Manufacturers have received inquiries from facilities in regards to The Joint Commission requirements for Organizations providing fluoroscopy services effective on January 1, 2019. These new requirements, specifically in regards to the performance evaluation assessment, are understood to be purposefully non-prescriptive in order to allow a facility to find an appropriate methodology and approach to demonstrate compliance. In some instances, however, this method introduces uncertainty that introduces confusion for facilities that wish to comply.

One particular element, requiring “maximum exposure rate in all imaging modes”, has resulted in inquiries to manufacturers for their recommendations on how the element should be fulfilled. Non- recorded fluoroscopy in normal and High Level Control modes (according to the US regulation 21CFR1020.32) are the only imaging modes with regulated maximum exposure rates (i.e., maximum air kerma rates). 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.

Prolonged stress on the x-ray tube can result in premature degradation or failure, and testing in such a state is not recommended. International standards require manufacturers to include recommended QA/QC procedures in addition to “typical” exposure rates based on defined conditions in their documents accompanying the equipment (i.e., ‘information for users’). Manufacturers recommend that this information should be utilized whenever possible in order to best ensure optimal performance of the equipment. If equipment is tested in alternative ways, the results, meaning or consistency of the measurements cannot be guaranteed.

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