A new requirement of the Joint Commission for assessing the performance of fluoroscopy equipment may be a source of confusion for providers, due to its mandate that “maximum exposure rates in all imaging modes” be specified for each piece of fluoroscopic X-ray equipment.
Such devices, according to ECRI’s Jason Launders, director of operations for it health devices group, can be “worlds apart” in type and use, and come with a wide range of modes.
“Every part of the anatomy has a different mode,” he told HCB News. “Am I looking at the arteries or the ventricles? Am I looking at the brain, or am I looking at a leg? There are different types of imaging you can do in each mode. Are you going to be testing every single one? That could be a very long list.”
Such confusion has led many providers to reach out to manufacturers for advice and information on how to answer this question in full, a task that results in long and cumbersome testing, which may not be able to specify the maximum exposure rate for any piece of technology, according to MITA.
“Control modes (according to U.S. regulation 21CFR1020.32) are the only imaging modes with regulated maximum exposure rates (i.e., maximum air kerma rates),” it said in a statement. “On modern fluoroscopy equipment there may be dozens of fluoroscopy modes available, which may be based on clinical protocols and requirements, and include multiple dose modes and pulse rates that could impact the measured exposure rate. Non-regulated imaging modes could number in the hundreds and have no regulated maximum value.”
In addition, testing a piece of equipment by pushing it to its maximum exposure rate can place prolonged stress on its X-ray tube, causing the part to prematurely degrade or fail. This stress is further enhanced by the resistance exerted by the system, which will try to cut back its output when pushed to its highest rate.
Such damage can often destroy the tube, requiring the hospital to purchase another.
“A broken X-ray tube is not cheap,” said Launders, who says that the most a provider can do in this situation is contact their medical physicist, who, in turn, should consult with the manufacturers of the equipment to figure out the maximum exposure rate of each to help hospitals complete their Joint Commission surveys.
He stresses that while confusing, completing this task is important, as failure to do so could result in a citation.
“It really depends on the surveyor and what they’re looking for. They might not know about imaging to a great extent, and may not understand what this requirement is asking,” he said. “These instructions are directed to the medical physicists. The medical physicist should include this in their report and contact the manufacturer for guidance regarding this. They need to go to the manufacturer and say, ‘I need to specify what the maximum dose rates in each of these are. Can you give me a table?’”
MITA said it had no comment at this time.
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