V Congreso Latinoamericano de Ingeniería Biomédica (CLAIB2011)

Methodology for Risk Management of Biomaterials, its application to a case study
Meizoso Valdés Maria del Carmen, Morejón Alonso Lizette, Guerra Bretaña Rosa Mayelin

Última modificación: 2011-03-26 09:11


The risk managements are a very successful instrument used in the design and development of new medical products, its production and later insertion in the market, as a way of, guaranteeing the safety of the manufacturers, patients and medical personnel that applied. Also it is a mandatory for Medical Registry in almost all countries. The use of biomaterials as medical products entails some degree of risk. For this reason the manufacturers should be validate a systematic process in each and every one life cycle to manage all risks associated with the use of the product. The norm ISO 14971 specifies a methodology through the manufacturer may identify the dangers associated with the medical product, evaluate its risks, and make the monitoring of established controls. The norm ISO 14971 is easily to implement inside of almost Management of Quality System because also complies with the ISO 13485 standards related with manufacturers of medical products. In this work the main objective is to carry out a preliminary exploration of all risks associated to acrylic bone cement named BONACRYL, developed at the Biomaterials Center of the University of Havana. The ISO 14971 was employed in order to establish a semiquantitative methodology to estimate the main risks involved with the BONACRYL, based on the potential danger, the severity of the injury which might appear, and the possibility of detecting the risk.