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Vol. 9
ADVANCING THE BIOMEDICAL / HTM PROFESSIONAL
JULY 2018
BUSINESS PAGE 50
22 News and Notes
Service Industry Reacts to FDA Conclusion PAGE 28
Industry Updates
44 Roundtable
Sterilizers
69 AAMI Scrapbook
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CONTENTS
FEATURED 28
SERVICE INDUSTRY REACTS TO FDA CONCLUSION About a year after considering Congressional testimony from a variety of medical device servicing and manufacturing groups, the U.S. Food and Drug Administration (FDA) in May issued a long-awaited guidance document on “the quality, safety and effectiveness of servicing of medical devices” (FDARA 710).
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ROUNDTABLE: STERILIZERS echNation reached out to industry T professionals to find the latest information regarding sterilizers. The basic concept for sterilization has not changed too much over the years, however new technology has impacted the controls and capabilities of these devices.
Next month’s Roundtable article: Ultrasound Systems
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FAMILY BUSINESS I n the medical equipment industry and the HTM profession, it is common for family member to suggest the career path to a member of the next generation in the family. It is also common for a family member to start a business and pass it down to the next generation.
Next month’s Feature article: Lean Clean Fighting Machines
TechNation (Vol. 9, Issue #7) July 2018 is published monthly by MD Publishing, 18 Eastbrook Bend, Peachtree City, GA 30269-1530. POSTMASTER: Send address changes to TechNation at 18 Eastbrook Bend, Peachtree City, GA 30269-1530. TechNation magazine is dedicated to providing medical equipment service professionals with comprehensive, reliable, information concerning medical equipment, parts, service and supplies. It is published monthly by MD Publishing, Inc. Subscriptions are available free of charge to qualified individuals within the United States. Publisher reserves the right to determine qualification for a free subscriptions. Every precaution is taken to ensure accuracy of content; however, the information, opinions, and statements expressed in the articles and advertisements herein are those of the writer and/or advertiser, and not necessarily those of the publisher.
ADVANCING THE BIOMEDICAL/HTM PROFESSIONAL
JULY 2018
TECHNATION
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CONTENTS
INSIDE
PUBLISHER
John M. Krieg
VICE PRESIDENT
Kristin Leavoy
ACCOUNT EXECUTIVES
Jayme McKelvey Megan Cabot Lisa Gosser
ART DEPARTMENT
Jonathan Riley Karlee Gower Kathryn Keur
EDITOR
John Wallace
EDITORIAL CONTRIBUTORS
Jenifer Brown K. Richard Douglas Jim Fedele Inhel Rekik Manny Roman Cindy Stephens Steven J. Yelton
DIGITAL SERVICES
Cindy Galindo Kennedy Krieg Travis Saylor
ACCOUNTING
Kim Callahan
CIRCULATION
Lisa Cover Melissa Brand
WEBINARS
Linda Hasluem
EDITORIAL BOARD
Eddie Acosta, Business Development Manager, Colin Construction Company Manny Roman, Business Operation Manager, AMSP Salim Kai, MSPSL, CBET, Clinical Safety Engineer University of Michigan Health System Jim Fedele, Sr. Program Director, Clinical Engineering, BioTronics, UPMC Susquehanna Izabella Gieras, MS, MBA, CCE, Director of Clinical Technology, Huntington Memorial Hospital Inhel Rekik, Clinical Engineering Manager, Medstar Georgetown University Hospital
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Departments P.12 SPOTLIGHT p.12 Professional of the Month: James Jumper p.16 Department of the Month: ThedaCare Biomedical Systems Department p.18 Biomed Adventures: A Brewing Success P.22 p.22 p.28 p.32 p.34
INDUSTRY UPDATES News & Notes FDA Conclusion AAMI Update ECRI Update
P.36 p.36 p.38 p.40 p.42
THE BENCH Biomed 101 Shop Talk Tools of the Trade Webinar Wednesday
P.56 p.56 p.58 p.61 p.63 p.64
EXPERT ADVICE Career Center Ultrasound Expert The Other Side Roman Review The Future
P.66 BREAKROOM p.66 The Vault p.68 San Antonio HTM Week Scrapbook p.69 AAMI Scrapbook p.70 MedWrench Bulletin Board p.78 Parting Shot p.73 Service Index p.77 Alphabetical Index Like us on Facebook www.facebook.com/TechNationMag Follow us on Twitter twitter.com/TechNationMag
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SPOTLIGHT
PROFESSIONAL OF THE MONTH James Jumper Helping Patients Sleep BY K. RICHARD DOUGLAS
B
aylor Scott & White (BSW) is the largest not-for-profit health care system in Texas. The health care system grew out of the union of Baylor Health Care System and Scott and White Healthcare. With four-dozen hospitals and an additional 800 patient care sites, it offers services to a large patient population.
The expansive system keeps a lot of HTM professionals busy. One of those biomeds is James Jumper, an anesthesia field service biomedical technician with BSW’s Healthcare Technology Management department. Jumper did not make a beeline to the HTM profession originally. He was one of those people who liked to get into the mechanics of things though. “I pretty much stumbled upon the healthcare technology management profession after leaving the military. I was looking for my next step because I was never one of those people that, even as a child, just knew exactly what they wanted to be when they grew up,” he says. “My parents, knowing that I liked taking things apart and had an aptitude for mechanics, suggested that I look into the program options at Texas State Technical College in Waco. I saw the biomedical equipment technology program on the list and scheduled a tour and information session and
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decided that it sounded very interesting,” Jumper says. He received an associate’s degree in biomedical equipment technology from Texas State Technical College. “The program gave us a lot of information and hands-on experience with a variety of equipment typically found in hospitals as well as basic electronics knowledge. The biggest surprise for me after graduating and entering the field was how to document everything. I understand that each health care system or vendor is different in the database they use though so this would be difficult to train on,” Jumper says. His current specialty is with the GE Aisys and Aestiva anesthesia machines. He received training on both models from the manufacturer. He has also received vendor training from Draeger on Apollo anesthesia machines. Prior to working on anesthesia machines, Jumper got his start as a BMET I, where he was primarily responsible for equipment in operating rooms and sterile processing areas. “Today, I am an anesthesia field service technician, where my responsibilities are primarily anesthesia machines, anesthetic vaporizers and gas analyzers. As a field service technician, it is possible that I could end up at any campus in the Baylor Scott & White system on any given day,” he says.
TRAINING AND MAINTAINING In terms of the day-to-day challenges of the job, Jumper cites clinical staff training and finding the availability to get into operating rooms to perform maintenance. “There is so much turnover with the anesthesia technicians that it is sometimes difficult to keep up with proper training for the staff. It can also be difficult to quickly build relationships with the staff while being a field service technician since coverage at multiple campuses is required and, a lot of times, I am on-site outside of normal hours or on weekends,” he says. He says that with room availability, most of the campuses run from around 7 a.m. to as late as 7 p.m. “This can make trying to work a normal daytime schedule close to impossible when trying to get preventive maintenance done by a deadline,” Jumper says. “To work around the operating room schedule, communication with schedulers and supervisors is very important in setting up a time to perform planned maintenance. Some campuses will also give us access to view their schedules so that we can tentatively plan based on that information. I still try to call and speak with someone before heading to a campus though, their schedule can change quickly most of the time,” Jumper adds. He says that one of the projects that he
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SPOTLIGHT
FAVORITE MOVIE: “My favorite movie would tend to vary based on my mood, but some that I watch frequently are ‘Zoolander’ and ‘Top Gun.’ ” FAVORITE FOOD: Steak or Tex-Mex, it just depends on the day. HIDDEN TALENT: “I guess that my hidden talent is still hidden, I have not found any talents that I keep secret.” FAVORITE PART OF BEING A BIOMED: “I enjoy completing repairs and letting the customer know that their equipment has been returned to service. Most of the time they are excited and grateful, and that makes me feel good.”
James Jumper is an anesthesia specialist for Baylor Scott & White.
and his fellow anesthesia field service technicians are working on is offering in-services to the on-site biomed technicians and, when possible, to the anesthesia technicians. “Our hope is to make the technicians feel confident enough in replacing the user replaceable parts and doing user maintenance and troubleshooting that we can minimize the need to dispatch one of our field service technicians as frequently,” Jumper says. Last year, Jumper received a “great catch award” for identifying a potentially ADVANCING THE BIOMEDICAL/HTM PROFESSIONAL
hazardous situation and reporting it so that it could be rectified. Away from work, Jumper enjoys spending time outdoors and working on things around the house. He and his wife have two golden retrievers to keep them busy. “My wife and I enjoy kayaking, playing fetch with our dogs, home improvement projects and we are presently shopping for a classic Mustang,” he says. Patients can rest assured that a well-trained HTM professional has their backs.
WHAT’S ON MY BENCH? Wera 32-in-1 screwdriver set: Having 1 screwdriver with all of the bits that I need, and then some, is very helpful considering that I have to drag all of the tools I will need around with me. Zone perfect nutrition bar: This is my go-to when I start feeling hungry. Sometimes I don’t want to mess up my momentum to go to the cafeteria or leave campus to find food. Riken analyzer: The new Riken analyzers are digital and very fast. I can get vaporizer concentration checks done really quickly with this piece of equipment.
JULY 2018
TECHNATION
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SPOTLIGHT
DEPARTMENT OF THE MONTH ThedaCare Biomedical Systems Department BY K. RICHARD DOUGLAS
W
isconsin is known for cheese, beer, lakes and Harley-Davidson motorcycles. The northeast part of the state is home to a number of universities and colleges and miles of Lake Michigan shoreline.
Serving the health care needs of many of the communities in that part of the state is a seven-hospital health care system called ThedaCare. It is the largest employer in Northeast Wisconsin. In 1987, the Appleton Medical Center and Theda Clark Medical Center merged and created the Novus Health Group. A subsequent merger occurred in the mid-1990s and the resulting organization changed its name to ThedaCare in 1999. The health care system is composed of ThedaCare Regional Medical Center-Appleton, ThedaCare Medical Center-New London, ThedaCare Medical Center-Waupaca, ThedaCare Regional Medical CenterNeenah and ThedaCare Medical Center-Shawano. There are also a number of related physician office’s and other health services. Handling the management of the medical device inventory for ThedaCare is its biomedical systems department. The department is made up of eight biomedical technicians, seven biomedical imaging specialists,
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one secretary and a manager. They report to the director of materials management and then to the CEO. The ThedaCare Biomedical Systems Department is responsible for two primary hospitals with approximately 150 beds each and four critical access hospitals with approximately 20-25 beds each. They also manage the medical equipment at a critical access hospital with five beds, a surgery center, a large regional cancer center, a large clinic including endoscopy with several other clinics within it and more than 30 freestanding clinics. The team does what they can to keep as much of the service in-house as possible. “We have very few service contracts in place and we take a lot of pride with our ability to support and maintain equipment in house,” says Erin Schipper, biomed manager. “The majority of our contracts are on laboratory equipment or parts coverage (i.e. tubes and detectors) where appropriate. When we evaluate contract coverage, we consider the needs of the equipment to be able to support in-house versus a contract such as training, test equipment, uptime requirements, physical location, performance or historical information on the equipment/like equipment, impact to clinical care if equipment is unavailable/broken, etcetera,” she says.
“We are not afraid to take risks and we have a lot of tenure within the department that has extensive background knowledge and experience. We take a look at any warranty/prior contract coverage to evaluate what ThedaCare would have paid if we had not been previously covered-cost avoidance,” Schipper adds. The team provides preventative maintenance and repairs, keeping as much as possible in-house. They are also responsible for ordering parts and escalating with vendors as necessary for additional support or troubleshooting needs. They are still working out procedures for sharing responsibilities with their IT colleagues. “We have a pretty good working relationship however, as in most organizations, there is room for improvement. We are in the process of working through improvement opportunities and evaluating different structures and support models to be able to create a more seamless flow when issues arise that may be ‘gray’ in terms of ownership,” Schipper says. She says that they are especially concentrating on what the experience is like for end users because IS and biomed have different work order ticket systems and phone triaging within ThedaCare. The group employs data collection in several different ways.
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SPOTLIGHT
The ThedaCare Biomedical Systems Department maintains equipment at several facilities in Wisconsin including ThedaCare Regional Medical Center-Appleton (left) and ThedaCare Medical Center-New London (right).
“We utilize our asset management program to collect most of our metrics as a measurement of each individual technician. A monthly scorecard reflects each individual’s adherence to several indicators including PM completion rate — high versus standard priority,” Schipper says. They also look at the quantity of PMs assigned to each individual, PM completion throughout the month (showcases PMs worked on throughout the month versus the last minute), corrective maintenance/ repair completion within a specified time frame and the quantity of repairs that were assigned to each individual over the month. Schipper says that they also use data to look at closure of any outstanding repairs from the prior month and completion of any recall notification documentation. GOING ABOVE AND BEYOND The biomedical systems team has been very involved in projects that go beyond PMs and repairs. Expansion, purchasing and replacements keep the group busy. ADVANCING THE BIOMEDICAL/HTM PROFESSIONAL
“We have been heavily involved with the creation of a long-term capital planning process. We have been concentrating on imaging modalities and equipment within the peri-op environment, however this process/details are expanding to all facets of medical equipment,” Schipper says. They have also been involved with the implementation of additional 3D mammography systems throughout ThedaCare, replacement of cath labs with newer technology and the replacement and additional integration of new physiological monitors at the two larger campuses. “Approximately a year ago, we were heavily involved in the build and implementation of a hybrid OR room,” Schipper says. She says that, in affiliation with an area cancer treatment facility, they were also involved with the acquisition of assets and medical equipment including an additional linear accelerator and PET CT unit. They also coordinated the implementation of new and replacement fetal monitoring systems
at several campuses. They specialize in problem-solving. “Our asset management program has been vital to create the baseline for any of the capital planning projects that occur. This includes pivotal data such as purchase date, upgrade information, asset life expectancy, estimated replacement costs and performance history. Insurance that our asset management program is accurate and up to date is the only way to ensure a successful capital plan,” Schipper says. “We are heavily involved in the selection, planning, build/ construction, acquisition and installation of all medical equipment. We work closely with purchasing, department leadership, providers, construction/facilities and IS to ensure all facets are considered,” she adds. When a patient in Northeast Wisconsin needs medical treatment, they can rely on the ThedaCare Biomedical Systems Department to have their backs.
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SPOTLIGHT
BIOMED ADVENTURES A Brewing Success BY K. RICHARD DOUGLAS
F
or many people, given a choice of hobbies, brewing your own beer would be near the top of the list. If you could turn that hobby into a side business, it might rank up there with sailing the Caribbean and photographing the Northern Lights. All three would qualify as very cool.
For Garrett Seeley, who is an associate professor of biomedical equipment technology at Texas State Technical College, it all started with a need for supplies for a beer-brewing hobby. “My father, Glen Seeley, and I actually started brewing in the summer of 2015. We always did have a lot of hobbies together, and this one seemed like a natural way for us to work together on another project. We made an American Amber ale kit, using a recipe that is similar to one we now sell. It turned out great and that was what really sealed the deal for me,” Seeley remembers. Garrett says that he realized, at that time, that he could do this. “Those are very empowering words and it sort of propelled us forward. We started brewing regularly, about once a month thereafter. We formed a local club in 2016 with the local Karem Shrine — The Shriners — and became very interested in pursuing brewing socially. We joined the Waco Homebrewers Association that same year,” he says. The need for supplies was the impetus that sparked that big step into opening a store. “For the first year of our hobby, the only way we got brewing supplies was by either using the Internet or by driving to
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the nearest brewing shop, 50 miles away. In 2016, we discovered that there was a local brewing shop, and we were patrons of his store ‘Brewmeisters’ until it closed at the end of 2016,” Seeley says. He says that the closing was a setback to the brewing community in Waco, Texas. “It was at that point my friends and I in the Karem Shrine realized that we needed to make a local brewing shop. It really came out of a social club. We pooled our resources, bought out the local brewing store at the end of 2016. We then started to figure out how to open our own store. In August 2017, we had a property secured and we opened in October of that year. That is how the Craft Brewing Shop was born (craftbrewingshop.com),” Seeley adds. HANGING OUT A SHINGLE As Seeley explains, opening a brick and mortar shop is not for the faint of heart. There are many considerations, requirements and regulations that have to be met. “The first thing people need to do is to get familiar with the several layers of laws, rules, and regulations of business. People are willing to answer questions, but they do not always volunteer additional or ancillary information about running a business. We had to have our business registered, make sure zoning was not an issue, learn all about the tax law, and constantly badger the city and county health departments about all the little ‘what ifs’ that we came across,” Seeley says. He says that, to their credit, they were all very patient with the new brew shop entrepreneurs.
“They do want us to succeed and understand that we are just starting out. There are different regulations set at the federal, state, county and city level. All of these things have to be satisfied in order to be legitimate. In order to start a business, we had to ask questions of the government from the state level and below. We went online to see what the federal requirements were. Since we are in an industry with some federal regulation, we had to make sure that everything was legal with the feds,” he says. In addition to complying with all the regulations, Seeley says that they had to get an attorney, an accountant, a fire system contract, a pest control contract, a point of sale system contract, a credit processing contract, several marketing and web contracts, and a cybersecurity contract. “Yeah, all of this is needed just for a small ‘mom and pop’ shop,” he says. “There is always one more person to hire to ‘help out’ the operations. Mind you, these people are just to support us on day-to-day operations of the store. However, all of these things are important and play a part of shop. This all runs outside of the product ordering logistics of the shop,” Seeley adds. He explains that they then had to get everyone on the same page regarding the store operations. He says that this can be a phase that trips up many small businesses early on. “Heretofore, I have been paying to go to work. We all have. The thought that we cannot get any income until we turn a profit does not always set well with everyone. All parties need to know that in the beginning, it is long hours for no pay. Also, creative differences can make
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SPOTLIGHT
Garrett Seeley teaches biomeds and beer making. His hobby resulted in his Craft Brewing Shop in Waco, Texas.
enemies out of friends, so these are all reasons that early businesses fail. Make sure everyone is onboard with the goals before trying to get all of the operations set up. This is all stuff to get in place before even approaching payroll, which becomes a major federally legislated item,” Seeley says. Long before teaching biomed, Seeley received his own initial training at the Army/Navy joint school (USAMEOS) at Fitzsimons Army Medical Center in Colorado. “I was one of the last of the ‘Super Gs.’ I graduated at the end of 1995 and got a part-time job with Picker Healthcare Products while going to school for a BS-EE. I never did finish that degree as I met a great woman, got married, and got pregnant. We ended up taking a full-time position in Chicago. There I worked for Picker, then went in-house for Aramark/ ServiceMaster,” Seeley remembers. “Eventually, I moved back home to
ADVANCING THE BIOMEDICAL/HTM PROFESSIONAL
Waco, Texas and took a position in radiology services with Hillcrest Baptist Medical Center. I was there until a teaching position opened up at Texas State Technical College in 2008,” he says. “I did go back to school, finished a BAST degree in biomedical electronics, and got a MS in information systems. I earned the A+, Network+, and CBET certifications. I really never stopped moving forward with education until that MS degree. At that point in time, what I did had more weight than what I knew. Still, it is nice to have the professional credentials,” Seeley adds. He just recently celebrated his tenth year teaching at Texas State Technical College. What advice would he give other HTM professionals who might be contemplating a side-business? “Get ready for a lot of work for little pay. If you have a day job, understand that there has to be balance with the part-time
business and the full-time job in order for this to work. Some people even go as far as to say that the best way to make it succeed is to pursue it full time. Luckily, two of my other partners do that for me. It’s important to have a team of the appropriate size to accomplish the goal. Keep them working toward that common goal,” he suggests. He also brings a dose of wisdom to the table with this further suggestion. “Bobby Knight said something to the effect of: have a goal, surround yourself with people who can achieve that goal, and keep them excited, but know they will only be as excited about the goal as you are yourself. That’s management 101, really. Opening a store will give knowledge in management through trial and error. We all make mistakes. They do not define us. They teach us. Good luck,” he says. With that kind of perspective, it is a safe bet that the home brewers in the Waco area will have their supplies close at hand.
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INDUSTRY UPDATES
STAFF REPORTS
NEWS & NOTES
Updates from the HTM Industry FRIENDS, COLLEAGUES FONDLY REMEMBER FORMER AAMI BOARD MEMBER Friends and colleagues are remembering the life and contributions of former AAMI Board member John Daniel Hughes Jr. who died on May 3 at the age of 63. Hughes, who held a bachelor’s degree in applied behavioral science and a master’s degree focused on health services administration, worked at the Washington Hospital Center in Washington, D.C., as well as Bon Secours Health System in Marriottsville, Maryland, as corporate director for contract administration before retiring. “It seems as though it was not that long ago that I was interviewing John to be a supervisor at Washington Hospital Center,” recalled Dave Dickey, vice president of clinical engineering for McLaren Health Care. “As he moved up in the ranks, and eventually took over my director position when I moved on, John certainly developed his skills as a great negotiator and a stickler for detail and documentation. He was always willing to help with anything thrown at him.” Hughes was a longtime AAMI member and leader, having served on the association’s Board of Directors, AAMI Awards Committee, Annual Conference Planning Committee, BI&T Editorial Board, and Technology Management Council, and was one of the early advocates of bridging the gap between
the clinical engineering and information technology communities. However, Hughes might be best remembered for his wit, especially during the popular “Technical Iconoclast” session at the AAMI Annual Conference & Expo, in which he participated year after year alongside colleagues Malcolm Ridgway and Eben Kermit. Hughes’ commitment to the healthcare technology management field and sense of humor were common themes in remembrances by colleagues. Perhaps Elliot Sloane, president and executive director of the Center for Healthcare Information Research and Policy, summed Hughes life and legacy up best. “John was a good friend, father, and husband who will remain eternally in heart and memory. Never a shrinking violet, John fought every battle well, with wry, dry, sly, pithy, ever-insightful, and piercing humor. This last battle was no different; John was an iconoclast’s iconoclast to the last,” Sloane said. “In a while, after the sadness and grief passes, let’s always recall with a wry smile to our faces when we think of him! John’s bottomless spirit can now soar free into eternity.” •
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space,” said Jeremy Cook, senior director of healthcare technology management, Methodist Le Bonheur Healthcare. “Clinical engineering teams have tremendous skills but limited time, so it’s not a question of whether or not they can repair all medical equipment in-house, but rather, whether they should. PartsSource depot repair service optimizes engineering resources while reducing costs, and assuring equipment uptime.” Medical equipment must perform at high quality levels to successfully treat patients and support clinical service goals. To make operations more effective and efficient without disrupting quality patient care or customer satisfaction, PartsSource
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GLESEC LAUNCHES SEVEN ELEMENT CYBERSECURITY MODEL GLESEC announced the launch of its Seven Element Model (7eCSMTM) at the GLESEC event held at the National Center for Simulation. At the same time, GLESEC announced the launching of its operations in the state of Florida. The event, sponsored by the University of Central Florida (UCF), the Economic Partnership of Orlando, the National Center for Simulation and the Orlando Tech Association, filled the conference room and included presentations from the Federal Bureau of Investigation, Cyber Ark and Cyberbit (a wholly owned subsidiary of Elbit Systems). Both Cyber Ark and Cyberbit are GLESEC Technology Partners. GLESEC’s CEO Sergio Heker presented the new Seven Element Cyber Security Model. GLESEC’s Seven Elements Cyber Security Model (7eCSMTM) is a conceptual representation of the state of cybersecurity of a client organization
along with an alignment to a framework to proactively and responsibly address the client’s cyber security needs. The seven elements are: risk, vulnerabilities, threats, assets, compliance, validation and access. Each of these elements is activated by a combination of the many services from GLESEC’s proprietary TIP platform. These services monitor, test, protect, contain, remediate and investigate activity on behalf of GLESEC’s clients. “This is the culmination of an effort that started with the founding of the company in 2003, when the technology was not yet mature to permit these kinds of intelligence-based capabilities; this evolutionary process allows us to present an executive yet in-depth state of cybersecurity for an organization and an orchestration of a number of services and thus better serve our clients and the market,” says Sergio Heker, CEO. The 7eCSMTM is now available
with each of the current 11 managed security services that GLESEC offers. Once an organization acquires one or more of these services, it receives access to GLESEC’s transactional 7eCSMTM platform and can start viewing the executive, tactical and per-service dashboards. The services are actionable in that they provide protection, enforcement of compliance and policies, and the investigation of incidents and forensic services, to name a few. The orchestration and presentation of all services in a way that can be understood by a board of directors, but useful to the CISOs and technical areas of an organization, make this platform and announcement a unique and important one for all commercial and government organizations alike, according to a press release. •
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C&K LAUNCHES AUTOCLAVE SAFE MEDICAL SWITCH PRODUCT LINE AT EDS SUMMIT C&K has announced its new medical switch product line specializing in autoclave safe products at the EDS Summit in Las Vegas. The new medical switch series from C&K helps the medical community adhere to today’s strict industry sterilization standards protecting patients from the risks associated with reusable tools. Sterilization ensures safe reuse, eliminating contamination resulting from fluid and contagion ingress. Autoclave sterilization is one of the harshest environments a surgical instrument will encounter. Autoclave cycling sterilizes the device after exposure to bacteria, viruses, fungi and spores. Some medical devices are one time use, quarantined and disposed. Others are quarantined, sterilized and repackaged for reuse after sterilization. Similar to dental tool sterilization and reuse requirements, only these devices have active components that need to withstand autoclave cycling. An autoclave cycle reaches 135° C, under pressure, for up to 15 minutes. C&K’s medical switch product line features IP67 sealed switches that are biocompatibility tested, perfect for designers creating mission critical medical devices that require a
sterilization process step. “Medical device engineers are creating the applications that people entrust to keep them safe – from diagnostic equipment and active minimally invasive surgical tools to eHealth products – the switches in these devices need to work when activated, every time,” said C&K’s Roger Bohannan. “C&K’s new medical switch product line is ideal for designers creating the quality, superior performing devices that the medical community relies upon to work properly in the most challenging situations.” Testing demands of medical products vary and C&K’s new medical switch family offers a variety of sterilization safe products that can be customized and tailored to meet the changing requirements of the industry. The KSC series is autoclave safe and well-suited for medical devices that must withstand the shuffle of chaotic medical environments, such as that of an emergency room. These ultra-longlife switches can last up to five million cycles and their silicon actuators facilitate switch integration, providing possible pre-travel and post-travel depending on force and actuator hardness.
KMR microminiature SMT tactile switches are compact tact switches designed for a variety of harshenvironment applications, such as autoclave sterilization of medical devices and tools. These top-actuated switches come with gull wing termination and are available in four actuation forces. The K12 series dual action switch offers customization options to meet most application requirements. Its configuration can be combined to reduce the number of actions required for use, making it easier for medical professionals to complete complicated procedures with fewer movements. • For more information, visit www.ckswitches. com/markets/medical/.
SPBS APPOINTS DAVID HICKSON TO BOARD OF DIRECTORS SPBS Inc. announced the appointment of Dr. David Hickson, CEO and managing partner of MHSC Energy Management LLC., to its board of directors. “We are extremely pleased to welcome David to our board and look forward to the numerous contributions and years of experience and knowledge he brings to the table,” SPBS CEO Jeff Daugherty said. “David’s experience as an entrepreneur, industry leader and business expert will be an invaluable asset to the future growth of SPBS in the health care industry.” Hickson’s work experience culminates over 25 years of HTM industry leadership experience. He holds a master’s of science and a Ph.D. in food chemistry as well as a bachelor’s of science in biology from Texas A&M University. In addition to 16 journal articles and publications, Hickson has received several accolades and honor awards throughout his career. “I’m thrilled to be working with David again. I’ve known him since 2005 working in the capacity as CFO of Intellamed as well as serving on its board. David brings tremendous knowledge and health care relationships to SPBS in the healthcare technology management sector,” Daugherty continued. “SPBS is proud to welcome such a distinguished and knowledgeable leader to our board. Dr. Hickson is well poised to provide guiding influence as the company’s growth continues within the health care industry.” •
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BC BIOMEDICAL’S DFA2 TECHNOLOGY PATENTED BC Biomedical’s ESU-2400H Electrosurgical Unit Analyzer’s DFA2 Technology is now patented under U.S. Patent No. 9,883,903. The newly patented technology allows the ESU2400H to aggressively digitize the complex RF waveforms produced by electrosurgical generators. Each data point is analyzed to provide highly accurate measurement results, according to a press release from BC Biomedical. “The ESU-2400H is able to digitize complex RF waveforms due to its low impedance internal load bank, which has a wide range of 0 to 6400 ohms, in as little as one-ohm increments. It is a microprocessorbased analyzer that utilizes a combination of unique hardware and software to provide accurate and reliable test results, even from ‘noisy’ electrosurgical generator waveforms such as ‘Spray,’ ” according to the release. “The ESU-2400H, unlike most conventional ESU analyzers, has internal high voltage setup relays to control the measurement path. This allows the user to switch between power measurements, leakage measurements, REM/ARM/CQM testing, or even run an autosequence that could include any or all of these tests – without even moving wires around,” the release adds. “The current transformer internal to the ESU2400H senses the RF current flowing through the internal test load and produces a ratiometric voltage, which is digitized and analyzed by the microprocessor. Combining the standard and low ranges of the ESU-2400H with the use of the current transformer, the user has full control over the ability to get high-accuracy and high-resolution readings from all types of electrosurgical generators,” the release states. •
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VYAIRE MEDICAL TO ACQUIRE VENTILATOR DIVISION FROM IMTMEDICAL The U.S. company Vyaire Medical Inc. has signed an agreement to acquire the ventilator business and the imtmedical brand name. The second business unit, testing devices including test lungs, will remain in the possession of the previous Swiss ownership. For almost 20 years, Switzerland-based imtmedical ag has been developing and selling medical ventilators and biomedical test devices. Now the ventilator division and the brand name will be transferred to Vyaire Medical. “With this step, we want to help bellavista ventilators achieve the success they deserve. To reach this target, it requires a company like Vyaire, which already has strong distribution and financial structures worldwide,” says Jakob Däscher, one of the founders of imtmedical. The second business unit, biomedical test devices, will be handled under the new brand IMT Analytics. The company will continue to operate from its current location in Buchs, Switzerland, which also applies to imtmedical ag under Vyaire in the coming years. “In order to maintain the stable operation of imtmedical, there will be no adjustments to the site or personnel in the foreseeable future,” explains Harri Friberg, former CEO of imtmedical. The sale of the ventilator business unit brings benefits to users of all products previously offered by imtmedical. It is
now possible for IMT Analytics and its development partner IMT AG to concentrate more on the development and optimization of measuring instruments. In addition, IMT AG will be responsible for the development and lifetime maintenance of the ventilation products from Vyaire for the next few years. “For us, this contract is a windfall, which also reflects the high quality of our development services,” says Harri Friberg, managing director of IMT. In both business divisions, several devices are already in an advanced stage of development. •
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SERVICE INDUSTRY REACTS TO FDA CONCLUSION BY MATT SKOUFALOS
A
bout a year after considering Congressional testimony from a variety of medical device servicing and manufacturing groups, the U.S. Food and Drug Administration (FDA) in May issued a long-awaited guidance document on “the quality, safety and effectiveness of servicing of medical devices” (FDARA 710).
The 28-page report qualified a number of concerns in the medical device space from the agency’s perspective, including a handful of key points that could establish future ground rules for the interaction among original equipment manufacturers (OEMs) and third-party independent service organizations (ISOs). In short, the agency’s key conclusions: • “The currently available objective evidence is not sufficient to conclude whether or not there is a widespread public health concern related to servicing, including by third-party servicers, of medical devices that would justify imposing additional/different, burdensome regulatory requirements at this time; • “Rather, the objective evidence indicates that many OEMs and third-party entities provide highquality, safe, and effective servicing of medical devices. • “A majority of comments, complaints, and adverse event reports alleging that inadequate ‘servicing’ caused or contributed to clinical adverse events and deaths actually pertain to
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‘remanufacturing’ and not ‘servicing’; and • “The continued availability of third-party entities to service and repair medical devices is critical to the functioning of the U.S. health care system.” As a result of those findings, FDA said it will pursue the following: 1. Promote the adoption of quality management principles by medical device servicers; 2. Clarify the difference between servicing and remanufacturing; 3. Strengthen cybersecurity practices associated with servicing of medical devices; and 4. Foster evidence development to assess the quality, safety, and effectiveness of medical device servicing. Although the FDA report reads like a vindication of the long-held position of third-party parts, sales and service providers that their work is valuable to the U.S. health care system, many of those working in the field aren’t crowing in its wake. “I don’t think we were looking for a victory,” said Rick Staab, CEO of The InterMed Group of Alachua, Florida. “What we did do is substantiate that there is not anything indicating that there’s a problem with third-party service organizations. FDA responded and said, ‘These independent service groups are clearly a need for our health care system.’ ” “They just realized what we were
“ There is not anything indicating that there’s a problem with third-party service organizations. FDA responded and said, ‘These independent service groups are clearly a need for our health care system.’ ” – Rick Staab
saying,” Staab said. “FDA could have been plain vanilla and said, ‘We’re going to continue to investigate.’ They came back with a very strong stance, which is good.” Staab said that the FDA document doesn’t change dramatically the landscape of the medical equipment industry, but rather confirms the need for OEM and ISO business groups to come together around discussions of what data ought to be tracked. Top on its priority list is the challenge of mitigating or eliminating risks to patient safety, but responding to that challenge involves cultivating a multiplicity of perspectives from various types of players in the field. It also involves curating objective and
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universal standards for device maintenance, and sharing methodologies for doing so across the industry. “I think when we dig, what we should do as an industry is work together, both OEM and independents, to come up with the information that we can analyze to say, ‘We need to make changes [to our operating procedures],’ ” Staab said. “Even if you make changes, how do you know that they’re successful if you don’t know what you’re tracking? What we have to do before we make further regulation is to determine where we’re getting the information from to make these decisions. What do the numbers tell us? Are we better or worse at this?” Staab believes that more clearly defined standards will also go a long way toward alleviating categorical criticisms leveled at non-OEM vendors. A popular narrative among critics of the ISO industry is that companies that don’t build medical devices don’t know how to service and maintain them, or that allowing ISOs to do so would be dangerous. Instead, Staab thinks greater definition of and access to OEM specifications can help the industry reach a higher ground on the whole. “You can better our industry, or make sure that people are aware of what’s required in our industry, if you address what’s loose right now,” he said. “Overall, the entire industry is concerned with the anomalies – the people that are out there changing the intended function of the device because it’s cheaper for them to do. Everybody knows that’s not right. You just have to figure out how are we going to capture that. You shouldn’t make regulations that only addresses one percent of the population.” Staab said he is in favor of greater cross-disciplinary collaboration within the medical device industry, the better to press for standards-based repair guidance. Consistency in the handling of different classes of devices is one way to get there, and he said that ISOs have long requested
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greater access to device manuals and clearer definition of repair schedules in order to accelerate the pace and quality of device maintenance. OEMs typically deem such information proprietary and thus not fit to be shared on the grounds of preserving competition. But the existence of standards can only help open the door for improved device performance, uptime and overall safety. And if FDA wants the adoption of quality management principles by equipment servicers, a foundational precept of any quality system is having a standard to which to adhere. “Maybe some of the 510K processes will help the independents in the long run,” Staab said. “We have to follow the manufacturer’s preventive maintenance (PM) procedure, but there’s some where I can look at a manual on a device, and it will have certain procedures, and there will be another model, and it will have a change in procedure. How will you know that you’re following the right one? There’s no list, and I see manufacturers that don’t know which PM procedure to follow.” “It’s the same thing as with cybersecurity,” he said. “We don’t know a lot of times about the vulnerabilities unless you have put the things in place to identify the most updated software package. To me, the manufacturer has an obligation if they’re driving the fact that we have to follow their procedures: ‘Here is the list of
as a strategic priority for the medical device space also can help gather metrics to drive other of its objectives in FDARA 710, including defining servicing in the context of remanufacturing, reconditioning, and reselling; collecting data on device failures and their frequency rates; and improving cybersecurity practices. Those gains only come when a variety of industry groups like the Association for the Advancement of Medical Instrumentation (AAMI), Medical Imaging & Technology Alliance (MITA), International Association of Medical Equipment Resellers and Servicers (IAMERS), and the like sit down together and identify shared goals and pathways to achieve them. “I don’t think it’s going to change the landscape at all until we come up with a committee that helps or further defines the things that we may know or want to accomplish,” Staab said. “I think what you need is some body that can be transparent and open, and share the information. You’ve got to get people at the table that aren’t defensive. It’s there to build a better industry for the future, and it’s not something that should be used against you. I think you double the amount of time or quadruple the amount of time to do what it takes to do [when you silo].” Attorney Robert Kerwin, general counsel for IAMERS said he is hopeful that the FDA report will represent an
“ By no means are we treating this as the end. We’re continuing to improve our processes. We hope in the future that we’re going to be addressing further questions of independent servicer access to service keys, manuals and training.” – Robert Kerwin the procedures that you’re supposed to do.’ Otherwise, who’s going to check that? How are you going to police it?” Staab believes that the industry-wide collaborative communities that FDA notes
opportunity for greater collaboration. “The FDA’s report was thoughtful and deliberative, and we intend to continue to work on these issues,” Kerwin said. “By no means are we treating this as the end.
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We’re continuing to improve our processes. We hope in the future that we’re going to be addressing further questions of independent servicer access to service keys, manuals and training.” Kerwin said organizations like IAMERS and AAMI can help shape the conversations around important issues such as remanufacturing versus maintenance and servicing. Even though ISOs may constitute less than 10 percent of that industry, their contributions to the health care ecosystem are, as the FDA noted, essential. “We think further collaboration makes good sense,” Kerwin said. “We think all issues in the formation and implementation of standards need to be on the table including: service codes, passwords, access. If you want to calibrate equipment to a certain level but you’re not providing access to the service keys, etc., then we may have situations where we can’t fully meet the requirements. If it truly is about patient safety, why should this information be withheld?” “Many of our ISOs are alumni of manufacturers, and we see many successful multi-vendor relationships with manufacturers where the ISOs are working hand in hand with them,” he said. “The practical reality is that they’ve very successfully worked over the years. We think there are good, solid, economic concerns in addition to patient safety reasons for cooperation in this area, and we hope that the FDA report and its recognition of third-party servicers as necessary for the health care ecosystem, will bring about greater cooperation.” Medical device forensic investigator and author Mark E. Bruley, vice-president emeritus of the ECRI Institute of Plymouth Meeting, Pennsylvania, has combed the FDA Manufacture and User Facility Device Experience (MAUDE) database twice in the past 20 years to study the occurrence of adverse patient safety events related to the servicing of medical devices. From the MAUDE data, which includes medical device reports submitted to the agency by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters (health
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BY MATT SKOUFALOS
care professionals, patients and consumers), Bruley couldn’t find any evidence that third-party servicers were significantly adversely affecting patient outcomes. Out of about 900,000 clinical equipment reports, they found that just 0.2 percent, or some 240 adverse events, could have been attributable to servicing or manufacturing concerns, Bruley said. In 2016, the group led an updated search of the database, which in the time since had climbed to 4 million reports – some 2.4 million of which involve the servicing of
“ For the moment, the community can sit back and reflect on where things should effectively proceed in regard to improving self-management and oversight as opposed to regulatory management and oversight.” –Mark E. Bruley capital equipment – and found that the same adverse event rate had fallen by two orders of magnitude, to 0.005 percent. In FDARA710, the agency noted that “comments, complaints, and adverse event reports alleging that inadequate ‘servicing’ caused or contributed to clinical adverse events and deaths actually pertain to ‘remanufacturing’ and not ‘servicing,’ ” a note that Bruley described as “incredibly on-point and true as it relates to maintaining quality within U.S. health care.” “The collateral good that will come out of this will be the more focused attention on quality assurance for anybody that does medical device repair; more focused attention on putting quality measures for good, quality servicing,” he said. “I’m glad
FDA came to basically the same conclusion as it did in 1998 when I was presenting the data – but don’t ask me in another 20 years to come back and do the same thing.” Bruley said that he is disappointed that no contrary or additional analysis based on that data has been presented; in testimony before the House Committee of Energy and Commerce last May, groups like MITA criticized ISOs for failing to take more concrete steps toward creating the adverse event reports and complaint handling systems that OEMs must maintain. But none of them had any data to substantiate their criticisms beyond a handful of anecdotal instances. Bruley believes that if they want to get to the bottom of the patient safety issues at work in the field, manufacturers should publish the data in their own repair records. “In two years, nobody has done that other than ECRI,” Bruley said. “Our data went basically unchallenged except for the ‘yeah-but’ arguments that people make, which is, ‘Yeah, but there’s underreporting [of adverse events] and everybody knows it.’ If a manufacturer has any inkling that an injury or death was due to faulty repair of a third party, there’s every reason for them to make those comments from a self-defense medical and legal argument. So, I don’t buy into any argument that there’s under-reporting of faulty maintenance and repair.” Nonetheless, that conclusion is merely the jumping-off point for collaboration and standards development around the quality of device service and general oversight, which Bruley believes will take years to coalesce. “For the moment, the community can sit back and reflect on where things should effectively proceed in regard to improving self-management and oversight as opposed to regulatory management and oversight, which obviously is not needed,” he said. “Health technology managers and clinical engineers have a process for evaluating what’s wrong with a product, where to get the repair parts, and how to fix it. It’s all part of managing a clinical repair department.”
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BY AAMI
AAMI UPDATE
AAMI Honors Healthcare Technology’s ‘Best and Brightest’
T
he impressive contributions of a talented array of healthcare technology experts, innovators, clinicians, patient safety champions, young professionals and students were recognized during the AAMI 2018 Conference & Expo in Long Beach, California, last month.
AAMI President and CEO Robert Jensen offered his congratulations to everyone who won an AAMI award or scholarship. “Being able to recognize the best and the brightest in healthcare technology is an honor and, honestly, one of the highlights of AAMI’s year,” Jensen said. “This year’s award and scholarship recipients have demonstrated exemplary passion and dedication to helping make healthcare technology safer and more effective. It’s our pleasure to offer our thanks for all of the incredible work they have done and all that they continue to do to elevate and grow the field.” The 2018 AAMI award winners were: • Lauren C. Thompson, PhD, director of the Department of Defense/ Department of Veterans Affairs Interagency Program Office, who received the AAMI Foundation’s Laufman-Greatbatch Award. • The late Robert M.S. Dickinson, owner, consultant, and trainer at Fairmed, who was honored with the
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AAMI Foundation & Institute for Technology in Health Care’s Clinical Solution Award. • A multidisciplinary team from Beebe Healthcare, which serves Sussex County in southern Delaware, and RENOVO Solutions, which received the AAMI Foundation & Institute for Technology in Health Care’s Clinical Solution Award. • Frank Overdyk, MSEE, MD, professor of anesthesiology, who won AAMI & Becton Dickinson’s Patient Safety Award. • Jennifer Jackson, director of connectivity at Masimo, who received AAMI’s HTM Leadership Award. • J. Scot Mackeil, CBET, senior anesthesia biomedical engineer at Massachusetts General Hospital in Boston, who was named AAMI & GE Healthcare’s BMET of the Year. • Clarice Holden, chief biomedical engineer at the VA North Texas Healthcare System, who received AAMI’s Young Professional Award. • David Giarracco, vice president of global market development at Medtronic, who was honored with the Spirit of AAMI Award. • The California Medical Instrumentation Association (CMIA), which was named AAMI’s HTM Association of the Year. The AAMI Foundation scholarship winners, each of whom was awarded $3,000, were: • Kahkashan Afrin, who is earning
a PhD in industrial and systems engineering at Texas A&M University in College Station, Texas. • Montana Rae Delk, who is studying healthcare engineering technology management at Indiana University-Purdue University Indianapolis in Indiana. • Benjamin Hebel, who is studying biomedical engineering technology at Northwestern Michigan College in Traverse City, Michigan. • Alexis Henry, who is earning a master’s degree in biomedical/clinical engineering at the University of Connecticut in Storrs, Connecticut. • Bradley Klauss, who is studying biomedical equipment technology at Penn State University in State College, Pennsylvania. • Christopher Moreau, who is earning a master’s degree in engineering/healthcare engineering at Texas Tech University in Lubbock, Texas. • Baily Williams, who is studying biomedical electronics at Western Technical College in La Crosse, Wisconsin. More information about the AAMI awards program and this year’s winners is available at www.aami.org/awards. AAMI PUBLISHES CYBERSECURITY GUIDE FOR HTM PROFESSIONALS For too many healthcare technology management (HTM) professionals, navigating today’s cybersecurity
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landscape is akin to embarking on a trip abroad with no map and no compass – all the while trying to master a foreign language. Two cybersecurity experts are addressing those obstacles in a new book from AAMI that seeks to establish a common language and understanding for cybersecurity in health care, as well as provide clear and practical guidance for securing medical devices. The book, “Medical Device Cybersecurity: A Guide for HTM Professionals,” was edited by Stephen Grimes and Axel Wirth, both of whom are noted experts in the complicated and fastchanging world of healthcare technology cybersecurity. It features chapters by an array of experts with hands-on experience in putting cybersecurity concepts into action in health care facilities. “The concept of medical device security remains relatively new to HTM professionals,” said Grimes, who is a managing partner and principal consultant for Strategic Health Care Technology Associates LLC, and a member of the BI&T Editorial Board. “Most HTM professionals have little or no training in cybersecurity and, as a consequence, are often neither familiar with cyber risks nor equipped to take appropriate measures to reduce those risks.” Information technology (IT) experts in hospitals are limited in how they can help, Grimes added, because they typically don’t understand the “nuanced differences in how medical devices must be handled versus typical IT systems.” This new book speaks to the unique dynamic of health care cybersecurity and the role that HTM professionals can – and should – play. It includes chapters on cybersecurity fundamentals, understanding the regulatory and standards environment, inventory and configuration management, and risk assessment and mitigation. It also includes examples of policies, purchase agreements and vendor contracts from the Mayo Clinic, Intermountain Healthcare and Scripps Health. “We hope that the multi-author approach we took will provide insights on how several leading institutions have addressed the topic,” said Wirth, who is a distinguished technical architect at Symantec Corp., and a member of the BI&T Editorial Board. “There is no single path, and there is no one size fits all.” This valuable resource is available to purchase online at www.aami.org/store (product code MDC).
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BY ECRI
ECRI UPDATE
New Health Care Innovations that You’ll Hear Around the Watercooler
E
CRI Institute has addressed many new technologies in each edition of its annual “Top 10 Hospital C-suite Watch List.” Some have panned out, some have not, and some, like Google Glass, continue to be studied for new health care uses. As ECRI Institute celebrates its 50th anniversary of separating fact from fiction in health care, we trust that this 9th edition of the Watch List will help you better understand some of the technology and infrastructure changes in patient care this year.
This year’s list includes topics such as direct-to-consumer genetic testing, which is changing the face of what front-line clinicians encounter when patients walk in with test results they received on their own, asking, “What do variants of unknown significance mean? Should I be worried?” Below ECRI highlights two of the issues highlighted on the list; Magnetic Resonance Imaging (MRI) and microneedles. NEONATAL MRI SYSTEM – SHOULD YOU MOVE ONE INTO THE NICU? Magnetic resonance imaging (MRI) applications are rapidly expanding for all patient populations, including infants in the neonatal intensive care unit (NICU). When clinicians suspect that a neonate has experienced edema
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or hemorrhage, MRI is crucial for diagnosis to inform effective interventions. However, standard neonatal MRI requires transporting these vulnerable infants to radiology departments to undergo MRI, usually in a large, noisy scanner remote from the NICU, making transport a risk for these critically ill newborns. Although MRI is relatively safe, rare accidents in the MRI environment do occur, and a neonate is particularly vulnerable to MRI potential hazards, including projectile accidents, radiofrequency electromagnetic field effects, noise hazards, physiologic instability, and trauma resulting from transport, positioning, handling, and sedation. Enter the Embrace Neonatal MRI System (Aspect Imaging, Shoham, Israel), which FDA cleared in 2017. This device is designed for point-ofcare imaging in the NICU of the neonatal brain and head. This greatly reduces potential risk of transport issues and enables staff to rapidly perform emergency care. Also, when medically necessary, the neonate can be removed from the system quickly. The device has several unique features intended to minimize the risks of neonatal MRI and improve the imaging experience for the infant, parents and clinicians. The Embrace is fully enclosed and does not require a safety zone or a radiofrequencyshielded room, so it can reside in
close proximity to typical medical devices lacking “MR Safe” and “MR Conditional” designations. The device has an integrated incubator to control body temperature and measure vital signs during MRI. This removes the need for a hospital to invest in “MR Conditional” incubators compatible with standard MR systems. Aspect Imaging claims the system is significantly less noisy than conventional MR systems, which is particularly important because neonates can suffer hearing loss without noise protection while undergoing conventional MRI. WHAT YOU NEED TO KNOW If considering a new Embrace system, assess the annual volume of neonate
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MRI scans at your facility. You may determine that the scan volume does not justify the capital investment and resource allocation to adjust current imaging practices. If you decide to invest in the Embrace system, hold multidisciplinary planning meetings between NICU clinicians, radiology leaders, and healthcare technology management professionals to establish and review policies and procedures for implementing and utilizing this system in the NICU. (NEARLY) PAIN-FREE BLOOD DRAW: WILL MICRONEEDLES DISRUPT PHLEBOTOMY? The blood-draw process is timeconsuming and unpleasant for patients: drive to the lab, sign in, wait for one or more painful needlesticks. A large percentage of people don’t even show up for blood collection. From the health facility side, many laboratory tests require only small amounts of blood, but larger amounts of blood are drawn, producing excess waste that must be disposed of properly. Small-volume blood samples from fingersticks have also been problematic, as cell innards and interstitial fluids can be captured in the sample, and with small collections very little blood volume is available to wash out these extra components. Researchers have calculated that it takes 80 or more microliters to wash out excess material and reduce variability. To address patient concerns and workflow inefficiencies, Seventh Sense Biosystems (Medford,MA, USA) developed the recently FDAcleared TAP (touch-activated phlebotomy) microneedle bloodcollection device. The TAP single-use, 1.5-inch diameter device adheres to a patient’s skin. Once tapped, the device uses 30 microneedles and a small vacuum to collect 100
ADVANCING THE BIOMEDICAL/HTM PROFESSIONAL
microliters of capillary blood over 2 to 3 minutes until the fill indicator signals the collection is complete. The company says it is “nearly painless.” The extracted blood can then be tested on standard laboratory equipment. One potential drawback is that TAP blood samples currently must be tested within six hours of collection, which may put a damper on use in rural areas, where samples must be mailed for testing. The device could prove especially useful in pediatric populations, especially for children who require frequent blood draws for chronic conditions. A registration study rated traditional venipuncture or fingerstick at a pain level of five on the Wong-Baker Scale; pain from the TAP device was rated lower, at level two. Less pain also means less reliance on topical anesthetics and distraction techniques when blood is collected. Currently, the only FDA-cleared use of TAP is for hemoglobin A1c testing (blood glucose level). However, many laboratory tests could be performed with 100 microliters of capillary blood. Seventh Sense is working on obtaining additional clearances and integrating a digital chip that can date and time stamp the blood sample. The time stamp would be useful, especially if patients were to take their own blood sample in a nonclinical setting and mail it to a lab. TAP has the potential to decentralize phlebotomy, disrupting the established workflow of laboratory phlebotomists. Seventh Sense has since received a grant from the Bill and Melinda Gates Foundation and additional funding from Novartis, Siemens and LabCorp. TAP’s future may include integration with laboratory diagnostic platforms that analyze blood samples, allowing clinicians smartphone access to results within minutes of completion. Seventh
Sense’s recent partnership with LabCorp is likely to accelerate this integration. Seventh Sense indicates that future functionality, such as connectivity, additive array, sample separation and dried blood spots, can be added. WHAT YOU NEED TO KNOW Watch for new tests to become available using TAP blood samples. Assess your laboratory technology to determine where smaller-volume samples can be used on your existing equipment. Develop plans for lab equipment slated to be replaced in the next five years so that it will be able to accept small sample sizes. Consider transitioning to TAP for in-clinic use in your diabetes program for monitoring HbA1c. Work with your laboratory director, providers and supply chain to assess feasibility of transitioning to TAP samples in place of traditional vials for care areas such as pediatrics. Consider trialing TAP as the blood sample source rather than fingerstick for your pointof-care testing in the ED and for in-home use. Be sure to obtain approval from your health system for any off-label use. Stay tuned! In the next issue of TechNation, we’ll take a deeper dive into other topics featured on ECRI Institute’s 2018 Top 10 Hospital C-Suite Watch List. This article is excerpted from ECRI Institute’s 2018 Top 10 Hospital C-Suite Watch List. To download the full report, visit www.ecri.org/2018watchlist. For more information on ECRI Institute’s evidence-based health technology assessment or consulting services, contact communications@ecri.org, or call (610) 825-6000, ext. 5889.
JULY 2018
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THE BENCH
BY SHEILA O’DONNELL
BIOMED 101
Why Women in Technology Should Consider Healthcare Tech BY SHEILA O’DONNELL
I
was recently asked what attracted me to the healthcare technology industry since there are relatively few senior executive women in our business. I have to admit, I was a little surprised by the question. But the more I pondered it, images of my career flashed by.
Why was I attracted to this industry and how do other women find a career path to healthcare technology? I work closely with four other extremely talented women at Crothall’s Healthcare Technology Systems (HTS) business, which manages the life cycle of all medical devices and clinical technologies in more than 200 U.S. hospitals. After speaking with them, I learned that there is not a conventional path to a successful career. But there is a desire to make a difference in peoples’ lives and take on just about any challenge that will open up new opportunities. We all agree that a career in healthcare technology is rewarding and each of us encourages young women getting ready to graduate to consider it for the following reasons: • It provides endless opportunities to learn practical knowledge you can apply to your job every day. • People will respect your expertise and you can build your confidence while leading by example. • You will be developed by compassionate leaders. • You will experience the gratification that comes with meeting a client’s needs. • You can learn the importance of delivering results and achieving success. Our paths into healthcare technology vary widely. My career in healthcare
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technology started four years out of school when I became a senior buyer for University of Virginia’s (UVA) Replacement Hospital Project. It was a fascinating time to start in health care. I was a brand new mom; my son, Tim was born just six weeks earlier. On the first day, I was asked to manage the procurement of all movable medical equipment and imaging equipment requests for proposal for UVA’s brand new Level III trauma center replacement hospital; the challenging task drew me in and I was hooked. As my career advanced, I joined General Electric (GE). I was fortunate to work for a company that invested in developing its high potential managers by providing “stretch” assignments. I worked as the quality leader reporting to the chief executive officer for a GE joint venture and earned a Six Sigma Master Black Belt certification. As a result, I’m able to lead a wide variety of process improvement projects that can help reduce costs and increase customer satisfaction. At about the same time, I completed my master’s degree in business administration by taking evening classes. GE continued to provide me great career opportunities, and I was soon the general manager for its $260 million southeast zone imaging business in health care and later as general manager for its imaging installation services. As the GM for imaging installation services, I led several large projects that helped me gain even more experience including managing the installation of all GE MRI, CT scanner, PET and X-ray machines in the United States. In 2016, I was fortunate to join Crothall. Today I oversee compliance, informatics, purchasing, capital equipment
SHEILA O’DONNELL Vice President, Technology Resource Group, Crothall Healthcare
planning, imaging and costing for the technology resource group. So, what about my other four female counterparts in Crothall’s healthcare technology business? Terri Crofts is Crothall’s northeastern regional director of operations. She is a mechanical engineer with a master’s degree in biomedical engineering. While her original dream was to design prosthetics, while she was working on her degree she worked part-time as a biomedical engineer and learned more about healthcare technology management that piqued her interest. After graduation, she read a newspaper article and saw that Brigham and Women’s Hospital was looking for clinical engineers. She responded to the opportunity and says, “the rest is history.” Lisa Fry is Crothall’s southeastern regional director of operations. She has a degree in business management with a focus in information technology. Her career started as a coordinator at Sentara Hospital in Virginia where she fell in love with the health care industry. As her career progressed, she worked with GE Healthcare and, like me, was exposed to several growth opportunities as a high potential manager. Before Crothall she was
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the director of service at Aramark and was the corporate customer director. In November 2014, she joined the Crothall family. Jodie Nixon is the director of procurement. Like Lisa Fry, she started out as an administrator at another hospital, Carolinas Hospital System. Nixon’s willingness to jump in and take any challenge thrown her was the catalysts for her success. For example, on one occasion early in her role, her manager asked her to work over a weekend. Her manager tasked her with acquiring a specialized glassware part that is used on CT scanners in hospitals. In hindsight, it seems small but was truly a pivotal moment that built trust between her and her manager and it led to future opportunities including her current role as director of procurement in healthcare technologies solutions. Her skill and market knowledge is critical to the success of healthcare technologies. Tiffany Bruce started her journey as a certified nurse technician right out of high school scheduling patient appointments on CT scanners and MRI machines. She contemplated nursing but decided to go back to school and get an associate degree in business. In 2012, she joined the Crothall family as a customer service representative and was recently promoted to technical buyer. In her role as technical buyer, she is learning not just about parts acquisition, but about the contracting process and use of terms and conditions. She is now completing a four-year degree at Western Governors University. Throughout each of these woman’s stories are common themes of a passion for health care, learning, persistence and a commitment to excellence. Young women looking to care for others through their work in engineering should look no further; we want your enthusiasm and talent to help us continue to grow. – Sheila O’Donnell is vice president, technology resource group, Crothall Healthcare.
ADVANCING THE BIOMEDICAL/HTM PROFESSIONAL
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JULY 2018
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THE BENCH
STAFF REPORTS
SHOP TALK Q:
The FDA has released its report “FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices In accordance with Section 710 of the Food and Drug Administration Reauthorization Act of 2017 (FDARA).” What are your thoughts?
A:
Thank you MD Publishing (TechNation and ICE magazines) and AAMI for keeping the HTM community informed and “on point” as this issue made its way through the process. Thank you to my peers who participated in forums, local and national meetings and submitted comments to the FDA. I salute all of you. However, please pay attention to the actions that the FDA will continue to pursue. It is incumbent upon us as professionals to continue to grow our programs with a constant pursuit of patient safety and delivering an exceptional experience for that patient that depends on us to be excellent everyday. To that point, do not let down your guard or take your foot off of the accelerator! If you are not familiar with quality systems and/or the ISO 13485:2016 standard, learn it! Put that standard into practice for everything you and your teammates do for healthcare technology management. Are you paying attention to the devices in your inventory that are connected to a network? What about devices that contain PHI? Are your USB ports on 38
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your medical devices locked out either with software or physical controls? Do you know what the MAC addresses and IP addresses are for the devices in your inventory? What about the operating systems for these devices? Is all of this information documented in your CMMS product and easily accessible for your HTM technical staff as well as your Information Services co-workers? Our patients are depending on us. The FDA is depending on us. Your employer is depending on you. Be excellent! Drive your program toward excellence! Leadership is not about the title you have, it is about doing the right thing and being an example for the responsibilities you have in your career. Read! Attend conferences (local and national) or webinars (many of them are no cost to attend)! Communicate with your peers. Join professional organizations! There are so many resources available to you and most have little or no cost associated with them. Heck, make the investment into your career. Make the investment into yourself! Forgo that cup of coffee everyday and use that money to join a professional organization.
A:
Well said! Or, increase the continuing education and training of your team members.
A: A:
They got it right this time!
Q:
I have a problem with my Thermo Fisher Scientific Shandon Excelsior ES valve clogging. Could you help? The valve section of the device is filled with paraffin or similar crystals. The device is clogging. I cleaned it, but then it was the same problem again. I need your suggestions to solve this problem. The motor section is filled with a paraffin-like substance. We clean it up, but then it fills again. What is the solution to this problem in your opinion? A: The motor is underneath the chamber. If I understand what you said, the processor is working, but you are getting a repeated build up of residue on the motor, coming from the chamber. I would expect that it is due to the agitate seal, and possibly the static seal. If you are going to replace these, you would want to replace the port seal at the same time. Do not replace the rotor outer seal, unless necessary. If you don’t have a service manual, you definitely need one. SHOP TALK is compiled from TechNation’s ListServ and MedWrench.com. Go to www.1TechNation.com/Listserv or www. MedWrench.com community threads to find out how you can join and be part of the discussion.
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THE THE BENCH BENCH
STAFF REPORT
TOOLS OF THE TRADE PRONK TECHNOLOGIES BMET Pack Pro
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ronk Technologies has introduced the BMET Pack Pro, a compact pack that holds all the Pronk products, accessories and extra space for tools. Simulators (SimCube NIBP, OxSim SpO2, SimSlim Multi-parameter), the new Safe-T Sim Automated Safety Analyzer, and multi-function FlowTrax IV Pump Analyzer all fit within the customized padded compartments to make it easier than ever to travel with all your test equipment between hospitals and clinics. The BMET Pack Pro also includes a padded compartment which holds up to a 15.6-inch laptop/tablet (not included) secure. The compact size of Pronk test equipment combined with an easily transported pack offers maximum mobility and versatility to biomedical engineers. For more information, contact Pronk Technologies at 800-609-9802 or www.pronktech.com.
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STAFF REPORT
WEBINAR SETS NEW HIGHS STAFF REPORT
T
he Webinar Wednesday set new highs this year with the presentation “Electrical Safety Testing – Planned Preventative Maintenance.” The webinar featured Jack Barrett, national business development manager at Rigel Medical, and set record highs for 2018 with 779 registrations and a live attendance of 557 people.
Attendees participating in the live presentation were eligible to receive 1 CE credit from the ACI. Barrett has been providing consultative solutions for engineering and medical needs for 40 years. In addition, he has participated in national seminar programs along with sessions for regional biomedical associations. In his webinar presentation, he reviewed the importance of electrical safety testing and provided an overview of test criteria, classifications, terminology and safety standards, including IEC60601, IEC62353 (direct, differential and alternative techniques) and NFPA99. The webinar received positive reviews and comments in a post-webinar survey. “The webinar took things back to basics but broke it all down in a way that was easy to digest. Great reminder of what to keep in mind in the day to day,” Clinical Engineer N. Kubendran said. “Very educational and applicable to everyday work flow,” Technician J. Salazar wrote. “Great webinar, good to know that there are new standards that protects the patients as well as the healthcare technology management sector. Keep it up! Hope to hear and learn more,” Biomed M. Mendoza said.
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“The presenter was very knowledgeable and the webinar was full of useful information,” said J. Magill, BMET. “Very informative! Was not aware of the amount of information that was provided in an hour that has helped me be a better biomed,” Biomed G. Farningham said. “The webinar I attended was very educational, easy to understand, and directly related to the work I do in medical equipment repair. It helped to easily understand what, how and why we test for electrical leakage, giving me much better context and understanding of the tests I perform on a daily basis,” Ultrasound Probe Repair Engineer W. Spitzel said. The recent webinar “X-ray QA and the Drive for Efficiency” received high ratings from attendees as well as several compliments in a post-webinar survey. The RTI Group-sponsored webinar drew almost 200 attendees and received a 3.9 rating on a 5-point scale with 5 being the best possible rating. Participants were eligible for 1 CE credit from the ACI. This 60-minute webinar featured RTI Group International Sales Manager Lee Evans. He provided an overview of X-ray quality assurance by looking at how technology has driven efficiency over the past 20 years. “Great overview of X-ray technology,” Biomed G. Fraser said. “This webinar was simple but very informative. It was very straight to the point and had good flow. I’ve been a BMET for about 15 years now, and for the past year I’ve been teaching students, my future co-workers. I love Webinar Wednesday webinars. No matter what
the topic is I always learn something. If not for me, for my students,” BMET Instructor J. Seriosa said. “Informative and to the point. Great way to pick up quick information on a relevant subject,” Biomed Engineering Team Leader W. Younkin said. The recent Conquest Imagingsponsored webinar “Testing of New Technology Ultrasound Probes” attracted 292 registrations and each individual who attendeed the live webinar was eligible to receive 1 CE credit from the ACI. The webinar featured Conquest Imaging Senior Director of Technical Operations Bob Broschart. He explained how ultrasound probes often get damaged over time. He said there can be tremendous savings in probe damage and high-level repair costs if facilities know what to look for and if they proactively test probes. Just like many medical devices, lower level needs that go unaddressed can result in costly repairs down the road. In this webinar, attendees learned what to look for as well as information about the newest technology and best-practices for proactive probe testing. The webinar received high marks via a post-webinar survey. “As usual some great information to improve my ability to service the equipment at our facility. Keep up the good work,” Biomed L. Shelman said. “It was very informative and I would certainly recommend other biomedical engineers in my facility to attend to this,” Biomed S. Chand said. “This Webinar Wednesday was very helpful and full of information relevant to servicing ultrasound equipment. The
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presenter was obviously knowledgeable and passionate on the subject and had up-to-date info on current and emerging technologies,” Imaging Specialist R. Marek said. “Many thanks for this, it was very enlightening regarding new technological advancements in probe designs,” Biomed D. Aloyo said. The recent Nuvolo-sponsored webinar “How to Create a Single System of Record for HTM and Healthcare Facilities” adds to the great education offered through the Webinar Wednesday series. Participants not only gained valuable knowledge, they also were eligible for 1 CE credit from the ACI. The 60-minute webinar featured Nuvolo Senior Director for Solution Consulting Ben Person. Many hospitals run several legacy CMMS applications for the clinical engineering and facilities departments. This webinar discussed how Nuvolo Facilities EAM enables HTM and facilities teams to work together on a single platform, with its modern, cloud-based CMMS alternative. Webinar attendees learned how to align HTM/clinical teams with facilities to innovate health care facilities management and improve workplace experiences. They also learned how to create a single system of record and engagement for significant application consolidation as well as how to easily route work orders to improve productivity.
Attendees praised the session in a post-webinar survey. “I am always willing to learn about the biomedical field. This webinar was well done! Ben is a great speaker and very knowledgeable,” wrote C. Donmoyer, biomed manager. “First webinar I have attended and was not disappointed, the system in question seems to be a very great system and I would hope to actually utilize it one day,” said J. Townsend, biomed. “Today’s webinar was educational and very well presented. It was quite informative. I highly recommend for others to attend these webinar sessions,” shared S. Chand, biomed. For information about the Webinar Wednesday series, including a calendar of upcoming presentations and recordings of previous sessions, visit WebinarWednesday.live.
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ROUNDTABLE
STAFF REPORT
ROUNDTABLE
Sterilizers
TechNation reached out to industry professionals to find the latest information regarding sterilizers. The basic concept for sterilization has not changed too much over the years, however new technology has impacted the controls and capabilities of these devices. Mediquip Parts Plus Inc. Vice President David French, Honor Health Biomedical Equipment Technician Chris Mrazek and Prohealth Care Senior Biomed Tech Steve Pries shared their insights on these valuable medical devices. Also participating in this roundtable on sterilizers is a trio of professionals from BayCare Health System in Regional Manager J.R. Richardson, Field Service Specialist-Sterilization Christopher Wilson and Field Service Specialist-Sterilization Germaine Kinder. Q: WHAT ARE THE LATEST ADVANCES IN STERILIZERS? BayCare: Today’s sterilization equipment, similar to most medical equipment devices today, now have the capability to network to an event management database through the hospital network. Where in the past cybersecurity concerns were exempt from sterilization equipment, this is no longer the case. Additionally, today’s technology provides more options as it relates to the number and types of cycles provided by the sterilization equipment. French: Sterilization time and load sizes. Quicker cycles and bigger loads. Traceability and remote monitoring are improving. Mrazek: Over the last few decades, there have been major advancements in that just the doors alone have undergone major upgrades from manual locking to pneumatic and hydraulic doors. Now, we can even have the units hooked up to a computer system to follow the loads from OR to the sterilizers. Manufacturers can even log into systems to do remote diagnostics for reduced downtimes. Pries: While the basic sterilization process remains the same, the addition of more sensors and the increasing sophistication of the programming have made this equipment more efficient and more foolproof from a user perspective. There also continues to be a steady increase in the use of low-temperature sterilization, such as hydrogen peroxide. Q: HAS NEW TECHNOLOGY AND/OR CYBERSECURITY CONCERNS IMPACTED STERILIZERS? IF YES, HOW? BayCare: Yes. The latest sterilization equipment in the market today will connect to your network and provide alerts as well as cycle count data. Now that the sterilizer/washer connects to the 44
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ROUNDTABLE
network, the same cybersecurity concerns apply as they do with any other medical device.
more costly, we believe it pays for itself with far fewer breakdowns and a much longer lifespan.
French: Anytime you have remote access there are concerns.
Q: HOW CAN A FACILITY WITH A LIMITED BUDGET MEET ITS STERILIZER NEEDS?
Mrazek: There is always a risk, but as long as IT has a good firewall there should be no problems.
BayCare: Facilities with a limited budget may be able to meet their sterilization needs by either using more disposable inventory that do not require sterilization, using centralized sterilization methods or sub-contract the facility’s sterilization needs.
Pries: Regarding cybersecurity, most sterilization equipment now has the ability to be connected to the net. However, this also opens the equipment up to cyber-attack, so adequate protections must first be put in to place. Our sterilization equipment is intentionally not connected to the net, so cyber-attack is not a concern. The only exception we have made are the scope washers, which are quite complex, and require frequent remote troubleshooting by the vendor. New technology would mainly pertain to the addition of an ever increasing number of sensors within the equipment, as well as the increasing sophistication of the controls and programs that run these units. These additions are meant to make the equipment as foolproof as possible for the user. However, the downside is that it also leads to more frequent problems. Q: WHAT ARE THE PROS AND CONS OF BUYING BRAND NEW VERSUS BUYING REFURBISHED STERILIZERS? BayCare: Sterilization equipment consumers today primarily look for improved efficiency or productivity, when selecting new equipment. Although there may be other determining factors, the following attributes are the most common for sterilization equipment consumers: efficiency/throughput (Can we increase our productivity?), cost, chamber size, standardization and utility requirements. If the refurbished systems are competitive in these areas, or if cost containment becomes the number one emphasis of the facility, then buying a refurbished unit may make sense.
French: Refurbished sterilizers are less expensive than new. A facility must do their due diligence when selecting a refurbishing company. Know what questions to ask. Mrazek: This, again, goes back to new or refurbished? How big of a unit is needed? How much are they sterilizing? Places on limited budgets have many options such as used or refurbished units. There are lots of companies out there offering sterilizers and washers rebuilt at half the cost of new. Pries: When there is a limited budget, this usually means refurbished equipment will be purchased from a third party or the OEM. This may be cheaper in the short run, but our experience is that it usually costs us big in the long run – both in repair costs and shorter equipment lifespan. If at all possible, first choice is to purchase new from the OEM, second choice is refurbished from the OEM and third choice is refurbished from a third party. Q: WHAT ARE THE MOST IMPORTANT THINGS TO LOOK FOR WHEN DECIDING TO USE IN-HOUSE OR EXTERNAL SERVICE PROVIDERS? BayCare: Cost of service, response time and historical uptime statistics from the OEM/vendor. French: Qualifications first and price second.
French: Everything is about quality and will the company stand behind their product. Price is important, but with new or refurbished equipment if the quality is not there the price makes no difference. Mrazek: Always depends on the facility; for small rural hospitals and outpatient surgery centers refurbished is always the better option for cost effectiveness. Hospitals, I would suggest, should always buy new for the latest and greatest software and warranties – not to mention longer lifespan. Pries: Unless the budget is really tight, we will always opt for a new unit, rather than a refurbished unit. Our experience with refurbished units, whether from the OEM or a third party, has generally been negative. The OEM will stand behind their equipment, whether new or used. Third-party refurbished units are generally lower cost, but we have had problems with warranty coverage, and have also had quality problems with the refurbishing that was done. While buying a new unit is initially
ADVANCING THE BIOMEDICAL/HTM PROFESSIONAL
Mrazek: Always up front costs. In-house repairs will cost the hospital an extra FTE, but reduces downtime and costly contracts. Pries: You must do a very careful cost comparison between a vendor contract and the cost of having someone in-house. The vendor contract needs to be gone over thoroughly to verify what is actually being covered. There are always exclusions that can be very costly and are not always spelled out. If you have enough equipment, it can be very cost effective to do it in-house. However, you must take into account the cost of training, having adequate parts on hand and whether you are going to train a second person as a backup or call in the OEM when your in-house person is not available. Also, be aware that some OEMs are trying to discourage having in-house people through two methods. First, by raising the cost of parts sky high. Second, by saying that the training is only good for a certain number of years. After that, you must take another test. If you fail, you must be retrained, which is always costly.
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BUSINESS By K. Richard Douglas
ome of the world’s greatest companies have started as family businesses. Many remain family businesses after many years and, frequently, family members own large positions in the company’s stock. Well known examples include Walmart and Ford Motor Company.
About one in five firms (19.3 percent) are family-owned, according to the Small Business and Entrepreneurship Council. As of 2013, family businesses made up 35 percent of the Fortune 500. Some examples of famous father/son CEO successions include Ralph Roberts and Brian Roberts, both CEOs of Comcast. Also, Daniel Amos and his dad, Paul Amos, of Aflac. Then, there is Howard Levine and his dad, Leon Levine, CEOs of Family Dollar stores. In the trades, skilled tradespeople who have been self-employed have handed the baton off to their offspring to carry on a family business, whether it be plumbing, electrical work, roofing or drywall. The parents have understood that the work they have done has provided a healthy living and they feel confident that their trade will do the same for their kids. In the medical equipment industry and the HTM profession, the thinking goes much the same. Family members who have started out as biomeds, or who have started medical equipment companies, know that both will always be in demand. There is a level of confidence that this is a good path for the next generation of their family. With a graying baby boomer
generation requiring more health care, health care related professions are in demand. Those same baby boomers are retiring from the HTM profession, leaving a glut of unfilled positions and growing demand for more biomeds and imaging service engineers. It’s natural for a parent or other family member to suggest this beneficial career path to a member of the next generation in the family.
HTM IS A GREAT CAREER According to data from the U.S. Census, by the age of 30, 22 percent of working American men will work for the same employer, at the same time, as their fathers. The tendency to follow a parent into the same profession isn’t a complete surprise since much of it can be traced to household culture. Parents frequently instill interests into their children that they have. The parent who is working in a shop in the garage may impart that hobby or interest to a son or daughter. A child, who sees a parent working with their hands and creating something, will often seek to duplicate that skill. Glenn Scales retired from HTM in North Carolina and is a past-president of the North Carolina Biomedical Association and the group’s first vice president. He got his start as a BMET in 1967. His son was working in another
field until Scales suggested he investigate HTM. “David worked following high school at a nearby multiplex cinema in a variety of jobs including systems maintenance and digital projectionist for the 16 screens and their IMAX. It was keeping him quite busy. He was offered a supervisor’s position, but chose not to pursue this as he was hoping to find employment soon and didn’t want the theater to invest in his training, etcetera., only to leave,” Scales says. He says that his wife and he persuaded their son to enroll at a local campus of East Coast Polytechnic Institute University. “He graduated last fall with a degree in electronic engineering technology. While a student, he helped start a local chapter of IEEE and was inducted into the Phi Theta Kappa Honor Society. Half-way through his degree, he decided that he was interested in working in HTM and was able to complete an internship at Durham Regional Hospital, one of the campuses of the Duke Healthcare System,” Scales says. “So far, he has had interviews at local hospitals, but has not yet been hired. Most of the positions have been filled by candidates with several years of experience and he is getting a bit frustrated but is still looking to get into HTM. Many of the local hospitals want to interview people with multiple years of experience and it’s difficult to get into entry level positions straight out of a two-year engineering program,” Scales adds. Dave Francoeur, senior director of
BUSINESS brand and quality at Sodexo Clinical Technology Management, has been an influence on several family members’ decision to join the HTM ranks. Francoeur, who has a long history in HTM management, and was once the chair of AAMI’s Technology Management Council, introduced his brother, stepdaughter, godchild/ second-cousin and nephew to the field. “Morgan had just graduated high school and did not know exactly what she wanted to do,” he says of his stepdaughter. “She was thinking about becoming a radiologist, I was able to get her visits to the radiology department as well as the HTM department so she could review them both. After a few conversations she chose to get her AS in HTM. Today she is a successful HTM professional.” “My godchild/second cousin obtained his bachelor’s degree in computers. I hired him to be the department CMMS manager/overseer. Once he got into the day-to-day operations of the HTM community, I sent him to training for maintaining fetal monitoring and telemetry systems. Today, he is fully integrated into the HTM department,” Francoeur says. His nephew had served in the military as a helicopter maintenance
mechanic individual for five years. Francoeur worked with him to acquire a few skill sets and apply for a role within HTM. He is now a successful HTM professional. “My brother was a tool and die individual and not happy,” Francoeur says. “I was able to work with him and got him an opportunity within the organization I was working. Today he is one of the organization’s, for which he works, highest regarded site managers.” Bill Hart, a clinical engineering supervisor at Lakeland Regional Health in Lakeland, Florida, passed the baton to the next generation also. Hart’s son decided to enter the HTM profession after having the opportunity to rub elbows with those in the field. “He was in high school and had mentioned a few professions that included health care like EMT, etcetera. I had brought him into the hospital on many occasions for school projects and student day. Then, when EMT was not his thing, he asked about HTM,” Hart says. Hart says that he has always been active in the local and state HTM societies and yearly symposium. “I would encourage him to attend with me and see if this was something he would be interested in. It didn’t take
long that he started to know on a first name basis individuals and manufacturers in the HTM field. Soon afterward, he enrolled in a local technical school call Aparicio-Levy. I would speak to the students from time to time and elaborate on the HTM field. After graduating, he landed a job just north of Orlando and the rest is history,” Hart says. With two generations in the HTM profession, the conversation changes as the learning curve advances, as Hart has learned. “For him it was a lot of questions in the beginning, such as how would I perform this or who would be a good contact for this,” he says. “Now, I have someone to talk to about the HTM field. We bounce ideas back and forth. I would ask about his daily activities and see if I could use some of the ideas, such as what CMMS or test equipment. Altogether, it feels that as a dad, I have extended my knowledge through him to continue and contribute to a profession that we both have a passion for. As I have told him; ‘We work on equipment that works on you,’ ” Hart adds.
“ I am second generation imaging service as well. My father, Dale Cover Sr., was with Picker X-Ray/Philips from the early 1970s until he retired. In the mid-1980s, I was working for various government contractors in the communications field. Employment issues between contracts was a problem and my father convinced me to give imaging a try. My dad and Terry’s father were friends, so I went to RSTI for basic X-ray classes and the rest is history.
”
– DALE COVER JR., PRESIDENT AND COO OF RADIOLOGICAL SERVICE TRAINING INSTITUTE (RSTI) 52
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FAMILY BUSINESS IN MEDICAL EQUIPMENT The medical equipment industry reflects the larger business community with family-businesses well-represented. It has been common for a parent to strike out on their own and start a small business, with an offspring joining in later. Many of the medical equipment businesses, that are familiar to biomeds, are either family-run or include the next generation. At Radiological Service Training Institute (RSTI), in Solon, Ohio, the founder’s son, Terry Speth, remains as the second-generation in the business. WWW.1TECHNATION.COM
“ There is a strong trust and Speth’s late father started the business in 1985 and his wife is the company’s CFO and CEO. The company’s president and COO, Dale Cover Jr., also followed his dad’s lead in the imaging business. “Terry Jr. worked at RSTI on summer breaks during college and began working here full time thereafter. Terry actually purchased his shares of the company from existing shareholders several years ago,” Cover says. “I am second generation imaging service as well. My father, Dale Cover Sr., was with Picker X-Ray/Philips from the early 1970s until he retired. In the mid-1980s, I was working for various government contractors in the communications field. Employment issues between contracts was a problem and my father convinced me to give imaging a try. My dad and Terry’s father were friends, so I went to RSTI for basic X-ray classes and the rest is history,” Cover says.
mutual respect between the two of us. My father laid the foundation of Technical Prospects which has given myself and my team the opportunity to lead the company into the future.
”
– JEREMY PROBST, PRESIDENT AND CEO OF TECHNICAL PROSPECTS
Bruce Hull, general manager for Network Imaging Systems (NIS) in Charlotte, North Carolina, started his business in 2002. He was the lone employee for the next couple of years. “As business picked up, I was spending most of my time taking service calls, looking for new customers and managing accounts,” Hull says. His son, Brent, was not yet a part
of the company. “Brent had graduated from Georgia Tech in 2002 with a master’s in mechanical engineering, and he was working for an engineering firm in D.C.,” Hull says. “In 2004, during the week between Christmas and New Year’s Eve, Brent was at home for the holidays and we were discussing what I did on service calls. He went with
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BUSINESS me on a call during that week, and he liked the CT technology. Six months later, he was the first dedicated NIS Field Service Engineer. Within the next 12 months, we had added new service accounts and opened our first warehouse for inventory storage, parts testing and system testing,” Hull adds. He says that NIS was restructured from a LLC to a S Corporation and Brent and he became partners in 2008. “Today, we both enjoy the variety in our work. We have dedicated employees – field engineers, salesman and an office manager – and a shop with four CT bays, a paint booth and MRI trailer that we use for training and testing. We buy, refurbish, sell, install and maintain CT/MRI systems. We are thankful every day for the opportunity to do it again tomorrow,” Hull says. In 1997, Robert Probst founded Technical Prospects. “He wanted to fill an industry gap by offering Siemens-specialized equipment engineering and turn-key equipment sales,” says his son Jeremy Probst, who is now the president and CEO of the company.
“ My junior year, my dad told me that I could come work for him and learn the business and take it over from him when he retired, if I wanted to. He made it very clear that if I did not want to DO it, it would not upset him and he would support me in whatever career path I chose, but he wanted me to know it was an option.
”
– SARAH LEE, CUSTOMER RELATIONS MANAGER AT THE INTERMED GROUP.
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“He then moved into the parts business shortly after noticing an opportunity to supply the industry with quality replacement parts. Having previously worked on Siemens CT equipment for more than 18 years,” he adds. When his dad made the move to venture into additional modalities beyond Siemens CT, he was going to need help. “I had recently graduated from the University of Wisconsin-Platteville with a degree in industrial technology management and, with that, offered a new perspective and understanding of the industry and technology,” Probst says. “I joined him, and with the help of my brothers, we grew the company.” What began as a one-man operation in a 10-foot by 10-foot bedroom has grown into a 72,000-square foot facility. “To keep that momentum, we invested in enterprise resource planning (ERP) software to help streamline processes and better manage all aspects of the company, further helping us set Technical Prospects up for infinite growth in the years to come,” Probst adds.
“I believe that having our roots as a family business has created an extra emphasis on providing the best quality parts, services and training possible. Our team works to provide health care facilities with the same level of quality support that we would want to receive if our own family members were receiving care there,” he says. What is it like taking the reins of a business that a parent began? “There is a strong trust and mutual respect between the two of us. My father laid the foundation of Technical Prospects which has given myself and my team the opportunity to lead the company into the future,” Probst says. “In the same way I push my team to provide the best services and parts possible, he always pushes me to ask myself, ‘How can we continue to improve?’ He is just as excited for the future of the company as any of us, and to see how our business continues to grow and evolve to meet customers’ distinct needs,” he adds.
GETTING MANY FAMILY MEMBERS INVOLVED Carolina Medical Parts has also been a family-run business in the medical parts space since its inception. The company was founded by Rick Sagadin and his wife, Kay, in 2004. “Rick started his career in the medical field with GE in the mid-80s in their CSI research and development department in California,” says Kay Sagadin. “From there, he moved on to Diasonics (Toshiba) as a field service engineer. After a move to Pennsylvania and then North Carolina, he decided to start his own MRI service company, Technology Management Group (TMG) along with two partners,” she says.
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Kay also worked at TMG as a sales consultant and administrator. TMG became successful as a service company and also as a repair facility for other independent service organizations parts as well as repairs for the OEMs. TMG was purchased in 1998 by Picker International. Rick remained with Picker-Marconi-Philips for five years. Sagadin says that in 2004, she and Rick left Philips to start Carolina Medical Parts as a stand-alone repair facility. In 2005, their daughter, Katrina, and their son-in-law, Chuck, joined the company as a sales consultant and refurbishment specialist, respectively. “Again, in 2014, the family part of the business expanded when grandson, Kyle, joined the company as a part-time employee after school and during the summer. Now younger brother, Jason, is on board doing the essential low-tech jobs that no one else wants to do,” Sagadin says. Carolina Medical Parts has grown from a new entity in 2004 to a company with worldwide recognition today. Sometimes families grow a business and then sell it. That was the case with Rick Player, the owner of Medical Imaging Technologies Inc. and his daughter, Sarah Lee, who was the company’s chief operating officer. “My dad started his business in 1987. He had worked for Phillips for a little while and decided to start his own CT service business. Growing up, I always went to the office with him and traveled all over when he went on service calls. I was attending Florida State University, planning on either going to medical school or pharmacy school,” says Lee, who is now the customer relations manager at The InterMed Group. “My junior year, my dad told me that I could come work for him and learn the business and take it over from him when he retired, if I wanted to. He made it very clear that if I did not want to do it, it would not upset him and he would support me in whatever career path I chose, but he wanted me to know it was an option,” she says. “I decided to take him up on his offer, so after I graduated, I moved to Augusta and started working for him to learn the business.” She says that in April of 2018, he sold the business to The Intermed Group. What would Lee suggest to an HTM professional considering making the leap to self-employment? “I would tell them it is harder than you think to just start a business in health care, so to make sure they do their research about everything you need, like liability insurance, state certifications, etcetera,” she said. Whether supplying medical device parts, service or training, in addition to maintaining those devices as part of an in-house operation, the importance of supporting patients and health care has been worth keeping in the family. With the need for health care increasing and the growing complexity of technology, the goal of passing these important roles to the next generation cannot be underestimated.
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EXPERT ADVICE
BY CINDY STEPHENS
CAREER CENTER
Questions to Ask During a Job Interview BY CINDY STEPHENS
Y
ou made it to the face-to-face interview and everything seems to be going great. Then, the hiring manager asks, “Do you have any questions for me?” All of sudden your mind goes blank. How you respond can make a difference in the hiring decision.
First, it’s important to remember that interviews are an exchange of information. The job interview is not only for the hiring official to determine if you are the perfect person for the job. It is also a critical time for you to gather the right information to make an intelligent decision. You should be prepared with questions that show your sincere interest in the company and the position. This will help determine if the job is a good fit for you. Prior to the interview, you should research the company and the job requirements. It is important to think ahead. Asking the hiring official questions shows your interest in the job and the company as a whole. Prepare questions about the specific job duties and responsibilities to clarify the job description you reviewed prior to your interview. Also, ask who will serve as your direct supervisor (Director of Healthcare Technology Management, Shop Supervisor, Regional Manager). After researching the company, develop well-crafted, probing questions. If you have an opportunity to interview with a peer, ask them “What did you do yesterday?” This may tell you more about that person, the job and the company culture than you will get from the person describing the job to you. During the interview, consider asking your interviewer to describe the company’s philosophy and values to
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determine whether you are a good fit with the company’s culture. This is when you show your interviewer how much you truly know about the company. Inquire about the history of the position. It’s important to understand why the position is now available. You may want to ask the reason the position is open and how long it has been vacant. You might inquire as to why the previous person left the position. If they want to share the answer to your question, you can very quickly tell from their answer if this is a company that advances its people (person was promoted) or if there is an issue with expectations or internal differences. Either way it opens the door for further discussion. Ask about the biomedical or service department’s strengths and weaknesses. Interviewees rarely ask this question, however, it will allow you to better understand the current dynamics of your potential colleagues. It gives you the opportunity to elaborate on how you can complement their strengths. For example, if one of the BMETs is known for seeing the big-picture, you can complement this with your attention to detail. Ask about the accomplishments of the previous employee; this may provide you with some insight as to expectations. Ask about the goals of the position and the department. Determine what the hiring manager wants you to accomplish. If you are really interested in the position, and you want the job, then be sure and ask, “What is it you want me to get accomplished in the first six months – first year – in the position?” That will get their attention very quickly and
CINDY STEPHENS, CPS/CTS Stephens International Recruiting, Inc.
shows the interviewer that you are an individual that plans for the long term. Also, ask the interviewer about their professional background. Some interviewers love the opportunity to talk about their career. These questions show you’re interested in the job, as well as the company and the interviewer. Before the close of the interview, ask the hiring manager to explain the selection process and ask when you can expect to hear back from the company. Also be prepared to respond to specific questions about your resume including gaps in employment, reasons for leaving, etc. However, be sure to never speak negatively about any prior employer, supervisor or company. Never stretch the truth, either, about possible discrepancies or vagueness in your responsibilities or salary. Remember that it is up to you to convey enthusiasm, confidence, energy, motivation and technical skills during your interview. The interview is also your opportunity to exhibit excellent communication skills.
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EXPERT ADVICE
BY MICHAEL DAVIS
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ULTRASOUND EXPERT Saving Money on Replacing Parts BY MICHAEL DAVIS
W
e’ve all been there. A control panel is not functioning, and you send it in for repair. A few days later you receive a call stating that the part is not repairable, and you will have to order a new one. This is even more frustrating when a full replacement is substantially more than an exchange. What happened? Why is it not repairable?
Many companies return a piece of hardware on exchange with the expectation that there is no physical damage to the hardware. If a cosmetic piece is cracked, disfigured or broken, it cannot be repaired. An example would be a control panel for a Siemens S2000. These come in with chunks out of them. At that point, all we can do is scrap the housing and order a new panel. This purchase price must then be added to the customer’s final cost. When we receive a control panel that is not damaged, we can begin the refurbishment process. We will replace any defective electronic components, thoroughly clean the cosmetics and boards, replace the membranes and fully test the panel. This process comes with a substantial cost savings to the customer. The best way to keep your cost of repair down is to remove the hardware you want to exchange carefully. Bent pins, missing plugs and damage can make the hardware unrepairable.
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Here are some tips to ensure proper removal of the hardware. 1. Ensure all the fastening hardware is removed. All of the screws and clips need to be removed. 2. Ensure that every cable is disconnected. Some cables are more difficult than others to disconnect. 3. Lift or slide all hardware in a straight line avoiding contact with other hardware. 4. If you feel any resistance, stop and check to see why. Some hardware has hidden fasteners that are easily missed. 5. If you have never removed this part before, please refer to the service manual for guidance. If a service manual is unavailable, contact technical support. Conquest Imaging offers free technical support 24x7. 6. When packaging the parts for shipping, make sure it is fully protected. Electronics need to be in an antistatic bag. And the box needs to be fully padded with a minimum of 1 inch of room on each side of the hardware. As always, take it slow, no need to rush removing the parts. These steps will insure that the part you are sending for repair or exchange will arrive undamaged and repairable.
MICHAEL DAVIS Technical Support Specialist
For installation and removal videos, or ultrasound technical tips and tricks visit www.conquestimaging.com. Conquest Imaging Technical Support is available 24/7/365 at 866-900-9404.
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ISN’T IT TIME FOR YOU TO FIND OUT MORE? Come grow with us. Please contact: Come see why Crothall has earned Modern Healthcare’s Best Places to Work four years in a row.
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EXPERT ADVICE
BY JIM FEDELE
THE OTHER SIDE
Medical Equipment Management Plan Evaluated by Patient BY JIM FEDELE
T
oday, I write from the perspective of the other side of equipment. I, unfortunately, needed to spend some time in my hospital as a patient. These situations are always stressful and frightening. I used the experience to assess how our medical equipment management plan works and if the message gets to the nursing team.
I was admitted in the off shift for catheterization, I had been experiencing chest pains on and off for a week, but did not have any other symptoms. To make a long story short, one our most gifted cardiologist saw something on my EKG that no one else detected and decided we were going to the cath lab. This situation exposed me to our emergency department, our cath lab, our ICU and our step down unit. I can’t imagine a better sampling of departments to evaluate our plan. For my problem, they used X-ray, ultrasound, EKG machine, patient monitors, IV pumps and scales. I know this sounds odd; I should have been focusing on taking care of myself first. However, I had a lot of down time to think. I am not very good at turning off work. So, I used this situation to my advantage and to get a perspective that I had never considered in all my years here. Although this situation was frightening I was able to observe staff actually utilizing the equipment. I was able to see firsthand if staff really knew what was going on with their equipment and if they knew how to use it correctly. What also made the evaluation more
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impactful is that I was admitted during the second shift, which means we had a lot of newer nurses on and even some agency nurses. Luckily for me the catheterization procedure went very well, all the equipment worked as expected, no delays or complications. They did what they needed to do and had me in the ICU in about an hour. However in the ICU they had me connected to an IV pump that started beeping “low battery.” I summoned the nurse who checked the pump and stated it wasn’t charging. I resisted telling him why (they had the cord wrapped tightly on the mount and damaged the strain relief). He checked the plug and the cord and decided to change the pump out. I watched with pride as he put the red defective label on the pump and sent it to be cleaned. One test passed! The next issue I had was a telemetry transmitter, I noticed it lit up in my pocket and beeped with a message to “discharge patient.” I paged the nurse, she reset the box and went on her way. The unit worked for about 10 more minutes and then did the same thing again. This time I waited a little before calling the nurse, I wanted to see if the telemetry tech would notice the problem. Within a few short minutes the nurse came back in with a new telemetry transmitter to replace the malfunctioning one. I felt great that they solved the problem perfectly. As I was going through this situation with my health and worrying about what was happening to me, I felt good about the equipment they were using to diagnose me. I am a strong proponent of evidence-based maintenance and
JIM FEDELE, CBET Director of Clinical Engineering for Susquehanna Health Systems
AEM principles. I feel patient safety is not impacted by the decisions to implement these strategies. However, the decision becomes very real when they are hooking up that monitor to you or diagnosing you with an ultrasound because they can’t figure out what is going on. I was not worried at all about the information the clinicians were getting from the equipment. Frankly, when they did get a reading that did not make sense they just redid it to make sure the reading was true. I know that sometimes I feel like the people using and breaking the equipment are careless and clueless, but I found out that the majority of our clinicians are really smart people. They know how to use the equipment, they know how to follow policies and they know how to take care of people. I feel good that our equipment management plan is followed and mostly understood, even if they don’t know they are following a plan. For me, my situation is only going to get better, they found a blockage, fixed me up and I feel better than ever. I can’t wait to get back outside to enjoy the outdoors. Jim Fedele, CBET, is the director of clinical engineering for Susquehanna Health Systems in Williamsport, Pa. He can be reached for questions and/or comments via email at info@mdpublishing.com.
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EXPERT ADVICE
BY MANNY ROMAN
ROMAN REVIEW Smart and Funny BY MANNY ROMAN, CRES
I
am amazed at how many times recently I heard “(S)He is smart and funny.” Now putting aside what amazes a simple mind, I decided to explain in detail what it means to be smart and funny.
In context, this statement is often used to describe why the speaker is attracted to someone, especially if we want to avoid any sexual connotations. Often the discussion is a serious justification for the feelings and emotions involved. It may even be the explanation why the individual has been selected as the significant other (this having to be politically correct is killing me). Smart alone is not really enough as it may present itself as arrogance and distant. Funny alone is not enough as it may present itself as a charlatan and foolish. It is the perfect balance of smart and funny that makes for an attractive and desirable individual. Smart and funny go together to form an attractively balanced package. Throw in “generous” and you have perfection. Generous adds that giving component that makes a person want to be kind and giving. After all, we all want to be on the receiving end of that. So what does it mean to be smart? It does not mean intelligent or all knowing or book learning. It is a kind of street smart, which is defined by practical
ADVANCING THE BIOMEDICAL/HTM PROFESSIONAL
knowledge of situational awareness. It is knowing what is needed in the moment by the audience. As a professional instructor, I have always said that one must know the audience prior to stepping in front of them. Smart is having experience in quickly assessing a situation to ascertain what is appropriate and relevant now. What about funny? It is simply the ability to perceive humor in almost everything and presenting the humor with appropriate timing in a nonthreatening and chuckle-eliciting fashion. The key here is to time the humor to get just a chuckle or a smile. Raucous laughter is not a requirement. Thus, conversation is not permanently interrupted and no one gets their feelings hurt. So, does that mean that people will not be attracted to people who are just smart or just funny? No, of course not. If that were true most of us would go through life in full knowledge of why we are alone or in the tears of a clown. Luckily, there is a difference between long-term and short-term attraction. In the short term, we are attracted to a huge variety of things such as beauty, wealth, profession, lifestyle, etc. If you are not carful, you may wind up like the girl in the song “Lyin’ Eyes” by the Eagles. Smart and funny provide long-term attraction. I asked my lovely wife, Ruth,
MANNY ROMAN, CRES AMSP Business Operation Manager
why that is so. She said, “Going through life is difficult enough without having some entertainment factor.” This explains why, when I say something funny and others give her a quizzical look, she says, “What can I say? He’s entertaining.” So, we are all looking for someone with whom we can have an intelligent conversation sprinkled with just the right amount of humor. This provides the opportunity to bond. We are all bonded by nature, nurture, chance or choice. This falls into the choice bonding which makes the relationship more satisfying. Smart and funny are not just for the selection of the significant other. They play an important part in the friendships and other relationships we establish. So, what can you do if you suspect that you are only smart or funny or neither? Ask someone you trust to provide the answer for you. Be prepared to be disappointed in the answer. I always say, “Don’t ask a question if you don’t want to hear the answer.” Not everyone can be as smart, funny, generous, tall, dark, handsome, shy, modest and humble as I am.
JULY 2018
TECHNATION
63
EXPERT ADVICE
BY STEVEN J. YELTON
THE FUTURE
Recruiting HTMs into the Field BY STEVEN J. YELTON, P.E., CHTM
O
ne of the most difficult challenges facing the HTM field is attracting professionals to join the profession. This is also true of educators trying to recruit students into their HTM programs. This isn’t a unique challenge facing only HTM. I find it to be the case for most of our college programs and for the same reasons that I will mention in this article. When the economy is strong and unemployment is low, we have difficulty recruiting.
For the past several years, AAMI has put considerable effort into helping address this issue. With the help of HTM leaders in the field, AAMI has developed videos, promoted the profession in radio interviews, created brochures for all of us to distribute at career days and developed an IamHTM.org website where many free resources are located. AAMI has also become the lead society for accrediting HTM educational programs within the Technology Accreditation Commission of the Accreditation Board for Engineering and Technology (TACABET). In addition, AAMI has created a task force within the Technology Management Council to continue to focus on the issue, and recently hosted a Future Forum IV event that focused on the challenge of recruiting HTM professionals into the field. I had the privilege to participate in the Future Forum IV event, a two-day
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event held at AAMI headquarters where constituents from AAMI membership were well represented. It was remarkable to meet with people from all areas of HTM and to put our heads together to further our work toward a solution to this problem. It became clear that there is no simple solution to the problem and it will take some thinking outside of the box to be successful. Initially, I thought that if we could all recruit a large number of students into our programs we would be able to solve this shortage of HTM professionals. The shortages that I’m really referring to are technicians at the associate and bachelor’s degree level. Now, I’m not sure that this is the solution. In my experiences in the community college environment, most students do not want to relocate. Many are mid-life career changers, have spouses with jobs locally and have children in school. This becomes a big challenge. If I was able to recruit a large number of students into my program, I wouldn’t be able to place all of them into co-operative education positions while they are in school. There wouldn’t be enough open positions locally for everyone. In my opinion, if graduates would be willing to relocate, they would have it made. However, that’s not generally their preference. It became clear in the Future Forum IV meeting that most educators around
STEVEN J. YELTON, P.E., CHTM
the country are experiencing the same problem with students not wishing to relocate. We need to figure out a way to enable many more HTM programs to open in areas without programs close by. The first thing to remember is that HTM programs are expensive with equipment requirements and other expenses. Most HTM programs tend to be small in comparison to other programs within the college. College administrators are generally not interested in funding programs like this. For a long time, I have been thinking that maybe AAMI can help in that area. I’m currently talking with AAMI University about offering HTM courses online that could be add-on courses to programs that are offered at many more colleges than have HTM programs. We are in the beginning stages of trying to figure out if this is feasible. My suggestion is that if a local college offers an electronics or electromechanical program they could have any interested students also take the AAMI HTM courses that would give them biomedical instrumentation
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experience. There are many colleges with electronics-related programs that do not have an HTM program. I also recommend that these students partner with a local hospital to do laboratory experiments that AAMI would provide as part of the course work. I would also like to note that there currently are colleges that offer HTM courses online for anyone to take. There are hospitals and health care organizations that hire people without formal biomedical instrumentation experience. They have an electronics and troubleshooting background, but lack formal training in HTM. This online arrangement from AAMI would be helpful to this group. I feel that educating HTM professionals is an area where we have always looked at new and innovative ways to provide students with needed information. We have to be open to new ideas and be willing to use new modalities for delivering instruction. We also have to
be willing to use them to recruit for our field. Remember, when we go to work each day we have the opportunity to change people’s lives for the better. When we recruit someone new into our field, we are changing their life for the better. We are helping them to embark on a rewarding and exciting career that they can be excited about for years to come.
– Steven J. Yelton, P.E., CHTM, is a senior HTM engineer at the Christ Hospital Health Network in Cincinnati, Ohio and is an HTM professor at Cincinnati State Technical and Community College. He is a member of AAMI’s Board of Directors executive committee, AAMI Foundation Board of Directors, 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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BREAKROOM
THE VAULT
D
you consider yourself a history buff? Are you widely regarded among coworkers as an equipment aficionado? Here is your o 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-july-2018. Good luck!
JULY PHOTO
MAY 2018 WINNER David Green, Biomedical Equipment Support Specialist VA Hospital Kerrville, Texas
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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BREAKROOM
SCRAPBOOK
San Antonio HTM Week Celebration
T
he Medical Education and Training Campus (METC), a United States Department of Defense (DoD) integrated campus under a single university-style administration, at Joint Base San Antonio on Fort Sam Houston, Texas celebrated Healthcare Technology Management (HTM) Week by promoting the awareness and appreciation for the critical work of biomedical equipment technicians (BMETs), clinical engineers and other members of the healthcare technology management field. The celebration was built around the theme “The Founders and the Future: 71 Years of HTM Excellence.� The initial kickoff consisted of an Esprit de Corps Fun Run with Army, Air Force and Navy tri-service. This catapulted into multiple breakfasts and lunches throughout the week to build unit and team cohesion. The staff participated in two career fairs at the STEM Expo representing the organization. The team also coordinated multiple BMET program tours for high school students and vendors from across the nation. A conventional vendor fair for over 500 BMETs, clinical engineers and other members of the healthcare technology management field provided an opportunity to learn about different vendors. They showcased new products, technologies and equipment, then coordinated guest speakers from different organizations to provide education and background of their operations. The BMET program finalized the HTM Week celebration with a BBQ/potluck luncheon.
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BREAKROOM
AAMI 2018 - Long Beach, CA
H
TM professionals discovered new technologies that can improve a facility’s health care delivery and increase their own productivity and professional knowledge at the AAMI 2018 Expo. Representatives of about 200 exhibiting companies, including many of the world’s leading medical device manufacturers and service providers, were on hand along with more than 2,500 HTM professionals from across around the world.
1. S uly Chi of the American College of Clinical Engineering providing information to AAMI attendees.
during Sunday’s expo hall hours. 5. TechNation team members look on as President John Krieg welcomes more than 300 readers and advertisers to TechNation’s 10th annual VIP Reader Party, sponsored by MedWrench.
2. T he AAMI Expo Hall boasted more than 200 medical equipment manufacturers and service providers. 3. The Siemens Healthineers booth encouraged attendees to be creative with a giant coloring board.
6. D atrend Systems Inc., a biomedical engineering company focused on manufacturing biomedical testing equipment, was one of over 200 exhibitors at AAMI 2018.
4. Tim Michener led an informative discussion for HTM professionals
8. T he TechNation team has a great streak at AAMI. 2018 was another year of knocking it out of the park by hosting the best attended networking event during the conference.
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7. MedWrench Director of Sales & Marketing Kaylee McCaffery celebrates a successful 1st annual MedWrench Scavenger Hunt with over $2,500 in prizes
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BREAKROOM
BULLETIN BOARD
A
n online resource where medical equipment professionals can find all the information needed to help them be more successful! The easy to navigate Bulletin Board gives you access to informative blogs, expos and events, continuing education opportunities, and a job board. Visit www.MedWrench.com/BulletinBoard to find out more about this resource.
Career Opportunities
CONTINUING EDUCA TION
Visit www.MedWrench.c om/BulletinBoard for m ore details and to register for these upcoming classes .
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Imaging Product Specialist
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Effectively advance Imaging sales through the existing customer lists Navigate the internal hospital/IDN environments to reach decision makers Update customer records with relevant information (contact names, titles, etc.) Schedule meetings and presentations to organizational leadership Execute strategic sales plans and work with leadership to achieve overall performance goals.
Visit https://www.medwrench.com/bulletin-board/careers for more information.
Q ua lit y
ISO 90 01 :20
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Aug 7 – C onquest Im aging: Ultrasoun d Basics C ourse
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BREAKROOM WHAT IMPACT DO AUDITS HAVE ON BIOMEDS A Q&A with James Linton at Canadian Blood Services
Link to content- https://www.medwrench.com/article/52395/a-q-a-with-james-linton-at-canadian-bloodservices-what-impact-do-audits-have-on-biomeds What impact do Audits have on Biomeds? We talked with James Linton at Canadian Blood Services to answer this question once and for all! What do audits mean to a biomed department? Audits are completed for a variety of reasons ranging from health and safety to procedural and policy to general supplier audits and so forth. Each of these have very different missions but they all share the same principals of being in place to ensure all work an work related activities are performed as required. In general audits however mean a stressful time for biomed managers and frontline staff as they may feel unfairly scrutinized. Quite often feelings of resentment or dread can occur prior, during or post audit, which lead to unnecessary stress. I say unnecessary because at their core the audit is to Right the ship and point out opportunities for improvement. In fact a well-run department may point an auditor at areas they are concerned with to have them help diagnose problems. My advice is to welcome auditors with open arms and an open mind. In the end they are not there to discipline (which many believe can be the case) or cause chaos, but to improve the safety of the staff and equipment we are responsible for. It is vital that this message is believed at all levels of a biomed department to avoid any negative impacts. Read more here: www.medwrench.com/bulletin-board/
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SERVICE INDEX TRAINING
SERVICE
Cardiac Monitoring
A.M. Bickford 800-795-3062 • www.ambickford.com
67
Entech 800-451-0591 • www.entechbiomedical.com/
FC
P
Gopher Medical 844-246-7437 • gophermedical.com
11
P P
RepairMED 855-813-8100 • www.repairmed.net
76
USOC Bio-Medical Services 855-888-8762 • www.usocmedical.com
7
Soaring Hearts Inc (855) 438-7744 • www.soaringheartsinc.com/
P
P P
Asset Management Asset Services 913-383-2738 • www.assetservices.com
PARTS
Anesthesia
Company Info
AD PAGE
TRAINING
SERVICE
PARTS
AD PAGE
Company Info
Batteries 62
PartsSource 877-497-6412 • www.partssource.com/shop
6
P
Gopher Medical 844-246-7437 • gophermedical.com
11
P P
InterMed Group 386-462-5220 • www.intermed1.com
3
P
Southeastern Biomedical, Inc 828-396-6010 • sebiomedical.com/
57
P P
Southwestern Biomedical Electronics, Inc. 800-880-7231 • www.swbiomed.com/
15
P P
Injector Support and Service 888-667-1062 • www.injectorsupport.com
39
P
RSTI 800-229-7784 • www.rsti-training.com
INS
P P P
Tri-Imaging Solutions 855-401-4888 • www.triimaging.com
20
P P P
39
P P
Cardiology
Computed Tomography
37
Holden Battery Services, LLC 800-594-9257 • www.x-raybatteries.com
53
P
Biomedical
Contrast Media Injectors
ALCO Sales & Service Co. 800-323-4282 • www.alcosales.com
67
BC Group International, Inc 314-638-3800 • www.BCGroupStore.com
BC
Crothall Healthcare Technology Solutions (800) 447-4476 • www.crothall.com
60
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Diagnostic Imaging
D.A. Surgical 800-261-9953 • www.da-surgical.com
23
P
Advanced Ultrasound Electronics, Inc. 1-866-620-2831 • www.auetulsa.com
Entech 800-451-0591 • www.entechbiomedical.com/
FC
P
Endoscopy
iMed Biomedical 817-378-4613 • www.imedbiomedical.com
67
P
Healthmark Industries 800-521-6224 • HMARK.COM
27
Master Medical Equipment 866-468-9558 • masterfitmedical.com
43
PRN/ Physician's Resource Network 508-679-6185 • www.prnwebsite.com
77
P P
oneSOURCE 1-800-701-3560 • oneSOURCEdocs.com
21
Total Scope, Inc (800) 471-2255 • www.totalscopeinc.com/
25
P P
oneSOURCE 1-800-701-3560 • oneSOURCEdocs.com
21
General
PRN/ Physician's Resource Network 508-679-6185 • www.prnwebsite.com
77
P P
ReNew Biomedical 844-425-0987 • www.ReNewBiomedical.com
67
P
RepairMED 855-813-8100 • www.repairmed.net
76
P P
Total Scope, Inc (800) 471-2255 • www.totalscopeinc.com/
25
P P
ADVANCING THE BIOMEDICAL/HTM PROFESSIONAL
Injector Support and Service 888-667-1062 • www.injectorsupport.com Maull Biomedical Training
440-724-7511 • www.maullbiomedicaltraining.com
ALCO Sales & Service Co. 800-323-4282 • www.alcosales.com
57
P
33
P P P
67
Imaging Entech 800-451-0591 • www.entechbiomedical.com/
FC
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SERVICE INDEX CONT. TRAINING
SERVICE
PARTS
USOC Bio-Medical Services 855-888-8762 • www.usocmedical.com
Infection Control Healthmark Industries 800-521-6224 • HMARK.COM
Company Info
AD PAGE
TRAINING
SERVICE
PARTS
AD PAGE
Company Info
7
P P
6
P P P
MRI
27
PartsSource 877-497-6412 • www.partssource.com/shop
Infusion Pumps AIV 888-656-0755 • aiv-inc.com
55
P P
Nuclear Medicine
Elite Biomedical Solutions 855-291-6701 • elitebiomedicalsolutions.com
31
P P
Global Medical Imaging 800-958-9986 • www.gmi3.com
2
P P P
Master Medical Equipment 866-468-9558 • masterfitmedical.com
43
P P
InterMed Group 386-462-5220 • www.intermed1.com
3
P
Infusion Therapy
Online Resource
AIV 888-656-0755 • aiv-inc.com
55
P P
MedWrench 866-989-7057 • www.MedWrench.com
41
Elite Biomedical Solutions 855-291-6702 • elitebiomedicalsolutions.com
31
P P
oneSOURCE 1-800-701-3560 • oneSOURCEdocs.com
21
FOBI 888-231-3624 • www.FOBI.us
62
P P
Webinar Wednesday
Master Medical Equipment 866-468-9558 • masterfitmedical.com
43
P P
Oxygen Blender
RepairMED 855-813-8100 • www.repairmed.net
76
Select BioMedical 866-559-3500 • www.selectpos.com
62
P
USOC Bio-Medical Services 855-888-8762 • www.usocmedical.com
7
P P
FOBI 888-231-3624 • www.FOBI.us
Labratory 59
62
P P
PACS RSTI 800-229-7784 • www.rsti-training.com
P
INS
AIV 888-656-0755 • aiv-inc.com
55
P P
Ampronix, Inc. 800-400-7972 • www.ampronix.com
4
P P
P P
BMES 888-828-2637 • www.bmesco.com
79
P P
P P P
Gopher Medical 844-246-7437 • gophermedical.com
11
P P
Integrity Biomedical Services 877-789-9903 • www.integritybiomed.com
37
P P
Master Medical Equipment 866-468-9558 • masterfitmedical.com
43
P P
47, 60
P P
P P
Mammography Ampronix, Inc. 800-400-7972 • www.ampronix.com RSTI 800-229-7784 • www.rsti-training.com
4 INS
Monitors Select BioMedical 866-559-3500 • www.selectpos.com
62
P
Pacific Medical
Monitors/CRTs
800-449-5328 • www.pacificmedicalsupply.com
Ampronix, Inc. 800-400-7972 • www.ampronix.com
4
P P
BMES 888-828-2637 • www.bmesco.com
79
P
Integrity Biomedical Services 877-789-9903 • www.integritybiomed.com
37
P P
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Patient Monitoring
Ozark Biomedical 800-457-7576 • www.ozarkbiomedical.com
74
800-906-3373 • www.1technation.com/webinars
JULY 2018
PartsSource 877-497-6412 • www.partssource.com/shop
6
P
PRN/ Physician's Resource Network 508-679-6185 • www.prnwebsite.com
77
P P
ReNew Biomedical 844-425-0987 • www.ReNewBiomedical.com
67
P
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SERVICE INDEX CONT. P P
Software
Southeastern Biomedical, Inc 828-396-6010 • sebiomedical.com/
57
P P
MediMizer Inc. 888-838-4440 • www.MediMizer.com
Southwestern Biomedical Electronics, Inc. 800-880-7231 • www.swbiomed.com/
15
P P
Surgical
USOC Bio-Medical Services 855-888-8762 • www.usocmedical.com
7
P P
Healthmark Industries 800-521-6224 • HMARK.COM
Radiology 4
Holden Battery Services, LLC 800-594-9257 • www.x-raybatteries.com
62
RSTI 800-229-7784 • www.rsti-training.com
INS
P P P P P
Recruiting 59
Refurbish AIV 888-656-0755 • aiv-inc.com
27
P
Repair 67
Elite Biomedical Solutions 855-291-6701 • elitebiomedicalsolutions.com
31
55
P P
BMES 888-828-2637 • www.bmesco.com
79
P P
Elite Biomedical Solutions 855-291-6701 • elitebiomedicalsolutions.com
31
P P
Gopher Medical 844-246-7437 • gophermedical.com
11
P P
Integrity Biomedical Services 877-789-9903 • www.integritybiomed.com
37
P P
Master Medical Equipment 866-468-9558 • masterfitmedical.com
43
P P
47, 60
P
ReNew Biomedical 844-425-0987 • www.ReNewBiomedical.com
67
P
RepairMED 855-813-8100 • www.repairmed.net
76
P P
Southwestern Biomedical Electronics, Inc. 800-880-7231 • www.swbiomed.com/
15
P P
USOC Bio-Medical Services 855-888-8762 • www.usocmedical.com
7
P P
800-449-5328 • www.pacificmedicalsupply.com
31
ALCO Sales & Service Co. 800-323-4282 • www.alcosales.com
AIV 888-656-0755 • aiv-inc.com
Pacific Medical
55
Rental/Leasing Elite Biomedical Solutions 855-291-6703 • elitebiomedicalsolutions.com
26
Telemetry
Ampronix, Inc. 800-400-7972 • www.ampronix.com
Stephens International Recruiting Inc. 870-431-5485 • www.bmets-usa.com/
TRAINING
76
SERVICE
RepairMED 855-813-8100 • www.repairmed.net
PARTS
Company Info
AD PAGE
TRAINING
SERVICE
PARTS
AD PAGE
Company Info
P P
Replacement Parts
Test Equipment A.M. Bickford 800-795-3062 • www.ambickford.com
67
Advanced Ultrasound Electronics, Inc. 1-866-620-2831 • www.auetulsa.com
33
P P P
BC Group International, Inc 314-638-3800 • www.BCGroupStore.com
BC
P P
Elite Biomedical Solutions 855-291-6701 • elitebiomedicalsolutions.com
31
P P
PRN/ Physician's Resource Network 508-679-6185 • www.prnwebsite.com
77
P P
Engineering Services, KCS Inc 888-364-7782x11 • www.eng-services.com
14
P
Pronk Technologies, Inc. 800-609-9802 • www.pronktech.com
5
Radcal Corporation 800-423-7169 • www.radcal.com
39 57
P P
33
P P P
Respiratory A.M. Bickford 800-795-3062 • www.ambickford.com
67
P
Southeastern Biomedical, Inc 828-396-6010 • sebiomedical.com/
FOBI 888-231-3624 • www.FOBI.us
62
P P
Training Advanced Ultrasound Electronics, Inc. 1-866-620-2831 • www.auetulsa.com
ADVANCING THE BIOMEDICAL/HTM PROFESSIONAL
JULY 2018
TECHNATION
75
SERVICE INDEX CONT. 8
P P P
RSTI 800-229-7784 • www.rsti-training.com
INS
P
Global Medical Imaging 800-958-9986 • www.gmi3.com
2
P P P
Tri-Imaging Solutions 855-401-4888 • www.triimaging.com
20
P
X-Ray Engineering Services, KCS Inc 888-364-7782x11 • www.eng-services.com
14
P
PARTS
SERVICE
Conquest Imaging 866-900-9404 • www.conquestimaging.com
AD PAGE
P
Tubes/Bulbs
Company Info
TRAINING
TRAINING
48
SERVICE
AD PAGE
ECRI Institute 1-610-825-6000. • www.ecri.org
PARTS
Company Info
PartsSource 877-497-6412 • www.partssource.com/shop
6
P P P
Holden Battery Services, LLC 800-594-9257 • www.x-raybatteries.com
62
Tri-Imaging Solutions 855-401-4888 • www.triimaging.com
20
P P
InterMed Group 386-462-5220 • www.intermed1.com
3
P
RSTI 800-229-7784 • www.rsti-training.com
INS
P P P
Tri-Imaging Solutions 855-401-4888 • www.triimaging.com
20
P P P
Ultrasound Advanced Ultrasound Electronics, Inc. 1-866-620-2831 • www.auetulsa.com
33
P P P
Ampronix, Inc. 800-400-7972 • www.ampronix.com
4
P P
REPAIRMED OFFERS A NO-HASSLE WARRANTY ON ALL REPAIRS!
SAV E THE DATE !
9
RepairMed is a one-stop component-level repair depot whose services include the most comprehensive and cost effective flat rate repair pricing in the industry!
RepairMed repairs all models of these devices to component level: • Infusion Pumps Including Baxter Sigma Spectrum
• Defibrillators/AED
• Feeding Pumps • Syringe/PCA Pumps
• Precision Flow – Vaportherm
• Patient Monitors
• Electro Surgical Units (ESU)
• EKG Carts
• External Pacemakers
• Vital Signs Monitors
• Many other devices not listed.
• Pulse Oximeters
• LCD/Surgical Displays
FEBRUARY 17-19, 2019 • TAMPA/CLEARWATER
FEBRUARY 17-19, 2019 WYNDHAM GRAND CLEARWATER BEACH
9
TAMPA/CLEARWATER
FEBRUARY 17-19, 2019 • TAMPA/CLEARWATER
ISO 9001 : 2015 Certified
Phone: 855-813-8100 Email: biomed@repairmed.net Website: www.repairmed.net
76
TECHNATION
JULY 2018
WWW. AT T E ND IC E .CO M
WWW.1TECHNATION.COM
ALPHABETICAL INDEX
Watch your
money grow with PRN.
A.M. Bickford..................................................................................................67 Advanced Ultrasound Electronics, Inc............................................................33 AIV..................................................................................................................55
Physician’s Resource Network
ALCO Sales & Service Co.................................................................................67 Ampronix, Inc....................................................................................................4 Asset Services.................................................................................................37 BC Group International, Inc............................................................................ BC BMES..............................................................................................................79 Conquest Imaging.............................................................................................8 Crothall Healthcare Technology Solutions.......................................................60 D.A. Surgical...................................................................................................23 ECRI Institute..................................................................................................48 Elite Biomedical Solutions...............................................................................31 Engineering Services, KCS Inc........................................................................14 Entech............................................................................................................FC FOBI................................................................................................................62 Global Medical Imaging.....................................................................................2 Gopher Medical..............................................................................................11 Healthmark Industries....................................................................................27 Holden Battery Services, LLC..........................................................................62 iMed Biomedical.............................................................................................67 Injector Support and Service...........................................................................39 Integrity Biomedical Services..........................................................................37 InterMed Group................................................................................................3 Master Medical Equipment.............................................................................43 Maull Biomedical Training..............................................................................57
A national leader in the sale of new, used, and refurbished medical equipment. Our equipment is tested and serviced in-house so that we can guarantee its integrity.
MediMizer Inc.................................................................................................26 MedWrench....................................................................................................41 oneSOURCE...................................................................................................21 Ozark Biomedical............................................................................................59
AUTHORIZED NORTHEAST DISTRIBUTOR OF
Pacific Medical .........................................................................................47, 60 PartsSource......................................................................................................6 PRN/ Physician’s Resource Network...............................................................77 Pronk Technologies, Inc. ..................................................................................5 Radcal Corporation.........................................................................................39 ReNew Biomedical.........................................................................................67 RepairMED.....................................................................................................76 RSTI.............................................................................................................. INS Select BioMedical...........................................................................................62 Soaring Hearts Inc..........................................................................................53 Southeastern Biomedical, Inc.........................................................................57 Southwestern Biomedical Electronics, Inc......................................................15 Stephens International Recruiting Inc.............................................................59 Total Scope, Inc...............................................................................................25 Tri-Imaging Solutions......................................................................................20 USOC Bio-Medical Services..............................................................................7 Webinar Wednesday.......................................................................................49
ADVANCING THE BIOMEDICAL/HTM PROFESSIONAL
1.800.284.0967 www.PRNwebsite.com
JULY 2018
TECHNATION
77
BREAKROOM
PARTING SHOT
“ ACCEPT THE CHALLENGES, SO THAT YOU MAY FEEL THE EXHILARATION OF VICTORY.” – GEN. GEORGE S. PATTON
78
TECHNATION
JULY 2018
WWW.1TECHNATION.COM
Biomeds take vacations... P.M’s don’t.
managed p.m. programs available.
www.bmesco.com 888.828.2637
BC Group is Your One-Stop Biomed Shop BC Group Can Cover all Your Biomedical Test Equipment Needs We design and manufacture a complete line of Biomedical Test Equipment, all at our facility. Most BC Biomedical products are offered in a series, so you choose which features you want. We calibrate, repair and manage test equipment both in house and onsite. BC Onsite is a nationwide service program designed to minimize your downtime and shipping costs. We sell over 75 different product lines, including our own line, BC Biomedical, in our BC Marketplace. Shop online at BCGroupStore.com.
IPA-3400
ESU-2400H
NIBP-1030 ULT-2020
DA-2006P
ISO 9001 & 13485 Certified ISO 17025 Accredited 1-888-223-6763 sales@bcgroupintl.com www.bcgroupintl.com