Matt Tomory, vice president of sales and marketing for Innovatus Imaging, shares his insights with 24×7 on the common failures and maintenance strategies for ultrasound transducers and systems. In the interview, he discusses how to enhance equipment reliability and performance through proper repair and preventive measures.
24×7: What are the most common types of failures or damage seen in ultrasound transducers and systems?
Matt Tomory: Damage can be broken down into two categories: preventable and normal wear. With probes, the majority of damage we see is preventable. Physical trauma is most common, followed by chemical damage. Most people believe they are using the proper chemicals to clean and disinfect their probes—and they may be—but are they using the proper chemicals properly? In other words, are they following the instructions for use? OEMs spend a lot of time and money evaluating how their materials might be affected by the hundreds of different cleaners and disinfectants available in today’s marketplace. Users must consult OEM manuals before choosing a cleaner or disinfectant.
Innovatus also goes to great lengths to evaluate all our materials (plastics, lenses, cable sheaths—even adhesives!) to ensure chemical compatibility with all OEM-approved agents. An extra step we perform is ISO 10993 certification, which verifies biocompatibility and cytotoxicity for patient contact materials. As far as systems go, one of the most important preventive activities is regular cleaning of the system’s air filters. Another very important item for end-users is proper cable management. When performing portable scans or moving the system, be sure that the cables do not get caught in the system mechanics or under the system casters. It’s also very important to follow the proper system shutdown procedures. Ultrasound systems should never be unplugged without following the proper sequence.
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24×7: What key factors impact the reliability and performance of a repaired ultrasound probe?
Tomory: There are two methods to “repair” a probe: getting it working again, or restoring it back to OEM form, fit, function, and intended design. Please note, an ultrasound probe is a Class II medical device with its own FDA 510(k) clearance. It is not difficult to get probes working again, but how do you determine OEM intent for safety, performance, and effectiveness? OEMs do not sell parts for transducers and do not provide specifications. It is up to each repair provider to determine the manners in which they address probe failures, which can lead to variations in output. We see many organizations using the terms “OEM specifications” in their ads, collateral, and on their websites, which is inaccurate at best.
Innovatus has an FDA-registered acoustic lab in Denver, Colorado, where we can benchmark OEM probes to determine intent, create work instructions, and determine materials which conform to those standards, and then repair to those standards.
24×7: How does the repair process differ between standard ultrasound probes and advanced technology probes like 4D or Doppler?
Tomory: It all circles back to precisely measuring OEM probe performance, determining proper materials for everything (including all components of the probe), and developing repeatable processes to demonstrate you can restore that device. Can your repair provider furnish data which proves the probe has been returned to OEM form, fit, and function? Even the most complex probes can be repaired, provided the proper steps are taken when developing materials and processes.
24×7: Are there any specific maintenance strategies that can help extend the lifespan of ultrasound equipment?
Tomory: First, follow the OEM-recommended cleaning and maintenance guidelines. You also want to ensure you are getting all the OEM software updates to keep your software and security current. Notice I stated updates and not upgrades—there is a difference. OEMs are required to furnish certain updates for systems which address reliability, safety, and security. Upgrades are adding additional features or functionality and typically have a fee attached unless you are under warranty or full-service contract.
24×7: How do repair services handle calibration and testing to ensure ultrasound systems are functioning correctly after repair?
Tomory: Most systems have a self-test function which runs on startup or you can access through service menus. If this is not available, this is where it is critical for HTM departments to be involved with the purchase of new equipment—ensure any proprietary software needed for self-service is provided for post-warranty use. When I see the word “calibration,” my mind goes back to my early service days where I carried an oscilloscope and literally had to manually calibrate the receivers on ultrasound systems—those days are long past. Systems are extremely software-dependent today, and calibration is not needed.
24×7: What are the key indicators that an ultrasound system may need repair or preventive maintenance?
Tomory: Systems displaying error messages, unexpected lockups or shutdowns, image quality issues unrelated to the probes are all prompts to get your system serviced quickly. Regarding preventive maintenance, most OEMs only recommend once annually, if at all. It is my recommendation the system is serviced at least twice annually where the filters are addressed, probes are evaluated for safety and effectiveness, and software backups are performed in addition to any OEM-recommended items. In addition, if the department is accredited by the American College of Radiology (ACR), the American Institute of Ultrasound in Medicine (AIUM), or the Intersocietal Accreditation Commission (IAC), additional steps and QC documents must be completed.
24×7: How can the repair process help mitigate the risk of recurring issues with ultrasound equipment?
Tomory: Along with following the OEM guidelines and recommendations, healthcare providers have a responsibility to ensure that their repair providers are utilizing proper repair processes, materials, and testing criteria. Circling back to the point made in question 1, is the provider just getting the device working again, or are they restoring it back to OEM intent, and can they provide data to prove it?
