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24x7mag.com
November 2014
Telemedicine:
Ready to join the mainstream
The Shellshock Bug:

Should you be worried? p18
KLAS:
Watchdog of the Healthcare
Industry p32
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Contents
November 2014 Volume 19 Number 11
12
Departments
8
Up Front
Features
12 COVER STORY
Telehealth: Turning the Corner
At the turn of the 21st century, the role telehealth would play in
the overall healthcare system was still uncertain. Not anymore
By Chris Hayhurst
16
Saving Lives by Reducing
Telemetry
How a team at one health system used evidence-based guidelines
to cut costs, reduce alarm fatigue, and improve patient safety
By Jenny Lower
18
Shellshocked: Are You
Prepared?
As HTM departments scramble to address the Bash Bug,
cybersecurity experts warn that more vulnerabilities are almost
certainly bound to follow it
By Chris Hayhurst
24
Networking
Tiny Area Networks, Part 2: Body Area Networks
By Jeff Kabachinski, MS-T, BS-ETE, MCNE
26
RSNA Preview
Whats Coming in Imaging Equipment
By Jenny Lower
On the cover:
Macrovector | Dreamstime.com - Mobile Health
Icons Set Photo
The Power Strip Saga: What CMS

Giveth, CMS Has Also Taken Away
By John Bethune
18
10
Real Time
News and trends of interest to the healthcare technology
management community
28
CCE Prep
Revised Joint Commission Standards for Medical Equipment
By Arif Subhan, MS, CCE, FACCE
30
Tools of the Trade
Simulation Finger, Surgical Monitor, Portable Ultrasound Device,
Wireless 2D Barcode Scanner
32
Focus On
KLAS: Watchdog for the Healthcare
Industry
By Phyllis Hanlon
30
34
Industry Insider
Andrew Hicks, Coalfire
By Jenny Lower
38
Soapbox
Details Matter Now More Than Ever
By Tim Hoof, CBET
READ IT ON THE WEB
Go to 24x7mag.com to read expanded and enhanced versions of

the articles in this issue. While youre there, catch up on the latest
news and events for HTM professionals.
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without written permission from the publisher. Entire contents 2014 by Allied Media LLC. POSTMASTER: Send address changes to 24x7, PO Box 47708, Minneapolis, MN 55447-8909. While the publishers have made every effort to ensure the accuracy of the materials presented in 24x7, they are not
responsible for the correctness of the information and/or opinions expressed.
November 2014
24x7mag.com
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November 2014
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Up Front
The Power Strip Saga: What
CMS Giveth, CMS Has Also
Taken Away
alternative level of protection may be achieved

ne of the best bits of news for hardby compliance with the 2012 edition of the
working and frustrated healthcare
LSC, which has extended allowances on the use
technology management profesof power strips in patient care areas.
sionals this fall was the CMS
CMS is permitting a categorical
about-face on power strips. As
waiver to allow for the use of power
you can read in the lead story
strips in existing and new health
in Real Time on page 10, the
care facility patient care areas, if
agency has determined that
the provider/supplier is in comrequiring healthcare providers
pliance with all applicable 2012
to comply with its originally
LSC power strip requirements and
planned restrictions on power
with all other 2000 LSC electrical
strip use would impose unreasystem and equipment provisions.
sonable hardships on facilities.
Resident rooms in long-term
Now, CMS says, facilities can
care or other residential care faciliinstead simply document that John Bethune, Chief Editor
ties that do not use line-operated
they are electing to use a new
electrical appliances for diagnostic, therapeutic,
CMS waiver from the requirements.
or monitoring purposes are not subject to
In a way, it would be unfair to say that CMS
the more restrictive NFPA 99 requirements
has changed its mind, since so far as I know, the
regarding the use of power strips in patient care
agency never actually made a previous public
areas/rooms. Resident rooms using line-operated
statement of its intent regarding power strips.
patient care-related electrical equipment in
Our insight into what CMS had planned came
the patient care vicinity must comply with the
from a statement made by George Mills, direcNFPA 99 power strip requirement and may
tor of engineering for The Joint Commission,
elect to utilize this categorical waiver.
at a talk he gave at the AAMI annual meeting
Individual waiver applications are not
on June 1. Mills told his listeners that CMS
required: Providers and suppliers are expected
had informed him that power stripsor, to
to have written documentation that they have
use the more specific terminology, relocatable
elected to use the waiver. A provider or supplier
power tapswould no longer be sanctioned
must notify the LSC survey team at the entrance
for use with medical equipment in patient
conference that it has elected the use the waiver
care areas.
permitted under this guidance and that it meets
I was in the audience for that announcethe applicable waiver requirements. The survey
ment, and can attest that the room went very
team will review the information and confirm
quiet on hearing the news. The response to our
the facility meets the conditions for the waiver.
online story covering the news later that day
also underscores just how dramatic this turn of
One of the curious aspects of this waiver
events was: It received the most page views in
policy to me, as a lay observer, is that facilities
the history of our website.
Because of the level of interest in this topic, need a waiver to use a much more up-to-date
its appropriate to provide the CMS summary set of standards. I have no doubt that there is a
legitimate reason for this strange situation. But
of its new waiver policy here:
as a patient, which standards would you rather
Categorical Waiver: CMS has determined have your healthcare facility followthe Life
that the 2000 edition of the National Fire Safety Code from 2000, or the one from 2012?
Thats just one of the issues well be looking
Protection Association (NFPA) 101 Life
Safety Code (LSC) contains provisions on at next month when we publish a feature story
the use of power strips in health care facilities on power strip safety and the events that led to
that may result in unreasonable hardship for this CMS announcement.
Stay tuned! 24x7
providers or suppliers. Further, an adequate
John Bethune
jbethune@allied360.com
8
November 2014
Editorial
Advisory Board
Matthew F. Baretich, PE, PhD
President
Baretich Engineering
Fort Collins, Colorado
Roger A. Bowles, MS, EdD, CBET
Professor, Department Chair
Biomedical Equipment Technology
Texas State Technical College
Waco, Texas
Barbara L. Christe, MS
Associate Professor
Biomedical Engineering Technology
IUPUI
Indianapolis, Indiana
David Harrington, PhD
Health Care Consultant
Medway, Massachusetts
Wayne Hibbs, CCE
President
LifeStructures Technology Planning
Indianapolis, Indiana
Michael R. Kauffman, CBET
Solution Delivery Consultant
Philips Healthcare
Mid-Eastern, Pennsylvania
Jeffery Kabachinski, MS-T, BS-ETE
Director, Technical Development,
Healthcare Technologies
Aramark
Charlotte, NC
Dennis Minsent, MSBE, CCE, CBET
Director, Clinical Technology Services
Oregon Health & Science University
Portland, Oregon
Ken Olbrish, MSBE
Communication Product Manager
Arthrex California Technology
Santa Barbara, California
Elliot B. Sloane, PhD, CCE
Assistant Professor
Villanova School of Business
Villanova, Pennsylvania
Arif Subhan, MS, CCE
Chief Biomedical Engineer
VA Greater Los Angeles
Healthcare System
Los Angeles, California
24x7mag.com
Real Time
CMS Backs Off on Power Strip Crackdown
In a September 26 letter to state survey agency directors, the Centers for Medicare &
Medicaid Services (CMS) waived the expected enforcement of controversial rules banning the use of power strips in many hospital patient care settings. The letter, written by
Thomas Hamilton, the director of the Survey and Certification Group within the CMS,
provides for a categorical waiver to allow for the use of power strips in existing and
new health care facility patient care areas. In the letter, Hamilton says that the 2000
edition of the National Fire Protection Association (NFPA) 101 Life Safety Code (LSC)
contains provisions on the use of power strips in health care facilities that may result in
unreasonable hardship for providers or suppliers. In place of that edition of the code, Hamilton says, the CMS will look to the 2012 edition, which
has extended allowances on the use of power strips in patient care areas. For hospitals, the bottom line for the CMS can be found in the following
statement in the letter: We are permitting a categorical waiver to allow for the use of power strips in existing and new health care facility patient care
areas/rooms, if the provider/supplier complies with all applicable 2012 NFPA 99 power strip requirements and with all other 1999 NFPA 99 and
2000 LSC electrical system and equipment provisions. Word of the earlier and more stringent CMS view on power strips first came out at the AAMI
annual meeting last June, when George Mills of The Joint Commission announced it. The news caused substantial consternation among the nations
HTM professionals. For more details on the categorical waiver and how to invoke it, refer to the full text of the letter, S&C: 14-46-LSC, which may
be downloaded from the CMS website. Find more information and links at 24x7mag.com/#1411rt1.
Kabachinski Joins 24x7 Advisory Board

Healthcare IT expert Jeff Kabachinski, the columnist behind 24x7s Networking column for the past 4 years, has joined the
publications editorial advisory board. He replaces retiring board member Raymond Zambuto, president of Clinical Engineering
Concepts, Ashland, Mass. Kabachinski is the director of technical development for Aramark Healthcare Technologies,
Charlotte, NC. He has more than 20 years of experience as an organizational development and training professional in the
healthcare industry. He has worked in many areas of healthcare, including manufacturing, regulatory, quality assurance, R&D,
and engineering. His primary focus has been in service, professional development, and technical training. His certifications
and academic degrees include a Master Certified Netware Engineer (MCNE) and NETWORK+ certifications, an MSc in
Training and Development from Leicester University, and a BS in Engineering Technology from the Milwaukee School of
Engineering. Kabachinski holds two US patents and is a certified Six Sigma Black Belt. He also serves as an editorial board
member for AAMIs journal BI&T (Biomedical Instrumentation & Technology). When not busy with keeping up with technology,
Kabachinski sings and plays guitar in his rock band, The Malcontents. Find more information and links at 24x7mag/#1411rt2.
AAMI Survey Reveals Top 10 Device Challenges

A survey of 195 US hospitals recently conducted by the Association for the Advancement of Medical
Instrumentation (AAMI) identifies the 10 most problematic issues involving medical devices. The
survey found that the largest number of respondents, 62%, rated ensuring that networked devices and
systems work properly as challenging or extremely challenging. Coming in second was integrating
data into electronic health records, rated as a top concern by 52%. Third in the list, named by 44%,
was maintaining infusion pump systems. The results of the survey appear in the September/October
issue of AAMIs BI&T (Biomedical Instrumentation & Technology) journal. The article is currently available from the journals highlights page. Find more information and links at 24x7mag.com/#1411rt3.
Aramark Opens Health Technology & Innovation Center
Jeff Kabachinski
TOP 10 MEDICAL DEVICE

CHALLENGES
Networked devices & systems
management
Integrating EHR data
Infusion pump maintenance
Cybersecurity
Device incident reporting
Recalls
Spectrum and wireless
management
Battery management
Endoscope management
Nonhospital devices brought in
by patients
In the search of more efficient ways for hospitals to manage clinical equipment assets, Aramark
opened a new Healthcare Technology & Innovation Center in Charlotte, NC, on October 8.
According to a company press release, the new Center strengthens Aramarks position to provide
versatile and cost-effective hospital clinical equipment management programs by increasing its
research and development expertise, centralizing training and engineering capabilities, and integrating Aramarks clinical equipment parts sourcing organization into a single center of excellence. Included in the new center are simulated patient
care suites with more than 32 active MRI, CT scan, cath lab, and x-ray systems. According to Aramark, the suites provide the ability for hands-on
technical training and quality assurance testing. The suites are designed to quickly accommodate new systems from any manufacturer, allowing
engineers quicker access to training on new technologies. The new center incorporates Aramarks wholly owned ReMedPar organization, a provider
of diagnostic and imaging parts and components. More than $40 million of parts inventory is now housed in a 90,000-square-foot facility. The
center also offers improved remote monitoring capabilities, enabling engineers there to digitally interface with equipment in Aramarks client locations to troubleshoot and correct issues in real time. Find more information and links at 24x7mag.com/#1411rt4.
READ IT ON THE WEB
Find updates on these stories and other recent news for HTM professionals on 24x7s website, 24x7mag.com.
10
november 2014
24x7mag.com
Telehealth: Turning
the Corner
At the turn of the 21st century, the role telehealth would play in the overall healthcare system was
still uncertain. Not anymore
By Chris Hayhurst
f you had asked Yadin David in 2001 for his take on telemedicinewas it for real, for instance, or just a bunch of hypehe
would have pointed out that more than 150 telemedicine programs were already in operation. David was perhaps the best person
in the nation to ask the question: He was then president of the Center for Telehealth and e-Health Law and director of biomedical
engineering at Texas Childrens Hospital in Houston. In his answer, he would have used words like promise, opportunity, and
possibility. Then, he most likely would have opined that for telemedicine to succeedto become a staple of medical practice
colossal changes would first have to take place in everything from the telecommunications infrastructure to clinical practice itself. Sure,
hed have said (as he did in his 2001 Journal of Clinical Engineering article, Telemedicine: I Can See the Highway, But Where is the
Ramp?1) that telemedicine is ready to roll. It just needs a better road map to achieve widespread use.
But that was 13 years ago. Today, says David, who is now a consultant, no one doubts how telemedicine might work, and almost
everyone is convinced that its a solution. Telemedicine has turned the corner, he says, and that rampthe one he referred to in
his articleis in place, well-marked, and open to traffic. In fact, Id argue today [that] telemedicine, if its not on Main Street, is
only a block away.
A 2013 report by the market research firm IHS supports Davids assessment. Telehealth, IHS claims, is set to expand tenfold by
2018.2 (Telehealth is broader than telemedicine in that it includes remote healthcare services that arent necessarily clinical in nature.)
The number of patients using telehealth services is expected to hit 7 million annually by that year. The report points out that telehealth offers solutions to many of the biggest problems associated with conventional healthcare delivery, from escalating costs to how
to handle an aging population in need of more and higher-quality care. Telehealth, IHS notes, has yet to reach its tipping point, but
it is nonetheless becoming an integral part of healthcare.
12
November 2014
24x7mag.com
Report
Challenges and Opportunities

As that tipping point approaches, then, are
biomeds prepared? Will the job of the HTM
professional change as telehealth becomes
more common?
David, who recently developed a telemedicine system for a hospital neurology department that wanted to make its concussion
service available to remote sites, considers
the growth of telehealth to be a tremendous opportunity for biomedical and clinical
engineering professionals, and especially for
those who do their homework. Currently,
he notes, telehealth systems are mostly managed by telecommunications and IT people.
Biomeds, for their part, are typically responsible for the same components theyve always
looked afterthe medical devices that connect to the system.
This division of labor is fine, he says, but
as telemedicine grows, those HTM professionals with the broadest range of skills will
stand to gain the most. If you think you
can just keep doing what youre doing and
become a telemedicine maven, youre in for
a big surprise. Biomeds who develop competencies in areas like telecommunications
and telemedicine-specific clinical protocols,
regulatory standards, and work processes, he
says, will be in the best position to advance
their careers as telemedicine evolves.
24x7mag.com
Wayne Hibbs, principal at the design

firm BSA LifeStructures, where he focuses
on technology and equipment planning for
healthcare facilities, agrees. Hibbs says hes
followed the development of telemedicine
closely since it first came into use in the
1990s, and has watched it reinvent itself
several times since.
Now, he notes, smartphones and highresolution webcams are increasingly allowing
patients to take vital signs and other health
readings themselves from home, and to then
send that information electronically to their
doctors, wherever they may be. This vein
of telemedicine is still in the beta-testing
phase, he says, but its beginning to happen,
and its on the horizon for everybody.
When that day comes, Hibbs adds, the
biomeds of the world [will] get involved by
making sure that the patients at home not
only have access to the right equipment, but
that it works correctly and they know how
to use it. He imagines a whole new category of biomed people who are like computer geeks on call. Theyll either form
their own consulting companies or work for
the insurance industry, making home visits
when individuals sign up for policies and
the insurance company wants to make sure
they actually have the right health apps and
know how to use their new Apple iPhone
6. This new frontier of telemedicine,

as Hibbs calls it, will require biomeds and
clinical engineers to be the quality-control
expertsthe boots on the ground ensuring
that the picture the physician is viewing
is color correct or the sound of the electronic stethoscope is clear.
Overlapping Worlds
Of course, even as telehealth gains ground
in the home, the biggest demand for its
use most likely will come from medical
facilities themselves. Inova Health Systems
enVision eICU in Falls Church, Virginia,
provides an example. There, nurses and
physicians work in a room with eight
workstations and six computer screens to
provide around-the-clock remote support
to patients and clinicians in the critical
care units of affiliate hospitals elsewhere in
the state. Inovas clinical engineering team,
working closely with IT, supports and
manages all of the technology involved,
from the audio and video equipment to the
carts, batteries, inverters, and other components of the telemedicine system. And they
do it on both endsnot only in the eICU,
but also in the hospitals themselves.
Inovas administrative director of telemedicine operations, Steven Dean,
calls the clinical engineering team a
November 2014
13
TELEMEDICINE RESOURCES
American Telemedicine Association:
www.americantelemed.org
Healthcare Information and
Management Systems Society
(HIMSS) Mobile Health Community:
www.himss.org/mhealth
International Society for Telemedicine
& eHealth: http://www.isfteh.org/
Telemedicine and e-Health (journal):
http://online.liebertpub.com/loi/TMJ
Journal of Telemedicine and Telecare
(journal): http://jtt.sagepub.com/
critical asset, and describes their role as

broader than that of the typical HTM
pro. Theyre not just working on medical
devices, he notes. In telemedicine, that
line between where networks and infrastructure meet, it starts to get blurry. At
Inova, Dean adds, the clinical engineers
have learned to handle that component
where those two worlds overlap.
The Telemedicine Program of Fletcher
Allen Health Care and the University of
Vermont College of Medicine (UVM),
meanwhile, leverages the Level I trauma
centers medical expertise primarily by
connecting its clinicians to remote hospital emergency departments throughout
the region, as needed. (The telemedicine
program is also used for instructional purposesbroadcasting, for example, grand
rounds from Fletcher Allen to its referral
hospitalsand as a means for technicalservices experts in Burlington to troubleshoot equipment problems at other sites.)
Each emergency department, explains
Tobey Clark, UVMs director of
Instrumentation & Technical Services,
has its own telemedicine system set-up
that is largely for face-to-face consultation. Theyll have attachments where you
can do things like hook up a camera to
an endoscope so a specialist here can
see the patient. UVM has a dedicated
staff of telecommunications professionals
that handles the networking aspect of the
operation, while the HTM department
manages the front-end equipment, just
like they would any other medical device,
14
November 2014
as well as the audio and video components.

(Microphones and audio technologies tend
to run into more problems than the video
components, Clark notes.)
Clarks advice for biomeds? Know the
basics of your system really well, and create a block diagram you can refer to when
problems arise. The only way youll be
able to troubleshoot problems is if you
know whats out there to begin with.
Breaking It Down
One person who does know exactly whats
out there is Tim Gee, principal at Medical
Connectivity Consulting in Beaverton,
Oregon. Gee describes himself as a connectologist who advises medical device
manufacturers and healthcare facilities
on workflow automation and the integration of devices and information systems.
In every telemedicine system, Gee says,
there are three classes of components:
the medical devices themselves, like the
blood pressure cuffs and otoscopes and
electronic stethoscopes; off-the-shelf parts
supplied by the telemedicine vendor, like
the video cameras and audio equipment
to which the medical devices attach; and
the telecommunications infrastructure of
the facility or facilities hosting the system.
Obviously, Gee notes, the component every biomed is familiar with is the
medical device. But the other two, they
may not be. If your hospital has a dedicated IT or telecommunications team, like
the one at UVM, that wont be an issue.
But even so, Gee says, there may not be
a biomed at the remote site, which could

be a prison, a school, an ambulance, or a
patients home. And there may not be an
IT person at that site, either. Or it may
be that in the hospital you have both,
while in the remote clinic you just have
a biomed. In other words, he says, who
does what can vary. It depends on the
facilitys resources, and on which end of
the telemedicine system youre on.
Complicating matters further, Gee
notes, when a component in a telemedicine system breaks, swapping out parts
can be difficult. While medical devices
tend to be bought for the long haul,
the telecommunications components they
connect to and are integrated with have
relatively short life cycles. Carts, TV cameras, routers, switches, softwaretheyre
constantly being changed and updated
and replaced with new models. Add to
that the fact that FDA regulations may
limit ones ability to simply replace broken, stolen, or misplaced telemedicine
parts, and you have a new dynamic that
people in biomedical and clinical engineering are typically not accustomed to,
Gee notes.
He recommends that biomeds be
involved in the planning stages of any new
telemedicine system so that they can talk
to the manufacturers and ask the right
questions before any purchases are made.
Ensuring a systems components are relatively easy to replace or service can have
a big impact on the cost of ownership,
he notes.
24x7mag.com
Telehealth offers solutions to many of

the biggest problems associated with
conventional healthcare delivery.
Putting It In Place
A telemedicine supplier who agrees with Gee (and there are certainly others) is Steven Normandin, president of Massachusettsbased AMD Global Telemedicine. The biomedical engineering
guysto them, what were bringing in is just another product, and
they already have 95% of the skill set they need to do everything
theyll ever have to do with it. Still, he says, training is an important part of the installation process (how a product is different
from the other devices theyre using, how to clean it, what to do if
something breaks), and the HTM department always signs off on
what were putting in.
AMDs best-selling device is a general-examination camera
most often used by correctional facilities, elementary schools, and
rural healthcare facilities where physicians are in short supply,
Normandin says. That real sexy stuff you read about? Like the
remote-assisted surgery, things like that? The majority of telemedicine is primary care. Its doing the same things that youd do in
any doctors office. Youre looking in the ears, in the eyes; youre
listening to the heart, to the lungs. Youre taking all the vital signs.
Thats the equipment were working with.
When AMD first opened for business almost 24 years ago,
Normandin continues, there was very little competition. Their
telemedicine products, he says, involved taking something like an
electronic stethoscope and hooking it up to an Adobe encoder. It
was finding a bunch of miscellaneous and usually nonmedical parts,
things like graphic equalizers from stereo systems, and putting
everything together until it all worked.
Back then, he remembers, most of the biomed guys looked
at this field with a little apprehension. A lot of it didnt match
their core competencies. There were some areas that they werent
used to. Today, though, thats changed. And while biomeds are
now expected to work more closely with their IT colleaguesor,
increasingly, to handle the basics of networking and communications themselvesthis shift has not been so sudden that there
wasnt time to prepare.
Wayne Hibbs of BSA LifeStructures describes it as a merging,
where the IT techs and the biomed techs are getting closer and
closer together every 6 months, and sometimes its getting harder
to tell them apart. Normandin, for his part, sees the same thing
and from his perspective, as a telemedicine vendor, thats been fine
with him. Theres very little push-back now, he says. For the
most part, these guys are just doing the things that theyre trained
to do. 24x7
Chris Hayhurst is a contributing writer for 24x7. For more information,

contact editorial director John Bethune at jbethune@allied360.com.
READ IT ON THE WEB

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24x7mag.com
November 2014
15
Saving Lives by
Reducing Telemetry
How a team at one health system used evidence-based guidelines
to cut costs, reduce alarm fatigue, and improve patient safety
By Jenny Lower
hen
the
Christiana
Care Health System in
Wilmington, Del, began
drastically
revamping
its ordering system for cardiac telemetry in
September 2012, the issue of cost savings was
never even discussed. Instead, its leaders were
responding to a communication failure.
One evening, the telephone lines between
the health systems two hospitals and the
central monitoring station, which tracked 377
patients for abnormal heart rate or rhythm,
abruptly went down. Nurses were left scrambling to decide which patients should receive
the limited number of portable telemetry
monitors available. At a follow-up meeting of
the hospitals safety committee analyzing the
incident, Andrew Doorey, MD, a cardiologist
with Christiana Care and a clinical professor
of cardiology at Thomas Jefferson University,
noted that the issue was part of a much larger
problemthe hospitals were monitoring far
too many patients to begin with.
The Society of Hospital Medicine, in its
Choosing Wisely campaign, discourages continuous telemetry monitoring outside the
ICU, citing little clinical benefit. Past efforts
to reduce the hospitals use of cardiac telemetry for non-ICU patients had failed. But
Dooreys observation led the safety committee
to appoint him and Robert Dressler, MD,
MBA, vice chair of the department of medicine, to fix the problem.
Their efforts led to a drastic 70% reduction in total telemetry hours, to the tune of
an estimated $4.8 million in annual savings,
all without any increase in code blue or rapid
response calls among non-ICU patients. That
accomplishment recently earned the hospitals
ECRI Institutes ninth annual Health Devices
Achievement award, which recognizes undertakings that increase patient safety, reduce
costs, and improve technology management.
Christiana Care accomplished all three.
Though the project resulted in massive savings, Doorey says that benefit is secondary to
the payoff in improved patient care. Theres
16
November 2014
no question that theres money to be saved,

but its absolutely clear that patient care will
be improved by the reduction in nurse distraction, wasted nurse time, and alarm fatigue.
A Costly Distraction
Dressler led a multidisciplinary team involving
cardiologists, hospitalists, nurses, and IT and
pharmacy staff, and began gathering data to
assess the impact of telemetry on the hospitals
practices and costs.
Out of 1,100 beds, approximately 355
patients were on telemetry. The team discovered that 70% of calls from the monitoring
center to nurses involved technology issues
such as battery replacement, motion artifacts,
or lead placement; less than 1% of calls were
for critical cardiac arrhythmias. A time-motion
study found that nurses were spending an average of 19 minutes of administrative time per
patient per day dealing with telemetry-related
issues, for a daily total of 117 hours across the
facility. Those frequent interruptions contributed to a general sense of alarm fatigue and
increased the risk of other errors while reducing the time nurses could spend at a patients
bedside. Costs were also significant, calculated
at $53.44 per patient per day.
Prior to the redesign effort, the default duration for telemetry patients was 72 hours, but
that time regularly got extended. Nurses were
sometimes reluctant to terminate telemetry,
and were faced with tracking down physicians
to assist in making a determination, while
nighttime or weekend physicians were more
likely to defer the decision to the patients
regular doctor. The obstacles contributed to an
overall sense of inertia.
We did not have a concern with our
clinicians decisions, Dressler says. Our
clinicians and nurses are very busy providing
patient care and analyzing clinical information. Altering their routine use of cardiac
telemetry was not their highest priority. By
hardwiring the guidelines into the ordering
process, we were able to facilitate the appropriate use of telemetry by clinicians.
Andrew Doorey, MD
Robert Dressler, MD
Hardwiring a Solution
When the process began, cardiac telemetry
was embedded in 144 order sets, most of
which were not directly related to heart conditions, such as migraines. Working closely
with IT, the team began overhauling the
hospitals software system to remove the
telemetry option and place it in a separate
order set. Physicians requesting telemetry
were required to select a clinical indication,
which was programmed to a specific duration based on guidelines from the American
Heart Association (AHA). Doctors could
still order telemetry without a specific indication by checking an other category, but
that request had to be renewed daily.
We wanted to preserve physician autonomy. We didnt want to get between them,
their patient, and their clinical judgment,
Dressler explains.
We really wanted to give docs whatever
they wanted, Doorey adds. But we werent
going to give it to them forever.
The team also developed a clinical decision
tool to facilitate nurses critical decision-making and help them safely discontinue telemetry
at the previously ordered time. An hour before
telemetry was scheduled to cease, an automatic
notification would pop up at the nurses station. The system guided staff through a brief
list of questions, inquiring about the patients
heart rate, blood pressure, and overall clinical
status. Last was what Doorey calls the hair
on the back of the neck moment: Have you
observed any significant deterioration in the
patients overall condition?
That phrasing led one nurse to question
what exactly constituted significant. Couldnt
the question just ask about deterioration?
It was a great point, Doorey says.
Deterioration was deterioration. So we took
out the word significant.
A single response raising a potential clinical concern was sufficient to prompt nurses
to consult with a physician to address it,
along with consideration for extending the
telemetry duration. But those cases have been
24x7mag.com
relatively rare. Instead, the total number of

orders dropped 40%, while duration dropped
47%. With the two factors combined, total
telemetry hours were reduced by 70%.
A Team of Allies
Previous reform efforts had employed a topdown approach that cardiologists resisted.
They resented what appeared to be administrative attempts to interfere with patient care
in order to save money.
As the clinical lead, Doorey recognized

that the effort would fail unless he had
cardiologists on board, so he approached
them first. We were careful never to use
the words money or cost, he says.
Instead, he cited the AHA recommendations, framing the discussion in terms of
clinical benefits.
Cardiologists are very evidence-based,
Doorey continues. They approved it unanimously. With their support in hand, he
and Dressler went out to sell other groups

on the concept.
Throughout the process, they consulted
with stakeholders to ensure their buy-in
and support. The nursing staff proved to be
key allies. They knew from experience that
patients on telemetry often got tangled up in
wires or tripped over them while walking. For
elderly or postsurgical patients, the 2-pound
units could inhibit mobility and change their
center of gravity, leading to falls. Confronted
with evidence that excessive telemetry was not
only not helping, but sometimes hurting, their
patients, many doctors were quick to sign on.
The campaign revealed a challenge no
doubt faced by many hospitals in their reform
efforts: nobody wanted to be the only physician whose patients werent on telemetry.
The changes impacted all clinicians across
the board, Dressler says. This made it easy
because we said, This is what the evidence is;
lets follow the guidelines. Since everybody
was put into that situation, the herd mentality
made adoption easier.
A Model for Safety
Jim Keller, vice president of health technology evaluation and safety for ECRI Institute,
will travel to the facilities before the years
end to present the award. Among the 20 or
so submissions ECRI receives each year from
Health Device member organizations, a key
component is not only tackling an important
issue, but measuring the effectiveness of the
implemented solution.
Christiana Cares application excelled
because it demonstrated a simple, direct problem-solving method that is easily reproducible for other hospitals. You have to
go through the work and the effort they
applied to do this kind of project, but its
fairly straightforward. This is an elegantly
simple design to minimize an important
patient safety concern, Keller explains.
Now that monitoring patients is no longer the norm across the facilities, its been
surprisingly easy to make the changes stick,
Doorey says. If you get another unmonitored patient, its not a big deal. It kind of
redefines the standard of care in our hospital and our community. 24x7
Jenny Lower is 24x7s associate editor.
Contact her at jlower@allied360.com
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at 24x7mag.com/#1411f
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November 2014
17
Shellshocked: Are You Prepared?

As HTM departments scramble to address the Bash Bug, cybersecurity experts warn that
more vulnerabilities are almost certainly bound to follow it
By Chris Hayhurst
he news, Chris Peters recalls,

arrived in an advisory from
the University of Michigans
Information and Infrastructure
Assurance (IIA) division. A security vulnerability was announced today that requires
immediate remediation, the notice, from
September 24, began.1 Please readto see
if servers for which you are responsible are
affected and take action if appropriate.
Peters, a clinical engineer in the biomedical
engineering department at UM Hospitals
and Health Systems, did as he was asked. A
vulnerability in Bash, the notice continued,
could allow an attacker to execute arbitrary
commands on a server, which could result in
exposure of sensitive information or negative
impact to critical services. Any service running on a system with a vulnerable version
of Bash may be susceptible to attack. And
then, ominously, widespread exploitation is
expected to occur quickly.
The advisory, explaining that affected systems included anything running on Linux,
Apple, or other Unix-based operating systems, recommended applying vendor patches to those systems as soon as possible. But
it also noted that, IIA will not be scanning
campus networks to identify vulnerable systems because a reliable method for remotely
detecting such systems was not available.
This, Peters remembers thinking, was a
problem. I mean, you look around, and
there is equipment everywhere that may or
may not be vulnerablephysiological monitors, ultrasound machines, tablet computers
being used to interface with medical equipment through the wireless network. The
big question for me was, and still is, What
equipment does this affect? Is it just a few
devices? Or is it a lot more than we might
think? And if there is an attack, what could
it do to our network?
A Nasty Bug
Chances are, like Peters, youve already
been briefed on the Shellshock bug. First
made public in an alert2 by the Department
of Homeland Securitys US Computer
18
November 2014
Emergency Readiness Team (US-CERT),

Shellshock, or the Bash Bug, is a security vulnerability in Bash, a computer program in Unix-based operating systems that
allows users to enter and execute commands.
Because the flaw is so easy to take advantage of, and because exploitation could, as
software security company Trend Micro
put it, do significant widespread damage,3
the National Institute of Standards and
Technology has given it a 10 out of 10 rating
on its vulnerability-severity scale.4 Its really
very nasty, notes Axel Wirth, a healthcare
cybersecurity expert at Symantec Corp. If
its exploitedin a healthcare environment
or elsewherethe attacker can take full
control of a system.
Mike Ahmadi, global director of medical security at Internet security firm
Codenomicon, adds that the Bash Bug is
interesting, mainly because its so ubiquitous. It really affects an enormous number
of Linux systems, and Linux is very popular
for a lot of applications in healthcare. Web
servers, routers, firewalls, and embedded
medical devices with connections to the
Internet are most vulnerable, Ahmadi says.
Building systems like HVACs, elevator
controls, and refrigeration units may also
be affected.
Other industries that depend on Unixbased operating systems in their day-today affairs may simply deploy the recommended patches that were released almost
immediately after the flaw was announced.
In healthcare, howeverand as Peters has
seen at the University of Michiganits
not always so simple.
There are a couple of problems,
Ahmadi says. First, theres no easy way
to know which devices and systems are
affected. The FDA tracks things like food
ingredients, but they dont track which
versions of operating systems are included
in the medical devices that they approve.
Certain versions of Linux have the Bash
Bug, while other versions do not. And
while any good manufacturer should
know which version of Linux is in their
device, Ahmadi says, because reporting
is not mandated, that information may be
hard to obtain.
If youre a device manufacturer, patching an OS is a big, big deal. Manufacturers
must test any patch extensively before issuing it to ensure it wont cause a device to
malfunction or fail, he explains. Then,
once they have made a patch available,
warranty limitations may prevent end users
from applying that patch on their own.
24x7mag.com
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The bottom line is, if its a medical device

youre worried about, theres very little that
you can do quickly. (When representatives
at GE Healthcare were asked how they were
addressing potential Shellshock vulnerabilities in their medical devices, they referred
to a written statement posted on the GE
Security and Compliance page: We are
actively monitoring our data security systems
in response to [the Bash Bug], and are taking
swift action where necessary.5)
Action Steps
If your department already practices good
inventory management, remediation may
be a relatively straightforward process. As
Wirth points out, any asset-management
system should include information on
the operating-system versions used in the
devices on your network, and that should
allow you to look up, typically on the
support website of the vendor, whether
that version is affected, whether it should
be patched, or whether they recommend

other security measures. And if you cant
find that information online? Then you
should pick up the phone and call the
vendor.
Most noncritical systems (what Wirth
describes as standard IT components),
like web servers, print servers, and internal routers and firewalls that arent used
directly in patient care, are typically easy
to patch and dont require close vendor
oversight. Patch these systems immediately, Wirth says.
NIST has given Shellshock

a 10 out of 10 rating on its
vulnerability-severity scale.
Devices that cannot be patched easily,

on the other hand, should be safeat least
temporarilybehind the standard protections provided by your facilitys networksecurity architecture. Best practices, Wirth
notes, include the use of firewalls and
segmenting off [vulnerable devices] in
protected VLAN networks.
And traffic monitoring is key. If a
device is attacked, you want to know
about it. (The Symantec blog post,
How to Prevent Your Data from Getting
Shellshocked,6 lists more intrusion-prevention strategies; a list of Linux vendors
that have issued security advisories is
available on the Symantec website.7)
Unfortunately, Wirth says, Shellshock
will likely be remembered as just one
bug on a long list of high-profile flaws
fundamentally inherent to software infrastructure. Well inevitably hear news, as
we did with Heartbleed, of Bash-related
system breaches and data pilfering in the
months ahead. And the next vulnerability?
Dont blink, because its already here.
This, Wirth predicts, is just the
beginning. 24x7
Chris Hayhurst is a contributing writer for 24x7.
For more information, contact editorial director
John Bethune at jbethune@allied360.com.
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Find the references for this article

at 24x7mag.com/#1411f2
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November 2014
23
Networking
Tiny Area Networks, Part 2: Body Area Networks
By Jeff Kabachinski, MS-T, BS-ETE, MCNE
n part 1 of this two-part series, we 802.15.6 standard.1 The standard specifies

examined near-field communication. all the other aspects and configurations of
In part 2, we turn our attention to MBANs, including media access control
another tiny area network in health- (MAC), frame formats, security services,
care called body area networks (BANs). and a choice of narrow band, ultra-wide
band, or human body commuBAN technology uses sensors
nications (physical layer specs).
that can be located on or in
the body. These wearable or
implantable sensors communiStar Configuration
cate with a controller within
The basic BAN is set up as a
near-vicinity of the body. The
star network, with a hub in the
biosensors are very small, needmiddle of the star and nodes
ing so little power that they can
connecting to the hub. There is
harvest available kinetic body
only one hub in a BAN, but it
Jeff Kabachinski
can coexist with other BANs, up
energy for their power supply.
(In other words, no batteries are needed.) to two to four networks per square meter.
This also makes them suitable for long-term Each BAN can support up to 100 nodes
in vivo applications.1 In this installment of with ranges up to approximately 6.5 feet.3
Networking, we will look at the technical In some cases, nodes are built with the abilside of BANs and how theyre being used ity to forward data from another node to
in healthcare.
the hubbut no deeper. Figure 1 depicts a
There are several types of BANs. The BAN where the green node has the ability
Federal Communications Commission to connect another node to the hub in the
(FCC) calls them medical body area net- middle of the network.
works (MBANs), dictating their broadcast
Typically, the nodes will contain bodyfrequency ranges and maximum RF power connected sensors, and the hub would be
limits.2 As long as the vendors that make a worn device. Examples of hub locations
the MBAN devices stay within the FCC would be in a necklace, on a belt, on the
limits, they wont need a specific license wrist like a watch, or in the sole of a shoe
for each network installation. The two (where it would also be a likely place to
frequency ranges used are in the Industry absorb and reuse the kinetic energy of walkScience and Medical (ISM) bands of 2,360 ing). Alternatively, the hub may be placed
to 2,390 MHz and 2,390 to 2,400 MHz. away from the body as part of the bedside.4
These ranges are part of the so-called
quiet ISM band, as opposed to the noisy Three Physical Layers
and jam-packed 2,400 to 2,483.5 MHz Published in 2012, the IEEE standard defines
range, where Wi-Fi and other wireless a common MAC layer with three possible
technologies operate.
physical layers, in addition to security levels
In the 2,360 to 2,390 MHz band, maxi- and methods. The three physical layers are
mum output is limited to 1 mW. BANs narrow-band (NB), ultra-wide band (UWB)
in this range are also limited to indoor use and human body communication (HBC).
to help ensure they do not interfere with
aeronautical mobile telemetry and radio Narrow-Band
telescopes, which use the same quiet band NB was designed for use in medical applicarange. The 2,390 to 2,400 MHz band can tions as wearable or implantable devices. NB
be used anywhere, and is allowed a bit supports data rates from 120 Kbps to nearly
higher output of 20 mW. (For compari- 1 Mbps, depending on location and power
son, note that 802.11 wireless networks levels. NB also uses less of the available power
like Wi-Fi typically use 100 mW radios for general operation (approximately 33%)
for communication.)
than a comparable communication method
The IEEE has the additional specifica- like Bluetooth Low Energy, which uses about
tions for MBANs, but refers to them as 80%. This means that NB has more power
wireless body area networks in the IEEE available for sensors and local processing.4
24
November 2014
THE NIST APPROACH

The National Institute of Standards
and Technology (NIST) has several
research projects under way with
regard to what it calls pervasive IT,
as noted on the NIST website:
Radio Frequency (RF) Propagation
from Wearable and Implantable
Medical Sensors: NIST is working to
better understand RF propagation
within and on the human body surface.
Modeling and Characterization
of Harvestable Kinetic Energy for
Wearable Medical Sensors: NIST is
studying the statistical characteristics
of harvestable kinetic energy generated from human motion. The result of
this study can facilitate the development of efficient energy-management
protocols for low-power wearable
medical sensors.
Interference Analysis and Mitigation
for Body Area Networks: NIST
researchers are developing software
tools that can help study the interference on wearable and implantable
wireless medical devices.
Smart Autonomous Sensors and
Environments: NIST is conducting
research to examine the optimal deployment of sensor devices (with controlled
mobility) and the relevant possible
trade-offs between coverage (ie, connectivity) and information sensing.
Ultra-Wide Band
UWB in MBAN use comes in two flavors
impulse radio (IR-UWB) or wideband FM
(FM-UWB). The impulse radio uses either a
single pulse or a burst of pulses to represent the
digital symbols of 1 and 0. UWB in general
provides lots of implementation methods to
generate high performance, low complexity
to be robust with ultra-low-power operation.
Low-power UWB radios that can handle up
to 20 Mbps are already available5technology marches on! Another main reason that
MBANs often use UWB is that UWB signal
power levels are in line with the medical
implant communications service band, providing safe power levels for the human body and
very low interference to other devices. UWB
can be used in its default mode as defined in
the standard, where IR-UWB transceivers are
24x7mag.com
Networking
Figure 1: A BAN layout. The green node can connect another node
to the hub.
mandatory and FM-UWB transceivers are optional for medical and

nonmedical use. UWB can also be used in a high quality of service
mode (QoS), in which IR-UWB transceivers are mandatory. (There are
no FM-UWB transceivers in QoS.) QoS traffic can trump other, less
urgent traffic in high-priority medical applications,1 as in: Here comes
the ambulance. Better pull over and let it by!
Human Body Communication
Probably the most interesting of the three communication methods is
HBC.6 The MBAN standard for HBC as the physical layer uses electric
field communication technology. As in the other methods, the HBC
standard covers the entire physical-layer protocol for MBANs, such as
packet structure, modulation, and preamble. The band of operation is
centered at 21 MHz.6
Information is exchanged among electronic on-the-body devices by
capacitive coupling pico-amp currents through the body. HBC does not
require traditional antennas, which means HBC-based systems need less
power than others, often less than 1 mW.
Power is distributed via the bodys conductive medium like a bus.
Likewise, data and control information are also distributed over the
human body. The power source can use DC or AC signals. Devices can
also be selectively powered using different AC power signal frequencies.
In an example from a Microsoft patent related to BANs, for instance,
a 100-Hz signal powers one device, while a 150-Hz signal powers
another.6 Digital data modulate the power signal using frequency and/
or amplitude modulation techniques (FM or AM).
The patent sums it up pretty well: The power source and peripheral devices can interact to form a complete computer network where
the body serves as the bus coupling the devices together.6 Kinetic
power converters can be used in the MBAN to provide the networks
power and signaling needs. For example, there can be a kinetic power
converter in the sole of a shoe, or in a wristwatch getting kinetic
power from arm movement.
Summary
BANs provide communication between ultra-small and ultra-lowpower intelligent sensors that are on or in the body. The radio-enabled
24x7mag.com
sensors can continuously transmit physiological data. Implantable medical devices can also deliver medication called smart pills for precision
drug delivery. There are also smart endoscope capsules, glucose monitors, and eye pressure sensors. There are wearable sensors that provide
electrocardiogram, temperature, respiration, heart rate, and blood pressure information.
One example of a BAN application is a sensor that also controls
an insulin reservoir and pump. The system can sense glucose levels
and deliver just the right amount of insulin at the right time for the
diabetic patient.7
Another example is the MobiHealth cardiac monitoring system,
which integrates an ECG system with a GPS for serious or high-risk
cardiovascular patients. When the ECG system alarms, patients can be
easily found with their GPS data. The complete system is embedded
into a shirt made from a smart fabric that is comfortable and washable. The MobiHealth system is considered an autonomous system, in
that it looks for anomalies using the configured alarm levels and makes
the call to the medical team dispatcher based on its ECG analysis.3
It is systems like these that make smart sensors and BANs a key element in the ongoing transformation of healthcare by technology.7
References
1. IEEE. (2012, Feb 29). IEEE Std 802.15.6-2012. IEEE Std 802.15.62012 IEEE Standard for Local and metropolitan area networks Part
15.6: Wireless Body Area Networks. New York, New York, USA:
IEEE Standards Association. Available at: http:// http://ieeexplore.ieee.
org/xpl/articleDetails.jsp?reload=true&arnumber=6161600. Accessed
October 20, 2014.
2. Federal Communications Commission. (2013). Small Entity
Compliance Guide. FCC. Washington DC: US Govt. doi: FCC 12-54
ET Docket No. 08-59. Available at: https://apps.fcc.gov/edocs_public/
attachmatch/DA-13-1086A1.pdf. Accessed October 20, 2014.
3. Karulf E. Body area networks survey paper. St Louis; Washington
University in St Louis; 2008.
4. Davenport D. (2011). IEEE 802.15.6 Tutorial. Project Meeting:
IEEE P802.15 Working Group for Wireless Personal Area Networks
(WPANs). 2011; 4, 8-15, 17-20, 23-26. IEEE. Available at: https://
mentor.ieee.org/802.15/dcn/08/15-08-0491-00-0006-fcc-publicnotice-2360-to-2400-mhz-mbans-proposal-update.pdf. Accessed
October 20, 2014.
5. Imec International. (2012, Oct 30). Ultra-Low Power Circuits for
Small Connected Devices. Belgium: Imec International.
6. Williams L. (2000). United States of America Patent No. US6754472
B1 - Method and apparatus for transmitting power and data using
the human body. Available at: http://www.google.com/patents/
US6754472. Accessed October 20, 2014.
7. NIST. (2014). Body Area Networks & Pervasive Health Monitoring
Fact Sheet. Retrieved from NIST Healthcare: http://www.nist.gov/
healthcare/emerging/ban.cfm. Accessed October 20, 2014. 24x7
Jeff Kabachinski is the director of technical development for Aramark
Healthcare Technologies in Charlotte, NC. For more information, contact
jbethune@allied360.com.
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November 2014
25
RSNA Preview
Whats Coming in Imaging Equipment
By Jenny Lower
he annual meeting of the

Radiological Society of North
America (RSNA) marks one
of the largest scientific gatherings in the world. With some 55,000
expected attendees, next months conference in Chicago will have another reason
to celebrate: its theme is A Century of
Transforming Medicine, recognizing the
many ways imaging technologies have
shaped our health system. For a sneak preview of which technologies vendors have
planned for display and the year ahead,
see below.
CR/DR
Canon USA Inc, Melville, NY, will

introduce the RadPro Delinia 200, a DR
retrofit solution that utilizes auto-detection software to acquire digital x-ray images using the x-ray source from an existing
fixed radiographic room or analog mobile
system. Designed to accommodate customers using CR, DR, or both, this turnkey solution offers improved image quality
and lower patient radiation dose. (South
Bldg, Hall A, Booths 1241 and 1241X)
26
November 2014
CT
Carestream Health, Rochester, NY,

will spotlight the two latest enhancements
to its imaging systems: a new feature for
its fully automated DRX-Evolution DR
room that allows operators to manually
move the overhead tube with assistance
from the systems motors to help reduce
technologist fatigue, and a ceiling-mounted tube option for its DRX-Ascend system
to provide versatile positioning for a variety of imaging exams. (South Bldg, Hall
A, Booth 4735)
Varian Medical Systems, Lincolnshire,

Ill, will exhibit its PaxScan 4336W wireless flat-panel detector, featuring sixthgeneration architecture incorporating
16-bit data acquisition. At 43 cm x 36
cm and 3.4 kg with battery, the 4336W
transmits image data across a wireless
link with transfer rates up to 170 Mbps,
for a preview time of as little as 2 seconds. (South Bldg, Hall A, Booths 4721
and 4721X)
GE Healthcare, Waukesha, Wis, will

display a number of CT scanners, including
the Revolution CT, introduced last year and
now FDA-cleared. Capable of performing
cardiac exams in a single heartbeat and whole
brain imaging in less than a second, the system is 50% quieter than previous-generation
CTs and comes equipped with ASiR-V, a
technology that reduces dose up to 82%
while maintaining consistent image quality. Also featuring ASiR-V, the Revolution
EVO includes a Clarity imaging system that
provides up to 100% better spatial resolution
over previous GE CT scanners. The system
enables advanced studies such as TAVI planning and high heart rate CCTA. (South
Bldg, Hall A, Booths 3539 and 4039)
Toshiba America Medical Systems,

Tustin, Calif, has made a number of software
and hardware enhancements (some pending
510(k) clearance) to its Aquilion CT scanners, as well as new dynamic clinical applications that take advantage of wide-detector
CT technology to improve a clinicians ability to accurately plan a patients treatment.
(North Bldg, Hall B, Booth 7333)
24x7mag.com
RSNA Preview
Ultrasound
Samsung Electronics America, Ridgefield

Park, NJ, will spotlight its RS80 ultrasound
system, offering a 23-inch LED-lit display,
a 13.3-inch tilting tablet touch screen, and
a six-way motorized adjustable console.
Hybrid beam-forming technology and nextgeneration SDMR and Single Crystal Probe
technology help deliver consistent image
clarity, while the S-Flow feature delivers
improved Doppler sensitivity and enhanced
color spatial resolution when documenting
small vessels. (North Bldg, Hall B, Booths
7360 and 8355)
Zonare, Mountain View, Calif, is exhibiting the companys new Z.One Pro ultrasound system, a cost-effective, durable unit
with a small system footprint and a wide
variety of transducers covering numerous
applications. The in-progress, intraoperative curved array C9-3sp transducer (pending regulatory approval) is the newest addition to the Zonare family of transducers,
offering multiple frequencies and highly
sensitive color and PW Doppler. Zonare
will also display a major upgrade to its
premium ZS3 system, available at no additional cost to current customers. (North
Bldg, Hall B, Booth 6729)
X-Ray
Toshiba America Medical Systems,

Tustin, Calif, is showing enhancements to its
Dose Tracking Systems (DTS) for the Infinix
family of cardiovascular x-ray systems. DTS
now offers expanded front and lateral biplane
coverage and the ability to track cradle movement. The T.RAD and Kalare x-ray systems
can also accommodate up to four registered
wireless flat-panel detectors (FPDs) at one
time for increased flexibility and reduced exam
times. Recently cleared by the FDA, the Kalare
FPD digital R&F system features a 17- x
17-inch FPD and reduces scatter radiation by
more than 95%. (North Bldg, Hall B, Booth
7333) 24x7
Jenny Lower is associate editor of 24x7 magazine.
Contact her at jlower@allied360.com.
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at 24x7mag.com/#1411rsna
SCAN ME!
Siemens Healthcare, Malvern, Pa, will

introduce the Acuson X600, a cost-effective
ultrasound system for general imaging and
OB/GYN. Ultrasensitive wideband transducers, including new lightweight 3D/4D
transducers for womens imaging, improve
image resolution and penetration. Advanced
workflow solutions include ergonomic
design, QuikStart rapid boot, wireless data
transfer, and tissue grayscale optimization.
(South Bldg, Hall A, Booth 1934)
24x7mag.com
Fujifilm Medical Systems USA,

Stamford, Conn, will debut a new x-ray
image-processing tool currently under FDA
review. Virtual Grid intelligently adapts
contrast to improve image quality for exams
that are taken without a grid, reducing degradation of image quality caused by scatter
radiation. The feature can improve mobile
imaging where a grid may not be available,
and eliminates artifacts due to misalignment. (South Bldg, Hall A, Booth 2511)
Scan the QR code above

with your smartphone to
connect to our
Online Buyers Guide.
November 2014
27
CCE Prep
Revised Joint Commission Standards for
Medical Equipment | By Arif Subhan, MS, CCE, FACCE
n March 31, 2014, the Joint

Commission added a new element of performance (EP 24) to
the primary medical equipment
standard EC.02.04.03 for deemed status
hospitals. This requirement was intended
to go into effect on July 1, 2014.1 This
additional requirement was in response to
the Centers for Medicare and
Medicaid Services (CMS) memo
dated December 20, 2013 (S&C
14-07-Hospitals), which had
relaxed some of the restrictive policies on preventive maintenance
of medical equipment.2-4 The
term deemed status is described in
a previous CCE prep article.4
Arif Subhan
According to the Joint
Commission, however, the CMS
was of the opinion that this additional EP
did not bring the Joint Commission standards in line with the CMS requirements for
deemed status hospitals. Consequently, the
Joint Commission has expanded and added
EPs in the two main Joint Commission standards EC.02.04.01 and EC.02.04.03. The
previously approved EC.02.04.03, EP 24, has
been removed. These updated requirements
went into effect on July 2, 2014.5
EC.02.04.01 EP 1
This EP is unchanged. It requires the hospital
to seek input from individuals who operate
equipment (clinicians and nurses) and those
who service equipment (biomedical/clinical
engineering) when the hospital chooses and
purchases medical equipment.6
EC.02.04.01 EP 2
This EP was changed. It formerly required the
hospital to maintain either a written inventory of all medical equipment or a written
inventory of selected equipment which would
be classified by physical risk associated with
its use and equipment incident history. This
requirement was retained for the hospitals that
do not use Joint Commission accreditation for
deemed status purposes.
However, deemed status hospitals must
now include all medical equipment in their
inventory. This new rule will require these
hospitals to reassess their current medical
equipment inventory based on the defini-
28
November 2014
tions of the term medical equipment, which

can be found in the glossary of the Joint
Commission standards.5,6 (See box for a
summary of the definitions.)
EC.02.04.01 EP 3
This is a new EP. It requires the hospital
to identify high-risk medical equipment
in the inventory. This category
of equipment includes items for
which there is a risk of serious injury or death to a patient
or staff if the equipment fails.
The high-risk medical equipment
encompasses life-support equipment, including items such as
a robotic surgical system. The
term high-risk is new to Joint
Commission medical equipment
standards and is considered comparable to
the CMS term critical equipment. The term
high-risk is defined in the glossary of the
Joint Commission standards.5,6
EC.02.04.01 EP 4
This new, revised EP combines the concepts
of maintenance activities and frequencies of
the earlier EP 3 and EP 4. It now requires the
hospital to identify the activities and associated frequencies, in writing, for maintaining,
inspecting, and testing all medical equipment in the inventory.
In order to determine the frequencies of
maintenance and testing, hospitals must
follow manufacturers recommendations or
develop strategies of an alternative equipment maintenance (AEM) program. This
AEM program must not reduce the safety of
equipment, and must be based on accepted
standards of practice. For medical equipment, suggested accepted standards are the
American National Standards Institute/
Association for the Advancement of Medical
Instrumentation handbook, ANSI/AAMI
EQ56: 2013, Recommended Practice for a
Medical Equipment Management Program.5,6
EC.02.04.01, EP 5
This is a new EP for deemed status hospitals. It requires the hospital to use manufacturers recommendations for maintenance
activities and frequencies for the following
types of equipment:
KEY JOINT COMMISSION

DEFINITIONS
Medical equipment: Fixed and portable
equipment used for the diagnosis,
treatment, monitoring, and direct care
of individuals.
High-risk equipment: Any device or
components of building utility systems
for which there is a risk of serious
injury or death to a patient or staff
member if the device or component
fails. High-risk equipment includes
life-support equipment.
Medical laser devices;

Imaging and radiologic equipment
(whether used for diagnostic or therapeutic purposes);
Medical equipment that is subject to federal or state law or Medicare Conditions
of Participation. It should be tested and
maintained according to manufacturers
recommendations or by following an
approach that establishes more stringent
maintenance requirements;
New medical equipment that usually does
not have adequate maintenance history to
support the use of AEM strategies. The
maintenance history must include records
provided by the hospitals contractors,
information made public by nationally
recognized sources, and records of the hospitals experience over time.5,6
The next CCE Prep column will discuss
other changes to the Joint Commission
medical equipment standards. 24x7
Arif Subhan, MS, CCE, FACCE, is the chief
biomedical engineer at VA Greater Los Angeles
Healthcare System and a member of 24x7s editorial advisory board. The suggestions and views
expressed in this article are of the author. They
do not represent the views of the Department of
Veterans Affairs. For more information, contact
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at 24x7mag.com/#1411cce
24x7mag.com
1.800.456.6695
www.rudolphkc.com
Lung Simulators
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November 2014
29
Tools of the Trade

Simulation Finger
The PULS-R universal SpO2 simulation finger from Rigel Medical, Tampa,
Fla, can produce accurate SpO2 simulations in 1% resolution from as low as
30% using the preprogrammed, manufacturer-specific R-curves. A configuration tool enables the device to meet customer-specific R-curves, improving
the detection of degrading and inaccurate SpO2 probes and reducing incidences of failure. According to the company, when combined with its handheld
UNISIM simulator, the PULS-R provides the worlds smallest, all-in-one vital
signs solution. The UNISIM simulator is capable of undertaking NIBP, SpO2,
ECG, temperature, IBP, and respiration functionality tests simultaneously,
providing improved and customized vital signs simulation and measurement.
Direct, automatic data recording and storage also reduce administrative time.
(813) 886-2775; www.rigelmedical.com
Surgical Monitor
The latest offering from Sony Electronics Medical Systems, Park Ridge, NJ, is a 27-inch, highresolution surgical monitor available in either a digital/analog (LMD-2765MD) or digital-only
(LMD-2760MD) version. Ideal for use in a range of environmentsincluding operating rooms,
medical centers, clinics, and doctors officesthe monitor fits in the same chassis footprint as
most 26-inch models, so facilities can use existing current carts or boom arms. The design also
allows for use in either a cart system or ceiling-mounted configuration. The monitor displays full
HD (1920 x 1080) images from surgical endoscopic or laparoscopic camera systems and other
compatible medical imaging systems. According to Sony, it features the brightest panel in use on
a surgical monitor, with a brightness of 1000 cd/m2 (maximum brightness of 800 cd/m2 at D65
adjustment). (201) 358-4305; pro.sony.com
Portable Ultrasound Device

The Sonon from Healcerion, South Korea, is an iOS- and Android-compatible ultrasound
device that enables healthcare providers to perform ultrasounds anywhere with the product
and mobile devices they already use. The wireless, pocket-sized device is highly portable
and flexible, requiring only an existing smartphone or tablet to conduct scans. The Sonon
mobile application allows providers to scan patients in remote field locations and then
transmit images and recordings securely via Wi-Fi, 3G, or LTE networks throughout
the world for analysis, diagnosis, and storage. Suitable for applications in a variety of
medical fields, including radiology, obstetrics and gynecology, cardiology, otolaryngology,
enterology, and pulmonology, the device has already received CE certification in Europe.
Healcerion expects to receive FDA and other regional certifications in early 2015 prior to
a global product launch. +82 70 7582 6326; www.healcerion.com
Wireless 2D Barcode Scanner

Denso ADC, Long Beach, Calif, has introduced the SE1-QB Bluetooth wireless 2D barcode
scanner, a pocket-sized device designed to interface with a scanner and host smartphone or tablet
in a mobile data-capture system. Measuring 3.9 inches long, 1.6 inches wide, and 1.1 inches
thick, and weighing 2.1 ounces, the SE1-QB reads 2D or 1D barcodes displayed on LCD screens
of mobile devices or printed on paper. Two AA batteries provide up to 50 hours of operating
time. A one-touch feature enables display of a virtual keyboard on iOS devices. (888) 693-3676;
www.denso-adc.com
30
November 2014
24x7mag.com
24x7mag.com
November 2014
31
Focus On
KLAS: Watchdog for the Healthcare Industry
By Phyllis Hanlon
omeowners seeking a new refrigerator might check out the ratings

on popular models at Consumer
Reports, trusting the extensive testing the magazine performs on every product,
before making a purchase. On the other hand,
a buyer in the market for a new
motor vehicle might scan the J.D.
Power rankings, which hold significant sway in not only the automotive industry, but in several others
as well. When Kent Gale, founder
of KLAS, noticed a lack of similar
options for medical device purchasers, he decided to do something
Kent Gale
about it.
In 1996, Gale was working in Tucson,
Ariz, for Sunquest Information Systems, a
lab information system that obtains readings
from chemistry and hematology equipment
and sends results to the doctors offices. The
company had filed an initial public offering
and began conversations about how to be
more financially strong, basically considering a support reduction. That triggered a
thought, he says. Wouldnt it be interesting to measure vendors on how well they are
keeping their commitments?
With that idea in mind, Gale left Sunquest
in July 1996 and spent the next few months
creating a 130-question questionnaire, which
he brought to the HIMSS conference in 1997.
Each question sought performance information from providers on the products they were
using. It took one-and-a-half to 2 years to get
enough information to compare major players, Gale says. Within 3 years he realized a cash
stream, and KLAS was off and running.
Digging for Data
After 25 years in the business, Gale had built
an extensive network, so reaching out to
healthcare executives for opinions was not
insurmountable. Realizing that networking
is key to assembling a critical mass of useful
information, KLAS continued to build those
alliances. It now has a strong partnership
with almost every hospital in the country.
The combined feedback from these entities
provides a wealth of data that is disseminated
to providers to help them make informed
decisions regarding equipment purchase.
Our key passion is to find hard-to-get
data and tell the provider things they dont
32
November 2014
already know. We dont waste energy on public knowledge, Gale says, emphasizing that all
data is confirmed and validated.
In the early 2000s, KLAS began measuring performance on more expensive devices,
such as magnetic resonance imaging, computed tomography, and ultrasound
machines. We measure the data
to determine the real versus magical promises. Ads might be deceptive. KLAS investigates to see if
the vendor has data to back up its
claims, Gale says. For example,
KLAS worked with a large organization that wanted to buy an EMR
system. This was a $250 million
decision, he reports. Another group faced a
$750 million decision. Smaller organizations
sometimes buy clinical decision support software that costs half a million dollars.
Providers usually come to KLAS with a
request to evaluate a particular company, but
sometimes KLAS assesses companies on its
own initiative. Referrals are easy to come by,
and conference attendee lists offer a rich source
of clients to measure vendor performance.
We get pressure every day to rate companies,
but we dont have enough bandwidth to
do them all, Gale says. You have to have
more energy beyond just one vendor request.
Sometimes we get fascinating requests. And
some vendors dont want to be measured, but
its not up to them.
Transparency Is Key
KLAS staffers take between 2 and 6 months
to collect and report the data. Our focused
mission is that everything we do benefits the
provider. Throughout the last 15 years, the
providers have been loyal in providing data,
Gale says.
KLAS advisory board, which comprises 12
providers, along with a special advisory board
for medical imaging equipment and an international advisory board, helps decide who will
be evaluated. The boards also ensure that data
remain accurate, honest, and transparent. Gale
emphasizes that transparency is a key principle
for KLAS. If a vendor can buy a higher rating,
then none of the data is valid, he asserts.
Since its inception, KLAS has evaluated
a number of major vendors, including GE,
Siemens, McKesson, Cerner, Epic, Fuji,
Toshiba, and others. We look at companies
with a wide swath across the world, for sure

including companies that have a bigger footprint, Gale says. When it comes to fringe
players, we have to decide who well measure.
KLAS conducts approximately 2,000 interviews a month, 90% of those by phone from
its Orem, Utah, headquarters, although staff
sometimes make on-site visits to major healthcare providers.
The data collected by KLAS is available to
participating providers at no charge. If they
choose to pay a fee, KLAS takes on the role of
a concierge, and will schedule conference calls
to discuss specific questions with the provider.
Eighty percent of funding for the company comes from vendors and investment
and consulting firms, according to Gale.
Moreover, 90% of the vendors they rate
buy some access to the data. Vendors have
become interested intimately in the scores,
he says. Our model is unique in that the
customers are providers and they dont have
to pay for the data. Our energy goes into
what the provider needs.
Software Under the Microscope
In addition to measuring medical device performance, KLAS has also been monitoring
software for the past 17 years across a number of acute and ambulatory care organizations. The types of software covered range
from business intelligence, cardiology, lab
information systems, and labor and delivery
software to oncology, PACS systems, emergency department, EMR, practice management, and pharmacy. The software questionnaire poses 25 questions. The data collected
offer healthcare providers information on
sales and contracting, implementation and
training, functionality and upgrades, service
and support, and general issues.
In 2004, KLAS began measuring performance of professional service firms. The
company rates 15 criteria and uses a scale
of 1 to 9 (1 = extremely dissatisfied and 9
= extremely satisfied) and yes and no,
when appropriate. KLAS added imaging and
medical equipment to the list in 2005, and
asks questions related to operation of medication dispensing equipment, functionality,
and satisfaction with product uptime and
availability of parts. Equipment evaluated
includes radiation therapy, CR/DR/CT,
ultrasound, and MR scanners.
24x7mag.com
Focus On
Reviews Matter
KLAS data has been known to bolster a
companys reputation and, in other cases,
to inspire behavior change when a vendor
receives a negative review. Weve seen a
major shift. Some vendors proactively want
to do better. Some feel the pain of publicly being measured, Gale says. When a
vendor sees KLAS data will make a difference, they have no problem coming to us
to talk. But we have to be incredibly careful
to get accurate data. We have to be transparent. Confidentiality protects providers who
request information on vendors, Gale adds.
Gale cites a classic case of improvement
following a low rating. In 1998, McKesson
bought HBOC, a company that produces
Paragon Community Hospital Information
Systems. However, McKesson soon found
that the companys key product was not
performing up to par. The new president at
the HBOC division of McKesson decided
to pull the product off the shelf. They
stopped delivering the product and made
some changes, Gale says. Within 3 years,
this became a top-rated product.
One of the latest metrics KLAS began to
measure is infrastructure, a difficult concept

to define. According to Gale, infrastructure
comprises unique elements, such as security,
engineering, data interface, service, and support. KLAS attempts to bring all the pieces in
the puzzle together. We started this measure 3
years ago and it has plateaued, but it is core to
an organizations operation, he says, pointing
to the recent data breach of millions of customer records from one health system. This
is an example of infrastructure.
On-the-Spot Reviews
Most recently, KLAS released myKLAS, an
app which allows the user to see vendor performance from a mobile device. So far, this app
has gotten a huge response, Gale says. You
have instant access to a vendors performance.
For example, if physicists, directors, and physicians are trying to make a decision on equipment for oncology treatment and are talking
to the COO, they can look up performance
measures on the spot that indicate whether a
vendor company delivers on its promises or
not. Alternately, you could be talking to the
vendors and want to find out if what theyre
saying about their product is accurate. Its
Better medicine.
Better technology.
Better careers:
BJC HealthCare.
right there at your fingertips. The app is a great

catalyst for vendor confirmation and opens the
door to see more, Gale asserts.
When he first started the company,
Gale misjudged the importance of the job
he was undertaking. I thought thered be
10 to 15 of us in a room measuring 50 areas.
Now, we have more than 100 employees who
spend the majority of their time working with
providers and documenting information, he
notes. It turned out to be much more, including measuring payroll, billing, clinical decision
support, analytical pathways, blood bank, electrophysiology, echocardiography, catheterization, radiology, and imaging systems. Provider
appetite exploded.
And as long as providers are hungry, KLAS
will continue to feed them. 24x7
Phyllis Hanlon is a contributor to 24x7. For
more information, contact editorial director John
Bethune at jbethune@allied360.com.
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November 2014
33
Industry Insider
Andrew Hicks, Coalfire
By Jenny Lower
igh-profile data breaches have

lately affected consumer and
financial entities from Target
and Home Depot to JPMorgan
Chase, but they havent occurred at quite the
same level for healthcare organizationsyet.
Coalfire, an independent IT audit firm
with offices throughout the United States,
specializes in HIPAA compliance and data
security for its healthcare clients. We spoke
with Andrew Hicks, practice director for
Coalfires healthcare division, who says that
when it comes to HIPAA compliance, a
checklist mentality only takes facilities partway. He offered some advice on spotting
security blind spots, the differences between
a gap assessment and a risk analysis, and
how small organizations can get started
locking down their sensitive data.
24x7: How did you get involved with IT

compliance?
Hicks: Ive been doing this almost 15 years
now. I kind of stumbled into IT security
and compliance when I came out of college.
I knew I wanted to do something in information technology; I just didnt know what.
Ive done IT audit, and that rolled over into
more of an IT security-focused role, and
that got defined into healthcare. Coalfire
is IT security compliance. Theyre all very
much interrelated.
24x7: What is Coalfires emphasis?
Hicks: Coalfire has been around for about
13 years. We started with doing PCI compliancethats compliance for the processing of
credit card numbers and how those numbers
are secured. From there we merged into healthcare, which is the area where Im the practice
director. Im responsible for making sure that
our offices are all standardized regarding our
methodology and that we all achieve a holistic, comprehensive assessment that ties back
to what the industry requirements are at any
given point. The biggest differentiator between
us and other companies is that we dont sell
anything outside of services. We come in and
do advisory and consulting, but well never sell
a company anything over and above advice.
We would never come in and say, You need
to implement a data loss prevention solution
and by the way, we can sell you that.
34
November 2014
24x7: What exactly do the HIPAA compliance requirements stipulate?

Hicks: This goes back to 1996, when the
original Health Insurance Portability and
Accountability Act came out. There were
two partsthe Privacy Rule in 1996 and the
Security Rule in 2003. We dont do a whole
lot of Privacy Rule assessments. Were more
on the security side, which tends to be more
electronic and technology-based. Since then,
weve seen HITECH (the Health Information
Technology for Economic and Clinical Health
Act). That was in 2009. It broadened the scope
of how we do our assessments. The Omnibus
Rule came out in 2013. Its those three major
regulations that we are trying to conform our
regulations to. So when a company says, We
want to be HIPAA-compliant, that means
the Security Rule, Privacy Rule, HITECH,
Omnibusall of those different things.
24x7: For the security rule, what is required
of organizations from a compliance
standpoint?
Hicks: At a high level, there are required
administrative safeguards. Those would be
policies and procedures, business process
controls. There are physical safeguards, making sure that only authorized people have
access into facilities that contain patient
informationso things like keycards and
badges. There are technical safeguards. Those
are things like integrity controls, audit controls, logging and monitoring, encryption.
On top of that, there are organizational
requirements around making sure that you
have business associate agreements in place
with your downstream vendors, if you have
those relationships. A business associate
agreement is a contract with the vendor
that says, As the business associate, I agree
that I am HIPAA-compliant and I meet all
the requirements.
In todays environment, we try to have our
covered entities customize those agreements so
they include right-to-audit clauses, so they can
go in periodically and make sure the downstream vendor is actually satisfying their obligation to be compliant. Some facilities think
that if they hire a third party through their data
center, that gets them off the hook for compliance and theyre more or less outsourcing risk.
In some ways that is true, but youve got to do
Andrew Hicks
your due diligence on your own side to make

sure they really are protecting it.
The last one is documentation requirementspolicies and procedures for how long
you retain your policies and how you make
your policies available.
24x7: Does purchasing an EMR automatically make a hospital HIPAA-compliant?
Hicks: Epic, Cerner, McKessonall these
companies that develop these EMR/EHR
technologiesare adapting to what IT security means and implementing the right controls into their software. Were seeing that, and
thats good.
But because a hospital goes out and buys
one of these EMR applications, that doesnt
mean that they are automatically compliant by
any stretch of the imagination. Sure, they can
leverage what controls are in place in the technology, but part of what theyre on the hook
for is understanding where all their electronic
protected health information is throughout
the entire company.
So its not just the EMR system, because
those systems could have integrations to other
systems, other databases, and applications.
They may push data out of the corporate
network. You have to understand the business
process and how they interact with data. Its
way more holistic than just a piece of software.
24x7: Do you have any sense of how many
companies understand that?
Hicks: Most of those companies tend to be on
the business associate side. These are smaller
companies that have been pulled into HIPAA
24x7mag.com
Industry Insider
just because of the kind of data they have, like
billing companies or cloud service providers.
Theyre not set up to be HIPAA-compliant;
theyre just getting dragged into it by their
covered entities. They dont know what the
regulations are.
24x7: Any there any other common
misperceptions?
Hicks: That HIPAA is once and done. A lot
of companies think that once theyve written
their policies or done a HIPAA gap assessment, theyre done. Same with the compliance
assessment. We constantly tell our customers,
Do assessments on an annual basis. That way
youre covered, you know the vulnerabilities to
your environment. OCR (the Office for Civil
Rights) doesnt actually require an annual
assessment, but just knowing the speed of the
industry, an annual assessment is certainly a
worthwhile activity.
The other time for an assessment is with any
big changes to the environment. Companies
that go through the merger and acquisition process, for example, should do one at
that point. Youre integrating systems and
integrating people, and there could be major
vulnerabilities that slip through the cracks that

wouldnt go noticed until you do your annual
assessment later in the year.
When we do our assessments, were primarily focused on the IT group, but we also include
control owners from HR, legal, and the various
business functions that utilize ePHI. IT will
say, We have these five IT applications and
these 10 databases. But when we actually go
on-site and start talking with the business, the
business knows a lot of information IT doesnt
know. They may say, Just so you know, we
get direct feeds from our production SQL
database that we pull over into our Access database. So now IT has no visibility into that.
IT doesnt know everything about the flows
of data. Its really important to keep others
integrated into that process as well.
24x7: How is security in the healthcare
sector different from other areas?
Hicks: Theres this conflict of being able
to provide patient care in a timely manner
without hindering security. We fight that
fight a lotwhat is the right amount of
control over data that doesnt prohibit a
doctor from performing patient care?
24x7: Are there any upcoming regulation

changes we should be aware of?
Hicks: Were seeing a transition to a new
director for the OCR. Leon Rodriguez
moved over to a new role, Susan McAndrew
retired, and now Jocelyn Samuels is the new
director. Its going to be really interesting
to see what she does now. We all know
the HIPAA requirements are so broad and
vague and outdated, really. Were hoping to
see something come out that trumps what
we have today, a much more authoritative
requirement. Were seeing continued penalties and enforcement for noncompliance,
but unless you tell someone what you want
and youre very specific about it, youre not
going to get the results you want.
I preach this all the time: Dont strive for
compliance, strive for security. 24x7
Jenny Lower is associate editor of 24x7 magazine.
Contact her at jlower@allied360.com.
READ IT ON
THE WEB
Read the full interview online at

24x7mag.com/#1411ii
THEY
COPIED
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COPY MY MIND,
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November 2014
35
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November 2014
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37
Soapbox
Details Matter Now More Than Ever
By Tim Hoof, CBET
hen I began my career as

a BMET in 1985, it was
impressed upon me how
important details were.
We BMETs were sometimes referred to as
tweakers. Pocket protectors were often a
dead giveaway to our job title,
and many of those pocket protectors carried a small screwdriver.
Calibration of the medical
equipment of that era was often
accomplished by slight adjustment to small potentiometers.
ECG maintenance included
stylus pressure and temperature
Tim Hoof
checks. If they used ink, like
the old Marquette units, then we checked
ink reservoir levels and even lapped pen
tips. Frequency response and dampening
measurements, as well as paper chart speed
verification, often revealed adjustments
were necessary.
Conductive flooring and line isolation
monitoring systems were starting to be
phased out of the surgical suites but were
still fairly common. Some of the equipment
was old, and individual units were like old
friends. We knew what to expect before we
even checked the calibration. When a service
manual was required, it was always a printed
copy, not something you could view on a
computer screen and certainly not something you received in an email. Tech support
was found at the end of a wire coming out of
the wall, mobile phones were not common,
laptops didnt exist, and portable computers
were the size of todays desktop, sporting a
9-inch or so, monochrome CRT as a display.
Not only were the details of fine tuning
and adjustment for calibration critical, but
so were communication skills and documentation. This was my first experience in
the biomedical electronics field. Western
Wisconsin Technical College did not spend
as much time teaching people skills as it
did electronic theory and troubleshooting.
When a service call came in from a hospital many miles away, I was on my way to
fix the problem. Some of those problems
could have been solved with a few simple
questions over the phone. So in some ways,
I had to learn on the go how to deal with
users in order to make a complete repair of
the whole system.
38
November 2014
The Digital Era

Today, details are even more important than
ever. Communication and documentation
have never been more critical. The job of the
BMET is still the same in many ways, but
the forms have changed. Electronic communication has taken the place,
in many instances, of verbal communication and handwritten or
printed copy. The situation has
improved tremendously, thanks
to voicemail, email, text messages, pdf files, DVDs, and faxes.
Still, the customers we serve
are no less human. With increasing responsibilities, they are
oftentimes preoccupied with the tasks at
hand. This makes communication more
challenging and critical.
The way we maintain equipment has
changed dramatically as well. Calibration is
more often accomplished by software settings,
revisions, and component replacement than
with the twist of a screwdriver. Discreet component replacement is nearly a lost art, and
the board swap is the norm rather than the
last resort. Many more manufacturers simply
request the unit be shipped to the factory for
repair these days.
This changes the service reporting somewhat. Now we have to track RMA numbers, software versions, and rev levels of the
replacement boards. User training, failure
rates, user errors, and voluntary and involuntary Medwatch reports submitted to the FDA
are types of data we keep. The maintenance
record itself has evolved from hard copy to
computerized maintenance management systems, capable of recalling details in seconds
with a simple query. Manufacturers are held
to a much higher level of tracking and control today as well. The Safe Medical Devices
Act, Current Good Manufacturing Practices
requirements, and the Quality Systems regulation have all had a profound impact on
todays medical device manufacturing.
Asset Management
An important component of equipment management, particularly for an in-house program,
is asset management. Equipment support by
the manufacturer and the direction of the
industry are significant factors in equipment
evaluation and selection.
These are tough times, and nobody gave us

a crystal ball. Still, we are expected to make
sound decisions. Questions we must ask may
include the following:
Will this technology interface with systems
we already use?
How long will there be support for these
devices?
What technology will be required in the
future?
Can it be serviced and maintained in-house?
What is the cost of ownership?
Again, details are critical. Being an effective
BMET today is challenging, sometimes frustrating, and yet very rewarding. Supporting one
of the biggest industries in the national spotlight today, and helping to control the cost of
healthcare while bringing the newest technologies on board, keeps us enthusiastic. We need
to stay abreast of the developing technologies.
Teamwork
The way we contribute to the organization
involves much more than just repair and
maintenance. Sometimes we are relied upon
for input, too. Our perspective is valuable.
Knowing where to find information is as
important as what we know. We can research
the details that are essential to good decisions
for the overall health of our organization.
I recently read a book about Steve Jobs. He
was a brilliant man, but many of his innovations were not his but were the result of his
engineers. He recognized great ideas. He was
able to take multiple ideas and combine them
into a product, and ultimately a corporation.
It takes a team, and each member of that team
has something to offer.
Where will we be in the next 30 years? No
one can say. But we know this: There is exciting change to come, and BMETs will be at
the forefront with the needed details. 24x7
Tim Hoof, CBET, is biomedical equipment support
specialist for the USPHS Indian Health Service in
Browning, Montana. Comment on this
article at 24x7mag.com/#1411sb.
Whats on Your Mind?

Got a gripe? A recommendation? Does
someone or something deserve praise? Share your opinions
and insights with your peers. Soapbox columns should
be 850 to 900 words in length and can be e-mailed to
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