Ch 7 Managing Medical Devices within a Regulatory Framework

What is it about?

Risk management is an important aspect of regulation and one positive example of internal controls to protect patients and healthcare workers from harm in the healthcare environment. But patient safety requires the application of risk management, quality management, and clinical engineering (CE). In this chapter, we review the positive and negative aspects of collaboration while focusing on the sizeable contribution of CE towards workplace safety in relation to specific hazards to patients and healthcare workers in order to properly address the widespread use of this relatively new management tool from diverse professional perspectives. We bring forth specific information on hazards such as radiation and current guidance on imaging equipment. Further, we present a case study on the start-up operations for the Rawalpindi Institute of Cardiology Pakistan to illuminate the multi-faceted aspects of the software engineer in CE.

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