Here are some of the latest innovations in test equipment and how they’re keeping devices safe and functional
By Ray Pelosi
Some of the latest features and capabilities that have been developed for biomedical test equipment are delivering improved performance parameters for the validation and testing of medical devices. Recent advancements in areas, such as automation, have enabled test instruments to function more quickly, accurately, and cost-effectively, and enhance the capture, storage, traceability, and interpretation of critical data.
Advances in Precision and Speed
A case in point for better precision and speed are the newer infusion pump analyzers that are now available. Several years ago, these tools couldn’t satisfy the need to quickly assess an infusion pump or demonstrate the accuracy necessary to ensure that pump performance met manufacturer specifications. Today, they can readily perform both tasks.
Test equipment precision is improving to the nth degree. For instance, by placing its sensors on a fast, mobile carriage, Sun Valley, Calif.-based Pronk Technologies has reduced the 60-microliter resolution that had been the industry norm for infusion pump analyzers down to where it can accurately measure as little as 0.8 microliters of fluid movement. Similarly, the company’s new OxSim Flex pulse oximetry simulator measures oxygen saturation levels all the way from 10% to 100% in 1% increments.
A second new wrinkle in infusion pump analyzers introduces speed of another sort. St. Charles, Mo.-based BC Group International’s soon-to-be-released offering in this space, for instance, has removable flow modules that simplify calibration so that only the modules need to be calibrated instead of the whole testing unit.
There also are more displays that make use of the most advanced touchscreen technology. They save time by accelerating test setup procedures and analysis of measurement results. And, there are feature-rich, faster processors that are better able to analyze and store data and, subsequently, give more accurate information to biomeds—without the downside of making equipment sluggish or non-responsive.
“These devices can capture 10 times more data per second than traditional processors,” says Thomas Ying, director of engineering at Seaward Group’s Rigel Medical division in Tampa, Fla.
Given the new accreditation mandate requiring electrical leakage testing on all transesophageal electrocardiogram (TEE) probes after each use, speed—as well as user-friendly application—is of the essence here, too, in order to stay compliant. New ultrasound leakage testers on the market—specifically, BC Group International’s ULT-2000 series—can accomplish this test in less than 60 seconds.
Patient simulations take less time as well, thanks to devices like Rigel Medical’s PatSim 200, released in December, whose home and recall function easily navigates between tests and stores heavily used sequences so that biomeds don’t need to click and scroll through a cumbersome list to perform every test. This is a corollary to the trend toward simplifying operating system menus on test machines; streamlining test menus for electrocardiogram (ECG) patient simulators, for one, is critical because of all the in-depth measurements that could be performed, such as invasive blood pressure, respiration, and temperature tests.
“There are a lot of functions that go on in one actual simulation, so we need to be able to access those functions very easily,” notes Ying. “We work with biomeds to see how they want to get into the menus and then get back out of them to perform the actual tests.”
Devices also are becoming more portable, which enables biomeds to more easily and quickly transport their equipment within a hospital or when travelling to satellite facilities. Smaller, more flexible electrical safety analyzers that are much smaller in size and weight than their predecessors have battery-powered capabilities that eliminate the need for mains voltage and let their users take them anywhere. They also can significantly reduce the time necessary to conduct a given test.
Further, advanced microcontrollers have been developed that allow manufacturers to build smaller test equipment with greater testing proficiency and will boost the volume of compact devices on the market.
The development of mobile apps that run on iOS devices such as Apple smartphones and iPads is a different, but no less exciting, take on portability that makes these devices into wireless displays and control panels for diagnostic x-ray measurement instruments. Test equipment tie-ins to these wireless tools should become more commonplace in the near future, according to experts interviewed for this article.
The challenge with creating more portability, however, is avoiding—or at least minimizing—the tradeoff of sacrificing the benefits that might accrue to slightly larger packages.
Simulation and Data-Capture Capabilities
Having more simulation options is another innovation focus. New pulse oximetry test simulators—another nod to Pronk’s OxSim Flex device—let users choose whatever simulation value they want for saturation, pulse rate, and perfusion index. Simulation systems with all-in-one capability, such as British Columbia-based Datrend Systems’ vPad-A1 patient simulator, are coming to the form. This equipment marries a multi-parameter patient simulator, Sp02 test module, and a noninvasive blood pressure (NIBP) simulation module that can be used concurrently, separately, or in different combinations.
While much existing test equipment relies on manual entry of test results, more of it has technology integrated into its design to allow it to perform functions such as direct-to-file test reports, automated tests and procedures, and results assessment.
Moreover, data capture capabilities are expanding as manufacturers develop products that can achieve cross-platform access to electronic test results from equipment such as infusion pump analyzers. These solutions are easily importing data into all types of documents, databases and file formats. Along these lines, new ultrasound leakage testers can use a USB interface link to transfer a complete test report to a personal computer.
A caveat here is instructive, though. The downside to capturing a ton of data on a test device is that if the data doesn’t transfer, all that work must be repeated. Even when data transfer works, it will add complexity and expense to the test equipment itself. Pronk officials think they have a better idea, however.
“We really feel like the direction to go in the future is to utilize the customer’s platform—PC, tablet, etc.—where the [computerized maintenance management system] (CMMS) system resides and have it ‘talk’ to our devices directly,” says Greg Alkire, Pronk’s director of sales and marketing. “The CMMS would control our product and capture those results into that platform or to the CMMS in real time, instead of storage on the test equipment.”
The Benefits of Multi-functionality
Device multi-functionality is being built into new equipment to give operators smaller, lighter-weight, and less expensive simulators. In fact, versatile, handheld products on the market can now combine the test functions of ECG, NIBP, and SpO2 simulators. They contain customizable pulse-position modulation (PPM) protocols and test sequences, and enable user-configured calibration settings that deliver very accurate and realistic NIBP simulations. In this and in other product categories, multiple usage in a single instrument is replacing multiple devices.
Functional consolidation into a single device also is being done with ultrasound transducer testing, where a recently formulated special charge-coupled device chip is replacing the conventional multiple connectors—which can number as many as eight or 10—that are deployed by OEMs to plug into their ultrasound systems.
“It creates an image of the ultrasound as it leaves the face of the ultrasound transducer to determine if all of the piezoelectric crystals within that transducer are functioning properly,” explains Levi Moore, vice president of operations and OEM engagement at Longmont, Colo.-based Acertara Acoustic Laboratories, which has developed the chip technology. The chip-generated image enables biomeds to quickly and conveniently determine if the transducer is performing correctly or requires repairs.
The other benefit of the chip image is that it eliminates the need for a graph to explain the implications of the ultrasound image data for the transducer—an explanation “that can be hard to convey in a meaningful way,” says Moore. “But when you show up with an image, you can point to and say ‘Look, there’s a gap in your image, there’s something that’s not there.’ It’s so much easier to translate that information. It’s a clearer, more comprehensible way to show professionals throughout the hospital value chain if the transducer isn’t working.”
(In general, he explains, the advancement of mixed-signal systems on chip technology is resulting in smaller, more cost-effective test equipment with fewer components, since much more testing capability can be put on that chip.)
Another variation on the versatility theme is a new breed of defibrillator analyzers that handle new test requirements for all waveforms now in use, including pulsed biphasic and the accommodation of variable test loads.
The Automation Common Denominator
Automation is at the heart of much of the next-generation test technology, with the emphasis on automating not for automation’s sake, but to save time, ensure testing consistency and repeatability, and configure test automations to directly follow OEM procedures so that whoever administers the test can meet all test requirements.
It’s happening in auto-sequencing programs that sharply reduce the time needed to perform power measurements: High-accuracy electrosurgical unit (ESU) analyzers that can cut preventative maintenance almost in half—to wit, BC Group’s ESU-2400 series product—allow end users to download additional auto sequences as they become available or even develop their own sequences.
Doing more things with fewer manual operations is a staple automation goal. And it’s happening with new devices, such as the Rigel UNI-Therm standalone diathermy tester, which automates all test procedures and bypasses the hands-on working of the numerous connections required for testing in favor of a foot-switch plug-in for on-and-off control of the electrosurgery analyzer.
Focusing on R&D
It’s clear that automation and device size reduction have been, and continue to be, research and development focal points. But other emphases include extending battery life and enhancing connectivity modes and upgradability—and in many cases, making it easier for HTM professionals to understand and use the test device. The latter, experts say, is paramount.
Pronk, for one, is heavily focused on product development that simplifies the user interface and minimizes complexity to help the user access needed functions. “We’re huge fans of biomeds not having to go through training on the test equipment so that they can, instead, focus their energy and training on the medical device,” Alkire says. “We want biomed to be able to spend less lead time in learning the test equipment itself.”
In riding the wave of the future, though, it’s important that providers have test equipment that can interface with new medical devices. But that’s not always happening—a key example of that being the new electrosurgical unit (ESU) pulsed waveforms that older ESU analyzers are unable to handle.
Ken O’Day, vice president of sales and marketing for BC Group, says that’s why adequate preparation is key. “Make sure your test equipment can handle not only today’s needs but what’s coming down the road,” he advises. “Purchasing a device that has an upgrade path is much more economical than throwing out a current obsolete model and replacing it with another device.”
The larger innovation idea that the industry has embraced is to future-proof test equipment with software that makes a device easily upgradable so that it can accommodate additional testing functions down the line. It’s about producing scalable testers that have the flexibility to grow in proportion to the providers’ needs. A related emphasis is designing equipment that can talk with devices from multiple manufacturers—and where interoperability exists between CMMS and test equipment manufacturers.
Ray Pelosi is a contributing writer for 24×7. For more information, contact chief editor Keri Forsythe-Stephens at [email protected].