asistencia/noticia-espana-crea-primer-registro-seguimiento-vigilancia-dispositivos-asistencia-circulatoria-respiratoria-20210916110916.html