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The Association of Electrical Equipment and Medical Imaging Manufacturers n www.nema.org n March 2012 n Vol. 17 No.

MITA Looks Beyond the Machine

to People-focused Medical Imaging

ALSO INSIDE

n Beyond the Imaging SuiteTransforming the Patient Experience n Ensuring Electrical Safety in Healthcare Facilities n Healthcare Market Uncertainties Point to Modest Growth n MITA Reaches Agreement with FDA on Medical Device User Fees n Cybersecurity in the Electrical Industry n MITA Reorganizes Staff to Strengthen Public Policy Expertise

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FEATURES:
As Medical Imaging Services Decline, Patient Care is Threatened ...........................12

Electroindustry News ...................................22 MITA Reorganizes Staff to Strengthen Public Policy Expertise .................................................22 Fish Where the Fish Are ...............................................23 NEMA Releases ROI Document for Smart Grid ...........23 Electrical Safety is Not Optional...................................24 Cybersecurity in the Electrical Industry .......................25 2012 Illuminations Weekend Returns to Sunny Florida ...............................................................25 Code Actions/Standardization Trends ............26 Old Safety Inspectors Dont Retire, They Just Become Enlightened....................................26 Pennsylvania Code Council Recommends Six-Year Code Adoption Cycle ......................................26 NEMA, Industry Secure Needed Changes in California Electrical Code for Nurse Call Systems..........27 Healthcare Facilities Codes Ensure Electrical Safety ....28 Hospital-Grade Wiring Devices Ensure Patient and Staff Safety............................................................28 Changes to Dimensional Requirements and Test Procedures for Paper-Covered Magnet Wire Highlight Next Release of MW 1000 ..................30 International Roundup ................................31 Mexico Energy Efficiency Labeling Law Sticks ............31 Economic Spotlight .....................................IBC Healthcare Market Uncertainties Point to Unsteady, Modest Growth Ahead ...............................................IBC

CONTENTS

How Medical Imaging Helps Patients: Spotlight on Erika Hanson Brown and Suzanne Lindley ..........................................14 A Global Perspective on Medical Imaging ......17 Transforming the Patient Experience ............18 Stewardship Needed the Helium Shortage ...................................20

NOTES:
NEMA Officers ................................................................2 Comments from the C-Suite..........................................2 View from the Top ..........................................................3 View from the Hill ..........................................................4 Policy & Politics ..............................................................6 Learn More ...................................................................32

DEPARTMENTS:
Government Relations Update ........................7 Energy Savings through Innovation and Market Transformation...................................................7 Transportation on the Agenda as NEMA Group Visits Capitol Hill ............................................................8 RoHS Recast Expands Scope to Medical Imaging Sector...............................................................9 Improving the Medical Device Review Process: A Perspective on MDUFA ............................................10 NEMA Advocates for CO Detection in Maryland Schools ........................................................10 NEMA Weighs in on DOE Transmission Proposal.........11 NEMA Carbon Footprint Initiative Approaches Second Phase ...............................................................11

Did you know?


NEMAs Electroindustry Business Confidence Index (EBCI) for current North American conditions can be found at www.nema.org/Feb12-EBCI.

ECO BOX
NEMA electroindustry text and cover pages are printed using SFI certified Anthem paper using soy ink. SFI certified products come from North American forests managed to rigorous environmental standards. SFI standards conserve biodiversity and protect soil and water quality, as well as wildlife habitats. SFI forests are audited by independent experts to ensure proper adherence to the SFI Standard. SFI participants also plant more than 650 million trees each year to keep these forests thriving.

Innovative lighting, a gentle wash of color, and projected images all contribute to a stress-free, patient-oriented environment in medical imaging. See page 18. Photo courtesy of Philips Healthcare

Publisher | Joseph Higbee Managing Editor / Editor in Chief | Pat Walsh Contributing Editors | William E. Green III Chrissy L. Skudera Economic Spotlight | Timothy Gill Standards | Al Scolnik Government Relations Update | Kyle Pitsor Art Director | Jennifer Tillmann Media Sales Team Leader | Stephanie Bunsick

electroindustry

electroindustry (ISSN 1066-2464) is published monthly by NEMA, the Association of Electrical Equipment and Medical Imaging Manufacturers, 1300 N. 17th Street, Suite 1752, Rosslyn, VA 22209; 703.841.3200. FAX: 703.841.5900. Periodicals postage paid at Rosslyn, VA, and York, PA, and additional mailing offices. POSTMASTER: Send address changes to NEMA, 1300 N. 17th Street, Suite 1752, Rosslyn, VA 22209. The opinions or views expressed in electroindustry do not necessarily reflect the positions of NEMA or any of its subdivisions. Follow NEMA: www.nema.org/facebook, blog.nema.org, podcast.nema.org, twitter.com/NEMAupdates, www.youtube.com/NEMAvue, www.nema.org/linkedin

Officers
Chairman Dominic J. Pileggi Chairman of the Board & CEO Thomas & Betts Corporation First Vice Chairman John Selldorff President & CEO Legrand North America Second Vice Chairman Christopher Curtis President & CEO Schneider Electric Treasurer Thomas Gross Vice Chairman & COO Eaton Corporation Immediate Past Chairman David J. FitzGibbon Vice Chairman & CEO ILSCO Corporation President & CEO Evan R. Gaddis Secretary Clark R. Silcox

COMMENTS FROM THE C-SUITE


According to the New England Journal of Medicine, medical imaging is one of the top advances that changed the face of clinical medicine during the last millennium. Today, imaging and radiation therapy are cornerstones of quality care. The Medical Imaging & Technology Alliance (MITA), a division of NEMA, is the leading organization and collective voice of medical imaging equipment manufacturers, innovators, and product developers. It represents companies whose sales comprise more than 90 percent of the global market for medical imaging technology. The electrical equipment and medical imaging manufacturing industries are a great example of products and systems that have far-reaching benefits for millions of individuals. I hope you enjoy this edition of electroindustry. It offers insights into advancements in medical imaging technology and descriptions of awe-inspiring human outcomes. Heres to progress!
ei

Dominic J. Pileggi Chairman

NEMA Board of Governors is accepting nominations for the 2012-2013 term. Consideration will begin in March. Contact NEMA President and CEO Evan R. Gaddis with nominations via Karen.Sterba-Miller@nema.org

NEMA electroindustry

March 2012

View from the Top


New Horizons for Medical Imaging
Medical errors are a major challenge. Worse, they are not a new problem. In fact, evidence of medical errors date back to the Stone Age. There is evidence of botched brain surgery being performed as far back as 5,000 BC. Over the past decade, however, a patient safety movement has driven greater awareness of medical errors and their costly impact. Several alarming stories from amputations of the wrong limb to wrong-site surgerieshave given rise to an impressive mobilization of patient safety advocates. In 2000, the Institute of Medicine validated advocates cause with a report confirming that more people die each year from medical errors (44,000 90,000) than from breast cancer (42,000). Medicine has been working to overcome these errors. While solutions have focused on the reduction of medication errors and improvement of systems to prevent incorrect surgery, we are now realizing that many members of the medical community have failed to recognize that diagnostic errors are just as important a problem. In 2009, the Journal of the American Medical Association published a study that highlights diagnostic errors as the next frontier for patient safety. The study noted that an estimated 40,000 to 80,000 U.S. hospital deaths result from misdiagnosis each year, while approximately five percent of autopsies reveal lethal diagnostic errors. To put this in context, physician errors are much more likely to be diagnostic(fourteen percent) than medicationrelated (nine percent). Additionally, malpractice claims for misdiagnosis Based on a speech delivered November 28, 2011, at the Radiological Society of North America by Greg Sorensen, MD, Chief Executive Officer of Siemens Healthcare North America and Chair of the MITA Board of Directors. are twice as common as those for medication errors and they result in the largest payouts. Deaths and disease from medical errors represent a concerning trend, suggesting those who perform diagnostic tests and those who use diagnostic tests need to chart a new course of strategic thinking that promotes both innovation and the value of these diagnostic methods. Quantifying the Value of Diagnosis Specifically, we need to focus on quantifying the value of accurate and timely diagnosis. This will, in turn, facilitate the safe and appropriate use of these lifesaving medical imaging technologies. We also need to continue to advocate for a clear and timely pathway to market for our new innovations and preserve patient access to an accurate diagnosis, such as through imaging services, by fighting against additional Medicare reimbursement cuts. These efforts will ensure that our industry can continue to add value in addressing the important issue of diagnostic medical errors.

CT Dose Check Initiative


As part of its ongoing commitment to ensuring safe, appropriate, and effective medical imaging and radiation therapy, MITA supports the following principles to reduce exposure to unnecessary radiation: Expand and integrate appropriateness criteria into physician decision-making. Create a national dosage registry to ensure longitudinal tracking of dose levels for patients. Adopt a standardized method of storing diagnostic imaging and radiation therapy information within electronic health records. Explore the expansion of mandatory accreditation for advanced imaging facilities. Establish minimum standards for training and education for hospital and imaging facility personnel who perform medical imaging exams and deliver radiation therapy treatments. Develop enhanced operational safety procedures and checklists to reduce medical errors. Expand and standardize the reporting of medical errors associated with medical radiation across stakeholders in a manner that is transparent for patients, families, and physicians.

Those who perform diagnostic tests and those who use diagnostic tests need to chart a new course of strategic thinking that promotes both innovation and the value of these diagnostic methods.
Imaging manufacturers ability to innovate isnt only driving down diagnostic errors. Were also unlocking the ability to diagnose diseases and disentangle complex medical problems that have long been challenging.

NEMA electroindustry

March 2012

View from the Top


Learn more about MITA at www.medicalimaging.org
Brain imagers have made great strides these past few decades as the tools of advanced imaging have brought on not just pictures but mathematical tools. Specialists are now able to analyze the brain in ways we could never before using mathematical models and representations to understand imaging data that go far beyond visual and move to quantitative interpretation. Technologies like hybrid modalities that simultaneously acquire both magnetic resonance (MR) and positron emission tomography (PET) scans have the potential to transform diagnosis by enabling combinations of information that unlock exciting insights. We are now beginning to investigate diseases at a much deeper level than ever before possible. Diagraming the human Brain For example, there is a substantial level of interest in Alzheimersinterest that has been enabled and accelerated by technological developments that help to understand the disease. Radiologists and other imaging specialists are working to build the tools that will let us see into the brain using sophisticated and impressive machines that go beyond where we have ever gone before. This exemplifies tremendous potentialwe are now beginning to identify the wiring diagram of the living human brain, offering a level of insight that we cant get any other way. MITA member companies are wellpositioned to continue on the pathway of innovation and develop improved technologies that can facilitate earlier and more precise detection. Importantly, our imaging innovations can and must help better prevent misdiagnosis and play a critical role in taking on this new frontier in patient safety. It is such an exciting time to be in medical imaging, and its not just me who thinks so. In a now-classic survey, when physicians were asked to identify the most important innovations they have encountered in the past decades, at the very top of list was cross-sectional imagingthe very things developed by MITA companiesranking higher than even therapeutic innovations. These results speak to the vibrancy and relevance of radiology. ei

View from the Hill


Sunshine Act Strengthening Doctor-Patient Relationships through Disclosure
Sen. Herb Kohl Later this year, companies that manufacture drugs, biologics, and medical devices will be required to report information on payments given to doctors under the bipartisan Physician Payments Sunshine Act (Sunshine Act), which was signed into law as part of the Patient Protection and Affordable Care Act. And, next year, the information that is collected about these payments will start being made available to the public online. The Sunshine Act, which was developed along with my colleague Senator Chuck Grassley (R-Iowa), will provide accountability, openness, and transparency to the financial ties between doctors and the drug and device industries. While these relationships can be important in developing new therapies and diffusing new technologies, it is essential that these ties do not lead to conflicts of interest that impact patient care. Many states already require this type of reporting, and we have seen that disclosure has helped to curb inappropriate payments. Specifically, the Sunshine Act will improve the publics understanding of how companies interact with physicians by providing not only the amounts that are paid, but also the context in which these payments are given. Americans will be able to search for their own doctors and see what types of payments and gifts were given and why. The Sunshine Act is a reflection of recommendations of major medical, consumer, and industry groups, as well as the Medicare Payment Advisory Commission and the Institute of Medicine. The policy has been supported by a diverse group of stakeholders, including consumer and patient groups, professional medical associations, provider organizations, and industry. As we developed the final bill, we worked hard to address the legitimate concerns of industry, consumer groups, and other stakeholders. More recently, we pushed

NEMA electroindustry

March 2012

the Department of Health and Human Services (HHS) to issue timely draft guidance about how the information will be collected and categorized. Senator Grassley and I will continue to press HHS to consult with industry, consumer groups, and other stakeholders in developing these rules, particularly with regard to categorizing these often complex relationships and providing

adequate context to consumers about how the data should be interpreted. We will also continue to push to ensure that impacted industries receive adequate time for implementation. We realize that many companies have already made significant investments in developing systems and protocols to comply and may need time to modify these systems based on the final rule.

As we move forward, I believe that the Sunshine Act will help keep healthcare costs down and strengthen patient-doctor relationships. I look forward to continuing to work with industry, consumer representatives, and HHS to ensure timely and effective implementation. ei Senator Kohl (D-Wisc.) is chairman of the Senate Special Committee on Aging.

Imaging Technology Sparks Economic Engines


Sen. John Kerry In just the last few decades, weve witnessed staggering advances in medical imaging technologyand an inspiring story of American innovation and hard work. From CT and ultrasound to MRI and PET, imaging technology has not only made exploratory surgery nearly obsoleteits become a sparkplug in the economy of communities across the country, particularly in my home state of Massachusetts. Medical imaging has created and sustained more than 10,000 jobs in Massachusetts, from the innovators who build cutting-edge machines to the suppliers that provide component parts to the hospital employees that use them to benefit patients. This economic dynamism is one of the reasons I worked in the Senate Finance Committee last year to prevent a $400 million reduction in Medicare payments for medical imaging. In tough economic times, when budget dollars are strained, its a daily struggle to find ways to pay for the investments we must make. In this case, the cut to medical imaging was proposed to pay for the Trade Adjustment Assistance (TAA) Extension Act of 2011, a do or die investment for struggling workers. But simply putwhether from a patient, provider, or economic standpointwe just couldnt afford to make medical imaging the piggybank to pay for TAA when there were other options available. The economic impact of cutting medical imaging would have been problematic. Lowering Medicare reimbursement for medical imaging encourages doctors to keep old equipment longer, resulting in fewer patients getting access to the newest technologies that are better able to find early-stage diseases. The proposed cuts also would have resulted in job losses for Massachusetts workers and hurt too many physicians, patients, and manufacturers. There was a better way forwardand together we found it. The outlook for medical imaging remains precarious. There have already been six imaging reimbursement cuts in the last seven years, and recent studies indicate they have taken a measurable toll. For example, the use of imaging services declined by 2.5 percent in 2010, according to the Medicare Payment Advisory Commission (MedPAC), the independent congressional advisory agency. Similarly, the most recent research by the Medical Imaging & Technology Alliance (MITA) shows that imaging utilization per Medicare beneficiary declined by three percent in 2010. Moreover, in contrast to the decline in imaging, spending for nonimaging Medicare services has grown by 20 percent since 2006 and non-imaging utilization increased 2 percent in 2010. In fact, the MITA analysis found that imaging is now a smaller portion of Medicare spending than it was at the turn of the century. Clearly, imaging Medicare reimbursements are still threatened. We need to make our casepowerfully. Thats why, last July, I organized a group of bipartisan senators to urge the president to reject deeper cuts in spending for these vital services. We asked the president to work with us on reforms that ensure each patient who needs imaging gets it. We are still working on a sustainable solution, and thats why now, more than ever, its vital that the imaging community continues to work with members of Congresson both sides of the aisle and in both chambersto raise awareness about how imaging saves lives, reduces healthcare costs, and creates jobs. Lets get to work now not only to preserve these important reimbursements and to ensure patient access to important care, but also to encourage the kind of innovation that creates jobs, strengthens the economy, and continues to write the American success story of medical imaging. ei Senator Kerry (D-Mass.) is the chairman of the Foreign Relations Committee.
NEMA electroindustry

March 2012

Policy & Politics


Federal Budget: And Now It Begins
Kyle Pitsor, NEMA Vice President of Government Relations In presenting his 2013 budget, President Obama carried through on initiatives and policies he outlined in his 2012 State of the Union address. In an election year, the presidents proposal is politically significant as it lays out policies and initiatives that will shape the campaign season while offering a template for funding levels. In terms of policy impact, the proposal has no chance of passing Congress. Over the coming weeks, various budget hearings will be held and beginning in May, appropriations work will commence aimed at crafting 12 bills for funding the functions of government. Looming in the background to the appropriations work is the fact that the 2011 Budget Control Act mandates $1.2 trillion in cuts (half from defense). Whether Congress completes appropriations work for fiscal 2013 or ends up passing another continuing resolution (CR) remains to be seen. Given the election year, another CR is likely, which means the time between Election Day and New Years Day will see significant legislative intensity. NEMAs advocacy focus is on funding support for key industry priorities and policies that foster economic growth, job creation, and competitiveness. These include research and development, innovation, advanced manufacturing, energy efficiency, technology deployment, exports, and trade enforcement. NEMA will also continue to oppose repeal of LIFO (last-in, first-out) inventory and accounting as a revenue raiser. We will also oppose proposals in the budget that would harm patient access to medical imaging and advanced technologies. ei

BILL NAME Smart Energy Act HR 4017

SUMMARY OF BILL AND IMPORTANCE Establishes a federal loan program for energy- efficiency upgrades in commercial, multifamily residential, industrial, municipal, government, school, and hospital buildings. It also enables the federal government to use energy savings performance contracts in support of its deployment of electric vehicles or electric vehicle supply equipment. The legislation would also require that federal agencies participate in demand response programs, where available, to reduce agencies energy costs. It would also require an analysis of best practices in federal buildings for the advanced metering of energy use, including recommendations on standard requirements or guidelines for automated energy management systems. Establishes investment tax credits for a broad array of energy storage technologies that are connected to the grid (20% credit) or used on-site at industrial, commercial, or residential locations (30% credit).

NEMA POSITION Support: Promotes energy efficiency and greater adoption of energy efficient technologies in buildings.

STATUS Introduced 2/14/12. Next Step: House Energy & Commerce Committee hearing

Storage Technology for Renewable and Green Energy (STORAGE) Act, S 1845 Energy Savings and Industrial Competitiveness Act S 1000 Regulatory Accountability Act HR 3010, S 1606

Support: Accelerates adoption of energy saving technologies

Introduced in Senate Next Step: Senate Committee on Finance

Creates federal-state loan programs for commercial building and industrial facility energy efficiency upgrades that the market is not currently encouraging. Incents states to adopt national building energy codes developed by ASHRAE or ICC. The bill modernizes and updates the 1946 Administrative Procedures Act (APA) for economically significant regulations. Provisions would enhance public participation in rulemakings; require agencies to choose the lowest cost option or explain compelling need otherwise; on-the-record administrative hearings with agency officials; include direct and indirect cumulative costs, benefits, and estimated impact on jobs, growth, innovation, and competitiveness; consider reasonable alternatives including no federal response.

Support with modification: Promotes energy efficiency, supports manufacturing jobs, and increases U.S. competitiveness. Modification to building code provisions pending. Support: Incorporates established cost/benefit principles in considering rulemaking, makes the process more transparent, agencies more accountable, and overhaul out-moded APA.

Voted out of Senate Energy and Natural Resources Committee 7/14/2011 Next Step: Senate Floor Approved by House 253-167 12/2/2011 Next Step: Senate consideration

High Performance The bill promotes energy efficiency and high performance in federal buildings through the Federal Buldings Act use of an integrated and holistic approach to building design, construction, operations, and maintenance including use of building information modeling (BIM), lifecycle costing, HR 3371 commissioning, and compliace verification. Critical Materials Policy Act, S 1113 Directs Department of the Interior to prioritize minerals, including rare earths, based on importance to the U.S. economy and outlines a set of policies to bolster domestic production of these minerals, expand manufacturing, promote recycling and alternatives, and maintain strong environmental protections.

Support: Promotes energy efficiency in federal buildings and greater adoption on energy efficient technolgies in these buildings. Support: Leverages work already done at Interior and Energy deparmtents and brings greater urgency and coordination at the federal level necessary to create opportunities for U.S. manufacturers.

Introduced 11/4/2011 and referred to House Transportation and Infrastructure Committee Next Step: House committee hearing Senate Energy and Natural Resources Subcommittee hearing held 6/9/2011 Next Action: Senate committee consideration

NEMA electroindustry

March 2012

Government Relations Update


Energy Savings through Innovation and Market Transformation
The lighting industry has long been a fountainhead of research and innovation in response to the quest for brighter, cheaper, more efficient, and more effective lighting components and systems. Because lighting is an immediately visible subject, its performance and application merits are very quick to be gauged. However, lighting energy consumption metrics and proof of effective operation, while easy to see at the home or commercial level, are harder to quantify over a larger scale. National energy use for lighting is a diverse topic with many different solutions and installations. Recently, the Department of Energy (DOE) released two reports on lighting energy consumption and predictions for the future of lighting in the U.S. lighting-relateD energy usage DOEs 2010 U.S. Lighting Market Characterization1 (LMC) was released January 23, 2012. It follows up and builds on the 2001 LMC2. NEMA and its Lighting Systems Division members have been poring through it and the 2001 version to perform a tailored analysis. The following items were noted: In 2001, lighting accounted for approximately 765 terawatt-hours (TWh) of electricity consumption, equal to 22 percent of total U.S. electricity consumption. In 2010, lighting accounted for approximately 700 TWh of electricity consumption, or 19 percent of total U.S. electricity consumption. In 2001, there were approximately 6,977 million permanent lamps in the U.S. In 2010, there were approximately 8,203 million permanent lamps in the U.S. This means that lighting consumption went down by 65 TWh while the number of lamps went up by more than one billion (an increase of about 15 percent). Residential settings still maintain the highest percentage of incandescent lamps at a near identical level62 percent in 2010 versus 63 percent in 2001. In 2010, compact fluorescent lights (CFLs) comprised 23 percent of residential lamps, and linear fluorescent another 10 percent. Though most houses have one or more CFLs, there is still twice the number of incandescent lamps in residences compared to CFLs, meaning there is still much energy savings to be realized. If the lighting energy consumption in 2001 had not been affected by new, efficient products, consumption in 2010 should have been around 880 TWh, not 700 TWh. But something happened energy consumption over that decade went down, despite a 15 percent increase in potential demand. What caused it? The lighting industry is one of constant innovation and improvement. New products are increasingly more energy efficient. Federal, state, local, and industrysponsored outreach and education were effective in encouraging new products. Industry innovation enabled the implementation of new and efficient products and in doing so, transformed the nations energy consumption habits. Between 2001 and 2010, the only significant federal regulation that could have affected the energy consumption of lighting products was the 2005 Energy Policy Act (EPAct). The lighting products most affected by EPAct are CFLs, which according to the 2010 LMC are still making inroads and therefore could not be responsible for the huge energy savings noted. What Does the future holD? The second report by DOE regarding energy efficiency in lighting application is the Energy Savings Potential of SolidState Lighting3 (SSL), released January 27, 2012. In it, DOE claims that LEDs (light emitting diodes) in general illumination applications has the potential to reduce U.S. lighting energy consumption by nearly one-half. LED lighting is expected to represent 36 percent of lumen-hour sales on the general illumination market by 2020, and 74 percent by 2030. By 2030, the annual site energy savings from market penetration of LEDs will be approximately 300TWh, or the equivalent annual output of about 50 1,000-megawatt power plants. The total energy consumption for lighting would decrease by roughly 46 percent relative to a scenario with no additional LEDs on the market enough electricity to completely power nearly 24 million homes. These are impressive claims and will be the subject of much consideration going forward. Will energy consumption for SSL become as regulated as most of the preceding lighting technologies? Regulations passed too early in a technologys development and discovery lifetime can easily hinder innovation and progress, despite all good intentions. With this in mind, SSL regulations are regarded as premature at this time. SSL is also the first lighting innovation of the global age, and as such, collaboration is occurring at the highest levels of scientific and governmental oversight. As SSL reaches maturity, it will be interesting to see how codes and regulations adapt to this innovative product field. Alex Boesenberg, Regulatory Affairs Manager | alex.boesenberg@nema.org
1

http://apps1.eere.energy.gov/buildings/publications/pdfs/ssl/2010lmc-final-jan-2012.pdf Executive Summary: http://apps1.eere.energy.gov/buildings/ publications/pdfs/ssl/2010-lmc-summary-jan-2012.pdf http://apps1.eere.energy.gov/buildings/publications/pdfs/ssl/ lmc_vol1_final.pdf http://www1.eere.energy.gov/buildings/ssl/tech_reports.html

NEMA electroindustry

March 2012

Government Relations Update


Transportation on the Agenda as NEMA Group Visits Capitol Hill
A delegation of NEMAs Transportation Management Section visited Capitol Hill on January 26 as the House of Representatives prepared to consider multi-billion-dollar legislation to support roads, bridges, highways, and transit infrastructure. The group, led by Section Chairman Bryan Mulligan of Applied Information, visited six offices in the House and Senate to discuss prospects for a multi-year bill to reauthorize federal surface transportation programs and to emphasize the importance of ITS technology and standards to the future of our countrys transportation networks. The Senate is preparing its own two-year version of the legislation and at the time of the NEMA meetings, two major pieces of the package had been put forward by the Committee on Environment and Public Works (EPW) and the Committee on Commerce, Science, and Transportation (CST). In a meeting with Democrat and Republican staff of the EPW committee, NEMA welcomed that committees support for the deployment of ITS in federally funded road projects but offered recommendations for further improvements. The NEMA group also met with staff for Sen. Pat Toomey (R-PA), a member of the CST committee, and Sen. Tom Carper (D-DE), a member of the EPW committee, to seek their support. Shortly after the NEMA groups visits, the House Committee on Transportation and Infrastructure (T&I) was scheduled to consider a bill authorizing five years of transportation infrastructure activities. NEMA met with the offices of Rep. Bill Shuster (R-PA), a senior member of the T&I committee; Rep. Rob Woodall (RGA), a freshman member serving on the House Rules Committee; and Rep. Brian Bilbray (R-CA), a member of the Energy and Commerce Committee whose

Members of the NEMA Transportation Section pause between meetings on Capitol Hill, January 26: (l-r) Bill Klyczek, Traficon USA; Russ Brookshire, Intelligent Devices; Kleinjan Deetlefs, McCain; Section Chairman Bryan Mulligan, Applied Information; Robert Rausch, Transcore ITS; Bill Russell, Eberle Design; Ray Deer, Peek Traffic; John Miller, NEMA Industry Director; and Jean Johnson, NEMA Technical Services. Photo by Craig Updyke

district was affected by the September 89, 2011 blackout. In each meeting, NEMA promoted open national consensus standards, institution of performance measurement and metrics for the transportation network, and the application of ITS technologies on all high-traffic roadways to reduce congestion, vehicle emissions, safety risks, and associated costs. NEMA also recommended both houses approve and send to the president a fiveor six-year bill that would achieve greater stability and predictability and enable longer-term planning and investments. Four member companies of the NEMA Transportation Section have operations in Rep. Woodalls Atlanta-area district. Three individual members of the group

also held one-on-one meetings with offices of their local laegislators. The meetings marked the consecutive third year that the Transportation Section has held annual outreach meetings with federal decision makers in Washington with assistance from NEMAs Government Relations Department. ei Craig Updyke, Manager, Trade and Commercial Affairs | cra_updyke@nema.org

Learn more NEMAs Transportation Management Systems and Associated Control Devices Section at www.nema.org/prod/elec/trans

NEMA electroindustry

March 2012

RoHS Recast Expands Scope to Medical Imaging Sector


Over the past decade, regulations spawned by the European Union (EU) have had a dramatic, worldwide impact on product design and marketing within the electrical and electronic manufacturing sectors. The principal driver of this new regulatory paradigm of course has been Directive 2002/95/EC on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipmentaka the RoHS Directive. When promulgated in January 2003, the RoHS Directive applied to eight designated product categories drawn from the scope of Directive 2002/96/EC, the so-called WEEE Directive, which established a regulatory structure for the EU governing how electro-products are managed at end-of-life. Noticeably excluded from the scope of RoHS were medical devices, meaning that MITA members and other global manufacturers of diagnostic imaging technology were not subject to the strict hazardous substance thresholds that the directive imposed on much of the rest of the electrical product industry. These thresholds, which apply to mercury, lead, cadmium, chromium, and certain brominated flame retardants, have led to burdensome compliance costs across many product sectors. A 2008 study conducted by the European Commission estimated past costs of complying with RoHS, including R&D and capital costs, as averaging 1.9 percent of annual revenues or 3,185 ($4,240) per employee per year. Costs for small and medium enterprises were considerably higher at 5.2 percent. The same study pegged future ongoing compliance costs as 0.4 percent of annual revenues or 273 ($363) per employee per year, with costs to small and medium enterprises again being much higher1. The exemption for medical devices from these thresholds was always known to be temporary, however, and the recently enacted RoHS Recast Directive (2011/65/ EU), which updates and amends the original RoHS framework, lays out a schedule for bringing medical imaging devices into compliance (Note: the exclusion will remain in place for all implants and infected products). This is no surprise to the imaging industry, which advised EU authorities for years in their effort to craft a timeline that accords with the directives priorities of environmental protection while granting manufacturers the flexibility needed to avoid any compromise in the lifesaving benefits of imaging technology. The industrys position was validated in the EUs own study of the issue, which concluded in 2006 that: The date for inclusion of [medical devices] in the scope of RoHS will need to take into account the specific characteristics and requirements of [diagnostic imaging] equipment. One essential characteristicis high reliability. This could be affected detrimentally if these Categories were to be included in the scope of RoHS at too early a date. In addition, sufficient time is required for testing, validation, trials and obtaining approvals.2 On the basis of extensive consultations in the wake of this study, the recast stipulated that medical devices must come into compliance with the substance thresholds by July 22, 2014, which amounts to an eight-year extension of the compliance date established under the original directive. In-vitro diagnostic medical devices, meanwhile, are granted an extra two years and will not be subject to these thresholds until July 22, 2016. In addition, the RoHS Recast features a modified schedule of exempted applications of the six hazardous substances in covered products. A portion of this schedule applies specifically to medical imaging devices and encompasses applications that must be maintained to ensure patient safety and operational effectiveness (e.g., lead in shielding for ionizing radiation). Industry stakeholders worked diligently with EU authorities to define critical exemptions that manufacturers need to transition smoothly into compliance. Substance thresholds are only part of the story with the recast, however, as RoHS is now a CE mark directive. Manufacturers of covered products must now construct a self-declaration of conformity, maintain technical documentation, cite relevant harmonized standards, implement internal production controls, and keep a register of nonconforming products. The CE mark is well known to manufacturers as a part of doing business in the European Union, but its applicability to the RoHS Directive promises to greatly expand the cost and complexity of compliance. MITA members, like all sectors within NEMA, believe that environmentally conscious design of electrical products is fundamentally appropriate and, to the extent feasible, should include limiting the use of hazardous substances. But this goal cannot take precedence over the safety, performance, and reliability of imaging systems. The industrys diligent effort to ensure a graduated schedule for coming into compliance under RoHS reflects this value. ei Mark A. Kohorst, Senior Manager of Environment, Health, & Safety | mark.kohorst@nema.org

Study on RoHS and WEEE Directives N 30-CE-0095296/0009, Final report, European Commission, DG Enterprise and Industry, March 2008 Dr. Paul Goodman, Directive 2002/95/EC (RoHS) Categories 8 and 9Final Report, ERA Technology, ENV.G.4/ ETU/2005/0014, Exec Summary, 2006

NEMA electroindustry

March 2012

Government Relations Update


Improving the Medical Device Review Process: A Perspective on MDUFA
For the past decade, inefficiencies associated with the Food and Drug Administrations (FDA) medical device review process have contributed to significant delays in bringing innovative imaging technologies to market. The prevailing obstacle has been identifying solutions that quicken the review process while still maintaining patient safety and, at what cost to companies. As with many bureaucratic processes, the stickier the red tape, the greater the impact of costly delays. Not only has the lengthy and unpredictable medical device review process effectively restricted patient access to lifesaving technologies, but slow approval times also have dissuaded external parties from investing in medical devices. Fortunately, FDA announced last month that it had reached an agreement with the industryrepresented by MITA and two other industry associationsto reauthorize the medical device user fee program. Though the details of the program extension are still to be finalized by Congress, the agreement sets forth very promising provisions regarding timetables for clearance, with the overall aim to correct lagging review times and improve patient access to new diagnostics and therapies. The five-year user fee agreement includes, for the first time, new goals for total review time for premarket reviews. Reconciling FDA and industry interests, the agreement aims to reform both the pre-submission interaction and guidance development processes by establishing mechanisms for earlier, more effective communications between manufacturers and FDA. In exchange for more than doubling the funding from device companies, FDA agreed to reduce the time between the submission of an initial review application and the final decision. If clearance submissions run up against pre-established deadlines, FDA will be required to meet with companies to explain and address the underlying reasons for the delay. In the name of increased transparency, FDA will also be required to provide frequent progress reports regarding review time goals. Moreover, in an effort to increase program capacity, FDA will hire more than 200 full-time employees, including 140 new device reviewers. To further promote transparency, the new agreement requires a third-party audit of how FDA manages the premarket review program to identify ways the agency can become more effective and efficient. Taken together, these program improvements will create a more predictable and productive review process, ensuring that patients have access to safe and effective medical imaging and radiation therapy technologies. Greater predictability and consistency in the approval process will not only correspond to enhanced product safety and effectiveness, but will help shrink the gap that currently prevents innovative technologies from reaching the market in a timely manner. Though the compromise entails higher costs to be incurred by medical device manufacturers, the new user fee agreement illustrates a true commitment by FDA and industry to provide patients with the safest and most advanced technologies available. In a time of tremendous innovations in imaging and radiation therapy technologies, we must prioritize patient access and safety. This long-awaited agreement reached by FDA and industry will enable the industry to bring innovative, lifesaving technologies to market faster than ever before, so that patients across the U.S. receive the care they need. ei Lindsay Morris, Senior Director, MITA | lmorris@medicalimaging.org ei

NEMA Advocates for CO Detection in Maryland Schools


At the beginning of the 2012 legislative session, Maryland Delegate Cheryl Glenn (D) introduced HB 2, legislation to require the installation of carbon monoxide (CO) detection and warning equipment in Marylands public schools. A Senate companion bill, SB 173, has been introduced by Senator Kathy Klausmeier (D). A hearing on HB 2 was scheduled for February 2, 2012. NEMA actively supports enactment of this legislation and has engaged a lobbyist to advocate before the Maryland General Assembly on its behalf. Partnering with life safety advocates, non-industry partners, and the Maryland State Fire Marshal, NEMA is working to ensure that students, faculty, and school support personnel are not subject to CO dangers when at school. If Maryland enacts this legislation, it will be the second state to require CO detection in schools. The State of Connecticut enacted a similar law in 2011, largely due to NEMAs successful advocacy in the state. Expansion of CO detection requirements to public schools builds on the successful enactment of state laws and codes requiring installation of CO detection in various residential and commercial occupancies. To date, over three dozen states have enacted such requirements. A map of these state requirements is available at www.lifesafetysolutionsonline.com. ei Sarah Owen, Government Relations Manager | sarah.owen@nema.org

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NEMA Weighs in on DOE Transmission Proposal


On January 27, NEMA filed comments with the Department of Energy (DOE) in response to its proposal (Coordination of Federal Authorization for Electric Transmission Facilities, RIN 1901-AB18) to streamline the way in which federal agencies carry out their responsibilities to review and make permitting decisions on certain transmission projects. NEMA shared with DOE its view that the proposal makes some progress in better coordinating the administrative process that plagues transmission projects, but that true reform would include expediting environmental reviews and establishing additional and tighter deadlines for federal agencies to meet in completing various components of their project evaluations. The DOE proposal would automatically put in place federal coordination for projects that are 230kV and above, built for the transmission and sale of wholesale electricity in interstate commerce, and at least in part cross the jurisdiction of more than one federal agency. Other projects that do not meet these criteria may voluntarily apply for federal coordination. DOE would coordinate the selection of a lead agency, defined as the one most impacted by the transmission project. The lead agency is then responsible for preparing a unified environmental review document under the National Environmental Policy Act and maintaining a consolidated administrative record. The proposed rule sets some basic permit decision deadlines to reduce delays after environmental reviews are completed. For projects that receive a categorical exclusion or environmental assessment that results in a Finding of No Significant Impact (FONSI), federal permit decisions must be made within one year of the exclusion determination or publication of the FONSI. For projects that require an Environmental Impact Statement (EIS), federal agencies have to make their decisions within one year and thirty days after the close of the public comment period for a draft EIS. The lead agency would also collaborate with DOE to populate a website that displays pertinent information for qualifying projects so stakeholders and the public can be better informed. The sheer number of parties that are required to review and sign off on transmission projects is a big reason that the permitting process is unable to keep up with the need to rapidly modernize the electric grid. The nine agencies affected by this proposed rule are the Departments of Agriculture, Commerce, Defense, Energy, and Interior; the Federal Energy Regulatory Commission; the Environmental Protection Agency; the Council on Environmental Quality; and the Advisory Council on Historic Preservation. Improving coordination among these agencies is a first step to simplifying the interaction between transmission developers and the federal government.

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Jim Creevy, Director of Government Relations | jim.creevy@nema.org

NEMA Carbon Footprint Initiative Approaches Second Phase


The NEMA strategic initiative designed to help member companies assess the carbon footprint of electrical products is poised to move beyond the early stages of crafting the methodology and testing it on selected focal products. As expected, the initial trial run evaluations generated insights to factors that drive the carbon impacts of products under evaluationenergy efficient lamps and ac induction motors. NEMAs intent is to provide a tool specifically for the electro-product sector that helps expose the links between materials and processes used to create products, and greenhouse gas emissions. These are measured in kilograms of carbon dioxide equivalents. The methodology accounts for all phases of product life (resource extraction and acquisition, manufacturing, transport to market, use, and disposal/recovery). Knowledge of how the carbon is distributed across the lifetime of a product can help inform design strategies and enable companies to respond to regulatory and market pressures. More importantly, it tells manufacturers concerned with reducing their carbon footprint where to direct their resources and how much of an impact those investments are likely to have. Last year, the NEMA Board of Governors approved a second year of funding for the Carbon Footprint Initiative. Staff is working with expert contractors at MITs Materials System Lab to extend the project plan. One of the key tasks involves selecting additional focal products for evaluation that are more complex in terms of design, production, or operation than lamps and motors. This is a crucial step in ensuring that the methodology ultimately produced through this initiative is as broadly applicable as possible within the NEMA product scope. To participate in a technical advisory group, contact Mark Kohorst. ei Mark A. Kohorst, Senior Manager of Environment, Health, & Safety | mark.kohorst@nema.org
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As Medical Imaging Services Decline, Patient Care is Threatened


lindsay morris, senior Director, medical imaging and technology alliance

n an era of boundless innovation, the medical imaging industry remains at the forefront. New improvements to medical imaging technology have rendered invasive, diagnostic surgery virtually obsolete. These advancements not only reduce the need for potentially dangerous surgical procedures, they also prevent devastating injuries and improve quality of life during treatment.

imaging-specific reimbursement cuts from the Deficit Reduction Act took effect, and imaging utilization per-beneficiary declined by 3 percent in 2010. Moreover, the report found that imaging currently represents a smaller portion of Medicare spending than it did in 2000. MITAs analysis also found that spending for non-imaging Medicare services grew by 20 percent since 2006 and non-imaging utilization increased 2 percent in 2010. MedPACs conclusions are not the only independent confirmation of MITAs findings that Medicare imaging use and spending are down. On the heels of MITAs report, researchers at Thomas Jefferson Medical University in Philadelphia released a similar study examining how advanced imaging modalitiessuch as computed tomography (CT), positron emission tomography (PET), and MRI scanshave been used in recent years. Their findings show that from 2007 through 2009, there were significant reductions in the growth of CT and MRI. Furthermore, the rate of nuclear medicine utilization actually decreased.

One area in which we have seen such innovation is magnetic resonance imaging (MRI). Recently, researchers at Massachusetts General Hospital and the University of Pennsylvania were able to utilize MRI scans to pinpoint patient risk for Alzheimers disease before symptoms were noticeable. Through earlier detection, physicians are able to treat Alzheimers at earlier stages than has ever been possible. Despite such innovations, several independent analyses of Medicare claims data in 2011 reveal an alarming downward trend in the utilization of these imaging services. Not only is spending on medical imaging declining, Medicare patients are actually receiving fewer imaging procedures, which debunks the widely proliferated myth that lifesaving diagnostic imaging and radiation therapy are being overused and increasing the cost of healthcare. Notably, during a public meeting in December 2011, the Medicare Payment Advisory Commission (MedPAC) reported that imaging services declined by 2.5 percent in 2010. This confirmed MITAs own analysis of Medicare claims data commissioned earlier that year. Our analysis revealed that per-beneficiary spending on imaging services had dropped 13.2 percent since 2006, when significant

MITA is committed to working with stakeholders in order to encourage the proper use of imaging devices, and to ensure that patients have access to the right scan at the right time.

Benefits of Medical Imaging Far Outweigh Risks


In spite of a clear downward trend in utilization, the value of advanced medical imagingto both patients and physicians is on the rise. In late 2011, CT-based lung cancer screening was named one of the top five advances in the fight against cancer by the American Society of Clinical Oncology (ASCO). The ASCO ranking was based on a large clinical trial that illustrated the effectiveness of lung CT scans in lowering risk of death by 20 percent.

Image courtesy of GE

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PEOPlE-FOcUSED MEDIcAl IMAgINg


Unfortunately, policymakers seem unable to publicly recognize the value of medical imaging to patients and their families. Congress and the current administration have cut imaging reimbursements seven times in six years, with payments for some services being reduced by over 60 percent. This includes bone density screenings, arm and leg artery x-rays, and MRIs of the brain. These cuts reduce patient access and undercut the benefits of early detection, making it harder for doctors to use these lifesaving technologies. A peer-reviewed study on dual energy x-ray absorptiometry (DXA) screening for osteoporosis published in the December 2011 issue of Health Affairs demonstrated this very point. Medicare payment cuts have a significant and direct impact on the health and safety of patients. The study found that DXA testing in all Medicare Part B settings plateaued between 2007-2009 after the Deficit Reduction Act of 2005 (DRA) cut Part B imaging payments, following a decade of growth in the use of DXA to detect osteoporosis. In those years, 800,000 fewer tests were performed than expected for Medicare beneficiaries. These tests could have prevented 12,000 fractures and the associated healthcare costs. The authors also observed that DXA utilization continued on an upward trend in hospital outpatient settings where payments were not affected by the DRA. This suggests that Medicares office-specific payment cuts were largely responsible for the decline in overall testing. The Health Affairs study on DXA screening highlights the undeniable correlation between Medicare reimbursements for medical imaging and patient health. Further attempts to limit access to medical imaging technologies will surely have similar outcomes for individuals with cancer and other deadly diseases. When used safely and appropriately, evidence shows that these technologies can have a tremendous positive impact on patients during treatment and recovery. This is not to say that members of the medical imaging community ought to discount the importance of radiation reduction and appropriate use criteria. Physician-derived best practices, appropriateness criteria, and investment in programs such as MITAs CT Dose Check Initiative (see page 3) illustrate the industrys commitment to Vascular chest MRI. Photo courtesy GE the safe and appropriate use of medical imaging technology. MITA is committed to working with stakeholders in order to encourage the proper use of imaging devices, and to ensure that patients have access to the right scan at the right time. The irrefutable decline in spending and utilization of imaging technologies, coupled with the industrys sustained commitment to protecting patients from unnecessary radiation, suggest that any further attempts to slash Medicare reimbursements and obstruct patient access to potentially lifesaving medical imaging technologies would be unnecessary.

Without access to these technologies, patients will simply not receive the care they need.
It is unsettling to see such downward trends in Medicare beneficiaries use of medical imaging services during a time of such tremendous advances in imaging and radiation therapy technology, which are seen to be increasingly integral to medical best practices and early disease detection. Without access to these technologies, patients will simply not receive the care they need.

Medical Radiation Exposure


While exposure to medical radiation remains an issue that doctors and patients must discuss, many in the medical community say that hype around medical radiation should not dissuade screenings. In fact, in response to concerns about risks related to radiation dose from medical imaging procedures, the American Association of Physicists in Medicine (AAPM) issued a statement in December 2011 that highlighted the near negligible radiation risk associated with medical imaging. In the statement, AAPM urged patients not to decline diagnostic radiation procedures because of misguided perceptions that the tests could be harmful, saying that the benefits of medical imaging far outweigh the risks.

Promoting Adequate Reimbursement


The proof ultimately lies in the data, and utilization is on the decline. Inadequate Medicare reimbursement and restricted access to medical imaging technology lead directly to adverse patient outcomes, including preventable bone fractures. There are already enough barriers in place that prevent patients from getting the care they need. As policymakers work toward a more balanced budget in the coming months, they should refer to the most current information on medical imaging innovation and consider the very real impact that additional Medicare payment cuts will have on the health and safety of patients. ei
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ow Medical Imaging Helps Patients:


gail m. rodriguez, PhD, executive Director, mita and Vice President, nema

Spotlight on Erika Hanson Brown and Suzanne Lindley Why did you found COLONTOWN?

Millions of Americans are survivors of cancer and other deadly diseases today because they had access to lifesaving medical imaging technology. From preventive care and early diagnosis to radiation therapy and guided treatments, medical imaging services are responsible for saving countless dollars and lives each year.

I was going through colon A. Whenoften felt alone in navigatingcancer nearly a decade ago, I my treatment and

When it comes to the value of medical imaging, survivors and caregivers know better than anyone how important it is to have the right scan when it is needed most. Peer-reviewed studies continue to confirm this, showing that when disease is detected early, treatment will be more cost-effective and patient outcomes improve. Medical imaging technology and radiation therapy are key to identifying, monitoring, and treating cancer. Patient advocates like Erika Hanson Brown and Suzanne Lindley, who have experienced firsthand the value of these technologies, continue to foster connections among other cancer survivors and spread hope throughout the community. They have inspired a worldwide network of cancer patients and survivors and continue to work tirelessly to provide invaluable resources for those struggling with the disease. Through sharing their personal stories and encouraging others to do the same, these survivors have demonstrated to the world the undeniable value of medical imaging.
Erika Hanson Brown, Mayor of COLONTOWN

found it difficult to stay connected with others, especially within my community here in Denver. Six months into treatment, I decided to become a committed advocate in the fight with cancer. I began reaching out to others who had a similar diagnosis, researching available resources, and seeking second opinions about my own prognosis. I refused to be complacent. That proactive mentality ultimately led me to found COLONTOWN, a patient advocacy network that connects colorectal cancer patients at a local, diseasespecific level to create a village of resources to help them cope with the disease.

goal is to teach people that A. Theliving with colorectal cancer.community is central to In COLONTOWN,

What is the mission of COLONTOWN?

members are able to interact with one another both online and in person at community meetings. Members are encouraged to share experiences and resources with one another.

feel a wonderful support A. Most peoplefamilylike they have but whats lacking is a network of and friends,

How does COLONTOWN create a sense of community among colon cancer patients?
local connection to someone going through colorectal cancer. COLONTOWN members, known as colonists, speak the language of colorectal cancer, know about new treatments, and have an intimate knowledge of the personal journey that only colorectal cancer survivors go through. COLONTOWN is unique because it creates a safe community for people grappling with colorectal cancer, as well as those who have successfully gone through treatment, encouraging them to stay involved and educated. It provides a comfortable, protected space for these individuals to discuss their disease openly, sharing thoughts, tips, and tools without fear of judgment.

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One of the unique features of COLONTOWN is that it goes beyond providing support to patients and includes survivors, families, and caregivers. How did this idea come about?
drop-off point when people no longer have cancer by mobilizing these survivors and keeping them engaged even when other resources start to disappear.

In addition to helping those going A. Thats exactly right. COLONTOWN addresses the through treatment,

Often, after their therapy is complete, patients stop feeling support from the community they had while going through treatment and are left feeling high and dry. This is a critically important point. Even though colorectal cancer survivors no longer receive treatment, friends, family, and other caregivers must encourage them to continue with routine imaging procedures to catch any recurrences as early as possible.

Suzanne Lindley, Founder of YES! Beat Liver Tumors

course A. After finishing my prescribed neededof treatment, I, like many colon cancer survivors, to visit my doctor regularly for follow-up appointments. Medical imaging was a routine, essential part of these visits, checking for re-growth or new tumors. This technology allows for early detection and treatment of recurrences.

How has medical imaging technology affected and guided your course of treatment for colon cancer?

was 31 old when learned had colon cancer A. Iand that yearscancer had Ispread to Imy liver. The doctor the

You have an incredible storycan you share a bit about your battle with cancer?
told me I had six months to live. For a very short time, I accepted my prognosis and asked other cancer patients for guidance on how share this news with my family. But I soon changed my outlook and chose to become more active in my fight against cancer instead of giving in to the disease. I started receiving the only therapy for colon cancer available at that timechemotherapy. After cycling through many different types of chemooften seeing short-term results only to then see the cancer grow strongerI turned to clinical trials. Despite these aggressive treatments, the liver tumors began to grow and multiply and I suddenly found myself back at square one. Like many cancer patients in a similar position, I heard the words, Im sorrythere are no more options.

When I was going through colon cancer, I was just lucky. I want people to be more than thatto be smart and empowered with the resources to advocate for themselves.

therapy A. After chemotherapy, I tried radioembolization,ina tumors in which tiny radioactive beads are implanted to reduce and eliminate cancerand it worked. There was a 65 percent reduction in my liver tumors and some even died completely.

Yet you refused to accept this prognosis. What was the next step in your treatment?

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grassroots organization that provides cancer A. YES! is awith support, resources, options, education, and patients

To date, youve had a long and impactful history as a patient advocate. In fact, at one time, Katie Couric of CBS News named you the medical matchmaker. Can you tell us about your current work with YES! Beat Liver Tumors?
hope in their fight against liver tumors. It is made up of survivors who have undergone treatment for primary hepatocellular (liver) cancer or liver metastases (cancer that has spread to the liver) from other cancers. Through YES!, we have also connected hundreds of patients across the U.S. with doctors and new treatments.

Erika Hanson Brown, Mayor of COLONTOWN (left) and Suzanne Lindley, Executive Director of YES! Beat Liver Tumors at the Denver Liver Symposium. Photos courtesy of Ms. Hanson Brown and Ms. Lindley

Since then, medical imaging and radiation therapies guided much of my treatment. In addition to radioembolization, I also received targeted radiation treatments including external beam radiation for cancer that had spread to the spine, Gamma Knife1 for cancer that spread to the brain, radio frequency ablation for a single returning liver tumor, and Cyberknife2 for lung tumors.

continue to receive A. Itargeted radiological systemic chemotherapy for tumors, therapies when needed, and diagnostic imaging to assess and guide treatment.

Where are you today in your journey with YES! Beat Liver Tumors and in your own personal battle with liver cancer?

suffering from liver cancer depend A. Patients at risk for orfor early diagnosis and treatment. on imaging services

How does medical imaging and radiotherapy technology impact patients living with liver cancer?

Our organizations ultimate goal is to change cancer from being a terminal disease to being a chronic one that can be managed with the help of advanced medical imaging technologies and radiation therapies. By building genuine, supportive patient advocacy communities, YES! spreads hope to those who need help finding it. ei

Specifically, liver cancer patients depend on advanced PET, CT, ultrasound, and MRI because the liver is a common site of metastatic spread and the early detection of liver tumors is critical for treatment of the disease. The advanced radiation therapy technologies I received in treatment gave me a lifetime of experiences. I was able to watch my daughters grow up, spend more time with my husband, and start the patient advocacy organization, YES! Beat Liver Tumors.

Gamma Knife radiosurgery, also known as stereotactic radiotherapy, is a noninvasive treatment that uses tiny beams of radiation to target cancerous cells. Cyberknife is a non-invasive robotic radiosurgery system that uses computers, image-guided cameras, and robotic technology.

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A Global Perspective on Medical Imaging


Zach helzer, manager, administration and international, mita

n the past few decades, radiation therapy and diagnostic imaging technology have revolutionized healthcare delivery in America and around the world. These technologies are not only fundamental to standards of care, but they also help limit the need for more invasive procedures and help patients return to their families, lives, and work more quickly.

ITA will provide more than $200,000 in funding to support MITA activities that promote the export of medical imaging products, specifically to China and India. Working closely with ITA and other stakeholders over the next three years, MITA will use MDCP funds to streamline government approval processes, decrease the time required to bring devices to market, and lower the cost associated with the sale of lifesaving diagnostic and therapeutic imaging products to China and India. MITA will be able to better identify market access issues, work more closely with incountry regulators to improve device safety, and assist them in integrating internationally-accepted standards into their regulatory regimes. MITAs MDCP activities build on its ongoing efforts through DITTA (the Global Diagnostic Imaging, Healthcare IT and Radiation Therapy Trade Association) to improve collaboration with international partners COCIR (the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry) and JIRA (Japan Industries Association of Radiological Systems) to help educate international decision makers on the practical implications of their policy decisions and to encourage regulatory environments that allow patient access to these lifesaving technologies. The award will also help medical imaging and radiotherapy manufacturers create jobs here in the U.S. by increasing exports of medical imaging products. This effort aligns with the National Export Initiative, a key component of the Obama administrations economic recovery plan, which sets an ambitious goal of doubling U.S. exports by the end of 2014 to create millions of new jobs for Americans. The bottom line is that innovative diagnostic services are essential to the detection of disease when it is most treatable. Through initiatives like MDCP that promote access to these products, the extraordinary innovations we have seen in the medical imaging industry in the United States can be shared with nations throughout the world. As market access continues to improve through the harmonization of international standards, millions of patients in China, India, and beyond will benefit from the enhanced diagnostics and care provided by lifesaving medical imaging and radiotherapy devices MITA members manufacture. ei
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Medical imaging manufacturers have made extraordinary advances to help researchers unlock the mysteries of cancer and other deadly diseases, while also enabling physicians to diagnose and treat an increasingly wide range of diseases. Todays modern imaging and radiation therapies offer highly personalized, non-invasive care that can be tailored to the specific needs of an individual patient. Peer-reviewed research confirms that these medical technologies not only improve health outcomes and save lives, but also reduce healthcare costs and drive down long-term spending. Moreover, great strides have been made to ensure that radiation therapy and medical imaging technologies are delivered in a safer and more effective manner than ever before. For example, manufacturers have revolutionized computed tomography (CT) by developing technology that delivers quality images at a radiation dose far below what it was twenty years ago. Despite tremendous progress in research, technology, and patient safety, impediments to international trade continue to prohibit the industry from exporting advanced medical imaging and radiotherapy products. Restricting market access threatens the lives of millions of patients who would otherwise benefit from clinically proven diagnostic and therapeutic devices. Fortunately, the U.S. Commerce Departments International Trade Administration (ITA) has begun to address this issue through its Market Development Cooperator Program (MDCP), which provides financial and technical assistance to support well-defined business plans that increase exports and U.S. competitiveness. In November 2011, MITA was recognized for its participation in MDCP at the Radiological Society of North Americas Scientific Assembly and Annual Meeting in Chicago. The MDCP award, the Global Diagnostic and Therapeutic Imaging Access Improvement Initiative, is designed to promote the harmonization of international standards, reduce unnecessary regulation, and expand market access to enhance the global competitiveness of MITA member companies, including small- and medium-sized enterprises. For this project,

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Ambient Experience addresses the tenor of the imaging space itself, making it psychologically supportive. Photo courtesy Philips Healthcare

Transforming the Patient Experience


Innovative concepts for people-focused healthcare
thomas van elzakker, Director ambient experience Business unit, Philips healthcare

atients as consumers are now the norm. Well-informed and selective, they simply demand more. Todays most successful hospitals understand

Holistic Approach
Four over-arching principles guide the development of unique healing environments and go beyond traditional approaches to facility planning and design: Comfort Build an environment that contributes to the well-being of patient and clinical personnel. ContaCt Maximize the interaction between medical personnel, patients, and loved ones by decreasing physical barriers.

that patients not only want to get the best care, but they are seeking a more comfortable experience. By providing a welcoming environment, these institutions stand above the competition.

In an atmosphere that is psychologically supportive, both patients and staff experience healing in its truest sense. Using technology as an enabler, hospitals can create an immersive, multi-sensory environment that enhances the patient experience.

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WorkfloW Remove disjointed, cluttered, and isolated work areas that adversely impact staff efficiency and satisfaction. PersonaliZation Give patients a sense of control over their experience by allowing them to modify their surroundings. In order to incorporate these principles into the design of a healing environment, every aspect of the patient journey throughout the hospital should be evaluated, each pathway and interaction mapped. Patients, families, nurses, and physicians can be quietly shadowed for insight into their physical and emotional needs. Based on the findings, areas that can be positively influenced through a combination of technology, spatial design, and workflow improvements emerge. lighting Plays key role It is well-established that lighting plays a major role in our well-being, influencing emotions and affecting performance. Choosing the right lighting solution for a specific space can transform that space. A calming wall wash in the imaging suite soothes anxious patients and improves exam compliance. Customized lighting in the patient room provides a sense of personalization for patients and families. Comfortable lighting in common spaces helps create a welcoming sense of ease or wayfinding for all visitors. Each well-conceived lighting solution takes into account patient well-being, staff efficiency, and overall ambiance. Dynamic LED lighting installed around the perimeter decreases the reliance on harsh overhead lighting. With a gentle wash of color, walls appear to fade away, softening the atmosphere and helping to reduce patient stress. A ceiling projector displays video and animations selected by the patient from a library of themes. The peaceful imagery is accompanied by soothing audio, creating an ambiance designed to relax. Offering patients some personalized control over their experience helps distract and refocus emotions. When anxieties fade, patients can be more cooperative and staff can manage clinical processes more efficiently. Patient and staff satisfaction improves.

A Differentiating Factor
Innovative lighting and projection are but two elements Philips Healthcare brings to the redesign of a hospital environment. Through its program, Ambient Experience, Philips looks beyond the walls, the beds, and the medical equipment to address the tenor of the space itself. Transformation from acceptable to exceptional is further expressed by: integrated cabinetry de-cluttered spaces rounded room corners privacy glass warm, comfortable waiting areas As reimbursement guidelines continue to place an even greater focus on patient satisfaction, attention to all aspects of the patient experience is crucial. When considerately applied, the concept of patient-focused healthcare can help hospitals thrive, assuring better visibility in a competitive landscape. ei Mr. van Elzakker is also General Manager New Ventures, Global Customer Service, at Philips Healthcare.

Giving Patients Control


Nowhere do all elements of an effective experience come together as well as in the imaging suite, a room where patient fears may well be exacerbated.

CT image courtesy of GE

CT image courtesy of Siemens

CT image courtesy of GE

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Stewardship Needed
Brian Connell, Director, state & federal government relations

elium isnt just for childrens balloons. Many dont realize helium cools electronics, empties rockets of fuel, and is critical to medicine primarily for its use in magnetic resonance imaging (MRI). The problem is that there is a growing shortage of this essential element.

Helium is a non-renewable resource created by the suns nuclear fusion or radioactive decay on Earth, and scientists have yet to discover how to create helium artificially or replace its properties with another element. Congressional actions have had the unintended consequence of undervaluing the gas. The National Helium Reserve, mandated to sell two billion cubic feet of helium per year is rapidly depleting the nations federal supply of helium. Some estimates project that at current rates the U.S. could transform from the worlds largest repository of helium into a net importer of helium within 10 to 15 years.

Without an adequate supply of helium, the use of MRI technology would grind to a halt, patients would be unable to access lifesaving equipment, and imaging manufacturing jobs would be at risk.
This is a large problem for medical imaging manufacturers and the doctors and patients who rely on MRI technology to diagnose and treat disease. MRI devices consume 7,000 tons of helium annually to cool the equipments magnets to appropriate temperatures for imaging. MRI magnets work optimally at approximately 4.2 degrees Kelvin. Hydrogen, the next best element for extreme cooling, can only cool to 20 degrees Kelvin and is extremely flammable. MRI use of helium is not restricted to magnets and is now being used directly in diagnostic procedures. Scientists and doctors are using a rare isotope of helium, He-3 during an MRI exam to provide exceptionally clear images of a patients lungs while

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the Helium Shortage


they breathe normally. This research is helping to further the detection of lung disorders and lung cancer. It is, however, also dependent on access to helium. Without an adequate supply of helium, the use of MRI technology would grind to a halt, patients would be unable to access lifesaving equipment, and imaging manufacturing jobs would be at risk. Preserving the supply of helium and encouraging responsible use is a critical priority for the medical imaging industry. The U.S. contains about 35 percent of the worlds crude helium reserves. The gas is located in the same regions as many major oil and gas production fields, making the southwest home to most of Americas reserves. The federal government maintains the National Helium Reserve in Texas, which is the largest stockpile of crude helium in the world. The reserve was originally created in 1925 to ensure a robust national supply of helium for the militarys dirigible fleet. As dirigibles phased out, the reserve was used to provide helium supplies for the Air Force intercontinental ballistic missile fleet and NASA during the Cold War. By 1995, the reserve was considered largely obsolete and a financial liability. To resolve a $1.3 billion debt owed to the U.S. Treasury by the reserve, Congress voted to liquidate the nations supply with the Helium Privatization Act. The act mandates that the Department of the Interior sell helium to repay the reserves debt to the Treasury and exhaust the reserves helium supply by 2015. In Washington, D.C., MITA is pursuing more effective federal stewardship of the nations helium resources. A key step to better managing the shortage is to resolve the issue of the congressionally mandated rapid depletion of the National Helium Reserve. Potential options include assuring that federal crude helium is sold at fair market value, maintaining sustainable and consistent national refining capacity, prioritizing helium for critical uses, and slowing disbursement from the reserve. Beyond the beltway, MITA members are already making medical use of helium a high priority. During the MRI manufacturing process, helium is now often captured and recycled as magnets are cooled to optimal temperatures. Recycling helium during magnet cooling helps limit its use during this resource-intensive step in the manufacturing process.

PEOPlE-FOcUSED MEDIcAl IMAgINg

Manufacturers are also working to preserve helium over an MRIs operational lifetime. While all MRI devices lose some helium due to evaporation, newer devices are designed to recapture evaporating helium, reducing lifetime loss to nearly zero under optimal conditions. MRI manufacturers continue to perfect recycling and conservation measures, and are well-prepared as helium becomes more expensive and difficult to obtain. The days of wanton helium use are likely coming to an end. As more industries become aware of this precious resources looming shortage, helium recycling, recapture, and careful utilization will become a national priority. MITA will continue to work closely with industry and government officials to assure that this important resource is ready and available for future generations. ei

Helium Extends Beyond Medical Imaging into Other NEMA Sections


Medical imaging devices consume more than 7,000 tons of helium annually to cool magnets as well as directly facilitate diagnostic procedures. In gas metal arc welding, also known as GMAW or metal inert gas (MIG) welding, helium-enhanced mixtures provide increased arc stability at greater wire feed speeds. This increases weld metal deposition rates when compared to conventional argon/carbon dioxide (Ar/CO2) mixtures. Because of heliums greater heat conductivity, performance over mild base metal contamination is also improved, which helps to eliminate the need for costly rework. Argon/helium enhanced mixtures are commonly applied for MIG welding of thicker aluminum sections (>12mm). The enhanced mixtures typically increase deposition rates while eliminating the need to perform a costly preheating operation. The use of helium-enhanced shielding gas mixtures provide an improvement in the penetration profile of the completed weld deposit when compared to pure argon or Ar/CO2 blends.
John Miller, Industry Manager | john.miller@nema.org

NEMA electroindustry

March 2012

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Electroindustry News
MITA Reorganizes Staff to Strengthen Public Policy Expertise
As medical imaging manufacturers continue to develop innovative technologies that enhance early disease diagnosis, staging, and treatment, it is vital that MITA and its member companies educate policymakers about how imaging improves health outcomes and reduces costs. In a strategic move to deepen the associations significant imaging and public policy expertise, MITA has reorganized its staff to augment policymakers understanding of the value medical imaging technologies play in improving healthcare and creating advanced manufacturing and employment opportunities. with the federal budget and public policy. In his role, Mr. Konigsberg will contribute expertise to NEMAs electrical equipment and medical imaging manufacturing businesses. He previously served in senior positions in the U.S. Senate, the White House Office of Management and Budget, and non-profit organizations. Konigsberg is also the author of the newsletter, US BudgetAlert.com, which provides a nonpartisan, expert analysis of taxes, spending, and fiscal policy. including leading its regulatory, educational, health economics, and coverage initiatives. Prior to joining MITA, Ms. Rodriguez directed policy and business development for the industry group Institute for Molecular Technologies.

Charles S. Konigsberg, JD, Chief, Strategy and Policy, NEMA and MITA Charles S. Konigsberg is a new hire who brings 30 years of bipartisan experience

Gail Rodriguez, PhD, Executive Director, MITA and Vice President, NEMA MITAs former Director of Policy Gail Rodriguez has been named executive director of MITA. She previously oversaw the X-ray Imaging Products Section and directed the MITA Positron Emission Tomography (PET) Group,

Lindsay Morris, Senior Director, MITA Former Director of Government Relations Lindsay Morris has been promoted to senior director. Ms. Morris, a former Senate staffer, will build on MITAs existing outreach and advocacy efforts with lawmakers and staff on Capitol Hill. Under the new staff leadership, MITA will continue to work with policymakers to underscore the numerous health and economic benefits of medical imaging and the importance of ensuring patient access to the right scan at the right time. ei

Theyve got the MITA touch: (from left) Stephen Vastagh, International and Industry Programs, and General Secretary DICOM; Brian Connell, Director, State & Federal Government Relations; Pam Larbig, Administrative Assistant; Zach Helzer, Manager, Administration and International Programs; Richard Eaton, Industry Manager. Photos by Pat Walsh

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Fish Where the Fish Are

Evan R. Gaddis, NEMA President and CEO I recently saw a picture of myself back when I was a young general with a flat belly and dark hair. I had a formidable missionto enlist more than 120,000 soldiers. I had to convince them I was offering a great deal: Ill take you away from home, work you like youve never worked before, and then send you away to fight a war. It got me thinking about sales. The traditional way of doing business wasnt going to work. I had to focus efforts where they would garner the greatest returns. To say it simply, I had to fish where the fish are. What that meant for me at the time was closing rural sites and shifting the emphasis to cities and suburbs. But what does this mean for NEMA member companies? One of the sources we make available to our members is the NEMA Intelligence Portal. Im happy to say right now that a lot of senior executives and engineers are actively reading the top-ranking articles, which are emailed to them daily. Still there is opportunity waiting in the wings. If I were a salesperson at a NEMA member company, the NEMA Intelligence Portal would make me salivate like a dog in a meat house. In one daily digest, you can access information on what is happening in your industry across the globe as well as in federal government actions, legislation, and contracts. In sales, knowledge is power, and the right information is available in the NEMA Intelligence Portal. Im encouraging all member companies to get their sales staff hooked on the portal so they can start fishing where the fish are. Go catch em! ei

www.nema.org/portal

NEMA Releases ROI Document for Smart Grid


December 2011 marked the fourth anniversary of the day President George W. Bush signed the Energy Independence and Security Act of 2007, better known as EISA. As electroindustry magazine has often noted, Title XIII of the Act introduced the federal government to the term Smart Grid and laid the groundwork (one work, no space) for what a recent Memoori Research report estimated to be a $2 trillion global market for Smart Grid products and services between now and the year 2030. According to a Memoori press release that accompanied its report, Smart Grid spending was about $16 billion in 2010 and is expected to peak at about $155 billion in 2018. Its not every day that a new trilliondollar market is created, said Ric Talley, PhD, Senior Vice President, NEMA. As the recent ARPA-E (Advanced Research Projects Agency-Energy) hearings on Capitol Hill and the Department of Energy Inspector General report on the Smart Grid Investment Grant program have shown, Congress and the administration are starting to ask what theyre getting for their money. To address this market, the NEMA Smart Grid Council has drafted a Return on Investment (ROI) whitepaper as it relates to the Smart Grid business case. The paper describes itself as a catalog of utility company and consumer benefits, and includes descriptions of the benefits derived by utility company investment, consumer involvement, transmission optimization, and other strategies that have come about because of Smart Grid technologies. Its important for regulators, legislators, and consumers of every stripe to understand the benefits of Smart Grid, said Dr. Talley, and now that we have some experience with a deployed base of smart systems and technologies, we can start to deliver that message. ei

Download the whitepaper at www.nema.org/smartgrid.


Paul A. Molitor, Assistant Vice President, Strategic Initiatives and Special Projects | paul.molitor@nema.org

NEMA electroindustry

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Electroindustry News
Electrical Safety is Not Optional
New ESFI program reinforces the importance of workplace electrical safety programs Every year in the U.S., workplace electrical incidents result in nearly 300 deaths and more than 3,500 injuries. Although not the leading cause of workplace fatalities, electrical incidents are disproportionately fatal. For every 13 electrical injuries, a worker dies. These statistics raise alarming questions about electrical safety in the workplace. Are your workers properly trained in accordance with NFPA 70E Standard for Electrical Safety Requirements for Employee Workplaces? Are they using the proper insulated tools and personal protective equipment (PPE)? Is your electrical safety program effective? Are you prepared to deal with the consequences if its not? How do you know? Occupational Safety and Health Administration (OSHA) regulations and NFPA 70E standards provide the groundwork for an electrically safe work environment. Complying with these requirements and following industry best safety practices is the best way to ensure you are doing everything possible to keep your workplace safe from electrical hazards. Nearly 96 percent of survey respondents said they worked on applications requiring PPE according to NFPA 70E, yet more than half (59 percent) said they rarely or never wore the required PPE. Another 27 percent indicated that they donned required PPE only sometimes. Until electrical safety becomes a priority for everyone in every workplace, serious incidents will continue to occur. Could it happen at your workplace? How do you know? The Electrical Safety Foundation International (ESFI) is a 501(c)(3) non-profit organization dedicated to reducing the number of workplace electrical injuries and fatalities through education, awareness, and advocacy. ESFI recognizes that a comprehensive, effective electrical safety program is the key to keeping people safe on the job. standards and regulations that you must follow AND that you need to know. Yet, survey findings published in a recent issue of Control Engineering1 underscore a serious problem facing facility managers, safety professionals, and supervisors. Many employees choose not to follow workplace standards and regulations, like NFPA 70E, when it comes to working on energized equipment. But how do you know if your program is effective? How do you communicate the importance of electrical safety to your managers and employees? The How Do You Know program will help you answer these important questions and others. The programs video modules reinforce the importance of electrical safety programs and compliance with standards and regulations while demonstrating how safe electrical practices are vital to everyone in your business. The Electrical Safety Self-Assessment will help you review and analyze your companys electrical safety practices related to facilities, personnel, and procedures. This online tool guides you through a series of questions that will help you identify areas of your electrical safety program that may require further examination. Even if you have a good, solid program in place, you will likely uncover a few areas that could be improved. Thats exactly what the tool is designed to help you do. The Electrical Safety Self-Assessment will help you answer that nagging question, How do you know? Once you identify areas that need to be addressed, what do you do next? Every workplace is different. There is no one solution that will work in every situation. ESFI has compiled a library of safety resources and links on our website to help you find the information you need to take the next step. Adopt a proactive approach to electrical safety. Dont wait until something bad happens and then try to fix it. Visit www.esfi.org to start improving the electrical safety of your workplace today. ei Kate Janczyk, Director of Programs, ESFI | kate.janczyk@esfi.org

Many employees choose not to follow workplace standards and regulations... when it comes to working on energized equipment.
Its more than just a good idea. Its the right thing to do from a legal standpoint, and minimizing the risk of injuries makes good business sense. These are

www.controleng.com/single-article/how-safe-are-yourelectrical-system-work-practices/9f8059ec79.html

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NEMA electroindustry

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Cybersecurity in the Electrical Industry


Cybersecurity is at the forefront of information technology and information systems development as increasing numbers of devices and systems are connected to publicly visible communications networks. What is cybersecurity? By definition, cybersecurity is actions taken to protect information system assets and data from attack by physical and electronic means. As an outgrowth of the original concept of computer security, cybersecurity involves the protection of more than what we think of as computers in the traditional sense. In todays world, it may be necessary to protect devices that are merely transmitters of data, such as a smart meter, or recorders and transmitters like medical imaging equipment that now have networking capability. Cybersecurity has certain concepts that are common across all security implementations. Among them are: Authenticationpositively identifying the person/entity that wants access to data or a system Authorizationallowing access only to the systems or data that the person/entity needs access to, and preventing access where need to know does not exist Accountinglogging and recording the activities of access sessions for later reconstruction when needed Secure communicationwhen necessary, encrypting transmissions in such a way that intercepted transmissions would be unreadable, and ensuring that transmissions received have not been tampered with Intrusion detection and response detecting unauthorized access attempts, determining the intruders identity if possible, and promptly terminating the unauthorized access before harm can be done The concepts above apply equally to physical and electronic means of access. A robust cybersecurity implementation takes both into account, ensuring that all pathways into data and systems are constantly monitored to ensure the highest possible security environment is established. NEMA members have, and will continue to have, an ever-increasing role in cybersecurity in the manufacturing and distribution of electrical and medical imaging equipment. More and more products are created with intelligence that includes the ability to communicate over data networks. Whether its a household lamp that is capable of reporting its real-time energy consumption to an information management system or a smart meter that wirelessly transmits information relevant to utility provider demand/ response systems, cybersecurity must be a consideration in the design and implementation of the communications. Beyond the products themselves, it is equally important today for all businesses to consider the security of customer data as business transactions are increasingly conducted electronically. Recently, staff members from NEMA offices visited a newly-established GE Information Security Center outside Richmond, Virginia. The center conducts activities related to any and all aspects of cybersecurity as they apply to GE businesses, from protecting customers private data to engineering the latest in security applications for GE products. Such a center demonstrates the importance of security in the current manufacturing, industrial, and economic environment that we live in, and represents a critical investment that must be made to ensure that the principles and mechanisms of cybersecurity enforcement meet todaysand tomorrowschallenges. Steve Molitor, Manager, High Performance Buildings and Industrial Energy Efficiency Coalition | steve.molitor@nema.org

2012 Illuminations Weekend Returns to Sunny Florida


Join us November 9 and 10 in beautiful Miami, Florida, at the Turnberry Isle Miami Resort for a mix of seminars, general sessions, strategic planning, and networking opportunities. This is the premier opportunity for NEMA members to discuss the most important issues facing electrical equipment and medical imaging manufacturers.
NEMA electroindustry

Stay tuned for details about this years programs and speakers in upcoming issues of ei. ei

March 2012

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Code Actions/Standardization Trends


Old Safety Inspectors Dont Retire, They Just Become Enlightened
John Minick, NEMA Field Representative for the past 19 years, retired last month. John leaves a legacy of public service and a commitment to electrical safety that will be hard to beat. Relationship building with members and authorities having jurisdiction is probably the most important aspect of success as a NEMA field representative. Of course, knowledge of electrical products and systems and the various installation and safety codes is critical for the Field Reps job, but being in the right place at the right time to communicate with key people is really what defined Johns experience as a NEMA Field Rep. From Florida to Texas, John will long be remembered for regularly offering his considerable technical knowledge and experience to achieving and maintaining the goal of electrical safety. John has been actively engaged in the electroindustry for more than 50 years. A graduate of the University of Texas (UT) at Arlington, he began his career as an electrician in the 1960s working for various companies in and around Dallas, Texas. He became Chief Electrical Inspector for the City of Grand Prairie, Texas, and remained there until 1993. John has been continuously active in many electrical and fire safety organizations including the International Association of Electrical Inspectors, National Fire Protection Association, and the International Code Council. He served as a member of the NEC Code Panel 1 from 1995 to 2007 and as its chair from 2000 to 2007. He was a member of the North Central Texas Council of Governments and of the Texas Standard Electrical Examination Advisory Board. In addition to doing many workshops at meetings of electrical inspectors, John taught at the Building Professional Institute at UT Arlington and at the University of Houston. He is the recipient of several professional certifications and licenses including master electrician, electrical inspector general, and plumbing inspector. On behalf of the NEMA membership, we wish John and his family all the best as he takes on new challenges. I suspect Johns next endeavor will have something to do with electrical safety. ei Al Scolnik, Vice President of Technical Services | alv_scolnik@nema.org

John Minick

Pennsylvania Code Council Recommends Six-Year Code Adoption Cycle


At the January 18, 2012, meeting of the Pennsylvania Uniform Construction Code Review and Advisory Council (RAC), the council voted to recommend to the Pennsylvania Legislature that a six-year code adoption cycle be instituted under the Uniform Construction Code. This recommendation will require an amendment to Act 45 of 1999 (as amended), which establishes a uniform construction code imposing powers and duties on municipalities and the Department of Labor and Industry providing for enforcement, imposing penalties, and making repeals. The act also provides for the duties of RAC, which include the review of the latest triennial code revisions issued by the International Code Council (ICC). If these recommendations are accepted, the 2009 ICC Codes (I-Codes) that are currently in effect will remain in effect until at least 2015 when RAC must review changes in the 2015 I-Codes. The 2008 National Electrical Code (NEC) is adopted by reference in the 2009 International Building Code, and for one- and two-family dwellings, the 2009 International Residential Code is adopted with electrical provisions that are based on the 2008 NEC. ei Gil Moniz, Field Representative | gil.moniz@nema.org

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NEMA, Industry Secure Needed Changes in California Electrical Code for Nurse Call Systems
Carl Cox, VP & Director of Engineering, Rauland-Borg Corporation Title 24, Part 3, Article 517 of the California Electrical Code (CEC) covers Californias requirements for nurse call systems. The code is reviewed on evennumbered years, with the latest revision the 2010 edition. Recently, the California Office of Statewide Health Planning and Development (OSHPD) has become very active inspecting new installations and allowing occupancy. The OSHPD inspector would not allow occupancy of a building until the contractor included an audible tone for code calls at the corridor light. Article 517 of the 2010 CEC included several sections that manufacturers believed were ambiguous. The ambiguity led to open interpretations of the code by inspectors. There were also some sections that were dated with respect to modern communications systems and the hospitals use of them. These factors led to many unnecessary installation rejections or delays. In addition, inconsistent interpretation of the code often resulted in expensive site modifications with no real meaningful benefit to the healthcare facilities or patient safety. There were several areas of concern with the requirements set forth in the 2010 CEC: One of the most troublesome was a requirement to annunciate code calls visually and audibly at the corridor light outside the room of initiation. This requirement was unique to California. No manufacturer fabricated standard equipment that could sound tones at the corridor light. This meant that either custom products or installations were necessary, resulting in increased costs for the facility, but having no positive impact on improving patient safety or staff response time. There was no requirement for code calls to be supervised. There was no requirement for the nurse call systems to be listed to UL1069 Hospital Signaling and Nurse Call Equipment. The requirement for annunciating calls was sometimes interpreted to require the display of 100 percent of calls simultaneously. In a 500-bed hospital, this would require a huge display. Modern nurse call systems typically display a more reasonable number of calls simultaneously, which are automatically prioritized. The nurse call system helps the operator address calls effectively by assessing the highest and lowest priorities. In October 2010, I became aware of the draft changes to the CEC that presented the nurse call industry with an opportunity to fix the problems with the existing requirements. As a member of the NEMA Health Care Communications and Emergency Call Systems Group (3SB-2), as well as the UL Standards Technical Panel for UL1069, I raised the issue with the 3SB-2 Technical Committee in December 2010 on the basis that this was an industry issue, not specific to a particular supplier. The Technical Committee agreed to review the potential changes and provide any additional comment that would help clarify the code. NEMA field reps were instrumental in understanding the California code process, including how to submit proposed changes. NEMA headquarters staff was also vital in incorporating multiple manufacturers comments and facilitating a united industry response. All of this was accomplished in the short timeframe allowed for public comment. The official NEMA proposal was submitted to the California Building Standards Commission (BSC) in June 2011. BSC adopted NEMAs recommendations on July 1, 2011. The new provisions became effective January 1, 2012, with enforcement by OSHPD scheduled to commence on June 1, 2012. The changes to the code result in the following: Elimination of the requirement for supervised audio annunciation devices. Assurance that high priority calls display first on the master station. Elimination of the requirement for a special notification for special needs patients or fall risk patients. Clarification of the requirement for a visual indication of open audio patient station to accept a recurring monitoring tone in place of visual indications. Acceptance that a toilet station can cancel a shower station if both stations are within sight of each other. Elimination of the requirement for a code station to sound at the corridor light when activated, and inclusion of an option to have a visual or audible call assurance signal at the corridor light (previously California required both audible and visual indication). ei Mr. Cox has been in the nurse call industry since 1974. He has participated in NEMA 3SB-2 since its origin in the 1980s and is on the UL Standards Technical Panel for UL1069 Hospital Signaling and Nurse Call Equipment and the UL Standards Panel for UL2572 Mass Notification Systems.

NEMA electroindustry

March 2012

27

Code Actions/Standardization Trends


Healthcare Facilities Codes Ensure Electrical Safety
Three primary codes, all published by the National Fire Protection Association (NFPA) address healthcare facilities: NFPA 101 Life Safety Code ; NFPA 99 Health Care Facilities Code; and NFPA 70 National Electrical Code (NEC). The Life Safety Code specifies the minimum requirements for the design, operation, and maintenance of buildings and structures for safety to life from fire. Other than illumination and identification of means of egress, it does not address electrical systems to any degree. The two other codes Health Care Facilities Code and NEC do address electrical systems in healthcare facilities. NFPA 99 provides minimum requirements for the installation, inspection, testing, maintenance, performance, and safe practices for facilities, material, equipment, and appliances in hospitals, ambulatory healthcare centers, clinics, medical and dental offices, nursing homes, and limited care facilities. Chapter 6 is dedicated to electrical systems and addresses the hazards that relate primarily to electrical shock, power continuity, and fire. NEC addresses the practical safeguarding of persons and property from hazards arising from the use of electricity. Article 517 is dedicated to healthcare facilities and focuses on electrical construction and installation criteria in health care facilities that provide services to human beings. The purpose of Chapter 6 of NFPA 99 is to define the performance required of the electrical systems to ensure the optimal level of safety. The purpose of the NEC is to define the ways in which the systems must be installed to best achieve the desired level of performance. Since it is sometimes impossible to express performance objectives purely divorced from installation terms, there is a great deal of referencing back and forth between the two codes. essential eleCtriCal systems NFPA 99 describes three types of essential electrical systems (EES.) Each requires a normal power source, an alternate power source, and the means for automatically switching between the two. Usually, the source for normal power is an electric utility and the alternate source is on-site generation. In certain situations, however, the power sources could be reversed. There must always be at least two independent power sources, and at least one of them must be located onsite.

Hospital-Grade Wiring Devices Ensure Patient and Staff Safety


James Osterbrock, Vice President, Engineering, Pass & Seymour/Legrand Reliable and safe electrical power becomes even more important when a persons health is involved. It is particularly essential that there be a highly reliable and low-resistance ground path. Patients can often be attached directly to a number of electrical devices and may be in a weakened condition as well. Furthermore, receptacles in hospitals are subject to many more cycles of plugging and unplugging often under emergency conditions. Despite heavy mechanical and electrical wear and potential abuse, these devices must continue to perform like new. It was with these requirements and conditions in mind that hospital-grade receptacles, plugs, and connectors were developed and required over the past 30-plus years. Electrical requirements for healthcare facilities are outlined in the NFPA 70 National Electrical Code (NEC) Article 517 and NFPA 99 Health Care Facilities. Hospital-grade receptacles are required in patient bed locations in general and critical care areas of healthcare facilities per 517.18(B) 517.19(B) of the 2011 NEC.
Note the green dot in the upper right. Courtesy of Pass & Seymour, Legrand

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Type 1 EES comprises three separate branches capable of supplying a limited amount of lighting and power service that is considered essential for life safety and effective facility operation during the time the normal electrical service is interrupted for any reason. The three separate branches are the life safety, critical, and equipment branches, each with its own set of requirements and purpose. Type 2 EES has two separate brancheslife safety and equipment. Their requirements are almost identical to those for Type 1 EES. Type 3 EES has one branch with the specific objective of being capable of supplying a limited amount of lighting and power service that is considered essential for life safety and orderly cessation of procedures during the

time normal electrical service is interrupted for any reason. NFPA 99 also defines the types, minimum number, and locations of electrical receptacles in healthcare facilities. The code permits the use of an isolated power system as a means of limiting ground-fault currents without interrupting power. Article 517 of NEC also covers all of these requirements, but from an installation perspective. Section 517.11 General InstallationConstruction Criteria states: The purpose of this article is to specify the installation criteria and wiring methods that minimize electrical hazards by the maintenance of adequately low potential differences only between exposed conductive surfaces that are likely to become energized and could be contacted by a patient.

Ground-fault protection, selectivity, and hospital-grade receptacles (the receptacles with the green dot on the face) are also specified in Article 517. See below for information on hospitalgrade receptacles for more information. Finally, Article 517 addresses various requirements for connecting and disconnecting x-ray equipment (fixed and stationary as well as portable, mobile, and transportable) to the supply circuit. ei Daniel DeHanes, Lead Project Engineer, GE Healthcare | Daniel.DeHanes@ge.com Vince Baclawski, Senior Technical Director, Codes and Standards | vin_baclawski@nema.org

Product standards for hospital-grade receptacles, plugs, and connectors are contained in UL498 Attachment Plugs and Receptacles. These devices must undergo additional testing that includes abrupt removal, ground contact overstress, terminal strength, and assembly security. Hospital-grade plugs and connectors must meet the same strict requirements with additional crush, drop, and cord strain relief tests due to their portable nature. Hospital-grade devices are identified as having met these strict test requirements by displaying a green dot and the words Hospital Grade or Hosp. Grade. The green dot is always visible, but on some receptacles the words Hospital Grade may be covered by the wallplate because of space limitations. ei

NEMA electroindustry

March 2012

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Code Actions/Standardization Trends


Changes to Dimensional Requirements and Test Procedures for Paper-Covered Magnet Wire Highlight Next Release of MW 1000
NEMA has released the third set of amendments to ANSI/MW 1000 Magnet Wire. The publication, which will be designated MW 1000-2011, will include new standard dimensions for all NEMA MW constructions for paper-covered magnet wire. These amendments should be approved as an American National Standard in early March 2012. Previously, NEMA MW 1000 specification sheets for paper-covered and tape-wrapped magnet wire were not harmonized in terms of their dimensional requirements. In MW 1000-2011, new general requirement tables in Part 1 will establish a common set of dimensional values for all of these constructions. Along with these tables, the standard will provide the formulas necessary for deriving the increase in diameter of round tape-covered wire and the increase in thickness of rectangular and square wire due to the tape covering. The standard also specifies that the increase in width of square and rectangular wire caused by the tape covering must always be less than the increase in thickness. In addition, new definitions for number of tapes and number of layers were added to the terms and definitions clause of Part 1 of the standard to facilitate the use of common terminology in the industry on this subject. The coverage procedure for papercovered magnet wire has been deleted from the standard because the Magnet Wire Section Technical Committee determined that the Coverage requirements in specifications MW 33-C, MW 60-A, MW 60-C, MW 61-A, and MW 61-C were in fact Adherence and Flexibility requirements. Within the Adherence and Flexibility test procedures, a new set of protocols specific to paper-wrapped magnet wire were developed, one for round wire 4/07 AWG and another for rectangular wire. one-foot intervals for dimensional measurements is impractical for the production environment and results in excessive scrap wire. Also, the procedure will specify measurement of the conductor radii of rectangular bare wire using a standard radius gauge or other acceptable method. In response to frequent inquiries manufacturers receive as to how much tension should be applied to the magnet wire as it is de-reeled for use on customer equipment, a new Appendix G of industry recommended winding tensions will be added. These tensions are informative recommendations only, not requirements, as appropriate winding tensions can vary from one magnet wire end user to another. Finally, the introduction to MW 1000 Part 2 Properties and Requirements has been amended. In cases where magnet wire products fall outside of the AWG wire size range indicated in a particular specification sheet under Dimensions, the testing protocol and requirements will be based on agreement between the customer and supplier. This addition was made in response to requests for an interpretation of the standard from parties who were purchasing magnet wire of sizes outside the size range of the NEMA specification. Users of NEMA MW 1000 can order the new 2011 edition of the standard in hard copy, electronically, or both by visiting www.MW1000.com. ei Mike Leibowitz, Program Manager | mike.leibowitz@nema.org

Listen to the Podcast


NEMA Magnet Wire Section Adopts New Appendix for Next Release of NEMA MW 1000 In response to numerous requests from end users of magnet wire for winding tension recommendations, Mike Leibowitz of NEMA and Jim Avery of MWS Wire Industries discuss the new Appendix G. http://podcast.nema.org/index.php?id=97
MW 1000-2011 will also include a reworked procedure for determining the dimensions of rectangular filminsulated magnet wire. The current procedure is intended to take into account hourglass-type variations caused by the rolling process; the revised procedure, however, will address concerns that cutting three specimen lengths at

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March 2012

International Roundup
Mexico Energy Efficiency Labeling Law Sticks
Several years ago, the Mexican Congress passed seemingly innocuous legislation known as the Law for Sustainable Energy Use. Among other things, it was intended to inform consumers about the amount of energy used by the products they purchased, and thus improve the likelihood they would select more efficient products. The law requires two Mexican Federal Agenciesthe National Commission for Energy Efficiency (CONUEE), part of the Secretary of Energy, and the Federal Consumer Agency (PROFECO)to promulgate a system of labeling and reporting on the energy consumption of a broad list of products, currently covering 186 different categories. NEMA members products are named in about a dozen of these categories (the number is approximate because there continues to be disagreement about the definition of some products), including lighting, welding, motors, voltage regulators, and some wiring devices. The regulation sets no limits on energy consumption or efficiency requirements. It requires that all products contain labels that indicate energy consumption during operation, standby energy consumption (if applicable), and the output of the product (e.g., hp, lumens, etc.) per unit of energy consumed. This same information is required to be reported to both CONUEE and PROFECO, not only electronically, but delivered to federal offices in printed form as well. During the process of developing the reporting requirements, NEMA, along with several other trade associations, notified the Office of the U.S. Trade Representative and the Department of Commerce, that this regulation was not notified to the World Trade Organization, placing affected companies at a significant disadvantage for meeting the implementation timetable that identified October 1, 2011, as the deadline for submitting all energy consumption data and having all products properly labeled. At the same time, NEMA argued that the reporting requirements of delivering printed reports to specific federal offices in Mexico City created a significant burden on companies not having local offices. It is also very inefficient. Despite considerable efforts by the U.S. government on behalf of industry, the Mexican government has remained adamant that none of the original requirements of the regulation will be altered. NEMAs Mexico office and headquarters staff have been working with the different NEMA product sections and member companies affected by this regulation to design more efficient reporting formats, develop testing protocols for specific products to ensure a level playing field, and provide feedback from the two named Mexican federal agencies in response to ongoing inquiries. We were able to obtain a ruling that products such as motors and ballasts already covered by mandatory energy efficiency requirements (energy-efficient NOM standards) were exempted from the new requirements. However, we have little indication that the regulation will be significantly modified in the foreseeable future. NEMA member companies having questions should contact our offices for assistance. ei Gene Eckhart, Senior Director for International Operations | gen_eckhart@nema.org

USNC Seeks Nominations for IEC Young Professionals


The U.S. National Committee of the International Electrotechnical Commission is seeking nominations for its 2012 IEC Young Professionals Competition. U.S. stakeholders are encouraged to nominate young professionals who work for industry, government, academia, consumer organizations, or any entity within the U.S. voluntary standards and conformity assessment community. Learn more at www.iec.ch/members_experts/ypp/programme/what.htm.

NEMA electroindustry

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Learn

More
DICOM (Digital Imaging and Communications in Medicine), a global standard managed by MITA, enables the transfer of medical images in a multi-vendor environment and facilitates the development and expansion of picture archiving and communication systems. DICOM standards (NEMA PS3) are available for download at no charge at www.nema.org/stds/dicom.cfm. MITA is a leading standards development organization for medical imaging and radiation therapy equipment. To see a complete list of MITAmanaged standards, visit www.nema.org/prod/med.

November April
Just think of ita building as a living, breathing entity. Whether it is still on the drawing board or a renovated historic treasure, a high performance building (HPB) is more than the sum of its parts. In April, ei looks at how an HPB functions as an integrated entity just like a human body. Motors and generators are the heart and circulation; industrial automation is the brain; lighting becomes its eyes; cybersecurity functions as the immune systems; and energy baselines monitor the daily regime. You get the picture. Multiple systems contribute to its overall physical wellbeing and individuality. By the time were done, you just might find the soul of the HPB.

Coming in

Medical imaging is widely acclaimed as a hallmark of modern medicine. But what is CT, MRI, PET, RT, X-ray? When are they prescribed? How are they used? For answers, visit www.medicalimaging. org/medical-imaging-primer. MITA supports using diagnostically appropriate research to improve the quality of healthcare, believes that transparency is key to a smooth and efficient regulatory process, and champions the principle of radiation dose management. Learn more about MITAs policies and positions at www.medicalimaging.org/ policy-and-positions.

stoCk art CreDits:


12 & 13 iStockphoto.com/ Baks 14 & 15 iStockphoto.com/dra_schwartz 20 keren-seg/Shutterstock.com

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Economic Spotlight
Healthcare Market Uncertainties Point to Unsteady, Modest Growth Ahead
Changes in the healthcare marketplace, some brought on by larger demographic and business trends and others resulting from the Patient Protection and Affordable Care Act (ACA), are pointing to an unsettled period in the months ahead for those, like diagnostic imaging equipment manufacturers, involved in that sector of the economy. Although ACA was signed into law nearly two years ago, its effects on healthcare providers and the industries that serve them, remains uncertain. Perhaps the greatest uncertainty at this point is the pending Supreme Court hearing on the constitutionality of the individual mandate, which is on the courts docket for the spring of 2012. That decision may well render many of the remaining points moot, and as such it remains the single greatest point of uncertainty regarding this market. Working from the assumption that most, if not all, of the statute remains in force after the court has done its work, the healthcare market still faces considerable uncertainties. Left unanswered at this point are questions of ACAs effect on Medicare/Medicaid as countervailing forces of cost containment efforts and expanded coverage meet and how the states will handle their role in managing the laws various provisions. Diagnostic imaging equipment manufacturers will face a subset of the greater Medicare/Medicaid concern as they will be serving a larger insured population, albeit one that is likely younger and healthier than the current cohort with health insurance, but they will also be underwriting a portion of the changes through payment of a device tax. A couple of trends already underway will also shape the future of healthcare delivery, and may present significant opportunities to those who understand them and position their businesses appropriately. Healthcare-related systems appear to be undergoing consolidation on many levels. In many cases hospitals are merging or expanding through buyouts, doctors are moving to highervolume practices, and larger insurance companies are building their portfolios as smaller companies fail to compete. This trend toward consolidation, coupled with the movement to electronic recordseven ahead of the mandateis likely to spur growth in the healthcare IT field. The accompanying charts help to illustrate the potential and the perils facing the industry over the next several quarters. Real consumer spending on healthcare, which has recently been growing at an annual rate of between one and two percent, is expected to surge by four to five percent beginning in 2014 with the influx of the newly insured. Again, this growth in spending may not have as much direct effect on the diagnostic imaging industry as one might think, given the demographic makeup of many of those who will be added to the insurance roles. Likewise, after lagging for several quarters, hospital/healthcare facilities construction is likely to resume growing, but anecdotal evidence suggests that much of that growth will be in the form of renovation rather than new facilities, which indicates the potential for a modest boost to diagnostic imaging manufacturing. ei Steve Wilcox, Director of Market Research | wilcoxs@nema.org

Real Consumer Spending on Healthcare


2000.000 1500.000 1000.000 500.000 0 2009
y/y % ch (right) Billions of dollars, SAAR (left)

Real Investment, Hospital/Healthcare Facilities Construction


40.0000 33.7500 27.5000 21.2500 15.0000 2009

y/y % ch (right) Billions of dollars, SAAR (left)

2010

2011

2012

2013

2014

2011

2013

Tuesday, January 31, 2012

Tuesday, January 31, 2012

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