Arthur Spring (Kerry North-West Limerick, Labour)
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257. To ask the Minister for Health if the clinical trial published in the AJR 2009 complies with ethical standards; and if it demonstrates an increase in breast cancer [12564/14]

Arthur Spring (Kerry North-West Limerick, Labour)
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258. To ask the Minister for Health if a safety statement and risk assessment are available for digital mammogram machines. [12565/14]

James Reilly (Dublin North, Fine Gael)
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I propose to take Questions Nos. 257 and 258 together.

A ‘Comparison of the digital mammography and screen-film mammography in breast cancer screening: a review in the Irish breast screening program’ was published in the American Journal of Radiology (AJR) in 2009. This study reviewed the use of full-field digital mammography (FFDM) in a population-based cancer screening programme and compared the results with screen-film mammography. FFDM resulted in significantly higher cancer detection and recall rates than screen-film mammography in women aged 50 to 64 years old.

This does not represent an increase in breast cancer rather digital mammography has resulted in enhancement of image quality, particularly associated with improved visualisation of dense breast tissue. Digital mammography results in significant reductions in radiation dose associated with screening examinations, and allows images to be acquired in a shorter time and it is possible to manipulate images at the time of reporting to obtain better specificity. Information regarding manufacturers' manuals and safety data for digital mammography equipment is included as part of the BreastCheck tendering process. Quality assurance processes and measurements are a vital aspect of the BreastCheck programme and their ‘Guidelines for Quality Assurance in Mammography Screening’ are consistent with those of the European Reference Organisation for Quality Assured Breast Screening and Diagnostic Services which is the EU standard.