As medical devices become more connected and software-driven, test equipment is evolving to keep pace. Healthcare technology management (HTM) teams are looking for tools that go beyond basic safety checks; they want equipment that supports automation, simplifies documentation, and integrates smoothly into today’s digital hospital environments.

In this roundtable, 24×7 Magazine speaks with four test equipment leaders—Justin Barbour, director of business development at BC Group; Lewis Lennard, product manager, the Americas, at Rigel Medical; Greg Alkire, vice president of business development at Pronk Technologies; and Jamie Spragis, CBET, technical sales engineer at Fluke Biomedical—about changing customer expectations, the rise of automation, and where diagnostic tools are headed next.

They also weigh in on today’s biggest challenges—from cybersecurity concerns to training gaps—and offer practical advice for HTM teams looking to upgrade their test equipment portfolios in the coming year.

24×7: How are your customers’ expectations of test equipment changing as medical devices become more connected and software-driven?

Barbour: Surprisingly, even though the clinical engineering field is usually slow to change, software-driven tools like automated testing have caught on quickly. Everyone’s chasing greater efficiency, and it’s the software’s job to boost functionality and usability. Today’s customers expect modern test equipment to come with graphical diagrams and help menus that show them exactly how to run the tests. Every CMMS is different, and each customer brings its own security requirements for software installations.

Lennard: As medical devices become more connected and software-driven, our customers increasingly expect test equipment to match that level of sophistication. There’s growing demand for wireless connectivity, app-based devices, and seamless integration with CMMS platforms. We’ve responded with tools that support Bluetooth, CMMS integration, and mobile applications.

Everyone’s chasing greater efficiency, and it’s the software’s job to boost functionality and usability.

– Justin Barbour, BC Group

Alkire: Overall, we are seeing a rapid increase in interest from the HTM community for wireless control and data capture with test instruments, as we have led the way in designing these capabilities that reduce testing time. Biomeds can now bypass the process of writing results down by hand and typing them up later into work orders. They can improve their workflow with a wide array of new digital tools, and we will continue to expand on these. A specific example of customers’ expectations of test equipment changing related to more medical devices being software-driven: The medical device’s operating system may not recover well from a sudden power-off and may not reboot as expected. Consequently, biomeds have to look for test equipment that doesn’t cause an unexpected powering off of the medical device.

Spragis: Customers are prioritizing test equipment that is intuitive and user-friendly. The Fluke ESA710 Electrical Safety Analyzer exemplifies this with its 5” color LCD touchscreen and intuitive user interface, making it easier for users to perform tests efficiently. Workflow automation is also a critical feature that customers are looking for in modern test equipment. The ESA710, integrated with OneQA software, automates testing and documentation processes. This not only saves time but also reduces the likelihood of human error, ensuring more accurate and reliable results. There is a growing demand for test equipment with wireless and Bluetooth capabilities. The ESA710 supports wireless connectivity, enabling seamless data transfer and remote monitoring. This feature is crucial for integrating with other digital health systems and enhancing connectivity.

Additionally, efficiency is a top priority, and test instruments are being designed to be more compact, portable, and faster. The ESA710’s portability and the ability to integrate with barcode scanners help streamline processes by automating data capture and reducing manual entry errors. This integration enhances overall lab efficiency and ensures accurate tracking of samples.

24×7: How has automation changed how HTM teams interact with test equipment—especially when it comes to routine preventative maintenance (PM) or safety checks?

Barbour: Automation has streamlined most processes and, when documented well, enables an experienced technician to achieve the same testing quality as a senior technician. Because most clinical engineering programs lack a structured training regimen for developing technicians, automated testing helps fill that gap.

Lennard: Automation is transforming how HTM teams approach testing. For routine PMs and safety checks, automated test sequences significantly reduce human error and save time. Devices like the Uni-Therm feature guided workflows and on-screen prompts that simplify these tasks, especially valuable in high-volume settings such as hospitals and OEM service teams.

Alkire: Before we developed the Safe-T Sim Safety Analyzer with Bluetooth capabilities that connects to smart devices, most HTM teams were still writing down the tests performed and typing results into work orders later or only capturing pass/fail results. Now, controlling multiple tests in an automated sequence at the press of a single button from an iPad or iPhone, with its time savings, has led a large percentage of HTM teams to abandon their notepads. They can also utilize their smart devices to access step-by-step dynamic procedures with all test results captured. These procedures can be modified easily to create a “library” of procedures that extend from generic device type testing to comprehensive manufacturer-based PMs. The Pronk Mobilize solution offers biomeds a lot of flexibility to address their broad array of responsibilities in a systematic manner while also freeing them from constantly navigating software menus on the test equipment after it has been connected to the medical device.

Now, controlling multiple tests in an automated sequence at the press of a single button from an iPad or iPhone…has led a large percentage of HTM teams to abandon their notepads.

– Greg Alkire, Pronk Technologies

Spragis: Automation helps establish consistent procedures and protocols across the board and enables the systematic capture and storage of test results in a searchable format. The Fluke ESA710 with OneQA software standardizes test processes and documentation, ensuring that all equipment is tested and maintained to the same high standards. It facilitates this by automatically saving and syncing test results, which can then be analyzed to identify trends, predict equipment failures, and optimize maintenance schedules. This standardized approach helps create a clear and consistent record of maintenance activities and provides verifiable evidence that all necessary checks and maintenance were performed according to established protocols, which can be crucial in audits and mitigating the risk of lawsuits.

Automated systems and standardized workflows make it easier and faster to train new biomedical equipment technicians. With the ESA710 and OneQA, new hires can quickly learn and adapt to the required tasks, reducing the time it takes for them to become fully operational.

Automation systems like OneQA can capture and store the valuable, often undocumented knowledge held by experienced technicians. This “tribal knowledge” includes best practices, troubleshooting tips, and historical data that can be invaluable for training new staff and maintaining consistency in operations.

24×7: What types of tasks are now automated that weren’t five years ago?

Barbour: Small chores, like putting a device into service mode, used to chew up time while you hunted for the right codes or button combos. Now those steps take seconds, thanks to photo guides and pop-up tips. Controlling one test device wirelessly has been possible for years, but with improved Bluetooth, you can now send and receive data from multiple devices simultaneously.

Lennard: Tasks that once required manual intervention, such as configuring test parameters and compiling reports, can now be completed automatically. Automatically controlling medical devices and capturing test results with integrated test equipment is a relatively new advancement, offering significant efficiency gains for HTM teams.

Automatically controlling medical devices and capturing test results with integrated test equipment is a relatively new advancement, offering significant efficiency gains for HTM teams.

– Lewis Lennard, Rigel Medical

Alkire: Automation that existed over five years ago was largely inaccessible in terms of cost or required a high learning curve. Pronk has, from its inception, envisioned new approaches to achieve greater efficiency in support of biomeds. So, Pronk introduced Mobilize approximately six years ago which provides biomeds the capabilities to automatically load dynamic procedures onto a smart device, to use the smart device as a secure “remote control” to start autosequences, to capture measured values via Bluetooth during and after testing, and to print out PM stickers wirelessly, among many other automated efficiencies that we developed. The days of having to enter handwritten results into a CMMS system are dwindling as Mobilize’s integrations, for example, allow direct uploads of automated work order results.

Spragis: Previously, entering asset information was a manual and time-consuming process. Now, with the integration of barcode scanners in devices like the Fluke ESA710, asset information can be quickly and accurately captured. This automation reduces human error and speeds up the data entry process. The user interfaces of modern test equipment, such as the ESA710, have become more intuitive and user-friendly. HTM teams can easily navigate, build, and utilize PM procedures that are saved on the device. This automation simplifies complex workflows and ensures that procedures are followed consistently.

Automation also has made accessing information more straightforward and efficient. The ESA710 with OneQA software allows for real-time data access and procedure sharing. This ensures that all relevant information is readily available to technicians, enhancing decision-making and reducing downtime. Automated process control has become a fundamental part of HTM operations. The Fluke ESA710 and OneQA software enable precise control over testing and maintenance processes. This automation ensures that all steps are performed correctly and consistently, improving overall efficiency and reliability.

24×7: Data logging and digital recordkeeping are becoming more important for compliance. How are your tools helping HTM teams meet documentation and reporting requirements more efficiently?

Barbour: Not only are we streamlining the collection of data from the test equipment to the CMMS work order, but also myBC Connect adds a layer of redundancy by maintaining its own copy of test data. 

Lennard: Accurate documentation is essential for compliance. Rigel devices feature internal memory and USB/Bluetooth export to streamline digital recordkeeping. Our software tools, such as Med-eBase and the 288 Downloader app, help HTM teams meet requirements set by The Joint Commission and NFPA 99. For simpler needs, we also offer devices like the SafeTest 60+, which provide clear on-screen results without requiring additional software.

Accurate documentation is essential for compliance.

– Lewis Lennard, Rigel Medical

Alkire: It is extremely rare to find a solution that saves time and improves quality. Generally speaking, those two goals conflict with each other, where improving quality would result in more time involved with a task. Pronk Mobilize breaks that paradigm by automatically populating records in CMMS work orders with detailed data captured wirelessly from digital test procedures (aka checklists) running from a smart device and providing incredible consistency in the work being performed. Mobilize also allows biomeds to create comprehensive records that incorporate, for example, the results of ECG/respiration/SpO2 simulations, plus electrical safety and defibrillator analyses into a single report. Mobilize improves efficiency in other ways, such as by employing the smart device camera as a barcode scanner (ie, no additional purchase) and as a camera to document visual inspections to add to the electronic record. We have also continued to focus on maintaining the Mobilize platform to significantly benefit HTM teams, whether or not they utilize a CMMS system.

Spragis: With Fluke OneQA Workflow Automation Software, HTM teams can automatically capture measurement data from the Fluke ESA710 Electrical Safety Analyzer. Using open API and JSON language, this data can be seamlessly transferred directly into CMMS. This integration eliminates manual data entry, reduces errors, and ensures that all test results are accurately recorded and easily accessible.

The Fluke ESA710 and OneQA software also incorporate built-in redundancy to ensure data integrity and reliability. This means that even if your CMMS fails, you still have the data backed up on your test instrument with a storage capacity of more than 10,000 measurements or saved on the cloud with OneQA and unlimited capacity. This redundancy will help maintain continuous operation and data preservation. This feature is crucial for compliance, as it guarantees that all documentation and reporting requirements are met without interruption.

24×7: What are the most common challenges HTM professionals face when using test equipment today, and how are they being addressed?

Barbour: The greatest challenge is having sufficient test equipment to equip a full staff of technicians. Management usually cuts corners with the quantity of test equipment on hand. The second greatest challenge is technician training on proper testing procedures and test equipment usage. Videos are the best format for usage training. BC Group and other manufacturers have spent a lot of time and money in making complete catalogs of training videos.

Lennard: HTM professionals often cite equipment complexity, training gaps, and reporting as key issues. We address this with simple user interfaces, standardized test menus, and free training resources. Our goal is to make test equipment easy to learn and reliable under pressure.

Some of the most common challenges…are access to knowledge and expertise in the operation and setup of test equipment and the medical devices being tested, due to so many experienced HTM professionals retiring.

– Greg Alkire, Pronk Technologies

Alkire: Some of the most common challenges for HTM professionals today are access to knowledge and expertise in the operation and setup of test equipment and the medical devices being tested, due to so many experienced HTM professionals retiring. Fortunately, important guidance from service and operator manuals can now be laid out in customizable digital checklists on smart devices using Pronk Mobilize. In fact, the checklists themselves can be automated such that the engineer can start a test sequence without directly navigating often complex software menus on the test equipment, and the results are automatically captured in a comprehensive test record or work order. Another significant challenge with test equipment in the HTM community is the ruggedness and reliability of the devices. It’s why we always drop test all our designs 50 times at three feet onto a hard surface to make sure we can reduce downtime, and we offer a four-year warranty on all our products at no additional charge.

Spragis: Modern test instruments are becoming more compact and capable, allowing biomeds to perform more tests with fewer devices. This not only reduces the physical burden but also lowers calibration and maintenance costs. The Fluke ESA710 is a prime example, offering a range of testing capabilities in a portable form factor. This enhanced capability means that fewer instruments are needed to perform comprehensive testing, streamlining the workflow and reducing costs.

Reliability is a critical concern for HTM professionals, as test instruments must consistently perform accurately to ensure patient safety and compliance. The Fluke ESA710 is designed with robust construction and high-quality components to ensure long-term reliability and accuracy. Additionally, the integration with OneQA software provides automated calibration reminders and maintenance schedules, ensuring that the equipment remains in optimal condition.

24×7: As cybersecurity concerns grow, are there new risks or considerations HTM teams should be aware of when using or maintaining test equipment?

Barbour: Web-based data collection and vetted iOS and Android apps have eliminated most of the IT fears related to software installation on hospital networked computers.

Lennard: As cybersecurity concerns grow, the primary focus remains on securing medical devices themselves. However, test equipment also plays a role and must be designed with secure data protocols and controlled access. In future developments, we’re incorporating features such as user authentication to help HTM departments align with hospital IT and security standards. While not as critical as the devices being tested, it’s still an important consideration.

Alkire: Yes. Test devices that have Wi-Fi communications can be exposed to cybersecurity issues, just like a medical device that is connected to Wi-Fi or networked to the hospital system. This is why we chose Bluetooth communications between smart devices and all Mobilize test equipment. 

Test devices that have Wi-Fi communications can be exposed to cybersecurity issues, just like a medical device that is connected to Wi-Fi or networked to the hospital system.

– Greg Alkire, Pronk Technologies

Spragis: Secure data transfer is crucial to protect sensitive information from cyber threats. The Fluke ESA710 and OneQA software utilize secure APIs and encrypted communication protocols, such as TLS, to ensure that data transmitted over WiFi is protected. This encryption safeguards the integrity and confidentiality of the data, preventing unauthorized access and ensuring compliance with cybersecurity standards. 

With the increasing importance of data security, HTM teams must ensure that test data is backed up and stored redundantly. The Fluke ESA710, integrated with OneQA software, provides robust data backup solutions. This ensures that all test data is securely stored and can be easily recovered in case of data loss or cyberattacks. Redundant storage mechanisms further enhance data security by maintaining multiple copies of critical information, reducing the risk of data loss.

24×7: What role do you see artificial intelligence (AI) or machine learning playing in the future of test equipment?

Barbour: AI will play a larger role in about five to 10 years. Expect a knowledge base of known medical device issues that is publicly shared and updated live. If an industry trend is noticed, testing procedures will dynamically change. 

Lennard: While still early, we see machine learning playing a role in predictive maintenance, analyzing historical test data to flag early signs of device failure. AI will also support smarter diagnostics and test result interpretation, helping HTM teams make more informed decisions faster.

Alkire: AI could be useful with test equipment in the future as it continues to mature. One possible advantage of using AI in test equipment could be providing faster access to commonly used tests and testing modes, as well as making manufacturers’ test procedures more accessible to newer engineers or quicker to navigate for more advanced engineers.

Expect a knowledge base of known medical device issues that is publicly shared and updated live.

– Justin Barbour, BC Group

Spragis: AI and machine learning are set to revolutionize data analytics in test equipment. These technologies can analyze vast amounts of data generated during testing to identify patterns, trends, and anomalies. The Fluke ESA710, when integrated with OneQA software, can leverage AI to ensure that the data collected is clean and accurate. Machine learning algorithms can automatically scrub data, remove errors, duplicates, and inconsistencies, which enhances the reliability of the insights derived from the data.

Predictive maintenance is another area where AI and machine learning will play a crucial role. By continuously monitoring the condition of medical devices and analyzing historical data collected on test instruments, AI can be used to predict when maintenance should be performed, preventing unexpected failures and reducing downtime. The Fluke ESA710, combined with OneQA software, can help provide the data needed to utilize machine learning models to analyze test results and predict maintenance needs, ensuring that medical equipment remains in optimal condition.

24×7: Looking ahead, what features or capabilities do you think will define the “next generation” of safety analyzers and diagnostic tools?

Barbour: Touch screens, Bluetooth, internal and networked data collection, and self-calibration verification are all components of modern and next-generation test devices.

Lennard: Future test devices will be defined by portability, automation, connectivity, and integration. We expect an emphasis on multifunction analyzers, enhanced simulation accuracy, and plug-and-play compatibility with asset management systems.

The future…will be defined by enhanced connectivity and integration, advanced data analytics and AI, user-friendly interfaces, improved safety and compliance features, and portability and durability.

– Jamie Spragis, Fluke Biomedical

Alkire: Automation and connectivity to CMMS systems are rapidly becoming the focus across all test devices, and this trend will likely continue. In addition, “future-proofing” test equipment with thoughtful design and engineering will lead to the next generation of tools with extended equipment life cycles. Even more intuitive, smart, small, and reliable equipment should be the defining characteristics of next-generation safety analyzers and diagnostic tools.

Spragis: The future of safety analyzers and diagnostic tools will be defined by enhanced connectivity and integration, advanced data analytics and AI, user-friendly interfaces, improved safety and compliance features, and portability and durability. These advancements will enhance their effectiveness, reliability, and user experience, making them essential for preventive maintenance and safety assurance.

24×7: What’s one piece of advice you’d give HTM teams who are considering upgrading or expanding their test equipment portfolio in the next 12–18 months?

Barbour: Buy once, cry once. Standardizing your test equipment will greatly improve technician familiarity and efficiency. Buy into a test equipment ecosystem, and ensure you have enough for all your technicians to be equipped. Invest in automation software suites, and correctly document each type of testing procedure your technicians are expected to complete. A correctly equipped team of four can do the same amount of work as a poorly equipped team of six.

Lennard: Don’t just focus on spec sheets; look for platforms that integrate easily into your workflows and are backed by strong training and support. Choose equipment that’s scalable, not just for today’s devices but for where your hospital is headed over the next five to 10 years.

Focus on future-proofing your investments by selecting equipment that meets current needs and adapts to future technological advancements and regulatory changes.

– Jamie Spragis, Fluke Biomedical

Alkire: The one piece of advice I’d give HTM teams would be that waiting to adopt more advanced test equipment may prove costly in terms of requiring both post-sale equipment upgrades and downtime, once the “right” time arrives. Even if organizations may not be ready to adopt a CMMS system today, they can take advantage of wireless control, data capture, detailed records, automated checklists, wireless on-the-go PM stickers, etc, right now. They can benefit by looking for “future-proof” test equipment with four-year warranties from manufacturers with a track record of offering software updates as part of the initial purchase and hardware designs that have advanced technology and will accommodate future needs like expanded CMMS connectivity.

Spragis: Focus on future-proofing your investments by selecting equipment that meets current needs and adapts to future technological advancements and regulatory changes. Prioritize tools with enhanced connectivity, integration capabilities, advanced data analytics, user-friendly interfaces, portability, and compliance with the latest safety standards. 

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This guide compares several digital pressure meters currently on the market, highlighting key features—such as pressure ranges, accuracy, connectivity, and power sources—to help HTM professionals identify the right tool for their specific use cases.

Netech Biomedical Digimano 2500

Pronk Technologies Pressure MAX Digital Pressure Meter

BC Group Intl DPM-2200

BC Group Intl DPM-2300

Information for this guide is based on data submitted by digital pressure meter marketers. 24×7 strives for accuracy in all data but cannot be held responsible for claims made by marketers. All digital pressure meter marketers get one listing at no charge. Advertisers are offered multiple listings. All digital pressure meters may not be included. Email editor@24x7mag.com to be considered for the next update.

NAMSA, a US-based medtech testing, clinical, and regulatory consulting firm, announced that it acquired WuXi AppTec’s US medical device testing operations on Feb 28.

The acquisition brings together two companies specializing in medical device biological safety testing, serving more than 4,000 manufacturers worldwide.

“Together, we now have unmatched scientific expertise in biocompatibility, microbiology, preclinical and extractables, and leachables testing. With the addition of WuXi AppTec medical device testing facilities in the US, we now have more scientists, more lab capacity, and more expertise with a wider variety of medical devices than any other company,” says Lisa Olson, NAMSA senior vice president of global laboratory services in a release. “This combined expertise will continue to enable our work with clients to develop testing and consulting strategies tailored to their specific device and regulatory pathways.”

NAMSA has been expanding its reach in recent years as it continues to diversify its offering beyond biological safety testing. Since 2021, the company has acquired no fewer than six companies focused on preclinical or clinical research. 

“This acquisition is part of our larger strategy to broaden our service offering and solidify our position as the go-to resource for manufacturers bringing new life-saving technologies to market while upholding the same high standards of client-focused service you have come to expect from NAMSA,” says Brian Smith, NAMSA’s recently appointed CEO, in a release. 

Summary:

NAMSA, a medical device testing and regulatory consulting firm, has acquired WuXi AppTec’s US-based medical device testing operations. The move expands NAMSA’s laboratory capacity and expertise in areas such as biocompatibility, microbiology, and regulatory testing. The acquisition is part of NAMSA’s continued expansion in contract research services, following a series of acquisitions in recent years aimed at broadening its role in medical device testing and compliance.

Key Takeaways:

• NAMSA Acquires US Testing Operations – The medical device testing firm has expanded its lab network by acquiring WuXi AppTec’s US-based facilities.
• Increased Capacity for Device Testing – The acquisition adds resources in biocompatibility, microbiology, and regulatory testing for medical device manufacturers.
• Part of Ongoing Expansion Strategy – The deal continues NAMSA’s efforts to grow its contract research and regulatory consulting services for the MedTech industry.

ID 353659539 | Acquisition © Ramirezom | Dreamstime.com

Key Takeaways:

• The integration between FSI and OneQA automates device testing and recording, reducing manual data entry and delays between systems.
• This collaboration improves workflow efficiency for HTM professionals, allowing them to focus on healthcare maintenance rather than data management.

FSI has announced an integration with Fluke Biomedical OneQA workflow automation software to enhance efficiency and accuracy in device testing workflows. The integration allows OneQA device testing to be launched from within a CMS work order with results automatically recorded, reducing manual data entry and time spent switching between platforms.

Key Benefits of the OneQA Integration

OneQA software works with FSI’s CMMS, reducing duplication in device testing for biomedical professionals. This partnership addresses common challenges in device testing management, such as:

• Delays in work orders requiring device testing and documentation across two systems
• Complicated data entry processes and inaccurate reporting
• Friction in preventive maintenance, equipment reliability, and compliance workflows

“We are looking forward to seeing how the device testing experience changes for OneQA users from utilizing this new capability. Integrating with FSI is bringing a frictionless experience in using OneQA software, allowing users to test and record data from within an associated work order without having to switch platforms or manually enter information,” said Jeremy Olson, director of product management (EQA) at Fluke Health Solutions.

Improved Efficiency and Data Accuracy

The OneQA integration is the latest development in FSI’s efforts to ensure software compatibility and optimized workflows with tools that users frequently rely on. By introducing integrations focused on compatibility, FSI minimizes time needed for device testing workflows and improves data accuracy, supporting healthcare maintenance management functions.

“Fluke Biomedical OneQA software is a tool that we have heard being utilized by many of FSI’s biomed users, and we are excited to introduce an integration that adds efficiency and reduces the margin of error in managing device testing data,” said Chris Lang, VP of product and strategy at FSI.

Key Takeaways:

• Strategic Partnership: Rigel Medical has partnered with MEAK Solutions to expand its reach in the US government and military sectors.
• Enhanced Support: The collaboration will improve the supply and support of biomedical test equipment to VA hospitals, aligning with the commitment to enhance veteran care.

Biomedical device test and measurement specialist Rigel Medical has agreed on a new partnership with a US government and military contractor as it continues to expand its North America operations.

Collaboration with MEAK Solutions

The collaboration will see Tampa-based Rigel Medical link-up with small business certified service-disabled and veteran-owned (SDVOSB) MEAK Solutions in a move that marks a ‘significant step forward’ in developing and improving the supply and support of biomedical test equipment provided to US government and military sectors.

Working together, both companies will bring their respective technologies and specialist expertise to a broader market, while driving the development of solutions for customers, including additional reach into military veterans’ hospitals and healthcare facilities across the country.

MEAK Solutions’ Role

“Rigel Medical testers comply with US regulations, so leveraging MEAK’s SDVOSB status will effectively enable the company to meet the requirements of VA hospitals with sector-leading biomed equipment solutions,” said Lewis Lennard, product manager, North America.

“MEAK Solutions’ SDVOSB status positions us perfectly to serve government agencies, particularly the Department of Veterans Affairs (VA),” said Lennard. “Our new partnership allows us to provide VA hospitals with high-quality biomedical test equipment, ensuring the best care for the country’s veterans. Indeed, supporting VA hospitals with advanced biomedical solutions directly contributes to the health and well-being of veterans, aligning with our commitment to improve patient care.”

Located in Mentor, Ohio, MEAK Solutions specializes in providing solutions for government, military, and commercial clients.

“We are excited to partner with Rigel Medical, which has a strong track record of delivering innovative biomed testers into the US market,” said Eric Kettani, director at MEAK. “We will be working together to strengthen our offering and in partnership, we will be committed to advancing the development of innovative applications and solutions for the benefit of VA hospitals and their patients.”

Key Takeaways:

• The SafeTest 60+ offers enhanced usability with a color-coded interface and push-button operation, designed for high-volume testing regimes.
• The device ensures compliance with international safety standards and provides comprehensive safety testing for various medical equipment, with features like active pass/fail thresholds and automatic warnings for secondary ground paths.

Rigel Medical has launched an upgraded SafeTest 60+ handheld safety analyzer designed for rapid and accurate medical device and laboratory equipment testing.

Compact and Rugged Design

The upgraded SafeTest 60+ is a compact and rugged safety analyzer that is designed to accommodate the demands of high-volume testing regimes. The device offers a color-coded user interface, push-button operation, and fast step selection of test routines. It is available in a wide range of power configurations to suit local and international markets. The tester features point-to-point insulation resistance testing from 100K – 100MΩ with added patient-applied parts testing.

Featuring an accessible and clear user interface (UI), which allows the operator to select the required tests quickly with a single key, the high-performance instrument includes an extensive selection of safety tests for hospital and medical equipment.

The SafeTest 60+ provides basic testing of medical equipment with applied parts, including both patient current leakage and insulation measurement to ensure the electrical safety of medical beds and chairs, operating tables, hoists, infusion pumps, CPAPs, centrifuges, and other similar equipment that do not require patient lead testing.

Compliance with International Standards

The SafeTest 60+ is suitable for electrical testing to ensure compliance with a range of international safety standards, including leakage testing to AAMI ES 60601, NFPA-99, IEC 62353, and IEC 61010. Key features for dynamic testing include:

• Active pass/fail thresholds during measurement
• Patient applied parts testing
• Manual control of fault conditions and tests
• Accurate high current, low energy earth bond testing
• Automatic warning of secondary earth/ground paths
• Point-to-point insulation testing

Advanced Capabilities

To meet the needs of specific types of equipment, the unit also has the capability to carry out accurate ground bond testing to NFPA-99, IEC 62353, and IEC 61010 using Rigel’s high current, low energy test technology. In all cases, full manual control means only those specific tests that are required need to be carried out.

For a streamlined approach to carrying out electrical safety tests, an automatic warning of secondary ground paths alerts users when invalid results occur, eliminating time-consuming re-tests and ensuring correct and valid results are being provided, according to Rigel Medical.

24×7: What are the latest trends in biomedical test equipment, and how do they impact the development of new technologies?

Greg Alkire: Healthcare technology is in a constant state of evolution and advancement. We at Pronk are passionate about supporting biomedical engineers and others in HTM with products that solve issues raised by this dynamic landscape. This is very much true with our latest product, Pressure MAX Digital Pressure Meter. Designed to address a greater need for high accuracy, portability, and efficiency, it features multi-channel capabilities—i.e., two meters in one, to test fluid, gas, or air.

It includes automated testing and data collection capabilities, plus a new target feature for speed and ease of use. The Pressure MAX is both tiny and highly durable, passing our industry-leading 50-times drop testing without any failures and still operating within specifications. With a tool like this, biomeds save time and gain flexibility to get more accomplished.

Tim Welby: The field is looking for more automated processes that include auto-sequences based on OEM requirements. This allows more throughput and reduces missed steps. Additionally, having the opportunity to run tests via Bluetooth on an app is very inviting. This reduces transcription errors as the app captures the actual readings, eliminating the opportunity for keystroke errors or reading the wrong information due the information being illegible.

Lewis Lennard: There is a trend toward portability in biomedical test equipment to meet the demand for compact, lightweight, and handheld devices. Portable analyzers enable healthcare facility testing and field service applications, expanding access to testing capabilities in remote or resource-limited environments. Several of Rigel’s portable analyzers have been used in harsh, remote conditions, and the durability of the equipment has been recognized. 

Integration with IoT technology stands out as another prominent trend. We recently released an app that can generate PDFs and test reports, which helps facilitate real-time data capture and storage, simplifying the management of test results and documentation.

Elliot Weldon: As with many other areas in healthcare, workflow automation is becoming a focus in the biomed arena. Most biomedical test equipment companies are now offering some form of automation.

What distinguishes Fluke Biomedical is our OneQA workflow automation software. OneQA facilitates the standardization of test procedures and records test results for the technician, saving valuable time and reducing human error. Additional features include the ability to save notes and pictures in the procedure, allowing for the tech to easily follow the necessary test steps. Plus, OneQA has an open [application programming interface]that allows the solution to work with most major CMMS platforms.

24×7: What are some of the biggest challenges facing the biomedical test equipment sector today, and what strategies are being employed to overcome them? 

Weldon: Biomeds face multiple challenges daily. Some of these issues include:

• An aging and rapidly retiring workforce.
• The diminishing availability of colleges to train a new workforce.
• Increased equipment counts that require maintenance.
• Rapidly changing technology that blurs the line between IT and biomed.
• Seemingly daily changes of rules and regulations.

Workflow automation offers a solution to manage testing processes, boosting compliance and enhancing patient safety amid multiple responsibilities.

Welby: Identifying the needs of current and future biomeds to create more efficient processes.  Fortunately, we have an in-house engineering department that allows us to respond to new requirements and demands from the field. BC Group is engaging with outside agencies to capture a much broader audience to gather information than we could on our own.  This will allow us to be more proactive and less reactive.

Alkire: We look at test equipment as more than just devices with features requiring biomeds to navigate through menus to find the needed test or feature, but rather as solutions-based products. Biomeds can utilize our products as standalone devices or, with our Mobilize Wireless solution, they can create testing protocols for a wide range of medical devices, set the test parameters, and run automated tests wirelessly to the test equipment via our Pronk Mobilize App on their smart device.

Automated test sequences are user-programmable, including the option to run detailed checklist-type procedures with both test and set-up instructions, as well as customizable pass/fail limits per the medical device manufacturer’s requirements. This allows biomeds to conduct necessary testing and address the challenge of performing services on the spot, completing all required tests, and electronically recording all data.

Lennard: Keeping pace with rapidly evolving technology is challenging. Test equipment manufacturers need to be innovative with the next generation of test equipment. Collaborating with biomeds, biomedical equipment technology colleges, and medical device manufacturers keeps us up-to-date on emerging technologies and ahead of the curve.

One of the biggest challenges is connected devices and IoT integration. If biomedical test equipment is on the same networks as patient data, the risk is clearly high.  To enhance cybersecurity measures, test equipment must implement encryption protocols and secure network processes in the same way that medical devices do. 

24×7: How does your company ensure efficient, flexible servicing of medical devices, especially in emergencies, amid the growing demand for portable solutions in biomedical testing?

Alkire: Biomedical engineers must be as mobile as possible to manage the high volume of demand for maintenance and repair from hospitals, clinics, and other remote sites. Having portable and highly reliable products in this environment is a must-have. At Pronk, product development is very focused on maximum portability, high reliability and durability, and great accuracy to support biomeds’ responsibilities in meeting the testing requirements of medical devices.

Our latest product, Pressure MAX Digital Pressure Meter, reflects this philosophy. It is the smallest multichannel pressure meter with tremendous accuracy and range for both positive and negative pressure measurements, eliminating the need to purchase multiple meters.

Welby: BC Group offers both onsite and depot calibrations with our team of technicians. If urgent, we have a Quick-Fire process to quickly address the customer needs.

Weldon: Fluke Biomedical offers advanced portable solutions in the biomedical test equipment industry. Our products are designed for multiple functional testing in one single unit—aka: carry less and do more. With our enhanced automation and CMMS integrations, our products help ensure quick diagnostics and effective reporting during maintenance and emergency repair. This streamlined approach helps ensure biomeds can depend on fast and accurate equipment when it matters most.

Lennard: Rigel has seen a growth in testing requirements for smaller, remoter healthcare facilities. The design of portable test equipment is important so that it can be easily transported to healthcare facilities, clinics, or remote locations during emergencies. These devices are lightweight, compact, and often battery-powered, enabling rapid deployment and onsite testing without the need for a specialized infrastructure. Test equipment solutions need to be diverse, catering to a range of settings, from large metropolitan hospitals to remote communities in Alaska.

24×7: What measures does your company take to ensure the precision and dependability of test equipment calibration and servicing, particularly in environments where accuracy is critical for patient safety?

Lennard: A test equipment manufacturer must have calibration to standards such as ISO 17025 for calibration laboratories, and at the very least ensure reference standards and calibrated equipment are traceable to national or international standards. This ensures the accuracy and traceability of measurements and minimizes uncertainties in calibration processes. Our service and calibration arm, Calibrationhouse, has [United Kingdom Accreditation Service] (IEC 17025) capabilities for biomedical test equipment and counts worldwide medical device manufacturers and healthcare organizations among its customers.

Weldon: We are ISO 9001 and ISO 13485 certified and provide ongoing service and support to ensure continuous customer satisfaction. We recommend annual calibration for all Fluke Biomedical tools. While third-party companies may be able to verify if the analyzer is in tolerance, the Fluke Biomedical service program will calibrate the device, update firmware, and complete any necessary repairs in a timeline under a single purchase order.

Welby: BC Group is ISO 13485:2016 certified, ISO 9001:2015 certified, ISO/IEC 17025:2017 accredited, National Institute of Standards and Technology traceable, American National Standards Institute Z540-1-compliant, and FDA Current Good Manufacturing Practices-compliant. 

Alkire: The key to ensuring accuracy and reliability starts with the product’s design. Products must be designed to withstand the rigors of the service environment—the wear and tear, such as test equipment accidentally falling to the ground—as well as to travel well in hot and cold environments, etc. Emphasizing these factors is a primary focus of every Pronk product.

Extensive field testing with customers ensures maximum accuracy and reliability for real-world applications. This, combined with our manufacturing and service quality standards that require a 100% inspection, test, and calibration of each product according to international standard ISO-17025, provides great confidence in the use of our products.

24×7: How does your company assist HTM officials in utilizing and maintaining test equipment through training and educational programs?

Lennard: We assist biomedical engineers by providing comprehensive training and education initiatives. These include online webinars, onsite training sessions, and video tutorials covering equipment operation, troubleshooting, and preventive maintenance. Rigel also offers certification programs, continuing education courses, and technical support to address topics, regulatory compliance, and any issues biomeds encounter.

We strongly believe in cultivating the next generation of biomeds. We have donated test equipment to colleges as this greatly benefits students by providing enhanced access to new learning experiences and preparing them for future careers in the field. Through hands-on experience with equipment, students develop crucial technical skills in equipment operation and maintenance. Additionally, networking opportunities with HTM professionals may arise, helping students’ educational experiences.

Weldon: Fluke Biomedical uses an assortment of tools and events to support training and education initiatives. Our Advantage Training program has over 13,000 users globally, providing education from the basics of biomed theory all the way to advanced technical training on our devices. We also host multiple live and on-demand educational webinars and have an in-depth product video library on the Fluke Biomedical website. Our global channel partner network assists with technical training, sales, and local biomed events.

Alkire: We’re proud to support our customers who purchase our products. This includes offering training videos and interactive online classes to help them make the most of our products, like our Pronk Mobilize™ Wireless Solution.

Our classes cover advanced features of our Mobilize App, such as creating your own test protocols and running manufacturer or AEM procedures while communicating wirelessly to Pronk test equipment, in addition to the defibrillator and ventilator analyzers available on the market. We provide training to help optimize automation for test equipment and electronic record-keeping within a CMMS.

Welby: BC Group holds periodic webinars—nationally, regionally, and locally. We have developed and continue to develop many how-to videos that are available on YouTube and our bcgroupstore.com website. We design and manufacture under one roof; this allows the biomeds to talk directly with our support team as needed.

The app is part of a digital toolkit used to support the 288+, an electrical safety analyser designed to perform routine field tests on medical electrical equipment. The tests play a critical role in revealing faults with medical equipment in hospitals and healthcare facilities, highlighting any compliance issues and improving patient safety.

Data downloaded directly from the Rigel 288+ via Bluetooth connection to mobile devices can be stored and managed, reducing the time it takes to transfer and store completed test records on asset maintenance software, as part of a planned preventive maintenance schedule.

Available in English, French, German, Italian, Polish, Portuguese, Spanish and Turkish, the app also allows company logos and other details with personal signatures, to appear on individual engineer reports for secure identification. Single test results, multiple results, or all results can also be added to these reports by selecting the relevant checkbox, which can then be viewed and forwarded to databases in PDF and/or CSV formats.

“The paperless nature of the app means engineers can easily transfer their records online on the move and store them on databases, as opposed to printing them off,” said Michael Walton, category manager at Rigel Medical. This is a great time saving advantage for busy biomed equipment test teams, enabling them to complete maintenance schedules even quicker and ever more efficiently.”

UL Solutions’ laboratory in Rochester Hills can test to various methods and specifications provided by medical device manufacturers, with services such as accelerated lifespan and environmental testing. The facility features extensive capabilities to quickly reconfigure testing based on manufacturers’ needs and processes that minimize contaminants, such as volatile organic compounds (VOCs), in the environment to support testing accuracy.

“Medical device technology has continued to thrive in Michigan, which is a leader in the United States for talent, workforce and manufacturing in this industry,” said Mary Joyce, vice president and general manager of the Mobility and Critical Systems group at UL Solutions. “Launching medical device testing at our laboratory in Rochester Hills, Michigan, enables us to meet the rising demand for these services and help manufacturers advance the safety, security, usability and interoperability of devices consumers depend on.”

To maintain the pace of innovation and protect medical device users, manufacturers must balance speed and potential risks, including quality, safety and cybersecurity issues. UL Solutions now has the capabilities in Michigan to provide medical device manufacturers with third-party verification and validation, auditing, cybersecurity services, usability testing, and compliance training to help take on these challenges.

“Establishing these capabilities in Rochester Hills brings us closer to customers in Michigan’s growing medical device technology industry, where our safety science expertise will help enable innovation and speed to market,” said Joyce.

The tester is also used by team leader Adam Taylor to check the in-service safety of a variety of electric kettles, cookers, dishwashers and microwaves available in the kitchens of these venues, ensuring that they are safe to use by people attending events and comply with appropriate electrical safety regulations. Taylor volunteers to help out and travel from venue to venue to check that musical equipment is safe to use before every gig.

“I had never used a PAT tester before, so the fact that the PT 100 is very simple and straightforward to operate is a great help,” said Taylor. “It’s easy for me to check every electrical appliance and item of equipment quickly and accurately. This is something I really appreciate – it’s reassuring to know that we are complying with electrical safety standards and our insurance requirements.”

The Prime Test 100 forms part of a comprehensive range of Seaward PAT instruments, accessories and software that have been specifically designed to meet the needs of electrical safety duty holders in all workplaces.

Roots Community is a group of volunteers, which has been brought together by Lancashire-based charity Red Rose Recovery. The organization draws on the lived experience of its staff to help people struggling with alcohol and drug misuse, as well as mental health issues, homelessness, offending behavior, and domestic abuse.

“We are delighted that Roots Community has opted for the PrimeTest 100,” said Richard Slade, field sales manager at Seaward. “The charity does some outstanding work in the community and can now look forward to the tester having a significant impact, improving levels of electrical safety at the venues it uses and for the bands that come and play at its meetings.”