TechNation - December 2016 by MD Publishing

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VOL. 7

EMPOWERING THE BIOMEDICAL / CE PROFESSIONAL

DECEMBER 2016

Biomed Aventures High-Speed Hobby

Roundtable Test Equipment

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44 52

TECHNATION: EMPOWERING THE BIOMEDICAL / CE PROFESSIONAL

THE ROUNDTABLE: TEST EQUIPMENT (BIOMEDICAL) HTM professionals cannot do their jobs without the correct tools. Some of the most important tools are the test equipment the biomeds use to test and service medical equipment. TechNation contacted leaders in the test equipment sphere and asked them for tips and what HTM professionals should be aware of as we head into 2017. Next month’s Roundtable article: Paitent Monitors

HOW DOES YOUR DEPARTMENT MEASURE UPUSING METRICS TO GAUGE YOUR SUCCESS This notion of constantly improving, running a tight ship and providing a cost-eﬀective product has not escaped the HTM world. Someone, somewhere is always evaluating how eﬃciently things are getting done and how well medical equipment is maintained and repaired, utilizing various criteria for measurement. TechNation examines how departments can gauge success. Next month’s Feature article: CBET Review & More: A Look at the New Cerification Requirements

TechNation (Vol. 7, Issue #12) December 2016 is published monthly by MD Publishing, 18 Eastbrook Bend, Peachtree City, GA 30269-1530. POSTMASTER: Send address changes to TechNation at 18 Eastbrook Bend, Peachtree City, GA 30269-1530. TechNation magazine is dedicated to providing medical equipment service professionals with comprehensive, reliable, information concerning medical equipment, parts, service and supplies. It is published monthly by MD Publishing, Inc. Subscriptions are available free of charge to qualified individuals within the United States. Publisher reserves the right to determine qualification for a free subscriptions. Every precaution is taken to ensure accuracy of content; however, the information, opinions, and statements expressed in the articles and advertisements herein are those of the writer and/or advertiser, and not necessarily those of the publisher.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

DECEMBER 2016

TECHNATION

INSIDE

Departments PUBLISHER

John M. Krieg

VICE PRESIDENT

Kristin Leavoy

ACCOUNT EXECUTIVES

Warren Kaufman Jayme McKelvey Chandin Kinkade

ART DEPARTMENT

Jonathan Riley Jessica Laurain Kara Pelley

EDITOR

John Wallace

EDITORIAL CONTRIBUTORS

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

P.12 SPOTLIGHT p.12 Professional of the Month: Kurt Krenz p.16 Department of the Month: Rochester General Clinical Engineering Department p.18 Biomed Adventures: High-Speed Hobby P.23 INDUSTRY UPDATES p.23 News and Notes: Updates from the HTM Industry p.26 MD Expo Recap p.30 ECRI Institute Update p.32 AAMI Update P.34 p.34 p.36 p.38 p.40

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

P.60 p.60 p.62 p.64 p.66 p. 68 p.70 p.72

EXPERT ADVICE Career Center Tech Savy Ultrasound Tech Expert Sponsored by Conquest Imaging Karen Waninger Thought Leader The Future Roman Review

Robert Preston, CBET, A+, 2014

P.74 p.72 p.76 p.78 p.80

BREAKROOM Did You Know? The Vault MedWrench What’s on Your Bench? MD Expo Scrapbook

Salim Kai, MSPSL, CBET, Clinical Safety Engineer University of Michigan Health System

p.82 Index

WEB DEPARTMENT

Taylor Martin Cindy Galindo Alicia Dent Adam Pickney

ACCOUNTING

Kim Callahan

CIRCULATION

Lisa Cover Laura Mullen

EDITORIAL BOARD

Eddie Acosta, Clinical Systems Engineer at Kaiser Permanente Manny Roman, CRES, Founding Member of I.C.E. Karen Waninger, MBA, CBET

James R. Fedele, Director, Biomedical Engineering Izabella Gieras, MS, MBA, CCE, Director of Clinical Technology, Huntington Memorial Hospital Inhel Rekik, Biomedical Engineer, MS, Clinical Engineer

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TECHNATION

DECEMBER 2016

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SPOTLIGHT

BY K. RICHARD DOUGLAS

PROFESSIONAL OF THE MONTH: KURT KRENZ Biomed Becomes Patient

t is common to hear HTM professionals mention that they treat medical equipment as if a family member will be the next person it is used for. In the professional profiles featured in TechNation this is a recurring theme. It is obvious that the biomed community thinks about this possibility.

As the laws of probability go, an HTM professional’s family member will eventually need to depend on that medical equipment and the HTM professional, themselves, may also. The fact that HTM professionals can envision themselves or their family members as potential patients helps their commitment and attention to detail in carrying out their work. For 17 years, Kurt Krenz has been a biomedical equipment technician at Essentia Health-Virginia hospital in Virginia, Minnesota. Essentia Health-Virginia is a Level IV Trauma Center that was built in 1936. It is an 83-bed hospital. An $18 million state-of-the-art clinic was added in 2005. The hospital was once a city-owned hospital and Krenz worked there when it was the Virginia Regional Medical Center before Essentia Health took over. Krenz says that Essentia Health has three different regions. He has been a part of the east region. He says that Virginia Hospital is a smaller hospital, served by only two biomeds. The main hub in Duluth for the east region has eight biomeds. He says that with only two biomeds, it was busy quite often. The two biomeds determined who handled what based on area of specialty. Krenz says that his areas of specialty are monitoring, telemetry and the emergency room. While a vexing problem with equipment troubleshooting or the build out and equipping of a new facility might be

TECHNATION

DECEMBER 2016

a real challenge that many biomeds face, Krenz faces a challenge that eclipses those and one that has taken him off the job for months. Krenz has been dealing with two grade 4 Glioblastoma brain tumors as well as one grade 1 tumor. His path to the HTM profession, to which he to which he hopes to return, began after serving his country. PURSUING HTM Krenz sought out a professional career after leaving the service. “After I got out of the U.S. Coast Guard, I was looking at what different tech colleges had to offer. I saw biomedical equipment technology and thought that was an interesting field,” he says. “I had gone to Northwest Technical College in Detroit Lakes to get my AAS degree,” Krenz says. Krenz has been to several specialty training courses. He went through Spacelabs monitoring school, Alaris Medley series infusion pumps, and in March, Olympus OER-Pro scope washer, but he received his diagnosis just shortly afterwards. Krenz says that there were some bigger projects around the hospital for the biomeds 10 or 12 years ago and a new set of projects would be coming up soon. HOBBIES One of Krenz’s hobbies has been beer making. Ironically, because of the

medications he takes, he is not able to imbibe. Despite that, over the years, he obtained a lot of experience in the craft after walking into a beer making store for the first time. “I walked in there and just asked questions and bought a starter kit and started from there. It’s time consuming,” he says. Krenz says you start by boiling about three gallons of water. “You need certain ingredients. Whatever type of beer you’re making, whether it’s a dark beer or light beer, a lager or ale, you boil the water and then depending on what beer you are making, you add the ingredients during certain times of the boil. Malt is one of the main ingredients, hops is another and grains, and it all depends on what type of beer you’re making that determines what type of hops you use or what type of malt you use,” Krenz says. The boiling and ingredients portions of the process only take about an hour and a half to two hours, according to Krenz. “Then, you put it into a fermenter and let it ferment (depending on the type of beer you are making) for about two weeks. Then, you bottle it and let it sit in the bottle for about four weeks and then it should be about ready to drink. It’s a long process,” Krenz says. Krenz also enjoys fishing and gardening. He has fished for Walleye and he grows tomatoes and peppers to use in his homemade salsa. Family includes his dad, brother, twin sisters, two nieces and four nephews. He says that his brother lives in the Virginia area and the other family members live near the Mankato area.

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SPOTLIGHT

Favorite book:

“The Hunger Games”

Favorite movie: “The Warriors”

Favorite food: Prime rib

Hidden talent:

Making homemade beer

Favorite part of being a clinical engineering director:

“The job is different every day.” Kurk Krentz enjoys the open road and making beer.

“After I got out of the U.S. Coast Guard, I was looking at what diﬀerent tech colleges had to oﬀer. I saw biomedical equipment technology and thought that was an interesting field.” DEALING WITH CANCER He has made many trips to Duluth, Minnesota, a 64 mile drive one-way, to have chemotherapy in pill form. More recently, Krenz has been living in an assisted care facility closer to family because of the effects of the chemo. He hopes that, as those side effects improve, he can return home. “What the chemo was doing to me, I wasn’t able to be by myself. Most of my family is in the Mankato area and found an assisted living that takes somebody my age (45). Hopefully this is temporary because I am not reacting to the chemo (side effects), these other sessions, as I did to the fi rst one,” Krenz says. He says that the fi rst sessions of chemo really put him out and caused a lot of fatigue. “When I fi rst found this

out, I went through six weeks of radiation along with a low dose of chemo pills. The radiation was for six weeks, five days a week, Monday through Friday. The chemo pills, I took every day, seven days a week for that six-week period while I was doing the radiation,” Krenz says. “Then, I had a four-week break. And then, I was doing another session of chemo; it was a stronger dose, it was double the dose of what I was taking when I was doing radiation. That was one pill a day for five days and then a 23-day break and then I started over again,” he says. That would be six sessions in total. As of this writing, he had just completed the third and he has three more sessions of taking five daily pills and 23 day breaks in between to go.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

One of the side effects of chemo is that many foods have no taste and others taste bad. Krenz says that even bread didn’t taste good. He could eat chicken soup or bananas, but anything that wasn’t on the bland side would upset his stomach. He normally likes spicy foods, but those could not be considered, along with tomato-based foods. The grade 1 tumor has affected his sight and he needs stronger reading glasses to read. Krenz is fi nding that health care insurance isn’t covering all of the required treatments and the out-ofpocket expenses are mounting. A Go Fund Me account was set up to make up the shortfall. You can help and read more about what he has endured at www.gofundme.com/2b94ub2c

DECEMBER 2016

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SPOTLIGHT

BY K. RICHARD DOUGLAS

DEPARTMENT PROFILE

Rochester General Clinical Engineering Department

n upstate in New York, you will find the birthplace of amateur photography in a city with access to the Finger Lakes and people who may have some Canadian coinage in their pockets. Rochester, New York is a place that gets a lot of snowfall and people really like Wegman’s grocery store. Sitting on the southern shore of Lake Ontario, the locals would prefer to say they live in Western New York. Just an hour and a half from Niagara Falls, the city also has direct access to the famous Erie Canal. Serving the people of Rochester is Rochester General Hospital, a 528-bed hospital tertiary care facility which is part of the Rochester Regional Health System. The Sands-Constellation Heart Institute (SCHI) is located at Rochester General Hospital and has been designated as a Thomson/Solucient Top 100 Cardiovascular hospital nine times. The clinical engineering department that services the hospital also handles approximately 100 offsite clinics. The department consists of three clinical engineering technicians, three clinical engineering tech seniors, four clinical engineering imaging tech seniors, one supervisor and a system level director. The group is overseen by Dave Weed, director of Facilities and Biomedical Engineering. The team’s supervisor is Anthony Alongi. The Clinical Engineering technicians include Ronnie Cooper, Rickey Harris and Jennifer Fuller. The Clinical Engineering technician seniors include Connie Lubberts and Gary Reagan. The Clinical Engineering technician senior imaging staff include Kim Pulver, Rick Formicola and Julie Farabell.

TECHNATION

DECEMBER 2016

The team at Rochester General has experience and expertise in the areas of anesthesia, ventilators, balloon pumps, ESUs, general X-ray, cardiovascular labs, MRI, CT, nuclear medicine, LINACs and clinical networks. Data is maintained, and assets are managed, using Four Rivers Total Maintenance System (TMS). PROJECTS The Clinical Engineering department has been involved in a number of projects that have kept the team busy. Some of these projects have included medical device integration and implementation, a 3T MRI installation, a CT installation, ECG management systems, an IV pump management system project and a enterprise patient monitoring project. “As we were implementing the use of GE Muse in the hospital to network our EKG orders and facilitate the use of the EKG machines and streamline the workflow for the patient care technicians, biomed and the IT department faced many obstacles,” Alongi says. “Started with multivendor EKG systems; in our case Philips and the new GE models. For them to talk in the Muse, the Philips would need a translator. Biomed decided to go with Datamed to facilitate the translation.” He says that after much testing was performed, the system would not translate properly; if at all. In a joint effort IST, Datamed and the biomed team went on a venture to solve any issues and make the system work. “We found all the issues and resolved them. We met the datelines and surpassed all expectations in regards to the upgrades to the Philips TC70 carts that had to be

performed before [the] go live date. We pulled together as a team and we conquered victory. It’s a pleasure to work with a team that knows that when the going gets tough, only the tough get going. Our team is tough,” Alongi says. There have been some challenges along the way; sometimes vexing, but always within the team’s abilities. Kim Pulver says that one team member was trying to figure out how to get the GE and Siemens ultrasounds to interface to the EP and Cath Lab Flex monitors for the Echo Lab techs. She says that the department was able to figure out what cables and video splitters were needed and trained the echo techs how to connect with the least amount of effort. “Regarding the GE and Siemens ultrasounds in the EP and Cath Labs to the Philips Flex monitors. That entailed figuring which DVI-I or DVI-D output

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SPOTLIGHT

“It’s a pleasure to work with a team that knows that when the going gets tough, only the tough get going. Our team is tough.” port on the ultrasound to use without degrading the signal, whether a splitter cable alone could be used to go to two outputs (Monitor on Flex and ultrasound), amplifier needed or not (was), where to get power for amplifier and ordering long enough cables from amplifier to Flex monitor (10 feet) to give techs flexibility of movement of ultrasound during cases,” Alongi explains. “Then training techs which cables and amplifiers to hook up to which machines/ ports depending on which they are using on that day,” he adds. Pulver also remembers a time when there was a telemetry dropping issue a couple of years ago and biomed ordered in several mobile monitors, got them ready for deployment and manned the office around the clock while GE resolved a front end issue.

Creative thinking, resourcefulness and patient safety have all combined to lead the group to new ideas and ways to benefit patients and clinicians. “Gary Reagan located a smaller length air hose to use on the sequential compression device (SCD) in an effort to reduce a trip hazard cause by longer length hoses. This effort reduced patient falls and increased patient safety,” Alongi says. “We developed an emergent response cart of patient monitors to be utilized during patient census surge in emergency department or in the event our telemetry system failed,” he adds. There was also a time when the team needed to come up with a solution for broken network cables in the MOU, which were an expensive item. “When network cable to wall and monitor is connected and a patient

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

needs to walk, they would forget to disconnect the network port and walk away which would result in the network port ripping off the CPU board of the Dash 3000 resulting in a $1,800 expense,” Alongi says. “[We] found that GE had a breakaway cable available that connects to the network port that when a patient walks away the cable will disconnect with little force before the network port on the wall or the CPU board is damaged. Cable cost is $78. Major CPU board repairs were saved and network ports on walls were no longer damaged,” he says. In the land of the Finger Lakes and finer grocery shopping experiences, there is also good news for residents who have to visit the hospital; the Rochester General Clinical Engineering team is on the job.

DECEMBER 2016

TECHNATION

SPOTLIGHT

BY K. RICHARD DOUGLAS

BIOMED ADVENTURES High-Speed Hobby

or anyone who has ever pointed a car down a quarter-mile straight-away and accelerated at high speed to the finish line, the experience is exhilarating. The powerful sound, shaking and rumbling of a car made for the drag strip, the feeling of being pushed back in your seat upon acceleration and the end of the strip, fast-approaching make for a unique, adrenaline-rush experience.

It should come as no surprise that people with mechanical and technical skills should make the foray into this exciting sport, where compression ratios, flow rates, gear ratios and spring rates, all require a special knowledge. Drag racing would seem to be a natural fit for a biomed; a person who has just the right set of critical thinking skills for the sport. If you asked Richard Marshall, CBET, CRES, a regional operations manager for HSS, based at the company’s corporate office in Denver, Colorado, there is no doubt that he would agree. Marshall is a good example of a biomed who has proven that the dual skill sets of working on medical equipment and building a drag racer go hand-in-hand. Not only is drag racing a good fit for a biomed, but just working on cars may be second nature for those used to working with tools and diagnostic equipment. “I first got interested in working on cars when I was about very young. My dad had always worked on the family vehicles when I was growing up so I spent lots of time tinkering and helping him,” Marshall remembers. “Once I got my license, I was always trying to do something to the car I was driving. My first car was a 1974

TECHNATION

DECEMBER 2016

“ My first car was a 1974 Dodge Dart that wasn’t in the best shape. I would spend many hours working on getting it running right, and seeing if I could make it just a little faster.” Dodge Dart that wasn’t in the best shape. I would spend many hours working on getting it running right, and seeing if I could make it just a little faster. My second car is the 1981 Firebird that I race today. I bought it

knowing it needed some work, and spent what little money and time I had working on it,” Marshall says. EVOLVING DRAG CAR “I have only raced my Firebird. When I first started racing, my Firebird would run about 14 seconds in the quarter mile. After countless engine, transmission, suspension and rear end modifications, it currently runs 10.97 at 115 mph in the quarter mile,” Marshall says. In drag racing, two cars normally compete going down a quarter mile or 1,320-foot drag strip. At the start of the race, the two cars “pre-stage” and “stage” as an infrared beam signals the cars position. A sequence of lights on a pole (Christmas tree) light to show that both cars have staged and are ready to race. In some types of races, one slower car is allowed to leave the starting line first. “I am currently running a small block Chevy motor bored and stroked to a 383 cubic inch. It has 13:1 compression and a Holly 830 carburetor. I have a Turbo 350 transmission with a transbrake,” he adds. The Firebird has survived to go through many iterations to become a much faster car than it was in the beginning. Work continues though as every modification and tweak can gain that tenth of a second that is so important. The latest modification was a Ford 9-inch rear end with 4:30 gears. “I finished the 9-inch install a couple of weeks ago and was able to participate in the final race at

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SPOTLIGHT

Richard Marshall races in a 1981 Firebird that he continues to work on to make faster.

Julesburg Dragstrip this past weekend. The car ran consistent 11.06 at 121 mph and I was eliminated in the third round of competition due to a bad light on my part. Addition to the roll cage and a possible switch to E85 (special fuel) are planned for the winter,” Marshall says. Marshall’s love for the drag strip isn’t new. He started out by going to Bandimere Speedway with his dad or with some friends and watching the races. “It was always so interesting to watch the races and then watch the crews work on the cars to get them ready for the next round,” he remembers. “After watching a few times, I decided to take my car to the High School Drags. One trip down the track with my adrenaline pumping and I was hooked.” MANAGER AND PRESIDENT On the job front, Marshall has worked his way up at HSS after starting out in the fi eld. “I have been a Biomed since 2008 when I graduated from DeVry University. I started as a Field Service Engineer for HSS and over the last eight years, I have worked up to being the Regional Operations Manager for HSS. I currently manage 40 technicians all over the state of Colorado in multiple locations,” Marshall says.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

Besides working out of HSS’s corporate offi ce, Marshall spends a lot of time traveling to accounts to meet with technicians and customers. “I am currently responsible for the biomed activities in all of Colorado, Kansas and New Mexico,” he says. He is also responsible for multiple business units throughout the Rocky Mountain Region. “This includes approximately 40 technicians. It involves working with customers on contract renewals, additional services, budgeting and capital planning,” Marshall says. Just as the Firebird has evolved, so does Marshall. Along with his CBET and CRES, he is working on an additional certifi cation. “I have signed up for the CHTM certifi cation test and will be taking that in December,” he says. Marshall has other skills besides drag racing and his skills as an HTM professional. In 2010, he won the Colorado Association of Biomedical Equipment Technicians (CABMET) essay contest and earned a trip to the Association for the Advancement of Medical Instrumentation (AAMI) conference, which was in Tampa that year. Today, he is CABMET’s president. His term will end on January 1. “After that, I will continue to serve on the board for one year to ease the transition of the new president,” he says. Revving up the career and the Firebird are all in a day’s work.

DECEMBER 2016

TECHNATION

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INDUSTRY UPDATES

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NEWS & NOTES

Updates from the HTM Industry INDUSTRY VETERAN MAX ENDE DIES After a brief illness, Max Ende died in September at the age of 61. He founded BMX-Ray Inc. in December 2010. He was a U.S. Navy Veteran with 20 years experience in video imaging electronics and 16 years experience in the medical imaging field. His vision was to create a company that could offer great service, repairs, imaging products and technical support for biomedical engineers in the field of radiology imaging from troubleshooting problems to helping them get all the information they needed to make their job a little easier. More importantly, he wanted to create a company where everyone – employees and customers – felt like family. He brought people into the company and took them under his wing and helped them to grow, from the sales team to the technicians to the engineers. Over the past year, he inspired every employee to spread their wings, not only to work and solve problems independently, but also to work together as a team and as a family.

Max Ende

HAI FORUM PROBES ROLE OF MEDICAL DEVICES AND EQUIPMENT To stop the spread of healthcare-associated infections (HAIs), more attention needs to be paid to the role of medical devices and equipment. This was the thought that sparked a two-day forum on medical technology and HAIs hosted by AAMI in collaboration with the American Hospital Association, the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration’s Center for Devices and Radiological Health (FDA/CDRH), and The Joint Commission in Herndon, Virginia. During the invitation-only event, which served as a followup to the 2011 summit on medical device reprocessing convened by AAMI and the FDA, 100 experts were tasked with identifying a list of HAI hazards and articulating potential solutions and mitigation strategies. The HAI risk factors they identified included facility design, water quality, device reprocessing, and competency and training. Based on CDC estimates, there were 722,000 HAIs in U.S. acute care hospitals in 2011. About 20 percent of these infections are transmitted through the health care environment, which includes medical devices, said William A. Rutala, director of hospital epidemiology for the occupational health and safety program at the University of North Carolina. But the problem of HAIs is much larger than device reprocessing, a number of presenters were quick to point out. For example, the FDA sent out a safety communication after EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

the heater-cooler units found in bypass machines used during open-heart surgery were linked to the transmission of nontuberculous mycobacterium. The agency said it had received 32 reports of patient infections associated with these devices between January 2010 and August 2015. Still, the FDA said it is unsure exactly how many people may have been impacted by this HAI, as it can take years for symptoms to develop, making it “challenging for a health care facility, health care provider, manufacturer, or patient to recognize that infections … may be associated with the use of or exposure to a particular medical device.” This type of indirect exposure to potentially harmful bacteria is something that hadn’t been on the radar for many health care professionals. For many in attendance, implementing a quality management system seemed like the most effective way to structure solutions to many of these problems. In fact, a new standard – ST90 – that adapts the quality management system guidance found in ANSI/AAMI/ISO 13485 to device processing in health care facilities is expected to be published sometime next year. This event was a first step in gaining the consensus needed to take such a systems approach. A summary report of the proceedings will be available by the end of the year. AAMI is also planning to develop a guide to help health care delivery organizations conduct HAI risk assessments in 2017. DECEMBER 2016

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ST. JUDE MEDICAL ADDRESSES CYBERSECURITY St. Jude Medical Inc. is forming a Cyber Security Medical Advisory Board (CSMAB) to advise the company as it continues to advance cybersecurity standards in the medical device industry by working with experts and government agencies. The company recognizes that improving technology to address cybersecurity risks must be balanced with how to best care for patients benefitting from medical devices. Creating the CSMAB ensures direct feedback from leading physicians on patient management considerations. St. Jude Medical’s ongoing commitment is to ensure the medical device ecosystem always puts patient safety at the forefront. “Our mission is to deliver innovative technologies that save and improve lives,” said Dr. Mark Carlson, chief medical officer at St. Jude Medical. “We take the cybersecurity of our devices very seriously and creating the Cyber Security Medical Advisory Board is one more demonstration of our ongoing commitment to advancing standards of patient care around the world without comprising safety and security.” St. Jude Medical has spent years working with third-party experts, researchers, and government agencies to assess potential vulnerabilities, prioritize real-world threat levels, and then develop appropriate safeguards as part of the company’s product development process. “We are in the process of finalizing membership for the Cyber Security Medical Advisory Board, and we will announce its members once finalized,” Carlson said. “We anticipate this Board will work with technology experts at St. Jude Medical as well as external researchers to help us maintain and enhance cyber security and patient safety.” 24

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CYBERSECURITY SPENDING SET TO TRIPLE The medical Internet of Things is set to transform health care through smart medical devices. ABI Research believes that the millions of connected medical devices introduce dangerous new threat vectors into the healthcare IT infrastructure, and will seriously undermine patient safety and effective care delivery if left unchecked. “We estimate spending by health care providers and OEMs on health care cybersecurity to reach $5.5 billion by 2016,” says Michela Menting, Research Director at ABI Research. “However, only $390 million of that will be dedicated to securing medical devices. Health care stakeholders have to understand that there is a new hostile environment that will emerge around networked medical devices and that threat actors have multiple levels of skills and diverging motivations for attacking the medical IoT.” The money spent on securing medical devices will primarily be due to OEMs embedding security in the hardware, reviewing, analyzing, pen testing, developing patches, and performing other-the-air updates, among other functions. The rest of the expenditure will focus on data protection. But medical devices suffer from numerous vulnerabilities, and many often compound several critical vulnerabilities: code errors in software, use of hardcoded passwords, disabling of firewalls, lack of authentication mechanisms, unencrypted communications, among many other issues. Protecting devices requires addressing technical issues, health care delivery, and business challenges. To do this, collaboration across the various stakeholder silos is necessary. The industry, however, is at the beginning stages of the discussion. Globally, the efforts are poor, and the U.S. is the only country currently putting significant energies into the matter. However, awareness is growing, which will push spending on devices to triple globally by 2021, resulting primarily from dynamic U.S. public and private efforts in the space. A few companies are already fully embracing medical device cybersecurity. These findings are from ABI Research’s Securing Medical Devices. WWW.1TECHNATION.COM

INDUSTRY UPDATES

BC GROUP RELEASES UPDATES FOR ESU-2400, ESU-2400H Testing with a BC Group ESU-2400 Analyzer has gotten easier. The ESU-2400 Electrosurgical Unit Analyzers have a new software update, which renews compatibility with the new Covidien ForceTriad Software Update 3.8. The new ForceTriad Software 3.8 adds compatibility with more accessories. The ForceTriad can now automatically detect a wider range of accessories that are plugged into the generator. When using the ESU-2400, the analyzer reads the software version of the ForceTriad and automatically loads the correct autosequence. All users are required to do is press “Start Triad PM” and the analyzer determines the correct software version. An update for the ESU-2400H will be available soon. Automated autosequences are also available for the CONMED System 2450 and System 5000 Generators using the ESU-2400 Series and CONMED Automation Kit. The CONMED Automation Kit (part number BC20-00133) contains the CONMED Footswitch Cable and CONMED Communications Cable for use with ESU-2400 Series. Using this kit allows users to perform automated testing using the ESU2400 Series Autosequence function. The CONMED Automation Kit allows the ESU-2400 to remotely configure CONMED System 2450 and System 5000 Electrosurgical Generators and trigger the generator output without user intervention. The CONMED Automation Kit is required for the ESU-2400 Series fully automated CONMED PM

Autosequence. There is also a manually triggered autosequence for the ConMed System 2450 and 5000 using the ESU-2400 Series and Monopolar Handpiece Simulator. The CONMED Automation Kit requires an ESU-2400 running Software v1.0.4.0 or later or an ESU-2400H running Software v1.1.6.0 or later. Also available to download is the new autosequence for the Valleylab FT10 Generator. The autosequence is user triggered and requires the Footswitch Port Adapter (BC20-03050). FIND UPDATES and more information online at www.bcgroupintl.com.

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DECEMBER 2016

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MD EXPO WRAP UP HTM World Converges at MD Expo

Expo just keeps getting better. For more than 15 years, MD Expo has served as a must-attend event for health care technology technicians.

The biannual conference has expanded and continues to offer new experiences each year. In 2016, the spring conference in Dallas was one of the biggest ever for parent company MD Publishing. The fall conference, recently held at Mohegan Sun in Uncasville, Connecticut, was MD Expo’s first venture to New England. “The New England MD Expo provided an opportunity to meet many new attendees who were attending MD Expo for the first time mainly because it was local and their facility didn’t have to pay travel expenses,” MD Publishing Vice President Kristin Leavoy said. “We pride ourselves in providing a quality product at an affordable price – it’s free for health care professionals to attend! This is our way of supporting the HTM community with each and every event we host.”

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DECEMBER 2016

MD Expo New England was a hot ticket as HTM professionals packed the hotel just as the leaves were starting to change colors in the Connecticut countryside. More than 600 people

events included a golf tournament, the networking happy hour, keynote address, door prize extravaganza, and the wrap-up party at Margaritaville. The Leadership Summit was another popular

“I look at it as an educational opportunity to see what changes are taking place so that I can better position not only myself but also my organization to better meet the future.” - Joseph F.

attended to take advantage of more than 30 hours of accredited CE education and a world-class exhibit hall featuring the latest technology, products and services. MD Expo, with the support of the New England Society of Clinical Engineers (NESCE), also provided its signature brand of networking events throughout the conference. Networking

event at MD Expo New England. The 2016 TechNation and Medical Dealer award winners were introduced via short videos immediately following the keynote address by The Joint Commission and included TechNation Professional of the Year – Jennifer DeFrancesco, TechNation Department of the Year – New York Presbyterian Hospital Biomedical Engineering Department, 2016

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Medical Dealer Humanitarian – Greg Goll, and the Medical Dealer Lifetime Achievement was awarded posthumously to– Myron Hartman. Attendees and exhibitors appreciated the quality of the conference and its more intimate setting compared to other large conferences. HTM professionals praised the MD Expo in an online survey. “This was my first MD Expo and I think overall it was very well done. Everything was easy to find. The staff was great,” biomed specialist Vasilios F. said. “I look at it as an educational opportunity to see what changes are taking place so that I can better position not only myself but also my organization to better meet the future,”

Healthcare Technology Systems Manager Joseph F. said. “For my first MD Expo you did great, now you have to beat it,” Senior Biomed Wallace E. said. Company representatives manning booths in the exhibit hall also gave MD Expo an A+. “Well organized, and it was fun,” Owen Liu from Datrend Systems Inc. commented in his survey. “It is a great show to meet with potential customers,” John Vandersteen from Technical Prospects added. “Our customers enjoy MD Expo and the experience they have. It is nice to visit with them outside of the hospital. They are much less tense and stressed. You provide great opportunities for us

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to meet and network with our customers,” Paul Wessler from Pronk Technologies said. Sponsors played a role in the success of MD Expo New England and included Sodexo, DirectMed, PartsSource, USOC Bio-Medical Services, AIV, Elite Biomedical Solutions, Northeast Electronics Inc., MedWrench, Varian Medical Systems, RPI, TriMedx, MW Imaging, Mobile Medical Repair, Philips, Select Biomedical, Connectiv, Technical Prospects and GE Healthcare. For the spring of 2017, MD Expo is headed west. The next MD Expo will be held in Irvine, California on April 9-11. Find the latest information online at MDExpoShow.com.

DECEMBER 2016

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ECRI UPDATE

Don’t Get Sucked into Purchasing the Wrong Ultrasonic Aspirator

n ultrasonic aspirator, typically controlled by a footswitch, consists of a control unit and a handpiece. The control unit houses an ultrasound generator and a pump used for suction and irrigation. The ultrasound generator produces an ultrasonic signal, which is sent to a transducer. The signal is transformed into mechanical motion, vibrating the tip. Control units can have either a console or tabletop configuration; a combined cable and tubing set connects the control unit to the handpiece. The handpiece has either a piezoelectric or a magnetostrictive transducer, which causes the hollow titanium tip to oscillate, fragmenting cellular matter. Transducers are usually permanently housed inside the handpiece.

Handpieces are typically frequency specific, operating either at a low frequency (e.g., 23 kHz) or a high frequency (e.g., 55 kHz). A lower-frequency, higher-amplitude probe is more effective in removing calcified or elastic tissue as it has a broader tissue effect. A higher-frequency, lower-amplitude handpiece provides a more focused tissue effect, making it more effective for softand medium-density tissue and accommodating smaller tips for procedures that entail delicate dissections. When the vibrating tip of an ultrasonic aspirator handpiece comes into contact with cells of high water content, vapor pockets form within the cells, causing them to separate and eventually collapse. Due to the nature of the vibrations, low-water-content, collagen-rich tissues, such as blood vessels or ducts, will remain virtually intact when they encounter an ultrasonic aspirator. Therefore, encapsulated and invasive tumors can be delicately resected without injury to adjacent blood supplies. Manipulating the handpiece allows the surgeon to determine the consistency of the tissue touching the tip, allowing very precise removal. FLUIDIC SYSTEM The ultrasonic aspirator has a fluidic system that controls irrigation, aspiration, and cooling. Irrigation is provided by a bottle of irrigant (saline or lactated Ringer’s) mounted on an adjustable intravenous pole. On most units, the

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DECEMBER 2016

irrigation tubing passes through a solenoid valve that opens when the footswitch is pressed. Fluid then flows through the irrigation tubing to the handpiece and through an irrigation sleeve, which surrounds the tip and provides a flow path between the tip and the surgical site. The irrigant cools the tip of the handpiece during surgery to prevent thermal trauma to the tissue and dilutes the fragmented tissue to prevent obstructions from flowing into the handpiece or tubing. The aspiration line runs from the handpiece to a vacuum pump and a collection container. Suction is used to hold larger fragments to the tip, where they can be emulsified; irrigant and smaller fragments are then aspirated into a collection container through the aspiration line. Irrigation/aspiration (I/A) systems commonly use peristaltic, diaphragm, and venturi pumps to create a vacuum. In most diaphragm and venturi pump systems, only the vacuum levels can be set; the rate at which objects are drawn to the tip – the aspiration flow – can be changed only by adjusting these levels. Peristaltic pump systems, on the other hand, can alter the flow by varying the pump speed; a separate vacuum control is used to adjust the maximum vacuum at the probe tip. HANDPIECE CONFIGURATIONS Ultrasonic aspirator handpieces are

lightweight, typically between 113.4 and 284 g (4 and 10 oz). Most suppliers offer straight and angled configurations, often with extensions, which can facilitate access to areas that are difficult to reach or see (e.g., a deep-seated brain tumor). Some suppliers offer handpieces that fit through a laparoscopic trocar cannula, and some offer 55.5 kHz handpieces that can coagulate. Some handpieces have a one-piece construction, while others can be disassembled for cleaning and routine maintenance. The transducers are either air- or water-cooled to prevent them from overheating. Irrigation and aspiration lines may run along the outside or the inside of the casing; most handpieces can be steam sterilized, while others are sterilized with ethylene oxide (EtO) or gas plasma sterilization. Ultrasonic aspirator tips can be either reusable or disposable and are generally flat. The ability of a handpiece to emulsify tissue is determined by the amplitude (stroke length) and frequency of the vibrating tip; the shape and sharpness of the tip; the ability of the handpiece to maintain the resonance, or natural frequency, of the vibrating complex (consisting of the handpiece, the tip, and the object contacting the tip); and the level of aspiration. Most ultrasonic systems have a continuous autotuning feature that allows the generator to adjust its output signal to match the changing resonance of the handpiece system.

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CONTROLS Front-panel controls for the ultrasonic aspirator are used to select power setting, vacuum limits, and irrigation rates. These modes are used simultaneously during active ultrasonic aspiration; some models also have a standby mode that allows for constant low-level irrigation and aspiration. In the ultrasonic (or vibration) mode, the unit delivers the preset aspiration vacuum and ultrasound output levels immediately with footswitch activation (preset control). In addition, by using the footswitch, the surgeon can individually control the vacuum or ultrasound output level (linear control). For example, in the linear mode, the handpiece output is directly proportional to the displacement of the footswitch in the ultrasound position. Most ultrasonic aspirators control and display the status of irrigation, aspiration, and vibration. Many specify error code messages for troubleshooting; these messages include clogged or damaged tips and handpiece malfunctions, as well as suction, electronics, and footswitch problems. Many systems offer a touch screen user interface. REPORTED PROBLEMS Some ultrasonic aspirator handpieces need to be disassembled for cleaning and routine maintenance. Special accessories such as a torque wrench or handpiece holder are typically required for proper disassembly and reassembly. Improper use of these accessories or improper reassembly can compromise the handpiece, resulting in inefficient operation. Using an inappropriate handpiece for a given tissue density can also result in inefficient operation. There have been reports that ultrasonic aspirators can produce a fine mist or aerosols that may travel upward and potentially contaminate the environment and the staff. It is therefore advisable that the surgical team wear protective eyewear and take other effective measures for

infection control. Risks of contamination can also be minimized by using adequately upgraded instruments at optimal irrigation and aspiration settings. PURCHASE CONSIDERATIONS ECRI Institute Recommendations Included in the comparisons are ECRI Institute’s recommendations for minimum performance requirements for ultrasonic aspirators. Both ultrasonic aspirator transducer assemblies should be housed permanently in the handpieces. An piezoelectric oscillation system capable of operating at an amplitude of 300 µm and a frequency of 20 to 80 kHz for ultrasonic aspirators. Ultrasonic aspirator fluidic systems should be capable of operating at a maximum vacuum of 600 mm Hg. The footswitch control should possess both preset and linear modes. The aspirator should include power, vacuum, irrigation levels, and application time displays, as well as irrigation, aspiration, and ultrasound controls. The unit should also display error code messages. Other Considerations Some ultrasonic aspirator systems are self-contained; they incorporate a vacuum pump and a standard suction canister for holding aspirated tissue. Other systems may require the use of the hospital’s central vacuum or irrigation system. Some systems require manual tuning before the tip is used. Once the tip encounters a change in mass, the unit may no longer be tuned to resonance. Other systems have a continuous autotuning function and may or may not have a pre-use tuning button. Autotuning enables the ultrasonic generator to constantly change its output to match the changing resonance of the handpiece, thereby eliminating the need for manual tuning and increasing the efficiency of the ultrasound circuit and tip. Because of the complexity of the technology, clinical evaluations should be

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performed before a purchase decision is made to ensure that the surgeon is comfortable with the ultrasonic aspiration system. Handpieces are generally chosen for particular clinical procedures on the basis of the size and weight of the handpiece and tip, the consistency of the tumor or tissue to be removed, and the importance of minimizing damage to surrounding tissues and structures. Each system has different performance characteristics, and its effectiveness depends on the surgeon’s comfort level and familiarity with the system. COST CONTAINMENT The cost of ultrasonic aspiration systems varies greatly, not only because of differences in the initial price, but also because of vast differences in the cost per procedure, which can include such items as handpiece tips and I/A tubing sets. Many suppliers offer disposable handpiece tips, while others offer reusable tips that usually have a limited number of uses. Because ultrasonic aspirators entail ongoing maintenance and operational costs, the initial acquisition cost does not accurately reflect the total cost of ownership. Therefore, a purchase decision should be based on issues such as the average cost per procedure, cost of disposables, initial cost of reusables, cost per procedure for sterilization of reusables, cost of additional handpieces, discount rates and non-price-related benefits offered by the supplier, and local service support. ECRI Institute recommends that hospitals negotiate pricing for service contracts before the system is purchased. Discounts may be available for multiyear agreements or advance payments. THIS ARTICLE IS ADAPTED from ECRI Institute’s Healthcare Product Comparison System (HPCS), a searchable database of technology overviews and product specifications for capital medical equipment. The source article is available online to members of ECRI Institute’s HPCS; learn more at www.ecri.org/components/HPCS.

DECEMBER 2016

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INDUSTRY UPDATES

BY AAMI

AAMI UPDATE AAMI Welcomes New CEO

ast month, Robert D. Jensen, a longtime executive in the healthcare industry, became AAMI’s third president and CEO. Jensen officially began his tenure on Nov. 14.

“Most of my professional life has been dedicated to the service of others, and this will be a capstone in my career,” said Jensen. “It’s clear to me that AAMI is a high-quality organization with a culture of teamwork and collaboration, and a community of members that cares a lot about the organization and its mission.” Jensen, a former U.S. Marine, has been with the MITRE Corporation since 2003. He currently serves as vice president and director of the CMS Alliance to Modernize Healthcare (CAMH), which is the nation’s first federally funded research and development center (FFRDC) broadly focused on healthcare. He conceived of and established the MITRE Center for Transforming Health, dedicated to improving healthcare nationwide through systems thinking, advancing technology, and providing transformative services for government health-related organizations. The transition to a new leader comes just ahead of AAMI’s 50th anniversary in 2017 and at a pivotal moment in AAMI’s history. Healthcare technology is changing fast, placing new training and education demands on those who work within that realm, and challenging standards development organizations to keep up. There are more general trends that all nonprofit and professional associations face. Industry mergers

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impact membership, while new modes of communication and the growth of the Internet – which has opened up a raft of networking and resourcegathering opportunities – have forced all associations to redefine and demonstrate their value to members in new ways. Amid these challenges, AAMI enjoys robust financial health and has succeeded in launching new initiatives, such as a series of high-profile summits with the Food and Drug Administration and the launch of AAMI University, and in setting new records, such as the attendance for its annual conference. “AAMI is a unique and unrivaled organization in that we bring a number of different voices to everything we do, including manufacturers, regulators, healthcare technology management professionals, academics, and clinicians,” said AAMI Board Chair Phil Cogdill, who also led the Executive Search Committee. “I’m confident that we’ve chosen the right person to build on our recent success and take us to new heights.” A native Nebraskan, Jensen holds a bachelor’s degree in psychology from Doane College in Crete, NE, and a master’s degree in information systems from the Naval Postgraduate School in Monterey, CA. He also is a fellow with HIMSS (Health Information Management and Systems Society) and certified in healthcare information and management systems. AAMI CERTIFICATION PROGRAMS RECEIVE ANSI ACCREDITATION In a major acknowledgment of the quality of AAMI’s certification pro-

grams, three of them have been accredited by the American National Standards Institute (ANSI). The association’s certifications for biomedical equipment technicians (CBET), laboratory equipment specialists (CLES), and radiology equipment specialists (CRES) were recognized by this widely respected standards body. There are more than 3,000 people who hold CBET, CLES, and CRES credentials, demonstrating their commitment to the profession, mastery of skills, and experience in core competencies. These certifications also help highlight a professional’s ability to provide quality and trustworthy service, which ultimately leads to a safer, more reliable healthcare environment. “Earning ANSI accreditation is a major milestone for the AAMI Credentials Institute (ACI),” said ACI Board Member George Mills, director of engineering at The Joint Commission and member of the AAMI Board of Directors. “The value of being recognized as a CBET, CLES, or CRES is enhanced with this recognition and shows the significant benefits these professionals bring to their organizations.” ANSI accreditation is based on an international standard that ensures the use of best practices and involves an application process and onsite assessment. Only 57 organizations have received this recognition. “I am delighted by the ANSI accreditation of the AAMI Credentials Institute’s certifications. Adding the credibility and capability of the ANSI organization to AAMI’s reputation

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serves to further solidify how meaningful the CBET, CRES, and CLES certifications are to the industry,” said ACI Board Chair Larry Hertzler, vice president of technical operations at Aramark in Charlotte, N.C. “We are so proud of this achievement,” said Sherrie Schulte, senior director of certification and the annual conference at AAMI. “It is a testament to the contributions of our volunteers who work to ensure that ACI-certified professionals represent the best in their field.” AAMI PUBLICATION PROBES COEXISTENCE OF HEALTHCARE AND WIRELESS The availability of wireless technology in the healthcare environment is expanding rapidly, but its implementation can be complicated. Navigating

the challenges of wireless technology in healthcare is the focus of the newly released issue of AAMI’s award-winning journal supplement Horizons. The articles and commentaries featured in the fall 2016 edition include: • A roundtable discussion in which leading experts weigh in on questions such as: What lessons have the wireless community taken away from recent high-profile cybersecurity incidents? What are the opportunities and challenges associated with wireless medical devices moving healthcare in people’s homes? What will changes in the FCC spectrum open up for patients and industry, and what new risks do they introduce? • Advice for healthcare delivery organizations and medical device manufacturers for improving the state of wireless.

• An experimental method for evaluating wireless coexistence of Wi-Fi medical devices. • A case study on deploying real-time location services in a hospital system. • Evidence to dispel common wireless technology myths and steps for success. • An approach to assessing the operational reliability of a wireless device and/or system. • An evaluation of the potential impact of changes in the Wireless Medical Telemetry Service bandwidth. • A perspective on combining unique device identifiers with link-layer discovery protocol to secure networked medical devices. Horizons is a peer-reviewed supplement to AAMI’s journal BI&T (Biomedical Instrumentation & Technology).

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DECEMBER 2016

TECHNATION

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STAFF REPORTS

SHOP TALK

Conversations from the TechNation ListServ Q:

I am interested in current examples of companies who offer service training, but who place an expiration date on it. These may include certain dialysis, ventilator, anesthesia, or other medical equipment. If you have examples of technical training that expires, please send me copies of either training certificates or emails from the company so that I have something to post to show the world who these players are.

Welch Allyn had us do that this year. We needed to attend training to receive the Gold license which is good for a couple of years. Now this year we had to redo the training online in order to attain the license for the next few years. The training evidentially expires when the license expires, but is available at a reduced rate of course.

A: A:

Dräger Breath (Alcohol) Analyzers.

Maquet requires technicians to renew certification on ventilators every other year.

A: A:

Sounds like a good reason to not buy any ventilators from them.

I am apparently missing something here. If a medical device is complex enough to need certification to work on it why wouldn’t that license/ certification expire? As a patient, I want some assurance that the person that is working on critical devices has up-todate training.

TECHNATION

DECEMBER 2016

Certification by the manufacturer has nothing to do with the complexity of the device. It has to do with maintaining control and earning revenue because they are no longer making money for service. A service technician does not lose their skills to repair something in two years, especially if they are working on it regularly.

have only had one manufacturer send TSBs after a request and zero manufacturers send them automatically.

Q: A:

Would it be reasonable to advise halogen surgical lights are obsolete?

It is not a problem to keep techs up-to-speed or stay certified on a device by keeping up on it, but is it right to keep making them pay for it? Sure it is their time and no time should be free, but if they want to make us keep up with the equipment by continually (every year or two) showing us improvements or add-ons, or upgraded info, that is fine, I will accept that. But not the cost that comes with it.

I would say that it depends on which model lights they are, and how long ago did they become obsolete? Case in point, the Skytron 58 lights. The bulbs are still available by various vendors, but almost all of the parts themselves are no longer available. The final blow was the glass diffusers and polycarbonate dome covers being obsolete, then scarce to find, and finally unobtainable. Without them, the light is useless and dangerous. Otherwise, they’d probably still be in use today, even though they’re over 20 years old.

Working for manufacturers we had annual training and we only worked on our equipment. Supposedly this was an ISO/FDA requirement. There was a cost to the company to do this training. So, if the company making money from servicing the equipment (hospital or ISO) isn’t suppose to pay for the training then who is?

In my opinion, if the manufacturers were that concerned about proper servicing of their equipment after training they would automatically send technical service bulletins to those who have attended training. I would be interested to find out if anyone has received any TSBs with or without requesting them. I

Just because it is halogen does not deem a device as being end of life. Case in point, the Steris/Amsco Examiner 10 lights are still supported, still manufactured and still being sold after 30 years and are still utilizing halogen.

Do I have to replace batteries for my medical equipment as per manufacturer recommendations? How do I justify if I do not want to?

Batteries are the same as anything else that you do to a piece of equipment. It is about the equipment, its function, the function that the batteries play, the effect if the batteries fail, and what supporting evidence that you have is to justify not following the manufacturer’s

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Services specific to your facility’s needs.. recommendations. Could you defend your decision in a court of law? If not, follow the manufacturer.

A: A:

Unless you can prove why you shouldn’t, yes.

Preventive maintenance is subjective at best but at the heart of any full coverage program is the necessity to prevent unnecessary downtime along with keeping cost of ownership low. How you arrive at the determination means identifying methods which may mean you adopt a policy of time, criticality, or run to failure depending upon your comfort of risk associated with the failure of the battery while in use.

For life support, imaging and ultrasound you should follow the manufacturer recommendations. In the past, I did work for some hospitals that wanted to replace them only if they failed, but my feeling is if you order something with a battery than you should maintain it. I have been involved with several power failures over the years, where we lost both normal power and emergency, so having equipment with batteries that were maintained was crucial. I am a believer of following the recommendations of replacement per the manufacturer. We have even changed some items earlier than recommended, because we found out the batteries were failing before the recommended replacement schedule. For UPS units, we have these on a schedule too.

To add to this, if your hospital is under CMS, you would need to have an approved Alternative Equipment Management strategy if you were to deviate from the manufacturer’s recommended planned maintenance.

As someone who has been deposed for medical equipment failures (not caused by lack of maintenance but by operator errors thank goodness) I can tell you with certainty that a lawyer will dig up all the recommended maintenance requirements and hopefully you will have a good answer on why someone delayed the recommended battery change other than economic reasons. I never really signed off on “predictive maintenance” even though approved by CMS! THE SHOP TALK ARTICLE is compiled from TechNation’s ListServ and MedWrench.com. Go to www.1TechNation.com/Listserv or www. MedWrench.com/?community.threads to find out how you can join and be part of the discussion.

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BY LARRY NGUYEN

BIOMED 101 What do ISO Certifications mean to you? M

any people ask us during training classes and at trade shows why we have two ISO certifications? The ISO 13485 medical device standard differs from the more broadly focused ISO 9001 standard. A primary difference is that ISO 9001 requires the organization to demonstrate continual improvement in processes, whereas ISO 13485 requires only that the certified organization demonstrate that a quality system is effectively implemented and maintained. In addition, the ISO 9001 requirements regarding customer satisfaction are absent from the ISO 13485 medical device standard. Summit wanted to ensure its customers that they were getting the best of both standards in maintaining the highest quality levels for medical devices while continually improving our services and providing our customers with the highest satisfaction.

The easiest ISO certification for a company to obtain is 9001:2008. The article “What is ISO Certification, and What Does It Mean?” by Gary Moore, B.Sc., MA, FASE, states that this certification establishes the criteria for an overall quality management system and can be applied to any company, regardless of the industry. Any organization, from a coffee shop to a zoo, can obtain 9001 certification to prove that it meets customer satisfaction requirements. If a medical device company is 9001 certified, it’s a good indicator that they adhere to standard business practices, but it does not prove that they are certified to manufacture or repair medical devices. ISO 13485:2003, however, is much more specific to the medical device industry. Moore explains that ISO 13485 was designed to produce a QMS that demonstrates objective evidence that a company can provide medical devices and related services that consistently meet customer and regulatory requirements. While being 13485 certified does not fulfill the requirements of either the FDA or foreign regulators, the certification aligns an organization’s management system

TECHNATION

DECEMBER 2016

to the requirements of the FDA’s Quality System Regulation (QSR) requirements and a variety of other international regulatory requirements. Therefore, the 13485 certification creates a QMS that serves as a framework on which companies can build compliance to various regulatory and customer requirements. For example, if a company wants to include ultrasound probe repair in the scope of its ISO certification, it must pass a detailed ISO 13485 audit by a certified independent third party. The auditor will focus on the elements of the QMS and relevant regulatory requirements related to probe manufacturing and repair. If the company passes its annual audit, it demonstrates that they are certified to be in compliance with the ISO 13485 standard. The International Organization for Standardization (ISO) developed ISO 13485 as an international set of requirements to help manage medical device companies and serve as a baseline to measure their services against. Compliance by medical device companies is voluntary. However, ISO is not involved in the certification process. A third-party accreditation firm that has been approved by the ANSI-ASQ National

LARRY NGUYEN

CEO & CTO of Summit Imaging

Accreditation Board (ANAB) performs an audit of the company seeking certification, which could take anywhere from a couple days to a month to complete. Audits are then performed annually to monitor the company’s progress. HTM professionals can review a list of certified companies, including a scope of the services they provide, the certification they hold, and who certified them, on the Independent Association of Accredited Registrars’ website. This will give HTM professionals a better idea of which accreditation firms are used most commonly and what the scope of each company’s certification entails. For companies that manufacture or repair medical equipment, the 13485 certification is a good measurement of their abilities and the quality of the equipment that they produce. However, the same certification requirement is applied to all companies in the medical

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brokerage firm, for example, can help determine whether the parts are being repaired correctly. Obtaining vendor references from other health care organizations is another good method for verifying the quality of a vendor’s services. When it comes to ultrasound equipment support companies, HTM professionals should also consider the length of the warranty they offer. Companies with a longer warranty are likely more confident about the equipment they are offering. HTM professionals should also ask if equipment is repaired using original equipment manufacturer (OEM)specified parts. Although there is no guarantee that the vendor will answer honestly, it is important for HTM professionals to state that they expect OEM-specified parts in order to ensure the highest level of quality. Although ISO certifications can be incredibly confusing, it’s in the best interest of HTM professionals to have a general understanding of what the various certifications represent and how they are applied to different types of companies. So take a few minutes, or hours, to review background materials on ISO and peruse the companies listed on the Independent Association of Accredited Registrars’ website. In the long run, it will greatly benefit the overall safety of your organization.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

U l t r a s o u n d

device industry even though some requirements are not applicable to all companies. If there are ISO requirements that aren’t applicable to a company’s services, the company is allowed to redact the irrelevant requirements from the scope of its ISO application. For example, not all ultrasound support companies repair the same parts. Some may repair only probes, while others will repair parts and transducers. Due to the ability to redact requirements from the scope of ISO audits, both companies can receive an ISO 13485 certification. The fact that the scope of ISO audits and certifications can vary so widely presents a challenge for health care administrators seeking the best service providers to support their organization’s medical equipment. ISO certifications can be a great measurement of a company’s business processes and abilities, but if a company in the medical device industry claims to be ISO certified it’s important for HTM professionals to look closely at the scope of its ISO certification claim. In some cases, particularly when it comes to brokerage firms, ISO certifications may not be the best indicator of the company’s ability to provide high-quality medical device parts. HTM professionals should seek out another way to vet the company. Seeking information about the companies that conduct repairs for the

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TOOLS OF THE TRADE

IPA-3400 Infusion Pump Analyzer - BC Group

he IPA-3400 is the newest addition to the line of BC Biomedical test equipment. With its large 7-inch touch screen display, dual syringe stepper motor driven system and built-in autosequences, the IPA-3400 is a compact and fully featured four channel analyzer. The IPA-3400 has full touch screen control of all processes, leaving no need for buttons and knobs.

The IPA-3400 Infusion Pump Analyzer also features a patent-pending design that uses a dual syringe stepper motor driven system. This provides continuous monitoring of the fluid flow whereas older technology needs to stop and perform intermittent drains. The IPA-3400 provides a more realistic flow path for the infusion device being tested, as well as more accurate readings. The independent stepper

TECHNATION

DECEMBER 2016

motor control of the custom designed, ceramic valving allows the system to run quietly and smoothly, with a bidirectional powered fluid flow for use in the built in cleaning cycle. The IPA-3400 has built-in autosequence capabilities that allows the user to perform automated test procedures. Users can run specific test routines specified by various manufacturers, saving time as well as reducing the risk of human error. Advanced features in autosequences even allows for the inclusion of pictures to aid with the setup and configuration of each step. All test results are stored internally in the large, 32 GB memory. Results can also be downloaded to a USB fl ash drive or directly to a PC. FOR MORE INFORMATION, about the IPA-3400, contact BC Group at 800-242-8428.

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STAFF REPORTS

Webinar

Wednesday

WEBINAR WEDNESDAY Educational Series Continues to Deliver

he TechNation Webinar Wednesday series continues to provide free continuing education opportunities to HTM professionals around the world. Recent webinars have received stellar reviews from participants following the live webinars and the recordings have been viewed by thousands on 1TechNation.com/webinars.

A recent webinar sponsored by Conquest Imaging – “Ultrasound Accreditation and Regulatory Compliance from A to Z” – impressed attendees. More than 200 people participated in the live webinar presented by Conquest Imaging Training Director Jim Rickner. During the presentation, Rickner demonstrated the various complex requirements and testing protocols for all the accreditation and regulatory organizations overseeing the ultrasound industry – including the American Institute of Ultrasound in Medicine (AIUM), American College of Radiology (ACR), Intersocietal Accreditation Commission (IAC) as well as Centers for Medicare and Medicaid Services (CMS) and National Fire Protection Association 99 (NFPA 99). The webinar described the requirements of testing protocols used by various accreditation and regulatory organizations overseeing the ultrasound industry and explained how one can apply the protocols in their facilities/departments. It included a discussion regarding the difficulties encountered at facilities trying to meet the various requirements. The webinar “Testing Today’s ESU Generators – Focusing on the Valleylab FT Series Energy Platform” sponsored by Rigel Medical attracted 286 attendees. Rebecca Adkins, CBET, of Rigel

TECHNATION

DECEMBER 2016

Medical, and Jack Barrett, National Business Development Manager at Rigel Medical, introduced attendees to electrosurgery, the common terminology used, sample PM requirements, manual and automated testing and the power of data management. The webinar taught attendees how to develop familiarity with various manufacturer ESU testing requirements including CQM, safe power output testing; monopolar, bipolar, and LigaSure. HF Leakage and cross coupling testing requirements. It also discussed how to develop a standard process of ESU testing and the advantages of test

provide comprehensive data on their asset spend. Jon Kocurek, Director of Clinical Engineering at Dartmouth-Hitchcock Medical Center, and Dan Brenner, PMP, Strategic Program Director at PartsSource, took attendees through the process they used to identify, track, analyze, and evaluate key metrics to help transform the Dartmouth-Hitchcock Clinical Engineering Department. During the webinar, attendees learned how to highlight the value of clinical engineering to their health care organizations. The webinar also included proven methods to track and update necessary data. Kocurek and Brenner explained an ongoing data measurement process of all assets under a clinical engineering department’s care.

“I kept ignoring the emails and webinar invitations from TechNation, until I finally attended one and found out what I’ve been missing. These webinars provide so much very helpful information. Now, when I see an email from TechNation, it gets my devoted attention.” - Bob W.

automation, data management and traceability, AEM impact. The PartsSource-sponsored webinar “The Use of Advanced Analytics to Meet Performance Objectives” examined how clinical engineering departments are facing increasing pressure to track and

The webinars have been viewed by HTM professionals from around the world. The webinars, which are available online at 1TechNation.com/ webinars and on YouTube, received high marks from attendees in postwebinar surveys.

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“The webinars TechNation is providing are an invaluable service benefiting the hospitals, patients and technicians – all biomeds should take advantage of this opportunity,” wrote Robert C. “I kept ignoring the emails and webinar invitations from TechNation, until I finally attended one and found out what I’ve been missing. These webinars provide so much very helpful information. Now, when I see an email from TechNation, it gets my devoted attention. Thanks for all you do to enhance our knowledge and understanding,” Bob W. wrote. “Wherever you are in the world, TechNation’s webinars keep you up to date with skills and information that really helps in the biomed world,” Tony R. said. “TechNation’s webinar series is the best. The links are easy to use and presentations are easy to understand. I’m a U.S. Air Force biomed tech stationed in Okinawa, Japan. I usually wake up and get on the computer around 3 a.m. to join the webinar. If I happen to miss it, I know that I can just access their archives later. Their presentations are very good for training for new biomeds and veterans alike. The best part

is that I still learn new things despite being a BMET for 13 years and I get credit for it,” Jabrielle S. wrote. TO FIND OUT MORE about the TechNation webinar series, including a schedule of upcoming presentations, visit www.1TechNation.com/ webinar. TECHNATION WEBINAR WEDNESDAY would like to thank the sponsors who participated in thie webinars featured in this article. For more information on either company, just visit www.conquestimaging.com, www. rigelmedical.com, and www.partssource.com.

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ROUNDTABLE

STAFF REPORTS

ROUNDTABLE Test Equipment

TECHNATION

DECEMBER 2016

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ROUNDTABLE

TM professionals cannot do their jobs without the correct tools. Some of the most important tools are the test equipment the biomeds use to test and service medical equipment. TechNation contacted leaders in the test equipment sphere and asked them for tips and what HTM professionals should be aware of as we head into 2017.

The panel of experts participating in the roundtable discussion on test equipment include Pronk Technologies Vice President of Sales and Marketing Greg Alkire, Rigel Medical National Business Development Manager Jack Barrett, BC Group International Inc. Vice President Business Development Mike Clotfelter, Datrend Vice President of Product Development Ron Evans, Radcal President and CEO Curt Harkless, Fluke Biomedical Senior Marketing Manager Shirin Khanna and Netech Corporation Sales and Marketing Manager Wijin Joe Oommen.

WHAT ARE THE MOST IMPORTANT THINGS TO LOOK FOR WHEN PURCHASING TEST EQUIPMENT? Alkire: Today’s fast paced HTM market needs test equipment that is portable, easy to use and backed with a multi-year standard warranty to ensure a low cost of ownership. It is important to identify the features needed for the inventory of medical devices to be serviced and to evaluate the test equipment performance specifications. Test equipment companies specify the accuracy and range of their devices in very different ways and may not use the same terminology as the medical device manufacturers. The accuracy of the test equipment needs to be four times (4:1 ratio) more accurate than the medical device’s testing requirements as a general rule. This is critical when adjusting/calibrating medical devices and even more crucial

GREG ALKIRE,

for life support equipment. Barrett: Functionality. The ability to completely accomplish the manufacturer’s defined PM. Future functionality. With budgets being what they are, that piece of test equipment will be used for a long time. Is the feature set one that can potentially cover future needs? Does it make your life easier and is the test equipment manufacturer easy to work with? Clotfelter: Price is always important, but you also need to make sure the features and specifications are adequate for your applications. Portability and durability is often very desirable, especially if the equipment will be used for field service. When delivery time is important, consider selecting a supplier that stocks inventory, rather than builds to order, which can extend delivery times to several weeks. Consider selecting suppliers that have active quality systems and are ISO 9001 certified.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

Pronk Technologies Vice President of Sales and Marketing

Evans: The use of technology integrated into the test equipment to enable the user to work more effectively, both today and in the future. A lot of test equipment is still based on the legacy model of “do a test, write down the results.” Today’s technology allows us to do a lot more, like automated tests and procedures, direct-to-file test reports, results evaluation, remote access, and much more. Look for test equipment that has this type of technology integrated into its design. Harkless: In X-ray imaging quality assurance, the lifetime of an instrument is critically important and varies greatly. Some providers offer service and support for 10, 20, even 40 years while others terminate service of systems after as little as 5-10 years. Since these instruments have strict

DECEMBER 2016

TECHNATION

ROUNDTABLE

looking for large savings in time, costs, and manpower while at the same time fulfilling their accreditation needs. Automation helps achieve these goals.

calibration and service requirements, the relationship one has with their provider is as important as the instrument itself. Look for a longstanding provider that can be your partner in the industry. Khanna: In today’s environment, technicians have to do more with the same or less and time is of the essence. The most important things to look for when purchasing equipment is high accuracy, proven reliability, ease of use and electronic documentation. The combination of these will get the job done quickly and efficiently while minimizing risk. Oommen: There are several important factors to be considered before buying test equipments. First, ensure that the equipment fully meets your organization’s testing requirement standards. Next step to consider is the quality and reliability of the equipment. You also need to factor in that the equipment is compact and portable, easy to operate with all necessary features and is worth the value. Lastly, it is imperative that the manufacturer provides you with excellent after sales support and service after purchase.

WHAT ARE SOME OF THE FUNDAMENTAL TEST EQUIPMENT CAPABILITIES REQUIRED FOR BIOMEDS TO BE ABLE TO DO THEIR JOB? Alkire: Each biomedical engineer needs to have their own complement of test equipment required to manage their workload. It should be very portable with multi-functional features allowing it to be utilized on a wide range of medical devices. This minimizes the size of the “tool bag” for each bio-

TECHNATION

DECEMBER 2016

JACK BARRETT,

Rigel Medical National Business Development Manager

medical engineer and maximizes the return on the investment of the test equipment. Barrett: Pretty simple really. Does it do the needed PM tests as specified by the medical device manufacturer? Clotfelter: Various pieces of test equipment are needed for biomeds to do their job. Electrical safety analyzers, multi-parameter patient simulators, infusion pump analyzers, ventilator analyzers, ESU analyzers, oscilloscopes, as well as DMMs cover many of the basic parameters required for biomed shops to maintain most medical equipment. Additional test equipment is needed if biomeds are going to handle specialty modalities, such as anesthesia service. Evans: I would suggest that test equipment with a high degree of automation will result in the biggest impact for a biomed. Facilities are

Harkless: In X-ray diagnostics, the required measurements (dose, dose rate, kV, mA, filtration, pulse count, HVL, and exposure duration) are well defined. What is often overlooked is the ability to rapidly translate the acquired measurements into the final product (often a report). In addition to ensuring that an instrument checks the boxes for required measurements, it is worth considering what happens to those values once they’ve been acquired. Increasingly automated and streamlined methods for acquiring, reporting, and archiving these measurements in a single step are now available. Khanna: Biomeds (Healthcare Technology Management professionals) today need test equipment designs that make using it very efficient – in other words quick and easy to set up, connect up, select measurement functions, and observe measurements or other test results. Whenever possible, the test instrument should already have or allow to be selected based on International Performance and Safety Standard so that the measurement is automatically assessed/compared to those limits and an objective Pass or Fail test result is stored for later download, or uploaded immediately to the test record and included in the databased device history record of the medical device under test. Furthermore, all aspects of the test procedure provided by the manufacturer of the medical device must have a way of recording/reporting that the prescribed action has been carried out, and what the result is – Pass or Fail or Not Applicable as appropriate.

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urable preset simulations and is Masimo rainbow SET compatible. Next, we just introduced the second-generation FlowTrax Infusion Pump Analyzer that adds Electronic Occlusion, Quick-Prime and advanced, easy-to-use maintenance features for even greater speed. This, in combination with DataSnap and HydroBalance, makes FlowTrax the most accurate and complete IV pump analyzer on the market.

MIKE CLOTFELTER

BC Group International Inc. Vice President Business Development

Oommen: Biomeds, in modern medical practice, are such an integral part of our industry as they are entrusted with the maintenance and calibration of equipment in hospitals and all medical facilities. Hence one fundamental capability is to have an in-depth understanding and knowledge of the testing equipment. It is important that they understand the performance, functions and safety standards of the equipment before purchasing the unit.

Q: WHAT NEW TEST EQUIPMENPRODUCT OR DEVICE ARE YOU THE MOST EXCITED ABOUT? Alkire: We are excited about two new product introductions. First, the next-generation SpO2 simulator, OxSim Flex, takes the smallest SpO2 simulator currently on the market and expands its features to provide the user complete control of any simulation for saturation, pulse rate and perfusion level. OxSim Flex also has user-config-

Barrett: With Rigel Medical’s product profile, we have always had the product with test automation and internal memory. To me, taking that level of expertise and bringing it into lower price point products with some interesting twists is pretty exciting. Clotfelter: BC Group recently released our latest Infusion Pump Analyzer, which is our IPA-3400. The IPA is the most compact full-featured, four-channel analyzer on the market. Some of the functions are; Flow Test, PCA/ Bolus, Back Pressure Simulation, Occlusion Alarm, Trumpet Curve Analysis, data download, customizable test templates, self-cleaning, auto-sequence capabilities, etc. The IPA-3400 features field swappable modules and only the modules need to be calibrated. Evans: Datrend Systems is most excited about our recently-introduced new Patient Simulator, the vPad-A1 Multi-Parameter Patient Simulator, which is based on our revolutionary Vision-Pad Technology. It is an all-in-one patient simulation system. vPad-A1 is modular and is comprised of a Multi Parameter Patient Simulator, SpO2 test module, and a Non-Invasive Blood Pressure simulation module which may be used together, independently, or in various combinations.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

RON EVANS

Datrend Vice President of Product Development

An Android handheld device or vPad tablet provides the user interface. Harkless: Remarkably, in today’s world the response to any technical challenge has become... “there’s an app for that.” This has become equally true in the field of X-ray diagnostic quality assurance. One of the things I’m most excited about are instruments for which iOS devices such as the Apple iPhone and iPad can serve as a wireless display and control unit. Just download the app to your phone and make your measurements. Khanna: The new INCU II Radiant Warmer Analyzer is exciting for Fluke Biomedical. Infants in a NICU ward cannot communicate whether they’re too hot or too cold. The INCU II is an all-in-one analyzer that accurately assess the environments in incubators and radiant warmers, ensuring each baby gets a good start to life. The QA-ES III is another product we are

DECEMBER 2016

TECHNATION

ROUNDTABLE

mance data into the automation process will greatly improve efficiency. We are excited most about designing scalable equipment to account for future capabilities and ensuring equipment will communicate with devices from different manufacturers, including interoperability between CMMS manufacturers and test equipment manufacturers.

excited about. It’s been a trusted tool for biomedical technicians for more than a decade. Fluke Biomedical improved its performance, added wireless functionality, and is ready-outof-box with all the cables and leads needed for testing. Its lighter frame makes it ideal to carry from test location to test location. Oommen: It’s an exciting time in biomedical research and development, and as technology advances we continue our pursuit of developing high-quality and innovative biomedical test equipment that is compact, affordable and meets your application for today’s requirement. We continue to play a vital role in helping customers increase their confidence in us by developing newer products as the market requirement changes.

ADVANCES IN TECHNOLOGY ARE IMPACTING THE TEST EQUIPMENT MARKET. WHAT EXCITING THINGS DO YOU THINK ARE POSSIBLE IN THE NEXT 3 YEARS? Alkire: We are seeing a significant evolution in technology now that is creating many opportunities in the medical test equipment market. We believe companies can take advantage of these tools to engineer products with open architecture, enhanced wireless communication capabilities and automation of testing protocols to really advance the effectiveness of test equipment for biomeds. Barrett: The technical side of what to test is a constant. The medical equipment OEMs defines that. Where I see coming changes is the user interface side. How can the biomed’s daily tasks

TECHNATION

DECEMBER 2016

CURT HARKLESS

Radcal President and CEO

become easier to accomplish? Additionally test data; the associated traceability and management, the potential impact to AEM programs provide benefit. Clotfelter: We anticipate continued advancements in the test equipment market in the next few years, mainly in the area of auto-sequence programs. Auto-sequence programs improve efficiency for biomeds and can sometimes include capturing test data. Auto-sequence programs can also reduce labor time for PMs. Evans: Biomedical engineers are constantly being asked to do more with less. The biggest impacts involve reducing time costs and manpower through the use of automation as much as possible. Automating not only electrical safety tests, but also incorporating inspection reports and perfor-

Harkless: I anticipate that test equipment will become more tightly integrated with wireless devices such as phones and tablets. As this integration becomes richer, more streamlined automation will be achieved. Measurements will be made and immediately entered into centralized databases on cloud based storage. This, in turn, will enable deeper trend analysis and more effective condition-based maintenance. Khanna: One thing that we can count on is the need and the desire for more “smart” technology where our devices can do more for us. We’ve seen this with calculators, evolving from doing basic math to being able to graph and calculate complex equations, to common household items such as a cellphone, evolving from making calls to controlling your TV and home security alarm. We expect this to continue within the test equipment market. Fluke Biomedical is continuing its work on cutting edge innovation and technological advances that will make things easier for biomeds to perform their jobs effectively and efficiently. Oommen: Technology is perhaps the greatest agent of change in the modern world. With the development of advanced microcontrollers, newer test

WWW.1TECHNATION.COM

ROUNDTABLE

maximum return on your investment. Barrett: The biomeds know their technical needs better than anyone. Budgets are continuously squeezed. Do more with less is the mantra. Just do your research and pick the best match for you and the facility.

SHIRIN KHANNA

Fluke Biomedical Senior Marketing Manager

equipments can be built smaller and with more improved functions and higher testing capabilities. We will see a rise in the number of compact devices in the years to come.

WHAT ELSE DO YOU THINK TECHNATION READERS NEED TO KNOW ABOUT PURCHASING TEST EQUIPMENT? Alkire: Investing in test equipment is a long-term decision and it can be difficult to foresee what requirements could change in the years ahead. So it’s important to look for products that provide flexibility to select the features you need today as well as an upgrade path to add features after the initial sale. The product should be designed to be “forward compatible” so it can be upgraded with new features as they are released. This ensures the test equipment can grow with you and provides a

Clotfelter: A term that we like to use is future proofing. We have several products that are upgradeable to the next generation product. This includes our state of the art ESU analyzer and our new infusion pump analyzer. Our new infusion pump analyzer can have from 1 to 4 channels. You can purchase it with 1-4 channels and later purchase additional modules and install them in the field for easy expansion. Evans: It is important to remember that there are options out there. While it may seem safe to buy what you have always bought, you could be missing out on significant functionality by not considering other sources. Also, be careful not to lock yourself into a single vendor by selecting a system that can’t or won’t interface with another company’s products. Look for flexibility and scalability so you can choose what is best for you and expand your test suite accordingly. And, be sure to check the warranty, service availability and service turn around time for the test equipment you are considering. Harkless: It is important for today’s professionals to consider the broader aspects of how their instruments are used. The days of hand copying numbers into a lab book are fast disappearing. Look for a partner willing to tailor your instrument, software, and service to your individual needs. The time savings and im-

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

WIJIN JOE OOMMEN.

Netech Corporation Sales and Marketing Manager

proved user experience are well worth the effort. Khanna: Purchase equipment that can meet the demands of the future. This could be in terms of the capability of the equipment, the manufacturer’s ability to service the equipment effectively, or the demands of your department. With patient safety first, reliability and accuracy are key. Purchase equipment/technology that has a proven track record for safety and reliability. Oommen: First, you need to understand the exact needs/requirements of your department/organization. Second, evaluate the equipment and see if it meets your requirements. Ask for a demo and understand the technical operation of the unit. Finally, ensure after sales support from the manufacturer.

DECEMBER 2016

TECHNATION

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How Does Your Department Measure Up? Using Metrics to Gauge Your Success BY K . R I C H A R D D O U G L A S

COVER STORY

you have ever called into a telephone customer service line for help with a product, most likely the person on the other end was having their performance measured by a series of metrics that included how fast they resolved your problem or simply finished the call, how accurately they entered data related to your call, if they were able to up-sell you to another product or the response time after your call hit the queue. In many cases, your call would have been recorded and a supervisor would have later listened to the recording, using an evaluation form, and notated how many criteria were achieved.

Most customer-facing jobs include a set of metrics which allow management to measure performance, reduce overhead by minimizing repeat calls, evaluate customer satisfaction and minimize the percentage of customers who might jump ship and defect to competitors. While the experience of many customers is that they wait on endless hold, get a snarky person on the phone or end the call with no resolution, the fact remains that metrics are widely used in call centers. Evaluating costs and performance, using a predetermined set of criteria, is a common practice and it allows management to determine who might qualify for a pay raise, promotion or dismissal. It is also a way to find ways to remain within a budget and measure the effectiveness of current procedures. In the end, it’s about getting better; improving. This notion of constantly improving, running a tight ship and providing a cost-effective product has not escaped the biomed world. Someone, somewhere is always evaluating how efficiently things are getting done and how well medical equipment is maintained and repaired, utilizing various criteria for measurement. “CE /HTM departments mostly just do their jobs. The good departments know the importance of the hospital doing well financially so they are very aware of the cost of running their department. These departments run their operation like a business,” says Frank R. Painter, MS, CCE, assistant professor and Clinical Engineering program director in the Biomedical Engineering Department in the School of Engineering at the University of Connecticut. “This is what separates the mediocre operations from the very good operations,”

TECHNATION

DECEMBER 2016

he says. “So to run like a business you need to know how much it costs you to provide services to those you work for. This is a simple calculation, but few do it.” Painter points out that this calculation consists of the total cost of running the CE department for a year – salaries, beneﬁts, supplies, space, utilities, etcetera – divided by the number of hours of service the department is able to provide to its customers in a year. “This will come out somewhere in the range of $75 to $120,” he continues. “If you know this, you can then calculate the cost of providing services to a particular department and compare yourself to other providers (GE, Aramark, Sodexo, etcetera). This is a valuable benchmarking metric but is also a useful number needed to run like a business.”

MULTI-METRIC “Historically, clinical engineering programs have tracked such metrics as PM comple-

FRANK R. PAINTER, MS, CCE, Assistant Professor & Clinical Engineering Program Director, Biomedical Engineering Department at the University of Connecticut

CHE, CCE, corporate director of Clinical Engineering for McLaren Health Care in Flint, Michigan. “Do any of these metrics have anything to do with measuring ‘efficiency or success?’ Perhaps, but most likely, they do not,” he says. “Efficiency of a CE program could perhaps be quantified by measuring the degree to which a desired outcome was achieved with the least effort.” “I guess this was more relevant long ago, where the focus was on doing electrical safety tests, as a driver to prove that a PM was done comes into play. We got really

“... to run like a business you need to know how much it costs you to provide services to those you work for. This is a simple calculation, but few do it.” - FRANK R. PAINTER

tion rate; percentage of scheduled inspections completed on time; number of device failures; number of equipment problems found to be ‘use’ related (i.e., operator error); service response time; and “cost-ofservice ratio (COSR),” says Dave Dickey,

high numbers, with little work effort involved with pushing that little ‘lift ground’ button. Cranked out 50 inspections in a day. Does this mean our program was efﬁcient,” Dickey asks? Dickey questions if success can be

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COVER STORY

quantified by the degree to which goals are obtained. He asks if doing 100 percent of scheduled inspections mean you have a successful program? “Perhaps, but what if 10 percent of your inspections actually induced post inspection failures of the equipment tested, due to improper maintenance being done (i.e., put it back together incorrectly),” he says “Hitting a financial target could also mean you were successful in meeting the goal, but what if this was achieved by spending far too much time on equipment repairs, say, taking three days to fix equipment using in-house staff or used parts that were DOA, as opposed to biting the bullet and calling in the vendor, who may have had the device repaired in half the time? You may have saved some cash, but to what expense,” Dickey adds. Dickey also says that some metrics, which are commonly used, may not have an even application across different institutions and programs. “Also, cost-of-service ratio, while I believe is a great benchmark for tracking year to year trends; to identify overall financial cost of equipment ownership trends; and to support the annual budgeting exercise, is not a good benchmark to use from one hospital to another, since it is highly dependent on equipment type; what’s included in your program; and purchase cost,” he says. “However, I do suspect it is quite useful when comparing in-house versus outsourced program options, assuming you have an apples to apples comparison of program inclusions (example; an in-house program may cover abuse related repairs, whereas an outsourced program may not). Another thing to watch for, when attempting to benchmark cost-of-service ratio, relates to equipment types covered. For example, our program includes costs for surgical instrument sharpening, power equipment, rigid and flex scopes; linear accelerators and some image management systems, whereas another HTM programs may not,” Dickey adds. The variability in the cost-of-service metric is one reason that other approaches

are utilized as well according to Benjamin Lewis, MBA, CHTM, director of Clinical Engineering GA/FL for Novant Health Inc. “Because of our close relationship with our supply chain, we are still able to calculate our cost-of-service ratio. However, this is a difficult metric to capture and can also be somewhat fluid,” Lewis says. “There are other ways to measure and track your performance. The depth and meaningfulness of these key performance indicators are only limited by the data you accurately track in your CMMS.” Lewis says that some of these other key performance indicators (KPIs) include: “Parts Cost Savings: The difference in OEM and third-party parts costs. Success in this metric will be based on your organization’s savings versus spend trend over time.” Another KPI he cites is: “Contractual Cost Savings: The reduction of contract spend by bringing contracts in-house or negotiation of a reduction in existing spend.” He also lists Contractual Cost Avoidance; the cost savings from the avoidance of contracts due to in-house maintenance along with Actual Cost versus Budgeted Cost, which is the ratio of actual cost to budgeted cost. “CE expenditures can vary due to maintenance needs like tubes and detectors, but the goal is to be, at or below, budget by five percent. The goal is not to pad your budget but not to go over,” he adds.

TRIED AND TRUE “Cost-of-service ratio is an excellent ﬁnancial benchmark,” Painter says. “It tells your cost of doing business – running your HTM operation – but it is then ‘normalized’ so you can compare yourself to others of different size or capability.” “The normalization factor is the purchase price of the inventory you support. So if you are relatively small, or very large, if you support imaging or you just do general biomedical equipment, the total cost of the inventory you support will be the factor which helps us all to compare ourselves to each other. The problem is that only in the

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

DAVE DICKEY, CHE, CCE, Corporate Director of Clinical Engineering, McLaren Health Care

“Another thing to watch for, when attempting to benchmark cost-ofservice ratio, relates to equipment types covered. For example, our program includes costs for surgical instrument sharpening, power equipment, rigid and flex scopes; linear accelerators and some image management systems, whereas another HTM programs may not.” - DAVE DICKEY

DECEMBER 2016

TECHNATION

COVER STORY

BENJAMIN LEWIS, MBA, CHTM, Director of Clinical Engineering, GA/FL for Novant Health Inc.

“There are other ways to measure and track your performance. The depth and meaningfulness of these key performance indicators are only limited by the data you accurately track in your CMMS.” - BENJAMIN LEWIS

TECHNATION

DECEMBER 2016

last five years or so have many CE departments been aware that there is value in collecting acquisition cost,” Painter adds. “Prior to that, most had little or no data about the cost of the inventory; but to properly calculate COSR we need the data. The mediocre departments, or the departments which have been squeezed by administration and are short staffed are not able to do the research to find or estimate these important numbers. So you can see that it is a mad cycle. If you don’t have the ability to collect the data, then you won’t get the metrics which will show how well you are doing,” Painter says. Painter, Baretich and Ted Cohen co-authored a 2015 guide to benchmarking published by the Association for the Advancement of Medical Instrumentation (AAMI) called the “HTM Benchmarking Guide; Why Benchmarking Matters, and How You Can Do It.” The guide provides examples from AAMI’s web-based “Benchmarking Solutions” platform. The guide helps in establishing some degree of standardization, as well as covering a case study and reasons for benchmarking. “My experience as one of the subject matter experts for the AAMI Benchmarking program is that COSR is increasingly recognized as a fundamental performance metric for HTM,” says Matt Baretich, P.E., Ph.D, president of Baretich Engineering, Inc. in Fort Collins, Colorado. “That’s certainly the case among my consulting clients and the professional colleagues I communicate with.” Baretich says that the challenge is that many HTM programs do not have data for the dollar value of the equipment they manage. Since the objective of performance monitoring and benchmarking is performance improvement, he recommends that one of the first performance improvement initiatives is to get the data. “That means working with Finance to make sure that HTM routinely gets cost data on all new purchases. For existing equipment, I recommend making good

estimates and focusing ﬁrst on high-value equipment such as imaging devices and systems,” Baretich says.

SETTING THE BAR Painter differentiates between completing regularly assigned tasks and making measurable incremental improvements. “The metric ‘PM completed’ is not a metric anyone should consider to be a performance improvement benchmark. It is a basic requirement of the CE department to get these things done as required by TJC,” he points out. “Following them is good, as it will help you keep your job, but it cannot be considered a performance improvement metric. You either get them done or you’re toast,” he adds. “Related to performance improvement, there are two types of benchmarking. Benchmarking against yourself and trying to continuously improve your own performance,” Painter says. “This is the purest form of benchmarking and if done carefully and with eyes wide open, it can result in good forward progress in supporting your hospital’s healthcare technology.” “The other method is to benchmark yourself against others. We do this to ‘keep up with the Jones’ or as a self-defense measure to show your boss you are in the ballpark and are worth investing in,” he adds. Quality work equals devices that run smoothly and with fewer disruptions. Tracking data accurately can provide additional beneﬁts. “In addition to quantitative metrics, qualitative metrics also allow us to increase cost savings through performing alternative equipment maintenance on some equipment that meets the parameters for being part of our AEM program, excluding imaging and laser equipment,” Lewis says. “Through proper work order tracking and accurate data pulled from our CMMS, we can study metrics like time between failure and total corrective

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MATT BARETICH, P.E., PH.D, President of Baretich Engineering, Inc.

maintenance work orders for a speciﬁc model of equipment over a period of time which enables us to make informed decisions on maintenance intervals and procedures.”

THE NEXT EVOLUTION Finally, much in the way CMS holds a measuring stick up to a health care provider with its own set of metrics, the approach spills over into the HTM department. “At McLaren Health Care, we are launching a new set of metrics which will allow us to track quality and effectiveness of our medical equipment management program, which I believe are more appropriate for demonstrating an HTM program’s value to the health care organization,” Dickey says. “The focus here is to determine how our work affects (1) patient care outcomes, and (2) impact on patient’s length of stay. While focusing on these metrics is somewhat new, and a ‘works in process,’ the reality is that, so long as the inspection agencies keep asking about PM completions, our industry will continue to measure, report, brag and/or, hide from what these values, these numbers actually reﬂect; which is, not much,” he concludes. When a call comes into a call center, a well-prepared customer service agent can provide the right answer and send the customer happily on their way. When medical equipment is up and running, a patient, who came in through the ER, may be able to get back home before the sun goes down. A measure of success in achieving these things goes a long way.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

DECEMBER 2016

TECHNATION

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EXPERT ADVICE

BY TODD ROGERS

CAREER CENTER A Peek Behind the Scenes at Online Job Applications

estimate that I spend about fifteen percent of my day reviewing resumes and on-line job applications. The same goes for the rest of our recruiting team. I have an informal method that I use to screen applicants. I want to explain this method to TechNation readers as a sort of public service. By explaining this, I hope that some of the ambitious and talented readers can get a simple take-away that will have a positive impact on their careers. Additionally, I might gain access to more high-caliber talent. So, read the following paragraphs with the idea that you’re getting a behind-the-scenes look at what exactly happens after you apply for a job for a good reason that can help you and us.

TODD ROGERS Talent Acquisition Specialist for TriMedx

TECHNATION

DECEMBER 2016

I don’t think that there is a single person who’s ever had a positive experience completing an on-line job application. Who likes creating a user name and password and then answering a dozen or so semi-personal questions, which will surely include disclosing how much money you make in a year? No one likes that. Furthermore, as you read the questions, it occurs to you that a lot of your answers to those questions could potentially disqualify you from consideration. Sadly, no one is going to ever tell you which question it was that got you disqualified and they aren’t going to disclose what was so bad with you answer. So, you spend a bunch of time sorting through on-line job ads, applying to those that seem appropriate. Each application is basically the same: create account, upload resume, answer questions, hit “Save” and then cross your fingers. You do this a few dozen times and then maybe you get an email or phone call. You do a few phone screens. If you’re lucky, you get invited in for an interview. If you’re less lucky, you get a no-thank-you-email. If you’re even less lucky, you never hear from the employer again. Candidly, the odds are stacked against you and it seems like the dice are loaded. But unlike a dice game or casino blackjack, rarely does anyone actually tell you that you lost!

Let’s cover the basics. Recruiting software, otherwise known as an applicant tracking system (ATS) is finicky. There are literally thousands of users for any given company’s ATS. Each of those users has a slightly different variation on how he or she engages that system. With this enormous set of user-variables, the system is prone to error. Avoid the negative consequences of these errors by following some very basic rules. Use as MS Word resume BUT, and this is really important, DO NOT USE A RESUME TEMPLATE and DO NOT USE A HEADER/FOOTER on that document. Templates and headers/footers cause most ATS software to do bad things to the resume. Templates, headers, and footers also cause the parsing feature to simply go haywire. You know how you can upload your resume and then it seems to magically use that information to complete a lot of those fields so you don’t have to actually type them out? When you use a template or headers and footer, that magic gets disrupted. Chances are, you won’t even notice that your beautifully crafted template resume turned into a bunch of squiggly lines and number that make no sense to anyone. After you upload and parse the resume, you really should go through all of the fields that the software populated for you. Check to make sure that the parsing didn’t mince up your prose. It’s likely that

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EXPERT ADVICE

it did and it’s up to you to fix it. Next comes the general application questions. These are questions asked to anyone and everyone who applies. These questions relate to eligibility to work in the United States, are you over 18 years of age, are you willing to relocate if necessary, how did you hear about us, and the dreaded request to disclose your current income and your desired income. Just be truthful. On the income question, everyone labors over this. Do I inflate my income? Do I reach for the stars and state that I want $250,000 per year? Do I leave it blank? Do I put zeroes in the box, do I write negotiable? I’m not going to make any suggestions on what to do in this box. Each answer has its own risks and also its own potential benefits. Think carefully, make a decision, and be prepared to deal with the possible consequences of your decision. Most ATS software pulls your experience from your resume and parses it in the experience section of the application. It also adds in the dates. Double check to make sure that this parsed correctly, as well. The system has high potential for errors. Like I already wrote, it’s your job to make sure it’s correct. You’re probably more than halfway through the application at this point. The next step might include job-specific screening questions. Some places use these questions, some do not. These questions usually have multiple choice answers. Sometimes there are text-box answers (common) as well as ranking questions (rare) and forced choice (very rare) questions. Multiple choice

questions are frequently used for knockout purposes. There are 1-2 acceptable answers and 2-3 unacceptable answers. You can usually read the question and easily figure out which answer is the one they are hoping that you will select. While it’s tempting to follow this method and answer with what you think they want (even if it’s not truthful), let me tell you how I handle

I know what you’re probably thinking, truthfulness is often subject to interpretation. I know this. But, there are also truths that, practically speaking, just can’t be fudged. this. My questions follow this formula. I ask the applicant to “Please select the best or most accurate answer to the following…” Whatever answer you provide, when we end up on the phone together, know this: I am going to ask you about that specific question and I’m going to ask you to provide me with at least one example that supports your answer. If you tried to slip one past me on the application, I assure you, I will

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

catch it right then and right there. When you attempt to use the, “I guess I misunderstood the question,” just know that you’ve been caught fudging and it’s probably going to end the interview. Finally, you’ve got the integrity-check. There’s this big paragraph that tells you a few things about being an equal opportunity employer among other disclosures, and then it asks you to check a box and type your name attesting that you’ve been truthful about the whole application. I know what you’re probably thinking, truthfulness is often subject to interpretation. I know this. But, there are also truths that, practically speaking, just can’t be fudged. Now is the time to go back to the questions and spend some time being honest with yourself. Did you really manage 4 staff members or did you manage a project that had 4 project team members? Do you really make $85,000 a year or do you make $78,000 a year but might be eligible for a $7,000 bonus? You know how clean your answers are and this is the time to check yourself and also to check your answers. The last thing to consider is using a site such as LinkedIn. Make a polite attempt to contact the person who you believe is most likely to be the one who will review your resume. Your chances of getting a response are pretty low but it’s a low-effort, low-risk, high-return task that takes about thirty seconds. I really hope that this is helpful. I know the application process can be frustrating. But I truly hope that those who read this recognize that there’s a method to the application-madness and that it serves a very noble purpose.

DECEMBER 2016

TECHNATION

EXPERT ADVICE

BY JEFF KABACHINSKI

TECH SAVVY

A New Interoperability Standard on the Horizon

t’s not a news flash that computer networks continue to grow in size, traffic and function. Healthcare Information Systems (HIS) are in the same boat. Router functions and configurations become some of the most important methods to help manage traffic conditions and preserve medical device security and interoperability function. This month Tech Savvy delves into router terminology and basic functionality. Being aware of these terms and general concepts will help when meeting with your local healthcare IT team.

JEFF KABACHINSKI Senior Director of Technical Development, ITD

First a side note for clarification about router terminology is the use of the terms router and gateway. Originally routers were known as gateways. As router function evolved it was viewed as a special kind of gateway and the term router came into use. The older terminology is still in use however such as default gateway in a routing table. The default gateway is the go-to path when a router does not recognize the destination network. Included in the network level packet is a time to live metric. Each time a router sends a packet to its default gateway the time to live counted is decremented by one. Eventually a bogus or corrupted packet’s time to live metric reaches zero and the last router will discard it. This way the bogus packet will not run around the network forever. ROUTING TERMS The first acronym to look at is Autonomous System (AS). Within the Internet, an AS is a single or group of networks controlled by a common network administrator. In Figure 1 – the Healthcare Information System (HIS) is an AS – a network system that is internally

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controlled without need of the Internet – a “standalone network”. Managing traffic in the AS are strategically deployed Internal Routers (IR). All of the various routing connections shown in Figure 1 are running Border Gateway Protocols (BGP). Within the AS or intra-network the IRs are running IBGP or Internal BGP, where the connections and routes are trusted and freely exchange information. When connecting to another AS via Internet routers will use EBGP or External BGP, with EBGP connections containing only pre-specified information with other pre-specified external routers is allowed. The HIS in St. Jeff’s hospital (Figure 1) shows the remaining router terminology to be aware of: • ABR – Area Border Router. An ABR manages traffic within different areas of an AS • ASBR – Autonomous System Boundary Router. This one is rather obvious – this type of router manages traffic control between 2 or more AS. • Stub area – a stub area is a network that has no other connections to the internet or any other network – a dead end.

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Rx-IT

RMON Border Gateway Protocol

LIS IBGP Internal Gateway Protocol & IRs Internal Routers

Medical Device

Network

Stub Area

AS Autonomous System

HIS

Autonomous System Boundary Router ABR

Area Border Router

EHR

RIS

PACS 1

Figure 1 – HIS at St. Jeff’s Hospital

Other acronyms used in Figure 1: • RIS – Radiology Information System • PACS – Picture Archive Computer System • Rx-IT – Pharmacy Information System • RMON – Remote Monitoring • EHR – Electronic Health Record • LIS – Laboratory Information System Please note that Figure 1 is built as an example to enable router terminology discussion. As such several department areas have been left out. Terms like AS and BGP are not immediately clear and is why they’re covered in Tech Savvy. The main thing to be aware of is that the position of the router within an AS or straddling more than one AS will determine its function and security trusts.

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