NEMA ei November 2016 - 10MITA


MITA

The Value of Quality
Jim Nestel, Manager Service Projects and Installations,
Hitachi Medical Systems
Mr. Nestel chairs the MITA Service Committee.

O

nly original equipment manufacturer
(OEM) service providers are required by the
Food and Drug Administration (FDA) to have
a quality management system (QMS) to assess
medical imaging equipment.
Although many non-OEM medical imaging device
service providers perform excellent work, the lack
of such a requirement leaves the door open to low
quality and unsafe practices that may be hidden from
equipment owners, patients, and healthcare providers.
What could go wrong?
If a magnetic resonance image (MRI) is blurry
due to poor calibration, a tumor could be missed.
If a computed tomography (CT) scanner is out of
operation, an emergency room patient might wait
hours for a complete exam. If an ultrasound is
improperly sealed, the patient or provider could be
electrically shocked.
Why, then, would a medical device servicer
forgo a QMS?
Unfortunately, the answer may come down to shortsighted concerns about finances. The development and
implementation of a quality system require upfront

Strategic Priority 3:
Achieve consistent regulation
of all service providers by FDA

costs of money and time. Adoption of new processes
means that resources may be temporarily diverted to
bringing about necessary changes.
Change, however, can be rewarding. Adoption of
a quality system is a rigorous process in which an
organization undergoes thorough self-assessment and
documentation. These processes allow management
to understand not only specifics, such as day-today operations, but also larger issues, such as the
organization's overall direction and integrity.
An in-depth development and registration process
often exposes opportunities for improvement, yet
improved efficiency may save time and money. Quality
systems may also help an organization become more
efficient and productive through better business
intelligence and increase marketability. A QMS
registration conveys credibility and integrity. It proves
the organization is dedicated to quality, whether
negotiating with existing customers or acquiring
new ones. This commitment to quality may result
in increased customer satisfaction, acquisition, and
retention in new and existing markets.
A properly implemented and managed QMS will drive
an organization to improve continually. When new
problems are investigated in an organized and timely
manner, root causes can be identified and solutions
developed and implemented to prevent problems from
reoccurring. Persistently identifying and eliminating
impediments to product quality improves overall
performance and reliability; reduces costs from
product defects, work errors, and liability claims; and
increases safety for employees, customers, and patients
Given all of these benefits, how can an
organization afford not to adopt a QMS?
MITA recommends that the FDA require everyone who
services a medical device be held to minimum quality,
safety, and regulatory requirements that include
the implementation of a QMS. The MITA Service
Committee is developing a standard that outlines what
must be included in a proper servicing program to
ensure patient safety and device performance. ei

10 MITA

NEMA electroindustry *  November 2016



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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