Reinventing the biomed's equipment testing toolkit

May 05, 2016
by John W. Mitchell, Senior Correspondent
Biomedical engineers have felt the tectonic plates shifting to value-based care beneath their feet. One aspect of their work that has seen increased scrutiny is equipment testing protocols. Over the last couple of years, CMS and the U.S. Joint Commission have introduced maintenance standards that must be met in order for a facility to remain eligible for Medicare and Medicaid. Although such regulations can take years to become implemented, some hospitals believe there’s no time like the present to ensure compliance.

James Schneider, Biomed Technician 3 at Lawrence Memorial Hospital in Lawrence, Kansas, told HealthCare Business News that his facility is revamping its entire preventive maintenance (PM), safety and risk evaluation system in order to satisfy the Joint Commission standards. “This is the biggest change for us in the past year,” reports Schneider. “We don’t want to be in a position to say in response to a lawsuit or the Joint Commission that we’re doing something different than what CMS recommended. This is the new standard.”

In some instances, these standards will reduce the amount of PM work being done at Lawrence Memorial. Schneider offers the example of patient monitors that will require a PM every other year instead of annually, as they currently conduct them. In other cases — such as maintaining electric thermometers — the hospital will replace a simple “break/fix” policy with annual PM in order to remain compliant. Dependable maintenance is crucial to keeping a hospital humming and its patients safe. Ensuring that maintenance is a key responsibility of biomedical engineers.

Fortunately, new devices are being developed to streamline their workflows, reduce redundancies, eliminate human error from their reports and ensure their facilities continue being reimbursed. Some biomedical technicians struggle to convey their value to the nurses and doctors who depend on the equipment they service.

For James Blount, owner of Biomed Plus LLC in Hammond, Louisiana, this lack of understanding can sometimes get in the way of their services and impede the benefits they provide. “It just rocks my world when I point out that the failure could have been avoided with regular yearly preventive maintenance testing — which I offer to schedule, and the doctor says no, just fix it and get it running again,” says Blount. “They also don’t understand that they are required to do the testing to be in compliance with safety regulations.”

For executives and hospital workers, keeping a facility up and running should be a simple matter of scheduling maintenance. For biomedical engineers, however, completing these tasks requires an array of expertise involving pneumatics, electronics, watts and energy output. For Blount and his peers, the demand for adaptable test equipment that can automate and simplify the job has never been higher.

“Something that has been a big help for me is the new tablet technology,” he says. “I’m able to follow the checklist criteria, inputting pass or fail, and make comments. The tablet translates it to a PM test report that generates for the customer and I’m finished.”

Automating processes
Smaller devices with increased automation and recording are among the things that characterize the recent evolution in medical testing equipment, according to Jonathan Gaev, MSE and CCE, business line manager for BiomedicalBenchmark, a biomed inspection, preventive maintenance and best practices database service at the nonprofit ECRI.

As budgets and staffs get smaller, these innovative systems are poised to make a big impact on reducing health expenses while also increasing patient safety. The emphasis is on designing helpful features with an eye toward better compliance and productivity. Manufacturers have heard the call. Smart, portable, interoperative and multifunctional tablet technology is increasingly emerging to simplify the process of health technology maintenance.

Curt Harkless, CEO at Radcal Corporation in Monrovia, California, empathizes with the pinch on biomedical engineers, who he says are increasingly pressured to perform faster and more efficiently. His company specializes in radiation measurement solutions that aim to meet the needs of biomeds and the providers they service. “You’re seeing interoperability standard in a lot of products now, from thermostats to cameras,” says Harkless. “In analyzing customer workflow, we find there has been an overall shift away from instruments using text display where you write the results down, to getting measurements and putting them into a tailored [electronic] report to help lower costs.”

Tampa, Florida’s Rigel Medical, which manufactures a comprehensive range of advanced-technology biomedical test equipment, is also focused on streamlining the management process. Jack Barrett, the company’s national business manager, says his customers take its test reports and attach them directly to the work order so that the data is traceable and the possibility of errors is smaller.

Rigel Medical’s testing equipment, such as a compact electrosurgical analyzer called UniTherm, is designed to be easy to use while also speeding up the testing process. The internal memory in the equipment also uploads to any computerized maintenance management system (CMMS) without the need for a separate computer to capture data during the test.

“The strength of our design is the speed of working through the PM for shorter times, data management, traceability and analysis,” says Barrett. Enhancing a biomedical engineer’s ability to work efficiently is a crucial component to keeping a hospital properly maintained, regardless of which department that engineer is maintaining.

“We’re seeing continued innovation in the X-ray side, as well as defibrillators and patient monitors,” says Eric Conley, general manager at Fluke Biomedical and RaySafe in Everett, Washington, which makes a range of advanced technology biomedical and imaging test equipment. Although implementing new testing systems requires an initial investment, many experts agree that the innovations taking place with the new devices are accelerating — and the increasingly simplified transfer of PM data to a CMMS is yielding benefits that will support regulatory compliance and ultimately save on the bottom line. “Standards are changing more and more, and in the U.S., hospitals want all data broadly available on multiple devices to improve operations,” says Conley.

Doing more with less
“Think of a biomed tech that has 10 dentists on his route, or multiple X-ray rooms in a hospital,” says Gary Bischoff, president of Electronic Control Concepts in Saugerties, New York, “Our equipment measures X-ray parameters, and our customers want a way to accurately measure these parameters with easy set up and report,” he explains. Electronic Control Concepts caters to biomedical engineers who are servicing and calibrating X-ray rooms in multiple locations, and their products are built to simplify that process by meeting a diverse range of needs.

Bischoff cites their UXI tablet, which is capable of generating test reports via wireless Internet and has been designed to save time in the workflow. “The tech can send the results from a tablet to a spreadsheet and then go on to another site,” he says. In addition, the system keeps the tech out of the X-ray room and away from radiation exposure, added Bischoff.

Ron Evans, president of Datrend Systems in British Columbia, Canada, which makes biomedical instruments and devices, says the company is seeing an increase in interest from customers who are looking to interface with a CMMS. “In the current climate where biomeds are being asked to do more with less and also with regulatory requirements placed on hospitals, interoperability is an important feature,” says Evans. “Our vPad platform uses WiFi and 3G communication to transfer data easily. Having this functionality built into the test equipment means that the biomed does not need to carry around a laptop.”

David Dallaire, vice president of sales and marketing at Acertara Acoustic Labs in Boulder, Colorado, which prototypes and manufactures specialty medical probes, echoes the sentiments of other manufacturers and biomeds. With customers focusing more than ever on complying with accrediting bodies and looking for cost-saving opportunities, his company is hoping to meet their needs. “All of our test equipment is designed to complement each other and reports can be integrated into a centralized database from which a single report can be produced,” Dallaire says. “We have long known that one in four probes on the market will have image degradation that cannot be identified through conventional testing.”

Acertara’s advanced test equipment, such as Aureon technology and its Active-Z device, identifies probes with image degradation. Dallaire says this alerts buyers to probes that need to be rejected before the user becomes responsible for the cost of a probe that never should have been sold to them in the first place.

ECRI’s Gaev describes this kind of verification as among the most important functions in medical device testing. “Typically, the health technology department performs that type of check when equipment is received by the hospital, which is called an incoming inspection, and after a major repair. It is usually part of the PM procedures,” he says. “That ’pre-use’ check has shown to be a very effective method to ensure that equipment is safe to use on patients.”

Ken O’Day, vice president of sales and marketing at BC Group International in St. Charles, Missouri, makers of biomedical test and measurement equipment, notes that customers want comprehensive testing devices that can perform multiple tasks and be upgraded as demands change. “Nearly all of our devices have remote communication available,” he says. “This allows them to be integrated to work together for data collection and test automation. We are currently working on a software package that will do this, as well as add compatibility for test equipment from all manufacturers.

“We provide many choices for each modality so customers can purchase only what they need,” he says. “When possible, we provide a path so the customer can take their existing model and have it upgraded to the latest version available.”

Communication is key
Conley at Fluke Biomedical/RaySafe says his company spends a great deal of time talking to medical device manufacturers. He says there is very little in a hospital or X-ray room that Fluke’s devices cannot test and agrees that data collection and automatic reports are becoming increasingly standard. He also reports that hospitals are coming to Fluke and RaySafe to demand more portability and efficiency. According to Conley, the FDA and the Joint Commission are emphasizing regular defibrillator and infusion pump testing.

“Patients are the ultimate beneficiaries from proper testing,” says Conley. “We spend heavily on innovation and apply predictive modeling to design new products.” As an example, he says the new INCU II Incubator-Radiant Warmer Analyzer, a portable baby incubator testing system that is designed to be user-friendly, is the first new design on the market in over four years for incubator testing devices.

“Some of the themes in this device really show what we’re doing with our products. To make them smaller, easier to use with limited training to do PMs quickly, and it automates with software well,” says Conley. Harkless, with Radcal, also speaks of a product line engineered to be totally interoperative to digitize and manipulate reports into Windows-based tablets. He says that such interoperability also fosters redundancy. Harkless cites the Accu-Gold line of products designed to provide interoperability.

“The Accu-Gold products include sensors, digitizers, and display modular components. Each of these components is fully interoperable with other elements of the system,” he says. “This is unique and important with regard to redundancy.” In systems that are interoperable, when a sensor breaks it can be replaced with a sensor from the customer’s inventory, rather than returning the entire unit for a repair. “Our role is to ensure an X-ray provides the minimum dose to get the highest quality image,” adds Harkless.

Manufacturers and biomeds are in agreement that health care providers must never get complacent about equipment testing. “I’ve seen someone buy a tabletop sterilizer off eBay, take it right out of the box and start using it without reading the manual,” says Blount. “A year later, when the valves get dirty and it stops working, they have an expensive repair on their hands. Customers have to keep up with their monthly and annual maintenance provided by a biomed tech.

This will keep costs down, maintain uptime and lengthen the life of the equipment.” Keeping hospital technology running properly yields a ton of financial benefits to the care system, and when the best testing equipment is utilized it allows biomeds to do more with their time. But most importantly, it ensures that patients are being treated safely — and in ways that will produce the best possible outcomes.