TechNation Magazine - February 2020 by MD Publishing

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Vol. 11

ADVANCING THE BIOMEDICAL / HTM PROFESSIONAL

FEBRUARY 2020

CONNECTIVITY,

IoMT &CYBERSECURITY 30 Ribbon Cutting

Global Med Cables

41 Tools of the Trade Tamper Evident Probe Cover

69 Roman Review

The Magic of Trust

75 Scrapbook

FBS Symposium

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CONTENTS

FEATURED

CONNECTIVITY,

IoMT &CYBERSECURITY

HE ROUNDTABLE: T PATIENT MONITORS TechNation invited several industry leaders to share their insights regarding patient monitors in this roundtable article. A trio of experts accepted the invitation to share information with our readers regarding some new features HTM professionals should be aware of as well as cybersecurity concerns and more. Next month’s Roundtable article: Ultrasound

ONNECTIVITY, IoMT AND CYBERSECURITY C The interconnection of things in a house has come to be known as a smart home. If the Internet connection is broken, or the power is out, the “smart home” becomes a not-so-smart home with many inconveniences. However, those challenges are trivial when compared to what could happen in a hospital if connected devices are compromised by a rogue invader intent on hijacking patient information, interfering with the functioning of medical devices or holding a hospital’s data hostage. The threat of new and more sophisticated cyber attacks has created a seismic shift in prevention, mitigation and device design. Next month’s Feature article: Disaster Preparedness: Lessons Learned and How to Prepare

TechNation (Vol. 11, Issue #2) February 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

FEBRUARY 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 Jennifer Godwin

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

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

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Proud supporters of

P.12 SPOTLIGHT p.12 Department of the Month p.14 Company Showcase: Cynerio p.18 Professional of the Month p.20 Association of the Month P.25 p.25 p.30 p.33 p.34

INDUSTRY UPDATES News and Notes: Updates from the HTM Industry Ribbon Cutting: Global Med Cables AAMI Update ECRI Institute Update

P.37 p.37 p.38 p.41 p.42

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

P.55 EXPERT ADVICE p.55 Career Center p.56 20/20 Imaging Insights sponsored by Innovatus Imaging p.59 Cybersecurity p.60 FDA Update sponsored by Master Medical Equipment p.62 The Future p.64 View on Value p.66 The Other Side p.69 Roman Review P.70 BREAKROOM p.70 Did You Know? p.72 The Vault p.75 Scrapbook: FBS Symposium p.76 Where in the World is Ben C.? p.82 Service Index p.85 Alphabetical Index

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SPOTLIGHT

DEPARTMENT OF THE MONTH The Hoag Memorial Hospital Presbyterian Biomedical Engineering Department BY K RICHARD DOUGLAS

outh of Los Angeles is the southern California coastal city of Newport Beach. The city is known for its beautiful harbor, which is made up of two bodies of water; upper and lower Newport Bay. The upper bay is known for its 10-mile loop trail and the four-mile-long lower Newport Bay is the setting for shops and restaurants.

A little further inland is the city of Irvine. It is located within Orange County, as is Newport Beach, and is home to many global corporations and manicured business parks. Delivering medical care to the residents of Orange County is Hoag Memorial Hospital Presbyterian, a 499-bed hospital that is part of a nonprofit regional health care delivery network. The other Hoag facilities in Orange County include 120-bed Hoag Hospital Irvine and 72-bed Hoag Orthopedics. Providing biomed services to these facilities is a Renovo Solutions team of biomeds headed by Director Bob Meninno. Other members of the administrative staff include Supervisor Theresa Heitchler, CBET; Asset Management Specialist Chris Sanchez and Administrative Assistant Elijah Sipin. Other members include Clinical System Engineers Brandon White and

TECHNATION

FEBRUARY 2020

Alexis Luna as well as Clinical Engineer KC Sanjong. Biomedical engineers at the Newport Beach location include BMET IIIs Hai Tran, Lee Santos and Derrick Velarde. The BMET IIs on the team are Aaron Naraine, Christopher Pike and ultrasound technician Anthony Mekdara. The BMET Is are field service engineer Ryan Garrity, Michael Dempsey, Santiago Guevara and Rainier Solidum. Biomedical engineers at the Irvine location include BMET II Chris Weiho Su and BMET Is Tannaz Hemati and Wayne Cormier. “We also service and manage over 42 smaller offsite clinics, sports centers, women’s health, pediatrics and urgent care facilities,” Heitchler says. “The biomedical engineering department at Hoag owns all medical device service agreements. We are vested with the responsibility for negotiating agreements to make certain they meet Hoag standards. We utilize both ServiceNow and our own CMMS,” Heitchler says. She says that the team is notified 90 days before a contract is set to expire. During that 90-day window they audit the vendor’s previous adherence to the contract, request a new quote, review the terms and conditions and review pricing to see if they need to negotiate further.

The team’s data collection efforts are in the process of employing more synergy and automation. For now, information is carefully gathered and recorded. “Data collection is primarily a manual effort, but we are working on an integration feature between the hospital’s purchasing system and our own CMMS that should help alleviate some of that. When equipment comes in, our biomedical asset specialist will capture the service contract information, warranty dates, etcetera and is retroactively adding it into the asset’s equipment page,” Heitchler says. She says that when technicians are unboxing the equipment, the purchase order from the receiving documents capturing service/operator literature is forwarded to the QA team at the corporate office to be added to the CMMS. They are capturing manufacturer dates, assigning it a control number adding serial numbers, and adding equipment locations under the assigned cost centers. “Like I said, highly manual now but we things are in the works to make this process much more effective and efficient,” she says.

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SPOTLIGHT Opposite Page: Clinical systems engineer Brandon White tests a device. Left: The Hoag Memorial Hospital Presbyterian Biomedical Engineering Department is vital to Orange County. Below: Santiago Guevara work on an IV pump.

ACQUISITIONS, ALARM MANAGEMENT AND OTHER PROJECTS The biomedical engineering team has been involved in several projects lately in addition to its repair and maintenance duties. Among those projects is an aggregator effort. “Biomedical engineering owns device integrations. We are the application owner of our Biomedical Device Integration (BMDI) solution. As the name suggests, it integrates medical devices such as cardiac monitoring, ventilators, pulse oximeter, etcetera and aggregates their data. This is also the pathway to send our secondary alarm notification for the integrated devices to nursing staff via a text/voice platform,” Heitchler says. She says that the platform houses full life cycle of any given alarm event hence the data trends across multiple devices and can be used to create “smart alarms.” The biomed team has also played an important role in clinical alarms management. “Biomedical engineering is one of two business sponsors for the clinical communications and alarm management program. We act as a liaison between the BMDI vendor, medical device manufacturers and the clinical communications team,” Heitchler says. “All supporting equipment acquisitions and integration are supported by our team. The goal of this team is to minimize alarm fatigue and provide actionable alarms utilizing the

The Irvine team includes Tannaz Hemati, Wayne Cormier and Weiho Su. data trends from the source devices to the frontline staff,” she adds. The biomed team also brings its skill set to the capital acquisition process. “Biomedical engineering is actively involved in medical device replacement planning at Hoag and acts as a business sponsor to the biomedical asset management (BAM) program. The program required that workflows were developed/improved to streamline processes between multiple departments involved in sending out RFPs and purchasing the equipment, managing service delivery on the devices during its life cycle, to the decommissioning and disposal of the equipment,” Heitchler says. Heitchler says that the BAM program utilizes various data on the equipment such as capital/non-capital, equipment age, AHA useful life, equipment

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

supportability, mean time between failure and life expectancy to prioritize replacement across multiple years. The biomed team has also solved problems regarding the development of innovative workflows and tweaks to current procedures. “As an organization, we had observed that access to the most recent manufacturer IFUs was not available. We looked at the problem as a larger team including quality, risk, infection prevention, EVS, nursing and biomed. We also recognized that keeping hard copies of these documents or embedding them into policy had the potential for a regulatory ‘gotcha’ moment,” Heitchler says. Heitchler says that to solve the problem, biomedical engineering created a dedicated group email so that members of the team can receive requests as documents that can be used to aid in the creation of policy and competencies. “We request that departmental leaders request the most recent version from us when reviewing their policies so that we can be sure we are complying with the most recent instructions for use. This practice has been relatively simple to manage and is a much-appreciated service we can provide to our clinicians,” she says. The Renovo Solutions biomedical engineering team at Hoag has added to the value of living in Orange County and providing patients with a high standard of care.

FEBRUARY 2020

TECHNATION

SPOTLIGHT

COMPANY SHOWCASE Cynerio

ynerio is a medical-first cybersecurity platform that works directly with healthcare delivery organizations (HDOs) to secure clinical ecosystems so they can focus on what’s most important: patient care. Thanks to connected medical devices, healthcare management and delivery of patient care is easier today than ever. However, despite the advances in automation and convenience these devices afford, lower costs and patient access to selfcare products, Internet of Things’ (IoT) gains in health care expose clinical ecosystems to cyber threats.

Cynerio delivers robust medical device security solutions by working hand-inhand with biomedical engineering, Healthcare Technology Management (HTM), and IT teams at HDOs of any size. We provide a 360-degree view of device inventory, communications, and hospital ecosystems that helps to outline and prioritize each teams’ respective responsibilities. Customers leverage Cynerio’s platform to facilitate the seamless alignment of IT and biomed security goals and structure risk mitigation plans according to their unique business objectives. Customized mitigation plans allow HDOs to establish remediation strategies prioritized according to device criticality and organization-specific impact. Hospitals can then: • Align risk mitigation plans

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FEBRUARY 2020

with business goals • Achieve long-term and scalable threat remediation alongside quick wins • Execute effective segmentation schemes • Operate without service disruption “Biomed teams are integral to the successful enforcement of cybersecurity policies for medical devices at every HDO,” Leon Lerman, CEO and co-founder of Cynerio asserts. “Hospitals can only beat cyber threats with close collaboration between the IT security and biomed teams and by endorsing a healthcare IoT security solution that integrates with your facility’s asset management and workflows.” MEDICAL DEVICE SECURITY Vulnerable medical devices are the weakest link in healthcare IoT security and having a strong medical device

security strategy in place is critical to protecting clinical networks of any size. Many medical devices were – and continue to be – developed without taking security into account and cannot be patched because they run on obsolete operating systems, a pervasive problem device manufacturers are slow to address. Healthcare providers are forced to rely on manufacturers to patch their devices or risk invalidating device warranties. This leaves critical devices and connected networks exposed to cyber threats for long periods of time and has made the healthcare industry a favorite target of cyber criminals who steal: • PHI • Social Security numbers • Financial data • Sensitive personal information Weak device security allows for clinical staff to inadvertently expose the

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SPOTLIGHT

network to threats by connecting to email or browsing the Internet. Furthermore, weak security gives hackers access to medical devices like CT and MRI scanners, pacemakers, insulin and IV pumps, and other automated drug-delivery systems. A single cyber attack can cost a healthcare organization tens of thousands of dollars at minimum. Even more, device-specific attacks interrupt patient care and can cost patients their lives. These conditions make integrating medical device security programs crucial to protecting clinical networks and to safeguarding the delivery of

patient care, but this task gets more difficult by the day. According to Lerman, “implementing organizationwide network policies is the only way to ensure effective risk mitigation, which can dramatically reduce the attack surface.” SECURING VULNERABLE CYBER ENVIRONMENTS WITH CYNERIO Cynerio’s medical-first platform integrates directly and seamlessly with healthcare network infrastructures and streamlines collaboration between biomed and IT security teams. The platform’s intuitive UI includes

interactive visualizations of network topography to provide comprehensive and actionable insights. It lists groups of devices; profiles device-specific functions, vulnerabilities and typical behaviors; flags suspicious behavior on a continuous basis; and provides information on vendor and manufacturer communication with devices. Cynerio’s customers use the platform to view all network activity on the micro and macro levels and act upon it accordingly to: • Configure firewall and NAC policies • Set ACLs • Monitor real-time network events and changes • Enforce segmentation policy CYNERIO: PROTECTING THE ASSETS THAT SUPPORT LIVES HDOs are fighting to keep their patients safe and their networks secure while adapting to a cyber threat landscape that accelerates at the pace of the lifesaving technologies they rely on. Cynerio sees cybersecurity as integral to the delivery of patient care and adapts to hospital-specific ecosystems and organizational infrastructures to achieve remediation without affecting operations. FOR MORE INFORMATION, visit us at https://www.cynerio.com/. At Cynerio, we protect the assets that support lives so you can focus on saving lives. Secure your HDO with the only medical-first IoT cybersecurity solution.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

FEBRUARY 2020

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SPOTLIGHT

PROFESSIONAL OF THE MONTH Tony Cody, CBET, CHTM: Learn from Every Experience BY K. RICHARD DOUGLAS

earning from your mistakes and focusing on ways to grow from them just may lead you to become a clinical engineering director. It’s all in your perspective.

That was the experience of Tony Cody, CBET, CHTM, tech management, ENTECH director in Clinical Engineering at Banner Health in Greeley, Colorado. Cody learned from every experience on his way to leadership. “I was 19 years old and looking at joining the U.S. Air Force. The recruiter pulled out a great big binder of Air Force specialty codes – job titles – and I spent about two hours reading the descriptions. I was drawn to the biomedical equipment repair technician description and the thorough training it entailed. I went to the Military Entrance Processing Station (MEPS) in Oakland, California and I only chose two jobs with BMET being the one I was assigned,” Cody says. The choice to pursue a BMET career started with getting the right training. “I attended the BMET training program at Sheppard AFB, Texas in 1994 after attending 10 weeks of electronics at Lackland AFB. I loved the training and challenge, but the stress was very high. We started with a class of 10 and graduated only five. I may be biased, but I thinks the pre-Tri-force merger training was the best you could receive in HTM,” Cody says.

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FEBRUARY 2020

Tony Cody is proud of his HTM team. His military BMET training led to a career of varied positions and increasing responsibility for Cody. “After serving as a BMET in the U.S. Air Force, I have worked for many different companies and many different jobs. I worked for an independent service organizations (ISO) as a BMET, single-entity hospital as a BMET, field service technician for OEMs as a laboratory specialist, lead tech for a small ISO, senior manager for Banner Health over North Colorado Medical Center (NCMC), and I presently hold the position of TM/ENTECH director over technology management over NCMC and all Banner Health Clinical Engineering East,” Cody says. Those varied position allowed for a lot of specialization and training. “As a technician, I specialized in laboratory and information technology. I earned several IT certifications (A+, N+, MCSE) and two AAMI certifications (CBET, CHTM). As a director, I bring a good understanding of regulatory and developing tools for reporting,” he says.

GROWTH COMES THROUGH EXPERIENCE Some of those varied biomed experiences over the years offered some interesting challenges for Cody. From disaster preparation to HTM leadership in a big organization, he has experienced some noteworthy situations. “In 2005, as a technician for PerkinElmer, I landed in New Orleans and helped secure laboratory equipment at the Department of Health as they braced for Hurricane Katrina. I ended up leaving 12 hours before landfall,” Cody says. He says that Hurricane Katrina made a last-minute turn toward New Orleans, and that earlier, it appeared that Brownsville, Texas was going to be where it would hit. “I checked the previous night and it appeared New Orleans wasn’t in direct danger. I took the earliest flight in from Kansas City, Missouri and I drove in toward the Department of Health Newborn Screening Laboratory with the intention of doing an installation,” he says. “The traffic was extremely light and I arrived on site. That’s when I found out that overnight Katrina made an unexpected turn and it was now a Category 5. (It landed as a Category 3.) After changing my flight plans to leave that afternoon, I helped to safely shutdown equipment, cover all the equipment with plastic and raise all portable equipment off of the floor,” Cody adds. He says that the flooding of Hurricane Katrina was beyond what was predicted.

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SPOTLIGHT

Above left: Tony enjoys being active in the community, including giving out candy at Halloween. Above right: Tony enjoys spending time with his two sons. Below: Rock climbing and hiking are a few of Tony’s hobbies.

“ If you are not where you want to be, then look at your failures and learn from them. Move forward with integrity and discipline.”

“Ultimately, the prep did not prevent the equipment from being damaged. PerkinElmer shipped in all new equipment to Baton Rouge and installed it at a contingency laboratory in Baton Rouge, Louisiana,” Cody says. Cody considers himself fortunate for having great mentors and great people on his team. “As the new clinical engineering senior manager for Banner Health, I took over the management of an HTM shop with little prior leadership experience and a group of technicians with little previous HTM experience. I had to learn on the fly while teaching best practices, developing SOPs and building relationships,” he says. “I had a great group of men and women that had the core values to learn and grow. Within a year, the shop became one of the strongest I have ever

become a part of. I am truly thankful for the mentoring I received in becoming a leader and for the opportunity to grow my team,” Cody says. When not on the job, Cody enjoys hiking, mountain biking, disk golf and vintage audio gear. “To be honest, presently, my time is monopolized by my three-year-old boy,” he says. “I have been married for 16 years to my lovely wife, Katie. We have a 15-year-old, Brendon, and a three-yearold, Ronin,” Cody says. Looking back on his career and experiences, Cody is philosophical about what it all means. “I have not always been a great employee by any stretch of the word. I made so many mistakes and made poor decisions. If there was a way to do something wrong, I probably did it. The good thing is I grew up and learned from my mistakes. It took a heart change and a mind change. The point I have is this: If I can do it then anyone can. If you are not where you want to be, then look at your failures and learn from them. Move forward with integrity and discipline,” he says. From BMET to director, those lessons have paid off.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

FAVORITE BOOK

“The Gilded Chin” by David Duncan

FAVORITE MOVIE

“Young Frankenstein”

FAVORITE FOOD

Burnt ends from Joe’s Kansas City

HIDDEN TALENT

I could be on the single A affiliate of Dude Perfect.

FAVORITE PART OF BEING A BIOMED

“As a technician, I got a lot of satisfaction from fixing a device or system of devices. As an HTM director, I have the opportunity to have a greater impact by ‘fixing’ the system. I get to grow a team to be better technicians and future leaders. I get to help with SOPs and policies that keep us compliant and running smoothly. I get to help the patient have a better experience. I love it!”

WHAT’S ON MY BENCH

• A bank of three monitors • Cup of water • Whatever candy I can steal from other hospital directors • Kansas City Royals bobble heads • Picture of my family

FEBRUARY 2020

TECHNATION

SPOTLIGHT

ASSOCIATION OF THE MONTH

The Baltimore Medical Engineering and Technician Society (BMETS) BY K. RICHARD DOUGLAS

he city of Baltimore sits beside a historic harbor that lies at the head of the Patapsco River estuary. Baltimore is the only city in Maryland not located within a county. It was a ship building center during the Revolutionary War.

Serving the HTM community in this historic area is the Baltimore Medical Engineering and Technician Society (BMETS). The society’s acronym may be one of the most memorable among similar organizations nationwide. The society’s roots go back more than 37 years. BMETS evolved out of a need for a local biomed society. “The Baltimore Medical Engineering and Technician Society (BMETS) held a ‘fact finding’ meeting in September of 1982. The purpose of this meeting was to determine if there was a need/interest for such a group in the Baltimore area,” says BMETS Treasurer Wayne Jenkins, CBET, clinical engineering manager at Carroll Hospital, a LifeBridge Health Center. “There was a large turnout of interested biomeds (directors, managers and technicians) in attendance. The group was the idea of three people: Ethan Hertz from The Johns Hopkins Hospital (later Duke University Medical Center director; now retired); Richard Schrenker from The Johns Hopkins Hospital (later engineer at Mass

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FEBRUARY 2020

On a snowy day, a group of BMETS members boarded a chartered bus to AAMI Headquarters, in Northern Virginia, to tour the facility, and speak about synergy. General); Frank Weinberg (later vice president at MedStar Health; now retired) from South Baltimore General Hospital,” Jenkins says. After the meeting, it was determined that there was a need and interest for such an organization in the Baltimore area. “So, this group of three, along with some others including myself, drafted a set of bylaws and BMETS was formed and met in January of 1983 to present the bylaws and get approval from those who wanted to join,” Jenkins says. He says that once the bylaws were adopted, the group started collecting membership dues. According to the group’s website, one of the bylaws established the group’s founding purpose as: “The purpose of the Society is to

provide a forum to enhance communication between and the technical education of its members.” “Over the years, the membership grew, and today we have a membership of about 135 all over the Maryland area including Northern Virginia and Southern Pennsylvania hospitals,” Jenkins says. BMETS Vice President Michael Milan says that from the time he was nominated for the position in 2016, he decided that his mission would be to select great, centrally located venues, and vendor sponsors that would create events that people really looked forward to attending. “We have seen membership and monthly attendance grow, even drawing members from out of state,” he says.

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SPOTLIGHT

Left: Zoll sponsored meeting, at Blue Hill Tavern, in Canton, Maryland. Center: Monthly meeting, at Heavy Seas Brewery, sponsored by Innovatus Imaging. Right: BMETS current President Chris Endres (Atlantic Biomedical), Past President Chris Jones (Johns Hopkins) and Past President Johns Sears (VA Hospital of Baltimore). “We’ve done our best to draw presenting sponsors that provide educational training, new product information, and sharing of industry news and standards. Every meeting, I enjoy hearing the conversations happening among people working in different health systems, the same health systems, and vendors providing solutions for challenging problems. That is what BMETS was founded to do, to share ideas and solutions within the industry, to advance medical care,” Milan says. He says that the group’s vendor sponsors have always given gracious feedback about how they were able to connect with attendees in a casual setting, and keep their attention in order to deliver their message. “As a salesperson, I know how difficult it can be to have productive conversations, during the middle of a busy work day. The result is that clinical professionals get a better understanding of the products and services offered, by their local vendors. It’s a win-win,” Milan adds. Milan says that another initiative of the current board is to grow the scholarship fund and support the growing need for biomedical professionals in the local and national market. “Our committee has dedicated our support to the local Howard County Community College Biomedical

Technician Program, where our esteemed treasurer, Wayne Jenkins, was one of the first students of the program. We are actively looking into ways to grow our scholarship fund, through matching gifts or endowment solutions, to keep growing the fund for years to come,” Milan says. BMETS provides members with regular training opportunities. “We have educational meetings September through April (excluding December) with an average attendance of 55 to 60 per meeting. The meetings are sponsored by various vendors to present educational material on their product or to introduce new ideas of things to come. We have not hosted an annual conference/symposium. However, in 1986 we did co-host an ASHE conference held in Baltimore, at which we provided some of the classes and teachers,” Jenkins says. BMETS was also an active supporter of MD Expo when it was held in Baltimore this past October. MAKING CONTACTS AND FUNDING THE FUTURE Networking opportunities and encouraging the next generation of biomeds are both on the society’s agenda. “We do have a scholarship fund and have made donations to the AAMI and Howard Community College scholar programs. The group has

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

developed a close relationship with the biomedical program at Howard Community College, with one of the program educators being a member, and we offer free membership to current students enrolled in the biomedical program. We also offer membership to vendors as well as those who work for hospitals/medical centers,” Jenkins says. He says that one important thing that the group does at the monthly meetings is to start the evening with a social/networking time which gives members an opportunity to talk and interact. “This is an important time to gather information and sometimes problem solve on issues we may be having with equipment at work. As a side note, with vendors as members, they see us interact with other techs and this helps keep them ‘honest’ when they come to our hospitals to make a sales pitch,” Jenkins says. “As I’m sure is true of other societies of this type, finding officers is a struggle; that’s why some of us have held office for a number of years and in various positions. I’ve held all the offices a number of times for a total of 25 years,” Jenkins adds. This Baltimore-area biomed group, with the easy-to-remember acronym, is helping strengthen the HTM community in the region for this generation of biomeds and the next.

FEBRUARY 2020

TECHNATION

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INDUSTRY UPDATES

NEWS & NOTES

Updates from the HTM Industry STAFF REPORTS

DIRECTMED PARTS & SERVICE ACQUIRES MEDICAL SYSTEMS TECHNOLOGIES

INNOVATUS IMAGING ENGINEERS NEW REPAIR SOLUTIONS FOR THE PHILIPS X5-1

DirectMed Parts & Service LLC, a medical imaging parts and service company, has acquired Medical Systems Technologies LLC, a specialist in magnetic resonance imaging (MRI) and computed tomography (CT) component-level repair and testing. Based in Longmont, Colorado, Medical Systems Technologies (MST) is a comprehensive service provider for subassemblies, circuit boards and subsystems for medical imaging equipment. Founded and owned by Bruce Smith, an electrical engineer with 40 years of experience in medical imaging, including 16 years with GE Healthcare, the company is a depotlevel repair service provider for health care networks, independent service organizations and diagnostic imaging parts suppliers. Both companies are certified and compliant with ISO 13485:2016, the quality management system that meets the most rigorous regulations for the medical device marketplace. “In our 10 year history of working together, we have trusted MST with our most complex electronic repair requirements,” said Brad de Koning, CEO of DirectMed Parts & Service LLC. “This acquisition accelerates our plan to vertically integrate and control additional key component repair capabilities and quality metrics. DirectMed will rebrand the MST business, operate the company’s facility in Colorado, retain its employees and appoint Bruce Smith as our senior engineer.” “DirectMed Parts & Service is the perfect home for Medical Systems Technologies,” Smith said. “DirectMed has made a concerted effort to insource more of its imaging parts repair capabilities, so MST is a natural fit. My team will greatly benefit from DirectMed’s larger customer base, financial and operating resources, and commitment to supplying parts and services for the most recent technologies. I look forward to supporting the success of our newly combined customer base.” Tanner LoRusso, vice president of sales for DirectMed, added “For MRI, CT and PET/CT systems made by GE, Siemens, Philips and Toshiba, our company now has the ability to perform component-level repairs for these additional high-failure parts: RF and gradient amplifiers, power supplies and support electronics. We have also expanded our 24/7/365 technical support capabilities for our end-customers, the field service engineers and biomedical engineers.” •

Innovatus Imaging’s Ultrasound Center of Excellence has expanded testing and repair capabilities on the Philips X5-1. Due to the technically advanced design of this probe model, failures usually result in high-cost aftermarket exchanges or replacements through the OEM. “We’ve invested significant R&D with this model which has resulted in maximum repair rates for our customers,” says Matt Tomory, vice president of the company’s Ultrasound Center of Excellence. “Our engineers have designed proprietary test fixtures and new methodologies which allow us to isolate and interrogate the various components of the probe and we are currently able to address all repairable components within this model.” Innovatus repairs start at just $500 and are backed by a long warranty period. For customers preferring an exchange model versus repair and return, the company has enhanced its inventory of X5-1’s to provide replacements as well as outright purchases at extremely competitive prices. Innovatus Imaging also offers full repair on over 100 probe models and very significant repair capabilities on over 300 others. •

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

FOR MORE INFORMATION, visit www.innovatusimaging.com.

FEBRUARY 2020

TECHNATION

INDUSTRY UPDATES

PREMIER AWARDS PARTSSOURCE CONTRACT FOR PARTSSOURCE PRO PartsSource has been awarded a group purchasing agreement with Premier for PartsSource Pro, a managed service that provides evidence-based support for clinical engineering. The new agreement allows Premier members, at their discretion, to take advantage of terms pre-negotiated by Premier and join more than 1,000 top-performing hospitals that are already part of the growing PartsSource Pro community. “In the past, we had to go to different vendors to source and order parts. Now, as a PartsSource Pro member, I’m going to one single source, which has created a very streamlined process,” said George Reed, director of clinical engineering, WakeMed Health & Hospitals. “And the technology

has helped us minimize our expenses.” In line with Premier’s goal of improving quality outcomes while safely reducing costs, PartsSource Pro delivers top-quartile performance for clinical engineering organizations. The program simplifies the time-consuming procurement process into a single evidence-based platform that provides visual analytics to identify opportunities for cost and quality improvements, and advanced formulary controls to simplify compliance with enterprise purchasing policies. “PartsSource Pro offers visibility into spend and quality and supports standardization and predictability in the challenging area of purchased services,”

said Phil Settimi, M.D., president and CEO of PartsSource. “Digitizing procurement workflow, adding realtime communication to front-line teams and providing 24/7 concierge support have improved quality, cost and productivity at the more than 1,000 hospitals that have joined the PartsSource Pro community.” Premier is a health care improvement company, uniting an alliance of approximately 4,000 U.S. hospitals and 175,000 other providers to transform health care. With integrated data and analytics, collaboratives, supply chain solutions, and advisory and other services, Premier enables better care and outcomes at a lower cost. •

VENTILATED ENCLOSURES FOR LABORATORY ENVIRONMENTS EnviroMax Vented Enclosures are designed to isolate and contain processes and procedures that may not be able to be accommodated in a typical fume hood, either because of size or accessibility requirements. HEMCO vented enclosures protect personnel form hazardous fumes to ensure a safe working environment. Enclosures can be constructed either unitized or modular depending on whether the unit needs to be disassembled. Access can be on any or all sides with accessories and components installed as required. Lighting, worksurfaces and support tables or cabinets are engineered as part of the system. Enclosures are designed and built to exact size and design specifications. HEPA filtered supply air creating a positive pressure clean workstation is an optional design feature. •

TECHNICAL

PROSPECTS

Experts in Siemens Medical Imaging

TECHNICAL PROSPECTS ADDS CT SCANNERS, MRI SYSTEM TO QA BAY Technical Prospects is expanding its quality assurance bay with the addition of two Siemens CT scanners and its first Siemens MRI system. The new equipment, which includes a Siemens Somatom Scope and a Siemens Somatom Perspective, will be used for training courses and parts testing beginning in quarter one of 2020. “With the new Siemens Scope and Perspective CT scanners and the Siemens MRI system, we are on the leading edge of the third-party market for training and quality assurance,” said Technical Prospects Director of Technical Engineering Kevin

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FEBRUARY 2020

Brinkman. “We are training field engineers in preventive maintenance, troubleshooting and servicing with a hands-on approach that allows them to actually fix the newest equipment available.” The new training courses will cover the major system components that make up the Somatom Family system platform, with students engaging in discussions, lectures and labs centered on the core principles of operation, configuration and repair. • FOR MORE INFORMATION, visit TechnicalProspects.com.

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INDUSTRY UPDATES

TRUMP’S SIGNATURE KILLS MEDICAL DEVICE TAX As part of Fiscal Year 2020 Appropriations Legislation, President Donald Trump signed a bill that repealed the medical device tax. “The government funding bills I just signed into law contain big victories for my Administration and the American people. They enable us to continue to advance our pro-growth, pro-worker, pro-family, America First agenda,” Trump said. Later, he spoke about the medical device tax. “We have now also repealed the Obamacare Medical Device Tax, which threatened access to cutting-edge devices that save lives and enhance the quality of life for all Americans. We also eliminated the Obamacare Cadillac Tax, which would have imposed a 40 percent tax on 1 in 5 employers in 2022, ultimately placing severe financial burdens on employees,” Trump said.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

The Advanced Medical Technology Association (AdvaMed) President and CEO Scott Whitaker was pleased with President Donald Trump’s signing of legislation to repeal the medical device excise tax. “This is a great day for American patients, American jobs, and American innovation: The medical device tax is officially history,” Whitaker said. “With the end of this burdensome tax, the U.S. medtech industry can do what it does better than anyone else in the world: develop life-changing innovations that save and improve patients’ lives, and create high-paying, high-tech jobs to keep the American economy booming.” “We thank President Trump and his administration for their strong support of medical innovation and for their leadership as we worked with Congress to repeal this onerous tax,” he added. •

FEBRUARY 2020

TECHNATION

INDUSTRY UPDATES

UPDATED INTERNATIONAL GUIDANCE FOR REDUCING RISKS OF MEDICAL DEVICES

UNC REX AMONG NATION’S TOP TEACHING HOSPITALS UNC REX Healthcare was named one of the country’s “Top Hospitals for 2019” by the Leapfrog Group, a distinction achieved only by an elite group of hospitals that meet the nation’s highest standards for safety and quality. The Leapfrog Top Hospital award is widely acknowledged as one of the most competitive honors U.S. hospitals can receive. The Top Hospital designation is awarded by The Leapfrog Group, a national watchdog organization of employers and other purchasers focused on health care safety and quality. About 2,100 hospitals were considered for the Leapfrog Top Hospital award. A total of 120 hospitals were selected as Top Hospitals. UNC REX was recognized as one of 55 Top Teaching Hospitals across the country. UNC REX has evolved from a community hospital serving mostly Raleigh and surrounding communities into a top regional medical center providing specialized care for patients from across Eastern North Carolina. UNC REX’s education initiatives include cardiology, vascular and urogynecology fellows; medical students who work with the Hospitalist team; and students studying nursing, pharmacy, radiology, EMT and more. “UNC REX is honored to be recognized by Leapfrog as one of the nation’s top hospitals,” said Ernie Bovio, president of UNC REX. “I’m proud of our co-workers and physicians for providing excellent care for our patients and their families and helping to train the next generation of clinical providers.” The Top Hospital Award follows the news last month that UNC REX is the only hospital in North Carolina – and one of only 36 hospitals nationwide – to receive straight A’s since Leapfrog began grading hospitals for safety in 2012. Performance across many areas of hospital care is considered in establishing the qualifications for the Top Hospital award, including infection rates, practices for safer surgery, maternity care, and the hospital’s capacity to prevent medication errors. The rigorous standards are defined in each year’s Top Hospital Methodology. “We are pleased to recognize UNC REX as a 2019 Leapfrog Top Hospital,” said Leah Binder, president and CEO of The Leapfrog Group. “This demonstrates extraordinary dedication to patients and to the North Carolina community. We congratulate the board, staff and clinicians whose efforts made this honor possible and know they share pride in this achievement.” To qualify for the Top Hospitals distinction, hospitals must rank top among peers in the 2019 Leapfrog Hospital Survey, which assesses hospital performance on the highest known standards for quality and patient safety, and achieve top performance in its category. •

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FEBRUARY 2020

Virtually no medical procedure is without risk, but there are many ways to minimize it. One such way is through applying sound risk management processes to medical devices. The International Standard to do just that has now been updated. The newly revised International Standard will improve safety of medical devices. ISO 14971, Medical devices – Application of risk management to medical devices, specifies the terminology, principles and process for managing the risks associated with medical devices, including software as a medical device (SaMD) and in vitro diagnostic (IVD) medical products. Primarily intended for medical device manufacturers, the ISO standard promotes the safety of devices and equipment used for medical purposes. It covers the risks of injury related to the health of patients, the operator and other persons, as well as potential damage to property, equipment and the environment. The standard was updated to better align with changes in medical device regulations around the world. The ISO 14971 revision was aimed at clarifying the standard’s technical requirements by including more detailed information on the steps manufacturers must take to meet those requirements. It also includes new and updated terminology to reflect the current market needs. The guidance has been moved to the standard’s accompanying technical report ISO/TR 24971, Medical devices – Guidance on the application of ISO 14971, which was revised in parallel. Peter Linders, chair of the ISO technical committee that developed the documents, said it is a manufacturer’s responsibility to reduce the risks of medical devices. “ISO 14971 helps manufacturers to identify the hazards and estimate the risks associated with a medical device, enabling them to control those risks and monitor the effectiveness of the controls they put in place,” Linders said. ISO 14971 was developed jointly by technical committees ISO/TC 210, Quality management and corresponding general aspects for medical devices, and IEC/TC 62, Electrical equipment in medical practice, of the International Electrotechnical Commission (IEC), with the active involvement of many regulators from around the world. It can be purchased from a national ISO member or through the ISO store.

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INDUSTRY UPDATES

RIBBON CUTTING Global Med

extraordinary customer service policy. We cannot give you the secret sauce ingredients, but I can tell you “customer service is always king.” Client liaison representatives and outreach endeavor opportunities are other services we offer.

Cables

BY ERIN REGISTER AND PENNY JOHNSON

he concept of Global Med Cables, Inc. (GMC) came from a simple “napkin plan” based on patient safety, a passion for the medical industry and the realization that everyone is trying to lower costs in health care. “I have been a part of this industry for as long as I can remember,” stated Global Med Cables CEO and Founder Byron Webster. “It has been the sole provider for myself and family my entire life. Therefore, it was a natural progression to expound on this recurring vision to be in service and to do my part, which became the premise of our mission: We are dedicated to patient safety as we help lower the cost of health care one cable at a time.”

Early in his career, Webster was the co-founder of Professional Defense Specialists, Inc., servicing major employer insurance companies in Southern California. He credits his mentor, Dorothy Livingston, with encouraging a strong work ethic. TechNation learned more about Global Med Cables in a question-and-answer session. Q: WHAT IS THE MAIN FOCUS OF GLOBAL MED CABLES? A: Global Medical Cables (GMC) is our boutique corporation that officially launched January 2020. Essentially, we provide the fundamental requirements of all global health care solutions: cables and sensors. We bring to bear all of our lessons learned to every customer and associate we work with, ensuring our clients and partners that the GMC brand is built on a foundation of expertise, great customer service and the best quality products in the marketplace to ensure the patient’s safety. I personally recruited every skillfully trained

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FEBRUARY 2020

Byron Webster CEO/Founder professional on the GMC team, and I have had a successful business relationship with many of them over the years. When I was in sales, we would practice a “win-win” philosophy. Without these extremely knowledgeable individuals, none of this is possible. Our GMC team includes Dr. Robert Gruner, Leonardo Carlito, Dario Veron, Roderick Bell II, Penny Johnson, Gina Massenzo and Scott Thompson. Another focus of GMC is our online shopping network, globalmedcables.com, which is solely for contracted clients. We do not sell to the public. We work exclusively with purchasing entities, such as hospitals, IDNs, surgery centers, clinical technology management companies and outpatient and long-term care facilities. We also offer our members free support with our client liaison representatives. With such an extensive catalog of products, we would like our clients to think of us as the “go-to” for all things cable and sensor or an encyclopedia of cables and sensors. The biggest difference is our clients order and save. Q: WHAT ARE SOME SERVICES GLOBAL MED CABLES OFFERS? A: We have the highest quality OEM, ISO and FDA certified compatible cables below market price. An estimated 3,000 product items covering all name brands are ready to ship to 90 countries. We have also implemented an

Q: HOW DOES GLOBAL MED CABLES STAND OUT IN THE MEDICAL EQUIPMENT FIELD? A: Our testing methods are one thing that stands out. FDA certifications with the vendor are performed. Each individual cable is tested before being shipped, and afterwards, our in-house quality control process is performed with each order. I personally monitor the final testing process. Additionally, we have extremely favorable discounts, including up to 30% off savings depending on the length of your contract with GMC. Any of the aforementioned services are uniquely tailored to this industry. I am a people’s person, so patient safety and the quality of service is at the top of my list. That applies to the treatment of not only our clients, but also our employees, partners, vendors and all those who we come in contact with. Q: DO YOU HAVE ANY SPECIFIC GOALS THAT YOU WANT GLOBAL MED CABLES TO ACHIEVE IN THE NEAR FUTURE? A: We want to expand on the current platform GMC has developed, implement innovative products and technology. We would like to ultimately advance the heath care industry as we consistently work on new cost-effective approaches which benefit our clients and their patients. We have one simple goal to attain: sustainability. We would like to make a difference and still be here in the decades to come! FOR MORE INFORMATION, visit Globalmedcables.com

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SUPPORT SOLUTIONS CONTRAST INJECTOR SERVICE TRAINING, WHERE AND WHEN YOU NEED IT Servicing injectors is more than preventive maintenance. Now, with the talents of InTraServ on the Althea US team, we provide extensive, hands-on training on troubleshooting and repairs. • On-site training available • Group discounts available • Most popular models of injector training • Short notice requests are usually acommodated p: (888) 652-5974 e: us.sales@althea-group.com

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FEBRUARY 2020

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INDUSTRY UPDATES

AAMI UPDATE BY AAMI

AAMI TO OFFER CBET REVIEW COURSE IN APRIL AAMI will again offer its popular review course to help biomedical equipment technicians (BMETs) prepare for the Certified Biomedical Equipment Technician (CBET) certification exam. The eight session CBET Study Course that will be held every Monday and Wednesday evening, 7-9:00 p.m. starting Monday, April 6 and ending Wednesday, April 29. All sessions are recorded, so you can begin the study course at any time up until the end date. These intensive online sessions cover each area of the CBET exam outline, including anatomy and physiology, public safety in the healthcare facility, fundamentals of electricity and electronics, healthcare technology and function, healthcare technology problem solving, and healthcare information technology. FOR MORE INFORMATION and to register, visit www.aami.org/Certification.

AAMI EXCHANGE 2020 Registration is now open for the premier global health technology event, AAMI Exchange 2020, taking place in historic New Orleans, LA, June 12-15. The AAMI Exchange provides a forum for broad conversations among these stakeholders on the ever-changing industry of medical technology. AAMI Exchange 2020 will feature: • More than 80 education sessions • More than 200 industry-leading brands and exhibitors • More than 130 world-class speakers and industry experts • Networking with more than 2,500 health technology and sterilization professionals • Up to 15 ACI continuing education units (CEUs) FOR MORE INFORMATION and to register, visit www.AAMIExchange.org.

RECRUITING THE NEXT GENERATION WITH ‘HTM IN A BOX’ With fewer qualified candidates in the hiring pool and an aging workforce, recruiting new healthcare technology management (HTM) professionals is more important than ever. To make promoting HTM easier, AAMI created “HTM in a Box,” a free online presentation to inform students and the public about career opportunities in HTM. “HTM in a Box” contains three presentation modules that are tailored to specific age groups: middle school, high school and adults. “It’s important to get the word out because we need to increase the HTM personnel pipeline. “HTM in a Box” helps users do that by giving them a resource with a standard and strong message about the field,” said Danielle McGeary, vice president of HTM at AAMI, who spearheaded the project with the Technology Management Council and demonstrated the resource at HTM events around the country. In addition to the presentation modules, the “HTM in a Box” webpage has links to other free resources that make it easier to promote HTM careers. These include: • A list of HTM academic programs in the U.S. by state. • A printable HTM career brochure. • A document with tips and sample text for contacting schools. • An orientation video for using “HTM in a Box.” YOU CAN DOWNLOAD “HTM in a Box” and several other resources at www.aami.org/HTMinaBox.

HITTING THE ROAD FOR HTM AAMI staff members traveled to several cities and states in 2019 to meet with healthcare technology management (HTM) professionals and spread the word about careers in HTM. Their visits included state HTM association meetings from Massachusetts to Florida, as well as

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

youth leadership and professional conferences, such as a Girl Scout gathering in Bedford, NH, and the MD Expo in Houston, TX, and Baltimore, MD. SEE THE FULL MAP at www.aami.org/HTM_Map.

REGISTRATION OPENS FOR 2020 INTERNATIONAL STANDARDS CONFERENCE The AAMI/FDA/BSI International Conference on Medical Device Standards and Regulation (and associated meetings and symposia) will be held the week of April 20, 2020 at the AAMI Center for Excellence and Westin Arlington Gateway Hotel. This year’s conference program will focus on the health technology lifecycle and delivering better patient outcomes. FOR MORE INFORMATION and to register, visit www.aami.org/ISC.

HOW TO GET STARTED WITH AN HTM COMPLIANCE PROGRAM So, you want to develop a compliance program for your HTM department. But where do you start? Technology Management Council Member and ACCE President Elect Priyanka Upendra is offering a free “starter kit,” as she explained in a recent post on the AAMIBlog (https:// bit.ly/392pKVo). AAMI’S HTM LIVE! WEBINAR SERIES AAMI has launched a new, webinar series just for healthcare technology management professionals, called HTM Live! This series of free webinars connects HTM professionals from around the world with experts who will discuss many of the biggest issues facing the profession, from medical device cybersecurity to reducing alarm fatigue. FOR MORE INFORMATION, visit www.aami.org/events for these webinars and other upcoming events from AAMI.

FEBRUARY 2020

TECHNATION

INDUSTRY UPDATES

ECRI UPDATE

Hazardous Drug Handling: A look at closed-system transfer devices

losed-system transfer devices (CSTDs) are adapters that connect two medication vessels – syringes, vials or IV bags – to allow hazardous drugs (HDs) to be transferred between the vessels without leakage. The devices are intended to minimize personnel environmental exposure to HDs from the time the drugs are compounded in the pharmacy to the time they are administered to the patient.

The need to use CSTDs is detailed in a newly implemented United States Pharmacopoeia (USP) standard, USP General Chapter <800>. To help when comparing available products, the National Institute for Occupational Safety and Health (NIOSH) has spearheaded efforts to develop a test protocol that can be used to assess CSTD performance. To date, however, stakeholders have been unable to agree upon a fully satisfactory methodology. (See www.cdc.gov/niosh/topics/ hazdrug/CSTD.html.) With such uncertainty surrounding CSTD selection and use, how can health care facilities make wise purchasing decisions? ECRI Institute has been examining CSTD models in its lab to help find some answers. THE DANGERS POSED BY HAZARDOUS DRUGS Some drugs that are used in health care – such as those used for cancer therapy, some antiviral drugs, hormone agents, or bioengineered drugs – are toxic or

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FEBRUARY 2020

otherwise harmful by nature and must be handled in a way that minimizes exposure by health care workers involved in their preparation and administration. NIOSH notes that workplace exposures can lead to acute as well as chronic health effects, from skin rashes, to infertility or other adverse reproductive outcomes, to the development of leukemia or other cancers. (See www.cdc.gov/niosh/topics/ hazdrug/.) The agency estimates that 8 million U.S. health care workers are potentially exposed to HDs. In addition to pharmacy and nursing personnel, those at risk of exposure include veterinary care workers, environmental services workers and shipping and receiving personnel. Protecting workers from such exposures requires the use of protective equipment and a combination of administrative and engineering controls. CSTDs are a supplemental engineering control that can be used to provide some protection, but they should not be the only means used. CSTD FORM AND FUNCTION A CSTD system comprises a manufacturer-specific set of male and female adapters, which enable fluid transfer between, for example, a drug vial and a syringe or a syringe and an IV bag in a closed manner—that is, without leakage or vapor escape. CSTD adapters remain closed until connected together. A connection of male and female adapters opens a pathway enabling access for liquid transfer.

A pathway is established using either of two approaches: • Needle-based systems: A needle protected inside the adapter punctures a septum upon connection to open a pathway; the needle then retracts upon disconnection. • Needle-free systems: The membranes within each CSTD component are opened when the adapter connection is complete. One important consideration when transferring fluid between different containers is that pressure equalization will need to occur; and during equalization, drug vapors that may be present in the drug vial will need to be released. Because the drug is hazardous, those vapors need to be contained. Two technologies for preventing vapor escape are dominant: • Barrier technology: Pressue is equalized using a balloon air reservoir in the vial adapter that is intended to contain all resulting HD vapor. • Filter technology: Pressure is equalized using a filter in the vial adapter that is intended to capture all resulting HD vapor. For pharmacy compounding, a CSTD may be used as follows: A CSTD vial adapter is connected to a drug vial. The vial adapter is accessed using a syringe with a compatible CSTD syringe adapter attached. Required transfers are conducted (e.g., reconstitution, drawing of drug). The drug is injected into a final container or, alternatively, held in the syringe if that is the final container.

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IV bags or other fluid containers are accessed with appropriate adapters (e.g., IV bag adapter). The final container is labeled and sent to the care unit with CSTD adapters attached that enable administration to a patient. For drug administration: The HD is received in a clinical area in a syringe or IV bag or other final container with CSTD adapters that enable connection to a patient administration line. A clinician administers the HD via an infusion pump, by gravity or by manual push by connecting it to the patient administration line with appropriate CSTD administration set adapters. Some types of CSTDs may require separate administration set adapters to be added by the clinician, while others connect directly to a needle-free connector. SELECTION CONSIDERATIONS Unresolved questions surrounding the testing of device effectiveness is a significant challenge, admits Juuso Leinonen, senior project engineer in ECRI Institute’s Health Devices Group. “But even so, there are factors that facilities can consider when assessing products for purchase.” Following are five key considerations that ECRI Institute has identified: 1. Leakage and vapor containment. Any leakage of medication from a CSTD is a cause for concern, as it could lead to HD exposures. Vapor containment and/or reduction in environmental HD exposure is likewise an important factor –

though it is more difficult to assess. Objective product comparisons in this regard are hampered by the current lack of agreement about what constitutes an appropriate test methodology. The availability of published peer-reviewed clinical studies that assess a device’s performance in this area are thus desirable. 2. Usability/ease of use. Devices that are difficult to use – or difficult to use correctly – offer less reliable protection. Mistakes in use or, worse, decisions not to use the device at all increase the risk of HD exposures. ECRI Institute conducts significant ease-of-use testing during its product evaluations to identify potential issues. The organization has observed that opinions about a product often differ depending on the user’s role: that is, some devices favored by clinicians were not well regarded by pharmacists and vice versa. 3. Number and types of components. The use of CSTDs could require stocking dozens of different components to meet the needs of expected use cases. Additional factors that warrant consideration include: the availability of components for specific applications (e.g., for use with various vial sizes); the number of components and the amount of assembly required for specific applications; and the impact that the component mix will have on workflow.

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4. Preventing incorrect disconnections. During use, CSTD components need to remain firmly connected to protect the clinician and other personnel from HD exposure. Incorrect disconnection—for example, disconnecting components from the wrong connection point—could compromise the closed system. Features such as binding adapters or fused adapters, which aid in preventing such accidental disconnections or component removal, are thus beneficial. Similarly, the incomplete connection of components could result in accidental environmental exposure of the HD or result in a delay in therapy. Thus, features that help users identify a complete connection are desirable. 5. Cost. As an add-on technology, CSTDs represent an added cost that must be budgeted for. This article is adapted from ECRI Institute’s “Evaluation Background: Closed-System Transfer Devices” (Health Devices 2019 Nov 20). The complete article – including model-specific test results and product ratings, along with additional guidance for purchasing and using CSTDs – 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.

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BIOMED 101

A Guide to Surviving Your First Year as a Clinical Engineer BY CONNOR WALSH

hen looking at the big picture in the world of clinical engineering, it is very overwhelming to think about the extensive work involved in maintaining a hospitalâ&#x20AC;&#x2122;s entire inventory of medical equipment and technology. However, with the right mindset from the get-go, it is very possible to grasp and manage this process over time.

The most important resources that you have as a clinical engineer are your technicians. They are the experts on the equipment and how it operates. It is imperative that you spend time early on building a relationship with them. They are the foundation of any successful clinical engineering department, and ensuring that they receive adequate training goes a long way. Communicate with them, see what concerns or issues they have and create an understanding that they are able to come to you for anything that they may need. Without them, a department cannot function, and showing them respect and generating a healthy working environment facilitates growth within. Clinical engineering is unique in the fact that many college courses cannot teach you everything you must know to be successful, and grasping this knowledge early in your career is

extremely important. Medical devices are continually evolving, and what was once a standalone unit is now an integrated medical system with our hospital medical record. As a result, we as clinical engineers are absorbing more IT responsibilities, and the knowledge of how these types of systems work can go a long way. Use the first year to dive into conferences or training that will help you better understand this side of clinical engineering. Whether itâ&#x20AC;&#x2122;s a CompTIA certification, a PACS administration course or any of the many other options, understanding a basic knowledge of IT/clinical devices is an excellent idea to pursue in your first year. Within my first year of clinical engineering at the Veterans Affairs (VA), I have been able to see the tremendous benefits that can come with personal networking. There is no need to re-create the wheel. Reach out to other clinical engineers when you are trying to implement a new process in your facility to see if there might be a similar idea already in place. In addition to the other 151 clinical engineering departments in the VA that we can contact, we have developed a relationship with the clinical engineering staff at the private hospital located near us and also have affiliate agreements in place with local colleges

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

Connor Walsh U.S. Department of Veterans Affairs

to provide additional opportunities for co-ops, interns and volunteers. Step out of your comfort zone and think outside the box at how and to whom you can develop a connection with. The resources that can be gained by networking with individuals in your field can be very beneficial. It is important to set the groundwork for these relationships in your first year. Clinical engineering is an exciting, growing field and the opportunities that lie within are vast. Starting your career down the right path can shape the kind of experiences you face, making sure to take advantage of these opportunities early on is essential. Build a relationship with your technicians, pursue various training options and build a network of clinical engineers that you can rely on to help ensure the success of your department. Utilize your first year to its full potential and never lose the ambitious trait that all clinical engineers should have. CONNOR WALSH is a supervisory biomedical engineer at U.S. Department of Veterans Affairs.

FEBRUARY 2020

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Webinar Series Reaches New Highs STAFF REPORT

he 2019 Webinar Wednesday Series ended on December 18 with 11,687 registrations for the year and an average of 216 attendees per webinar. These are among the new highs and records achieved during 2019.

Vizzia Technologies sponsored the final webinar of 2019 and 260 people registered for the presentation. Participation in the presentation was eligible for 1 CE credit from the ACI. In the special C-level industry panel, professionals from Vizzia Technologies and Cooper Lighting Solutions discussed a new Internet of Things (IoT) connected platform. Trellix is an advanced real-time location system (RTLS) which empowers “smart hospitals.” The live discussion and audience Q&A was moderated by Dave Wiedman, Vizzia CCO. Topics covered included advances in location-based IoT by Cooper CTO Parth Joshi as well as the Trellix connected IoT platform by Eric Jerger, Cooper vice president and general manager. Vizzia CEO Andy Halasz discussed asset management and patient flow. Along with positive reviews, attendees answered the question “How much new information did you receive from today’s webinar?” “Good presentation, mentioned obstacles and recent improvements, keeps getting better with tech inventions, thank you,” said M. Wujek, senior biomed.

TECHNATION

FEBRUARY 2020

“ Well, I was expecting ultrasound basics, but didn’t expect such a deep dive into the physics and construction. That was awesome.” D. MINKE, BIOMED “This presentation made things more understandable from a different perspective,” said L. Santos, BMET III. “Valuable info for our hospital. I gained insight into the systems and actually learned a lot more than I expected. Good job. Always something of value in each webinar I can attend. Thank you for keeping me rounded out and up to date,” said T. Johnson, CBET III. “Very interesting they are using lighting for RTLS – great idea and saves on batteries,” said D. Braeutigam, president/consultant. ULTRASOUND BASICS The “Basics of Diagnostic Ultrasound Imaging” webinar sponsored by Philips was eligible for 1 credit from the ACI. The 60-minute webinar featured a panel of Philips experts including Stone Dupree, ultrasound technical trainer and developer; Mark Potts, senior service product manager, ultrasound; Terri Richardson, senior global product manager; and Jim Moran, North America service product manager, ultrasound. The team discussed the principles of diagnostic ultrasound, how to identify basic types of transducers as well as understanding different types of applications and different modes that

are typically used. The webinar drew 179 people for the live presentation and more have viewed a recording of the session online. Attendees gave the webinar high marks in a post-webinar survey. They were also asked “How well did the content that was delivered match what you were promised when you registered?” “Very good overview of ultrasound. I enjoyed learning the theory behind the technology,” Biomed T. McKinney said. “This was a very good presentation of the fundamental technology of ultrasound,” shared Field Service Engineer D. Banister. “It was more detailed than I expected, which was great. I expected it to just cover a few basic things, but it went into a lot of details. I knew some of the details, but they explained things very well, and I learned a lot,” said O. Stephen, biomedical technologist. “Great content, lots of in-depth information,” said T. Beute, service technician. “Well, I was expecting ultrasound basics, but didn’t expect such a deep dive into the physics and construction. That was awesome,” Biomed D. Minke said. “One of the best webinars I have attended, really helpful information to

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understand the basics of ultrasound,” said L. Quinonez, BMET I. “It was an overload ... in a good way. Very informative and the presentation inspired me to look into the Philips classes they offer. [I] didn’t know about them until today. And if all the classes are this informative, one can walk away with much information,” shared Biomed II J. Clark. FUTURE OF TEST EQUIPMENT More than 200 people logged in for a live presentation sponsored by Pronk Technologies. The session “Preventive Maintenance: Wireless Test Equipment Connectivity to CMMS with Automated Electronic Records is Possible!” was eligible for 1 credit from the ACI. The 60-minute webinar featured Technologies Regional Sales Director Julio Castro. Healthcare Technology Management professionals from around the world heard him discuss a new technology available to instantly transfer a CMMS PM checklists/ procedures and work orders to a mobile device, scan or enter asset ID and run equipment checklists, plus work on-the-go and transfer completed records back to a CMMS daily or weekly. The webinar received positive feedback via a post-webinar survey. “Great test equipment, love the way they incorporate the practical process for the technicians,” System Director M. Philpott said. “Very informative and explained the topic and ways to use it in a way that

wasn’t complicated to understand,” Biomed A. Stetzer said. “Wonderful presentation and very informative as well,” said W. Doctor, clinical engineering technician. “Informative on how test equipment can be integrated with CMMS,” said C. Robinson, BMET II. “It was interesting to see the future of test equipment and what it can lead to,” said J. Carter, BMET II. MEDICAL EQUIPMENT ADVISORY NOTICES The Webinar Wednesday presentation “Medical Equipment Advisory Notices – Impacts and Best Practices” drew 171 attendees. The webinar was sponsored by Universal Medical and attendees were eligible to receive 1 credit from the ACI. In the presentation, Craig Snodgrass, from Universal Medical discussed medical equipment advisory notices. He shared definitions and terminology as well as examples of advisory notices and potential problems. Attendees learned what to do when they receive an advisory notice and what to do if a department is down due to an advisory notice. The webinar also explored: • After notice support and fix • Finalization of advisory notice • How a quality service provider can help • HTM’s role in advisory notices The webinar received positive reviews and comments in a postwebinar survey. “It was a good review on the basics and what they mean. Recalls from equipment manufacturers, how to

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handle them,” Biomedical Technician C. Aron said. “It was a good reminder of what should be done when you receive an alert/recall,” Biomedical Manager T. Forsch said. “The information was valuable because so many medical device alerts often get put aside, not intentionally, but they do take time to follow through with. Sometimes the alerts get put aside or even forgotten about. It is critical that all medical device alerts have a follow through flow process,” said B. Hayes, CBET. “I wish this webinar had been available 12 years ago – useful info for someone who has just been given responsibility for recalls and alerts,” said P. Phillipps, biomedical manager. “Good information from the OEM and customer viewpoint,” said J. Thielen, clinical engineer. THE WEBINAR WEDNESDAY SERIES continues in 2020. Find a list of upcoming webinars and recordings of previous webinars online at WebinarWednesday.Live.

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SHOP TALK POWERED BY

GE HEALTHCARE – VIVID 7

My Vivid 7 has a Windows error at startup saying Windows could not start because the following file is missing or corrupt: WINDOWS\SYSTEM32\CONFIG\SYSTEM PLZ HELPOUT. Any expert brother advise needed.

Many times the software is in a sleeve on the left side of the unit under the big plastic cover. Just need to pop it off and look either inside the plastic panel of the computer (BEP). Hopefully you have a copy or it is written somewhere, your license option string. You can probably get away with reloading the C partition since you have a Windows error, but I believe you will still need this string.

Try running chkdsk on all partitions. Try running chkdsk on all partitions.

1. Boot into Windows (if you have a service key. If not, it’s a SW load) 2. Open CMD prompt 3. Type chkdsk /f c: 4. Type y then Enter to the question about scheduling for next boot 5. Type chkdsk /f d: 6. Type n then Enter to the question about force dismount 7. Type y then Enter to question about scheduling for next boot

8. Type chkdsk /f e: 9. and 10. Repeat steps 6 and 7 Exit command prompt remove service key and reboot. Don’t touch any keys during the chkdsk process. The system may reboot several times before booting normally.

As previously said, the software installation disks are often stored inside the system. Remove the left side plastic cover by turning the large screws a quarter turn so that the slot is horizontal and then pulling out on the front left corner. That exposes the Back End Processor with a disk sleeve attached to the BEP cover. You need 2 disks, one for the Base installation and one for the Applications software. If you have a picture of the About screen or know what version of software your Vivid 7 has, check the disks to see if they are the correct ones. The software with the system may not match what is installed if upgrades or updates have been done. When reinstalling software the Option Key(s) will usually restore automatically. If not, you will need to enter the Option Key after installing software in order to get the system to function as an ultrasound system. Sometimes a record of the SW Option Key(s) such as a printout of the System Admin page is inside the disk sleeve, or it may be on a label attached to the Back End Processor frame. Be sure to run the DC Offset Calibration after installing software.

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.

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ROUNDTABLE

ROUNDTABLE Patient Monitors

echNation invited several industry leaders to share their insights regarding patient monitors in this roundtable article. A trio of experts accepted the invitation to share information with our readers regarding some new features HTM professionals should be aware of as well as cybersecurity concerns and more.

Participating are ReNew Biomedical’s Biomed Director Neil Davidson, Medical Equipment Doctor CEO Albert Negron and Southwestern Biomedical Electronics Vice President Larry Neilson. Q: WHAT ARE SOME NEW FEATURES BIOMEDS SHOULD SEEK OUT WHEN A FACILITY PURCHASES PATIENT MONITORS? DAVIDSON: Data transmission is important on any new piece of equipment. Assuring that the unit’s software is compatible to EMRs is

Neil Davidson ReNew Biomedical

always pertinent when preparing for a change. New technology displays are featuring useful reporting capabilities for service technicians. Ask for a sample of the reporting technology. These “smart” units have the ability to tell you what is wrong and where to look first. Both are helpful when the units are

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

desperately needed and you are in a time crunch. Plug and play technology makes any unit easy to use so look for that. Remember to ask questions such as: Is it easy to do software updates on the units? Is it configurable to meet the needs of the medical practice? Does it have a battery backup and what is the lifespan of the battery? (Be aware that touch screen technology may bleed the lifespan of battery backup.) Touch screen versus button technology may present different challenges too. Is there a simple preventative maintenance plan for the unit or does the unit need a OEM-certified technician to do the work? NEGRON: Integration ease with hospital electronic health records, ease of calibration and clear cyber protection plans. We are currently in an integration environment which allows departments to function more effectively. A product that can deliver more health information into the patient’s medical record would

FEBRUARY 2020

TECHNATION

ROUNDTABLE

be ideal for the access and patient flow within a health care organization. Non-invasive blood pressure calibration during preventive maintenance on certain monitors is not an easy process and biomeds should have a clear procedure to get it completed. A clear cyber protection plan that is innovative and developed for future vulnerability mitigation is another feature that should be considered. Patch management, configuration management and virus protection should be detailed and put into a plan by the manufacturer to reduce the cyber risk. NEILSON: In a perfect world, a facility would replace all patient monitoring from ER to all critical care areas at the same time, but that doesn’t usually happen. Look for compatibility with what other areas are using. Look for improved patient vitals that are not on previously owned equipment and if these features are needed in every area to be populated with new equipment. Make sure to purchase equipment that can use currently stocked accessories as this can be an unforeseen headache if not considered early. Today there are more choices in pulse oximetry, meaning different OEMs can be installed in newly purchased equipment. Nellcor and Masimo are two that come to mind for oximetry and are available in most manufacturers. Q: WHAT MEASURES SHOULD BE TAKEN CONCERNING CYBERSECURITY? DAVIDSON: Nothing could be more underrated than the importance of cultivating a good working relationship with the IT department. Having an open line of communication with the OEM service department will also go a

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FEBRUARY 2020

addressed by the facility’s IT specialists in-house or otherwise. Q: HOW CAN BIOMEDS HELP EXTEND USEFULNESS OF AN OLDER PATIENT MONITOR?

Albert Negron Medical Equipment Doctor

long way to resolve issues fast. Most newer models have software that requires updating periodically. It’s important to follow through on those updates because most manufacturers are offering solutions before problems occur. NEGRON: Cybersecurity is like predicting the future and being innovative enough to anticipate future vulnerabilities. Developing a product that has reduced remote access to limit vulnerabilities or a product that can be networked to include intrusion protections. Patch management and clear instructions on what needs to be done as operating system updates are released. Education to the risks should be provided and MSD2 forms should be reviewed during the incoming inspections. A cybersecurity plan should be developed for each network-capable device and tracking of cyber protection activities should be documented. NEILSON: Cybersecurity is a serious consideration and will need to be

DAVIDSON: Yearly cleanings of the internal and external components of your units will certainly extend the life. Replacing the coin cells and batteries on a yearly basis or sooner will ensure that there is no unexpected down time. Make sure that your biomed staff has access to all of the product manuals and each book is open to assist when necessary. NEGRON: Resource management and establishing relationships with parts/ service vendors that can supply the refurbished parts needed for continual service is key. Knowing the difference between “end of life” and “end of service life” is also an important aspect of extending the usefulness of a patient monitor. Providing assessments on an annual basis that consists of contacting vendors and getting par levels on parts that are high volume replacements. NEILSON: A regular maintenance schedule is the best way to extend the life of most monitors. If equipped with a cooling fan, that will need to be replaced as will any display using CCFL back lighting, and usually only the light bar. If kept clean and maintained, monitoring can run for years. In many opinions, too long as parts will eventually become an issue. Q: WITH SYSTEMS TRANSITIONING, HOW CAN BIOMEDS ENSURE THAT MONITORS ARE COMPATIBLE? DAVIDSON: Never underestimate the value

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ROUNDTABLE

of research. Many OEM sales technicians can answer your questions before you sacrifice your budget on a unit that is not compatible with your EMR or other medical devices. NEGRON: Standardization of medical device manufacturers is always the proper approach for integration and compatibility. It also ensures that the clinical staff remains educated and it reduces the risk of errors. It’s also important for biomeds to know the back-end technology (networking) and how it can be integrated so the proper decisions are made when there is transition.

Larry Neilson Southwestern Biomedical Electronics

NEILSON: The only way to ensure compatibility is through testing. If the sales presentation says it is compatible and the literature says it is compatible, it still needs to be tested for peace of mind. Can a new device be swapped into the position of an older device? Will all cables (video, communication, PS, other) work without having to use adapter after adapter to make it work?

conducted as close as possible to the real time operation. For example, ask the end user or clinician how the device is used and then perform your operational test to their settings. Manufacturer specifications and PM procedures can still be utilized but trying to re-enact a daily function is ideal. AEM programs should be developed with this intent.

Q: WHAT ARE THE MOST IMPORTANT THINGS TO CONSIDER DURING A PM?

NEILSON: It has been our experience at SBE Inc. that thorough cleaning can be one of the most important things done during a PM. If batteries are used in the device, they can be a problem waiting to surface if left overlooked.

DAVIDSON: Invest in top quality testing equipment. Do your due diligence and check every box suggested by the OEM when testing. Keep clean documentation and file it away with the product’s serial number and additional materials. Clean the units with safe and gentle solutions. If you are outsourcing your service, make sure that your company of choice is ISO certified. Quality equipment can only stay in excellent condition if it has been serviced properly. NEGRON: PMs should always be

Q: WHAT ELSE DO YOU THINK TECHNATION READERS NEED TO KNOW ABOUT PURCHASING AND SERVICING PATIENT MONITORING DEVICES? DAVIDSON: Take the time to do your homework and do your best to foresee the work arounds of ever-changing technology. Ask about the manual overrides, warranties or OEM service

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

department contact numbers in case they are needed for future use. Saving all of that information in one file folder will go a long way in securing accurate information fast. Don’t forget how valuable that information can be in increasing the resale value of the unit. Consulting your service team when purchasing units will help to answer many unforeseen problems with new equipment. Most technicians have enough experience to assist any buying agent through a necessary equipment purchase. Allowing a service technician and a medical professional to test drive a unit before purchase should answer most questions ahead of time. Renting a new unit can also save money and worry. No one wants to make the wrong decision, and many need more information than what the product manual provides. Our motto is, “It never hurts to ask.” NEGRON: Servicing procedures should be changing with technology. There are new risks associated with new technology. It is important to think outside the box and develop plans that are innovative and creative. Patient safety should always be a top priority and now that includes physical and personal protection from cyber risks like identity theft. NEILSON: At the time of purchase will be your opportunity to secure multiple technicians receive manufacturer training on use, maintenance and service. At this time, service documentation should be secured by the facility. And, of high importance, software updates must be included in the purchase as well as the reason for the updates, which are often not disseminated to the user.

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f the Wi-Fi went out in many homes, it would cause more than the computer going offline. It may mean that

the front door would not unlock electronically, the

thermostat might not maintain the correct temperature or the security cameras might show a blank screen. Times have changed and the Wi-Fi used for home wireless devices on a network means that more than the laptop, tablet and network printer are not functioning; it could mean much more. As the Internet of Things grows, it connects everything from the washing machine to the front door, the refrigerator to the lights. This interconnection of things in the home has come to be known as a smart home. If the Internet connection is broken, or the power is out, the “smart home” becomes a not-so-smart home. The additional capabilities afforded by remote surveillance or the easy unlocking of the front door or remote climate control are negated. These inconveniences are trivial when compared to what could happen in a hospital if connected devices are compromised by a rogue invader intent on hijacking patient information, interfering with the functioning of medical devices or holding a hospital’s data hostage. It was that type of attack on health care facilities that caused a stepped-up effort in confronting a cryptoworm like WannaCry or the SamSam malware, both of which impacted the health care sector. Points of entry for these incursions include third-party websites, email, compromised medical devices, infected software or hardware or a service or provider linked to a network through the cloud, according to a HIMSS Cybersecurity Survey. These attacks, and the threat of new and even more sophisticated cyber attacks, were a wake-up call to the industry and health care organizations. In

the last two or three years, there has been a seismic shift in prevention, mitigation and device design.

Patient safety could be at risk. “The company’s latest research – which surveyed security decision makers at global health care organizations to OUR CONNECTED WORLD gauge perceptions of IoT security – found Devices across the spectrum are that 82% of health care organizations connected to routers in homes and the experienced an IoT-focused cyber attack workplace. All of these networked devices in the last 12 months; nearly a third of are potential targets for cybercriminals those hit reported compromised end-user and hackers. In a report provided by safety as a result,” the report states. Declan Bradshaw with Babel PR Limited, The report also revealed that only six the enormity of the problem in health care percent of health care organizations have is exposed. everything they need to tackle IoT “Use of the Internet of Things (IoT) is cybersecurity challenges, with an urgent booming, with IHS Markit forecasting requirement for increased skills and more there will be 73 billion connected budget for security identified. devices in use around the “IoT devices are often world by 2025. IoT targeted by cybercriminals technology has moved as they are much easier beyond speakers and to compromise than smart fridges and is businesses’ more CONNECTED DEVICES increasingly being sophisticated perimeter WILL BE IN USE BY utilized for critical cyber defenses. The applications across the problem is that growth health care industry like in the use of IoT has far – IHS MARKIT FORECASTING insulin delivery devices, outstripped the increase in connected inhalers and even trained professionals cancer treatments,” according to emerging. As a result, health a report by digital platform security care organizations often don’t have the specialist Irdeto, located in the expertise internally to ensure the Netherlands. connected devices they are using within Irdeto software and cyberservices their organizations are secure,” the report already protect over 5 billion devices and claims. applications and protects platforms and Findings from the report revealed that applications for video entertainment, 90 percent of those hit by IoT-focused video games, connected transport and IoT cyberattacks experienced an impact, the connected industries. most common of which was operational The report says that the health care downtime (43 percent). Also noticeable is sector is severely lacking the resources to that 30 percent of attacks compromised tackle a growing cybersecurity threat. end-user safety.

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73 billion

2025

FEBRUARY 2020

TECHNATION

“ Having an accurate CMMS is essential to assist in how fast mitigation can happen if a vulnerability DAVID is identified.” YAEGER Also, 96 percent believe their organization has some form of cybersecurity vulnerability, with 42 percent identifying IoT devices as the biggest threat and a quarter of health care organizations identifying their greatest cybersecurity weakness as their own employees. The report states that 98 percent of all health care organizations believe the cybersecurity of IoT devices could be improved. More than one in four manufacturers of IoT devices for health care only update the security of devices they manufacture while they are in warranty. One in five leave it to the customer to install updates. “IoT cyberattacks will continue to be prevalent as use of IoT devices grows. However, as they are increasingly used in mission-critical scenarios in industries like health care, the impact of operational downtime and compromises to end-user safety become far greater than just a financial cost,” says Steeve Huin, vice president of strategic partnerships, business development and marketing at Irdeto. “Securing each and every potential ‘entry point’ is critical to ensure the integrity of a business’ network as a whole. Manufacturers have a greater responsibility when dealing with potentially critical IoT in health care, and thus need to move away from the traditional ‘build, ship and forget’ mindset and incorporate multiple layers of security into the devices they manufacture,” Huin adds. He says that the consequences of failing to properly secure health care IoT devices are real, and need to be taken seriously. HTM’S ROLE When it comes to HTM’s involvement in

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FEBRUARY 2020

the cybersecurity puzzle, the need for vigilance and knowledge is important. Consulting with the IT team is one of the first steps. “First and foremost, get with your IT security folks to determine what cybersecurity framework your organization uses,” says David Yaeger, biomed security data base analyst, HTM and biomedical engineering for ProHealth Care in Waukesha, Wisconsin. “Having an accurate CMMS is essential to assist in how fast mitigation can happen if a vulnerability is identified. There are third-party applications available for purchase that can identify, categorize and monitor, using AI capabilities, of medical and other IoT devices to get a better understanding of what is on your network and what these devices are talking with. It can, if desired, connect to your CMMS and update identified fields as requested,” Yaeger says. “In the end, it comes down to a solid ‘defense in depth’ approach with multiple security control points across an enterprise, combined with meaningful end user security training,” says Axel Wirth, chief security strategist at MedCrypt. Wirth says that one trend that has evolved over the past few years is that of “security orchestration,” meaning that the various security tools across the enterprise work together in an automated fashion. “A security breach may not be reliably detectable at a single point, but if for example your email security system can share information with the endpoint product one cannot only detect more reliably, but also much earlier and with fewer false positives. Or, if a security incident is detected on one system, it is important to understand the preceding events and to see if similar events can be detected on other systems so they can be

addressed before the device is compromised,” Wirth says. Some suggested steps from Yaeger include: Network segmentation via ACLs, penetration testing on a regular basis, phishing email testing on a regular basis, yearly cyber training via CBLs and planting spoof workstations on the network seeking out hackers. With the safeguards that manufacturers are including with devices, and the work of IT to monitor the network, what role does HTM play to protect their facility from hacking, ransomware and other dangers? “Simply put, HTM’s responsibility should be to help build a more secure medical device infrastructure. Security considerations are now part of every step, this begins with the procurement and contracting process and continues over device incoming inspection (and potentially incoming testing), secure device handling and operation, all the way to device end of life and secure disposal (or return),” Wirth says. He says that HTM professionals need to understand the potential impact of insecure devices on patient safety, privacy, delivery of care and security posture. A medical device-specific security risk management program is key and should span the entire life cycle of the device, but also should include all internal and external stakeholders including clinical engineering, IT and IT security, clinical representatives, executive management and the manufacturer. “Besides protecting devices, HTMs are also users of IT and IT services, meaning they need to be vigilant when using email or web services on the hospital network. Any malicious link or compromised website is a risk to the larger organization and we all need to be security conscious and responsible users,” Wirth says. Yaeger says that HTM can employ USB locks, encrypt hard drives on devices, and use active directory authentication, if applicable, to reduce who has access to a device.

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“HTM can also keep up with patching with vendors authorization, get devices with old operating systems replaced as soon as possible. HTM and IT can work on network segmentation by creating ACLs from third-party applications and inputting these ACLs in your network switches,” Yaeger says. How does HTM prioritize the most important first steps in a cybersecurity plan? “At the risk of being repetitive, getting an accurate inventory in your CMMS is first and foremost so you know what is on your network. Knowing what patch level these devices are at is important. In addition, the focus could turn to the devices with the oldest operating systems, as there are no patches available for these items,” Yaeger says. He says that the next easiest targets would be to look at vendors that are on top of their game with patch availability especially if they are under a service contract. These vendors should be maintaining the patch level on their devices. “The key steps should be procurement, asset visibility, risk management, change management (e.g. patch deployment), end user education, incident response and device end of life. I think we are now in a better place than only a few years back in a sense that for most of these tasks we now have commercial products or published best practices that can be applied,” Wirth says. “We need to realize that the devices we have on our hospital networks are, for the most, insecure relative to today’s cyber threats, meaning that for at least another decade we need to reduce device risks through external (network-based) measures like network segmentation, firewalls and dedicated anomaly detection solutions,” he adds

at-risk devices? “I think this question should start with the requirement for a complete inventory of all devices. Traditional medical device asset systems and the quality of asset inventory have not been sufficient to address the security challenge. Either because asset inventories were incomplete or lacked security-relevant information. These systems are improving and even automated systems start to appear in the market. This will lead to better inventory visibility and will allow us to specifically focus on the higher risk devices – higher risk either based on the device being more vulnerable or a device incident having higher impact potential,” Wirth says. Wirth says that once these devices are identified, they can be protected through network segmentation, firewalls or similar measures. “We also should not forget about device handling, e.g. the use of USB thumb drives on a device or other user-initiated actions that could expose a device,” he adds. Yaeger believes that an accurate inventory can help with identifying devices by creating a complete knowledgebase of operating systems [and] third-party applications that are included in the device. “Knowing if a device is susceptible or not is difficult as some of the vulnerabilities are not known yet. Having an accurate inventory is always the first step in keeping your devices, network and patients safer,” Yaeger says. HOW CAN CMMS BE UTILIZED? How can CMMS be updated to include

all devices which may be exposed to hacking or cyber threats? “As I mentioned above, the challenge with traditional CMMSs is that they were not designed for security management purposes in mind. This is changing now and systems entering the market today provide these features through, for example, automated network-based discovery (improving completeness of inventory) and collection of security-relevant information like software and patch level, open ports, communication patterns, etcetera,” Wirth says. “I am not sure you could specify what device may be vulnerable to hacking and cyber threats so the best practice may be to inventory all devices in your CMMS and try and gather as much detail about that product so it becomes mineable in the event of a cyber threat becoming known,” Yaeger says. He says that another potential would be to purchase a third-party application, as mentioned before, that identifies items on your network. Details that this application gathers could be sent to the CMMS to update, accurately, the details of a device. This knowledge would assist in the speedy mitigation of a vulnerable device. The experts had much more to say about this subject, but the scope of this discussion here is limited. Cybersecurity experts have a number of suggestions that can help button down a network and connected devices. There are good published guides from AAMI, NIST, ANSI and the Health Sector Council.

Article Contributors

CREATING AN INVENTORY OF SUSCEPTIBLE DEVICES How does the HTM department go about the task of developing an inventory of

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

Axel Wirth

CHIEF SECURITY STRATEGIST, MEDCRYPT

David Yaeger BIOMED SECURITY DATA BASE ANALYST, HTM AND BIOMEDICAL ENGINEERING, PROHEALTH CARE

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Modernize Healthcare Technology Management We realize that your clinical devices are getting more sophisticated and diverse. We can help put your maintenance challenges behind you. Nuvolo empowers your HTM team to streamline maintenance operations, ensure compliance, maximize uptime, optimize spending, and

empower teams to do their very best work. We understand your challenges managing healthcare technology: → Passing Joint Commission and DNV Audits → Negotiating Vendor Contracts → Managing AEM Programs → Addressing Cyber Security → Keeping Equipment Running

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CAREER CENTER

These Careers Show the Most Growth, Promise BY KATHLEEN FURORE

s job seekers get ready to polish up their resumes and head into the new year, what are some of the careers that are growing/show the most promise (in the U.S. specifically)? I posed this question to LinkedIn Principal Economist Guy Berger, fresh off evaluating data from the company’s 2020 Emerging Jobs Report. According to Berger, there are three key categories to focus on when considering areas that show the most promise for job seekers moving forward:

1. ARTIFICIAL INTELLIGENCE (AI) It’s a brave new world out there where technology is concerned, and it’s impacting the employment marketplace in significant ways. Berger says roles like data scientist, robotics engineer and cybersecurity specialist are on the upswing; and not only in areas you’d generally consider “hard sciences.” AI is entering industries like real estate and business development too. “AI is going to be pervasive in the economy of the future, and lots of jobs will be reliant on AI, at least behind the scenes, impacting and boosting our jobs and lives in ways that we’re not even conscious of,” Berger says. “Think about all the AI systems already running on your smartphone that you use every day!”

2. ENGINEERING This is a big one: More than 50 percent of the emerging jobs on the 2020 list are related to engineering, Berger reports. And there’s some overlap with the AI category, since these roles include careers as robotics engineers and data scientists. One reason for the appeal: “Engineering is one of the fields that also has great opportunity for flexibility, a perk that’s turning into a must-have,” he adds, noting that LinkedIn data show that almost half of all U.S. professionals work from home on occasion. 3. MENTAL HEALTH CARE AND RECOVERY There’s no denying health care is a big topic today, and the good news is that all the discussion and debate has made mental health top of mind. “New mental health benefits have become more mainstream following changes to health care insurance, and as Gen Z pushes this conversation in the workplace, jobs related to care and recovery are on the rise,” Berger says. “We saw an example of this on the Emerging Jobs list this year: behavioral health technician has seen 32% annual growth.” According to Berger, this is one area that doesn’t always require employees – many who work with patients with autism or behavioral disorders, often with children in school environments –

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Kathleen Furore to have a four-year college degree. What skills and experience do job seekers who are interested in this field need? They range from “somewhat expected” areas like mental health and psychology to “the more unexpected” like community outreach, crisis intervention, public speaking and teaching, Berger explains. You can get a copy of LinkedIn’s 2020 Emerging Jobs Report at https:// business.linkedin.com/content/dam/me/ business/en-us/talent-solutions/ emerging-jobs-report/Emerging_Jobs_ Report_U.S._FINAL.pdf. 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.

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20/20 IMAGING INSIGHTS

Philips X5-1 Got You Down: Part II

Ted Lucidi, CBET Innovatus Imaging

BY TED LUCIDI

ast month’s column focused on the technological differences between traditional ultrasound probes and newer live-3D volumetric probes. Even though we highlighted some of the differences between the Philips S5-1 and X5-1, it can be expected that, regardless of the OEM, there are similarities across the technologies.

Let’s review some of the differences (Refer to last month’s column for more detail). Design Element

Philips S5-1

Philips X5-1

Acoustic Array

Traditional

PureWave array/ASIC combination

Acoustic Elements

3040

Scanhead Electronics

1 PCB

4 PCB’s

Wires

163 (151 for signal, 12 for ASIC control)

As you can see, there is a 1:1 wire-to-array element ratio on the S5-1. The same isn’t true for the X5-1. The advanced design has 12 of 163 wires used as control lines for the ASIC with single signal wires responsible for acoustics from up to 20 array elements. Common failures with cardiac probes result from breakdowns of one or more wires (or shields) in the wiring harness. The problem is seldom physically visualized but presents itself as excessive INTERMITTENT static in CW Doppler mode when the cable is moved. Extreme cases result in image dropout in B-mode or flashing in color Doppler. There are several approaches to address this failure, but the most

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FEBRUARY 2020

effective method, offering sustainability, is replacement of the entire wiring harness. Adapting this type of failure from the traditional design of the S5-1 to the more-advanced X5-1 … What if intermittencies develop in one or more of the control lines of the X5-1 versus just the signal lines? How do they affect performance and how does the problem present itself to the user? Common points of wear on both probes, and scanners alike, is at the probe/scanner interface. With repeated use or over time, the tension between the pins on the probe and the connection(s) on the scanner can weaken. It’s also possible for a probe to become partially unseated from the

scanner or the probe may not be squarely or tightly seated to the connector. Pins can become very easily bent or even broken from accidental trauma or hasty connections. Over time or with exposure to chemical disinfectants, oxidation or corrosion can build up on the pins. Dust can also build up in both the probe’s pin-bank as well as the scanner’s ports. Traditionally, if a poor/compromised connection occurs, there are related, but transient, image artifacts or random performance issues noted by the sonographer (i.e. intermittent dropout, occasional ID failures, other issues not always repeatable). Raising the similar question as before … What if a poor connection occurs AND is related to one or more of the control lines when using the X5-1? Based on the hundreds of X5-1’s evaluated at our Center of Excellence for Ultrasound Repair, a good percentage have reports of CONSTANT static in CW Doppler mode (versus intermittent static when the cable is moved). If you have X5-1’s in your fleet, your echo techs have, no doubt, experienced this frustrating scenario and it is, very-likely, the reason for which many X5-1’s have been replaced. As with any probe, it’s possible for

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COME GROW WITH US X5-1 body the array to sustain damage which can result in performance issues. With the X5-1, combine a more sophisticated array design consisting of thousands of subminiature elements with the possibility of an electronic/ASIC failure and the sonographer and ultimately, the technician can now be presented with non-traditional types of failures. Although array/ASIC failures do occur and can present CONSTANT static in CW Doppler mode, it is possible that the issue experienced in the clinical environment is unable to be duplicated. Our engineers have developed custom fixtures and new test methodologies to isolate and interrogate various electronics within these probes and after thorough research, we’ve identified that IF a poor, intermittent, compromised or questionable connection results on one or more of the 12 control lines within the X5-1, then CONSTANT static in CW Doppler mode may be experienced. Ultimately, ANYTHING that compromises the connection of one or more of the control lines leading to the array may result in, what seems to be, a hard probe failure. Next month, I’ll conclude this series with tips to enhance your troubleshooting skills for X5-1’s. As today’s transducers become more advanced, you can bet that tomorrow’s breakdowns are going to be based upon obscure, nontraditional points of failure. Be sure to partner with a provider that has advanced as much as the products you support. Currently, Innovatus Imaging can address all repairable components within this model. TED LUCIDI, CBET, Customer Experience and Clinical Insights, Centers of Excellence for Ultrasound and MRI Coil Repair, Radiography, Design and Manufacturing, Innovatus Imaging.

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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.

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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

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CYBERSECURITY

Goals, Resolutions and Planning Ahead BY JOSEPH E. FISHEL

e have moved into the second month of 2020. The groundhog Punxsutawney Phil should be predicting if we are going to have six more months of winter or an early spring. Last month, many of us made New Year’s resolutions. Losing weight, getting healthy and making more money seem to be common resolutions. What about departmental goals or resolutions? Windows 7 will no longer be supported by Microsoft. Have you decided how you are going to protect devices that still use Windows 7? This past year saw many vulnerabilities pop up requiring patching and identifying devices where patching won’t work. We have had to look at alternative ways to protect our devices. The year behind us was a major leap forward in cybersecurity. Yesterday is behind us and the only thing we can change is the future. So, are you preparing for the future?

We developed cybersecurity plans to prevent, remediate and address issues last year. How is that going? Have you reviewed it lately? Have you updated the dashboard? Have any of the standards changed? The Joint Commission, CMS, IMQ, AAAHC, NEC, NFPA, NIST,CIS CSC 12,OBIT 5, ISA 62443-2-1:2009, ISO/IEC, etc. have updates that came out at the beginning of the year. Make sure you take the time to incorporate these new updates into your various plans, policies and procedures. This prepares you for the year and new expectations that have to be met. This will also allow time to prepare for changes in areas that you may not have

addressed previously. Remember the red, yellow and green fields behind the standards in your cyberplan dashboard to identify where you are in your program? You may want to update these and look at what can be done to move toward all green. An example would be “Have you been able to identify further the software on the devices” requirement? If you did, make sure you update your dashboard to reflect the progress. Look over the dashboard and review your timelines on what is needed. Update your successes and delays as needed. Pick a few requirements to work on in the upcoming year. For things that are going to take longer, list out the tasks or things that might need to be done first. Develop a plan for this and put a standing time on your calendar each month to work on these each month. By doing that, and sticking to it, you will be surprised how much you will accomplish this year. When you were addressing the multiple vulnerabilities in 2019 did everything work on your plan or were there some irregularities where the plan can be improved? Did all of the communication plans work? Did we miss anyone that should have been notified? Reviewing the program itself is important, especially if you used names and not titles. Are those employees still in the same positions? Do you need to update or expand the steps you identified as needing some work? Assessing the event and correcting what didn’t work prepares you for the next go round. This is also a point where you can evaluate if IoT tools

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Joseph E. Fishel, CBET, MBA HTM Manager for Sutter Health eQuip Services could have eliminated the time you spent in identifying which devices were vulnerable. Could they have provided mitigating controls to isolate the device and whitelist it? The hours/dollars spent are probably fresh in your mind to use for justification. Are there fields of data that could make identifying affected devices easier? Did you have the data without the ability to sort it? An example would be a field that has the OS version with the service pack such as XP SP3. Sometimes trying to sort using words in a field doesn’t work well because someone didn’t insert a space or used lowercase letters or all capital letters or spelled it wrong. Have you started creating those fields and collecting data? Sometimes, we have to request assistance from outside our department and it can take time to get what is needed. So, start early. Writing this reminds me that I need to get started on my program goals for this year.

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EXPERT ADVICE

SPONSORED BY:

FDA MAKES A CRITICAL CHANGE IN 2020 BY MARK TAYLOR

t MME and ReNew Biomedical, we want to keep our customers up to date and informed on any FDA regulatory actions that will cause issues or problems within their course of business. One of the most comprehensive actions taken by the FDA is the institution of the Pre-Market Authorization (PMA) requirements that will directly affect all automated external defibrillators (AEDs) and AED capable devices in the market. As a nationwide leader in the sales and service of AEDs and AED capable ALS defibrillators, we would like to help educate and inform those end-users in our industry who will be dealing with the financial and operational issues caused by this action.

In an effort to make AEDs and AED capable devices more reliable, the FDA made a final order in February 2015 (Section 515(b)(1)(A) of the FD&C Act (21 U.S.C. 360e(b)) stating that current and future devices with an AED function would have to go through the more robust PMA process to carry the FDA’s approval. Not only does this include AED defibrillators for public access but also any ALS defibrillator in professional settings with AED or analyze functions. There are thousands of defibrillators currently located in hospitals, surgery centers and EMS organizations around the country that will be affected. This FDA-mandated PMA process is very similar to what pharmaceuticals must go through to get approval for use in the U.S. Previous to 2015, the FDA allowed

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FEBRUARY 2020

these Class 2 devices to go through a less rigorous process called the 510k approval, which is still required in addition to PMA. The new processes are time-consuming, expensive and have caused manufacturers such as Zoll, Stryker/Physio Control, Cardiac Science and Philips Medical (not to mention other makers of existing devices and/or accessories) to evaluate whether or not to pursue the PMA for older products that they do not expect to manufacture or support any longer. In an official letter in September of 2019, the FDA designated February 3, 2020 as the last date for manufacturers of any new-to-market AED products or previously manufactured AED products to be PMA-approved in order to be sold in the U.S. medical marketplace. Furthermore, if a PMA is not filed by February 3, 2020, manufacturers must also cease marketing non-conformed accessories by February 3, 2021. Device OEMs are not the only ones required to submit to this PMA ruling. Aftermarket manufacturers of all necessary AED and defibrillator accessories such as batteries, pad electrodes, adapters and other patient hardware must file a PMA by February 3, 2020. As a result, if an AED or AED capable device is not PMA approved, no accessory, part or supplies can be manufactured or marketed after February 2021. What does this mean for the thousands of AEDs and AED capable ALS devices that are not PMA-FDA compliant? Contrary to some rumors, all previous 510k approved devices have been

Mark Taylor Owner/President of MME and ReNew Biomedical

“grandfathered” in and are still usable as intended until the needed parts or accessories are no longer available in 2021. Most of these devices, which have already been discontinued by the OEMs, were at the end of their life cycle. At MME and ReNew Biomedical, we are advising our customers to make plans to replace their units as budget permits in the next 12 to 18 months. We will be able to support some of these devices for an additional period past February 3, 2021, but the duration depends on availability of vital components and the date the manufacturers cease to produce them (specifically defibrillation electrodes and batteries). Available support could be as little as 12 to 24 months, but there are no guarantees of compatible parts after February 2021, as we are expecting some customers to back-stock their

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EXPERT ADVICE needed parts and accessories as that date approaches. As a reminder, AED and defibrillator pads have an expiration of 24-36 months. However, if they are opened or used there will be no replacement. Similarly, most batteries will last 2-4 years, but once they are dead there will be no replacements available. As a seller of recertified AEDs and ALS devices, we are also seeing a strong demand for used PMA-approved devices. Most of our customers had not budgeted for purchasing or replacing their existing equipment at the time of this FDA mandate and are currently searching for a cost-effective solution other than buying new units. As an ISO 9001:2015 certified equipment company, we feel it is part of our duty to inform our customers and the market we serve about vital information to assist stakeholders in making the best decision on equipment before they make a critical mistake that can cost them their entire budget. We see our role in the replacement of non-PMA FDA approved devices as vital to our mission to provide the best service and highest quality equipment to our customers. FOR MORE INFORMATION for sales of PMA FDA cleared units, call our sales team at MME, or for questions on the service life of existing nonPMA compliant devices, reach out to our ReNew Biomedical team. As always, we are prepared to help guide you if you need assistance. MARK TAYLOR is owner/president of MME and ReNew Biomedical.

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Professional OF THE Month SPOTLIGHT FAVORITE BOOK “The Romance of Photogen and Nycteris” by George MacDonald FAVORITE MOVIE “Blazing Saddles” FAVORITE FOOD My wife’s Mulligatawny soup and pecan pie HIDDEN TALENT Problem solving/troubleshooting ability Favorite part of being a biomed “The satisfaction of completing a repair and knowing that a patient will receive the care they need. I also like working with our interns to make sure they begin their careers off right.”

SPOT

WHAT’S ON MY BENCH? Coffee, my favorite soldering iron, a book of 19th and 20th Century paintings from the Art Institute of

LIGHT

NAL ESSIO PROFHE MONTH OF T rtoglio ic Rock

Chicago, flash drives with equipment documentation and notes, my Day-

Timer to keep track of activities for documentation purposes

Nathan Burks enjoys being outdoors. When not working on medical equipment, Gravel Grinder. seen participating in the Lowell 50

Above he is

not you to places you would otherwise had nearly every day. I hit a plateau and there are fewer cars to deal visit and the G ISSUES job to change my eating habits to lose in several races and IMAGIN I’ve ridden the with. with TY AND next 75 pounds. My weight still k Iceman Cometh, come including SECURIbut ges challenges, pounds, 10 RK networ fluctuates plus or minus d onBottoms Gravel Grinder, NETWO and challen Funk seven worke s for about weight off g issues. of I’ve kept the g to Project Mayhem, Lowell glio has imagin Michigan Mountain care and to a meetin s and now by staying active taking Grinder, and Marto are Little Miami Dirty wentyears . I was 50 Gravelthere I eat.” security projectchallenging I), and nt seemed what d that Dozen, and be as itwatching lly whenPittsburgh Dozen, at differe Dirty t I receive tion (BAAM as good suppor “It canover the has had many hobbies especia Burks time t Burks says. it was by the many others,” le sites, the same playing t see if RICHAR or medat er at included years, which have multip that doesn’a suppor elmed BY K. few guys like to create issues on cars a few lio says. r, a manag ately, “Me and overwh with computers, only guitar, tinkering get good or ourselves whenever we critical Martog Booke you work there are g ns. Fortun routes and I and abuse als. Notand hether night,” knowin ent, David locatio very often service staff We completed a 213 photography hospit ns, heothers. stics, “I met BayCare I is cycling and have time free. questio ical equipm– diagno as tanding hobby current happen other field says. “My my it out. the past nts this ging of adventure unders of road he the out mile-in-a-day check fit in r all and consta one I started I general.from The goal site,” can be challen many self-supported tryingtoto stay answe shop s on as with toolsnents work. summer, as well of people le causes did he me to the the short als work make and commuting biomed cyclinghospit or roads near road M issues are multip on caliber to hilly how to t compo both; to cturer gravel grinders invited “DICO up a e there d. Thedistance of the access work. I picked with I have ul Itomade have areas how differen nshipshe adds. Ohio,” becaus Loudonville, the same as the manufa was hooke in all relatio tions, well and not always to commute in the winter bikethankf fat me with Burks spends time good homefront, is always e work do make work bike trails that I as of. HavingOn thel applicabeen key mountain ian ues to started adds. riding that machin l and gets out in nature. his family technic contin withclinica ,” he d it to. rs has king, contro auto been he says. some well,” 18 intende membe I have been networ wife and I’ve y married the changefrom the “My ne who with on y team I started cycling past year, “Thismeant he adds.“ someo g. Marto son. Going into HTM seven-year-old a securit have k that d and wenetwor yearsg,” trainin receive Gravel and securitshootin (gravel sion gravel roads ized and grinding). e then, automobilesion r of y assiste profes trouble My wife is a runner surpris on numbe recentl and recently time. they cantotake to school nal specialgoare because transit great same d in a projects. I ns It’s no to to work set to additio ableroads sion. at the d involve ring ion r locatio profes the skill is trained glio involve glio was experience nics enginee have the HTM and migrat and vasculak. This Marto unity on tions, would to heart Chuck Comm handshe networ l applica special the electro skills three PROFESSIONAL roughTHE BIOMEDICAL/HTM A.S.,” to our to ensure erthose exactly whatfield service “I took EMPOWERING e clinica an Hillsbo a is migrat with our l engine y teams secured m at ted with g That glio is the clinica re progra and gradua and securitred and workin a chance healthking, at BayCa of did. Marto und, in , I got eer. I College configu in out ges of ment networ in school a volunt ing was 1802_TNMag.indd 15 ist, ultraso s depart challen very active is based says. as I was isor at everyth With the been , which I ing service ly. “While Dave’s shop superv have ent. My out ian for System . proper in y, we biomed at a BAAM technic Florida Health al, securit medical equipmd locking tech to work Bill Hart, ater, repair a career care include and al Hospit me PM g our Clearw of an auto I also met Region were s have patching, securin a part-ti nd “I was was in need of what sibilitie mine Cry y team,” I Lakela and landed opportunities I respon no idea a friend of ned Wanna g, 23 years.but had our securit nce whilefter ports, meetin there. These for day, , mentio USB n le experie says.“A change to do. One therapist ing data ues. positio at good gather ely valuabMartoglio biomed be a wanted respiratory glio contin II ,” extrem as a Marto is a bers. school t I would hired to a biomed who ion, I was was in M ted he though glio remem profess tion, n, field TION.CO that the hed it, gradua I was promo t positio d,” Martoheard of TECHNA I researc what re. biome WWW.1 more never BayCa to my currenhe says. “I had into it. The was exactly the and thenultrasound,” that it , and joined Bay but lookedI realized service the found for. I group, the more entaking looking l Instrum networ I was Medica biomed tion of local Associa Area

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My completed her first half marathon. son loves to play Minecraft and harass are our cats. The Toledo Metroparks of awesome, so you will find us at one says. them at least once a week,” Burks the For his efforts on the job, he won Shining Star, an award given to outstanding UTMC employees. There’s little doubt why Burks was nominated for the award and to be that featured in TechNation; he proves when you set your sights on something, you can achieve it.

FEBRUARY 2018

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THE FUTURE

How Does HTM-IT Work in the Hospital Environment? BY STEVEN J. YELTON

ne of the nuances within the hospital environment is the interaction of HTM and IT. We have written in the past about the CE-IT technician sometimes called the HTM-IT technician. We have described the need for this profession and also the training required for the position. I felt it would be helpful to define HTM and IT and discuss where they do and don’t converge. My colleague, Greg Herr, and I have been discussing this subject and getting the message out within our organization to help people understand the mission of the HTM-IT collaboration. The following is an overview of our structure and training.

Clinical engineering is now often referred to as Healthcare Technology Management (HTM). HTM works in the world of the medical device/FDA environment and systems closely aligned with these systems. Information Technologies (IT) structure has different types of information services; hardware (server, desktops, printers, network services, software applications, interfaces, etc.). Applications vary from clinical applications, to business (financial, revenue stream, purchasing) across the enterprise.

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IN OUR WORLD, WHERE DO IT AND CE CONVERGE? These converge when medical devices/ systems are both a medical device and an IT system, or component of an IT system. If the system is an FDAapproved device/system or is critical to the clinical department work, often these devices/systems will fall into clinical engineering. This requires the knowledge of both medical systems (biomedical or imaging) and IT (various fields). Devices integrated into the Electronic Medical Record (EMR) or other IT-type system (PACS, EKG, etc.) require a skill set to work with the clinical staff, OEM and IT staff. These staff members must also understand budget impacts. IT services tend to handle non-FDA devices and/or services. Typically IT services are geared around non-medical technology, often referred to as IT devices or systems. IT usually uses a “Help Desk” access number or site to provide user access to a knowledgeable staff person to answer questions. Service and repair functions are usually secondary. CE and IT departments converge on the area where medical systems and IT systems converge. Physiological monitoring, imaging equipment,

Steven J. Yelton, P.E., CHTM HTM Engineer and Professor cardiology information systems, PACS and device integration are a few examples. Medical devices and the HTM field are constantly changing. We will see more changes with advances in home health, tele-health and other remote access technologies. WHERE DO WE SEE HTM AND IT NOT CONVERGING WITHIN OUR ORGANIZATION? Stated simply, where devices are not IT or computer based. The following are some examples: Surgical beds, surgical lights, general biomedical devices, electromechanical devices, probes, endoscopes and hydro-mechanical systems. Probably 60% of the biomed technology does not communicate to the EMR or is not able to be integrated. Ten years ago, it was 70% and 35 years ago, only very proprietary networks and systems sold by OEMs were networkable (in the sense of what was a network back then). HTM is a call and dispatch operation. If users have a problem, they usually need to get an immediate on-site

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response by HTM. A typical situation is the patient may be on the table, or patient work may be delayed. IT is generally a “Help Desk” where the questions and answers are initially directed, and if they cannot answer, then someone may be dispatched, or more likely call and ask if they can log into the system. HTM generally is less siloed and more horizontally integrated. Major groups in our HTM department are biomedical systems, imaging, CE-IT, laboratory (outsourced in our case). Other areas HTM may take care of in some hospitals are nurse call, patient beds, sterilizers, laboratory equipment and “central management of equipment dispersion” (central service). More and more equipment is being integrated into the EMR or other hybrid

systems. CE must be able to communicate with clinical users, vendors, IT, management and understand the legal and regulatory environment. HOW DO WE ATTAIN TRAINING FOR THESE PERSONS? WHAT DO THEY NEED? We have found that these technicians and engineers require biomedical and imaging backgrounds, IT knowledge, as well as mechanical and electrical knowledge. In addition, much equipment runs on software and hardware systems, so they must also be software aware. We have found that we have our best success when our HTM technicians start out with a solid background and training in HTM. This is usually an associate degree in HTM or a similarly named program.

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From there, they may have background and training in imaging systems. We then suggest that they return to school on a part-time basis to complete training in a computernetworking program. With this training, in addition to the experience they receive on the job, they become a very valuable resource to the organization. STEVEN J. YELTON, P.E., CHTM; is a senior HTM engineer at a large health network in Cincinnati, Ohio and is an HTM professor at Cincinnati State Technical and Community College. He is Chair-elect of AAMI’s Board of Directors, AAMI Foundation Board Chair, former Chair of AAMI’s Technology Management Council (TMC), Chair of AAMI’s HTAC Committee, Accreditation Board for Engineering and Technology (ABET), Board of Delegates and Board of Directors, World Seniors Golf Federation.

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VIEW ON VALUE

Diagnostic Imaging: Falling from Favor BY PATRICK FLAHERTY AND JOE HADUCH

ased on the last HTM industry demographics survey we reviewed as well as the composition of our own organization, we have witnessed an unprecedented expansion of imaging and laboratory services over the past two decades. The rationale for this expansion was simple, “build it and they will come.” And they did. Volume-based care, certainly from a business perspective, was simple. The more you scan the more you make. In this environment, imaging and laboratory services were the darlings of CFOs across the industry, but now they’ve become their bane. What happened, and how can HTM adapt to this new dynamic?

During the expansion years of the health care fee-for-service business model, the two clinical areas whose growth and success were directly connected were laboratory services and diagnostic imaging. Given the variety of diagnostic tools and tests both services afforded, it was not surprising that health care providers made material capital and operating investments in order to increase capacity as capacity and referrals were seemingly the only barriers to an attractive operating margin. For diagnostic imaging, capacity meant increasing investment in heavy-iron and outpatient imaging while increased referrals provided an ROI to acquire physicians and practices, often at prices that required subsidies from the healthy margins created by diagnostic imaging services. Fast forward to 2019 and a significant

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portion of the erosion of operating margin can be found in the desiccating bones of this strategy: 1. CMS and commercial payers identified diagnostic imaging (and clinical labs) as the primary culprits of excessive testing 2. Given that testing volume was a massive component of physician practice acquisition, its reduction made the subsidy of the acquisitions difficult or impossible 3. The expansion of the diagnostic imaging equipment was done with as much or more of an eye toward capacity creation as opposed to clinical and business efficiency, leaving care providers with a harder path in objective value creation With all of this as the back-drop, the final contributor to the perfect storm for diagnostic imaging was the massive shift in health care financial responsibility from employers to patients; simply put, when confronting a high-cost bill coming from their own wallets, patients opted to defer more elective tests and procedures. Consumerism began to self-regulate imaging procedures based on affordability. Diagnostic imaging was and is far-down the road of converting from profit center to cost center. As diagnostic imaging enters the cost-center phase, it is incumbent on care-providers to efficiently use its diagnostic services to lower its financial overhead in order to compete for procedural and capitated patient populations. In order to obtain contracts as a center of excellence locally, regionally or nationally with

Imaging and laboratory services were the darlings of CFOs across the industry, but now they’ve become their bane. How can HTM adapt to this new dynamic? large employers like Walmart and Lowes, objective data needs to be produced and analyzed. Among the obvious and customary data sources for clinical data are the EMR, RIS and hemodynamic systems but none of these sources document detailed information regarding the clinical equipment used in the diagnostic or therapeutic care of the patient. This missing bridge between the clinical outcome and the diagnostic equipment is a major issue in objectively defining and operating a fleet of optimized diagnostic equipment. In addition to not having basic information like make, model and combinations of software utilized connected to the procedure, other critical and objective information is absent related to the cost of owing the equipment. Objective information related to expected and warrantable parts performance and diagnostic efficacy is not currently provided by manufacturers, nor is there any reliable comparison of the variable contribution (good and bad) of the many models and vintages of diagnostic

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language that increasingly connects diagnostic imaging equipment and services to objective patient populations in order to assess value appropriately. This data is available through OEM portals like iCenter and LifeNet/ teamplay. HTM leaders can easily access non-PHI data that directly connects exam count, protocol use, patient demographics, scan times, gap times and more to equipment utilization and clinical use. Providing this data for clinical and financial decision making in an increasingly analytics driven environment will position HTM well in a value-based market. Many of us take personal and professional satisfaction in extending the life of our equipment well beyond its intended life. It’s a badge of honor to some, a necessary evil for others. As the healthcare market continues to evolve so too does the HTM mission. Maintaining equipment longevity will soon accompany the need to right size equipment fleets, identify and match clinical needs to equipment configurations and identifying operating signals for predictive failure analytics. Our basic tool kits will see little change; however, a concise pivot table and Tableau software will elevate your HTM department into the new world of health care and better position it for the strategic analysis required for success.

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PATRICK FLAHERTY is the vice president of operations for UPMC BioTronics.

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equipment on broad-based clinical outcomes. Frequently overlooked is the significant labor cost associated with maintaining general clinical and diagnostic imaging equipment. Labor costs for each can easily account for 50% of an organization’s service budget, and lifetime service costs for heavy iron devices typically materially exceed their initial purchase cost. The future requires more detailed expected parts performance information in order to drive cost-overhead management as well as drive toward cost-removal via predictive failure analytics. The organizations and manufacturers who succeed in this space can generate re-investable margin to strategically manage their expensive imaging equipment while inefficient management leaves fleets of older equipment. In Dickensian fashion, Healthcare Technology Management (HTM) mimics the famous intro to “A Tale of Two Cities,” it is “the best of times and the it is the worst of times.” HTM’s best virtue and worst flaw is keeping equipment functioning. Given that matching both the functional value and cost to own the equipment is mandatory in a value-based business, it is clear that absent data needs to be collected as well as connected in ways previously not contemplated. The HTM professionals of 2020 and beyond have to partner with their clinical colleagues in product and patient matching so that just the right amount of clinical functionality, not too much and not too little, is achieved. HTM also has to be a large part of defining the clinical business

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THE OTHER SIDE How Much Information? BY JIM FEDELE

ately, I have read many posts about documentation, specifically, what information should be required and what is required. The opinions vary and it is hard to know with any certainty what should be documented. Personally, I have always wondered about all the documentation we are required to do and if it is necessary.

If you ask 10 biomeds what needs to be documented on work orders you will get at least five different answers. Where the biomed was trained, their age and experience, will all influence the answer. For instance, biomeds trained by the military are very good at documenting every measurement and step they took to fix a problem, while some of the younger techs see less value in writing everything down. It is hard to say who is right. The military-trained tech is taught this is exactly how you do the task and this is how you record what you did, no room for interpretation. A traditional school trained tech may not see any value in writing everything down therefore it is not done. When I first started as biomed tech, I found it very helpful to look up old work orders on equipment to see if the problem occurred before and how it was solved. Frequently, I could cut my repair time down because I found the answers in the equipment’s history file written down in the work request documentation. Lately,

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FEBRUARY 2020

these opportunities are not so frequent. One would think that advances in computerized maintenance programs would make it faster and easier to check for previous problems. It is easier; however, equipment is not failing as it used to in the past. No longer do we “replace Q2 on the processor board.” Now, we just swap out a black box that only takes you a minute to figure out. With all that being said, is it really necessary to document everything you do to solve a problem? Is your time better spent doing something else? Documenting preventive maintenance (PM) results is also subject to many opinions. However, the differences that seem to guide opinions is usually driven by the biomed’s personal experience. For example, if one has testified in court about a piece of equipment or an accreditation/licensing agency has asked for the recorded output of some piece of equipment, it will influence the tech’s opinion on what needs to be recorded during a PM. To me, these situations reveal how little people know about biomeds and equipment service. If an entity is going to require that an output be recorded, I wonder what purpose it serves. Does it really make sense to document that the output measured 10 on setting 10? Would anyone ever document that the output was six? I would hope they would fix it first. The purpose for mandating that outputs be documented is an attempt to ensure that

Jim Fedele, CBET Senior Program Director, UPMC and BioTronics

the outputs get measured. My thought on this is that if a person is going to “paper whip” a PM, writing down an output that must match the spec isn’t going motivate them to do the right thing anyway. But what about from a legal perspective? Being told that your records are being subpoenaed by the defense in a lawsuit give many biomed techs chills. Think about it, what would happen if you made a simple mistake like transposed a number when writing it down, or you forgot a decimal point? Now a lawyer is questioning your competency and placing doubt in the jury’s minds. Just the thought of it makes me feel uncomfortable. So, what should

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be documented? I personally like pass/fail, put the equipment specifications on a label affixed to the unit or have your CMMS print them with the work order, so every tech can easily know and find them. Test the equipment and then document pass or fail, if fail fix it and recheck and document passed. To me it is clean and simple, there is little room for mistakes and it keeps you from answering any potentially embarrassing question. So, at the end of the day, what is the best solution? I think it depends. If you have an aggressive accreditation surveyor or DOH surveyor you need to do what they say. However, if you don’t, I think less is more. Remember that all work requests are legal documents. I personally have read work request repair descriptions that have had a little too much information. A frustrated technician decides to editorialize a repair description and made comments like “the staff refuses to learn how to use the unit,” “staff is too lazy” and etcetera. I think that as an industry, we should be united and willing to explain to those mandating documented outputs that there is questionable value to that exercise. JIM FEDELE, CBET, is the senior director of clinical engineering for UPMC. He magazines six Susquehanna Health hospitals. He has 30 years of HTM experience and has worked for multiple service organizations. Send questions or comments to Editor@MDPublishing.com.

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ROMAN REVIEW The Magic of Trust BY MANNY ROMAN, CRES

recently ran across an article about “15 magic phrases to make anyone trust you” by Marissa Laliberte. Whenever I visit a magician I am duly impressed so I thought that the article would include magical relationship advice. It is a fairly long article so I suggest that you “Google” it. It is worth the read.

So what am I going to write about? If you guessed trust you are correct. Specifically trust in general. I once saw trust defined as behaving in such a way that causes others to feel comfort dealing with you personally. Others don’t really care about your titles or position, they care about the person in them. This is a good statement since it describes trust in terms of behavior and since behavior can be learned then trust can be learned. Trust is a very personal concept. By this I mean that what trust means to me, is not the same as the meaning that you or anyone else applies to that word. So, the best way to describe trust is to speak on the degrees of trust. This way we can take into account the personal bias and modifications applied by individuals. Trust is really a belief in the reliability, truth, ability or strength of someone or something. Being a belief, trust then must be based on experience, thus the learning part. So, if trust is a belief usually tempered by the personal experiences of the individual having that belief, the trust may not be well-founded. (Google “Ladder of Inference” to see why beliefs may be all wrong.) You often hear of people betraying someone’s trust in them. Why were they trusted in the first place? Were they actually deceived or was the trust misplaced?

We have all had that moment of immediate like or dislike for someone at first sight. We like therefore we trust. We dislike therefore we distrust. Our experiences, and the emotional tags we attach to these experiences, may lead us to trust someone merely because they look like someone we do trust. “She looks like my Aunt Josie. Aunt Josie was always good to me and kept her promises. I could trust her.” This is an emotional bonding type of trust. There are many types of trust. There is unconditional trust, such as a child may have in a parent. As the child grows, that trust begins to diminish as their world of bonding and influence expands. If you have teenagers, you know exactly what I mean. Their friends get smarter and you get dumber, right? There is conditional trust such as when your boss tells you that if you get this project done right and on time you will get a promotion. These conditions, and his authority, cause you to trust his bold promise. He then squashes you like a grape by finding a reason not to promote you. “I’m sorry, but all promotions have been frozen for the next 37 years.” There is situational trust such as trust in a health care provider. He has a diploma on the wall from the University of Trust Your Doctor so you trust in him to make decisions in your best health interest. We don’t want to change the situation by a second opinion because we won’t know which one to trust. There is the misled-by-information trust (I couldn’t come up with a cute title). This is where that commercial tells you that if you drink this brand of beer and eat this brand of pizza, you will be surrounded by great looking happy and adoring people. Trust them. They have videos.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

Manny Roman, CRES AMSP Business Operation Manager

There is necessity trust that happens when your car breaks down on Interstate 15 on your way to Las Vegas. You are stranded on the side of the road in the desert. A funny looking ’60s hippie guy stops and offers to take you to the nearest gas station. You trustingly get into his Volkswagen bus for the 200-mile ride to Primm, Nevada. In the December Roman Review I wrote “Spending a few minutes with others in a non-threatening and personal conversation works wonders. The trust process can be enhanced by the mutual sharing of some minor personal vulnerabilities.” It is the escalation of this sharing from minor to major that forms strong bonding and trust. In my humble, yet correct opinion, this is the way to establish long and mutually shared trust by individuals. Why am I telling you all this? Well, I am recommending that before you go blindly trusting anyone or anything in the future you determine a couple of things. First, determine why you feel that this is a situation where trust is needed. Determine the type of trust that is needed. Establish the degree of needed trust and what your belief system says about this particular situation. Be a little more cognizant of the trust you give and you will have less anxiety knowing that you did your homework. They will still betray your trust, but you will feel less anxiety. You can trust me on this one.

FEBRUARY 2020

TECHNATION

BREAKROOM

DID YOU KNOW? Science Matters

Where do heavy metals come from? New observations of exotic “neutron stars” produced an answer to an old mystery: How were the universe’s heavy elements – those more massive than iron – formed?

The elements arose in three ways:

Big Bang’s original products Three lightweight elements 1 were created out of primordial matter in the Big Bang 13.8 billion years ago

Hydrogen

Helium

Dust from exploding stars, the next 23 From time to time, a star will contain too much gas or use up all its hydrogen and helium fuel and explode in a catastrophic blast

Supernova

• Atoms crash together, forming larger atoms, ejecting new elements into space

Neutron star, dense remnant

of a supernova; a mass of neutrons packed tightly by gravity

About 10 km (6.2 mi) across; mass equal to 1.4 suns

Source: Darach Watson of University of Copenhagen; Nature journal Graphic: Helen Lee McComas, Tribune News Service

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FEBRUARY 2020

• Now the most abundant elements in the universe

• The dominant ingredients of stars

Lithium

Beryllium Boron Carbon Nitrogen Oxygen Fluorine Neon Sodium Magnesium Aluminum Silicon Phosphorus

• When neutron stars collide, new atomic nuclei form • They take up protons and become atoms of heavy, new elements Some familiar examples:

Sulfur Chlorine Argon Potassium Calcium Scandium Titanium Vanadium Chromium Manganese Iron

27 Cobalt 29 Copper 38 Strontium 47 Silver 50 Tin 53 Iodine 78 Platinum 79 Gold 80 Mercury 82 Lead 88 Radium 92 Uranium

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EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

Pen Stylus

FEBRUARY 2020

TECHNATION

BREAKROOM

THE VAULT

o you consider yourself a history buff? Are you widely regarded among coworkers as an equipment aficionado? Here is your chance to prove it! Check out “The Vault” photo. Tell us what this medical device is and earn bragging rights. Each person who submits a correct answer will be entered to win a $25 Amazon gift card. To submit your answer, visit 1TechNation.com/vault-february-2020. Good luck!

JANUARY PHOTO Travenol Dialysis Model Coil Kidney Pump

SUBMIT A PHOTO Send a photo of an old medical device to editor@mdpublishing.com and you could win a $25 Amazon gift card courtesy of TechNation!

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TECHNATION

FEBRUARY 2020

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

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Riken FI-8000P Portable Gas Indicator Reliable, easy-to-use solution to measure anesthetic gas concentration. To order, or to request a price quote, call 800-795-3062 or email timk@ambickford.com.

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

800-795-3062 | ambickford.com

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Knowledge. Experience. Integrity. < / ŚĞůƉƐ ǇŽƵ ĚĞůŝǀĞƌ DZ/ ĂŶĚ d /ŵĂŐŝŶŐ ^ĞƌǀŝĐĞƐ ƚŽ ǇŽƵƌ ƉĂƚŝĞŶƚƐ͘ RepairMed is the industry BEST one-stop component-level repair depot whose services include tŝƚŚ ŽƵƌ ƚĞĂŵ ŽĨ ƐĞƌǀŝĐĞ ĞŶŐŝŶĞĞƌƐ ĂŶĚ ŝŶǀĞŶƚŽƌǇ ƐƉĞĐŝĂůŝƐƚƐ͕ < / ŝƐ ǇŽƵƌ WŚŝůŝƉƐ ƌĞƐŽƵƌĐĞ the most comprehensive and cost effective flat rate repair pricing! 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

Who are YOU doing business with?

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

RepairMED Facts: • ISO 9001:2015 Certified • Independently Owned Women Business Enterprise (WBE) • Supports the HTM Industry

• Offers a No Hassle Warranty on ALL Repairs • Fast Turn around (typically less than 7 days)

• Provides Consistent Reliable Credible Depot Repairs RepairMed repairs all models of these devices to component level: • All Models of Infusion Pumps Including Baxter Sigma Spectrum , Medfusion, Medley, and Plum Series, including Plum 360’s.

• Vital Signs Monitors , Fetal Monitors

• Feeding Pumps /Kangaroo Pumps

• Defibrillators/AED

• Syringe/PCA Pumps

• Electro Surgical Units (ESU) including FT10

• Physiological Monitors

• External Pacemakers

• Most OEM Monitors/ LCD/Surgical Displays

• Most Makes and Models of biomed devices

• EKG Carts ,Pulse Oximeters, Respiratory, and OR Equipment including Smart Pump Tourniquets, and Surgical Light Sources

ISO 9001 : 2015 Certified Phone: 855-813-8100 | Email: biomed@repairmed.net Website: www.repairmed.net

TECHNATION

FEBRUARY 2020

WWW.1TECHNATION.COM

BREAKROOM

SCRAPBOOK FBS Symposium

he Florida Biomedical Societyâ&#x20AC;&#x2122;s 2019 Symposium was held December 6-9 in Orlando, Florida. Attendees had the opportunity to participate in a variety of educational courses dedicated to the latest advancements and issues in the healthcare technology management field. The event also featured an extensive exhibit hall where attendees networked with vendors.

1. Garrett Seeley, associate professor of biomedical equipment technology at Texas State Technical College, presents an educational session for attendees to receive CE credits. 2. The TechNation and MedWrench teams were excited to invite FBS attendees to save the date for MD Expo Tampa, November 8-10, 2020. More details at mdexposhow.com.

3. TechNation gave away a drone to one lucky attendee as part of the exhibit hall scavenger hunt. 4. One of the biggest draws for the annual FBS symposium is the location. Attendees enjoy partaking in the Disney magic. Donald Duck made an appearance at one of the networking events.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

FEBRUARY 2020

TECHNATION

BREAKROOM

WHERE IN THE WORLD IS BEN C.? SPONSORED BY

Show us what Ben Calibrating has been up to for a chance to win lunch for your department. Follow MedWrench on twitter @medwrench facebook.com/medwrench

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TECHNATION

FEBRUARY 2020

Step 1: Like the MedWrench Facebook or Twitter company page. Step 2: Post your picture of Ben Calibrating to Facebook or Twitter and tag MedWrench in your photo. Step 3: Post a funny caption with your picture. Step 4: Use #BenC

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EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

FEBRUARY 2020

TECHNATION

Engaging Minds, Empowering Success

New Orleans, LA • June 12–15, 2020

#AAMIExchange2020 www.AAMIExchange.org

INJECTOR SUPPORT & SERVICE

• On-Site Repair • Depot Repair • Parts Sales and Parts Identification • Loaner Availability • Technical Support • Training • Injector System Sales • Preventative Maintenance Tools To learn more visit www.injectorsupport.com or call 888.667.1062

SPECIAL REPORT

Top 10 Health Technology Hazards for 2020

Expert Insights from Health Devices Unexpected health technology hazards can blindside hospitals and harm patients. Our top 10 hazards report can help you prioritize efforts and reduce risks to patients.

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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

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SERVICE INDEX TRAINING

multidiagnostic.com • 800-400-4549

RepairMED

www.repairmed.net • 855-813-8100

USOC Bio-Medical Services

www.usocmedical.com • 855-888-8762

74 7

Association

Nuvolo

www.nuvolo.com • 844-468-8656

GE Healthcare

Injector Support and Service

Multi Diagnostic Imaging

Tri-Imaging Solutions

www.gehealthcare.com • 800-558-204

P P

www.aami.org • 703-525-4890

Biomedical

multidiagnostic.com • 800-400-4549 www.triimaging.com • 855-401-4888

Acela Medical

acelamedical.com • 770.371.8661

ALCO Sales & Service Co.

www.alcosales.com • 800-323-4282

BC Group International, Inc

www.BCGroupStore.com • 314-638-3800

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

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

D.A. Surgical

www.shroudguard.com • (800) 261-9953

GE Healthcare

www.gehealthcare.com • 800-558-2040

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

InterMed Group

www.intermed1.com • 386-462-5220

Master Medical Equipment

MMEMed.com • 866-468-9558

Multi Diagnostic Imaging

multidiagnostic.com • 800-400-4549

Multimedical Systems

www.multimedicalsystems.com • 888-532-8056

RepairMED

www.repairmed.net • 855-813-8100

SVI International, Inc.

www.sviinternational.com • 800-321-8173

P P

71 88

P P 57 P P 58 P 86

22 58

P P P 36 P P 48 P 63 P 74 P P 71

Calibration

Contrast Media Injectors Injector Support and Service

www.seaward-groupusa.com • 813-886-2775

Cardiac Monitoring Coro Medical

www.coromed.us • 800-695-1209

Jet Medical Electronics Inc

www.jetmedical.com • 714-937-0809

Master Medical Equipment

MMEMed.com • 866-468-9558

Multi Diagnostic Imaging

multidiagnostic.com • 800-400-4549

61 36 48

Cardiology Multi Diagnostic Imaging

multidiagnostic.com • 800-400-4549

Southeastern Biomedical Associates sebiomedical.com/ • 828-396-6010

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

FEBRUARY 2020

P P P P P P

Defibrillator Coro Medical

Master Medical Equipment

P P P

www.coromed.us • 800-695-1209 MMEMed.com • 866-468-9558

Diagnostic Imaging Multi Diagnostic Imaging

multidiagnostic.com • 800-400-4549

Education HTM Education

www.htmeducation.org

44 32

P P P P P

Endoscopy Healthmark Industries

Multi Diagnostic Imaging

HMARK.COM • 800-521-6224 multidiagnostic.com • 800-400-4549

Multimedical Systems

www.multimedicalsystems.com • 888-532-8056

Fetal Monitoring Multi Diagnostic Imaging Multimedical Systems

www.multimedicalsystems.com • 888-532-8056

P 63 P P 63 P 48

Biomedical Repair & Consulting Services, Inc. 86 www.brcsrepair.com • 844-656-9418

General ALCO Sales & Service Co.

www.alcosales.com • 800-323-4282

P P

Hand Switches inRayParts.com

www.inrayparts.com • 417-597-4702

Imaging 48

IntraServ Biomedical LLC

Gas Monitors 16

P P P P P

P P 31 P www.intraservbiomedical.com/ • 980-269-5787 P P Maull Biomedical Training 73 www.maullbiomedicaltraining.com • 440-724-7511 P www.injectorsupport.com • 888-667-1062

multidiagnostic.com • 800-400-4549

Rigel Medical, Seaward Group

Computed Tomography

www.injectorsupport.com • 888-667-1062

AAMI

TECHNATION

SERVICE

CMMS

Multi Diagnostic Imaging

PARTS

Anesthesia

Company Info

AD PAGE

TRAINING

SERVICE

PARTS

AD PAGE

Company Info

P P

GE Healthcare

Health Tech Talent Management, Inc.

KEI Medical Imaging

www.gehealthcare.com • 800-558-204 www.HealthTechTM.com • 757-563-0448

www.keimedicalimaging.com • 512-477-1500

WWW.1TECHNATION.COM

SERVICE INDEX

aiv-inc.com • 888-656-0755

Coro Medical

www.coromed.us • 800-695-1209

Elite Biomedical Solutions

elitebiomedicalsolutions.com • 855-291-6701

Master Medical Equipment

MMEMed.com • 866-468-9558

Multimedical Systems

www.multimedicalsystems.com • 888-532-8056

Infusion Therapy AIV

aiv-inc.com • 888-656-0755

Elite Biomedical Solutions

elitebiomedicalsolutions.com • 855-291-6702

RepairMED

www.repairmed.net • 855-813-8100

Select BioMedical

www.selectpos.com • 866-559-3500

USOC Bio-Medical Services

www.usocmedical.com • 855-888-8762

www.ozarkbiomedical.com • 800-457-7576

P P 16 P 6 P P 36 P P 63 P 31

www.ampronix.com • 800-400-7972

Multi Diagnostic Imaging

multidiagnostic.com • 800-400-4549

31 6

multidiagnostic.com • 800-400-4549

Select BioMedical

www.selectpos.com • 866-559-3500

www.ampronix.com • 800-400-7972

Multi Diagnostic Imaging

multidiagnostic.com • 800-400-4549

USOC Bio-Medical Services

www.usocmedical.com • 855-888-8762

www.gehealthcare.com • 800-558-204

Innovatus Imaging

www.innovatusimaging.com • 844-687-5100

Multi Diagnostic Imaging

multidiagnostic.com • 800-400-4549

Multi Diagnostic Imaging

P P P

multidiagnostic.com • 800-400-4549

MedWrench

www.MedWrench.com • 866-989-7057

Webinar Wednesday

www.1technation.com/webinars • 800-906-3373

P P

4 48

P P P

49 81

PACS Multi Diagnostic Imaging

Patient Monitoring AIV

P 4 P 40 P 86 P 16 P 61 P P 31

aiv-inc.com • 888-656-0755 www.ampronix.com • 800-400-7972

BETA Biomed Services

www.betabiomed.com/ • 800-315-7551

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

Coro Medical

www.coromed.us • 800-695-1209

Jet Medical Electronics Inc

www.jetmedical.com • 714-937-0809

Multi Diagnostic Imaging

RepairMED

P P P P

P P

www.repairmed.net • 855-813-8100

Southeastern Biomedical, Inc

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

USOC Bio-Medical Services

www.usocmedical.com • 855-888-8762

Acela Medical

acelamedical.com • 770.371.8661

Portable X-ray inRayParts.com

www.inrayparts.com • 417-597-4702

P P

48 7

P P

Multi Diagnostic Imaging

Power System Components Interpower

www.interpower.com • 800-662-2290

P P

Radiology

www.ampronix.com • 800-400-7972

multidiagnostic.com • 800-400-4549

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

P P P P

multidiagnostic.com • 800-400-4549

Ampronix, Inc.

P P P P

multidiagnostic.com • 800-400-4549

Patient Monitors 48

multidiagnostic.com • 800-400-4549

sebiomedical.com/ • 828-396-6010

MRI GE Healthcare

P P P

Monitors/CRTs Ampronix, Inc.

P P P P

Monitors Multi Diagnostic Imaging

Ampronix, Inc.

Mammography Ampronix, Inc.

InterMed Group

Online Resource

Labratory Ozark Biomedical

TRAINING

Infusion Pumps AIV

Nuclear Medicine www.intermed1.com • 386-462-5220

SERVICE

HMARK.COM • 800-521-6224

PARTS

Healthmark Industries

Company Info

AD PAGE

Infection Control

TRAINING

SERVICE

multidiagnostic.com • 800-400-4549

PARTS

Multi Diagnostic Imaging

AD PAGE

Company Info

Multi Diagnostic Imaging

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

FEBRUARY 2020

TECHNATION

SERVICE INDEX aiv-inc.com • 888-656-0755

Rental/Leasing

AIV

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

Elite Biomedical Solutions

elitebiomedicalsolutions.com • 855-291-6703

elitebiomedicalsolutions.com • 855-291-6701

Repair

Multimedical Systems

www.multimedicalsystems.com • 888-532-8056

RepairMED

Acela Medical

acelamedical.com • 770.371.8661

ALCO Sales & Service Co.

www.alcosales.com • 800-323-4282

Elite Biomedical Solutions

elitebiomedicalsolutions.com • 855-291-6701

Jet Medical Electronics Inc

www.jetmedical.com • 714-937-0809

71 6 61

Replacement Parts Elite Biomedical Solutions

elitebiomedicalsolutions.com • 855-291-6701

Engineering Services, KCS Inc

www.eng-services.com • 888-364-7782x11

GE Healthcare

www.gehealthcare.com • 800-558-2040

Multi Diagnostic Imaging

multidiagnostic.com • 800-400-4549

P P P P P P

www.repairmed.net • 855-813-8100

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

USOC Bio-Medical Services

www.usocmedical.com • 855-888-8762

Test Equipment BC Group International, Inc

www.BCGroupStore.com • 314-638-3800

Clinical Dynamics Corp.

clinicaldynamics.com • 203-269-0090

6 17

P P P

Pronk Technologies, Inc.

www.pronktech.com • 800-609-9802

Rigel Medical, Seaward Group

www.seaward-groupusa.com • 813-886-2775

Southeastern Biomedical, Inc

Training

sebiomedical.com/ • 828-396-6010

Respiratory

College of Biomedical Equipment Technology

Multi Diagnostic Imaging

ECRI Institute

www.cbet.edu • 866-866-9027

multidiagnostic.com • 800-400-4549

RTLS

www.midmark.com • 1-877-9VERSUS

Software www.cybermdx.com

Medigate

www.medigate.io

Midmark RTLS

www.midmark.com • 1-877-9VERSUS

Nuvolo

www.nuvolo.com • 844-468-8656

Tri-Imaging Solutions

www.triimaging.com • 855-401-4888

Multi Diagnostic Imaging

Tri-Imaging Solutions

Ultrasound

Sterilizers

multidiagnostic.com • 800-400-4549 www.triimaging.com • 855-401-4888

Ampronix, Inc.

www.ampronix.com • 800-400-7972

Innovatus Imaging

www.innovatusimaging.com • 844-687-5100

Acela Medical

acelamedical.com • 770.371.8661

Surgical Healthmark Industries

HMARK.COM • 800-521-6224

Multi Diagnostic Imaging

multidiagnostic.com • 800-400-4549

P P

29 48

Tables

Multi Diagnostic Imaging

multidiagnostic.com • 800-400-4549

P P

43 5 3 44

P P

11 80 31 24

Engineering Services, KCS Inc

www.eng-services.com • 888-364-7782x11

Innovatus Imaging

www.innovatusimaging.com • 844-687-5100

InterMed Group

acelamedical.com • 770.371.8661

Multi Diagnostic Imaging

multidiagnostic.com • 800-400-4549

FEBRUARY 2020

P P

Multi Diagnostic Imaging

multidiagnostic.com • 800-400-4549

Tri-Imaging Solutions

www.triimaging.com • 855-401-4888

P P P P

48 24

P P

8 48

X-Ray

www.intermed1.com • 386-462-5220

Acela Medical

TECHNATION

www.intraservbiomedical.com/ • 980-269-5787

P P 86 P P 6 P P 63 P 74 P P 32 P P 7 P P 31

Tubes/Bulbs

CyberMDX

www.ecri.org • 1-610-825-6000.

IntraServ Biomedical LLC

Midmark RTLS

TRAINING

Telemetry aiv-inc.com • 888-656-0755

AIV

SERVICE

Refurbish

PARTS

Company Info

AD PAGE

TRAINING

SERVICE

www.bmets-usa.com/ • 870-431-5485

PARTS

Stephens International Recruiting Inc.

AD PAGE

Company Info

8 71 48 24

P P P P P P P

WWW.1TECHNATION.COM

ALPHABETICAL INDEX A.M. Bickford…………………………………………………… 74 AAMI…………………………………………………………… 78 Acela Medical…………………………………………………… 27 AIV……………………………………………………………… 31 Alco Sales & Service.…………………………………………… 71 Ampronix, Inc.……………………………………………………… 4 BC Group International, Inc…………………………………… 88 Beta Biomed Services, Inc……………………………………… 40 Biomedical Repair & Consulting Services, Inc.………………… 86 Clinical Dynamics Corp.………………………………………… 43 College of Biomedical Equipment Technology………………… 11 Coro Medical…………………………………………………… 16 Crothall Healthcare Technology Solutions……………………… 57 CyberMDX……………………………………………………… 43 Cynerio……………………………………………………… 14-15 D.A. Surgical…………………………………………………… 58 ECRI Institute…………………………………………………… 80 Elite Biomedical Solutions………………………………………… 6 Engineering Services…………………………………………… 17 GE Healthcare…………………………………………………… 22 Health Tech Talent Management, Inc………………………… 58 Healthmark Industries………………………………………… 29 HTM Education………………………………………………… 36 Injector Support and Service, LLC……………………………… 79 Innovatus Imaging………………………………………………… 8 InRayParts.Com………………………………………………… 43

InterMed Group………………………………………………… 71 Interpower Corporation………………………………………… 87 IntraServ Biomedical, LLC……………………………………… 31 Jet Medical Electronics………………………………………… 61 KEI Medical Imaging Services………………………………… 74 Master Medical Equipment…………………………………… 36 Maull Biomedical Training……………………………………… 73 Medigate………………………………………………………… 68 MedWrench…………………………………………………… 49 Midmark RTLS…………………………………………………… 2 Multi Diagnostic Imaging Solutions…………………………… 48 Multimedical Systems………………………………………… 63 Nuvolo…………………………………………………………… 54 Ozark Biomedical……………………………………………… 67 Pronk Technologies, Inc…………………………………………… 5 RepairMED……………………………………………………… 74 Rigel Medical, Seaward Group…………………………………… 3 RSTI…………………………………………………………… Insert Select Biomedical……………………………………………… 16 Southeastern Biomedical Associates, Inc.……………………… 44 Southwestern Biomedical Electronics, Inc…………………… 32 Stephens International Recruiting Inc………………………… 61 SVI International Inc…………………………………………… 67 TriImaging Solutions…………………………………………… 24 USOC Bio-Medical Services……………………………………… 7 Webinar Wednesday…………………………………………… 81

e n i Irv S A V E

HOTEL I

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

T H E

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APRIL 20-2202 20

M D E X P O S H O W. C O M FEBRUARY 2020

TECHNATION

QUALITY BIOMEDICAL SOLUTIONS FOR YOUR SPECIFIC NEEDS EQUIPMENT INCLUDES: • • • • • •

Patient Monitors Biomedical Modules Telemetry Systems Central Monitoring Gas Analyzers Transmitters

• Case Kits Available for: GE Apex Pro! GE Apex Pro CH! GE Apex Pro FH! Carescape T-14! • Bezels for the Dash Series Monitors

SERVICES INCLUDE: Flat Rate Repair | Replacement and Exchange Parts | Free Tech Support

(844) 656-9418 www.brcsrepair.com

ISO13485:2016 CERTIFIED ISO9001:2015 CERTIFIED

Carescape T14 transmitter flat rate! Call about our Carescape V100 & Procare Specials!

Order Just What You Need!

Interpower offers replacement cords and special orders— made to your specifications. With no minimum order or dollar requirements, order the quantity of one (or more) from Interpower®! All Interpower manufactured cords are made in the U.S.A. so you can order just what you need.

Benefit from value-added options. For example, with special labeling you can include identifying information on the cords (e.g. Operating Room 1 or ER 2) and should you need to replace a cord, you only have to order one cord.

Secure Connections are Essential To help prevent accidental power interruptions, secure your cord set with the new Interpower Connector Lock.

Contact Customer Service for More Information •

Made in U.S.A.

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No minimum order or dollar requirements

•

1-week U.S. manufacturing lead-time on non-stock Interpower products

•

Value-added options available

•

Same day shipments on in-stock products

•

Blanket or scheduled orders available

Before selecting your connector components, consult the appropriate medical equipment standards for connection security requirements.

Order Online! www.interpower.com

Business Hours: 7 a.m.–6 p.m. Central Time

Visit BC Group at ICE 2020 at Booth 105 February 9-11th, in Scottsdale, AZ

Star Test Patterns RTI Cobia SmartTM

BC Group is your OneStop Shop for all of your imaging and biomedical test equipment needs.

RTI Black PiranhaTM

Collimator Alignment Test Tool

View pricing, datasheets, manuals and more online at www.BCGroupStore.com.

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