In this installment of the monthly roundtable article experts from throughout the HTM industry share their insights and opinions regarding test equipment.
Participating in the roundtable article are Pronk Technologies Vice President Sales and Marketing Greg Alkire, Radcal Corporation President and CEO Curt Harkless, Datrend Systems Inc. Director of Business Development Owen Liu , BC Group International Inc. Vice President Sales and Marketing Ken O’Day and Fluke Biomedical Global Training Manager Jerry Zion.
Q: What are the most important things to look in a test equipment manufacturer?
ALKIRE: Having spent the last 25 years in the medical device industry and 16 of those focusing on test equipment for HTM engineers, without a doubt the most important thing to look for in a test equipment company is how firmly they stand behind their products. The easiest way to determine how a company stands behind its products is to ask what level of warranty is included in the price of the device. The bare minimum one-year parts and labor warranty should be considered a lack of confidence in the reliability of the product given the fact there are some test equipment companies offering four years of warranty at the same or lesser price point.
HARKLESS: Since your test equipment represents a major investment that is critical to your business for many years to come, one should look for a partner who is proven, stable, reliable and established. Consider the lifecycle of the relationship including service, repair and calibration that are critical to operating and maintaining test equipment over the long run. As diagnostic imaging continues to grow and evolve, the requirements of your test equipment may grow and will likely evolve as well. One should select test equipment from a line that is modular, interchangeable and extensible to meet changing needs.
LIU: Ease of use, platform integration, path to upgrade, and user customizable automation are some of the most important areas when considering test equipment. The current generation of Datrend test equipment is centered around a 10-inch Android tablet. This large high-resolution screen completely changes the user experience of interacting with simulators and analyzers. With more and more users being comfortable with smartphones and tablets, creating user-friendly apps that are simple and intuitive has really improved the usability of test equipment. With our platform running on a tablet and really taking advantage of the technology has opened the doors to improved software delivery, software upgrades, support, training and user customization for long-term usage of our solution.
O’DAY: There are many things that need to be considered when evaluating a manufacturer and they are all equally important. The manufacturer should have a good reputation of standing behind their products and not frequently obsoleting a model requiring you to purchase their next latest and greatest. Offering an upgrade path for existing products is a more cost-effective solution. Do they manufacture under published and known quality control systems? Are they registered with and inspected by the FDA and follow the Good Manufacturing Practices (GMP) as well as comply with the QSR (Quality Systems Regulation) 21CFR820? Do they give you good cost of ownership? The initial cost is only part of what you will pay. How long will it last? How much does it cost to maintain? Can it be upgraded?
ZION: Do they have the equipment to do the job you need – a full line to answer your needs; what is their quality system including metrology; how do they support you with training, service and tech support?
Q: What are some basic test equipment devices every HTM professional needs?
ALKIRE: HTM engineers have such a wide range of departments and off-site facilities they support on a daily basis, and it just isn’t practical to share test equipment. It is a must that they each have their own portable safety analyzers, ones that can be programmed to automatically run the facility testing protocols and capture results into an electronic report. A portable safety analyzer combined with a voltmeter, a set of hand tools, small multi-parameter vital signs simulator and a pressure meter would provide each engineer with the basic equipment needed to address most tasks they may encounter without having to return to the shop to finish their work.
HARKLESS: In X-ray imaging, basic measurements are aimed at assessing the beam spectral characteristics for appropriateness to the applications and machine settings under study. As such, the basic measurements include dose, dose rate, kV and HVL. In this field, integrated sensors are now available that provide these metrics in a single exposure and for a range of diagnostic systems including radiography, mammography, fluoroscopy and dental. Other basic equipment might include ion chambers tailored for basic measurements such as CT or mammography.
LIU: Electrical safety has still got to be at the top of our list. Almost everything managed under a biomedical engineering department requires scheduled electrical safety testing. All-in-one patient simulators and defibrillator analyzers also form part of the core equipment used by biomeds.
O’DAY: HTM professionals should have a safety analyzer, DMM, set of hand tools (including standard and metric), thermometer, pressure vacuum meter and a patient simulator (number of parameters should include the parameters of the devices being tested). Beyond that, many of the other test devices can be shared or placed at test stations within the department. Some of those devices include analyzers for ESU, defibrillators, infusion pumps, anesthetic agents, ventilators and a variety of specialty simulators (SP02, Cardiac Output ECG, etc.).
ZION: Electrical safety analyzer, DVM/DMM, pressure and/or flow measurement devices, patient simulator, defibrillator/pacer analyzer and hand tools.
Q: What are some of the newest test equipment products HTM professionals may want to consider purchasing and why?
ALKIRE: Newer test equipment can help significantly reduce test time. The very small, portable Safe-T Sim Automated Safety Analyzer eliminates hand writing tests performed and test records/results. The FT-2 FlowTrax can dramatically reduce both the equipment footprint and the IV pump test time to complete the volume and occlusion tests required for preventive maintenance. Both products are multi-functional, eliminating the need to carry extra equipment. The Safe-T Sim includes a full-featured 12-lead ECG/Respiration simulator and the FT-2 includes both a full-featured pressure meter, as well as, temperature meter.
HARKLESS: In recent years, there are two significant trends in diagnostic imaging that are shaping the evolution of quality measurement on these systems. Simultaneously, systems are becoming more complex (i.e. combination modes for mammography) and certain subsystems are becoming increasingly stable and reliable (i.e. kV generation). These changes make some measurements more routine and others more important, Dose Area Product (DAP) for instance. As a result, HTM professionals should consider planning for expanded DAP requirements and choose instruments that support these measurements.
LIU: Our ESU analyzer, vPad-RF, and our Infant Incubator Analyzer, vPad-IN, have proved to be very popular with our customers. Both electrosurgical units and Incubators have very strict IEC testing standards, plus both types of devices can be dangerous to the patient or even the user if they are not tested and maintained properly.
O’DAY: ESU generators seem to be one of the most rapidly changing products. OEMs are introducing new devices with strange wave forms and requiring high accuracy levels for calibration. There are many testers on the market that were designed to test previous generations of those devices but no longer have the ability or accuracy to properly test the new models. Anesthesia machines are another device requiring a newer approach than what was available just a couple of years ago.
ZION: New test instrument designs help capture the measurements that matter, for example, innovations in the medical device being tested. That’s why our gas flow/pressure analyzer now includes the option of adding gas concentration measurements. It’s also why our defib/pacer analyzer includes the option of including variable loads – defibrillators have changed.
Q: What are some test equipment features biomeds look for or expect?
ALKIRE: One feature of test equipment that is often overlooked is the uncertainty (aka accuracy) of the simulations or measurements and how they stand up to the medical device accuracy and/or the manufacturers’ requirements for test accuracy. The general rule of thumb is a 4:1 ratio between the test equipment and the device under test (DUT) as this can ensure that the accuracy of the test equipment does not influence whether the DUT truly passes or fails the manufacturer’s specified accuracy. This ensures that when making calibration adjustments to the DUT, the measurements referenced are within the requirements listed. Verifying that the test equipment meets the accuracy requirements listed in the medical device service manual and/or making sure it is 4 times more accurate is something that should be evaluated prior to servicing any device.
HARKLESS: Biomeds are increasingly aware of their total workflow and how the interface between different procedures affects their efficiency. For this reason, biomeds should examine how their measurements are made and how they flow into the final product (typically a report). Flexible instruments now provide multiple mechanisms for automating report generation or transferring data between applications.
LIU: When you participate in an HTM conference, it’s no surprise to see a large number of CMMS product offerings. We also believe this technology is key to the success of biomeds with an ever-increasing number of devices to manage and the continuation of staffing shortages in our industry. Datrend is the only company on the market today to offer on-device, end-to-end CMMS integration. This means the users can download the equipment data, work orders, PM instructions and checklist tasks all from the same user interface they would use for controlling their test device. And after the work is complete, users can upload the test reports back to their CMMS system directly from the analyzer’s user interface to automatically close out the work orders. This simplified process can save users a significant amount of time at the end of a shift.
O’DAY: Handheld devices and test equipment that interfaces with CMMS software are becoming more and more important to biomeds. Almost all our BC Biomedical test equipment has communication capability now but going forward, all units will be designed with built-in Bluetooth capability. Probably the most important feature of any test device is the ability to meet the testing needs now and the future. None of us know for sure what the future will bring, so it is important to have an upgrade path available for their existing test devices. This will extend the life of the tester plus save a great deal of money by not having to replace a tester every couple of years to get the next, more capable device.
ZION: Biomeds should look at the whole situation and evaluate equipment based on how they will need to use it. If they are mobile, it’s not just portability that matters. What about having a battery and not having to plug in? What about the life of the battery, will it last all day? Saving data? Can they read the data and results quickly and easily?
Q: Can you tell readers about one product or update your company offers HTM professionals?
ALKIRE: We really believe in providing products that can help make biomedical engineers’ jobs easier today and also continuously focusing on new technologies for the future. We believe that every customer that has invested in our products should benefit from new advancements we develop. A good example is our safety analyzer, Safe-T Sim. We have introduced additional tests and increased the maximum current rating on the product, and we offer these upgrades, free of charge, during the annual preventative maintenance service. This also applies to our app-based software products as well. We added 1,000 record storage capability to our Safe-T Sim App, and we provide those upgrades free of charge to our customers. We are working on new features on our other products that will support emerging needs of the HTM community and, as always, will make sure the customer that purchased our very first product 16 years ago, the SimCube NIBP simulator, has a path to upgrade their device.
HARKLESS: Radcal recently revamped its flagship product line to include a stand-alone instrument, the AccuGold Touch Series. Sporting the largest touchscreen in the industry, these systems support all Accu-Gold Series sensors including a dual radiography/mammography multi-sensor and the largest selection of ion chambers in the industry. Recent updates to the sensor family are two DAP solutions, the 10×60 DAP and the DAPCheck Plus. The 10×60 DAP is aimed at small beam systems such as CBCT while the DAPCehck Plus is aimed at satisfying the new JHACO fluoroscopy requirement.
LIU: Datrend has recently released our vPad-EQT app. This is a brand-new app for our vPad-ES/ES2/Rugged/Rugged2 electrical safety analyzers has allowed us to elevate electrical safety testing to new levels by offering: recall of the previous year’s test sequence and device data when a previously tested control number is entered; fully customizable autosequences; simultaneous connections of B, BF, CF applied parts; customized inspection checklists; test record management; built-in user guide and support for all commonly used testing standards.
O’DAY: BC Group is truly a one-stop biomed shop. We design, manufacture, calibrate and repair all our own test devices in addition to all our competitors’ products. We also offer over 75 product lines with devices we do not manufacture. Our three latest products are the AA-8000 family of portable anesthetic agent analyzers, our new patented IPA-3400 Infusion Pump Analyzer and our NIBP-1040 Multiparameter Simulator. The NIBP-1040 provides 13 simulations in one small battery operated device.
ZION: Fluke Biomedical believes in continuous improvement. Innovation doesn’t stop once a stellar product is launched. We continue to improve our designs to give them the ability to test new technologies. We do this by working with leading medical device manufacturers. For example; we added new-to-market R-curves to our flagship patient simulator ProSim 8 and rolled them out as firmware updates. We have continuously improved our workflow automation offing since 1987.
Q: What else do you think TechNation readers need to know about test equipment going into 2020?
ALKIRE: We have heard from our customer base that the trend toward automation and electronic records is becoming even more important. We are very focused on meeting those needs building on our 16 years of designing the world’s smallest, most rugged test devices in the HTM market while maintaining our substantial advantage of extremely easy-to-use devices. Providing both the small footprint and connectivity to CMMS systems and electronic documentation in a flexible way with our portable safety analyzer has proven to be extremely important to our customers. We believe expanding on these features into 2020 will benefit a majority of the HTM community going forward.
HARKLESS: Readers may want to consider alternatives to ownership of their QA instruments going into 2020. As in the mobile phone industry, costs for service and calibration of your instrument throughout its lifetime can easily exceed the purchase price of the equipment. For this reason, leasing your instrument provides a means to establish predictable overall costs through the life of the instrument and avoid large upfront expenditures. Radcal is piloting its Red Carpet Leasing Program as one such example of an increasingly popular business model.
LIU: Keep a look-out for Datrend in 2020 as we will continue to improve our test automation features, enhance the features and operation of our existing apps and introduce more innovative, new products.
O’DAY: The need for innovative test equipment is not going to go away anytime soon. When looking for your next test device, take the time to shop and compare. Look for the best value and consider the total cost of ownership before making the purchase. The ability to purchase an item today that can be upgraded down the road to meet some new testing situation is invaluable. Too many manufacturers just obsolete a product and then state the only solution is to purchase their newest product and the cycle continues. When considering software that communicates and stores your test records, look for something that will work with all manufacturers products and not just limited to the products that one OEM manufactures.
And lastly, do yourself and the country a favor and buy USA made products and support our country’s manufacturing efforts.
ZION: In the category of workflow automation, the notion of capturing failures, analyzing these to get failure rates and long-term trending to be able to predict medical device failures and plan down time for quicker repairs to control costs is possible through end-to-end interoperability with CMMS systems. It’s about more than just simple compliance with regulations. On the topic of training your newest employees, think about shortening learning curves. How easy is it to access effective training? Training should make it quick and easy to learn how to use test instruments and understand concepts. Whether the training is on-demand (training available when you have time), live online (webinars) or live on-location training events. We’ve got your back.
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