TechNation Magazine - January 2020 by MD Publishing

1technation.com

Vol. 11

ADVANCING THE BIOMEDICAL / HTM PROFESSIONAL

JANUARY 2020

ISO CERTIFICATION Quality Management for HTM Departments

18 Biomed Adventures

Intern in Rome

Goals

Mentors

KAMI

36 Biomed 101

77 Roman Review 81 Scrapbook

One source to maximize capital equipment performance

avantehs.com/MD

Avante Health Solutions provides a single source solution for all of your capital equipment replacement and service needs from one powerful partner. We are a one-stop, brand-agnostic supplier of best-in-class service, parts, and repair.

800.979.6142

ISO 13485:2016 Certified

YOUR ONE UNBEATABLE SOURCE FOR THE LATEST SERVICE MANUALS

PATIENT SAFETY IS EVERYTHING. The medical staff rely on you and your team for one crucial aspect of it – biomedical equipment care. And just one mistake can cost someone their life. With oneSOURCE you’re covered. We’re 100% dedicated to patient safety and have been for 10 years. Our comprehensive oneSOURCE database gives you instant access to thousands of service manuals. And if we don’t have it, we’ll do our best to find it for you asap. It makes adhering to CMS, The Joint Commission, JCI and AAMI guidelines quick and easy, and when an on-site HTM needs a service manual, you’ll have it covered. Call or visit our website to sign up for a free webinar or for a price quote.

ONESOURCEDOCS.COM

1-800-701- 3560

Celebrating 10 years of changing the face of patient safety

ASK YOURSELF: IS YOUR EQUIPMENT

Cath Lab

Displays

Surgical

Displays

UP TO DATE?

Clinical Displays

MODALIXX

Modality Solutions

HD RECORDERS

PRINTERS & MEDIA

Ampronix is the LEADER in Medical Imaging Technology. We are your go-to Resource for Cath Lab Displays, Surgical Displays, Clinical Displays, Diagnostic Displays, Medical Recorders, Ultrasound Machines, Medical Video Converters, Digitizers, Printers, & Media. We o f f e r S a l e s , S e r v i c e , R e p a i r, R e p l a c e m e n t , & E x c h a n g e s both Domestically and in 135 countries across the world. Our extensive outreach allows us to extend our Direct pricing from the OEM’s, such as Sony, Barco, Eizo, NDS, NEC, LG, Mitsubishi, Elo, & Panasonic. Whether you’re replacing your unit, having it repaired, or are in search of a new product - Ampronix can help.

www.ampronix.com US and Canada: 1.800.400.7972

15 Whatney, Irvine, CA 92618 USA International: + 1.949.273.8000

info@ampronix.com

See. Secure. Manage.

everything

Heyâ&#x20AC;&#x201D;where is that infusion pump? Every day, your medical device footprint gets more complex. But managing that inventory shouldnâ&#x20AC;&#x2122;t have to. From

inventorying to integration into your CMMS and NAC. From CVE and patching alerts to utilization analytics, Medigate provides real-time identification, detection, protection and utilization metrics for your networked medical devices. So you can spend less time searching for things, and more time optimizing them.

LEARN MORE AT MEDIGATE.IO

SIMPLE SOLUTIONS FOR

COMPLEX DEVICES

Check out our new website usocmedical.com

PATIENT MONITORING PARTS • PATIENT CABLES

MANUFACTURERS

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

20 MORGAN • IRVINE, CA 92618

CARE FUSION • SECHRIST

CALL: 1.855.888.8762 VISIT: USOCMEDICAL.COM ISO 9001:2015 Certified

T 2 8 X D N A 7 X S P I L I H P OUR M A R G O R P R I A RAPID REP …Keeps You and Your Clinicians in the Fast Lane

With our TEE RapidRepair Program for Philips X8-2t and X7-2t, you can get your TEE probes evaluated, fully restored, and returned to you within 3–5 days of our receiving it. Our exclusive RapidRepair program is like having your very own pit crew. Once we know your probe is coming, we assign a team to stand by for your shipment and get started in record time, using our exclusive system. It’s how we keep your most valuable imaging services on track, and you in the driver’s seat when it comes to managing your facility’s life-saving devices for optimum performance when your patients need it most. For information about our RapidRepair programs, call 844 687 5100 or email our VP of Ultrasound, Matt Tomory, at MattT@innovatusimaging.com. You can also browse our full probe capability list and loaner inventory online at www.innovatusimaging.com. Let us help you cross the finish line every day, faster, and better than ever before. Look for us at the Imaging Conference and Expo (ICE) in Scottsdale, February 9-11. Attend your own "Ted Talk" featuring our clinical specialist Ted Lucidi, CBET and meet with our team at Booth 204 to learn more about our unique savings plans, inventory strategies and RapidRepair programs.

Chat with our experts live at InnovatusImaging.com email us at MattT@innovatusimaging.com or call us at

844-687-5100

Centers of Excellence for Ultrasound and MRI Coil Repair, Radiography, Design and Manufacturing

CONTENTS

FEATURED

ISO CERTIFICATION Quality Management for HTM Departments

HE ROUNDTABLE: T CYBERSECURITY Cybersecurity, 3D printing and artificial intelligence continue to be buzz words throughout the healthcare technology management world. Cybersecurity is an especially hot topic among biomeds and clinical engineers. In an effort to keep readers informed about the latest cybersecurity trends, TechNation invited industry experts to share their insights. Next month’s Roundtable article: Patient Monitors

I SO CERTIFICATON: QUALITY MANAGEMENT FOR HTM DEPARTMENTS The end goal of HTM departments and the organizations they belong to are focused on patent safety. The goal of a good quality management system in health care is aligned with this goal as well. We look at ISO certifications, standards and other measures biomeds may consider to maintain quality across teams and organizations. Next month’s Feature article: Connectivity, IoMT and Cybersecurity

TechNation (Vol. 11, Issue #1) January 2020 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. ©2020

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

JANUARY 2020

TECHNATION

CONTENTS

INSIDE

Departments

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

CIRCULATION

Lisa Lisle

WEBINARS

Linda Hasluem

ACCOUNTING

Diane Costea

EDITORIAL BOARD

Manny Roman, CRES, Business Operations Manager, Association of Medical Service Providers 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

P.12 SPOTLIGHT p.12 Professional of the Month p.16 Department of the Month p.18 Biomed Adventures P.21 p.21 p.28 p.30 p.32 p.34

INDUSTRY UPDATES News and Notes: Updates from the HTM Industry Ribbon Cutting: Acela Medical AAMI Update ECRI Institute Update Welcome to TechNation

P.36 p.36 p.38 p.41 p.42

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

P.56 EXPERT ADVICE p.56 Career Center p.58 20/20 Imaging Insights p.61 Cybersecurity p.62 Key Considerations When Choosing a New CMMS Platform p.65 The Future p.66 Does a Refurbished Anesthesia Machine Make Sense for Your Facility? p.68 View on Value p.70 A Cybersecurity Solution that Drives Value for Procurement? p.72 The Other Side p.74 ISO 13485:2016 p.77 Roman Review P.78 BREAKROOM p.78 Did You Know? p.79 The Vault p.81 Scrapbook: KAMI p.82 MedWrench Bulletin Board p.90 Flashback p.84 Service Index p.89 Alphabetical Index

MD Publishing / TechNation Magazine 1015 Tyrone Rd., Ste. 120, Tyrone, GA 30290 800.906.3373 â&#x20AC;¢ Fax: 770.632.9090 Email: info@mdpublishing.com www.mdpublishing.com

TECHNATION

JANUARY 2020

Proud supporters of

Like us on Facebook, www.facebook.com/TechNationMag Follow us on Twitter, twitter.com/TechNationMag WWW.1TECHNATION.COM

College of Biomedical Equipment Technology Building the Healthcare Technology Workforce of the Future

Accredited Online Certificate & Degree Programs Externship & Career Services

WWW.CBET.EDU

The College of Biomedical Equipment Technology provides nationally recognized and accredited biomedical equipment and healthcare technology management (HTM) educational and professional opportunities that meet the needs of our students and are responsive to the evolving needs of employers in the healthcare industry. The Online Programs offer educational opportunities for working adults seeking to advance their healthcare careers by obtaining a professional certificate or a college degree. All classes are taught online for the convenience of our students. Externships for hands-on practical training. Faculty are scholar-practitioners with realworld experience to provide the industry specific education.

linkedin.com/school/ cbetcollege

facebook.com/cbetcollege

SPOTLIGHT

PROFESSIONAL OF THE MONTH

Scott Gillett, BSAST, CBET: Dental Tech to Senior Biomed Tech BY K. RICHARD DOUGLAS

t may not seem like too much of a stretch to go from working on teeth to working in a different clinical area that requires medical knowledge. Working alongside a dentist is still working with a doctor and can still involve anesthesia, syringes and X-rays.

It may be a bigger jump to go from dental technician to biomed. Working on teeth and working on medical equipment do not share a common skill set, yet that is what one biomed in Texas did as part of his entry into the field. Scott Gillett, BSAST, CBET, is a senior biomedical equipment technician in the healthcare technology management department at Baylor Scott & White in McKinney, Texas. Gillett always had an interest in the medical field. His dental work experience, along with military training, was his launching point into an HTM career. “I joined the Navy and started my career as a dental technician. Not long after, a co-worker sparked my interest in the dental repair field. I applied and was selected for the dental repair school. Soon after, the Navy combined the dental repair and the biomed programs, and I was off to biomed school; Sheppard Air Force base in Wichita Falls, Texas,” Gillett remembers. He says that after training, he was stationed at Pearl Harbor, Hawaii and received comprehensive biomed training. “Fresh out of school, I was exposed to a wide variety of biomed experiences. We serviced everything from vital signs machines to X-ray networking. I returned to Wichita Falls to complete the bridge training portion of my biomed education, then transferred to Connecticut to finish out my (military) career,” Gillett says. In addition to his military biomed training, Gillett has been through various vendor training sessions including classes on Philips telemetry, Ascom Nurse Call, Fresenius dialysis and Midmark sterilizers. “I have been the new guy repairing a variety of basic medical equipment, shop Leading Petty Officer to my current

TECHNATION

JANUARY 2020

Scott Gillett stays busy away from work with a blended family of five children.

WWW.1TECHNATION.COM

SPOTLIGHT Scott Gillett enjoys motorcycles and working on cars.

FAVORITE BOOK: “The 4 Disciplines of Execution” by Chris McChesney, Jim Huling and Sean Covey

FAVORITE MOVIE: “Deadpool”

FAVORITE FOOD: Tacos

HIDDEN TALENT: Ping-Pong

FAVORITE PART OF BEING A BIOMED: “I like knowing that we play an integral part in keeping the hospital up and running even though many people don’t really know all we do.”

WHAT’S ON MY BENCH? Phone, needle nose Vice-Grip pliers, keys to low voltage closets, Fluke multimeter, Mountain Dew

position,” Gillett says. Nurse call and Philips telemetry are Gillett’s areas of specialty. THE RIGHT TEMPERATURE With biomed, there is never a dull moment, and a diagnostic challenge or a new facility can test even the most experienced HTM professional. Gillett recounts a couple of recent examples. “We just opened a heart hospital at our current location. We were involved in every aspect of equipment planning – scheduling vendors for installs, testing and set up. One of the major challenges was being short-staffed. We took care of our main hospital as well as another heart facility over 30 miles away,” he says. The project involved inventory and inspection of new equipment and then finding a place to store it until the building was completed enough to move it in. “We tagged and inventoried over 300 pieces of equipment and had it staged ready for opening,” Gillett says. “Since the new heart facility is attached to our current facility, they are separated by only a hallway. Many items were transferred from our location to the new one. Equipment records and control numbers had to be changed and or updated. Maintenance schedules and AEM identifiers placed into effect. Keeping track of equipment and other items as they travel back and forth between the two facilities will continue to pose a challenge for the biomed team,” Gillett says. He says that they encountered a few challenges, but all services were up and running on opening day.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

The importance of temperature monitoring, and the capabilities of modern technology, offered another test. “Another challenge we overcame was the new temperature monitoring in the new facility. This was a new system, for us as well as the staff. After the physical installation of the temperature sensors, we received training from the vendor, then access to the monitoring system via Internet. We loaded all information into the database; locations of the sensors and what they were monitoring, set temp ranges for refrigerators and freezers, uploaded staff members’ phone number and emails for call escalations,” Gillett says. Gillett says that they arranged and filtered escalations for alarm parameters; high range low range, which staff member received which escalation depending on their title and time of day the escalation started. He says that they then informed the staff on the use and what they actually had control over when units go onto alarm state. When not setting up temperature monitoring systems, Gillett can be found engaging his love of working on cars and motorcycles in his offtime. He also likes photography including aerial photos. He is married and has a blended family of five; four girls and one boy. Gillett says that one trait of his is that he is always willing to help others and learn new equipment. “Enjoy each day and make the best out of any situation,” he says. The new heart hospital and other Baylor Scott & White facilities in McKinney, Texas are in good hands with this senior biomed on the job.

JANUARY 2020

TECHNATION

WE BUILD

IMAGING ENGINEERS At Tri-Imaging Solutions, we strive to live up to our name and be a Solution for our Customers and ultimately, helping to Empower the EngineerTM

WHAT WE DO Tri-Imaging Solutions is a replacement parts, equipment, service support, and technical training company. We provide quality tested imaging parts, buy-sell-move equipment, and provide technical support. All replacement parts come with a 180-day warranty. Available 24/7/365

PARTS

Tri-Imaging’s goal is to carry the replacement parts inventory critical to supporting the imaging service engineer. We appreciate your business and support during this exciting time of strategic investment and growth.

EQUIPMENT

At Tri-Imaging, we have the equipment and connections to help you with all types of purchases, sales, installations and/or de-installations. We have experience with most all modalities, including CT, R&F and Digital Mammography.

SOLUTIONS

VISIT TRI-IMAGING’S EDUCATION CENTER IN NASHVILLE, TN

Completion of our BMET to Imaging 1 course now offers 73 CEUs from the AAMI Credentials Institute.

TRAINING

The Tri-Imaging Technical Training is a unique and intuitive training program that will prepare the service engineer to efficiently and effectively trouble shoot today’s diagnostic imaging systems.

ISO 13485:2016 Certified

VISIT WWW.TRIIMAGING.COM OR CALL 855.401.4888 (24/7/365)

SUPPLYING YOUR

GE AT&AOEC Cables PRICE YOU CAN AFFORD Kenneth Saltrick, President of Engineering Services in Twinsburg, Ohio, knows from his long experience that C-arm machines themselves are absolute workhorses.

9900, 9800 R E C E P TA C L E CABLES

For customers looking to blend the gap between expensive OEM and unreliable used assemblies, WE have your solution. Our complete repair contains a new cable assembly, utilizing all OEM cable and components with a harvested plate and connector housing as they are proprietary items. These completely repaired products will have a significant cost savings with build quality above new OEM products and carry a warranty of 180 days, which is untouchable in the market.

9900, 9800 INTERCONNECT CABLES

We want your HV Cable Cores! Call or email us the condition of the cable(s) and we will submit an offer to purchase the part. We will then inspect and test the part to see if it can be repaired. If it is deemed repairable, we will process the transaction and mail you a check the next day. Email photos and requests to: info@eng-services.com

Buying Repaira ble 9800 / 990 0 HV Cable Cores

SPOTLIGHT

DEPARTMENT OF THE MONTH The Edward-Elmhurst Health Clinical Engineering Department BY K. RICHARD DOUGLAS

aperville and Elmhurst are suburban cities that sit west of Chicago, Illinois. The populations of the two cities and the surrounding areas can have their health care needs addressed by the Edward-Elmhurst Health hospitals and clinics.

The health system is the amalgamation of Edward Hospital and Health Services and Elmhurst Memorial Healthcare, which merged in 2013. Each of the merged systems has histories that go back to the early 1900s. The health systems are joined by Linden Oaks Behavioral Health, which was acquired by Edward Hospital during the 1990s. Today, Edward Hospital has 352 beds and Elmhurst Memorial has 259 beds. Linden Oaks Behavioral Health adds an additional 108 beds. The combined health system is served by the Edward-Elmhurst Health Clinical Engineering Department, which is an onsite TRIMEDX program. The clinical engineering team supports the three main

TECHNATION

JANUARY 2020

facilities along with 100 off-site clinics. The department has eight technicians at Elmhurst Memorial and 12 technicians serve Edward Hospital and Linden Oaks. The TRIMEDX senior site manager is Michael McDonald, CBET. The department’s cyber specialist is Kevin Chendjou. The team members at Elmhurst Memorial include Senior Technician Adam Hartmann; Tad Kulikowski, BMET III; Paul Jarecki, BMET I; Brad Smaga, BMET II; Glenn Zarek, BMET II; and Ed Barker, BMET III. The Elmhurst team also includes imaging specialists Melissa Kapolka, Imaging I; and Scott Gobble, Imaging II. The Edward Hospital and Linden Oaks Behavioral team includes Senior Technician George Gaines; Tom Kaminksi, BMET II; Shawn Martin, BMET III; Shelby Suttles, BMET I; Kyle Taylor, BMET II; Michael Sabatin, BMET I; Drexel Johnson, BMET II; and Philip Yeglic, BMET II. Their imaging colleagues include Stefanie Gottberg, Imaging I; Keith

Above: The department has 12 technicians that serve Edward Hospital and Linden Oaks. The TRIMEDX senior site manager is Michael McDonald, CBET. The department’s cyber specialist is Kevin Chendjou. The Edward Hospital team includes Senior Technician George Gaines; Tom Kaminksi, BMET II; Shawn Martin, BMET III; Shelby Suttles, BMET I; Kyle Taylor, BMET II; Michael Sabatin, BMET I; Drexel Johnson, BMET II; and Philip Yeglic, BMET II. Their imaging colleagues include Stefanie Gottberg, Imaging I; Keith Kupres, Imaging II; Esco Smith, Imaging II; and Mike Kesler, Imaging III.

Kupres, Imaging II; Esco Smith, Imaging II; and Mike Kesler, Imaging III. “We have advanced imaging engineers that specialize in CT, MRI, general X-ray and ultrasound. We have biomedical engineers that specialize in a wide range of equipment, from anesthesia to respiratory, patient monitoring and even lab specialists. We also have a CE cyber/ IT specialist on staff for both facilities,” McDonald says. The department handles service contracts on a case-by-case basis. “If the contract proves to be less than what a typical time and materials spend would be, we can justify a service contract. Also, TRIMEDX does a good job of identifying equipment that should be covered under contract on a national level. They often negotiate national agreements (MSAs) or national contracts

WWW.1TECHNATION.COM

SPOTLIGHT to cover equipment that would benefit from a service contract,” McDonald says. Data collection is comprehensive. “TRIMEDX uses a version of ServiceNow called RSQ. It allows us to collect multiple points of data, as well as a detailed service history. It allows us to collect in detail, every aspect of each piece of equipment. For example, make, model, serial number, vendor site ID, network connectivity, IP address, MAC address and any pertinent information we could imagine,” McDonald says. In a nod to the direction of biomed, the clinical engineering team has a full-time CE cyber specialist. “He not only assists with IT/network issues, but will also assist with any cybersecurity issues. He is heavily involved with all incoming equipment and providing security assessments to the hospital, as well as any necessary network configurations that are required. He is a new addition to our team over the last couple of months but has already proved to be invaluable with solving network related issues as well as confirming any Windows patching is up to date on all medical devices,” McDonald says. INNOVATORS AND CONSULTANTS The TRIMEDX clinical engineering team is very involved in every aspect of medical equipment management and capital planning considerations. “We are heavily involved with all incoming projects. We assist with equipment purchasing and give

recommendations as to what we feel is the best option to pursue,” McDonald says. “The most recent projects include upgrading our telemetry. We were involved with not only determining proper AP coverage throughout the hospital, but also configuration for future expansions. We were also instrumental in the recent update to our OR/anesthesia department to allow for network connectivity for all devices into the hospital EMR. Not only did we assist with installing the devices, but the configuration and testing as well,” McDonald adds. He says that the team is also deeply involved with capital planning and purchasing. “Most recently, with the hospital’s aging infrastructure group, which has been put together to identify items that are aging and considered end of life or end of support. With this group, we have identified what the hospital will need to plan to replace in the next one to five years,” McDonald says. The clinical engineering team has been instrumental in helping solve problems and lend insights based on their specialties. “We have recently had a lot of equipment suddenly lose network connections. Our CE cyber specialist was able to identify that the hospital DNS server was dropping these devices. His assistance allowed us to show IT and their networking team what was happening so that this could be resolved,” McDonald says.

He says that up until this year, the team had not been involved with capital planning. “Now that the hospital is asking us for some guidance, we have identified a few devices that will soon be end of support. The hospital now has a plan to replace these devices before we are not able to support them. This will prevent any future downtime and impact to patient care,” McDonald says. The team has proven to be innovative as well. “We have developed what we call a ‘pump station.’ This allows us to PM multiple IV pumps at one time. Not only does this save us time, but also gets the pumps back into clinical use much faster,” McDonald says. “This pump station has been implemented across multiple TRIMEDX sites across the country this year. In the same spirit of the pump station and continuous improvement, we have also redesigned the shop at Edward Hospital to be more practical for the size and space provided. We have expanded the team in the last few years and have been limited to the same size space, we have been able to make the space more efficient and reduce the amount of time a technician needs to search for parts, tools or test equipment,” McDonald says. The end of the workday does not mean that the technicians and imaging specialists on the team hang up their biomed thinking caps. “We are heavily involved in the Clinical Engineering Association of Illinois (CEAI). We will often attend both chapter meetings and their annual conference. TRIMEDX also sponsors a booth each year during the annual conference,” McDonald says. The CE team at Edward-Elmhurst Health offers cutting edge biomed and imaging support that allows the facilities to support the people in the western Chicago area. The department has eight technicians at Elmhurst Memorial in Senior Technician Adam Hartmann; Tad Kulikowski, BMET III; Paul Jarecki, BMET I; Brad Smaga, BMET II; Glenn Zarek, BMET II; and Ed Barker, BMET III. The Elmhurst team also includes imaging specialists Melissa Kapolka, Imaging I; and Scott Gobble, Imaging II.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

JANUARY 2020

TECHNATION

SPOTLIGHT

ICEHTMC attendees took time to see the sights in Rome.

BIOMED ADVENTURES Intern in Rome BY K. RICHARD DOUGLAS

taly invokes romantic images of gondola rides and sipping wine in Tuscany. The country’s capital and most populous city is Rome. The city of Rome was founded in the mid-8th century and saw Julius Caesar rise to power and later Augustus. Christianity eventually took hold in the city and centuries later; the art of the Renaissance and Baroque periods adorn the city.

For 2019, Rome was host to the third International Clinical Engineering and Health Technology Management Congress (ICEHTMC) in October. Previous

TECHNATION

JANUARY 2020

congresses were held in Hangzhou, China and Sao Paulo, Brazil. The congress is organized by the Clinical Engineering Division of The International Federation for Medical and Biological Engineering (IFMBE). The event took place at the A. Gemelli Europa Conference Center on the campus of the Faculty of Medicine of the University Cattolica del Sacro Cuore of Rome. One of the congress’s U.S. attendees was second-year University of Connecticut (UConn) Clinical Engineering Internship Program master’s student Rebecca “Shasha” Graves. She is doing her internship through the VA Greater Los

Rebecca “Shasha” Graves enjoyed the third ICEHTMC.

Angeles Healthcare System. Graves attended the event as a recipient of a young professional grant, which covered her registration and hotel stay. “I first learned about the ICEHTMC from an email from the former program director of the UConn Clinical Engineering Internship Program, Frank Painter. Last June, I had the opportunity to attend sessions from presenters from around the world at the AAMI conference in Cleveland. It opened my eyes to universal challenges, the way different countries’ standards/regulations impact the field in

WWW.1TECHNATION.COM

SPOTLIGHT respective countries, and the different approaches people take to address those challenges,” Graves says. She says that ICEHTMC seemed like a great opportunity to continue to learn about what is happening in the field across the globe. “When this opportunity came up, I actively searched to figure out how to make attending this conference a reality,” she says. The conference venue was a fitting location for a gathering focused on health care. “The building was marvelous and having the backdrop of the conference be a medical school in Rome was special,” Graves says. WORLDWIDE GATHERING OF ENGINEERS Graves is enthusiastic about the global nature of the gathering and the quality content that was available for attendees. “The energy of the conference was palpable. I am so glad I had the opportunity to go. While there, it was hard to decide which sessions to attend because they all sounded interesting. Overall, I found the content very thought provoking. Friends and coworkers probably got tired of hearing me talk about it,” Graves says. She says it was great to hear about the innovative approaches people were taking to address problems and improve processes. “As a student in the UConn Clinical Engineering Internship Program, I am constantly making connections between material in my classes and my experience in the Biomedical Engineering Department at the VA Greater Los Angeles, and vice versa. It was fun to do that at ICEHTMC as well,” she says.

“For example, this semester I am taking a course on human errors and medical device accidents. We spent a week learning about electrosurgical units and accidents related to them. While at the conference, there was a workshop on electrosurgical units where they went in depth on how they work and also on how to communicate this information to ensure safe usage to prevent accidents,” Graves says. She says it was neat to have people from all over the world under one roof. “During down time/lunch time/in between sessions/on the shuttle going from the hotel to the site of congress, I had the opportunity to meet people in every stage of their career, learn about the projects they’re working on, the challenges they face, how they got involved in the field, how responsibilities vary, got advice from more experienced people about what they recommend for someone starting out in the field, etcetera. Also met a lot of young people in a similar place that I’m in and the energy that they bring makes me excited for the field,” she adds. SEEING ROME Graves was able to take in some of the world-renowned architecture, art and statuary in the Eternal City. It was a trip to remember. “I extended my trip to last the whole week. It was my first time going to Italy, and Europe as a whole. I utilized ground transportation and found it very easy to get around,” Graves says. “I was able to fit in quite a bit of sightseeing. ICEHTMC notified us of the papal audience the following morning after the conference and that was a very memorable experience. Hearing welcoming speeches in many different

languages and crowds of people so excited to catch a glimpse at the Pope,” Graves says. She says that following the papal audience, she visited St. Peter’s Basilica, Vatican Museums and the Sistine Chapel. “Breathtaking; it was fun to learn about the history and fun details/anecdotes about each. While in Rome, I also visited the Colosseum, the Forum and Palatine Hill. I did a day trip to Ostia Antica,” Graves says. She says that growing up in New England, where the oldest buildings are 200-plus years old, there was something extra cool about walking around 2,000plus year-old ruins and just being around so much history throughout the whole time in Rome. “Back in the city, I spent a lot of time wandering around following the smell of good food, the sound of people and music. Ate lots of delicious food throughout the week,” Graves adds. Back in L.A., Graves returned to her duties as an intern at the Los Angeles VA, as a participant in the UConn Clinical Engineering Internship Program. “This program offers an in-depth, rigorous, clinical experience that matches the engineering expertise gained in the classroom. My internship component is being completed through the VA Greater Los Angeles Healthcare System. The VA GLAHS is one of the largest VA hospitals. We support veterans across the area. We have an MEAV of $140 million. I am involved in a variety of HTM activities from every stage of the technology life cycle, recall management, TJC preparation (we were recently surveyed), etcetera,” Graves says. With her coast-to-coast clinical engineering program and internship site and her new international experience, Graves will be one well-rounded HTM professional ready for any environment. For more information on the UConn CE internship program, visit bme.uconn.edu/clinical-engineering. For more information about the IFMBE, visit ifmbe.org/about-ifmbe.

ICEHTMC attendees were able to attend a papal audience.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

JANUARY 2020

TECHNATION

VISUALLY INSPECT WITH REMARKABLE CLARITY The FIS includes a distal �p composed of a light source and camera lens at the end of a 110cm ﬂexible sha�, which features gradua�on marks. The Flexible Inspec�on Scope is a perfect tool to get a visualiza�on of any poten�ally soiled device. So�ware is included and allows viewing and recording.

FIS-005SK 110CM LONG 2.0MM DIAMETER

FIS-006SK 110CM LONG 1.3MM DIAMETER

HEALTHMARK OFFERS MANY OPTICAL INSPECTION TOOLS TO SUIT YOUR NEEDS

MAGIC TOUCH MAGNIFIER

HANDHELD MULTI-MAGNIFIER

MADE IN AMERICA MAGNIFIER

HEALTHMARK INDUSTRIES CO. | HMARK.COM | 800.521.6224 | HEALTHMARK@HMARK.COM

4X LED MAGNIFIER

INDUSTRY UPDATES

NEWS & NOTES

Updates from the HTM Industry STAFF REPORTS

2020 TECHNATION TOUR STARTS IN CALIFORNIA The first stop of the TechNation Tour is set for the California Medical Instrumentation Association (CMIA) Connect Conference at the Crowne Plaza San Diego from January 23-25. The TechNation Tour is a series of free networking events scheduled for HTM professionals throughout 2020. The TechNation Tour will host a welcome reception at the CMIA conference as part of the first stop. MD Publishing Vice President Kristin Leavoy said the TechNation Tour is a way for the magazine to continue its support of the HTM/clinical engineering industry in the same

way that its biannual MD Expo is a go-to resource for networking and training. Each tour stop includes a unique networking event. Admission is free for magazine subscribers and advertisers. Also, a limited number of TechNation Tour T-shirts will be given away at each stop. 2020 TechNation Tour stops include CMIA Connect Conference, AMSP Winter Meeting, MD Expo Irvine, AAMI Exchange, NCBA Symposium, HTMA-MW Symposium, BAW Symposium and MD Expo Tampa. •

MEDINAS OPENS FLORIDA OFFICE Medinas, a technology-driven asset management and remarketing company for hospitals, has announced the opening of a new Florida office, putting the software provider in the middle of one of the highest concentrations of large hospitals and imaging centers in the country. “Florida’s more than 300 hospitals are struggling to manage their inventory of medical equipment, control environmental waste and contain skyrocketing health care costs amidst razor-thin margins. They don’t have a good outlet to remarket their equipment assets or are locked into legacy providers who haven’t innovated to meet the changing needs of a modern health care system,” according to a press release. “Current remarketing providers take advantage with subpar service and predatory pricing.” By making it easy to track, buy and sell equipment assets, Medinas enables hospitals and imaging centers to save

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

millions of dollars while boosting productivity, increasing capital, giving buyers a trusted source of assets and reducing hazardous waste, the company states in a press release. “Medinas is going to revolutionize hospital asset remarketing throughout Florida with modern and intuitive software to track and organize their assets,” said Chloe Alpert, co-founder and CEO of Medinas. “The ability to redeploy, sell or donate unneeded medical equipment with the click of a button cuts down on waste and saves hospitals money.” The Florida team is being led by Lisa Glidden, Medinas’s director of hospital solutions for the southern region. Medinas has plans to sign up 100 partner hospitals in the first year, with an eye toward expanding its Florida operations and creating more warehouse and operational jobs in the health care sector. •

JANUARY 2020

TECHNATION

INDUSTRY UPDATES

CLINICAL DYNAMICS INTRODUCES THE NEW ACCUSIM HANDHELD, HILL-ROM/WELCH ALLYN EDITION Clinical Dynamics created a custom simulator with a preventative maintenance (PM) sequence in the new AccuSim Handheld, Hill-Rom/Welch Allyn Edition. Alongside its automation enhancements, this device offers built-in support for many vital signs monitors from industry-leading manufacturers. Clinical Dynamic’s manufactures and services the AccuSim Handheld, Hill-Rom/Welch Allyn Edition, and created the simulator in conjunction with Hill-Rom/Welch Allyn. This specific AccuSim Handheld improves patient safety by ensuring that patient monitors are performing correctly, a vital part of both patient safety and effective medicine. The AccuSim streamlines the preventative maintenance and service tasks of biomedical engineers and supports technicians whose duties include maintaining and servicing a health care organization’s patient monitoring inventory. It is the recommended service tool to perform test and calibration of Hill-Rom/Welch Allyn monitors (ref. CSB 80022216) but can also be used for virtually any monitor from any of the supported manufacturer brands. In addition to patient safety, the AccuSim Handheld, Hill-Rom/Welch Allyn Edition, also contributes to the overall scope of the health care industry. The preloaded PM enhancements help take user error out of the equation for how patient monitors are serviced. The enhancements also allow companies, such as Clinical Dynamics, to work with the manufacturer to ensure the correct test parameters and sequence are followed by end-users to get the best performance and longest life out of their monitors.

“The greatest part about developing the software that drives the AccuSim was working with Hill Rom/Welch Allyn and gaining their insight into what would be a great way to streamline and improve the service aspect,” stated Clinical Dynamics Chief Engineer Eric Butkus. “The on-screen instructions and sequence really help users complete their service tasks easily and consistently.” All of Clinical Dynamic’s products are made in the United States with all U.S.-made parts. • For more information visit www.clinicaldynamics.com/welch-allyn-accusim.

ROLTA|ADVIZEX PARTNERS WITH CYNERIO TO DELIVER IOMT CYBERSECURITY SOLUTIONS Rolta|Advizex and Cynerio have announced a partnership to deliver IoMT cybersecurity solutions throughout North America. Rolta|Advizex is a national partner and a trusted advisor for over 44 years providing services drawing from a team of over 2,500 IT specialists. Cynerio ensures health care organizations’ patient safety, data protection, service continuity and good reputation by protecting hospitals’ connected medical devices and health care IoT. “With the growing number of cyberattacks that threaten patient data and safety, the vulnerability of connected devices is becoming a key concern for health care management,” said Steve Kucker, vice president and general manager with Rolta|Advizex. “We are proud to represent Cynerio’s technology to provide health care organizations with the confidence that their patient’s safety and data is fully protected.” “We are gratified to join forces with Rolta|Advizex, one of

TECHNATION

JANUARY 2020

the top IT consulting firms in North America,” said Leon Lerman, Cynerio CEO. “With over a dozen closed deals with leading hospitals since we opened our New York office in January, Rolta|Advizex’s robust network of health care cybersecurity experts will enable us to reach and serve a wider range of customers. We continue to leverage our strategic partnership with Tech Data and work with its premium partners.” “Tech Data is focused on helping our vendor’s team with our resellers to deliver innovative solutions to their customers. We are excited to see Cynerio partner with Rolta|Advizex to deliver cutting edge cybersecurity, enabling hospitals to secure their biomedical devices and clinical ecosystem,” said Steve Unger, senior healthcare manager (North America) Tech Data. The two companies will soon announce a joint special offering tailor-made for the health care industry. •

WWW.1TECHNATION.COM

INDUSTRY UPDATES

NYANSA, GE HEALTHCARE INTRODUCE ONWATCH NP Nyansa Inc., a fast-growing innovator of a new generation of AI-based analytics technology, released new technology developed in collaboration with GE Healthcare for CARESCAPE networks and clinical devices that provides unprecedented visibility and analysis into critical statistics impacting patient care. GE Healthcare OnWatch NP, powered by Nyansa, combines a host of new data sources and features tailored for health care-specific use cases. The release includes the ability to synthesize GE Unity health care protocol information with other network metrics to solve common, but difficult to resolve problems. With OnWatch, health care organizations with GE CARESCAPE infrastructure have, for the first time, the ability to automatically identify the root cause of incidents impacting the transmission of vital patient waveform telemetry data as well as detect important medical device timing issues within CARESCAPE networks that may negatively impact operation and patient data integrity. “As medical devices, and the networks they connect to,

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

become ever more critical to patient care, expectations for maintaining the availability and performance of health care networks are changing rapidly,” said Gerois Di Marco, general manager with clinical care solutions at GE Healthcare. “Healthcare technology managers and IT teams need to be armed with modern solutions that eliminate blind spots and support close operational alignment.” The new Critical Device dashboard provides a full view of network assets, including inventory, performance and operational status of critical clinical devices. HTM and IT teams can now share a single source of truth for incidents and operational status of health care networks and devices. Teams become better aligned and no longer need to cobble together data from multiple tools or engage in manual data correlation when troubleshooting issues. The dashboard, proactive alerts and workflows within OnWatch NP, can be customized by role and serve as the starting point for intuitive workflows supporting specific use cases. This allows the responsible team to quickly take action while keeping all stakeholders informed. •

JANUARY 2020

TECHNATION

INDUSTRY UPDATES

BINSENG WANG JOINS SODEXO Sodexo Healthcare announced that Binseng Wang, ScD, CCE, has been appointed to vice president, CTM program management. “Wang will assume responsibility to strategically align the organization with the regulations and quality standards required by the governing bodies, both federal and state, and position Sodexo as ‘best in class’ in the clinical engineering industry,” according to a Sodexo email. “His wealth of experience and knowledge will drive our strategic plan and roadmap for continuous improvement, lean practices and standardization across the enterprise. In this role, he will oversee the regulatory compliance program, quality management system, ancillary product offerings, as well as partner with operational leadership to drive employee engagement. “Binseng is highly recognized for his many contributions to the clinical engineering industry. He has over 25 years of experience in medical device quality management, regulatory compliance and teaching biomedical engineering worldwide,”

according to the email. Wang is a fellow of the American College of Clinical Engineering (ACCE) and American Institute of Medical & Biological Engineering (AIMBE), a senior member of American Society for Quality (ASQ) and Institute of Electrical and Electronics Engineers (IEEE), and a member of Association for the Advancement of Medical Instrumentation (AAMI) and Health Technology Technical Advisory Group of the World Health Organization (WHO). He is also a member of the Underwriters’ Laboratory’s Standards Technical Panel 60601-1. He received the 2010 AAMI Clinical/Biomedical Engineering Achievement Award and the 2015 ACCE Lifetime Achievement Award, was inducted into the Clinical Engineering Hall of Fame by ACCE in 2017 and received the inaugural AAMI John D. Hughes Iconoclast Award in 2019. He holds bachelor of science degrees in both physics and electronics engineering from the University of Sao Paulo, Brazil, and earned a doctor of science degree from the Massachusetts Institute of Technology. He is also a Certified Quality Systems (ISO 9001) Auditor and a Certified Clinical Engineer (CCE). •

NEW LINE OF REPLACEMENT BATTERIES FOR UPS SYSTEMS ANNOUNCED Global Technology Systems (GTS) announced the introduction of a complete line of replacement batteries for APC and TrippLite uninterruptible power supply (UPS) models. GTS’s UPS replacement batteries are designed for use with APC and TrippLite UPS models.They are 100% OEM compatible and are shipped fully assembled with new cables, connectors and components. They are hot-swappable, user-replaceable, maintenance-free and lower in cost than OEM batteries. Each GTS UPS replacement battery assembly comes with a 24-month warranty. GTS also includes simple installation instructions, as well as information on proper recycling of the used battery. “Virtually every organization must use UPS systems to protect its critical data and operations. Millions of these UPSs are in operation 24/7,” said Scott Carlson, director of product management and development, GTS. “But over time, the batteries lose their ability to hold a full charge. This can lead

TECHNATION

JANUARY 2020

to shorter runtimes, costly downtime and data loss. Timely replacement of these batteries is imperative.” “Many organizations don’t realize UPS batteries are replaceable. And those that do, actually replace them randomly and without a plan. They often replace them too late, and spend too much money in the process,” added Larry Murray, CEO, GTS. “Now we can provide our customers with a single, perfectly matched replacement UPS battery or a plan for timely replacement of thousands of batteries enterprise-wide. And at the same time, we can provide them with important operational and budgetary savings.” The new UPS battery replacement program is complementary to GTS’s battery, charger and power management solutions for bar code scanners, mobile printers, two-way radios and voice transmission devices of all kinds. All GTS products can be combined with GTS’s Managed Services programs to cut costs, maximize productivity and minimize downtime. •

WWW.1TECHNATION.COM

INDUSTRY UPDATES

ECRI, ISMP JOIN FORCES Leaders of ECRI Institute and the Institute for Safe Medication Practices (ISMP) announced a definitive agreement that bolsters efforts to make medication, medical devices and health care practices across care settings safer for patients, now and in the future. Under the terms of the affiliation agreement, ISMP will be an ECRI Institute subsidiary when the transaction closes, which is expected to occur January 2, 2020. ECRI and ISMP are joining forces to create one of the largest patient safety entities in the world, driving greater value to the health care organizations they serve by creating a single source with unrivaled expertise, resources and solutions. ECRI Institute and ISMP are globally respected, nonprofit organizations that promote patient safety by sharing adverse effects, near misses and unsafe conditions across all health care settings, including ones associated with pharmaceutical product and medical device use. Four out of five U.S. hospitals rely on ECRI Institute’s data and recommendations to protect patients from unsafe practices and ineffective products. ISMP’s world-renowned efforts to improve patient safety have prompted significant clinical practice and public policy changes, including improvement in how drugs are labeled, packaged, prepared and administered. “This agreement will strengthen our critical contributions to medication safety,” says ISMP President Michael Cohen, RPh, MS, ScD (hon.), DPS (hon.), FASHP. “It allows both organizations to retain their core missions while immediately extending our ability to share lifesaving information and further a vision where safe, high-quality health care is more readily available. We look forward to this new chapter.” Under the terms of the affiliation agreement, ISMP will operate as a wholly owned subsidiary of ECRI Institute. Cohen and ISMP’s Executive Vice President Allen J. Vaida, PharmD, FASHP, will continue to lead ISMP, working closely with ECRI Institute executives. ECRI Institute President and CEO Marcus Schabacker, MD, PhD, will immediately join ISMP’s board of trustees, along with two other ECRI Institute leaders “Two trusted organizations deeply committed to improving the safety of medical treatments are even more effective when they work together,” says Schabacker. “For both organizations, this agreement furthers the mission, deepens expertise and broadens relationships. It’s a good move for both of us and for all of the organizations we serve, and ultimately for the patients worldwide. ” Cohen and Schabacker say the integration of their organizations brings a comprehensive set of unmatched patient safety capabilities that will immediately benefit health care providers, patient advocates, governments and, most importantly, patients globally. •

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

Precise. Reliable. Powerful. Join a team as innovative as the technology we manage. Sodexo Clinical Engineering is a part of a global network, giving you unmatched access to resources and training to expand your skills and grow your career. Find Clinical Engineering Jobs at SodexoCTM.com

Sodexo is an EEO/AA/Minority/Female/ isability/Veteran employer.

JANUARY 2020

TECHNATION

INDUSTRY UPDATES

THE JOINT COMMISSION NAMES NEXT DIRECTOR OF DEPARTMENT OF STANDARDS AND SURVEY METHODS The Joint Commission has named Kathryn D. Petrovic, MSN, RN-BC, the next director of the Department of Standards and Survey Methods (DSSM). Mary Brockway, RN, MS, the current director, announced her retirement earlier this fall. In her new position, Petrovic will report to David W. Baker, MD, MPH, FACP, executive vice president, Division of Health Care Quality Evaluation. As director of DSSM, Petrovic will play a critical role in the future of The Joint Commission’s standards and survey processes. She will oversee the research, testing, development and revision of Joint Commission standards as well as the development and evaluation of Joint Commission survey practices. DSSM develops standards for all Centers for Medicare & Medicaid Services (CMS) recognized programs as well as Disease-Specific Care Certifications. The department also supports research and framework for The Joint Commission’s National Patient Safety Goals.

“I think Kathryn will be terrific as director,” Baker said. “Her past leadership positions in health care organizations and her roles in other divisions of The Joint Commission give her unique experience and perspective that will help ensure our standards address key quality and safety issues, can be applied consistently by surveyors and can help health care organizations drive improvement and achieve better patient outcomes.” Petrovic was previously a field director in the Department of Surveyor Management and Development for the Behavioral Health Care and Psychiatric Hospital programs at The Joint Commission where she provided direction, leadership and training to surveyors. Petrovic also served as senior associate director in The Joint Commission’s Standards Interpretation Group and a surveyor for the Psychiatric Hospital program. Additionally, for the last two years, she has co-facilitated The Joint Commission’s Suicide Risk Reduction Expert Panel. • For more information, visit www.jointcommission.org.

AVANTE HEALTH SOLUTIONS ANNOUNCES MANAGEMENT CHANGES Avante Health Solutions has announced that Sterling Peloso, president of Avante Ultrasound, has assumed the operating responsibilities of Avante Patient Monitoring. This expanded role will be in addition to his current duties at Avante Ultrasound and will provide greater continuity as the ultrasound and patient monitoring businesses continue to work more closely together. This management change comes as Andy Bonin, founder of Avante Patient Monitoring (formerly Pacific Medical), has decided to step away from the day-to-day operations and move into a strategic advisory role for the overall Avante organization. This new role will allow all of the Avante companies to capitalize on Bonin’s strengths focused around product development, strategic sourcing, supplier relations and business development. “I am proud to have built the leading patient monitoring business in the industry and excited about the future as we continue to execute on Avante’s growth strategy of being the premier provider of all medical equipment solutions,” said Bonin. Peloso added, “As patient monitoring, ultrasound and the overall Avante organization continue to come together, I look forward to growing the collective businesses and providing a complete suite of products and services that is unmatched in the health care industry.” Steve Inacker, president and COO of Avante, said he

TECHNATION

JANUARY 2020

believes that the newly announced changes will allow Avante to capitalize on the continued strengths of both leaders and put the company in the best position to provide enhanced services to its combined customer base. “I am pleased to announce these new responsibilities for Sterling as he continues to leverage his leadership capabilities, enthusiasm and dedication to grow both ultrasound and patient monitoring,” said Inacker. “In addition, I am excited that we will continue to benefit from Andy’s extensive engineering and sourcing acumen in his new role and know that these management changes will allow both Sterling and Andy to be instrumental in the future success of Avante.” The Avante family of companies is comprised of: • Avante Ultrasound (formerly Global Medical Imaging and Ultra Solutions) • Avante Patient Monitoring (formerly Pacific Medical) • Avante Medical Surgical (formerly DRE Medical Group) • Avante Rental Services (formerly Integrated Rental Services) • Avante Oncology Services (formerly Oncology Services International) • Avante Diagnostic Imaging (formerly Transtate Equipment Company and Equipment Maintenance Solutions) Avante expects additional acquisitions to further expand across these platforms. • For more information, visit avantehs.com.

WWW.1TECHNATION.COM

INDUSTRY UPDATES

FDA CLEARS FIRST DUODENOSCOPE WITH DISPOSABLE ELEVATOR PIECE The U.S. Food and Drug Administration has cleared for marketing in the U.S. the first duodenoscope with a sterile, disposable elevator component that will reduce the number of parts that need to be cleaned and disinfected (reprocessed) between uses. The Pentax Medical Video ED34-i10T2 model duodenoscope is intended to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems. “Duodenoscopes with a disposable elevator component represent another major step toward lowering the risk of infection among patients who undergo procedures with these devices,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Improving the safety of duodenoscopes is a top priority for the FDA since such devices remain critical to life-saving care for many patients in the U.S. We encourage manufacturers of these devices to continue to pursue innovations that will help reduce risk to patients, and also encourage hospitals and other health care facilities where these procedures are performed to begin or continue transitioning to devices with disposable components that are easier to reprocess. Today’s clearance is another step in the FDA’s ongoing effort to advance the development and availability of safer duodenoscopes.” The FDA has previously cleared duodenoscopes with removable endcap components. This clearance is the first

device with a disposable elevator component – a part that has been traditionally difficult to clean and reprocess. The elevator part of the duodenoscope facilitates access to the bile and pancreatic ducts, and is used to position endoscopic instruments during the procedure. The Pentax Medical Video Duodenoscope ED34-i10T2 is intended to be used with endoscopic devices, introduced in the patient’s mouth, to provide visualization via a video monitor of and therapeutic access to the biliary tract (liver, gall bladder and bile ducts) through the upper gastrointestinal tract. Risks of using the Pentax Medical Video Duodenoscope ED34-i10T2 include the potential for injuries, including, but not limited to, burns, electric shock, perforation, infection and bleeding. The Pentax Medical Video Duodenoscope ED34-i10T2 was reviewed through the premarket clearance (510(k)) pathway. A 510(k) notification is a premarket submission made by device manufacturers to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. As part of the premarket clearance review, the manufacturer submitted evidence to the FDA demonstrating that the device is substantially equivalent to a predicate device. The FDA granted clearance of the ED34-i10T2 to Pentax of America.

We ONLY use OEM Parts!

Providing support services and quality rebuilt equipment for over 18 years! BIOMED DEPARTMENTS…

EQUIPMENT PURCHASERS…

• Our technicians repair circuit boards, pump mechanisms and LCD screens at the component level.

• We sell and rent the highest quality refurbished infusion pumps available.

• Look to Select for BEST IN CLASS Pricing, Quality and Turnaround Time.

• We work with you to provide tailored solutions specific to your equipment needs. • Our IOT experience ensures we can help with your M2M connectivity issues.

Contact us today! www.selectbiomedical.com 866.559.3500 Information@selectpos.com Select also buys equipment. Call us if you have surplus pumps or monitors to sell. We offer top dollar!

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

JANUARY 2020

TECHNATION

INDUSTRY UPDATES

RIBBON CUTTING Acela Medical BY ERIN REGISTER

ased in Canton, Georgia, Acela Medical provides asset management and equipment maintenance support to small hospitals and health care facilities that need professional, technical and proactive support. “Currently, we offer preventive maintenance plans, repair and sales services in Georgia and neighboring states,” Acela Medical owner Mark Mayeux said. “We also offer HTM department support for surgery centers, urgent care facilities, as well as help larger organizations with project support, including onboarding equipment, asset management and staff augmentation during busy maintenance periods.”

TechNation learned more about Acela Medical in a question-and-answer session with Mayeux. Q: WHAT IS THE MAIN FOCUS OF ACELA MEDICAL? A: Class-leading customer service around all aspects of medical equipment sales, maintenance and repair is the main focus. This is especially important going forward regarding very large and new health care providers and their focus on reduced cost structures. Our strengths in Lean Six Sigma and value-based services enable these clients to achieve cost savings, reduced turnaround times and unique service solutions they would not see with other legacy providers. Q: WHAT SERVICES DOES ACELA MEDICAL OFFER? A: We are a veteran-owned business that repairs and services surgical and clinical

TECHNATION

JANUARY 2020

medical equipment. We repair and maintain infusion pumps, patient monitors, EKGs, CO2 monitors, powered beds, stretchers and also provide a sophisticated cloud-based client portal that enables asset management, email reminders and other convenient tools for our clients. We provide free on-site service and support in our Georgia service area, as well as free equipment repair evaluations. We also offer equipment rentals and short-term loans. Our hands-on engineering staff has been a valuable resource to clients when they have needed support to help solve unique, unexpected or unfamiliar equipment issues. As one example of a value-based client solutions provider, we have seen a need in the industry for repair services for hard to find powered bed and table remotes. In some cases, a damaged remote connector will render the entire bed unusable. There has been some work on our end to identify the right suppliers who can provide legacy, hard to find components, which allows us to get these devices back to working condition and save clients the cost of replacement remotes or beds, extend the service life and improve their ROI. Q: HOW DOES ACELA MEDICAL STAND OUT IN THE MEDICAL EQUIPMENT FIELD? A: Our commitment to client satisfaction, successfully solving complex equipment issues and being a trusted partner in improving equipment performance and ROI goals have been key differentiators for us. We are proudly veteran-owned, SAM registered and also have experience

Mark Mayeux Acela Medical with managing and providing large equipment consumable product orders for large clients in multiple locations. We have a great, knowledgeable staff who is ready to actively help clients with all aspects of their medical equipment needs. Q: DO YOU HAVE ANY SPECIFIC GOALS THAT YOU WANT ACELA MEDICAL TO ACHIEVE IN THE NEAR FUTURE? A: Our three-year goal is to have sales reps in all major U.S. markets. This will enable us to expand our unique value-based medical equipment service offerings and continue to provide class-leading technical support. We also have a new industry vertical partnership with ivpump.com, and we look to significantly grow that relationship to serve customers who need infusion pumps, repairs, parts, rental services and consumables worldwide. Ultimately, our goal is to be the most trusted equipment solutions partner in the medical services industry. For more information, visit www.acelamedical.com or email info@acelamedical.com.

WWW.1TECHNATION.COM

Thinking about

TAKING THE CBET?

Our 91 students have a 90% success rate and an average score of 134 out of 165. Sign up for the 9 week prep Patient course today!Safety

Is Our Focus.

Innovation Is Our Posture.

Learn more at HTMEDUCATION.ORG Quality

Is Our Habit.

Passion Is Our Promise.

HTM EDUCATION

Experience the Elite Difference Call Today or Schedule a Visit 1.855.291.6701

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

JANUARY 2020

TECHNATION

INDUSTRY UPDATES

AAMI UPDATE BY AAMI

AAMI’S HEALTH TECHNOLOGY COLLECTION PUTS INNOVATION ON DISPLAY AAMI has unveiled its Health Technology Collection, museum-like exhibit housed at the AAMI Center for Excellence in Arlington, Virginia. The Collection displays the breadth and depth of medical devices designed to treat disease and improve the quality of life of patients. The first 14 devices and artifacts include an infusion pump, artificial joints and even medical instruments used on the battlefield. All are loaned or donated by AAMI member organizations and individuals. “The Health Technology Collection represents not only great innovations in health technology, but the many people who have dedicated their lives to developing and using this life-saving technology,” said Sabrina Reilly, vice president of membership at AAMI. “Ensuring the safe and effective use of health technology is the mission of AAMI and its global community of stakeholders. We are incredibly grateful to all who have donated so far.” AAMI is seeking additional donations or loans of medical devices or health technology artifacts for display that demonstrate significance in standards development or improving patient safety. If you or your organization are interested in submitting artifacts to the collection, please contact sreilly@aami.org. 2020 GRANT CYCLE OPENS FOR MARY K. LOGAN RESEARCH AWARDS The AAMI Foundation is now accepting applications for its Mary K. Logan Research Awards, a grant program aimed at supporting research that enhances the safe adoption and safe use of health technology. Recipients are eligible to receive up to $80,000 in funding for their projects. Topics can vary widely – focusing on, for example – device technology, processes, sterilization, dialysis, healthcare technology management and other issues. Priority is given to topics that do not have other available sources for funding. Junior investigators with strong mentorship are encouraged to apply. Research projects should seek to:

TECHNATION

JANUARY 2020

• Yield results that can be applied or used by other health care organizations. • Improve methods of patient safety with a defined and direct path to implementation into patient care settings. • Study problems for which deeper understanding is needed before effective solutions can be applied. Applications for the Logan grant should be submitted no later than 5 p.m. ET on Dec. 31, 2019 at www. AAMIFoundation.org/MKL-Awards. To learn more about AAMI Foundation scholarships, awards and grants, visit www.AAMIFoundation.org.

NEW PROJECTS FOR STERILIZATION AND HTM EDUCATION The AAMI Standards Board approved three new work item proposals in November – two projects in the sterilization area and one in the medicinal equipment management area. • AAMI ST108, Water for the processing of reusable medical devices, is a new standard that is intended to replace the technical information report AAMI TIR34:2014/(R)2017, Water for the reprocessing of medical devices. ST108 will establish the minimum requirements for the appropriate grades of water used at different points in the medical device reprocessing sequence. These minimum requirements will help ensure successful cleaning, disinfection and sterilization of devices and minimize the chance of device damage during processing. • AAMI TIR109, External transport of medical devices processed by health care facilities, is a new TIR that will provide comprehensive guidance on externally transporting medical devices from one health care facility to another health care facility or centralized processing plant, either for use, sterilization, disinfection or decontamination. • AAMI EQ110, Guidance for health care technology management education programs, is a new standard that will provide a baseline for healthcare technology management (HTM) education programs that offer associate degrees in arts or a bachelor’s of arts degrees.

WWW.1TECHNATION.COM

INDUSTRY UPDATES

EQ110 will offer a recommended framework for new or established degree programs in HTM. It will define the basic requirements for starting such a program and provide guidance on resolving gaps in existing HTM educational programs. AAMI FOUNDATION OFFERS 10 SCHOLARSHIPS IN 10TH YEAR OF PROGRAM To celebrate the 10th anniversary of the Michael J. Miller Scholarship Program, the AAMI Foundation will award 10 scholarships to students pursuing a career in a healthcare technology management (HTM) field. So far, the AAMI Foundation has awarded a total of $99,000 to 35 students to help fund their education. “We’ve come a long way in the last decade – from awarding two, $2,500 scholarships to 10 scholarships at $3,000 each in 2020,” said Steve Campbell, executive director of the AAMI Foundation. “These scholarships are vitally important to help the next generation of professionals who will ensure that health technology is both safe and effective.” For the first time, all scholarship recipients will receive an all-expense paid trip to attend the AAMI Exchange, June 12-15, 2020 in New Orleans, Louisiana. “This conference experience will be a great way for the students to get to know AAMI, to network, to look for career opportunities and to learn,” said Steve Yelton, chair of the AAMI Foundation Board of Directors. The application process is now open for the 2020 scholarships – nine of which will be given to students studying to become HTM professionals, including biomedical equipment technicians or clinical engineers; and one to a systems engineering student. To apply, complete an online application form by Jan. 6 and include: A short essay that details the student’s career plans and demonstrate their academic excellence and technical aptitude. Two letters of recommendation from professional contacts. The most recent transcript and proof of admission into a healthcare technology program. “These scholarships are possible thanks to the support of so many generous contributors,” said Campbell. “That support is going directly to the students and it’s making a world of difference.”

MRI MRI&&CT CTServices Services

MRI&&CT CTParts Parts MRI

MRI & CT Services

For more information about the AAMI Foundation scholarship application or about making an individual or corporate donation to the scholarship program, go to www.aami.org/Scholarship.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

MRI & CT Parts

Knowledge.Experience. Experience. Integrity. Knowledge. Integrity.

< / ŚĞůƉƐ ǇŽƵ ĚĞůŝǀĞƌ DZ/ ĂŶĚ d /ŵĂŐŝŶŐ ^ĞƌǀŝĐĞƐ ƚŽ ǇŽƵƌ ƉĂƚŝĞŶƚƐ͘ tŝƚŚ ŽƵƌ ƚĞĂŵ ŽĨ ƐĞƌǀŝĐĞ ĞŶŐŝŶĞĞƌƐ ĂŶĚ ŝŶǀĞŶƚŽƌǇ ƐƉĞĐŝĂůŝƐƚƐ͕ < / ŝƐ ǇŽƵƌ WŚŝůŝƉƐ ƌĞƐŽƵƌĐĞ < / ŚĞůƉƐ ǇŽƵ ĚĞůŝǀĞƌ DZ/ ĂŶĚ d /ŵĂŐŝŶŐ ^ĞƌǀŝĐĞƐ ƚŽ ǇŽƵƌ ƉĂƚŝĞŶƚƐ͘ ĨŽƌ ƐǇƐƚĞŵ ƉĂƌƚƐ ĂŶĚ ĨŝĞůĚ ƐĞƌǀŝĐĞ͘ < / ƌĞĂĐŚĞƐ ĞǀĞƌǇ ƚŝŵĞ ǌŽŶĞ ĂŶĚ ǁŽƌŬƐ ƚŽ ŵŝŶŝŵŝǌĞ tŝƚŚ ŽƵƌ ƚĞĂŵ ŽĨ ƐĞƌǀŝĐĞ ĞŶŐŝŶĞĞƌƐ ĂŶĚ ŝŶǀĞŶƚŽƌǇ ƐƉĞĐŝĂůŝƐƚƐ͕ < / ŝƐ ǇŽƵƌ WŚŝůŝƉƐ ƌĞƐŽƵƌĐĞ ĚŽǁŶ ƚŝŵĞ ĂŶĚ ĐŽƐƚůǇ ĚŝƐƌƵƉƚŝŽŶƐ ƚŽ ǇŽƵƌ ǁŽƌŬĨůŽǁ͘ WĂƌƚŶĞƌ ǁŝƚŚ < /͕ ĐĂůů ƚŽĚĂǇ͘ ĨŽƌ ƐǇƐƚĞŵ ƉĂƌƚƐ ĂŶĚ ĨŝĞůĚ ƐĞƌǀŝĐĞ͘ < / ƌĞĂĐŚĞƐ ĞǀĞƌǇ ƚŝŵĞ ǌŽŶĞ ĂŶĚ ǁŽƌŬƐ ƚŽ ŵŝŶŝŵŝǌĞ

ĚŽǁŶ ƚŝŵĞ ĂŶĚ ĐŽƐƚůǇ ĚŝƐƌƵƉƚŝŽŶƐ ƚŽ ǇŽƵƌ ǁŽƌŬĨůŽǁ͘ WĂƌƚŶĞƌ ǁŝƚŚ < /͕ ĐĂůů ƚŽĚĂǇ͘ keimedicalimaging.com

keimedicalimaging.com

Tel: 512.477.1500 Email: info@keimedicalimaging.com of IAMERs Tel: 512.477.1500 Member Email: info@keimedicalimaging.com

MemberofofIAMERS IAMERs Member

Knowledge. Experience. Integrity. JANUARY 2020

TECHNATION

INDUSTRY UPDATES

Mobile and sit-to-stand patient lift designs lined up for testing in ECRI Institute’s laboratory.

ECRI UPDATE

Patient Lifts Can Handle the Load, but Which Designs Are Best?

CRI Institute has recently tested and rated 21 patient lift models, focusing on issues of performance, workflow, and safety. The independent testing organization evaluated patient lifts that are intended to be moved about the healthcare facility, as well as lift systems that are fixed in place within a patient room or other area.

Patient lifts are used to support patients who are unable to bear some or all of their own weight. The devices are designed to hoist and transfer patients safely to and from beds, wheelchairs, toilets, or bathtubs and shower chairs, as well as to help patients to practice standing. Some designs can also be used to lift fallen patients from the floor. In addition to protecting patients

TECHNATION

JANUARY 2020

during the lifting and transfer process, these devices play an important role in reducing lifting-related strain injuries among healthcare workers and other caregivers. A lift that is unable to safely support the weight of patients of all sizes, or that otherwise fails during use, can lead to severe patient, staff, or bystander injury. Lifting capacity, therefore, is a key performance factor. “We bent a few frames when we load tested patient lifts about a decade ago,” recalls Rebecca Kwasinski, ECRI Institute’s lead test engineer for the organization’s recent patient lift evaluations. “Fortunately, all the models we load tested this time around passed that part of our test protocol.” ECRI’s testing nevertheless did identify several differentiating factors among the various designs tested.

Here’s a brief overview of patient lift designs and some of the key capabilities to look for when selecting a model. MOBILE AND SIT-TO-STAND DESIGNS Many lift designs incorporate casters and are intended to be moved from location to location. ECRI Institute distinguishes between two different designs for such applications: mobile lifts and sit-to-stand lifts. Mobile lifts can fully lift/lower a patient and do not require the patient to have any ability to physically assist. In addition to moving patients from one location to another, these models can be used to lift fallen patients from the floor, and some models can be used to ambulate patients. Sit-to-stand lifts, by comparison, are used when a patient is able to bear some

WWW.1TECHNATION.COM

INDUSTRY UPDATES

weight at least on one leg and has trunk stability to aid balance. Also referred to as active lifts or standing aids, sit-tostand models are used to encourage patients to use/maintain their ability. Both designs consist of a support base (including casters that enable the lift to roll), a mast, a boom (or lift arm), a lifting mechanism, and a spreader bar that supports a sling or other body support mechanism. The lifting process is typically controlled by either a corded hand control or a control panel on the patient lift. CEILING-MOUNTED DESIGNS Ceiling-mounted patient lifts follow tracks mounted to the ceiling. These fixed-in-place systems are designed to hoist and transfer patients safely to and from beds, wheelchairs, toilets, or bathtubs within the range of the ceiling tracks. These designs consist of a track system that is mounted to the ceiling and a lifting apparatus. The lifting apparatus includes the following: a ceiling console containing the motor that does the lifting and the rollers that ride on the track, a suspension system (the lifting strap, the spreader bar, and the sling), and a hand control that regulates the lift’s movement. In addition to being used to support patients who are unable to bear their own weight, ceiling-mounted lifts can be used to ambulate a patient, aid in rehabilitation, and lift/support limbs to promote wound treatment. They also can be used to lift fallen patients from the floor. Some ceiling-mounted designs are specifically intended for use with bariatric patients. Whereas a standard lift can be expected to handle a weight capacity of at least 500 lbs, bariatric lifts would typically be rated to handle twice that limit.

SELECTION FACTORS Decisions about what type of patient lift to purchase—mobile, sit-to-stand, ceiling-mounted, or often a combination of those options—will depend on budget and the intended application. When it comes to comparing specific models, ECRI Institute’s testing revealed several differentiating factors. Following are four areas that should be considered when making patient lift purchasing decisions. 1. Feature set. While modern patient lifts have been around for decades, manufacturers continue to add advanced features that may increase the versatility of the lift. Controls have become powered in recent years, but the selection of powered features can differ among models. For example, in addition to the standard upward/downward movements, some mobile lift models offer electronically controlled patient sit-up/recline controls, and some ceiling-mounted designs include powered lateral movement of the patient. Additional safety measures available on some models include anti-collision detection for components such as the spreader bar, and load sensors to prevent the lift from lifting more than its rated load. 2. Maneuverability. For both mobile and sit-to-stand designs, the maneuverability of the lift is a key factor to consider. Potential purchasers should assess the ease of moving and maneuvering the lift around the intended area of use while the lift is fully loaded—that is, while supporting weight that is equivalent to what can be expected for the patient population. It’s also important to assess how well the user can see around the lift while maneuvering it. ECRI’s test participants found that the size and

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

shape of the slings on some models made it difficult to see obstacles that might be encountered during movement. 3. Height range. Patient lifts need to have sufficient height range to lift a fallen patient from the floor and raise the patient to the height of the intended surface, which itself might not be adjustable. ECRI Institute’s testing showed that several models had insufficient clearance to be used with certain non-height-adjustable surfaces, such as imaging systems and older OR tables and hospital beds. 4. The patient experience. If using the lift is unsettling or uncomfortable for the patient, the patient may resist its use and nurses may in turn opt for a less safe means of lifting, to avoid upsetting the patient. During its testing, ECRI Institute asks its “patients” (testing volunteers) to rate factors such as how secure they feel in the lift and sling, the smoothness of patient transfer (particularly the degree of swinging and bouncing that they felt), as well as sling comfort and support. For a few of the models, volunteers reported that the amount of swinging and bouncing they experienced while in the lift made them feel uneasy. This article is adapted from four of ECRI Institute’s evaluation projects, published in the last half of 2019. The complete articles—including model-specific test results and product ratings, along with additional guidance for purchasing and patient lifts—is available to members of ECRI Institute’s SELECTplus, Health Devices System, and associated programs. To learn more about membership, visit www. ecri.org/solutions/evaluation-and-comparison, or contact ECRI Institute by telephone at (610) 825-6000, ext. 5891, or by e-mail at clientservices@ecri.org.

JANUARY 2020

TECHNATION

INDUSTRY UPDATES

NEW ADVERTISERS:

WELCOME TO THE

TECHNATION COMMUNITY! HTM EDUCATION

Q: TELL US ABOUT YOUR COMPANY. A: HTM Education offers a 9-week, fast-paced but thorough CBET exam prep course. Each week, students are prepared for a section of the test through classroom instruction and quizzes. A mock exam at the end sums it all up. The course is offered twice a year, and can be attended in-person or online. SEE OUR AD PG. 29

Q: WHAT IS ONE QUALITY THAT DIFFERENTIATES YOUR COMPANY? A: The goal of the prep class is to maximize the amount of information students retain while minimizing the amount of time they spend in class. With the efficient teaching methods, such as using the top-down approach with the learning material, students can find where the concepts fit into the Healthcare Jenga. This way, the knowledge that students obtain can be remembered long after the exam and applied in the field. •

Meet Patel Clinical Engineer

CLINICAL DYNAMICS

Joseph Rebot President

SEE OUR AD PG. 60

TECHNATION

JANUARY 2020

Q: TELL US ABOUT YOUR COMPANY. A: Clinical Dynamics designs, manufactures and customizes patient simulators for all of our customer’s calibration and testing needs. Our core AccuPulse(TM) NIBP simulation technology is driven by CalTables which are developed with and approved by most major patient monitoring companies. Our line of NIBP Simulators come with built-in support for most patient monitors; including an array of calibration and service features. We also offer synchronized 12-lead ECG simulation and electrical/optical SpO2 simulation technology as options on our simulators, as well as other useful features and simulation modes. Whether you’re looking for an All-in-one solution, or anything in between, Clinical Dynamics provides accurate and dependable service instruments to meet your needs. Clinical Dynamics prides itself in having very close working relationships with major patient monitoring manufacturers such as Hill-Rom/ Welch Allyn, Sotera Wireless, Masimo, Philips, GE Medical System, etc. This allows us to be able to work on what’s cutting edge and to be able to fulfill the needs in the

industry. Working alongside these companies and providing custom simulators/testing tools for their development requirements establishes our ability to offer factory-approved and recommended tools specifically made for their end user’s needs. Q: WHAT IS ONE QUALITY THAT DIFFERENTIATES YOUR COMPANY? A: Clinical Dynamics differentiates from other simulator companies because of our commitment to providing accurate and dependable custom service tool solutions for patient monitor management. We work closely with patient monitor manufacturers to ensure our simulators can support their monitors in the field. Our AccuSim can be configured to help automate Preventative Maintenance tasks according to the monitor maker’s recommended test settings. The on-screen instructions and sequencing also helps to minimize user-error and maximize through-put. With over 30 years of experience and countless custom applications of our technology, it’s easy to see that our ability to customize our technology to fit a customer’s requirements is what makes us stand out.

WWW.1TECHNATION.COM

IT ALL STARTS ONLINE WEBINARWEDNESDAY.LIVE

Enjoy a new webinar every week! TURES N E V D A IN THE

R A BIN

D E W

Y A D NES

E E R F

Pssst! W

! OW

You can register online to view our live webinar series every Wednesday OR watch recorded webinars in our online archives!

E C n r a E ! s t i d e Cr ed

entials

E-APPRO

itu

AAM

e d by th provide entials ed aami cr ute instit •

VISIT WEBINARWEDNESDAY.LIVE

• C

THE BENCH

BIOMED 101 Importance of Goals BY BEN LEWIS

new year creates new opportunity. It is also the time of year when resolutions and goals are made. Why do we make goals and why are goals important? Goals help give us vision for our future, whether it is a near-term or long-term goal. They give us something to aim toward. Goals propel us forward and allow us to improve ourselves and our teams. They help focus our efforts into a plan of action that result in growth. Finally, goals provide us with satisfaction by challenging us and training us in the fulfillment of accomplishment.

Daily and short-term goals are great ways to train yourself to succeed. A daily goal may be to read for 30 minutes a day, go for a walk or get to bed on time. Feeling accomplished in tiny steps daily will make it easier to maintain discipline to reach a short-term goal, like losing that 10 pounds that refuses to go away. In turn, short-term goal success feeds into long-term and lifetime goal success. Winning becomes a habit. Being committed to goals personally will bleed into your professional life. An example of a short-term professional goal that I was tasked with this past year was as follows: Insource bed maintenance to the HTM department from an outsourced facilities maintenance vendor by March of 2019. With this goal, my team created a plan. A plan is the roadmap to realizing your goal. It has been commonly said that a goal without a plan is just a wish. The plan consisted of hiring personnel, securing space, creating a budget, completing manufacturer training, marketing the change to affected stakeholders and creating and approving a bed

TECHNATION

JANUARY 2020

maintenance standard operating procedure (SOP). When you are setting goals, it is important for goals to be “SMART.” What does it mean for a goal to be SMART? Goals that are SMART are Specific, Measurable, Attainable, Relevant and Time-Oriented. When goals are vague, planning for them may be difficult. By creating a specific goal, gauging the success of its completion becomes much easier and is also the foundation of the goal’s path to success. Be specific when you are creating your goals so you can make a comprehensive plan that’s success or failure can be easily gauged. The measurement of a goal may be as easily done or as complicated as the goal itself. Completed or not completed are the simplest measurements for goals. You may also quantify the measurement, at which point you will want to identify the unit of measure. Examples of measurements are percentages of improvement, number of incidents or work orders, financial improvements using dollars in budget variance, increased revenue or decreased spend. It is important that your goals are also realistic. This does not mean that some of your goals should not be a “stretch goals,” but they should be attainable. As a 40-year-old man, being drafted onto a Major League Baseball team is not a realistic goal and would not likely be attainable. By setting unrealistic goals, failure becomes expected and when it is excepted, failure becomes acceptable. To prevent this perspective, it is important to set goals that you and your staff can achieve. The relevance of your goals simply means that the goal that you set is pertinent to the improvement of your

Ben Lewis HonorHealth life, career or department, and that it is part of your scope. It is wise to set goals in areas that are in your control. Another way to look at relevance is to ask yourself what you “get” for accomplishing a goal? Is there a reasonable return on investment? When there is, there is a much greater chance that you will find the time and resources to achieve your goal. The final step to a SMART goal is to ensure that it is time-oriented. Goals without timelines tend to fail, so deadlines are vital to the success of your goals. It holds you and your team accountable for the timely deliverables and provides basic guardrails that keep you on track. By creating daily, short-term and long-term goals that are SMART, you will find personal and professional success due to the direction, clarity, focus and satisfaction goals provide. Welcome to the new year, where great things become possible with a SMART goal, a plan, time and discipline. BEN LEWIS, MBA, CHTM, is the associate vice president of support services (SCSS) at HonorHealth.

WWW.1TECHNATION.COM

DIAGNOSTIC IMAGING EQUIPMENT:

Bringing hope to healthcare. INTERMED1.COM 800-768-8622

∙ Nuclear Medicine ∙ Fluoroscopy

∙ CT

∙

∙ PET

∙ Cath Lab

∙ MRI

∙ Ultrasound

∙ DR

∙ Bone Densitometry

∙ CR

X-Ray

∙ PACS

∙ Preventive Maintenance

HTM

∙ Cost-Effective Solutions ∙ Quality Service Engineers

JUMP TEAMS™

∙ Tailored Service Agreements ∙ Fast Response Time & Resolution ∙ Comprehensive Multi-Vendor Services

CLINICAL ENGINEERING

CONTRAST INJECTOR SERVICE TRAINING, WHERE AND WHEN YOU NEED IT Servicing injectors is more than preventive maintenance; we provide extensive training on troubleshooting and repairs. Contact us about on-site training or our classroom training located in Charlotte, NC.

• Group discounts available • Short notice requests can usually be accommodated • On-site training available • Most popular models of injectors available

intraservbiomedical.com | 980-269-5787 | training@intraservbiomedical.com

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

JANUARY 2020

TECHNATION

THE BENCH

WEBINAR WEDNESDAY Continues to Grow STAFF REPORT

ebinar Wednesday continues to amaze, attracting professionals from around the world. Since being launched in 2014, thousands have benefitted from the series with many obtaining credits to renew certifications.

The latest webinars included information about ISO certifications, defibrillator testing and more. PRESENTER EXPLORES ISO 13485 The Webinar Wednesday presentation “Practical Applications of ISO 13485 and What It Means for HTM Professionals” was sponsored by Innovatus Imaging. Attendees are eligible to receive 1 credit from the ACI. Dennis Wulf’s insightful presentation drew a crowd with 149 people tuning in for the live presentation, including at least one individual in Thailand. A recording of the webinar is also available online where even more people can access the material. Wulf, founder of Innovatus Imaging, presented a working understanding of what this quality certification means. He discussed why it matters for health care facilities and what to expect from repair providers that are ISO 13485 certified. He also spoke about those organizations that do not have the quality certification. Thanks to his more than 35 years of experience working with medical devices specializing in ultrasound, Wulf was able to provide valuable knowledge and advice. Attendees shared feedback via a

TECHNATION

JANUARY 2020

post-webinar survey that included the question “How will today’s webinar help you to improve in your role?” “(The webinar) helped to put a new perspective on quality metrics. It had a big push for using the metrics to try and be the best organization you can be as opposed to just meeting the metrics because they are required,” Biomedical Engineer D. Nitinthorn said. “The speaker’s experience and expertise in the market sector will help in our planned addition of ISO 13485 to our current ISO 9001,” said S. Cushing, quality manager. “Dennis presented outstanding information very relevant to the field. The topic is timely and I hope many of my peers are paying attention to Dennis’ subject matter,” Senior Director C. Nowak said. “I will be using this content to help me understand the differences between ISO 9001 and 13485. I will also use the terminology to develop more concise policies and procedures,” said L. Robert, associate director. “We are in the process of ISO certification and it was good to hear other people’s perspectives on it and how long it roughly took till completion from the speaker,” Sales Director P. Byrne said. DEFIBRILLATOR TESTING BEST PRACTICES The Webinar Wednesday presentation “Defibrillator Testing Best Practices” was eligible for 1 credit from the ACI. The webinar was presented by Jerry Zion and sponsored by Fluke Biomedical. Zion, global training manager at

Fluke Biomedical, discussed how testing changes when HTM professionals think of AEDs as a fire extinguisher or an ACLS defibrillator as a fire hose! And what about the times when the defibrillator includes a temporary external pacemaker – how would that change the testing procedure? He shared valuable insights with 271 attendees during the live presentation and more have viewed a recording of the webinar online. Attendees gave positive reviews and answered the question “How useful was the information presented in today’s webinar?” in a post-webinar survey. “I work with Lifepak 12 and 15 defibrillators at my hospital and the information provided in this video has shown me a better understanding for testing,” said Clinical Engineer J. Galindez. “Very applicable information to biomeds and engineers. Defib safety and testing is largely important and often the testing is overlooked/underperformed,” shared Biomedical Engineer T. Wade. “Great information backing up what I’ve been insisting we do as a shop – especially concerning AEDs. Some people are satisfied with only what the manufacturer recommends instead of the purpose of the tests,” Biomedical Engineering Support Specialist S. Rodriquez said. “This was one of the most useful webinars yet. I learned I need to step up my AED testing,” Biomedical Engineer P. Phillips said. “I really enjoyed the webinar and the information was very relevant because I

WWW.1TECHNATION.COM

THE BENCH

PM defibrillators for our hospital and clinics around town. We have the Lifepak 12s and it was great to hear how the Lifepak 15s were capable of doing more things. Thanks for the webinar,” said R. Kelley, biomedical technician. “The information was very useful. I will be bringing up a few of these points to re-evaluate our defib and AED testing practices. Especially testing AED output,” said B. Branning, BMET II. TRAINING AND EDUCATION FOR HTM EFFICIENCY The Webinar Wednesday session “The Impacts of Training and Education for HTM Efficiency” was eligible for 1 credit from the ACI. Presented by Summit Imaging and the College of Biomedical Equipment Technology, and sponsored by Summit Imaging, the presenters delivered great insights. The experts from Summit Imaging and the College of Biomedical Equipment Technology discussed industry dynamics shaping HTM professional development and continuing education. The demands placed on HTM professionals have increased exponentially based on technological advancements and other increasingly complex dynamics shaping the health care industry; consequently, HTM professionals need access to innovative education and training solutions designed to guarantee efficiency and patient safety. Following the webinar, attendees were asked, “How did today’s webinar meet your expectations?” Their responses are a testament to the continued growth and success of Webinar Wednesday. “This provided great insight about the industry needs today and into the future,” Field Service Engineer D. Banister said. “There was definitely some very eye-opening content in this webinar,”

said F. McVean, business process engineer. “Informative. The HTM was discussed now and before. This is highly useful information particularly in managing today’s trend of technology in health care,” said E. Gonzales, biomedical engineer. “I am an international BMET/HTM student of CBET, and participating in this webinar was worth it,” said E. Enyi, chief biomedical technologist, Nigeria. “Great feedback on the current and future trends for education and the industry,” Technology Manager J. Ruiz said. “I learned some of the steps being taken to address the challenge of educating and preparing the current and future HTMs,” Supervisor G. Meikle said. “I was not aware of online biomed programs so that was good to know. Interesting conversation,” HTM Director T. Dess said. VITAL SIGNS AND MONITOR TESTING The Webinar Wednesday presentation “An Introduction to Vital Signs and Monitor Testing” was sponsored by Rigel Medical and delivered vital information regarding vital signs monitoring. The 229 attendees who attended the live presentation are eligible to receive 1 credit from the ACI. In the 60-minute webinar, Rigel Medical National Business Development Manager Brittany Schmidke discussed understanding vital signs, the importance of monitoring them in a clinical environment and the importance of testing them with a patient simulator during the PM process. Attendees were asked to give three words to describe the webinar, but they were so impressed many exceeded the word count. “Very informative from the point of

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

checking the connections on the patients,” Clinical Engineer G. Walker said. “Job related and informative,” added L. DeDominicis, CBMET Specialist. “Good as a brush up on some of the techniques needed to diagnose and troubleshoot vital signs monitors,” shared P. Dorsey, BMET III. “Informative, clear, educational,” Biomedical Supervisor S. Keeny said. “Informative, detailed, easy to understand,” said Biomed F. Flowers. “Good information for new technicians without clinical backgrounds,” said P. Thibodeaux, clinical engineering supervisor. “I used this week’s webinar for our monthly training objective. It was very helpful for our two new technicians,” explained P. Phillipps, biomedical manager. “Good topic and background on the testing procedures. I have never been exposed to the invasive blood pressure apparatus. It was great to actually see the equipment and the placement so I can be better prepared for any questions from the nursing staff if I am asked to help problem solve issues that can arise,” said H. Martin, clinical engineer. For more information about Webinar Wednesday, including a calendar of upcoming sessions and recordings of previous presentations, visit WebinarWednesday.Live.

Thank you to our sponsors:

JANUARY 2020

TECHNATION

Authentic. Made with Peace of Mind.

Get back to life.

GE Healthcare

CT Tubes AFFORDABLE EXCELLENCE. DELIVERED.

www.multidiagnostic.com DIAGNOSTIC IMAGING & SURGICAL SOLUTIONS

990 E. Cedar Street Ontario, California 91761

Toll-Free: (800) 400-4549 International: (909) 591-6444 Fax: 909-591-5293

THE BENCH

TOOLS OF THE TRADE Clinical Dynamics

OPTICAL FINGER Clinical Dynamics has introduced an optical finger option that allows a user to produce synchronized SpO2 simulation in place of the traditional direct electrical SpO2 simulation. This alleviates the need for proprietary cables and allows a user to conduct a more thorough test of an oximeter utilizing an actual finger probe. This functionality further expands upon the AccuSim’s all-in-one features, such as • Fully synchronized patient monitor simulation system • Accurate NIBP simulation with CalTables • 12 lead ECG simulation • Invasive blood pressure, respiration and temperature simulation For more information, visit www.clinicaldynamics.com.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

JANUARY 2020

TECHNATION

THE BENCH

SHOP TALK POWERED BY SIEMENS - ACUSON SEQUOIA 512 When I turn on the ultrasound it doesn’t pass the screen with the trees. The loading bar that says “system starting” loads to the end and doesn’t do anything else. Can someone please help me with this problem?

weren’t dead or damaged before they reached you. Also, you have a power supply issue that isn’t charging them, converting properly, etc. 2080s occasionally have a regulator issue on the power supply. Check your battery voltages first, then plug it in and see if they are getting enough power to charge.

A: A:

You need to reload software. It is corrupted! You may have to replace the HHD if it doesn’t take.

STERIS - AMSCO 3085 I need help determining the following problem. Our remote suddenly stopped working. It started with all lights flashing when you first turn it on and then everything went out. Sometimes it would turn on normally and you could use it, but only for a few seconds and then it dies. After that it makes a clicking sound when you press ON and OFF, but you can’t control anything. This is my first encounter with this technology and any help/advice is greatly appreciated.

Does the hand control cut off when you wiggle the cord? These are bad about wire breaks near the strain relief. Replacement cords are available and easy to replace. Swap to another table if you have that luxury and see if the issue is in the hand control. Normally the only “clicking” noise you hear on these is when you first apply A/C voltage. If it is cycling or chattering or clicking multiple times, I would suspect the A/C plate assembly where the power cord plugs in, the cord itself or the voltage selection rotary switches on the power supply. I have seen these cause issues several times and is normally sorted by simply exercising the switches by turning them back and forth a few times with the A/C disconnected. Turning the hand control “ON” or “OFF” will also produce a clicking noise, but it would be impossible to “chatter” those clicks or cycle them quickly as those relays latch either way dependent on input from the hand control. Basically, once the hand control is ON, lost connection, bad board, bad blister pad, lost power, etc. would just turn OFF. The ON command is not restore-able and will have to be sent again by the hand control to hear another click.

Since it gets to the end of the boot-up before it fails, that might be caused by corrupted presets or a corrupted patient database. Try restoring the last good backup done on the system. If that doesn’t do it, reset the Aegis data, the patient database. In our experience, one of those two things fixes about 90% of these problems when this is the symptom.

There may be two sets of battles pending your model. Are the small batteries 12VDC 2.5Ah good? Does it drive while plugged in? Verify these points.

Call Steris tech support 800-333-8848 or 8828 and verify whether the remote control board is good. If there are lights on the control board on the column, one of the cables from the control board to the power supply may have a bad section or bad connections. I have one that is doing the same thing. I can’t remember the pins right now. Steris tech support will help.

There are two sets of batteries under the base cover. One set for the remote control to work, the other for the motor. The control batteries are probably dead or not plugged in properly, if your aux controls only work when plugged in, I’d say motor batteries as well. Even though they were replaced recently, that doesn’t mean that they were plugged in properly or that they

Have you removed the cord/cover from the bottom of the hand control? The connector is bad about unplugging itself from the board, especially if it wasn’t secured properly. Could be something that simple, otherwise, I would suspect one of the three components in the hand control assembly. Cord, board or case/switch pad. It is difficult to further nail it down without spares. Does the time the lights will stay on seem consistent? Or random? If consistent, I would lean toward the board, if random I would look more at the cord and case. Also, keep in mind that actuating any of the manual override switches, including the floor lock, will turn the hand control off. I would stick with A/C powered testing only until you have everything back to normal in that state before delving into battery issues. It is easy to chase yourself in circles with battery/power issues.

I have had a very similar issue. The problem ended up being a bad override board.

SHOP TALK

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

TECHNATION

JANUARY 2020

WWW.1TECHNATION.COM

WE ARE HERE FOR LIFE ™

YOUR ON-DEMAND TECHNICIAN SOLUTIONS

COMPREHENSIVE EQUIPMENT REPAIR, MAINTENANCE AND SALES SOLUTIONS

MULTIMEDICAL SYSTEMS ...here for life!

Our Services Include: Biomedical Equipment Repair and Maintenance

Join the MMS Team!

Endoscopy Repair/Sales

Experienced BMETʼs in the

Medical Equipment Sales

Western United States! Email your resume to resume@multimedicalsystems.com

Infusion Device Annual Preventative Maintenance

1.888.532.8056

WWW.MULTIMEDICALSYSTEMS.COM

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

SALESSUPPORT@MULTIMEDICALSYSTEMS.COM

JANUARY 2020

TECHNATION

ROUNDTABLE

ROUNDTABLE Cybersecurity

ybersecurity, 3D printing and artificial intelligence continue to be buzz words throughout the healthcare technology management world. Cybersecurity is an especially hot topic among biomeds and clinical engineers as more and more hackers seem to be focusing their crosshairs on the health care industry.

In an effort to keep readers informed about the latest cybersecurity trends, TechNation invited industry experts to chime in. The experts share what to be wary of in 2020 as well as valuable tips and insights into this ever-evolving segement of the HTM world. Participating in the roundtable article on cybersecurity are Medigate CEO Jonathan Langer, Cynerio CEO and Founder Leon Lerman, CyberMDX Vice President of Business Development Safi Oranski, MedStar Health Director of Health Technology Security Inhel Rekik and Nuvolo Director of Product Management Andrew Sweet. Q: WHAT IS SOME BASIC INFORMATION HTM PROFESSIONALS NEED TO KNOW REGARDING CYBERSECURITY? REKIK: Information security needs to be embedded in HTM processes as more

TECHNATION

JANUARY 2020

Inhel Rekik MedStar Health

and more medical devices are now connected. HTM needs to know what wormable vulnerability, exploit and threat means in order to perform a risk assessment of the security vulnerability and assess likelihood of it being exploited within their environment. They need to be able to read an ICSCERT security advisory, assess the criticality of the vulnerability and understand the recommended mitigation. LANGER: Effective cybersecurity of health careâ&#x20AC;&#x2122;s dramatically expanding IoT landscape requires a modernized, more

coordinated approach that includes asset tracking, maintenance and management. Although forwardthinking HTM leaders now recognize that professionals in IT/IS security, biomed, clinical engineering and even supply chain management (SCM) must converge to effectively address the risk, the cross-functional collaborations required to resolve the problem remains hit/miss. In addition to IT/IS security leadership, biomed, clinical engineering and SCM leaders must be stakeholders in the solution investigations/buy decisions now being made. Beyond IT/IS security professionals, not only are HTM professionals the ones who buy, maintain and manage IoT devices, but also, some of the highest value emerging use-cases are directly relevant to their workflows. LERMAN: No device is risk free, especially network-connected devices. And in a hospital environment, medical devices are the weakest link: they are not designed with security in mind, have extensive life cycles and often cannot afford any downtime. Collaboration is key â&#x20AC;&#x201C; no hospital IT organization has the same access to clinical assets that HTM professionals do, and so it is important for those teams to work together, along with InfoSec and the

WWW.1TECHNATION.COM

ROUNDTABLE

fully attributed IoT inventory capability (e.g. continuously collected MAC, IP address, serial numbers, firmware details including OS versions, application versions, etc.) with each device/system’s respective mission profile (i.e. authorized use cases, connections, etc.) and then, via integrations, send those contextualized data to firewalls, NAC and SEIM, long-standing gaps in the current ecosystem toolsets have been finally bridged.

medical device security engineer (MDSE), if one is already in place. ORANSKI: One of the biggest challenges in establishing a cybersecurity strategy is gaining visibility into the devices in a hospital’s ecosystem – both managed and unmanaged. Medical devices, IoMT and IoT assets are more ubiquitous than ever before and HTM professionals must help institute a cultural shift within their organizations whereby HTM, IT, IS and the C-level all work together in staff-wide cybersecurity awareness initiatives. Silos amongst these departments must be broken down in order to understand asset inventory. What devices are connected to the network? What does the attack surface look like? What are the risks associated with each device? SWEET: A lot of hospitals are looking for that “magic pill” that will solve all their cybersecurity risks, but they need to understand that cybersecurity for medical devices is a people, process and technology problem and solutions must address each area. People and processes need to be aligned to coordinate procurement, security assessment, secure deployment, vulnerability management and secure disposal of the equipment. Technology must provide a single repository of all device security risks, controls and control procedures as well as risk scoring, correlation of risks across the fleet and prioritization and organization of the risk remediation work. Q: WHAT ARE THE LATEST DEVELOPMENTS IN CYBERSECURITY? REKIK: The latest development in medical device security has been the revision of the FDA premarket guidance. Medical

Jonathan Langer Medigate

device manufacturers are now required to provide the Software Bill of Materials (SBOM) which is the list of third-party software included in the medical device in machine readable format. HTM needs to determine how they can incorporate this information in their vulnerability management program. The MDS2 had a makeover and has now 349 lines to include details about cybersecurity updates, SBOM and remote services. However, the biggest development of all was the fact that the FDA started issuing recalls of medical devices due to security vulnerabilities. In addition, the FDA and DHS have released their first joint vulnerability disclosure which was about URGENT/11 vulnerabilities. LANGER: The ability to passively “sniff” network traffic to fingerprint the originating/transmitting IoT devices and, via integrations, parse/send the relevant, collected data to the appropriate tools/workflows of all the aforementioned professionals, is not a nice improvement to existing tools. By combining a real time, dynamic and

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

LERMAN: Any answer to this question will be not be current by the time this article is published. New vulnerabilities are published daily. Ransomware is old news, but as relevant as ever (a recent study shows correlation between ransomware and data breaches and an uptick in fatal heart attacks). Awareness is growing around the inherent risk in network-connected health care IoT, however those devices are a blind spot for traditional security solutions. ORANSKI: Some of the main trends we see include: • Ransomware attacks are getting highly targteted against health care organizations, with attackers leveraging intelligence to inflict maximum disruptions. • Use of IoT connected device is accelerating dramatically increasing the network vulnerability • Cybercriminlas are starting to take advantage of AI to help them find more vulnerabilities and develop more sophisticated attacks. • Cloud migration brings on new exposures At CyberMDX we see in the field that these trends are sparking new approaches to cybersecurity. Best-inclass health care delivery organizations

JANUARY 2020

TECHNATION

ROUNDTABLE

are deploying specialized security solutions built for the unique workflows and business requirements of hospitals. Generic IoT security solutions are no longer sufficient in dealing with the growing threats that hospitals face. SWEET: Progressive health delivery organizations (HDOs) are implementing unified governance, risk management and compliance programs that leverage new assessment technologies to build security profiles for devices that ensure they are securely deployed, as well as security monitoring to ensure they can respond as new threats are found.

mitigation and remediation is inevitable. Modern solutions provide the required visibility. IT/IS security will increasingly depend on biomeds as front-line actors to any practicable solution. LERMAN: We mentioned collaboration already. Champion the endorsement of a health care IoT security solution that can integrate with your asset management and workflows, provide deep visibility and up-to-date inventory of networked clinical assets, and perform an ongoing risk assessment on each and every device. Such a system

Q: WHAT ARE SOME MEASURES BIOMEDS CAN USE TO ENHANCE A FACILITY’S CYBERSECURITY MEASURES? REKIK: Biomed can incorporate security into the life cycle management of medical devices. They can document OS and network attributes of their connected medical devices and make sure that this data is always accurate. They can also partner with information security to stay up to date with current threats and vulnerabilities. They can mitigate security vulnerabilities on medical devices by installing the security update or implementing compensating controls if the medical device manufacturer hasn’t released the fix yet. LANGER: As stated, biomed’s involvement is critical, as its professionals are directly responsible for the maintenance and management of connected devices. Often, that includes patching for newly published vulnerabilities which requires the ability to immediately correlate any threat to potentially affected devices. Risk takes many forms. Biomed’s increasing involvement in both

TECHNATION

JANUARY 2020

Leon Lerman Cynerio

can ensure you stay up to date and are aware of new patches, vulnerabilities and recalls, and know when your devices “misbehave.” ORANSKI: Have a solution that will allow you to check that your medical devices are patched. Also, engage IT/IS teams to make sure: • They have full visibility of your asset inventory • Assets are not connected directly to the Internet

• Your assets are well segmented with clear VLANs • Devices are only communicating with authorized end-points • Taking preventative measures to reduce the attack surface • Make sure clinical staff is not using medical devices to surf the web SWEET: The foundation of securing operational technology (OT) devices – like medical devices and building systems – is having an accurate inventory, complete with what devices are on the network, their IP addresses, their operating systems, patch versions, etc. If you don’t know what you have and where it is, you can’t secure it. Biomeds should also validate these configuration items when performing an initial inspection or PM on a device. Keep in mind that networked devices are not the only devices at risk. Any device that stores or transmits patient data poses a risk, and if it’s mobile – like a portable ultrasound – it should be identified in your CMMS as such, and the biomed department needs to make sure ePHI is not stored on the device or that it is encrypted and/or tethered to a cart, so it can’t easily walk out of the facility. Q: WHEN IT COMES TO OLDER EQUIPMENT, WHAT STEPS CAN BE TAKEN TO PREVENT CYBERSECURITY ISSUES? REKIK: We need to start at the procurement level since the development life cycle of a medical device is typically five years, it often means that by the time it’s being placed in the market, it’s already outdated. HTM can control this issue by making sure that medical devices with the most up to date OS are being purchased as well as negotiating an upgrade up front. They can plan for

WWW.1TECHNATION.COM

ROUNDTABLE

such as making sure that they change default credentials and not plug USBs into medical devices without scanning them for malware.

the capital replacement of equipment without OS support and collaborate with IT security to identify the appropriate compensating controls for these devices which can include isolation and network segmentation. LANGER: As mentioned above, “patching” for cybersecurity purposes represents more than having the visibility required to quickly act on a threat. Obviously, the proactive mitigation of risk requires a multidimensional view of the entire landscape. For example, while access to utilization metrics is clearly valuable information for SCM professionals, for biomed, it enables far more intelligent, proactive preventive maintenance scheduling. Biomed has been given the responsibility of device maintenance. Soon, they will have true responsibility for device management. LERMAN: Keeping up to date with vendor and FDA security advisories is important, but not always easy. Moreover – when a device is affected by known vulnerabilities, or runs unsupported software, more often than not there is no patch available or even a clear upgrade path. Implementing network policies is the only viable method to effectively mitigate the risk, by reducing the attack surface by 99%. A health care IoT security solution such as the one mentioned above can make all of that feasible. ORANSKI: Have a credible system that can help you track and manage the life cycle of all devices. This includes devices that have FDA recalls on them and end of life cycle devices. Use a technology solution that monitors device analytics to determine asset usage. Retire old equipment that usually has a higher

Safi Oranski CyberMDX risk. Look for devices with low usability and high risk – these are the first ones to be replaced. SWEET: Older devices present real challenges due to unsupported software components. Technologies that allow for the analysis and generation of a detailed SBOM are essential to profiling these risks to prioritize device modernization plans. External mitigating controls like network micro-segmentation are also effective at mitigating risks that cannot be addressed due to manufacturer updates no longer being available. Q: WHAT TRAINING/EDUCATION DO CLINICIANS NEED TO PREVENT CYBERSECURITY ATTACKS? REKIK: It has been published by multiple studies that user behavior represents a large percentage of threats HDOs face. It’s paramount that clinicians are given tailored training in addition to the training provided to all hospital staff. It’s not enough that they do not click on the phishing link, they need to be trained on specific security practices

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

LANGER: Not just more details surrounding the number and frequency of successful attacks; or, more generalities about potential financial and reputation risks; and not just the facts surrounding the FDA’s changed guidance or the Joint Commission’s latest edicts; or, how failure to comply is going to result in reimbursement penalties. Clinicians must understand the risks from a patient safety perspective. On a daily basis, clinicians are working with patient-connected devices that are designed to be controlled remotely. That point needs to be communicated more effectively – with real world examples of how easily these devices can be compromised. LERMAN: Awareness training for clinicians should cover the risks posed to network connected devices, from your smartphone and laptop to – yes – an IV pump. Understanding that targeted attacks are real, and that at the same time your assets are just as likely to be infected by malware because someone browsed to the wrong website from a tablet in another ward. Use secure passwords and do not write them on post-it notes or share with others. Know how to identify phishing emails, suspicious links and avoid browsing the Internet from medical workstations. ORANSKI: The growing number of instances of attacks underlines the importance of regularly training staff in basic cybersecurity awareness. All it takes is one click on a phishing email link to open the entire health care network to attack. We recommend 2 to

JANUARY 2020

TECHNATION

ROUNDTABLE

3 staff-wide trainings sessions a year around cybersecurity in order to keep clinical engineers abreast of current threats and protection practices. Another important aspect is to include cyber hygiene and device-specific dos and don’ts into staff-wide medical device SOP training. We also have seen some of our customers engage in staff-wide training to educate all stakeholders on the cybersecurity technology deployed.

Andrew Sweet Nuvolo

SWEET: Most hospitals should have a cybersecurity education program for their clinicians that explains why it’s important for devices that store or transmit ePHI to be password protected and/or encrypted and thus should go through a proper on-boarding process before they’re put into use. They also need to be educated about accessing the network from a medical device, like through Internet Explorer, to limit risk exposure. For HTM departments, organizations like AAMI have excellent cybersecurity guides and training. There also are a lot of good online networking and security training courses. The best

TECHNATION

JANUARY 2020

training is the most practical. HTM departments need to look to these guides and then work with your security team to learn, hands-on, about best practices. Q: WHAT ELSE DO YOU THINK TECHNATION READERS NEED TO KNOW ABOUT CYBERSECURITY? REKIK: Medical device manufacturers face major challenges when it comes to securing medical devices. They need to comply with multiple different regulations when designing medical devices they want to sell in different countries. In addition, HDOs deploy different practices when securing medical devices which can add significant delay to the development life cycle since manufacturers need to test for every scenario. It’s important that medical device manufacturers and HDOs work together in order for the medical device security field to advance. LANGER: The current IoT cybersecurity solution market, especially in health care, is white hot. The proliferation of EMRs and ever-fragmenting models of care delivery will continue to drive the market. As a result, risk capital has poured into the space and start-up companies that address the problem are abundant. Because these vendors share an exceptionally strong business case, their sales narratives are often strikingly similar. This has made it difficult for health system solution evaluators to structure effective competitive trials. Among other reasons, this is why cross functional evaluation teams are essential, as the value propositions of potential vendors are more easily differentiated when a diverse set of stakeholders are doing the vetting. IoT cybersecurity cannot be treated as a “check the box” matter. It’s mission critical.

LERMAN: Your home laptop crashing due to malware is an inconvenience. A credit bureau experiencing a data breach can put you at risk of identity theft. A CT or LINAC emitting dangerous amounts of radiation because a workstation that controls them is overloaded by a cryptocurrency miner can result in a negative patient outcome. While cybersecurity is an ever-changing landscape, the inherent weaknesses of hospital networks are not going away anytime soon. ORANSKI: That is a loaded question! Readers should understand that the landscape is changing rapidly and all health care delivery organizations must begin planning their cyber strategy in a prioritized, phased approach. Partner with vendors that are focused on the health care market and can help answer key questions such as: • How do we identify risk factors that need immediate action? • How do we fit our unique network architecture into an IoT strategy? • How do we address integration amongst all of the different security solutions? SWEET: Cybersecurity is dauntingly complex, and many organizations and HDO staff find the jargon and acronyms bewildering. A world-class security practice is focused on multitiered and effective solutions. Build a trusted inventory, assess new models before purchasing, assess the most critical and most numerous existing models in your fleet, then implement a regimen of thoughtful and thorough practices to secure your devices. Cybersecurity is about best practices and securing your patient care is a journey, not a destination.

WWW.1TECHNATION.COM

ON-SITE TRAINING AVAILABLE

CONTRAST INJECTOR TRAINING OPERATION AND SERVICE • Training BMETs since 2008 • Spectris Solaris, Stellant, Mark 7, ProVis and many other models • MIST Maintenance Software • Extensive troubleshooting info/support VIDEOS • 100s of additional error codes not found in OEM lit

“

LICATION

AD SIZE

”

hands-on and ORTODAY the training HALF manuals and EDICALClass DEALERis veryTECHNATION PAGE HORIZONTAL procedures OTHER are high quality. I highly recommend it. UYERS GUIDE NOTES – Matt S.

NTH

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

ISO CERTIFICATION Quality Management for HTM Departments

BY K. RICHARD DOUGLAS

“E

vidence” has become a very important concept in health care and HTM departments. What has, or hasn’t, worked in the past provides the best guidelines for what path to take. Physicians and other clinicians make decisions using evidence-based practices. Treatment protocols, as well as PM schedules, can result from evidencebased information. AEM programs make decisions based on historic evidence. It should not be a surprise that evidence is cited as support for ISO 9001 certification.

For instance, according to the International Organization for Standardization (ISO) organization, there are more than a million companies in 170 countries with ISO 9001 certification. It is a quality management system with a focus on the customer, the process and continual improvement. The International Organization for Standardization is a non-governmental organization that was formed in 1947. It is composed of representatives from a number of national standards organizations. It is headquartered in Geneva, Switzerland, but was founded originally in London. While previously being a standard and model for the manufacturing industry, ISO 9001 today has been broadened and can be applied to any type of organization. The standard looks at the processes

TECHNATION

JANUARY 2020

used to achieve results. DNV-GL Healthcare has had CMS Deeming Authority since 2008. The organization, through its HIAHO program, accredits nearly 500 hospitals across the U.S. The organization says that implementing an “effective quality management system, is the first step for organizations looking to become certified.” The DNV-GL Healthcare website states: “As DNV GL hospitals often say, ISO provides the structure for the staff to focus on common goals, like patient care and safety.” The designation of ISO 9001 certification demonstrates to customers or patients the certification-holder’s focus on customer satisfaction. The certification can also demonstrate to professional contacts and the customers

or independent service and parts organizations, that they follow a quality management system. “As medical equipment technology, health care reform and cybersecurity continue to progress, there will be a need to ensure HTM organizations are meeting standard requirements to provide a safe environment for patients. This must be accomplished while continuing to focus on reducing cost for the health care consumer. So, it becomes imperative that ‘all’ organizations work together to focus on moving in the right

WWW.1TECHNATION.COM

“ As medical equipment technology, health care reform and cybersecurity continue to progress, there will be a need to ensure HTM organizations are meeting standard requirements to provide a safe environment for patients.” – F. MIKE BUSDICKER direction,” says F. Mike Busdicker, CHTM, FACHE, system director of clinical engineering at Intermountain Healthcare in Midvale, Utah. “This effort must include health care delivery organizations, manufacturers, independent service organizations, regulatory agencies and others involved with healthcare technology management,” Busdicker adds. Busdicker says that over the years, the topic of patient safety in relation to healthcare technology management continues to be a topic of discussion, so he doesn’t think it is just a trend, but a reoccurring theme. “It is time we all get on the same page, stop protecting our ‘turf’ and work together for the benefit of our health care consumers,” he says. HTM PREPARATION FOR ISO 9001 While HTM departments strive daily to meet many standards and regulatory requirements, it is the department in an organization accredited through DNV-GL Healthcare that also focuses on the ISO 9001 certification standard. “Make sure all of your documentation is complete and accurate. Have current calibration certificates on all test equipment used for PMs, etcetera. Have a means of documenting which items of test equipment were used during the PM procedure and record it in every

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

record,” suggests Matt Yates, director of biomedical engineering services, who is with The Intermed Group and assigned to Pardee UNC Healthcare in Hendersonville, North Carolina. Yates says that in his second-year interview, he was asked “What happens when you have a piece of test equipment fail calibration testing?” “He suggested that I write a policy so that if for some reason I wasn’t here, there would a guideline to follow. I wrote the policy stating step-by-step instructions in the event that this happened. I did have this happen a few years ago and was able to see what equipment was tested with the failed analyzer,” Yates says. “In my next interview with the DNV inspector, I was asked the same question. I was able to show the exact actions taken from notification to completion per our policy. During the summation meeting, he stated that the documentation ‘would hold up in a court of law.’ Make sure that you follow exactly what your policy states,” Yates adds. “I feel that it’s good for HTM departments to be under the guidelines of ISO 9001. First of all, the requirements to achieve certification make you more efficient. DNV is an unannounced, annual inspection with ISO every third year, so you have to stay ready,” he says.

JANUARY 2020

TECHNATION

Courtney Haschke, biomed supervisor at BSA Health System in Amarillo, Texas also has experience with DNV-GL accreditation and the ISO 9001 certification. She says that one of the more obvious differences of DNV is the annual inspection versus every three years. Being inspected every year is one of the best parts of being accredited through DNV. “Get your MEMP in order and documentation. Documentation is the key to your success. DNV wants to know that you – the clinical engineering department – knows what is going on with your equipment. Whether the equipment is in service and PMs are up to date, not located and in the process of trying to find and complete service, or out of service waiting on parts or vendor service,” she says. Haschke says that another great stride her team made to have a successful survey is getting clinical staff involved. “We have set up processes and educated staff on what to do if equipment is broken or malfunctioning, how to read our PM stickers, and what to do if the equipment is past due for service. The opening of communication between clinical staff and clinical engineering has been the game changer on our surveys. I remember sitting through a seminar at MD Expo in Nashville about reaching 100 percent completion rates, provided by Steven Kelley. We have adopted the mentality he spoke on, that PM completion is patient safety, and patient safety is everyone’s responsibility,” Haschke says. She sees the more frequent inspections as a benefit. “With only nine to 12 months between inspections, there is constant talk of the upcoming, next or most recent inspection. We are always on topic of how to improve our next survey. Which has us striving to be the

TECHNATION

JANUARY 2020

best possible health organization. DNV stays in the forefront of everyone’s mind and there is less opportunity to stray away from policies and procedures, and to become lax in our day-to-day operations,” Haschke says. “Annual inspections are very stressful but so rewarding. Under ISO guidelines, I know that my organization is top notch and constantly aiming to improve,” she adds. DNV-GL INSIGHTS One of the broadest implementations of the ISO 9001 standard in health care is related to accreditation by DNV-GL. What suggestions do they offer to HTM departments, that are part of a health care organization seeking ISO 9001 certification? “I would suggest first of all that the HTM department obtain a copy of the ISO 9001:2015 requirements. They are published by the International Organization of Standardization. Once the HTM department obtains the requirements they should review them and familiarize themselves with the terminology and try to get a good understanding of what is being required. The ISO 9001 standards are a Quality Management System (QMS) that requires those implementing it to perform risk-based thinking, which comes naturally for a health care organization,” says Kelly Proctor CHFM, CHSP, CHOP, physical environment sector lead with DNV-GL Healthcare. Proctor would know since he holds the ISO 9001 Lead Auditor Certification, has 30 years of health care engineering experience and has a master’s degree in mechanical engineering. Proctor says that the ISO 9001:2015 requirements were originally written for manufacturing and will require those implementing them in the health care business to think about how they

apply to health care. “For example, ISO 9001 mentions ‘interested parties;’ these are individuals who have an impact on the hospital’s quality management system (QMS) and it leaves it up to the hospital to determine who these ‘interested parties’ are. The requirements also mention ‘customers.’ Typically speaking, just about anyone can be the hospitals customer, but for the most part, the hospital should consider the customer as the patient. The ISO requirements also mention products and services. Products are considered things such as durable medical equipment, blood, medication and even food. ‘Services’ are services such as emergency services, ambulance service, imaging, dialysis, rehabilitation and even housekeeping,” Proctor says. He says that one of the most important and effective requirements of ISO 9001 is the “internal audit” process. Internal audits are expected to be performed in areas where the organization sees the need for improvement. “For the HTM departments, this is more than just rounding, it’s identifying a weak or broken process and then identifying where the failure is occurring and establishing a corrective action plan (CAP) to improve on the weak or broken process. Once the CAP is established, the health care organization is required to follow up on the CAP to ensure it is effective. If the CAP is not effective, or is not making an improvement, it is the organization’s responsibility to reconsider the CAP and make adjustments in an effort to make the CAP effective. Internal audits have proven to be very beneficial for the HTM departments as well as other departments throughout the health care organization,” Proctor says. Proctor says that once the ISO 9001 requirements are understood, they become easier to implement and

WWW.1TECHNATION.COM

manage. “Once properly implemented, the ISO 9001 requirements will prove to reduce risks, errors and will save time. ISO 9001 implemented in the health care setting is one of the best steps a hospital can take to better itself and to ensure constant improvement,” Proctor says. “Those hospitals, who are accredited by DNV-GL, are required to implement ISO 9001 within three years. DNV-GL does not expect the hospitals to have a perfect ISO 9001 QMS at the three-year mark, but expects the hospital to have the basics in place and to improve on its QMS over time.” While the entire health system or hospital is taking specific steps to implement ISO 9001, it is the HTM department that has an important role in this process. “The HTM department has numerous roles in the organization’s QMS and meeting the ISO 9001 requirements. Some of the items that stand out for the HTM department are for example, the verification of competencies. ISO 9001 requires that

sprinkler system are certified to do so. It also requires that the hospital’s own staff be competent and meet the requirements specified in the job descriptions,” Proctor says. He says that ISO 9001 also requires that the organization have an effective process in place to ensure that measuring equipment such as testing/ calibration tools be calibrated per the manufacturer’s recommendations. “This is one of the areas where DNV-GL and ISO 9001 stand out amongst the accreditation organizations. ISO 9001 requires that measuring devices be calibrated per the manufacturer’s recommendations with traceability to a national organization such as the National Institute of Standards and Technology (NIST); this ensures the organization is using calibrated and safe test equipment and has a process in place to prevent the unintended use of equipment that is not suitable to be used. This requirement is not limited to the organization’s biomedical department, but also includes measuring tools that may be used in the organizations HTM

“ I remember sitting through a seminar at MD Expo in Nashville about reaching 100 percent completion rates, provided by Steven Kelley. We have adopted the mentality he spoke on, that PM completion is patient safety, and patient safety is everyone’s responsibility.” – COURTNEY HASCHKE

anyone working under the hospital’s control be competent to perform the duties they are doing. Sometimes this can be simple and sometimes it can get a little complex. Basically, it is the organization’s responsibility to ensure that those working on the medical gas are certified or licensed, those working on the fire alarm system are certified to do so and those working on the fire

departments,” Proctor says. He adds that the ISO 9001 requirements force the organization to have an effective process in place for the control of customer and external providers property, control of documents both internal and external, and ensures continual improvement is supported by top management. “ISO 9001 requires top

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

management to communicate the QMS to staff as well as interested parties and holds them responsible for providing resources to support an effective QMS. Basically, ISO 9001 is the foundation for all of the organization’s processes and works very well with LEAN programs and other quality management programs,” Proctor says. FDA GUIDANCE While ISO certification may prove of great benefit to patients and customers, it is not yet a requirement of the government for HTM departments. In the last couple of years, the government has been hesitant to add to the thousands of pages of regulations that already help protect patients and guide health care providers. The FDA considered additional regulation at one time as it pertained to medical device servicing and any risk to the public health based on current practices. “On May 15, 2018, FDA published on its website a report entitled ‘FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices’ in accordance with section 710 of the FDA Reauthorization Act of 2017 (FDARA). The report discussed the continued quality, safety and effectiveness of servicing of medical devices by original equipment manufacturers and third-party entities,” says Kristen Pluchino, Ph.D. MPH, press officer in the office of media affairs, office of external affairs at the U.S. Food and Drug Administration. “The report was informed by feedback and comments from an open docket and a public workshop held in 2016, among other information. Based on the available information, the FDA stated the current available evidence is not sufficient to conclude whether or not there is a widespread public health concern related to servicing of medical devices that would justify imposing

JANUARY 2020

TECHNATION

burdensome regulatory requirements at this time,” she says. Pluchino says that the “report” included several actions that FDA intends on pursuing. One of these actions is publishing a draft guidance to assist in differentiating servicing and remanufacturing to allow more consistent interpretation and categorization. In turn, this will clarify regulatory responsibilities for entities performing these activities and allow FDA to focus its regulatory oversight on those activities that have the greatest impact on the quality, safety and effectiveness of medical devices. She says that in accordance with FDA’s Good Guidance Practices, FDA intends to publish the guidance in draft form and accept public comments before issuing final guidance. “We encourage all stakeholders to comment when the draft becomes available,” Pluchino says. Will there come a time when the FDA does look for some evidence that a quality management system exists? Possibly. “I do feel, as the FDA continues to evaluate the safety/quality related to the servicing of medical equipment, there is a very high probability that there will be a recommendation, if not a standard, that will drive towards a Quality Management System (QMS)/ process-type activities. I don’t believe it will be prescriptive to the point of ISO 9001/13485 or any other specific program, however, the essence/intent behind the value of a QMS will be required,” says Dave Francoeur, senior vice president of marketing and sales, Tech Knowledge Associates (TKA), based in La Palma, California. Francoeur says that organizations with a responsibility to provide service on medical equipment will, at some point in the future, be required to demonstrate components of servicing that validates safety/quality. “There is a collaborative community

TECHNATION

JANUARY 2020

established currently comprised of 25 individuals representing OEMs, ISOs, HDOs, regulatory and auditing bodies. These groups are being asked to participate in additional subcommittee’s that would help demonstrate safe/quality of servicing medical equipment,” Francoeur says.

Whether or not the QMS practices of ISO 9001 will ever be a regulatory requirement for HTM departments and their parent organizations as a directive of the government is in doubt. The drive toward QMS best practices or standardization is more likely. “We already have the FDA, CMS,

“ There is a collaborative community established currently comprised of 25 individuals representing OEMs, ISOs, HDOs, regulatory and auditing bodies.” – DAVE FRANCOEUR He says that the topics identified (in no particular order) are QMS best practices, training, crosswalk education and benchmarks/data collection. “My belief is that something will come out of each of these opportunities, driving consistency, quantifiable, repeatable and impacting safe/quality servicing of medical equipment,” Francoeur adds. According to Francoeur, the collaborative community he referred to is a formal group established by the FDA in December of 2018. Busdicker is also a member of this group. “We have been meeting monthly since. The collaborative community was established in an effort to create a solution/response to the MITA claim that individuals performing service on medical devices, other than OEMs or not being trained/approved by OEMs, are performing less than safe/quality medical equipment servicing,” he says. He says that as of October, the FDA created four sub groups. “This is in an effort to spend focused attention in these areas looking to generate outcomes moving the group forward,” Francoeur says.

TJC, DNV, ACR and state health departments, just to name a few. These regulatory agencies, along with many others, perform routine inspections to ensure HTM departments are performing in accordance with standards. In my opinion, a well-run HTM department is already accomplishing the majority, if not all, of the requirements under ISO 9001,” Busdicker says. “In my opinion, we all need to be on the same page when it comes to certifying that an HTM program has a robust QMS and is providing a safe and cost-effective environment for the patients we serve. The industry must support a collaborative community, or steering committee, that is willing to include all appropriate personnel in the process of achieving objectives outlined by the FDA,” Busdicker adds. The end goal of HTM departments and the organizations they belong to comes down to patient safety. The goal of a good quality management system in health care is aligned with this goal as well. In the end, the patient wins and that’s what it is all about.

WWW.1TECHNATION.COM

DON’T ROLL THE DICE

WE’RE HERE TO SERVE YOU. WE WILL REPAIR YOUR SPACELABS EQUIPMENT.

WHEN IT COMES TO PATIENT MONITOR REPAIR. GO WITH THE ACE.

SPACELABS • DRAGER • SCOTTCARE • NIHON KOHDEN• DATASCOPE • GE • PHILIPS SPACELABS • DRAGER • SCOTTCARE • NIHON KOHDEN• DATASCOPE • GE • PHILIPS • BEDSIDE & CENTRAL MONITORING • BEDSIDE & CENTRAL • MODULES MONITORING • TELEMETRY • MODULES • FLAT PANELS • TELEMETRY

• FLAT PANELS

• RECORDERS ACCESSORIES •• RECORDERS • FREE TECHNICAL SUPPORT • ACCESSORIES • FREE REPAIR EVALUATIONS • FREE TECHNICAL SUPPORT

• FREE REPAIR EVALUATIONS

“We Put The ACE In Spacelabs!” “We Put The ACE In Spacelabs!” WWW.SWBIOMED.COM • 800.880.7231

WWW.SWBIOMED.COM • 800.880.7231

EXPERT ADVICE

CAREER CENTER

How Honest Should You be in an Exit Interview? BY KATHLEEN FURORE

reparing for an interview is something most job seekers are always a bit nervous about, so it’s something they take time to prepare for. But what about an exit interview? What are some typical questions/conversations that someone who’s leaving a company can expect? And, how honest should they be about any negative things they’ve experienced during their tenure?

First, if you’re nervous, acknowledge that and try to figure out why, says Adrienne Cooper, chief people officer at FitSmallBusiness.com. “Do you distrust the person who is conducting the interview? Are you afraid to speak up about issues?” Cooper asks. “It could be the reasons for being nervous are also part of the reasons you are deciding to leave, and those can be difficult to discuss. Now is a time for you to clear the air.” “It’s perfectly natural for an employee to experience apprehension before an exit interview,” says Frederick L. Shelton, chief executive officer at attorney recruiting firm Shelton & Steele LLC, who preps attorneys for exit interviews every week. “Unlike a job interview where both parties have a potential upside, an exit interview only benefits the company.” According to Shelton, the reasons for an exit interview vary. The employer might want to improve the organization,

TECHNATION

JANUARY 2020

document why things didn’t work out or even gain evidence in case the employee sues the company. “So, the only potential upside for the employee would be the emotional gratification of telling HR how poorly the company is run, how bad the boss was and so on,” Shelton says. “And that is the last thing they should ever do.” So how can you get ready for that last chance to express yourself before you walk out that door? Cooper and Shelton suggest being prepared to answer these typical questions: • What is your next job going to be? • When and why did you decide to look for a new position? • Who did you go to with any issues/ concerns? What did they do to resolve the problem? • How was your boss? Is there anything he or she could do to improve their management style? • How were the resources you had access to – software and training, for example? • Did the company help you fulfill your career goals? • Is there anything that could have been done to keep you on staff? • Did you ever experience discrimination or harassment here? • What did you like most about your job and/or this company? The least? • How would you describe the overall culture and morale? • If you could change anything about your job or the company, what

Kathleen Furore

would it be? • What do you think it takes to succeed here? • What should we look for in your replacement? • Would you consider coming back to work here in the future? If so, in what kind of role? Cooper says it’s important to be frank during the interview. “Please be honest. Give the data points – what happened – and share why those moments or things were impactful – who did they affect and how,” Cooper advises. “The only way organizations can grow, evolve and address issues is by first hearing about them. This is an opportunity to make sure this happens.” Maintaining control is also important, Shelton stresses. “While interviewing to get a new job

WWW.1TECHNATION.COM

EXPERT ADVICE requires honesty and integrity, exit interviews require control, diplomacy and street smarts,” he says. “Departing employees need to think long game and protect themselves. The goals for departing employees are to make sure that no bridges are burned and positive references are preserved.” And here’s something departing employees might not realize: Exit interviews aren’t required. “The good news for professionals facing this situation is a simple paraphrase of the Nike slogan: Just don’t do it,” Shelton says. “You are under no legal or contractual obligation to go through an exit interview. If you do decide to go through the process and you’re nervous, just remember that you don’t have to answer any of the questions asked ... employees can relax and know they are in complete control!” KATHLEEN FURORE is a Chicago-based writer and editor who has covered personal finance and other business-related topics for a variety of trade and consumer publications. You can email her your career questions at kfurore@yahoo.com.

WE KNOW TRANSPORT VENTILATORS • REPAIR AND PM SERVICE • HIGHLY TRAINED AND CERTIFIED TECHNICIANS • OEM NEW AND RECERTIFIED PARTS • QUICK TURNAROUND TIMES • COMPREHENSIVE PARTS AND LABOR WARRANTY

MAKE CARDIOTRONIX YOUR NEXT SERVICE CALL

(855)-4DEFIBS IF IT’S MEDICAL EQUIPMENT RELATED, WE HAVE YOUR SOLUTION! CARDIOTRONIXHEALTH.COM

Don’t Let Your Medical Devices Fall Victim to Cyber Attacks With the proliferation of smart, connected clinical devices, HTM teams are entering uncharted territory when it comes to Cyber Security risks.

Take Control with Nuvolo • Maintain an accurate inventory for all connected devices (IP/MAC address, current software version, patch levels, etc.) • Proactively identify all devices requiring urgent security patch updates • Integrate with leading security monitoring solutions like Medigate, Asimily, CyberMDX, Ordr, and Zingbox • Generate remediation work orders automatically for all affected devices

To learn more about our Cyber Security solution for connected clinical devices, contact us at sales@nuvolo.com or visit us at nuvolo.com.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

JANUARY 2020

TECHNATION

EXPERT ADVICE SPONSRED BY:

20/20 IMAGING INSIGHTS Philips X5-1 got you down? BY TED LUCIDI

Ted Lucidi Innovatus Imaging

trust that if you, or your team, supports the ultrasound modality in any way, that you have at least heard of the Philips X5-1 transducer. In my opinion, it’s THE transducer that revolutionized modern trans-thoracic echo-cardiography. For those not so familiar, rather than producing traditional 2D cross-sectional images, X-Matrix transducers can create live-3D volumetric images. Initially released on the iE33 platform, it was one of the most technically advanced transducers of its day and after multiple iterations and design changes, and after almost 10-years, it is still one of the most popular cardiac transducers on the planet.

No doubt, if you have these transducers in your fleet, then you’ve spent tens of thousands from your service budget supporting them. But, why are these transducers more costly to support? Why do they seem to fail much more often than traditional transducers? If, for the moment, we focus on Philips cardiac transducers, you’ll see that there’s a quantum leap in technology between the legacy S5-1 and the X5-1. The typical legacy cardiac transducer, in this case the S5-1, was designed around a traditional acoustic

TECHNATION

JANUARY 2020

X5-1 array array, consisting of 80 acoustic elements, bonded to backing material to control the direction of and efficiency of the sound energy. The array is electronically connected to a single PCB within the scanhead via several flexcircuits. The PCB is fairly simple but handles the connection to the wiring harness (consisting of 80 miniature coax-cables, the thickness of a human hair). The acoustic array in the X5-1 is of a

newer design than traditional arrays. Although now commonplace within most Philips transducers, PureWave arrays are much more efficient and have the capability of providing greater penetration and resolution than traditional arrays. The X5-1 array boasts 3040 elements in roughly the same physical space as the 80-element S5-1. It’s mounted, not on traditional backing material, but sits atop of an Application Specific Integrated Circuit

WWW.1TECHNATION.COM

EXPERT ADVICE

(ASIC) which handles much of the control and beamforming of the array. Beamforming and control traditionally lie within the scanner itself. There is a series of four PCBs within the scanhead to assist with array/ASIC control as well as handle the connection to the wiring harness. The cable, rather than consisting of 80 wires, now has 163 consuming roughly the same physical dimensions. 12 wires are designated for control, 151 for signal. This will be important later. The X5-1 exhibits failures similar to other transducers … lens damage, strain relief damage, cable pulls, connector damage, premature electronic failures and, the ever-favorite, accidental trauma. For years, the primary mode of failure on almost all cardiac probes was a breakdown of the individual coax’s within the wiring harness due to the way echo studies are performed. One particular cardiac image requires the patient to rest on their left side while the probe is placed between the patient and the exam table. Besides being uncomfortable to the patient, this requires the cable to be bent at extreme angles often resulting in excessive stress and strain being placed upon the wiring harness. Even though echo labs are using specially designed exam tables to address patient comfort (and cable strain), a healthy percentage of cardiac studies are performed on traditional beds across hospital campuses. Cable/wiring failures are still common on the X5-1, but all the technological advancements in this probe have presented new modes of failure, never seen before. Another very common mode of failure with this probe model is constant static in continuous wave (CW) Doppler mode at only specific locations within the image. The problem may or may not actually be repeatable, which makes it extremely frustrating for echo-techs as well as service personnel. A strong percentage of the X5-1 transducers exhibiting this phenomenon may actually have no problem whatsoever, however; I can confidently say that it is likely that it is THE most frequent reason for which the probe is replaced. As today’s transducers become more advanced, you can bet that tomorrow’s breakdowns are going to be based upon obscure, non-traditional points of failure. Next month, we’ll look at the reasons WHY the constant static artifact occurs, and I’ll provide some tips to help you test for and hopefully minimize this problem for your customers. TED LUCIDI, CBET, Customer Experience and Clinical Insights, Centers of Excellence for Ultrasound and MRI Coil Repair, Radiography, Design and Manufacturing, Innovatus Imaging.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

COME GROW WITH US

Build Your Career at Crothall Healthcare Technology Solutions Career opportunities abound when you are part of a growing Team. Crothall Healthcare Technology Solutions (HTS) has grown 373% in just the last 5 years and an amazing 20 times over in the last 10 years. With growth comes new jobs and new opportunities.

Come see why Crothall has earned Modern Healthcare’s Best Places to Work six years in a row.

ISN’T IT TIME FOR YOU TO FIND OUT MORE? Come grow with us. Please contact: Glenn Garrett Talent Acquisition Recruiter Glenn.garrett@compass-usa.com

CROTHALL.COM

JANUARY 2020

TECHNATION

WE HAVE YOUR HAND SWITCH! AND MANY OTHER PARTS AND SERVICES FOR YOUR PORTABLE X-RAY MACHINE

We are your source for custom “Medical Simulation Solutions.”

We manufacture NIBP, ECG and SpO2 simulator service tools for patient monitoring management. All products are manufactured and serviced in our Connecticut facility with US-made sourced and produced components.

ORDER ONLINE

24/7

At inRayParts.com, you’ll find: • The largest stocking selection of X-ray Hand Switches for Mobiles • Generators & Portables • Large stock of Replacement X-ray Collimator Parts • New Collimare Medical Collimators

Our customers include: • • • •

Medical Device Manufacturers Hospital Biomedical Engineering Departments Independent Service Organizations Military/Government Health Organizations

Service Globally: 203-269-0090 clinicaldynamics.com

info@clinicaldynamics.com

Call: 417-597-4702

Email: sales@inrayparts.com

2020 vision: See savings & uptime with ShroudGuard.

ShroudGuard™ OR Table Pedestal Protector

Prevent expensive repairs and keep OR tables in service. ShroudGuard™ Protects against damage caused by equipment left on table base. table, yet easily removed for cleaning. Sturdy, powder coated 3003 Aluminum.

ShroudGuard™ 60

TECHNATION

JANUARY 2020

www.shroudguard.com

info@shroudguard.com

(800) 261-9953

L11138IA7.5

WWW.1TECHNATION.COM

EXPERT ADVICE

THE IMPORTANCE OF TRADE SHOWS BY JOSEPH E. FISHEL

don’t know about your operation and how you are addressing HTM issues. If you attend a conference or trade show, we may be at a seminar where a topic comes up and find out we are dealing with common issues. You may have some solutions that I want to get more detail on. So, we exchange contact information and I take some notes about what to follow up on. Everyday changes regarding regulations, standards, cyberattacks and more makes trying to keep up with technology difficult.

I attend conferences for many reasons, but primarily it is for information. This information can be in many different categories including imaging, biomedical, cost savings, alternate parts suppliers, alternate service suppliers, batteries, changes in regulations, new products, cybersecurity solutions and the list goes on. Many attend a conference and just sort of drift around to look. I have developed a strategy that seems to work well for me. Most conferences today (such as AAMI, Imaging Conference and Expo, ISE and MD Expo) publish a pre-conference schedule lists seminars and speakers as well as an overview of the material to be covered. It also has a vendor list of who will have demos or a booth in the exhibit hall. Recently, I was looking at companies that provide risk monitoring, vulnerability identification and management as well as mitigation, patching and vulnerability assessment.

Conference attendance is a great way to view and compare vendors. Let’s say vendor A can do X and Y and then you see vendor B can do X, Y and Z. You can go back to vendor A and find out if they can do Z as well. This approach provides a broad view of what is available and who can provide it. At the most recent conference I attended, I had the opportunity to look at many network detection offerings from different companies. All of these companies have been at conferences and are willing to show what their products can do. I sometimes have a list of recent issues and ask if a company’s product or solution can help. Many of us are being hit up with servers that need to be replaced. Quite often we have no clue what devices are talking to the server. With detection tools, you can see what devices are talking to a particular server IP address and the direction of the traffic – inbound, outbound or both ways. It took an eight-person committee working for four days to do what could have been done in less than 5 minutes. Have an issue that is slowing you down? Throw it on the table and ask a vendor what they can do to help? You might get a solution. Before attending a conference, you should look over the classes and make selections prior to arriving. It may change once you get to the conference, but it helps keep you on track. Many conferences offer a free scheduling app so that you can select seminars ahead of time. I like to make a list of issues I am

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

Joseph E. Fishel, CBET, MBA HTM Manager for Sutter Health eQuip Services having whether they be technical or cost savings. Many will ask how they can help and I will throw out some of these issues. It is surprising how many times I actually get an answer on how they can help me with an issue. I also make sure I make a list of vendors I want to talk to or vendors to look for that do certain things. Recently, a friend was at a conference and received an urgent call. He needed to get a nuclear medicine camera de-installed and disposed of in the next five days. Not only did he find someone at the conference who could remove it, but they bought it from the hospital to use for parts instead of having to pay to have it hauled away. It was a win-win situation. My best advice is to bring your problems and issues to a conference. They might get solved or you may get ideas on how to address them. See you at the next conference.

JANUARY 2020

TECHNATION

EXPERT ADVICE