Ultrasound devices are important tools when it comes to delivering quality healthcare. TechNation reached out to experts in the field to find out more about ultrasound devices and probes.
Members of the TechNation panel for this roundtable discussion are Robert Broschart, director of technical services for Axess Ultrasound LLC; G. Wayne Moore, FASE, president and CEO of Acertara Acoustic Laboratories; Hobie Sears, senior sales service manager at Trisonics Inc.; James “Jim” Carr, director of service and international operations at Advanced Ultrasound Electronics; Lawrence Nguyen, CEO of Summit Imaging; Matt Tomory, vice president of sales, marketing and training for Conquest Imaging; and Drew Brown, Director of Operations at GMI. Here is what we found out.
Matt Tomory Vice President of Sales, Marketing and Training for Conquest Imaging
Broschart: The greatest change has been in the use of single crystal technology. This has increased the bandwidth and number of active “elements” that can be used. A dramatic increase in image quality has resulted from this technology.
Moore: In terms of array materials recent advances made using single crystal arrays, 2D matrix arrays, and the progress being made with cMUT and pMUT technologies are all at the forefront. In terms of electronic advances in ultrasound probes, it would be that more ASICs and other integrated circuit technologies are migrating into the design of the acoustic stack and away from the front-end of the ultrasound system. Additionally, new commercially available wireless probe technology obviates the need for a cabled connection between the probe and the ultrasound unit, a major component of probe cost.
Sears: The OEMs all have their own names and new concepts in transducer development over these last few years. The real take-away from this is that transducer design is at the forefront of ultrasound development. It will continue beyond single crystal and matrix technology possibly pushing into CMUT or other yet to be developed technologies. What is important is strategic planning to deal with the higher cost of these transducers and technology as it relates to the cost of ownership.
Carr: The biggest advance in transducer design has been the so-called single crystal probes that are “grown” with thousands of individual elements and are capable of producing volumetric 4D (real-time 3D) images in multiple planes. The essentially perfect homogeneity of the piezoelectric elements can be used to create a significantly better 2D image, as well. These are replacing the mechanical 4D probes that could be seen as a new advance, but are really a rebirth of the old “wobbler” probe technology used before electronic phased array probes were viable.
Nguyen: The latest and most exciting advancement in ultrasound transducer technology is the added capability of live 3-D imaging during Transesophageal Echocardiogram (TEE) studies. These new TEE transducers utilize complex matrix arrays to obtain significantly more data than standard phased arrays. This allows clinicians to scan and view the human heart with live 3D image data to quickly provide more comprehensive data to better diagnose patients.
Tomory: Probe technology has evolved in several areas recently. Manufacturers have developed a process to grow transducer crystals that are homogenous at the atomic level. These probes allow for greater frequency bandwidth and improve image quality. Another development is the wireless transducer by Siemens. These probes are the beginning of what I see to be remote ultrasound scanning where the scan takes place at one location and is processed at another. The other development is the maturing of the matrix array transducers. These probes have thousands of elements and are used for 2D, 3D and 4D imaging. The advantage of these with 3D/4D imaging is they are solid state with no motors, oils and are smaller and lighter than ever.
Brown: The significant increase in the use of multiplexing and sparse array technology.
Robert Broschart Director of Technical Services for Axess Ultrasound LLC
Broschart: The probe technology has allowed ultrasound to move into markets previously thought impossible for ultrasound – oncology, podiatry, MSK, etc. More patients can now be scanned effectively with ultrasound thus increasing patient care. In terms of probe maintenance, with the new technology, it has become paramount that proper and accurate testing be performed. If we cannot test these new probes, then we cannot hope to properly repair them.
Moore: Ultrasound continues to narrow the gap in clinical imaging performance with both CT and standard MRI for several clinical applications and that should keep the ultrasound market growing at a faster pace than the other “heavy-metal” modalities. Lastly, ultrasound is more easily and economically deployed into more clinical environments and is more versatile in both applications and configurability. Probes are becoming more complex and more expensive, so the number of companies with the technological sophistication to test and repair them will trim down.
Sears: Ultrasound is likely to continue to grow into new areas of imaging with new transducer developments. This may create niche fields with specialized transducer development. It will be up to each facility to decide if those new studies and niche fields are right for them. Specialty transducers are going to be more expensive to maintain and may require specific training, these cost should be part of the discussion for the facility. It is clear that the new developments in transducer technology will require new tools and test devices for major repairs. Some of these devices have become recently available; others will need to be developed. However, the best strategy for maintenance is one of education on care and handling of transducers. Experienced ultrasound service engineers are the best ambassadors to get that discussion going in departments that use ultrasound.
Carr: The matrix array or single crystal designs have provided capability to do faster and earlier diagnosis of many anomalies, and the research on ways to use this exciting technology is still in the infant stages. However, these complex probes are exacerbating an already large problem in the industry; the ability to test a transducer and system to assure the clinical efficacy of the diagnostic results. A white paper published over 10 years ago revealed that just two dead elements or channels next to each other caused the Doppler measurement and results to be incorrect. There is no test equipment or diagnostics available today that can detect just two dead elements on even a 128-element probe, let alone one that might have 9,600 elements! The manufacturers have taken out or restricted access to any diagnostics that might help us determine if the probe and system are working properly. I believe that regulation may be necessary to protect patients if companies can’t provide tools capable of testing these highly complex systems in order to have confidence in the clinical results.
Nguyen: Multi-dimensional technology enables clinical technicians to accelerate the image capture and improve the diagnosis by utilizing comprehensive 4-dimensional data that reduce anomalies. Live 3D TEE transducer failures become significantly more difficult to service because the damage from electrical shorts become more catastrophic due to its higher power and smaller form factor. A quality transducer service provider will be able to yield higher repair success rates from these complex devices which will help lower the total cost of ownership of the device. The alternative is a replacement at a much higher cost. Hospital administrators will want to ensure they are working with a reputable and well-trained team of ultrasound support technicians who can repair beyond the component level. This will provide the highest probability of repair success and lower the total cost of support by up to 97 percent relative to OEM replacements.
Tomory: These new technologies add to the diagnostic quality of ultrasound systems but also the cost initially. Independent organizations are developing repair capabilities for these new generation probes but usually are a few steps behind so the cost of maintenance will be higher than conventional probes. Once a technology has been out for a year or so, the market does catch up and the cost is usually driven down by increased supply.
Brown: Image quality continues to improve, but it is also driving up the cost of maintenance. Many of the new multiplexing and sparse array technologies are designed so that they cannot be repaired completely and they also have a shorter average life span than more traditional transducers.
Lawrence Nguyen CEO of Summit Imaging
Broschart: Again, the best new technologies are in single crystal probes. By adding these probes to your ultrasound inventory you can dramatically improve the quality of scans and increase the number of patients you can effectively scan. These probes do require potentially a newer system or upgrades to existing units. If budget is a concern, you can obviously look into refurbished/used equipment as a way to install the better technologies into your facility.
Moore: It is more a function of the intended clinical use and the results needed by the physician to make a good diagnosis. For example, if you are a cardiologist or a cardiac surgeon you invest in the 2D matrix array technology which provides volumetric 3D images in real-time. By focusing on the level of technology, both for the probes and the ultrasound unit that will be required to accomplish the clinical needs of a given facility – don’t overbuy.
Sears: It is really up to the individual department to define which technology is worthwhile. Where we come in is explaining how that technology may perform in the long run or how it may affect the lifetime cost of ownership. The customer then gets to make an educated decision.
Carr: As a longtime service engineer and manager, I would caution any customer to avoid the bleeding edge of technology unless cost is of no object. Even though there is exhaustive validation required by FDA and other regulatory agencies, new designs almost always are full of bugs. The other big problem with the latest system is that the cost of ownership will be much higher unless and until there are independent service and parts providers for that system and probes. Buying a used or refurbished system and getting probes and the system repaired by independent service organizations can provide the same diagnostic capabilities at a much lower cost over a typical 7-year period of ownership. And most of the latest single crystal probes cannot be repaired, which can drive those costs through the roof.
Nguyen: Due to its safe, non-invasive method to obtain images, the reliance on ultrasound technology is escalating in the healthcare system and encroaching into areas where X-ray and CT have been predominantly used. Given the frequency with which ultrasound technologies are being applied, I believe that all ultrasound technologies are worthy of their initial investment. A facility with a limited budget can control equipment service costs with careful handling and sterilization of its transducers, and should consider partnering with a credible ultrasound support organization that can repair transducers and systems with high-quality refurbished and tested replacement parts. This cost-effective approach can maximize the useful life of equipment and save operators as much as 97 percent relative to OEM replacements.
Tomory: We always want to examine ROI and patient care when evaluating newer, more expensive technology. Will the newer technology affect patient outcomes? If a probe has additional capabilities, will clinical staff be trained to use it? A perfect example is the fact that many people have a 3D TEE probe but only use it for 2D exams. The difference in cost between a 2D and 3D TEE probe is threefold. The proof of a probe is in a demonstration. Some of these technologies are very cool and the marketing is captivating, but the bottom line is this: Does the technology improve diagnostic outcomes and will it be used to its fullest capabilities? If there are new capabilities, are you able to use and get reimbursement for them?
Brown: You never want to buy Rev 1 of anything. In addition, while the new technology does produce beautiful images, is it really going to improve the quality of care or drive more dollars to the bottom line. Has a C5-1 ever saved a life that a C5-2 would not have? Often the newest technologies are not worth the cost differential.
Broschart: Only buy from known probe suppliers is one requirement. Anyone can “sell a probe,” but how do you know it has been tested properly? Make sure both your suppliers and repair companies can test, evaluate and repair probes to the correct OEM specs. Too many people say they “repair” probes. Are they using new parts? Scrap/re-used parts? Make your suppliers provide test results in writing with photos when needed.
Moore: Test the probes before you accept them into service in your hospital. Some OEMs ship brand new probes with dead elements. If you find these on initial inspection, reject them and demand a fully functional probe. If you are going to send probes out for repair, know your vendor, know their testing and repair capabilities, trust but verify and test the probes when they come back from repair to insure quality work
Carr: The user of the system is not able to detect defects that can cause clinical results to be incorrect, due to the massive amount of interpolation and post-processing that is done to the image on modern ultrasound systems. I know a clinical engineer whose wife, a nurse at the same hospital, got an unnecessary and potentially deadly angiogram because the probe used had multiple dead elements. There are some test devices capable of objectively testing probes, even those with matrix array or single crystal designs, and TechNation readers should be asking for documented test results when they buy a probe or get one repaired. Otherwise, how does one know if they are using a probe that is clinically efficacious?
Wayne Moore FASE, president and CEO of Acertara Acoustic Laboratories
Nguyen: It is critical to know the testing protocols performed by the supplier prior to purchasing or servicing any transducer. The quality of the product is completely dependent on testing and quality protocols. This should include image quality testing on a live ultrasound system conducted by technicians trained to specifically look for image quality. There is no sufficient replacement to a live ultrasound scan as it is the only reliable method to capture intermittent problems experienced by end users.
Tomory: The ultrasound probe is a critical component of image quality on any ultrasound system. They should be cared for as though they are a delicate instrument (they are) and cleaned/disinfected using OEM approved solutions and processes. When you need a replacement, quality should be your primary concern, not cost. There are many degrees of quality on the market and when I, or a loved one, is on the exam table, I want to know that the probe is completely up to OEM specs. When researching probes, it is important to also research companies that sell and repair them to ensure you are getting the highest quality product.
Brown: Visit potential vendors if you can. That will tell you a lot about where you purchase your probes. If you are going to get a transducer repaired, find out who is really repairing your probes. Are you sending it to a facility that actually does the repair, or are you sending it somewhere that is just “managing the repair”?
James “Jim” Carr Director of Service and International Operations at Advanced Ultrasound
Broschart: I believe the obvious things. Do they properly test probes? Do they have the correct test equipment? Are they technically savvy in probe technology? Do they really understand probes? (How they are constructed, how they work, what do test results mean, etc?) What quality metrics do they use? How is their warranty rate?
Moore: Make absolutely sure that the third-party repair company is ISO 9001:2008 and ISO 13485:2005 certified. Make sure they have the test equipment that can accurately evaluate the probes functionality. A good rule of thumb is: “If you can’t test it, you can’t repair it.” Ask your supplier if they have probe-testing technology.
Sears: Foremost is standing behind their service or product and providing what they say they will. A company that is growing and attracting strong experienced employees is a definite differentiator.
Carr: I believe the most important things to check for when choosing an independent probe repair company are: The test equipment they have and use. Does it provide objective results that demonstrate the key performance specs of the probe? Do they actually repair or do they just sell probes on exchange? Your costs should be lower over time if you institute proper user maintenance of probes and the service company actually repairs what breaks on your probes, instead of selling you a different probe that they repaired or purchased in the past. Do they have good customer referrals? They should be willing to let you call any of their customers, and you should do it! The company should have a quality system, preferably certified to ISO 13485 by what is called a “notified body,” auditors that are certified by the European Union. If they don’t have that ISO 13485 certification, ask for some referrals for customers that filed a “complaint” against the company so you can get an idea of how they respond when they make a mistake.
Nguyen: When looking for a reputable third-party ultrasound provider, you want to know: Do they fully refurbish and thoroughly test products in-house? Do they use bootleg parts from other countries? Do they farm out their work to another service provider? Do they support products and services with a strong warranty? Do they have the technical expertise to provide in-depth forensic analysis of failures? Selecting a transducer repair facility that performs all repairs and testing in-house will deliver quick and reliable repairs. A strong warranty provides peace of mind ensuring that repairs performed on the equipment are dependable and will be fully supported. A quality supplier will also provide in-depth forensic analysis to help educate the end users about the likely cause of failures to prevent unnecessary damage in the future.
Tomory: Providers should be examined for their quality processes, warranty and reputation. What quality processes do probes go through to ensure they are safe and performing to OEM specifications? Find a provider that performs computerized, clinical, electrical safety, mechanical and tissue mimicking phantom tests to ensure every probe it provides will produce the highest quality patient outcomes.
Brown: Carefully consider what your needs are and then look at the full spectrum of product offerings from each vendor. Choose a vendor who can meet all of your needs as your primary vendor. In the long run, it will save you time and money.
Drew Brown Director of Operations at GMI
Broschart: It is possible to purchase used newer technology probes in the after-market. Again, just be careful of where you buy them. Make sure they have been tested and proven good.
Moore: In some cases yes, there is a fairly robust after-market for newer probes, provided they have been on the market for at least 12 to 14 months.
Sears: Yes, refurbished transducers are reasonable and a smart business move in obtaining new types of ultrasound transducers. Often these transducers are not actually refurbished; they have just had some use. With testing and verification of performance these transducers perform as well as new transducers.
Carr: It is possible to buy systems that are in current production on the used market. They may be a year or two behind on the latest software or probe design, but usually all the probes can be upgraded to that technology if or when needed. And some 4D probes can be repaired by reputable third-party companies, although that is limited to just a few models. Since probe repair will be the biggest single component of the cost of ownership for an ultrasound system, it makes sense to buy a system with probes that can be tested and repaired, and to make sure that everyone handling and disinfecting the probes is properly trained and equipped to inspect the probes so they can be repaired as soon as any signs of trouble are found.
Nguyen: It is very easy for any healthcare facility to keep up with the latest technology advances because the independent service providers usually have the capability to obtain the equipment within one year of the launch dates from the OEMs.
Tomory: Matrix probes and pure crystal probes have been around for some time so they are repairable. As for the wireless, there are limited quantities on the third-party market and only one system utilizing them.
Broschart: In purchasing new probes it still goes back to proper testing and quality control. Can your provider give you all the details on the probe? (Test results, image photos, etc.) Good repair/probe suppliers can provide you with the requirements to maintain and test your probes. There is specific probe test equipment available in the market, and new products coming out that will allow facilities to properly test and maintain their probe inventories.
Moore: Test probes before you put them into clinical service, and reject those new probes that have dead elements. If they are using a reputable third-party probe repair company that company should supply them with this.
Sears: This is another area where experience matters and again it comes to proper education.
Carr: The purchaser should either be able to do an objective and comprehensive test of the probe, or get it tested before purchasing one so they know the quality and performance of it and can estimate the remaining useful life. The manufacturing date on the probe means almost nothing, because if it sat in a drawer unused for 10 years in a climate controlled environment, it will still be like new in useful life and performance. Probes lose sensitivity and bandwidth over time due to use, and dead elements are a sign of defects or damage that could worsen quickly. Even new probes from the OEM may have dead elements and, from working with and for transducer manufacturers, I can tell you that even one dead element is a sign that something went wrong in the manufacturing process, and that only gets worse over time.
Nguyen: Purchasers have a lot of control over where they procure equipment and how they receive their training. The length of warranty is a strong indicator of quality as companies that repair the products in-house have the capability to support the products and services. For the most part, the independent market supports all of the transducers currently manufactured by the OEMs, providing significant savings on the initial procurement cost. Additionally, purchasers can control the total cost of ownership by using reputable transducer repair companies that guarantee their work and repair the equipment back to OEM specifications. Training literature is available through the OEMs and some independent service providers also provide high-level training enabling users to properly care for their high-value equipment.
Tomory: People should always purchase on quality first and price second. I see probes advertised on places such as eBay for a fraction of what they would sell for by a reputable organization. A transducer is a sophisticated instrument and going back to my scenario of you or a loved one on the exam table, where would you want the probe to come from? I would look for a company that has transducer care training programs dedicated to educating people on how to care for probes. A program that examines every aspect of the transducer care and handling process within a facility to include environment, storage, transportation, chemicals, soak times and staff training. Even within a single make and model, there may be different approved disinfectants approved for the materials the various probes are composed of so education is critical to probe longevity.
Brown: Most probes are available from every third-party vendor. Don’t purchase based purely off of price. Consider the other complement of services that the vendors offer as well as the warranty. Often perceived transducer problems turn out to be system issues. Can the vendor help you if that happens? The care documentation is usually available from the OEM and sometimes on the OEM website. However, often OEM care and handling instructions are lacking. Ask the vendor if they offer specialized training for your needs. Not only the documentation, but hands-on training for your biomed and clinical departments.
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