This report originally appeared in the July 2011 issue of DOTmed Business News

The thought of a biomedical technician often evokes an image of someone tucked away in a hospital basement, tinkering with a piece of medical equipment.

That perception might have a ring of truth, but as the professionals responsible for the upkeep of medical devices, biomeds also regularly survey the facility’s floors.

“We’re out and about through the hospital quite a bit, doing both preventative maintenance and answering service calls,” says Mark A. Luebbe, a senior biomedical technician with Alegent Health, Immanuel Medical Center in Omaha, Neb.

And in today’s health care environment, the responsibility of fixing and maintaining medical equipment is arguably more demanding than ever.

In response to the national focus on care quality, federal device regulators are upping enforcement and issuing stricter rulings. And at the same time as manufacturers are racing to bring cutting-edge technologies to the market, hospitals are looking for ways to trim their budgets.

The convergence of these factors means that biomeds have to do more with less, driving the trend of high-performance, regulatory-compliant testing, Dominic Ivankovich, general manager of Fluke Biomedical, told DOTmed News in an e-mail.

A healthy market
Despite the cost and efficiency pressures on biomeds, test equipment companies say business has been stable or growing over the past year. In part, their sustained success can be credited to how the companies are responding to the needs of their customers in a strained financial and regulatory environment.

For instance, Fluke has upped its engagement with customers worldwide by introducing the Fluke Biomedical Advantage, according to Ivankovich. The program is a free training platform that includes hands-on and online training, as well videos and demos to help biomeds stay up-to-date on their skills.

BC Group International, Inc., a major manufacturer and distributor of test equipment, prides itself on offering customers a “one-stop approach,” says Mike Clotfelter, the company’s vice president of business development.

In addition to offering equipment manufactured by BC Group, the company also sells products from about 80 different manufacturers. “We try to give our customers as many choices as possible,” says Clotfelter.

Take BC Group’s PS-2200 series of multi-parameter patient simulators, for example. While each model offers ECG, blood pressure, respiration and temperature simulation, customers can choose a unit with one, two or four independent blood pressure outputs. The variety of options allows biomeds to get exactly what they need.

Other companies strive to anticipate their customers’ needs before new medical devices even make it to market. X-ray test equipment maker Unfors Instruments has a history of partnering with diagnostic imaging companies throughout the transition process from analogue to digital.

“We continuously work with manufacturers of imaging equipment to ensure that our test equipment meets all of their new specifications,” says Kelly Fitzgerald, Unfors’ marketing director.

Not long ago, Hologic introduced its Selenia Dimensions 3D mammography system but Unfors had worked with the company for two years prior to the unit’s release to ensure its products could be used by service engineers on the system when it appeared in hospitals and imaging centers.

Other companies strive to arm biomeds with light, portable tools that not only help them do their jobs faster and easier but also enable them to spend more time rubbing elbows with the clinical team.

Pronk Technologies markets the SC-5+OXSLIM Kit, a complete vital signs simulation system, which comes in a package that resembles a small messenger bag. The portability of the product gives biomeds the opportunity to work in any part of the hospital, which increases their visibility and emphasizes the importance of their role in the health system, explains Karl Ruiter, Pronk’s president.

“I think biomed can be a forgotten department,” he says. “It’s important for biomeds to get the recognition they need because that leads to them getting the budget and the equipment that they need.”

While manufacturers offer the latest and greatest test equipment, diminishing budgets often tie the hands of CE departments when it comes to purchasing new tools. For such customers, Fluke is now offering new monthly leasing options for its products and services, according to Ivankovich.

The latest & on the horizon
Immanuel Medical Center’s Luebbe remembers the days when he walked around his facility with a clipboard, tracking all of the needed data. He then had to go back to the shop and enter all the information into the computer.

Today’s test equipment not only shortens the process but makes it more efficient. It’s automated and programmable, enabling biomeds to use one piece of equipment for several types of medical devices. Plus, the tools now effortlessly transfer the data onto the computer. “Automation makes for smoother record keeping,” says Luebbe.

In addition to automation, portability and the ability to test a number of devices with one piece of equipment, manufacturers are also improving the accuracy and efficiency of their latest products – factors that make a biomed’s job easier.


In the last couple of years, BC Group’s ESU-2400 Electrosurgical Unit Analyzer has been in high demand.

The ESU-2400 uses patent pending DFA Technology, which “allows the system to aggressively digitize the complex RF waveforms produced by electrosurgical generators, analyze each individual data point, and provide highly accurate measurement results,” the user’s manual reads.

“Accuracy is the driver, that’s why this product has been so successful,” says BC Group’s Clotfelter.

In the last several years, Fluke has launched the ESA612 and ESA620 Electrical Safety Analyzers, along with the Impulse 7000 Defibrillator Analyzer and the TNT 12000 X-Ray Test Tools for testing diagnostic imaging equipment. The products have “proven very successful,” Ivankovich said.

When it comes to the responsibilities of designing X-ray test equipment, the job is only getting harder. Diagnostic X-ray manufacturers are continuously changing their devices to improve on their technologies. According to Unfors’ Fitzgerald, today’s test equipment manufacturers have to account for evolving imaging devices that employ lower dose rates, increased filtration and new target/filter combinations.

In January, the company launched the Platinum Plus Edition of its flagship Unfors Xi product. It’s a complete system for multiparameter measurements on modalities such as mammography, dental, R/F and CT. It can simultaneously measure a number of values, including kVp, dose rate, pulse, dose/frame, mA, mAs, time and waveforms. And it comes in a portable package.

“In the old days, service engineers used to have a trunk full of equipment and now they have one silver case that carries around everything they need to do those measurements,” says Fitzgerald.

The company says it’s capable of meeting the needs of service engineers with the contents of an aluminum briefcase because it employs solid state technology.

Unlike ion chamber technology, solid state allows for test equipment to be small and durable. It eliminates the need for manual corrections for beam quality and enables streamlined reporting, since the computer connects to the base. One product also performs all of the measurements.

Plus, it saves plenty of time. “In the old days, it would take two hours to do one measurement that we can now do in 30 seconds,” says Fitzgerald.
For customers who are looking for specific measuring capabilities, the company manufactures a line of Unfors Solo products. There are currently five models available, including Unfors Solo CT, Unfors Solo Dose and Unfors Solo RAD.
Fluke Biomedical is also hoping to boost productivity by speeding up the testing process with two products that are currently pending Food and Drug Administration approvals.

The ProSim 4 is the company’s handheld, touch screen patient simulator for one-touch testing and troubleshooting “to get you in and out of the field location in 60 seconds,” Fluke’s Ivankovich said.

The ProSim 8 is a multifunction tester that can perform a complete patient monitor PM in five minutes, and the world’s only patient simulator “capable of testing new Masimo Rainbow SET SpO2 technology,” according to Ivankovich.
Whatever the tool, manufacturers know to take customer needs into account when it comes to product design. “We see that biomeds want to do their work faster and have more options about how they do their work,” says Pronk’s Ruiter. “They want to be portable and mobile. They want equipment that’s flexible, simple and easy to use.”

Measuring up?
While test equipment companies continue to innovate, it could be difficult to see how the latest tools actually affect the CE department.

To not only track their own performance but also compare themselves to peers across the country, many hospitals are now using benchmarking products. Programs are available from the ECRI Institute, Thomson Reuters and the Association for the Advancement of Medical Instrumentation.

Frank Painter, a subject matter expert who was hired to create AAMI’s Benchmarking Solution (ABS) product, has been in the industry for a long time and has always used benchmarking in one way or another to improve quality or measure progress.

ABS consists of a set of benchmarks for biomeds that are most commonly used by CE departments and can be accessed online, explains Painter, who is also a clinical engineering consultant and an adjunct professor of clinical engineering at the University of Connecticut.

The solution covers benchmarks such as budgeting, personnel qualifications, interdepartmental relations, reporting structures, certification issues, staffing levels and inspections.

“Clinical engineering departments that subscribe to ABS put their data in and then can see their data, compare themselves to last year and the year before and also then look at [the data] of all their colleagues,” Painter says.

For instance, a 400-bed hospital in the Midwest can compare itself to all other 400-bed facilities that are using ABS or narrow it down by certain demographics or criteria, such as say, children’s hospitals, explains Painter.

One of ABS’ key features is its ability to bring users across the country together, according to Painter. “Not only is it a benchmarking tool but it’s a networking tool for performance improvement, which really is something we didn’t have at our fingertips before,” he says.

If two hospitals had similar performance across several areas but one was much better than the other in a particular measure, the CE department can ask the association to reach out to the better performing hospital. “If the hospital was agreeable, AAMI would put us in touch and we could begin to communicate about the practices that hospital uses to obtain such good results,” Painter says.


AAMI’s subject matter experts also employ the solution’s data to write and submit articles to the Biomedical Instrumentation & Technology journal, as well as share best practice findings at AAMI’s annual meeting and with regional biomed associations.

According to Painter, ABS also enables CE departments to meet The Joint Commission’s standards for performance. By using a benchmarking solution, biomeds can see identify areas for improvement in their programs. Currently, ABS has more than 200 sets of data in its database.

A role shift?
In addition to benchmarking data, AAMI’s product also provides a venue for an interactive online community, where users can ask questions and share information with each other.

And these days, biomeds are leaning on networking more and more. Tight budgets may limit the availability of dollars for educational purposes, so many departments also depend on cross-training to stay up-to-date on the latest equipment.

According to Immanuel’s Luebbe, who is also the secretary treasurer of the Heartland Biomedical Association, Omaha has about 75 biomeds throughout the area’s eight hospitals. All of them are friendly with each other and often swap knowledge and share advice. “I’m familiar with different brands of equipment because I’ll hear someone talk about their experience with it,” he says.

And in today’s IT health-focused environment, it’s becoming more and more challenging for biomeds to stay on top of all the requirements and regulations.
Just recently, the International Electrotechnical Commission published its IEC 80001 regulations, which address risk management with IT networks and the connection of medical devices. Understanding the new standards will take time and potentially, will require partnerships.

Several hospitals have already begun integrating the IT and CE departments, and some administrators may face resistance from IT and biomed staff, two groups whose skill sets don’t overlap much.

The two departments are still separate at Luebbe’s facility, but they’re “just starting to work more closely together,” he says.

And while biomeds will always be responsible for making sure a hospital’s equipment is in perfect condition to ensure the best patient care, their knowledge base will continuously evolve. In the biomed realm, “the only constant is change,” says Luebbe.

DOTmed Registered testing Equipment Companies

Names in boldface are Premium Listings.
Domestic
Gregory Alkire, Pronk Technologies, CA
Kevin McMahon, UNFORS INSTRUMENTS INC, CT
Woody Owen, Clinical Measurements, FL
Max Ende, BMX-RAY, INC, FL
Brandon Karas, InterMed Biomedical Services, Inc., FL
Lucas Mason, Imprex International Inc., MO
John Weymouth, MEDiSURG, IN
DOTmed Certified
David Pac, American Radiology Resource, MD
DOTmed Certified
DOTmed 100
Contact Support, BC Group International, Inc., MO
Chris Boon, Universal Hospital Services, MN
Alison Fortin, Global Inventory Management LLC, NH
DOTmed Certified
DOTmed 100
Ryan W. Gilday, Clinical Imaging Systems, NJ
DOTmed 100
Marc Fessler, Independence Cryogenic Engineering, NJ
Barry Spring, Mobile Medical Maintenance, OH
Sean Chen, Grand Medical Equipment, PA
DOTmed 100
Brandon James, NucMed Systems Inc, PA
Michael Lawson, DoctorsManagement, TN
Mandy Allen, Fluke Biomedical, WA

International
Haluk Aktas, Penta Technic, Turkey
Detlef Goerlich, PTM-Network Services LTD., Germany
Frank Lin, REXMED Industries Co., Ltd., Taiwan
DOTmed Certified
Henry Gu, Shenzhen Wata Sound Industrial Co., Ltd., China
Michael Erwine, Datrend Systems, Canada
Artemio Santacruz, ARA.ELECTRIC SRL, Paraguay
Julio Baltazar, Cristel Eletromedica, Brazil
Cicero Oliveira, Kuf Electronics, Brazil
Walter Gallegos, Walter D. Gallegos, Uruguay
Muhammad Siddique, Global Medical Imaging, Pakistan
Fernando Garo, FATEC X-RAY EQUIPMENT, Brazil