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Title: TU-AB-204-03: Research Activities in Medical Physics

Abstract

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explainmore » the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose.« less

Authors:
 [1]
  1. Food & Drug Administration (United States)
Publication Date:
OSTI Identifier:
22653926
Resource Type:
Journal Article
Resource Relation:
Journal Name: Medical Physics; Journal Volume: 43; Journal Issue: 6; Other Information: (c) 2016 American Association of Physicists in Medicine; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
60 APPLIED LIFE SCIENCES; 61 RADIATION PROTECTION AND DOSIMETRY; BIOLOGICAL MARKERS; BIOMEDICAL RADIOGRAPHY; COMPUTER CODES; DRUGS; EQUIPMENT; IMAGES; REGULATIONS; SAFETY

Citation Formats

Badano, A. TU-AB-204-03: Research Activities in Medical Physics. United States: N. p., 2016. Web. doi:10.1118/1.4957390.
Badano, A. TU-AB-204-03: Research Activities in Medical Physics. United States. doi:10.1118/1.4957390.
Badano, A. 2016. "TU-AB-204-03: Research Activities in Medical Physics". United States. doi:10.1118/1.4957390.
@article{osti_22653926,
title = {TU-AB-204-03: Research Activities in Medical Physics},
author = {Badano, A.},
abstractNote = {The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose.},
doi = {10.1118/1.4957390},
journal = {Medical Physics},
number = 6,
volume = 43,
place = {United States},
year = 2016,
month = 6
}
  • In response to a world in which cancer is a growing global health challenge, there is now a greater need for US Medical Physicists and other Radiation Oncology professionals across institutions to work together and be more globally engaged in the fight against cancer. There are currently many opportunities for Medical Physicists to contribute to alleviating this pressing need, especially in helping enhance access to Medical Physics Education/training and Research Excellence across international boundaries, particularly for low and middle-income countries (LMIC), which suffer from a drastic shortage of accessible knowledge and quality training programs in radiotherapy. Many Medical Physicists aremore » not aware of the range of opportunities that even with small effort could have a high impact. Faculty at the two CAMPEP-accredited Medical Physics Programs in New England: the University of Massachusetts Lowell and Harvard Medical School have developed a growing alliance to increase Access to Medical Physics Education/training and Research Excellence (AMPERE), and facilitate greater active involvement of U.S. Medical Physicists in helping the global fight against cancer and cancer disparities. In this symposium, AMPERE Alliance members and partners from Europe and Africa will present and discuss the growing global cancer challenge, the dearth of knowledge, research, and other barriers to providing life-saving radiotherapy in LMIC, mechanisms for meeting these challenges, the different opportunities for participation by Medical Physicists, including students and residents, and how participation can be facilitated to increase AMPERE for global health. Learning Objectives: To learn about the growing global cancer challenge, areas of greatest need and limitations to accessing knowledge and quality radiotherapy training programs, especially in LMIC; To learn about the range of opportunities for Medical Physicists, including students and residents, to work together in global health to help increase AMPERE and alleviate the growing global burden of cancer; To present and discuss a new model for harmonizing Medical Physics Training across countries and how this model (UMass and Heidelberg) could be extended to LMIC in collaboration with the IAEA; To highlight a new platform and program for facilitating contributions by Medical Physicists to increase AMPERE towards the elimination of global cancer disparities. Challenges in Cancer Control in Africa Twalib A. Ngoma, MD, Professor, Executive Director, Ocean Road Cancer Institute, Dar Es Salaam, Tanzania Cancer care in Africa is beset by lack of attention, political will, cancer registries, cancer plans, human resources, financial resources and treatment facilities.. As a result of this, cancer patients in Africa are far more likely to die of their disease than those in developed countries. According to data from the WHO 750,000 new cancer cases occur in Africa every year and this number is predicted to rise by 70% by 2020. To make matters worse, an estimated 75% of cancer patients in Africa have advanced or incurable cancers at diagnosis making palliative care the most realistic approach to their management. Furthermore, Cancer prevention is nearly nonexistent, cancer detection is rare and treatment usually comes too late and is inefficient. The overall mortality-to-incidence ratio for men with cancer in the Africa is 0.75 compared with 0.54 in the developed world while the ratios for women in Africa, is 0.65 compared with 0.45 for women in the developed world. There is also limited access to radiotherapy. According to the International Atomic Energy Agency (IAEA), whilst developed countries usually have one radiotherapy machine per 250,000 people, most African nations have only one machine per ten million people. The above numbers are alarming and speak for themselves. The only solution to improve this alarming situation is to address the major challenges which African countries face in provision of cancer services which include but not limited to lack of cancer registries, lack of funding, lack of human resources, lack of radiotherapy machines, lack of cancer drugs and lack of accessible and affordable cancer screening, early diagnosis, treatment or palliative care services. Since there are considerable differences among African countries, in my presentation I will share with the audience how we address cancer control challenges in Tanzania in general and specifically in radiation oncology. The African continent cancer plan 2013 2017 Folakemi Odedina, PhD, Professor and Director of Health Disparities, UF Health Cancer Center, University of Florida The burden of cancer is rising in Africa, in addition to current heavy burden of communicable, and other non-cancer related non—communicable diseases. Conquering cancer in Africa will require a comprehensive collaborative approach with cancer clinicians, scientists, patients, advocates, policy makers and community leaders working hand-in-hand at the local, state, national, and continent levels with the primary mission: To reduce the number of deaths from cancer and improve the quality of life of cancer patients, survivors and caregivers. Unfortunately, less than 40% of African countries have a credible cancer control policy and program. The African Organization for Research and Training in Cancer (AORTIC) decided to create an African Cancer Plan to provide cost-effective strategies that can be employed throughout the continent to fight cancer. Based on the African proverb that “It takes a village to raise a child”, the Cancer Plan provides specific strategies that can be used by individuals, employers, organizations and policy-makers to fight cancer. In addition, we have provided overarching strategies to address cancer in Africa and targeted 5-year plan for prostate, breast, cervix, lung and liver cancers. In developing this Cancer Plan, our primary goal is to decrease cancer incidence and mortality in Africa. This goal can only be achieved by stakeholders and dedicated individuals to lead and implement the strategies outlined in this plan. If you are interested in partnering with AORTIC to reduce the burden of cancer in Africa, please send an email to info@aortic-africa.org. Synergies in research and clinical care through international collaboration Thomas Bortfeld and David Gierga, Massachusetts General Hospital, Harvard Medical School, MA Medical Physics relies on high technology that is not distributed equally. The whole spectrum of Medical Physics technologies is not available at every hospital or research institute, and not even in every high income country. One example is heavy ion therapy equipment which is currently only available in Japan, Germany and Italy. There is also a large global variation in terms of research infrastructure and focus. A student of Medical physics cannot gain broad experience, certainly not hands-on experience, by staying at one place only. While it is debatable what a good trade-off between breadth and depth in Medical Physics education is, it is generally agreed upon that some breadth is necessary. Researchers in Medical Physics have to cross borders if they need specific technologies for their projects. Therefore it is self-evident that international programs in Medical Physics education and research make sense. Yet, very few programs of this type exist. In this presentation we will report on our own experience of pursuing an international career in Medical Physics, with international student programs, and with the international exchange of researchers. We will present new or planned opportunities such as the medical beamline at CERN in Geneva. We will also report on the synergies in clinical care through international collaborations between partners in high and low income countries. One example is the partnership of the MGH/Harvard Medical School community with the oncology community and government of Botswana to form the BOTSOGO (BOTSwana Oncology Global Outreach) initiative. This collaborative effort in oncology care was spurred by existing relationships in HIV/AIDS research and care delivery developed within the Botswana-Harvard AIDS Institute Partnership (BHP). The initial efforts of the BOTSOGO initiative have been organized as follows: 1) on-site visits to share expertise in clinical cancer care for capacity building purposes (e.g. cervical brachytherapy), 2) developing a forum for multi-disciplinary case discussions and education and 3) relationship building with local stakeholders for long-term sustainability and growth. An international system for the certification of medical physicists Raymond K. Wu, Chairman, IOMP Professional Relations Committee; Chairman, AAPM Exchange Scientist Program Subcommittee An international system for the certification of medical physicists is an important issue. The International Organization for Medical Physicists (IOMP) has in collaboration with a number of member countries established the International Medical Physics Certification Board (IMPCB) to address this issue, and to provide a mechanism to mark the milestone for the professional development of clinical medical physicists. Raymond Wu, PhD, is the CEO of IMPCB and the Chairman of the IOMP Professional Relations Committee. He is the invited speaker recommended by IOMP to give a talk on this important subject. He will give the latest update of the work of IMPCB, its near term goals, and pathways to the goals. He will also discuss the importance of such an International System of certification in the training/education of next generation Medical Physicists, including those in low and middle income countries (LMIC) where such training is crucial in the fight against cancer. Learning Objectives: Understand the certification program as described in the IOMP Policy Statements. Understand the plan of the IMPCB to establish the accreditation process of national certification programs. Understand the goals of this international collaborative effort and the potential impacts to the quality of clinical medical physics practice. Medical Physics Education Across Continents: The UMass Lowell and Heidelberg University Joint Coordination Effort Erno Sajo, Director of Medical Physics, University of Massachusetts at Lowell Medical Physics education has unique flavors across institutions within the US and shows significant differences across continents. In the latter, even the definition of Medical Physics may differ. Not only is there a difference in topical coverage, but often what is considered a cohesive topic in one institution, and taught as a single course, is fragmented among several other courses in the other institution due to a different philosophy. Because of the regulatory and certification requirements, these differences impact the mobility of medical physicists across continents. As a result, physicists who wish to practice in the US or Canada but have completed their education elsewhere often find that they have to take remedial courses or even obtain a new degree in Medical Physics despite the fact that they already have one. Outreach to developing countries, therefore, is even more difficult. The University of Massachusetts Lowell and Heidelberg University recently completed a joint coordination effort, in which they identified topics that are common versus complementary in their medical physics curricula. A student exchange program was developed that permits students to take any of the common topics at the other institution while taking complementary courses as electives, which count towards their degree requirements at their home institution. Thesis research is also mutually accepted. When properly documented, in this way CAMPEP recommendations can be met across the institutions. Therefore, students participating in this program satisfy both the American Board of Radiology (ABR) requirements and the European regulatory requirements. The framework on which this collaboration rests and the cross-comparison methods developed therein may be implemented in other exchange programs and thus a similar approach can be adopted in outreach programs with developing countries. IAEA PACT Program and opportunities for support and collaboration Susan Morgan, Program Coordinator, International Atomic Energy Agency, Vienna, Austria In response to the developing world's cancer crisis, the International Atomic Energy Agency (IAEA) established the Program of Action for Cancer Therapy (PACT) in 2004 to fully realize the public health impact obtained through global partnerships in cancer control and technology transfer in radiation medicine. PACT's vision strives for global partnerships to confront the cancer crisis in developing countries, notably with our sister United Nations agency, the World Health Organization (WHO), and our Joint Programme on Cancer Control established in 2009. The IAEA, through PACT, the WHO, the International Agency for Research on Cancer (IARC) and other cancer-related organizations work together to make a coordinated global response in supporting low and middle income (LMI) IAEA Member States in the implementation of comprehensive national cancer control programmes. PACT's goals are: To build global partnerships of cancer-related organizations committed to addressing the challenge of cancer in LMI Member States in all its aspects; To mobilize resources from charitable trusts, foundations, and others in public and private sectors sources to assist LMI Member States to develop and implement their radiation medicine capacities within a national cancer control programme (NCCP); and, To ensure the effective and sustainable transfer of radiation medicine technologies or knowledge to all LMI Member States where unmet needs exist. PACT work focuses on: imPACT: Assessing Cancer Burden PMDS: Developing Global Partnerships VUCCnet: Promoting Cancer Control Training AGaRT: Making Radiotherapy Accessible Facilitating increased participation and professional development of Medical Physicists and other Radiation Oncology professionals in global health Wilfred Ngwa, Harvard Medical School, University of Massachusetts Lowell, MA The 2014 World Health Organization (WHO) Cancer report highlights an alarming increase in the global burden of cancer. It also highlights what it terms “the cancer divide”, or disparities, evinced by a substantially higher cancer burden in low and middle income countries (LMIC) in Asia, Central/South America and Africa. The WHO even predicts a potential African cancer epidemic by 2020 if significant progress is not made in global cancer control efforts. Evidence that collaborative global health approaches have led to major progress in controlling infectious diseases including in LMIC suggests that similar approaches will be useful for non-communicable diseases like cancer. In consonance with this, leaders in cancer policy from the USA and 14 economically diverse countries recently concluded that successful campaigns to control cancers with existing methods and to improve current strategies will increasingly depend onconcerted multinational collaborations (Sci Transl Med 5, p. 175, 2013). Hence there is growing urgency for increasing collaborative global cancer Care Research and Education (CaRE), as well as support for greater effectiveness of already existing initiatives involving partners from different nations, diverse economic and cultural backgrounds. The good news is that there is a growing awareness of the importance of global health and growing interest including amongst Medical Physicists and other Radiation oncology (RadOnc) professionals to participate in global health. However, many are unaware of currently existing opportunities for participation that even with small effort could have a high impact. Over 50% of cancer patients in the developed world depend on RadOnc professionals for their treatment, and hence participation of RadOnc professionals in global health efforts in the global fight against cancer is crucial. It is also important that the next generation of RadOnc professionals (students, and residents) be trained with a global perspective, to be global health leaders in cancer CaRE. This presentation will highlight a novel platform for enhancing participation and professional development of Medical Physicists and other RadOnc professionals in global health. Ways in which this platform can facilitate contributions by Medical Physicists and other RadOnc Professionals, students and residents in global health towards the elimination of global cancer disparities will be discussed. This will be followed by a panel discussion by some of the pioneers/leaders in collaborative global cancer CaRE on the growing cancer burden, challenges and opportunities for greater active involvement and professional development.« less
  • Medical physics is learned in a combination of activities including classroom sessions, individual study, small-group collaborative problem solving, and direct experience in the laboratory or clinical environment. Each type of learning activity is characterized by its effectiveness in producing the desired knowledge for the learner and the cost in terms of resources and human effort required providing it. While learning and teaching is a human activity, modern technology provides a variety of tools that can be used to enhance human performance. The class or conference room is the common setting for educational sessions in both academic institutions and continuing educationmore » conferences and programs such as those sponsored by the AAPM. A major value of a class/conference room program is efficiency by bringing a group of learners together to share in a common learning experience under the guidance of one or more experienced learning facilitators (lecturers or presenters). A major challenge is that the class/conference room is separated from the real world of medical physics. The design of an educational activity needs to take into consideration the desired outcomes with respect to what the learners should be able to do. The distinction is that of being able to apply the knowledge to perform specific physics functions rather than just knowing and being able to recall facts, and perhaps do well on written examinations. These are different types of knowledge structures within the human brain and distinctly different learning activities to develop each. Much of medical physics education, especially at the post-graduate and continuing education level, is for the purpose of enhancing the ability of physicists and other related professionals to perform applied procedures and tasks and requires specific types of knowledge.In this session we will analyze various learning activity models, the values and limitations of each, and how they can be used in medical physics education. An example we will use is optimizing CT image quality and dose which is an important topic for medical physicists, radiologists and residents, along with technologists. The knowledge structure for this is best developed by a combination of learning activities including class/conference discussions, individual study and review, and direct observation and interaction in the clinical setting under the direction of a knowledgeable leader.The function of the human brain will be considered with respect to learning experiences that contribute to effective medical physics knowledge structures. The characteristics of various types of educational activities will be compared with respect to their effectiveness for producing desired outcomes along with their limitations. Emphasis will be given to the design of highly-effective classroom/conference presentations, and activities will be demonstrated with an emphasis on using technology to enhance human performance of both learners and the learning facilitators. Learning Objectives: Develop and provide highly effective medical physics educational sessions. Use technology to enhance human performance in the educational process. Identify and analyze various models of educational activities Select and use educational activities that contribute value to the medical physics profession.« less
  • A collaborative effort by researchers at the Idaho National Engineering Laboratory and the Brookhaven National Laboratory has resulted in the design and implementation of an epithermal-neutron source at the Brookhaven Medical Research Reactor (BMRR). Large aluminum containers, filled with aluminum oxide tiles and aluminum spacers, were tailored to pre-existing compartments on the animal side of the reactor facility. A layer of cadmium was used to minimize the thermal-neutron component. Additional bismuth was added to the pre-existing bismuth shield to minimize the gamma component of the beam. Lead was also added to reduce gamma streaming around the bismuth. The physics designmore » methods are outlined in this paper. Information available to date shows close agreement between calculated and measured beam parameters. The neutron spectrum is predominantly in the intermediate energy range (0.5 eV - 10 keV). The peak flux intensity is 6.4E + 12 n/(m2.s.MW) at the center of the beam on the outer surface of the final gamma shield. The corresponding neutron current is 3.8E + 12 n/(m2.s.MW). Presently, the core operates at a maximum of 3 MW. The fast-neutron KERMA is 3.6E-15 cGy/(n/m2) and the gamma KERMA is 5.0E-16 cGY/(n/m2) for the unperturbed beam. The neutron intensity falls off rapidly with distance from the outer shield and the thermal flux realized in phantom or tissue is strongly dependent on the beam-delimiter and target geometry.« less
  • The Medical and Biophysical Sciences have often made use of technical developments in the Physical Sciences. High Energy Physics has made its contributions in recent years by bringing the use of scintillation and solid state detectors in trace element detection and in gamma imaging. More recently, the use of position sensitive detectors such as Multi-wire Proportional Chambers (MWPC) has been introduced into Medical and Biophysical Research. Some of the applications of MWPC to problems in Medical Imaging of X-rays and ..gamma.. rays, Neutron Radiography and X-ray Crystallography of complex organic molecules are discussed. The fact that these devices can bemore » used to produce digitized information as well as analog image displays makes them very useful for 3-dimensional Reconstruction of Radioisotope Images. Details of the construction and associated electronics of MWPC are covered.« less