Revista Eloctroindustry - Mar14

Also Inside:
n Special Report: The Ins and Outs of the Sustainable Growth Rate in Medicare
n International Harmonization of Medical Devices Promotes Patient Safety
n Protecting Medical Devices through Cybersecurity
n DICOS and the Flying Public
How innovation in medical
imaging and radiation therapy
has transformed healthcare
Published by the National Electrical Manufacturers Association | www.NEMA.org | March 2014 | Vol. 19 No. 3
the magazine of the electroindustry
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please contact ULHELPS@ul.com or call 1.877.ULHELPS (1.877.854.3577)
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FEATURES
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Did you know...
The U.S. Energy Information Administration (EIA.gov) expects the U.S.
residential price of electricity to average 12.4 cents per kilowatt-hour
during 2014, an increase of 2.2 percent from 2013.
The Ins and Outs of the Sustainable Growth Rate in Medicare ...............................................................10
Moving Forward on Waves of New Medical Imaging Technologies ..........................................................12
Customizable Radiation Therapy Delivers Healthy Doses of Accuracy, Safety ..........................................14
Successful Healthcare Policy Rooted in Research and Evidence ..............................................................15
Protecting Medical Devices through Cybersecurity Requires Implementation of Vigorous Measures ........16
Medical Imaging Innovations Ofer Limitless Possibilities .....................................................................18
Global Harmonization Promotes Safety ...............................................................................................19
DICOMs Comprehensive Nature Enables Medical Image Interoperability ................................................20
DICOS and the Flying Public .................................................................................................................22
Product Showcase ...............................................................................................................................32
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electroindustry (ISSN 1066-2464) is published monthly by NEMA, the Association of Electrical Equipment and Medical Imaging
Manufacturers, 1300 N. 17th Street, Suite 900, Rosslyn, VA 22209; 703.841.3200. FAX: 703.841.5900. Periodicals postage paid at
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electroindustry
Publisher | Paul Molitor
Managing Editor / Editor in Chief | Pat Walsh
Contributing Editors | Phallan K. Davis,
Chrissy L. S. George, William E. Green III

Economic Spotlight | Tim Gill
Codes & Standardization | Vince Baclawski
Government Relations Update | Kyle Pitsor
Art Director | Jennifer Tillmann
Media Sales Team Leader | Stephanie Bunsick
CONTENTS

Also Inside:
n Special Report: The Ins and Outs of the Sustainable Growth Rate in Medicare
n International Harmonization of Medical Devices Promotes Patient Safety
n Protecting Medical Devices through Cybersecurity
n DICOS and the Flying Public
How innovation in medical
imaging and radiation therapy
has transformed healthcare
Published by the National Electrical Manufacturers Association | www.NEMA.org | March 2014 | Vol. 19 No. 3
the magazine of the electroindustry
Newsmakers NOTES
DEPARTMENTS
Government Relations Update ...............................................................................................................6
Targeting Repeal of Device Tax ............................................................................................................................................................. 6
NEMA-Backed Smart Grid Study Passes House Committee ................................................................................................................ 6
The Street Corner Comes to the Hill ..................................................................................................................................................... 7
Confict Minerals Resource Center Serves Members ............................................................................................................................ 8
Legislation Introduced to Improve Manufacturing Competitiveness .................................................................................................. 8
Supporters Seeking Urgency on Critical Minerals Bill .......................................................................................................................... 9
Electroindustry News ..........................................................................................................................23
MITA Board of Directors ......................................................................................................................................................................23
Theyve Got the MITA Touch ...............................................................................................................................................................24
ESFI Educates Consumers on Surge Protection ..................................................................................................................................25
Jim Pauley Ascends to NFPA Presidency ...........................................................................................................................................26
Code Actions/Standardization Trends ...................................................................................................27
Optimizing Radiation Dose through Standards and Policy ...............................................................................................................27
NEMA Standards Available on Website ..............................................................................................................................................28
Calling All Young U.S. Electrotechnology Professionals ....................................................................................................................28
International Roundup .......................................................................................................................29
MITA Takes Aggressive Action to Improve Regulatory Cooperation in the TTIP ................................................................................29
Economic Spotlight .............................................................................................................................30
NEMA Forecasters at the Top of Wall Street Journal Survey for Third Straight Year ...........................................................................30
Current Conditions EBCI Rebounds in February; Optimism for First Half of 2014 Remains Strong .................................................30
NEMA Ofcers ....................................................................................................................................................................................... 3
Comments from the C-Suite ................................................................................................................................................................. 3
Views from the Top ............................................................................................................................................................................... 4
Ask The Expert .....................................................................................................................................................................................31
NEMAs 400+ member companies
employ more than 800,000 workers
in the U.S.
NEMA Transportation Management
Section brings its message to Capitol Hill
Dennis Durmis and Guru Sundar join
MITA Board of Directors
Jim Pauley ascends to NFPA presidency
8
23
26
COMMENTS FROM
THE C-SUITE Ofcers
Evan R. Gaddis
President and CEO
Im very proud of the accomplishments of NEMAs medical division, the Medical Imaging
& Technology Alliance (MITA). In 2013 MITA released its frst Smart Dose standard,
designed from the ground up to provide optimal radiation dose levels in computed
tomography (CT) procedures. Awareness of this issue has become such a big part of my
life that I recently refused an imaging procedure because the equipment didnt comply
with the latest MITA standards for safety.
Te MITA Smart Dose standard ofers important tools to optimize and manage radiation
dose delivery for medical imaging technologies. Te attributes of a MITA Smart Dose
include structured dose reporting that is compliant with the Digital Imaging and
Communications in Medicine (DICOM) standard, pediatric and adult reference protocols
for clinicians, the NEMA CT Dose Check notifcation and alert standard, and automatic
exposure control (AEC).
Te federal agencies regulating medical imaging are very diferent from the others
we deal with in NEMA. In the MITA world, they are typically the Food and Drug
Administration for clearing the sale of medical imaging technologies, and the Centers
for Medicare & Medicaid Services for establishing coverage and reimbursement rates in
government-run insurance programs.
As a refresher, Medicare and Medicaid were established as part of the Social Security
Amendments enacted under President Lyndon Johnson in 1965. Today, Medicare, a
program to provide health insurance to people age 65 and older, has four parts: acute care
insurance (Part A), outpatient medical insurance (Part B), managed care administered
by private insurers (Part C), and prescription drug coverage (Part D). A more recent
consideration for Medicare is the sustainable growth rate (SGR) that was enacted in 1997.
A special report in this issue of ei deals with SGR and the current doc fx challenges
facing Congress (page 10). For more than a decade, SGR has been a contentious issue for
healthcare providers. Subsequently, there have been a number of tweaks to the formulas
and their application to physician reimbursements. How to pay for the SGR reform is a
contentious and problematic issue for MITA and its members.
Another industry challenge is the medical device tax, a levy that MITA and its members
passionately oppose. Tis excise tax results in purely negative consequences by dampening
enthusiasm for medical imaging technologies. MITAs recently-announced Imaging
Forward campaign (page 12) is designed to overcome the arguments of the device tax
proponents by highlighting the positive impacts of medical imaging. Te best example of
this is how imaging has all but eliminated the need for exploratory surgery.
I encourage you to be as informed as possible given that Medicare, SGR, and the device tax
touch every American. One way or another you will be afected, either as a taxpayer or as a
healthcare consumer. I hope you fnd this issue of ei as benefcial as I do.
ei
NEMA electroindustry March 2014 3
Chairman
Christopher B. Curtis
CEO, North America
Operations, Schneider Electric
First Vice Chairman
Thomas S. Gross
Vice Chairman & COO
Eaton Corporation
Second Vice Chairwoman
Maryrose Sylvester
President & CEO
GE Lighting
Treasurer
Don Hendler
President & CEO
Leviton Manufacturing Co., Inc.
Immediate Past Chairman
John Selldorff
President & CEO
Legrand North America
President & CEO
Evan R. Gaddis
Secretary
Clark R. Silcox
Donald Fowler
New medical imaging technologies
have revolutionized medical care in one
short generation. Evidence continues
to accumulate that early detection
and accurate diagnosis save lives. By
increasing access to appropriate imaging
technologies for target populations
through expanded coverage, we are
improving patient outcomes and
advancing healthcare.
Lung cancer, for example, claims nearly
160,000 lives each year, making it the
leading cause of cancer death in the
U.S.
1
A chest x-ray can detect lung
tumors as small as a dime, but by the
time a tumor reaches that size, the
cancer is already at a late stage, making
treatment much less efective.
Low-dose computed tomography (CT),
however, can fnd tiny tumors the size
of a grain of rice
2
, which has been
shown to reduce lung cancer deaths
by 20 percent compared to chest
x-ray alone.
3
Tats why the evidence
demonstrates that low-dose lung CT
for high-risk populations could save
12,000 lives every year.
4
MITA advocates
that healthcare insurance, including
Medicare, cover this procedure for
everyone in high-risk categories.
Colorectal cancer, the third leading cause
of cancer deaths in the U.S., claims some
50,000 lives annually.
5
While standard
colonoscopy can detect polyps and
Increasing Access through Expanded Coverage
Gregory Sorensen, MD, President and CEO North America, Siemens Medical Solutions, Inc.
Donald Fowler, President and CEO, Toshiba America Medical Systems
tumors early, some people are nervous
about the procedure. Tats where
computed tomographic colonoscopy
(CTC) or virtual colonoscopy can play
an important role in increased screening
for high-risk populations.
CTC uses a low-dose scan to spot polyps
and tumors. A recent study from the
National Naval Medical Center/Walter
Reed Army Medical Center found that,
for patients who had had a CTC and
a colonoscopy, 95 percent of patients
preferred CTC, and 37 percent of those
who had colon screening said that they
would not have done so without a CTC.
6
Tese trends are especially pronounced
in ethnic minority communities, which
have generally lower compliance with
colonoscopy, and therefore, higher
rates of colorectal cancer mortality.
Colonography has the potential to
reverse this disturbing trend.
PROMOTING CERTAINTY
IN UNCERTAIN TIMES
According to Te National Breast Cancer
Foundation, 98 percent of breast cancer
patients survive if detection occurs early.
Tis is especially important for women
with dense breast tissue. Tey have a
signifcantly increased risk of developing
breast canceras much as four to fve
times higher than other women.
Women with dense breasts no longer
have to settle for traditional x-ray
mammography, which is less sensitive
in detecting tumors. With magnetic
resonance imaging (MRI) and
ultrasound, fewer women undergo
follow-up screening and invasive
biopsy; time and money are saved; and
needless worry can be avoided. MITA
is advocating for increased coverage of
supplemental screening for women with
dense breasts.
Alzheimers disease poses another
diagnostic challenge to clinicians. It
is estimated that by 2025, the number
of people age 65 and older with
Alzheimers disease will increase by
40 percent to 7.1 million from the fve
million currently afected. Unlike other
imaging technologies, positron emission
tomography (PET) allows doctors and
researchers to see the brain in action.
PET helps doctors identify brain deposits
of beta-amyloid plaque, a substance that
is a hallmark of Alzheimers disease.
Tat knowledge means that a
better diagnosis is a step closer.
MITA is leveraging the recent CMS
coverage decision to promote access
to this service.
With our partners in the provider,
patient, and payer communities,
manufacturers are ensuring that
lifesaving technologies are accessible
to the millions of patients who
can beneft from them. MITAs
advocacy demonstrates manufacturers
commitment to public health and
the patients who inspire our
continued innovation.
ei
1
Cancer Facts and Figures. American Cancer Society. (2012).
www.cancer.org/acs/groups/content/@epidemiologysurveilance/
documents/document/acspc-031941.pdf
2
Low-Dose CT Scan vs. X-ray. Swedish Medical Center. (2013).
tinyurl.com/m9vucxo
3
Reduced Lung-Cancer Mortality with Low-Dose Computed
Tomographic Screening. NEJM. 2011 Jun 29 [cited 2013 Mar 22].
Available from www.nejm.org.
4
J Ma, et al. Annual number of lung cancer deaths potentially
avertable by screening in the United States. Cancer. 119.7
(2013):1381-5. dx.doi.org/10.1002/cncr.27813
5
Cancer Facts and Figures. American Cancer Society. (2012).
www.cancer.org/acs/groups/content/@epidemiologysurveilance/
documents/document/acspc-031941.pdf
6
CT Colonography May Improve Colorectal Cancer Screening
Compliance. American Society of Roentgenology. 2010
November [cited 2014 Feb 11]. Available from www.ajr.org
Greg Sorensen
4 NEMA electroindustry March 2014
Views from the Top
Over the past 40
years, progress in
medical imaging
has outpaced all
other specialties
of medicine.
As one whose
career in imaging
began in the mid-1970s with a radiology
residency, I have been most fortunate to
have witnessed a remarkable succession
of major innovations that have
revolutionized patient care:
Te advent of ultrasound in the early
1970s coincided with the appearance
of the frst computed tomography (CT)
scanners in the U.S.
MRI followed in the early 1980s.
Although rudimentary positron
emission tomography (PET) scanning
was extent as early as 1980, its clinical
translation was delayed until at least
the 1990s.
Creative interventional radiologists
applied these new technologies to further
the goal of image-guided treatment.
Perhaps the most remarkable thing about
these leaps in medical imaging is that,
unlike most innovations in medicine that
are directed to a single or at best a few
applications, the new technologies have
been useful for the gamut of possible
applications to patient carescreening
and early detection, diagnosis and the
evaluation, image-guided treatment, and
evaluation of the efectiveness of therapy.
Moreover, the utility of imaging
innovations has been broad-based and
applicable to nearly all organ systems.
Indeed, a fn d siecle poll of American
physicians ranked the advent of CT and
MRI (magnetic resonance imaging)
to have been the most important new
contributions to patient care of the last
quarter of the 20th century.
InnovationRoot and Heart of Revolutionized Patient Care
Bruce J. Hillman, MD, Professor of Radiology and Medical Imaging and Public Health Sciences, University of Virginia
It has not been only the big advances
that have made medical imaging so
important to improved patient care.
Evolutionary improvements in spatial,
contrast, and temporal resolution have
progressively enhanced the number
of clinical applications and improved
its accuracy and safety. Paired with
innovations in information and
connectivity technologies, medical
imaging has reduced the risk of invasive
procedures, minimized required post-
procedural convalescence, and provided
a safe approach to repeated assessment of
the efectiveness of therapy.
At the rootand heartof this success
story has been innovation. Indeed,
continuous innovation is nearly wholly
responsible for taking medical imaging
from little-visited dank hospital
basements to the premier position it
occupies in modern healthcare. Te
engine for innovation has been an
enduring partnership between industry
and academe. Each has depended on the
other and both have prospered. Many
although by no means allof the most
exciting innovations in imaging have
originated in the minds of university
faculty, who have turned to industry to
fnance development and bring an idea
to clinical application. Similarly, imaging
companies have turned to university
departments to help them translate an
idea into reality and test its capabilities
as a viable clinical modality.
For imaging to maintain its place in
healthcare, innovation must continue
apace in the future. Moreover, future
innovation must consider major
changes in the healthcare milieu.
Increasingly, medical care will grow
more personalized and molecularly
based. Tere are renewed demands
for cost reduction. Te preferences of
patients will become ascendant over
the traditional paternalistic healthcare
model. Industry will need to think much
more strategically about what new ideas
they will pursue and providers must
more realistically consider what new
technologies they will adopt.
Accepting these concepts will ensure
the continuing contributions of medical
imaging to improving patient care and
facilitating better healthcare outcomes.
ei
Dr. Hillman is editor in chief of the
Journal of the American College of
Radiology and chief scientifc ofcer of
ACR Image Metrix.
MITA Responds to Medical Device Tax Survey
In response to a survey taken by the Emergo Group
regarding the medical device tax, Gail Rodriguez,
PhD, executive director of MITA, said, This
unscientifc and fawed questionnaire fies in the
face of countless reports over the last two years
of the device tax leading to layofs and reduced
investment in new medical innovation.
The fndings, she said, are based on responses from
regulatory professionals, not business executives.
As any CEO can attest, a tax that has thus far
required medical device manufacturers to pay out an
estimated $2.6 billion to the IRS poses an undeniable
threat to an industry that contributes to more than
300,000 jobs nationwide, generates approximately
$25 billion in payroll, pays out salaries that are 40
percent higher than the national average, and invests
nearly $10 billion in R&D annually.
Read the entire response on the MITA website.
Government Relations Update
Targeting Repeal of Device Tax
NEMA-Backed Smart Grid Study Passes House Committee
A heated political environment and a
lack of congressional activity in 2013
produced yet another year in which
Congress failed to repeal the medical
device tax.
1

We are heartened, however, that of
the multitude of concerns on the
congressional priority list, the device
tax issue was one of the few considered
during discussions involving the
government shutdown and debt ceiling.
For 2014, device tax repeal remains the
top priority for MITA and our partners
in the Device Tax Repeal Coalition.
MITA intends to build upon last years
successes. Tis includes device tax
repeal provisions in the Senate Budget
Resolution, the document that serves
as the blueprint for Senate priorities.
Since 2014 is an election year, there are
a number of potential pitfalls as well as
opportunities , and the likelihood of
even less legislative activity than in 2013.
As Senate Democrats seek to preserve
their majority, they may use device tax
1
Section 4191 of the Internal Revenue Code imposes a 2.3
percent excise tax on the sale of certain medical devices by the
manufacturer or importer of the device. It was part of the 2010
Patient Protection and Afordable Care Act.
Te U.S. House of Representatives
Committee on Homeland Security
adopted an amendment that would
result in a comprehensive assessment
of actions necessary to expand and
strengthen the capabilities of the
electrical power system to prepare for,
respond to, mitigate, and recover from
a natural disaster or cyberattack.
Ofered by Rep. Donald Payne, Jr. (D-NJ)
to HR 3696 National Cybersecurity and
Critical Infrastructure Protection Act,
the amendment directs the National
Research Council to conduct a study on
the resiliency and reliability of the nations
repeal as an opportunity to demonstrate
independence and bipartisan job-
creating bona fdes.
Regardless of what we expect to happen
in Congress, MITA has put the highest
priority on repealing the device tax.
MITA has a robust advocacy strategy
that includes, but is not limited to
meeting with congressional staf,
engaging with reporters, and spreading
the positive message of job growth that
we expect to follow repeal.
Our industrys strongest advocates
are naturally the member companies
who employ thousands in the states
and congressional districts. Member
company CEOs and executives are
encouraged to continue building on the
relationships they have established with
members of Congress. To assist these
eforts in 2014, MITA will continue to
host advocacy fy-ins where executives
meet with members and their staf to
keep up the drumbeat for repeal.
Our message continues to be that repeal
of the device tax is not a healthcare
or Afordable Care Act (ACA, or
Obamacare) issueit is a jobs and
power grid and related issues. Te Payne
amendment is backed by NEMA.
Cybersecurity is only one threat facing
the grid. A 2013 report by the Executive
Ofce of the President estimates that
nationwide, the annual cost of weather-
related grid outages averages between $18
and $33 billion.
Furthermore, a February 4, 2014, Wall
Street Journal article detailed a physical
attack on a California transmission
substation in 2013 in which multiple
snipers disabled 17 high-voltage
transformers. Many of the same
innovation issue. Regardless of ones
views on the ACA, we should agree that
taxing products that save lives is not
the right way to raise revenue. Tese
technologies require the very jobs that
those inside and outside of Washington
routinely endorsehigh-paying
manufacturing jobs. Tis 2.3 percent
device tax on salesnot proftsonly
reduces employment and innovation,
restricting patients access to tomorrows
technologies.
At the onset of 2013, no one could have
foreseen the strides device tax repeal
would take and that we would continue
to be a priority on the wish lists of both
Democratic and Republican members
of Congress. We remain cautiously
optimistic about what this year holds
for addressing device tax. MITA
looks forward to continuing to work
with member companies and other
stakeholders on this issue.
ei
Brian Connell, Director of
Government Relations, MITA |
bconnell@medicalimaging.org
technologies that can make the system
more resilient and more reliable serve to
increase its everyday energy efciency,
power quality, and cost-efectiveness
as well.
Bloomberg New Energy Finance has
determined that U.S. utilities spent
$9.4 billion on Smart Grid technology
in 20112012. McKinsey projects the
potential value of a fully developed
Smart Grid by 2019 to be $130 billion.
ei
Jim Creevy, Director of Government
Relations | jim.creevy@nema.org
The Street Corner Comes to the Hill
Transportation Management Section
Chairman Bryan Mulligan, President of
Applied Information, Inc., led a delegation
that met with key Capitol Hill ofces
and allied organizations on January 16.
Mr. Mulligan was joined by Ray Deer
(Peek Trafc/Signal Group), Tom Becker
(Daktronics), Jesse Swinea (Adaptive
Micro Systems), and NEMA staf.
Te visits marked the ffh consecutive
year that the section set aside the day
prior to its winter meeting at NEMA
for a series of outreach engagements
around Washington, D.C. Fueled
by this outreach, a notable trend
each year has been the increasing
familiarity on Capitol Hill with
intelligent transportation systems
(ITS): monitoring, control, and
communications products applied to
roadway networks.
Another major factor has been MAP-21,
the federal law providing authorization,
policy, and funding for highway and
transit programs that is set to expire at
the end of September 2014. Approved in
2012 and with NEMA support, MAP-21
made fully eligible all ITS technologies
for federally-funded highway projects.
In each of three meetings on Capitol Hill,
the group acknowledged the daunting
challenge of funding ongoing federal
highway programs, but emphasized that
a fully funded multi-year bill is needed
to provide states and businesses sufcient
time to plan and make investments in
applying new technologies.
Performance measures mandated by
MAP-21 are in development and, once
implemented, should be an important
big data tool for transportation
agencies. Building on that, Congress
should look at changes to the traditional
asset-focused contracting undertaken
by states for transportation projects, the
group recommended. Tese messages
were well received by staf for the Senate
Committee on Environment and Public
Works and the Committee
on Commerce, Science and
Transportation, as well as
by an aide to Sen. Johnny
Isakson (R-GA). Te section
is considering proposals
that could be included in
legislation to be introduced
this summer to build on and
extend MAP-21.
In addition to Hill visits,
the section delegation
built bridges to three
organizations that
play an infuential role
in the transportation
infrastructure debate
National Association
of Manufacturers, U.S.
Chamber of Commerce,
and American Council
for an Energy Efcient
Economy (ACEEE). In each
encounter, Mr. Mulligan
explained NEMA members
perspective and role of
implementing technology
at the roadside, including
trafc control cabinets on
the street corner, as well as
above and below the road surface. His
colleagues were able to share examples
of projects their companies have built
that are having positive efects on trafc
congestion, travel times, traveler safety,
and smart parking.
A central theme of the NEMAACEEE
meeting was the importance of energy
efciency as a key performance metric
for the transportation network. As work
ramps up this spring and summer to
build support for legislation, the section
looks forward to sharing more stories
about the value of ITS through NEMA
and these allied organizations.
ei
Craig Updyke, Manager,
Trade and Commercial Afairs |
craig.updyke@nema.org
Calling Transportation
and Logistics Pros
NEMAs Global Transportation and Logistics
Committee will meet May 13 in conjunction
with the spring meetings of the Industrial
Automation Section. A longstanding joint
creation of the Industrial Automation and
Low Voltage Distribution Equipment sections,
the Global Transportation and Logistics
Committee is open to participation by members
of any NEMA section. It is chaired by Tom
Mauerer, Rockwell Automation Manager for
International Transportation.
For more information, contact
harry.massey@nema.org or
Making the rounds on the Hill were (from left) Jesse Swinea, Adaptive Micro Systems;
John Miller, NEMA Industry Director; Tom Becker, Daktronics; Bryan Mulligan, Applied
Information; and Ray Deer, Peek Trafc/Signal Group. Photo by Craig Updyke
Government Relations Update
Conflict Minerals Resource Center Serves Members
Legislation Introduced to Improve Manufacturing Competitiveness
On January 22, NEMA and a coalition
of organizations launched an online
training and resource center for
companies wrestling with regulations
and requirements related to so-called
confict minerals. NEMA got involved in
the coalition to ensure that its members
would have access to knowledge and
understanding needed to work toward
compliance with the Securities and
Exchange Commission (SEC) rule on
confict minerals or respond to requests
for information from supply-chain
partners and customers.
On August 22, 2012, the SEC adopted
a fnal rule to implement Section 1502
of the Dodd-Frank Wall Street Reform
and Consumer Protection Act (Dodd-
Frank). Te rule requires publicly-held
companies to disclose whether their
products contain confict minerals
as defned by the Dodd-Frank: tin,
tantalum, tungsten, and gold (collectively
known as 3TG), originating in the
Democratic Republic of the Congo and
adjacent countries. Te frst reporting
period for the SEC confict minerals
disclosure rule ended on December 31,
2013. Te frst reports to the SEC are
required by May 31, 2014.
On February 10, Senators Mark
Pryor (D-AR) and Mike Enzi (R-
WY) introduced S 2002, Te Motor
System Market Awareness Act of
2014, which authorizes the U.S.
Department of Energy (DOE) to assess
current market conditions for motor
system technologies, identify areas of
improvement in the marketplace, educate
end users on efciency benefts of new
motors, and help encourage the greater
use of rare earth and other advanced
technologies to achieve efciencies in
motor systems.
Senators Pryor and Enzi have
introduced legislation that shows
NEMA worked with six industry
association counterparts to engage
Source Intelligence, a leading provider
of cloud-based confict minerals
compliance programs, and Schulte Roth
& Zabel LLP, a full-service law frm
with recognized expertise in confict
minerals compliance. Te partnership
developed a web-based resource center
with comprehensive confict minerals
compliance tools. Te website is
accessible by NEMA members at www.
confictmineralsresourcecenter.com.
Te goal of the joint initiative has been to
deploy understandable confict minerals
compliance tools across the NEMA
membership. By providing member
companies and their vendors and
contractors with the information needed
to understand the complex and costly
compliance requirements, all companies
along the supply chain will improve their
efciency in responding to supply chain
inquiries.
Te tools developed with Source
Intelligence and Schulte Roth & Zabel
LLP, are meant as a resource to help
companies understand the complicated
SEC requirements. In developing these
compliance tools, all parties recognize
their commitment to bettering the
manufacturing environment and
ensuring manufacturing competitiveness
in the global market, said NEMA
President and CEO Evan R. Gaddis. We
are grateful for their leadership on this
important issue.
According to DOE, motor systems
are responsible for 63 percent of all
electricity consumed by U.S. industry.
An update of the previous study, issued
in 2002, is needed given technological
advances in motor systems and changes
in industrial end-users. Te legislation
also calls on DOE to undertake in
consultation with industry a targeted
the real challenges that all manufacturers,
retailers, and others are facing as they
work diligently and in good faith to
build their compliance frameworks. In
addition, all parties recognize that it
remains the responsibility of individual
companies to identify their specifc
compliance obligations.
Our hope is that by providing NEMA
member companies and their vendors
with the web-based training and resource
center, all companies throughout
the supply chain will have a better
understanding of what the SEC rule
requires and what they are expected to
undertake in attempting to comply with it.
Te other organizations involved in the
efort are the American Apparel and
Footwear Association, the Fashion Jewelry
and Accessories Trade Association, the
National Association of Manufacturers,
the National Retail Federation, the Toy
Industry Association, and the United
States Fashion Industry Association.
ei
Clark Silcox, NEMA Counsel |
clark.silcox@nema.org
public awareness program on end-
user energy efciency opportunities,
procurement practices, and research and
development needs.
NEMA will continue to work with Sens.
Pryor and Enzi to advance the legislation
in Congress and with DOEs Advanced
Manufacturing Ofce, which focuses on
industrial energy efciency.
ei
Justin Neumann, Government
Relations Manager |
justin.neumann@nema.org
Supporters Seeking Urgency on Critical Minerals Bill
Mere days before leaving the
chairmanship of the Energy and
Natural Resources Committee in
February, Sen. Ron Wyden (D-OR)
convened a hearing on NEMA-supported
legislation to reinvigorate federal policy
on mineral resources, information,
research, and know-how. Te Critical
Minerals Policy Act (S1600) aims to
improve U.S. knowledge and forecasting
on availability of critical minerals;
bring a more even-handed approach
to the permitting process for new
hard-rock mineral extraction on
federal lands; and invigorate research,
development, and training eforts
related to critical minerals.
New Committee Chairwoman Mary
Landrieu (D-LA) has not taken a public
position on the bill, whose primary
author is Committee Ranking Member
Lisa Murkowski (R-AK). Te prospects
for moving the bill forward, however,
are unclear. NEMA is making the case
to move it through the committee as
soon as possible. To support that goal,
it has joined forces with a group of
stakeholders pointing to the need for
the federal government to maintain its
leadership role in providing objective
information and analysis on mineral
reserves and supplies worldwide.
In remarks at the January 28 hearing,
Sen. Wyden emphasized the importance
of updating federal policies in order to
support not only domestic mining but
also mineral processing activities. He
showed keen interest in federal research
underway to make economically
viable more activities to reclaim and
recycle critical minerals from waste
manufactured products, including
lithium batteries.
Sen. Murkowski cited the low ranking
of the U.S. in terms of mining
permitting and added that the Senate
should take into consideration the
approach supported by the House of
Representatives in 2013 to address that
directly. HR761, sponsored by Rep.
Mark Amodei (R-NV), passed the
House on September 18 and would allow
permitting agencies to exempt mining
from broad environmental review. Sen.
Murkowski touted the comprehensive
approach taken in her bill to address U.S.
capabilities all along the supply chain.
In a statement fled with the committee,
NEMA cited manufacturers dependence
on foreign supplies for many critical
minerals and the challenging supply and
price conditions they can face. NEMA
fnds that, taken together, the provisions
of S1600 represent a comprehensive and
balanced strategy to modernize domestic
policy related to availability of minerals
to the electroindustry.
First, the bill directs the Department
of Interior to work with stakeholders
to determine which minerals are most
critical to the U.S. economy.
Second, it provides a set of policies across
multiple federal agencies to address issues
associated with the discovery, production,
processing, use, and re-use of critical
minerals. For example, the White House
is directed to establish a forecasting
capability that enables mineral policies
to keep up with mineral markets and
federal agencies to take steps to support
economic competitiveness while
maintaining environmental protections.
Te bill mandates a close look at federal
permitting for mining and processing
activities to eliminate unnecessary delays.
Tird, the legislation addresses the
challenges of making better use of
mineral and human resources. It directs
the Department of Energy (DOE) to
continue and deepen its information,
research, and development activities on
alternative materials and reclamation and
recycling of critical minerals that have
moved through the manufacturing supply
chain to the consumer value chain.
In testimony, Assistant Secretary
of Energy for Energy Efciency and
Renewable Energy David Danielson,
PhD, touted the tremendous
opportunities for recycling electric
vehicle batteries, permanent magnets
from electric motors and wind turbines,
and phosphors from fuorescent lighting.
Dr. Danielson stated that current DOE
research includes development of cost-
efective technology to separate materials
and that DOE is researching designs that
make products easier to disassemble in
order to facilitate recycling. He noted,
however, that DOE had not taken a
formal position on the bill.
S1600 would also direct the Department
of Labor to assess the U.S. workforce
trained in mineral-related skills, identify
present and future gaps in know-how,
and develop ways to enable more U.S.
workers to become part of a vital U.S.
minerals supply chain.
In a related development, NEMA joined
14 organizations to form the Minerals
Science and Information Coalition to
advocate for reinvigorated minerals
science and information functions in the
federal government. Formally launched
on February 20, the coalition emphasizes
the economic and strategic importance
of accurate, timely information on
mineral resources and on the domestic
and global fow of minerals and
mineral materials. Te coalition will
advocate for stepped up investments in
federal minerals research, information
collection, analysis, and forecasting.
ei
Te fee schedule was updated annually by a combination of the
MEI and an adjustment factor designed to counteract increases
in the volume of services being delivered per benefciary. Tat
factor, known as the volume performance standard (VPS),
was based on historical trends in volume. However, the VPS
mechanism led to highly variable changes in payment rates, and
the Congress replaced it with a new mechanismthe SGR
starting in 1998.
Te SGR mechanism aims to control spending for physicians
services. It does so by setting an overall target amount of
spending (measured on both an annual and a cumulative basis)
for certain types of goods and services. Included are payments
for physicians services as well as payments that Medicare
makes for items such as laboratory tests, imaging services, and
physician-administered drugs that are furnished incident to
(in connection with) physicians services. Payment rates are
F
air Medicare reimbursements as a means to maintain patient access
to medical services is an issue that MITA has supported for years.
On the surface, it seems as if the process of paying doctors
for routine medical services should be a straightforward
transaction between the Medicare program and the clinician
performing the service. In reality, Medicare reimbursements
are a complicated mix of formulas governing how the Centers
for Medicare & Medicaid Services (CMS) will pay for thousands
of diferent medical products and serviceswith additional
adjustments made to those rates based on location, patient
characteristics, quality measures, and a number of other factors.
One piece of this formula, the sustainable growth rate (SGR),
has vexed physicians for almost a decade, and it remains one
of the most intractable health policy issues on Capitol Hill.
Paying for Coverage
According to the Congressional Budget Ofce (CBO)
1
, since
the Medicare program was created in 1965, several methods
have been used to determine how much it pays physicians
for each covered service. Initially, the program compensated
physicians on the basis of their charges and allowed them to
bill benefciaries for the full amount above what Medicare paid
for each service. In 1975, Medicare payments were still linked
to what physicians charged, but the annual increase in fees
could not exceed the increase in the Medicare economic index,
or MEI. Because those changes were not enough to prevent
total payments from rising at an unsustainable rate, from 1984
through 1991 the yearly change in fees was determined directly
by Congress through legislation.
Starting in 1992, the payment system based on physicians
charges was replaced by a fee schedule. Tat schedule bases
payment for individual services on measures of the relative
resources used to provide them. Te schedule was not intended
to control spendingit was designed to redistribute spending
among various physician specialties.
1
www.cbo.gov/sites/default/fles/cbofles/fpdocs/75xx/doc7542/09-07-sgr-brief.pdf
The Ins and Outs of the
Sustainable Growth Rate in Medicare
Brian Connell, Director of Government Relations, MITA
Paul A. Molitor, Assistant Vice President, NEMA
How Money and Services Flow in the Medicare Environment
Special Report
Over the years a number of people have called for repeal of the
SGR formula, the so-called permanent doc fx. While simply
repealing the SGR formula would cure the frequent override
legislation that must be passed in Congress, it wouldnt solve
the problem of how Medicare reimbursement rates would be set.
A recent CBO report estimated that a permanent repeal of the
doc fx formula would cost the federal government $138 billion
between 2014 and 2023.
2

In 2013, the three congressional Medicare committees approved
similar, bipartisan legislation to repeal the SGR formula and
establish several physician ofce and hospital outpatient
Medicare payment reforms. Te intent of many of these
reforms is to shif Medicare payments away from fee-for-service
payments based on volume, toward limited payments that
account for the quality of the care provided.
Although Congress made unprecedented progress in advancing
these reforms last year, 2014 holds another set of hurdles that
will need to be overcome to eliminate the SGR and establish a
new mechanism to guarantee access to care while ensuring that
the promise of Medicare remains for future generations.
ei
Mr. Connell (bconnell@medicalimaging.org) was a legislative
director on healthcare policy for a member of Congress.
Mr. Molitor (paul.molitor@nema.org) is the publisher of ei.
2
www.cbo.gov/sites/default/fles/cbofles/attachments/43907-BudgetOutlook.pdf
adjusted annually to refect diferences between actual spending
and the spending targetupward if spending is below the
target, downward if spending is above the target.
Policymakers had two main goals when they adopted the SGR
mechanism: ensuring adequate access to physicians services
and controlling federal spending for those services in a more
predictable way than the VPS mechanism did. Te SGR
mechanism has a mixed record with regard to those goals.
Shifting Nature of Reimbursements
Not long afer the adoption of SGR, a curious economic
condition began to afect the application of the formula.
Beginning in 2002, spending as measured by the SGR method
began to signifcantly outpace the targets established by the
formula. Te impact of this would have resulted in a substantial
reduction in the payment rates for physicians services over the
next several years. Annual CBO estimates since 2006 describe
conditions that would have caused payment rates to decline by
25 to 35 percent.
A decrease of this magnitude would likely have a devastating
efect on access to the program as physicians would likely
decline accepting any new Medicare patients. Rather than
risking potential program access for senior citizens, Congress
stepped in to override the SGR formula on 14 separate occasions
since the payment rate defciency was uncovered in 2002. Tis is
commonly known as the Medicare doc fx.
Medicare Timeline
1935. Social Security Act of 1935 (Public Law 74271, now codifed as 4
2 U.S.C. ch. 7) created the Social Security System in the U.S.
1965. Social Security Amendments of 1965 (Public Law 8997) created
Medicare and Medicaid as coordinated healthcare insurance programs
under the Social Security Administration in the Department of Health,
Education, and Welfare (HEW).
1965-1974. Medicare paid physicians based on physicians actual charges.
Although payments were subject to Medicare carriers determinations of a
reasonable charge, there was no set fee schedule or benchmark that limited
payment rates.
1975. The Medicare Economic Index (MEI) was instituted to set a fxed fee
schedule, based on 1973 prices. MEI was planned to limit annual fee increases
to increases in the costs of producing physician services and increases in
general earnings levels.
1977. The Health Care Financing Administration (HCFA) was established
under HEW and became responsible for the coordination of Medicare
and Medicaid.
1984-1991. Annual Congressional action was required to set Medicare
physician fee increases, because policymakers were concerned that prices
were rising too quickly.
1992. The Resource Based Relative Value Scale system was instituted.
Physician payments were to be updated annually based on the MEI, plus
the application of an adjustment factor (the Medicare Volume Performance
Standard [MVPS], predecessor of the SGR formula) designed to counteract
increases in the volume of services being delivered per benefciary.
1998. Balanced Budget Act of 1997 (Public Law 10533) creates the SGR
system to replace MVPS as the mechanism to ensure Medicare physician
spending did not exceed expenditure targets.
2001. HCFA changes its name to the Centers for Medicare and Medicaid
Services (CMS).
2002. Healthcare costs began to outpace gross domestic product growth
resulting in decreases in physician fees for Medicare services. Productivity
ofset changed from being based on labor productivity to multi-factor
productivity resulting in the so-called doc fx adjustments to SGR.
TRANSFORMING HEALTHCARE
Hybrid Technologies
Todays physicians now have a powerful new diagnostic tool
to assist with cancer staging. Combining positron emission
tomography (PET) and computed tomography (CT), PET/CT
provides detailed images of internal structures as well as signs of
abnormal activity. Tese hybrid scans show the size of the tumor
and whether or not it has spread in the body, which helps the
physician target areas for biopsy, design efective radiation therapy
regimens and determine long-term prognosis. Another example
is the combination of PET with magnetic resonance imaging
(commonly known as MRI), which has demonstrated value in
detecting small local recurrences of prostate cancer in men.
Technology to Steward
a Childs Brain Development
Because babies cant describe how they feel, doctors rely on
imaging technology to monitor their health.
Magnetic resonance spectroscopic imaging (MRSI) captures
not only a detailed image of an infants brain that a traditional
MRI would obtain, but also detects changes in brain chemistry.
It can identify imbalances long before these changes manifest
outwardly as problems in a childs behavior or body function.
Tis could mean catching cases of brain injury in babies in time
to take steps to protect the brain.
MRSI plays a signifcant role in diagnosing Shaken Baby
Syndrome, leaving doctors to decide whether respiratory
support or surgery to stop internal bleeding is the better
lifesaving measure.
In babies who dont receive enough oxygen during childbirth,
MRSI can assess what stage of brain impairment may have
occurred. Newborns with congenital heart disease are also at
high risk for brain injury and impaired brain development.
Here too, MRSI determines the severity of brain injury to better
assess treatment options.
Computer-Aided Sharing and Detection
Doctors and researchers now can instantly share images
electronically with colleagues in the next ofce or on the other
side of the world, thanks to a standardizing platform called
DICOM (Digital Imaging and Communications in Medicine).
When DICOM standards are used, physicians of all specialties
from cardiology to radiology to neurologyhave better access
I
n just 20 years, medical imaging has transformed modern healthcare. Every
day around the world, imaging technology once only imagined is now the
medical standard of care, leading to earlier detection and diagnosis as well as
better treatment.
Medical imaging manufacturers continue to develop innovative
technologies and features that allow more targeted diagnosis
and treatment, clearer images, and a wider range of options to
treat complex conditions.
Clearer Breast Imaging
with 3D Mammograms
Mammography requires some contortion and discomfort,
and doesnt always result in the best image. Now, breast
tomosynthesis is available to screen an estimated three million
women annually in the U.S. Tis is especially benefcial for
women with severe arthritis, osteoporosis, and other conditions
that may make clear imaging difcult using traditional two-
dimensional mammography.
Approved by the U.S. Food and Drug Administration in 2011,
tomosynthesis produces a clear, 3D image that can see through
overlapping breast tissue. By combining multiple digital x-rays,
radiologists can fip through breast images like the pages of a
book. Less distortion allows doctors to confrm that suspicious
breast abnormalities may not cancerous, which means less
additional imaging and fewer biopsies.
Tomosynthesis also looks at the entire breastnot just a single
problem area. Tis is important because 15 percent of women
diagnosed with breast cancer have another tumor in the same or
other breast.
Targeted Radiation Therapy
For many years, treating cancerous cells ofen meant risking
harm to adjacent healthy tissue. Tanks to technological
advances, this process has become much more precise. For
example, stereotactic radiosurgery uses robotic positioning and
real-time, continuous imaging to guide radiation therapy with
sub-millimeter precision. By limiting harm to nearby tissues
and organs, noninvasive radiosurgery can even be used to treat
spinal tumors without risk of paralysis.
Moving Forward on
Waves of New Medical Imaging Technologies
Orkideh Malkoc, Director of Reimbursement Policy, MITA
Increased Portability and Accessibility
A critical priority for medical imaging manufacturers today
is increasing the portability and accessibility of lifesaving
technologies. For example, until recently, ultrasound use
been limited by its size and need for electricity. Now, smaller
ultrasound machinessome so tiny they can ft into the palm
of ones handcan deliver color imaging, ofen on battery
power alone. Given their size, and the fact that they are cost-
efective, their use is spreading worldwide, bringing state-of-the
art imaging to developing nations, health clinics, remote rural
areas, and disaster recovery sites.
Imaging and other medical data gathered from portable devices
during an ambulance ride today can be sent to the emergency
room or trauma center before the patient arrives, enabling
physicians to detect critical conditions such as brain trauma or
stroke. A randomized clinical trial found that having a portable
CT in the ambulance reduced the time between alarm to
therapy decision from 76 to 35 minutes.
ei
Ms. Malkoc (omalkoc@medicalimaging.org) oversees MITAs
reimbursement, coverage, research, and service policies.
to image data and reports so they can arrive at an appropriate
diagnosis much more quickly.
Because DICOM helps facilitate interoperability and streamline
workfow between physicians, patients beneft from receiving
faster, more efective care. Additionally, new flmless picture
archiving and communication systems (PACS) acquire, sort,
transmit, store, and share images. PACS are less expensive than
flm archives, require less storage space, enable remote access
from anywhere in the world, and allow multiple people to view
images simultaneously. Plus, PACS can ease workfow for medical
personnel, allowing them to spend more time caring for patients.
Similar to a computers spell check capability, computer-aided
detection (CAD) today enhances doctors ability to read scans
and quickly spot abnormalities. Tese sophisticated computer
programs use high-speed pattern recognition to pinpoint dense
areas that could signal tiny tumors or disease. Tis technology
can also be used to fnd colorectal polyps, spot lung nodules, and
diagnose coronary heart disease and congenital heart defects.
Imaging Forward, MITAs campaign to highlight innovation in medical imaging, demonstrates the
impact of recent advances in science and technology on patient care. It is designed to increase
awareness about how innovation in medical imaging and radiation therapy has transformed
healthcare and the delivery of medicine, thereby improving health outcomes and reducing costs.
Using new MRI technology (left), a
growing patient populationold,
young, very ill, or uncooperative
can be scanned more reliably and
more comfortably. This pair of images
shows the increase in image quality.
Images courtesy of Siemens
Intensity-Modulated Radiation Terapy (IMRT)
In January, research published in the journal Cancer
4

reported that IMRT could lead to better survival rates for
patients with head and neck cancer when compared to
conventional RT. Te research, conducted by the University
of Texas MD Anderson Cancer Center, found that patients
experienced improved outcomes and reduced toxicities. Tis
is not surprising, given that IMRT uses multiple beams of
radiation to target cancer cells, while limiting exposure to
surrounding tissue. It is generally acknowledged to produce
fewer side efects.
Ensuring Safe, Appropriate Use of RT
Coupled with this unparalleled technological advancement
in RT is product manufacturers steadfast commitment to
promoting safe and appropriate use of these innovative tools.
Te RT treatment process is highly sophisticated, involving
multiple transfers of patient data. By combining diferent sets
of data, including complex imaging information, physicians are
able to accurately deliver the appropriate amount of radiation
and efectively monitor the course of treatment. A high level of
accuracy is essential at every step in this process to ensure that
patients ultimately receive appropriately prescribed treatment.
In support of this goal, MITA RT section members support the
Radiation Terapy Readiness Check Initiative, an industry efort
to develop and provide additional patient protection features for
RT equipment. By making these features more readily available,
manufacturers ensure that RT equipment, accessories, and
patients are properly positioned prior to delivery.
RT is a foundational pillar of quality care, ofering highly
personalized, non-invasive and cost-efective cancer treatment
for patients who need it most. As progress continues,
manufacturers remain dedicated to advancing the technology,
safety and efectiveness of these life-saving technologies.
ei
Mr. Vastagh (svastagh@medicalimaging.org) has been on the
MITA staf since 2001. During this period, he was staf manager/
director for RT, X-Ray, and MII Sections. He is currently the
general secretary for DICOM.
4
onlinelibrary.wiley.com/doi/10.1002/cncr.28372/abstract
R
adiation therapy (RT), also known as radiotherapy, is a cornerstone of
cancer therapy, helping to treat more than one million patients each
year. By delivering targeted radiation directly to cancerous tissue, RT kills
malignant cells while simultaneously minimizing radiation exposure to
surrounding healthy tissue.
RT technologies are advancing at an unprecedented pace.
Researchers have developed highly targeted and customizable
tools that enable physicians to better detect disease, stage
treatment, and deliver precise therapies. Tese advances are
translating directly into better clinical outcomes, as well as
greater safety and convenience for patients, including fewer
treatment-related side efects or complications, and shorter
courses of therapy.
Tese advances have catapulted RT to the forefront of cancer
care. Indeed, it is integral to treating most types of cancer,
including breast, prostate, lung, head and neck, rectal, and
central nervous system tumors. In some instances, radiation
treatments are used instead of surgery.
Image-Guided Radiation Terapy (IGRT)
While there is no match for RT in attacking cancer cells,
there is also the risk that healthy tissue can be damaged in the
process. IGRT targets tumors with great precision, limiting
the harm to healthy cells.1 Tis is especially useful in treating
moving organs, such as the lungs, or tumors located near
critical organs such as the heart. In one study, prostate cancer
patients treated with IGRT fared signifcantly better three
years afer treatment than those who received non-IGRT.
2

Stereotactic Body Radiation Terapy (SBRT)
Noninvasive radiosurgery can remove tiny tumors as well
as eliminate malignancies in hard-to-reach areas. SBRT,
also known as stereotactic radiosurgery (SRS), uses real-
time, continuous imaging to guide RT with sub-millimeter
precision. Because it limits harm to nearby tissues and organs,
noninvasive radiosurgery can be used to treat spinal tumors,
minimizing the potential of paralysis. One study found that
radiosurgery decreased spinal tumor pain by 85 percent and
was 90 percent efective in controlling spinal tumors locally.3
Te fexibility of these technologies also means that they can
be used to fght tumors anywhere in the body, and patients
dont need to recover from surgeryor stitches.
1
orlandoprostate.com/igrtimrt.html
2
www.ncbi.nlm.nih.gov/pubmed/22330997
3
www.ncbi.nlm.nih.gov/pubmed/23676858
Customizable Radiation Therapy Delivers
Healthy Doses of Accuracy, Safety
Stephen Vastagh, Industry Director, MITA RT Section
The RT treatment process is highly sophisticated,
involving multiple transfers of patient data.
CT COLONOGRAPHY
CMS has also signaled that it will consider coverage of CT
colonography for colorectal cancer screening if USPSTF
provides a favorable rating. Fortunately, there have been signs
of progress. In January, USPSTF released its draf research
plan on colorectal cancer screening, initiating serious policy
consideration of this procedure.
Te research plan outlines methodological approaches
and questions that USPSTF seeks to answer as part of its
investigation. MITA is working with the Colon Cancer Alliance
and ACR to gather all available research and data supporting the
value of CT colonography to build a compelling case to USPSTF.
In September 2013, MITA participated in a Food and Drug
Administration (FDA) joint meeting of the Gastroenterology-
Urology Panel and Radiological Devices Panel on CT, which
favorably recognized CT colonography as a valuable alternative
to traditional colonoscopy. MITA led and coordinated
comments to the FDA on its use. MITAs Coverage Committee
continues to compile evidence on the clinical and cost-
efectiveness of CT colonography and potential complications
associated with traditional colonoscopy.
BETA AMYLOID PET
In September 2013, CMS released its fnal coverage decision
for the use of beta amyloid PET to rule out the presence of
Alzheimers disease. Te coverage with evidence development
(CED) policy for patients enrolled in an approved clinical study
limits access to this technology to a single scan.
Following release of this decision, MITA convened industry
stakeholders to discuss the design and implementation of
the CED and has a position on the Alzheimers Associations
Industry Roundtable, which is informing CED design.
Separately, MITA members are discussing CED implementation
and reimbursement considerations.
Tese policy initiatives are strengthened by research and
evidence to support coverage decisions that will impact
countless lives by expanding patient access to the safest, most
advanced imaging and radiation therapy services. MITA,
together with other industry partners, stakeholders, physicians,
and policymakers, has built compelling cases grounded in
objective fact to support these national policies.
ei
Ms. Malkoc (omalkoc@medicalimaging.org) oversees MITAs
reimbursement, coverage, research, and service policies.
R
esearch rooted in evidence-based strategies promotes innovation,
reduces costs, and saves lives. It is also central to healthcare
policymaking. Without evidence to support the efcacy of a particular
procedure or tool, policymakers cannot confdently recommend its
widespread use.
MITA has long supported research initiatives to investigate
knowledge and evidentiary gaps in various policies that afect
medical imaging and radiation therapy services. Currently, its
Coverage Committee is using research to highlight pathways
for low-dose computed tomography (CT) for lung cancer, CT
colonography for colorectal cancer, and beta amyloid positron
emission tomography (PET) to rule out Alzheimers disease.
Expanding Medicare coverage of these safe and efective
technologies is critical to the detection, diagnosis, and treatment
of diseases that afect millions of lives, and will provide support
for the imaging market.
LOW DOSE CT FOR LUNG CANCER DETECTION
In late 2013, the U. S. Preventive Services Task Force (USPSTF)
fnalized its recommendation for the use of annual low-dose
CT to screen individuals 55 to 80 years old who are at high risk
for lung cancer. Tis means that private insurance plans will be
required to cover the procedure as early as January 2015 without
cost sharing, according to an Afordable Care Act requirement.
MITA led other stakeholders such as the Lung Cancer Alliance
and the American College of Radiology (ACR) in an efort to
urgently fnalize the rating by submitting supportive comments
to the task force.
A coverage decision for low-dose CT for the early detection of
lung cancer in high-risk patients will be made by the Centers for
Medicare & Medicaid Services (CMS) and require a thorough,
systematic review of all available research and data on this
service. Ultimately, this will determine if CMS will provide
national coverage for low-dose CT and if it will expand access to
millions of Medicare benefciaries.
To underscore these eforts to expand coverage, MITA is
working with the ACR Imaging Network on a report that
demonstrates the cost-efectiveness of low-dose CT for lung
cancer detection. Tis research is expected to be published in
2014. MITA is simultaneously compiling cost-efectiveness
evidence, rallying stakeholders, and taking inventory of the
clinical evidence included in USPSTFs literature review in order
to develop a supportive, community-wide efort to recommend a
national coverage decision by CMS.
Successful Healthcare Policy
Rooted in Research and Evidence
Orkideh Malkoc, Director of Reimbursement Policy, MITA
I
n an increasingly global world, continual advances in technology pose both
immense benefts and incalculable threats. One such danger is that of a
cybersecurity breach, which has the potential to jeopardize the security of
governments, industries, and individuals alike. While something as common
as a computer virus is certainly irritating, cyberattacks on medical imaging
and radiation therapy systems have the potential to be life-threatening.
With the increased proliferation of mobile health technologies
and networked medical devices, real-world incidences of
medical cybersecurity breaches are on the rise. Recognizing the
importance of patient safety, MITA has made cybersecurity a
high priority.
Just as computer systems depend on sofware to function,
medical imaging and radiotherapy equipment rely on sofware
to detect, diagnose and treat disease. Sofware efectively
translates and displays the image the images captured by
medical imaging technologies, such as x-ray, ultrasound,
positron emission tomography (PET), computed tomography
(CT) or magnetic resonance imaging (MRI). Tese image
translations enable physicians to appropriately diagnose, treat,
and monitor a variety of diseases. With respect to radiotherapy,
this sofware also enables physicians to regulate the right dose
for treatment.
Protecting Medical Devices through
Cybersecurity Requires Implementation
of Vigorous Measures
Rich Eaton, MITA Director of Industry Programs
It takes powerful software to integrate thousands of slices from high-tech
imaging systems into 3D pictures used to diagnose and treat patients. Image
courtesy of Siemens
Since the device industry is highly regulated and manufactures
products to be used on patients, we currently maintain robust
risk management processes and cybersecurity measures that are
used to both design and manufacture medical devices. Tis is
refected in the number of existing standards to protect against
these threats; IEC 80001-1, IEC 80001-2, and ISO 14971 are
only a few of the standards that manufacturers employ to create
resilient cybersecurity measures for their products.
Additionally, MITA created HIMSS/NEMA Standard HN 1-2013
Manufacturer Disclosure Statement for Medical Device Security
to provide a simple, fexible way of collectinginformationto
begin medical device information security risk assessments.
Our response to the NIST framework, as well as the FDA
draf guidance, was clear: manufacturers alone cannot protect
these devices. Usersthose who work with this equipment
dailyneed to implement vigorous measures to help achieve
cybersecurity protection.
Similar to locks on front doors, cybersecurity protections are
only efective when used properly. Regardless of how sturdy a
device is built, it wont be efective if the homeowner doesnt
engage it. Tats why advances in patient care, as well as sofware
security, have resulted in limited opportunities for users to
accidentally or purposely create cybersecurity threats to
medical devices.
Cybersecurity will no doubt grow as a concern across industries,
including medical devices. MITA and NEMA will continue to
work with government agencies and others to build upon our
already robust measures.
ei
Mr. Eaton (reaton@medicalimaging.org) holds a bachelors
degree in political science from the Johns Hopkins University and
a law degree from Rutgers University.
Given the critical function that sofware serves for potentially
life-saving diagnostic equipment, it is essential that the sofware
system works as intended, and is protected from both internal
and external threats.
In part due to recent cybersecurity initiatives from federal
government agencies, including the U.S. Food and Drug
Administration (FDA), MITA has been working closely with
the NEMA Cybersecurity Council to create a standard for
supply chain integrity and respond to requests for comments on
cybersecurity initiatives.
Te supply chain integrity standard will complement the work
of the Edison Electric Institute, an association of shareholder-
owned electric companies, to safeguard cybersecurity
protections in other areas of a products lifecycle. Another
beneft of the council has been to serve as a clearinghouse
for industries within NEMA to comment collectively on
cybersecurity initiatives. Most recently, the MITA Cybersecurity
Task Force worked within the Cybersecurity Council to
comment on the National Institute of Standards and Technology
(NIST) Preliminary Cybersecurity Framework.
In 2013, President Barack Obama issued an executive order to
develop a voluntary cybersecurity framework to strengthen the
countrys critical infrastructure. Over the course of last year,
NIST worked to develop this framework, which is applicable to
industries as varied as telecommunications, medical devices,
and electrical equipment. Te framework attempts to use
risk-based criteria to adapt to cybersecurity threats, including
currently known threats, as well as those that emerge in the
future. NIST also attempts to provide high-level guidance,
suitable for a host of industries, and is a credible reference for
industries that may not have robust cybersecurity measures.
MITAs comments in response to the framework, developed in
collaboration with colleagues in other industries, were similar
to those in response to the FDA draf cybersecurity guidance.
MITA and NEMA maintained that any cybersecurity initiatives
must include the acknowledgement and acceptance of current
and future standards in cybersecurity measures.
Users need to implement vigorous measures to help
achieve cybersecurity protection
What the industry is saying:

Many healthcare information assets have been
compromised, and no organization is immune, according
to a report issued by Internet security frm SANS Institute
and sponsored by security frm Norse. Radiology sofware
was among the most prominent healthcare sources of
malicious Internet trafc.
Between September 2012 and October 2013, radiology
imaging sofware contributed seven percent of malicious
trafc specifc to healthcare that was recorded by the Norse
threat intelligence infrastructure, a global network that
analyzes more than 100 terabytes daily. Over the study
period, Norse monitored 49,917 unique malicious events,
723 unique malicious source IP addresses, and 375 U.S.-
based compromised healthcare-related organizations.
AuntMinnie, February 24, 2014
Someone might believe, therefore, that the PET scan is not really
much of a development since it cannot diagnose. However, that
person would be wrong. Te pathology of Alzheimers disease
has eluded medical professional for decades and still remains
relatively mysterious. In the past, all one could do is look for
the physical signs of dementia and watch a loved one slowly
succumb to it. Being able to image the brain and methodically
track developments is a crucial step in being able to predict and
maybe even prevent it. While the medical community is still in
the tracking phase, it has only been able to get there through the
innovation of medical imaging.
Getting Personal
My research at MITA granted me not only general knowledge,
but personal applications as well. While most of the focus
in my research was lung and colorectal cancer, one day a
project on pancreatic cancer struck close to home. I knew
that my godmother had died from cancer. Tat was clear from
the vague language and my moms constant trips to Johns
Hopkins Hospital.
While reading about the indicators for pancreatic cancer, I was
struck by how the disease is associated with few early warning
signs and rapid deterioration, just as in my godmothers case.
Although she died more than four years ago, I fnally confrmed
what specifcally had taken her away from me.
Recently, I came to understand why swollen lymph nodes on
my neck were troubling to my doctor. Hoping to rule out
cancer, he made an appointment for me to get a chest CT and
other tests. In the moment, I did not appreciate the chalky
white substance I had to drinktwice. However, receiving my
negative test results made it worth the hassle. Efective medical
imaging saved me the stress of more tests and having to wait
and see if cancer developed.
My time at MITA has opened my mind to the innovations and
limitless possibilities that medical imaging ofers.
ei
Ms. Lamb is a recent graduate of Ohio State University.
L
ast September, I knew that cancer was a horrible disease and that CAT
scans helped you see the inside your body. Four months later, I can tell
you that a CAT scan is really computed tomography imaging (CT for short)
and that it produces 2D and 3D renderings of your body. Cancer is still a
horrible disease, but now I know that stages T, N, and M are related to current
locations and progression of cancer from its original site.
Tis knowledge stems from my work with MITA as a
research intern. My researchI read more than 300 scientifc
publications, the majority of which pertained to medical
imaging and cancer, as well as related policiestaught me an
exceptional amount about the innovations of medical imaging
and how it is transforming the world.
As I completed research, I became increasingly fascinated by
medical advances generated by medical imaging. For example,
before 2002, computed tomography colonography (CTC) was
barely a viable option for screening colorectal cancer. Today,
it is primed to become the leading methodology. Te swif
development and implementation of CTC is a testament to its
efcacy and overall potential. Meanwhile, in the world of lung
cancer, low-dose CT has risen as the most efcient and highly
recommended method for screening and staging.
Looking into Dementia
Medical innovations are not limited to cancer research. Te
identifcation of proteins associated with Alzheimers disease
evolved last year. A hallmark of this disease, which accounts
for 50 to 80 percent of dementia cases, is the buildup of plaque
in the brain of a protein called beta-amyloid. Advances in
positron emission tomography (PET) imaging has enabled use
of radioactive tracers to identify the presence of beta-amyloid
and seen how much has built up in a patients brain.
Although the buildup of plaque is associated with Alzheimers
disease, it may not be a determinant of it. Te majority of people
with the disease have clumps of beta-amyloid, but people with
the same clumps will not always develop it.
Medical Imaging
Innovations Oer
Limitless Possibilities
Olivia Lamb, MITA Research Intern
particular company does business, relieving manufacturers
from duplicative and repetitive audits. Te pilot will include
Australia, Brazil, Canada, and the U.S. It launched in January
2014, with initial audits under the new system anticipated to
begin in June.
Changes Seen in Brazil and China
Medical imaging and radiation therapy manufacturers are
particularly interested in alleviating regulatory challenges and
access barriers in Brazil, where the healthcare system is growing
rapidly and demand for services is steadily increasing. Since
ANVISA (Brazils federal healthcare regulatory agency) was
created, it has been difcult for U.S. manufacturers to complete
the product registration process.
In 2013, MITA conducted a series of promising meetings
with industry partners in Brazil to explore opportunities to
harmonize international medical device standards, improve
transparency in the regulatory process, and expand market
access for MITA member companies in Brazil and throughout
Latin America. As a result of conversations with ANVISA,
representatives indicated their openness to regulatory
improvements that will provide more timely access to the
newest, most innovative medical technologies.
MITA supports member companies in China, the worlds fastest
growing market for medical imaging equipment, by reducing
discrepancies between treatment of foreign and domestic
companies and speeding overall time to market. It has successfully
advocated for down-classifcation of x-ray and opened fast-track
registration for innovative products to foreign companies. MITA
also encourages and supports increased participation by Chinese
regulators in the International Medical Device Regulators Forum,
so that as the country modernizes its regulatory system, it is
harmonized with global standards and best practices.
Decisions made at the global level increasingly afect national
markets. MITA looks forward to its ongoing work with industry
partners toward a globally harmonized regulatory framework
that is not only smart, efcient, and transparent, but more
importantly, one that improves patient safety and
access to the high quality medical technologies
that MITA members manufacture.
Mr. Northup (anorthup@medicalimaging.org) is
responsible for MITAs international regulatory
harmonization programs. He served two terms as
president of Young Trade Professionals.
F
or more than a century, medical imaging technologies have
revolutionized healthcare delivery in America and elsewhere. Now,
physicians from urban metropolises to rural communities have the ability to
peer deep inside the human body without lifting a scalpel.
In an increasingly global medical community, it is more possible
than ever for medical professionals and patients to access life-
saving technologies that combat disease and improve health
outcomes. However, global access depends largely on regulatory
convergence and the implementation of internationally accepted
standards that enable manufacturers and regulators to use
common methods for product registration and testing.
MITA works to expand access to medical imaging, radiation
therapy, and radiopharmaceuticals around the world. In
partnership with DITTA (the Global Diagnostic Imaging,
Healthcare IT, and Radiation Terapy Trade Association),
MITA has undertaken market development activities to
promote harmonization of international standards and
expand market access to enhance the competitiveness of
MITA member companies.
For example, in November 2013 MITA announced support
of the pilot program for the Medical Device Single Audit
Program MDSAP). Details were unveiled at the November
2013 International Medical Device Regulators Forum
Stakeholder Meetings.
Currently, medical device manufacturers with operations and sales
in several countries face duplicative audits from regulators. Tis
can result in a single company facing multiple audits throughout
the countries in which they operate, in some cases interrupting the
normal fow of work and limiting resources for weeks.
Under MDSAP, the auditing process will be similar to
that of the Canadian Medical Devices Assessment System
program. Most routine auditing will be done by third-party
entities, whose competency and oversight will be assessed
and monitored by regulators. Auditors will assess compliance
for all the countries participating in the program in which a
Global Harmonization Promotes Safety
Andrew Northup, Director of Global Afairs, MITA
In partnership with DITTA, MITA promotes the harmonization of international
standards and expanded market access for MITA member companies.
International Conference and Seminar. Te frst day was
devoted to DICOM tutorial lectures; the second day was
flled with papers on implementation of the standard for
acquisition, management, and analysis of medical images and
related data; and the fnal day was dedicated to discussion of
the unique challenges and opportunities of telemedicine, for
which DICOM is an enabling standard.
Update to DICOM Website
MITA hosts the DICOM website and anticipates a major
upgrade to support better public understanding of the
standard and its role in health IT and healthcare. Tis is
especially critical with respect to public policy on healthcare
interoperability standards, as well as for making the updated
XML-based standard interactively accessible. Tis upgrade
will yield signifcant savings for member companies product
development, testing, and maintenance functions.
2014 Opportunities
Te maintenance and continued expansion of DICOM
provide critical support for the continued technological
evolution and product innovations of MITA members. MITA
manages this process for the members at a cost signifcantly
below the operating cost of similar organizations.
Te universality and robustness of the DICOM standard
have largely succeeded in taking the worrisome issue of
medical image interoperability of the table for healthcare
professionals and policy makers. Te DICOM community
will continue to develop the next generation of web-based
interoperability to ensure continued efectiveness for MITA
member companies customers.
D
ICOM (Digital Imaging and Communications in Medicine) is the
international standard (ISO 12052) for medical images and related
information such as images, waveforms, derived measurements and
assessments, image presentation controls, and workfow management in
medical imaging departments.
DICOM defnes the formats for medical images and related data
with the completeness and quality of data necessary for clinical
use. It also serves specialties beyond radiology and cardiology
(e.g., pathology, ophthalmology, and surgery), thereby
contributing to expanding markets.
Broad Community of DICOM Experts
MITA manages the maintenance and extension of the
DICOM standard by administering the work of 30 working
groups; MITA member company employees; non-member
medical device manufacturing company representatives;
and physicians, medical physicists, and others in the medical
informatics community. Te total number of persons on the
rosters of DICOM working groups exceeds 1,500.
Extensive Revisions and Additions to the DICOM Standard
In 2013, DICOM balloted 87 minor revisions and 7 major
additions to the standard. Of particular note is the expansion
of DICOM web service features.
Translating the Standard to Machine Readable Documents
Recent signifcant DICOM initiatives include contracting
for the translation/conversion of the DICOM Standard into
machine readable (XML) documents.
DICOM International Conference and Seminar
A record 267 registrants converged on the Indian Institute
of Science in Bangalore in March for the DICOM 2013
DICOMs Comprehensive Nature Enables
Medical Image Interoperability
Stephen Vastagh, DICOM General Secretary
SUPPLEMENT 159 NM DOSE STRUCTURED REPORT
Tis introduces a template for reporting of radiation dose due to
administration of radiopharmaceuticals, as in nuclear medicine
(NM) or positron emission tomography (PET) imaging. Te
dose report records radiopharmaceutical activity amount,
and administration time and other information. NM and PET
modalities can also read the reports to receive information
essential for calculations.
SUPPLEMENT 160 PATIENT POSITIONING WORKFLOW
Tis presents patient positioning and workfow instructions for
the second generation radiation therapy object.
SUPPLEMENT 164 CONTRAST AGENT
ADMINISTRATION REPORTING
Te performed contrast administration SR is for reporting the
actual plan or program that was used to deliver the contrast
agent during a medical imaging study. It is intended to cover
all modalities in which radiographic, radiopharmaceutical
or other agents are introduced into a circulatory system in a
controlled fashion.
Te scheduled contrast administration object is for representing
the plan or program to deliver contrast agent to the patient for
a contrast study. It could be programmed at the time of schedule
of a study or beginning of the study. Ofen, it is programmed
at the power-injector device console by the modality technician
or radiologists.
SUPPLEMENT 167 X-RAY 3D ANGIOGRAPHIC IOD
INFORMATIVE ANNEX
Tis explains the usage of DICOM attributes for the x-ray 3D
angiographic image IOD to:
give more information beyond the defnitions in PS 3.3
(detailed text vs. scenarios, examples, drawings, etc.)
identify scenarios where the x-ray 3D angiographic image
will be applied
indicate restrictions on the applicable scenarios (defned
terms recommended, values ranges, recommended presence
of attributes)
encourage usage of Type 3 attributes under particular
scenarios
assess the applicability for some conditional attributes under
particular scenarios
ensure that the introduction of private attributes is a last
resort only situation
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.
DICOM Supplements (Major Additions) in
Development in 2013
DICOM SUPPLEMENTS BALLOTED IN 2013
Seven DICOM supplements were balloted in 2013:
Supplement 157 Multi-Frame Converted Legacy Images
Supplement 161 WADO by Means of RESTful Services
Supplement 162 Comprehensive 3D SR Storage Service-Object
Pair (SOP) Class
Supplement 163 STOW (Store over the Web)
Supplement 165 Breast Projection X-Ray Image
Storage SOP Class
Supplement 166 QIDO-RS (Query based on ID for DICOM
objects by RESTful Services)
Supplement 168 Corneal Topography Map Storage SOP Class
SUPPLEMENT 121 MODALITY PROCEDURE PLAN AND
PROTOCOL STORAGE
Tis defnes a trio of information objects and network services
to distribute planned computed tomography (CT) protocols
and to record performed CT protocols. Similar trios for other
modalities may be added in other supplements.
SUPPLEMENT 124 COMMUNICATION
OF DISPLAY PARAMETERS
Tis defnes a display system information object allowing
retrieval of standardized display system characteristics and
performance information including image quality factors.
Medical image quality and display quality control are system-
wide challenges involving multiple devices. In particular, it
is necessary to continually track image quality performance
factors of output devices, including PACS (picture archiving
and communications system) sofcopy and hardcopy output and
modality consoles.
SUPPLEMENT 147 SECOND GENERATION RADIOTHERAPY
Tis addresses the need for a new generation of information
objects and network services required for use in radiation
therapy. In particular, workfow management is now a key
aspect of DICOMs domain of application, and the introduction
of unifed work list and procedure step have begun the growth
of radiation therapy into workfow management.
SUPPLEMENT 156 MULTI-DIMENSIONAL
PRESENTATION STATE
Persistent storage of display parameters used by a display
algorithm to obtain a presentation from a set of volume-
related data is called a multi-dimensional presentation state.
Tis supplement adds a DICOM standard representation
of this multi-dimensional presentation state as a new
multi-dimensional presentation state information object
defnition (IOD).
DICOS is based on DICOM (Digital Imaging and
Communication in Medicine), which defnes the formats for
medical images and related data. (See DICOMs Comprehensive
Nature Enables Medical Image Interoperability, page xx.) As a
security standard, it establishes the initial negotiation between
communicating devices. In other words, the requesting device
needs to know the capabilities of the receiving device. Te
exchanges are based on the capabilities that the two entities have
in common, which are communicated in the initial handshake.
It also addresses the diferences in how imaging devices
represent values and defne the transfer syntax.
DICOS allows extended communication across the boundaries
between heterogeneous or disparate applications, devices, and
systems used for security and protection purposes and covers:
computed tomography for checked bag attributes
digital x-ray for checked bag and carry-on bag attributes
threat detection reports and report attributes
advanced imaging technology and defnitions for data
transmission
DICOS enables TSA, along with rail, mass transit, shipping,
nuclear plants, port security, and other venues to achieve
interoperability among several imaging and data capture
modalities and individual manufacturer platforms.
During a recent meeting with DICOM experts, NEMA agreed
to engage TSA in a dialogue on how to implement the DICOS
standard. DICOM agreed to stand by in support DICOS members.
DICOS can quicken the airport experience for travelers and
make security less expensive and more efcient for airports,
airlines and government agencies.
ei
Mr. Massey (harry.massey@nema.org) serves as industry
specialist to the association, media, industry, and consumers.
A
viation and government authorities worldwide have begun automating
aspects of airport security and immigration, including the use of
computers to verify fiers identities. This efort to reduce wait times is raising
questions over its efect on safety, according to the Wall Street Journal.
What does the reliance on machines mean for your airport
experience and aviation security overall?
With DICOS (Digital Imaging and Communication in
Security), it means better protection and more efcient fow in
security lines. When NEMA started working on the DICOS
standard in 2010, the value of interoperability in the airport
security was unexplored.
NEMA brought together users, vendors, service providers,
manufacturers, and the government to develop standards for
digital security. In partnership with the U.S. Department of
Homeland Security, and in cooperation with Transportation
Security Administration (TSA), NEMA developed a standard
for digital imaging and communications for security
applications. Te resulting DICOS standard enables network
and component integration, to send and receive digital images
and related information.
DICOS covers systems, devices, components, and accessories
used in imaging and communications for security purposes.
Tis includes hardware and sofware used in image generation,
transmission, and capture. It is used to integrate imaging
information with other information in human, animal, checked,
and carry-on baggage scanning, inspection, and analysis.
As the processes for scanning, inspection, and analysis becomes
more automated and the need for immediate and consistent
information becomes more criticalparticularly for homeland
security reasonsNEMA and its member companies developed
DICOS to enable equipment users to install or upgrade
devices that conform to widely accepted standards and are
manufactured by multiple companies.
DICOS and the Flying Public
Harry Massey, NEMA Industry Director
Electroindustry News
MITA Board of Directors
Te MITA Board of Directors
encompasses leadership from a wide
range of member companies. Its chair
is Greg Sorenson, President and CEO
North America Siemens Medical
Solutions, Inc. Donald Fowler, President
and CEO of Toshiba America Medical
Systems, is vice chair.
New to the board in 2014 are Dennis
Durmis, Head, Americas Region, Bayer
Radiology and Interventional; and
Guru Sundar, Senior Acoustic Systems
Designer, FUJIFILM Visualsonics.
CHAIR
Greg Sorensen
President & CEO
Siemens Medical Solutions, Inc.
VICE CHAIR
Donald Fowler
President & CEO
Toshiba America Medical Systems
Paul Biggins
Director, Regulatory Afairs
Toshiba America Medical Systems
Rajinder Dhada
Vice President, Strategic Partnerships
Elekta, Inc.
Dennis Durmis
Vice PresidentHead of Americas Region
Bayer Radiology and Interventional
Elisabeth George
Vice President of Global Government
Afairs, Regulations and Standards
Philips Healthcare
Michael Green
President & CEO Americas Region
Agfa Healthcare
Brian Leck
Vice President & General Manager
FUJIFILM Sonosite, Inc.
Nelson Mendes
CEO
Ziehm Imaging, Inc.
Marcelo Mosci
President & CEO, US & Canada
GE Healthcare
Henri Primo
Director, Strategic Relationships
Siemens Healthcare
Manfred Richter
Vice President of Services & Support
FUJIFILM Medical Systems USA
Joe Robinson
Senior Vice President, Enterprise &
Government Solutions
Philips Healthcare
Glen Sabin
Regulatory Afairs Director MR
GE Healthcare
Sheldon Schafer
Vice President & General Manager,
MR/CT
Hitachi Medical Systems
Charles Stearns
Chief Engineer, PET/CT
GE Healthcare
Guru Sundar
Senior Acoustic Systems Designer
FUJIFILM Visualsonics
Tomas Tulip
President & Chief Business Ofcer
Navidea Biopharmaceuticals
Guru Sundar Dennis Durmis Donald Fowler Gregory Sorensen, MD
Theyve Got the MITA Touch
Gail Rodriguez, PhD
Executive Director
703-841-3235
grodriguez@medicalimaging.org
Kathleen Hampton
Assistant Manager
703-841-3276
khampton@medicalimaging.org
Brian Connell
Director, Government Relations
703-841-3237
bconnell@medicalimaging.org
Orkideh Malkoc
Director, Reimbursement and
Coverage Policy
703-841-3247
omalkoc@medicalimaging.org
Andrew Northup
Director, Global Afairs
703-841-3242
anorthup@medicalimaging.org
Richard Eaton
Director, Industry Programs
703-841-3248
reaton@medicalimaging.org
Olivia Lamb
Research Intern
703-841-3228
Olamb@medicalimaging.org
Stephen Vastagh
DICOM General Secretary
703-841-3281
svastagh@medicalimaging.org
Erin Doty Georges
Director, Federal & State
Government Relations
703-841-3217
edotygeorges@medicalimaging.org
ESFI Educates Consumers on Surge Protection
Tis May, during National
Electrical Safety Month,
the Electrical Safety
Foundation International
(ESFI) gives the public
the understanding needed
to identify and correct
electrical hazards in
their homes.
Tis years campaign
will feature the launch
of Electrical Safety
Illustrated, a special
edition magazine that
provides important
electrical safety resources
to better protect your
home, family, and
communities.
Among the resources
featured in Electrical
Safety Illustrated is
Surge and Protect,
which provides an
overview on the
importance of surge
protection.
Be sure to visit ESFI.org
for more information on
electrical safety including
our National Electrical
Safety Month resources.
ei
Julie Chavanne,
Communications
Director, ESFI |
julie.chavanne@esf.org
Jim Pauley Ascends to NFPA Presidency
Te National Fire Protection Association
(NFPA) Board of Directors voted
unanimously in January to name Jim
Pauley of Lexington, Kentucky, as the
next president of NFPA. He succeeds
James M. Shannon and will assume his
new role in July.
Mr. Pauley, Senior Vice President of
External Afairs and Government
Relations for Schneider Electric,
received NEMAs Kite & Key Award
in 2009 for his contributions to standards
development. In addition to being the
longtime chair of the High-Performance
Buildings Council, chair of the NEMA-
UL Policy Committee, and former
chair of the Low Voltage Distribution
Equipment (LVDE) Section, he has
held membership in the NEMA Codes
and Standards Committee, served on
NEMA Government Relations Trade
Policy Committee, and has provided
leadership on many other NEMA
section panels and committees related
to electrical safety.
Other codes and standards-related
leadership roles include chairing the
American National Standards Institute
board and NFPAs Standards Council.
For more than 115 years, NFPA has
been a leader in fre, life, and electrical
safety through codes and standards
development, research, training and
education. Tis appointment ensures the
continued pursuit of the critical mission
of NFPA and positions the association to
address the challenges of our times, said
Philip C. Stittleburg, NFPA Chairman of
the Board.
ei
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Code Actions/Standardization Trends
Optimizing Radiation Dose through Standards and Policy
Above all else, medical imaging and
radiation therapy manufacturers are
committed to patient safety. At the heart
of eforts to ensure that patients receive
safe, efective care is the implementation
of physician-developed appropriateness
criteria to guide decision-making as
well as industry standards to optimize
radiation dose exposure.
MITA has a long history of developing
standards and driving consensus among
manufacturers and other industry
stakeholders to improve medical imaging
technologies for the beneft of patients.
In recent years, MITA has published four
standards to address dose optimization
and dose management.
MITAs most recent dose standard is
XR 29-2013Standard Attributes on
Computed Tomography (CT) Equipment
Related to Dose Optimization and
Management, or MITA Smart Dose.
It includes a set of four dose-mitigating
attributes for computed tomography
(CT) technologies:
DICOM Dose Structured Reporting
enables recording of post-exam
dose information in a standardized
electronic format.
Pediatric and adult reference protocols:
pre-loaded protocols on a CT system
that serve as a baseline for a variety of
clinical tasks.
CT Dose Check incorporates two
featuresdose notifcations and
dose alertsthat can warn operators
and physicians when dose exceeds
established thresholds.
Automatic exposure control (AEC)
automatically adjusts the amount
of radiation used, based on the size,
shape and composition of the patient,
in order to achieve a specifed level of
image quality.
MITA member companies can promote
compliance to the MITA Smart Dose
brand to market technologies that meet
this standard, and MITA is leveraging
the standard to promote provider
adoption of innovative CT technologies
and improve public health.
In addition to presenting the policy to
congressional committee staf charged
with developing Medicare reform, MITA
gathered additional support for the
policy from other stakeholder groups,
such as the American Association
of Physicists in Medicine and the
Intersocietal Accreditation Commission.
MITA urges policymakers to consider
a Medicare reimbursement policy
that would incentivize the adoption of
radiation dose optimization technologies
by paying relatively more for medical
imaging services on equipment that
meets the MITA Smart Dose standard.
Trough this policy, Congress would
help expand patient access to the safest
medical imaging technologies.
Other stakeholders have lauded MITA
Smart Dose, including Image Gently,
Image Wisely and the Food and Drug
Administration (FDA). Upon publication
of XR 29, Mary Pastel, PhD, Deputy
Director for Radiological Health, Ofce
of In Vitro Diagnostics and Radiological
Health, FDA, Center for Devices and
Radiological Health stated, Te FDA
values the collaboration and work done
by industry and the medical imaging
community to promote patient safety.
We also encourage radiology facilities
to use equipment safety features and to
adopt imaging best practices.
MITA Smart Dose is an important step
in a long series of initiatives to optimize
radiation dose. MITA joins the imaging
community in championing the ALARA
principle, which stands for as low as
reasonably achievable. Tis principle
of radiation dose management and
optimization is incorporated into all
imaging procedures and technologies,
and it is mandated by nearly all
regulatory bodies and licensing agencies,
including the Nuclear Regulatory
Commission.
With many new innovations and
standards available to help ensure safe
and efective use of medical imaging
technologies, successful radiation dose
optimization necessitates continued
collaboration across companies,
industries, regulatory bodies and
government agencies, and MITA is
poised to spearhead the charge.
ei
Gail M. Rodriguez, PhD,
Executive Director of MITA |
grodriguez@medicalimaging.org
MITA champions the ALARA principle in all imaging procedures
and technologies. This is an example of technology designed to
administer the lowest dose while imaging patients faster than
ever. Image courtesy of Siemens Healthcare
NEMA Standards Available on Website
Calling All Young U.S. Electrotechnology Professionals
Recently published NEMA standards are
available on the NEMA website.
ANSI C18.3M, Part 1-2013 American
National Standard for Portable Lithium
Primary Cells and BatteriesGeneral
and Specifcations applies to portable
lithium primary cells and batteries.
Tis edition includes the following
electrochemical systems: lithium/
carbon monofuoride, lithium/
manganese dioxide, and lithium/
iron disulfde. Tis document may
be downloaded may be purchased in
electronic or hardcopy format on the
NEMA website for $88.
ANSI C136.41-2013 American
National Standard for Roadway and
Area Lighting EquipmentDimming
Control Between an External Locking
Type Photocontrol and Ballast or
Driver describes methods of light level
control between an external locking
type photocontrol (or similar device)
and a dimmable ballast or driver for
street and area lighting equipment.
Tis document may be purchased
in electronic or hardcopy format on
the NEMA website or purchased in
hardcopy for $52.
Te U.S. National Committee (USNC)
of the International Electrotechnical
Commission (IEC) seeks nominations of
young electrotechnology professionals
to participate in the 2014 IEC Young
Professionals Workshop, which will be
held November 1014, 2014, in Tokyo
in conjunction with the 78th IEC
General Meeting.
ANSI C136.46-2013 American
National Standard for Roadway and
Area Lighting EquipmentConcrete
Lighting Poles applies to concrete
lighting poles used in roadway
and area lighting equipment and
includes nomenclature, performance
criteria, marking and recordkeeping
requirements, and certain minimal
material needs. It does not cover
concrete poles manufactured with any
modifed concrete mix incorporating
the use of polymers or other modifers.
Tis document may be may be
purchased in electronic or hardcopy
format on the NEMA website for $52.
ANSI/NEMA WC 66/ICEA S-116-
732-2013 Standard for Category 6 and
6A, 100 Ohm, Individually Unshielded
Twisted Pairs, Indoor Cables (With
Or Without An Overall Shield) for
Use In LAN Communication Wiring
Systems covers mechanical, electrical,
and fammability requirements for
cables having thermoplastic-insulated
and jacketed copper conductors,
individually unshielded twisted
pairs, and optional overall shields.
Tis standard may be purchased in
electronic or hardcopy format on the
Nominations can be submitted using
the USNC Young Professionals Workshop
Nomination Form on the IEC website
until April 30, 2014.
USNC will select up to three individuals
to represent the U.S. Tey may be
employed by industry, government,
academic bodies, consumer
organizations, or other members of
NEMA DC 3-2013 Residential
ControlsElectrical Wall-Mounted
Room Termostats covers self-
contained, electrical and electronic,
wall-mounted room thermostats. Tis
standard may be downloaded at no
cost or purchased in hardcopy on the
NEMA DC 3 Annex A-2013
Energy-Efciency Requirements for
Programmable Termostats contains
the performance requirements for
programmable thermostats described
as energy-efcient. Tis document may
be downloaded at no cost or purchased
in hardcopy format on the NEMA
website for $42.
NEMA LSD 68 Remote Phosphor
Devices Used in LED Lamps, Engines
and Luminaires facilitates development
of testing and certifcation procedures
that will allow the qualifcation of
pump or source devices, pumped
conversion materials / remote
phosphors, and refective materials
independently. Tis white paper may
be downloaded at no cost on the
NEMA website.
ei
the U.S. standards and conformance
community that uses, benefts from,
or contributes to the IECs work in
electrotechnical standardization and
conformance. Te program is intended
for individuals who have completed their
undergraduate education and are in the
early years of their professional career.
ei
Ken Gettman, Director of International
Standards | ken.gettman@nema.org
International Roundup
MITA Takes Aggressive Action to Improve Regulatory Cooperation in the TTIP
Te U.S. and EU embarked on an
ambitious trade negotiation known as
the Transatlantic Trade and Investment
Partnership (TTIP) in 2013 as a result
of more than a year of high level
government-to-government analysis
and discussions that included input
from private sector stakeholders.
NEMA and MITA provided comments
to representatives of the governments
involved during this evaluation phase,
identifying specifc objectives for our
industry sectors.
Upon the launch of negotiations, NEMA
and MITA immediately participated in
the frst stakeholder event established
by the U.S. Trade Representative and
the European Commission Trade
Department. Tis reiterated the positions
expressed during the run up to the actual
negotiations and set the stage for formal
discussions with negotiators from both
sides of the Atlantic.
MITA members products are federally
regulated in the U.S. and the EU,
so the TTIP Chapter on Regulatory
Cooperation is the most important area
for measuring results. MITA has been
aggressive in identifying regulatory
objectives in collaboration with other
medical device industry associations
in the U.S. and the EU (i.e., AdvaMed,
COCIR, EDMA, and Eucomed), based
on a vision of providing products and
services that ofer the highest quality,
maximum safety, easy accessibility, and
cost efciency.
Collectively, they identifed three key
priorities within the healthcare sector:
single audit of medical technology
manufacturer quality management
systems
single harmonized standard for
marketing application format
unique device identifcation (UDI)
HARMONIZING FORMATS
Currently, the regulatory requirements
of quality management systems in the
U.S. and EU are similar but not identical.
Te national authorities and assessment
bodies do not use each others reports
and they base their audits on diferent
standards. MITA identifed specifc
actions the regulators could take that
would ultimately result in a single multi-
purpose QMS (quality management
system) audit program acceptable to the
U.S. and EU. Te outcome would result
in signifcant savings of costs.
In the area of a single harmonized
standard for marketing application
format, regulators in the U.S. and EU
follow diferent practices that essentially
require manufacturers who want to sell
their products in both regions to prepare
similar but diferent sets of documents
and submit them for approval. Te
industry group recommends using a
harmonized format that has already
been developed, allowing for a single
protocol and electronic program of
compliance evidence. Te outcome
would be regulatory simplifcation and
reduced costs for both the regulators and
the industry, while maintaining the high
standards embraced ty the vision.
UDI is a global initiative in which the
U.S. and EU are deeply involved, so
that convergence should be possible.
However, the EU should speed up
its implementation, particularly
development of its database. Te industry
provided key recommendations urging
convergence on marking/labeling levels
for products, optimization of U.S.
and EU databases with harmonized
messaging protocol for electronic
submission, harmonization of core
data elements, and establishment of
a U.S.-EU working group of database
experts from industry and government.
Tis would result in convergence of
the UDI databases, keeping cost of
implementation and daily operation
lower for regulators and industry.
Te approach taken by MITA and the
other industry partners in this example
is strongly preferred by TTIP negotiators
from the U.S. and EU because it allows
them to focus on incorporating the
preferred language in the text of the
document without the need for further
haggling. It also provides a template
for the joint regulatory process to
infuence that in other parts of the
world, one of the stated outcomes of
both governments.
ei
Gene Eckhart, Senior Director for
International Operations |
gene.eckhart@nema.org
Andrew Northup,
Director, Global Afairs |
anorthup@medicalimaging.org
MITA has been aggressive in
identifying regulatory objectives in
collaboration with other medical
device industry associations in
the U.S. and the EU.
Economic Spotlight
NEMA Forecasters at the Top of Wall Street Journal Survey for Third Straight Year
Current Conditions EBCI Rebounds in February;
Optimism for First Half of 2014 Remains Strong
NEMA Vice President and Chief
Economist Don Leavens, PhD, and
Deputy Chief Economist Tim Gill placed
in the top ten in the Wall Street Journals
monthly economic forecast survey for
the third consecutive year.
NEMAs team had the seventh most
accurate macroeconomic forecast in
2013 among the more than 50 nationally-
recognized economists who participate
in the survey. Afer taking the top spot
for their 2011 forecast, Dr. Leavens and
Mr. Gill followed up with a ffh place
showing in 2012. No other participant
has compiled as consistent a record of
accuracy in recent years.
NEMAs Electroindustry Business
Conditions Index (EBCI) for current
conditions in North America rebounded
in February, rising to the 50 point mark
typically associated with a stable business
environment. Te gain came on the heels
of a sharp drop in the wintery month of
January. Confdence in future business
conditions strengthened in February for
the ffh consecutive month.
Te EBCI for North American conditions
six months hence rose to 91.2 from 90.6
in January, again one of the highest
readings in the history of the survey.
Tim Gill, Deputy Chief Economist |
tim.gill@nema.org
Te WSJ panel includes leading
economists from academia, Wall Street
investment frms, commercial banks,
consulting frms, private companies, and
trade associations. Teir contributions
are evaluated using a methodology
designed by the Federal Reserve Bank
of Atlanta.
NEMAs team has also won past
recognition for their forecasts of housing
market conditions.
How do NEMAs forecasters expect the
economy to perform in 2014?
Broad economic growth is likely to
remain below its long-run average,
according to Mr. Gill, but improvement
in the manufacturing, construction,
and export sectors should give the
electroindustry recovery a second wind
in 2014 and 2015.
Detailed analyses and forecasts of
macroeconomic and industry conditions
are available in NEMAs monthly
Electroindustry Economic Outlook
publication.
ei
Phallan K. Davis, Public Relations
Specialist | phallan.davis@nema.org
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Electroindustry Business Conditions Index:
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North American Current Conditions Magnitude:
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February 2014
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Expert
ASK THE
Economic Spotlight
STOCK ART CREDITS
Cover, 1, 15: iStockphoto.com/Eraxion
12: iStockphoto.com/aleksandarvelasevic
14: iStockphoto.com/cajoer
16: iStockphoto.com/marigold_88
18: iStockphoto.com/dimdimich
20: Sergey Nivens/Shutterstock.com
22: iStockphoto.com/allanszeto
April
Coming in
Q
A. Medical imaging is a powerful
tool that helps clinicians make
treatment decisions. As with any
medical procedure, physicians and
patients must weigh the benefts and
risks of any scan that uses ionizing
radiation. In recent years, medical
imaging manufacturers have
developed innovative technologies
that reduce radiation dose by up
to 91 percent while maintaining
image quality.
For more information:
www.medicalimaging.org/imagingforward
Q. Is x-ray imaging safe?
Got a question? Ask the experts at ei@nema.org
Were getting comfortable with the
concept of net zero commercial
buildings, but a zero net energy
home? Why not?
Beginning in April, ei will publish
regular updates on Te Patrick
Project, a home improvement venture
by Patrick Hughes, NEMAs policy
director for high-performance
buildings, and his fance Amy
Sticklor. Renovations will include
installation of solar panels, smart
home automation, energy-efcient
lighting, insulation, tamperproof
receptacles, and other technologies,
many of which are manufactured by
NEMA members.
Well also look at integrating smart
buildings, homes, stadiums, and
cities into the Smart Grid.
MITA Executive Director Gail Rodriguez, PhD
Charting the Course to
a New Energy Future
Just a stones throw from our nations capital, the PES General Meeting will attract thousands
of professionals from every segment of the electric power and energy industries. It will feature
a comprehensive technical program, including super sessions, panel sessions, tutorials,
technical committee meetings and standards activities. Plus, enjoy a lineup of excellent
technical tours, a student program, companion activities and much more.
About National Harbor
Located on 300 acres of prime real estate along the scenic Potomac River in Washington, D.C., National
Harbor is the new gateway to the National Capital Region. This spectacular urban-waterfront community
offers stunning views of downtown Washington, D.C. and Old Town Alexandria, and is just a 15-minute
driveor water taxi rideto the heart of the nations capital.
2014
IEEE PES
GENERAL
MEETING
July 2731, 2014
National Harbor, MD
For More Information and
to Register Today visit
pes-gm.org/2014
Registration is
NOW OPEN
Gaylord National Resort
and Convention Center
MITA Product Showcase
TAURUSblue and CARINAnav
LAP LASERs most advanced solution for virtual simulation
LAP has been delivering state-of-the-art patient alignment laser systems for
radiation therapy, nuclear medicine, and diagnostic radiology since 1984. New
solutions for therapeutic radiological applications are developed in close cooperation
with leading institutions and equipment manufacturers.
TAURUSblue, LAPs latest innovation, integrates blue lasers into the worlds most
proven virtual simulation laser system. The new Blue Vision laser diodes reduce
scattering of light and keep difuse refections to a minimum. The lasers short
wavelength minimizes the scattering efect inherent in laser light skin absorption.
This all but eliminates the physiological reasons for laser light difusion on the
surface of the skin. The laser lines appear fner, more in focus, and much clearer.
LAP has developed the advanced CARINAnav laser marking software for easy
and intuitive control of the TAURUSblue laser system. The CARINAnav software
includes: a touch screen tablet PC, specially designed touch sensitive laser marking
control software, and the latest wireless communication technology. The software
comes pre-installed and provides the user with a complete laser marking software
environment on a compact and convenient hardware platform.
TAURUSblue and CARINAnavAdvanced Systems for Virtual Simulation
Philips Vereos
At the 99
th
Annual Meeting of the Radiological Society of North America (RSNA)
in Chicago, Philips introduced a fundamentally new development: its Vereos PET/
CT system. Vereos is the worlds frst and only fully digital positron emission
tomography/computed tomography (PET/CT) imaging system.
Based on Philips proprietary Digital Photon Counting technology, the Vereos
PET/CT is the frst PET/CT system in the industry to use innovative digital silicon
photomultiplier detectors instead of traditional analog detectors, resulting in a
step change in performance that includes an approximately two-times increase
in sensitivity gain, volumetric resolution, and quantitative accuracy compared to
analog systems.
1
These radical improvements can ultimately be translated into high
image quality, increased diagnostic confdence, improved treatment planning, and
faster workfows.
Also of note, in a recent survey, nine out of ten referring physicians preferred
Vereos digital PET/CT images over images taken with an analog system.
2
Philips has
received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to
market its digital PET/CT system in the U.S.
1
Analog system: Philips GEMINI TF 16
2
Based on a recent survey, commissioned by Philips, among referring oncologists when shown Philips
GEMINI TF 16 images (analog system) and Philips Vereos PET/CT images (digital system).
Agfa HealthCares ICIS
Agfa HealthCares ICIS enterprise imaging solution allows you to see beyond
disconnected departmental imaging systems that struggle to support EHR
strategies. Optimize your EHR with a centralized imaging management services
platform for a truly comprehensive medical recordeasily viewed by clinicians
within the context of the EHR. Learn how our ICIS solution lifts images up to the
healthcare enterprise and helps make certain all imagesDICOM, non-DICOM
multimedia information, and paper documentsfnd their way into the correct
patient record.
Agfa HealthCares vendor-neutral ICIS enterprise and regional visual healthcare
platform provides the ability to expand clinical and medical image sharing
and collaborative patient care across HIEs and ACOs in one comprehensive, yet
incrementally deployable solution. With ICIS, any clinician within a health system
can create, collaborate, exchange, and manage a patients multi-disciplinary visual
medical history using the clinical context of the EHR.
NeuroLogicas BodyTom
The NeuroLogica Corporation is a subsidiary of Samsung Electronics. NeuroLogica
develops, manufactures, and markets innovative medical imaging equipment for
healthcare facilities and private practices worldwide.
The BodyTom is the newest ofering in NeuroLogicas line of computed
tomography imaging products. It is a portable, full-body, 32-slice CT scanner that
boasts an impressive 85 cm gantry and 60 cm feld of view. The BodyTom can
interface with PACS, HIS/RIS, and surgical navigation systems.
The BodyTom features an internal drive system that allows a single operator to
move the scanner anywhere it needs to go. The intuitive variable-speed control bar
allows for easy navigation in and out of elevators, over doorway thresholds, and on
any type of foor or carpet, similar to portable chest x-ray systems. The BodyTom
has a wide-angle drive camera that provides a 180 feld of view, making it easy to
maneuver through busy hospital corridors. The BodyTom is also battery powered
and plugs into a standard wall outlet. Its unique capabilities provide high quality CT
images wherever needed.
For more information visit: www.neurologica.com.
SenoBright CESM Mammography
GE Healthcares SenoBright is the frst imaging tool to use Contrast Enhanced
Spectral Mammography (CESM). Performed as an adjunct to inconclusive
mammography and ultrasound, a patient is injected with an iodine-based contrast
agent that makes areas of increased blood fow more visible to the x-ray. Because
cancer cells stimulate the development of new blood vessels, these areas may
indicate that cancer is present. SenoBright then generates the images of the breast
using two diferent x-ray energy levels and digitally combines the images. The
resulting image highlights any areas with increased blood supply, while removing
any unnecessary visual information from the background.
The exam is performed using the same mammography equipment, the same day,
in the same room and takes less than 10 minutes. With SenoBright, patients get
answers faster thereby reducing their anxiety.
Shimadzu Sonialvision G4
Since 1896 at its world headquarters in Kyoto, Japan, Shimadzu Corporations
research scientists, engineers, and designers have been producing x-ray equipment
that is used globally in conventional, interventional, and digital X-ray systems.
In 2014, Shimadzu will be highlighting two state-of-technology systems that
made their commercial debut last year, currently pending U.S. Food and Drug
Administration clearance and as yet not for sale in the United States. The Sonialvision
G4 universal fat-panel R/F table system is designed to perform a wide variety of
examinationsangiography, endoscopy, video-fuoroscopy for gastrointestinal
series and swallowing exams, orthopedic exams, and general radiography.
Acquiring high-resolution images rapidly using low radiation dose levels, its new
ergonomic design ofers workfow-efciency features to help improve technologist
productivity. Weights up to 700 pounds (318 kilos) are supported, making the G4
ideal for bariatric patients.
The Trinias C12/F12 digital angiography systems incorporate Shimadzus ultra-high
speed SCORE image processing technology, one of many workfow efciency-
oriented features of these versatile interventional systems. Shimadzus SMART Design delivers operational functionality in accordance with an operators intent without
impeding the procedure being performed. Images are acquired using any of the seven SMILE Dose-eye radiation dose exposure reduction features.
Visit www.shimadzu.com for detailed information.
Revolution Computed Tomography (CT)
GE Healthcares 501(k) pending Revolution CT has captured a motion free image
of the human heart in just one beat. With Revolution CT, clinicians can clearly see
specifc areas of the heart that were previously compromised either by a patients
movement, high heart rate, or a patients inability to hold his or her breath.
Revolution CT makes this possible through the convergence of spatial resolution,
temporal resolution, coverage, and low dose all-in-one, providing uncompromised
image quality and clinical capabilities.
Revolution CT continues GEs commitment to even lower CT doses, with innovations
such as the new Gemstone Clarity detector, a dedicated 70kVp scan mode for
pediatric use, and ASiR-V*, GEs next generation of iterative reconstruction
technology. For the patient, the system provides a wider, more comfortable
80cm bore and a quiet scanning experience with the new Whisper Drive system.
Ultra-fast scanning with streamlined workfow makes it a perfect scanner for
emergency rooms.
*Trademark of the General Electric Company
Silent Scan Magnetic Resonance (MR)
Silent Scan, an exclusive and revolutionary GE technology, is designed to address
one of the most signifcant impediments to patient comfortexcessive acoustic
noise generated during an MR scan. Conventional MR scanners can generate noise
in excess of 110 decibels, which is roughly equivalent to rock concerts and often
requires ear protection.
GEs exclusive Silent Scan technology is designed to reduce MR scanner noise to
ambient (background) sound levels and thus can improve a patients MR exam
experience. Noise is one of the major complaints from patients who undergo an
MR exam. Historically, medical manufacturers have addressed the noise issue by
using a combination of acoustic dampening material or performance degradation to
reduce the noise level. With Silent Scan, a radically new type of 3D MR acquisition, in
combination with proprietary high-fdelity gradient and RF system electronics, noise
is not merely dampened; it is virtually eliminated at the source.
microSTARiiA New System for Medical Dosimetry
The new microSTARii and proven nanoDot dosimeters from LANDAUER provide
fast, accurate, repeatable and highly cost-efective point-dose measurements in
medical dosimetry applications. The microSTARii features innovations in electro-
optical, mechanical and software design, including new technology developed for
the US Army RadWatch OSL dosimetry system, which was designed to monitor
radiation exposure to battlefeld personnel. These technological innovations
signifcantly improve signal-to-noise in dosimetric measurements. The microSTARii
uses state-of-the-art manufacturing techniques and aerospace-grade materials
and coatings to improve durability and to increase dosimeter positioning accuracy.
The microSTARii has new features to improve clinical workfow. For example, the
dosimeter drawer can be quickly loaded and easily slid into position, which enables
faster reading of nanoDots, and the microSTARii software is now tightly integrated
with the readers operation to streamline data analysis and to automate quality
assurance tracking.
Clinical evaluations indicate that LANDAUER Screened nanoDot dosimeters and
the microSTARii reader provide exceptionally stable, accurate and repeatable
measurements of point-dose in medical dosimetry applications. The new technology
and measurement techniques available in the microSTARii provide a new level of
performance for medical dosimetry.
IMRIS VISIUS Surgical Theatre
Inside VISIUS Surgical Theatre by IMRIS equipped with either high-feld
intraoperative MR (iMRI) or 64-slice computed tomography (iCT) imaging, surgeons
have on-demand access to real-time data and diagnostic quality imaging during
surgery without moving the patient. This state-of-the-art intraoperative vision which
travels into the OR on ceiling-mounted rails assists clinicians in decision making
and enhances precision in treatment. With VISIUS iCT, the scanner provides patient
personalized radiation dose management while maintaining image quality.
Using IMRIS imaging, the surgeon can visualize, evaluate and confrm results or
make adjustments prior to ending the procedure preserving optimal surgical
access and techniques. As part of a complete integrated image guided therapy
solution, IMRIS has developed workfow procedures, software applications, coils,
head fxation devices and OR tables that have been optimized for the intraoperative
imaging environment. The breadth of open surgical applications and catheter-based
treatments in this environment creates a complete intraoperative advantage for full
asset utilization.
VISIUS Surgical Theatres serve the neurosurgical, spinal, cardiovascular and
cerebrovascular markets and have been selected by 58 leading medical institutions
around the world. For more information, visit www.imris.com.
Siemens MAMMOMAT Inspiration Prime Edition
The MAMMOMAT Inspiration Prime Edition is a premium mammography system
from Siemens Healthcare that lowers patient radiation dose by up to 30 percent
without compromising image quality in 2D mammography. The system eliminates
conventional mammographys anti-scatter radiation grid, which absorbs a portion
of the all-important primary radiation that creates the X-ray image as it absorbs
the extra scattered radiation in a typical mammography exposure. Use of the anti-
scatter grid forces physicians to use a higher patient dose to obtain breast images
of diagnostic quality. Siemens Prime (Progressive Reconstruction, Intelligently
Minimizing Exposure) algorithm corrects the scattered radiation by identifying
scatter-causing structures and recalculating the breast image, leaving intact the
primary radiation upon which radiologists rely for a quality image. MAMMOMAT
Inspiration Prime Edition obviates the need for a scatter grid, and lower patient
doses are sufcient to generate high-quality breast images using less patient dose.
The MAMMOMAT Inspiration Prime Edition also has features that foster a more
positive patient experience. The systems Opcomp function applies compression only
as long as the patients breast is soft and pliable, stopping at the point of optimal
compression. Additionally, the MoodLight LED glass panel can be illuminated with
selectable colors to create a relaxing environment.
www.NEMA.org/illuminations
Join NEMA for its premier event
exclusively for CEOs and senior level
executives of electrical equipment and
medical imaging manufacturers
Illuminations Weekend
The Grand Del Mar Hotel and Resort
November 6-8, 2014
San Diego, California
#WhereLeadersAndIdeasMeet
IW2014-SaveTheDate-7.5x4.125.indd 1 2/27/2014 3:07:22 PM
North America I Europe I Asia www.csagroup.org
CSA Group goes beyond the expected to expand possibilities and help your business succeed. Our testing solutions
are designed to meet your goals for speed, efficiency and global market access while also contributing to a safer and
more sustainable planet. It starts with our in-depth understanding of your testing requirements, and it also includes
proven workflow processes, marks accepted across North America, and an office and laboratory organization that
is poised to serve you anywhere in the world. Our one-stop capabilities combine testing for safety, energy efficiency
and performance in a single, seamless program that helps reduce your time-to-market and can save you money.
Contact the experts at CSA Group to discuss your next project.
1.866.797.4272 | cert.sales@csagroup.org
EXPECT MORE FROM YOUR TESTING AGENCY.

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Revista Eloctroindustry - Mar14

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