EI Mar13

The Association of Electrical Equipment and Medical Imaging Manufacturers n www.nema.org n March 2013 n Vol. 18 No.
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n Imaging and the future of Alzheimers Disease
n A glossary of medical imaging
n ESFI debuts new toolkit for older adults
n Mexico adopts a new electrical code
n NEMA/BIS forecasters rise to top for accuracy
Advancing the Future
of Medical Imaging and
Radiation Therapy
UL-electroInd-ad-v3-FINAL-OL.indd 1 12/18/12 3:20 PM
CONTENTS FEATURES:
NEMA electroindustry text and cover pages are printed using SFI certifed Anthem
paper using soy ink.
SFI certifed 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.
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
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Suite 1752, Rosslyn, VA 22209. The opinions or views expressed in electroindustry do not necessarily refect the positions of NEMA
or any of its subdivisions.
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electroindustry
Managing Editor / Editor in Chief | Pat Walsh
Contributing Editors | William E. Green III
Chrissy L. S. George

Economic Spotlight | Timothy Gill
Codes & Standardization | Vince Baclawski
Government Relations Update | Kyle Pitsor
Art Director | Jennifer Tillmann
Media Sales Team Leader | Stephanie Bunsick
Policies Afecting Medical ImagingSafeguarding Medical Imaging and the U.S. Economy ......................7
Medical Imaging Advancements in Cardiovascular Disease Quantify Cost ...............................................10
Imagings Role in the Future of Alzheimers Disease ..............................................................................11
Radiation Therapy Detects, Treats, Prevents Cancer ..............................................................................12
Industry Reinforces Commitment to Safe and Efective Care with New Standards ...................................13
Making Strides in Radiation Dose Reduction ........................................................................................14
Patient Well-Being Underscores Clinical and Economic Value of Medical Imaging ...................................16
An International Perspective on Imaging
Globally Harmonized Framework Improves Patient Safety and Access ...................................................18
Medical Imaging Advocates Take to Capitol Hill ....................................................................................20
Glossary of Terms ................................................................................................................................22
Getting to Know MITA .........................................................................................................................24
Did you know...
Knowledge is power, and its yours through the NEMA Intelligence Portal.
Available to members at
portal.nema.org
PET imaging detects beta amyloid plaque in the brain,
indicating the presence of Alzheimers Disease. Story on
page 11. PET/MR image courtesy of Siemens Healthcare
CONTENTS NOTES:
NEMA Ofcers ....................................................................................................................................................................................... 3
Comments from the C-Suite ................................................................................................................................................................. 3
View from the Top ................................................................................................................................................................................. 4
Learn More ..........................................................................................................................................................................................32
DEPARTMENTS:
Government Relations Update ...............................................................................................................5
Device Tax Creates Obstacle to Innovation and Economic Growth ...................................................................................................... 5
Transportation Section Briefs Hill Ofces on Industry Priorities .......................................................................................................... 6
Electroindustry News ..........................................................................................................................25
ESFI Debuts New Fire Safety Resources for Older Adults ...................................................................................................................25
[Re-]Introducing the Smart Grid Interoperability Panel ....................................................................................................................26
Code Actions / Standardization Trends ..................................................................................................27
NEMA Joins Transatlantic Conference to Strengthen EV and EVSE Standards ..................................................................................27
NEMA Addresses the Embedded Meter .............................................................................................................................................28
Iowa Legal System Attacks Electrical Code ........................................................................................................................................28
Pacifc Northwest Picks Up Pace of Code Adoption ..........................................................................................................................29
International Roundup .......................................................................................................................30
Mexico Adopts a New Electrical Code ................................................................................................................................................30
U.S.Mexico Smart Grid Technology & Business Conference Scheduled this Month.......................................................................30
Economic Spotlight .............................................................................................................................31
Policy Environment Leads to Continued Uncertainty in the Diagnostic Imaging Market .................................................................31
NEMA/BIS Forecasters Leavens and Gill in Top Five for Accuracy .....................................................................................................32
EBCI Online ..........................................................................................................................................................................................32
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The Breakers Palm Beach
Take a Visual Journey at
www.thebreakers.com
NEMAS 87th
Annual Meeting
Illuminations Weekend
Where Leaders and Ideas Meet
Friday, November 8 and
Saturday, November 9, 2013
6
About MITA
The Medical Imaging & Technology Alliance (MITA), a division of NEMA, is the leading organization
and collective voice of medical imaging equipment, radiation therapy, and radiopharmaceutical
manufacturers, innovators, and product developers. It represents companies whose sales comprise
more than 90 percent of the global market for medical imaging technology.
www.medicalimaging.org
NEMA electroindustry March 2013 3
COMMENTS FROM
THE C-SUITE Ofcers
Chairman
John Selldorff
President & CEO
Legrand North America
First Vice Chairman
Christopher Curtis
President & CEO
Schneider Electric
Second Vice Chairman
Thomas S. Gross
Vice Chairman & COO
Eaton Corporation
Treasurer
Don Hendler
President & CEO
Leviton Manufacturing Co., Inc.
Immediate Past Chairman
David J. FitzGibbon
Vice Chairman & CEO
ILSCO Corporation
President & CEO
Evan R. Gaddis
Secretary
Clark R. Silcox
Evan R. Gaddis
President and CEO
Tis is a rare moment for our medical and electroindustry members. Policymakers on
both sides of the aisle are increasingly focused on technologies that will rein in healthcare
costs and make our electric grid, homes, businesses, and factories more energy efcient
and competitive.
Imaging technologies (CT, MR, PET, RT, ultrasound, and x-ray) have revolutionized
healthcare delivery, changing how physicians diagnose and treat diseases, ultimately
improving health and saving lives. MITA, NEMAs medical division, represents the
companies that champion radiation dose optimization and management standards.
Another beneft of these eforts is that imaging lowers healthcare costs. A recent study
found that the use of non-invasive coronary CT imaging in the emergency room can save
hospitals billions of dollars.
On the electroindustry side, our companies have the solutions to save energy, make our
electric grid more resilient, and create jobs.
Severe weather, most recently Superstorm Sandy, coupled with an aging and overstressed
electrical infrastructure, is having a dramatic impact on the U.S.16 states experienced
outages during Sandy. Te core principal of any major reconstruction efort should be
to rebuild smartensuring that reconstruction funds maximize the deployment of
technologies to mitigate future power outages, protect lives and property, and improve
energy efciency.
Resilient and reliable power is critical for hospitals, frst responders, communications,
transportation, water treatment, emergency food and shelter, and other vital services.
When smart technologies are in place, power outages can be avoided while lives, homes,
and businesses are protected.
Examples of these technologies are self-healing Smart Grid solutionsinformation and
communications technologies such as smart meters and high-tech sensors to isolate
problems and bypass them automatically; microgrids and backup generators that use
their own power sources and storage capabilities to support vital services; and wiring,
cabling, and electrical components that can stand up to high winds and fooding.
In its recent publication, Storm Reconstruction: Rebuild Smart, NEMA provides a
guide to making our nation more competitive and energy efcient in the afermath
of severe weather.
Te 400-plus member companies of the National Electrical Manufacturers Association
and our staf of experienced engineers, medical imaging and electroindustry experts,
spanning more than 50 industry sectors, stand ready to assist industry and government
ofcials at all levels in saving energy and saving lives.
We have the solutions.
ei
4 NEMA electroindustry March 2013
Views from the Top
We are at a pivotal
time in our
nations history
with regards
to healthcare.
While the Patient
Protection and
Afordable Care
Actmany pieces
of which will soon be implemented
provides access to care for approximately
30 million Americans, the process to
improve how healthcare is delivered is
yet to be determined.
One element that must remain in the
equation is that accurate diagnosis at
the beginning focuses providers on
providing the best, most efcient care.
Evidence shows that not only do earlier,
more accurate diagnoses increase quality
of care in the short-term, they can also
dramatically reduce long-term healthcare
Solutions over
products.
Consistency over
variance. And
innovation in
everything.
In an increasingly
costly, complex,
and consumer-driven U.S. healthcare
environment, medical device
manufacturers recognize the importance
of investing in innovative solutions
that improve quality, accessibility, and
afordability for patients and physicians.
Tese solutions must be connected
across health systems and across disease
pathways. More than the sum of cutting-
edge products, synergistic solutions can
reduce costs and enable faster, earlier,
and more accurate diagnosis.
U.S. economy by supporting hundreds
of thousands of jobs across many states.
From the physician reviewing a CT
scan, to the technician performing
a procedure,to the factory worker
assembling a machine, medical imaging
provides jobs.
MITA member companies are well-
positioned to continue on the pathway
of innovation by developing safe and
efective technologies to facilitate earlier
and more precise disease detection,
while also bolstering the domestic
economy. As we continue to focus
on improving our healthcare system
from the inside out, the key to success
will be giving medical professionals
the necessary tools and techniques
to diagnose patients more accurately,
treat conditions more efectively, and
ultimately reduce medical costs by
eliminating unnecessary treatment.
ei
sophisticated diagnostic tools that help
determine at a molecular level which
treatment is most appropriate for a
particular patient. And it means billion
dollar investments in personalized
technologies that can help identify and
treat cancer, Alzheimers, and other
devastating diseases.
While the future of U.S. healthcare is
still evolving, the path forward involves
three things: a solutions-based approach
that values outcomes over widgets,
consistent best practices and data that
minimize variance, and innovative
personalization that serves the most
important end for those involved in
healthcarethe patient.
ei
costs. In essence, theres clinical and
economic value in knowing. Diagnosis
and more importantlymisdiagnosis,
matters.
Fortunately, this is also a time of
tremendous innovation in diagnostic
tools, from computed tomographic (CT)
colonography, which has been shown
to promote early detection of colorectal
cancer, to positron emission tomography
(PET), which ofers physicians a uniquely
enhanced look inside the body, enabling
them to identify illnesses ranging
from cancer to heart disease. Accurate,
timely diagnosis serves the patients
best interests and ofers signifcant cost
savings to the broader healthcare system
by preventing misdiagnosis and ensuring
appropriate treatment.
At the same time, companies that
manufacture diagnostic and therapeutic
tools are improving the health of the
Te inconsistency of healthcare delivery
and outcomes from region-to-region, and
even hospital-to-hospital, is signifcant.
Evidence shows variance is bad for
patients, providers, and the healthcare
system as a whole. Managing variance
will help simultaneously improve
healthcare quality and drive down costs.
Hospitals today are using big data and
information technology to identify
problem areas, better coordinate patient
care, and drive day-to-day process
improvementsincluding improved staf
scheduling and simplifying the patients
continuum of care.
Yet innovation in healthcare involves
more than process improvements
and technology advances. It also
means personalizationdeveloping
Precise Disease Detection Bolsters Economy, Diagnoses Patients More Accurately
Greg Sorensen, MD, Chief Executive Ofcer of Siemens Healthcare North America and Chair of the MITA Board of Directors
Medical Device Manufacturers Deliver Personalized Technologies
Marcelo Mosci, President & CEO,GEHealthcare U.S. & Canada
Government Relations Update
many patients, for multiple years. As
a result, even if a hospital or doctors
ofce experiences an increase in
patients, it will not necessarily purchase
additional equipment. Despite this key
diference, frms manufacturing imaging
equipmentand other multi-patient
devicesare required to pay this 2.3
percent tax without a substantial increase
in demand for their products.
LEviEd oN SALES, Not profit
Even companies making no proft will
pay a large tax, which makes it harder
for entrepreneurs to attract investment
required to support innovative new
companies. For example, a start-up
company with annual revenue of $10
million and net income of $0 would be
taxed $230,000, plunging it into the red.
Although the IRS has implemented the
tax, repeal eforts are far from over.
Democrats and Republicans are uniting
to repeal it as a way to grow the economy.
In early February, Representatives Erik
Paulsen (R-MN), Ron Kind (D-WI), and
186 members of Congress cosponsored a
bipartisan bill to repeal it. Concurrently,
Senators Orrin Hatch (R-UT) and Amy
Klobuchar (D-MN) introduced a device
tax repeal bill with the support of 28
Democratic and Republican senators.
With meaningful bipartisan momentum
and good policy on our side, MITA
continues to lead the fght to repeal the
device tax and looks forward to working
with policymakers to protect American
innovation and manufacturing.
ei
David Cooling, Director of State and
Federal Government Relations, MITA |
dcooley@medicalimaging.org
people, creates a growing trade surplus,
and develops technology essential
to advancing patient care in the U.S.
and around the world. Recently,
global competition has amplifed the
incentives to outsource R&D and move
manufacturing abroad. Despite these
options, many frms have largely resisted
the trends seen in other manufacturing
sectors and maintained successful
research centers and manufacturing
plants domestically. A $29 billion tax
burden on these companies amplifes
these pressures and has already forced
companies to consider fnding cost
savings in their U.S. operations.
StifLiNg hEALthcArE iNNovAtioN
Te medical imaging industry is in a
state of constant innovation, which each
year brings exciting new advances in
reducing radiation dose and improving
imaging clarity. Tese developments give
physicians new tools to diagnose and
treat diseases at earlier stages, improve
patient care, and reduce downstream
costs. Unfortunately, this tax reduces
the resources that the industry
currently uses to fund R&D and invest
in manufacturing. Less investment in
R&D slows the pace of innovation and
postpones patient access to the next
generation of care.
NEgAtivE iMpAct oN iNduStry
While this tax was designed to
complement an increase in demand
for medical devices resulting from the
Afordable Care Acts insurance coverage
expansions, this logic does not extend
to imaging equipment. Unlike other
devices, imaging equipment is considered
infrastructure, based in hospitals and
physician ofces. While many other
devices are designed to be used once
per patient, imaging equipment is
designed to be used multiple times, on
Device Tax Creates Obstacle to Innovation and Economic Growth
On January 1, the IRS imposed a new
$29 billion excise tax on companies
producing innovative medical devices
that are crucial to efective and efcient
healthcare. Tis tax hits the devices
and radiopharmaceuticals that MITA
members manufacture, including
computed tomography (CT) scans,
magnetic resonance imaging (MRI),
x-ray, and ultrasound equipment.
Although used as a way to plug a
budgetary hole in the 2010 Afordable
Care Act, this tax creates an enormous
obstacle for an industry that supports
hundreds of thousands of good-paying
American jobs.
Device manufacturers made their frst
device tax payment of nearly $100
million at the end of January. Tose
funds could have been spent on research
and development (R&D) orwith the
average medical technology industry
employee earning about $58,000
annuallyabout 1,700 jobs. According
to the Lewin Group
1
, the average U.S.
salary is $42,000. Compared to this,
medical technology jobs pay 38 percent
more. Tese are high-paying, American
manufacturing jobsthe jobs our
policies should be incentivizing.
Many pro-tax supporters say that the
revenue windfall from healthcare
reform will provide more than fair
compensation for the device tax, but that
is a misguided argument considering the
bulk of patients who use medical devices
are already covered under Medicare.
Despite various unknown contingencies,
the negative efects of the device tax
are certain.
hArMiNg jobS ANd EcoNoMy
Te American medical technology
industry is a true economic success
story. It employs more than 400,000
1
factfnder2.census.gov
Government Relations Update
of the American Association of State
Highway and Transportation Ofcials
(AASHTO), and John Horsley, who
retired from that position at AASHTO in
February. Te NEMA group thanked Mr.
Horsley for his many years of partnership
with NEMA on ITS standards and other
issues and briefed Mr. Wright on new
projects on which the organizations
can collaborate.
ei
Craig Updyke Manager, Trade
and Commercial Afairs |
craig.updyke@nema.org
Press for a greater share of overall
federal funding for transportation to
be devoted to technology deployment
and for associated changes in project
contracting to focus on network and
system performance rather than
asset management.
Tese messages, especially NEMAs
ofers of assistance, were well received.
Staf plans more dialogues for the
coming months.
Te fnal meeting of the day was with
Bud Wright, incoming executive director
Transportation Section Briefs Hill Offices on Industry Priorities
As Washington, D.C., readied itself
for the presidential inauguration on
January 17, a delegation of NEMAs
Transportation Management and
Associated Control Devices Section spent
the day on Capitol Hill meeting with key
staf members.
Led by Section Chairman Bryan
Mulligan (Applied Information), the
group had constructive dialogues
with staf for the Transportation &
Infrastructure (T&I) Committee of
the House of Representatives, the
Environment and Public Works (EPW)
Committee of the Senate, as well as three
Senate ofces. T&I and EPW are the lead
committees in the House and Senate for
transportation legislation. In addition to
the group meetings, some members also
took time for NEMA-facilitated meetings
with their home legislators ofces. Tis
event marked the fourth consecutive
year that a member companydelegation
visited with executive branch or
legislative decision makers.
NEMAs message was threefold:
Tank legislators for the two-year
transportation law approved in
summer 2012, known as MAP-
21, and the laws support for
greater deployment of intelligent
transportation systems (ITS)
technologies in federally-funded
transportation infrastructure projects.
State a strong preference for a longer-
term law to allow for better project
and business planning and ofer
NEMAs assistance in crafing the
next bill for 2014.
NEMAs 3TS Section on Capitol Hill, from the left: Ray Deer (Peek Trafc), John Miller (NEMA), Tom Becker (Daktronics), Bob Rausch
(TransCore ITS), Jessie Swinea (Adaptive Micro Systems), Bryan Mulligan, Section Chair (Applied Information), Russ Brookshire
(Delcan Technologies), Bill Klyczek (TrafconUSA), Dan Dietrich (FLIR Systems), and Jean Johnson (NEMA). Photo by Craig Updyke
See Bipartisan Helium Bill Introduced in House, page 11.
SAFEgUARDINg ThE FUTURE OF MEDIcAl IMAgINg
A
s the leading organization and collective voice of medical imaging
equipment, radiation therapy and radiopharmaceutical manufacturers,
innovators, and product developers, MITA has a high stake in a broad
spectrum of policy issues. Whether driving innovation and economic growth,
championing patient access to the right scan at the right time, working with
industry stakeholders to minimize radiation dose, advocating for transparent
and efcient regulatory processes, or protecting reliable access to helium,
MITA is at the forefront of political advocacy.
Safeguarding timely access to safe and efective medical
technologies is critical not only to ensuring quality patient care,
but also driving innovation and protecting American jobs.
Employing more than 400,000 workers nationwide, the medical
device industry generates approximately $25 billion in payroll,
pays out salaries that are 40 percent higher than the national
average ($58,000 vs. $42,000), and invests nearly $10 billion
in research and development (R&D) annually. In spite of this,
policymakers have recently levied a new tax that will threaten
the health of the U.S. economy and its people.
Leading into 2013, MITA advocated tirelessly alongside its
medical device industry partners for repeal of the burdensome
2.3 percent medical device excise tax, which is estimated
to collect over $30 billion in taxes from medical device
manufacturers over the next ten years. MITA called for repeal
of the tax on the grounds that such a large, new tax would
jeopardize thousands of American jobs and pose a serious threat
to companies ability to develop and bring to market life-saving
imaging technologies.
In fact, in a 2012 MITA survey
1
of member companies, four
out of every ten respondents anticipated having to reduce their
1
www.medicalimaging.org/2012/12/17/mita-announces-results-of-member-company-survey-
illustrating-impact-of-medical-device-tax-on-u-s-jobs-and-innovation
Policies Afecting Medical Imaging
Safeguarding Medical Imaging and the U.S. Economy
brian connell, director of government relations, MitA
U.S. workforce in response to this new tax, while 29 percent of
those surveyed expected to respond in part by reducing R&D.
Despite evidence proving the devastating fallout if implemented,
policymakers did not repeal the device tax, which took efect
on January 1, 2013. While a stand-alone repeal of the device
tax is highly unlikely in 2013, MITA is working closely with its
industry coalition partners to articulate the impact of the tax and
continues to argue for full repeal as a piece of a larger package.
Advocating Medicare Policies
In spite of the clear clinical and economic value of imaging,
Medicare reimbursements for medical imaging procedures have
been under constant threat of cuts. Since 2006, reimbursement
rates for medical imaging procedures have been slashed eleven
times, with yet another cut set to be implemented in 2014. Tese
cuts jeopardize patient access to lifesaving technologies which
are critical to detecting, diagnosing and treating cancers and
many other diseases.
Additionally, several recent independent analyses have
confrmed a recent downward trend in utilization of medical
imaging procedures. Te Medicare Payment Advisory
Commissions annualreport
2
to Congress in March 2012
confrmed that imaging services declined by 2.5 percent in 2010,
while non-imaging utilization increased two percent.
Recent data
3
also shows that imaging is the slowest growing
category in Medicare fee-for-service spending. Since 2006, per
benefciary spending on imaging services has declined by 16.7
percent and advanced imaging services declined by 27.6 percent.
In contrast, non-imaging services experienced 21.3 percent
growth in spending over the same time period.
2
www.medpac.gov/documents/Mar12_EntireReport.pdf
3
www.medicalimaging.org/2012/09/20/new-mita-analysis-confrms-continued-decline-in-medical-
imaging-utilization-and-spending-within-medicare/
Cutting Medicare reimbursements for medical imaging or
instituting roadblocks such as radiology benefts managers and
prior authorization programsboth of which require providers
to obtain permission from a third-party private contractor prior
to ordering imaging serviceshave been shown to signifcantly
delay and even deny services without yielding signifcant cost
savings for taxpayers
4
. According to a 2010 national survey of
physicians by the American Medical Association, requiring
physicians to ask for preauthorization from health insurance
companies harms patient care and creates an expensive and
confusing claims process. Delays and denials resulting from
these complications can exacerbate patients conditions,
necessitating more invasive, intensive, and costly treatments
down the road.
As an alternative, MITA advocates for the integration of
physician-developed appropriateness criteria, which provide
physicians with access to information at their fngertips to
ensure that an imaging procedure is appropriate for their
patient. In order to provide optimal care and prevent medical
errors, physicians and technologists must account for a patients
individual needs, condition, and characteristics. Along with
physician-developed appropriateness criteria to efectively
guide treatment decisions, MITA advocates for comprehensive
training of hospital and imaging facility personnel who perform
medical imaging exams to ensure the safe and efective use of
imaging in every setting.
MITAs Positron Emission Tomography (PET) Group has been
working with the Centers for Medicare and Medicare Services
on separate payment for diagnostic radiopharmaceuticals under
the Medicare Hospital Outpatient Prospective Payment System.
Te PET group is also working to advocate for local coverage
for PET tracers in neurology and cardiology (not just oncology),
as well as for beta amyloid imaging (see Imagings Role in the
Future of Alzheimers Disease, page 11).
Promoting Efficient Regulatory Processes
In addition to enabling physicians with the necessary tools to
deliver optimum care to patients, policymakers should institute
transparent and efcient regulations for medical devices,
and MITA is committed to working with the U.S. Food and
Drug Administration (FDA) to provide helpful resources and
guidance to ensure that the agency understands the efects of its
proposals on innovation and patient access.
For example, throughout 2011 and into 2012, MITA worked
closely with FDA and industry partners to negotiate the latest
Medical Device User Fee Agreement (MDUFA) to promote
timely patient access to safe and efective medical devices.
Initially enacted in 2002 as the Medical Device User Fee and
4
www.medicalimaging.org/wp-content/uploads/2012/04/MITA-PAF-Imaging-Report-
Summary-4-23-12.pdf
Photo courtesy of GE Healthcare
Modernization Act, the regulations sought to equip FDA
with the necessary resources to review medical devices more
efciently and ultimately ensure their safety and efectiveness.
MDUFA III, the outcome of the 2012 negotiations, took efect
on October 1, 2012, representing an agreement between the
medical device industry and FDA to increase the efciency of
regulatory processes in order to reduce the time it takes to bring
safe and efective medical devices to market in the U.S.
Helium Crisis Rising
MITA also works closely with members of Congress to protect
access to the critical U.S. helium supply. (See Bipartisan
Helium Bill Introduced in House, below.)
Helium is an essential component used in the creation and
operation of magnetic resonance imaging (MRI) machines,
which are critical to the diagnosis of stroke, aneurysms, cancers,
multiple sclerosis, and other deadly and debilitating diseases.
Liquid helium is the only element that can feasibly cool MRI
magnets to temperatures suitable for imaging; thus, MRIs in
hospitals must be regularly replenished with helium in order to
maintain the necessary operating temperature.
Te U.S. has more than one billion cubic meters of helium
gas stored in Amarillo, Texas, at the Federal Helium Reserve.
However, we are now facing a helium shortage, and if Congress
fails to act this year, the Bureau of Land Management will be
forced to shut down the Federal Helium Reserve. Tis will have
far-reaching impact on medical imaging manufacturers as well as
computer chip and optical fber manufacturers.
In October 2012, MITA submitted a letter to Congress calling
on policymakers to keep the reserve operational. Today, MITA
continues to work with the House and Senate to pass legislation
that will help resolve the looming helium supply crisis.
From Medicare reimbursement to taxation to access to helium,
MITA member companies are deeply invested in a wide spectrum
of policy issues that afect the wellbeing of American patients and
the health of the domestic economy. In 2013, MITA will continue
its eforts to communicate the undeniable value of medical
imaging and radiation therapy technologies to U.S. policymakers,
stakeholders, physicians, and patients.
ei
Prior to joining MITA, Mr. Connell (bconnell@medicalimaging.org)
was a legislative director on healthcare policy for a Midwestern
member of Congress.
Bipartisan Helium Bill Introduced in House
On February 7, Reps. Doc Hastings (R-WA) and Edward Markey (R-MA) introduced the Responsible Helium
Administration and Stewardship Act (HR 527) to keep the Federal Helium Reserve operational and to ensure
taxpayers get a fair price for helium sold by the Department of the Interior. The bill was considered at a February
14 hearing of the Natural Resources Committee, of which Mr. Hastings is the chairman and Mr. Markey the ranking
minority member. HR 527 could be reported out of the committee to the full House of Representatives before the
end of March.
MITA Executive Director Gail Rodriguez welcomed the introduction of HR 527 as an important step forward in
fnding a solution to the uncertainty of U.S. helium supplies. MITA and NEMA are working for passage of legislation
as soon as possible in 2013 since, under current law and absent decisive congressional action and the presidents
signature, the Federal Helium Reserve is scheduled to shut down as early as October 2013 and take as much as 30
percent of the worlds helium supply of the market. At press time, staf for Senate Energy and Natural Resources
Committee Chair Ron Wyden (D-OR) was considering an alternative legislative proposal.
Helium is an essential component used in the creation and operation of medical imaging equipment, such as
magnetic resonance (MRI) machines. Liquid helium is the only element that can feasibly cool MRI magnets to
temperatures suitable for imaging; thus, MRIs must be regularly replenished with helium in order to maintain
normal operating temperatures. Helium gas is also used in the welding of stainless steel and in the manufacturing
process for semiconductor chips, including light-emitting diodes (LEDs).
Brian Connell, Director, Government Relations | bconnell@medicalimaging.org
Craig Updyke, Manager of Trade and Commercial Afairs | craig.updyke@nema.org
C
ardiovascular diseasecommonly known as heart diseasegenerally
refers to conditions that involve narrowed or blocked blood vessels that
can cause chest pain, a heart attack, or stroke. It is the leading cause of death
for men and women in the United States and one of the nations most costly
health problems. In fact, the Centers for Disease Control and Prevention
estimates that coronary heart disease costs $108.9 billion each year, including
the cost of healthcare services, medications, and lost productivity.
Fortunately, advances in cardiac imaging are transforming
the diagnosis of heart disease and reducing healthcare costs
by minimizing expensive invasive procedures and shortening
the length of patients hospital stays. Coronary computed
tomography angiogram (CCTA) is one method that uses
advanced CT technology, along with contrast dye, to obtain
high-resolution, three-dimensional pictures of the heart and
blood vessels. It is noninvasive and can be used to rule out
or confrm a heart attack, as well as serve as a gatekeeper
for triaging patients for expensive or potentially risky,
invasive procedures.
With this technology, a patient today can walk into an
emergency room with chest pain, receive a CCTA scan that
discovers heart blockage and obtain a stent in two hours.
Alternatively, CCTA can rule out any blocked blood vessels
and the patient can be discharged and on his way home
within hours without compromising safety. Several recent
studies have confrmed that CCTA demonstrates signifcant
clinical and cost-efectiveness, saving lives and doing so quickly
and efciently.
In March 2012, the New England Journal of Medicine published
results from the largest trial to date examining the efcacy of
CCTA as a triage tool for patients with suspected coronary
artery disease. Conducted by the American College of
Radiology Imaging Network (ACRIN), the trial evaluated the
use of CCTA vs. standard care among 1,370 emergency room
patients with acute, low-risk chest pain and possible coronary
artery disease. It found that use of CCTA allowed more
patients to be discharged from the emergency room rather than
admitted (49.6 percent vs. 22.7 percent) with a shorter time
spent in the hospital (median 18.0 hours vs. 24.8 hours, p=.001).
Most importantly, the use of CCTA did not compromise safety,
with no signifcant diference between groups in the occurrence
of heart attack or cardiac death within 30 days of the emergency
room visit
1
.
CCTA has also proven to be benefcial in non-emergency
settings when used prior to cardiac catheterization, an
invasive procedure to diagnose coronary artery disease, by
selecting patients who are the best candidates for coronary
catheterization. A study published in the January 2012 issue
of the American Journal of Cardiology compared coronary
catheterization in all patients vs. selective catheterization among
patients with greater than 50 percent stenosis (narrowed blood
vessels) as identifed through CCTA imaging, and found that
use of CCTA saved an average of $3,061 per patient through
avoidance of unnecessary angiography
2
.
Both of these recent studies add to the body of evidence that
quantifes the signifcant cost savings associated with the use of
advanced cardiac medical imaging technologies such as CCTA
and demonstrate the value imaging technology is contributing
to the diagnosis and treatment of heart disease in the U.S.
ei
Mr. Eaton (reaton@medicalimaging.org) joined NEMA as
an industry manager in 1988. He holds a bachelors degree in
political science from the Johns Hopkins University and a JD from
Rutgers University.
1
Litt HI, Gatsonis C, Snyder B et al. CT angiography for safe discharge of patients with possible acute
coronary syndromes, N Engl J Med 2012;366(15):1393-1403
2
Patel N, Pal RS, Flores F, Budof M. Utility of cardiac computed tomography angiography to exclude
clinically signifcant obstructive coronary artery disease in patients afer myocardial perfusion
imaging, Am J Cardiol 2012;109(2):165-168
Medical Imaging
Advancements in
Cardiovascular Disease
Quantify Cost
richard M. Eaton, director of industry programs, MitA
P
ositron emission tomography (PET) ofers a uniquely enhanced look inside
the human body. Used in conjunction with a camera and a radioactive
drug known as a tracer, PET imaging enables physicians to identify illnesses
such as cancer, ischemic heart disease, and neurological disorders.
For many years, Alzheimers Disease (AD) has been difcult
to distinguish from other common conditions associated
with aging, such as dementia. PET imaging is one of the only
tools that can accurately and decisively confrm an ofen
fatal condition, otherwise verifable only by autopsy. Without
brain imaging, the presence of AD in a patient could not be
afrmatively confrmed or denied, hindering doctors ability to
provide an accurate early diagnosis.
Te U.S. Food and Drug Administration (FDA) recently
approved the use of a new PET tracer to help physicians make
a defnitive diagnosis of AD. Tis new tracer, F-18 Florbetapir
(Amyvid), and several others that are expected to be approved
by the FDA, detects beta amyloid plaque in the brain. Tis
plaque is an indicator of AD. When beta amyloid plaque is
present, physicians can make treatment decisions with more
confdence than just through the symptomatic indicators they
had up until this frst approval.
Ron Petersen, MD, PhD, director of the Alzheimers Disease
Research Center and the Study of Aging at the Mayo Clinic,
attested to the necessity of brain imaging throughout the
diagnostic process, remarking that imaging can assist the
clinician in being more specifc regarding the cause of the
cognitive impairment, especially when diferentiating a subtle
memory impairment associated with early Alzheimers Disease
from that seen in aging.
Recently, AD garnered national media attention when legendary
University of Tennessee womens basketball coach Pat Summitt
was diagnosed with AD through the use of brain imaging.
Feeling that something was of and noting that things were
not coming to her as quickly, Ms. Summitt sought a full mental
examination at the renowned Mayo Clinic. Tere, she received
a PET scan, which helped her doctors distinguish AD from
frontotemporal dementia, another potential cause of memory
loss. Results confrmed that Ms. Summitts lapses in memory
were mild, albeit distinct, signs of early-onset AD.
According to one caregiver, early diagnosis is critical. Te
diagnosis lends itself to quality of life and helps the caregiver
make necessary decisions before a crisis.
Expanding Medicare Coverage
To ensure that more patients like Ms. Summitt have access to
critical diagnostic tools, MITA supports expanded Medicare
coverage of PET radiopharmaceuticals and imaging procedures,
which have proven valuable in diagnosing, treating, and
monitoring a multitude of diseases. In November 2012, MITA
convened a PET Endpoints Workshop, bringing together
industry, government, and physician representatives to discuss
development of a framework for the coverage of emerging PET
procedures by the Centers for Medicare & Medicaid Services
(CMS) and to gain a common understanding of the clinical
evidence necessary for CMS to provide coverage to benefciaries.
Specifcally, the PET Workshop focused on establishing a
platform to determine how inherently the diagnoses resulting
from PET images, otherwise known as PET endpoints, should be
considered for coverage by CMS. Given the potential of PET to
signifcantly improve patient outcomes, even incrementally, the
consensus was that coverage from CMS is warranted and needed.
In addition to considering a PET coverage strategy that provides
its benefciaries with the earliest possible access to demonstrably
valuable imaging innovations, CMS proposed to remove
the national non-coverage decision for PET following the
MITA PET Endpoints Workshop. If fnalized, local Medicare
administrative contractors may determine coverage for new
oncologic PET tracers within their respective jurisdictions,
which will expand cancer patients access to the cutting-edge
tools physicians need to efectively diagnose and manage
treatment of their disease.
It is clear that this is an exciting time for PET manufacturers,
physicians, patients, and their families. Tanks to new PET
radiopharmaceuticals and imaging procedures, diseases that
once eluded the medical community, like Alzheimers, can now
be better understood and detected earlier than ever before, which
gives us great hope of eventually fnding an efective treatment.
MITA will continue to fght to protect and expand patient access
to these lifesaving imaging technologies.
ei
Mr. Abraham (babraham@medicalimaging.org) was director of
coding and reimbursement at IBA Molecular prior to joining MITA.
He served on MITAs PET Working Group and participated in the
PET Coverage Workshop and follow-up activities.
Imagings Role in the Future
of Alzheimers Disease
brian Abraham, Senior policy director, MitA
C
ancer is inarguably one of the most common, deadly, and costly medical
conditions that we face. Annually, more than one million Americans are
diagnosed with some form of it, and malignancies claim a half million lives.
National Cancer Institute statistics, however, show that the occurrence of new
cases and mortality rates are decliningtrends that may be evidence of
important gains in prevention, early detection, and treatment.
Radiation therapy (RT) is a cornerstone of cancer therapy; 50
to 60 percent of all cancer patients receive either external beam
RT (directing a therapeutic dose from an external source) or
brachytherapy (delivering radiation from inside the patients
body). Tese therapies cause malignant cells to either stop
growing or die while minimizing exposure to surrounding
healthy tissue. RT provides safe and efective treatment for an
increasingly wide range of primary cancers and even for tumors
that have metastasized. As a generally non-invasive therapy,
it is typically performed in an outpatient setting, minimizing
disruption of usual activities for more than 600,000 patients
who receive treatments annually.
Researchers have developed highly targeted and customizable
radiation planning and delivery tools. In three-dimensional
conformal radiation therapy, for example, advanced imaging
(MRI, PET) and specialized computer algorithms are used to
tailor the treatment dose to the patients anatomy, and make
real-time adjustments for even minute movement of either the
patient or the tumor.
Intensity-modulated radiation therapy, image guided radiation
therapy, adaptive radiation therapy, stereotactic body radiotherapy,
stereotactic body radiotherapy (SBRT), and stereotactic
radiosurgery (SRS) are noninvasive techniques that allow
clinicians to deliver therapeutic doses more quickly and accurately
than ever before. In some cases, a single treatment is all that is
required. Tese advances translate directly into better clinical
outcomes (e.g., longer disease-free survival), as well as greater
safety and convenience (e.g., fewer treatment-related side efects).
Based on evidence from a large and ever-expanding body of
scientifc and medical literature, recommendations for radiation
medicine have been incorporated into guidelines for best
clinical practices as a standard of care for most types of cancer.
ExAMpLES of AppLicAtioNS
In early-stage prostate cancer, radiation can enable patients to
avoid surgical removal of the prostate (prostatectomy) and the
complications that may occur with invasive treatment, while
providing disease-free survival. Radiation treatments are also
a viable option for patients who cannot tolerate prostatectomy
or who have an increased risk of the cancer spreading beyond
the prostate.
Te use of RT as an adjuvant therapy for women who have
undergone mastectomy or lumpectomy has had a profound
infuence on survival, so it is not surprising that radiation
medicine is a defning element of breast cancer care. Evidence
supporting this therapeutic strategy is voluminous and
documents survival benefts over periods as long as 15 to 20 years.
A major goal and challenge in cancer care is achieving cure
while preserving vital functions. Tis is particularly true in
head and neck cancers where the anatomy is complex. Both the
cancer and therapy afect nearby structures and their functions.
RT is used for early-stage and advanced disease.
Radiation treatments are used extensively in managing most
malignant and many benign primary central nervous system
tumors. Tey are ofen used following surgery to decrease local
recurrence, delay tumor progression, and prolong survival. For
example, radiation medicine is the mainstay of treatment for
malignant gliomas, which account for 70 percent of malignant
primary brain tumors diagnosed in the U.S. every year. SRS
has a long history of being used very successfully for treating
small intracranial lesions, where a single high-dose treatment is
ofen sufcient.
Radiation therapy is also recommended for palliative care
to alleviate some of the symptoms of advanced or metastatic
disease, including cancer-related pain. One-quarter of patients
with pain from bone metastases would typically experience
complete relief within one month of receiving radiation; nearly
half of all patients could expect at least 50 percent pain relief.
Treatment of liver metastases is another area where RT is
showing tremendous promise. A recent multi-institution study
of patients with liver metastases demonstrated that SBRT is safe
and efective. In this study, SBRT achieved local control of up to
100 percent for small tumors.
ei
Mr. Vastagh (svastagh@medicalimaging.org) has been on the
staf of the Medical Division since 2001. During this period, he
was staf manager/director for X-Ray, MII, and RT Sections,
CAD Group, TRC and international committees, and CAD
compensation groups.
Radiation Therapy
Detects, Treats,
Prevents Cancer
Stephen vastagh, dicoM general Secretary
Photo courtesy of Elekta Inc.
I
n recent years, medical imaging manufacturers have introduced new
products, innovations, and patient safety initiatives for a wide variety
of medical procedures, while continually improving the ability of these
cutting-edge technologies to aid physicians in diagnosing disease,
monitoring its progression, and staging treatment options. Imaging has
become not only an essential diagnostic tool, but a critical component
of a patients course of treatment.
Today, there is no doubt that medical imaging and radiation
therapy (RT) are integral to medical care, and their use reduces
hospital stays and helps return patients to their families, lives,
and work more quickly. Yet as the technology advances, the
industry has a responsibility to develop and implement the
necessary safeguards to protect patients from the possibility of
overexposure to radiation while still receiving quality care.
Trough NEMA, MITA leads the development of standards
for medical imaging and RT equipment. Tese standards are
voluntary guidelines that establish commonly accepted methods
of performance measurement, safety, design, testing, and
communication for diagnostic imaging and therapy systems
products. Clearly defned technical standards are important
because they improve patient safety and create efciencies in
how care is delivered.
Once a safe and efective protocol for imaging equipment
is established, it is essential that these protocols are not
inadvertently changed. NEMA XR 26 Access Controls for
Computer Tomography: Identifcation, Interlocks, and Logs,
published in October 2012, provides an extra safeguard
by standardizing quality assurance tools so that only an
authorized operator can alter the controls of a computed
tomography (CT) scanner.
Te industry-wide XR 26 standard requires assigning specifc
permissions to selected uses beyond those needed for routine
scanning, such as the authorization to alter protocols, and
implementing provisions to manually lock the user interface
to prevent unauthorized users from accessing system controls.
Te standard also contains features for use in a facilitys quality
assurance program, such as recording operator and patient
information, and tracking any changes made to protocols.
As CT technology continues to become more complex, it
is more important than ever that CT manufacturers put
safeguards in place to ensure that only authorized users can
perform or change CT protocols, said Marilyn Goske, MD,
chair of the Alliance for Radiation Safety in Pediatric Imaging,
sponsors of the Image Gently campaign. CT manufacturers and
MITAs rapid development and implementation of these new CT
Access Control Standards are signs of their strong commitment
to continuously improving patient care.
In November 2012, NEMA published the interventional x-ray
standardXR-27 User QC Standard, which helps imaging
facilities conduct quality testing and monitoring of x-ray
equipment used for interventional procedures. Interventional
radiologists use imaging to see inside a patients body, guiding
catheters through the vascular system, skin, or other pathways
to treat diseases directly at the source without invasive surgery.
Quality control user interfaces provide controlled access for
x-ray dose-related constancy testing, access to and export
of imaging data, electronic documentation of dose-related
parameters in exam protocols, and direct access to radiation
dose structured reports. Te addition of these new controls will
improve the ability of medical physicists to assess regulatory
compliance and promote patient safety.
It is important to note that these latest industry standards
build on past industry-wide initiatives to develop and
implement additional patient protection features for diagnostic
imaging and RT equipment. Tis includes XR 25 Computed
Tomography Dose Check, which incorporates two featuresdose
notifcations and dose alertsto help the operator and physician
better understand dose implications of protocol choices. Tese
features have the potential to signifcantly reduce exposure
caused by inappropriate scan parameter settings.
Looking forward, it is essential that we continue to work
closely with industry partners to ensure patients have access
to the safest, most innovative technologies available. MITA
looks forward to further collaboration with the members of
its working groups to develop new standards that will allow
for safe and efective use of the next generation of imaging
technologies.
ei
Mr. Abraham (babraham@medicalimaging.org) was
director of coding and reimbursement at IBA Molecular
prior to joining MITA. He served on MITAs PET Working
Group and participated in the PET Coverage Workshop and
follow-up activities.
Industry Reinforces Commitment to Safe and
Efective Care with New Standards
brian Abraham, Senior policy director, MitA
W
hile medical imaging includes a variety of modalities, many of the
most commonly used technologiescomputed tomography (CT),
x-ray, and nuclear medicineuse radiation to help physicians better detect,
diagnose, and treat disease. In recent years, advances in these medical
imaging technologies have enhanced diagnosis and lowered mortality rates
across a wide range of diseases, while using less radiation than ever before.
For example, CT scans and x-ray fuoroscopy have dramatically improved the
treatment of heart disease, cancer, and stroke. Additional advances in nuclear
medicine have demonstrated potential to help detect and treat complicated
neurological disorders such as Alzheimers Disease (see page 11).
To ensure the safe and appropriate use of these technologies, the
medical imaging and radiation therapy industry has a long-
standing commitment to efective radiation dose management
through a variety of collaborative and innovative initiatives.
As a proactive step toward reducing radiation dose exposure,
MITA investigates dose reduction and proposes measures to
decrease radiation dose. Since then, the task force has worked
diligently to establish standards to reduce radiation, and its
collective eforts have resulted in low-dose standards for almost
all radiation-emitting imaging equipment.
MITA is also a long-time partner with the U.S. Food and
Drug Administration (FDA) on initiatives to promote the safe
and efective use of medical imaging equipment for adults
and children. In 2012, MITA received the FDAs Leveraging/
Collaboration Award for developing a collaborative network
aimed at reducing unnecessary radiation exposure from imaging
exams to pediatric patients. Today, MITA and its members
remain committed to lowering pediatric radiation dose by
collaborating with the FDA to establish regulations
on premarket notifcations for x-ray imaging devices used
with children.
Gentle and Wise
In addition to ongoing collaborations with FDA, MITA has
partnered with the Alliance for Radiation Safety in Pediatric
Imaging and its Image Gently campaign, established in 2008 to
educate medical professionals and parents about protocols that
reduce imaging-related dose for children.
Making Strides
in Radiation Dose Reduction
orkideh Malkoc, director of reimbursement policy, MitA
MITA also supports the Image Wisely campaign, which focuses
on minimizing unnecessary radiation exposure for adults by
ofering information and resources to physicians, radiologists,
medical physicists, and patients. Additionally, MITA members
are leaders in the development of hardware and sofware
innovations to reduce exposure and minimize medical errors.
Comprehensive training is key to ensuring any safety features
are properly installed and utilized by physicians, radiation
therapists, and radiation technologists. Many of the worlds
leading medical imaging and radiation therapy manufacturers
have developed product training programs and intensive
technical tutorials to ensure that the lowest possible levels of
radiation are utilized.
As an added measure to help ensure that the most cutting-edge
technologies available are used safely and appropriately with
each and every patient, MITA advocates for the integration of
physician-developed appropriateness criteria into the physician
decision-making process, as well as the mandatory accreditation
of imaging facilities. Adherence to these criteria is essential so
that patients receive the right scan at the right time without
unnecessary exposure to radiation.
MITA and its members have a long-standing commitment to
patient safety and quality care. Meaningful dose reduction is
possible through the development of hardware and sofware
innovations, protocols, regulations and standards, as well
as collaborative eforts to improve education of physicians,
radiologists, physicists, technologists and, importantly, patients
and their families.
Tanks to the industrys leadership, patients can receive high
caliber scans with signifcantly lower radiation dose than
before. In the year ahead, MITA members will continue to
lead the development of evidence-based protocols and system
innovations to reduce unnecessary exposure to radiation
without compromising critical diagnostic information.
ei
Ms. Malkoc (omalkoc@medicalimaging.org) has an extensive
background in advocacy, with a specialty in health policy. She
previously served as the director of government relations for the
Muscular Dystrophy Association.
Privacy and Exposure Show Concern for Backscatter
Toward the end of last year, the Transportation Security Administration (TSA)
removed many of its controversial backscatter x-ray full body scanners
from major U.S. airports in favor of alternate technology equipped with
privacy software.
TSA concluded that it would stop using backscatter body scannersnot
over concerns raised about ionizing radiation emitted from the devices,
but rather over a legal requirement that TSA upgrade all advanced imaging
technology (AIT) scanners with software that does not show revealing x-rays
of air travelers.
But the move does not necessarily mean TSA is done with exploring the
possibility of using backscatter x-ray. The agency has commissioned a study
on the safety of backscatter AIT devices and has included the technology in
the mix of its next generation of AIT scanners.
In December 2012, the Department of Homeland Security (DHS) announced
it contracted the National Academy of Sciences to convene a committee
to review previous studies as well as current processes used by DHS and
equipment manufacturers to estimate radiation exposure resulting from
backscatter x-ray AIT systems used in screening air travelers and provide a
report with fndings and recommendations.
This study would examine the health concerns of backscatter x-ray devices,
which some suggest are more dangerous to people than the millimeter
wave devices. The privacy concerns that led to the removal of the Rapiscan
backscatter x-ray devices from U.S. airports are a separate issue.
Harry Massey, Industry Director |
harry.massey@nema.org
Photo courtesy of Philips Healthcare
Computed tomography (CT) combines multiple
x-ray images taken from diferent angles to
produce a very precise three-dimensional
image of areas inside the body. Image courtesy
of GE Healthcare
M
edical imaging technologies have revolutionized healthcare delivery
in the U.S. and around the world. Ofering physicians a look into the
human body, medical imaging has become integral to disease diagnosis,
treatment, and monitoring, turning countless patients into survivors. In
addition to being fundamental to standards of care, imaging technologies
help patients avoid or limit more invasive procedures and return to their
everyday lives more quickly. Peer-reviewed research confrms that medical
imaging not only improves health outcomes and saves lives, but also reduces
long-term healthcare costs.
To highlight this research, MITA published a literature review
in December 2012, Clinical and Economic Value of Medical
Imaging
1
, which spotlights scientifc, peer-reviewed studies that
demonstrate improved patient outcomesfocused on survival
and quality of lifeand cost savings associated with various
1
www.medicalimaging.org/wp-content/uploads/2012/12/Clinical-and-Economic-Value-of-Imaging.pdf
imaging technologies. Te research compendium shows that
medical imaging reduces the costs of unnecessary and invasive
procedures, while improving patient outcomes and quality of
life through early detection and more sophisticated and diverse
treatment options.
Te literature review used comprehensive search methodology
to critically evaluate select publications from the past fve
years indexed in the U.S. National Library of Medicine
(MEDLINE) and from leading health policy journals. Resulting
analyses indicate that diagnostic imaging is a sound economic
investment and efective across many disease states. Following is
just a summary of the overwhelming evidence from the review
that supports this conclusion.
cANcEr
Medical imaging has improved diagnosis and treatment of many
acute and chronic conditions. Cancer treatment has benefted
signifcantly from advanced imaging, which gives physicians
the ability to conduct minimally invasive biopsies and surgeries
Patient Well-Being Underscores Clinical and
Economic Value of Medical Imaging
gail rodriguez, Executive director, MitA
and orkideh Malkoc, director of reimbursement policy, MitA
and targeted radiation therapy. Computed tomography (CT)
and integrated positron emission tomography (PET)/CT have
led to a 6.7 percent reduction in all cancer mortalities, including
a 20 percent reduction in lung cancer alone. Results of a large
randomized controlled trial estimated that low-dose spiral CT
scans would lead to 130,000 additional lung cancer survivors in
2012 vs. no scans.
Breast cancer trends over the last several decades emphasize
that screening made possible by imaging saves lives. For
example, mammography has dramatically reduced breast
cancer mortality since becoming a recommended routine
health screening. Researchers at the Medical University of
Vienna found magnetic resonance imaging (MRI) to be
signifcantly more sensitive for detecting breast cancer than flm
mammography, with 24 out of 28 detected cases of breast cancer
identifed by MRI (vs. 14 by mammography).
Te use of ultrasound has also been shown to be benefcial for
the preoperative staging and evaluation of patients with breast
cancer, yielding a cost savings of $4,682 per patient through
elimination of unnecessary procedures.
cArdiovAScuLAr diSEASE, vAScuLAr diSEASE,
ANd StrokE
Medical imaging is transforming the area of cardiac diagnostics
and therapeutics, as well as in the diagnosis and treatment of
stroke. For instance, a study of 203 patients found that multi-
slice CT efectively rules out or confrms coronary disease as
the source of chest pain in 75 percent of patients, signifcantly
reducing diagnostic time and costs. A British study determined
that providing CT or MRI for all patients presenting with
stroke-like symptoms is a cost-efective diagnostic strategy. Te
scan all approach was reported to be less expensive than even
a no scan approach; savings resulting from shorter hospital
stays more than ofset the additional costs associated with
delivering the scans.
Non-invasive imaging also plays an important role in the
management of coronary artery disease, the leading cause of
death for men and women in the U.S. Sophisticated cardiac
imaging provides anatomical and physiological information,
allowing physicians to accurately diagnose patients, stratify
them into risk categories, and determine treatment strategies
tailored to their unique needs.
orthopEdicS, oStEoporoSiS, ANd ArthritiS
Te ability to more clearly visualize the structure of bones and
joints has broadened the diagnostic and treatment options
within orthopedic care, especially with the development of
minimally invasive surgical techniques. MRI has proven a
valuable tool for assessing lesions in the knee, and studies show
that the technology not only accurately identifes meniscal
and anterior cruciate ligament (ACL) tears, but also avoids the
risks associated with arthroscopy for those patients who do not
ultimately require surgical knee repairs.
Advances in diagnostic imaging have also made it possible to
identify bone loss early, before an osteoporotic fracture occurs.
Researchers at Procter & Gamble Pharmaceuticals estimated
that bone mineral density scanning of an additional one million
women in 2001, followed by appropriate osteoporosis therapy,
would have averted 35,000 fractures and generated $119 million
in Medicare savings by 2003.
In addition, MRI changed the clinical management in half of all
patients examined with rheumatoid arthritis, with 80 percent
of patients showing a subsequent improvement in symptoms,
according to a study conducted at the University of Virginia.
coNcLuSioN
Across a wide spectrum of disease states, imaging technologies
detect and diagnose disease at the earliest, most treatable stages
and guide physicians and patients in determining the most
appropriate and efective treatment plan. Te research compiled
in MITAs literature review underscores the clinical and
economic value of medical imaging and the many ways in which
it improves health outcomes and reduces costs.
Te full report is available online at www.medicalimaging.org/
wp-content/uploads/2012/12/Clinical-and-Economic-Value-of-
Imaging.pdf.
ei
Dr. Rodriguez (grodriguez@medicalimaging.org) has been
involved in imaging policy since 2008 when she served as
policy and membership director for the Institute for Molecular
Technologies. Ms. Malkoc (omalkoc@medicalimaging.org)
has an extensive background in advocacy, with a specialty in
health policy. She previously served as the director of government
relations for the Muscular Dystrophy Association.
Prepared for the Medical Imaging & Technology Alliance,
a division of the National Electrical Manufacturers Association
Clinical and Economic
Value of Medical Imaging
MITAs literature review
An International Perspective on Imaging
Globally Harmonized Framework Improves
Patient Safety and Access
Zach helzer, international director, MitA
M
edical imaging has changed the face of healthcare delivery in America
and around the world. From detecting a disease in its early stages to
minimizing invasive procedures, imaging technologies have proven critical
to the diagnosis and treatment of disease. Peer-reviewed research confrms
that medical imaging saves lives, improves clinical outcomes, and lowers
healthcare costs.
Its important that medical professionals and patients around
the world have access to these lifesaving technologies in order
to combat disease and improve health outcomes. However,
impediments to international trade continue to hinder the U.S.
medical device industrys export of advanced medical imaging
and radiotherapy products, threatening the lives of millions of
patients who would otherwise beneft from clinically-proven
diagnostic and therapeutic devices. Internationally accepted
standards and regulatory convergence where appropriate are
needed to improve access to care by enabling manufacturers
and regulators to use common methods for product registration
and testing.
To help open the global market, the U.S. Commerce
Departments International Trade Administration started the
Market Development Cooperator Program (MDCP), which
provides fnancial and technical assistance to support well-
defned business plans that increase exports and enhance U.S.
competitiveness in other markets. In November 2011, MITA
was awarded more than $200,000 as part of MDCPs Global
Diagnostic and Terapeutic Imaging Access Improvement
Initiative to support activities to promote the export of medical
imaging products, specifcally to China and India.
Expanded Patient Access in China
MITA has focused its MDCP eforts on working closely
with decision-makers to expand patient access to lifesaving
imaging technologies. MITA has made Chinas medical device
market, the second largest in the world, its top international
priority. Working with in-country regulators to improve
device safety and integrate internationally-accepted standards
into their regulatory regimes, MITAs eforts are already
bearing fruit.
In September 2012, MITA
organized a workshop in
Beijing on international
standards, during which
the State Food and Drug
Administration of the Peoples
Republic of China (SFDA) released
a timeline outlining its transition
to IEC 60601-1 third edition. Tis is
the internationally accepted standard for
testing the safety of electrical medical equipment.
Chinas transition to this standard will ensure that doctors
have access to the newest, most innovative medical imaging
technologies.
Furthermore, at the U.S. China Joint Commission on
Commerce and Trade Pharmaceuticals and Medical Devices
Subgroup meeting, which was held in coordination with the
workshop, SFDA announced the down classifcation of x-ray
products. Tis development lowers the risk classifcation to
approve x-ray equipment for sale in line with international
norms. Tis will greatly reduce the time and cost it takes x-ray
equipment to reach the Chinese market. Tese activities are just
the beginning of MITAs eforts to enhance the international
competitiveness of member companies as well as to improve
the associations visibility and stature as an industry leader
outside the U.S.
Brazil Increases Demand
for Quality Healthcare
Recently, MITA began work in Brazil, the largest market for
medical devices in Latin America. Te market in Brazil is
growing rapidly due in large part to its expanding private
health insurance sector, which is increasing demand for quality
healthcare. State-run hospitals and clinics in Brazil are also
looking to upgrade outdated equipment, which is a huge export
opportunity for U.S. device manufacturers.
Similar to its work in China, MITA seeks to expand access to
medical imaging and radiation therapy equipment in Brazil
by working to streamline government approval processes
in order to reduce the time and cost it takes for products to
reach the market. To accomplish these goals, MITA plans to
undertake a number of market development activities that will
promote the harmonization of international standards, reduce
unnecessary regulation, and expand market access to enhance
the competitiveness of MITA member companies in Brazil.
DITTA Enhances Global Reach
Growth in MITAs international portfolio is linked to ongoing
eforts with the Global Diagnostic Imaging, Healthcare IT and
Radiation Terapy Trade Association (DITTA). DITTA works to
improve the global regulatory environment for manufacturers
to ensure that they remain at the forefront of technological
innovation and are successful in the global marketplace as they
continue to develop products that improve quality, safety, and
patient access around the globe.
DITTA is composed of eight organizations, including MITA
(U.S.), COCIR (Europe), JIRA (Japan), MEDEC (Canada),
THAIMED (Tailand), IMEDA (Russia), CAMDI (China),
and ABIMED (Brazil). MITAs work with DITTA enhances
the global reach of US manufacturers and establishes a global
industry voice that enables manufacturers to more efectively
advocate for harmonized standards and improved regulation.
Under MITAs leadership in 2012, DITTA experienced
signifcant growth. Tis included its ofcial incorporation, the
addition of four new member associations, and the creation
of a formal organizational structure and governance model.
Over the past year, DITTA has worked to build its relationship
with multinational institutions such as the World Health
Organization (WHO) where DITTA is working to gain status as
an ofcially recognized non-governmental organization. DITTA
has also made notable gains with the Asian Harmonization
Working Party and International Medical Device Regulators
Forum, which as a result of DITTAs eforts now includes
industry representation in its management committee meetings.
In September 2012, DITTA convened a frst-of-its-kind
roundtable meeting with the World Bank that included medical
device industry representatives from fve continents to discuss
opportunities to improve World Bank procurement processes
for medical technology. Under MITAs leadership through
DITTA, industry provided recommendations that would make
the procurement process more efective and reliable, which were
well received. Te World Bank agreed that an ongoing dialogue
would beneft everyone, particularly borrowers in less developed
countries, ensuring that doctors and patients have the tools they
need to combat diseasea common goal shared by the medical
device industry and the World Bank. Both sides see the dialogue
as critically linked to poverty reduction and economic growth.
MITA looks forward to its ongoing work with industry
partners toward a globally harmonized regulatory framework
that is smart, efcient, transparent, and more importantly,
improves patient safety and access to the high quality medical
technologies that MITA members manufacture. Te successful
development and advancement of medical imaging equipment
in the global marketplace promises to save the lives of millions
of patients around the world.
ei
Mr. Helzer (zhelzer@medicalimaging.org) earned a masters
degree in international studies with a concentration in
international politics from the Josef Korbel School of
International Studies at the University of Denver.
W
hen Erika Hanson Brown fnished her prescribed course of treatment
for colorectal cancer, like many cancer survivors, she needed to visit a
doctor regularly for follow-up appointments.
Medical imaging was a routine but essential part of my doctors
visits and checking for re-growth or new tumors, said Ms.
Brown. I was fortunate to have access to these services, but that
isnt always the case.
In the face of impending budget cuts and policy proposals that
could impact patient access to life-saving medical imaging and
radiation therapy services, this concern resonates strongly for
many. Tats why the Access to Medical Imaging Coalition
(AMIC) and the Medical Imaging & Technology Alliance
(MITA) convened more than 50 patients in Washington,
D.C., for the 2012 Right Scan Right Time and COLONTOWN
Advocacy Academy.
Right Scan Right Time Advocates
A cALL to ActioN
Knowing how important access to medical imaging is to my
survival story, Im concerned for the millions of patients who
will require these services in the future to identify their illness
and receive the best course of care, said Ms. Brown.
Imaging has already been cut twelve times since 2006, and
further proposals to reduce Medicare payments for advanced
imaging and radiation therapy services or to implement
burdensome prior authorization mechanisms, such as radiology
benefts managers, continue to threaten patient access. In
September 2012, patients few in from across the United States
to join AMIC and MITA in calling on Congress to protect
Medicare reimbursement for advanced medical imaging and
radiation therapy services so that patients nationwide can
continue to have access to the right scan at the right time.
right ScAN right tiME AcAdEMy
In preparation for meetings on Capitol Hill, advocates spent
a day sharing their stories and diving into the complex policy
issues that impact access to these critical services. Te Advocacy
Academy programming included an interactive storytelling
session and a patient all-star panel to help advocates learn how
to communicate their unique stories efectively with media and
congressional stafers.
We wanted the academy to be a truly unique and engaging
experience, with an emphasis on relationship buildingnot
only among the advocates themselves, but with their legislators,
said Ms. Brown. Tats why our curriculum focused on the
power of storytelling and fostering an understanding of the
complex policy issues at play.
MITA Director of Government Relations Brian Connell talks to Right Scan Right Time patient
ambassadors at the Advocacy Academy in preparation for 2012 Capitol Hill Day.
Advocates share their stories at the Right Scan Right Time Advocacy Academy.
Medical Imaging Advocates
Take to Capitol Hill
david cooling, director of State & federal government relations, MitA
Right Scan Right Time Advocates
Advocates with prior Hill experience joined seasoned
government relations experts during the training sessions to
provide relatable experiences to the group. One experienced
Right Scan advocate, Vanessa Ghigliotty of New York, N.Y.,
ofered this advice to the academy, Its important for legislators
to hear directly from you, because your stories make these Hill
meetings real. Tis is your fght!
Troughout the day, advocates practiced sharing their stories,
ofering feedback and assistance to hone in on what Ms.
Ghigliotty calls the hook, line, and sinker.
MEEtiNg with poLicyMAkErS
Te following day, patient advocates headed to the Hill for a
breakfast briefng with AMIC and MITA leadership prior to a full
day of meetings with policymakers. During a press conference,
AMIC unveiled a letter to congressional leaders signed by 22
patient groups urging against the implementation of prior
authorization mechanisms and cuts to Medicare reimbursement
for medical imaging and radiation therapy services.
Advocates participated in more than 80 Hill meetings
with senators, representatives, and congressional staff.
During Capitol Hill Day, advocates participated in more than 80
Hill meetings with senators, representatives, and congressional
staf. Patient advocates put a face to Medicare cuts by sharing
their stories to further communicate the value of preserving
access to medical imaging.
Additionally, several advocates stopped by other member ofces
on their own with the hope of speaking with a congressmen or
staf. As a result, advocates from Colorado were able to have an
impromptu meeting with Representative Ed Perlmutter (D-CO).
Colorado advocates meet with Rep. Perlmutters staf.
coNtiNuiNg thE fight for AccESS to iMAgiNg
Motivated by their time in Washington, advocates continued
to use Facebook and other mechanisms to expand their
conversations with fellow advocates and share updates about
further contact with legislators.
As Congress looks for solutions to reduce our national defcit,
I hope they keep our stories in mind and work with patients
and physicians to implement thoughtful imaging policies
that promote patient access to the right scan and the right
therapy at the right time, said Ms. Brown. Cancer patients are
already in the fght of their lives. Access barriers to innovative,
life-saving imaging technologies available will only make this
fght harder.
ei
Prior to joining MITA, Mr. Cooling worked at Pfzer on advocacy
and legislative issues. He graduated from the McDonough School
of Business at Georgetown University with an MBA and an
emphasis on healthcare economics and pharmaceutical medical
device regulation.
All photos are by Mike Kleinfeld
Advocacy All Stars
I wanted to say a HUGE, HUGE thank you for such
a wonderful experience. Its so empowering! ... All it
takes is one person who is willing to make change.
Angela Garrett, Missouri
The [MITA and AMIC staf] you had in our meetings
were excellent! These folks had the data and
percentages and lingo talk needed to answer those
additional questions by the aides, and we were
delighted to have them there with us!
Joanne Hoerrner, Connecticut
I want to thank youso much for the tremendous
opportunity you provided us in attending the Right
Scan Right Time events. It was someaningfuland
inspirational to meet so many great individuals
struggling with cancer situations, and so powerful
to be able to express avoice to our Congressional
members. I am re-energized andmore committed
than ever to making a diference.
Linda Woltkamp, Colorado
MEdicArE rEiMburSEMENt: Te payment that
physicians and hospitals receive for services rendered to
patients who are covered under the Medicare program.
MuLti-SLicE ct: A medical technique of acquiring several
cross-sectional images in a single rotation of the x-ray tube
and detector assembly, allowing physicians to obtain high
resolution and high speed at the same time.
NucLEAr MEdiciNE: A branch of medicine that involves
the use of radioactive materials to help diagnose and treat a
variety of diseases.
pEt/ct: A medical imaging technique that combines PET
and CT, allowing images acquired from both devices to be
taken sequentially and combined into a single superposed
image, enabling physicians to more precisely measure tumor
volumes and prepare patient treatment plans.
poSitroN EMiSSioN toMogrAphy (pEt): A type of
nuclear medicine that uses a scanner and a small amount of
Glossary of Terms
AccESS to MEdicAL iMAgiNg coALitioN (AMic):
A coalition that represents more than 100,000 physicians,
medical providers, and patient organizations throughout
the U.S. AMIC conducts public afairs, advocacy, and
educational activities to address payment reductions and
promotes the adoption of policies that focus on medical
imaging quality and appropriateness.
AppropriAtENESS critEriA: Evidence-based guidelines
to assist referring physicians and other providers in making
the most appropriate imaging or treatment decision for a
specifc clinical condition.
coMputEd toMogrAphy (ct): A medical imaging
technique that combines multiple x-ray images taken from
diferent angles to produce very precise three-dimensional
images of areas inside the body.
coroNAry coMputEd toMogrAphy ANgiogrAM
(cctA): A medical imaging technique that uses advanced CT
technology along with contrast dye to obtain high-resolution,
three-dimensional pictures of the heart and blood vessels.
iSchEMic hEArt diSEASE: A disease characterized by
reduced blood supply of the heart muscle, usually due to
coronary artery disease.
fLuorodEoxygLucoSE (18f-fdg): A radiolabelled
sugar molecule used as a radiotracer with PET to characterize
and localize many types of tumors.
Low-doSE SpirAL ct: An advanced imaging technology
in which x-ray detectors rotate around the body to produce a
three-dimensional image of internal structures.
MAgNEtic rESoNANcE iMAgiNg (Mri): A medical
imaging technology that uses radio waves and a magnetic
feld to create detailed images of organs and tissues.
MAMMogrAphy: A breast cancer detection exam that uses
x-ray technology to produce an image of inner breast tissue.
Courtesy of Siemens Healthcare
Courtesy of SonoSite
radiopharmaceuticals injected into a patients vein to assist
in making detailed, computerized pictures of areas inside
the body, providing physicians with information about how
tissues and organs are functioning.
prior AuthoriZAtioN: A policy that requires providers
to obtain authorization before providing imaging services.
rAdiAtioN thErApy (rt): A medical technique that
delivers highly targeted radiation to cancerous cells,
destroying their ability to grow and divide while leaving
healthy cells intact.
rAdioLogy bENEfitS MANAgErS (rbMS): For-proft
companies that evaluate physicians orders of imaging
studies and, using proprietary systems, determine whether to
approve or deny the requested service.
rAdiophArMAcEuticALS: Radioactive substances used
in very small doses to diagnose, treat, and prevent disease.
thE MEdicAL iMAgiNg & tEchNoLogy ALLiANcE
(MitA): Te leading organization and collective voice
of medical imaging equipment, radiation therapy and
radiopharmaceutical manufacturers, innovators, and
product developers. MITA, a division of NEMA, represents
companies whose sales comprise more than 90 percent of the
global market for medical imaging technology.
uLtrASouNd: A medical imaging technology that sends
high frequency sound waves into the body and converts the
returning sound echoes into images of the inside of the body.
x-rAy: Te oldest and most commonly used form of medical
imaging, which sends beams of ionizing radiation through
the body to produce images of a persons internal structure.
x-rAy fLuoroScopy: A procedure that shows a
continuous x-ray image on a monitor so that the movement
of a body part can be seen in detail.
M
ITA is widely recognized as the leading organization and collective
voice of medical imaging equipment, radiation therapy, and
radiopharmaceutical manufacturers, innovators, and product developers.
Fittingly, MITAs staf is well-versed in a wide variety of policy issues. But
theres much more to us than meets the eye!
Gail Rodriguez, PhD, executive director, has worked in
the nuclear medicine industry for 18 years in various sales,
marketing, training, and management roles. Before becoming
an expert in nuclear medicine and medical imaging, Gail
ranked as one of the top spellers in the United Statesin 1974,
she won second place in the National Spelling Bee.
While her spelling skills remain unrivaled at MITA, David
Cooling, MITAs director of state and federal policy, outpaces
her in one distinct activity: running. In the midst of honing his
health policy expertise in the private sector, on Capitol Hill and,
ultimately, at MITA, David has managed to run six marathons.
Stephen Vastagh, general secretary and administrator for
NEMAs Digital Imaging and Communications in Medicine
(DICOM) standard, has been a downhill skier his entire life.
Stephen and his wife founded a Junior Ski Racing Program at
a central Pennsylvania resort, which they managed for more
than a decade. During this time, their daughter represented the
Vastaghs native country, Hungary, at the Salt Lake City Winter
Olympics. Stephen is still participating in amateur racing
whenever his schedule permits. Meanwhile, his daughter is now
nearly six months pregnant and skiing as fast as ever until the
last minute possible.
Did you know Richard Eaton, MITAs director of industry
programs, and Brian Abraham, director of policy are seasoned
travelers? While Rich enjoys steam train excursions, Brian
prefers to venture ofshore. Prior to joining MITA, Brian
spent a few years living on the sovereign island of St. Lucia in
the Caribbean.
MITAs manager of international programs, Zach Helzer,
came to MITA in 2010 afer graduating with a masters degree
in international studies from the Josef Korbel School of
International Studies at the University of Denver. Zach joined
MITA as much for his love of international policy as he did
for personal reasons. In his youth, he battled life-threatening
asthma, resulting in a childhood characterized by seemingly
endless hospital visits. Having been so acutely aware of the
importance of medical imaging afer routine chest x-rays,
Zach developed a keen interest in and appreciation for medical
imaging technologies and health policy, which he has honed
at MITA.
Te gif of giving prevails strongly at MITA, whose director
of government relations, Brian Connell, is married to a woman
from Santa Claus, Indiana. But the spirit of giving also extends
to the animal kingdomOrkideh Malkoc, MITAs director of
reimbursement policy, also volunteers at a local animal rescue.
Te woman who keeps the whole show running, Pamela Larbig,
MITAs senior administrative assistant to the executive director,
is the daughter of summer camp owners and spent most of her
childhood summers with family, and fellow camperssome of
whom became lifelong friends.
ei
Getting to Know MITA
MITA
Theyve got the MITA touch. From left: Stephen Vastagh, Richard Eaton, Brian Connell, Pamela Larbig, Gail Rodriguez, Brian Abraham, David Cooling, Zach Helzer, and Orkideh Malkoc
Electroindustry News
Cooking Safety Tips for Older Adults
provides safety tips on cooking safely
and preventing cooking fres.
Home Electrical Safety Tips for Older
Adults helps this population identify
and prevent common electrical
hazards that can result in a home fre.
Tey are available on ESFIs
website and YouTube channel
(www.youtube.com/user/esfdotorg).
ESFI provides all Home Fire Safety for
Older Adults Safety Awareness Program
resources at no cost. We encourage local
safety educators and community leaders to
use these resources to promote fre safety
awareness among the older adults in their
communities. Families and caregivers are
also urged to help older adults review this
safety information and/or perform their
smoke alarm maintenance activities and
home fre safety checks.
Visit www.esf.org/educators for ESFIs
Home Fire Safety for Older Adults
program resources and for more
information on how you can promote fre
safety awareness among older adults in
your family and in your community.
ei
Kate Janczyk, Director of Programs,
ESFI | kate.janczyk@esf.org
Te frst component of ESFIs Home Fire
Safety for Older Adults Safety Awareness
Program is the comprehensive program
toolkit, which encourages older adults
to adopt a proactive approach to home
fre safety. Te toolkit includes detailed
safety tip sheets that provide strategies
for preventing home fres related
to cooking, heating, and electrical
equipmentthe leading causes of home
fres every year. Illustrated smoke alarms
and escape planning tip sheets help
older adults adequately prepare for a
fre emergency. Additionally, Te Home
Fire Safety Checklist ofers a user-
friendly and convenient tool for giving
homes a fre safety check-up. Lastly,
the Emergency Information Sheet and
Smoke Alarm Maintenance Calendar
are handy and easy-to-use reference
tools to help older adults keep fre safety
information right at their fngertips.
To complement the toolkit, ESFI has
produced a safety video series with fre
safety messages developed specifcally for
adults over the age of 65. Te video series
includes three professional, 60-second
public service announcements that
provide critical home fre prevention tips:
Home Heating Safety Tips for Older
Adults demonstrates how to prevent
home heating fres.
ESFI Debuts New Fire Safety Resources for Older Adults
Home fres in the U.S. are a severe
problem. According to the National
Fire Protection Association, U.S. fre
departments responded to an estimated
average of 371,700 home structure fres
per year from 2006 through 2010. Tey
caused an average of 2,590 civilian deaths
and 12,910 civilian injuries annually.
Older adults are burdened with the
gravest risk, and are consistently more
threatened with injury or death by fre
than any other age group. In fact, adults
over the age of 65 have the highest risk
of death from fre, and this risk increases
with age. During 20032007, 28 percent
of people fatally injured in home fres
were age 65 or older. Tis age group
only accounted for 12 percent of the
population, putting them at a risk more
than twice that of the general population.
For those age 75 and over, the risk is 2.8
times higher. While only 2 percent of
the population was 85 or older, 6 percent
of the home fre deaths were in this age
group, giving these elders a risk 3.7 times
greater than the general population.
Raising awareness among this vulnerable
population is the key to reducing home
fres and preventing deaths. With that in
mind, the Electrical Safety Foundation
International (ESFI) has developed a
multi-faceted home fre safety awareness
program that provides tools to educate
older adults and their families about
home hazards related to major causes of
fre as well as the critical importance of
smoke alarms.
Tese program resources were developed
with funds provided by a FY 2011 Fire
Prevention and Safety grant from the
U.S. Department of Homeland Securitys
Federal Emergency Management
Agency, and are part of a comprehensive
multi-generational fre safety awareness
campaign that encourages family
members of all ages to work together
to identify and correct potential home
fre hazards.
Electroindustry News
non-proft benefactors and through
federal funding opportunities.
Other signifcant members of SGIP
include NEMA, the Edison Electric
Institute, the Electric Power Research
Institute, NIST, the U.S. Department
of Energys Pacifc Northwest National
Laboratory, and Ministries of Energy
from India and Japan.
Additional information is available on
the SGIP 2.0 website (http://sgip.org) or by
contacting John Caskey or Paul Molitor.
ei
John Caskey, NEMA Assistant Vice
President for Industry Operations;
Vice Chair of the Governing Board of
Directors for SGIP 2.0; and Chair of
SGIP 2.0 Technical Committee |
john.caskey@nema.org
Paul Molitor, NEMA Assistant Vice
President for Strategic Initiatives;
on loan as Transition Manager
for SGIP 2.0 |
paul.molitor@nema.org
organizations in other countries to
continue to share lessons learned from
the U.S. Smart Grid experience
1
.
Te leadership of SGIP 2.0 also displays
a remarkable level of continuity as 20
of the 25 members of the former SGIP
governing board are now on the Board
of Directors for SGIP 2.0. In the past,
NEMA staf and its member companies
have held the director positions for
Commercial and Industrial Equipment
Manufacturers; Consumers
Residential, Commercial, and Industrial;
Power Equipment Manufacturers;
and Standards and Specifcation
Development Organizations.
In its frst quarter of operations, SGIP
2.0 signed up more than 90 members
totaling almost $700,000 in revenue.
Further funding is being sought from
1
Te Global Smart Grid: An Introduction to Smart Grid
Interoperability Panel International Task Force, December
2012, Vol. 17 No. 12
[Re-]Introducing the Smart Grid Interoperability Panel
One of the great success stories that
came out of the Energy Independence
and Security Act of 2007 is the National
Institute of Standards and Technology
(NIST) Smart Grid Interoperability
Panel (SGIP). Originally established in
November 2009 to provide NIST with
access to the electrical industry, SGIP has
become an important force in accelerating
the identifcation and adoption of Smart
Grid standards. According to Dr. George
Arnold of NIST, SGIP has become the
model for the structure of public-private
partnerships in the Department of
Commerce and the U.S. government
as a whole.
Among its successes, SGIP counts the frst
standard in the U.S. developed from the
ground up for Smart Grid, NEMA SG-
AMI 1-2009. Other contributions include
adaptations to Zigbee Smart Energy 2.0
and identifying the underlying standards
that form the basis for the Obama
administrations Green Button Initiative,
a method for providing electricity
consumption information to consumers.
In late 2011, NIST announced that it would
no longer fund the administration of SGIP
and that it would turn over the panel to
industry collaborators. Seizing on this
opportunity, the SGIP governing board
developed a business sustainment plan and
formed a non-proft corporate entity, SGIP
2.0, Inc., to carry on the work.
Te form and function of SGIP 2.0 is
nearly an exact mirror of its predecessor.
Most importantly, the standing
committees dealing with Smart Grid
Architectures, Testing and Certifcation,
Implementation and Sustainability, and
Cybersecurity remain intact. So too
will the Priority Action Plans, or
PAPsthe working groups that create
requirements and recommendations
for Smart Grid standards.
Internationally, SGIP 2.0 continues
to pursue Letters of Intent with peer
Work Products & Interoperability Knowledge Base
SGIP Membership Board of Directors
Working
Groups
Coordinaon funcons
Priority Acon Plan (PAP) Teams
Standing Commiees
& Working Groups
Domain Expert
Working Groups
SGIP 2.0, Inc. Sta and Outsource Service Providers
Stakeholder
Elected (22)
H2G B2G
TnD I2G
BnP V2G
P i it
PAP 1
A P
PAP 2
Pl (PAP) Pl
PAP 3
TT
PAP
Architecture (SGAC)
Tesng & Cercaon (SGTCC)
Cyber Security (CSWG)
Implementaon Methods (IMC)
Project Management
One Organizaon, One Vote
Use Cases Requirements Priority Acon Plans White Papers
Standards
Descripons
Conceptual Model
& Roadmaps
Catalog of
Standards
DRGS
EMII
ITF
Gas
BOP
CME
IPR
BSP
B d f Di t
Commiees
Audit
Execuve
Governance
Membership
Technical
At-Large
Elected (3)
Ex-Ocio from
Standing Cmte.
Ex-Ocio
Non-Vong
Code Actions/Standardization Trends
To prevent the proliferation of conficting
standards, participants agreed to
continue cooperating on promoting
and enabling the harmonization and
alignment of standards in this area.
Tey also recognized that governments,
including the European Commission and
other inter-governmental bodies, must
work toward increased harmonization of
relevant laws and regulations.
During the conference, NEMA member
Shantanu Kothavale (ChargePoint) and
Harry Massey (NEMA industry director)
reported that NEMA is addressing EVSE
network interoperability, which will:
locate available, compatible
charging stations
reserve stations
permit use at any participating station
ease billing/payment
initiate EVSE directory schema
standard (static and dynamic
information)
support RFID card and station
identifcation standards
enable standard interface for
authentication/authorization,
charging/fault update, and billing
It is expected that the fnal standard and
protocols will be available for ballot in
the third quarter of 2013.
Scheduled to be held in United States,
an International eMobility Standards
Symposium is being organized by
SAE International, IEEE Standards
Association, and DIN German Institute
for Standardization to examine EV
standards strategies and major initiatives,
and determine what can be done to foster
EV adoption in the global marketplace
through the development and
implementation of standardization.
ei
communication protocols is already
taking place between IEC and SAE
but further work is needed. Eforts
are also underway to address various
interoperability issues when an EV is
roaming between charging networks
and to address communication of
electric vehicle supply equipment
(EVSE) metering data.
As Smart Grid technologies evolve,
communications interoperability
will require intensifed collaboration
among relevant actors including
automakers, charging network and
utility providers, and SDOs.
Wireless charging
Early cooperation among
standardizers is taking place,
including at the international level,
which will help to avoid future
compatibility issues. Safety aspects and
seamless charging are challenges that
standardization must address.
Safety of EV infrastructure
and batteries
Much standards work has been
undertaken to ensure the safety of
lithium-ion batteries and EVSE.
Additional investigation into safe
storage, transport, and interoperability
aspects of EV batteries is needed,
for example to support the battery
exchange infrastructure market,
and extensive work is still needed on
testing in line with standards.
NEEd for hArMoNiZAtioN
Participants acknowledged that a
number of organizations produce
globally relevant standards following
open, transparent, and consensus-based
processes. While one global standard
is always the preferred objective,
intellectual property, copyright, and
commercial issues sometimes result in
more than one SDO working on the
same or similar issues. Regulatory/
infrastructure diferences between
regions can also result in variations.
NEMA Joins Transatlantic Conference to Strengthen EV and EVSE Standards
Cooperation on eMobility
standardization was the focus of a recent
transatlantic roundtable organized
by the European Committee for
Standardization (CEN), the European
Committee for Electrotechnical
Standardization (CENELEC), and the
American National Standards Institute
(ANSI). It brought together technical
experts from industry, government,
and other stakeholders to compare and
discuss standardization priorities for
electric vehicles (EVs) as outlined in
the October 2011 Report of the CEN-
CENELEC Focus Group on European
Electro-Mobility and the April 2012
Standardization Roadmap for Electric
VehiclesVersion 1.0, developed by the
ANSI Electric Vehicles Standards Panel.
Eforts are already underway
among organizations involved in
EV standardizationInternational
Electrotechnical Commission
(IEC), International Organization
for Standardization (ISO), SAE
International, and Underwriters
Laboratories (UL).
Te discussions concentrated on:
Coupler safety and interoperability
fast charging
Many relevant international standards
are already in place or in progress.
Dialogue between the diferent
standards developing organizations
(SDOs) is improving, and industry
is working to make ISO and IEC
standards address the diferent
charging scenarios as comprehensively
as possible, for instance through
incorporating the SAE J1772TM
combo coupler.
Vehicle-to-grid communications
integrating EV with infrastructure
Tere is a need for common standards
for communication between the
vehicle and the grid, and to address
roaming of electric vehicles and smart
charging. Harmonization of the
addressing embedded meters. During
a recent conference call chaired by
Murray Jones (ECOtality), members
addressed the substance of the NIST
EVSE project, which was started at the
suggestion of CPUC. NIST will defne
the EVSE dispensed energy Method of
Sales in Handbook 130 Uniform Laws
and Regulations in the Area of Legal
Metrology and Engine Fuel Quality. Its
basic model was the gas station pump.
Once approved by the National
Conference on Weights and Measures
during its annual meeting, the Method of
Sales will become law when adopted by
local jurisdictions.
Members also considered how the NIST
project will afect the work on the NEMA
submetering project.
ei
Agricultural Buildings (Article 547),
Electrically Driven or Controlled
Irrigation Machines (Article 675), and
Natural and Artifcially Made Bodies of
Water (Article 682). Tese NEC articles
were all designed to protect people and
property from the hazards of electricity
which should be allowed to be inspected
and enforced in Iowa.
Te moral of this story is that when
politicians begin to tinker with electrical
safety, safetyespecially in this case
was put out to pasture.
ei

Don Iverson, NEMA Midwest Field
Representative | don.iverson@nema.org
It must enable customers to split
bills from a single premise meter
and EVSE submeter, and allow EV
service providers to separately pay the
submetered portion of the bill or the
entire premise bill, subject to appropriate
authorization by the consumer.
It should include reasonable consumer
safeguards, including requirements
for customer authorization and
indemnifcation, and ensure that
lines of communication and dispute
resolution are clear and defned.
NEMA ofered to provide further input
on whatever standardization requirements
emerge. Te industrys contribution
would ensure a balanced and viable
process that would achieve consumer-
friendly and pro-EV growth objectives as
well as an expeditious outcome.
Te National Institute on Standards
and Technology (NIST) is also
the proponents say the inspection
requirements may have cut electrical
fres in Iowa by 35 percent since the
requirement was enacted into law.
Unfortunately, a district judge decided
in January 2013 that the states electrical
board over stepped its bounds by
including farms in the 2009 law. Te
judge mentions in his decision that
requiring farmers to go through red tape
to secure a permit and make repairs to
a building that houses animals is illogical.
Te National Electrical Code (NEC)
includes several important articles that
directly afect agricultural settings:
NEMA Addresses the Embedded Meter
Iowa Legal System Attacks Electrical Code
In response to a request from the
California Public Utility Commission
(CPUC), NEMA expressed its support to
develop a submeter protocol that would
ensure consumer choice by supporting
submeters embedded in electric vehicle
supply equipment (EVSE). Tis would
provide consumers with a lower cost
alternative to costly second meters for
EV charging purposes.
Te process should address submetering
protocol as follows:
It must include appropriate standards
for submeters embedded in EVSE.
It must include a straightforward
process for EVSE submeter
certifcation and testing that it is
appropriate for the technology and
purpose, and that is not unduly
burdensome and expensive for EV
users, EVSE manufacturers, and EV
service providers.
Iowa enacted a law in 2009 that required
permitting and inspections of new
electrical installations in all commercial,
industrial, and agricultural (farms)
operations. Tis action upset agricultural
groups like the Iowa Farm Bureau, which
lobbied against the new requirements.
In June 2012, the governors ofce
called for the requirements on farms
to be dropped because of the economic
hardship to family farm operations.
Opponents contend that this will
allow inspectors to focus on homes
and businesses rather than on farm
structures that are not, in most cases,
occupied by the public. However,
has also launched a strategic initiative
and formed a task force on state code
adoption. Task force members meet
regularly to address these issues on a
state-by-state basis.
Washington and Idaho currently use the
2008 NEC. By the adoption actions they
are taking, they will skip the 2011 NEC
and go directly to the 2014 edition. Tis
should enable electrical industries in
these states to move forward by taking
advantage of new technology provisions
in such areas as electric vehicle charging
equipment, solar photovoltaics, data
centers, and energy management systems.
Washington and Idaho are commended
for moving forward with adoption of
the 2014 NEC. We hope other states and
jurisdictions throughout the U.S. will do
the same and help their constituencies by
adopting the most current codes.
ei
Mike Stone, NEMA West Coast Field
Representative | mike.stone@nema.org
As this article goes to press, legislation
has been introduced in the state of
Washington that could permanently
change the code adoption cycle for all
construction codes from three years to
six years.
Important NEC safety provisions
have also been reduced in some states,
including Washington and Idaho,
because of supposed excessive costs. Te
added costs are typically only a small
fraction of one percent of the overall cost
of building a house, but the added safety
is signifcant.
To maintain the highest level of
safety available, NEMA has joined
a coalition with the National Fire
Protection Association, the International
Code Council, and other industry
partners. Tis coalition promotes,
to the maximum extent possible, the
unamended adoption nationwide of
NEC and all the model construction
codes on a three-year cycle. NEMA
Pacific Northwest Picks Up Pace of Code Adoption
In the Pacifc Northwest, Idaho and
Washington have begun the process of
adopting the 2014 edition of the National
Electrical Code (NEC), becoming
among the frst states in the nation to
do so. If adopted as planned, the 2014
edition will be efective in these states
by approximately July 2014. As always,
this newest edition of the NEC contains
a number of updates and new articles
that refect advancing technology and
improvements in the safe use of electricity.
In recent years, some states and
jurisdictions, including Idaho and
Washington, have fallen behind with
timely code adoptions. Some of this
delay was due to the perception that new
codes would somehow add unnecessary
requirements and costs to construction.
Developers in some states have been
successful in convincing legislatures
and other decision makers to delay the
implementation of any new regulations
that would add cost, no matter how
miniscule, to building new structures.
International Roundup
Te results of more than one and a
half years of eforts are now coming to
fruition and generating an exceptionally
large amount of interest and attention.
For example, afer the Mexican
government published the draf revision
for a mandatory 60-day period of public
comments, NEMA Mexico reported
that a record number of comments had
been submitted. NEMAs Mexico staf
is already felding calls from member
companies asking about specifc articles
in the code.
ei
Gustavo Domnguez, NEMA Director
for Latin America |
guguez@prodigy.net.mx
Gene Eckhart, Senior Director for
International Operations |
gene.eckhart@nema.org
Ricardo Vazquez, Mexico NEMA |
r_vquez@prodigy.net.mx
efciency, and sustainability goals aimed
at raising the countrys international
competitiveness. Increased grid
reliability, reduction in energy power
loss, grid integration of renewables,
and customer service are also creating
demand for smart grid technology
deployment. Although currently at
an early stage, projections place it
as a burgeoning multi-billion dollar
market over the next decade. Hence,
technologies, systems, and pilot projects
are being identifed and evaluated
creating opportunities for U.S. Smart
Grid technology frms to enter in the
upstream decision-making process.
ei
Gene Eckhart, Senior Director for
International Operations |
gene.eckhart@nema.org
by NEMA member companies for the
last decade will now be required. Tis
presents enormous marketing prospects,
as well as opportunities to organize
workshops to instruct key stakeholders
on the important changes, as well as the
benefts, the new code will bring about.
NEMA Mexico staf started work on the
latest revision in early 2011, noting that
the process was entirely controlled by
the National Consultation Committee of
Electrical Installation Standardization
(CCNNIE), made up exclusively of
Mexican organizationsgovernment
agencies, trade associations, professional
organizations, and others. NEMAs work
was therefore channeled through several
of the more than 22 diferent entities.
Of particular importance was the close
work between the staf experts from the
Mexico ofces of NEMA and NFPA,
which publishes NEC.
of U.S. companies to promote their
technologies as well as hear about the
latest Mexican grid modernization
eforts from CFE, the Mexican Ministry
of Energy, industry leaders, National
Institute for Standards and Technology,
Smart Grid Interoperability Panel, and
other Smart Grid industry associations.
Te event will consist of a full day
conference covering policy, regulation,
interoperability standards, cybersecurity,
international collaboration, technology
trends and investment, and business
opportunities. U.S. panel participants
will be able to showcase their Smart Grid
technology solutions.
Mexicos emerging market for Smart
Grid technologies is being driven by
aggressive renewable energy, energy
Mexico Adopts a New Electrical Code
U.S.Mexico Smart Grid Technology & Business Conference Scheduled this Month
Te government of Mexico recently
published the new electrical installation
code known as NOM-001-SEDE-2012.
Te new code will go into efect
nationally in May 2013. It is a major
accomplishment by NEMA Mexico
staf, not only because it ensures that
members products will continue to
be named as part of the regulation,
but the new version takes a major leap
forward by embracing the 2011 edition
of the U.S. National Electrical Code
(NEC) almost in its entirety, with some
national deviations necessary to ensure
compatibility with the Mexican electrical
installed base.
Tis is the frst time in history that
the Mexican electrical code is based
on the latest (and current) version of
NEC. For example, the present and
soon to be obsolete code (NOM-001-
SEDE-2005) was based on the 1999
NEC. All new technology introduced
For the second time in as many years,
NEMA is collaborating with the U.
S. Commercial Service in Mexico to
organize and conduct the second annual
U.S.Mexico Smart Grid Technology &
Business Conference, March 12, 2013, in
Mexico City.
Te event is one of a series of activities
that have been launched as part of
NEMAs ongoing North America Smart
Grid program, designed to ensure
that the electrical grids in Canada,
Mexico, and the U.S. continue to exhibit
interoperability as each is upgraded to
Smart Grid capability.
Tis high-level business development
event is designed to foster the U.S.
Mexico commercial relationship in this
strategic market and enable a delegation
Economic Spotlight International Roundup
numbers, but positive growth is now
expected to take hold in the fourth
quarter of this year. Meanwhile, the
growth of real consumer spending on
healthcare, which had not declined in
many years, slowed but still remained
positive through the so-called Great
Recession before gaining strength in
2011. In 2012 that spending returned
to less robust growth, but as the major
provisions of the ACA come online in
2014, consumer spending is likely to
increase signifcantly.
With so many factors pushing and
pulling on the diagnostic imaging
industry, the only thing certain about the
months ahead is continued uncertainty.
ei
Steve Wilcox, Director of Market
Research | wilcoxs@nema.org
years ahead. For example, even though
the ATRA temporarily forestalled SGR-
related cuts, topics such as utilization
rate assumption may once again be
considered fair game.
Te economic environment facing the
diagnostic imaging industry should be
less turbulent than the political situation
described above. Two drivers afecting
the market for imaging equipment are
now, or are expected soon to be, moving
in a direction that should support
industry growth. Afer several quarters
of negative growth, real investment in
hospitals/care facilities construction
began the frst half of 2012 by providing
a ficker of hope that a reversal of that
trend was at hand.
Hope for a near-term turnaround
dimmed with third quarter 2012
Policy Environment Leads to Continued Uncertainty in the Diagnostic Imaging Market
Although uncertainty is a given in
business, highly regulated industries
face the added ambiguities brought on
by political and regulatory decisions
over which they have little control. Te
diagnostic imaging industry has faced
its share of economic and political
uncertainties over the years, and the
twists and turns show little evidence of
subsiding any time soon.
A quick review of the last couple of
decades reveals challenges such as the
healthcare reform eforts of the early
1990s, the nearly annual battle to hold
of the Sustainable Growth Rate (SGR)
cuts to Medicare reimbursement, varying
Certifcate of Need requirements, Defcit
Reduction Act cuts to advanced imaging
reimbursements, evolving restrictions
on physician self-referral, multiple
procedure payment reduction, changing
assumptions on equipment utilization
rates, and other alterations resulting
from the passage of the Afordable Care
Act (ACA).
Not all the changes have afected the
industry negatively, and in fact it
remains to be seen if the infux of newly
insured patients precipitated by ACA
may ultimately increase the demand
for cutting-edge diagnostic equipment.
Understanding where the industry is
heading is simply more difcult because
of the consequences, intended or
otherwise, of the furry of policy changes
it must face.
Now comes the fscal clif and its
afermath. Te American Taxpayer
Relief Act (ATRA), which was passed
to avert the signifcant budget cuts and
tax increases Congress and the Obama
administration built into previous
debt negotiations, leaves a great deal of
budgetary dilemmas unresolved. As the
federal government assumes a larger role
in the healthcare sector, it becomes ever
more likely to be an even greater focus
of cost-cutting eforts in the months and
0
1
2
3
4
5
6
7
1250
1300
1350
1400
1450
1500
1550
1600
1650
1700
2010 2011 2012 2013 2014 2015
BiIIions of doIIars, SAAR (Ieft)
y/y % ch (right)
Real Consumer Spending on
Healthcare
-30
-20
-10
0
10
20
30
10
15
20
25
30
35
2010 2012 2014
BiIIions of doIIars, SAAR (Ieft)
y/y % ch (right)
Real nvestment, Hospital/Healthcare
Facilities Construction
Economic Spotlight
More Learn
April
Coming in
Dont know a CT from a PET? An
x-ray from an MRI? Te illustrated
medical imaging primer at
www.medicalimaging.org/
about-mita/medical-imaging-primer
puts it all in focus.
Want to learn the impact of medical
imaging on neurodegenerative
disease, traumatic brain injury, or
cancer? www.medicalimaging.org/
publications-and-research compiles
publications and research on related
to medical imaging.
DICOM (Digital Imaging and
Communications in Medicine)
is the international standard for
exchanging medical images and
related information. DICOM has
revolutionized the practice of
radiology, much as the internet has
done for consumer information.
To receive MITAs daily media
report, contact plarbig@
medicalimaging.org.
ESFIs Home Fire Safety for Older
Adults Safety Awareness Program
encourages older adults to adopt
a proactive approach to home fre
safety. Te toolkit includes tips on
fre safety, smoke alarms, escape
planning, safety check-ups, and
maintenance calendars.
High performance buildings
(HPBs) create demand for energy
efciency. In April, ei looks at the
market-based model for HPBs
with a focus on:
public policies
energy savings performance
contracts
performance design
building labeling
products manufactured by
NEMA members
case studies
a methodology designed by the Federal
Reserve Bank of Atlanta.
ei
How do NEMAs forecasters expect the
economy to perform in 2013? We see
economic growth in the frst half of
2013 looking much like it has over the
last several years, said Mr. Gill. But a
steadily recovering housing market and
more robust consumer spending gains
should contribute to a stronger economy
later in the year and into 2014.
Approximately 50 forecasters serve
on the Wall Street Journal panel each
year, representing academia, fnancial
institutions, consulting frms, private
businesses, and industry associations.
Teir contributions are evaluated using
NEMA/BIS Forecasters Leavens and Gill in Top Five for Accuracy
NEMAs economic forecasters Don
Leavens, vice president and chief
economist, and Tim Gill, director
economics, fnished in ffh place
for 2012 in the Wall Street Journals
Economic Forecasting Survey. Te team
ranked number one in 2011. It marks a
notable degree of consistency during an
extended period of difcult-to-predict
economic conditions.
Weve long held that the recovery from
the Great Recession was going to be slower
than in past business cycles, said Mr.
Leavens. Tat view has been borne out by
the data over the last couple of years.
North American conditions continued
to fash strongly positive signals in
February. Te complete February 2013
report can be found at www.nema.org/
Feb13-EBCI.
EBCI Online
NEMAs Electroindustry Business
Confdence Index (EBCI) for current
Don Leavens (seated) and Tim Gill scored high in the Wall
Street Journals Economic Forecasting Survey for their 2012
macroeconomic forecast. Photo by Pat Walsh
Stock Art Credit
Cover, 1 MonkeyBusinessImages/
Shutterstock.com
2 albund/shutterstock.com
2 iStockphoto.com/TPopova
7 iStockphoto.com/SchulteProductions
9 iStockphoto.com/davidf
10 iStockphoto.com/IngramPublishing
11 iStockphoto.com/itsmejust
13 xiver/shutterstock.com
14 Andresr/shutterstock.com
18 AliEnderBirer/shutterstock.com
22 iStockphoto.com/Raycat
23 iStockphoto.com/beerkof
25 iStockphoto.com/john500
Economic Spotlight
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The Association of Electrical Equipment and Medical Imaging Manufacturers n www.nema.org n March 2013 n Vol. 18 No.

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