Healthcare Technology Management professionals cannot do their job without test equipment. Testing and maintaining medical devices is as much a part of the job as repairing life-saving devices. Of course, that means having the right testing equipment is just as important as having the right tools. We reached out to industry experts to find out the latest about test equipment and what features to search out when upgrading.
The roundtable panel of experts includes Greg Alkire from Pronk Technologies Inc.; Jack Barrett, National Business Development Manager, Rigel Medical; Mike Clotfelter, Vice President Business Development – BC Group International Inc.; Ron Evans, Vice President of Product Development, Datrend; Patrick Pyers, Vice President, Sales, Marketing & Business Development, Radcal Corp.; and Jerry Zion, Global Training Manager, Fluke Biomedical.
Q: What are the most important things to look for when purchasing test equipment?
Alkire: We believe, after assessing the test equipment has adequate features, the most important factors are portability, ease of use and reliability. Our experience in the medical device market has shown that having the flexibility to quickly grab your test equipment, go to where it’s needed, rapidly find the feature you need and having complete confidence the product will work every time, is of the upmost importance in the demanding hospital environment.
Barrett: Durability, portability and data traceability. Durability in consideration of ever tightening budgets. What is purchased must last a long time. Portability to ease the burden of what the biomed needs to carry when visiting satellite locations or simply moving about in the hospital. And finally, data traceability. Looking forward, simple pass/fail is being replaced with what device functionality was tested and measured values. The requirement for data will continue to become increasingly important.
Clotfelter: Value, but not necessarily the lowest price. Features and specifications are important, but often portability is also desirable. Instruments that measure multi-parameters are important because 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.
Evans: The use of technology integrated into the test equipment to enable the user to work more effectively, both today and in the future. A lot of test equipment is still based on the legacy model of “do a test, write down the results.” Today’s technology allows us to do a lot more, like automated tests and procedures, direct-to-file test reports, results evaluation, remote access and much more. Look for test equipment that has this type of technology integrated into its design.
Pyers: The most important thing to look for is the quality of the product and the stability of the manufacturer. You are making an investment and you want to be sure that your investment will last and be supported for many years. The test equipment should possess the latest technology with provisions to upgrade as new functions are developed. Specifications should meet your testing requirements so the biomed is able to perform their job with ease and accuracy.
Zion: Considerations include – Can the instrument be used out of the box without additional training? Is it part of or comprise a complete portable solution? Does it provide the necessary accuracy? Will it deliver the test results in a format that makes documentation easy? Is the price supported by the value delivered?
Q: What are some of the fundamental test equipment capabilities biomeds need to be able to do their job?
Alkire: Each biomedical engineer should carry their own complete set of tools which should include their own test equipment. With the demands and workload they have to manage, it is critical to have a complete set of test equipment required to service all the medical devices in the facility. This includes, and is not limited to, patient simulators, electrical safety analyzers, as well as, specialized test equipment for critical medical devices such as infusion devices, defibrillators and ventilators.
Barrett: A manufacturer’s suggested preventive maintenance procedures pretty much spell out what capabilities are needed. Certainly electrical safety testing is core. From a different perspective, I would suggest test automation is an important capability as it positively impacts the biomed’s time and increases bandwidth.
Clotfelter: electrical safety analyzers, multi-parameter patient simulators, ventilator analyzers, esu analyzers, as well as dmms cover many of the basic parameters required for biomed shops to maintain most medical equipment. Additional equipment, such as anesthetic agent analyzers and ambient nitrous oxide analyzers are needed in order to maintain and test specialty equipment, such as anesthesia equipment.
Evans: I would suggest test equipment with a high degree of automation will result in the biggest impact for a biomed. Facilities are looking for large savings in time, costs and manpower while at the same time fulfilling their accreditation needs. Automation helps achieve these goals.
Pyers: Test equipment makes up a very broad arena of products used today by the biomed. It is comprised of many different testing instruments from electrical safety analyzers to sophisticated diagnostic X-ray test meters. Each instrument should have the latest capabilities for that modality to allow the biomed to perform all the required tests to diagnose a problem or verify the machines are working correctly. Each instrument has its own specific capabilities that makes it unique and the right tool for the job.
Zion: The medical device categories present in inventory of a hospital or medical facility dictate the fundamental capabilities needed in test instruments used by the biomed. For example: Electrical safety (volts, ohms, micro-Amperes); liquid flow, volume, and pressure; gas flow, volume, and pressure; defibrillator: volts, amperes, power in joules; and gas concentration measurement
Q: What are some of the latest features or capabilities that biomeds should look for when purchasing test equipment?
Alkire: Test equipment that has significant advancements in terms of accuracy and speed should always be a consideration during the purchasing process. An example of this are the infusion pump analyzers available five years ago could not meet adequate accuracy or speed requirements to both quickly assess an infusion pump and be accurate enough to be certain the pump was performing to the manufacturer’s specifications. This is no longer the case.
Barrett: Test automation and ease of data capture on conducted tests. Self-contained analyzers for enhanced portability.
Clotfelter: Test equipment that includes auto-sequence programs can provide PMs to be done in less time. Auto-sequence test results reports can be saved or printed. Other products offer pass/fail and numerical test results.
Evans: Automation should be a big factor when looking at the features of new test equipment. But automation capabilities should be looked at closely as well, and consideration should be given to available forms of connectivity, integration with CMMS systems, integration with digital service manuals, remote service and training, and interfaces to other test devices, to name a few.
Pyers: The use of new displays utilizing the latest in touch-screen technology is more prevalent today than in the past. With the emphasis on time savings, touch-screens speed up the testing setup procedures and analyzing the results obtained from the measurement. In addition, faster processors with better capabilities to store and analyze data provides more accurate information to the biomed.
Zion: Evolving features include wireless capture of test results and on-board automation.
Q: What is NIST traceability and why is it important?
Alkire: Traceability to NIST standards is all about an unbroken record of documentation that shows objective evidence proving the test instrument performance ties back to NIST standards and/or references. This provides critical information to the customer to determine whether the test equipment is adequate for testing a device based on its uncertainties (a.k.a. accuracy). This is extremely important because without it there would be no traceable method to have confidence that a medical device, for example, was ready to be returned to service for use on a patient. A general rule for adequate uncertainty of a test device is the 4:1 ratio – meaning the test instrument needs to be four times as accurate as the device under test (IV pump accuracy=5 percent, analyzer needs to have accuracy of 1.25 percent or better).
Barrett: NIST traceability provides the path for the instruments used to calibrate the biomedical test equipment back to national standards. The accuracy of the tester or analyzer used for conducting PMs is critical. If the test equipment is not accurate, the end result could be that the medical device is calibrated incorrectly and theoretically adjusted outside the manufacturer’s specification.
Clotfelter: National Institute of Standards and Technology. Calibration labs use calibrated standards to calibrate UUT (units under test). All calibration and reference standards used in the lab must have an unbroken chain of calibrations traceable to NIST. By using a calibration lab that uses standards traceable to NIST, you can have confidence in the accuracy of the measurements made by the calibration lab.
Evans: NIST traceability relates to the ability to trace the calibration of a test instrument back to an “official” reference standard (such as voltage, resistance, current, pressure, etc.), which is at or approved by NIST. It is important because it provides assurance that the test device is able to meet its specifications to perform the tests for which it is designed.
Pyers: Traceability is defined as an unbroken record of documentation and/or measurements with associated uncertainties. NIST, National Institute of Standards and Technology, maintains the standard that traceability is referenced to for accuracy. These standards are essentially the gold standard that all NIST traceable instruments are compared to. The importance is one of standardization to allow all users the same level of accuracy and like measurements within limits of uncertainties.
Zion: It’s not just NIST traceability. Traceability can be through a national measurement institute (NMI) like NIST or directly to SI. The critical factors include unbroken chain of traceability to the primary standard of the test instruments used in the calibration of the medical device; the accuracy including uncertainties of all measured values.
Q: How important is it to have test equipment that interfaces with CMMS software?
Alkire: Interfacing test equipment to CMMS software systems can be somewhat important depending on several factors. For example, if the test instrument doesn’t actually measure anything (i.e. an SpO2 simulator) the value of interfacing it directly to a CMMS system is virtually non-existent since there are no results from the tester to “capture” into a test record within the CMMS software. On the other hand, if a hospital has determined they need to document results for the accuracy of infusion pumps, interfacing the IV pump analyzer to the CMMS can reduce errors and save time over an engineer writing down results or manually typing them in. The importance of that interface varies depending on a department’s policy on what has to be documented during testing, the benefit-cost analysis of capturing results over stating pass or fail of the device under test.
Barrett: It eases the burden, and time required, for the biomed to close out their work orders. There are options ranging from a direct interface, purchasing another piece of software or simply attaching a data file. Some are easier, and less expensive, than others.
Clotfelter: If you think about it, all test equipment is currently compatible with all CMMS systems. The real question is how does the data get into the system. If you use manual entry, everything is compatible. If all you need is a record that the test was performed, this is not too bad. If you need to keep all of the test data then an automated solution makes a lot of sense. The most important future proofing for test equipment is to be sure it has serial communication capabilities. Software will continue to evolve and if the test equipment can communicate, you will have options in the future even if you don’t need them now.
Evans: Maintenance of medical devices can be an onerous task in a health care facility, and CMMS software has a major role in managing this task. Anything that reduces the need for printing or data transcription is beneficial in this management role. Test equipment that interfaces to CMMS software (importing work orders/PM schedules, and exporting completed test reports) performs an important role in this process; reducing time, enduring compliance, standardizing reports, reducing errors and enabling results evaluation.
Pyers: For the biomed maintenance world, the CMMS can be an essential tool for recording, tracking and analyzing the recorded data to help manage the work with the ultimate goal of controlling costs. It allows the biomed the ability to keep detailed records of the test equipment, safety procedures, measurements, equipment downtime and historical data to be used in determining to repair or replace when the time comes.
Zion: Having test equipment that interfaces with CMMS is critical to productivity and to be documentation compliant with regulation. Without this capability, a biomed would be less productive, because all of the documentations would be manual, and prone to error. Such an interface provides key measurement values that when properly populating a long-term trend functionality in the database can allow analysis resulting in predictive maintenance, including greater cost savings, and less downtime during critical clinical-need seasonality. This functionality is typically missing from CMMS today.
Q: What else do you think TechNation readers need to know about purchasing test equipment?
Alkire: We believe that all test equipment in the health care market should come with at least four years of warranty. Our customers should never have to run to a service call and find out their test equipment is malfunctioning. This is why, in part, all of our products are designed and tested to withstand being dropped 50 times at three feet. The four-year warranty is not only about the manufacturer standing behind the product, but also eliminates the possibility of expensive repair costs that can really impact the cost of ownership.
Barrett: Define the must have and nice haves, with consideration to future need. Evaluate the options, do trial evaluations and select “best in class” for your price point.
Clotfelter: When purchasing test equipment, all of the items listed above are important, but one thing I’ve seen customers do that’s a mistake is to only base their purchasing decision on the lowest price. In other words, to only look at the initial purchase price, rather than the long-term cost if they purchase something with minimal parameters or inadequate specifications. The best value is not always the lowest-cost instrument.
Evans: It is important to remember that there are options out there. While it may seem safe to buy what you have always bought, you could be missing out on significant functionality by not considering other sources. Also, be careful not to lock yourself into a single vendor by selecting a system that can’t or won’t interface with other company’s products. Look for flexibility and scalability so you can choose what is best for you and expand your test suite accordingly. And be sure to check the warranty, service availability and service turn around time for the test equipment you are considering.
Pyers: When purchasing new test equipment, consider the features of each system and compare them against your needs. Do not base your decision solely on price, but think how the new tool will benefit you the most. Consider all options for purchasing your new test equipment to meet your budget constraints. Purchasing equipment that is advanced today will allow for updating in the future to insure many more years of use and to be more cost-effective.
Zion: An ongoing issue biomed departments have is getting funding to purchase new test equipment. Another issue is how to verify performance and accuracy claims made by manufacturers, and why that’s important. Also, how to get the best value for the dollar when evaluating test equipment.
