Committees and Sections

MITA is organized by the following cross modality committees and modality specific sections. These groups are made up of MITA staff and member company representatives that specialize in a given field.

COMMITTEES

International Committee – Public Relations Committee – Reimbursement Committee – State Committee – Technical and Regulatory Affairs Committee – Washington Representatives Committee

SECTIONS

Magnetic Resonance Section – Medical Imaging Informatics Section – Molecular Imaging Section – Radiation Therapy Section – Ultrasound Section – X-Ray Section

COMMITTEES

INTERNATIONAL COMMITTEE

Scope:

The International Committee addresses medical imaging and radiation therapy issues at the global level. The Committee is MITA’s primary resource for member companies to engage with lawmakers, organizations and stakeholders abroad. The Committee represents the interests of MITA members in emerging markets to promote global competitiveness and harmonize standards among international regulatory bodies.

Goals:

The goals of this committee are to limit unnecessary regulatory burdens, harmonize international standards and expand market access for MITA members.

Functions:

The Committee meets regularly by phone to discuss international medical imaging issues, and meets more frequently when necessary. Committee members monitor international events for their companies, and are well versed in international trade, political and regulatory matters.

The Committee works to create a level playing field for member companies against local competitors, and to broaden and develop straightforward regulatory environments that conform to accepted international norms.

While the Committee is looking to expand its reach, the bulk of MITA’s international activities were focused on China in the past. This included product registration, testing, classification, and environmental impact; coordination with regional associations; development of industry positions; and preparing Department of Commerce officials for joint U.S.-China trade negotiations.

To accomplish its goals, the Committee works closely with the U.S. government, embassies, international organizations and professional associations that include: the European Coordination Committee of the Radiological, Electromedical and Health Information Technologies (COCIR); Electro Federation Canada (EFC); Japan Industries Association of Radiological Systems (JIRA); European Committee of Medical Devices (EUCOMED); Japan Federation of Medical Device Associations (JFMDA); Global Medical Device Network (GMTN); Global Harmonization Task Force (GHTF); and the Congress of Diagnostic Imaging and Therapy Systems Trade Associations (DITTA).

The scope of this committee will continue to grow as demand for medical imaging technology in emerging markets increases. To ensure members remain at the forefront of technological innovation and maintain continued success in the global marketplace, the Committee has developed a strategic plan to further its international reach and adapt to complex environments. This includes expanded international communication mediums, enhanced monitoring capabilities, public outreach and partnership development, and improved coordination between MITA committees and product sections.

PUBLIC RELATIONS COMMITTEE

(PR)

Scope:

The Public Relations Committee addresses MITA and industry media activities. These efforts include an aggressive media outreach strategy, regularly drafting materials for press releases, website development and integration of social media. The Committee works with the MITA Rapid Response Network and is the primary public affairs contact for member companies. The Rapid Response Network was formulated to respond to negative stories associated with medical imaging and radiation therapy in a quick and effective manner.

Goals:

The goals of this committee are to support and defend imaging and radiation therapy manufacturing, and increase public support for member companies and their products through different communication mediums.

Functions:

Members of the Public Relations Committee meet regularly by phone and if necessary through the Rapid Response Network. Committee participants are public relations and media professionals from member companies. This committee is particularly important, because it provides strategic advice regarding the public image of the industry.

The Public Relations Committee and MITA utilize a number of media activities to positively represent member companies. Media monitoring of state and national, print and on-line material are distributed daily; press releases, statements, op-eds and letters to the editor are routinely drafted for circulation; interviews are often conducted; updates and improvements to MITA’s website, medicalimaging.org and blog, Imaging in Focus are made on a regular basis; and copy is uniquely designed for targeted placement in key newspapers around the country.

In recent years, MITA’s public message has focused on Medicare and private payer reimbursement for screening services, improvement of the 510(k) clearance process, user fee negotiations, FDA investigations and expanded patient access to imaging equipment.

The Committee’s promotional activities build on relationships with patients, physicians, lawmakers and other stakeholders to develop common themes and targeted messaging that best illustrates the value of medical imaging. MITA has recently redesigned its website, which is quickly becoming a mainstream source for medical imaging and radiation therapy information. With the website, MITA can more effectively respond to industry developments by posting statements and blogs on-line within minutes after a story breaks. Depending on the story’s level of importance, MITA can quickly refocus the homepage to draw additional media attention to an industry position.

The growth of social media has led MITA to find new ways to connect with people about imaging news and research. As a result, MITA worked with the Access to Medical Imaging Coalition (AMIC) to launch the Right Scan Right Time Ambassador Program in April 2009. This initiative includes the rightscanrighttime.org website, monthly newsletter distribution, e-mail alerts about industry and related political developments, an AMIC Facebook page and @RightScan Twitter feed.

REIMBURSEMENT COMMITTEE

Scope:

The Reimbursement Committee focuses on payment issues related to federal and private payer systems. The Committee works primarily with the Centers for Medicare and Medicaid Services (CMS), Medical Payment Advisory Commission (MedPAC) and private insurance companies to strategize and advocate on behalf of the medical imaging industry.

Goal:

The goal of this committee is to support fair reimbursement for imaging and radiation therapy services.

Functions:

The Reimbursement Committee meets on a regular basis by phone to discuss CMS and other payment related issues. Committee members are generally made up of reimbursement specialists from member companies. Membership in this committee provides participants with information and an opportunity to participate in the development of industry positions on this very important issue.

The Committee conducts annual analysis of CMS regulatory proposals to determine their impact on payment, and drafts MITA-wide position statements for CMS and MedPAC to review. This committee works closely with the Washington Representatives Committee (WashReps) to address reimbursement issues at the federal level. This committee is the primary MITA contact for member companies to comment on CMS and private payer activities.

MITA works tirelessly to reduce the incidence of reimbursement rate cuts, especially when so many hospitals and physicians recognize the value of medical imaging for their patients. Imaging is clinically proven to save lives and lower healthcare costs in the long run through early diagnosis and better treatment. As a result, MITA continues to work with CMS, MedPAC and private payers to illustrate the negative impact that reimbursement cuts have on patient health, market competitiveness and the innovation of future advancements in medical imaging and radiation technologies.

STATE COMMITTEE

(STATE)

Scope:

The State Committee addresses medical imaging and radiation therapy issues at the state level. The Committee is MITA’s primary resource for member companies to engage state lawmakers, organizations and stakeholders. The Committee represents the interests of MITA members in individual states to educate policymakers, promote pro-industry legislation and prevent the passage of harmful policies.

Goal:

The goal of this committee is to limit adverse regulatory and reimbursement decisions at the state level.

Functions:

The Committee meets regularly by phone to discuss issues before state legislatures across the country, and meets more frequently pending political activity. Committee members are considered experts in state legislative issues and monitor these events for their companies.

The Committee works closely with state legislators and advocacy groups to increase their understanding of the value of medical imaging and educate them on the importance of promoting new technologies in their state. The State Committee coordinates with other MITA committees to relay important technical, regulatory and reimbursement information to individual states.

The Committee analyzes legislative proposals, drafts comments and presents their findings to state lawmakers on behalf of member companies. To effectively voice industry concerns and recommendations, the Committee develops state-specific positions and strategies to direct state lobbying efforts, organize member companies, increase MITA involvement with state groups, provide expert testimony, hold workshops and draft and re-draft legislative language. These efforts play an integral role in helping to bolster support or opposition to legislation that impacts the medical imaging and radiation therapy industries.

As state regulators seek guidance on medical imaging technology, the Committee continues to build trust and credibility with state agencies to promote MITA as the industry expert and primary point of contact on imaging issues. The Committee continues to address state efforts that tighten self-referral laws; change Certificates of Need statutes; increase transparency; tax providers; and make additional reimbursement cuts to reduce deficits and balance their budgets.

The Committee continues to take proactive steps with private health care providers, legislators and other state level stakeholders to reach consensus on areas of concern for device manufactures. Some of those issues include mandatory accreditation without a reasonable timeline to gain accreditation, ratings systems for imaging centers and equipment standards for reimbursement.

TECHNICAL AND REGULATORY AFFAIRS COMMITTEE

(TRC)

Scope:

The Technical and Regulatory Affairs Committee (TRC) is focused on the regulatory processes required to bring products to market in the U.S. and around the world.

Goals:

The goals of this committee are to enhance member competitiveness in the marketplace, streamline access to life saving products and promote innovation of medical technologies through transparent predictable and timely regulatory processes.

Functions:

TRC members meet regularly by phone to discuss Food and Drug Administration (FDA) activity, hold three annual meetings throughout the year and meet more often when necessary. Subgroups that address specific issues hold similar meetings. The Committee is generally made up of regulatory experts from member companies.

Medical devices are regulated by the FDA and the Committee is responsible for providing the Agency with policy, advocacy and program expertise on issues that foster innovation and protect public health.

Imaging and radiation products are generally cleared for sale using the 510(k) process, which is based on the principle of “substantial equivalence.” Historically, MITA has found this process to be unpredictable, inefficient and expensive. To improve 510(k) and other processes, TRC continues to facilitate dialogue with FDA and other regulatory bodies; as well as analyze legislative proposals, develop MITA positions and voice industry concerns to lawmakers.

The Committee believes that changes to the Agency’s review process and decision-making, coupled with upgrades in policy and procedural quality, will enhance transparency and improve the clearance of medical imaging products. To further these reform efforts, MITA works closely with a coalition of national and regional medical device associations to share information, coordinate activity and develop comments on 510(k) reports and recommendations. TRC continues to involve member companies in FDA activities, and the Agency regularly solicits MITA for feedback on industry specific issues.

WASHINGTON REPRESENTATIVES COMMITTEE

(WashReps)

Scope:

The Washington Representatives Committee (WashReps) addresses government activities at the federal level, and assists in the coordination of most MITA activities.

The Committee represents member companies in the formulation of legislation that impacts medical imaging and therapy equipment innovators, product developers and manufacturers. The Committee is MITA’s primary tool to discuss political and legislative affairs with member companies. This committee is also tasked with the development of MITA-wide strategies, positions and programs relative to legislation before Congress.

Goals:

The goals of the Committee are to advocate for reasonable legislative proposals that spur innovation, ensure market competitiveness in the medical device industry and encourage investment in research and development.

Functions:

The Committee meets regularly by phone and in person when necessary to discuss proposals being considered by Congress, the Administration and related agencies. Member participants are lobbyists or other staff that monitor legislative matters and related activity in Washington for their companies.

WashReps educates the Administration, members of Congress, and others in Washington on the life-saving and cost-cutting benefits of medical imaging technology. To increase awareness and understanding of the value of imaging and radiation therapy, WashReps coordinates with other MITA committees to relay important information to Capitol Hill and the Administration. The Committee analyzes legislation to determine their impact on member companies, and drafts comments to present industry recommendations and concerns to lawmakers.

MITA’s skilled and experienced government relations staff helps guide the Committee to direct lobbying efforts, organize member companies around pending legislation, meet with members of Congress, and hold events on Capitol Hill. In order to ensure a united policy front, WashReps and MITA partner with physician and patient groups to emphasize the value of imaging products that member companies manufacture. WashReps works closely with industry champions in Congress to foster bipartisan consensus on issues that promote the safe and effective use of medical imaging equipment. MITA has also worked with WashReps to create a political committee of company representatives to plan industry focused political events.

WashReps continues to aggressively lobby policymakers in an effort to ensure fair payment and reimbursement systems that expand access to imaging and radiation services. The Committee will continue to work with MITA’s Reimbursement, Public Relations and Technical and Regulatory Affairs (TRC) committees to provide expert guidance that educates the federal government on initiatives, standards and best practices within the medical imaging community to promote innovation and positively impact the device market.

SECTIONS

Magnetic Resonance Section – Medical Imaging Informatics Section – Molecular Imaging Section – Radiation Therapy Section – Ultrasound Section – X-Ray Section

MAGNETIC RESONANCE SECTION

(MR)

Scope:

The Magnetic Resonance Section (MR) includes imaging and scanning systems, MR magnets for diagnostic purposes on humans and MR compatible accessory devices such as radiofrequency coils, patient monitoring devices and stereotactic localization devices.

Goals:

The goals of the MR Section are to support both domestic and international policies, regulations and standards that drive innovation of MR products; enhance the market competitiveness of MR manufacturers; and coordinate with stakeholders to promote the highest levels of safety and technical expertise.

Functions:

The Section works to enhance the competitiveness in the marketplace through the collection of date and development of statistical programs. The MR section regularly interacts and communicates with the Food and Drug Administration (FDA) as the Agency considers new regulations and guidance documents for MR equipment manufacturers. Federal regulators have found it difficult to keep up with the innovative pace of the medical imaging industry.

The MR Section routinely monitors domestic and international guidelines, regulations, reimbursement policies and practices that are in the interest of member companies. For example, the International Commission on Non-Ionizing Radiation Protection (ICNIRP) sets magnetic field exposure limits. They also have the ability to influence other standards setting organizations. As a result, the MR Section continues to examine ICNIRP decisions for language that negatively impacts MR device manufacturers and takes action when necessary.

The MR Section coordinates with third-party standards organizations like the International Electrotechnical Commission (IEC) to promote the use of voluntary standards throughout the regulatory process. The MR Section has its own Technical Committee to serve the interests of its members as well as advance both NEMA and IEC standards harmonization within the industry. The Technical Committee is responsible for the development and continued maintenance of MR measurement standards. There are currently 12 MR standards that define the procedure used to measure parameters such as signal to noise ratio, specific absorption rate and slice thickness. Members of the Technical Committee also serve on a host of other task groups and committees including the IEC and International Society for Magnetic Resonance in Medicine (ISMRM).

The MR Section helps member companies achieve accreditation from the American College of Radiology (ACR), which ensures the quality of systems, workers and facilities. The MR Section collects market data and develops statistical programs for member companies. This section also provides resource materials about MR safety and technology to related organizations and associations throughout the industry, medical community and government.

MEDICAL IMAGING INFORMATICS SECTION

(MII)

Scope:

Since medical records can now be managed electronically, diagnostic images can be collected, processed, stored and transferred with the push of a button. The MII Section includes all equipment, components and accessories used in medical imaging informatics. Specifically, products that perform the following functions: information and workflow management; integration of imaging information; connection to image acquisition devices; digital archiving and storage; communication networks; electronic display; image coding; image processing; integration of imaging and information systems; and image distribution.

Goals:

The goals of the MII Section are to improve access and reduce medical errors when patients are treated by a team of doctors, enhance the seamless and efficient transfer of data to further modernize and harmonize medical systems around the world, and address privacy and security concerns raised by patient advocate groups and consumers.

Functions:

The Section has developed policies to help IT manufacturers assess and manage security risks to medical information systems. MII has also worked closely with member companies to outline a process for the design of secure health care systems.

MII utilizes statistical reporting to collect market and sales data for MII device manufacturers and picture archiving and communication systems (PACS) vendors. This section has developed recommendations for PACS on image viewing, distribution and display quality requirements.

The MII Section also promotes the advancement of the Digital Imaging and Communications in Medicine (DICOM) Standard. DICOM was created as a standards committee in 1983 to develop and maintain international standards of communication for diagnostic and therapeutic devices that use digital imagery. Before the creation of DICOM, medical imaging and radiotherapy equipment operated on different systems with their own terminology, information structures and file encoding systems.

DICOM is administered by MITA and major medical imaging manufacturers around the world incorporate the Standard into their product design. DICOM is a cooperative standard where both professional societies and device makers participate in its enhancement. The Standard is divided into working groups that address specific areas of diagnostic imaging and radiotherapy, for example, WG – 03 covers nuclear medicine.

The demand for MII is growing rapidly, and DICOM continues to develop standards that promote consistency within the marketplace. With medical imaging and PACS technology constantly evolving, the MII Section and DICOM are coming closer to achieving universal harmonization of imaging information across all medical information systems.

MOLECULAR IMAGING SECTION

(MO)

Scope:

The Molecular Imaging Section (MI) represents the interests of companies who produce the equipment and drugs used in molecular imaging procedures. By including manufacturers of both equipment and drugs, companies get a broader picture of the industry and receive additional value for their membership.

Molecular imaging includes manufacturers of equipment, components, accessories and drugs used for molecular in vivo studies and therapeutic treatments. Specifically, this includes scanners, scintillation cameras, diagnostic probe systems, film systems, image processing systems, data processing systems, crystals and radiopharmaceuticals.

The PET Working Group is a newly-formed team that focuses on PET and PET/CT (PET combined with computed tomography). PET and PET/CT are both highly accurate modalities that diagnose and manage heart disease, many cancers and neurological disorders. PET/CT studies offers a high-level combination of physiologic and anatomic detail that is unmatched by other imaging techniques.

Goals:

The goals of the MI Section are to promote international standards and harmonize approval requirements within various markets, improve the regulatory environment for molecular imaging, and move forward policies that encourage growth and innovation within the molecular imaging community.

Functions:

The Pet Working Group works closely with the Food and Drug Administration (FDA) to improve the regulatory environment for molecular imaging. The group utilizes its own Coverage Committee to address both public and private health insurance coverage issues and ensure patient access to molecular imaging equipment; Education Committee to inform referring physicians and policy makers about the value of molecular imaging in appropriate patient populations; and Health Economics Committee to conduct research that broadens the evidentiary base for molecular imaging services.

The MI Section maintains relationships with professional associations to promote the use of International Electrotechnical Commission (IEC) standards. The MI Section routinely updates its own standards with input from product developers and device manufacturers to complement IEC, and keep pace with technological advancement. To comply with industry best practices and remain competitive in the marketplace, the MI Section works with device manufacturers to regularly test their products against performance limits set by MITA and IEC. To ensure repeatability and comparability in these measurement techniques and other parameters of testing molecular imaging devices, the MI Section also provides guidance to industry representatives and the IEC.

RADIATION THERAPY SECTION

(RT)

Scope:

The Radiation Therapy Section includes all equipment, components and accessories used in the planning and execution of radiation therapy. This includes x-ray, ion, electron, proton, neutron, microwave, radio frequency and isotope radiation.

Goals:

The goals of the RT Section are to achieve efficient and reasonable regulation of radiation therapy technologies; improve reimbursement programs; advocate for proposals that encourage innovation, investment in research and development; and promote the global competitiveness of RT products.

Functions:

The RT Section operates with top level management from member companies to discuss relevant issues, and make strategic decisions for RT involvement in MITA’s industry initiatives. The RT Section works closely with the Washington Representatives (WashReps), State and Reimbursement Committees to lobby policymakers and public and private health care insurance providers on behalf of member companies.

The RT Section works directly with the Technical and Regulatory Affairs Committee (TRC) to reach industry consensus on Food and Drug Administration (FDA) regulations that impact manufacturers of radiation therapy equipment. TRC also drafts materials and holds meetings with the Agency to communicate industry concerns over the approval and clearance for radiation therapy technology.

To further improve patient protection, MITA led an industry-wide effort with AdvaMed to develop the RT Readiness Check Initiative. This initiative created additional safety features for radiation therapy devices.  These safety features ensure that treatment plans are delivered as intended, and that patients, equipment and accessories are properly positioned during treatment. The Initiative provides technologists, physicists and physicians additional guidance to make sure treatment procedures are performed correctly. Visit our website to learn more about the RT Readiness Check Initiative.

RT market data is managed by a special NEMA’s Business Information Services (BIS). The RT Section utilizes their expertise to collect, analyze and develop statistical data for member companies. NEMA/BIS distributes actionable market information for device manufacturers to increase the competitiveness of their radiation therapy product lines. NEMA/BIS also works to reduce member susceptibility to economic downturns, and is expanding its scope to include global markets.

ULTRASOUND SECTION

(UD)

Scope:

The Ultrasound Section (UD) includes all ultrasound diagnostic instruments and systems. These products include image, measurement and monitoring systems; and accessories such as transducers, test instruments and displays.

Goals:

The goals of the UD Section are to support policy and regulation that promotes market competitiveness and the continued innovation of ultrasound technology. This includes the expansion of minimally invasive diagnostic procedures and therapies to streamline patient care, further miniaturization of ultrasound equipment to remove barriers to care, and new wireless and lightweight ultrasound systems to increase mobility and make advanced diagnostic procedures more widely available.

Functions:

The UD Section monitors domestic and international regulation that has the potential to impact ultrasound device manufacturers. The UD Section works closely with member companies to develop technical guidance and promote harmonization of safety and performance standards throughout the industry. The Section maintains liaisons with the  National  Council on Radiation  Protection  and  Measurements (NCRP), American  Institute  of  Ultrasound in Medicine (AIUM),  World  Federation  of Ultrasound  in Medicine and  Biology (WFUMB), Electronic Industries Association of Japan (EIAJ),  and the United Kingdom’s National  Physics Laboratory (NPL) to further promote the interests of member companies.

Due to cost pressures in the marketplace, manufacturers compete to provide technologically advanced yet cost-effective devices. To give our members an aggregate picture of this market, the UD Section collects market data and provides statistical analysis to their companies. While the current marketplace for ultrasound devices is highly competitive, the outlook for ultrasound manufacturers continues to grow.

The UD Section will continue to remain actively engaged with MITA committees and industry partners to ensure a united voice for device manufacturers. The UD Section works closely with the MITA Washington Representatives Committee (WashReps) to leverage the position of ultrasound manufacturers. This section is also committed to improving federal reimbursement systems in Congress and will continue to press the Food and Drug Administration (FDA) to reform the 510(k) clearance process for imaging equipment.

X-RAY SECTION

(XR)

Scope:

The scope of the X-Ray Section (XR) includes all equipment, accessories and devices used in the application of x-rays for medical diagnostic, dental, inspection, and nondestructive testing or analysis purposes. These product types include but are not limited to projection radiography, digital radiography (DR), computed radiography (CR), mammography, computed tomography (CT), angiography and fluoroscopy. XR is the most extensive of MITA’s six program sections. To meet the needs of member companies, the XR Section is closely integrated with MITA committees and divided into specific product groups: mammography, CT, interventional, CR-DR; functional committees: standards, regulatory affairs and market data; and task forces.

Goals:

The goals of the XR Section are to create new industry standards that improve the quality and safety of x-ray products, incorporate recommendations from medical professionals, and continue to strive for reductions in ionizing radiation dose to patients.

Functions:

There are three issue specific XR committees that make up the XR Section: the XR Standards Committee develops, manages and reviews NEMA X-ray standards in coordination with device manufacturers; the Regulatory Affairs Committee works to reach industry consensus on Food an Drug Administration (FDA) regulations that specifically impact X-ray products; and the Market Data Committee collects, analyzes and distributes market data to participating companies as an additional benefit of their membership.

The XR Section makes critical decisions and develops industry positions on federal policy and regulations of X-ray products, specifically by the FDA. This effort includes nominating member companies to FDA advisory committees; and building strategic relationships and maintaining close ties with professional societies, regulators, device users, academia and other stakeholders.

Each modality group has taken proactive steps to highlight their industry’s commitment to the highest levels of product safety. As such, member companies continue to monitor new developments, respond to public opinion and changes in regulation, draft industry positions and take proactive steps to improve patient safety. Each group also provides equipment technical expertise to the government, medical professionals and member companies; develops alternative accreditation and quality control standards; as well as user specifications and acceptance testing.

XR groups actively promote industry education initiatives that reduce unnecessary radiation exposure from medical imaging devices such as the Image Wisely and Image Gently campaigns. The CT Group oversees the technical requirements of MITA’s. The Initiative is a radiation dose safety standard that has gained widespread approval in the medical community and national media. Visit our website to learn more about the CT Dose Check Initiative. The CT group is also working with industry, government, and other professional associations to develop CT radiation incident reporting criteria.