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MITA Statement Regarding FDA Public Meeting on Medical Radiation

Wednesday, March 31, 2010 Press Release J E 4
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WASHINGTON, March 30 The Medical Imaging & Technology Alliance (MITA), the leading association representing the manufacturers, innovators and developers of medical imaging and radiation therapy systems, today said it is supportive of the Food and Drug Administration's (FDA) ongoing interest to further reduce exposure to unnecessary medical radiation and minimize medical errors.

"Reducing patients' exposure to medical radiation has been, and continues to be, a primary focus of the medical imaging industry -- part of our ongoing commitment to innovation. As a result, medical imaging manufacturers have made tremendous strides in reducing radiation while improving the ability of doctors to see and diagnose disease at earlier and earlier stages. In fact, our members have introduced new products and system innovations during the past 20 years that have reduced radiation dose for many procedures by up to 75 percent," said Dave Fisher, Executive Director of MITA.

"Medical technologies that utilize radiation to diagnose and treat patients are integral to today's standards of care, and critical to the delivery of high quality health care. Every day - thanks to significant investment in research and development - life-saving medical imaging and radiation therapy technologies, bring immeasurable value to millions of patients, survivors and their loved ones," Fisher said.

As part of its ongoing commitment to ensuring safe, appropriate and effective medical imaging and radiation therapy, MITA recently announced a new industry-wide commitment to more expansively address patient safety in medical imaging by ensuring that CT equipment includes additional radiation safeguards. These new radiation dose check features will alert CT machine operators when radiation dose levels - as determined by hospitals and imaging centers - will be exceeded. The radiation dose upper-limit alert (or warning) will notify operators when an error may have occurred in setting parameters. This feature can be configured to prevent a CT scan from occurring.

In addition to the Dose Check Initiative, MITA also recently endorsed the following key principles to reduce unnecessary radiation exposure and medical errors:

"MITA remains concerned that new clinical data requirements in the clearance process or other new burdens will delay these essential dose reduction innovations' entry into the market," Fisher said.

"MITA looks forward to working with the FDA and all stakeholders involved in the delivery of health care to ensure that we continue to develop innovative technologies that reduce radiation dose and safeguard against human error, while ensuring that patients have access to the life-saving technologies that are critical to providing high quality health care," Fisher said.

The Medical Imaging & Technology Alliance (MITA), a division of the National Electrical Manufacturers Association (NEMA), is the collective voice of medical imaging equipment manufacturers, innovators, and product developers. For more information visit www.medicalimaging.org

-- Expanding and integrating appropriateness criteria into physician decision-making. -- Creating a national dose registry to permit longitudinal tracking of dose levels. -- Exploring the expansion of mandatory accreditation for advanced imaging facilities. -- Establishing minimum standards for hospital and imaging facility personnel who perform medical imaging exams and therapy treatments using radiation. -- Developing minimum standards for training and education for hospital and imaging facility personnel and checklists to reduce medical errors. -- Expanding and standardizing the reporting of medical errors associated with medical radiation across stakeholders in a manner that is transparent for patients, families and physicians. -- Working with stakeholders to develop radiation dose reference values to provide a data point to compare the dose level of a specific procedure.

SOURCE Medical Imaging & Technology Alliance (MITA)
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