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DITTA Standards Workshop

“Standards for better regulatory framework”

Taking place during the 8th meetings of IMDRF in Kyoto, Japan

Monday 14 September 2015 from 09:00 to 12:30

Location: Shimadzu Corporation

1 Nishinokyo Kuwabara-cho, Nakagyo-ku, Kyoto 604-8511, Japan

 Our motto as DITTA has been since long: “Approved once, accepted everywhere”. However, our practical goal is “to reduce multiple processes, cost and time loss” when putting new medical device and innovative technologies on the market.

DITTA requested IMDRF Management Committee to include standards in the Long Term goals and strategic plan. After that, IMDRF Management Committee decided to establish the strategic plan at the Kyoto meeting. With this Workshop, DITTA supports the introduction of Standards into the IMDRF strategic plan, by providing rationale and offering the possibility to discuss priorities and possible timing.

Detailed programme attached.

DITTA Calls For Immediate Inclusion Of ‘Technologies’ In United Nations Sustainable Development Goal 3

BRUSSELS, BELGIUM – DITTA, the Global Diagnostic Imaging, Healthcare IT and Radiation Therapy Trade Association, urgently calls for the inclusion of the word ‘technologies’ in the Sustainable Development Goal (SDG) 3, Target 3B, which highlights the importance of ensuring healthy lives and promoting well-being.

Sustainable Development Goals (SDGs) are set to be ratified at the United Nations (UN) General Assembly in September 2015. They are an expansion on the Millennium Development Goals (MDGs) agreed by governments in 2000.

DITTA is particularly concerned with the changes in Target 3B, SDG 3, where the word ‘technologies’, referring to medical technologies, has been deleted. DITTA wants ‘technologies’ after ‘medicines’ in the suggested final version of the Target 3B, SDG 3, as follows:

“3.b support research and development of vaccines and medicines for the communicable and non-communicable diseases that primarily affect developing countries, provide access to affordable essential medicines, technologies and vaccines, in accordance with the Doha Declaration which affirms the right of developing countries to use to the full the provisions in the TRIPS agreement regarding flexibilities to protect public health and, in particular, provide access to medicines for all.”

Nicole Denjoy, DITTA Vice-Chair, said, “Medical technology saves lives and this term should not be removed from SDG 3. Without medical technology, there would be no radiotherapy treatment for cancer, no infant warmers for babies suffering from hypothermia, no LED phototherapy for neonatal jaundice and the detection and cure of tuberculosis and HIV would not be possible. These are just some examples of medical technology’s contributions, taken from the World Health Organization’s (WHO) Compendium of innovative health technologies for low-resource settings.”

Nicole Denjoy added, “Medical technology is vital in diagnosing, monitoring and treating diseases. Without medical technologies, health systems would simply collapse. Therefore, it is an imperative for the term ‘technologies’ to be included in the SDG 3.”

Imaging for Saving Kids – the Inside Story about Patient Safety in Pediatric Radiology

GENEVA, SWITZERLAND – DITTA, the Global Diagnostic Imaging, Healthcare IT and Radiation Therapy Trade Association is, for the first time, attending the World Health Organization’s (WHO) Sixty-Eighth World Health Assembly (WHA) from 18-26 May 2015 since DITTA granted the status of NGO in official relationship with WHO.

The World Health Assembly (WHA) is the supreme decision-making body of the World Health Organisation (WHO) and is held annually in Geneva. The Assembly is attended by delegations from the 194 WHO Member States, the NGOs in official relations with the WHO and representatives from other UN agencies.

The Sixty-eighth session of the WHA took place in Geneva from 18–26 May 2015. On May 26th 2015, four WHO Member States and nine NGOs in official relations with the WHO[1] co-organised a side event during the 68th WHA entitled “Imaging for Saving Kids – the Inside Story about Patient Safety in Pediatric Radiology”.

This event conducted at the United Nations Office at Geneva (UNOG), brought policymakers, health care providers, patients and equipment manufacturers together to jointly discuss what could be done to improve health and service delivery by maximising the benefits and minimising the risks when using medical imaging in children and how this could be achieved.

Universal health coverage aims to ensure that all people obtain the health services they need without suffering from financial hardship. This outcome requires efficient health systems, suitable health financing approaches, access to essential medicines and technologies, and sufficient capacity of well-trained and motivated health professionals.

Medical imaging enables earlier diagnosis and offers less invasive treatment for sick children. Timely access to basic life-saving procedures, e.g. ultrasound and computed tomography (CT) is important. While resources vary between regions and settings, all stakeholders are improving access to these imaging procedures.

Children are more vulnerable to ionizing radiation-related health risks, e.g. x-ray exposure during CT scans. Whenever appropriate, medical imaging without ionizing radiation has to be used, e.g. ultrasound or MRI. Good communication with the patient and carers facilitates informed decision-making and minimizes procedure delay or refusal due to unfounded concerns. Every procedure should be justified, tailored and optimized.

The participating stakeholders provided during the session the perspectives of health professionals, patients, families, and health authorities. The current situation in different regions, priorities, and improvement opportunities were discussed.

Improvement in patient safety in pediatric radiology requires multidisciplinary teamwork, collaboration and an integrated framework for actions covering research, advocacy, education, infrastructure, and evidence-informed policy. These actions will help to improve the performance of practitioners, facilities, and healthcare systems. Some examples include: implementing the Radiation Basic Safety Standards (BSS)[2] through national regulations; putting into practice the ten priorities identified in the Bonn call-for-action[3]; taking into account the ICRP recommendations on radiation protection in medicine; increasing access to imaging procedures; improving appropriate use of pediatric imaging by policies, providing guidance and tools, ensuring practitioner education and training; and promoting awareness of stakeholders’ roles and responsibilities.

It is important to foster an effective dialogue and build partnerships between health authorities, radiation protection regulatory bodies, practitioner organizations, patients’ families and equipment manufacturers. Facility-based and system-wide actions are complementary for the establishment and maintenance of a radiation safety culture in pediatric imaging. Integration avoids duplication and promotes synergy.

Nicole Denjoy, DITTA Vice-Chair, said “I am delighted to lead DITTA’s delegation to the WHA and to support the multi-stakeholder approach on Imaging for saving kids. DITTA and its members fully support initiatives at global level to build awareness on how to best use innovative technologies that can save lives of adults and kids. CT manufacturers’ aim is to ensure the appropriate, safe and effective use of imaging equipment by the clinical user. This includes the provision of specific training curricula on existing and new dose reduction techniques provided by manufacturers, on how to deploy these product features in daily practice, and to enable users to continue to reduce patient dose”.

Local implementation of a globally developed improvement model can save resources. The WHO plays a leadership role in facilitating and coordinating improvement actions in different regions and settings. DITTA is committed to improving the access to safe and more appropriate use of pediatric imaging and is working with other stakeholders on this priority. For further information, please visit our website www.globalditta.org .

[1] Governments of Kenya, Malaysia, Spain, and Uganda; NGOs in official relations with the WHO: Diagnostic Imaging, Healthcare IT and Radiation Therapy Trade Association (DITTA); International Commission on Non-Ionising Radiation Protection (ICNIRP); International Commission on Radiological Protection (ICRP); International Organisation for Medical Physics (IOMP); International Society of Radiology (ISR), International Society of Radiographers and Radiological Technologists (ISRRT); RAD-AID International; World Federation for Ultrasound in Medicine and Biology (WFUMB); and World Organisation of National Colleges, Academies and Academic Associations of General Practitioners / Family Physicians (WONCA).

[2] The International Basic Safety Standards (BSS) for Protection against Ionising Radiation and for the Safety of Radiation Sources is the international benchmark for radiation safety requirements, with major implications for policy and decision making. The BSS edition 2014 is co-sponsored by the European Commission (EC), the Food and Agriculture Organisation (FAO), the International Atomic Energy Agency (IAEA), the International Labor Organisation (ILO), the Nuclear Energy Agency (NEA/OECD),  the Pan American Health Organisation (PAHO), the United Nations Environment Program (UNEP) and the World Health Organisation (WHO). Available at http://www-pub.iaea.org/MTCD/publications/PDF/Pub1578_web-57265295.pdf

[3] The Bonn call-for-action identified 10 priority actions to improve radiation protection in medicine. Available at  http://www.who.int/ionizing_radiation/medical_exposure/bonncallforaction2014.pdf

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