












AAMI’s biggest conference for healthcare technology management (HTM) professionals is coming to New Orleans!
From June 20-23, the 2025 AAMI eXchange will convene the HTM community, as well as some sterile processing professionals, for an unforgettable weekend. But AAMI is not content to simply play the hits. The programming at the 2025 eXchange was chosen based on your feedback from past years and is sure to provide exceptional value. Read on to learn about the education sessions, available CEUs, HTM leadership training, career fair, charity golf tournament, and much more!
REGISTRATION AND NEW EXHIBITORS
Register today! Early bird rates for full conference and one-day registration are available until April 19, 2025. AAMI members enjoy a discounted rate, as do students, active military personnel, and government workers. You can find more information on registration rates for the 2025 AAMI eXchange here. Questions? Contact us at exchange@ aami.org. Registration for the 2025 eXchange is graciously sponsored by TRIMEDX.
eXchange KEYNOTES
The opening keynote will be delivered by Aaron Horowitz,
CEO of Empath Labs. Empath Labs specializes in developing guides for pediatric clinical research called Clinical Companions, which are used by more than 175,000 children worldwide to alleviate anxiety and improve their medical treatment. Join us to learn about ‘Empathy as a Superpower!’
The 2025 AAMI award winners will be recognized in New Orleans.
Jinesh Patel, CEO and Co-Founder of Uptime Health, will deliver a keynote on ‘Expanding Horizons: How Biomedical Technicians Can Diversify and Capture New Markets.’ Patel will discuss how clinical engineers and technicians already have the skills to enter new markets and expand their services to non-traditional settings.
The expo hall will feature more than 150 exhibitors, including medical device manufacturers, independent service organizations, third-party servicers, non-profits, professional associations, and members of the trade press. Attendees with expo hall passes have access to 10 hours of exhibit time over three days, including a welcome reception on Friday, June 20. Various exhibitors will also host dozens of in-booth sessions, presentations, and product demos throughout the weekend.
The AAMI Studio, generously sponsored by GE Healthcare, is also returning at this year’s eXchange. As in past years, we will interview leading figures from around the HTM field, recognize AAMI award winners, and host livestream programming including Live @eXchange!
There are a total of 80 education sessions at this year’s eXchange, divided into the following tracks. Each track includes multiple sessions over the three-day show. You can earn CEUs for your AAMI certifications by attending these courses. Notable topics within each track are listed below.
Sterilization Track: Featuring sessions on steam sterilization, sterile packaging, isolation gowns, borescope inspection, and more.
Patient Safety and Regulatory Track: Focusing on incident investigations, lessons learned from hurricane response, and the debate over remanufacturing.
Cybersecurity Track: Addressing enterprise risk, the aftermath of cyberattacks, and ITO cybersecurity.
Artificial Intelligence (AI) Track: Discussing AI in preventative maintenance, clinical integration issues, and using chatbots in HTM.
Home Health and Hospital at Home Track: Addressing planned maintenance and the integration of digital technology into biomedical engineering.
Career and Professional Development Track: Including sessions on disability in HTM, career progression, vendor relations, and how female professionals can navigate the HTM field.
Equipment Management Track: Featuring topics like department financials, navigating equipment end-of-life, and more.
HTM Recruitment: Including discussions on how to change HTM recruitment, strategic talent acquisition, and attracting new BMETs to the field.
Virtual and Augmented Reality: Incorporating sessions on how the VA is using VR/AR tools and how to use AR to deliver precision-guided service.
Are you ready to apply for that management position? HTM professionals interested in taking the next step in their careers are encouraged to sign up for the HTM Leadership Training course. This 7-hour course is taught by staff from the College of Biomedical Equipment Technology and includes material on vendor negotiations, business ethics, new technologies, team building, company culture, change management, and much more.
Attendees can also sign up for this year’s Technical Training course. Entitled Introduction to Servicing Radiologic and Fluoroscopic Imaging Services, it focuses on the systems and technologies found in most medical imaging departments. Biomedical equipment technicians, managers, and students alike are encouraged to attend.
The eXchange will also feature several concurrent symposiums on June 21, including the annual symposium of the American College of Clinical Engineering (ACCE) and an Industry Symposium presented by Philips.
After receiving rave reviews in 2024, the AAMI Career Fair is back! Held on June 22-23, the career fair is a one-stop resource for job seekers and employers alike.
Job seekers will have access to representatives from some of the best employers in HTM. Representatives from the Department of Veterans Affairs, Kaiser Permanente, GE Healthcare, Sodexo HTM, the Mayo Clinic, and TRIMEDX will be at the fair, and more organizations are expected to be announced soon. Job seekers may sign up for a free professional headshot courtesy of AAMI, and one-onone resume review sessions with AAMI’s human resources staff are also available.
On Friday, June 20, AAMI will also host an event for high school students from the New Orleans area. This event will introduce them to the HTM field, allowing them to talk to HTM professionals and explore opportunities in the field.
The HTM field is vast, but if you find yourself on the list below, consider joining us in New Orleans! Typical eXchange attendees include:
• HTM leaders, clinical engineers and biomedical equipment technicians.
• Management staff from hospitals, clinics, and other healthcare facilities.
• Members of U.S. government agencies like the Department of Defense and Department of Health and Human Services.
• Experts in cybersecurity, risk management, and systems engineering.
• Students in biomedical engineering, biomedical technology and related fields.
• Professionals involved with standards development with AAMI or ISO.
• Sterile processing professionals.
• Trade press reporters covering medical devices, sterilization, or standards.
For all these groups and others, attending eXchange is a great chance to meet colleagues from across the field and discover new professional opportunities. Register today!
Education Sessions, Available CEUs, HTM Leadership Training, Career Fair, Charity Golf Tournament, And Much More!
Tri-Imaging Solutions introduces a cutting-edge platform that enhances supply chain management, engineer performance, and system monitoring. It provides engineers with diagnostic tools and video tutorials, and streamlines parts ordering and tracking. Designed for efficiency, the platform minimizes downtime and optimizes operations, setting a new standard for reliability in medical imaging.
XperTIS proactively monitors system health, supports engineers in repairs, and enhances the supply chain process by giving teams seamless access to parts ordering and order tracking.
XperTIS offers step-by-step repair guidance, helping engineers troubleshoot efficiently while ensuring faster, more accurate parts ordering This helps maximize uptime and minimize repair costs.
n the fast-paced world of medical imaging, system efficiency and reliability are crucial. Downtime can lead to delayed diagnoses, increased patient wait times, and costly repairs. Tri-Imaging Solutions recognizes these challenges and has introduced XperTIS, a cutting-edge platform designed to enhance supply chain management, engineer performance, and system monitoring. This revolutionary technology sets a new standard in medical imaging maintenance, streamlining processes and minimizing disruptions.
XperTIS is more than just a platform – it’s an all-in-one solution that transforms how engineers and health care providers manage medical imaging systems. By integrating advanced diagnostic tools, video tutorials, and streamlined parts ordering, XperTIS improves efficiency, reduces downtime, and optimizes repair workflows. With the increasing complexity of modern imaging technology, having a resource that proactively supports engineers and facilities is invaluable.
1.
One of the standout features of XperTIS is its ability to proactively monitor system health. Instead of waiting for a failure to occur, the platform continuously assesses system performance, identifying potential issues before they escalate. This predictive approach reduces the likelihood of unexpected breakdowns and ensures that imaging departments can maintain high levels of service without interruptions.
Medical imaging engineers play a critical role in maintaining and repairing complex systems. However, even the most experienced engineers face challenges in diagnosing and fixing technical issues efficiently. XperTIS provides engineers with step-by-step repair guidance, empowering them with the knowledge and tools needed to troubleshoot effectively. The platform includes:
• Comprehensive diagnostic tools that simplify issue identification
• Video tutorials for hands-on learning and quick resolutions
• Guided troubleshooting assistance to improve repair accuracy and speed
By equipping engineers with these resources, XperTIS helps minimize downtime and maximizes system uptime, which is essential for health care facilities that rely on imaging equipment daily.
Timely access to replacement parts is crucial in medical imaging maintenance. A delayed order or mismanaged inventory can extend system downtime and create operational inefficiencies. XperTIS streamlines the parts ordering and tracking process, giving teams seamless access to essential components when they need them most. Key advantages include:
• Automated order tracking for real-time updates
• Faster parts procurement to minimize wait times
• Optimized inventory management to reduce waste and ensure availability
By improving the supply chain process, XperTIS reduces administrative burden and ensures that engineers have the right parts at the right time.
The introduction of XperTIS is a game-changer for health care facilities and service engineers. Its ability to integrate proactive monitoring, technical support, and supply chain management in one unified platform makes it a first-of-its-kind solution in the industry. The benefits extend beyond just equipment maintenance – XperTIS enhances operational efficiency, reduces costs, and ultimately improves patient care.
For hospitals and imaging centers, XperTIS offers a solution that ensures their imaging systems remain operational, reducing the risk of patient care disruptions. By minimizing equipment downtime, facilities can:
• Maintain consistent diagnostic imaging availability
• Reduce financial losses associated with system failures
• Enhance overall patient experience by preventing appointment cancellations
Medical imaging engineers now have a reliable support system that enhances their ability to perform repairs efficiently. With access to in-depth troubleshooting resources, engineers can diagnose and fix issues faster and more accurately, reducing the dependency on
external service calls. This leads to:
• Increased productivity and confidence in handling repairs
• Greater autonomy in maintaining medical imaging systems
• Reduced service costs for health care facilities
As healthcare technology continues to evolve, so do the challenges of maintaining advanced imaging systems. XperTIS is designed to meet these challenges head-on, offering a forward-thinking approach to equipment maintenance. Its combination of predictive monitoring, real-time engineer support, and efficient parts procurement makes it an essential tool for modern health care facilities.
For those in the medical imaging industry looking to optimize their operations and improve system reliability, XperTIS is the solution of the future. With Tri-Imaging Solutions leading the way, the medical imaging sector is on the brink of a new era in efficiency, reliability, and innovation.
To learn more about XperTIS and how it can revolutionize your imaging maintenance strategy, visit www.triimaging. com or contact their team at sales@triimaging.com.
626 Holdings weare626.com
Booth #2524
ALCO Sales and Service Co. alcosales.com Booth #2529
BC Group International, Inc. bcgroupstore.com Booth #2618
Claroty claroty.com/healthcare-cybersecurity/ medigate Booth #2632
College of Biomedical Equipment Technology cbet.edu Booth #2437
CPN Power, Inc cpnpower.com Booth #2408
ECRI ecri.org Booth #2613
Elite Biomedical Solutions elitebiomedicalsolutions.com Booth #2842
EQ2, LLC eq2llc.com
Booth #2528 Innovatus Imaging innovatusimaging.com
Booth #2402
Integrity Biomedical Services, LLC integritybiomed.com
Booth #2432
MedWrench medwrench.com Booth #2944
RS&A
Booth #2314
MultiMedical Systems, LLC multimedicalsystems.com
Booth #2737
PM Biomedical pmbiomedical.com
Booth #2531
Pronk Technologies pronktech.com
Booth #2612
QRS Solutions / Datrend Systems Inc qrs-solutions.com
Booth #2629
USOC Medical usocmedical.com
Booth #2409
TechNation 1technation.com
Booth #2845
VIZZIA Technologies vizziatech.com
Booth #2536
Tenacore LLC tenacore.com
Booth #2513
TruAsset, LLC truasset.com
Booth #2400
BY BRYANT HAWKINS SR., SITE MANAGER, TRIMEDX
To all attending AAMI eXchange in New Orleans, I have a special gift for you! You can thank me later! New Awlins (yes, that’s intentional) isn’t just a place. It’s a vibe. It seeps into your soul like the scent of jasmine on a warm night. Here, history and culture move together like a second line parade. Every bite of food is an experience. Music isn’t just something you hear, it’s something you feel. This city isn’t just where I’m from, it’s a story that’s meant to be shared. I can’t wait for you to experience it.
Whether it’s your first visit or your fiftieth, New Awlins (ok, last time making the joke) doesn’t just welcome you, it claims you.
No visit to the Crescent City should begin without beignets and café au lait. Head to Café du Monde, grab a table under the green-and-white awning, and prepare to be covered in powdered sugar. The people-watching here is next level. Street musicians and artists all set the scene in Jackson Square, where history and culture meet.
After breakfast, take a slow stroll through the French Quarter. The iron-laced balconies, the pastel-colored Creole townhouses, the faint sound of a trumpet floating through the air. It’s a sensory overload in the best way possible. Stop by St. Louis Cathedral, the oldest cathedral the country, and peek inside to soak up the centuries of stories within its walls.
For lunch, step into the French Quarter and grab a bowl of authentic Creole goodness at The Gumbo Shop. Located on Saint
Peter Street, this spot serves up some of the best gumbo in the city. It’s rich, flavorful, and steeped in tradition.
If history calls, answer it at the National WWII Museum. A stunning, immersive tribute to those who fought on the front lines and served on the Home Front.
The Mississippi River is the lifeblood of New Orleans. Walk along Woldenberg Park, watch the steamboats roll by, or hop on the Steamboat NATCHEZ for a jazz-filled cruise.
For a different kind of waterway, head to Bayou St. John and rent a kayak. Paddle past moss-draped cypress trees and historic Creole cottages—this is the city’s quieter, more reflective side.
Dinner in New Orleans is more than a meal—it’s an event. If you’re looking for a high-end experience, Commander’s Palace is a must. The service is impeccable, the turtle soup is legendary, and the Creole cuisine is unforgettable. If you’re after something a little more casual but just as iconic, Drago’s serves up the city’s best charbroiled oysters, drenched in butter, garlic, and parmesan. And if FrenchCreole elegance is your style, Arnaud’s is the place to be.
Of course, these are just a few. New Orleans has too many great restaurants to name, and every local has their own favorite hidden gem.
After dinner, the night is yours, and Bourbon Street is its own universe. Stretching 13 blocks from Canal Street to Esplanade Avenue, this is where live bands, DJs, and street performers create a non-stop party. It’s wild, it’s chaotic, and it’s uniquely New Orleans. One block might have a brass band second-lining down the street, and on the next you’ll find a rock band spilling out of a bar. Grab a frozen daiquiri, soak it all in, and let the night take you where it may.
If you want to shift gears, make your way toward Frenchmen Street—but first, take a detour to Port of Call. This spot is legendary for its massive, juicy burgers (some say the best in town) and famous rum-based drink, the Monsoon
Once you hit Frenchmen Street, you’ll know you’ve arrived. The neon is softer, the crowds are smaller, and the music is real. At The Spotted Cat, jazz musicians play like their lives depend on it. Over at The Blue Nile, brass bands shake the walls. Some nights, the best show is right on the street, where impromptu bands turn the sidewalk into a stage and the whole block into a dance floor.
This is the real New Orleans, the one you don’t just hear but feel.
New Orleans has layers, and if you’ve got time, it’s worth peeling them back.
City Park is bigger than Central Park. This 1,300acre wonder is a photographer’s dream. The ancient oak trees, draped in Spanish moss, make for the perfect backdrop. I do most of my senior photo shoots here. You can stroll through the Sculpture Garden, visit the New Orleans Museum of Art, or rent a paddleboat on Big Lake Audubon Park runs along St. Charles Avenue. This Uptown gem is the perfect place to take a breather. Joggers, bikers, and picnickers all gather under the shade of massive oak trees. The Audubon Zoo, located here, is world-class, home to everything from Louisiana swamp creatures to African wildlife.
Every visitor I bring around town gets a meal at New Orleans Food and Spirits. Why? The Voodoo Rolls. Deep-fried, packed with seafood, and just the right amount of spice—these things are extraordinary. The rest of the menu? Crawfish étouffée, blackened redfish, and stuffed baked potatoes, all equally incredible.
Lake Pontchartrain is just one mile from New Orleans Food and Spirits. The 630-square-mile lake is a peaceful escape from the city buzz. Drive across the 24-mile-long Causeway Bridge (the world’s longest continuous bridge over water), or stick to the Bucktown Marina and West End, where you can watch sailboats drift by. The sunsets are absolutely breathtaking.
Studio Be was created by New Orleans artist Brandan “Bmike” Odums. It’s a massive warehouse-turned-gallery filled with powerful, large-scale murals that tell the story of Black culture, resilience, and social justice. It features the kind of art that stays with you long after you leave.
Jean Lafitte Swamp is right outside the city. This is Louisiana’s wild side. Alligators, cypress trees, and Spanish moss create an eerie, almost mystical landscape. Take a swamp tour, or if you’re feeling adventurous, go for a walk on one of the boardwalk trails.
New Orleans doesn’t just stay in your memories, it stays in your soul. It’s a city that lingers, that calls you back, that makes you feel like part of something bigger than yourself. Whether it’s the taste of gumbo, the sound of a trumpet, or the warmth of a stranger’s smile, this city has a way of making sure you never truly leave.
Can’t wait to see everyone in June at AAMI eXchange in New Orleans!!!
Learn more on how to implement effective and efficient strategies regarding Exposure Management in Claroty xDome for Healthcare. In Claroty xDome, you can benchmark your risk against your industry peers, understand device risk scores and profiles and better manage vulnerabilities and exposures. For more information, visit claroty.com
WEDNESDAY, JUNE 18
1:00 PM - 5:00 PM—Exhibitor Set-up (by appointment only, for booths 600 sq. ft. or larger ONLY)
THURSDAY, JUNE 19
8:00 AM - 4:30 PM—Set-up for all Exhibitors
8:00 AM - 5:30 PM—Registration Open
FRIDAY, JUNE 20
7:30 AM - 7:00 PM—Registration Open
7:30 AM - 2:00 PM—3rd Annual Golf TournAMent (buses to depart at 6:00AM from the convention center)
8:00 AM - 12:00 PM—Set-up for all Exhibitors
9:00 AM - 5:00 PM—HTM Leadership Training
3:00 PM - 5:15 PM—Concurrent Education Tracks/Sessions
5:30 PM - 7:00 PM—Welcome Reception in the Expo Hall
SATURDAY, JUNE 21
6:30 AM - 5:30 PM—Registration Open
7:15 AM - 10:15 AM—Concurrent Education Tracks/ Sessions
7:30 AM - 10:15 AM—Clinical Engineering Symposium - Presented by ACCE
7:30 AM - 11:00 AM—AAMI's Career Fair
8:00 AM - 10:00 AM—Technical Training: Intro to Servicing Radiologic and Fluoroscopic Imaging Services
10:30 AM - 12:00 PM—Keynote Speaker & Awards Presentations Part I
12:00 PM - 1:00 PM—Lunch in the Expo Hall
12:00 PM - 5:00 PM—Exhibit Hall Open - click to view list of exhibitors
12:00 PM - 5:00 PM—Exhibitor In-Booth Theaters, Exhibitor
Innovation Hub, and AR/VR Theater in the Exhibit Hall
3:30 PM - 4:00 PM—AAMI's Annual Business Meeting
4:00 PM - 5:00 PM—Happy Hour in the Expo Hall
5:00 PM - 6:15 PM—Industry Symposium - Sponsored by Philips - More Information Coming Soon
6:00 PM - 8:00 PM—AAMI PARTY! @ Mardi Gras World & The Grand Oaks Mansion
SUNDAY, JUNE 22
6:45 AM - 8:00 AM—Industry Symposium: TBD
7:30 AM - 5:30 PM—Registration Open
7:30 AM - 11:00 AM—AAMI's Career Fair
8:00 AM - 10:15 AM—Concurrent Education Tracks/ Sessions
10:30 AM - 2:00 PM—Keynote Speaker & Awards Presentations Part II
12:00 PM - 1:00 PM—Lunch in the Expo Hall
12:00 PM - 4:00 PM—Exhibit Hall Open - click to view a list of exhibitors
12:00 PM - 4:00 PM—Exhibitor In-Booth Theaters, Exhibitor Innovation Hub, and AR/VR Theater in the Expo Hall
4:15 PM - 5:15 PM—Concurrent Education Tracks/Sessions
5:30 PM - Vendor Night - Open Night for Vendors and Attendees to Connect on their Own in the "Big Easy"
MONDAY, JUNE 23
7:30 AM - 12:00 PM—Registration Open
8:00 AM - 10:15 AM—Concurrent Education Tracks/ Sessions
10:30 AM - 12:00 PM—Keynote Speaker
Schedule current as of March 20, 2025 - subject to change.
Get ready for an adventure! AAMI eXchange attendees who take on MedWrench’s Scavenger Hunt have the chance to win over $2,400 in prizes
HERE’S HOW TO PLAY:
• Grab your Scavenger Hunt card at the MedWrench booth 2944 or from any of our awesome participating sponsors.
• Complete the hunt and turn in your finished card at the MedWrench booth before June 22nd at 2:00 PM CT.
• You must be present for the prize drawing at the MedWrench booth to be one of our lucky winners!
• AAMI #2719
• ALCO Sales and Service Co. #2529
• Block Imaging #2414
• FSI #2913
• Innovatus Imaging #2402
• Integrity Biomedical Services, LLC #2432
• Interlight #3045
• MedWrench #2944
• MultiMedical Systems, LLC #2737
• PartsSource #2837
• PM Biomedical #2531
• Prescott’s #2423
• Pronk Technologies #2612
• QRS Solutions/Datrend Systems, Inc. #2629
• Rigel Medical #2441
• Sage Services Group #3029
• TechNation #2845
• United Infusion #2523
• USOC Medical #2409
BY K. RICHARD DOUGLAS
Among AAMIs many offerings is its role as a standards development organization, so a standard for AEM is clearly within its wheelhouse. While very well known for certifications and education, AAMI, in collaboration with other organizations, develops standards recognized across HTM.
Since 2014, AEM programs have been developed based on internal data sets developed by HTM departments using evidence-based maintenance. The goal has been to determine the most reasonable frequency for maintenance and testing based on data sets that also track failure rates.
The Centers for Medicare and Medicaid Services (CMS) allowed HTM departments to deviate from OEM maintenance recommendations, with some categories of equipment, when the HTM department has evidence that their alternate schedule does not impact patient safety or equipment function.
The interpretation of what is suitable in these programs, along with the best approach to the development of a compliant AEM program, has been the subject of debate and discussion.
Healthcare systems must meet the CMS Conditions of Participation. A healthcare delivery provider must meet these standards to receive compensation from Medicare and Medicaid. The standards must be met for every patient, even if that patient was not a Medicare or Medicaid patient.
Although efficiency and cost savings might be a part of an AEM program, the regulators are not interested in efficiency or cost savings; they are only focused on patient safety. Although, in CMS’s 2013 memo titled “Hospital Equipment Maintenance Requirements,” the agency did state that hospitals: “may through experience have identified more efficient or effective maintenance activities which do not reduce the safety of the equipment.”
CMS also expects that the standards of accrediting organizations meet or exceed those same standards. Healthcare providers must comply with federal, state and local laws.
Against this backdrop is the issue of AEM programs that satisfy the exacting standards of the regulators. AAMI’s expert working group focused on this specific area of concern to develop a standard to help align AEM programs and allow them to stand up against scrutiny.
The EQ103 standard provides clarification in order to respond to accrediting bodies with justification and explanation for an AEM program’s parameters and guidelines.
The process of creating a standard requires discussion, debate, research, consensus, feedback and documentation.
The ANSI/AAMI EQ103: 2024 standard on alternative equipment management (AEM) programs in healthcare delivery organizations resulted from that process. The standard attempts to bring more broad standardization to AEM programs. The new standard was developed by a diverse group of participants in the working group, bringing a number of perspectives and experience to the process.
EQ103 provides a structured framework for what equipment should be eligible for the program, a risk-based assessment and the correct way to document the program. It includes sections on types of AEM activities, evaluating the performance of an AEM program, evaluating the safety and effectiveness of an AEM program and the decision to place equipment in an AEM program.
It lays out a best-practices approach for the management of an AEM program.
AAMI’s Medical Equipment Management Committee (EQ) develops standards on aspects of medical equipment management for healthcare technology managers. The EQ committee includes five working groups. The working groups include subject matter experts. There is cross-collaboration between the groups.
Many of the locally developed internal AEM programs have had a lot of thought and data put into their creation to produce greater levels of efficiency, but the paradigm developed through a national standard would offer a framework as guidance.
To provide more solid guidelines that can be implemented across the healthcare continuum and to satisfy CMS as well as those HTM professionals implementing an AEM program, the AAMI Alternate Equipment Management Working Group developed the EQ103 standard.
The two co-chairs of the committee, who spearheaded the effort, are Maggie Berkey, biomedical equipment specialist at Bio-Electronics, and Colleen Haugen-Ortiz, healthcare technology management quality specialist at GE HealthCare.
In developing the standard, the working group compared their framework to “what’s currently out there, including requirements from CMS and The Joint Commission, and other AAMI standards such as EQ56 and EQ89.”
The standard was approved by the American National Standards Institute (ANSI) in November of 2024; an important goal of the AAMI EQ103 working group.
Berkey says that there are many ways to implement an AEM program and the standard “makes it as easy as possible to get it right.”
Haugen-Ortiz says that uniformity is important in the new standard so that there is no conflicting information so that
comparing the standard to existing standards like EQ56 or EQ89 does not result in any conflicts. Also, reviewing what CMS or The Joint Commission has published on the topic of AEM programs, was reviewed to avoid any conflict.
ANSI/AAMI EQ56 is an HTM-specific standard to create a robust maintenance program.
Elements of the standard, which will be important to those obtaining a copy, include its guidance for dealing with regulators, consistency with other standards and ANSI approval.
What will be some of the most important standardized practices to come out of EQ103?
“The annual evaluation to ensure that safety has not been compromised,” Berkey says.
“A better definition of what new equipment is, such as new tech versus new to that hospital,” says Haugen-Ortiz.
She says that the standard will provide direction for what equipment is usable for AEM and how it’s used for AEM. Berkey says that the standard is useful when HTM is talking to an accreditation body in order to point to the standard as a reference for why an action was determined.
The co-chairs say that it is important to be able to defend your AEM program. Was a risk-assessment carried out and how is the program maintained? These elements allow an AEM program to
Bio-Electronics
be more robust and, as a consequence, more defendable.
The co-chairs say they are developing a technical information report (TIR) to support the new EQ103 standard. Training on the new standard is also being developed. That effort would be aided by feedback from the regulators.
AEM programs must be continuously re-evaluated and tweaked as time goes on.
How does the standard comply with CMS requirements?
“The CMS S&C: 14-07-Hospital was our main source of information and we built this standard to provide clarity on everyday processes in HTM,” Haugen-Ortiz says.
How does the standard allow for variations/divergences from the OEM recommendations? What are some examples?
“We used CMS’ ‘S&C: 14-07-Hospital’ memo as our guide. We didn’t want to contradict the current guidelines but expand on them to help answer some of the burning questions that tend to bubble up. In the section titled ‘Elements of an AEM Program,’ we included several notes that delve into various scenarios,” Haugen-Ortiz says.
ANSI approves AAMI standards and the previous experience of many in the AAMI AEM working group, who worked on other standards, had input.
“While creating this standard, we followed ANSI guidelines to build a consensus document. The definitions are consistent with current standards as we didn’t want to include any conflicting
HealthCare
The process of creating a standard requires discussion, debate, research, consensus, feedback and documentation.
information. Many of the participants were also involved in creating or very familiar with EQ56 and EQ89 which helped ensure all the information was current,” Berkey says.
The process for developing a standard like EQ103 can take years. How were the committee and stakeholders able to accelerate this timeline? Many in the AAMI alternate equipment management (AEM) working group put in lots of time and energy and worked tirelessly to bring the standard to fruition. Haugen-Ortiz described members of the group as a “passionate group of people.”
“We had an awesome group of professionals who donated so much of their time, knowing that this standard was needed some time ago. We had multiple meetings per week and people willing to meet rigorous deadlines. They were the true drivers of this standard. Yes, there were hours when we would argue over one word or a sentence. It’s unavoidable but that is the point of having a consensus body, to make sure there is representation and that everything is worded correctly,” she says.
There were stakeholders who had a history in standards development who lent their AEM experience and their standards experience to the group’s work.
Berkey said the goal was to create a standard that “would make sense to everybody, anybody, everywhere, anywhere.” The insights of the experienced group members ensured this outcome.
CREATED FOR EXISTING OR NEW AEM PROGRAMS
How difficult will the standard be to implement for those who have set up parameters and criteria based around their own AEM programs, and will it potentially require major changes to documentation, inputs, procedures and timetables?
“If you already have a great AEM program, you’ll see where you stand and be confident when your surveyor comes. For those who are not sure, or are just getting started with AEM and want help or clarification, this standard is a great tool for them to make their program more robust, knowing all the t’s are crossed and i’s dotted,” Berkey says.
Does the new standard offer any flexibility?
The co-chairs say that the flexibility is with the authorities having jurisdiction such as state and local laws.
“We wrote this with a group of people from various backgrounds and job titles to ensure that there was representation to meet the needs of the entire HTM community,” Haugen-Ortiz says.
Adoption of the standard by CMS or The Joint Commission, and feedback from those bodies, would reinforce the confidence that AEM programs have in bringing their programs in line with the new standard.
Aligning the elements of an AEM program into commonly accepted standards that satisfy surveyors and others, while assuring the highest degree of patient safety and equipment performance is a big lift. ANSI/AAMI EQ103 endeavors to make that feat possible.
TechNation is celebrating Healthcare Technology Management (HTM) Week, taking place May 18-25, 2025, with a special contest for HTM professionals.
Each weekday, one lucky biomed will win a $100 gift card in a contest sponsored by FSI.
TO ENTER:
Scan this QR code or visit 1technation.com/htmweekcontest and create a fun caption for a selected photo.
Winners will be announced daily during HTM week on TechNation’s Facebook and LinkedIn pages.
MAY 14
SPONSORED BY
WEBINAR WEDNESDAY
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WEBINAR WEDNESDAY
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Choosing the Best Modern Healthcare CMMS Solution
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BY TYLER SMITH, CHTM
The medical equipment market in the United States is poised for significant growth, with projections indicating an increase from $188.68 billion in 2024 to $199.06 billion in 2025, according to Fortune Business Insights. As the market expands, the demand for third-party service providers to support the capabilities of Original Equipment Manufacturer (OEM) service departments is becoming increasingly critical. OEMs, bound by stringent FDA regulations in their maintenance and repair processes, often struggle with prolonged turnaround times. These regulatory requirements, while ensuring safety and quality, contribute to significant delays and backlogs in equipment servicing, ultimately leaving healthcare providers without the necessary tools to provide optimal patient care. In contrast, Independent Service Organizations (ISOs) offer a more flexible, responsive solution that can help mitigate these challenges.
Independent Service Organizations present a unique alternative to OEMs when it comes to servicing medical devices. One of the most significant advantages of working with ISOs is their ability to provide fast turnaround times. While ISOs still adhere to high standards of service quality and safety, they are not subject to the same extensive regulatory processes that OEMs must navigate. This operational agility allows ISOs to service medical equipment more quickly, ensuring that healthcare facilities experience less downtime and can maintain continuous patient care.
In addition to their speed, ISOs benefit from adaptable business models that allow them to support a wide range of medical devices from various manufacturers. While large OEMs may expand their service offerings to include multi-vendor support in major service hubs, their field service work is generally limited to their own products. ISOs, on the other hand, can train their technicians to service a broader variety of devices and technologies, making them a versatile option for healthcare providers. This ability to support multiple manufacturers’ equipment adds considerable value, particularly for hospitals or healthcare facilities that rely on a wide variety of medical devices from different sources.
However, there are challenges third-party service organizations must overcome to remain competitive and successful in the service market. One significant obstacle is the complexity of modern medical equipment. As technology advances, the need for OEM-supported training becomes more critical. While some OEMs are open to the idea of providing training to ISO technicians to meet their standards, others refuse to authorize such training, limiting the service capabilities of third-party vendors. The lack of OEM training support can also create issues with proprietary software. Many medical devices require specialized software to conduct regular maintenance and post-repair verifications. Without access to this software or the proper training, ISOs are unable to perform maintenance effectively, which hinders their ability to provide comprehensive service.
Another ongoing issue in the medical equipment service market is the supply of repair parts. OEMs and their parts suppliers must balance the demand for new unit manufacturing with the need to reserve parts for servicing and repairs. When projections for new unit sales
fall short, this can lead to a shortage of parts, affecting both OEMs and ISOs. This supply chain issue poses a challenge for all parties involved and can further delay repairs or maintenance.
Despite these challenges, Independent Service Organizations remain a strong contender in the market due to flexibility and the ability to offer a wide array of services. ISOs can adapt their business models to meet the specific needs of their customers. For example, some ISOs offer depot repair services, where they maintain an established foundation of parts, tools, and test equipment for more extensive repair and maintenance work. While a different department of the same ISO might focus on providing on-site service to minimize equipment downtime and reduce disruptions to patient care, by eliminating the need for shipping times and ensuring faster service.
When selecting a service partner, healthcare providers may face challenges, especially if they’re unfamiliar with working with third-party service providers. Although ISOs are not typically subject to the same FDA regulation as OEMs, it is still essential for them to demonstrate their commitment to high-quality service. To build trust with their customers, ISOs take steps to ensure their work meets the highest standards. This includes following service manuals, using parts that meet OEM safety and performance specifications, and maintaining proper
traceability and service history records. Providers might ask themselves these questions about the ISO being considered: Are they ISO 13485 certified for a Quality Management System relating to medical equipment? Do they show proof of calibrated test equipment? Do they provide documentation verifying device performance to OEM standards?
As the medical equipment market continues to grow, the role of Independent Service Organizations like ReNew Biomedical in supporting healthcare providers will become increasingly important. While OEMs will continue to lead in product knowledge and support, ISOs offer a more adaptable, cost-effective, and responsive alternative. With many ISO options available, it’s crucial for healthcare providers to carefully research potential partners to ensure they receive the highest level of service and quality. By making informed decisions, healthcare providers can ensure their medical equipment is serviced quickly, efficiently, and to the highest standards, ultimately improving patient care and operational efficiency.
Tyler Smith, CHTM, is an Assistant Biomedical Manager with ReNew Biomedical.
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