Ultrasound transducers and probes seem to grow more and more important to health care each year. These sometimes fragile instruments are critical when it comes to diagnostic imaging and treatments.
TechNation recently contacted industry experts to find out the latest about ultrasound probes and transducers and what HTM professionals need to know to maintain these devices and help prepare their health care facilities for the future.
The panel for this roundtable article on probes and transducers include Kyle Grozelle, Manager of Training and Education, Summit Imaging; Mike Justice, Senior Territory Manager for Trisonics Inc.; Tony Morales, Repair Director/R&D Engineer, Conquest Imaging; Kenny Scally, BSN, Western U.S. Account Executive, with Exclusive Medical Solutions; Björn B. Segall, CEO and Founder BBS Medical AB/ProbeHunter Sweden; and Matt Tomory, Head of Strategic Advancement, Bayer Healthcare-Multi Vendor Service.
Q: What are the latest advances in ultrasound probes/transducers in the past few years?
Grozelle: Recently the innovations in ultrasound can be found in both crystal density along with new wireless technology. By increasing crystal density systems are able to image at higher resolutions and also create 3D images without the need for moving parts. Adding wireless and new battery technology has enabled new bedside quick use transducers to be used with systems as simple as a tablet.
Justice: The change in technology for transducers seems to be migrating to volume imaging and matrix style element configurations. The advantages are the ability to completely control the beam in multi-plane scanning while also providing 3D or 4D images. The manufacturing process has also been improved which creates crystals with less defects and higher signal to noise ratios along with larger gain.
Morales: Just like everything else in the medical device industry, everything is moving toward smaller, faster, cheaper and mobile. The processing power available in today’s technology is so powerful that what used to be considered hobby processors (i.e. Arduino, Raspberry Pi) are now being considered for ultrasound coupled with an FPGA. Processing is intensive, using either a computer or laptop. Also we are seeing more and more wireless probes on the market that are being used with handheld ultrasound devices. Even though it’s only been around for about 5 years, 3D/4D technology is now becoming more mainstream. This is opening up some exciting possibilities and outcomes.
Scally: Transducers in the last several years have gone from between 64-256 elements to 3,000-6,000 elements (ex. x6-1 Matrix Transducer Philips). The more elements in a transducer the narrower the beam is. More piezoelectric elements mean better detailed resolution. Not only do transducers have more piezoelectric elements within the transducer, they have gone from being just 2 dimensional to having 3D/4D transducers as well. Along with general and endo-cavity probes becoming more advanced, TEE (Transesophageal-Echocardiography) probes are getting more advanced with 3D/4D imaging availability. More technology that used to be inside the ultrasound machine is now inside the transducer itself. We are seeing transducers that are able to tell you when they are overheating and handheld transducers with imaging screens attached to them. The biggest advancements in transducers has been the capability to use the actual transducer wirelessly. Clarius has put out one of the most advanced wireless transducers yet.
Segall: One advance is moving from narrow band to broadband due to digitized delay lines. Also, pure wave, matrix probes, higher frequencies, an increase in the number of elements from hundreds to thousands, built-in beam former, combination probes with optics and ultrasound are some advances. Wireless transducers connected to apps on phones, PC and tablets. There are new materials for the arrays like soft silicon as an alternative to PZT. With software developments, the border between the probe and the system is fading away.
Tomory: There have been several significant technological advances of ultrasound probes and transducers recently, such as the growing use of single crystal and high density matrix arrays. Such advances have provided clearer and more detailed images, improving image quality and diagnostic outcomes. However, these new techniques could lead to significant cost increases, as well as technical difficulties when it comes to repair.
Q: How will these advances impact the maintenance of probes/transducers and ultrasound systems?
Grozelle: With these new compact high-density transducers the risk from impact damage and misuse increases. These transducers require a closer eye for care before repairable damage occurs.
Justice: This is a hot topic for the industry. The care of transducers starts with the end users understanding the complete process of cleaning, disinfection, and handling. The advancement of technology adds to the high cost of replacement and repair which creates a lot of financial stress for medical institutions. I believe that as the cost of transducer replacement goes up it will drive the industry and manufacturers to offer more options for repair.
Morales: Ultrasound technology is advancing in leaps and bounds compared to just a few years ago. All current systems, as well as units only a few years new, will soon be obsolete by OEM standards, placing a stop date on parts manufactured. However, that does not mean that older equipment will cease to produce accurate results and that facilities that rely on diagnostic equipment beyond the end of life date arbitrarily set by OEMs will stop doing so. As long as the systems are repairable and functioning, many hospital facilities can and should continue to service and replace parts. If the medical industry wants to maximize their return on diagnostic equipment investment, there will always be a vital role for firms that manufacture parts for systems deemed “obsolete” by the OEM. Lastly, as probes get more affordable, they are becoming less of a capital expense and more like a consumable. As a result, transducer budgets and purchasing behaviors will eventually change.
Scally: Transducers are becoming more advanced and more expensive. This has opened a large marketplace for companies to repair them and offer loaners while being repaired, instead of purchasing a new probe directly from the OEM. Once new technology comes out on transducers it usually takes a year before Independent Service Organizations can develop the repair capabilities on the transducer. Hospitals need to make sure that their ultrasound engineers are being trained to find early probe defects on the transducer, and have them fixed before the problem becomes more significant. Thus driving down the actual cost of the repair, instead of having to replace the entire transducer.
Segall: We see two paths; probes that are easily repairable and those that are very hard to repair. For the hard to repair probes, the customers need to use the OEM’s exchange program to a considerable cost. This increases the need for the facility to have a probe care program in place. You have to monitor and validate the performance of probes by frequently testing. The earlier a problem is detected the lower the cost to repair.
Tomory: As with any transducer, proper care and handling is critical to ensure optimal functionality and to maximize lifespan. Due to the high cost and limited availability of repair options for newer technologies, it is even more important to care for your product in order to extend its shelf life and time between repairs. This will likely be the case until research and development teams create consistent repair solutions for these new products, thereby offering more options and reducing prices.
Q: How can a facility with a limited budget meet its probe and transducer needs?
Grozelle: Maintain a PM schedule that involves inspecting transducers on a quarterly basis. Catching issues like cuts in the lens or noise when the cable is moved will lead to lower repair costs along with a lower total cost of ownership.
Justice: It starts with the initial purchase of the ultrasound equipment. I am often asked to compare manufacturers for quality and service. There are very fragile and expensive transducers on the market. My advice is to make an informed purchase knowing what your replacement costs are going to be. Once an institution knows its replacement costs they can make informed decisions on alternatives to replace. Transducer repair is one of the most effective ways of reducing service costs. The repair process is a very technical and challenging process, but does offer a significant cost savings. Concerning capital equipment purchases, Trisonics has saved customers significant money by offering refurbished transducers. A facility may choose to purchase a new system from a manufacturer and then add refurbished transducers to complete the order.
Morales: To offset the cost of probe repair, it’s important to understand that an exchange option for damaged probes is the most economical choice with the least amount of risk. This is especially true when compared to the cost of a traditional repair and loaner model. Advantages include: no down time with continued exam flow since the exchange probe unit is sent next day; more complete warranty since probe is covered from tip to tail, unlike a repair, which only covers what is repaired; and no risk of loaner damage, which can be costly if the probe is dropped or exposed to cleaning agents while on loan.
Scally: With more health care facilities having limited budgets, we need to look at what preventative measures clinical engineering departments are doing to prevent damaging the transducers, but most importantly what are the health care providers doing to protect their equipment on the floor. Making sure that facilities are cleaning and using the transducers correctly is key. Look at the ultrasound’s user guide to help determine the OEM specifications for that transducer. Newer technology is very cutting edge and lucrative. Being in this industry for several years I have noted that the newer the technology the more bugs and glitches come with it. This can drive up the cost of repair and having to go directly to OEM.
Segall: Number one, check the exchange price locally and globally. The guideline is that the repair price should not exceed more than 50 percent of the global exchange price. The pricing on probes, new or refurbished, differs a lot around the globe. It is a big marketplace with fresh prices every minute; it is like a “stock market.” Also, implement testing upon arrival of a new probe (faulty frequency 5-10 percent), implement testing before the warranty ends, in month 11, (faulty frequency approximately 20 percent). Implement testing under the service contract. You will optimize the warranty within the service contracts.
Tomory: Our primary objective is for our clients to maximize the lifespan of their transducers. In order to do this, on-site educational sessions should be provided, such as care and handling assessments, gap analysis and webinars to make sure that clinical departments are using the equipment in the correct way and handling it with care. In my department, we always contact our customers five or so days after repair to ensure that everything is running smoothly; this is a great opportunity for facilities to provide feedback on the repairs and make the most of our consultative offerings. Regular testing and inspection of transducers is another component to mitigate costs. If a damaged probe is identified early on, the repair cost is significantly less than waiting for the problem to progress, which could dramatically impact performance. Prevention and proper care is critical, not just for organizations with limited budgets, but for all users of diagnostic ultrasound.
Q: What criteria should be used to compare and select a probe/transducer repair company?
Grozelle: A simple measure of quality from a repair company is an ISO 13485:2003 certification. Also consider their average repair time and use of OEM parts for repair.
Justice: It is important to know the reputation of the company. Ask for references and ask for an explanation of how the repair will be handled. Make sure that the company provides a formal quote with pictures and an explanation of what is wrong and what will be replaced along with the cost of repair. Finding a company that has local service engineers is also helpful because of the support that they will provide if something needs attention after the repair. Find a company that offers the best repairs for multiple manufacturs. Not all companies can offer quality repairs for most manufacturs.
Morales: Here are some questions you should ask everyone you are considering for probe or transducer repairs:
Scally: When it comes to transducer repair health care facilities need to look at several different things. Turnaround time is the most important part to repairs. A probe repair company should have a turnaround time of no more then 5 to 10 business days. Another important criteria is the almighty loaner. Does that repair company have a loaner probe for the probe you need to get repaired? Health care facilities cannot afford downtime when it comes to patient care. Making sure the company has the specific machines to test the image quality of the actual probe is a must. Customers do not want a repair if the image quality comes back worse due to not having the actual machine to scan the probe on. Many repair companies are now offering exchanges, does the company offer you an exchange because that probe is actually unrepairable or is it due to the fact that the company can’t actually repair the probe?
Segall: A basic requirement is that the repair lab has a testing functionality that is equivalent to the technology of the complex probes they are about to repair. In our fact-finding phase developing the test system ProbeHunter, we visited almost every repair lab around the world. We concluded that there is not one repair lab that can repair all brands and types to a high quality. Make sure that the company chosen really is the company doing the repairs, with no back door outsourcing. A loaner probe should be provided, with a test-protocol, and the repaired probe should be returned with a test-protocol as well. Make sure your returning probe comes in a new uncontaminated box.
Tomory: Despite the large number of repair providers in the industry, probe repair is an exact science. The discipline requires individuals specializing in a range of functions such as acoustics, materials technology, manufacturing operations and quality management. We believe an important criteria to look for is ISO 13485 certification – a quality standard required for medical device manufacturers, but optional for service providers. Having been in the ultrasound industry for 30 years, I thought I knew everything there was to know about probes; however, after recently completing an extensive study on repairing these devices, I realized that the complexity and precision of probe repair is not to be underestimated.
Q: What are the most important tips you can share when it comes to maintaining probes/transducers?
Grozelle: Inspect regularly and be vigilant on issues that might just seem cosmetic, a simple crack on the housing of a transducer can lead to gel getting into electronic components and causing costly damage.
Justice: It is important that end users understand the cleaning process in detail and how it affects the longevity of the transducer. Make sure that they review the approved up-to-date chemical list from the manufacturer’s website. They should know the minimum soak time to be affective and follow that time schedule. They should remove residual chemicals with water if allowed, to stop the chemical attach rubber lenses and plastic.
Morales: Although they sound simple and obvious, everyone in imaging should refresh themselves on proper probe care to avoid mishaps. Handle probes with care. Store them in an appropriate packaging and location. Clean or disinfect according to the disinfectant guidelines. These basic guidelines will help in ensuring your probe is maintained throughout its lifetime. For more detailed information, visit http://conquestimaging.com/education/resource-library/
Scally: When it comes to the maintenance of the transducers we need to make sure we are teaching ultrasound engineers along with clinicians what to look for in a damaged transducer. Use a magnifying glass to look for pin holes or gaps around the transducer head or insertion tube. Early detection of failure in a transducer can lower the cost of repair later on down the road. This is why it is important to come up with a QA program for transducers and for the ultrasound systems. If you suspect the probe is not working, or has any type of failure, make sure you take it off the floor and get the transducer sent in for testing ASAP.
Segall: Start a probe care program at the hospital. This will increase quality and lower the costs. Educate the staff on the importance of how to handle the probes and how delicate they are. Only use OEM-approved ultrasound gel, cleanser and disinfection method. Also, implement leakage testing on TEE probes in between patients. An important observation, we have made, is that there is a big difference in going from a phantom test to a single element probe tester. We are now seeing the same going from a single element tester to a multi element tester, with real time capabilities. With the multi element tester we detect new kinds of defects on probes that we did not see before.
Tomory: The three most important tips I would share would be to inspect the equipment early and often; follow the manufacturer’s recommendations for proper disinfection solutions/processes; and if any issues arise, have these repaired by a qualified provider and do this as soon as these are identified.
Using a low-cost provider who doesn’t have the appropriate expertise may not only compromise the intended performance of a probe, but may also prevent the probe from being repaired in the future. Providing clinical departments with training on appropriate care and handling is another critical aspect in maintaining and mitigating the cost of probes.
Q: What else do you think TechNation readers need to know about purchasing and servicing ultrasound probes/transducers?
Grozelle: Beware of “aftermarket” transducers. Many are available online, these items claim to be from the OEM but are mostly made up of low-cost substitute parts, and not cleared by the FDA for use on patients.
Justice: Get involved with your facilities purchasing department and let them know that there is an alternative and cost savings available to them for capital equipment purchases. As far as service is concerned, education and understanding of what causes most probe failures can drastically cut repair and replacement costs.
Morales: Know the OEM is not your only option. Savings can be as much as 70 percent in parts and probes. If the question is quality, know that the new standard is transparency. Vet all vendors by not only their pricing, service, certifications, warranties, track records, reputation, but also on their transparency. Let them show you how much they value your business. Conduct quarterly training for sonographers, sterile processing, and biomedical engineers. on proper care and handling techniques. This can extend the life of a probe and significantly reduce repair expenses.
Scally: When it comes to TEE probes, electrical leakage testing is important before and after every use. This protects patients and is a way to find cuts or bite marks that may be causing leakage inside the probe and damaging it. When purchasing a transducer, make sure the company that you are purchasing from has the technical support for your transducer and the machine. This is important because failure rate does not always have something to do with the probe but can also have something to do with the machine. Going with the lowest costing repair and transducer doesn’t mean it is the best. Think about if you, your loved ones or friends were getting an exam. Would you want the best that’s possible for them?
Segall: The OEMs are now moving into the MVS market. They want to regain the market they lost over 10 years ago. The prices on standard probes are dropping dramatically. The price and the repair cost on the advanced probes are maintained at a high level. For a facility, you need a probe tester to evaluate the performance of an ultrasound probe. If there is a problem on the Doppler you will almost never see it on the image. If you have a probe care program in place, you will save costs and you will increase the quality of care at the same time. You are more likely to get better pricing if you synchronize the purchase of probes with the purchase of a system.
Tomory: An ultrasound probe is an extremely sophisticated medical instrument. An incredible amount of time and resources have been invested in their design, technology, materials and manufacturing, and the approach to repair should require the same diligence. When considering the purchase or repair of a probe, it is critical to ask the right questions on process validations, certifications, staff competencies, biocompatibility testing, electrical safety testing, acoustic intensity and focus analysis, to ensure the provider is suitable for the repair or replacement of your probe or transducer.
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