In the market for test equipment? Consult this article beforehand.
In the quest to keep devices safe and ready for patient care, HTM professionals have some tools in their arsenal—a key one of which is test equipment. Below, executives from four biomedical test equipment manufacturers— Andrew Clay, product marketing manager, Fluke Biomedical; Ken O’Day, vice president of sales and marketing at BC Group International, Inc.; Karl Ruiter, president of Pronk Technologies; and Jack Barrett, national business development manager at Rigel Medical—sit down with 24×7 Magazine to discuss innovations in the test equipment sector and how HTM professionals should approach the handling and maintenance of test devices.
24×7 Magazine: What are the top trends in the biomedical test equipment sector, and how are they influencing the design and development of such technologies?
Jack Barrett: Simplicity, as well as the use of smartphones, tablets, and apps. After all, biomedical/clinical engineers, along with independent service organizations, demand portability and the desire to minimize cart space.
Andrew Clay: There are two competing trends in hospitals that affect the design of test solutions. First, there is an ever-increasing number of medical devices to be tested. The second trend is that there is a shortage of clinical engineering talent. This is driven, in part, from hospital consolidation and from decreasing educational programs. These two trends drive the need for biomedical test equipment companies to come up with solutions to increase efficiency and shorten learning curves. This includes the entire product offering, as well as value-added services and education.
Karl Ruiter: Portability is still the key factor for biomedical engineers in deciding which test equipment is the best solution. With their role expanding to support medical devices at a wide range of sites, having the capability for all their test equipment to be portable and easy to use is even more critical.
Ken O’Day: One trend that has not changed over the years is the budget pressure on HTM departments. As a result, test equipment OEMs need to provide equipment that gives HTM professionals the best return on their investment. [Not only does] the test equipment need to do a quality job for medical devices that are currently under HTM departments’ care, but it must also provide the ability to handle the new medical instrumentation of tomorrow.
24×7: How has the test equipment sector evolved in the past few years? How do you expect it to evolve even more in the future?
Ruiter: As the role of biomedical engineers continues to expand and as the next generation of HTM professionals enters the workplace, the need to standardize testing protocols is clear. That’s why we are focused on making advances in test automation. But biomeds also require testing to be customizable to fit specialized testing protocols. We see these dual goals—better standardizing and customizing—as two sides of the same coin: Minimizing the [number of] manual processes that biomedical engineers must deal with.
Barrett: From my perspective, changes in electrical safety testing have evolved the most. Two schools of thought continually develop: The first are those that want to save test data into their [computerized maintenance management system]. A growing number have embraced alternative equipment maintenance concepts and just do pass/fail testing. Continued changes to NFPA 99 also simplify testing requirements.
As the bandwidth of biomeds continues to be an issue, along with the need for more [professionals] to enter the field, I suspect the trend to simplify electrical safety testing to continue. I do not foresee the same happening with device performance testing, however.
Clay: There are periodically cycles of harmonizing and de-harmonizing of standards in the global regulatory [environment], and we are in the latter. We see more countries developing and adopting regulations, many with unique requirements. This creates more opportunities for biomedical equipment providers to help guide and educate emerging markets, but also creates the need for geographic-specific equipment. More global growth will drive more countries to adopt regulation and standards for medical device testing in the coming years.
O’Day: The test equipment sector is constantly monitoring the latest trends in medical devices and introducing new test equipment as the old device no longer meets the new higher-level demands. BC Group, for instance, tries to build test devices with a growth path so the device you purchase today will have less likelihood of being obsolete tomorrow. We [believe in] future-proofing our devices. This philosophy is contrary to the industry standard of saying: “Sorry, our previous device no longer meets your current needs; throw it away and purchase this new device.”
24×7: What are some of the biggest challenges currently affecting the biomedical test equipment sector? How are you actively working to overcome them?
Clay: One of the biggest challenges for our sector is the dynamics of the end-user community. We have hospital consolidations that are driving the need for greater efficiencies. There is also a movement toward more integration of clinical and biomedical engineering with hospital information technology departments. In many cases, the front-line people are expected to handle both medical device maintenance and IT infrastructure maintenance. Coupled with fewer biomedical programs, this causes workflow issues for hospitals. [Fluke, for instance, is] putting more focus on the total solution that includes easier-to-use products, coupled with more focus on workflow efficiency. Additionally, we are building more application and educational content to help our end users.
O’Day: The biggest challenge is to know what the consumer wants and to design test equipment that has a universal appeal. This is very difficult since these needs and wants are different from department to department. At BC Group, our philosophy is “one size doesn’t fit all.” Specifically, we offer our test equipment in families that include the most advanced devices on the market to a basic device for those who do not have a need for every bell and whistle. There is no need to purchase a device with more features than you need.
Ruiter: With the HTM community being stretched to do more, it’s very important to be as efficient as possible. Test equipment must be able to simplify and automate testing procedures, when possible. It must provide reports that are easily created and stored. At Pronk, we designed our Safe-T Sim Automated Electrical Safety Analyzer with this in mind. Specifically, it is customizable to match the testing protocols of the customer and runs all the tests automatically—including generating a test report right to your smartphone, PC or tablet.
Barrett: No surprise here—the scarcity of budget dollars remains a huge challenge for biomedical/clinical engineering departments. As an equipment manufacturer, we must pay attention to equipment costs, position products correctly in the market, and have a solid value proposition. Another challenge we face is training—both on the test equipment itself, [in addition to sometimes] assisting on questions on the [actual] medical device.
Rigel, for instance, helps with technical training. First is the installation and use of our video studio. We can set up a webinar and not only answer questions, but also show how to make test connections and run the tests. This is on-demand and our customer typically does not need to wait for a visit to be scheduled.
24×7: What do you want to tell HTM professionals about the handling and maintenance of biomedical test equipment and why?
Ruiter: We understand how busy biomedical engineers are, so they need to depend on test equipment at all times. Test equipment that is rugged and durable will not only ensure that it is always available, but it will also cut the downtime and repair costs—[which will lead to] a great return on your investment.
O’Day: Test equipment is only as good as the quality built in and the way it is treated after the sale. Do your homework; demand to see the credentials of the organization who fixes and calibrates your test devices. Are they truly ISO-certified, or do they just state that they agree with the principles of a strong quality program? Most OEMs do onsite visits of their service providers to ensure that quality is in place; however, many HTM departments cannot take the time for this type of visit.
In those situations, rely on the professional organizations who accredit to recognize standards and provide routine audits. All you need is to ask for a Certificate of Accreditation. If the service provider cannot show you one, it probably does not exist. Most organizations who have gone to the trouble of establishing the highest level of quality will post those certifications upfront with pride. Demand the best. After all, your HTM department should be able to state without hesitation: “Quality is important to us. Our patients deserve and expect it as well.” Proper test equipment can assure that the medical devices used are performing as best as they can.
Clay: We want HTM professionals to think about metrology and the growing need to ensure traceability and the uncertainties in that traceability. We also recommend calibration at a lab that has accreditation and traceability to national standards. We see growing requirements for products calibrated according to IEC/ISO 17025. It would also be recommended to calibrate at the original manufacturer to ensure proper calibration and product updates.
24×7: What else do you want 24×7 Magazine readers to know about the test equipment sector?
Clay: We would encourage your readers to ensure that their technology keeps up with medical device innovation.
Barrett: Evaluate products before purchasing them. Every manufacturer has its strengths; be sure the equipment fulfills your requirements at the right price point.
Ruiter: Some test equipment products have lots of features, but when it comes to set-up and actual operation, users discover that they are complex and time-consuming. Biomedical engineers want to focus on servicing medical devices, not on [dealing with] complicated test equipment. So, we believe that it’s vital that the test equipment is comprehensive, easy to use, durable, and comes with a good warranty.
O’Day: When evaluating which test device to purchase, it is important to take into consideration the total cost of ownership—rather than just how much it initially costs to purchase it. For instance, how much does it cost to calibrate? Does the equipment perform auto sequences, saving technician time, which [translates into] real dollar savings? Will the device be obsolete if new testing is required or is there an upgrade path available? And, finally, you need to ask: If help is needed, can you get it from the test equipment OEM?