Ultrasound Digital Supplement

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ULTRASOUND DIGITAL SUPPLEMENT FEATURED INSIDE P.2 WHAT YOU DON’T KNOW ABOUT TRANSDUCER REPAIRS COULD IMPACT PATIENT CARE

P.12 PREVENTING CROSS CONTAMINATION AND ENSURING IMAGE QUALITY ON TEE ULTRASOUND TECHNOLOGY

P.4 KNOWING CURRENT FDA REGULATIONS OF ULTRASOUND TRANSDUCER REPAIRS P.6 COMPANY SHOWCASE: SUMMIT IMAGING

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P.8 COUNTERFEIT ULTRASOUND DEVICES TRACEABILITY RISKS FOR HEALTHCARE FACILITIES P.10 CAN INCREASED “TRANSDUCER TIME” LEAD TO WORK-RELATED MUSCULOSKELETAL DISORDERS? DISCLAIMER: MD Publishing (ICE magazine) takes every precaution to ensure accuracy of content; however, the information, opinions, and statements expressed in the articles and advertisements herein are those of the writer and/or advertiser, and not those of our company.

WHAT YOU DON’T KNOW ABOUT TRANSDUCER REPAIRS COULD IMPACT PATIENT CARE By: Carolyn T. Coffin, MPH, RDMS, RVT, RDCS and Matthew Schwartz, MFA, RDMS

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very profession has a set of tools required for the work it performs and in healthcare, providers rely on durable medical equipment to perform their work tasks. There is an expectation that equipment purchased as used, or currently-owned equipment that has been repaired will function as well as new equipment purchased directly from the manufacturer. In sonography, an ultrasound system consists of several components that may need periodic maintenance, repair or replacement.

Heavily used ultrasound transducers often require repairs for damaged housings, internal wiring or acoustic elements. As sonographers, our ability to provide diagnostic-quality images for our patients depends not only on technical skill but also on the exacting design and manufacture of transducers used to create diagnostic images. We assume there are governmental and institutional regulatory standards that ensure the quality of the equipment we bring into direct contact with patients. But what do you know about these quality standards, or what happens to your transducer when it is sent out for repairs? If you are supplied with a repaired or remanufactured transducer, how do you know if it has been rebuilt using the original manufacturer’s components and to the original manufacturer’s specifications?

You may be surprised to learn about FDA regulatory policies for the repair or replacement of medical devices that specifically apply to ultrasound transducers. Every new transducer design to be brought to market must be filed with a 510(k) submission to the FDA to validate compliance with a wide range of standard safety measures. However, there is no provision for this filing when an ultrasound transducer has been repaired or serviced. This exposes healthcare facilities to counterfeit medical devices, one that contains non-validated crystals and/or cable assemblies, both critical parts to provide high quality diagnostic images, replaced with low quality counterfeits from those of the original equipment manufactur2

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L9-3 transducer with OEM components

L9-3 transducer with non-OEM components

er (OEM).1 These counterfeit parts are installed by third-party service entities and sold to the healthcare facility as OEM quality, which our simple study reveals is deceptive and inaccurate.

The generation of a quality image encompasses far more SPECIAL ADVERTISING SECTION

than just acoustic power, and the impact of diagnostic quality on patient care decision-making can have far-reaching consequences. As an initial exploration of the concept, a comparison was performed using 2 OEM transducers (L9-3 and C5-1) and 2 remanufactured transducers of the same design origin that contained non-OEM components to determine any difference in image quality. A tissue-equivalent phantom was scanned using each of the transducers to evaluate spatial resolution and acoustic penetration. The structures imaged in the phantom were a cluster of small, echogenic pins. A volunteer’s carotid artery was scanned to evaluate color saturation and vessel filling and to demonstrate the clarity of the intima-media thickness (IMT). All automatic image processing was turned off and a vascular pre-set was used for consistency. All transducers demonstrated the penetration expected for the transducer’s frequency. The pins in the phantom were imaged with higher resolution with the OEM transducers; the same structures scanned with the transducers that contained non-OEM components appeared “smeared” without good border resolution. The IMT of the carotid artery was slightly less clear with the remanuSPECIAL ADVERTISING SECTION

factured transducers as well. All tested transducers adequately demonstrated the carotid filling with color, but the transducers with non-OEM components generated images with more peripheral acoustic noise that could be appreciated as “fuzzy borders.”

This limited transducer evaluation demonstrated that, while penetration appeared unchanged, there is some difference in the image quality between transducers with OEM components and those with non-OEM components. The question remains, how might this difference in image quality influence patient care management? Diagnostic evidence of pathology not seen during an exam may result in unnecessary delays in a patient’s treatment. The resolution of small structures may be impacted the most.

Accurately measuring the IMT, resolving small gallstones, precise imaging of the fetal heart structures and procedures involving needle guidance could be compromised by transducers that are no longer performing at the high standard of the original ultrasound system manufacturer.

The cost savings of having a transducer repaired or remanufactured by a service facility that uses less-expensive, non-OEM components is not worth the

loss of diagnostic confidence and the potential negative impact on patient care.

References: https://www.fda.gov/MedicalDevices/ default.htm FS Resnic, SLT Normand, Postmarketing surveillance of medical devices – filling in the gaps, New England of Medicine; March 2012; 366:875-877 U.S. Food and Drug Administration, Guidance for Industry and FDA Staff - Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers - Sections 4 Through 6 and Appendix A Through H, https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089001. htm#e, accessed 3/31/19 U.S. Food and Drug Administration, White Paper: Evaluating Whether Activities are Servicing or Remanufacturing, https://www.fda.gov/downloads/ MedicalDevices/NewsEvents/WorkshopsConferences/UCM623972.pdf, accessed 3/31/19 SUMMIT IMAGING | DIGITAL SUPPLEMENT

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magine a world where medicine is not regulated. Where anyone who pleases can put up a sign and start treating diseases with unproven, unscientific methods, medications, and equipment. Imagine the risks to human health occurring only because companies are trying to maximize their profits with little concern for patient safety. Fortunately, the practice of medicine is both highly regulated by the FDA and scrutinized by potential patients. These standards put significant pressure on healthcare facilities to provide the highest level of care to earn patients while balancing aggressive budgets.

To comply with updated Medicare and Medicaid standards, the healthcare industry is striving to reduce costs. However, facilities must not sacrifice the quality of treatment or patient safety for incremental cost savings. This is critical, as the public

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possesses tools at their disposal such as Hospital Compare. This is a government initiative comprised of the efforts of Medicare and the Hospital Quality Alliance. Hospital Compare presents consumers with hospital ratings in a given zip code, allowing them to select a healthcare institution based on the following criteria: • General information • Survey of patients’ experiences • Timely and effective care • Complications • Readmissions and deaths • Use of medical imaging • Payment and value of care The higher the institution’s rating, the more likely consumers are to select that institution’s services. A lower rating will not only push patients to pick another healthcare provider, but may also result in significant penalties through reduced Medicare and Medicaid revenues(https://www.cms. gov/medicare/medicare-fee-for-service-payment/acuteinpatientpps/ readmissions-reduction-program).

Safety, reliability, and performance of

medical devices impact each of the above criteria significantly. The FDA is endeavoring to curtail low quality products from entering healthcare facilities through promoting certified Quality Management Systems in the third-party medical device market.

This is a welcome initiative and a great first step to ensure patients receive the quality of healthcare they expect and deserve.

There are still instances where medicine is either not practiced in accordance with regulations, or existing guidelines are misinterpreted or worse, deliberately ignored. This happens often with ultrasound transducers. Although the FDA has recently announced there is no new regulation of third party suppliers(https://www. fda.gov/media/113431/download), this does not mean there are not current regulations already in place that must be met to protect patients and provide high quality care.

A well-run hospital or clinic constantly maintains their medical equipment. Even the most cautious practitioner will occasionally have ac-

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cidents and end up with a damaged transducer. When repairs are needed, healthcare facilities look for suppliers who can help them stay within their budget without sacrificing quality.

With that being said, in the equipment aftermarket, some third-party companies are hiding critical NonOEM components used in repairs to meet demand and lower their costs.

Unfortunately, what is being overlooked is the quality of the components and repairs being performed.

These practices are often lumped into two definitions that are commonly misinterpreted, “Repaired” and “Remanufactured”. Unfortunately, they are misinterpreted by third party medical device organizations, usually to the favor of their financial gain and at the detriment of patient care. The accurate definitions of “Repaired” from the FDA website reads: A “ repaired” product is a type of servicing that returns a component to original specifications, including replacing non-working components or parts outside of routine or periodic upkeep for the current owner of the device(http://wayback.archive-it. org/7993/20171115051236/https:/ www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM529024.pdf).

“Repaired” does not specifically describe replacement of non-working components if non-OEM components are used and does not articulate the full context of all regulation around ultrasound transducers. If non-OEM components are used, the medical device is now considered “Non-OEM” and requires a 510k(https://www.fda. gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089001.htm#b).

Another misinterpreted medical device term often thrown around is “Remanufactured”. Many organizations avoid the remanufacturing term as this classification directly states from the FDA: Remanufacture: Process, condition, renovate, repackage, restore, or any other act done to a finished device that significantly changes SPECIAL ADVERTISING SECTION

the finished device’s performance, safety specifications, or intended use.”(http://wayback.archive-it. org/7993/20171115051236/https:/ www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM529024.pdf).

By definition, anything remanufactured is a modified device as the changes impact the devices performance and safety specifications, which requires a 510k.

Some third party “Remanufacturers” of ultrasound components such as arrays/crystals claim they have access to the original equipment manufacturer (OEM) specifications or can reverse engineer them.

But just like any other proprietary formula or process, OEMs do not disclose their designs, specifications and manufacturing processes, especially when it comes to ultrasound transducer arrays. Without this knowledge any reverse engineering is a best guess, a condition unacceptable by any hospital or patient standards.

Many remanufactured devices are, in effect, counterfeit, or “cloned” as they have not undergone proper validation with a 510k clearance. They are replicas that may or may not function exactly as the original, with the latter being the case more often than not. To make matters worse, their production and usage are, in fact, not in compliance with current FDA ultrasound transducer regulations, putting patients and hospitals at risk. The exact language is quoted below from the FDA describing this requirement: “Like new OEM transducers, nonOEM, reprocessed, and remanufactured transducers are new medical devices. As such, they are subject to the 510(k) premarket notification regulations (21 CFR 807.81). They need to have a cleared 510(k) prior to being marketed.”(https://www.fda.gov/ MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ ucm089001.htm#b).

Grave problems may arise from the use of non-OEM ultrasound transducers:

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Electrical safety: water-based gel is used to facilitate conductivity. If electrical components are not well-sealed, there is a risk of shock.

2. Contamination risk: if the device is not well-built and properly sealed, it can contaminate patients despite sterilization.

The FDA’s answer to the problem of non-compliant medical devices is to issue a 510(k) clearance. If a medical device servicing company has not been issued a 510(k) clearance, it cannot be trusted to service and repair devices safely and correctly. The best action for healthcare facilities to educate themselves on this risk and ensure their suppliers are complying with all regulations.

If you are seeking to have your medical equipment repaired or serviced, please use this link(https:// www.accessdata.fda.gov/scripts/ cdrh/cfdocs/cfpmn/pmn.cfm) to go to the FDA’s website to validate they have proper 510(k) clearance for every medical device model that is modified or Non-OEM. If patients suffer harm to their health or undergo an unpleasant or unprofessional experience during their healthcare interactions, the care-giving institution’s rating will go down, potentially depriving it of the patronage of discerning consumers and unnessecary reduce Medicare and Medicaid revenues. In short, your patients’ lives are at stake, as is the reputation and future success of your healthcare institution.

Sources Readmissions Reduction Program (HRRP) - Medicare and Medicaid Hospital Compare FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices FDA Repaired and Remanufactured Definitions FDA Non-OEM Transducer Regulations FDA 510k Clearance Check

SUMMIT IMAGING | DIGITAL SUPPLEMENT

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COMPANY SHOWCASE SUMMIT IMAGING

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ummit Imaging® is a technology-enabled ultrasound and mammography imaging equipment service business.

We provide our customers with the highest quality repair services and replacement parts so they can remain focused on their primary job of delivering excellent patient care. Since 2006, Summit has leveraged a unique combination of sophisticated component-level repair capabilities, software development skills and an exceptionally customer-focused team to meet the needs of our customers and their patients. Our products and services help Healthcare Technology Managers (HTMs) increase equipment uptime at their facilities at a significant savings compared to other options. Summit truly values collaborating with health care facilities that seek to enhance access to quality medical services at a competitive cost. Customers consistently report that the more they work with us, the more savings they realize via cost reductions and improvement of key HTM operating metrics.

Summit Imaging provides product support and service for ultrasound equipment in the following areas: • Ultrasound transducer repairs and replacements • Ultrasound system replacement parts • Best in class diagnosis and installation technical support • Detailed hands-on service training for technical personnel 6

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LARRY NGUYEN, SUMMIT IMAGING

In response to health care facilities requests, Summit has expanded the suite of solutions it offers into mammography equipment. We now offer mammography equipment support in the following areas: • Mammography digital detector plate repair and replacement • A comprehensive inventory of mammography system replacement parts • A knowledgeable and responsive technical support team

HOW DOES SUMMIT IMAGING FIT INTO THE HEALTHCARE TECHNOLOGY MANAGEMENT (HTM) INDUSTRY? Summit Imaging believes that our customers, sometimes with our help, have the ability to keep their imaging equipment running in tip-top shape.

Our goal is to enable HTMs to service their medical devices much faster and at a lower cost than traditional, full service-oriented options. Our ability to help health care facilities optimize and improve their equipment man-

agement programs has become an extraordinarily attractive and lucrative alternative for our customers. Often, in-house HTM and field service teams must focus on responding to a variety of failed medical device alerts with limited bandwidth to diagnose the faults.

Summit Imaging’s technical support team assists HTMs with the technical knowledge and guidance needed to properly and quickly diagnose faults, remove faulty components and install high-quality, warranted replacement parts they can trust to quickly return their systems back to service scanning patients. And, at Summit Imaging, we continue to develop new technologies and methods to repair these complex systems in order to meet the needs of our customers which represent some of the largest health care networks in North America.

SUMMIT IMAGING HAS A VERY UNIQUE OPERATING MODEL. WHAT INFLUENCED HOW SUMMIT IMAGING OPERATES? Summit Imaging’s humble roots began performing electronic component repairs on computer systems in medical devices. This was during a time when devices were transitioning away from analog and toward digital technologies.

This experience helps us hone a unique skill set recognized by our earliest customers as an effective way to help them reduce their service and maintenance costs. This further led to opportunities to partner with well-known and highly respected health care organizations in tackling larger and more complex challenges. Summit Imaging came to understand that the needs of these organizations revolved around rapid access to SPECIAL ADVERTISING SECTION

SHOWCASE high-quality replacement parts resulting in industry leading HTM performance benchmarks for time and cost savings.

Summit Imaging worked closely with these customers to align our operations and business model with our customers’ needs. Looking back, we now understand that this was the beginning of an industry shift toward health care facilities developing internal HTM service departments. We are grateful to these early customers for leading us to operate in a manner that best served their needs, both then and now. This model of increasing reliance on in-house support services at medical facilities has now become the norm rather than the exception. Today, Summit Imaging continues to evolve in response to our customers’ quest for greater operational cost savings alongside improving patient care.

WHAT ROLE DOES TECHNOLOGY SERVE TO SUMMIT IMAGING? Technology has fundamentally changed the HTM industry and leading-edge technology development is a philosophy deeply embedded in Summit’s culture. To us, it is one of the very best methods to reduce diagnosis and repair times as well as streamline installation time and complexity. Simply stated, our strategy is to resolve complicated problems and package solutions in simple-to-use form factors for health care facilities to deploy. These technologies do require significant development resources in order to deliver seamless, high-quality solutions. Some of our solutions have been transformative for healthcare facilities and how they operate their HTM programs. Some of the most promising outcomes include: higher yield on first service success, reduced HTM service time, lower total cost of fault diagnosis and repair, and increased patient care capacities. In the past, health care facilities’ repair options were limited to full-service solutions. Today, HTM groups can service their equipment with the support of an organization like Summit Imaging and realize savings ranging from 60% to 80% relative to traditional service options.

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Summit Imaging, alongside its health care facility customers, will continue trailblazing more support options for ultrasound equipment, mammography equipment and other medical devices that contain complex electronics.

Future growth in the HTM industry will require ongoing development of innovative solutions that drive increased productivity and efficiency. There is a generational shift underway in the HTM industry. As the experience level of engineers and technicians decreases and workloads increase, the need for powerful, technology-based solutions like ours becomes even more vital.

efited. The application of 14 years of experience and advanced analytics tools has allowed Summit to collect and aggregate data, to utilize that information for better planning a customer engagement and to improve the quality of the products and technical support we provide our customers. Summit Imaging enjoys the industry’s best quality of product and best technical support metrics with a 93% accuracy rating for first time diagnosis amongst HTMs. We are proud of our performance and remain committed to continue to improve for the benefit of our customers and the patients they care for.

HOW DO YOU PROVIDE YOUR TECHNOLOGY TO HTMS?

WHAT DOES THE FUTURE HOLD FOR THE HTM INDUSTRY?

Much of Summit Imaging’s technology is focused on repairing the sophisticated electronics of medical devices that are readily available when HTMs need it. Our core value proposition is delivering high-quality replacement parts that HTMs can install and, in the process, extend the mean time between failure, preventing additional unnecessary service calls. HTMs become very frustrated when they return to a recently repaired device only to find that the replacement part has failed again. It is abundantly clear to us based on our extensive experience with the healthcare technology management community, that the most precious resource for HTMs is time. We strive to help our customers fix things quickly, but most importantly to fix it right the first time.

Summit Imaging has invested significant resources to ensure the products we sell and help our customers install last well into the future in order to prevent unnecessary service calls. In 2015, the company earned its initial ISO 13485:2016 certification for its Quality Management System (QMS) and has successfully passed annual certification audits every year since. Summit Imaging has deployed its QMS through integration with its cloud computing-based, Enterprise Resource Planning system to help us manage, streamline and enhance our operations. The impact to our organization has been dramatic and our customers have really ben-

Society needs healthcare technology management to continue advancing in order to deliver better patient care while simultaneously containing rising health care costs. One of the focus areas must be an emphasis on health care facilities delivering high-quality patient care at a sustainable cost. This is a direction we must pursue because without this HTM movement, we are exposed to the risk of ballooning costs, making quality health care out of reach to increasing segments of our population. One of the best strategies available for health care facilities seeking sustainable growth is to lower costs while concurrently maximizing their revenue generating opportunities.

With health care facilities moving away from fully outsourced service models, it is clear they will increasingly need new solutions to expand their service capacity. Summit Imaging has always believed it is critically important to contribute to the welfare and evolution of the health care industry and we are excited to continue to evolve our current tools and develop new technological solutions to help health care facilities be in the best position to care for patients in need. • For more information, visit mysummitimaging.com

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Making our customers heroes™

Lowering Healthcare Facilities’ Total Cost of Ownership

ISO 13485:2003 Certified

Quality Management System

P: 866-586-3744 E: info@mysummitimaging.com W: mysummitimaging.com YouTube.com/SummitImaging

COUNTERFEIT ULTRASOUND DEVICE TRACEABILITY RISKS FOR HEALTHCARE FACILITIES

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s an ultrasound and mammography equipment support organization, Summit Imaging wants to take a moment to discuss the issue of counterfeit ultrasound probes and what healthcare facilities need to know when acquiring or repairing equipment.

We want to educate the healthcare community about this problem while, at the same time, lowering your total cost of ownership by maintaining high quality equipment and reducing frequency of failure.

Unfortunately, healthcare facilities and Healthcare Technology Managers (HTMs) have been misled and sold ultrasound transducers that contain counterfeit parts.

From discussions with our healthcare facility customers, we have heard that some transducers are represented as coming from original equipment manufacturers (OEMs) or are allegedly refitted with counterfeit parts that, some suppliers claim, meet OEM specifications; yet, that is not actually the case.

The primary concern is that these transducers are being repaired with low-quality counterfeit parts that have not undergone proper testing and certification.

Proper validation would include a 510K issued by the FDA, or other external certifications to prove that the performance and safety matches current regulations of components for each application of the re-manufactured part in every model of transducer in which it may be installed.

This burden of proof lies with the re-manufacturer, the supplier transplanting the low-quality counterfeit parts inside OEM marked casings, and any organization that takes ownership of the asset and resells it to healthcare facilities. We urge healthcare facilities to ask these critical questions of ultrasound suppliers as these significantly and unnecessarily SPECIAL ADVERTISING SECTION

increase operating and patient safety risks.

This situation occurs when ultrasound suppliers purchase low-quality, counterfeit ultrasound transducers, or certain counterfeit parts of the transducers, from offshore re-manufacturers. The ultrasound suppliers utilize the low quality internal parts and transplant the critical internal components into a defective OEM transducer (or other medical device) that displays the original OEM serial numbers and labeling. This masks the low-quality and non-validated re-manufactured parts on the inside of the “finished” transducer, resulting in a compromised medical device. The healthcare facility now unknowingly owns an asset that carries seemingly valid OEM serial numbers and labeling, yet has the internal structure of a counterfeit transducer that does not meet federal regulations. The worst part of the situation is that the equipment is used on unsuspecting patients who are assuming that they are receiving the best care possible.

Traceability and recalls have now become an extraordinarily difficult exercise for transducers with compromised components, something a healthcare facility would never be aware of as they are inside sealed casings. Making a valid investigation is almost impossible.

Adding another layer to the problem are the ultrasound suppliers who transplant counterfeit parts into OEM-labeled casings and sell these products to other ultrasound suppliers, without any disclosure of the improperly re-manufactured parts used inside the ultrasound probe. Then these ultrasound suppliers unknowingly sell the equipment to others in the market or directly to a healthcare facility, and nobody along the transaction chain has any insight into the compromised medical device that is now owned by the healthcare facility. These are being reported by end users as low-quality products that have a significant higher frequency of failure and this significantly increases total costs of ownership and

risks for healthcare facilities and patients.

Sonography Professor, Carolyn Coffin, who has performed research on image quality and ergonomics of ultrasound equipment, says, When it comes to imaging, quality, longevity, safety, and overall functionality, the original parts of a transducer are far superior to those of an improperly re-manufactured product. But cheap, imitation components are easy to pass along to you when they’re housed in original casing and you cannot see them. This is why it’s so important to ask questions, and vet your ultrasound suppliers to make sure [that] you’re getting the quality you’re paying for.

Healthcare facilities can best protect themselves from this practice by searching for suppliers with an ISO 13485 certified Quality Management System that has been designed to reveal these counterfeit components during transducer evaluations and repairs. Only then can the supplier to notify the healthcare facility of the findings, allowing them to make an informed decision of what to do with the compromised transducer. In our experience, healthcare providers universally reject the counterfeit equipment for all of the reasons previously described and more. After learning about these practices, healthcare facilities consider it a gross disregard of current FDA regulations to repair and sell improperly remanufactured equipment that lack a 510K or external safety and performance certifications. This situation is directly opposed to how you and your healthcare facility intend to use the equipment and creates unnecessary risk to your organization and the patient.

A more comprehensive discussion can be found on our youtube channel along with many more informative topics.

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CAN INCREASED “TRANSDUCER TIME” LEAD TO WORK-RELATED MUSCULOSKELETAL DISORDERS? Carolyn T. Coffin, MPH, RDMS, RVT, RDCS

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he answer is “yes”.

Historically, strain and fatigue caused by the use of hand tools have been identified by a number of investigators. In the 17th century, Bernardo Ramazzini, the founder of occupational medicine, noted that scribes writing with quill pens were experiencing fatigue of the hand and wrist, which resulted from strain on the muscles and tendons. Over time, this strain led to decreased gripping strength of the hand.

Other investigators have described “writer’s cramp” and “occupational neurosis” among various professions where hand tools were used extensively.1 Hand tools contribute to a large percentage of musculoskeletal disorders2, including those reported among sonography professionals.

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Musculoskeletal disorders are the major cause of workplace injury in all professions and have a significant economic impact on industries.3 Work-related musculoskeletal disorders (WRMSD) account for 56% of work-related illnesses reported to OSHA. The risk for these injuries depends on the duration of a worker’s exposure to a workplace hazard, the frequency of the exposure to that hazard, and the intensity of the exposure. Just as writing for long periods of time with a pen can cause “writer’s cramp” of the hand and fingers, long durations of holding an ultrasound transducer during a patient exam can cause fatigue of the scanning hand and fingers. When this is compounded by multiple exams performed by a sonographer during the workday, the risk for injury increases further.

The time needed for the acquisition of diagnostic-quality images varies from exam to exam and between sonographers. More expe-

rienced sonographers will require less time for an exam than those new to the profession. However, there are some factors that increase scanning time for all sonographers.

These factors are exam protocols, the patient’s body habitus and medical condition, and the quality of the transducer.

The factors related to the patient are not within the control of the sonographer, but the other factors are. Exam protocols should be reviewed by the department on a regular basis to ensure that outdated and/or unnecessary images do not continue to be part of the required components. Transducers should always be maintained and repaired by an ISO 13485:2016 certified transducer repair facility with a solid track record of high-quality products and repair services. Sonographers do not always recognize when a transducer is substandard or has a broken component. As a result, they struggle through exams SPECIAL ADVERTISING SECTION

trying to overcome poor quality images, adding extra time holding the transducer during each exam. Once a faulty transducer is identified, the repair should be performed by a facility that uses original equipment manufacturers’ (OEMs)parts and not “counterfeit” parts.

Non-OEM parts may not result in the image quality that the sonographers expect. Repair work utilizing nonOEM parts may seem less expensive up front but can ultimately result in added costs as those parts may not have the same life span of the OEM parts, thus requiring more frequent repairs. Additionally, the risk of a work-related injury increases, due in part to an increase in transducer time as the sonographers struggle to acquire a diagnostic quality image. Loss of productivity by an experienced employee who becomes injured, and medical costs for treatment of a work-related injury and Worker’s Compensation costs, have now made the cost of transducer repairs using non-OEM far more expensive than if those parts were repaired with OEM parts.

To ensure that image quality and patient care are optimal, and that your department is efficient and the risk for occupational injury is reduced, you should always research the repair facility servicing your transducers to know that you are receiving your transducer back in the best condition possible, worthy of what you are paying for.

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References: 1. WRMSD In Sonographers, Grahame Brown, BMUS Bulletin, Aug. 2003, Vol 11, No. 3 2. Design, selection & use of hand tools to alleviate trauma of the upper extremities: Part II- The scientific basis (knowledge base) for the guide. Anil Mital & Asa Kilbom, International Journal of Industrial Ergonomics, 10 (1992) 7-21 3. Pike I, Russo A, Berkowitz J, Baker J, Lessoway V; The Prevalence of Musculoskeletal Disorders Among Diagnostic Medical Sonographers; JDMS; 13(5); Sept.Oct. 1997: 219-27.

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PREVENTING CROSS CONTAMINATION AND ENSURING IMAGE QUALITY ON TEE ULTRASOUND TECHNOLOGY

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very physician and sonographer can understand the importance of image quality and preventing cross contamination when performing TEE ultrasound exams. Without a high-quality image, identifying abnormalities is increasingly difficult and less reliable, which is likely the result of microscopic damage to the TEE transducer that comprises the physical integrity of the probe designed to prevent cross contamination. This makes image quality critically important for proper diagnosis and to quickly identify failing equipment to prevent cross contamination.

One of the most exciting recent advances in ultrasound transducer technology is the added capability of live 3D imaging during transesophageal echocardiogram (TEE) studies. These new TEE transducers use complex matrix arrays instead of standard phased arrays, allowing the physician to obtain a more accurate visualization of the anatomy than with the lengthy traditional approach of rendering multiple 2D acquisitions offline. Because 3D TEE visualizes entire anatomic structures at 12

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a glance, the technology has been increasingly adopted to plan mitral valve surgery and to guide catheter-based mitral valve repair.

Technology Challenges As with any technology, the TEE transducer’s advanced multidimensional capabilities do not mean it is foolproof when it comes to performance. TEE transducers are very fragile, complex, and prone to many issues from poor image quality and missing information to noise and data-transmission problems. Combined with complicated disinfection processes these transducers can fall victim to physical damage that the naked eye may not see. The result is micro puntures and lacerations that allow fluid ingress and can carry to the next patient. These factors make it particularly important to understand how to use the new TEE ultrasound probes and identify anything amiss. Unfortunately, as sonographers are probably aware, no standard or objective method exists for measuring image quality.

Therefore, extensive practice and a trained eye are what sonographers typically rely on to identify artifacts and determine the quality of an image as it is a leading indicator of potential contamination.

However, as with standard ultrasound transducers, there are certain

signs sonographers can look for when using the new TEE transducers to spot anything out of the ordinary. Any image noise and color artifact, such as unintended variation in the brightness, color, saturation, or contrast of an image, is cause for suspicion. Some signs, such as image distortion (rearranged material) or color stripes or noise in a nonphysiologic pattern, clearly indicate an equipment problem. Are all of the scan lines parallel? Or are some out of line or fuzzy in comparison to adjacent scan lines?

In extreme cases, an image may appear too bright or white, or too dark—a sure sign of malfunction. The most difficult problem is when a change is subtle; the sonographer must then decide whether the artifact is clinically feasible or not—in other words, whether it is due to patient pathology, data error or damage and contamination. A dropout in the image (missing signal) is a good example: Ultrasound is famous for having dropouts, but judgment and experience are required to determine whether the dropout observed indicates a malfunction.

With a transthoracic echo probe, the sonographer could spend time checking previous reports on the patient to see whether any diagnostic image-quality problems had been reported on earlier exams. Or, the SPECIAL ADVERTISING SECTION

sonographer could struggle to properly image another patient—or two or three—to prove that “it’s not just that patient” and confirm the suspicion of a probe problem. For a TEE ultrasound probe, such steps are inadvisable—it is of paramount importance to ensure that the ultrasound equipment will not prevent a procedure from going smoothly.

In fact, sonographers should not have to wonder whether it is the patient or the probe causing an issue. Rather, they should be enabled to focus on learning to identify artifacts. Then they and their administrators should explore other, preventative measures to ensure image quality and accurate diagnoses.

Maintenance First and foremost, prevention comes from proper maintenance and care of the TEE system. When first receiving new equipment, the sonographer or biomedical engineer should conduct a live-system test to ensure it is in working order. The American College of Radiology (ACR) Technical Standard specifies that acceptance testing must be performed when new equipment is acquired as well as after equipment repairs and major upgrades. For example, the ACR standard notes that tests on transducers should include physical and mechanical inspection, image uniformity and artifact survey, geometric accuracy, system sensitivity, spatial resolution, and contrast resolution.

Once the system is accepted, careful handling and sterilization of probes helps control equipment service costs and reduce the risk of cross contamination. The American Institute of Ultrasound in Medicine (AIUM) has posted guidance regarding the cleaning and preparation of external and internal ultrasound probes on its website.2 It is critical to establish a regular surveillance schedule to guarantee that the transducer is functioning properly over time and with regular use. The AIUM has published recommended or mandatory equipment surveys to be performed, some daily and others at least once a year.

The Intersocietal Accreditation Commission requires that manufacturer’s guidelines be followed “for the appropriate care and cleansing of the TEE SPECIAL ADVERTISING SECTION

transducer and adhere to the appropriate infectious disease standards to prevent the transmission of disease.” In addition, beginning December 31, 2015, “the structural and electrical integrity of the transducer must be checked between each use, using an ultrasound transducer leakage tester. ‘Passed’ or ‘Failed’ must be documented in the routine TEE probe cleaning/maintenance log along with action taken if ‘failed.’

Testing and Repair Various tools are marketed to test whether a probe is in good shape. Scanners (calibration tools) can be used to identify imaging issues, while certain probe-testing devices can be used to measure and detect any issues related to the acoustic and electrical properties of an ultrasound probe. While these devices may help in certain instances, the best approach to ultrasound equipment testing is live-system testing. Only live-system testing is capable of capturing real images to assess their quality; only live-system testing can reveal the intermittent problems that comprise the majority of issues associated with a probe. Simply stated, there is no substitute for an image-quality test on a live ultrasound system.

Once a problem is identified, biomedical engineers and hospital administrators should first consider a repair.

The cost of repairing faulty equipment is much lower than the cost of replacement. Opting to repair rather than replace the technology can maximize its useful life and save healthcare facilities as much as 97% relative to the cost of original equipment manufacturer replacements. However, it is important to note that the repairability of a compromised TEE transducer decreases rapidly as time passes, due to the corrosion of its materials. For this reason, any technical problems should be acted upon as soon as they are detected to ensure a successful repair.

Prompt repair is particularly important for real-time, multidimensional TEE transducers. Delays in equipment failure diagnosis will make them significantly more difficult to service as the fluid ingress corrodes the fragile internal electronics. Due to their higher power and smaller form factor, damage

from electrical shorts from fluid ingress is more catastrophic in addition to the the risk of cross contamination. Hospital administrators should therefore seek to partner with a reputable, well-trained team of ultrasound support technicians who can repair equipment down to the component level. Factors to consider when choosing an ultrasound support provider include whether the provider does all the work in-house, has the technical expertise to provide in-depth failure analysis, and turns work around quickly.

Probe Integrity Is Critical When it comes to accurately assessing and diagnosing cardiac patients, TEE probe integrity should be taken very seriously. This is particularly true when 3D TEE is being used for procedural guidance. As reliance on TEE technology continues to grow and take over functions once dominated by other imaging modalities, ensuring high-quality images will become increasingly important to top-notch patient care. Learning how to spot image anomalies and properly test and care for equipment—and acting at the first sign of any deterioration or failure—will make all the difference.

This article was originally published by 24X7 Magazine.

References 1. ACR. Technical Standard for Diagnostic Medical Physics Performance Monitoring of Real Time Ultrasound Equipment.

2016. Available at: https://www.acr.org/-/ media/ACR/Files/Practice-Parameters/ US-Equip.pdf. Accessed January 2020.

2. AIUM. Guidelines for Cleaning and Preparing External- and Internal-Use Ultrasound Probes Between Patients.

2014. Available at: http://www.aium.org/ officialStatements/57. Accessed August 5, 2014.

3. AIUM. Routine Quality Assurance for Diagnostic Ultrasound Equipment.

2008. Available at: http://www.aium.org/ store/products.aspx?cId=102&page=2.

Accessed August 5, 2014.

4. IAC. Standards for Adult Echocardiography Accreditation. 2014. Available at: http://www.intersocietal.org/echo/main/ echo_standards.htm. Accessed August 5, 2014.

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