Health Technology Assessment and Medical Device Vigilance

Healthcare Technology Assessment

Healthcare Technology Assessment (HTA) is a multidisciplinary activity that systematically examines safety, clinical efficacy and effectiveness, cost, cost-effectiveness, organizational implications, social consequences as well as legal and ethical considerations of the application of healthcare technology. It is intended to provide a bridge between the world of research and the world of decision-making.

A health technology assessment survey of home hemodialysis and nocturnal home hemodialysis as replacement therapies in End Stage Renal Disease (ESRD) patients has been conducted focusing mainly on clinical effectiveness, cost-utility, patient satisfaction and patient’s quality of life.

This HTA activity is connected to the Healthcare Technology Assessment Division of the IFMBE (International Federation for Medical and Biological Engineering), chaired by the Head of the BITU for the period 2012-2018.

Software Tool for Predicting Future ESRD Patients’ Number

The software tool is designed for predicting the future number of End Stage Renal Disease (ESRD) patients. The basic component of the software is a Markov chain model, which consists of three mutually exclusive treatment states, i.e. Hemodialysis (HD), Peritoneal Dialysis (PD), Renal Transplantation (RTx), and death. The basic component of this chain is the transition matrix describing patients’ dynamics between these treatments. Age-specific data on incident and prevalent patients’ number on renal replacement therapy for Greece, available from the European Renal Association – European Dialysis and Transplant Association reports for the period 1998-2009, were used for the implementation of the model. This software tool was successfully used for predicting the future number of ESRD patients in Greece. The approach is potentially applicable to a broad range of countries and circumstances, because of the minimal data requirement necessary to implement the techniques.

Vigilance and User Reporting Systems

The purpose of a vigilance system is to improve the protection of health and safety of patients, users, and others, by reducing the likelihood of the same type of adverse incidents being repeated in different places at different times. MEDUR is a prototype telematics application, developed to cover the above mentioned needs, focusing on user reporting of adverse events related to medical devices. This product will be incorporated in the global vigilance system that is currently being developed under the EIPAS – THALIS project.

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