UK Medicines and Healthcare Regulatory Agency alert on X-ray c-arm damage to devices and their continued use:
This article was originally published in Clinica
Executive Summary
The UK's Medicines and Healthcare Regulatory Agency (MHRA) has issued an alert regarding the incidence of damage, continued use and subsequent failure of "various devices in cardiac catheterisation and interventional radiology laboratories", following collision with the c-arm of X-ray equipment. "Devices have been damaged by collision with the X-ray c-arm, but have remained in use and subsequently failed, causing injury," reported the MHRA on July 18. Earlier this month, the UK parliamentary committee of public accounts (CPA) issued a damning report on efforts to address device safety issues (see Clinica No 1214, pp 3 & 9).