NEMA ei November 2016 - 12MITA


MITA

X-ray Section: Recent Successes
MITA members collectively determine and develop section outputs in a non-competitive environment that benefit
their companies individually. The achievements of the X-ray Section represent the efforts of more than 110 MITA
company representatives.
RECAPPING 2016
The Computed Radiography and Digital Radiography
Group of the MITA X-ray Section published NEMA/
MITA XR 30-2016 Quality Control Tools for Digital
Projection Radiography in response to a request from
the American Association of Physicists in Medicine
(AAPM) Task Group (TG) 150 on Acceptance Testing
and Quality Control of Digital Radiographic Imaging
Systems. Before publication, MITA considered
input from AAPM TG 150 and the Food and Drug
Administration (FDA). XR 30 defines a set of
minimum requirements to facilitate
quality control of digital projection
radiography.
The section's Interventional Group
developed NEMA/MITA XR 31-2016
Standard Attributes on X-ray Equipment
for Interventional Procedures to offer
healthcare providers a reference to identify
key features that help manage patient
radiation dose delivery while providing
image quality. It describes eight
features that should be taken into
consideration when performing
risk management evaluations
on existing stationary
interventional x-ray
equipment.
In August, the FDA revised
its Guidance for the Submission of 510(k)s for Solid
State X-ray Imaging Devices. MITA's Solid State
X-ray Imaging Devices Task Force provided input
that applied concepts in a previous version to
current technology. This is significant because the
document went through an extensive process when
it was originally released in 1999; changes that added
alternatives to what previously existed did not have to
go through a lengthy revision process. This is a great
example of making regulatory clearance activities more
predictable and applicable to modern technology.
LOOKING AHEAD
MITA's X-ray Section will continue to work with the
FDA and the Conference of Radiation Control Program
Directors to allow the FDA and individual states to
accept compliance with International Electrotechnical
Commission (IEC) standards in lieu of outdated federal
performance standards.

12 MITA

NEMA electroindustry *  November 2016

In August 2016, the FDA released Medical X-ray
Imaging Devices Conformance with IEC Standards,
a draft guidance document. The FDA performance
standards, which are included in regulation, take
significant time and effort to revise and are, therefore,
often out of date. Relevant IEC standards referenced
in the document are developed in an open, consensusbased fashion, which provides flexibility and allows
them to keep up with technology.
The FDA seems committed to partnering with industry
and other stakeholders to consider conformance
to voluntary standards as a pathway for regulatory
compliance. This is important in eliminating
antiquated requirements and unnecessary duplication
across regulatory schemes.
MITA's X-ray Section's Mammography Group will
work with the FDA on its Virtual Imaging Clinical
Trial for Regulatory Evaluation project. Its goal is
to perform a complete in silico (i.e., performed on
computer) clinical study and compare the results to
those in a previously approved product submission.
The FDA wants to demonstrate that computational
modeling may be used to refine, reduce, and ultimately
replace the burden of expensive and lengthy imaging
clinical trials.
The MITA Computed Tomography Image Quality
Task Force designed a reference phantom for
objective quantification of head and body lowcontrast detectability (LCD). It offers the potential
to quantitatively assess LCD for clinical protocols
in the body and the head in relation to dose. During
development, researchers found that many approaches
are valid and different approaches may be appropriate,
depending on the situation. The task force is drafting
a white paper to provide details and rationale for
decisions that were made during the development of
the original project.
The group will engage the FDA and the Association
of the Heads of the European Radiological Protection
Competent Authorities to drive transparency and
consistency in how these agencies evaluate industries
efforts in documenting dose reduction that result from
technological advances.
Having established a successful track record, the
MITA X-ray Section continues to achieve the board's
strategic priorities. ei



Table of Contents for the Digital Edition of NEMA ei November 2016

Comments from the President
Breaking News
Survey: Benchmarking, Transparency Work
Centerfold: A look inside the Medical Imaging & Technology Alliance (MITA), a division of NEMA
2017 NEC Broadens Requirements for SPDs
Power Surges: Protect Your Home!
Grid Modernization Promotes Sustainability
Advocacy
Code & Standards
Revision Simplifies Magnet Wire Production
International
Business Analysis
NEMA ei November 2016 - Cover1
NEMA ei November 2016 - Cover2
NEMA ei November 2016 - 1
NEMA ei November 2016 - 2
NEMA ei November 2016 - 3
NEMA ei November 2016 - 4
NEMA ei November 2016 - Comments from the President
NEMA ei November 2016 - Breaking News
NEMA ei November 2016 - 7
NEMA ei November 2016 - Survey: Benchmarking, Transparency Work
NEMA ei November 2016 - 9
NEMA ei November 2016 - 10
NEMA ei November 2016 - 11
NEMA ei November 2016 - 12
NEMA ei November 2016 - Centerfold: A look inside the Medical Imaging & Technology Alliance (MITA), a division of NEMA
NEMA ei November 2016 - 2MITA
NEMA ei November 2016 - 3MITA
NEMA ei November 2016 - 4MITA
NEMA ei November 2016 - 5MITA
NEMA ei November 2016 - 6MITA
NEMA ei November 2016 - 7MITA
NEMA ei November 2016 - 8MITA
NEMA ei November 2016 - 9MITA
NEMA ei November 2016 - 10MITA
NEMA ei November 2016 - 11MITA
NEMA ei November 2016 - 12MITA
NEMA ei November 2016 - 13MITA
NEMA ei November 2016 - 14MITA
NEMA ei November 2016 - 15MITA
NEMA ei November 2016 - 16MITA
NEMA ei November 2016 - 2017 NEC Broadens Requirements for SPDs
NEMA ei November 2016 - 14
NEMA ei November 2016 - 15
NEMA ei November 2016 - Power Surges: Protect Your Home!
NEMA ei November 2016 - 17
NEMA ei November 2016 - 18
NEMA ei November 2016 - 19
NEMA ei November 2016 - Advocacy
NEMA ei November 2016 - 21
NEMA ei November 2016 - Code & Standards
NEMA ei November 2016 - Revision Simplifies Magnet Wire Production
NEMA ei November 2016 - 24
NEMA ei November 2016 - International
NEMA ei November 2016 - Business Analysis
NEMA ei November 2016 - 27
NEMA ei November 2016 - 28
NEMA ei November 2016 - Cover3
NEMA ei November 2016 - Cover4
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