Medical Devices and Patient Safety

Saleh S Altayyar
2016 Journal of Analytical & Pharmaceutical Research  
There is a worldwide requirement today for accreditation and quality standards in Healthcare. In all the standards and regulatory bodies, there are strong components of medical devices management, such as medical device defect reporting, incident management and reporting, and risk management. Medical devices represents the most sizable investment in hospitals, they play an important role in the diagnosis, Prevention, monitoring, treatment, or alleviation of disease. Medical devices are
more » ... throughout their life span from conception and development to disposal. The objective of medical devices regulations is ensuring their safety, quality, effectiveness, performance according to the intended purpose. There is significant risk to staff and patients from use and/or misuse of medical devices. However, appropriate implementation of medical devices regulation will enhance public health, patient safety, and the safety of health care professionals and environment. Only 65% of 145 countries have national authorities responsible for implementing and enforcing medical devices regulations. This paper will look at the three stages of medical devices regulation (i.e. pre market, on market, and post market), and will primarily focus on the post market surveillance as a monitoring activities of medical devices in use, such as collection of information on the quality, safety and performance of medical devices. It will also shade the light on the medical devices hazards and adverse events reporting, the type of reported adverse events, and their source.
doi:10.15406/japlr.2016.02.00034 fatcat:gqugjf2kergi3fs3dx52cgzpgi