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NEMA publishes XR-30 standard for evaluating CR and DR equipment

by Christina Hwang, Contributing Reporter | July 27, 2016
Business Affairs Medical Devices X-Ray
Compliant manufacturers must
meet the set minimum requirements
NEMA, The National Electrical Manufacturers Association, recently published standards for manufacturers that develop projection radiography equipment such as computed radiography (CR) and digital radiography (DR) X-ray. The standards aim to more easily facilitate a hospital’s quality control for the relevant equipment.

The NEMA/MITA XR 30-2016 Quality Control Tools for Digital Projection Radiography defines a set of requirements that manufacturers must meet in order to ensure that safety, regulatory compliance, and equipment performance are conducted in a cost-effective manner at a facility.

"NEMA worked in coordination with the medical physicist community to develop this standard based on their request for additional quality control tools for DR and CR equipment - in this case these requests were for more tools to allow physicists to more easily perform image quality analysis and to monitor this over time," Tony Roder, Chair of MITA's X-Ray Section, told HCB News.
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Companies that are XR-30 compliant have equipment that can access and export original data to an output device, and also be able to electronically document image processing parameters such as contrast (gradation), brightness (density), and sharpness (frequency) in a compatible format to the output device.

The manufacturer will provide a starting point for the parameters but the equipment user can modify them as long as the parameters are met with quality assurance.

According to Roder, NEMA has not performed any specific assessment of in-use equipment with regard to compliance to the clauses in the standard.

In May, CMS announced that outpatient facilities and physicians’ offices still using analog and CR X-ray equipment need to begin making the switch to DR in order to avoid Medicare reimbursement reductions starting next year

“The policy permits physicians to continue to use X-ray equipment used for film radiography and computer radiography. Physicians who elect to continue to use these modalities are subject to per-scan reimbursement reductions within the Medicare program,” the American College of Radiology said at the time of the announcement.

When asked what role XR-30 will have in meeting the qualifications that Medicare specified, NEMA said that it is currently not aware of a specific role that the new standard would have on those qualifications.

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