MITA and COCIR Issue Response to U.S. FDA Statement on Bonn Call for Action

04.02.15

Washington, D.C. – The Medical Imaging & Technology Alliance (MITA) and the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR) today issued the following response to the Food and Drug Administration’s March 25 statement on the Bonn Call for Action, a list of priorities for radiation protection over the next decade.

“Medical device manufacturers in the United States and abroad are committed to ensuring safe, high-quality patient care by developing new technologies and safety features, publishing safety standards, collaborating with the U.S. FDA and patient and professional societies, and advancing policy initiatives that incentivize adoption of equipment that meets specific standards for radiation dose optimization,” said Thad Flood, JD, industry director of MITA. “We are honored to be part of a global community that is working tirelessly to advance patient safety, and we look forward to ongoing collaborative dose-reduction efforts with FDA and others.”

The Bonn Call for Action, which resulted from an international conference co-sponsored by the International Atomic Energy Agency (IAEA) and the World Health Organization (WHO) in December 2012, highlights ten key actions that were identified as being essential for strengthening radiation protection.

Advanced medical imaging has revolutionized health care, giving doctors the ability to detect and diagnose cancer and other diseases earlier than ever before, when they can be treated more effectively. However, safe and effective imaging protocols are imperative to promoting patient safety while optimizing device performance. As such, MITA’s computed tomography (CT) and radiation therapy (RT) members have taken the lead in the United States on industry-wide initiatives to develop and implement additional patient protection features for CT and RT equipment. Most recently, MITA developed the XR-29 standard, also known as MITA Smart Dose, which includes four key features of CT equipment that enable optimization or management of radiation dose delivery while also providing high quality medical images. XR-29 is the fourth dose-related standard to be released by MITA since 2010, preceded by the XR-25, XR-26 and XR-27 standards. Collectively, these standards promote adoption and use of advances in dose management and mitigation.

“Our industry has made tremendous strides in promoting dose optimization around the world, thanks to the collaboration between manufacturers, regulators, physicians and the broader imaging community,” said Nicole Denjoy, COCIR Secretary General and DITTA Vice-Chair. “It is critical that we continue to cooperate with regulators and key stakeholders on this key matter. COCIR will continue to advocate for adoption and expansion of such initiatives within the international arena.”

MITA has a long history of working closely with industry partners, physicians, medical physicists, nurses and technologists to improve patient safety and care, including the “Image Gently” campaign to educate medical professionals and parents about imaging protocols that can reduce imaging-related dose for children. MITA also supports the “Image Wisely” campaign, which focuses on reducing unnecessary exposure for adults. Additionally, in 2012, the FDA awarded MITA its “Leveraging/Collaboration Award” for developing a collaborative network aimed at reducing unnecessary pediatric radiation exposure.

Likewise, COCIR has established close relationships with HERCA since 2011 on CT dose optimization, as mentioned in the FDA response to the Bonn Call for Action and has dedicated efforts interlinked with those from MITA. In addition, a CT manufacturer’s self commitment has been established since then with HERCA who commended COCIR for its engagement and effective progress over time. Key industry players in the field of CT have demonstrated their capabilities to work together under COCIR umbrella. COCIR also supports the “Eurosafe Imaging” initiative launched last year by European Society of Radiology and is an active member of its newly established Steering Committee.

###

The Medical Imaging & Technology Alliance (MITA), a division of NEMA, is the collective voice of medical imaging equipment, radiation therapy and radiopharmaceutical manufacturers, innovators and product developers. It represents companies whose sales comprise more than 90 percent of the global market for medical imaging technology. For more information, visit www.medicalimaging.org. Follow MITA on Twitter @MITAToday.

COCIR is the voice of the European Radiological, Electromedical and Healthcare IT Industry. COCIR is a non-profit trade association, founded in 1959, representing the medical technology industry in Europe and has an office in China since 2007. COCIR’s members play a driving role in developing the future of healthcare in Europe and worldwide. For more information, visit www.cocir.org. Follow COCIR on Twitter @COCIR.     

DITTA is the global trade association representing national and regional trade associations. DITTA represents the following industry sectors: diagnostic imaging, radiation therapy, healthcare IT, electromedical and radiopharmaceuticals. DITTA represents a vast range of technology with an annual value of over €100 billion. COCIR (Europe), JIRA (Japan) and MITA (United States) are the founders of DITTA. Today, DITTA includes representations from nine geographies: Brazil, Canada, China, Europe, Japan, Korea, Russia, Thailand and USA. DITTA’s mission is to be the global voice for our medical technology industry, and to communicate, coordinate and collaborate on matters of common interest between participating associations to more effectively work with policymakers, organizations, professional associations and stakeholders. DITTA was recently granted a NGO status at WHO level. For more information, visit www.globalditta.org. Follow DITTA on Twitter @DITTA_Online.