In this month’s installment of the popular Roundtable article we look at ultrasound – specifically ultrasound probes and transducers. We asked several experts from throughout the industry to participate and below we share some of their insights regarding these valuable diagnostic imaging tools.
Participating in the Roundtable forum are Avante Ultrasound Manager Stephen Goodbar, Summit Imaging CEO Larry Nguyen and Innovatus Imaging Vice President of the Ultrasound Center of Excellence Matt Tomory.
Q: What are some of the newest ultrasound software applications heath care facilities should consider?
Goodbar: I don’t know that I would pinpoint a new application/software, but a fundamental shift in the way that ultrasound imaging is approached. In the past, equipment such as CT and MRI have been the default imaging choice for certain types of studies. The advancements in image quality via single crystal transducers, matrix arrays and ultrasound processing power has allowed ultrasound to be a viable alternative. This option is a more cost-effective solution that allows for immediate results and ultrasound exams can be done without the need for special rooms or facilities to accommodate the machine.
Nguyen: There are many new applications of ultrasound being developed as a result of the rapid improvements in image quality for non-invasive scanning. We see two movements in ultrasound technology driven by software enhancements that are improving diagnostic capability. First, there are advancements to scan areas of the body traditionally scanned with other imaging technologies. Second, point-of-care scanning and applications have been rapidly growing, allowing ultrasound to be quickly mobilized to a patient with simplicity in operation and quick diagnosis. Both are fantastic improvements to health care.
Tomory: There is a lot of activity on artificial intelligence and how it can improve diagnoses, patient management and throughput and imaging equipment management. One of the first iterations of AI I remember was when Acuson introduced Auto DGC on the Sequoia platform in the late 1990s. This allowed the system to determine optimal gain settings to ensure image uniformity. Today, AI is being used to interrogate patient medical records for relevant information prior to an exam. This enables clinicians to augment a current exam by having a more comprehensive dataset of patient history, prior exams, pharmacy information, lab results, etc. Research is being performed on the impact of AI on image interpretation/diagnoses, and how it can potentially supplement physicians’ interpretations in the future.
Q: How is the increasing use of ultrasound impacting the maintenance of ultrasound probes and transducers?
Goodbar: Increased use equals increased processing and disinfection between patients which ultimately leads to more wear and tear. This is especially true with endo-cavity and transesophageal probes which require high-level disinfection. Utilizing the proper disinfection procedures and performing electrical safety testing is extremely important to increasing usable life and mitigating the cost of transducer repair and replacement.
Nguyen: The increasing frequency of ultrasound use expands the number of potential failures for both ultrasound transducers and system parts. It is essential to process and identify potential ultrasound transducer failures quickly, as the longer a hardware problem goes undiagnosed, the opportunity of cost-saving repairs decreases, increasing the alternative of costly replacements.
Tomory: Ultrasound is an ever-expanding modality and organizations are increasingly looking for ways to reduce costs and extend the life of probes. It is critical for facilities to keep their fleet in optimal condition and when repairs are needed, to have those repairs performed properly, assuring the processes, materials used and verifications meet the highest standards possible. Also, proper care is critical to probe longevity. There are many different cleaners and disinfectants on the market to choose from, yet they are not equal as some can cause serious damage although they may seem innocent. The usage of improper chemicals or proper chemicals improperly is one of the most common causes of probe performance and appearance degradation, so it is imperative the OEM-recommended chemicals are used and directions for usage are followed.
Q: What are the pros and cons of buying brand new versus buying refurbished probes/transducers?
Goodbar: Purchasing a refurbished probe can come with a few unknown variables such as an unknown age and remaining usable life. It’s important to use a trusted source that has quality processes in place to ensure you are getting a quality product. Buying new can come at a much higher price, while purchasing refurbished from a reputable dealer can give you a probe that should function like new with a better warranty and also at a better price.
Nguyen: Whether refurbished or new transducers are being used, there should be no negative impact to performance or safety of the devices when serviced or repaired. Refurbished transducers will help reduce health care facilities’ costs while maintaining high-quality patient care. However, sometimes health care facilities unknowingly assume risk by using transducers with counterfeit parts or components that have been previously installed by unqualified organizations. It is important to eradicate this risk by choosing ultrasound repair suppliers that have the quality management system and infrastructure in place to prevent the use of invalidated parts and components to preserve the performance and safety of the equipment health care facilities expect.
Tomory: New probes are built to OEM specifications with OEM materials and come with a great warranty, but also a premium price tag. A repaired probe can be substantially less expensive and come with a comparable warranty. If buying used, you should be sure to know who repaired it and the processes/materials used. Did the organization who sold the probe repair it? How was performance verified against the OEM? For patient safety, longevity and performance, a probe must be restored to an OEM’s original intentions for form, fit and function and the organization performing the repair must have the expertise, processes, materials, data and certifications to demonstrate that a probe performs as the OEM intended.
Q: What criteria should be used to compare and select a probe/transducer repair provider whether in-house, ISO or OEM?
Goodbar: Reputation is important. Can the vendor or repair facility deliver on what they say they can? I recommend looking for those repair facilities that hold ISO certifications or show evidence of a solid quality management system. Transparency and willingness to bring customers in for site visits and external audits. An example of some criteria around the quality of the sales transactions could be detailed repair quotes accessible through mobile devices, root cause information that can be used to prevent future avoidable transducer failures and loaner availability.
Nguyen: The most important criteria to use in selecting an ultrasound transducer repair supplier is to ensure the supplier is not installing or distributing counterfeit parts that hide inside the OEM marked casings. We regularly see counterfeit parts, and our health care facility customers often complain about the decreased lifespan, increased failures and inaccuracies with the equipment. When customers understand the risks, they typically remove these inferior devices and replace them with equipment from trusted partners.
Tomory: A probe is a sophisticated, Class II medical device with a tremendous amount of acoustic and materials science and technology integrated into the design and construction. As an OEM made the original probe, the complex part for an ISO is to determine how to restore the probe to OEM form, fit and function. Repair service providers with an ISO 13485:2016 certification specific to medical devices, have a much more solid foundation for repairs than those without. To achieve optimal quality in repairs, this certification is a bare minimum customers should look for when choosing a repair provider. Having a medical device manufacturing background and philosophy is another distinction that can set providers apart. Companies with a manufacturing mindset tend to look at each device from a holistic perspective which drives everything associated with the repair to a higher standard.
Q: What else do you think TechNation readers need to know about purchasing and servicing ultrasound probes/transducers?
Goodbar: “Knowing is half the battle,” applies to truly knowing your suppliers and being educated on the equipment in your charge. Vendors that make the investment to become ISO certified, perform material biocompatibility testing, provide care and handling training and have a strong track record should be on your short list of trusted partners. Education of clinicians and HTM professionals on the proper care and maintenance of ultrasound probes directly affects the life cycle of the probes, ensures up-time and lowers your operating cost.
Nguyen: There is a legal and proper way to repair and service ultrasound probes, and often decisions are made without the insight into quality of product. While all probes may look the same on the outside, counterfeit parts could be hiding underneath OEM casings. Choose ultrasound repair organizations that guarantee you will be receiving a validated OEM product. This can be done by verifying the supplier’s ISO 13485:2016 certified Quality Management System, as well as visiting the supplier’s facilities to better understand their commitment to quality. Look for evidence that supports inspection criteria and quality controls to recognize potential counterfeit parts inside these important medical devices.
Tomory: There is a massive difference between being able to get a probe working again and restoring it to perform as the OEM intended. If you, your organization and, ultimately, your patients, are trusting an organization to repair your probes, arrange a visit and see for yourself exactly how and why they deserve to serve you. There is a difference with highly qualified, holistic-minded organizations which is readily apparent upon a visit.
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