TechNation Magazine April 2021 by MD Publishing

1technation.com

Vol. 12

ADVANCING THE BIOMEDICAL / HTM PROFESSIONAL

APRIL 2021

Downtime Strategies

Tips for the Planned and Unplanned

12 Department of the Month Stanford Health Care Biomedical Engineering Department

14 Company Showcase

SOC Bio-Medical U Services

24 Medical Device Service

Debate Continues White Paper Sparks Heated Conversations

67 The Future

Learning After Lockdown

Right-sizing your equipment inventory could help your hospital save millions. Every hospital struggles with inventory shrinkage, and over-purchasing expensive medical equipment is commonly accepted as the solution to the problem. But buying more assets comes at a great cost—and those costs are avoidable with the help of real-time locating system (RTLS) technology. Keep tabs on your equipment, right-size your inventory, save on capital expenditures and work smarter with Midmark RTLS.

Learn more at midmark.com/asset

Visit us in BOOTH 209 at MD EXPO Dallas

DON’T FORGET surgical booms and lights require preventive maintenance too. ST I G

FOBI Medical has the expertise to handle your needs.

E R ED

ISO

• Preventive Maintenance • Repair and Service • Replacement Parts • Installation and Removal

6 :201 5 8 134

M PA

Overloaded with special projects? Need an additional technician…or two or three? FOBI Medical’s onsite service team can help!

TEMPORARY

LONG-TERM

Biomedical Services

Have a huge amount of medical equipment to check-in and tag for that new ICU tower or surgical suites? Thousands of infusion pumps or a hundred defibrillators to PM this month? Sometimes you need a temporary, extra set of hands to fill in the gaps. FOBI’s quick response teams (QRTs) are fully trained and qualified to fill personnel gaps and assist in getting your department back on track.

Have multiple clinics you just can’t cover? One or two small hospitals or surgery centers you just don’t have the in-house manpower to handle? Or a need specialty biomed for respiratory or anesthesia maintenance and don’t have the time or budget to search, hire and train? FOBI Medical can schedule a full-time technician in your facility. A technician dedicated to your specific clinical equipment needs who works as part of your staff.

Contact FOBI Medical about filling the personnel gaps in your department today!

www.FobiMed.com

888.231.3624

ABOUT SUMMIT www.mysummitimaging.com

Summit’s focus is to reduce system downtime with quality repairs that lower total cost of ownership. Our unique model to remotely support clinical engineers enables quicker equipment repairs with reported savings in excess of 65% relative to external service contracts. We offer comprehensive ultrasound support that includes Transducer Repair, Replacement Parts, Training, Technical Support, and use of our proprietary Adepto™ Diagnostics and Service Software to quickly help healthcare facilities resume caring for patients.

MAKING OUR CUSTOMERS HEROES™

NEED ULTRASOUND SUPPORT? OUR TEAM OF EXPERTS ARE AVAILABLE 24/7.

Learn more at:

Mysummitimaging.com

866-586-3744

See the full picture The business of healthcare needs a converged approach to security. Zero Trust needs to be recalibrated to protect each care protocol and the surface must expand to include the processes and procedures. Biomed needs to help cybersecurity teams understand what they are really protecting—good care for patients, not just access to devices.

Discover more at medigate.io

SIMPLE SOLUTIONS FOR

COMPLEX DEVICES

SIMPLE SOLUTIONS FOR PATIENT MONITORING • PARTS PATIENT CABLES • RENTALS

MANUFACTURERS PHILIPS • GE • COROMETRICS SPACELABS • MINDRAY • DATEX-OHMEDA WELCH ALLYN • MASIMO • NELLCOR CAREFUSION • SECHRIST

20 MORGAN | IRVINE, CA 92618 CALL: 1.855.888.8762 VISIT: USOCMEDICAL.COM

TODAY FOR ALL YOUR DEVICE NEEDS! ISO 9001:2015 and 13485:2016 Certified

UNDER PRESSURE OR OUT OF GAS?

Prevent Failures With Early Warning Signs

hankfully your car warns you when tire pressure and gas tanks get low, protecting us from potential catastrophes on the road. Unfortunately our imaging devices don’t do the same..

Innovatus Imaging’s repair processes for hundreds of makes and models of ultrasound probes and MRI coils include preventive assessments to check for early warning signs of issues that could become big drains on cost and performance, and repair them before you get stranded with non-performing devices. We Call It Preventive Repair. You Can Call It Life. To set up a repair or arrange for a loaner to keep you up and running, call for 844 687 5100. Browse our capabilities and loaner inventory at innovatusimaging.com. Meet with our experts at Booth 303 at MD Expo in Dallas, April 16-17

Customercare@innovatusimaging.com 844.687.5100 innovatusimaging.com Pittsburgh | Tulsa | Denver

CONTENTS

FEATURED

HE ROUNDTABLE: T DEFIBRILLATORS Healthcare technology management experts from Renew Biomedical, ProHealth Care, Coro Medical and Fluke Biomedical share feedback regarding the basic functions every automated external defibrillator (AED) should have and more. Next month’s Roundtable article: IV Pumps

DOWNTIME STRATEGIES: TIPS FOR THE PLANNED AND UNPLANNED Clinical technology has become more robust, more integrated and more interdependent. Read this month’s cover story on downtime planning. ext month’s Feature article: N Medical Device Risk Scoring

24 MEDICAL DEVICE SERVICE DEBATE CONTINUES: WHITE PAPER SPARKS HEATED CONVERSATIONS

TechNation (Vol. 12, Issue #4) April 2021 is published monthly by MD Publishing, 1015 Tyrone Rd., Ste. 120, Tyrone, GA 30290. POSTMASTER: Send address changes to TechNation at 1015 Tyrone Rd., Ste. 120, Tyrone, GA 30290. 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. ©2021

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

APRIL 2021

TECHNATION

INSIDE Departments

CONTENTS

PUBLISHER

John M. Krieg

VICE PRESIDENT

Kristin Leavoy

ACCOUNT EXECUTIVES

Jayme McKelvey Megan Cabot

ART DEPARTMENT Jonathan Riley Karlee Gower Amanda Purser EDITORIAL

John Wallace Erin Register

CONTRIBUTORS

Roger Bowles Jenifer Brown K. Richard Douglas Jim Fedele Joe Fishel Manny Roman Cindy Stephens Steven J. Yelton

DIGITAL SERVICES

Cindy Galindo Kennedy Krieg

EVENTS

Lisa Lisle

WEBINARS

Jennifer Godwin

HTMJOBS.COM

Kristen Register

ACCOUNTING

Diane Costea

EDITORIAL BOARD

Jim Fedele, CBET, Senior Director of Clinical Engineering, UPMC Carol Davis-Smith, CCE, FACCE, AAMIF, Owner/ President of Carol Davis-Smith & Associates, LLC David Francoeur, CBET, CHTM, Senior Vice President Marketing and Sales, Tech Know Associates - TKA Jennifer DeFrancesco, DHA, MS, CHTM, System Director, Clinical Engineering, Crothall Healthcare Rob Bundick, Director HTM & Biomedical Engineering, ProHealth Care

MD Publishing / TechNation Magazine 1015 Tyrone Rd., Ste. 120, Tyrone, GA 30290 800.906.3373 • Fax: 770.632.9090 Email: info@mdpublishing.com www.mdpublishing.com

TECHNATION

APRIL 2021

Proud supporters of

P.12 SPOTLIGHT p.12 Department of the Month: Stanford Health Care Biomedical Engineering Department p.14 Company Showcase: USOC Bio-Medical Services p.18 Professional of the Month: Harold L. Duryea, CBET: Solving the Actual Problem p.20 Shifting Gears: Community Involvement is Gratifying P.24 SERVICE DEBATE p.24 Medical Device Service Debate Continues: White Paper Sparks Heated Conversations P.28 INDUSTRY UPDATES p.28 News and Notes: Updates from the HTM Industry p.36 AAMI Update p.38 ECRI Update p.40 Ribbon Cutting: Medical Technology Management Institute P.42 p.42 p.44 p.46 p.48

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

P.62 EXPERT ADVICE p.62 Career Center p.64 20/20 Imaging Insights, sponsored by Innovatus Imaging p.67 The Future p.68 Working Smarter, Not Harder: 4 Ways to Improve HTM Department Efficiency, sponsored by Nuvolo p.70 Cybersecurity p.72 Why Zero Trust Matters to Biomedical Engineers: 5 Benefits of Clinical Zero Trust, sponsored by Medigate p.74 The Other Side P.78 BREAKROOM p.78 Did You Know? p.80 The Vault p.82 MedWrench: Where In The World Is Ben C.? p.86 iMed Biomedical: Get Up Clean Up Contest p.98 HTM Strong p.93 Service Index p.97 Alphabetical Index Like us on Facebook, www.facebook.com/TechNationMag Follow us on Twitter, twitter.com/TechNationMag

WWW.1TECHNATION.COM

SPRING 2

Classes Start May 10, 2021 Enrollment Deadline May 3, 2021

A PARTNER IN YOUR

CAREER

ASSOCIATE OF APPLIED SCIENCE IN BIOMEDICAL EQUIPMENT TECHNOLOGY

Lifelong Learning Our commitment to our students extends beyond the limits of the classroom. Through continuing career services, mentor-ship, and support, we foster lifelong learning and professional development designed to strengthen the relationship we share with our students,alumni and partners in the healthcare industry.

ABOUT US We are committed to providing exceptional educational and career services in a flexible online format. Our small classes are led by skilled faculty with real-world experience. Our programs emphasize applied instruction with a focus on both general and advanced b i o m e d i c a l e q u i p m e n t .

FINANCIAL ASSISTANCE VA EDUCATION BENEFITS SCHOLARSHIPS AVAILABLE NO-INTEREST FINANCING OPTIONS

Strategic Partnerships We maintain strategic partnerships with healthcare organizations, service providers, and biomedical equipment manufacturers to provide externships, hands-on training, mentorship, and career services globally. Our international network of strategic partners makes it possible for us to establish real-world training opportunities for students seeking careers as BMETs.

Placement Services We assist students in finding employment after training. We help students secure jobs through various means including job searches, career fairs, direct communication with employers to identify upcoming requisites, resume writing assistance, and interview coaching. Graduates are eligible to access the college’s placement assistance program at no additional cost.

844.879.9043 WWW.CBET.EDU

SPOTLIGHT

DEPARTMENT OF THE MONTH

Stanford Health Care Biomedical Engineering Department BY K. RICHARD DOUGLAS

nly a handful of universities enjoy national prominence and immediate name recognition. Stanford University is among that small group.

In 1968, the university purchased Palo Alto-Stanford Hospital Center, and it was renamed Stanford University Hospital. In November of 2019, Stanford Health Care’s new 824,000-square-foot and state-of-the-art Stanford Hospital opened. Although the hospital and university share a name, and leadership work in partnership, the two are separate legal entities. A cutting-edge, high-tech health care network can only be supported by the best in medical equipment technology management. That job falls to the enterprise’s biomedical engineering team. “At Stanford Medicine and the larger Stanford University family, the biomedi-

TECHNATION

APRIL 2021

cal engineering program is leading and pioneering the advancement of optimized patient care outcomes at Stanford Health Care (SHC) through the management of healthcare technology and digital solutions,” says Adam Alkhato, director of biomedical engineering. He says that biomedical engineering at SHC is an integral and strategic vertical of Stanford Medicine’s Technology and Digital Solutions (TDS) organization, reporting directly to Chief Technology Officer Christian Lindmark. “Stanford Health Care provides care as a Tier 1 Trauma Academic Medical Center which is known for innovation and research. Stanford Health Care delivers care services to patients with the highest levels of acuity and treats cancer, heart disease, brain disorders, primary care issues, specialty care and other patient services,” Alkhato says. “Our biomedical engineering program is built by the pursuit of

excellence of the foundational pillars of HTM and is fueled by the advancement of our discipline through continual self-refinement and development at the intersection of medicine and technology. Every day, our biomeds are embedded and are leading the vetting and implementation of new innovations, integrations and patient facing technologies and systems,” Alkhato adds. He says that as part of the TDS organization, the biomeds are cohesively connected to the infrastructure, networking, integrations, applications and data report teams, delivering the best-of-class and comprehensive medical technologies and digital solutions to their clinical business partners. “The SHC Biomedical Engineering Department is comprised of 68 members, supporting the enterprise of Stanford Medicine’s inpatient and outpatient hospitals and clinics throughout Northern California,” Alkhato says. The team also supports the new high-tech Stanford Hospital.

WWW.1TECHNATION.COM

SPOTLIGHT

COMMITTING TO A SERVICE MODEL With standardization of procedures across the system, the biomed department has been able to win the confidence of clinical staff while advancing a clearly defined service model. “Aside from our repertoire of technical Stanford Health Care receives support from talented biomeds. skills, the SHC biomedical engineering department takes great Fontanares adds. pride in incorporating the customer He says that this communication tool service experience into our work ethic. has been biomeds’ compass in promotIt’s important for us to resolve medical ing positive interactions from beginning device issues for our clinical staff, but to end. it’s as equally important to ensure that “One by one, this business model our customers are satisfied with how significantly helped change the percepthat service is delivered. A few years tion of biomed for our clinical staff ago, after SHC had acquired Valley members. A testament to this was a Memorial Hospital, now known as recent surprise visit in our biomed shop Stanford Health Care ValleyCare, the from none other than our SHC Valleyhospital had gone through a series of Care CEO, who personally thanked us equipment maintenance programs by for not only improving the quality of well-known service companies,” biomedical device support during our Fontanares says. tenure, but for creating a positive He says that frequent changes over cultural change within the entire the years decreased the quality of hospital. We not only regained the equipment maintenance. confidence of our customers, but we are “Service was adversely impacted, also able to positively influence and including the confidence of clinical staff motivate other support service departmembers to receive the biomed support ments to improve the quality of the they needed. Executive leadership made services they provide,” Fontanares says. the decision to establish a SHC biomed Systemwide, the department has even team in-house, (an extension of the gained the admiration of the organizabiomedical engineering department tion’s top technology leader. from our main campus in Palo Alto). “I’ve been working with health care Using our CI-CARE organizations for over 20 years and the customer service biomedical engineering department at model, which is an Stanford Health Care is, without a acronym for doubt, one of the best biomed teams I’ve ‘Connect, Introseen anywhere in the country. Their duce, Communiwork is vital to providing our patients cate, Ask, Respond, with the best patient care available. I am Exit,’ we were able very proud of the entire team and their to successfully commitment to excellence in support of standardize a our caregivers and patients,” Lindmark process for all says. interactions with Is there a better compliment for a clinical staff team that manages medical device members, vendors, technology within one of the most colleagues and technology-savvy health systems in the The Stanford Health Care Biomedical Engineering Department includes patients alike,” world? the Palo Alto team. “Designed with the patient experience in mind, the new facility features 368 single-patient rooms, a 76-bay trauma center and 20 state-of-the-art operating rooms. Enterprise-wide, the department supports over one thousand beds in Northern California,” Alkhato says. Among the biomed team’s leadership are Alkhato, Senior Managers Michael Kozuma, CBET, and Darwin Fontanares, MBA, CHTM, BS-BMET, CBET; and Assistant Managers Dean Peterson, CHT; Jerrell Cooper, John Bassler, CBET; Richard Engdahl, CBET; and Suruj Narayan. Other members include Senior IT/ Biomed Project Manager Divya Pandya, PMP, CPHIMS, CHTM; IT/Biomed Clinical Applications Eben Kermit CCE; Business Systems Analyst Marco Salvaggio; and Program Project Coordinator Charlene Phifer. The department’s technicians round out the staff. The biomedical engineering team supports Stanford Health Care’s enterprise network of facilities, which includes three inpatient hospitals, four multi-pavilion medical office buildings, three ambulatory surgery centers, 80-plus clinics, affiliate offices across Northern California and the Tri-Valley and over 770 licensed patient beds. “We’re proud to again be recognized as one of the top hospitals in the country,” said David Entwistle, president and CEO of Stanford Health.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

APRIL 2021

TECHNATION

SPOTLIGHT

SPECIAL ADVERTISING SECTION

COMPANY SHOWCASE USOC Bio-Medical Services

SOC Bio-Medical Services is a leader in the medical device industry determined to know its customers, provide high-quality services, build solid relationships and maintain vendor neutrality. The company’s core values, as stated in its mission statement, are quality, integrity, innovation, accountability, collaboration and leadership.

Ali Youssef founded USOC Bio-Medical Services in 2009 to offer “simple solutions for complex devices” –namely, biomedical, respiratory and durable medical equipment. His goal to create an efficient and reliable repair company that focused on biomeds continues to motivate the entire team at USOC Bio-Medical Services. Today, USOC employs more than 100 people who provide biomedical equipment repair solutions to health care facilities, clinics and medical companies of all types and sizes. The company’s commitment to providing high-quality, cost-effective equipment and services is reflected in its ISO 9001:2008 and 13485:2016 certifications. USOC, located in Irvine, California, has a proven approach designed to keep medical equipment running in peak condition at a guaranteed cost savings. The company is used as a reference by the market for patient monitoring equipment repair and for refurbished devices. Additionally, the USOC team strives to help biomeds who may not specialize in specific types of equipment when faced with the daunting task of maintaining patient monitoring devices and every type of hospital equipment. The company partners with

In 2016, the SBA presented a special achievement award to Ali Youssef, owner and founder of USOC. The company has grown from its original three employees in 2011 to its current magnitude of more than 100 staff members to date, not only makes it a leader in its field, but an integral part of

TECHNATION

APRIL 2021

the BMET community and is present at biomed tradeshows throughout the United States. For more about USOC, we asked them to share their insider knowledge about the company’s services, goals and customer service. lease share a little bit about P your company’s history and how you achieved success. USOC: One of the keys to USOC’s success lies in our commitment to understanding not just the equipment, but each customer’s unique situation, level of expertise and needs. The company has achieved success by understanding the pressures today’s health care professionals face. Its innovative practices and expert engineers have allowed USOC to reduce the price of patient monitoring service without sacrificing quality. The Small Business Association (SBA) is an agency that has been responsible for the livelihood of small businesses and entrepreneur ventures since 1953. The goal of the SBA is to reinforce the nation’s economy by providing capital as well as analysis to up-and-coming businesses around the United States. For more than 50 years the SBA has also recognized the excellence of those businesses who have surpassed the meaning of excellence and accomplishment.

the progress of today’s economy. Congratulations to Ali and to his family that he refers to as USOC Medical!

hat are some advantages that W your company has over the competition? USOC: Our added value is our value proposition, especially compared to the competition. We are more than a repair facility for our biomeds, we act as a partner to help facilitate the repair process. We create a partnership with the biomeds and support them. We are the biomed shop for our biomeds as well as 24/7 technical support. We understand more than anyone else the biomed’s needs as our CEO is a biomed and serves as our lead technician and head engineer. We have leveraged our experiences to create a unique repair facility that meets the quality standards and turn times of each valued customer. Our quality is the reason we have the confidence to offer a 12-month end-to-end warranty for most repairs. We facilitate our biomeds’ daily tasks through our updated customer portal (USOC e-link) that is used not only for repairs but also provides support and guidance. We also have an emergency kit for our biomeds. The emergency kit consists of the most popular items that break down. It can be used as an exchange program when devices break down.

hat were some of the challenges W your company faced last year during the COVID-19 pandemic? USOC: First of all, USOC would like to express our appreciation for the health care industry’s hard work and dedication during this time of crisis and uncertainty. We realized last year that

WWW.1TECHNATION.COM

SPOTLIGHT

we had a special role during this unprecedented time, supporting our families and communities both locally and nationwide. Although at times our stock ran short, we were able to respond to an increasing demand for our services and continue to give the best service to our customers.

lease explain your company’s P core competencies and unique selling points. USOC: USOC provides biomedical equipment repair solutions to health care facilities, clinics and medical companies in the USA and Canada. Here is how it works: The hospital calls for troubleshooting and, if necessary, sends equipment to us. We test, diagnose and repair it at our facility and then send it back to them. We offer a warranty that allows the biomed shop to send the equipment back free of charge if there is ever a problem. We also offer continuing troubleshooting over the phone. If the equipment needs to be sent in for repair, USOC Bio-Medical Services

will program a loaner based on the hospital’s data and expedite shipping to the facility.

hat product or service are you W most excited about right now? USOC: We are excited about patient monitoring and the development of cost-effective ways to perform repairs on products as well as the implementation of software that enriches and eases the customer experience. We are also excited about our brand new customer portal that will allow all our clients to manage their repairs, create a Return Goods Authorization (RGA), print a shipping label, follow the different stages of the repair and have a complete dashboard of all their repairs with USOC Bio-Medical Services.

hat is the horizon for your W company? How will it evolve in the coming years? USOC: Hopefully, continued growth as well as the addition of new product lines and services are on the horizon. We are also spearheading new ways of doing

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

things and performing repairs while developing relationships and partnering with market-leading companies to advance our services and offerings.

hat is your company’s mission W statement? USOC: Our vision is empowering better patient health with technical insights. Our three goals are to promote a healthier world, build value and create an inspiring workplace. Our five-point strategy to achieve our goals are innovative growth, drive operational excellence, simplify the organization, focus on technical information services and deliver great products and services. An important part of the USOC Bio-Medical Services environment are our behaviors, which are customer focused, performance oriented, united as one team, transparent and agile. The core values at USOC Bio-Medical Services are quality, integrity, innovation, accountability, collaboration and leadership. For more information, visit www.usocmedical.com

APRIL 2021

TECHNATION

Keep Your Medical Devices Safe From Cyber Attacks 99%

85%

Device Accuracy on Classiﬁcation

1,000

Reduction in manpower

Sites deployed

FEATURES INCLUDE

INVENTORY

RISK MONITORING

PRIORITIZE

FIX

REPORT

Monitor and Classify devices passively using machine learning, deep packet inspection and parsing; characterize security posture.

Monitor Threats, Anomalies and Cyber-policies.

ASIMILY prioritizes vulnerabilities with the highest likelihood and highest impact on clinical safety, business operations, and data security.

Plan mitigation of vulnerabilities using ASIMILY recommendations and block / quarantine devices if anomalies or security concerns are detected.

Generate reports on Medical and IoT device attribute, conﬁgurable reporting tool to create reports, access any out of the box ASIMILY reports.

REQUEST A DEMO TODAY asimily.com | info@asimily.com | Tel: 408-627-4097

SPOTLIGHT

PROFESSIONAL OF THE MONTH

Harold L. Duryea, CBET: Solving the Actual Problem BY K. RICHARD DOUGLAS

little more than a five-hour drive from St. Louis and due north from Kansas City, is the city of Maryville, Missouri.

Northwest Missouri State University is in the northern portion of the city. Mosaic Medical Center-Maryville is further south. The medical center offers a full spectrum of health care services including cardiology, an emergency room, maternity, respiratory care, an ICU, imaging and more. A healthcare technology management (HTM) professionals who made AAMI’s “HTM Standouts” list in 2018 works at the medical center. Harold L. Duryea, CBET, is a member of the biomedical engineering department as a BMET III. Duryea’s road to an HTM career began indirectly thanks to his brotherin-law. “I was working in industrial maintenance at a glass plant and he had a business selling chiropractic and physical therapy equipment at the time. He wanted someone to run his repair shop and asked me if I might be interested. Since I was already taking classes at the local junior college in AC and DC power and electronics, I told him I’d think about it. I even took a trip to Virginia to check out his facility,” Duryea remembers. He says that while he was on the trip, they announced the sale of the glass manufacturing business and the closure of the facility. “I changed my major to biomedical equipment technology. I didn’t go to work in Virginia either. I ended up

TECHNATION

APRIL 2021

working at a 26-chair dialysis facility as a machine tech while I went to school at night to finish my degree,” Duryea says. He enrolled at Tulsa Junior College and majored in biomedical equipment technology. “The curriculum included AC/DC electrical instruction, basic and advanced electronics, computer science, program writing, as well as the usual requirements for an associate degree. The main difference were three semesters of biomedical instruction. The course was taught by the owner of a local ISO that included medical salvage, as well as sales both domestically as well as internationally. As such, he brought in equipment for hands-on teaching, as well as theory and background,” Duryea says. He adds that the coursework included anatomy and physiology, as well as cardiac function and the history and the development of ECG. “Why have more biomeds heard of Einthoven’s Triangle than many new nursing students? His theory is that you have to know how it works before you can repair it,” Duryea explains. He later earned a bachelor’s degree in health administration.

IGNORE THE THINGS THAT WORK As a biomed, in addition to making repairs and routine maintenance, there are also challenges to overcome. What challenges has Duryea faced as an HTM professional? “The easy answer to this one is COVID. Like everyone else, we’ve had to deal with cutbacks in hours, wage freezes, area restrictions and the usual things associated with a health crisis. What wasn’t expected was all the delays in getting parts, shipping issues and getting tech support. Many businesses were shut down and unable to be reached,” he says. Duryea says that some suppliers were either not open or unable to get the parts needed to build the parts he needs. “I have some parts I ordered in August that show a current due date of March; and that may be pushed again. It’s ongoing, but every one of your readers is facing the same thing,” he says. He says that of past challenges, the biggest one was EMR integration. “The first time was the worst. It was integrating all of the systems with EPIC. EPIC was a good system, but it was our first foray into the world of HL7, and we had no idea what was involved. Being one of the smaller hospitals in the health system we were previously owned by, we got to be the test case,” Duryea says. He says that every department had its issues, but for him, the OR was the worst. “Eight percent of our anesthesia machines weren’t even capable of HL7, so we had to replace them with new ones. A silver lining on that one, as they

WWW.1TECHNATION.COM

SPOTLIGHT

Harold Duryea, CBET, helps maintain equipment at Mosaic Medical Center-Maryville.

needed to be replaced. Forty percent of the anesthesia monitors had to be upgraded, and then the interfaces had to be built, and then came the exciting part for me. Time for testing to make sure all the parameters were not only being transmitted, but in the correct format. Hours of testing as we had two models of anesthesia machines and two different manufacturers of patient monitors,” he recalls. He says that they started testing and tweaking those systems three weeks before “go live” and discovered the actual go live was rather anti-climactic. “It worked; not perfectly, but the changes required were minor parameter code errors that were easily fixed,” Duryea says. He says that the biggest challenge after that was that biomeds weren’t given access to the system, but they were the ones onsite that everyone called whenever any of the nursing staff had issues with patient data not flowing into the chart. “I blame this on corporate leadership rather than the program itself, and I have colleagues at other hospitals that love the system. When the health system sold us in April of 2019, we got to transfer everything over to another EMR system. Lots of testing again, but at least, instead of being on the other side of the state and inaccessible, headquarters is now only 45 minutes away and they answer their phones. Once everything was tested, and ready, issues have been minor,” Duryea adds. Duryea’s efforts in the HTM field have been recognized, not only by AAMI, but also by leaders in his part of the country. “I was chosen to be on the advisory board for the curriculum for the

biomedical equipment technology program and related fields for Tulsa Community College,” he says. Away from work, Duryea enjoys weekly “eat and rides” with his local motorcycle group. He also enjoys vacationing with his wife on their motorcycles and Civil War reenacting. In addition to his wife, his family includes a son and two grandsons. He characterizes himself as a problem solver. “I have no problem finding alternate methods to find a solution. I am not afraid to attempt to repair anything. If I have tools and a manual; I have discovered that most things are fixable,” he says. “The first thing to remember is that most complex equipment is made up of smaller systems, so determine what is working and what isn’t. Then, concentrate on the section that isn’t and ignore the rest of the unit. Once you figure out that piece, there is a good chance the rest of it is fine,” he adds. Since getting his biomed degree in 1996, there is something to be said for his voice of experience and his contribution to the Maryville community.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

FAVORITE BOOK:

“Depends on my mood, I own over 1,100 books; mostly sci-fi and fantasy, and read every day so I’m always adding more; currently books by Clive Cussler. I’m waiting for the release of his last one, since he is no longer with us.”

FAVORITE MOVIE: “Deadpool”

FAVORITE FOOD: Ribeye

HIDDEN TALENT:

If I told you, it wouldn’t be hidden.

FAVORITE PART OF BEING A BIOMED:

“The new challenges. Every day, you get to work on something different. It’s not the boring repetition of a lot of office jobs. You can have instant gratification. You have the results almost immediately. You can still show pride in your workmanship and know that you are helping to improve lives with what we do.”

WHAT’S ON MY BENCH?

• Magnifying bench light • Soldering station • Pegboard with specialty tools and chemicals • Multimeter • Sweet tea

APRIL 2021

TECHNATION

SPOTLIGHT

SHIFTING GEARS

A look at HTM professionals away from work Community Involvement is Gratifying BYLINE: BY K. RICHARD DOUGLAS

obert D. Putnam, a professor of public policy at Harvard University, once said; “What really matters from the point of view of social capital and civic engagement is not merely nominal membership, but active and involved membership.”

Civic engagement and community volunteerism are important contributors to quality of life on the local level. It benefits the local community when local residents get involved. Through someone’s own initiative, or through a community-focused employer, an individual can make a real difference in their city, town or county. Quality of life ranks first on the mission statement for the city of Casa Grande, Arizona. The city, which lies between Phoenix and Tucson, was founded in 1879 and named after the Hohokam Indian Ruins. With 19 city-maintained parks and 17 miles of mountain hiking and biking trails along with an 18-hole golf course; the city is a great place for outdoor enjoyment. Adam Shannon is a technology management senior manager at Banner Health’s Casa Grande Medical Center. Shannon has been involved with the city of Casa Grande through his employer and on his own. “Casa Grande is a wonderful town. Nestled between Phoenix and Tucson off of I-10, you can’t miss the city. It has the small-town feel, although we are growing at a rapid rate,” Shannon says. He says that the city has great

TECHNATION

APRIL 2021

Adam Shannon and Casa Grande Medical Center employees enjoy the annual Turkey Trot.

“ You can learn a lot from listening to the people. Sharing information back to our leadership and teams really provides a dynamic opportunity for improvement.”

technology manufacturing companies that have come to town; offering future growth. “It has been a great place to raise a family, and you still get that country feel with the multiple farms around Adam Shannon town. Casa Grande is an oasis in the desert for sure. We get plenty of sun and have these opportunities to get out there. It is plenty to get outside to do. It doesn’t so rewarding to interact with the have that full bustle of a large, big city; community any opportunity we can get. but we are growing fast,” Shannon says. It shows our level of commitment to Shannon adds that he became those whom we serve. It is our way to interested in local community activity give back to our community. This is because of the leadership at his facility. truly done in a volunteer nature, which “I have been fortunate to get to me is more rewarding than anyopportunities to be engaged with our thing,” Shannon says. facility within the community. I Shannon’s involvement with his local appreciate the action on behalf of the community has taken several forms and facility to reach out to the employees for has always been rewarding.

WWW.1TECHNATION.COM

SPOTLIGHT

Adam Shannon is among the Banner Health employees who support the annual Electric Light Parade. “I have been involved in many aspects of the community over my tenure at Banner Casa Grande Medical Center. From coaching a local little league team and the hospital softball team (Code Blue), to helping out at many of the local health fairs, where we greet the community and offer information and listen to our community members on how we can be an even greater service to the community,” he says. He also helps out at the city’s Veteran’s Day parades and other events in town. “We also are proud to be part of our city’s largest event in the Electric Light Parade where businesses create floats, and we parade down the main boulevard for several miles and greet and entertain the community,” Shannon says. “Our hospital-driven Turkey Trot is where we take the community members and exercise with them and do a two-mile walk or trot around the local community and end back at the hospital with a health fair. I also have engaged with the community to help clean blocks in the city to pick up trash. All of these items are coordinated through the facility, and it does not take long for me to sign right up. It is so great to be involved with the ones we serve,” Shannon adds. He says that it is such a great feeling to engage with the local community. “You can learn a lot from listening to the people. Sharing information back to our leadership and teams really provides a dynamic opportunity for

“ Some of the best times I have experienced are the thank you’s and the heartfelt gratitude when the community greets you in person. That is why I do the extra work.” Adam Shannon improvement. Many of these events the hospital has sponsored, or been a part of, for over 20 years. A great standing tradition in where we can work together over multiple service lines to come up with something great,” Shannon says He says that the staff at Banner Casa Grande are blessed and their facility works really close with the chamber of commerce. “They are always sending out opportunities to attend chamber events to the employees; this is another good way to be involved with the community. Great opportunity to connect with them and really learn to see how the city functions,” Shannon says. CHALLENGES CREATED BY A PANDEMIC Shannon says that the pandemic has created some challenges in how he and his colleagues engage with the community. As an important tradition, they did not want to stop the Turkey Trot event, but they had to make some adjustments to how it was

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

staged to focus on community safety. “Instead of getting a group of community members together for exercise warm-ups and a large group jog, we set up a station in front of our hospital with goody bags and information that we gave to the people who stopped by in their cars. We encouraged the community to send pictures of them walking or exercising,” Shannon says, He says that for the Electric Light Parade, the community decided on an Electric Light Tour, where many of the businesses and homes would decorate the front of businesses or homes and the community would drive around and vote on the best displays. “It was fun being a part of that to be dressed up and part of the display. Greeting our community each car at a time at a good distance and see everyone’s excitement. These are few of the good things I get to be part of that really makes an impact,” he says. What advice would Shannon give other biomeds who might want to become more involved with their local communities? “Bring your ideas to leadership and committee members when a call for help goes out, even if it may feel way outside your comfort zone. Never act as if this is just for yourself. Think of helping out as doing our part to give back to the community that trusts us for their care. Some of the best times I have experienced are the thank you’s and the heartfelt gratitude when the community greets you in person. That is why I do the extra work,” Shannon says.

APRIL 2021

TECHNATION

VERIFY THE INTEGRITY OF EQUIPMENT The Insulation tester, Leak Tester Tester and Cable Continuity Tester are easy-to-use devices for verifying the functionality of equipment for safety

McGan Insulation Tester Detect & locate defects such as pinholes, cracks and bare spots in the jacket or coating of laparoscopic and bi-polar electrosurgical instruments

Leak Tester Tester Test the functionality of automated & handheld endoscope leakage testers with healthmark’s new Leak Tester Tester.

Cable Continuity Tester Test the quality of monopolar and bipolar cords with this user-friendly, durable device. A green light notifies the user that the cable passed testing.

INTELLIGENT SOLUTIONS FOR INSTRUMENT CARE & INFECTION CONTROL HMARK.COM | 800.521.6224

For more of Healthmark’s intelligent solutions for instrument care and infection control, visit

HMARK.COM

Need Pump Support? Trust the Experts.

877.266.6897 aiv-inc.com 680C

SERVICE DEBATE

MEDICAL DEVICE SERVICE DEBATE CONTINUES White Paper Sparks Heated Conversations BY JOHN WALLACE

edical device service professionals maintain and repair a variety of equipment, including many devices that save lives on a daily basis. The quality of the work done by these unsung heroes is important. Their work is literally a matter of life and death for many health care patients.

The work of medical device servicers (biomeds, clinical engineers, healthcare technology management [HTM] professionals) continues to be a hot topic. A new white paper from the Medical Imaging & Technology Alliance (MITA), titled “Understanding Accountability in Medical Device Servicing” served as a spark once again igniting conversation and debate throughout the industry. MITA – which describes itself as

TECHNATION

APRIL 2021

the leading organization and collective voice of medical imaging and radiopharmaceutical manufacturers, innovators and product developers – says the white paper provides an overview of the types of organizations and entities that perform medical device servicing and the degree to which they are held accountable by federal regulations, accreditors and voluntary industry-established standards. “As this white paper makes clear, when servicing complex medical devices, crystal-clear accountability is indispensable to ensuring the devices’ ongoing safety and efficacy,” MITA Executive Director Patrick Hope said in a press release. “Servicers employed by device manufacturers are held to account by the U.S. Food & Drug Administration. Health care facilities are held accountable by

accreditation systems. Unfortunately, no authority – public, private or otherwise – holds third-party servicing businesses accountable for their actions or the quality and safety of their work. When interacting with highly complicated medical devices designed to detect life-threatening disease, this is troubling, to say the least.” MITA’s white paper does not represent a consensus opinion about all medical device service professionals. In fact, many within the HTM community disagree with MITA’s white paper. The International Association of Medical Equipment Remarketers and Servicers (IAMERS) membership is worldwide and represents companies ranging from the largest OEMs to smaller highly specialized companies that sell, service and finance pre-

WWW.1TECHNATION.COM

SERVICE DEBATE

owned medical imaging devices. IAMERS President Diana Upton expressed concern regarding the white paper. “We are disappointed by MITA’s white paper claiming a lack of servicer accountability and sadly MITA’s apparent continued efforts to portray the hard-working women and men who undertake independent servicers as not accountable. This really gives short shrift to the highly trained HTMs and the hospital EOCs,” Upton wrote in an email to TechNation after being asked about the white paper. “In an industry in which so much of the progress is evidence based, we would expect MITA’s renewed move for further regulation to at least acknowledge that the incidence of service-related adverse events is under 1% as reflected in the ECRI study of the FDA MAUDE reports cited in the 2018 Servicing Report. I fear that MITA’s zeal for further regulation of independents is but another attempt by an organization of large companies to gain further dominance. I hope my concerns are misplaced.” The ECRI Institute is the only organization worldwide to conduct independent medical device evaluations, with labs located in North America and Asia Pacific. ECRI is designated an Evidence-based Practice Center by the U.S. Agency for Healthcare Research and Quality and a federally certified Patient Safety Organization by the U.S. Department of Health and Human Services. A 2018 FDA report includes a summary of an analysis performed by ECRI Institute (section 5.3). “ECRI Institute searched over two million records, including the publicly available FDA Manufacturer and User Facility Device Experience (MAUDE) database; in addition, we analyzed our private databases of hazards and recalls and our investiga-

tions of hospital-based incidents. We concluded that there is no safety problem that is associated with the servicing, maintenance, and repair of medical devices either by the OEM or by third-party maintenance organizations,” according to the report. There are many voices from varied backgrounds in the ongoing debate. Original equipment manufacturers (OEMs) employ medical device servicers. Many health care facilities employ their own in-house team of service professionals. Other nonOEM service professionals include those employed by large corporations who staff departments that work within hospitals and other facilities. There are also independent service organizations that provide professionals who can be called upon to service equipment within a hospital or at a company’s facility. MITA Senior Director of Strategic Operations and Policy Peter Weems was asked to explain the difference between third-party servicers and in-house hospital servicers. “Third-party medical device service businesses compete with manufacturers and each other to win contracts to service medical devices. Third-party service businesses are currently not regulated by the FDA and are not required to meet any accreditation requirements,” Weems explained. “Health care facilities often employ in-house staff charged with the management and maintenance of medical devices. To participate in the Medicare or Medicaid programs, health care organizations must meet certain Conditions of Participation (CoPs). Health care organizations can be accredited as meeting applicable CoPs by accrediting organizations such as The Joint Commission. Under the Joint Commission’s Standards, a health care facility must meet certain Environment of Care (EC) Elements of Performance (EP) requirements,

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

including inspecting, testing and maintaining imaging and radiologic equipment in accordance with the manufacturers’ recommendations.” STANDARDS AND ACCOUNTABILITY The MITA press release announcing the white paper discusses how the different types of medical device service professionals are held accountable. “For OEMs, the principal oversight mechanisms are developed by the Food & Drug Administration (FDA) and include strict pre- and post-market requirements for device manufacturers such as registration, reporting of adverse events, and maintenance of a quality management system,” the press release announcing the white paper states. “Servicers directly employed by health care organizations are held accountable principally by rigorous accreditation systems such as those implemented by the Joint Commission.” Weems was asked if reports of adverse events could include information about third-party servicers. “FDA recently added a new question to Form FDA 3500A: ‘Was this device serviced by a third-party?’ followed by a checkbox for ‘Yes’ and a checkbox for ‘No.’ MITA supported the addition of this question to the reporting form. Increasing accountability and transparency of the third-party service industry is an important step to ensuring the safe and effective operation of all devices,” Weems replied. “Very little is currently known about unregulated third-party medical device servicing businesses. Nonmanufacturer, third-party servicer businesses do not even have to register with the FDA, and they are not held to any quality, safety and regulatory requirements. In May 2018, the FDA estimated that ‘total number of firms performing medical device servicing in the U.S. is between 16,520 and 20,830,’ but said

APRIL 2021

TECHNATION

SERVICE DEBATE

the ‘precise number of entities that perform servicing of medical devices in the U.S. is not known.’ Why do third-party medical device servicers refuse to make themselves known to the FDA?” Along those lines, IAMERS General Counsel Robert J. Kerwin was asked about a section of the white paper that states: “Third-party service businesses are currently not regulated by the FDA and are not required to meet any accreditation requirements. Third-party service businesses are not held accountable for their work’s quality or safety by any authority having jurisdiction (AHJ). Third-party service businesses are not held accountable by any AHJ for training their personnel, implementing quality or safety controls, sourcing qualified parts, tracking complaints, or reporting deaths or serious injuries.” “The white paper sadly omits reference to the accountability practices already in place in the health care ecosystem,” Kerwin stated. “One only needs to look at the length of the typical contract between the hospital and ISO to see the many contractual commitments.” “By declining to highlight the many checks and balances, I agree with Diana that it diminishes the hardworking HTMs, hospital EOC committees and the yearly reviews by medical physicists,” he added. “It also omits reference to the servicers who file reports with the FDA as to the assembly of diagnostic X-ray equipment under 21 C.F.R.” In addition, Kerwin pointed out that “were there to be across the board OEM training programs and cooperation, the white paper might be better received. But, right now, we have a pretty common situation where some OEMs are on the one hand not providing training programs and service keys and on the other 26

TECHNATION

APRIL 2021

hand complaining that the quality is a safety issue.” Kerwin also pointed out that the OEMs frequently use IAMERS members to support their multi-vendor service programs. He asks, “If these independent servicers were really ‘damaged goods,’ why would the manufacturers be using them to service devices?” Joseph Haduch, senior director of clinical engineering for UPMC BioTronics, also questioned the white paper. “Despite, on multiple occasion, being unable to make a case for regulation of third-party and potentially in-house service organizations MITA continues to falsely define the medical equipment service narrative,” Haduch said. “Unable to have their standards adopted by ANSI, unable to convince the FDA of the need for additional regulation and despite the FDA determining that ‘the continued availability of third-party entities to service and repair medical devices is critical to the functioning of the U.S. health care system’ MITA continues to lobby the FDA for additional regulation of the medical equipment service industry. Some of the facts associated with the MITA narrative are strangely absent. While MITA condemns third-party service and asks them to ‘come out of the dark’ they are profiting from the very type of service strategy they condemn. The major OEMs in MITA all have multi-vendor service solutions and perform service without access to OEM training and OEM diagnostics. There are many ways MITA, as an organization, can help improve the medical equipment service industry which they claim is their primary concern.” Haduch lists the following as ways MITA can improve the medical device service industry: • Train all equipment service

providers •M ake proprietary documentation available to all service providers • M ake proprietary service tools available to all service providers • C ollaborate with all service providers in establishing industry standards and protocols. “All of these would help advance MITA’s claimed goal,” Haduch said. “So, why haven’t they taken these steps? They alone have the power to make all of this happen and advance their cause. Because the goal isn’t better quality service, which the FDA previously determined isn’t an issue. The goal is to protect service margin and market share. OEMs profit from OEM service, they profit from in-house service, they make nothing from ISOs. Which solution do they deride?” MITA OBJECTIVE The MITA white paper does not conclude with a conclusion or call to action. Weems said the objective of the white paper is to show that MITA supports “policy reforms that would protect patient safety by requiring third-party servicing businesses to also meet the basic requirements that OEMs are currently meeting.” He described those basic requirements as: • R egistration: Medical device servicing businesses should be required to register with the FDA. • Q uality Management System: Medical device servicing businesses should be required to adopt and maintain a quality management system that ensures devices are returned to safe and effective condition. • R eporting of Adverse Events: Medical device servicing businesses should be required to report adverse events to the FDA when they encounter death, WWW.1TECHNATION.COM

SERVICE DEBATE

serious injury or device malfunction. Weems said interested parties can provide comments regarding the white paper at NEMA.org/about/ contact. FDA REQUESTS COLLABORATIVE APPROACH MITA’s call for non-OEM service professionals to register with the FDA is not in line with the FDA’s own recommendation after an examination of medical device service professionals. The FDA recommended a collaborative approach to medical device service in 2018 when it agreed with ECRI regarding a lack of evidence for increased regulation of service providers. ECRI shared the news on its website stating, “On May 15, 2018, FDA released FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices. This report was written to address concerns that have been raised about the quality of service provided by third-party organizations – that is, organizations other than original equipment manufacturers (OEMs). These third parties include hospitals and independent service organizations (ISOs). In developing the report, FDA held hearings and allowed for public comment about the issues. The main findings are: 1. F DA will not issue additional regulatory requirements regarding the servicing of medical equipment, as there is insufficient evidence to justify additional regulations. 2. T he evidence that is available shows that many organizations other than the OEM who service medical equipment are providing ‘high-quality, safe and effective servicing of medical devices.’

3. M ost of the events that have been attributed to service issues were actually associated with the ‘remanufacturing’ of medical equipment (defined by FDA as any ‘act to a finished device that significantly changes the finished device’s performance or safety specifications or intended use’) and not with its servicing. 4. T hird-party service providers are essential to ensure the safe operation of the U.S. health care system.” ECRI deemed this an “important announcement” explaining that if FDA were to conclude that only OEMs could service medical equipment, it would potentially more than double the cost of equipment service (which, during the life of the equipment, may already equal the acquisition cost). The report from ECRI also pointed out that service issues would take longer to correct causing additional expenses to health care facilities. Service and repair delays could also postpone the delivery of health care as well as increase the cost of health care as additional expenses could be passed on to patients. “Moreover, equipment would be unavailable for longer times than is currently the case, as the hospital would have to wait for the OEM to send repair staff. (Most hospitals have staff on-site to maintain and repair equipment.) Some hospitals would therefore need to purchase additional equipment to use while their current equipment is out of service, further increasing the cost of health care without improving service delivery,” the ECRI report states. Last year, manufacturer trade groups AdvaMed and MITA sent emails a week apart informing members of the FDA-recommended

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

Medical Device Servicing Collaborative Community (MDSCC) that they will no longer participate. At the time, a few of the remaining members provided feedback regarding AdvaMed and MITA’s exit. David Francoeur, senior vice president of marketing and sales for TKA, and Upton expressed disappointment regarding the departure of the two groups. “The Medical Device Servicing Collaborative Community (MDSCC) has been actively working through continuous opportunities since its inception in January of 2019. The group consists of 25 individuals made up of a comprehensive representation across the industry consisting of; Healthcare Delivery Organizations (HDOs), Independent Service Organizations (ISOs), regulatory/industry agencies and Original Equipment Manufacturers (OEMs),” Francoeur explained at the time. The MDSCC was intended to bring all entities representing the industry together to discuss issues in an effort to find opportunities/solutions related to establishing a baseline, verify tools/key performance indicators (KPIs) that demonstrate and, where possible, raise the level of quality, safe maintenance of medical equipment. At the time, the MDSCC reported that it had not made the progress it hoped/envisioned, however, progress has been made, and the membership is encouraged and engaged. For more regarding this topic, be sure to review a panel discussion and continuing education opportunities at the MD Expo in Dallas scheduled for April 16-17. Find out more at MDExpoShow.com. TechNation was awaiting comments from the FDA and the Alliance for Quality Medical Device Servicing at press time. This article will be updated at 1TechNation.com. APRIL 2021

TECHNATION

INDUSTRY UPDATES

NEWS & NOTES

Updates from the HTM Industry HTM WEEK 2021 TECHNATION ANNOUNCES HTM WEEK CONTEST TechNation joins healthcare technology management professionals everywhere in celebrating HTM Week 2021! One way HTM professionals can celebrate the week of May 16-22 is a new contest. TechNation knows it has been a hectic and difficult time during the COVID-19 pandemic. We want to

thank and acknowledge HTM professionals for all of their hard work! Each day of HTM Week, TechNation will award a prize worth approximately $250. In addition, one lucky biomed will win our grand prize – a paid trip to MD Expo Vegas this November! The prize includes airfare (up to $400) and 3 nights at the gorgeous M Resort!

Simply fill out the HTM Week form at 1TechNation.com/htm-week-contest/ to be entered to win! For extra entries, complete the form and upload a photo of yourself reading TechNation magazine. Winners will be announced daily, so follow the TechNation social media pages to see if you win! Good luck! •

PARTSSOURCE RELEASES PARTSSOURCE PRO 2021 PartsSource has updated its flagship solution, PartsSource Pro. PartsSource Pro 2021 features expanded benefits to improve uptime and accelerate productivity by providing members with the advisory services, toolkits, formulary starter sets and expanded guaranteed stock to achieve high performance health technology management. Over 1,000 hospitals subscribe to and rely on PartsSource Pro, a managed service that combines best processes, cloud-software and logistical support to deliver top-quartile performance for hospital clinical engineering and supply chain teams across the U.S., according to a news release. PartsSource Pro 2021 enhancements include the addition of healthcare technology management (HTM) advisory services, expertly curated medical device formularies to provide turn-key purchase policies across hundreds of quality products, HTM toolkits to accelerate best practices, and expanded guaranteed stock, which uses data science to increase supply chain reliability by increasing availability of products prone to backorders and shipping delays. “PartsSource’s commitment to clinical engineering is always expanding. I see PartsSource as a trusted partner, innovating with solutions, resources, and now formal advisory services focused on helping my peers and I continuously advance our teams to the next level of the HTM journey. The combination of proven expertise and decades of

TECHNATION

APRIL 2021

experience enables health systems like ours to improve quality, safety and efficiency, resulting in substantial operational benefits and financial savings,” said Jay Olson, director of biomedical services, Marshfield Clinic Health System. In addition to the PartsSource Pro 2021 updates, the company also unveiled an expanded PartsSource Command Center, which was designed during the pandemic to monitor critical key performance indicators along the supply chain. The PartsSource Rapid Response team provides real-time surveillance to prevent supply chain problems, such as backorders and shipping delays and proactively supports guaranteed stock for its PartsSource Pro members. This active supply chain management keeps orders on track, prevents quoting delays, routing delays and missed cut off times. “PartsSource Pro is driving the digital transformation of the hospital medical device supply chain, and the increasing cost, quality and resiliency challenges the health care industry faces require added levels of service, support and resources. Expanded benefits within the PartsSource Pro 2021 release are designed to meet the evolving needs of hospitals requiring new solutions to optimize their supply budgets, talent, use of data and decision-making processes,” said Philip Settimi, MSE, MD, president and CEO of PartsSource. • For more information, visit PartsSource.com.

WWW.1TECHNATION.COM

INDUSTRY UPDATES

iMed Biomedical MEDIGATE NAMED BEST IN KLAS

IMED BIOMEDICAL CELEBRATES SPRING CLEANING

Medigate, a health care dedicated device security and asset management company, was selected as the 2021 Best in KLAS for Healthcare IoT Security in the KLAS Software & Services Report. Medigate was rated as the top performing provider for its healthcare technology focus, responsiveness and close relationships with customers. The yearly KLAS report evaluates the overall performance of each product and service then grades the customer’s experience across the following pillars: culture, loyalty, operations, product, relationship and value. Medigate earned the title of Best in KLAS for its outstanding efforts to help health care organizations in their quest to deliver quality patient care. The Best in KLAS designation is awarded to only one vendor per category. Adam Gale, president of KLAS shares, “Each year, thousands of health care professionals across the globe take the time to share their voice with KLAS. They know that sharing their perspective helps vendors to improve and helps their peers make better decisions. These conversations are a constant reminder to me of how necessary accurate, honest and impartial reporting is in the health care industry. The Best in KLAS report and the awards it contains set the standard of excellence for software and services firms. Vendors who win the title of “Best in KLAS” should celebrate and remember that providers now accept only the best from their products and services. The Best in KLAS award serves as a signal to provider and payer organizations that they should expect excellence from the winning vendors.” Medigate’s deep understanding of medical workflows and communication protocols unique to health care IoT provides the clinical security context that health care cybersecurity specialists need to effectively reduce the attack surface. Medigate’s solution stands out because of its unique levels of visibility and insight, enabling automatic discovery of all connected devices on clinical networks to detect credible threats in real-time, prevent attacks and enforce clinically driven policies to protect patient safety and privacy. The platform’s unique identification capabilities extend its value beyond security to provide the entire organization with the data it needs to improve patient care, reduce costs and increase efficiency. “As this recognition is based directly on insights from health care professionals, it is a testament to how Medigate is achieving its mission of assisting health care organizations in making better security and asset management decisions to reduce risks and achieve better patient outcomes,” Medigate CEO Jonathan Langer said. “We remain committed to advancing our platform by partnering with the industry to make sure it meets their current and future needs.” •

The second annual Get Up Clean Up contest for healthcare technology management professionals promotes an organized and clean workspace. For the second consecutive year, iMed Biomedical encourages biomeds to spruce up their space. The motivation? Great prizes including a grand prize of $300! One lucky participant will win the grand prize of a $300 gift card and a lunch for their HTM department. The runner-up and third-place winner will each receive a $100 gift card. To participate in the contest, HTM professionals or departments should pick an area of their department, then get up and clean up. Submit a before and after photo of the workspace to be entered to win. Be sure to include yourself or members of the department in the photo. •

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

Submit photos to 1technation.com/contest to enter.

HEALTHCARE TECHNOLOGY GROUP INKS GPO AGREEMENT Healthcare Technology Group has announced a new agreement for medical equipment management and repair services with Intalere, a health care GPO. Through this agreement, Intalere members will receive negotiated pricing on HTG’s custom, flexible asset management plans to assist with the management and maintenance of medical devices across their member facility. The new HTG agreement is currently effective through the end of 2023. HTG’s suite of services include clinical asset management solutions, healthcare technology consulting and healthcare technology management temporary labor solutions. HTG President and CEO Steve Cannon stated, “The benefits of this dynamic partnership are significant for Intalere’s 100,000-plus members across the U.S., who will now have access to new clinical asset management solutions geared toward significant cost savings and the optimization of their technology management programs.” Cannon also noted that the new agreement aligns strongly with HTG’s strategic goal of offering asset management solutions and programs to the widest number of systems and providers nationally, both urban and rural. • For more information, visit https://htg-us.com.

APRIL 2021

TECHNATION

INDUSTRY UPDATES

ONESOURCE, TRUASSET OFFER ADVANCED MOBILE MAINTENANCE SOLUTION oneSOURCE will work with TruAsset to offer its computerized maintenance management systems (CMMS) solution. As trusted resources for industry agencies like The Joint Commission and AAMI, both organizations understand the importance of compliance and how this partnership will create streamlined access to oneSOURCE’s expansive archive of documents, according to a press release. “Strategic partnerships like this one with TruAsset continue to amplify oneSOURCE’s mission of providing health care professionals with the most up-to-date tools and resources for

facilities compliance,” said Heather Thomas, CMO and executive vice president of sales and marketing of oneSOURCE. “TruAsset’s platform perfectly integrates into our databases and overall goal of advocating for patient safety in everything we do.” Created with health care facilities management and HTM processes in mind, TruAsset is derived from working with ISOs and facility management groups over the last 15 years. TruAsset enables on-the-go functionality with its platform and will seamlessly merge oneSOURCE databases, allowing health care professionals access to manage

various actions. Users will find the integration within TruAsset’s system and can ensure access to compliance-related record keeping systems and health care facility maintenance standards support. “The TruAsset team is excited to be bringing the ease of obtaining documentation to our hospitals, health systems and ISOs,” said Jason Byers, president at TruAsset. “We are constantly striving to make everyday use of our system more intuitive.” • For more information, visit onesourcedocs.com.

SODEXO, PARTSSOURCE FORM PARTNERSHIP Sodexo and PartsSource have partnered to enhance healthcare technology management (HTM) for their health care clients across North America. Sodexo and PartsSource improve health care providers’ financial health and the lives of patients and care teams by ensuring optimal equipment maintenance and availability, according to a press release. In joining forces, both companies will deliver enhanced clinical outcomes by leveraging a software-enabled, evidence-based medical device supply chain and a proactive medical equipment repair and maintenance service offering. Across North America, health care facilities are challenged by the cost of managing and maintaining their medical equipment. This partnership expands the current capabilities of Sodexo Healthcare, whose clients will enjoy optimized performance, driven by an evidenced-based approach to healthcare technology management and a range of analytics to deliver better outcomes. Sodexo is gaining access to the PartsSource software, data and operational support to leverage an evidence and outcome-based method that will contribute to improving patient care, health care quality and productivity of human and medical capital. Through this partnership, PartsSource will expand its network of highly technical service partners in its recently launched On-Site Service marketplace offering with curated and credentialed access to over 1,300 service engineers from its base of 3,500 hospital clients. Health care systems across the U.S. and Canada are concerned with operating costs, equipment maintenance and patient

TECHNATION

APRIL 2021

fears associated with the COVID-19 pandemic. Sodexo and PartsSource are responding to these challenges with data-driven methods to provide comprehensive asset management to address operational challenges. “Sodexo Healthcare brings a suite of innovative best-in-class solutions that are inextricably linked to clinical care delivery. Analytics powered by real-time data helps us prioritize tasks that keep the patient at the forefront of care. We are taking this opportunity to invest in our healthcare technology management business to further strengthen our efficacy in delivering value and improved performance for our health care clients,” said Catherine J. Tabaka, CEO for Sodexo Healthcare North America. “Through our partnership with PartsSource we are enhancing our healthcare technology management expertise and continuing to drive financial and clinical outcomes for our clients with supply chain reliability and resiliency.” “PartsSource has built a leadership position by applying evidence-based methods to improve clinical outcomes and operational performance related to optimal management of the medical device supply chain – key to ensuring a safe patient experience, caregiver satisfaction and high clinical throughput,” said Philip Settimi, MSE, MD, president and CEO, PartsSource. “I am delighted with Sodexo’s decision to partner with us, which will extend our patented decision support technology to a new provider segment, resulting in a more reliable supply chain and better clinical outcomes for health care providers across the country.” •

WWW.1TECHNATION.COM

INDUSTRY UPDATES

EARN ACI-APPROVED CREDITS AT MD EXPO

ACCRUENT PARTNERS WITH ONESOURCE

MD Expo – to be held April 16-17, 2021 in Dallas, Texas – has been pre-approved by the ACI for up to 7 CEUs. The Certified Associate Biomedical Technician (CABT) Review to be held April 16, 2021 in Dallas, Texas has been pre-approved by the ACI for a total of 6 CEUs. In order for an attendee to claim the CEUs on their ACI journal, they’ll need a certificate of completion from each session. MD Expo strives to provide healthcare technology management (HTM) professionals with a unique, intimate and rewarding conference second to none. Clinical engineers, biomedical technicians, directors and managers, procurement/asset managers and others responsible for medical technology will gather in a one-of-a-kind safe and welcoming environment to network with peers, learn the latest technologies and advances in HTM. Find out what everyone has been talking about; this is one event you can’t afford to miss! •

Accruent will partner with oneSOURCE Document Management Services, an RLDatix company, to better empower Connectiv customers to stay compliant with regulatory guidelines and manufacturer requirements for medical equipment. This partnership, which is launching as part of Accruent’s Connectiv 8.2 release, will provide health care operations professionals with a comprehensive source of validated health care manufacturer documents detailing the safe use, care and maintenance of their products. To ensure compliance, this partnership gives users the ability to: • Open the Connectiv application to access information from oneSOURCE

For more information or to register, visit MDExpoShow.com.

• See documents related to both the asset manufacturer and model • Select a link to the document and return to Connectiv once a document is closed “In the wake of COVID-19, the health care industry is under unprecedented strain and in desperate need of solutions to help them strengthen their margins, improve their asset performance and maintain compliance with ever-changing regulations,” explains Al Gresh, vice president of healthcare strategy, Accruent. “This integration reflects Accruent’s ongoing efforts to simplify processes and facilitate the necessary digital transformation that organizations must undergo in order to face both current and future challenges.” •

discovery Solution WWW.MEDICALIMAGINGGROUP.COM

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

APRIL 2021

TECHNATION

INDUSTRY UPDATES

CYBERMDX ANNOUNCES NEW CEO CyberMDX, a health care cybersecurity provider delivering visibility and threat prevention for medical devices and clinical networks, announced the appointment of industry veteran Azi Cohen as CEO of the company to build on record 300% YoY growth in revenue. As part of the announcement, the company is launching a new brand image and website as well as introducing a new architecture for health care security. A veteran of the IT and cybersecurity industries for more than 25 years, Cohen joins CyberMDX from WhiteSource Software, a global leader in open-source security software, where he was the co-founder and senior vice president of global sales and successfully built the customer base to over 1,000 clients worldwide. As part of the continued momentum for 2021, CyberMDX is introducing a new paradigm for medical network and device security called Device-Centric Risk Management (DCRM). The new architecture will center on a layered approach to cybersecurity that protects each device, driving remediation and mitigation directly on your medical and Internet of Medical Things (IoMT) assets. In addition, CyberMDX also has rebranded its website which provides a wide range of educational and technical resources on health care security. The company also introduces a new tagline – We Protect the Things that Protect Human Lives. “Following a year of tremendous growth for us in 2020, we are now ready for the next phase of our global go-to-market

strategy,” said Amir Magner, president and co-founder of CyberMDX. “Azi has a proven track record for accelerating companies in their growth stage so I’m delighted he has joined us as our new CEO. He will be based in our New York headquarters and I will be collaborating closely with him from our product, research and development and operations center in Tel Aviv.” “It’s a great privilege to join CyberMDX,” said Cohen. “It’s clear from the major increase of ransomware attacks against hospitals and medical networks, that we must raise the bar for cybersecurity in the industry as a whole. For me, this was a big part of my decision to join. In addition to an amazing product and team, the primary mission to protect the things that protect human lives is one that compels me and has personal significance.” “On top of the company’s leading solution, CyberMDX also employs a highly accomplished vulnerability research and analyst team. The team regularly works with medical device manufacturers, health care organizations, as well as government bodies in the responsible disclosure of security vulnerabilities,” the release states. “The threat intelligence team dedicates its efforts to defending hospitals and health care organizations from malicious attacks and in 2020 alone responsibly disclosed major vulnerabilities in medical devices such as patient monitors, 104 different radiological devices, as well as Dell Thin Wyse devices common to health care organizations.” •

MINDRAY NORTH AMERICA LAUNCHES REFURBISHMENT PROGRAM Mindray North America has launched its new inReach Product Refurbishment Program. This Program will provide clinicians with access to high-quality patient monitors, anesthesia machines and ultrasound machines at Mindray’s best price points ever. In alignment with its mission to advance medical technologies and make health care more accessible, Mindray’s inReach Program provides solutions for those challenged by tight budgetary constraints. Mindray’s commitment to quality, innovation and durability is the foundation upon which the inReach Refurbishment Program was built. Each Mindray certified product goes through a 12-point comprehensive refurbishment process by trained technicians, ensuring every product

TECHNATION

APRIL 2021

meets Mindray’s strictest quality standards. Through the inReach Refurbishment Program, customers can acquire the highest-quality solutions backed by Mindray performance and reliability. “As the health care industry continues its shift to value-based care, facilities around the world are seeking new and improved ways to enhance patient care and manage costs without sacrificing quality,” stated Wayne Quinn, president, Mindray North America. “And with the increased pressure being put on health care systems due to the pandemic, Mindray’s role in the industry’s transformation has never been clearer – bringing customers cost-effective solutions that align with their financial objectives.” •

WWW.1TECHNATION.COM

INDUSTRY UPDATES

Operate Efficiently, Perform Real Time, Simplify Compliance

INTERMED GROUP ANNOUNCES ISO 13485:2016 CERTIFICATION The InterMed Group, an exclusive provider of scalable healthcare technology management services, announced the recent certification to ISO 13485:2016, via a news release. The certification is “a testimony that InterMed’s quality management system meets the most current standards for the service and sale of medical devices as set forth by the International Organization for Standardization [ISO],” according to the release ISO 13485 is a rigorous standard now considered to be the inline requirement for medical device manufacturers and service providers. For an organization of the InterMed Group’s size, to comply necessitates an on-going team effort and tremendous commitment at all levels of the organization. “Risk management is heavily emphasized in ISO 13485, demanding detailed and effective communications with our colleagues and customers. This aligns with InterMed’s core values and enhances customer and patient relationships. The industry will benefit as more organizations align their quality management systems to ISO 13485,” Dave Morgan, quality manager for the InterMed Group says. “Customers can be confident that InterMed takes a riskbased approach with patient safety as a priority, including assurance that we contribute great value toward their legal and regulatory compliance efforts,” Morgan adds. •

Your CMMS should provide:

• • • • •

Customization Seamless Workflow Tools for Compliance Solid Reporting Solid Customer Service

We offer this and so much more. Check us out!

214-276-1280 sales@truasset.com www.truasset.com

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

APRIL 2021

TECHNATION

INDUSTRY UPDATES

UNI-THERM AIDS EQUIPMENT TESTING AT ISRAEL HOSPITAL Investment in advanced medical device testing technology from Rigel Medical is reaping benefits at one of Israel’s private hospitals. The 110-bed Herzliya Medical Center has been using the Rigel Uni-Therm electrosurgical analyzer for several years as part of a suite of equipment to undertake comprehensive testing and calibration of approximately 70 items in operating rooms and outpatient clinics radio frequency generators. Capable of automating all required tests, the compact analyzer accurately measures the performance of equipment, including high frequency leakage, high current, power output and patient return plate alarm testing. Its ease-of-use and advanced capabilities have simplified performance testing procedures as part of the planned in-service preventative maintenance programs the hospital undertakes, which are overseen by Biomedical Department Director Tameem Jaber. He estimates that the time taken to complete these procedures has been cut by an estimated 40% using the Uni-Therm when compared to the biomed test equipment the hospital previously used. “Uni-Therm continues to contribute to raising test standards and delivering operational efficiencies. It has improved the ease by which our generators can be checked for electrical safety then a performance accuracy while the ability to produce one report covering all test procedures is extremely beneficial, saving even more time and effort,” he said. “We can customize our auto-test sequences using the analyzer and can run through all the manufacturer’s recommended tests in under 10 minutes. This is significantly quicker and easier when compared to the biomed test equipment we used to use before turning to Rigel.” Jaber explained that the adoption of the Uni-Therm, which connects to Rigel’s Med-eBase asset management software, meets the medical center’s requirements for the beneficial production of reports and certificates for the device under test, which can be stored on either a local or remote database using a CMMS developed by a local software company. “Using the analyzer makes IEC 60601-2-2 testing less complicated and easier at the hospital. The user-friendly screen on the unit provides step-by-step connection instructions and simple analysis data, which can be interpreted quickly to check the equipment under test is working properly,” he said. The Uni-Therm features onboard memory, test automation, comprehensive data management capabilities and a wide range

TECHNATION

APRIL 2021

of in-built resistors. USB technology improves connectivity to other equipment for the rapid downloading of test data and the uploading of the electrosurgical device’s power curves as well as test specific programs. Output waveforms can be examined through a built-in scope output, which allows for easy confirmation of the desired waveform shape. The Uni-Therm is among several Rigel defibrillator analyzers, infusion pump analyzers and combination vital sign simulators the hospital uses, which contribute effectively toward ensuring compliance with appropriate international test standards, including IEC 60601-2-2. These include the UNI-SIM, UNI-Pulse, Rigel 288+ and Multi Flow to test and calibrate patient monitors, infusion pumps and defibrillators. •

WWW.1TECHNATION.COM

The quickest path to becoming a skilled, in-demand, reliable imaging engineer.

TRI-IMAGING’S APPRENTICE PROGRAM Experience the best in imaging engineer training with our efficient, effective, immersive program where you will have real world experiences that will equip you with the skills necessary to service the “big iron” imaging equipment.

Small Classes

Comprehensive

Real Experience

Efficient

Personalize your experience and maximize your learning with our small classes that allow you more time with your expert instructors.

Multi-vendor, multi-modality, and blended learning to cover all your bases while learning.

Beyond the classroom; you will spend significant time in the lab. With more than 20 staging bays, you will get plenty of time working through real life scenarios.

Our experienced training team has developed a curriculum that will optimize your time in training while minimizing your time away from your facility.

READY TO GET STARTED?

Visit www.triimaging.com or email training@triimaging.com to request the course overview and curriculum.

SOLUTIONS

Call: 855.401.4888 | Visit: triimaging.com | Email: training@triimaging.com Located in Nashville, TN • ISO 13485:2016 certified

INDUSTRY UPDATES

AAMI UPDATE BY AAMI

REVAMPED GUIDANCE HELPS ‘CLEAN UP’ MEDICAL DEVICE INSTRUCTIONS FOR USE Medical device manufacturers, regulators and healthcare technology management (HTM) experts recently joined forces to solve a long-standing issue for medical device processing: confusing instructions for use (IFUs). These essential instructions explain how to properly clean, disinfect, sterilize and make the device ready for use on the next patient. This updated technical information report, TIR12:2020, Designing, testing and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers, standardizes manufacturer IFUs for the processing of clinically used medical devices and helps manufacturers understand how well the end users comprehend a device’s instructions and labeling. “Regulators have been pushing the message that end users need to follow manufacturer instructions, saying ‘Don’t make it up yourself.’ But when users look at an IFU, it can be confusing or incomplete,” explained Damien Berg, a regional manager of sterile processing at University of Colorado Health and past president of IAHCSMM. Berg co-chaired the AAMI working group that completely revamped TIR12, creating its new 2020 version. The working group determined early on that even though manufacturers and test labs have been validating IFUs all along, the conditions and terminology that they have used were not always an “apples-to-apples” comparison to the rapidly changing environment that is the clinical setting. To create more sensical instructions and labeling, manufacturers would need a way to reference the tools, terminology and expectations of device users and regulators alike. This is where the new report comes in. “It’s a much cleaner and easier to read reference document for the manufacturers,” Berg said. “In turn, the hope is that this will allow them to get their product through the FDA easier and quicker. Then I, as an end user, get to use their product with clear instructions. It all comes down to proac-

TECHNATION

APRIL 2021

tively reducing confusion for my staff.” Initially, sterile processing managers and device manufacturers worked at this problem from different directions, added AAMI working group co-chair Ralph Basile, vice president of marketing and regulatory affairs for Healthmark Industries Company Inc. “A number of manufacturers were going through the process of rewriting their IFUs alone. They were saying, ‘If we can’t figure this out, how are customers supposed to do it?’ Around that time, the working group had turned its attention towards standardizing IFUs, so the manufacturers shared what they had,” Basile said. “We got end-users, testing labs and even the FDA involved and that really got this whole effort going.” An important milestone was the 2017 update of the standard ANSI/AAMI/ISO 17664, Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices, which details what information must be provided to health care facilities (including instructions for pretreatment, cleaning, disinfection, drying, inspection, maintenance and functionality testing, and packaging). It also describes the validation testing that needs to be conducted to ensure each of these processes is suitable for the device. Three years after ISO 17664 was published, TIR12 now ensures that manufacturers not only know what information they need to provide, but also how to provide it. “This was an amazing collaboration of end users, manufacturers and testing labs. At one point we were comparing hundreds of different IFUs, figuring out what the commonalities were and where the gaps were,” said Berg. “Now, we’re approaching a point where we all say, ‘follow the manufacturer’s instructions’ with confidence!” CDRH LOOKS FORWARD TO A ‘RESET’ FOR COVID-DELAYED WORK The FDA’s Center for Devices and Radiological Health (CDRH) and its priorities were “overwhelmed” and “disrupt-

WWW.1TECHNATION.COM

INDUSTRY UPDATES

Healthcare Technology Recruitment & Placement Services Nationwide “Quality People, Quality Service”

Specializing in Military and Professionally Trained BMETs and Imaging Service Technicians ed” by COVID-19 and the massive increase of work that resulted – but there is hope that the coming year will provide a “reset” for delayed work to begin while still managing the COVID-19 response. That’s according to a call between AAMI and Jeffrey Shuren, director of FDA’s Center for Devices and Radiologic Health (CDRH) and Alliance for a Stronger FDA. COVID-19 “essentially disrupted the trajectory of the medical device program in 2020” delaying much of CDRH’s work while the agency dealt with emergency use authorizations (EUAs) and that the pandemic-related work likely cut down on the number of new technologies aiming for launch in 2020, Shuren said. The “reset” will give CDRH an opportunity to learn from its COVID-19 pandemic experience, as Shuren outlined his hopes, expectations and priorities for 2021 despite the “ripple effect” from COVID-19 related work. These include: • Addressing the next round of medical device user fees in MDUFA V • Launching programs such as the Safer Technologies Program (STeP) • Enhancing the 510(k) premarket clearance pathway • Testing a system that would allow companies to track the progress of their submissions • Finalizing guidance on clinical decision support software and patient-reported outcomes • Expanding the Case for Quality voluntary improvement program • Drafting guidance on artificial intelligence and machine learning • ISO 13485 alignment and 510(k) modernization Shuren concluded by saying that they hoped to further manage the COVID-19 work but also move forward with projects unrelated to the pandemic that had to be placed on the “back burner.” However, he noted that 2021 will also be busy as developers seek full marketing approval for COVID-19 devices. He also emphasized addressing MDUFA V as a top priority because those fees that enable FDA to work faster on reviews and authorizations.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

• Healthcare Technology Management (HTM) Careers • Radiology / Imaging Technicians & Managers • Biomedical Equipment Technicians (BMETs) • Equipment Field Service Technicians

30+ YEARS OF PERMANENT PLACEMENT AND TEMPORARY SERVICES NATIONWIDE!

870.431.5485

E-mail: info@BMETS-USA.com Website: www.BMETS-USA.com

Your Next Job is Here.

A specialized resource for HTM, Biomed and Clinical Engineers.

Get started at www.HTMJobs.com APRIL 2021

TECHNATION

INDUSTRY UPDATES

ECRI UPDATE

A Look at the Top 10 Health Technology Hazards for 2021

CRI’s annual list highlights 10 health technology management challenges that warrant priority attention. A point of emphasis for 2021 is the transition from the crisis phase of responding to a global pandemic to the more routine, though undoubtedly altered, delivery of patient care in the aftermath.

HIGH-PRIORITY HAZARDS IN CHALLENGING TIMES The 14th edition of ECRI’s Top 10 Health Technology Hazards list was developed under the shadow of the COVID-19 pandemic. Throughout the crisis, health care professionals have stepped up to devise new processes, often in the face of significant adversity, to provide the level of care that their patients deserved. While the challenge remains, we are hopeful that a return to normalcy is not too far in the distance. Many of the topics on this year’s list address that theme: the need to move from just trying to cope during an emergency to building stronger and more resilient processes, utilizing the innovations developed and the lessons learned along the way. “Several topics involve hazards that have developed in this environment of unprecedented stresses and rapid technological changes,” explains Rob Schluth, who manages the project for ECRI’s device evaluation group. “But that’s not the only focus. Standard health care practices continue, and the hazards that can develop under normal circumstances still demand vigilance.” ECRI recommends that health care organizations consider the following topics in their patient safety discussions.

TECHNATION

APRIL 2021

1. Complexity of Managing Medical Devices with COVID-19 Emergency Use Authorization To meet the unprecedented need for medical equipment and supplies during the COVID-19 public health emergency, FDA issued Emergency Use Authorizations (EUAs) to temporarily permit the use of (or new uses for) hundreds of products. The resulting need to manage large numbers of devices that are authorized only for temporary use poses a unique challenge. FDA can revoke or revise specific EUAs at any time. Plus, there’s no guarantee that the products being used under an EUA designation will be as safe and effective as products cleared through normal processes. Thus, health care organizations must monitor the safety and effectiveness of EUA devices, manage inventories of those devices and their documentation, continually track each device’s EUA status and determine what to do with these devices once the EUA ends. 2. Fatal Medication Errors Can Result When Drug Entry Fields Populate after Only a Few Letters To make drug searching and selection easier, many medication ordering, storage and delivery systems allow the practitioner to enter only a few letters of a drug name before the system populates the selection field with a list of drugs to choose from. The display of similar-looking drug names, which is intended to be a convenience, increases the risk that users will mistakenly select an incorrect drug. The Institute for Safe Medication Practices (ISMP) has reported on

several incidents in which such selection errors have led to severe harm or death. 3. Rapid Adoption of Telehealth Technologies Can Leave Patients and Data at Risk Telehealth programs were implemented with great speed this past year, but not likely with the depth of analysis required to assure their long-term success. As facilities transition from the pandemic response to new telehealth care-delivery models, programs may need to re-examine how they train users, coordinate patient care or address technology resource inequalities among patients. Also, some of the technologies adopted may not be suitable for long-term use or may not integrate well with existing clinical workflows and systems. 4. Imported N95-Style Masks May Fail to Protect Health Care Workers from Infectious Respiratory Diseases Shortages of NIOSH-certified N95 respirators prompted health care organizations to look for alternative products. Concerns exist, however, that some options – such as KN95 masks from China – may not adequately protect the wearer. ECRI testing through December 2020 found that, of the imported non-NIOSH-certified respirator alternatives tested, more than 60% failed to filter airborne particles as well as claimed. For individuals at high risk of being exposed to aerosols from COVID-19 patients, a mask that provides reliable, N95-level respiratory protection is essential. 5. Relying on Consumer-Grade Products Can Lead to Inappropriate Health Care Decisions

WWW.1TECHNATION.COM

INDUSTRY UPDATES

Products such as consumer-grade finger pulse oximeters, blood pressure cuffs and glucose monitors are being used not only in the home, but elsewhere within the health care continuum. Such devices can be useful to monitor a patient’s physiologic trends but should not be relied on for making health care decisions. The measurements from consumer-grade devices may not be sufficiently accurate or may be misleading. 6. Hasty Deployment of UV Disinfection Devices Can Reduce Effectiveness and Increase Exposure Risks Ultraviolet (UV) disinfection technologies can be a useful supplement to normal cleaning and disinfection practices, but improper use could not only compromise device effectiveness, but also put users and bystanders at risk of harmful exposure to UV light. With these technologies being considered for use in many new environments, and by users with little experience with UV light or disinfection processes, the chances for error are high.

7. Vulnerabilities in Third-Party Software Components Present Cybersecurity Challenges Vulnerabilities in third-party operating systems and other off-theshelf software components incorporated into medical devices could allow a device to be compromised, possibly disrupting patient care (locally or system-wide) or leading to a data breach. Obstacles to remediating such vulnerabilities include delays while the medical device vendor validates software patches, difficulties identifying the devices that include the affected software and challenges associated with applying the mitigation in a clinical environment. 8. Artificial Intelligence Applications for Diagnostic Imaging May Misrepresent Certain Patient Populations For medical devices and systems that incorporate AI, the quality of the output depends on the quality of the data used to train the AI application. Obtaining high-quality,

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

broad-based datasets for refining AI implementations is a challenge for AI developers. For health care providers, the challenge is determining how much trust to place in the AI application. Unreliable AI functionality can lead to misdiagnoses or can prompt inappropriate care decisions. 9. Remote Operation of Medical Devices Designed for Bedside Use Introduces Insidious Risks One option for hospitals coping with personal protective equipment (PPE) shortages and exposure risks during the pandemic has been to operate certain medical devices at a distance from the patient, rather than at the bedside, as intended. Concerns associated with the remote operation of bedside medical devices range from less frequent direct visual assessment of the patient, to adverse effects on device performance or workflow, to tripping hazards. 10. Insufficient Quality Assurance of 3D-Printed Patient-Specific Medical Devices May Harm Patients 3D-printing technology is being used to create a range of patient-specific devices, including implants, anatomical models for surgical planning, surgical guides for orthopedic procedures and prostheses. If such a device is created without appropriate clinical verification of the design, quality control of the manufacturing process and validation of the end product, the resulting object may not accurately represent key patient anatomy or may not perform as intended. Procedure delays, surgical complications, infection or patient injury could result. This article is adapted from ECRI’s Top 10 Health Technology Hazards for 2021. An Executive Brief version of that report is available for complimentary download at www.ecri.org/2021hazards. The full report, accessible to ECRI members, provides detailed steps that organizations can take to prevent adverse incidents. To learn more, contact ECRI at 610-825-6000, ext. 5891, or by email at clientservices@ecri.org.

APRIL 2021

TECHNATION

INDUSTRY UPDATES

RIBBON CUTTING Medical Technology Management Institute BY ERIN REGISTER

edical Technology Management Institute (MTMI) was formed in 1989 to fill the need for quality education for technologists in medical imaging. In the 1990s, as the need for cross-training grew, MTMI grew by adding cross-training in mammography, MRI, CT, ultrasound, bone densitometry and picture archive and communication systems (PACS) education.

By 1992, MTMI’s “Initial Training in Mammography” course was the first course to be accepted by the FDA to meet the Mammography Quality Standards Acts (MQSA) in the United States. As the company grew, courses were added for medical physicists and physicians. TechNation learned more about MTMI in a recent question-and-answer interview with Steve Cushman, MTMI Senior Director of Marketing. Q: WHAT IS THE MAIN FOCUS OF MTMI? A: MTMI’s mission is to provide world-class continuing education for medical imaging professionals to help improve patient care. MTMI strives to deliver the latest in medical imaging education in innovative and convenient formats, including on-site classes, webinars and on-demand videos. Q: WHAT ARE SOME SERVICES OR COURSES MTMI OFFERS? A: MTMI offers continuing education through on-site classes in Milwaukee, Houston and Las Vegas, as well as live

TECHNATION

APRIL 2021

and recorded online programs. Our programs, which include radiography, mammography, MRI, CT, ultrasound, bone densitometry and PACS are offered for technologists, medical physicists, physicians and biomedical technicians. MTMI’s personalized consulting services offer help with ACR re-accreditation, clinical competencies and team education. Additionally, 2021 brings the expansion of our biomedical engineering education with the debut of “The Fundamentals of Medical Instrumentation and Biomedical Equipment Technology,” a CBET exam preparation course taught by industry expert Larry Fennigkoh, Ph.D., CCE. Q: HOW DOES MTMI STAND OUT IN THE MEDICAL EQUIPMENT FIELD? A: MTMI’s focus on quality, expert instructors with clinical experience and

unique delivery platforms make us a leader in medical imaging continuing education. MTMI is the only provider of continuing medical education with programs accredited in all modalities for medical imaging professionals, including technologists (ARRT), physicians (ACCME), physicists (CAMPEP) and biomedical engineers (AAMI). MTMI is proud to host students from all over the country and world. Q: DOES MTMI HAVE ANY SPECIFIC GOALS TO ACHIEVE IN THE NEAR FUTURE? A: The future for MTMI holds global expansion, continued growth in technologist, physician and medical physicist programs and additional biomedical engineering courses. For more information, visit www.mtmi.net.

WWW.1TECHNATION.COM

Your Premier Source for Siemens and GE Medical Imaging Parts is Now Featuring Canon, Carestream and Shimadzu Parts!

CATH-LABS AND C-ARMS

R&F AND FIXED X-RAY

Including popular tubes and detectors in stock and available for immediate shipment! • Cost effective alternative for high quality medical imaging parts • OEM owned since 2011 • Still here for you, 24/7/365. On call customer service, technical support and shipping

PORTABLE X-RAY

Training available!

On these and many other modalities. Please visit allpartsmedical.com for our 2021 training calendar!

Order by calling 866-507-4793 or email apmsales@philips.com

THE BENCH

BIOMED 101 Promoting HTM Careers as Industry Faces Fewer Biomeds BY GEORGE HAMPTON AND DAVE FANCOEUR

very year, hospitals add more and more medical technology. Unfortunately, the number of individuals with the specialized skills to maintain and repair those devices is going in the opposite direction.

Currently, industry estimates indicate about 54,000 biomeds are working in health care systems from coast to coast. In the next five years, we project a significant portion of that workforce to retire, a pace that isn’t being mirrored in the number of people coming into our profession. Today, about 50% of biomeds in our field are over the age of 50. In contrast, we expect new biomed jobs to grow by at least 5% a year for the next decade, according to the U.S. Bureau of Labor Statistics. There simply aren’t enough future biomeds currently in the pipeline to meet that need. What’s at stake for hospitals is the risk of scaling back patient care when mission-critical equipment is out of service, which, in turn, translates into lost revenue when margins already are tight. How do you know when you are at risk? The early signs that your HTM team is understaffed include slower response times and longer downtimes. Simply put, if you don’t have the equipment available for necessary treatments, then you’re going to have to cancel patient appointments – which creates a high-risk situation for health systems. KNOWLEDGE LOST WHEN BIOMEDS RETIRE Within our industry, this watershed moment could redefine how we support our hospitals. One of the biggest

TECHNATION

APRIL 2021

George Hampton

Dave Francoeur

President, TKA

Senior Vice President of Marketing and Sales, TKA

obstacles with a dwindling workforce is that talented veteran biomeds will take important knowledge with them when they retire. When we were managing in-hospital teams, we often planned our staffing to have a few practiced veterans in every shop, something we still encourage our regional directors to strive for. Losing those accomplished experts will reduce the opportunities for side-by-side training and mentoring. Many hospitals already are seeing staffs stretched to extremes, which means the highest-skilled biomeds take more sophisticated calls while newer biomeds are assigned to develop their skills on a simpler piece of equipment. There’s no give-and-take where industry masters offer novice biomeds real-world lessons, which you can’t replicate even in the best training classes. When a human capital shortage is projected in nursing or other health care professions, you read it in the headlines and health care systems and educational partners pivot to recruit and prepare new talents to close those gaps. Outside

of that spotlight, our biomeds are professionals working on the front lines as well, and we ensure that providers have access to the increasingly critical numbers of medical devices used in treating patients. Today, hospitals average up to 24 medical devices per bed, which means a 500-bed hospital could have some 12,000 devices to service and maintain in patient rooms alone. That’s not counting critical equipment in imaging and surgical suites, laboratories and other treatment areas. ABOUT THE DISCIPLINE New medical equipment is becoming more sophisticated, which could lure new types of talent into the field. We’re seeing opportunities for a new generation of biomeds with natural affinities for networked and software-driven equipment, particularly with growing concerns about cybersecurity risks with HTM. In our early careers, when both of us worked in hospitals, we were able to

WWW.1TECHNATION.COM

THE BENCH

take apart and tinker with more equipment as we discovered what was wrong as we repaired devices. As you see in the automobile industry, today’s HTM requires more training and insight on digital advancements, and some equipment can even self-diagnose why it’s not working and guide biomeds to the right fixes. Even before COVID-19, many colleges were eliminating programs in biomedical equipment technology, which has further tightened the emerging pool of new biomeds. Dating from the 1970s, those programs focused heavily on electronics, anatomy and physiology, leading to associate degrees. One hurdle we’re working to overcome is that many people mistakenly believe that an engineering degree is required to secure a biomed job. Today, only 22 colleges – down from a high of 55 schools – are graduating 400 new biomeds every year. We still believe it’s a fascinating job, as you are surrounded by amazing people and share in the mission of quality health care. Today’s training now allows those interested in related fields, such as software and robotics, to find a niche in HTM, while also appealing to more diverse candidates. For example, we see more female biomeds today as the highly specialized women’s services segment allows them to move seamlessly and gracefully in and out of that environment. On a practical level, we see an

important need for individuals who are strong oral and written communicators. At the heart of the biomed profession is ensuring equipment is ready and available for patient care. As nurses and other providers are inundated by the growing volume of devices needed for effective patient care, they simply can’t keep up with the knowledge and skills to use each piece of equipment effectively. Too often, the HTM team retrieves a device that is reportedly not working, but the real issue is a lack of understanding of its functionality. At TKA, in particular, we prepare our biomeds to train front-line providers on those devices. Because that is just one way that the skill set of an effective biomed has evolved, we prepare teams with targeted people management and other soft-skills training, including budget development. We layer this on top of ongoing job training that ensures our biomeds are technically competent. This issue isn’t something that any of us can tackle alone. One recent big step came late last summer when the Association for the Advancement of Medical Instrumentation (AAMI) unveiled the Certified Associate in Biomedical Technology (CABT) program to provide a springboard for launching or changing career tracks.

ment and the technology behind it. You need your medical devices to be ready, working and clean when needed by providers and patients. Think about your laptop: When it works well, you don’t think much about it; when it doesn’t, then it becomes very apparent that you need help. Our industry – more importantly, our people – are vital to the health of the health care industry. We are the ambassadors for one of the largest underpinnings of patient care. We continue to speak with industry peers and hospital partners about the pending workforce shortage. Another strategy we’re deploying to generate interest is offering internships to recent high school graduates or career changers, as a way to experience the profession. We’re also in discussions with one college to develop a custom training program, specifically to prepare future TKA biomeds, to augment the training and educational support we currently offer all of our biomeds. As we work collaboratively to address this industry-wide concern, please share your ideas and successes in promoting this worthwhile career. Dave Francoeur will discuss this more when he presents “Updates to the Medical Device Servicing Community” at MD Expo Dallas this April. Find out more at tinyurl.com/MDXsession.

IN CONCLUSION The main mechanism for health care delivery, in this day and age, is equip-

GEORGE HAMPTON is the president of TKA. DAVE FRANCOEUR is the senior vice president of marketing and sales at TKA.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

APRIL 2021

TECHNATION

THE BENCH

TOOLS OF THE TRADE Jasper Electronics

Medical Grade Power Supply Portfolio

asper Electronics has expanded its line of medical grade power supplies with 27 new model series of external power adapters. The new adapters are compliant with International Electromechanical Commission (IEC) standards for the safety and effectiveness of medical electrical equipment, including IEC60601-3rd Edition, UL/cUL, TUV and FCC certification. Several of the wall-mounted model series have interchangeable AC plugs for international compatibility, and all units have custom connector and cable options. Jasper Electronics’ comprehensive range of medical-grade external power supplies includes both wall-mounted and desktop configurations with output power ratings from 4.5W to 310W. All models carry safety agency certifications (UL/cUL, TUV, CE, FCC, and IEC60601 – 3rd Edition), and many feature multiple sets of interchangeable AC plugs for worldwide compliance. The HEMG Series devices feature universal input harmonic power factor correction (PFC) with high efficiency. For more information, visit https://www.jasperelectronics.com.

TECHNATION

APRIL 2021

WWW.1TECHNATION.COM

ON-SITE TRAINING AVAILABLE

CONTRAST INJECTOR TRAINING

OPERATION, SERVICE, TROUBLESHOOTING • Up to $5,500 in FREE Parts, PM Kits and Service • Massive Troubleshooting Library

• 100s of Error Codes not found in OEM Lit • Online and Onsite Training Available • Training BMETs since 2008

Contrast Injector Troubleshooting Channel

w w w. M a u l l B i o m e d i c a l . c o m | 4 4 0 - 7 2 4 - 7 5 1 1 | s t e v e @ m a u l l b i o m e d i c a l . c o m

Join the MMS Team! Experienced BMET’s in the United States! Email your resume to resume@multimedicalsystems.com

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

APRIL 2021

TECHNATION

THE BENCH

WEBINAR WEDNESDAY

Experts Discuss CMMS, Career Advancement & RTLS STAFF REPORT

he TechNation Webinar Wednesday series continues to serve the HTM community with expert knowledge and insightful advice. The February 17 webinar “How to Get Your Budget Approved for a New CMMS” was sponsored by Nuvolo. During the live presentation, approximately 100 attendees learned steps they can take to acquire a new system. The session was eligible for 1 credit from the ACI. HTM professionals have also watched the webinar via the on-demand option offered at WebinarWednesday.Live.

The webinar was presented by Andrew Strong and Jim Liska from Yale New Haven Health System alongside Nuvolo Vice President of Product Marketing-Healthcare Heidi Horn and Nuvolo National Sales Director Tom Eilers. The 60-minute webinar walked attendees through the process of showing leadership a need for a new CMMS as well as how to justify the expense and document the value. The webinar showed how an HTM department that is still operating on an outdated legacy computerized maintenance management system (CMMS) has its performance and efficiency impacted by an older CMMS. The HTM department could be greatly improved with the implementation of a modern CMMS designed to meet the needs of today’s HTM departments and hospitals. The

TECHNATION

APRIL 2021

webinar provided participants with proven strategies and templates for getting a CMMS budget approved. Attendees provided feedback via a post-webinar survey that included the question, “What did you like most about today’s webinar?” “Very pertinent information as we are trying to get our CMMS replaced in the next year,” Biomed Coordinator S. Richardson said. “Provided good information from both the customer and vendor,” said S. Tarter, director of capital equipment services. “Presenters were very professional and knowledgeable with great information,” Biomed P. Ly said. HTM CAREER ADVANCEMENT TechNation teamed up with HTMjobs.com for the presentation “Advancing Your HTM Career” presented by Tech Knowledge Associates LLC Senior Vice President Marketing and Sales David Francouer, Banner Health Vice President of Technology Management Perry Kirwan, Insight HTM Founder Ray Marden and Agiliti Corporate Recruiter Erica Cuthbertson, SHRM-SCP. The session was eligible for 1 credit from the ACI. HTMjobs.com is a niche job board that connects qualified candidates to open positions in the HTM community. Free registration is available at HTMjobs.com.

In the webinar, the panelists discussed the hiring and training process in the HTM industry and how to excel and grow in an HTM career. The industry professionals also provided insight regarding how to begin an HTM career and how to address promotional opportunities. In short, they shared information on how to set oneself up for success in the industry. More than 100 individuals registered for the webinar. Attendees provided positive feedback about the webinar via a survey that included the question, “What were your key takeaways?” “One key takeaway was that soft skills are very important to employers since they can be harder to develop. I also was happy to hear about ways to advance a career and different ways of challenging myself. One of the biggest takeaways that I had, however, was about communication and the importance of it in a workplace environment,” said J. Weed, student. “To be prepared with real-life examples for standard interview questions. There is a need for more biomed training programs to fill the needs in the field,” said Tech Manager C. Bottomley, BMET II. “Attitudes and soft skills are extremely valuable and cannot be taught,” said HTM Director S. Sauseda. RTLS INSIGHTS The recent Webinar Wednesday

WWW.1TECHNATION.COM

THE BENCH

Advancing the Biomedical/HTM Professional

Continue your free subscription of TechNation magazine!

SUBSCRIBE TODAY! 19 ST 20

AUGU

1tec

Vol.

hnati

NCING ADVA

m on.co

DICAL BIOME THE

/ HTM

NAL ESSIO PROF

1tech

Vol. 10

, 3D

robots

natio

n.com

ADVAN CING THE BIO MEDIC AL / HT M PR OFESS IONAL

Lead

Treairns LE AD i ng ER S I

rs Printe

& Mor

case Show pany Com te iga s Med Note and tes News y Upda str Indu le dtab Roun ing Train Expo D M xx

P R E P A R I N G

N H T

n.com

PRS RT STD U.S. Pos tage PAI D Pub lishing

ADVANCIN G THE BIOM g.indd EDICAL / 1 HTM PROF ESSIONAL

Req ues ted

0-TN

-Ma

Comp Nuvo any Sh owca lo se Comp Asse any Sh t Servi owca se ces Comp Midm any Sh ark RT owca LS JULYse Roun 2019 CMMSdtable

Addre ss Ser vice

Vol. 10

191

R 20

D T ST PRSR stage . Po U.S PAID hing blis

1technatio

For more information about Webinar Wednesday, including on-demand videos and a calendar of upcoming sessions, visit WebinarWednesday.Live.

OCTO BE

9 shingBend 3026 k Publi y, GA MD stbroo e Cit ed 18 Ea tre est Peach Requ rvice ss Se dre Ad

g. 100 , Ste . 120

MD 105 Publish 1 Tyr ing Tyrone one , GA Rd., Bld 302 90

presentation “RTLS Asset Management: Clinical Best Practices for HTM” by CenTrak Clinical Nurse Educator Danielle Updegraff, BSN, RN; CenTrak Director of Clinical Consulting Chris Thompson, MSN, RN; and Vizzia Technologies Chief Commercial Officer Dave Wiedman, was eligible for 1 credit from the ACI. Vizzia Technologies and CenTrak co-sponsored the 60-minute webinar. The presenters explained that healthcare technology management (HTM) professionals are constantly looking for ways to reduce costs, streamline processes and improve patient care. The presenters, clinical and RTLS experts, discussed how to successfully implement a Real-time Location System (RTLS) in a health care facility. They shared valuable best practices, insightful lessons learned and ROI results from “go live” deployments at nationally recognized health systems. Attendees left the webinar with knowledge regarding the key components of creating an effective asset tracking program as well as stakeholder collaboration between biomed, clinical staff and IT departments. The webinar was well received by attendees who provided feedback in a post-webinar survey that included the question, “What did you like most about today’s webinar?” “Hearing about the experiences of others who have implemented RTLS to track equipment and perform other functions,” Supervisory Biomedical Engineer J. Patterson said. “Thorough explanation of the importance of having a good working program,” shared L. Santos, BMET III. “Learning more about RTLS and how it can be leveraged in the health care environment,” Senior Account Executive K. Smith said.

28 56

9/5/

7:45

Thank you to our sponsors:

Professi onal of the Mon Charlotte th Threlkeld Company Showca oneSOUR se CE News and Notes Industry Updates Roundta ble Ultrasoun d Systems

14 1techn

atio

n.com

.indd 1

Vol. 10

ING THE ADVANC

ICAL / BIOMED

9 BER 201

SEPTEM

izing Optim MS CM 44

1907-TN-MAG

AL FESSION HTM PRO

Your

6/6/19

Much

2:14 PM

than

les

hedu

PM Sc

Comp EQ2

any Sh

owcas

e owcas Inc. s, any Sh Comp Data System x Phoeni tes and No News Updates ry Indust le tab Round Therapy Infusion

9 7:30

8/5/1

ed Request Service Address

d lishing 30269 MD Pubbrook Ben , GA 18 East e City htre Peac

STD PRSRT age U.S. Post PAID g lishin MD Pub d 1

ag.ind

-TN-M

1909

www.1technation.com/subscribe EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

APRIL 2021

TECHNATION

THE BENCH

SHOP TALK POWERED BY

SIEMENS SONOLINE G40

The system is shutting down automatically to prevent permanent damage. The message is visible after 15-20 minutes. Can anyone help?

Concerning your system that is shutting down automatically, you have to properly check the power supply unit and that the voltage supplies are OK and also check the cooling fans within the unit.

cable, load software disk and select sip install. When you get to service message three click enter to restart then turn off with circuit breaker (do not let the machine restart). Remove jumpers and hook hard drives back up to normal spots. Turn machine on and select host install. SIEMENS SONOLINE SI-400

PHILIPS IU22Q

I am at a mission hospital in West Africa and have a Sonoline si-400 that is in German and I need to change it to English. Can someone give me instructions on how to do this? They are in desperate need to use it but are unable to use it because of the language. I am only here for one more day so a speedy reply or help would be greatly appreciated.

You need to clean all the boards, especially the dc-dc board that is at left of the ultrasound, open it and clean the fan normally and that will solve the problem.

I came to find out that the system could not boot. When turned on, it shows the normal Philips Healthcare and then returns to signal lost and becomes blank. I then had to reinstall the Windows XP OS. I want to install the embedded system OS, but the SIP is not seen. Must the embedded system be installed first before it sees the sip?

The sip has to be loaded first, make sure you have a copy or a backup of the license key.

You need to remove the two sip hard drives, change the jumpers making the had that goes to the dolphin the primary and the one that goes to the sip motherboard the slave, unhook the host hard drive and hook the two hard drives to the host had

There is no way for you to change the language on your Sonoline diskette. The only way that I know to change the language, is to build another Sonoline diskette. One of the startup questions is - What language do you select? I could send you another start up diskette, if you would like. TOSHIBA APLIO 300

How do I replace the two foam rollers that exist inside the trackball section? I’ve already removed the ball, but I have no idea where to find new foam and how to replace it.

You don’t replace the foam. You replace the trackball unit. Dependent on model it could just be the drop-in module.

STERIS AMSCO CENTURY V116

Does anyone have any good ideas for this alarm? Not passing Dart test.

Turn pressure regulator screw one full revolution clockwise to increase pressure. This answer is based only on the limited information you’ve provided. It’s not hitting set point (272-274 F) soon enough causing alarm.

You might want to check and see if something is clogging the removable screen in bottom of the chamber first.

More information would really help. Just being that alarm, we know you have some steam pressure because the door is sealed. If it is in the first pressure phase of condition, it is probably S2. It has to reach 26 PSIG before the set time limit. If it is in the Charge phase after the pre-vac pulses, it could be the PRV, S3, TR1 or debris in the chamber strainer. It has to reach set sterilize temp before the set time limit.

Did you accidentally open the ball valve on top left front above chamber just behind front door? It should be at a 90-degree angle. You’re only achieving 21 PSI which means there’s probably a leak, the S3 drain valve is blown or perhaps the chamber trap is not closing. The only other thing is the manual valve mentioned above.

SHOP TALK

is compiled from MedWrench.com. Go to MedWrench.com community forums to find out how you can join and be part of the discussion.

TECHNATION

APRIL 2021

WWW.1TECHNATION.COM

INTRODUCING THE ALL NEW LOWER LABOR COSTS

CMMS

INCREASE PRODUCTIVITY

AEM COSR

IMPROVE YOUR CMMS EXPERIENCE

Your CMMS Solution with

+ Robust Feature Functions Save Time and Money

3,000

+ Interface with Any Third Party Software

Hospitals in 20 Countries

+ Go Live in Less than 120 Days + Full Database Conversions - All Historical Data is Converted 3 5

Y E A R S

O F

E X P E R I E N C E

O P T I M I Z E D

I N

A I M S 3

Choose AIMS and You Will Never Search for Another CMMS® 800.541.2467

WWW.GOAIMS.COM

When It Comes To

CENTRIFUGES, One Name Stands Out

BIOMEDICAL Your Centrifuge Solutions Center • Free Tech Support • Depot Repair • Rental Units

• Re-manufactured Parts • New Parts • Exchanges

www.ozarkbiomedical.com EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

800-457-7576 APRIL 2021

TECHNATION

Find Your Next Job Here htmjobs.com

“

Companies like ours have such a difficult time finding qualified candidates for field service roles that it just made sense to publish our opening with HTMJobs. – K. White, HR/Compliance Manager

”

LOOKING TO FILL A POSITION? Visit htmjobs.com/start-posting/ to post a job. Companies that post with us:

We offer a wide array of positions and locations. Check out our website for even more!

• • • • • • •

Renovo Solutions Banner Health Source Support Services Mayo Clinic UHS Albany VA Medical Center Agiliti

POSITIONS: •

Manager Clinical Engineering

•

Account Manager

•

Imaging Service Specialist

•

BMET I, II, III

•

Director of Healthcare Technology Management

•

Regional Director of Operations

htmjobs.com

We are... 24/7/365 Technical Support • Complimentary • First response troubleshooting • Faster uptime • Parts identification • Call our contrast injector specialists today to find out how we can save you money! (888) 667-1062

We are

To learn more visit WeAreISS.com or call 888.667.1062

ROUNDTABLE

ROUNDTABLE Defibrillators

ealthcare technology management experts participating in this month’s roundtable article on defibrillators include ReNew Biomedical Director of Biomedical Services Neil Davidson, ProHealth Care Senior Biomedical Engineer Michael Howell, Coro Medical’s Kyle Kelly and Fluke Biomedical Global Training Manager Jerry Zion.

TechNation asked these industry insiders to share feedback regarding the basic functions every automated external defibrillator (AED) should have, what to look for when purchasing these devices, tips regarding maintenance and more. Q: WHAT ARE THE BASIC FUNCTIONS OR FEATURES EVERY AUTOMATED EXTERNAL DEFIBRILLATOR (AED) SHOULD HAVE? DAVIDSON: First and foremost, every

TECHNATION

APRIL 2021

requires the user to press a button to deliver the shock. By contrast, fully automatic AEDs will charge and deliver the shock without needing the user’s go-ahead. Also, some newer model AEDs have three-lead ECG capabilities, showing the ALS or advanced user a visual display to monitor the patient’s heart rhythm.

Neil Davidson ReNew Biomedical

AED should be biphasic. Even though it’s 2021, we still come across monophasic AEDs and always recommend an upgrade. Knowing whether your AED is semi-automatic or fully automatic is essential, as the semi-automatic will automatically charge but

HOWELL: Every AED should have automated voice prompts, tones and images that guide the user while they’re operating the device. The ability to display the waveform is important. That way the impaired person’s arrhythmia can be seen. There should be a status indicator to show the condition of the AED. For example, Zoll uses a green check mark to show that nothing is wrong and a red X if there is an issue with the AED. KELLY: There are several functions and features that every AED should have,

WWW.1TECHNATION.COM

ROUNDTABLE

but it really depends on where the AED is placed and who will be using it. The first thing you will want to consider is semi-automatic versus fully auto functionality. Are you comfortable pressing the shock button if prompted, or would you prefer that the AED analyze and deliver a shock on its own? Secondly, CPR Feedback is an invaluable feature which guides you to perform high-quality compressions via voice and/or text prompts on the AED. Depending on the device, the AED will correct you on rate, depth and release/ recoil. Lastly, pediatric capability is another function that is a must. Some devices require pediatric pads which reduce the amount of joules in the delivered shock; some devices use the same pads as adults, but they have a button for pediatric mode or use a “key” that reduces the joules when inserted. ZION: IEC-60601-2-4 and AAMI/ANSI DF80 provide the functionality for minimum performance and safety of automatic external defibrillators (AEDs). Among these are the ability for the device to distinguish among shockable and non-shockable heart rhythms, the ability to identify when a shockable arrhythmia has converted to a more normal rhythm, the ability to increase output delivery from an initial level to one or more increased levels (when no rhythm conversion has been achieved), the CPR coaching cycle between rhythm assessments and an internal quality assurance self-check. Though the internal quality assurance health check may not be the total

the user. The final step is to perform calibrations that generally cover pacing and defibrillation, specifically on ALS units on a Crash Cart or in EMS use. Ensuring that both of these functions are accurate is vital when it comes to saving a life.

Michael Howell ProHealth Care appropriate assessment to keep failure rates under control, they are an important function of the AED and collect a wealth of information about internal processes. Q: WHAT TYPES OF CHECKS AND REGULAR MAINTENANCE DO DEFIBRILLATORS/AEDS REQUIRE? DAVIDSON: At a minimum, all defibrillators and AEDs require annual maintenance. Every device has a service manual that sets testing guidelines from A to Z. The scope of testing needed can vary greatly depending on the device’s complexity, but all manufacturers require yearly upkeep and preventative maintenance checks. The complete operational analysis covers the unit’s buttons, printer, alarm, battery, power supply and testing all relevant parameters. Additionally, all units require a visual inspection to ensure safety for both the patient and

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

HOWELL: Defibrillators/AEDs require output delivery checks for energy output accuracy, gain checks to verify waveform amplitude and battery checks. Each manufacturer may require specific equipment to verify the energy delivery and create the correct type/size of waveform. Battery checks may require you to measure voltage, while others will have capacity indicators and will only need a visual check. In either case, the manufacturer will recommend a replacement time. KELLY: The AED battery and electrode pads are items that eventually will need replacing. Batteries can last 60 months or more and electrode pads range between 18-60 months depending on the model. However, all devices are different, and you should confirm expiration dates on all disposables. Most devices have audible “chirps” that call attention to the device when it needs to be serviced, and all AEDs have visual indicators that show you the status of the AED. All AEDs run self checks on predetermined intervals that confirm the readiness. Currently, there is no regular maintenance or calibration required. ZION: There are two categories of defibrillator: Advanced Cardiac Life

APRIL 2021

TECHNATION

ROUNDTABLE

Support (ACLS) and AEDs. Each has functionality that differs from the other. There are also different periodic checks, some of which are done by the nursing staff, and others (e.g., the semi-annual/twice per year testing) which is done by biomeds using test instruments. Nursing staff check the supplies and accessories to make sure they are up-to-date, not out-of-date, and high-level functions like the ability to safely discharge unneeded energy internal to the device. Biomeds have the responsibility to test to the manufacturer’s model-specific service manual test procedure, which runs through all features and functionality of the device, including those special AED functions discussed in the earlier question. Biomeds should also check pacemaker functionality (if applicable) and ensure that impedance sensing circuitry is performing as it should. Batteries are a common failure mode for AEDs, so they should be checked regularly for charge level and corrosion. The list of all these tests is quite long in order to ensure that the life saving device is safe and effective for clinical use. We have several webinars on this topic that we encourage all interested persons to view. Q: WHAT ARE THE MOST IMPORTANT THINGS TO LOOK FOR IN A DEFIBRILLATOR/AED? DAVIDSON: The most important thing to look for in a defibrillator is whether it was correctly tested and when the last date of service was. Next, know what capabilities and parameters your defib has. For instance, most hospital crash

TECHNATION

APRIL 2021

them like regular defibrillators. The battery usually needs to be replaced every 3-5 years.

Kyle Kelly Coro Medical

cart defibs are 3-lead with pacing for advanced users and the AED/Analyze functions on board are used by BLS staff to revive a patient. However, ambulance paramedics prefer defibrillators with the latest technology and monitoring capabilities including Bluetooth and Wi-Fi with 12-lead Interpretive ECG, SpO2, Et-CO2, NiBP, Non-Invasive Pacing and AED/ Analyze function. These communication options allow them to send the 12-lead ECG data ahead to providers at the hospital in real time. With many defibrillators on the market, select one for the proper job and correct provider. HOWELL: The defibrillator/AED should be easy to use. The automated voice should be clear and have understandable instructions. Reason being, you want anyone to be able to use it. It definitely needs to have a reliable battery capacity. You can’t recharge

KELLY: The most important things to look for in an AED are determined by your department’s needs. Are you on the go? You’ll want to consider a lightweight option. Will this be thrown around in a truck or get banged up? A durable device that can withstand a beating is the best option for you. Are you able to manage the AED and keep track of the status indicator? If not, Wi-Fi capability is a plus. For manual defibrillators, you’ll have several things to consider like functionality (SpO2, 3/12-lead, Bluetooth, etc.) and durability. ZION: The most important things to look for in a defibrillator/AED are the ability to recognize shockable versus non-shockable heart rhythms, an easy to use human interface, high reliability (low failure rate) and few manufacturer-initiated corrective actions or U.S. FDA recalls. Q: HOW CAN A HTM PROFESSIONAL EXTEND THE LIFE OF DEFIBRILLATORS/AEDS? DAVIDSON: HTM professionals can extend their defibrillators’ lives by following the service manual from front to back. The manual covers cleaning, testing and calibrating. At Renew Biomedical, we like to take this a step further and first open the device to replace the internal coin cell, which typically holds the time and date, but in some cases also maintains the

WWW.1TECHNATION.COM

ROUNDTABLE

number of self-checks to once a week will help maintain battery longevity. Lastly, keeping the device clean will also protect from possible corrosion of the internal components.

Jerry Zion Fluke Biomedical

ZION: Perform the periodic testing and justify by independent, objective evidence that the device remains safe and effective for clinical use. Follow the manufacturer’s service manual test procedure. Doing so adheres to medical device quality assurance best practices. We also have webinars available on these topics. Q: WHAT ELSE SHOULD TECHNATION READERS KNOW ABOUT DEFIBRILLATORS/AEDS?

device’s software settings. Inside, we verify the components’ integrity to include Main System PCB, Therapy PCB, high voltage modules, capacitor, system interconnect PCB and ensure the ribbon cables are correctly plugged in and secure. Once reassembled, we perform preventive maintenance (PM), referred to as planned or scheduled maintenance in the service manual. HOWELL: Generally, defibrillators are very reliable. The best way to make them last is checking for error codes, keeping an eye on the service light or service indicator. You should replace the battery as often as the manufacturer requires. Finally, make sure that there isn’t any physical damage. KELLY: The best thing you can do to extend the life of the device would be to keep it out of direct sunlight and out of extreme temperatures. Limiting the

DAVIDSON: To all readers out there, you can’t test your defibrillator often enough. Implementation of daily, weekly and monthly checks can ensure your defibrillator will function properly when needed most! A simple user test is as easy as powering on the device, verifying the AC power indicator is on, making sure your pads are ready and within expiration date, and running the self-test and user test that takes just seconds. Remember to change pads and batteries regularly, per the operator’s manual; this can and will save a life. HOWELL: Unlike the standard defibrillator, AEDs are made so that virtually anyone can use them. Therefore, you will see them in malls, churches, restaurants and other public facilities. They can be used on children but, there is a minimal weight. Because there isn’t a manual mode. AEDs only will allow

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

a patient to be shocked when “shock advised” is stated. So, if the person has a normal sinus rhythm or if there is no sinus rhythm, the AED will not shock. KELLY: To the average person, it may seem overwhelming to think about using a medical device on another person. You may be surprised to learn that an AED is very easy to use, and anyone can do so under any circumstance. An AED will give you verbal step-by-step instructions. As soon as an AED is turned on, the device provides clear instructions on how to begin, reminds you to call 911 and will guide you through every step of the rescue. The AED will analyze to determine if there is a shockable rhythm and will only send a shock to the person if one is detected. The device will only shock if it is needed, so there is no need to worry of hurting the person by using an AED. Providing life-saving treatment to a co-worker, loved one or stranger that has only minutes before permanent damage or death occurs is exactly what the AED was designed for. ZION: The 50-ohm test load in standard defibrillator analyzers may not be enough to evaluate innovative functionality meant to ensure that what you set (for energy delivery) is what you get (no matter the tissue impedance across which it must be delivered). Choose the right tools to perform the necessary testing to find problems while they are small and cost effective to fix. This helps ensure that the defibrillator will work properly for your biggest or smallest, oldest or youngest patient.

APRIL 2021

TECHNATION

DARE US TO SAY NO 35,000+ multi-OEM, multi-modality parts inventory

We are... • ISO 13485:2016 Certified • 0.87% DOA rate • Integrity and reliability • Cutting edge technology • Real time shipping • Adding inventory daily • Customer Centric

THE WORLD MOVES FAST. WE MOVE FASTER®

Call us to customize your solution! phigem.com

info@phigem.com

Jen Davis: 615.389.3075

PhiGEM HQ: 347.985.1679

COVERSTORY

Downtime Strategies Tips for the Planned and Unplanned

By K. Richard Douglas

TECHNATION

APRIL 2021

WWW.1TECHNATION.COM

COVERSTORY

cLaren Health Care’s clinical engineering department in Flint, Michigan, has a plan for scheduled downtime. It avoids busy shift changes or times when clinical staff is extra busy.

For those who manage medical equipment, there are myriad considerations in order to properly manage downtime. Clinical technology has become more robust, more integrated and more interdependent. Taking a device or system down, or having it go down unexpectantly, becomes a more common problem as more technology is depended on by end users and more can fail. The integration of devices can add complexity to downtime situations and the risk of critical devices going down. Device downtime can be planned and unplanned. It is the unplanned downtime that requires extra preparation and strategizing to mitigate disruption. Both scenarios require strategy, planning and communication. Having data available for quick action is also important. Planned downtime allows for scheduled repairs, upgrades and patches as necessary. This type of downtime requires preplanning with end-users to accommodate schedules and set expectations. The planning, coordinated with clinical staff, often has to take place weeks or months ahead of time. A planned downtime can be announced with a specific, predetermined time. Depending on the scope of the project, the planned downtime can cover minutes, an hour, a day or longer. Something as common as preventative maintenance work can require planned downtime. With a planned downtime event, coordination between departments can be executed beforehand to prepare all stakeholders and any member of the facility’s staff that will be impacted. These steps make certain that hospital staff members from various departments are aware of the downtime event

and allows them to make alternative plans to deal with it. A planned downtime can be managed. Unplanned downtime has its own set of circumstances. It often results from software glitches or a mechanical breakdown. A challenge of an unplanned downtime during the COVID-19 pandemic, or similar circumstances, is that parts and field engineers may not be as readily available. The pandemic has also placed a strain on clinical staff resources which can complicate downtime even more. Part of preparation includes having an updated contact list of those people who can be notified – night or day – when needed. Conference calls allow the various stakeholders to coordinate their efforts to minimize downtime. A command center can help manage more complex or lengthy planned downtimes and human resources can also be managed. The command center can manage “policies, plans, roles and responsibilities” according to Izabella Gieras, MS, MBA, CCE, FACCE, a clinical technology director at a hospital in southern California. She suggests following the Hospital Incident Command System (HICS) methodology. “Planned downtime may seem a bit easier to navigate around than unplanned, but it can go severely wrong if not designed properly,” says Leslie McGovern, CHTM, a director with Sodexo Clinical Technology Management who works at Northwest Community Healthcare in Arlington Heights, Illinois.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

She has several recommendations, including: • Give yourself plenty of time to plan for the downtime. • Ensure someone owns the downtime from an accountability perspective. • Ensure affected departments are invited to planning meetings, initially cast the

“ The most important part of successful planned downtime is a solid communication plan that identifies impacted departments, roles and responsibilities, scope of the downtimes and ensures required resources are in place.” Izabella Gieras invite wide to be sure all departments have a chance to provide input and clinical leaders must be involved. McGovern says to meet regularly when planning and send meeting minutes to all involved. She says to schedule downtime when the least number of users/patients are affected, if possible. She also suggests that you communicate to all departments involved before, at the start and at the end of downtime. McGovern says to ensure that all resources are available should something go wrong and don’t be afraid to reschedule the downtime if not 100 percent ready. LET ALL STAKEHOLDERS KNOW THE PLAN Communication is key with either planned or unplanned downtime. Interdepartmental messaging that both warns of downtime ahead of time when planned, or at the earliest moment when unplanned, and status updates are APRIL 2021

TECHNATION

COVERSTORY

important. “In both situations, planned and unplanned, the hospital has an outage alert system that not only can announce it overhead but a message goes to every desk phone in the facility with the impact. Then, a follow up once it is resolved,” says Michael McDonald, CBET, TRIMEDX Senior Site Manager at Edward-Elmhurst Health. Communication is easier with a planned downtime, so that all those who are affected are kept in the loop. Planned downtime can be caused by routine repairs, patches or upgrades that are an inherent expectation for those devices. “The most important part of successful planned downtime is a solid communication plan that identifies impacted departments, roles and

configure, OS, licensing), networking, infrastructure (wireless, fiber, headends, switches, telephony, etcetera), desktop PCs, laptops, interfaces to business software, all business applications,” says Pam Shuck, MS, CCE, senior clinical engineer with McLaren Health Care Corporation. She says that clinical engineering (CE) supports any clinical application that the hospital has purchased for clinicians as well as medical devices that are used for direct patient care. “IT regularly emails out planned downtime notices which include the system, hospital, departments, date, time and impact of the downtime. The notices often are one day to one week ahead of time. The managers of the affected departments will post these in areas that staff congregate,” Shuck says. She says that IT will also push notifications to each computer’s desktop notifying each user of security patches and other maintenance notices. Clinical Pam Shuck engineering reviews the downtime responsibilities, scope of the downtimes notices and acts to help workarounds. and ensures required resources are in For example, when physiological place,” Gieras says. monitors’ servers are planned to be Communication can be hastened by down, clinical engineering will distribemploying templates. This is a part of ute local strip chart printers to the units planning that allows for quicker so they can still print their strips when disbursements of important messages the print server is unavailable. when downtime is anticipated or when “For planned downtimes, CE tries to it comes as a surprise. The template can avoid busy shift changes and mornings be used for the initial communications when the staff is busy with huddles, and subsequent updates. rounds, new orders and discharges. “McLaren Healthcare has outBecause medical equipment vendors sourced our IT services. Our IT charge a premium to support downcompany is responsible for all our times during off hours, and CE also hospital-owned servers (purchase, prefers to be on site to support the

“ IT regularly emails out planned downtime notices which include the system, hospital, departments, date, time and impact of the downtime. The notices often are one day to one week ahead of time.”

TECHNATION

APRIL 2021

downtimes, we typically schedule them around lunch time Tuesday and Wednesday. We avoid any major changes on Mondays and days too close to the weekend in case something does not work as expected,” Shuck says. She says that her department does get feedback from affected departments because they also work around planned staff shortages and manager preferences. The involvement of all stakeholders and getting the word out cannot be emphasized enough. “For planned downtime, we have a committee that will include clinical engineering, IT and clinical staff – sometimes facilities, if it is needed. What that hopefully does is fill in any gaps so that something won’t get missed during the downtime, or when unexpected calls come in related to the downtime. Each team is aware and can address the concerns as they come up. Communication is the key here and even with the best plans it doesn’t always get to the right people, but if the ones who respond to outages and service issues know, then it does help,” McDonald says. UNPLANNED EVENTS Physicist and author Leonard Susskind once said; “Unforeseen surprises are the rule in science, not the exception. Remember; stuff happens.” While Susskind’s observation may refer to something exciting or challenging; an unplanned downtime simply throws a monkey wrench into a well-oiled machine. What should biomed’s first steps be when an unplanned downtime upsets the apple cart? “Communication, communication, communication; once biomed established the initial plan of action. This has to happen within the first few minutes of being notified there is an issue. The downtime policy kicks in,” Gieras says. In addition to getting the word out as quickly as possible, there is an element of information gathering as well. WWW.1TECHNATION.COM

COVERSTORY

“For unplanned downtimes, clinical engineering first has to verify that the complaint affects more than one hospital to classify it as a system versus local failure. If it is a local failure, the managers/users are communicated with to let them know the issue and that someone is working on it. If it is a system failure, the tech or engineer will notify the corporate CE call center to let them know that a system is down,” Shuck says. She says that another communication is sent via email or phone to the call center and individuals who reported the outage when the system is back up. “Most extended system downtimes result in the clinicians charting on paper,” Shuck says. She says that McLaren is moving toward Vocera’s hands-free communication badges which clinicians clip onto their scrubs. “For a recent downtime, it was very easy to broadcast a short 10-second notification that the communication system would be down for five minutes. We could see if anybody was in the middle of a call and once everybody had ended their call, we took the system down. Future installations, however, would be on a high availability server so we will not have to take down the system in order to upgrade the server,” Shuck adds. When downtime is network-related, there are some practical considerations. “Examples include various forms of patient monitoring equipment, where a caregiver may lose visibility on the patient’s physiological waveforms, clinical alarms. Depending on the specifics around downtime, it is important to ensure standby equipment is charged and ready to be used along with efficient ways of sourcing extra clinical staff to assist,” Gieras says. She also says that established partnerships with existing, core vendors are essential to assist in smooth vendor planning.

assist with future downtimes can be very helpful. “Documenting during an unplanned downtime may seem impertinent to the work at hand, but necessary, so lessons learned only must be learned once. Ensuring new applications are added to the categories and analyzing the recovery workbook should be done regularly to be sure nothing is missed. Policies around this can also be helpful,” McGovern adds. Leslie McGovern With any downtime, preparation and communication will improve the experience and sidestep “It needs to be done in advance as part any grief, or at least, minimize it. of initial kickoff meetings,” Gieras says. Notifying those impacted and having Some software can aid in incidents procedures in place for any contingency that are not foreseen. will reduce frazzled nerves. With “We have a few systems in place to planned downtime; be prepared or alert us for unplanned things like reschedule in order to have all resources outages. Our telemetry system is available. monitored by some IT software that “All perspectives need to be represends us alerts when something goes sented when planning for the inevitable offline; this allows us to respond quickly downtime situations. If HTM is instead of waiting for a service call,” planning the downtime, it is not McDonald says. expected we have all the answers, but it He says that his team is also impleis expected we get the right people to menting remote monitoring for MRI the table,” McGovern says. systems; which will monitor things like As long as HTM is prepared and temperature, pressures, etcetera, so that confident, then planned or they can respond proactively to avoid unplanned downtime them. can be managed “Unplanned downtime involving successfully with the multiple systems can seem a little more least amount of challenging to manage. Categorizing disruption to clinisystems into priority tiers based on cians and without business criticality, then creating a giving patients recovery order within the tiers, is a great anything else to way to approach this,” McGovern says. be concerned She says that if the unfortunate with during occurrence of a hospital-wide downtime their stay. is experienced; utilizing a workbook documenting recovery service tickets to

“ Unplanned downtime involving multiple systems can seem a little more challenging to manage. Categorizing systems into priority tiers based on business criticality, then creating a recovery order within the tiers, is a great way to approach this.”

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

APRIL 2021

TECHNATION

EXPERT ADVICE

CAREER CENTER

Relocation – Fast Track to Career Advancement BY JENIFER BROWN

he shortage of experienced imaging service engineers and biomedical technicians has made it even more crucial for employers to look outside of their geographical area for qualified candidates! Because of this, many employers now offer relocation assistance. Some even offer full relocation packages at the engineer/ technician level. Previously, those full relocation packages were only given to management-level hires by the majority of employers! NOTE: For those employers who do not offer any relocation assistance at this level, you may want to think twice about that because, believe me, your competition for candidates is offering it!

Even with this added enticement, there has been a significant drop in both imaging service engineers and biomedical technicians willing to relocate. This is especially apparent in the last year and a half during the COVID-19 pandemic. It is definitely understandable during this scenario. It is scary to leave what has now become not only your comfort zone but your sanctuary.

TECHNATION

APRIL 2021

Jenifer Brown Health Tech Talent Management LLC However, I personally feel, and have witnessed, that the reasons for not being willing to relocate are far more than that. Candidates know that there is a shortage and, consequently, there is a higher demand in this industry. They are being far more selective and waiting for that “perfect” opportunity – preferably in their own geographical area. The problem with that mindset is that they are missing out on many incredible career opportunities and growth! My mantra to candidates has

always been “the more flexible you are about relocating, the more career options you will have.” It’s just logical. Through my 25 years of recruiting and placement in the medical equipment service industry, I have observed over and over again that the candidates I placed who were flexible in this regard, moved up quickly in their careers. Many of which advanced in position level and salary every year or two. I don’t mean necessarily from one employer to another, but even within their own organization. So, if you are not getting the training, salary or title you feel your worth merits – or cannot even advance until someone retires or leaves – than it is time to look outside of your area. No one but yourself determines your career path! You have to ask yourself; am I in this industry for a true career or just for income? I hope you choose career, because the nation’s opportunities await you! The views expressed here are those of the author’s and do not necessarily represent or reflect the views of TechNation or MD Publishing.

WWW.1TECHNATION.COM

Our USA Manufacturing Is Growing Grow with us www.elitebiomedicalsolutions.com

EXPERT ADVICE