Medical device adverse incident reporting in interventional radiology

作者：Parvizi N^*; Robertson I; McWilliams R G

来源：Clinical Radiology, 2014, 69(3): 263-267.

DOI：10.1016/j.crad.2013.10.006

AIM: To investigate the current situation concerning adverse incident reporting by members of the British Society of Interventional Radiology (BSIR).
MATERIALS AND METHODS: A survey of the members of the BSIR was conducted between November 2012 and January 2013. The survey contained questions on the reporting of adverse incidents and attitudes to the reading of "Instructions for Use" for new devices.
RESULTS: The majority of the 119 members who completed the survey had experienced an adverse incident relating to the use of a device. Around 75% of respondents reported adverse incidents locally with only 42% reporting directly to the Medicines and Healthcare products Regulatory Agency (MHRA), which was explained by both a lack of time and a lack of awareness regarding mechanisms of reporting directly to the MHRA.
CONCLUSION: Adverse incidents related to the unexpected failure of medical devices have been experienced by the majority of interventional radiologists. The majority of these are reported, but there is significant confusion as to where and how these should be reported. Improvements in the number and quality of adverse incidents reported requires better education, avoidance of duplication of work, and improved feedback after reports have been made to ensure the delivery of high-quality, safe patient care.

• 出版日期2014-3