TechNation - January 2018 by MD Publishing

Vol. 9

ADVANCING THE BIOMEDICAL / HTM PROFESSIONAL

JANUARY 2018

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CONTENTS

FEATURED

48 54 48

HE ROUNDTABLE: T PATIENT MONITORS We reached out to experts throughout the HTM community and asked them for the latest information on patient monitors, including new features, cybersecurity issues and more.

Next month’s Roundtable article: Ultrasound Probes

FDA UPDATE – COMPETING PARTIES; STAGNANT LEGISLATION TechNation looks at the various reports, comments, suggestions and the latest from the FDA regarding the refurbishing, reconditioning, rebuilding, remarketing, remanufacturing and servicing of medical devices by HTM professionals at hospital, ISOs and OEMs.

Next month’s Feature article: Mergers and Acquisitions Generate HTM Challenges

TechNation (Vol. 9, Issue #1) January 2018 is published monthly by MD Publishing, 18 Eastbrook Bend, Peachtree City, GA 30269-1530. POSTMASTER: Send address changes to TechNation at 18 Eastbrook Bend, Peachtree City, GA 30269-1530. TechNation magazine is dedicated to providing medical equipment service professionals with comprehensive, reliable, information concerning medical equipment, parts, service and supplies. It is published monthly by MD Publishing, Inc. Subscriptions are available free of charge to qualified individuals within the United States. Publisher reserves the right to determine qualification for a free subscriptions. Every precaution is taken to ensure accuracy of content; however, the information, opinions, and statements expressed in the articles and advertisements herein are those of the writer and/or advertiser, and not necessarily those of the publisher.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

JANUARY 2018 JANUARY 2018

TECHNATION TECHNATION

9 9

CONTENTS

INSIDE

PUBLISHER

John M. Krieg

VICE PRESIDENT

Kristin Leavoy

ACCOUNT EXECUTIVES

Jayme McKelvey Lisa Gosser

ART DEPARTMENT

Jonathan Riley Karlee Gower

EDITOR

John Wallace

EDITORIAL CONTRIBUTORS

Roger Bowles K. Richard Douglas John Noblitt Todd Rogers Manny Roman David Scott Cindy Stephens Steven Yelton Alan Moretti Jeff Kabachinski

DIGITAL SERVICES

Cindy Galindo Jena Mattison Travis Saylor Kathryn Keur

ACCOUNTING

Kim Callahan

CIRCULATION

Lisa Cover Melissa Brand

WEBINARS

Linda Hasluem

EDITORIAL BOARD

Eddie Acosta, Business Development Manager, Colin Construction Company Manny Roman, Business Operation Manager, AMSP Robert Preston, CBET, A+, 2014 Salim Kai, MSPSL, CBET, Clinical Safety Engineer University of Michigan Health System James R. Fedele, Director, Biomedical Engineering Izabella Gieras, MS, MBA, CCE, Director of Clinical Technology, Huntington Memorial Hospital Inhel Rekik, Biomedical Engineer, MS, Clinical Engineer

MD Publishing / TechNation Magazine 18 Eastbrook Bend, Peachtree City, GA 30269 800.906.3373 â&#x20AC;¢ Fax: 770.632.9090 Email: info@mdpublishing.com www.mdpublishing.com

TECHNATION JANUARY 2018 10 TECHNATION JANUARY 2018

Proud supporters of

Departments P.12 SPOTLIGHT p.12 Professional of the Month: Bret A Grimm, BMET II p.16 Department Profile: Dartmouth-Hitchcock Clinical Engineering Department p.18 Company Showcase: BETA Biomed Services Inc. p.22 Biomed Adventures: From India to West Africa P.26 INDUSTRY UPDATES p.26 News and Notes: Updates from the HTM Industry p.32 AAMI Update p.34 ECRI Institute Update P.39 p.39 p.41 p.43 p.44

THE BENCH Shop Talk Tools of the Trade Biomed 101 Webinar Wednesday

P.62 p.62 p.64 p.66 p.69 p.72 p.75 p.77

EXPERT ADVICE Career Center Ultrasound Expert The Future Tech Tips Cybersecurity Expert The Other Side Roman Review

P.78 BREAKROOM p.78 Did You Know? p.79 The Vault p.81 Scrapbook Northwest HTM Mixer p.82 MedWrench Bulletin Board p.84 Service Index p.89 Alphabetical Index p.90 Parting Shot Like us on Facebook www.facebook.com/TechNationMag Follow us on Twitter twitter.com/TechNationMag WWW.1TECHNATION.COM WWW.1TECHNATION.COM

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SPOTLIGHT

PROFESSIONAL OF THE MONTH Bret A. Grimm, BMET II Knowing First Hand BY K. RICHARD DOUGLAS

ollege Station, Texas is a city of over 107,000 northwest of Houston. It has been ranked as one of the nation’s top places to live.

The city is also the location of the Baylor Scott and White Medical Center, a five-story, 143-bed hospital and level III trauma center. One of the members of the medical center’s healthcare technology management department staff is Bret A. Grimm, BMET II. Grimm saw that biomed was a stable profession and decided that was the route he would go. “Knowing that I can help and have an impact on others in their time of need is what got me into biomed. Also knowing that the job will be around as long as people will be sick,” he says. “I went from high school directly to Texas State Technical College and graduated in 2006 with dual degrees; associate in applied science for biomedical technology and medical imaging specialization.” Grimm plans to earn a bachelor’s degree, but says he hasn’t made that leap yet. He did his internship at Memorial Herman Hospital in Houston. “After my internship at Memorial Herman, I started work at Reynolds and Reynolds until I could find a position at Fresenius Medical Center. I started at Fresenius Medical Center at the Southeast Kidney Center. I started working there in 2006 and left in

TECHNATION

JANUARY 2018

2008 to join Aramark at the University of Texas Medical Branch, where I became a biomed tech 2/lab technician,” Grimm says. “I enjoyed my time there, but had a great opportunity to join Baylor Scott and White, that was just an hour away from family, so I had to jump at it and

they play in keeping medical equipment running and calibrated, Grimm’s appreciation of that equipment goes further. “Over the last two years, it has been a challenge to balance my work/ personal life,” he says. “We learned mid-pregnancy, with our youngest, that he would be born with medical issues We started at Baylor Scott and White Health in College Station then moved to Baylor Scott and White Health in Temple for a higher

“ Knowing that I can help and have an impact on others in their time of need is what got me into biomed. Also knowing that the job will be around as long as people will be sick.” – Bret A. Grimm, BMET II joined them, helping to open a new hospital in College Station in July of 2013. I am currently still at Baylor Scott and White Health College Station Hospital as a biomed tech 2,” Grimm adds. Grimm’s areas of specialty are patient monitoring and temperature monitoring. UNDERSTANDING MEDICAL EQUIPMENT’S ROLE While most biomeds have a clear understanding of the important role

level of care; then finally were sent to Texas Children’s Hospital in Houston, Texas,” he says. “We knew, when he was born, that he would have to have heart surgery within the first few days. He had an aortic arch advancement at 10-days old. We would soon learn that he had a rare genetic disorder Trisomy 9 Mosaic. And, at a month and half, he had a G-tube surgery so we could finally get him home at one day shy of two-months old,” Grimm says. “Through the whole time my wife

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SPOTLIGHT

FAVORITE MOVIE “I Robot” FAVORITE FOOD BBQ ribeye with fully loaded baked potato FAVORITE PART OF BEING A BIOMED “In the short time I have been in the field, I’ve seen how it has changed; more and more of it being networked and the changing environment of not only the biomed world but the whole hospital. Also every day presents a new challenge and you don’t know what you will be doing that day.” WHAT’S ON MY DESK? Laptop, multi-bit screwdriver, a large cup of water, photo of family and a radio.

stayed at the hospital with the little one, and after two weeks of him being born, me and the oldest son traveled back every Thursday night and returned home every Sunday to keep some normal life for the oldest.” Grimm says that work was amazing, working with him through the whole situation. “Everyone stepped up to help, but since we are only a two-person shop at this hospital, my coworker covered on call for me for over three months,” he says. “I have always worked on the equipment from the point of ‘if my family needs it’ then it should be in the best possible working condition, but seeing the

same type of equipment that I work on is what is responsible for keeping my son alive, was an odd feeling.” READY TO ASSIST Grimm has learned the realities of working in a hospital during a hurricane, as well as the challenge of a power outage. “[I] started at UTMB about two weeks before Hurricane Ike hit them. It was different seeing a hospital of that size evacuating. We did everything and anything our department could do to help the staff; even get and hold an elevator so that critical patients could make it from the ICU to an helicopter waiting for them just a little faster,” Grimm says.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

“Around a year after the hurricane, I was called in late at night to help Angel, our on-call tech, when he was on-call. When I arrived it was just me and him in the biomed department and we had the building that had the NICU in it lose all power, emergency and normal, with it not expected to return in a soon enough time, so we helped the nursing staff move the NICU to an area that they had arranged after the power went out,” Grimm adds. “We would unmount monitors from the old area and would set up a new area for a baby in the new building. After about four hours of this, we had all the babies moved over safely.” The patients at Baylor Scott and White Medical Center in College Station can know with certainty that there is a biomed there, working on equipment, who has a unique appreciation for the importance of those devices.

JANUARY 2018

TECHNATION

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SPOTLIGHT

DEPARTMENT OF THE MONTH

The Dartmouth-Hitchcock Clinical Engineering Department BY K. RICHARD DOUGLAS contract is either removed or modified and maintenance of that device or devices becomes maintained by the clinical engineering department,” Kocurek says. “Our clinical engineering department monitors the quality of service provided with each repair and tracks vendor service, ensuring proper documentation and compliance with For those who call the city home, they Because of the vast area covered by our standards. Additionally, the can find medical care at the Dartthe team, getting together periodically department has developed an excellent mouth-Hitchcock Medical Center helps with information exchange. relationship with our supply chain (DHMC). The medical center is part of “Because our technicians are department, which has resulted in a Dartmouth-Hitchcock, which is a constantly in the field servicing hospitals procurement model that allows the not-for-profit academic health system throughout New Hampshire and clinical engineering team to weigh in on that serves a population of 1.9 million in Vermont, we hold a biweekly team all purchases regarding maintenance of New England. meeting to share insights, news, and make a device or modality,” he adds. The clinical engineering team that sure communication is fluid throughout keeps the equipment working for the the department,” Kocurek says. SAVING LIVES AND WIRELESS TESTING benefit of all of those New Englanders is Along with its efforts to take a strategic The CE team has worked hard on the Dartmouth-Hitchcock Clinical approach to sharing information, the team certification, innovation and supporting Engineering team. It provides 24-hour applies practical criteria in its evaluation patient well-being. One member has even coverage for all clinical areas. of service contracts. helped those in a developing country. “We currently have 28 employees “We determine if each service contract “Our team has worked with a vendor covering over 15 facilities throughout is a benefit to Dartmouth-Hitchcock by as a beta-site for wireless patient New Hampshire and Vermont, which weighing the monetary cost of the monitoring products that transmit patient includes one director, two supervisors, contract over time with other factors such data directly from the patient to their one clinical engineer, one partsas timeliness of repair, cost of parts, electronic medical record. In many cases, procurement person and an convenience and customer service, age of this work has eliminated the need for administrative assistant,” says Jon the equipment, cost-of-service ratio patients to drag cables around with them, Kocurek, the department’s director. reports, supportability from the vendor which can lead to falls and broken In addition the team supports or third-party support entities, and equipment. Ultimately, this has resulted community outreach centers and overall cost of ownership,” Kocurek says. in higher patient satisfaction scores municipalities such as schools and fire “When a contract gets to a point regarding the delivery of care within the departments within a 100-mile radius of where it is deemed to no longer be of organization,” Kocurek says. its main campus. value to Dartmouth-Hitchcock, the He says that the department has

hen the leaves are changing in the fall, there are few places as beautiful as New England. A bike ride or walk along the Northern Rail Trail of New Hampshire is one way to see some of that beauty, and accessing it from Lebanon, New Hampshire is a good starting point. While in Lebanon, you might also want to see the Packard Bell Covered Bridge or the AVA Gallery and Art Center.

TECHNATION

JANUARY 2018

WWW.1TECHNATION.COM

SPOTLIGHT

The Dartmouth-Hitchcock Clinical Engineering Department covers over 15 facilities throughout New Hampshire and Vermont.

actively engaged in a goal to achieve 100 percent ICC certification of all technicians. “In support of this goal, a three tiered BMET level structure has been adopted that fosters career progression through the promotion of further education and certification, which allows technicians to realize progression in their field that is meaningful not only to them, but the organization and the patients it serves as well,” he says. Along with their patient safety officer and a vendor, the team was instrumental in establishing a program that sends alerts if any suspicious trends regarding patient deterioration are noticed by the equipment. “With this program, every inpatient at Dartmouth-Hitchcock is monitored for the entire length of stay. This has eliminated unwitnessed events,” Kocurek says. “The department takes pride that this project has saved lives and will continue to do so in the future. This project has also been awarded by ECRI. Many other institutions have done site-visits in hopes to collaborate with, or incorporate, this type of project themselves.”

Kocurek also says that a team of Dartmouth-Hitchcock doctors and nurses travel to Rwanda to support hospital education and improvements there. “This year, one of our technicians traveled with the team to teach proper PM procedures, share some of the latest technology and trends, help with repairs, and train some of their techs on equipment troubleshooting and use,” he explains. With the team’s role within IT, they are focused on cybersecurity threats. This recognizes the evolving role of CE departments. “As part of the IT/IS division, CE plays an important role in the integration of devices to the network and is currently working on a project to increase the cybersecurity of our medical devices. [The] clinical engineering team has evolved from being a separate department within DHMC, then merging with engineering and eventually becoming part of IT/IS as medical equipment became more reliant on computers, servers, and the hospital network,” Kocurek says. Away from work, the department’s team members stay active in the HTM community and updated on their skills

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

Jon Kocurek and Amanda Steele help lead the department

and knowledge. “We have several techs who are active members of the New England Society of Clinical Engineering, AAMI and a few other medical device associations,” Kocurek says. “Our technicians frequently attend events such as AAMI, MD Expo, RSNA and HIMSS. We try to send multiple technicians every year so that they can network and learn from their peers in an effort to bring back information on the latest technology and trends as well as suggestions for improvement.” If you are visiting New England, know you are in good hands if you seek medical attention at DartmouthHitchcock Medical Center where the medical devices are maintained by a knowledgeable CE team.

JANUARY 2018

TECHNATION

SPOTLIGHT

SPECIAL ADVERTISING SECTION

COMPANY SHOWCASE BETA Biomed Services, Inc.

n 1996 George Worley, his wife, Marie, and their daughter, Deidra, founded BETA Biomed Services, Inc. George was an experienced electrical engineer with many years of medical device manufacturing and sales under his belt. He was involved in the early days of biomedical engineering. He served on numerous new product committees that have brought about the development of products such as the demand pacemaker, micro oximeter, invivo oximeter, heart lung oxygenator, portable defibrillator, fiber optic diagnostic instruments, diagnostic cardiac catheters and cardiac output computer. It was his understanding of these and other medical devices that led him into the new field of pulse oximetry in the early 1980s. He has a number of patents on emerging technology in pulse oximetry. We interviewed BETA Biomed Services Inc. COO DR Flower to find out more about the company and what we can expect in 2018 and beyond.

Flower: BETA Biomed Services Inc. is a small, minority/woman-owned private company that can react quickly to the market’s needs. While many companies try to be all things to all people, we are a patient cable house focused on cables for the different monitors in the hospital and clinical environment. Not only can we replace patient cables, we have the ability to repair them as well. If a hospital has a monitor that has a broken cable, it is of no use to them. There may not be anything in the capital equipment budget for new purchases, but there will be money for a repair to keep the monitor up and running. This can also be a money saver. We are the manufacturer, not a third party bringing in the cable from overseas. This gives us the advantage of being able to respond to custom requests and make timely deliveries.

hat are some advantages that W your company has over the competition?

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JANUARY 2018

an you explain your company’s C core competencies?

Flower: As I mentioned, we are a patient cable house and focus our efforts there. It is this attention to detail and our laser focus on cables that allow us to be the premier cable manufacturer in the industry. We offer special, custom cables to all hospitals, including those with a special need.

DR Flower, COO BETA Biomed Services, Inc

What are some challenges that your company faced last year?

Flower: The number one challenge continues to be overseas competition, especially the influx of Asian products. However, we have maintained and, in some instances, grown our business due to the quality of our products and repairs.

hat product or service that your W company offers are you most excited about right now?

Flower: We are in the process of helping to open a cable manufacturing facility in Africa that will provide a whole new avenue for hospitals to utilize new and innovative cables in that region of the world. What is on the horizon for your company?

Flower: We are always looking to help companies with their cable needs. We

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SPOTLIGHT

BETA Biomed Services Inc. Vice President of Technical Services

Members of the BETA Biomed Services Inc. production team (pictured from left to right)

Christopher McIntire performs a quality control check.

Wenbo Liu, Vicki Pope and Ryan Parsley are seen working on items.

do a number of private labeling and contract manufacturing for different companies in the industry. This allows us a broad range of designs that we can offer to the medical industry. There are a few more on the horizon.

an you share a success story with C our readers – one time that you “saved the day” for a customer?

Flower: We have several instances where we have stepped in to help. Oftentimes, a customer that is either ordering a new cable will need it as soon as the next day or a customer may have sent in some repairs that they need back immediately. Not all hospitals have spare cables lying around. We always do our very best to make sure that we provide a quick turnaround for our customers. Recently, our state was hit by a hurricane and we had several hospitals and distributors that were either without power and/or flooded. They were in need of product and we were able to help them. It was a very difficult time for everyone involved and we managed to help by finding ways to make the logistics work.

Can you describe your company’s facility?

Flower: We have a 5,000-square-foot facility centrally located near Dallas in Rowlett, Texas. Half of our space is dedicated to production and repair operations while the other half houses the administration.

Can you tell me about your employees?

Flower: Each of our employees is special in their own right. Our least-tenured employee has been with us three years and he came on as a side job while going to college. While we always encourage our employees to do whatever they can to further themselves, we would love to keep this employee. We want to keep them all, they are integral to our success.

What is most important to you about the way you do business?

Flower: BETA Biomed Services Inc. takes pride in the quality of goods and services provided to our customers. Our objective is to achieve conformance to regulatory and customer requirements. We are committed

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

to producing quality rather than quantity. To accomplish this objective, we adhere to a preventative quality system that focuses on the identification and solution of problems at the point of occurrence thereby eliminating them from the final product. We are committed to maintaining the effectiveness of our quality system.

I s there anything else you want readers to know about BETA Biomed Services Inc.?

Flower: In order to fulfill our dedication to quality, we incorporate FDA Quality System Requirements (CCMP, CFR21) and international quality standards (ISO 14971, ISO 80601-2, ISO 13485 and MDD93/42EEC) in all areas of our facility. It does not matter whether it is repair or manufacturing, we have the same quality standard throughout the building. We are a registered Device Manufacturer with the FDA and are ISO 13845 accredited. We also believe strongly in working with charities to give back to the community, both local and international. We have worked with the Luz Fund, Samaritan’s Purse, Assist International, International Aid as well as our local EMS to name a few. To learn more, visit betabiomed.com.

JANUARY 2018

TECHNATION

WHEN IT COMES TO PATIENT CABLES BETA CAN PROVIDE IT ALL FOR YOU

High quality, affordable options for your cable needs

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SPOTLIGHT

BIOMED ADVENTURES FROM INDIA TO WEST AFRICA BY K. RICHARD DOUGLAS

he degree to which U.S. not-for-profit organizations, health care systems, manufacturers and ISOs help hospitals and clinics in developing countries is incalculable. It has to be assumed that the number of lives saved is just as incalculable, but very significant. These efforts, along with contributions from other countries, is one of the great stories of compassion of our time. Unfortunately, it goes mostly untold in any broad sense.

One of the organizations that is making a difference in this effort is Hospital Sisters Mission Outreach. The Springfield, Illinois-based medical surplus recovery organization “repairs, packages and distributes medical supplies and equipment to hospitals and clinics around the world,” according to its website. The organization secures these supplies from hospitals and clinics in the Midwest. The organization’s biomedical engineering supervisor is Ratish Kumar, an HTM professional who hails originally from India. Kumar was still a child when he realized that a career in health care was in his future. “My first excitement about health care blossomed when I saw the ability of a defibrillator to make a human heart function again when it was [used on] one of our relatives when I was 12,” he remembers. “I always intended to be associated with health care either as a doctor or as an engineer. Biomedical engineering perfectly fits in the middle and acts as a bridge between medicine and engineering, which excited me to take

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up as my bachelor’s major,” he adds. Kumar received lots of experience in India since hospitals there tend to keep equipment longer than U.S. hospitals. “I did my bachelor’s in biomedical engineering in India and moved to the U.S. in 2014 to pursue my master’s in biomedical engineering from the University of Texas at Dallas. After my bachelor’s, I worked in Sri Ramachandra Medical Center, a multi-specialty hospital in Chennai, India for two years as a biomedical engineer, working on life-saving and diagnostic equipment,” Kumar says. “During my tenure, I was made biomedical in-charge for neonatal ICU, pediatric ICU, urology and emergency and the trauma care departments, where I was responsible for corrective maintenance, preventive maintenance, installation, training and decommission,” Kumar adds. TRAVELING TO WEST AFRICA When Mission Outreach learned medical equipment and supplies were needed at a hospital in Togo, the

Hospital Sisters Mission Outreach provides assistance to hospitals around the world.

organization took steps to help out. Kumar would make the trip after the supplies were sent onboard and install the medical equipment. “The hospital in Togo is part of a larger community development initiative led by Pastor Kokou Loko. Working with friends from the University of Mississippi-Engineers Without Borders, Rotary International and churches in the Oxford, Mississippi area, Pastor Loko has built a school, a 600-foot water well

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SPOTLIGHT

and a hospital,” Kumar says. He says that the work continues as plans are in place for a farming cooperative to feed children in the school and the patients in the hospital. “Joey White, an Ole Miss engineering alumni from Springfield, participated in the building projects. Joey and his family made Mission Outreach aware of the need for medical supplies and equipment and provided generous support to make the container shipments a reality. Altorfer Inc., a Caterpillar dealership in Springfield, even donated an industrial generator to power the hospital. We have sent two containers and have more planned this year,” Kumar says. It’s a long way from the U.S. Midwest to Togo, a narrow country, sandwiched between Benin and Ghana on Africa’s west coast. Kumar points out that it is much easier to get around in Illinois. “Illinois and Togo both have a large percent of their land devoted to agriculture. You don’t see the big agri-business in Togo, but many people live in rural areas gleaning their income from farming. Travel is difficult. A 40-mile trip from the airport in Lome required two-hours of travel time over unpaved, and heavily pitted roadways,” Kumar says. “There was no public transportation or gas stations outside the city. People were selling gasoline in two-gallon bottles along the road. Clean water and improved sanitation is rare outside of the metropolitan area, requiring us to carry water with us at all times. I did not see any restaurant chains in Lome. No restaurants were available in the rural areas. Our hosts made sure that we had good accommodations and good food,” Kumar adds. Once there, Kumar stayed in the town of Vogan, which was 40 miles from the airport. They traveled by van from the airport to the hotel, which took nearly two-hours. “I installed a wide range of

equipment from [a] vital signs monitor, infant warmers, incubators, ultrasound, phaco emulsifier [to] slit lamps. The hospital in Vogan, Togo was just completed, and I also helped them to plan the deployment of other durable equipment in the ICUs, exam room, outpatient care and surgery room,” Kumar explains. “Prior to Mission Outreach’s involvement, the hospital had received shipments of old equipment from other organizations. I assessed the functionality of these donations and found that 90 percent were not functional. This highlights the importance of working with an accredited medical surplus recovery organization which will assess each

interested in developing equipment to meet the unique needs of mission medicine. Accredited medical surplus recovery organizations require biomed assessment, so there will be more positions like the one I hold at Mission Outreach,” he says. “The World Health Organization, USAID and other organizations understand the need and may have opportunities for employment. There are also ample opportunities for biomeds to participate in volunteer work helping medical surplus recovery organizations like Mission Outreach,” he adds. He points out that the work allows biomeds to contribute to missions, while remaining here in the U.S. Biomeds

Hospital Sisters Mission Outreach provides a variety of medicl devices to health care facilities. piece of equipment prior to donation. Mission Outreach hopes to donate equipment to replace these inappropriate donations,” he adds. FOR BIOMEDS ON A MISSION What advice does Kumar have for other HTM professionals who might want to make a difference by volunteering or working with an organization like Hospital Sisters Mission Outreach? “Global health offers a challenging and rewarding career for biomeds

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interested in traveling to provide training and support in the mission field should contact the TriMedx Foundation, Engineers without Borders and Engineering World Health for opportunities. Kumar has his sights set on visiting Haiti and Damoh, India to help out with his organization’s efforts in both locations. To learn more about making product donations to Mission Outreach, visit www.mission-outreach. org/product-donations.

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NEWS & NOTES

Updates From The HTM Industry ALLTECH MEDICAL SYSTEMS, RSTI ADOPT TRAINING AGREEMENT Alltech Medical Systems America and RSTI have reached a training agreement in which RSTI will offer an MRI service training program at Alltech Medical Systems America’s headquarters in Solon, Ohio. Both parties cited a desire to expand their offerings and leverage their core competencies, and the goal of this program is to offer a complete spectrum of service solutions by adding MRI training courses. RSTI has offered diagnostic imaging training for over 27 years and brings a proven teaching method to this opportunity; Alltech has engineered and manufactured superconducting 1.5T MRI systems for 12 years with solid experience in R&D, application, and service. Alltech will provide technical expertise on the MRI systems to assist the expansion of RSTI’s training program. “As the number of MRI installations grows worldwide, it’s important that a quality service training is provided to customers so they can ensure the performance of MRI systems by lowering

the costs over the lifetime of the MRI scanners,” said Alltech Medical System America President James Meng, Ph.D. “Our commitment to MRI innovation generates lots of market demand for our MRI products globally, which requires the efficiency and productivity of service utilization, including troubleshooting either on-site or remotely, spare parts management, 24/7 online technical support, and preventative maintenance.” The collaborative agreement also provides the technical training on generic platforms of MRI systems commonly used at customers’ sites. Because many of the installed MRI systems are older, customers learn how to keep the uptime by taking care of the aged MRI systems. For more information, visit www.rsti-training.com.

CYBERSECURITY TOPS ANNUAL HEALTH TECHNOLOGY HAZARDS LIST Health technology safety – from safeguarding medical devices and IT systems against ransomware attacks to avoiding misconnections of enteral feeding components – requires that health care facilities identify the possibility of danger or difficulty with those technologies and take steps to minimize the likelihood of adverse events. ECRI Institute recently announced the launch of its Top 10 Health Technology Hazards for 2018 list. The report identifies the potential sources of danger involving medical devices and other health technologies that ECRI believes warrant the greatest attention for the coming year. The guidance that accompanies each hazard provides practical strategies for reducing risks, establishing priorities and enacting solutions. “Patient safety is on everyone’s mind, but technology safety sometimes gets left behind,” says David T. Jamison, executive director, Health Devices Group, ECRI Institute. “As an independent medical device testing laboratory and investigator of technology-related incidents, we know what can go wrong and what steps hospitals can take to reduce patient harm related to specific technologies and processes.” This year’s No. 1 hazard calls attention to the patient safety component of ransomware and other cybersecurity threats. In the health care environment, ransomware and other types of malware attacks are more than just an IT nightmare. They are potential patient safety crises that can disrupt health 26

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care delivery operations, placing patients at risk. Multiple ransomware and other malware variants have infected health care organizations, as well as other private and public organizations, throughout the world. Endoscope reprocessing remains in the No. 2 spot this year, as health care facilities continue to struggle with consistently and effectively cleaning, disinfecting and sterilizing these instruments between uses. Reprocessing failures can lead – and have led – to the spread of deadly infections. Other topics on the list include bed and stretcher support surfaces that remain contaminated between patients, missed alarms, equipment malfunctions resulting from the use of incompatible cleaning agents, patient burns from electrosurgical electrodes that are not safely holstered between uses, and unnecessary radiation exposures during digital imaging procedures. The Top 10 Health Technology Hazards for 2018 Executive Brief is available for free download at www.ecri.org/2018hazards.

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CHAPUT CO-AUTHORS CHAPTER ON HOSPITAL RISK MANAGEMENT Clearwater Compliance CEO Bob Chaput, a recognized leader in the field of cyber risk management is co-author of a chapter in the recently released book titled “Health Care Risk Management Fundamentals” published by the American Society of Healthcare Risk Management (ASHRM). This comprehensive book is an authoritative insider’s perspective on best practices for hospital risk management, providing a complete introduction to risk management in health care and addressing today’s greatest challenges to patient safety. Chaput was part of a national team of experienced health care risk management professionals who worked together to create this publication. Chaput’s chapter, “Technology and Data in Healthcare,” presents an innovative and judicious approach to

the intersection of patient care and technology as more patient care is moving out of traditional health care settings and into the home and workplace. It provides timely, tangible, and specific actions that risk managers can take to improve their information and technology risk management posture. Included is background on the digitized health care ecosystem in systems, devices and applications. The book was released October 15-18 at the ASHRM annual conference in Seattle, Washington. It is intended for hospital risk managers, CIOs and CISOs interested in better understanding the need for and implementation of a comprehensive risk management process and approach that encompasses the entire organization. It will also be of particular relevance

Clearwater Compliance CEO Bob Chaput

to a broader academic audience as a comprehensive textbook, providing a complete introduction to risk management in health care.

BIOMEDICAL SCHOLAR, NIH EXECUTIVE JOINS TEXAS A&M TO LEAD ENGINEERING HEALTH INITIATIVE Roderic I. Pettigrew, PhD, MD, a physician-scientist and internationally recognized leader in biomedical imaging and bioengineering, will join Texas A&M to lead Engineering Health (EnHealth), the nation’s first comprehensive educational program to fully integrate engineering into all health-related disciplines. EnHealth will be an innovative, multi-college engineering health initiative in Houston to educate a new kind of health care professional with an engineering mindset who will invent transformational technology for health care’s greatest challenges. With Texas A&M’s interdisciplinary makeup and colleges of dentistry, medicine, nursing, pharmacy, public health and veterinary medicine, EnHealth will have a profound impact on both human and animal health. EnMed, the university’s engineering medicine track in

partnership with Houston Methodist Hospital, will serve as the first program for EnHealth. “The way to solve the world’s most challenging health care problems and perhaps prevent many of them in the first place,” said Michael K. Young, president of Texas A&M University, “is to take a more integrated approach to education and treatment. With this announcement, Texas A&M is harnessing the best across two historically different disciplines – engineering and medicine – to accelerate quality and delivery of care. It’s a new day for integrated health care, and we’re so proud to have Dr. Pettigrew at the helm of this endeavor.” At Texas A&M, Pettigrew will lead the continued development of EnMed, a partnership announced last summer between the state’s top-ranked Houston Methodist Hospital, the College of

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Engineering and the College of Medicine to educate a new type of doctor – a physician engineer – or “physicianeer.” EnMed, which will welcome its inaugural class in fall 2019, is expected to be the largest engineering-based medical degree program in the nation. “With the creation of our EnMed program and its unique focus on inventing and rapidly moving new medical technologies into practice, we realized the potential to impact all areas of health and the idea of EnHealth was born,” said M. Katherine Banks, vice chancellor and dean of Texas A&M Engineering. “Dr. Pettigrew is the ideal leader for this initiative and has the transformational vision to develop this new type of health care ecosystem.”

JANUARY 2018

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HEALTHMARK OFFERS WASHABLE KEYBOARD AND MOUSE Healthmark Industries has introduced the Washable Keyboard and Mouse to its ProSys Instrument Care product line. Manufactured from silicone, the waterproof white keyboard and mouse are intended for use in the decontamination area. Both items are designed with a USB connection and an enclosed silicone housing to resist frequent cleaning. The 375 x 150 x 11 mm Washable

Keyboard comes equipped with 106 keys including a numeric pad and can be cleaned with hospital grade cleaning agents and wiped down with hospital grade disinfectants. The 116.0 x 62.0 x 38.6 mm Washable Mouse is assembled with integrated scroll keys, laser detection and can be cleaned with hospital grade cleaning agents and wiped down with hospital grade disinfectants.

The Washable Keyboard and Mouse are available for purchase together or separately. For more information, visit www.hmark.com

CIRS ACQUIRES ATS LABORATORIES CIRS Inc. has announced the acquisition of ATS Laboratories. This merger brings together both companies’ technologies, providing a new level of choice in ultrasonic tissue mimicking materials while maintaining the same level of quality and customer service that ATS and CIRS customers have come to expect from these companies. ATS Laboratories Inc. was established in 1978 as a privately held corporation located in Bridgeport, Connecticut. ATS designs and

manufacturers tissue-mimicking phantoms for the routine performance monitoring, training and in-process production testing of ultrasound imaging systems. Each company’s ultrasound products are similar but use different tissue mimicking materials providing the best choice for all customers. “The incorporation of ATS into CIRS will transpire over the next few weeks. It should be a smooth transition for both ATS customers and their

distribution network,” states Ted Lynch, ultrasound manager. “ATS products will be readily available with little or no delay in filling customer orders.” Early in 2018 ATS products will be manufactured and delivered by CIRS from Norfolk, Virgina.

EXPERTS PROMOTE INFORMATION SHARING TO PROTECT AGAINST CYBERTHREATS

No organization can go it alone when confronting evolving cyberthreats, according to experts who presented at the Medical Device Innovation, Safety and Security Consortium’s fall conference in Arlington, Virginia. For conference participants, information sharing is key to protecting medical devices – and patients – from potential attacks by a variety of actors.

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Private companies such as Target aren’t asked to deploy surface-to-air missiles to protect themselves from a potential attack by Russia, said Jamil Jaffer, director of the National Security Institute at George Mason University. Yet, individual hospitals “are expected to defend themselves” from statesponsored cyberattacks – a threat that is “very real,” according to Jaffer. Instead of relying on health care delivery organizations (HDOs), medical device manufacturers, or health technology developers to address cyberthreats on their own, the Food and Drug Administration (FDA) has advocated for a “whole of

community” approach to cybersecurity, according to Suzanne Schwartz, FDA’s associate director for science and strategic partnerships. “No sole entity is capable of being able to address this complex issue alone,” Schwartz said during her presentation. A major part of building this community relies on sharing information, according to Evan Wolff, partner at Crowell & Moring LLP in Washington, D.C., where he co-chairs the firm’s Privacy and Cybersecurity Group. “Information sharing provides for a common defense,” he said.

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INDUSTRY UPDATES

Because Quality Matters.

AAMI CREDENTIALS INSTITUTE PRE-APPROVES CONQUEST IMAGING TRAINING Conquest Imaging has issued a press release announcing the pre-approved Continuing Education Units (CEUs) by the AAMI Credentials Institute (ACI), for its 2018 training calendar. “After seeing the recent growth (108 percent from previous year), I knew our quality training program was significantly impacting BMETs across the country,” explains Senior Director of Technical Services Jim Rickner. “Now that AAMI has approved our courses, we can easily offer a way for CBETs to keep up their credentialing requirements while providing a vetted, quality training option for any BMET.” ACI Certification for the Biomedical Equipment Technical (BMET) certification is a formal recognition by the AAMI Credentials Institute that individuals have demonstrated excellence in theoretical as well as practical knowledge of the principles of biomedical equipment technology. Once certified, continuing education credits can be obtained to maintain certification, and keep biomedical technicians and engineers up to date on the latest technology. The ACI award qualification process includes evaluation of all curriculums, course materials, syllabi and testing. ACI’s pre-approval program awarded Conquest Imaging’s training courses with Category IV CEUs as follows: • Ultrasound Bootcamp – 40 CEUs • Toshiba Aplio Series – 16 CEUs • Philips iU22/iE33 or Philips EPIQ 5/7 – 16 CEs • GE Logiq E9/Vivid E9 or GE Voluson E8/E10 – 16 CEUs • Siemens S2000/SC2000 – 16 CEUs • Ultrasound Basics or Multivendor Accreditation PM/DICOM – 8 CEUs

“Pre-approved CEUs are just one more way Conquest Imaging is simplifying enrollment in a quality training program to the health care industry. By continuously evaluating the curriculum, its delivery and its relevancy, Conquest Imaging is empowering the BMET to make a difference in their department’s bottom line by improving their technical skills and thereby lowering the total cost of ownership of their ultrasound systems,” according to the news release.

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TJC UPDATES EMERGENCY MANAGEMENT REQUIREMENTS Wildfires, hurricanes, active shooters and cyberattacks are just a few of the recent crises that have affected U.S. hospitals and other health care organizations. In response to the Centers for Medicare & Medicaid Services (CMS) final rule on emergency preparedness to ensure health care professionals and suppliers meet the needs of patients, residents, clients and communities during emergency events and throughout recovery, The Joint Commission is announcing updates to its emergency management requirements. The updates became effective November 15. The updated standards will help health care organizations more effectively plan for disasters and coordinate with federal, state, tribal, regional and local emergency preparedness systems. The standards apply to deemed status surveys for hospital, critical access hospital, ambulatory, home health and hospice settings. Enhanced requirements also will apply to rural health clinics and federally qualified health centers to support the consistency of implementation across ambulatory settings. “In recent years, there have been more reported emergencies affecting communities across the country. Health care organizations involved with incidents such as floods, power failures, mass casualty incidents, evacuations and cyberattacks over the last several years have credited Joint Commission standards for ensuring preparation that helped them manage in those emergencies,” says John Maurer, SASHE, CHFM, CHSP, engineer, Department of Engineering, The Joint Commission. “The updated standards

show a renewed focus on continuity of operations, integration with community and regional emergency planning, and leadership engagement.” Several new elements of performance (EPs) – statements that detail the specific performance expectations and/or structures or processes that must be in place in order for an organization to be in compliance with a standard – are part of the emergency management update. The EPs address key areas in planning and response, including: • Continuity of operations and succession plans • Documentation of collaboration with emergency management officials • Contact information on volunteers and tribal groups • Annual training of all new/existing staff, contractors and volunteers • Integrated health care systems The updated standards reflect new EPs as well as existing EPs revised for additional specificity. They provide for 21 new or revised EPs for hospitals and critical access hospitals, 29 for ambulatory surgery centers and 39 for home health agencies. For more information, visit www.jointcommission.org.

TRISONICS RELEASES 2018 TRAINING SCHEDULE Trisonics has implemented 16 classes throughout the year covering a wide range of the most commonly used systems in the field. Taught directly by Trisonics field engineers, the classes will serve as learning tools to those within the biomedical industry. Each system course is designed to provide the hospital biomed or imaging engineer a solid foundation from which to service a specific model of ultrasound equipment. Access to this level of

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experience provides an added benefit for any engineer who desires to service their equipment in-house. The 2018 schedule includes “Basic Ultrasound Training” on January 30 and “Philips Epiq 5/7 Training Course” January 31-February 2. February training classes include “Basic Ultrasound Training” on February 20 and “GE Logiq & Vivid E9 Training Course” on February 21-23.

For the complete 2018 schedule, visit Trisonics.com.

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SIEMENS HEALTHINEERS INTRODUCES SHARE360 TAILORED SERVICE PORTFOLIO To address the specific needs of medical imaging clinical engineering departments nationwide, Siemens Healthineers has introduced Share360, a flexible in-house service portfolio. Leveraging the company’s scalable service infrastructure, Share360 enables customers to select the level of support services and collaboration strategies that best meet the unique requirements of their in-house clinical engineering departments. Through offerings such as Share360 that potentially enable increased workforce productivity and optimal clinical operations, Siemens Healthineers helps customers transform the delivery of patient care. Share360 debuts amid ongoing changes to the United States health care market – changes that are prompting hospitals and other health care organizations to consider building the capabilities of their own clinical engineering departments. By doing so, these organizations hope to achieve operational efficiencies while maintaining a high level of service for their imaging systems. The new Share360 portfolio is designed to better support customer service strategies by providing them with flexibility in determining their degree of collaboration with Siemens Healthineers and helping them to optimize workforce utilization. Share360 offers various levels of engagement with the company, from as-needed assistance to augment the in-house capabilities of clinical engineering teams, to a comprehensive menu of second-level support services, all the way to an ongoing, synergistic support and consulting relationship that blends the expertise of customers and Siemens Healthineers to achieve a new level of engineering excellence. “With the introduction of our Share360 service portfolio, Siemens Healthineers proudly offers in-house clinical engineering teams an unprecedented level of flexibility in determining the level of service and maintenance support they receive from us,” says Matthew McCallum, vice president of services business management at Siemens Healthineers North America. “By tailoring a support solution designed around the unique capabilities and requirements of a particular clinical engineering team, Siemens Healthineers can help that team meet its goals, increase efficiency, and better work toward success.” For information, visit www.usa.siemens.com/share360.

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AAMI UPDATE

Nominate a Star in Your Organization for an AAMI Award

ach year, AAMI recognizes leaders and innovators in the healthcare technology community whose efforts have moved the field forward. Nominations for this year’s AAMI Awards are being accepted until February 8, 2018. Winners will be awarded monetary prizes and a plaque commemorating their achievements, and will be recognized during a special reception at the AAMI 2018 Annual Conference & Expo in Long Beach, California in June. The categories include: • The AAMI Foundation’s Laufman-Greatbatch Award, which honors an individual or group that has made a unique and significant contribution to the advancement of healthcare technology and systems, service, patient care or patient safety. This is AAMI’s most prestigious award. • The AAMI Foundation & ACCE’s Robert L. Morris Humanitarian Award, which recognizes individuals or organizations whose humanitarian efforts have applied healthcare technology to improving global human conditions. • The AAMI Foundation & Institute for Technology in Health Care’s Clinical Solution Award, which honors a healthcare technology professional (individual or group) that has applied innovative clinical engineering practices or principles to solve one or more significant clinical patient care problems or challenges facing a patient population, community or group. • AAMI & Becton Dickinson’s Patient Safety Award, which recognizes outstanding achievements by health care professionals who have made a significant advancement toward the improvement of patient safety. • AAMI’s HTM Leadership Award, which recognizes individual excellence, achievement and leadership in the healthcare technology management profession. • AAMI & GE Healthcare’s BMET of the Year Award, which is given to a biomedical equipment technician to recognize individual dedication, achievement and excellence in the field of healthcare technology management. • AAMI’s Young Professional Award, which is presented annually to a professional, under the age of 35, who exhibits exemplary professional accomplishments and a commitment to the health care profession. • AAMI’s HTM Association of the Year Award, which recognizes an HTM association that distinguishes itself

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JANUARY 2018

during the course of the year through outstanding society operations and meetings as well as a commitment to elevating the HTM profession at the local level. More information, including nomination forms and guidelines, can be found at www.aami.org/awards. REGISTRATION OPENS FOR THE AAMI ANNUAL CONFERENCE AAMI opened registration for the AAMI 2018 Conference & Expo in Long Beach, California, on December 4. Whether you’re a first timer or a long timer, the conference is the can’t-miss event of the year. In addition to education, networking and professional advancement activities, the conference offers the Expo Hall, which will feature the latest technology from more than 200 medical equipment manufacturers. Attendees include biomedical and clinical engineers, healthcare IT specialists, clinicians, healthcare technology management professionals and all whose work touches healthcare technology. Early-bird discounts are available until March 16. For more information about the conference and to register, visit www.aami.org/ac. UPDATED STEAM STERILIZATION STANDARD, ST79, NOW AVAILABLE AAMI has released a long-awaited update to a widely used steam sterilization standard for health care facilities, offering users a newly formatted resource with fresh guidance that could help them stay in compliance with accrediting bodies. The update to ANSI/AAMI ST79, “Comprehensive guide to steam sterilization and sterility assurance in health care facilities” comes as more health care delivery organizations face scrutiny over the sterility of medical instruments, with media reports casting an unflattering light on “dirty” instruments that have been connected to sick patients. ST79 provides comprehensive guidance to health care personnel who use steam for sterilization, regardless of the size of the sterilizer or the type of facility. “Readers will find the third edition of ST79 to be more user-friendly and useful as a tool to support best practice and provide a rational for why they process as they do,” said consultant Cynthia Spry, co-chair of AAMI’s steam sterilization hospital practices work group, ST/WG 40. “This new guidance should result in a significant reduction in citations while still meeting appropriate standards to which the reader is directed.” ANSI/AAMI ST79:2017 can be purchased from the AAMI Store, www.aami.org/store.

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ECRI UPDATE Deep Dive into Monitoring for Opioid-Induced Respiratory Depression

atients receiving parenteral and neuraxial opioids are at risk of depressed respiration. Traditional practice in medical-surgical units and other general care areas has been to intermittently monitor these patients, typically at four-hour intervals, using vital signs monitors. These monitors can be used to spot-check pulse rate, blood pressure, temperature, and oxygen saturation; and while the monitor is operating, the clinician counts respirations for a fraction of a minute to determine respiration rate.

Respiratory depression, however, can quickly lead to anoxic brain injury or death if not detected. Thus, assessing the condition of these patients at such long intervals will not reliably detect hypoventilation associated with this condition. As a result, several organizations now recommend that these patients be continuously monitored for respiratory depression. This recommendation presents some significant challenges for health care providers. ECRI Institute has identified and answered some of the key questions that will need to be addressed as health care facilities work to meet these challenges. WHICH MONITORING TECHNOLOGY SHOULD BE USED? Monitors for detecting respiratory depression need to continuously assess the adequacy of ventilation and alarm for incipient respiratory compromise. Two technologies offer promise for this application (ECRI Institute has tested and rated several models specifically for their ability to help detect respiratory depression): 1. Capnometers, which measure the amount of carbon dioxide in the exhaled breath that is sampled via a nasal/ oral cannula. This technology is commonly referred to as end-tidal carbon dioxide (EtCO2) monitoring. 2. Monitors that use bioimpedance to estimate minute ventilation. One model that ECRI Institute has evaluated uses a chest electrode padset to sense movement of the thorax and air associated with breathing. The monitor interprets frequency and amount of movement as respiration rate and volume of the exhaled breath (tidal volume), respectively.

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JANUARY 2018

Both types of monitors can be used in medical-surgical units for low-acuity, postoperative patients who are receiving parenteral opioids for pain management. They also can be used to monitor patients who receive opioids for pain management in general care areas and during procedural sedation for which sedatives or dissociative agents are administered with or without analgesics/anesthetics. Itâ&#x20AC;&#x2122;s worth noting that ECRI Institute does not recommend purchasing pulse oximetry to monitor patients receiving opioids. Respiratory depression is insidious in onset and may not be accompanied by oxygen desaturation, especially for patients receiving supplemental oxygen. Intensive care monitors are likewise not an appropriate option for this application. For patients in an intensive care setting, continuous physiologic monitoring is already standard practice. However, simply expanding the use of intensive care monitoring technologies to medical-surgical and other general care areas is not a viable option. Reasons include: 1. Intensive care monitoring systems are complex and rely on the use of a central station monitor; as such, these systems require a different model of care than is practiced in general care areas. 2. These systems have a very high cost of ownership. 3. Nurses have responsibility for more patients in a general care area than they do in an intensive care area; adding monitoring to the responsibilities of nurses in general care areas may be an excessive burden. 4. Nurses in general care areas typically have not been trained to use these monitoring systems.

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INDUSTRY UPDATES

HOW DOES A FACILITY BUDGET FOR ACQUIRING AND OPERATING MONITORS? Analyzing the costs for continuous monitoring technologies requires looking at more than just the acquisition cost. Hospitals should also: 1. Consider the cost of consumables. The cost of consumables can differ significantly among alternatives. Over the lifetime of the device, such expenditures can far exceed the monitor’s acquisition cost. 2. Calculate the number of monitors needed. Determining the number of monitors needed is not as simple as counting beds. It requires an understanding of how monitoring will be implemented in each care area. For instance, if a policy is adopted to monitor patients for at least 24 hours but then to discontinue monitoring if certain conditions are met, most clinical care areas will not require a monitor for every bed, since not all patients in the care area will be monitored for the full length of their stay. For example, a 20-bed medical-surgical unit might need only 12 monitors on rolling stands, allowing for one or two patients in a full-census unit to continue on monitoring after 24 hours. 3. Weigh the cost of ownership for continuous monitoring against the cost saving from early detection of respiratory compromise. WHICH PATIENTS WILL BE MONITORED, AND FOR HOW LONG? ECRI Institute suggests: 1. Continuously monitoring all patients who are receiving parenteral and neuraxial opioids for adequacy of ventilation for at least the first 24 hours after initiating opioid delivery 2. Discontinuing monitoring after 24 hours if there have been no alarms, the patient is medically stable, and opioid dosing has not been increased WHAT IMPACT WILL CONTINUOUS MONITORING HAVE ON WORKFLOW? Monitoring for opioid-induced respiratory depression will present clinicians with a significant change in workflow. Continuous monitoring is being introduced into clinical care

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areas where monitoring has typically been limited to taking vital signs at periodic intervals. A central station with real-time monitoring information from each room is not necessary. However, facilities must implement measures to ensure that: 1. Alarms from patient rooms are recognized by staff members at other locations within the care area at any time of day 2. Staff respond to these alarms in a timely manner HOW WILL THE MONITORS BE DEPLOYED? ECRI Institute recommends that that monitors be mounted on the same IV pole with a patient-controlled analgesic (PCA) pump whenever a pump is requested for parenteral or neuraxial pain management on general care units. When an opioid is not delivered using a PCA pump, we suggest deploying monitors on rolling stands or IV poles. HOW WILL CLINICIANS BE RELIABLY ALERTED TO ALARMS THROUGHOUT THE CARE AREA? Interfacing with a nurse call system can be a cost-effective option for remote alarm annunciation. Alternatively, a facility may wish to connect through a third-party integration solution to alarm management middleware. WHO SHOULD BE INVOLVED? Teams involved with implementing monitoring for opioid-induced respiratory depression should include the chief medical officer, the safety and quality officer, a risk manager, the director of nursing, the nurse manager, a pharmacist and a clinical engineering representative. This article was adapted from ECRI Institute’s PSO Deep Dive™: Opioid Use in Acute Care. The executive brief is publicly available for download. The comprehensive report is available to ECRI Institute PSO and partner PSO members online; nonmembers can purchase a PDF of the report. To learn more, visit www.ecri.org/opioids; call 610-825-6000; or email communications@ecri.org.

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SHOPTALK

Conversations from the TechNation Listserv Q:

Anybody else having issues with the Dash 3000s and malfunctioning sound? We have had dozens of these with the exact same issue, and the only resolve seems to be replacing the main board.

Just today I had this problem where the monitor was alarming VTachs, Asystole, etc. but there was no audible sounds. The monitor was running 7.2 software so I upgraded to 7.3 and it fixed the problem. I suggest getting your hands on a copy of the 7.3 software so you can start upgrading the monitors since 7.2 has been causing issues. The software upgrade will also fix problems with the monitor rebooting itself. You will need to buy through a GE sales rep, customer service cannot sell it. RESPONSE: When changing alarm volume the speaker makes a small pop noise instead of beeps. When powered off it beeps as it should. It also beeps when turned on. No error messages at all. The screen is normal. I changed speaker and power supply and had the same problem. I talked to tech support at GE and they said to replace main board that the sound generator is bad. However, the main board cost around $1,000.

I am in need of information about a fault that occurred with the Drager Evita 4. When it is turned on, it will trigger the ventilation and will not accept any programming.

If the E4 starts immediately with ventilation, this is a warm start, like if the vent lost power, and then had power restored. Logic for this function is on the CO2 carrier, so try there. Not sure what you mean by “not accept any programming.” If that means you can’t change settings, make sure the screen is connected to the main body.

What is the best SWAG (or freebie) you have ever received at a trade show or conference?

An illegal Cuban Cigar, can’t reveal my sources! Also, I’m old school so years back (before the sales crackdown on gifts), I used to rack up tabs in the thousands at dinner from the GE folks trying to sell us scanners and MRIs. They used to fly me and my wife to RSNA every year with all expenses paid – drinks, lunch, dinner, entertainment all included. Man, those were the days. The last training I went to in March the instructor said they couldn’t even give us a coffee mug.

At the AAMI conference in San Antonio a few years ago, I won a UPS … but it was a long carry back to my hotel across the street!

Not from a trade show or conference, but a local vendor always brings me homemade cookies around Christmas.

A: A: A:

Homemade chocolate candy is personal, good and heartfelt. Leathermen tool.

Flash drive or portable bank charger for cellphones are always nice trade show giveaways.

I am being told by some customers that our sales reps can no longer bring in doughnuts. I was doing some onsite training and the salesperson accompanying me offered to take us all to lunch and we were told that they could not even accept a pen anymore. I have been wondering how common that level of crackdown is.

Sounds like the Federal Government.

THE SHOP TALK article is compiled from TechNation’s ListServ and MedWrench. com. Go to www.1TechNation.com/Listserv or www.MedWrench.com/?community.threads to find out how you can join and be part of the discussion.

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TECHNATION

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he MATRIX medical gas verifier is designed for the real-time analysis and verification of hospital gases to ensure compliance with NFPA Method 99. This transportable multi-sensor system is fully self-contained and able to operate on site for 12 hours without external support requirements. The MATRIX has detection capabilities to simultaneously monitor carbon monoxide, carbon dioxide, oxygen, methane, nitrous oxide, trace hydrocarbons, anesthesia gases and dew point. The MATRIX-PLUS includes an internal sample pump, a USB port and real time data logging capability.

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BIOMED 101

Five Reasons for Evaluating Service Partners

hile it may seem logical to have a bucket of multiple vendors for finding medical parts and services, it can create major repercussions on your overall budget if not done efficiently. The number of service partners managed by clinical engineering can get into the hundreds, even thousands. Imagine managing each one of those relationships to get the best price, right quality and appropriate terms for your organization. There is a lot of time spent on the phone with these vendors – sometimes up to an hour per call. This can be significant when you look at the volume of orders. One person cannot manage that responsibility alone. By looking for ways to consolidate your vendors, you will reap the benefits from a budget and resource perspective.

BY BRENNAN STICE VP of Business Development for the Western U.S. at PartsSource

These five reasons will explain why a single service partner will produce more efficiency within your health care facility: ONE: INCREASED VENDOR ACCOUNTABILITY AND ESTABLISHED RELATIONSHIPS Collaborating with a single vendor creates a streamlined process. The vendor has the knowledge to consolidate order entry, management and reconciliation from all of your suppliers into one, consistent and simple-to-use process. By having this in place, you will gain a fully responsive vendor with unified accountability to contact when a need arises. It is why you shop at your local grocery store and go to the mall. It is a single accountable source with lots of products at guaranteed quality levels and consistent prices, and it should not be different in the medical procurement world. TWO: SIMPLE ADMINISTRATION AND OPERATIONS Vendor management is non-billable work, and it can cause a lot of stress for one person, due to the sheer number of vendors. Therefore, it can take away from doing core repair work, which affects equipment uptime. To improve your operations, work with fewer suppliers to decrease the number of separate transactions. The sourcing of every repair part can be costly when looking at labor cost and related overhead. The technology platform from a single vendor should help implement a standardized purchasing process and

reduce supply chain costs. Because the technology platform implements change, it can affect the entire organization. The evolution of change in healthcare technology management starts from the ground up, and your clinical engineering department can influence this change. THREE: INTEGRATED TOOLS FOR OPTIMAL REPORTING A health care system should consider the reporting and analytics a vendor could offer through their technology platform. The reporting should help you to validate savings and create visibility into the purchasing behavior of employees. When evaluating vendors, look to see if you will be receiving consistent communication for increasing savings, efficiency and tradeoff opportunities. FOUR: RELIABLE AND EFFICIENT PROCESSES Reduced steps within your procurement process present the largest opportunity for timesavings. A single technology platform from one service partner can help with identifying opportunities for improvement with price, vendor selection, asset data and vendor benchmarking. Evaluate the overall medical procurement process you currently use and consider the impact of managing multiple vendors. Every vendor works in a silo with its own individual goals and does not invest in your departmental strategy and overall success. Additionally, most suppliers do not focus on internal capabilities to provide

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parts and service. A simplified procurement process should help you to align your strategy with your vendor’s strategy. FIVE: INCREASED DISCOUNT POTENTIAL While you may have good pricing with your current vendors, you could be missing opportunities for leveraging potential discounts from one vendor. By leveraging the purchasing power of a single vendor who has relationships with many suppliers, you may have the ability to receive better pricing. By integrating procurement technology into your asset management system, you can create audit trails. You will be able to create predictive budgetary guidelines by incorporating approvals within your procurement workflow when selecting a part or service. A centralized vendor knows your processes and helps to streamline the entire workflow. The adoption of data-driven, purchasing technology has been slow because of the lack of awareness in vendor management. By increasing your knowledge on the amount of resources and cost that goes into managing multiple vendors, you will be able to evaluate service partners to help meet your organization’s needs for efficiency. Not only will you find a service partner, but you will also find a technology platform that best fits your procurement workflow.

JANUARY 2018

TECHNATION

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STAFF REPORTS

WEBINAR WEDNESDAY Series Provides Easy Access to Knowledge

he Webinar Wednesday series continues to deliver insightful knowledge to HTM and imaging service professionals around the world and most are eligible for1 CE credit from the ACI.

The recent webinar “Imaging – From Film to Digital” was sponsored by Technical Prospects. In the webinar, Technical Prospects Technical Trainer and Support Specialist John DiPasquale discussed the growth of the industry. He also examined how the current technology relates to and is an outgrowth of older technologies. DiPasquale, a Certified Biomedical Equipment Technician (CBET) with more than 25 years of experience in the HTM industry, shared his insights with more than 200 HTM professionals. The webinar received great reviews and positive feedback via post-webinar surveys. “Excellent webinar by Technical Prospects. It was a fresh point of view showing you can still troubleshoot using older methods and not rely on diagnostics and service keys to pinpoint your problem,” said K. Saager, MRI Service Engineer. “The presentation provided a very good, historical description of the imaging field and how it progress from the analog to the digital generation. His descriptions of the different types of problems and what things to check was excellent,” said T. Bracewell, Senior Biomed Instructor. “The imaging webinar was very informative for anyone in the medical profession dealing with radiology. John DiPasquale was very thorough and was

TECHNATION

JANUARY 2018

able to answer highly technical questions with targeted precision. I was very impressed with the quality of this training. It was definitely worth taking time out of my day! Thank you so much and I look forward to attending more Webinar Wednesdays,” wrote E. Huynh, Biomed. The recent Webinar Wednesday session “Performing a PM on the Medtronic/Covidien FT10 Surgical” sponsored by Rigel Medical provided insights to HTM professionals around the world. Rigel Medical National Business Development Manager Jack Barrett and Biomedical Sales Engineer Rebecca Adkins co-presented. They performed a PM on a Medtronic/Covidian FT10 surgical generator and demonstrated testing techniques on this well-know energy platform. The presentation also included hyperlinked video clips to show actual testing. “Great webinar on the importance of thorough ESU testing and how to perform tests effectively. Provided a wealth of knowledge about testing procedures and ESU operation. I’m very glad to have attended to this webinar,” wrote Biomed D. Mishchuk. “A very informative and expansive explanation of the FT10 PM. The webinar provided detailed information on the operation of the ESU allowing a better understanding of why we test

“ Webinar Wednesday keeps me in touch with the latest and greatest methods, technology, and information of today.” – H. Gonzalez, Biomed

specific parameters,” Clinical Engineering Specialist Z. Foreman said. “I was able to follow along with the slides as well as using my own equipment to almost be getting a hands-on experience in the comfort of my own shop,” wrote Biomed K. Kramer. Also, the recent Webinar Wednesday session sponsored by RTI proved informative for HTM professionals. This 60-minute presentation featured Rob Morrison, senior applications and product specialist at RTI Inc. Morrison has over 30 years experience working with and for RTI in the development, sales and support of non-invasive test tools for non-invasive QA measurements

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THE BENCH Earn an AAS degree in a high demand career! of diagnostic imaging X-ray generator parameters. In the webinar, he discussed the challenges encountered, along with tips and solutions, for measuring on today’s dental X-ray imaging devices. Morrison’s presentation impressed attendees because of his knowledge and the use of videos to illustrate his points. In a post-webinar survey, attendees did not shy away from saying how much they enjoyed Morrison’s presentation. “Thank you for the excellent presentation. I found it not only interesting and relevant but also very informative. You did an excellent job on the way that you presented material and the presentation was by far the best webinar I have had the opportunity to view, not that any of the other webinars were not great because I enjoy all of the Wednesday Webinars. This was particularly interesting and I really enjoyed it. Thank you for sharing your expertise and knowledge as well as showing the setup of the test,” Senior Biomed Tech J. Harwood said. “The presenter presented a lot of useful information. He was very knowledgable on the subject matter. I really enjoyed the video presentations which really nailed down how to use the testing products and to obtain data,” Biomed D. Parham said. The webinar series continues to receive amazing reviews. “If you are NOT involved in Webinar Wednesday, you are missing out on a golden opportunity to gain knowledge and experience without having to go to the manufacturer’s training,” said M. Bryant, Electronics, Service & Testing owner. “Webinar Wednesday has become a staple of my Wednesday afternoons. With diverse presenters and intriguing topics, this series is a great way to learn something new, or add on to the things you already know,” shared H. Gonzalez, Biomed. “Webinar Wednesdays get my standing ovation for presenting an avenue that the HTM field can easily

grasp and use in spreading information of new technologies, services and how to improve our overall jobs in providing the very root of what started this industry, patient safety,” shared A. Rock, Biomed Manager.

“ Webinar Wednesday has become a staple of my Wednesday afternoons. With diverse presenters and intriguing topics, this series is a great way to learn something new, or add on to the things you already know.” – H. Gonzalez, Biomed

“Webinar Wednesday is a great way to keep up with what is new and relevant in the world of healthcare technology. I have yet to attend a webinar where I didn’t at least learn one new thing from the presentation. Webinar Wednesday keeps me in touch with the latest and greatest methods, technology, and information of today,” Biomed H. Gonzalez said. For additional information about the Webinar Wednesday series, including a calendar of upcoming webinars and recordings of previous presentations, visit 1TechNation.com/webinars.

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TECHNATION

continue learning all year with

Click, click, click and another hour of training in the bag. Thank you Webinar Wednesday!! - Janet P.

View upcoming webinars at www.1TechNation.com/webinars!

Webinar Wednesday has become a staple of my Wednesday afternoons. With diverse presenters and intriguing topics, this series is great way to learn something new, or add on to the things you already know. - H. Gonzalez, Biomed

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ROUNDTABLE ROUNDTABLE

TECHNATION

JANUARY 2018

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ROUNDTABLE

ROUNDTABLE PATIENT MONITORS

echNation is starting off the New Year with a look at patient monitors. We reached out to experts throughout the HTM community and asked them for the latest information on patient monitors, including new features, cybersecurity issues and more.

The roundtable panel is made up of Mindray North America Marketing Manager for Patient Monitoring Beth Aquaviva, Tenacore Biomedical Engineer Brendan Barry, Pacific Medical Senior Account Manager Bob Brosan, BMES Co. Electronics Technician Iain Johnson, Elite Biomedical Solutions Manager of Patient Monitor Repairs Alero Olomajeye and Integrity Biomedical Services’ Brad Sailsbury. Q: WHAT ARE THE LATEST ADVANCES IN PATIENT MONITORING IN THE PAST YEAR? Aquaviva: Design innovation has provided compact, lightweight, multi-purpose patient monitors that serve as a transport monitor, multi-parameter module and/or a traditional bedside monitor – all in one device. These monitors move with the patient throughout their care path and provide uninterrupted data acquisition from patient to monitor to central station/EMR through seamless Wi-Fi and hardwired communications, easing clinical workflow and enabling a seamless medical record. Brendan Barry, Tenacore Barry: Remote patient monitoring has become a very useful advancement in the medical field. Not only is it cost effective keeping the chronically ill out of the hospital and more involved with their own health, but also by detecting early warning signs of any future complication which can arise. Wireless capabilities have also been a very functional advancement taking that usual image we have of someone on a hospital bed completely entangled in cables and giving that patient the ability to move around freely and to be more comfortable. Bob Brosan, Pacific Medical Brosan: Most equipment available now has similar functionality, including networking and integration compatibility, patient parameter availability, and ease-of-use for the staff (touchscreen,

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

straight forward menus, etc.) to name a few. The next big wave of innovation looks to be coming from the telemedicine sector but that integration into mobile apps and wearable technology is still in its infancy. Johnson: The most recent advance I’ve seen is the addition of remote monitoring to CPAP machines. Sleep therapists and doctors can remotely view sleep habits and analyze sleep patterns in almost real time. It’s like being part of a sleep study in your home, which is especially useful when trying to diagnose complex apnea or complicated sleep behaviors. Olomajeye: Some of the latest features are a swipe feature on a touchscreen and auto rotation of the display. Sailsbury: We have noticed in the last year that hospitals have trended on adding to existing systems or maintaining current systems. We have also noted that facilities may want to add more advanced monitoring options like full disclosure to older existing systems. Q: WHAT FACTORS SHOULD HTM CONSIDER TO DETERMINE COST OF OWNERSHIP? Aquaviva: Cost of ownership starts with the initial acquisition price of the system including monitors, telemetry solution and central monitoring system. But the costs of ownership go far further. For example there are installation expenses (for site surveys, cable installation, system rack installation), project management charges, and any charges associated with clinical training. For interoperability, there are not only the costs of the interface solutions, but also the implementation costs including HL7 mapping and ADT integration and long-term license and support fees sometimes collected annually. For long-term costs, the customer should also consider warranty and service contract expenses and the costs to access a technical team for phone or remote support. These factors are very much a part of the cost of ownership – and can far exceed the initial acquisition expenses. Barry: One of the most important decisions a hospital will ever make is choosing the right HCIT system given the enormous amount of money on the line. Total cost of ownership models focus primarily on upfront purchases and labor costs, and need to focus on the ongoing costs as well such as software upgrades, maintenance, staff training, future product purchases, server fees and even back up recovery. Johnson: Training should be inevitable regardless of the new product being brought in. In a good environment there should be

JANUARY 2018

TECHNATION

ROUNDTABLE some sort of annual training plan to ensure the workers stay at the top of their industry so that shouldn’t really be a factor other than the cost of the company providing the training. In my experience most are pretty comparable. I think one of the more important factors is whether you can use Lithium Ion battery packs or if the equipment is required to use disposable batteries as far as telemetry is concerned. Not only is that a financial cost but also a potential environmental concern. Costs associated with periodic maintenance is another factor to consider when evaluating cost of ownership. Is it something that can be performed in-house, will it need to be shipped off, can it be covered under a contract? Olomajeye: Factors include original cost (including technician and nursing staff training), maintenance cost (including preventive maintenance and software upgrades), costs of parts/repair/ replacement (under contract and not), cost to scale up (purchase more modules and software.) Brad Sailsbury, Integrity Biomedical Services Sailsbury: When purchasing equipment, you have to look at the costs of repairs and, depending on the equipment you purchase, the length of time you have a warranty, what that warranty covers and if there is an opportunity for an extended warranty. In addition to the cost of actual repairs, you need to keep these factors in mind: the time you will be down while waiting for repairs, what replacement equipment you will need to rent or purchase to use in the downtime, and the availability of service techs in your area. You will also need to look at how the company handles software updates and if you will be charged for those. Q: WHAT ARE THE PROS AND CONS OF BUYING BRAND NEW VERSUS BUYING REFURBISHED UNITS? Beth Aquaviva, Mindray North America Aquaviva: New monitors or systems provide the most up-to-date and advanced software, broadest parameter options, and the full standard warranty. Used monitors can come from a variety of sources, some offering the product “as is” without software updates and with only very limited warranties, if any. Mindray offers a certified refurbished program. The products offered for sale have been upgraded to the latest applicable software release with field updates, refurbished cosmetically, checked out through final quality procedures, and provided with a full six-month warranty. The program allows acquisition within tight budgetary constraints. Barry: Everyone in the medical field knows how expensive equipment can be. By buying refurbished you can cut that cost dramatically if that is an issue. Refurbished units usually come with a warranty as well and the original problem has been repaired, followed by testing that unit furthermore to make sure it meets all product specifica-

TECHNATION

JANUARY 2018

tions. The only downside would be any physical defects like scratches or blemishes. Brosan: The pros for purchasing refurbished/recertified equipment are numerous: drastically reduced upfront costs for the equipment itself, reduced costs for parts/repairs due to availability on the open market, and less troubleshooting/less difficult solutions due to maturity of the equipment. The con is how to decide what to do with all of the money saved! Decisions, decisions! Johnson: When you buy new you generally purchase a support contract which will include software upgrades and tech support for the duration. Refurbished equipment is obviously cheaper. I think the biggest advantage of going with refurbished over new is that generally smaller companies are providing the equipment and they are usually more willing to bend over backwards to ensure a satisfied customer. GE and Philips are as big as they come as far as a company, so even a large hospital purchasing a equipment to outfit a whole wing is merely a drop in their bucket. That amount of money to a small company is a much larger piece of their budget so they’ll make sure it’s taken care of properly. Olomajeye: The pros of new are longer warranty, latest models/ features/parts/software. The cons are the high costs. The pros of refurbished are cheaper, works as good as new, keeps the monitoring system working past the end of life thereby saving money. The cons of refurbished are shorter warranty periods and you may not get the latest software/upgrade. Sailsbury: When you purchase new you are paying for the newest technology and a warranty that covers repair costs. What people do not consider is that in the used market you can find that same technology and oftentimes the warranties will meet or exceed what the OEM is offering. You do not necessarily have to spend more to get more. Q: WHAT CYBERSECURITY MEASURES SHOULD BE TAKEN WHEN IT COMES TO PATIENT MONITORS? Aquaviva: It is essential that patient monitors, when adopting cybersecurity measures, use the hospital active directory to support user authentication which provides assignment of privileges to particular users to limit access based on need. This transmission of data from these monitors must be done via secure, encrypted protocols. Barry: Medical devices are just as exposed to a cyber attack as any IT system. Measures for cybersecurity should include eliminating exposure to external networks, using secure and remote access methods and implementing firewalls. Johnson: Obviously the most secure setup is a standalone system but that isn’t feasible with the new technology out there. Allowing doctors remote access is a great thing in providing the best care, but it’s important to remember to secure patient data. Using strong passwords and ensuring everybody is using their own log-in when accessing the hospital or clinic network are both good habits to

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ROUNDTABLE encourage. These are more important to keep in mind when accessing the network the patient monitor is attached to. On the patient monitor itself everything is self-contained so cybersecurity shouldn’t enter the equation. Alero Olomajeye, Elite Biomedical Solutions Olomajeye: Patient monitors are connected to the central stations which in turn is connected to long-term data storage, EHR, middleware, telemetry, etc. It is important to work very closely with IT and manufacturer of these devices to plan and execute recommended cybersecurity measures, such as patch installation and software upgrades and contingency plans. There should also be a proper password management process in place, as well as frequent cybersecurity risk assessment to reveal any loopholes in current processes. Sailsbury: There is no blanket answer because each facility is set up differently. With systems that have wired, wireless and virtual users it creates many different scenarios. I suggest techs work with the hospital IT provider to make sure the entire network is following the best processes to ensure the safety of the data. Q: CAN YOU EXPLAIN THE IMPORTANCE OF HOLDING AN IN-SERVICE OR CLINICIAN TRAINING ON HOW TO PROPERLY USE THE DEVICES? Aquaviva: Monitoring in-service training should be performed by a RN whose expertise with the operation of the solution is equal to their clinical knowledge in the care environment they are training in. Clinical in-service by such individuals for a monitoring solution enhances the operational efficiency of the end users and supports their efforts to provide high-quality patient care. Barry: Clinician training should be done on any and every device the person will be using. It’s very important to have that hands-on experience with a trained professional and to also read the operating and service manual. Each patient monitor has different settings, configurations, passwords and cables so knowing and getting trained on just one type will not suffice Johnson: Limiting downtime is always front and center. Everybody is trying to do more with less so wasting someone’s time is never good. Whether it’s a simple thing like knowing which type of sensor to use with a measurement module or knowing that software versions have to match can eliminate potentially damaging equipment by forcing the sensor onto a connector it’s not meant for or just tagging out a piece as bad when it isn’t. That takes man-hours from the BMET who is already probably overtasked to troubleshoot and bring back into service, or if they don’t have time, it will get sent off to a repair facility who will either charge a flat rate or bench fee for their time spent evaluating. Needless shipping costs are a part of that as well. Olomajeye: Clinician training on how to use patient monitors properly helps the staff to know what features are available. It

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gives them the ability and confidence to use the patient monitor efficiently and optimally. Knowing how to use the right type of cable and profile for the patient, for instance, helps to get the most accurate data on the patient and leads to fewer nuisance alarms. Sailsbury: Training is a must for both accurate use and patient safety. Not having proper training can lead to reduced patient care, alarm fatigue and higher equipment downtime due to improper set up and use by hospital staff. Additionally, without training you will be paying for technology the staff will either underutilize or not utilize at all due to not fully understanding how to operate the equipment. Q: WHAT ELSE DO YOU THINK READERS NEED TO KNOW ABOUT PURCHASING AND SERVICING PATIENT MONITORING DEVICES? Aquaviva: Selecting a patient monitoring system that fits the clinical requirements of a facility is just a start. The monitoring system must be flexible, scalable, fit multiple acuity levels, and provide intuitive operation. Ensuring that the system meets IT requirements is also critical. In this area, monitoring systems that offer standard and open interoperability options leveraging the hospital infrastructure and strengths, can offer overall reductions in system costs and speed the seamless integration of information within hospital systems. Barry: When it comes to purchasing and servicing patient monitor devices, I recommend using a reputable company that’s certified and has trained professionals. Iain Johnson, BMES Company Johnson: Honestly, when properly trained personnel are using the equipment patient monitors are made very well and will hold up to normal usage for years. It’s not the same as technology in your house that needs to be constantly upgraded. We see things come in for service that have been out in the field for years if not over a decade and are still running strong except when they finally fail. I’ve seen CO2 modules that haven’t been calibrated in 12 years still taking accurate measurements. This equipment is really quite reliable. When purchasing equipment and deciding between new and refurbished remember that there’s only so long a manufacturer will burn in their product before selling it. When you buy refurbished it’s pretty much like it’s had a longer burn-in process which could be years. Equipment will usually fail in the first six months, after that it may run for years without issue. For that reason alone, I would almost always recommend purchasing refurbished equipment except under certain circumstances. Sailsbury: Make sure you chose a product from a manufacturer or provider that you can use and support. Make sure that manuals and schematics are available and you receive copies of them. Make sure that parts are readily available and that there are service techs in your area to support your product. Finally, make sure you are buying the technology and functions that you need and will use.

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here is no way around government regulation. Yes, it has its purpose, and many regulations are designed to keep the public safe, but there are others that just seem burdensome. It’s enough to drive a good libertarian crazy.

One federal agency, tasked with keeping the public safe, is the FDA. It is a massive agency with 14,648 (2013 est.) employees and a budget of $5.1 billion. It is a part of the Department of Health and Human Services (DHHS). According to the FDA’s website, the agency is responsible for “protecting the public health by assuring that foods (except for meat from livestock, poultry and some egg products which are regulated by the U.S. Department of Agriculture) are safe, wholesome, sanitary and properly labeled; ensuring that human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective.”

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They are also responsible for “protecting the public from electronic product radiation, assuring cosmetics and dietary supplements are safe and properly labeled, regulating tobacco products and advancing the public health by helping to speed product innovations.” On the points of medical device safety and speeding product innovations, the agency has the role of regulating the companies that design, manufacture, repackage, relabel and import medical devices through its Center for Devices and Radiological Health (CDRH). The FDA also is one of the watchdogs over the cybersecurity of medical devices

make more transparent the premarket FDA device review process. This should benefit patients by getting new medical devices to market more quickly, while maintaining high standards for patient safety. The Reauthorization Act also requires that “Not later than 270 days after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall post on the Internet website of the Food and Drug Administration a report on the continued quality, safety, and effectiveness of devices (as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))) with respect to servicing (as defined in subsection (c)).” This report, by the HHS Secretary, must contain eight elements, including “the status of, and findings to date, with respect to, the proposed rule entitled “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Request for Comments” published in the Federal Register by the Food and Drug Administration on March 4, 2016 (81 Fed. Reg. 11477).” “I will say that with all the pending regulatory questions from the HR 2118, we have started assessing our third-party repairs and PMs, and are working to develop multiple plans to be able to take action on whatever decision is finally made,” says Joshua Virnoche, MBA, CBET, manager of clinical engineering for JPS Health Network in Fort Worth, Texas. “Obviously, over-regulation hurts everyone, the service industry, health care providers, and the patient, but providing a concrete baseline standard can prevent

“ Obviously, over-regulation hurts everyone, the service industry, health care providers, and the patient, but providing a concrete baseline standard can prevent third parties from ‘corner cutting’ as a way to undercut the OEMs. – JOSHUA VIRNOCHE

along with the Department of Homeland Security (DHS), OEMs, end users and security experts. In August, Congress passed the Food and Drug Administration Reauthorization Act of 2017. Essentially, the Act reauthorizes several user-fee programs, most notably, the Medical Device User Fee Amendments (MDUFA). It enhances the pre-market review process. President Donald Trump signed the bill into law. The Act will be in force from October 1, 2017 to September 30, 2022. Among other things, the impact of this legislation will be to speed up and

third parties from ‘corner cutting’ as a way to undercut the OEMs,” he says. “I feel with the parts component, a company that goes through the 510k approval process can provide us with an equivalent part with savings over the OEM, and I’m still comfortable using 510k approved third-party parts. That being said, there are certain cases over the last year where the OEM pricing has become more competitive, and sometimes better than a third party,” Virnoche adds. The HR 2118 proposed legislation that Virnoche refers to was introduced in the U.S. House on April 25, 2017. It is titled the: “Medical Device Servicing Safety and Accountability Act.” That legislation, among other things, would amend the Federal Food, Drug, and Cosmetic Act to require the registration of establishments that service devices. In May, it moved to the Health Subcommittee of the House Committee on Energy and Commerce. As of November 2017, no further action has been taken and there have been no votes on the legislation. The legislation would have to be passed by both the House and the Senate before going to the president for his signature before becoming law. MEDICAL DEVICES AND FDA REVIEW When an OEM of medical devices wants to bring a new product to market, they have a few approaches depending on the device and its use. If they want the device cleared, they need to first receive 510(k) (named for a section in the Food, Drug, and Cosmetic Act) clearance from the FDA. Manufacturers are pleased that the new legislation allows them to start selling their new products in a more timely manner. The FDA can either “clear” the device or “approve” it. The difference is that to get clearance, the submitter of a 510(k) form must show that the device is “substantially equivalent to a device that is already legally marketed for the same use,” according to the FDA’s website. For approval (premarket approval or PMA), the “PMA applicant must provide

reasonable assurance of the device’s safety and effectiveness.” This process requires a more stringent review than the 510(k) process as it is generally reserved for high-risk devices. Lower risk Class I devices and some Class II devices are considered to be 510(k) exempt and do not require FDA review. Although these devices are exempt, they must still “be suitable for their intended use, be adequately packaged and properly labeled, have establishment registration and device listing forms on file with FDA and be manufactured under a quality system (with the exception of a small number of Class I devices that are subject only to complaint files and general recordkeeping requirements),” according to the agency’s website. Not only does the FDA regulate the types of medical devices that might come to mind like imaging equipment, but also “simple items like tongue depressors and bedpans, heart pacemakers, dental devices and surgical implants and prosthetics.” In addition to clearing or approving medical devices, the FDA also tracks devices in case a device should present a risk to the public and must be recalled. Medical device OEMs must pay registration fees to the FDA along with fees when new devices are listed with the agency. Fees are also collected when the OEM develops a new device and takes it to market. Part of the purpose of these fees is to help the agency with its goal of bringing safe devices to patients in as expedient a manner as possible. EVALUATING THE SAFETY OF SERVICING On March 4, 2016, the FDA opened a “docket” requesting comments from those involved in the servicing of medical devices. All FDA dockets are administered under the Federal Dockets Management System (FDMS) located at Regulations. gov and allow for submission of comments electronically. The docket was later followed up with an FDA public workshop titled; “Refurbishing, Reconditioning,

Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers, October 27-28, 2016.” According to the FDA, the workshop included four general themes: “1) Establish

JOSHUA VIRNOCHE, MBA, CBET Manager of Clinical Engineering for JPS Health Network

working definitions for third-party and OEM activities. 2) Discuss benefits and challenges that stakeholders encounter, potential benefits and risks to patients/ users, and failure modes of devices introduced as a result of performing activities associated with third-party entities. 3) Identify current best practices and discuss alternative methods to mitigate risks associated with performing activities associated with third-party entities. 4) Determine whether specific procedures are necessary for each activity as it relates to third-party services performed.” The original request for comments included questions like; “What evidence exists regarding actual problems with the safety and/or performance of devices that result from these activities? Specific examples should be submitted” and “What are the potential risks (patients/users) and failure modes (devices) introduced as a result of performing the previously defined activities on medical devices?

Please speak to issues common to all devices as well as specific risks with specific devices.” Maybe most important to the HTM and ISO community was the question: “What information do third-party entities need in order to perform these activities in a way that results in safe and effective operation of the medical device? Please provide specific examples.” Another question that seemed to put the onus on non-OEM service was this question: “These activities are performed by OEMs and various third-party entities, including hospitals and humanitarian organizations. Are the risks different depending on who performs the previously mentioned activities?” The feedback received in response to the docket came from a variety of stakeholders including OEMs, HTM professionals, ISOs, professional associations and health care systems. The FDA identified several themes that interlaced the comments gathered from stakeholders. Among the most prominent themes were the need for quality management systems, the need for specialized training, the importance of utilizing quality replacement parts and the availability of those parts and the availability of full specifications. The goals and motivations of all stakeholders in this issue are not aligned. Some have competing interests. Many of the concerns were expressed in our October 2017 cover story; “Right to Repair; Pushing for Access and Concessions.” In that story, we stated that “The frustration for the HTM profession for several years has been the general inaccessibility of service manuals, passwords, replacement parts and/or access to training that fits into their employer’s budget.” While some issues related to this topic have begun to be addressed at the state level, the overlapping issue of service manuals, service keys and passwords is a point of contention that has been ongoing. These issues also revealed themselves in the FDA docket submissions, where the ability

to provide quality repairs is often seen as hampered by the lack of accessibility to these items. Also, an attempt to address the question of “What information do third-party entities need in order to perform these activities in a way that results in safe and effective operation of the medical device?” was made by George

Equipment Remarketers and Servicers Inc. (IAMERS), a diagnostic imaging trade association. IAMERS cites MITA’s imaging standard for servicers. Part of the organization’s concern is that MITA submitted comments to the FDA docket that it seeks to have all servicers of medical equipment providing the same level of quality and

“ First, we’ve completed our first qualification of a medical device development tool (MDDT) to provide a more objective platform for developing devices in a key area of medicine – cardiovascular health.” – Dr. Scott Gottlieb

Mills of The Joint Commission. In January of 2017, he added a new element of performance (EP) (EC.01.01.01, EP 3), which states: “The organization has a library of information regarding inspection, testing, and maintenance of its equipment and systems. Note: This library includes manuals, procedures provided by manufacturers, technical bulletins, and other information.” (Unfortunately, Mills has since left The Joint Commission). MANY BIOMEDS LACK ACCESS There is the concern that some service providers will be cut out of contention when it comes to the formation of any new standards from trade organizations that could influence the FDA. One of those newly proposed standards comes from the Medical Imaging and Technology Alliance (MITA), a division of the National Electrical Manufacturers Association (NEMA). This again gets back to the concern about the withholding of passwords, equipment manuals and service keys by manufacturers. This practice, which has long vexed those in the HTM community, has been ignored by MITA, according to the International Association of Medical

safety. This standard is expected in light of the fact that not all service providers have access to the resources needed to service that equipment. IAMERS’ contention is that the MITA standard would have the effect of excluding independent diagnostic imaging servicers from contracting with end users. They contend that the MITA standard would induce the same standards on ISOs that the FDA imposes on manufacturers (21 C.F.R. 820) with no means for those servicers to access passwords, equipment manuals and service keys. Many equipment buyers have learned that the one juncture of leverage they have is to request service manuals, software keys and passwords at the point of purchase. This should be a part of every negotiation. When capital purchases are not being made, this leverage is not a viable option. FDA RECOGNIZING PERSONAL MEDICAL TECHNOLOGY The FDA has recently announced some innovative ways it is helping in the development of new devices. In an October 24, 2017 press release, quoting FDA Commissioner Dr. Scott

Gottlieb, the FDA announced a new development tool that would be useful in providing feedback to engineers who design heart failure devices. “First, we’ve completed our first qualification of a medical device development tool (MDDT) to provide a more objective platform for developing devices in a key area of medicine – cardiovascular health,” Gottlieb says. “Today’s newly qualified MDDT is a 23-item questionnaire that measures health information that is reported directly by patients with heart failure. The tool can be used to measure a heart failure patient’s health status, including clinical symptoms and the physical and social limitations caused by this condition. Such a tool has the potential to help engineers designing heart failure devices to more efficiently and accurately quantify how much their device could actually improve a patient’s quality of life,” he adds. “By qualifying the tool under the FDA’s new, voluntary program, it will make it easier for product developers to rely on the outputs of this newly qualified tool as part of their development plans. Innovators can trust in advance that the agency has already found the outputs of these measures to be reliable,” the statement continues. According to a spokesperson at the FDA: “[The] FDA is still gathering and analyzing information to make an informed decision on changes in policy regarding those engaged in third-party service and repair. Our official remarks and proposals will be available in mid-May when our congressionally mandated report on the subject is due to become public.” As the FDA moves forward in its oversight of medical equipment and the safety of the public, it has several arguments to consider. What side it will come down on is not yet known, but that decision could impact the day-today work of biomeds and ISOs.

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JANUARY 2018

TECHNATION

EXPERT ADVICE

BY CINDY STEPHENS

CAREER CENTER

Fresh Start With Your New Year Goals

es, it is the time of year to begin thinking about what 2018 will look like.

Most of us are thinking about our future. We consider changes to make our personal and professional lives more fulfilling and successful. It is well known that the most successful people are those who made a choice to be successful, establish goals and set out to accomplish them. Ultimately, it is up to each of us to take charge of our professional and personal growth. However, achieving success in anything requires having a plan – setting goals and actions to carry them out. Whether it is professional or personal, the new year is a great time to make resolutions for change. We just have to make the choice of either continuing with the “old” habits or working toward a new improved self or routine! The key to achieving success is to motivate yourself to turn your goals into realities. Setting goals is a very powerful technique to make a positive difference in achieving success. Therefore, if you want your life to change, you must incorporate your goals into a plan, and take the necessary steps to be successful. It sounds easy enough, but studies show a majority of people don’t take the time to identify their goals and make a plan for reaching them. Goals give you a starting place and a destination. Knowing where you are going will help you get there! Here are

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some easy steps to put your resolutions and goals into action! Start out with small steps, and keep it simple so you can achieve your goals! Maybe you want to be more productive at work or add to your professional skills to work toward a promotion. You may just want to simplify your life, manage your time better, or find the time to do the things that are more important in your life. • Determine your objective. What do you want to achieve? What is it you want to do in your life and career? Once you have a vision and know what you really want to accomplish with your life, you will be able to define your goal and develop a focused plan to set you in the right direction. • Define specific and realistic goals. Categorize your goals as personal, financial, career, spiritual or another areas. However, don’t have too many goals because that can sabotage your success and become overwhelming. • Begin with well-defined goal statements that form the basis for your plan. One way to remember how to create a clear and accurate goal statement is to think of the “SMART” acronym used by many experts in goalsetting workshops. SMART stands for: Specific, Measurable, Achievable, Relevant (or Realistic), and Timely. Each goal statement should have clear steps

CINDY STEPHENS Stephens International Recruiting, Inc.

•

to provide direction and focus to achieve the goal, a plan of action that also allows us to track our progress toward the goal in a time frame that is realistic. Narrow down the list to concentrate on a few goals at a time. As soon as you achieve those goals, you can move down your list. You want your goals to be worth working toward. Once you have defined your specific goals, you need some direction to follow to achieve each goal. Create an action plan that gets results. If you don’t know where you are going, how can you expect to get there? Write down in detail how you will achieve it and by what date. This plan is your roadmap to

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EXPERT ADVICE

GET THE

success. The more specific and resolutions fail and consider the measurable the plan, the better. potential roadblocks that may The key is to have a written prevent you from achieving plan to keep you on track and them. Identifying roadblocks up moving forward. front will prepare you to • Goal setting is an ongoing overcome them. process that is accomplished • Stay motivated even in the face over time. Review your goals of obstacles or setbacks. Remain daily to become more flexible and willing to adjust productive, to remain focused your plan when necessary. and determine your priorities. Sometimes you may need to take As each set of goals is reached, a detour along the way, but you will be compelled to set new don’t get discouraged and let goals, but consider rewarding this throw you completely off yourself for your achievement! course. Stay committed and • Maintain a log of your keep going! along the wayCHANGES to help Whatever the reasons are for PROOFprogress APPROVED NEEDED keep you on track. Even small change, I hope these steps will give steps will get you a little bit you more focus and direction to assist CLIENT SIGN–OFF: closer to your goal. you in accomplishing your New Year’s • PLEASE Do not CONFIRM become frustrated if you resolutions! TakeARE charge of your THAT THE FOLLOWING CORRECT do not achieve your goals career by focusing on your goals and LOGO PHONE NUMBERachieving WEBSITE ADDRESS overnight. Keep in mind some success.

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JANUARY 2018

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EXPERT ADVICE

BY MICHAEL DAVIS

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Software Compatibility is Key

e all know that an ultrasound machine is a finicky piece of hardware. Systems require the correct version of software as well as compatible replacement parts. If the repair engineer isn’t using the compatible replacement parts or the correct software, interesting issues can occur that will turn a quick fix into hours of troubleshooting.

I recall an unusual case I had. One of our clients was having an issue backing up their patient data. The system had both a magnetic optical drive and a DVD writer. When they would go to write to either drive, the system would say that the drive was unformatted. When they attempted to format the drives, they got an error stating either the drive was write-protected or the media was incorrect. We dispatched a field service engineer to their location. My FSE was armed with a new back-end processor, new hard drive and the software. We verified the software version from within the system itself. First, the engineer backed up the customer’s configuration to a USB drive, removed the customer’s hard drive and then installed a blank drive. On the new drive, they loaded the software. They were still unable to write to either device. Several different CDs and DVDs were used as well as a known good magnetic optical disk. Still no luck. The engineer then installed the new back-end processor and loaded the software. Same issue. After putting the customer’s original parts back, they brought me the replacement back-end processor for troubleshooting. I installed the processor in an 64

TECHNATION JANUARY 2018 64 TECHNATION DECEMBER2018 JANUARY 2017

MICHAEL DAVIS Technical Support Specialist

identical system and resolved the MO drive issue. It turned out that the media we were using was the incorrect capacity. We needed a larger capacity disk. To resolve the DVD issue, I tried reloading software – no luck. I tried swapping out the DVD drive – no luck. I tried installing a new version of the base software –no luck. I did, however, get a little lucky when I tried installing a higher version of the application software and was able to verify that at least the hardware was working. I resorted to diving deep into the service manual to check the

compatibility of the base software and application software. It turns out that the base software was compatible with a higher level of application software. With this new-found information, I installed a compatible base with the application software. I placed a blank CD into the drive and everything was working perfectly. It turns out that somewhere down the road a software upgrade was done to the machine and this started the entire issue with the drives. Because we used the information that was on the machine, we were always reproducing the same issue. With the conflict figured out, we were able to perform the necessary steps to resolve the customer’s issue. Moving forward, we implemented a procedure to insure compatibility. Whether the issue is a hardware conflict or the reloading of a customer’s backup, compatibly is always key. For more ultrasound technical tips and tricks, or to view technical support videos visit www. conquestimaging.com. Conquest Imaging Technical Support is available 24/7/365 at 866-900-9404.

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JANUARY 2018

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EXPERT ADVICE

BY STEVEN J. YELTON

THE FUTURE

Using the Smartphone in the Classroom

have written about the use of the smartphone in the classroom in the past and in my experience the smartphone becomes an even more powerful tool each year.

My usual disclaimer is: “In my classroom and lab we have ground rules for use of the phone, tablet, laptop, etc. During a lecture, the student basically cannot use them. During a test, they definitely cannot use them. If their phone rings, beeps, chirps, preferably vibrates, etc. during a lecture they should very quietly leave the room and take care of the situation. Most of my students have families, jobs and other commitments where an emergency may occur and it’s important to take care of them. They learn that they should be courteous to the other students and professors. That being said, I’m a big fan of this technology when used with good manners.” Currently there are medical devices that are smartphone- or tablet-based coming out daily. Consumers in the home use many of these devices. A few examples are EKG monitors, pulse oximeters, blood pressure monitors, etc. These devices require repair and initially users may need help setting them up. Our curriculum includes computer networking classes and offer computer programming options as well. One area where our students are exploring is with mobile operating systems. They need to understand the operating systems of the mobile devices as well as the interfacing. The mobile devices have become a large

TECHNATION

JANUARY 2018

STEVEN J. YELTON PE, CHTM

part of students’ lives and they are going to be very adept at working with this technology. I have students who have attempted to take online examinations on their smartphone. Even though this is entirely possible to do, I don’t recommend trying this. Speaking of tests … I cannot tell you how many times a student has been able to text a friend, colleague, etc. for information that they can use for a laboratory problem that they are trying to solve. This could be something as simple as, “What is the factory default password setting for a patient monitor?” They have a camera where they can take photos of serial numbers, displays, connections, etc. They can email this information to others when they may have a situation that they cannot figure out. Students often include these photos in their laboratory reports which gives us actual information from the lab. This isn’t “cheating”; this is a good use of

their time. Once they figure it out, they will know it from then on. I don’t think that taking hours looking for the solution is any more valuable than if they are able to get help in a more effective manner. By the way, this isn’t true during tests, however this may happen during online tests. That’s why we design the online questions with this possibility in mind! Speaking of the laboratory reports, I feel that what my students are producing today with the use of digital devices and media are much better than in the past. The pictures depicting the laboratory projects every step of the way greatly enhances the laboratory report. In the laboratory, we are teaching the students to perform scheduled maintenance, repairs, upgrades, etc. on medical devices and systems but another outcome of the laboratory experience is helping the student problem solve and to learn to “think.” In many instances, the students work in groups and have the professor available for questions, but they are encouraged to use whatever resources they have to “figure it out.” In addition to just emailing or texting pictures to colleagues, we have used live video messaging in the laboratory to have a technician look at the problem in “real time.” This is an exciting and very effective learning activity for the students. Most of the time, the experts that we conference with are graduates, co-op student employers, graduate employers and/or industry advisors. They also find it rewarding to have an active role in the education of these future technicians.

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When Quality Matters

Repair Solutions For GE/Philips Patient Monitors The face of HTM education is changing and we must embrace change and make use of the technology that we have available to us today. Much of our educational content is online and is available to be delivered by distance. In my case, our biomedical instrumentation courses are presented in a hybrid nature. The class meets one time per week live and the majority of the material is online. The live portion allows for some lecture, a time to answer questions and a live laboratory. We also have some laboratory experiences that we have found to be more effective when presented online via video, etc. This technology is greatly helping with the delivery of the courses. I have been very impressed with how students are able to very clearly define problems, show how a device reacted based on inputs, and are able to get advice on how to proceed. The smartphone connects the world! I have also been told that this method has been used to help technicians from developing countries communicate with others to help solve problems. Not long ago, it would have been impossible to achieve this result so quickly. In conclusion, I still believe that we need to embrace the technology, but let’s do it courteously and remember the person standing in front of you takes priority. – Steven J. Yelton, PE, CHTM; is a Senior Consultant for HTM in Cincinnati, Ohio and a Professor at Cincinnati State Technical and Community College where he teaches biomedical instrumentation courses. He is a member of AAMI’s Board of Directors-Executive Committee, AAMI’s Foundation Board of Directors, Chair of AAMI’s Technology Management Council, Chair of AAMI’s HTAC committee and is a member of the ABET Board of Delegates.

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EXPERT ADVICE

BY INHEL REKIK & JOHN RASMUSSEN

TECH TIPS

Demystifying Medical Device Security, Part I

ay and June 2017 brought additional focus to the security of biomedical devices with the arrival of the WannaCry and Petya/NotPetya ransomware. These malware packages targeted vulnerabilities in the Microsoft operating system including Windows XP, 7 and 8. Many biomedical devices utilize these operating systems and without proper patching or controls in place could have become infected by this malware. Device manufacturers may send notifications to hospitals, or they may receive notification from NH-ISAC or ISC-CERT, alerting them to the risk and providing them with mitigation strategies which included turning off the devices. For hospitals and health systems, shutting off the devices is not an option for many reasons, first and foremost is patient safety. The security of these devices became an imminent threat, causing clinical engineering and information technology departments to shift into high gear to develop mitigation strategies. INHEL REKIK Clinical Engineering Manager

This article will demonstrate the importance of medical device security, identify some of the challenges to securing medical devices, recommend strategies and tools for addressing security on these devices, and discuss some of the long term implications of utilizing legacy medical equipment. Biomedical devices can be used for monitoring patients, delivering direct care, or supporting the patient care process (beds using embedded operating systems are an example). In order to support these functions, the clinical engineering and information technology (IT) departments must ensure the confidentiality, integrity and availability of electronic information stored and utilized by these devices. Some devices can contain large amounts of protected health information (PHI) which must be protected (confidentiality) in accordance with the Health Insurance Portability and Accountability Act (HIPAA). The Officer for Civil Rights, which enforces HIPAA, provided guidance in July 2016 that ransomware

is considered a “breach.” Thus, an infection like WannaCry may require a hospital to notify patients of the breach of their PHI. The integrity of data on these devices is of utmost importance when provisioning care. A provider relies on the data to be true and accurate from these devices so they can make the appropriate decisions about patient care. Malware infecting a device can accidentally or purposefully alter the data. As more devices feed or receive data directly into the electronic health record, the accuracy of this data becomes more important in the long term care of a patient. An example of this is integrated infusion management where the dose delivered to the patient depends on the patient data the infusion pump received from the electronic medical record (EMR). Corrupted patient information received by the infusion system, such as incorrect patient weight, can result in the wrong volume of drugs being delivered to the patient. The most important aspect of

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biomedical device security is “availability.” A device must be available, meaning operating in a normal manner. For devices like ventilators, infusion pumps and defibrillators, their availability is essential for patient safety. Many devices can be operated as “stand alone” or networked. An incident impacting a hospital network may force medical devices to operate in “stand alone” mode, interrupting an automatic workflow that’s already in place. As a result, clinical staff will need to do a lot of manual data entry and use their downtime procedures. This has the potential of limiting the number of patients that can be treated which results in a loss in revenue and delay in proving care and the appropriate documentation. CHALLENGES IN MEDICAL DEVICE SECURITY There are many challenges to supporting medical device security; among them are regulatory

JANUARY 2018

TECHNATION

EXPERT ADVICE

certification for biomedical devices, vendor support for systems and the lifespan of medical devices. In the Postmarket Cybersecurity final guidance issued on January 2016, the FDA states that the majority of updates and patches that are released to address cybersecurity concerns are considered device enhancement for which the FDA doesn’t need to be notified. However, if the medical device manufacturer releases corrections to cybersecurity vulnerabilities that can result in patient harm, they need to notify the agency. This statement can be a source of confusion, however it’s important to understand that the instances where the manufacturer needs to notify the FDA are very rare and that in most cases health care organizations can expect the manufacturer to correct cybersecurity vulnerability in a timely manner. Other medical devices belong to the category of Internet of Things (IoT) and these bring a whole new set of challenges since they are more vulnerable to cybersecurity hacks Oftentimes healthcare technology management (HTM) departments don’t support the entire medical device system. HTM does support the medical device but not the entire system which may include servers, infrastructure and information systems that may be supported by IT, third-party vendors or both. If part of the infrastructure is supported by the vendor, the hospital may need to validate that security updates are applied to maximize the security of the system. It’s important to note that if a high availability infrastructure is not set up and in place, a downtime needs to be scheduled at a time with less impact on patient care for security updates to be applied. In addition, hospitals keep medical equipment in use beyond its supported lifespan. Like other computer equipment, a device that has outlived the lifespan of support will not be patched or supported by the vendor. Special attention needs to be paid to these devices and additional controls applied to protect them from threats.

TECHNATION

JANUARY 2018

JOHN RASMUSSEN MedStar Vice President & CISO

BUILDING A PROCESS TO PROTECT DEVICES A hospital, health system or physician practice should have a sustainable program for biomedical device security. This program must include the HTM department, Information Technology, providers and medical device vendors to ensure a partnership and understanding of the impact of a program. The program must begin with the procurement process and be sustained throughout the medical device lifecycle. It must also take into consideration a rapidly changing IT landscape. The program should contain elements that include: asset management, contract review, ongoing risk assessment and management, application of security controls and incident response planning. Asset management is the foundation of an effective medical device security program. HTM departments need to have an accurate inventory of their medical devices that are updated regularly as medical devices are added or removed from service. In addition, some additional data needs to be collected in the asset management system such as whether the medical device has a wireless or wired network connection in addition to the wireless protocol used such 802.11 a, b, g and n. Open ports and communications protocols could be added as well if data is available. Some additional network information such as device network ID,

firmware version, software version, MAC address and underlying operating system need to be collected as well. This data allows health care organizations to quickly identify affected devices when vulnerability is known. Knowing which software version is installed on the medical devices can also assist in locating devices that are affected by a recall that affects a certain software version. Barcoding and asset tracking can also help ease maintenance. Integrating the asset management and asset tracking system will add the location of the medical device to the database. This is especially helpful when locating mobile devices for preventive maintenance or patch/ software updates. It is also important to record whether the medical device stores PHI. Providing expertise to the contracting process will help “built in” rather than “bolt on” security. Legal and contracting departments may not understand the scope of work or contract language around security so it is important to have someone with biomedical and IT security experience review new contracts and contract renewals to ensure that security controls and responsibilities are included and shared with the vendor. When reviewing contracts that are up for renewal the program should consider changes in the security landscape and add them to the contract when applicable. This process will also help identify the responsibilities of the IT department and clinical engineering in securing devices, thus keeping you from scrambling if there is an imminent threat that must be addressed. For example, a clause can be added to the contract to identify the responsible party for installing security patches and updates as well as a replacement strategy when operating system are out of support. Risk assessment and risk management is an integral part of procurement and of the device lifecycle management. As the environment of the medical devices change, risks should be periodically reevaluated. The HTM department needs to add the cyber risk classification to the basic risk classification as high risk and

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EXPERT ADVICE TRIM 2.25”

starting point of the medical device cyber risk and answers the MDS2 form questions. The cyber risk can further be evaluated by looking at all the points listed above. The risk assessment should also include scanning the device for vulnerabilities and open ports prior to deploying the medical device. Vulnerability scanning should be done periodically within the environment to assess new risks; however, care should be taken to ensure vulnerability scanning is not done when the device is being actively used for care. Application of security controls should be done as a partnership between clinical engineering, IT and the medical device vendor. This will ensure that there are layers of defense to prevent infection.

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non-high risk detailed in The Joint Commission Revised Equipment Maintenance Requirements, EC.02.04.01 EP2. Risk assessment includes evaluating the product upon procurement to determine if administrative, technical or physical safeguards need to be put in place to mitigate the risks. Risk assessments will look at the technology being used and its current vulnerabilities, as well as the type of data and operational use of the equipment. A risk assessment will ask about patching, password management, local data storage, Internet connectivity, device interoperability, remote support, etc. An important part of the risk assessment will be the Manufacturer’s Disclosure Statement of Medical Device Security (MDS2), which should be provided to clinical engineering prior to procurement. The Medical Device Innovation, Safety and Security Consortium can provide health care organizations with a good

EDITOR’S NOTE: This article will continue with Demystifying Medical Device Security, Part II in the February 2018 issue of TechNation.

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JANUARY 2018

TECHNATION

EXPERT ADVICE

BY JON BENEDICT

CYBERSECURITY EXPERT Securing Medical Devices: Where Do We Start?

here is no hotter topic in health care today than securing medical devices. With an electronic health record often fetching prices 10 times that of a credit card number, the motivation is easy enough to understand; it’s money! As information security professionals, we understand this threat is not a scare tactic for our customers in health care. Unfortunately, the threat is as real as it gets and with patient lives literally on the line, the stakes couldn’t be any higher. The question I am asked most often is, “Where do we start?” I’m not surprised; there is so much information out there in terms of sets of controls, like NIST, HIPAA and the Center for Internet Security (CIS). Defensive strategies like defense-in-depth and protected enclaves use tools like IDS, IPS, next-gen firewalls, etc. It’s a ton of information for even the most seasoned information security professional to digest. Imagine how overwhelming it can be to the health care professionals who are primarily focused on the treatment of patients. The one thing we know for certain is that “security through obscurity” is no longer a valid defensive strategy. It won’t protect patients, or their private ePHI, and it won’t help reduce the impact or fines in the event of a breach.

TECHNATION

JANUARY 2018

JON BENEDICT Director of Information Security and Jump Team Operations for The InterMed Group

So where do we start? In order to build an effective defensive strategy, I need to know what we’re attempting to protect. I would suggest our goal is to defend ePHI. With that in mind, I want to start with devices that generate, store or transmit ePHI. Once we know what we’re trying to defend, where it lives in the network, and what it should be connecting and communicating with; we can then start to develop a defensive strategy for these “crown jewels” of the clinical network. Translation: Let’s start with an accurate inventory of the medical devices that includes both physical and logical metadata. Until recently, when we mentioned an accurate inventory for

medical devices it typically included fields like make, model, serial number, department, PM dates, etc., but rarely included MAC address, IP address, operating system, software, firmware, and other more critical data fields needed to fully integrate with the larger enterprise network and leverage its defensive tools and capabilities. The collection of these data fields is more commonly known as “device profiling.” I feel the best place to start is to ensure we have an accurate inventory and the device profiling information necessary to integrate with the IDS and IPS systems that are likely already in place in the rest of the enterprise network. However, this may be easier said than done with medical devices, because they are quite often more like operational technology (OT) devices that are purpose-built to perform a specific set of functions, (like taking an X-ray image or performing a CT scan) than a more traditional information technology (IT) device like a laptop computer. The best results I have seen in obtaining an accurate inventory for medical device profiling is a combination of automated scanning tools with the good old-fashioned boots-on-the-ground concept with experienced service engineers.

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BY JIM FEDELE, CBET

THE OTHER SIDE Saying Hello and Goodbye

ello readers of TechNation! This is my first column in this great magazine. The new year brings a fresh start to reset ourselves with new goals and resolutions. It gives us that personal “reset” to get back on track with great resolve. For me, the new year is ushering in many changes in my personal and professional life. One important change for me professionally is that after 17 years of writing in Medical Dealer magazine, we are moving my column to TechNation. It is an honor to share editorial space with great industry leaders like Manny Roman, Roger Bowles and the other contributors to this magazine. My hope is that I can bring value to this magazine by sharing experiences and insights from daily experiences as a biomedical director.

I find comfort in what a new year symbolizes. It provides me with the necessary closure to a year worth of experiences – good and bad. It provides a natural catalyst to goal setting and career planning that you just don’t get any other time of the year. I would even bet people who say they can’t set goals have set goals or promises to themselves on New Year’s Day. I doubt anyone would be motivated to start a new project or set a new goal on July 1, there is just too much going on. Who can think about all that planning stuff when there are picnics and barbecues to go to? Not me. The new year is the clean slate I need to get motivated. I find it refreshing to mentally cleanse my spirit of all the worries, failures and fear from last year. Then resolve to take corrective action and to not repeat the experiences over again. I find many people get tripped up planning for the future because of some past negative experience or some unfounded fear. The new year can be a symbol of life anew and the inspiration to help you move forward with a clean conscience. There is absolutely no better time to get busy on projects, especially for procrastinators like me that use interruptions to delay unpleasant work.

The opportunity to focus on what needs done is never better than the beginning of the year. Setting yourself up for success this year is simple if you follow a few guidelines. First, be specific about what you want to accomplish. Beware of generalities. Ensure your goal is measurable, you can’t improve what you cannot measure. Ask yourself if you possess the talent to accomplish what you want or will you need help. Confide in a mentor or friend; tell them what you want to do. Write down the goal and put it some place you can read it every day, and track your progress. Finally, don’t be too hard on yourself if at first you fall off track or your progress is slow, just assess what you are doing and change your strategy, if necessary. It has been my experience that by following these steps for setting goals my success rate to stay on track increases dramatically. Don’t let this opportunity to start fresh with a clean slate pass you by. Challenge yourself to be more than you are. Take a course, attend a conference, develop a new skill or just try to improve your health. I think that once you start you will be glad that you spent

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JIM FEDELE, CBET

time on your own improvement. In closing, I would like to thank my readers in Medical Dealer for the past years of support and engagement. I am hopeful the great people who read TechNation will be the same. Happy New Year! JIM FEDELE, CBET, is the director of clinical engineering for Susquehanna Health Systems in Williamsport, Pa. He can be reached for questions and/or comments via email at info@mdpublishing.com.

JANUARY 2018

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EXPERT ADVICE

BY MANNY ROMAN, CRES

ROMAN REVIEW Bad Communication Begins Here

was conducting research on causes of poor communication and came across a great TED-Ed Blog by Julian Treasure on bad communication habits that we all seem to have. It seems that there are four “common emotional drivers that suck the power out of communication.” He appropriately calls these the four leeches.

I have always said that communication is key to everything. I speak on the factors that make for good communication such as telling the what, the why, providing expectation as a result of what was said and gaining acceptance or understanding. I also speak on the need for ensuring to ask for feedback and ensuring to provide feedback. As I write the above, I realize that I am attaching the first leech in our communication. The first leech is the desire to look good. We like to look good. I don’t mean physically appealing, as I most definitely am. I mean in how we are viewed in conversation. This desire manifests itself in the “I know” statement. We like to demonstrate that we know stuff so we prepare to broadcast the knowledge whenever we speak. However, if we know everything, how can we learn anything? We all have experienced talking with someone who cannot be impressed because they know and have done everything. It makes everything you are excited about secondhand, unimportant and trivial. It makes you want to get away physically or by shutting down. The second leech is being right. We tend to want to be the one who is right in conversations. We feel that being right will earn respect and admiration.

It will place us in a higher status than others. Often this desire causes us to interrupt the conversation to interject the “correcting” statement. Interrupting is, of course, detrimental to the communication because it keeps us from hearing the full details and may offend the speaker. So … do you want to be right or do you want to have this relationship? Often they are mutually exclusive. Leech number three is people pleasing. This is when someone is way too agreeable. They desire to avoid conflict or to be seen as likeable. They will agree even when they internally do not. They will readily acquiesce to a request even when it violates a personal value. Let’s not rock the boat. The final leech is fixing. Let’s make it all right. Let’s not allow others to have undesirable feelings or be upset about something. Fixers strive to propose a solution to whatever is bothering you even if there really is no resolution possible. In the process they prevent venting by the other person and cause even more stress since the person is not allowed to present their feelings. Also, sometimes the individual does not want to be probed for a solution. Men are great fixers by the way. When my wife Ruth seems upset, my first instinct is to solve and redirect. My approach is the classic “What is wrong

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MANNY ROMAN, CRES AMSP Business Operation Manager

and how can I fix it?” If she attempts to actually tell me, I bring out the above leeches and carefully and expertly place them for greatest effect. I make sure that I look good by knowing everything therefore I have the solution. I, of course, cannot possibly be wrong in anything I say or do. I am very pleasant in my own special patronizing way. And for the final leech, I let her know in a very loving way that her problem is now fixed never to resurface. My final act is to redirect her efforts into taking care of my needs such as the need for lunch and a glass of wine. Zen Proverb “Knowledge is learning something every day. Wisdom is letting go of something every day.”

JANUARY 2018

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BREAKROOM

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JANUARY 2018

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THE VAULT

o you consider yourself a history buff? Are you widely regarded among coworkers as an equipment aficionado? Here is your chance to prove it! Check out “The Vault” photo. Tell us what this medical device is and earn bragging rights. Each person who submits a correct answer will be entered to win a $25 Amazon gift card. To submit your answer, visit 1TechNation.com/vault-January-2018. Good luck!

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NORTHWEST HTM MIXER This year, the Washington State Biomedical Association (WSBA) and the Oregon Biomedical Association (OBA) joined forces to host the Northwest HTM Mixer, proudly supported by TechNation, Summit Imaging and Interstate Batteries. The HTM Mixer was held in November at the beautiful Hyatt Regency in downtown Bellevue, Washington. The two-day event featured a welcome reception, educational opportunities, a keynote address and various valuable networking opportunities for HTM professionals as well as leaders from the medical device equipment and service industry. Later this year, MD Expo will be held in Seattle, Washington, on October 5-7 at the Hyatt Regency Bellevue. For information about MD Expo, visit MDExpoShow.com or join the Facebook group. 1. HTM Professionals gathered from around the Pacific Northwest in Bellevue, Washington for the Northwest Mixer that

4. The Northwest Mixer was a great place to students and teachers to meet current HTM professionals

was hosted by the Washington State Biomedical Association (WSBA) and the Oregon Biomedical Association (OBA) and supported by TechNation magazine.

5. The Fluke team was onsite demonstrating all of its latest testing equipment.

2. The exhibit hall at the Northwest Mixer featured some of the top technologies and service options available to HTM professionals.

6. Most vendors had live equipment set up ready for demonstrations.

7. WSBA board member Ron deRu presents former WSBA President Brandon Keith with a token of thanks from the organization. 8. The WSBA held their annual meeting as part of the kickoff for the Northwest Mixer where they honored veterans and elected a new president.

9. TechNation’s Jayme McKelvey prepares for booth traffic just before the exhibit hall opens. 10. The Northwest Mixer featured outstanding educational sessions for biomeds and managers.

3. Networking events provided valuable interaction among industry leaders.

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JANUARY 2018

TECHNATION

BREAKROOM

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TECHNATION

JANUARY 2018

Feb. 5-9 – RSTI: GE Optima XR220 AMX Digital and XR200 AMX Portable

Philips: V60 Feb. 22-23 – aining Service Tr

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EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

JANUARY 2018

TECHNATION

INDEX

SERVICE INDEX TRAINING

SERVICE

PARTS

Anesthesia

Company Info

AD PAGE

TRAINING

SERVICE

PARTS

AD PAGE

Company Info

Computed Tomography

A.M. Bickford 800-795-3062 • www.ambickford.com

Injector Support and Service 888-667-1062 • www.injectorsupport.com

Gopher Medical 844-246-7437 • gophermedical.com

P P

RSTI 800-229-7784 • www.rsti-training.com

INS

P P P

Soma Technology, Inc 1-800-438-7662 • www.somatechnology.com

Tri-Imaging Solutions 855-401-4888 • www.triimaging.com

P P P

USOC Bio-Medical Services 855-888-8762 • www.usocmedical.com

P P

Injector Support and Service 888-667-1062 • www.injectorsupport.com

P P

Maull Biomedical Training 440-724-7511 • maullbiomedicaltraining.com

Advanced Ultrasound Electronics, Inc. 1-866-620-2831 • www.auetulsa.com

P P P

Asset Management Shared Imaging LLC 1-800-606-0266 • www.sharedimaging.com

Diagnostic Imaging

Biomedical ALCO 800-323-4282 • www.alcosales.com

71, 76

Shared Imaging LLC 1-800-606-0266 • www.sharedimaging.com

BC Group International, Inc 314-638-3800 • www.BCGroupStore.com

Education

Biomedical Repair & Consulting Services, Inc. 844-656-9418 • www.brcsrepair.com

Crothall Healthcare Technology Solutions (800) 447-4476 • www.crothall.com

P P

Endoscopy

D.A. Surgical 800-261-9953 • www.da-surgical.com

Healthmark Industries 800-521-6224 • HMARK.COM

Health Tech Talent Management, Inc. 757-563-0448 • www.HealthTechTM.com

PRN/ Physician's Resource Network 508-679-6185 • www.prnwebsite.com

P P

iMed Biomedical 817-378-4613 • www.imedbiomedical.com

Master Medical Equipment 866-468-9558 • masterfitmedical.com

24, 61

P P

PRN/ Physician's Resource Network 508-679-6185 • www.prnwebsite.com

P P

Minnesota State College southeastmn.edu/bio18

Gas Monitors Biomedical Repair & Consulting Services, Inc. 844-656-9418 • www.brcsrepair.com

P P

General ALCO 800-323-4282 • www.alcosales.com

Calibration Rigel Medical, Seaward Group 813-886-2775 • www.seaward-groupusa.com

Gopher Medical 844-246-7437 • gophermedical.com

P P

inRayParts.com 417-597-4702 • www.inrayparts.com

Southeastern Biomedical, Inc 828-396-6010 • sebiomedical.com/

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Imaging

Southwestern Biomedical Electronics, Inc. 800-880-7231 • www.swbiomed.com/

P P

Health Tech Talent Management, Inc. 757-563-0448 • www.HealthTechTM.com

TECHNATION

JANUARY 2018

71, 76

Hand Switches 21

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WWW.1TECHNATION.COM

INDEX

TRAINING

SERVICE

Healthmark Industries 800-521-6224 • HMARK.COM

PARTS

Infection Control

Company Info

AD PAGE

TRAINING

SERVICE

PARTS

AD PAGE

Company Info

Monitors/CRTs 38

Infusion Pumps

Ampronix, Inc. 800-400-7972 • www.ampronix.com

P P

BMES 888-828-2637 • www.bmesco.com

AIV 888-656-0755 • aiv-inc.com

P P

Integrity Biomedical Services 877-789-9903 • www.integritybiomed.com

P P

Elite Biomedical Solutions 855-291-6701 • elitebiomedicalsolutions.com

P P

USOC Bio-Medical Services 855-888-8762 • www.usocmedical.com

P P

Master Medical Equipment 866-468-9558 • masterfitmedical.com

24, 61

P P

Nuclear Medicine 2

P P P

Global Medical Imaging 800-958-9986 • www.gmi3.com

Infusion Therapy AIV 888-656-0755 • aiv-inc.com

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Online Resource

FOBI 888-231-3624 • www.FOBI.us

P P

Adel Lawrence Associates 866-252-5621 • www.adel-lawrence.com

Master Medical Equipment 866-468-9558 • masterfitmedical.com

24, 61

P P

MedWrench 866-989-7057 • www.MedWrench.com

Select BioMedical 866-559-3500 • www.selectpos.com

Minnesota State College southeastmn.edu/bio18

Soma Technology, Inc 1-800-438-7662 • www.somatechnology.com

Webinar Wednesday 800-906-3373 •1technation.com/webinars

USOC Bio-Medical Services 855-888-8762 • www.usocmedical.com

P P

Oxygen Blender FOBI 888-231-3624 • www.FOBI.us

Laboratory Ozark Biomedical 800-457-7576 • www.ozarkbiomedical.com

P P

RSTI 800-229-7784 • www.rsti-training.com

4 INS

Soma Technology, Inc 1-800-438-7662 • www.somatechnology.com

Tenacore Holdings, Inc 800-297-2241 • www.tenacore.com

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

INS

P P

Patient Monitoring

P P P

AIV 888-656-0755 • aiv-inc.com

P P

Ampronix, Inc. 800-400-7972 • www.ampronix.com

P P

BETA Biomed Services 800-315-7551 • www.betabiomed.com/

P P

Biomedical Repair & Consulting Services, Inc. 844-656-9418 • www.brcsrepair.com

P P

BMES 888-828-2637 • www.bmesco.com

P P

Elite Biomedical Solutions 855-291-6701 • elitebiomedicalsolutions.com

P P

Monitors Select BioMedical 866-559-3500 • www.selectpos.com

P P

PACS RSTI 800-229-7784 • www.rsti-training.com

Mammography Ampronix, Inc. 800-400-7972 • www.ampronix.com

P P P

JANUARY 2018

TECHNATION

INDEX

SERVICE INDEX

TRAINING

SERVICE

PARTS

Company Info

AD PAGE

TRAINING

SERVICE

PARTS

AD PAGE

Company Info

CONTINUED

Gopher Medical 844-246-7437 • gophermedical.com

P P

Replacement Parts

Integrity Biomedical Services 877-789-9903 • www.integritybiomed.com

P P

Advanced Ultrasound Electronics, Inc. 1-866-620-2831 • www.auetulsa.com

P P P

Master Medical Equipment 866-468-9558 • masterfitmedical.com

24, 61

P P

Engineering Services, KCS Inc 888-364-7782x11 • www.eng-services.com

MedEquip Biomedical 877-470-8013 • www.MedEqiupBiomedical.com

P P

Respiratory

Pacific Medical 800-449-5328 • www.pacificmedicalsupply.com

40, 53

P P

A.M. Bickford 800-795-3062 • www.ambickford.com

PRN/ Physician's Resource Network 508-679-6185 • www.prnwebsite.com

P P

FOBI 888-231-3624 • www.FOBI.us

P P

Southeastern Biomedical, Inc 828-396-6010 • sebiomedical.com/

P P

RTLS

Southwestern Biomedical Electronics, Inc. 800-880-7231 • www.swbiomed.com/

P P

Versus 1-877-9VERSUS • versustech.com/nowait

Tenacore Holdings, Inc 800-297-2241 • www.tenacore.com

P P

Software

USOC Bio-Medical Services 855-888-8762 • www.usocmedical.com

P P

Versus 1-877-9VERSUS • versustech.com/nowait

Portable X-ray

Surgical

inRayParts.com 417-597-4702 • www.inrayparts.com

P P

Radiology

Healthmark Industries 800-521-6224 • HMARK.COM

Telemetry

Ampronix, Inc. 800-400-7972 • www.ampronix.com

P P

AIV 888-656-0755 • aiv-inc.com

P P

RSTI 800-229-7784 • www.rsti-training.com

INS

P P P

Biomedical Repair & Consulting Services, Inc. 844-656-9418 • www.brcsrepair.com

P P

Soma Technology, Inc 1-800-438-7662 • www.somatechnology.com

BMES 888-828-2637 • www.bmesco.com

P P

Elite Biomedical Solutions 855-291-6701 • elitebiomedicalsolutions.com

P P

Recruiting Adel Lawrence Associates 866-252-5621 • www.adel-lawrence.com

Gopher Medical 844-246-7437 • gophermedical.com

P P

Health Tech Talent Management, Inc. 757-563-0448 • www.HealthTechTM.com

Integrity Biomedical Services 877-789-9903 • www.integritybiomed.com

P P

Stephens International Recruiting Inc. 870-431-5485 • www.bmets-usa.com/

Master Medical Equipment 866-468-9558 • masterfitmedical.com

24, 61

P P

MedEquip Biomedical 877-470-8013 • www.MedEqiupBiomedical.com

Pacific Medical 800-449-5328 • www.pacificmedicalsupply.com

40, 53

Southwestern Biomedical Electronics, Inc. 800-880-7231 • www.swbiomed.com/

P P

Tenacore Holdings, Inc 800-297-2241 • www.tenacore.com

P P

USOC Bio-Medical Services 855-888-8762 • www.usocmedical.com

P P

Refurbish AIV 888-656-0755 • aiv-inc.com

Repair ALCO 800-323-4282 • www.alcosales.com

TECHNATION

JANUARY 2018

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WWW.1TECHNATION.COM

WIDTH 3.25”

INDEX

TRAINING

SERVICE

PARTS

AD PAGE

Company Info Test Equipment A.M. Bickford 800-795-3062 • www.ambickford.com

BC Group International, Inc 314-638-3800 • www.BCGroupStore.com

P P

PRN/ Physician's Resource Network 508-679-6185 • www.prnwebsite.com

P P

Pronk Technologies, Inc. 800-609-9802 • www.pronktech.com

Rigel Medical, Seaward Group 813-886-2775 • www.seaward-groupusa.com

Southeastern Biomedical, Inc 828-396-6010 • sebiomedical.com/

We Obsess Over Diagnostic Imaging. Every. Quality Tiny. replacem ent parts and Detail. on-d emand service

—

P P

Training 63

Advanced Ultrasound Electronics, Inc. 1-866-620-2831 • www.auetulsa.com

P P P

ECRI Institute 1-610-825-6000. • www.ecri.org

RSTI 800-229-7784 • www.rsti-training.com

INS

Tri-Imaging Solutions 855-401-4888 • www.triimaging.com

HEIGHT 9.75”

Adel Lawrence Associates 866-252-5621 • www.adel-lawrence.com

Tubes/Bulbs Tri-Imaging Solutions 855-401-4888 • www.triimaging.com

P P

Advanced Ultrasound Electronics, Inc. 1-866-620-2831 • www.auetulsa.com

P P P

Ampronix, Inc. 800-400-7972 • www.ampronix.com

P P

Conquest Imaging 866-900-9404 • www.conquestimaging.com

P P P

Global Medical Imaging 800-958-9986 • www.gmi3.com

P P P

Summit Imaging 866-586-3744 • www.mysummitimaging.com

P P P

Ultrasound

X-Ray Engineering Services, KCS Inc 888-364-7782x11 • www.eng-services.com RSTI 800-229-7784 • www.rsti-training.com

INS

P P P

Tri-Imaging Solutions 855-401-4888 • www.triimaging.com

P P P

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

224-244-3726

partssales@sharedimaging.com www.sharedimaging.com

JANUARY 2018

TECHNATION

Ensure you KEEP receiving TechNation for another year by confirming your subscription information today! 2 Easy Ways to Renew your Complimentary Subscription! 1. Log onto www.1technation.com/subscribe OR 2. Complete the form below and fax to 770-632-9090 Please Print Clearly Name _______________________________________________ Title _______________________________ Hospital/Company ________________________________________________________________________ Address __________________________________________________________________________________ City _____________________________________________________________________________________ State ______________________ Zip _________________ Country ________________________________ Phone ___________________________________________________________________________________ Fax _____________________________________________________________________________________ Email ____________________________________________________________________________________ Website __________________________________________________________________________________ Signature ___________________________________________________ Date ________________________ 1. What is your primary job title?

(check only one) m Clinical, Biomedical or Radiology Engineer m Biomedical Equipment Technician m Service/Support Manager m IS/Network Manager m Purchasing Manager m Sales/Marketing Manager m Department Administrator/ Director or Manager m Other (please specify) _______________________________________ _________________

2. What is your company’s primary business? (check only one) m Hospital or Clinic m Medical Equipment m Computer/IT Equipment m Dealer or Distributor m Multivendor/Independent Service Organization m Depot Repair m Education/Training m Consulting m Other (please specify) ____________________________ ____________________________

3. Please check the statement that best describes your role in purchasing products/technolgy: (check only one) m Make final decision m Specify/recommend m No part in purchasing

4. Type of facility/business: (check only one) m ISO m OEM m Self Employed m Other (please specify) _________________________ _________________________

INDEX

Watch your

money grow with PRN.

ALPHABETICAL INDEX Adel Lawrence Associates………… 63

inRayParts.com…………………… 21

Advanced Ultrasound Electronics, Inc.………………… 29

Integrity Biomedical Services……… 71

AIV………………………………… 67 ALCO…………………………… 71, 76 A.M. Bickford……………………… 40 Ampronix, Inc.………………………… 4 BC Group International, Inc……… 92 BETA Biomed Services, Inc.……… 20 Biomedical Repair & Consulting Services, Inc.……………………… 37 BMES……………………………… 91 Conquest Imaging…………………… 8 Crothall Healthcare Technology Solutions…………………………… 65

Master Medical Equipment…… 24, 61 Maull Biomedical Training………… 63 MedEquip Biomedical…………… 65 MedWrench……………………… 74 Minnesota State College…………… 45 Ozark Biomedical………………… 76 Pacific Medical ………………… 40, 53 PRN/ Physician's Resource Network……………… 89 Pronk Technologies, Inc. …………… 5 Rigel Medical, Seaward Group……… 3

Select BioMedical………………… 31

ECRI Institute……………………… 52

Shared Imaging LLC……………… 87

Elite Biomedical Solutions………… 25

Soma Technology, Inc…………… 73

Engineering Services, KCS Inc……… 6

Southeastern Biomedical, Inc…… 60

FOBI……………………………… 33

Southwestern Biomedical Electronics, Inc.………………… 42

Gopher Medical…………………… 11 Health Tech Talent Management, Inc.……………… 73 Healthmark Industries…………… 38 iMed Biomedical…………………… 15 Injector Support and Service……… 37

A national leader in the sale of new, used, and refurbished medical equipment. Our equipment is tested and serviced in-house so that we can guarantee its integrity.

RSTI………………………………… INS

D.A. Surgical……………………… 21

Global Medical Imaging……………… 2

Physician’s Resource Network

AUTHORIZED NORTHEAST DISTRIBUTOR OF

Stephens International Recruiting Inc.………………… 24 Summit Imaging…………………… 59 Tenacore Holdings, Inc…………… 47 Tri-Imaging Solutions……………… 36 USOC Bio-Medical Services………… 7 Versus……………………………… 14

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

1.800.284.0967 www.PRNwebsite.com

JANUARY 2018

TECHNATION

BREAKROOM

“ W hen something is important enough, you do it even if the odds are not in your favor.” - Elon Musk

TECHNATION

JANUARY 2018

WWW.1TECHNATION.COM

Beyond the expected www.bmesco.com 888.828.2637

COMPLETE PATIENT SIMULATION Portable

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√ Cardiac Output √ Fetal Maternal

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NIBP-1040 Kit Cardiac Output Included

Tests 6 Separate Parameters Simultaneously

Optional SpO2

Features:

NIBP-1010

NIBP-1020

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+ ECG Simulation

+ Multi-Parameter Patient Sim

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Internal Rechargeable Battery

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All models are SpO2 Ready

Phone: 1-888-223-6763 Email: sales@bcgroupintl.com Website: www.bcgroupintl.com ISO 9001 & 13485 Certified ISO 17025 Accredited