Medical Journey March

8/2/2019 Medical Journey March

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The Association of Electrical Equipment and Medical Imaging Manufacturers n www.nema.org n March 2012 n Vol. 17 No. 3

to People-ocused Medical Imaging

MITA LooksBeyond the Machine

ALSOI

NSIDE

n Beyond the Imaging SuiteTransorming the Patient Experience

n Ensuring Electrical Saety 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 Staf to Strengthen Public Policy Expertise


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CONTENTS

FEATURES:

NOTES:

NEMAelectroindustrytext and cover pages are printed using SFI certifed Anthem

paper using soy ink.

SFI certied products come from North American forests

managed to rigorous environmental standards.

SFI standards conserve biodiversity and protect soil andwater 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.

ECO BOX

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 ofces. 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 reect 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

electroindustryPublisher | 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

DEPARTMENTS:Government Relations Update ........................7

Energy Savings through Innovation andMarket Transormation...................................................7

Transportation on the Agenda as NEMA GroupVisits Capitol Hill ............................................................8

RoHS Recast Expands Scope to MedicalImaging Sector...............................................................9

Improving the Medical Device Review Process:A Perspective on MDUFA ............................................10

NEMA Advocates or CO Detection inMaryland Schools ........................................................10

NEMA Weighs in on DOE Transmission Proposal.........11

NEMA Carbon Footprint Initiative ApproachesSecond Phase ...............................................................11

Electroindustry News ..................................

MITA Reorganizes Sta to StrengthenPublic Policy Expertise ...............................................

Fish Where the Fish Are .............................................

NEMA Releases ROI Document or Smart Grid .........

Electrical Saety is NotOptional..................................

Cybersecurity in the Electrical Industry .....................

2012 Illuminations Weekend Returns to

Sunny Florida .............................................................

Code Actions/Standardization Trends ...........

Old Saety Inspectors Dont Retire,They Just Become Enlightened..................................

Pennsylvania Code Council RecommendsSix-Year Code Adoption Cycle ............................ ........

NEMA, Industry Secure Needed Changes inCalifornia Electrical Codeor Nurse Call Systems ........

Healthcare Facilities Codes Ensure Electrical Saety ..

Hospital-Grade Wiring Devices Ensure Patientand Sta Saety ..........................................................

Changes to Dimensional Requirements and

Test Procedures or Paper-Covered MagnetWire Highlight Next Release o MW 1000 ................

International Roundup ...............................

Mexico Energy Eciency Labeling Law Sticks ..........

Economic Spotlight .....................................

Healthcare Market Uncertainties Point to Unsteady,Modest Growth Ahead ..............................................

As Medical Imaging Ser vices Decline,

Patient Care is Threatened ...........................12

How Medical Imaging Helps Patients:

Spotlight on Erika Hanson Brown and

Suzanne Lindley .......................................... 14

A Global Perspective on Medical Imaging ......17

Transorming the Patient Experience ............18

Stewardship Needed

the Helium Shortage ................................... 20

NEMA Ocers ................................................................2

Comments rom the C-Suite ....................... ................... 2

View rom the Top ....................................... ................... 3

View rom the Hill ..........................................................4

Policy & Politics ..............................................................6

Learn More ...................................................................32

Innovative lighting, a gentle wash o color, andprojected images all contribute to a stress-ree,

patient-oriented environment in medical imaging.

See page 18. Photo courtesy o Philips Healthcare

Did you know?NEMAs Electroindustry Business Confdence Index

(EBCI) or current North American conditions can

be ound at www.nema.org/Feb12-EBCI.


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COMMENTS FROMTHE C-SUITEOcers

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 CurtisPresident & 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

2 NEMA electroindustry March 2012

Dominic J. PileggiChairman

According to the New England Journal o Medicine, medical imaging is one o thetop advances that changed the ace o clinical medicine during the last millennium.oday, imaging and radiation therapy are cornerstones o quality care.

Te Medical Imaging & echnology Alliance (MIA), a division o NEMA, is theleading organization and collective voice o medical imaging equipment manuacturers,innovators, and product developers. It represents companies whose sales comprise morethan 90 percent o the global market or medical imaging technology.

Te electrical equipment and medical imaging manuacturing industries are a greatexample o products and systems that have ar-reaching benets or millions oindividuals. I hope you enjoy this edition oelectroindustry. It oers insights intoadvancements in medical imaging technology and descriptions o awe-inspiringhuman outcomes.

Heres to progress! ei

NEMA Board o Governors is accepting nominations or the 2012-2013 term.Consideration will begin in March.

Contact NEMA President and CEO Evan R. Gaddis with nominations via

[email protected]


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NEMA electroindustry March 201

View rom the op

New Horizons or Medical ImagingBased on a speech delivered November 28, 2011, at the Radiological Society o North America by Greg Sorensen, MD,

Chie Executive Ocer o Siemens Healthcare North America and Chair o the MITA Board o Directors.

Medical errors area major challenge.Worse, they arenot a new problem.In act, evidenceo medical errorsdate back to theStone Age. Tereis evidence o

botched brain surgery being perormedas ar back as 5,000 BC.

Over the past decade, however, a patient

saety movement has driven greaterawareness o medical errors and theircostly impact. Several alarming storiesrom amputations o the wrong limb towrong-site surgerieshave given riseto an impressive mobilization o patientsaety advocates. In 2000, the Institute oMedicine validated advocates cause witha report conrming that more people dieeach year rom medical errors (44,00090,000) than rom breast cancer (42,000).

Medicine has been working to overcome

these errors. While solutions haveocused on the reduction o medicationerrors and improvement o systemsto prevent incorrect surgery, we arenow realizing that many members othe medical community have ailed torecognize that diagnostic errors are justas important a problem.

In 2009, theJournal o the AmericanMedical Association published a studythat highlights diagnostic errors asthe next rontier or patient saety. Te

study noted that an estimated 40,000to 80,000 U.S. hospital deaths resultrom misdiagnosis each year, whileapproximately ve percent o autopsiesreveal lethal diagnostic errors.

o put this in context, physician errorsare much more likely to be diagnostic-(ourteen percent) than medication-related (nine percent). Additionally,malpractice claims or misdiagnosis

are twice as common as those ormedication errors and they result inthe largest payouts.

Deaths and disease rom medical errorsrepresent a concerning trend, suggestingthose who perorm diagnostic tests andthose who use diagnostic tests need tochart a new course o strategic thinkingthat promotes both innovation and the

value o these diagnostic methods.

Quantifying the Value

of Diagnosis

Specically, we need to ocus onquantiying the value o accurate andtimely diagnosis. Tis will, in turn,acilitate the sae and appropriate useo these liesaving medical imagingtechnologies. We also need to continueto advocate or a clear and timelypathway to market or our newinnovations and preserve patient accessto an accurate diagnosis, such as throughimaging services, by ghting againstadditional Medicare reimbursement

cuts. Tese eorts will ensure that ourindustry can continue to add valuein addressing the important issue odiagnostic medical errors.

Imaging manuacturers 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.

CT Dose Check Initiative

As part o it s ongoing commitment to ensuring

sae, appropriate, and eective medical

imaging and radiation therapy, MITA supports

the ollowing 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 o dose levels

or patients.

Adopt a standardized method o s toring

diagnostic imaging and radiation therapy

inormation within electronic health records.

Explore the expansion o mandatory

accreditation or advanced imaging acilities.

Establish minimum standards or training

and education or hospital and imaging

acility personnel who perorm medical

imaging exams and deliver radiation

therapy treatments.

Develop enhanced operational saety

procedures and checklists to reduce

medical errors.

Expand and standardize the reporting o

medical errors associated with medical

radiation across stakeholders in a manner

that is transparent or patients, amilies,

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.


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View rom the op

Later this year,companies thatmanuacturedrugs, biologics,and medicaldevices will berequired to reportinormation on

payments given to doctors under thebipartisan Physician Payments Sunshine

Act(Sunshine Act), which was signed intolaw as part o the Patient Protection and

Aordable Care Act. And, next year, theinormation that is collected about thesepayments will start being made availableto the public online.

Te Sunshine Act, which wasdeveloped along with my colleagueSenator Chuck Grassley (R-Iowa),

o innovation and develop improvedtechnologies that can acilitate earlierand more precise detection. Importantlour imaging innovations can and musthelp better prevent misdiagnosis and

play a critical role in taking on this newrontier in patient saety.

It is such an exciting time to be inmedical imaging, and its not just mewho thinks so. In a now-classic survey,when physicians were asked to identiythe most important innovations theyhave encountered in the past decades, athe very top o list was cross-sectionalimagingthe very things developedby MIA companiesranking higherthan even therapeutic innovations.

Tese results speak to the vibrancy andrelevance o radiology. ei

Brain imagers have made great strides

these past ew decades as the tools o

advanced imaging have brought on not

just pictures but mathematical tools.

Specialists are now able to analyze the

brain in ways we could never beore

using mathematical models and

representations to understand imaging

data that go ar beyond visual and move

to quantitative interpretation.

echnologies like hybrid modalities

that simultaneously acquire both

magnetic resonance (MR) and positron

emission tomography (PE) scans havethe potential to transorm diagnosis by

enabling combinations o inormation

that unlock exciting insights. We are

now beginning to investigate diseasesat a much deeper level than everbeore possible.

Diagraming the human Brain

For example, there is a substantial levelo interest in Alzheimersinterest thathas been enabled and accelerated bytechnological developments that help tounderstand the disease. Radiologists andother imaging specialists are working tobuild the tools that will let us see into thebrain using sophisticated and impressivemachines that go beyond where wehave ever gone beore. Tis exempliestremendous potentialwe are nowbeginning to identiy the wiring diagramo the living human brain, oering a level

o insight that we cant get any other way.

MIA member companies are well-positioned to continue on the pathway

View rom the HillSunshine Act

Strengthening Doctor-Patient Relationships through DisclosureSen. Herb Kohl

will provide accountability, openness,

and transparency to the nancial ties

between doctors and the drug and

device industries.

While these relationships can be

important in developing new therapies

and diusing new technologies, it is

essential that these ties do not lead to

conicts o interest that impact patient

care. Many states already require thistype o reporting, and we have seen

that disclosure has helped to curb

inappropriate payments.

Specically, the Sunshine Act will

improve the publics understanding o

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 w

be able to search or their own doctors

and see what types o payments and gi

were given and why.

Te Sunshine Act is a reection o

recommendations o major medical,

consumer, and industry groups, as well

as the Medicare Payment Advisory

Commission and the Institute o

Medicine. Te policy has been supporteby a diverse group o stakeholders,

including consumer and patient groups

proessional medical associations,

provider organizations, and industry.

As we developed the nal bill, we worke

hard to address the legitimate concerns

o industry, consumer groups, and othe

stakeholders. More recently, we pushed

Learn more about MITA at www.medicalimaging.org


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the Department o Health and HumanServices (HHS) to issue timely draguidance about how the inormation willbe collected and categorized.

Senator Grassley and I will continueto press HHS to consult with industry,consumer groups, and other stakeholdersin developing these rules, particularly

with regard to categorizing these oencomplex 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 or implementation. We realize

that many companies have already made

signicant investments in developing

systems and protocols to comply and

may need time to modiy these systems

based on the nal rule.

As we move orward, I believe thatthe Sunshine Act will help keep

healthcare costs down and strengthenpatient-doctor relationships. I lookorward to continuing to work with

industry, consumer representatives,and HHS to ensure timely and eectiveimplementation. ei

Senator Kohl (D-Wisc.) ischairman o th

Senate Special Committee on Aging.

Imaging Technology Sparks Economic EnginesSen. John Kerry

In just the last

ew decades,

weve witnessed

staggeringadvances in

medical imaging

technologyand

an inspiring story

o American

innovation and hard work. From C

and ultrasound to MRI and PE,

imaging technology has not only made

exploratory surgery nearly obsoleteits

become a sparkplug in the economy

o communities across the country,

particularly in my home state o

Massachusetts.

Medical imaging has created and

sustained more than 10,000 jobs in

Massachusetts, rom the innovators

who build cutting-edge machines to the

suppliers that provide component parts

to the hospital employees that use them

to benet patients.

Tis economic dynamism is one o the

reasons I worked in the Senate Finance

Committee last year to prevent a $400million reduction in Medicare payments

or medical imaging. In tough economic

times, when budget dollars are strained,

its a daily struggle to nd ways to pay

or the investments we must make. In

this case, the cut to medical imaging was

proposed to pay or the rade Adjustment

Assistance (AA) Extension Act o 2011,

a do or die investment or struggling

workers. But simply putwhetherrom a patient, provider, or economicstandpointwe just couldnt aord to

make medical imaging the piggybankto pay or AA when there were otheroptions available.

Te economic impact o cutting medicalimaging would have been problematic.Lowering Medicare reimbursement ormedical imaging encourages doctorsto keep old equipment longer, resultingin ewer patients getting access to thenewest technologies that are better ableto nd early-stage diseases. Te proposedcuts also would have resulted in job

losses or Massachusetts workers andhurt too many physicians, patients, andmanuacturers. Tere was a better wayorwardand together we ound it.

Te outlook or medical imaging remainsprecarious. Tere have already been siximaging reimbursement cuts in the lastseven years, and recent studies indicatethey have taken a measurable toll.

For example, the use o imagingservices declined by 2.5 percent in 2010,

according to the Medicare PaymentAdvisory Commission (MedPAC), theindependent congressional advisoryagency. Similarly, the most recentresearch by the Medical Imaging &echnology Al liance (MIA) showsthat imaging utilization per Medicarebeneciary declined by three percentin 2010. Moreover, in contrast to thedecline in imaging, spending or non-

imaging Medicare services has grown b

20 percent since 2006 and non-imagingutilization increased 2 percent in 2010.

In act, the MIA analysis ound thatimaging is now a smaller portion o

Medicare spending than it was at theturn o the century.

Clearly, imaging Medicare

reimbursements are still threatened.We need to make our casepowerully

Tats why, last July, I organized agroup o bipartisan senators to urge

the president to reject deeper cuts inspending or these vital services. We

asked the president to work with us on

reorms that ensure each patient whoneeds imaging gets it.

We are still working on a sustainablesolution, and thats why now, more

than ever, its vital that the imagingcommunity continues to work with

members o Congresson both sides othe aisle and in both chambersto raise

awareness about how imaging saves livereduces healthcare costs, and creates job

Lets get to work now not only

to preserve these importantreimbursements and to ensure patientaccess to important care, but also to

encourage the kind o innovation that

creates jobs, strengthens the economy,and continues to write the American

success story o medical imaging. ei

Senator Kerry (D-Mass.) is the chairmano the Foreign Relations Committee.


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Policy &Poitis

BILL NAME SUMMARY OF BILL AND IMPORTANCE NEMA POSITION STATUS

Smart Energy ActHR 4017

Establishes a ederal loan program or energyeciency upgrades in commercial,multiamily residential, industrial, municipal, government, school, and hospital buildings. Italso enables the ederal government to use energy savings perormance contracts in supporto its deployment o electric vehicles or electric vehicle supply equipment. The legislationwould also require that ederal agencies participate in demand response programs, whereavailable, to reduce agencies energy costs. It would also require an analysis o best practicesin ederal buildings or the advanced metering o energy use, including recommendations onstandard requirements or guidelines or automated energy management systems.

Support: Promotes energy eciency and greateradoption o energy ecient technologies in buildings.

Introduced 2/14/12. Next Step:House Energy & Commerce Commhearing

Storage Technologyfor Renewableand Green Energy(STORAGE) Act, S1845

Establishes investment tax credits or a broad array o energy storage technologies that areconnected to the grid (20% credit) or used on-site at industrial, commercial, or residentiallocations (30% credit).

Support: Accelerates adoption o energy savingtechnologies

Introduced in SenateNext Step: Senate Committee onFinance

Energy Savingsand IndustrialCompetitiveness ActS 1000

Creates ederal-state loan programs or commercial building and industrial acility energyeciency upgrades that the market is not currently encouraging. Incents states to adoptnational building energy codes developed by ASHRAE or ICC.

Support with modifcation: Promotes energyeciency, supports manuacturing jobs, and increasesU.S. competitiveness. Modifcation to building codeprovisions pending.

Voted out o Senate Energy and NaResources Committee 7/14/2011

Next Step: Senate Floor

RegulatoryAccountability ActHR 3010, S 1606

The bill modernizes and updates the 1946 Administrative Procedures Act (APA) oreconomically signifcant regulations.

Provisions would enhance public participation in rulemakings; require agencies to choosethe lowest cost option or explain compelling need otherwise; on-the-record administrative

hearings with agency ocials; include direct and indirect cumulative costs, benefts, andestimated impact on jobs, growth, innovation, and competitiveness; consider reasonablealternatives including no ederal response.

Support: Incorporates established cost/beneftprinciples in considering rulemaking, makes the processmore transparent, agencies more accountable, andoverhaul out-moded APA.

Approved by House 253-16712/2/2011Next Step: Senate consideration

High PerformanceFederal Buldings ActHR 3371

The bill promotes energy eciency and high perormance in ederal buildings through theuse o an integrated and holistic approach to building design, construction, operations,and maintenance including use o building inormation modeling (BIM), liecycle costing,commissioning, and compliace verifcation.

Support: Promotes energy eciency in ederalbuildings and greater adoption on energy ecienttechnolgies in these buildings.

Introduced 11/4/2011 and reerredHouse Transportation and InrastruCommitteeNext Step: House committee he

Critical MaterialsPolicy Act, S 1113

Directs Department o the Interior to prioritize minerals, including rare earths, based onimportance to the U.S. economy and outlines a set o policies to bolster domestic productiono these minerals, expand manuacturing, promote recycling and alternatives, and maintainstrong environmental protections.

Support: Leverages work already done at Interior andEnergy deparmtents and brings greater urgency andcoordination at the ederal level necessary to createopportunities or U.S. manuacturers.

Senate Energy and Natural ResourcSubcommittee hearing held 6/9/2Next Action: Senate committeeconsideration

Federal Budget: And Now It BeginsKyle Pitsor, NEMA Vice President o Government Relations

In presenting

his 2013 budget,President Obamacarried throughon initiatives andpolicies he outlinedin his 2012 State othe Union address.

In an election year, the presidentsproposal is politically signicant as it laysout policies and initiatives that will shapethe campaign season while oering atemplate or unding levels.

In terms o policy impact, the proposalhas no chance o passing Congress.Over the coming weeks, various budget

hearings will be held and beginning

in May, appropriations work willcommence aimed at craing 12 bills orunding the unctions o government.Looming in the background to theappropriations work is the act that the2011 Budget Control Act mandates $1.2trillion in cuts (hal rom deense).

Whether Congress completesappropriations work or scal 2013 orends up passing another continuingresolution (CR) remains to be seen.Given the election year, another CR is

likely, which means the time betweenElection Day and New Years Day willsee signicant legislative intensity.

NEMAs advocacy ocus is on unding

support or key industry priorities andpolicies that oster economic growth,job creation, and competitiveness. Tesinclude research and development,innovation, advanced manuacturing,energy efciency, technologydeployment, exports, and tradeenorcement.

NEMA will also continue to opposerepeal o LIFO (last-in, rst-out)inventory and accounting as a revenueraiser. We will also oppose proposals

in the budget that would harm patientaccess to medical imaging and advancetechnologies. ei


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Government RelationsUpdate

Energy Savings through Innovation and Market TransormationTe lighting industry has long beena ountainhead o research andinnovation in response to the quest orbrighter, cheaper, more efcient, andmore eective lighting componentsand systems. Because lighting isan immediately visible subject, itsperormance and application merits are

very quick to be gauged.

However, lighting energy consumptionmetrics and proo o eective operation,while easy to see at the home orcommercial level, are harder to quantiyover a larger scale. National energy use

or lighting is a diverse topic with manydierent solutions and installations.

Recently, the Department o Energy(DOE) released two reports on lightingenergy consumption and predictions orthe uture o lighting in the U.S.

lighting-relateD energy usage

DOEs 2010 U.S. Lighting MarketCharacterization1 (LMC) was releasedJanuary 23, 2012. It ollows up andbuilds on the 2001 LMC2. NEMA andits Lighting Systems Division members

have been poring through it and the 2001version to perorm a tailored analysis.

Te ollowing items were noted:

In 2001, lighting accounted orapproximately 765 terawatt-hours(Wh) o electricity consumption,equal to 22 percent o total U.S.electricity consumption.

In 2010, lighting accounted orapproximately 700 Wh o electricityconsumption, or 19 percent o total

U.S. electricity consumption.

In 2001, there were approximately 6,977million permanent lamps in the U.S.

In 2010, there were approximately 8,203million permanent lamps in the U.S.

Tis means that lighting consumptionwent down by 65 Wh while the numbero lamps went up by more than onebillion (an increase o about 15 percent).

Residential settings still maintain thehighest percentage o incandescent lamps

at a near identical level62 percentin 2010 versus 63 percent in 2001. In2010, compact uorescent lights (CFLs)

comprised 23 percent o residentiallamps, and linear uorescent another 10percent. Tough most houses have one ormore CFLs, there is still twice the number

o incandescent lamps in residencescompared to CFLs, meaning there is stillmuch energy savings to be realized.

I the lighting energy consumptionin 2001 had not been aected by new,

efcient products, consumption in 2010should have been around 880 Wh, not700 Wh. But something happenedenergy consumption over that decade

went down, despite a 15 percent increasein potential demand. What caused it?

Te lighting industry is one o

constant innovation and improvement.New products are increasingly moreenergy efcient.

Federal, state, local, and industry-sponsored outreach and education were

eective in encouraging new products.

Industry innovation enabled theimplementation o new and efcientproducts and in doing so, transormed

the nations energy consumption habits.

Between 2001 and 2010, the onlysignicant ederal regulation that could

have aected the energy consumption olighting products was the 2005 EnergyPolicy Act(EPAct). Te lighting products

most aected by EPAct are CFLs, which

according to the 2010 LMC are stillmaking inroads and thereore couldnot be responsible or the huge energy

savings noted.

What Does the future holD?

Te second report by DOE regardingenergy efciency in lighting applicationis the Energy Savings Potential o Solid-State Lighting3 (SSL), released January 27,

2012. In it, DOE claims that LEDs (light

emitting diodes) in general illuminationapplications has the potential to reduce

U.S. lighting energy consumption bynearly one-hal.

LED lighting is expected to represent36 percent o lumen-hour sales on thgeneral illumination market by 2020,and 74 percent by 2030.

By 2030, the annual site energy savinrom market penetration o LEDs wilbe approximately 300 Wh, or theequivalent annual output o about 501,000-megawatt power plants.

Te total energy consumption or

lighting would decrease by roughly46 percent relative to a scenario withno additional LEDs on the marketenough electricity to completely pownearly 24 million homes.

Tese are impressive claims and will bethe subject o much consideration goingorward. Will energy consumption orSSL become as regulated as most othe preceding lighting technologies?Regulations passed too early in atechnologys development and discover

lietime can easily hinder innovationand progress, despite all good intentionWith this in mind, SSL regulations areregarded as premature at this time.

SSL is also the rst lighting innovationo the global age, and as such,collaboration is occurring at the higheslevels o scientic and governmentaloversight. As SSL reaches maturity, itwill be interesting to see how codes andregulations adapt to this innovativeproduct eld.

Alex Boesenberg, Regulatory AaiManager | [email protected]

1 http://apps1.eere.energy.gov/buildings/publications/pds/ssl/201

lmc-nal-jan-2012.pd

Executive Summary: http://apps1.eere.energy.gov/buildings/

publications/pds/ssl/2010-lmc-summary-jan-2012.pd

2 http://apps1.eere.energy.gov/buildings/publications/pds/ssl/

lmc_vol1_nal.pd

3 http://www1.eere.energy.gov/buildings/ssl/tech_reports.html


10/36



Transportation on the Agenda as NEMA Group Visits Capitol HillA delegation o NEMAs ransportation

Management Section visited Capitol

Hill on January 26 as the House o

Representatives prepared to considermulti-billion-dollar legislation to support

roads, bridges, highways, and transit

inrastructure.

Te group, led by Section Chairman

Bryan Mulligan o Applied Inormation,

visited six ofces in the House and

Senate to discuss prospects or a

multi-year bill to reauthorize ederal

surace transportation programs and

to emphasize the importance o IS

technology and standards to the uture o

our countrys transportation networks.

Te Senate is preparing its own two-year

version o the legislation and at the time

o the NEMA meetings, two major pieces

o the package had been put orward

by the Committee on Environment

and Public Works (EPW) and the

Committee on Commerce, Science, and

ransportation (CS).

In a meeting with Democrat and

Republican sta o the EPW committee,

NEMA welcomed that committees

support or the deployment o IS

in ederally unded road projects but

oered recommendations or urther

improvements. Te NEMA group also

met with sta or Sen. Pat oomey (R-PA),

a member o the CS committee, and Sen.

om Carper (D-DE), a member o the

EPW committee, to seek their support.

Shortly aer the NEMA groups visits,

the House Committee on ransportation

and Inrastructure (&I) was scheduledto consider a bill authorizing ve years o

transportation inrastructure activities.

NEMA met with the ofces o Rep. Bill

Shuster (R-PA), a senior member o the

&I committee; Rep. Rob Woodall (R-

GA), a reshman member serving on the

House Rules Committee; and Rep. Brian

Bilbray (R-CA), a member o the Energy

and Commerce Committee whose

district was aected by the September

89, 2011 blackout.

In each meeting, NEMA promoted open

national consensus standards, institution

o perormance measurement and

metrics or the transportation network,

and the application o IS technologies

on all high-trafc roadways to reduce

congestion, vehicle emissions, saety

risks, and associated costs.

NEMA also recommended both housesapprove and send to the president a ve-

or six-year bill that would achieve greater

stability and predictability and enable

longer-term planning and investments.

Four member companies o the NEMA

ransportation Section have operations

in Rep. Woodalls Atlanta-area district.

Tree individual members o the group

also held one-on-one meetings withofces o their local laegislators.

Te meetings marked the consecutivethird year that the ransportationSection has held annual outreachmeetings with ederal decision makersin Washington with assistance romNEMAs Government RelationsDepartment. ei

Craig Updyke, Manager, Trade anCommercial Aair

[email protected]

Members o the NEMA ransportation Section pause between meetings on Capitol Hill, January 26:

(l-r) Bill Klyczek, racon USA; Russ Brookshire, Intelligent Devices; Kleinjan Deetles, McCain; Section

Chairman Bryan Mulligan, Applied Inormation; Robert Rausch, ranscore IS; Bill Russell, Eberle Design

Ray Deer, Peek rac; John Miller, NEMA Industry Director; and Jean Johnson, NEMA echnical Services

Photo by Craig Updyke

Learn more NEMAs Transportation Managemen

Systems and Associated Control Devices Section

at www.nema.org/prod/elec/trans


11/36


RoHS Recast Expands Scope to Medical Imaging SectorOver the past decade, regulations

spawned by the European Union (EU)

have had a dramatic, worldwide impact on

product design and marketing within theelectrical and electronic manuacturing

sectors. Te principal driver o this new

regulatory paradigm o course has been

Directive 2002/95/EC on the Restriction

o the Use o 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

rom the scope o Directive 2002/96/EC,

the so-called WEEE Directive, which

established a regulatory structure or the

EU governing how electro-products are

managed at end-o-lie.

Noticeably excluded rom the scope o

RoHS were medical devices, meaning

that MIA members and other global

manuacturers o diagnostic imaging

technology were not subject to the strict

hazardous substance thresholds that the

directive imposed on much o the rest o

the electrical product industry.

Tese thresholds, which apply to

mercury, lead, cadmium, chromium, and

certain brominated ame retardants,

have led to burdensome compliance

costs across many product sectors. A

2008 study conducted by the European

Commission estimated past costs o

complying with RoHS, including R&D

and capital costs, as averaging 1.9

percent o annual revenues or 3,185

($4,240) per employee per year. Costs

or small and medium enterprises wereconsiderably higher at 5.2 percent. Te

same study pegged uture ongoing

compliance costs as 0.4 percent o annual

revenues or 273 ($363) per employee

per year, with costs to small and medium

enterprises again being much higher1.

Te exemption or medical devices rom

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 ramework, lays out aschedule or bringing medical imaging

devices into compliance (Note: the

exclusion will remain in place or all

implants and inected products).

Tis is no surprise to the imaging

industry, which advised EU authorities

or years in their eort to cra a timeline

that accords with the directives priorities

o environmental protection while

granting manuacturers the exibility

needed to avoid any compromise in the

liesaving benets o imaging technology.

Te industrys position was validated in

the EUs own study o the issue, which

concluded in 2006 that:

Te date or inclusion o [medical

devices] in the scope o RoHS will

need to take into account the specic

characteristics and requirementso [diagnostic imaging] equipment.

One essential characteristicis high

reliability. Tis could be aected

detrimentally i these Categories were tobe included in the scope o RoHS at too

early a date. In addition, sucient time

is required or testing, validation, trials

and obtaining approvals.2

On the basis o extensive consultations

in the wake o this study, the recaststipulated that medical devices must

come into compliance with the substance

thresholds by July 22, 2014, which

amounts to an eight-year extension o

the compliance date established under

the original directive. In-vitro diagnosticmedical 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 eatures

a modied schedule o exempted

applications o the six hazardous

substances in covered products.

A portion o this schedule applies

specically to medical imaging devicesand encompasses applications that musbe maintained to ensure patient saety

and operational eectiveness (e.g., leadin shielding or ionizing radiation).Industry stakeholders worked diligentlywith EU authorities to dene criticalexemptions that manuacturers need totransition smoothly into compliance.

Substance thresholds are only part othe story with the recast, however, asRoHS is now a CE mark directive.Manuacturers o covered productsmust now construct a sel-declarationo conormity, maintain technical

documentation, cite relevant harmonizstandards, implement internalproduction controls, and keep a registero nonconorming products. Te CEmark is well known to manuacturers aa part o doing business in the EuropeaUnion, but its applicability to the RoHSDirective promises to greatly expand thcost and complexity o compliance.

MIA members, like all sectors withinNEMA, believe that environmentallyconscious design o electrical products

is undamentally appropriate and, to thextent easible, should include limitingthe use o hazardous substances. But thgoal cannot take precedence over thesaety, perormance, and reliability oimaging systems. Te industrys diligeneort to ensure a graduated schedule ocoming into compliance under RoHSreects this value. ei

Mark A. Kohorst, Senior Manago Environment, Health, & Saet

[email protected]

1 Study on RoHS and WEEE Directives N 30-CE-0095296/00

09, Final report, European Commission, DG Enterprise an

Industry, March 2008

2 Dr. Paul Goodman, Directive 2002/95/EC (RoHS) Catego

8 and 9Final Report, ERA echnology, ENV.G.4/

EU/2005/0014, Exec Summar y, 2006


12/36



Improving the Medical Device Review Process: A Perspective on MDUFAFor the past decade, inefcienciesassociated with the Food and DrugAdministrations (FDA) medical device

review process have contributed tosignicant delays in bringing innovativeimaging technologies to market. Teprevailing obstacle has been identiyingsolutions that quicken the review processwhile still maintaining patient saetyand, at what cost to companies.

As with many bureaucratic processes,the stickier the red tape, the greater theimpact o costly delays. Not only has thelengthy and unpredictable medical devicereview process eectively restricted

patient access to liesaving technologies,but slow approval times also havedissuaded external parties rom investingin medical devices.

Fortunately, FDA announced last monththat it had reached an agreement with theindustryrepresented by MIA and twoother industry associationsto reauthorizethe medical device user ee program.

Tough the details o the programextension are still to be nalized byCongress, the agreement sets orth

very promising provisions regardingtimetables or clearance, with the overallaim to correct lagging review times andimprove patient access to new diagnosticsand therapies.

Te ve-year user ee agreement includes,

or the rst time, new goals or total review

time or premarket reviews. Reconciling

FDA and industry interests, the agreementaims to reorm both the pre-submission

interaction and guidance development

processes by establishing mechanisms or

earlier, more eective communications

between manuacturers and FDA.

In exchange or more than doubling

the unding rom device companies,

FDA agreed to reduce the time between

the submission o an initial review

application and the nal decision. I

clearance submissions run up againstpre-established deadlines, FDA will

be required to meet with companies

to explain and address the underlying

reasons or the delay. In the name o

increased transparency, FDA will also

be required to provide requent progress

reports regarding review time goals.

Moreover, in an eort to increase

program capacity, FDA will hire

more than 200 ull-time employees,

including 140 new device reviewers. o

urther promote transparency, the newagreement requires a third-party audit o

how FDA manages the premarket review

program to identiy ways the agency can

become more eective and efcient.

aken together, these programimprovements will create a morepredictable and productive review

process, ensuring that patients haveaccess to sae and eective medicalimaging and radiation therapytechnologies. Greater predictability andconsistency in the approval process willnot only correspond to enhanced produsaety and eectiveness, but will helpshrink the gap that currently preventsinnovative technologies rom reachingthe market in a timely manner.

Tough the compromise entails highercosts to be incurred by medical device

manuacturers, the new user eeagreement illustrates a true commitmenby FDA and industry to provide patientwith the saest and most advancedtechnologies available. In a time otremendous innovations in imaging andradiation therapy technologies, we mustprioritize patient access and saety.

Tis long-awaited agreement reachedby FDA and industry will enable theindustry to bring innovative, liesavingtechnologies to market aster than ever

beore, so that patients across the U.S.receive the care they need. ei

Lindsay Morris, SeniDirector, MITA

[email protected]

NEMA Advocates or CO Detection in Maryland SchoolsAt the beginning o the 2012 legislativesession, Maryland Delegate CherylGlenn (D) introduced HB 2, legislationto require the installation o carbonmonoxide (CO) detection and warningequipment in Marylands public schools.A Senate companion bil l, SB 173, hasbeen introduced by Senator KathyKlausmeier (D). A hearing on HB 2 wasscheduled or February 2, 2012.

NEMA actively supports enactmento this legislation and has engaged alobbyist to advocate beore the MarylandGeneral Assembly on its behal.

Partnering with lie saety advocates,non-industry partners, and the MarylandState Fire Marshal, NEMA is working toensure that students, aculty, and schoolsupport personnel are not subject to COdangers when at school. I Marylandenacts this legislation, it will be thesecond state to require CO detection inschools. Te State o Connecticut enacteda similar law in 2011, largely due toNEMAs successul advocacy in the state.

Expansion o CO detection requirementsto public schools builds on the successulenactment o state laws and codes

requiring installation o CO detectionin various residential and commercialoccupancies. o date, over threedozen states have enacted suchrequirements. A map o these staterequirements is available atwww.liesaetysolutionsonline.com. ei

Sarah Owen, Government RelatioManager | [email protected]


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NEMA Weighs in on DOE Transmission Proposal

NEMA Carbon Footprint Initiative Approaches Second Phase

On January 27, NEMA led comments

with the Department o Energy (DOE)

in response to its proposal (Coordination

o Federal Authorization or Electricransmission Facilities, RIN 1901-AB18)

to streamline the way in which ederal

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 reorm would

include expediting environmental

reviews and establishing additional and

tighter deadlines or ederal agencies to

meet in completing various components

o their project evaluations.

Te DOE proposal would automatically

put in place ederal coordination or

projects that are 230kV and above,

built or the transmission and sale

o wholesale electricity in interstate

commerce, and at least in part cross the

jurisdiction o more than one ederal

agency. Other projects that do not meet

Te NEMA strategic initiative designedto help member companies assess thecarbon ootprint o electrical products ispoised to move beyond the early stages ocraing the methodology and testing iton selected ocal products.

As expected, the initial trial runevaluations generated insights to actors

that drive the carbon impacts o productsunder evaluationenergy efcientlamps and ac induction motors. NEMAsintent is to provide a tool specicallyor the electro-product sector that helpsexpose the links between materialsand processes used to create products,and greenhouse gas emissions. Teseare measured in kilograms o carbondioxide equivalents.

these criteria may voluntarily apply or

ederal coordination.

DOE would coordinate the selectiono a lead agency, dened as the one

most impacted by the transmission

project. Te lead agency is then

responsible or preparing a unied

environmental review document under

the National Environmental Policy

Actand maintaining a consolidated

administrative record.

Te proposed rule sets some basic permit

decision deadlines to reduce delays aer

environmental reviews are completed.For projects that receive a categorical

exclusion or environmental assessment

that results in a Finding o No Signicant

Impact (FONSI), ederal permit decisions

must be made within one year o the

exclusion determination or publication

o the FONSI. For projects that require

an Environmental Impact Statement

(EIS), ederal agencies have to make their

decisions within one year and thirty days

aer the close o the public comment

period or a dra EIS.

Te methodology accounts or all phases

o product lie (resource extraction andacquisition, manuacturing, transport to

market, use, and disposal/recovery).

Knowledge o how the carbon is

distributed across the lietime o a

product can help inorm design strategiesand enable companies to respond to

regulatory and market pressures. Moreimportantly, it tells manuacturersconcerned with reducing their carbon

ootprint where to direct their resources

and how much o an impact those

investments are likely to have.

Last year, the NEMA Board o Governorsapproved a second year o unding or

the Carbon Footprint Initiative. Sta is

Te lead agency would also collaboratewith DOE to populate a website thatdisplays pertinent inormation or

qualiying projects so stakeholders andthe public can be better inormed.

Te sheer number o parties that arerequired to review and sign o ontransmission projects is a big reason thathe permitting process is unable to keepup with the need to rapidly modernizethe electric grid.

Te nine agencies aected by thisproposed rule are the Departmentso Agriculture, Commerce, Deense,

Energy, and Interior; the FederalEnergy Regulatory Commission; theEnvironmental Protection Agency; theCouncil on Environmental Quality;and the Advisory Council on HistoricPreservation.

Improving coordination among theseagencies is a rst step to simpliyingthe interaction between transmissiondevelopers and the ederal government.

Jim Creevy, Director o GovernmeRelations | [email protected]

working with expert contractors at MIMaterials System Lab to extend theproject plan.

One o the key tasks involves selectingadditional ocal products or evaluationthat are more complex in terms o desigproduction, or operation than lamps anmotors. Tis is a crucial step in ensurin

that the methodology ultimatelyproduced through this initiative is asbroadly applicable as possible within thNEMA product scope.

o participate in a technical advisorygroup, contact Mark Kohorst. ei

Mark A. Kohorst, Senior Manager Environment, Health, & Saet

[email protected]


14/36


In 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.

One area in which we have seen such innovation ismagnetic resonance imaging (MRI). Recently, researchersat Massachusetts General Hospital and the University oPennsylvania were able to utilize MRI scans to pinpointpatient risk or Alzheimers disease beore symptoms werenoticeable. Trough earlier detection, physicians are able totreat Alzheimers at earlier stages than has ever been possible.

Despite such innovations, several independent analyses oMedicare claims data in 2011 reveal an alarming downwardtrend in the utilization o these imaging services. Not only is

spending on medical imaging declining, Medicare patients areactually receiving ewer imaging procedures, which debunksthe widely prolierated myth that liesaving diagnostic imagingand radiation therapy are being overused and increasing thecost o healthcare.

Notably, during a public meeting in December 2011, theMedicare Payment Advisory

Commission (MedPAC)reported that imaging services

declined by 2.5 percentin 2010. Tis conrmed

MIAs own analysis o

Medicare claims datacommissioned earlierthat year.

Our analysis revealedthat per-beneciaryspending on imagingservices had dropped

13.2 percent since2006, when signicant

imaging-specic reimbursement cuts rom the Decit Reductio

Acttook eect, and imaging utilization per-beneciary decline

by 3 percent in 2010. Moreover, the report ound that imaging

currently represents a smaller portion o Medicare spending

than it did in 2000. MIAs analysis also ound that spending

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

conrmation o MIAs ndings that Medicare imaging use

and spending are down. On the heels o MIAs report,

researchers at Tomas Jeerson Medical University in

Philadelphia released a similar study examining how advanced

imaging modalitiessuch as computed tomography (C),

positron emission tomography (PE), and MRI scanshave

been used in recent years. Teir ndings show that rom 2007

through 2009, there were signicant reductions in the growth

o C and MRI. Furthermore, the rate o nuclear medicine

utilization actual ly decreased.

Beneits o Medical Imaging

Far Outweigh RisksIn spite o a clear downward trend in utilization, the value o

advanced medical imagingto both patients and physicians

is on the rise. In late 2011, C-based lung cancer screening was

named one o the top ve advances in the ght against cancer

by the American Society o Clinical Oncology (ASCO). Te

ASCO ranking was based on a large clinical trial that illustrate

the eectiveness o lung C scans in lowering risk o death by

20 percent.

As Medical Imaging Services Decline,

Patient Care is Threatenedld m, s Dc, mdc i d tc a

Image courtesy o GE

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.


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Unortunately, policymakers seem unable to publicly recognize

the value o medical imaging to patients and their amilies.

Congress and the current administration have cut imaging

reimbursements seven times in six years, with payments or

some services being reduced by over 60 percent. Tis includes

bone density screenings, arm and leg artery x-rays, and MRIs

o the brain.

Tese cuts reduce patient access and undercut the benets

o early detection, making it harder or doctors to use

these liesaving technologies. A peer-reviewed study on

dual energy x-ray absorptiometry (DXA) screening or

osteoporosis published in the December 2011 issue oHealth

Aairs demonstrated this very point. Medicare payment cuts

have a signicant and direct impact on the health and saety

o patients.

Te study ound that DXA testing in all Medicare Part B

settings plateaued between 2007-2009 aer the Decit Reduction

Act o 2005 (DRA) cut Part B imaging payments, ollowing adecade o growth in the use o DXA to detect osteoporosis. In

those years, 800,000 ewer tests were perormed than expected

or Medicare beneciaries. Tese tests could have prevented

12,000 ractures and the associated healthcare costs.

Te authors also observed that DXA utilization continued on

an upward trend in hospital outpatient settings where payments

were not aected by the DRA. Tis suggests that Medicares

ofce-specic payment cuts were largely responsible or the

decline in overall testing.

Te Health Aairs study on DXA screening highlights the

undeniable correlation between Medicare reimbursements ormedical imaging and patient health. Further attempts to limit

access to medical imaging technologies will surely have similar

outcomes or individuals with cancer and other deadly diseases.

When used saely and appropriately, evidence shows that these

technologies can have a tremendous positive impact on patients

during treatment and recovery.

Medical Radiation ExposureWhile 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 act, in response to concerns about risks

related to radiation dose rom medical imaging procedures,

the American Association o 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 o misguided perceptions that

the tests could be harmul, saying that the benets o medical

imaging ar outweigh the risks.

Tis is not to say that memberso the medical imagingcommunity ought todiscount the importanceo radiation reductionand appropriate

use criteria.Physician-derivedbest practices,appropriatenesscriteria, andinvestment in programssuch as MIAs CDose Check Initiative(see page 3) illustrate theindustrys commitment tothe sae and appropriate useo medical imaging technology. MIA is committed to workingwith stakeholders in order to encourage the proper use o imagin

devices, and to ensure that patients have access to the right scan the right time.

Te irreutable decline in spending and utilization o imagingtechnologies, coupled with the industrys sustained commitmeto protecting patients rom unnecessary radiation, suggest thaany urther attempts to slash Medicare reimbursements andobstruct patient access to potentially liesaving medical imagintechnologies would be unnecessary.

It is unsettling to see such downward trends in Medicarebeneciaries use o medical imaging services during a time osuch tremendous advances in imaging and radiation therapytechnology, which are seen to be increasingly integral to medicabest practices and early disease detection. Without access to thetechnologies, patients will simply not receive the care they need.

Promoting Adequate ReimbursementTe proo ultimately lies in the data, and utilization is on the

decline. Inadequate Medicare reimbursement and restrictedaccess to medical imaging technology lead directly to adversepatient outcomes, including preventable bone ractures.

Tere are already enough barriers in place that prevent patientrom getting the care they need. As policymakers work towardmore balanced budget in the coming months, they should reerto the most current inormation on medical imaging innovatioand consider the very real impact that additional Medicarepayment cuts will have on the health and saety o patients. ei

Without access to these technologies, patients will

simply not receive the care they need.

Vascular chest MRI. Photo courtesy G

PEOPlE-FOcUSED MEDIcAl IMAgINg


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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.

When it comes to the value o medical imaging, survivorsand caregivers know better than anyone how important it isto have the right scan when it is needed most. Peer-reviewedstudies continue to conrm this, showing that when disease isdetected early, treatment will be more cost-eective and patientoutcomes improve.

Medical imaging technology and radiation therapy are key toidentiying, monitoring, and treating cancer. Patient advocateslike Erika Hanson Brown and Suzanne Lindley, who haveexperienced rsthand the value o these technologies, continueto oster connections among other cancer survivors andspread hope throughout the community. Tey have inspireda worldwide network o cancer patients and survivors andcontinue to work tirelessly to provide invaluable resources orthose struggling with the disease.

Trough sharing their personal stories and encouraging othersto do the same, these survivors have demonstrated to the worldthe undeniable value o medical imaging.

Why did you ound COLONTOWN?When I was going through colon cancer nearly a decadeago, I oen elt alone in navigating my treatment andound it difcult to stay connected with others, especialwithin my community here in Denver. Six months intotreatment, I decided to become a committed advocate inthe ght with cancer. I began reaching out to others whohad a similar diagnosis, researching available resourcesand seeking second opinions about my own prognosis. Ireused to be complacent.

Tat proactive mentality ultimately led me to oundCOLONOWN, a patient advocacy network thatconnects colorectal cancer patients at a local, disease-specic level to create a village o resources to helpthem cope with the disease.

What is the mission o COLONTOWN?Te goal is to teach people that community is centralto livingwith colorectal cancer. In COLONOWN,members are able to interact with one another bothonline and in person at community meetings. Members

are encouraged to share experiences and resources withone another.

How does COLONTOWN create a sense ocommunity among colon cancer patients

Most people eel like they have a wonderul supportnetwork o amily and riends, but whats lacking is alocal connection to someone going through colorectalcancer. COLONOWN members, known as colonists,speak the language o colorectal cancer, know aboutnew treatments, and have an intimate knowledge o the

personal journey that only colorectal cancer survivorsgo through.

COLONOWN is unique because it creates a saecommunity or people grappling with colorectal cancer,as well as those who have successully gone throughtreatment, encouraging them to stay involved andeducated. It provides a comortable, protected space orthese individuals to discuss their disease openly, sharingthoughts, tips, and tools without ear o judgment.

Erika Hanson Brown, Mayor o COLONOWN

A.

A.

How Medical Imaging Helps PatientsSpotlight on Erika Hanson Brown and Suzanne Lindleg m. rdz, PD, excv Dc, mita d Vc Pd, nem

A.


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One o the unique eatures o COLONTOWNis that it goes beyond providing supportto patients and includes survivors,amilies, and caregivers. How did thisidea come about?

Tats exactly right. In addition to helping those goingthrough treatment, COLONOWN addresses thedrop-o point when people no longer have cancer bymobilizing these survivors and keeping them engagedeven when other resources start to disappear.

Oen, aer their therapy is complete, patients stopeeling support rom the community they had whilegoing through treatment and are le eeling high and

dry. Tis is a critically important point. Even thoughcolorectal cancer survivors no longer receive treatment,riends, amily, and other caregivers must encouragethem to continue with routine imaging procedures tocatch any recurrences as early as possible.

How has medical imaging technologyaected and guided your course otreatment or colon cancer?

Aer nishing my prescribed course o treatment, I, likemany colon cancer survivors, needed to visit my doctor

regularly or ollow-up appointments. Medical imagingwas a routine, essential part o these visits, checking orre-growth or new tumors. Tis technology allows orearly detection and treatment o recurrences.

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

You have an incredible storycan youshare a bit about your battle with cancer

I was 31 years old when I learned I had colon cancerand that the cancer had spread to my liver. Te doctortold me I had six months to live. For a very short time, Iaccepted my prognosis and asked other cancer patientsor guidance on how share this news with my amily. BuI soon changed my outlook and chose to become moreactive in my ght against cancer instead o giving in tothe disease.

I started receiving the only therapy or colon canceravailable at that timechemotherapy. Aer cyclingthrough many dierent types o chemooen seeingshort-term results only to then see the cancer growstrongerI turned to clinical trials.

Despite these aggressive treatments, the liver tumorsbegan to grow and multiply and I suddenly ound myselback at square one. Like many cancer patients in a similposition, I heard the words, Im sorrythere are nomore options.

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

Aer chemotherapy, I tried radioembolization, a therapin which tiny radioactive beads are implanted in tumorsto reduce and eliminate cancerand it worked. Terewas a 65 percent reduction in my liver tumors and someeven died completely.

A.

A.

A.

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Suzanne Lindley, Founder o YES! Beat Liver umors


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Since then, medical imaging and radiation therapiesguided much o my treatment. In addition toradioembolization, I also received targeted radiationtreatments including external beam radiation orcancer that had spread to the spine, Gamma Knie1 orcancer that spread to the brain, radio requency ablationor a single returning liver tumor, and Cyberknie2 orlung tumors.

How does medical imaging and

radiotherapy technology impactpatients living with liver cancer?

Patients at risk or or suering rom liver cancer dependon imaging services or early diagnosis and treatment.Specically, liver cancer patients depend on advancedPE, C, ultrasound, and MRI because the liver is acommon site o metastatic spread and the early detectiono liver tumors is critical or treatment o the disease.

Te advanced radiation therapy technologies I receivedin treatment gave me a lietime o experiences. I was ableto watch my daughters grow up, spend more time withmy husband, and start the patient advocacy organization,YES! Beat Liver umors.

To date, youve had a long and impactulhistory as a patient advocate. In act, atone time, Katie Couric o CBS News nameyou the medical matchmaker. Can you

tell us about your current work with YES!Beat Liver Tumors?

YES! is a grassroots organization that provides cancerpatients with support, resources, options, education, anhope in their ght against liver tumors. It is made up osurvivors who have undergone treatment or primaryhepatocellular (liver) cancer or liver metastases (cancerthat has spread to the liver) rom other cancers. TroughYES!, we have also connected hundreds o patients acrothe U.S. with doctors and new treatments.

Where are you today in your journey withYES! Beat Liver Tumors and in your ownpersonal battle with liver cancer?

I continue to receive systemic chemotherapy or tumorstargeted radiological therapies when needed, anddiagnostic imaging to assess and guide treatment.

Our organizations ultimate goal is to change cancer robeing a terminal disease to being a chronic one that canbe managed with the help o advanced medical imagingtechnologies and radiation therapies. By building

genuine, supportive patient advocacy communities, YESspreads hope to those who need help nding it. ei

1 Gamma Knie radiosurger y, also known as stereotactic radiotherapy, is a noninvasive treatment that

uses tiny beams o rad iation to target cancerous cells.

2 Cyberknie is a non-invasive robotic radiosurgery system that uses computers, image-guided

cameras, and robotic technology.

Erika Hanson Brown, Mayor o COLONOWN (lef) and

Suzanne Lindley, Executive Director o YES! Beat Liver

umors at the Denver Liver Symposium. Photos courtesy o

Ms. Hanson Brown and Ms. Lindley

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In 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.

Medical imaging manuacturers have made extraordinaryadvances to help researchers unlock the mysteries o cancerand other deadly diseases, while also enabling physicians to

diagnose and treat an increasingly wide range o diseases.

odays modern imaging and radiation therapies oer highlypersonalized, non-invasive care that can be tailored to thespecic needs o an individual patient. Peer-reviewed research

conrms that these medical technologies not only improvehealth outcomes and save lives, but also reduce healthcare costsand drive down long-term spending.

Moreover, great strides have been made to ensure that radiationtherapy and medical imaging technologies are delivered in asaer and more eective manner than ever beore. For example,

manuacturers have revolutionized computed tomography(C) by developing technology that delivers quality images at aradiation dose ar below what it was twenty years ago.

Despite tremendous progress in research, technology, andpatient saety, impediments to international trade continue toprohibit the industry rom exporting advanced medical imaging

and radiotherapy products. Restricting market access threatensthe lives o millions o patients who would otherwise benetrom clinically proven diagnostic and therapeutic devices.

Fortunately, the U.S. Commerce Departments Internationalrade Administration (IA) has begun to address this issuethrough its Market Development Cooperator Program (MDCP),

which provides nancial and technical assistance to supportwell-dened business plans that increase exports and U.S.

competitiveness. In November 2011, MIA was recognized orits participation in MDCP at the Radiological Society o NorthAmericas Scientic Assembly and Annual Meeting in Chicago.

Te MDCP award, the Global Diagnostic and Terapeutic

Imaging Access Improvement Initiative, is designed topromote the harmonization o international standards, reduceunnecessary regulation, and expand market access to enhance

the global competitiveness o MIA member companies,including small- and medium-sized enterprises. For this project,

IA will provide more than $200,000 in unding to support

MIA activities that promote the export o medical imaging

products, specically to China and India.

Working closely with IA and other stakeholders over the

next three years, MIA will use MDCP unds to streamline

government approval processes, decrease the time required

to bring devices to market, and lower the cost associated with

the sale o liesaving diagnostic and therapeutic imaging

products to China and India. MIA will be able to better

identiy market access issues, work more closely with in-

country regulators to improve device saety, and assist themin integrating internationally-accepted standards into their

regulatory regimes.

MIAs MDCP activities build on its ongoing eorts through

DIA (the Global Diagnostic Imaging, Healthcare I and

Radiation Terapy rade Association) to improve collaboratio

with international partners COCIR (the European Coordinatio

Committee o the Radiological, Electromedical and Healthcar

I Industry) and JIRA (Japan Industries Association o

Radiological Systems) to help educate international decision

makers on the practical implications o their policy decisions

and to encourage regulatory environments that allow patient

access to these liesaving technologies.

Te award will also help medical imaging and radiotherapy

manuacturers create jobs here in the U.S. by increasing

exports o medical imaging products. Tis eort aligns with

the National Export Initiative, a key component o the Obama

administrations economic recovery plan, which sets an

ambitious goal o doubling U.S. exports by the end o 2014 to

create millions o new jobs or Americans.

Te bottom line is that innovative diagnostic services are

essential to the detection o disease when it is most treatable.

Trough initiatives like MDCP that promote access to theseproducts, 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 o international standards, millions o patients

in China, India, and beyond will benet rom the enhanced

diagnostics and care provided by liesaving medical imaging

and radiotherapy devices MIA members manuacture. ei

A Global Perspective on Medical ImagingZc hz, m, ad d i, mit


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Patients as consumers are now the norm. Well-informed and selective,

they simply demand more. Todays most successful hospitals understand

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 sta experience healing in its truest sense.

Using technology as an enabler, hospitals can create an

immersive, multi-sensory environment that enhances the

patient experience.

Holistic ApproachFour over-arching principles guide the development o unique

healing environments and go beyond traditional approaches to

acility planning and design:

Comfort

Build an environment that contributes to the well-being o

patient and clinical personnel.

ContaCt

Maximize the interaction between medical personnel, patients

and loved ones by decreasing physical barriers.

Transforming the Patient ExperienceInnovative concepts for people-focused healthcare

t v ez, Dc ab expc B u, Pp hc

Ambient Experience addresses the tenor o the imaging space itse

making it psychologically supportive. Photo courtesy Philips Healthca


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WorkfloW

Remove disjointed, cluttered, and isolated work areas thatadversely impact sta efciency and satisaction.

PersonaliZation

Give patients a sense o control over their experience byallowing them to modiy their surroundings.

In order to incorporate these principles into the design oa healing environment, every aspect o the patient journeythroughout the hospital should be evaluated, each pathway andinteraction mapped. Patients, amilies, nurses, and physicianscan be quietly shadowed or insight into their physical andemotional needs.

Based on the ndings, areas that can be positively inuencedthrough a combination o technology, spatial design, and

workow improvements emerge.

lighting Plays key role

It is well-established that lighting plays a major role in ourwell-being, inuencing emotions and aecting perormance.Choosing the right lighting solution or a specic space cantransorm that space.

A calming wall wash in the imaging suite soothes anxiouspatients and improves exam compliance.

Customized lighting in the patient room provides a sense opersonalization or patients and amilies.

Comortable lighting in common spaces helps create awelcoming sense o ease or waynding or all visitors.

Each well-conceived lighting solution takes into account patientwell-being, sta efciency, and overall ambiance.

Giving Patients ControlNowhere do all elements o an eective experience cometogether as well as in the imaging suite, a room where patientears may well be exacerbated.

Dynamic LED lighting installed around the perimeter decreasthe reliance on harsh overhead lighting. With a gentle wash ocolor, walls appear to ade away, soening the atmosphere and

helping to reduce patient stress. A ceiling projector displaysvideo and animations selected by the patient rom a libraryo themes. Te peaceul imagery is accompanied by soothingaudio, creating an ambiance designed to relax.

Oering patients some personalized control over theirexperience helps distract and reocus emotions. Whenanxieties ade, patients can be more cooperative and stacan manage clinical processes more efciently. Patient andsta satisaction improves.

A Dierentiating FactorInnovative lighting and projection are but two elements PhilipHealthcare brings to the redesign o a hospital environment.Trough its program, Ambient Experience, Philips looks beyonthe walls, the beds, and the medical equipment to address thetenor o the space itsel.

ransormation rom acceptable to exceptional is urtherexpressed by:

integrated cabinetry

de-cluttered spaces

rounded room corners

privacy glass

warm, comortable waiting areas

As reimbursement guidelines continue to place an even greateocus on patient satisaction, attention to all aspects o thepatient experience is crucial. When considerately applied, theconcept o patient-ocused healthcare can help hospitals thriveassuring better visibility in a competitive landscape. ei

Mr. van Elzakker is also General Manager New Ventures,Global Customer Service, at Philips Healthcare.

C image courtesy o GE C image courtesy o Siemens C image courtesy o GE


22/36


Helium 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 ia growing shortage of this essential element.

Helium is a non-renewable resource created by the suns nucleausion or radioactive decay on Earth, and scientists have yetto discover how to create helium articially or replace itsproperties with another element.

Congressional actions have had the unintended consequence oundervaluing the gas. Te National Helium Reserve, mandatedto sell two billion cubic eet o helium per year is rapidlydepleting the nations ederal supply o helium. Some estimatesproject that at current rates the U.S. could transorm rom

the worlds largest repository o helium into a net importer ohelium within 10 to 15 years.

Tis is a large problem or medical imaging manuacturersand the doctors and patients who rely on MRI technology todiagnose and treat disease. MRI devices consume 7,000 tons o

helium annually to cool the equipments magnets to appropriatemperatures or imaging. MRI magnets work optimally atapproximately 4.2 degrees Kelvin. Hydrogen, the next bestelement or extreme cooling, can only cool to 20 degrees Kelvinand is extremely ammable.

MRI use o helium is not restricted to magnets and is now beinused directly in diagnostic procedures. Scientists and doctorsare using a rare isotope o helium, He-3 during an MRI examto provide exceptionally clear images o a patients lungs while

Stewardship NeededStewardship Needed

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.

B C, Dc, s & fd gv r


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Helium Extends Beyond MedicalImaging into Other NEMA SectionsMedical imaging devices consume more than 7,000 tons o helium annually

to cool magnets as well as directly acilitate 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 eed speeds. This increases weld metal deposition rates when

compared to conventional argon/carbon dioxide (Ar/CO2) mixtures.

Because o heliums greater heat conductivity, perormance over mild base

metal contamination is also improved, which helps to eliminate the need

or costly rework. Argon/helium enhanced mixtures are commonly applied

or MIG welding o thicker aluminum sections (>12mm).

The enhanced mixtures typically increase deposition rates while

eliminating the need to perorm a costly preheating operation. The use o

helium-enhanced shielding gas mix tures provide an improvement in the

penetration profle o the completed weld deposit when compared to pure

argon or Ar/CO2

blends.

John Miller, Industry Manager | [email protected]

the Helium Shortagethey breathe normally. Tis research is helping to urther thedetection o lung disorders and lung cancer. It is, however, alsodependent on access to helium.

Without an adequate supply o helium, the use o MRItechnology would grind to a halt, patients would be unableto access liesaving equipment, and imaging manuacturing

jobs would be at risk. Preserving the supply o helium andencouraging responsible use is a critical priority or the medicalimaging industry.

Te U.S. contains about 35 percent o the worlds crude heliumreserves. Te gas is located in the same regions as many major

oil and gas production elds, making the southwest home tomost o Americas reserves.

Te ederal government maintains the National Helium Reservein exas, which is the largest stockpile o crude helium in theworld. Te reserve was originally created in 1925 to ensure a

robust national supply o helium or the militarys dirigible eet.As dirigibles phased out, the reserve was used to provide heliumsupplies or the Air Force intercontinental ballistic missile eetand NASA during the Cold War.

By 1995, the reserve was considered largely obsolete and anancial liability. o resolve a $1.3 billion debt owed to the U.S.

reasury by the reserve, Congress voted to liquidate the nationssupply with the Helium Privatization Act. Te act mandatesthat the Department o the Interior sell helium to repay thereserves debt to the reasury and exhaust the reserves heliumsupply by 2015.

In Washington, D.C., MIA is pursuing more eective ederalstewardship o the nations helium resources. A key step tobetter managing the shortage is to resolve the issue o thecongressionally mandated rapid depletion o the NationalHelium Reserve.

Potential options include assuring that ederal crude helium is

sold at air market value, maintaining sustainable and consistentnational rening capacity, prioritizing helium or critical uses,and slowing disbursement rom the reserve.

Beyond the beltway, MIA members are already making medicaluse o helium a high priority. During the MRI manuacturing

process, helium is now oen captured and recycled as magnetsare cooled to optimal temperatures. Recycling helium duringmagnet cooling helps limit its use during this resource-intensivestep in the manuacturing process.

Manuacturers are also working to preserve helium over anMRIs operational lietime. While all MRI devices lose somehelium due to evaporation, newer devices are designed torecapture evaporating helium, reducing lietime loss to nearlyzero under optimal conditions. MRI manuacturers continue tperect recycling and conservation measures, and arewell-prepared as helium becomes more expensive and difcultto obtain.

Te days o wanton helium use are likely coming to an end.As more industries become aware o this precious resourceslooming shortage, helium recycling, recapture, and careulutilization will become a national priority.

MIA will continue to work closely with industry andgovernment ofcials to assure that this important resource isready and available or uture generations. ei


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ElectroindustryNews

MITA Reorganizes Sta to Strengthen Public Policy ExpertiseAs medical imaging manuacturerscontinue to develop innovativetechnologies that enhance early disease

diagnosis, staging, and treatment, itis vital that MIA and its membercompanies educate policymakers abouthow imaging improves health outcomesand reduces costs.

In a strategic move to deepen theassociations signicant imagingand public policy expertise, MIAhas reorganized its sta to augmentpolicymakers understanding o the

value medical imaging technologiesplay in improving healthcare and

creating advanced manuacturing andemployment opportunities.

Charles S. Konigsberg, JD, Chie,Strategy and Policy, NEMA and MITACharles S. Konigsberg is a new hire whobrings 30 years o bipartisan experience

with the ederal budget and p

Documents

Medical Journey March