Deciding what test equipment to buy is often a stressful task. Fortunately, 24×7 has taken some of the guesswork out of the process. Below, four individuals with a vested stake in the biomedical test equipment market—Mike Clotfelter, vice president of business development at BC Group International, Inc.; Greg Alkire, vice president of sales and marketing at Pronk Technologies; John Shirlock, senior application engineer at Fluke Biomedical; and Michael James Walton, category manager at Rigel Medical’s parent company Seaward Group—sit down with 24×7 to discuss what’s new in test equipment and what purchasers should know before signing on the dotted line.
24×7 Magazine: As we enter a new decade, what are some of the biggest innovations in biomedical test equipment?
Mike Clotfelter: As we move into the ‘20s, test equipment that includes features that improve productivity will likely be the trend. This could include auto-sequences and data-logging features. Auto-sequence programs can reduce the time that it takes to perform PMs, since they guide users through testing processes step by step and store test results.
BC Group’s ESU-2400 is a good example of test equipment that offers these features. The ESU-2400 includes auto-sequence programs for several leading electrosurgical unit (ESU) generators. Auto-sequence test result reports can be saved or printed. Other products like BC Group’s ULT-2020 ultrasound transducer leakage tester offers “pass/fail” as numerical test results. And ULT-2020 test results can be saved using the data-logging feature or by printing test results with the optional printer.
Michael James Walton: Innovation doesn’t necessarily need to be technologically focused; human factoring can also be considered. The ease of use of test equipment is also equally important.
Also, there’s been a shift to a two-solution device—integration with smart devices and test equipment. This isn’t necessarily an innovation by biomedical equipment manufacturers; it’s more moving with the times. For instance, the 288+, Rigel Medical’s flagship electrical safety analyzer, allows users to generate PDFs via an app for quick and easy sharing of data and paperless filing to CMMSs for traceability.
Greg Alkire: Technology today has accelerated as a result of breakthroughs centered on compact, revolutionary equipment that can do more than their larger rivals. This is precisely the mission of our product designs. Pronk’s small, portable Safe-T Sim automated safety analyzer eliminates manually documenting the tests performed and is programmable to run only the tests the user wants.
John Shirlock: As the number of well-trained biomedical technicians is decreasing, and the number of medical devices to test is increasing, efficiency has increasingly become a focus. Automating test procedures—whether on the equipment or on a PC, tablet, or mobile device—helps reduce test time, as well as the risk of errors. These test results also need to be archived, so interoperability with computerized maintenance management systems has become a new focus in the industry. With standardized test procedures and test results, customers can move closer to predictive maintenance and away from preventative maintenance.
24×7: What are the top do’s and don’ts when purchasing biomedical test equipment and why?
Shirlock: Look at your hospital and all the medical equipment you need to test. When purchasing new test equipment, you want a manufacturer that can meet all of your testing needs and applications. Standardizing your test equipment can also help simplify service and calibration. Also, look for a manufacturer with a proven track record of reliability and quality.
Metrology matters—you want to make sure your test equipment meets industry-standard accuracy requirements. Look for manufacturers with National Institute of Standards and Technology traceability and ISO-accredited calibrations. After all, you need to be confident in your test results since, [as HTM professionals,] you directly affect patient safety.
Last, but not least, look at training. You want to understand what you are testing, why you are testing it, and how you are testing it. Look for a manufacturer that can guide and train you.
Alkire: One feature of test equipment that is often overlooked but very critical is the uncertainty (aka: accuracy) of the test equipment and whether it meets the medical device manufacturers’ requirements for testing accuracy. The general rule of thumb is a 4:1 test accuracy ratio between the test equipment and the device under test (DUT). In other words, the test equipment should have four-times less uncertainty (i.e., better accuracy) than the medical device test point specifications, which assures the user that the measurements are precise enough to confidently indicate “pass” or “fail” of the DUT.
When a minimum of a 4:1 test accuracy ratio is not achieved, the risk of making an incorrect “pass/fail” determination increases and could result in passing a device that fails or vice versa. Verifying that the test equipment meets the accuracy requirements listed in the medical device service manual and/or making sure it is four times more accurate than what is required is something that should be evaluated prior to purchasing any test equipment.
Walton: When selecting a product, the do’s center around patient safety and giving engineers the correct test tools to mitigate risk in a healthcare environment. Reliability is important, as is portability of the equipment, robustness, ergonomics, and ease of use. Also, how much training does the device require?
Do the technical specifications meet fundamental calibration methodologies, and is the equipment fit for purpose? For example, the standard compliance, range and magnitude of the parameters being measured must be closely examined. Then there are more pragmatic decisions: For instance, can the test equipment be serviced and will it be calibrated locally in a timely manner? Is there local after-sales technical support and training?
The “don’ts” are more subjective, but I would recommend avoiding equipment that inhibits workflow and quality management system requirements. Personally, I’ve seen test equipment being used inappropriately, such as engineers using 20-bar, full-scale pressure meters to verify [non-invasive blood pressure] monitors. This is bad practice since there’s no test-accuracy-ratio adherence between standard equipment and the device being tested.
Clotfelter: Do purchase test equipment that has the features and specifications you need. Don’t simply buy based on the lowest price. After all, the lowest price is not always the best overall value. If you need assistance selecting the right instrument for your application, reach out to test equipment OEMs. Do select instruments that measure multi-parameters since they can allow more work to be done with less equipment, which also saves on calibration costs since there’s less equipment to be calibrated.
24×7: What are the needs of your particular customers and how do your products meet their requirements?
Alkire: HTM professionals need very portable, comprehensive test equipment, due to the wide range of departments and off-site facilities they support on a daily basis. They also need to ensure consistent compliance to hospital standards, capturing objective evidence that they performed the correct test and that the medical device passed all required electrical safety tests. Pronk’s BMET Pack Pro focuses on both of these needs. Combining the smallest biomedical test equipment (SimCube, OxSim, SimSlim, Safe-T Sim, and FlowTrax) into a small backpack, the BMET Pack Pro provides maximum mobility with Bluetooth capabilities for safety testing. And, with our app technology, test results can be captured wirelessly to your smart device.
Now, customers can minimize manual record-keeping tasks, dramatically increase standards compliance, and take advantage of mobile technology, setting the stage for a faster pace of operations. Our latest software solution, LinxIT app, takes all this to the next level, wirelessly connecting our test equipment to customers’ CMMS preventive maintenance checklists.
Clotfelter: Most of BC Group’s customers need electrical safety analyzers, multi-parameter patient simulators, ventilator analyzers, digital multimeters, etc. These are just some of the instruments that cover many of the basic parameters required for biomed shops to maintain most medical equipment. [BC Group also offers] anesthetic agent analyzers and ambient nitrous oxide analyzers, which are needed to maintain and test specialty equipment, such as anesthesia devices.
Shirlock: Customers need test tools to help them comply with OEM-recommended procedures and regulatory standards. Fluke Biomedical products offer compliance to international standards, not just domestic one.
We look at all the medical devices you are required to test—the pain points that frustrate you and address them with the right tools for the job. Also, you need tools that will test to the published specifications for each medical device—and Fluke Biomedical does that. We also offer testing tools with a variety of automation options, such as onboard automation and software automation.
Walton: Application is key. Our devices enable users to have an overall solution, rather than an isolated bit of test equipment. Moreover, Rigel Medical’s ethos is centered around test equipment that embraces portability but is equally at home as a permanent bench-top device. Also, most of our devices store test records, providing full traceability of test data that can be saved to a CMMS.
24×7: From a safety perspective, what do you want to tell HTM professionals about handling biomedical test equipment?
Walton: Be informed decision-makers; understanding the application is integral. Even more essential than [knowing] how to handle biomedical test equipment is appreciating the equipment being tested and connecting the medical devices to the test equipment accordingly.
You’re dealing with hazardous sources of energy that can cause serious harm. It’s critical that everyone in the healthcare environment—patients, visitors, and staff—are safe from such hazards. [As HTM professionals,] you are responsible for mitigating this risk and keeping people safe.
Shirlock: Quality is important from a safety perspective. Your test equipment needs to handle the rigors faced in the field. Fluke Biomedical tools, for instance, undergo extensive quality testing such as drop testing, environmental testing, shock and vibration testing, and electromagnetic compatibility testing. Such testing ensures that it is safe to use the product. And if you are not safe using the product, you can’t ensure the medical device is safe for patients.
Clotfelter: Always handle biomedical test equipment with care. If test equipment has been dropped or if it has been potentially damaged during use, it should be evaluated to determine if it’s still operating correctly and within published specifications. Proper storage is [also necessary.] Ideally, test equipment should be stored in protective cases and in a [safe environment].
Alkire: Verify all cabling, check that the accessories are in good working condition, and verify that the test equipment has no physical damage that could impact its performance. Beyond that, the products must pass a complete quality and performance verification test of all features and functions.
24×7: What else should 24×7 Magazine readers know about biomedical test equipment?
Clotfelter: Regular calibration is very important to ensure that instruments are working correctly and are within published specifications. We recommend using the OEM for calibration or a laboratory that’s ISO-9001, ISO-17025, and American National Standards Institute-Z540 accredited, which BC Group is. And make sure you use a calibration provider that follows the requirements listed in these standards. After all, not all calibration providers are alike.
Alkire: We have heard from our customer base that the trend toward automation and electronic records is becoming even more important. Providing a small footprint and CMMS connectivity, as well as electronic documentation, in a flexible way via our portable safety analyzer is what our customers want. We believe expanding on these features in 2020 will benefit much of the HTM community going forward.
Walton: Biomedical test solutions are powerful tools that ensure electrical medical equipment performs to its intended purpose and any risk is mitigated. These products aren’t going away anytime soon, and I’m quite excited about the future of the test equipment market and how these devices will continue to help engineers execute their daily duties.