Key aspects to implement a medical devices surveillance plan in health care institutions and brief overview of this process enhancement through risk management

Abstract

Patient safety has become a topic of global concern and regulatory agencies of health systems in each country have taken steps to quality assurance in the health care services. Among these measures, the implementation of an institutional postmarket surveillance plan on medical devices is a key topic as there is a risk associated with the use of those medical devices. This paper presents a roadmap for the medical devices surveillance program implementation in a high complexity health care institution based on Colombian regulations, as well as a brief overview of the programs implemented by global leaders in this matter and an introduction to risk management in the medical devices postmarket surveillance.