Clinical relevance of biological incompatibility and role of a central register.
Different aspects relevant for the assessment and characterization of biomaterials are presented. Quite a number of basic concepts that play an important role when detecting unwanted adverse effects of drugs have to be taken into consideration when registering and evaluating unwanted effects of biomaterials. The institutionalization of the Central Bioregister at the University of Saarland is described. This Bioregister is a so-called "spontaneous" ad hoc recording system whose efficiency depends largely on the collaboration of physicians. Thus, the efficiency and rationality of the use of biomaterials can certainly be improved. The possibility of registering even rarely occurring unwanted effects as well as new indications will result in and allow a more general and/or a more specific therapy, depending on the biomaterial.
Seyfert
U T
UT
Department of Clinical Hemostaseology and Transfusion Medicine, University of Saarland, Homburg/Saar, F.R.G.
Bohnerth
S
S
Heinrich
W
W
Wenzel
E
E
D016907:Adverse Drug Reaction Reporting Systems; D000465:Algorithms; D001672:Biocompatible Materials / Q000009:adverse effects*; D016208:Databases, Factual; D005860:Germany, West; D006801:Humans; D012042:Registries
D001672:Biocompatible Materials