Barriers in reporting adverse effects of medical devices: a literature review

Abstract

Medical devices play an essential role in the delivery of healthcare but its use is not entirely risk free. There are several instances where it causes mortality or morbidity among users. It is important to evaluate the risks involved at every stage of its application to bring improvement in the standard of healthcare. For the purpose Materiovigilance Program of India was launched on July 6, 2015. Despite these efforts, available data suggests that reporting of adverse events is very low. The present study aims to identify barriers that influence the reporting of adverse events of medical devices and outline a strategy to overcome these barriers. Systemic review method has been adopted to achieve these ends. Thirty-one papers have been selected based on the inclusion criteria related to objective of the study. Lack of awareness, attitude, and resources are found to be major barriers at the individual level for not reporting adverse effects of medical devices. The organizational factors such as hierarchical set up, lack of time and incentives, and furthermore lack of industry responsiveness have been identified as prominent barriers to the reporting of adverse events. In order to improve the reporting level, it is important to make access and contact easier with the reporting system. Engaging healthcare professionals at various levels by acknowledging and appreciating their contribution. The adverse events of medical devices should not be restricted to physicians; only rather other health care professional such as nurses, pharmacists, and technicians should also be encouraged to report any adverse event of medical devices.