[Health technology assessment: focus on hemodialysis equipment].
BACKGROUND
The problem of the assessment of electromedical equipment and in particular hemodialysis machines, an important compartment of medical technology, is described here. The typical ''system'' approach is employed, which includes not only the extent to which the equipment meets legal and technical standards, but also proper training and updating of the personnel operating the machines.


METHODS
The main risk factors of hemodialysis machines are identified not only in relation to safety but also performance, which could have a direct impact on safety.


RESULTS
Some technical aspects are introduced which play a fundamental role in maintaining the principal characteristics of safety and performance and in guaranteeing proper risk analysis from the standpoint of both manufacturer and user. Also the importance of the professionals involved in the use of such equipment, as well as those who have to manage their correct and safe employment is underlined.


CONCLUSIONS
The technological progress that characterizes this important field of application will certainly in the future create the possibility of a more ''personalized'' dialysis with greater therapeutic efficacy and fewer side effects. This will, however, require continuous updating of the professionals using the equipment and maintaining it in optimal safety and performance conditions. The professional figure of the clinical engineer is a key element in meeting these objectives, also on the basis of the experience gained at an international level.
Cerutti
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Dipartimento di Bioingegneria, Politecnico di Milano, Presidente SC62D-Apparecchi Elettromedicali del Comitato Elettrotecnico Italiano, Milano. sergio.cerutti@polimi.it
D006801:Humans; D006435:Renal Dialysis / Q000295:instrumentation* / Q000379:methods / Q000592:standards*; D013673:Technology Assessment, Biomedical