Abstract

Medical devices can be hazardous despite their positive benefits. Reporting medical device adverse events are voluntary for all the health care professionals but the number of reporting adverse medical events are less when compared with all the available studies in India. Hence it is important to address the reasons and challenges that are faced by health care professionals in reporting the events so that safety and quality action can be taken in order to prevent them. Understanding the obstacles to and reasons for patient reporting is necessary and may help to increase the safety of medications. This review provides an insight into factors contributing to underreporting of MDAE such as Health care system capacity related, organizational related barriers, and Industry responsiveness. This review might offer helpful data for overcoming barriers in monitoring and support quality and safety management in hospitals.

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