TechNation July 2024

Page 1


ROUNDTABLE, PG. 54

P.12 | PRO OF THE MONTH Nicole Ruffin

P.28 | HTM EVENTS

P.44 | GUIDE TO ASHE

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CONTENTS

P.12 SPOTLIGHT

p.12 Professional of the Month: Nicole Ruffin

p.14 Department of the Month: UT Southwestern Medical Center’s Healthcare Technology Management Department

p.16 Next Gen: Rhey Quandt

p.18 Shifting Gears: Medical Mission to Cameroon

P.20 INDUSTRY UPDATES

p.20 News & Notes

p.27 Welcome to TechNation

p.28 HTM Events

p.29 HTM Mixer Scrapbook

p.30 AAMI Update

p.33 Ribbon Cutting: Pinnacle Health Radiology Services

p.35 ECRI Update

P.38 THE BENCH

p.38 Biomed 101

p.40 Tools of the Trade

p.42 Webinar Wednesday Recap

FEATURE ARTICLES

p.44 Guide to ASHE

p.54 Roundtable: Asset Management

p.60 Cover Story: Incident Management and Investigation

P.64 EXPERT ADVICE

p.64 Career Center

p.66 SPONSORED: Innovatus Imaging

p.68 Networking Notes

p.70 SPONSORED: TKA

p.72 Cybersecurity

p.74 SPONSORED: Emeritus

p.76 Right to Repair

p.78 Health-ISAC

p.81 The Future

PUBLISHER John M. Krieg

VICE PRESIDENT Kristin Leavoy

VICE PRESIDENT Jayme McKelvey OF SALES

EDITORIAL John Wallace

CONTRIBUTORS Roger Bowles

K. Richard Douglas

Jim Fedele

Joie Marhefka

Manny Roman Steven J. Yelton

ACCOUNT Megan Cabot

EXECUTIVES Emily Hise

ART DEPARTMENT Karlee Gower

Taylor Hayes

Kameryn King

DIGITAL SERVICES Cindy Galindo

Kennedy Krieg

Haley Harris

EVENTS Kristin Leavoy

WEBINARS Linda Hasluem

HTMJOBS.COM Kristen Register Sydney Krieg

ACCOUNTING Diane Costea

CIRCULATION Joanna Manjarrez

EDITORIAL BOARD

Rob Bundick, Director HTM & Biomedical Engineering, ProHealth Care

Carol Davis-Smith, CCE, FACCE, AAMIF, Owner/ President of Carol Davis-Smith & Associates, LLC

Jim Fedele, CBET, Senior Director of Clinical Engineering, UPMC

Bryant Hawkins Sr., Site Manager, Children’s Hospital of New Orleans

Benjamin Scoggin, MBA, MMCi, Director, Clinical Engineering | Biomedical Operations, Equipment

Distribution, Clinical IT, DHTS, Duke Health Technology Solutions

Allison Woollford, Biomedical Equipment Specialist at Duke University Health System

DIGITAL ADVISORY BOARD

Bryant Hawkins Sr., HTM on the Line, Trimedx Site Manager at Children’s of New Orleans

Dr. Brian Bell, HTM Workshop, Faculty Biomedical Engineering at St. Petersburg College in St. Petersburg, Florida

Carlos Villafane, BMET Latino, Certified Biomedical Engineering Technician III, Baycare Health Systems

Chace Torres, Bearded Biomed, Lead Technician SPBS, Dallas-Fort Worth Metroplex

p.86 HTMA-SC Scrapbook p.87 Biomed Brainbuster p.88 Preferred Vendors Marketplace p.94 #ShowUsYourShop

Service Index

Alphabetical Index

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to TechNation TV, youtube.com/@TechNation_TV

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PROFESSIONAL OF THE MONTH

Nicole Ruffin

Better Late Than Never

While many biomeds go into some form of technical training or electronics right out of high school, others find the HTM field later in life. Some of those biomeds come out of a related field, with foundational knowledge in regards to understanding diagnostics, circuit boards or turning a wrench. Then, they pick up some specific training to enter HTM.

There are also biomeds who return to school several years after high school in order to pursue an HTM career. These individuals often make a more radical career shift and enter formal training, along with on-the-job training and some OEM-training.

Nicole Ruffin is a clinical engineering technician with Crothall Healthcare. She works at Kent Hospital, as part of Care New England in Warwick, Rhode Island. She is among those biomeds who returned to school in their mid-thirties and began an HTM career.

“I have always wanted to work in the health care field, but I only saw nursing as an option. Once I learned about biomedical equipment technology, I jumped at the opportunity to return to college at the

age of 36. Returning to school was also in honor of my late mother who always wanted me to go back to school. She herself went back to school at the age of 36,” Ruffin says.

Ruffin had some familiarity with health care; her sister works as a medical assistant and her father served as a medic in the Army National Guard.

She attended the Community College of Philadelphia in pursuit of an Associate of Applied Science degree with a concentration in biomedical equipment technology.

After earning her degree, Ruffin started her HTM career as an intern and was hired immediately afterward into a biomed role.

“I am currently in ultrasound training and interested in pursuing an imaging specialty,” she says.

Ruffin has more recently added some diagnostic imaging certifications to her credentials.

DETERMINATION

Some things that come along with a biomed career don’t necessarily get taught as part of technical training.

“A special challenge I have encountered as a biomed is identifying how far to go on a project before pausing and coming back to it. I sometimes get hyper-focused on a project and want to finish a project the same day,” Ruffin says.

Apart from her more routine assignments, Ruffin says she has worked on special projects including software updates on ST80i stress testing systems,

replacing lead shields on a Luminos Agile Max and performing high-priority corrective service on a sterile instrument washer.

While at the Community College of Philadelphia, Ruffin made the academic honors list.

Off the job, her interests include driving, cooking, baking and singing.

Just as she proved by going back to school in her 30s, Ruffin’s philosophy is “never give up.”

“And, I hope my career serves as encouragement to others. We all have a place to serve our communities, in the HTM field. If we have a thirst to continue to learn, we will always win. Never give up,” she says.

The person who nominated Ruffin as a professional of the month stated, “She is new to the industry, but she has made an impression on everyone she has come in contact with.”

Even with a late start, Ruffin’s commitment to HTM makes her a valuable member of her team.

Nicole Ruffin was inspired by her mother (black and white photo) to return to college at the age of 36 and pursue an HTM career.

BIOMETRICS

FAVORITE BOOK:

Any R.L. Stein book from “Fear Street” to “Goosebumps”

FAVORITE MOVIE: “Labyrinth”

HIDDEN TALENT:

I played the alto saxophone in grade and high school. I earned the place of second chair in concert band and played in the marching band. And as a nod to my mother, she was the lead drummer in her high school marching band.

FAVORITE FOOD: Sushi

FAVORITE PART OF BEING A BIOMED?

Learning something new every day.

WHAT’S ON MY BENCH?

Gloves, Pronk bag, PM work list, Goo Gone and equipment stickers

DEPARTMENT OF THE MONTH

UT Southwestern Medical Center’s Healthcare Technology Management Department

The numbers are impressive; UT Southwestern Medical Center is a public academic health science center in Dallas, Texas, with approximately 23,000 employees, 3,000 full-time faculty and nearly 4 million outpatient visits per year.

The medical center has four degree-granting institutions: UT Southwestern Medical School, UT Southwestern Graduate School of Biomedical Sciences, UT Southwestern School of Health Professions, and UT Southwestern Peter O’Donnell Jr. School of Public Health

The institution has had six Nobel Prize recipients since 1985 and has been recognized as one of the top 10 best employers in the U.S.

The medical center’s 44-member healthcare technology management department manages an inventory of more than 45,000 assets spread across multiple counties in North Texas.

The team includes Director Josh Virnoche, AAMIF, CHTM, CBET; Imaging Equipment Manager Wes Pool, CHTM; Biomedical Manager Paul Stodolka, CHTM; Biomedical Supervisors Tim Wicker, Cory Williams, Josh Grams and Preston Gilstrap; Imaging Equipment Supervisor Tracy McCarthy; 18 biomeds, five imaging equipment specialists and a biomedical support coordinator. The team also has two part-time paid interns who serve as biomedical equipment assistants.

The large biomed team handles medical equipment management across 24 locations and two hospitals; including William P. Clements Jr. University Hospital, Zale Lipshy Pavilion - William P. Clements Jr. University Hospital, a cancer care outpatient building, along with 176 clinics and many others.

The triple-tower, 12-story Clements University Hospital and accompanying Zale Lipshy Pavilion features more than 820 beds and offers a complete range of emergency, specialty and surgical care in more than 80 specialties and subspecialties.

Virnoche says that the department has members assigned to dialysis, sterile processing, imaging, NICU and respiratory therapy.

“However, they still have responsibilities elsewhere, and while these specialty departments are a priority for them, they are able and expected to be flexible to the needs of the overall team,” he says.

The team recently completed a major reworking of its CMMS that Virnoche made a priority.

BIG PROJECTS

New construction can always present a big challenge to biomed departments, involving planning for installation, equipment choice, support and many other factors. In addition to its already large responsibilities, the HTM team has provided its expertise as the health care system has grown.

“UTSW is growing at an astonishing pace, and the HTM team has been involved in a significant amount of it. Much of the growth was prior to my time arriving, but we have much growth coming, as well,” Virnoche says.

He says that in the depth of the COVID-19 pandemic, UTSW was deep in the construction phase of a new tower connected directly to the existing hospital. The “Orange Tower” opened early in 2021, with significant work from the HTM team.

“Our technicians were vital in the testing and installation of all the new devices within the new space, as well as go-live support during opening. The expansion included a new 12-story bed tower, which included 291 additional beds to the 460 beds that already existed at Clements Hospital. In addition, an emergency department expansion was included, which increased the capacity by more than 50 percent,”

Virnoche adds.

Additionally, the Harold C. Simmons Comprehensive Cancer Center opened on November 7, 2022.

“The new cancer center is home to new MRIs, infusions rooms, and facilitates UTSW’s multidisciplinary treatment approach, where all the various specialties a patient might need are located in a single building, rather than in different locations. The HTM team was instrumental in ensuring the equipment was installed, functional and safe to use prior to opening,” Virnoche says.

In the realm of problem-solving, the diverse team has delivered as well. Virnoche says that he feels like problem solving is what members of the HTM field are best at. He tries to involve the HTM team in everything to showcase their value.

“Our HTM team has been involved in everything from assisting with floods, to helping solve infrastructure problems that prevent our equipment from functioning properly. I think one of the greatest traits of BMETs is being the jack-of-alltrades and having to figure out how to resolve issues, in areas where they may have limited resources or knowledge,” he says.

“As I mentioned earlier, being an academic medical center, we have a unique organizational structure, and certain things that may seem like ‘not a big deal’ can quickly escalate to a ‘big deal’ here because of structure and budgeting. Typically, when we run into these situations, our team tries to ensure we are ready to support, as we kind of exist in a space that can work and exist between all of the ‘grey.’ We’ve taken the lead on facility infrastructure issues, plumbing issues, electrical supply issues, and ensure that we can be a source of trust for our customers in a situation where they may be frustrated or confused,” Virnoche adds.

have been multiple phases of construction, while ZLP is under renovation, they have not stopped seeing patients. As we approach the end of the renovation, our team will reverse what we’ve already done, as well as install new, updated equipment into the space,” Virnoche says.

Beyond the major projects accomplished, Virnoche says that the future is bright.

“Currently, we are actively working on construction for a new psychiatric hospital. Governor Gegg Abbott approved $282.5 million in funding for the hospital, and our partner Children’s Health donated $200 million to support the pediatric wing, where UTSW pediatricians will exclusively treat children and adolescents. The facility will have 296 total beds, with 200 for adults and 96 reserved for pediatric patients. While our overall equipment footprint will be limited, due to the nature of psychiatric care, we will staff this hospital and ensure that the equipment in use in this new facility is maintained and functional for all those who need it,” he says.

“I think one of the greatest traits of BMETs is being the jack-of-all-trades and having to figure out how to resolve issues, in areas where they may have limited resources or knowledge.”
- Josh Virnoche

He says the Zale Lipshy Pavilion (ZLP) is undergoing a $138.5 million renovation that will increase the number of beds from 74 to 130.

“Our team has been involved in taking equipment offline at ZLP and bringing it online in its temporary home here at CUH. There

Away from work, some of the team members are involved with the newly revitalized HTMA-North Texas biomed association (HTMA-NTX).

“Our local HTM association is currently going through a revitalization and, as such, one of our supervisors was selected as a membership chair for HTMA-NTX, and I was selected as the V.P.-Dallas. Our first social event will be happening in just a couple of weeks, and I’m excited to see all the work that the team has put into making it happen,” Virnoche says.

With continuous improvements in this HTM team, tasked with a massive inventory of equipment and big improvements to the CMMS implementation since Virnoches’ arrival in early-2023, the UT Southwestern Medical Center’s mission to “Educate, Discover, Heal” moves forward to the benefit of north Texas residents.

NEXT GEN

POWERED BY YP AT MD

Rhey Quandt

A

dvocate Aurora Health

Biomed Equipment

Technician Rhey Quandt earned a degree at Marquette University before embarking on an HTM career. Her decision to become a biomed stems from a speech she heard while attending high school in rural Wisconsin.

TechNation recently found out more about this member of the next generation of HTM, including her goal to expand her knowledge and work on imaging equipment before 2030.

Q: WHERE DID YOU GROW UP?

A: Rural Wisconsin

Q: WHERE DID YOU RECEIVE YOUR HTM TRAINING/ EDUCATION?

A: Marquette University and the experience of those around me.

Q: HOW DID YOU FIRST DISCOVER HTM?

A: I discovered HTM through a speech given while in school by a clinical engineer, encouraging people to pursue careers on this side of medical technology.

Q: HOW DID YOU CHOOSE TO GET INTO THIS FIELD?

A: I did an internship for an OEM and realized I preferred this field because I was able to see the direct impact the work I do has for the hospital staff and the patients they serve.

Q: WHAT DO YOU LIKE MOST ABOUT YOUR POSITION?

A: I love learning new things from the more experienced technicians and my ability to interact with a wide variety of people every day.

Q: WHAT INTERESTS YOU THE MOST ABOUT HTM?

A: I like seeing how new technologies are used in the field and all the work that goes on behind the scenes to keep hospitals running.

Q: WHAT HAS BEEN YOUR GREATEST ACCOMPLISHMENT IN YOUR FIELD THUS FAR?

A: Hearing that a repair I made on a device allowed for a patient to receive treatment they otherwise would not have been able to get. Hearing that my contributions made a direct impact was incredibly rewarding.

Q: WHAT GOALS DO YOU HAVE FOR YOURSELF IN THE NEXT 5 YEARS?

A: I want to learn more about imaging equipment and learn enough to become a resource for new techs in the future.

FUN FACTS

FAVORITE HOBBY: Building Lego sets

FAVORITE SHOW OR MOVIE: “The Princess Bride”

FAVORITE MEAL: Sushi

WHAT WOULD YOUR SUPERPOWER BE? Teleportation

1 THING ON YOUR BUCKET LIST: Visit every National Park.

SOMETHING YOUR CO-WORKERS DON’T KNOW ABOUT YOU: I’m a terrible baker.

Supply Chain Resiliency and High Reliability for Facilities Management

Optimizing Your Facilities and Workspaces

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Healthcare Facilities Management and Support Services teams face a complex set of challenges when it comes to procurement of parts , supplies, and services needed to repair and maintain the physical plant. These include:

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Healthcare Facilities Management and Support Services teams face a complex set of challenges when it comes to procurement of parts, supplies, and services needed to repair and maintain the physical plant. Insufficient systems, limited to no visibility to spend & performance analytics, and a fragmented set of suppliers and service providers can lead to:

This leads to:

Healthcare Facilities Management and Support Services teams face a complex set of challenges when it comes to procurement of parts , supplies, and services needed to repair and maintain the physical plant. These include:

Healthcare Facilities Management and Support Services teams face a complex set of challenges when it comes to procurement of parts , supplies, and services needed to repair and maintain the physical plant. These include:

• Maintaining relationships with hundreds of suppliers and service providers

• Complicated procurement processes

• Maintaining relationships with hundreds of suppliers and service providers

• Time consuming product searches and sourcing

Missed opportunities for cost savings through a consolidated supply chain

• Complicated procurement processes

Reduced productvity—team members spend too much time searching, sourcing and tracking orders

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Missed opportunities for cost savings through a consolidated supply chain

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PartsSource combines people, process and technology to deliver an actively managed supply chain and streamlines the entire procure-to-pay process, resulting in increased capacity for facilities management teams to focus on high-value work. This technology platform enables process standardization, integrates best practices, and provides robust analytics for visibility and insight into spending trends and history. PartsSource also integrates with leading healthcare Computerized Maintenance Management System (CMMS), so facilities management professionals can track material costs for total equipment lifecycle management.

SHIFTING GEARS

Medical Mission to Cameroon

Th e western highlands of Cameroon can get 400 inches of rain from May through October; making it one of the wettest places on earth. The country, which lies on the coast of central Africa, is also one of the most ethically diverse in the world, with more than 200 different ethnic groups and 240 languages spoken.

There was a time when Cameroon was quite prosperous and it has natural resources like cobalt and oil, but an economic crisis during the 1990s impacted the country’s economy and resulted in major cut backs in health care spending. Medical supplies and health care professionals remain in short supply to this day.

That has been part of the impetus for Cameroon-born American biomed Alain Lengue to address the medical equipment and repair shortcomings in his homeland. He is a clinical engineer with Elite Engineering. Lengue has seen the vast disparity between the quality of health care in his adopted country and his native country and set forth to do something about it.

“I was born in Cameroon, Africa. I immigrated to the United States in year 1999. I did not speak English, and French was my first language. I went to school here to learn ESL (English as a Second Language). I continued my education and got my bachelor of science in biomedical engineering technology from DeVry University in Kansas City, Missouri,” Lengue says.

Lengue returned to Cameroon for a vacation in 2010 and got diagnosed with appendicitis. What

followed was harrowing to consider.

“I almost died due to the lack of medical equipment to perform the surgery. I was told I will die. Finally, I got operated on a kitchen table with one barely working generator. The surgery was successful and that is where I discovered the desperate need of medical equipment,” he says.

As a result of that experience, Lengue created a not-for-profit 501(c)3 organization called the African Biomed Group to educate and train medical and technical staff in developing countries.

“Since then, I have been traveling to Cameroon to assist with medical mission trips. I have collected used and defective medical equipment here in the United States, fix them and ship them to some facilities in Cameroon. Consequently, it was not productive because it’s important to properly select the equipment and accessories for optimal performance for the medical procedure,” he says.

He says that now he intends to build a clinic there to train the trainer on how to diagnose and fix medical equipment.

“I want to create awareness of the vast differences in medical procedures between third-world countries and the United States of America,” Lengue says.

TRAINING THE BIOMEDS OF CAMEROON

Lengue says it was providence that he met Dr. Jean Louis Benae in Dallas, Texas in 2019. Benae, a neurosurgeon, also happens to be a fellow Cameroonian.

“He invited me to his house for New Year’s party. I went there with my children – Jason, (and twins) Jeanna and Jayden – for the party. Once I arrived there, he pulled me to the side and told me about a big project, that he has to go to Cameroon to perform difficult surgeries on people for free. He told me about his organization called Brain Project Africa.

I then freely volunteered to donate my finances, time, talent and equipment to the cause,” Lengue says.

He paid for airfare, visas and immunization application fees, his lodging, including transportation fees, room and board fees; all out-of-pocket for a month.

“That medical mission was very successful. I got a lot done and the team also got a lot accomplished. I’m was very fulfilled and satisfied at the outcome of the mission. Unfortunately, the second medical mission trip to Ghana, I couldn’t go due to a lack of finances,” Lengue says.

He says that after seeing the need, he created the African Biomed Group to make an impact because of the severity of the need.

“They have no test equipment, no parts, no access to resources to troubleshoot and repair. For example, here in the USA, I have the luxury to call the manufacturer for troubleshooting or ordering parts. Over there, first of all, the access to the phone is a luxury, not to say calling an international line to ask about preventive maintenance or repair on a particular device,” Lengue says.

He says that it is important to understand that the concept of maintaining, repairing and performing regular PMs is non-existent in developing countries.

“If a piece of medical equipment does turn on, that’s good enough to be used despite the liability of that equipment,” Lengue explains.

Parts are often impossible to locate; including the most basic parts. Lengue provides an example from

a real-life experience while working on a dental chair and a surgical table.

“I needed a fuse 250V and 0.5A and a few screws to complete my repair. It took me all day long to search and find the fuse. I drove around town and I still couldn’t find the basic fuse. Therefore, you have to adapt by being creative. Creativity is your main and most important tool that you have to possess in order to function there,” he says.

In most of the facilities that Lengue has visited, the only person doing any repairs or maintenance might be a part-time electrician.

“That electrician employee is the one doing pretty much everything including carpeting, plumbing; you name it,” Lengue says.

He says that his overall experience making medical mission trips to developing countries has been humbling.

“I’m so grateful and it helps me to be really appreciative of my life and the opportunities that I currently have here in the United States of America. Yet, I’m devoted to continue my mission, therefore I created the African Biomed Group to educate and train medical and technical staffs in developing countries,” Lengue says.

Right now, Lengue needs the finances to put up a website, rent a warehouse and purchase replacement parts. He also needs to collect some training materials.

“All I know is that I have an elephant in front of me to eat. In order to eat that elephant, I will take one bite at the time,” he adds.

NEWS & NOTES

Updates from the HTM Industry

HEALTH CARE REACTS TO FTC’S NONCOMPETE BAN

Consensus does not exist when it comes to the Federal Trade Commission’s final rule banning noncompetes.

In a news release, the FTC says the final rule is “protecting the fundamental freedom of workers to change jobs, increasing innovation and fostering new business formation.”

“Noncompete clauses keep wages low, suppress new ideas, and rob the American economy of dynamism, including from the more than 8,500 new startups that would be created a year once noncompetes are banned,” said FTC Chair Lina M. Khan. “The FTC’s final rule to ban noncompetes will ensure Americans have the freedom to pursue a new job, start a new business, or bring a new idea to market.”

The FTC estimates that the final rule banning noncompetes will lead to new business formation growing by 2.7% per year, resulting in more than 8,500 additional new businesses created each year. The final rule is expected to result in higher earnings for workers, with estimated earnings increasing for the average worker by an additional $524 per year, and it is expected to lower health care costs by up to $194 billion over the next decade. In addition, the final rule is expected to help drive innovation, leading to an estimated average increase of 17,000 to 29,000 more patents each year for the next 10 years under the final rule.

While this may sound good to many, the American Hospital Association and AdvaMed issued statements

questioning the wisdom behind the rule.

In a statement shared with the media, Chad Golder, AHA general counsel and secretary, said, “For all of the reasons the AHA explained in its comment letter, the FTC’s final rule banning non-compete agreements for all employees across all sectors of the economy is bad law, bad policy, and a clear sign of an agency run amok. The agency’s stubborn insistence on issuing this sweeping rule – despite mountains of contrary legal precedent and evidence about its adverse impacts on the health care markets – is further proof that the agency has little regard for its place in our constitutional order. Three unelected officials should not be permitted to regulate the entire United States economy and stretch their authority far beyond what Congress granted it – including by claiming the power to regulate certain tax-exempt, nonprofit organizations. The only saving grace is that this rule will likely be short-lived, with courts almost certain to stop it before it can do damage to hospitals’ ability to care for their patients and communities.”

AdvaMed, a medtech association, recently commented on the FTC’s proposed rule that would ban employers from imposing or enforcing non-compete clauses in contracts with certain workers. AdvaMed opposes the FTC’s vastly overbroad proposed rule because it says that it threatens patient health, innovation and competition.

“The proposed rule would significantly impede medical technology innovation and reduce competition, resulting in diminished quality and increased cost of health care available to patients,” said Christopher White, general counsel and chief policy officer.

Danny Mobley, founder of Humans of Healthcare, has years of experience in the HTM field. He shared a different opinion of the final rule in a recent phone interview with TechNation. The new rule is exciting for Mobley who sees it as a great opportunity for technicians. It could create a “gig economy” for medical device service. He also said it will reward the bold and courageous who venture out and challenge the system quo.

“I think the HTM industry could change significantly with noncompetes,” Mobley said.

In an example he has used before, he talked about how an OEM may charge $1,000 an hour for imaging service with the technician earning $50 an hour which means the OEM pockets $950. Mobley explains that in a gig economy a technician could do the work and charge $400 an hour.

He sees this as the federal government taking a small step in one direction that creates an opportunity.

“If you want the money you have to fight for it.” Mobely said. “The government took a step here but how many steps will they take?”

“Why not create a gig economy,” he added. “The technician can keep the OEM job but also work on weekends and on the side.”

He said the technicians are the ones providing the service and they should have more power.

Mobley speculated that there could be an app like a ride-sharing app where a health care facility searches for a specific type of repair and has several offers with cost, service time and more spelled out. The information, along with ratings, could provide a process for making an informed decision when selecting a servicer.

Mobley also said he could see FTC’s final rule impacting the ongoing Right to Repair campaign in the medical device industry.

Challenges to the final rule are already underway with patient safety listed among the reasons it is a bad idea. Mobley disagreed.

He said patient care and patient safety could improve. He explains that in a gig economy technicians will take ownership of the repair work they perform more so than a technician working for an OEM or ISO. The technician’s reputation (and future repair work opportunities) will be on the line with each service performed.

Work-life balance is another positive, according to Mobley.

A gig economy could also allow retiring biomeds to ease into retirement by doing repairs/service on their own terms when the want to take on a job.

“The noncompete ban gives you an opportunity now that you’ve never had before,” he said. “Why not have an optimistic outlook? It may not come around again.”

LOOKING FOR A CMMS THAT IS DESIGNED FOR HTM BY HTM EXPERTS?

EQ2 HEMS: A "Smart CMMS" that Makes Everything from Managing Work Orders to Maintaining Compliance, Reporting, and Capital Planning Easier

 Numerous integrations, to streamline workflows

 Superior regulatory compliance reporting included

 Mobile app designed for offline and online work means you can always access what you need when you need it

 Data and information in the format that fits the needs of all levels of management and the hospital as a whole

INDUSTRY UPDATES

MD EXPO ADDS H.O.T. WORKSHOP

New for MD Expo New England is the Hands-On Training Workshop or H.O.T. Workshop.

The H.O.T. Workshop is being introduced at MD Expo to provide an all-day, hands-on training option for technicians to learn the ins and outs of servicing different types of equipment. Experts from the HTM community will be on site to provide immersive training.

The H.O.T. Workshop on tap for MD Expo New England is a session on patient monitors.

This session will be offered on Tuesday, October 8 from 9 a.m. to 4 p.m. (with an hour break for lunch) and will be eligible for CEUs through ACI. The cost to attend is $100 (discounts not applicable).

Biomeds and HTM professionals can register for the October 2024 conference at MDExpoShow.com.

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HEALTH INFORMATICS LEADER JOINS VIZZIA TECHNOLOGIES’ BOARD OF ADVISORS

Vizzia Technologies has appointed Petrena U. Saunders to the company’s board of advisors.

Saunders, MSHI, BSN, RN, LSSGB, CPHIMS, is founder and managing principal of Anertep. She has held a progressive series of clinical and informatics leadership roles for prestigious health care institutions, including vice president and chief health informatics officer at Trinity Health of New England and NY, one of the largest Catholic health care systems in the nation with 100+ hospitals.

“Vizzia provides clinicians with real-time data analytics, which produces meaningful results for prominent health systems nationwide,” said Petrena Saunders. “I look forward to advising Vizzia as they continue to develop innovative data solutions to improve patient care and health care efficiency.”

Petrena earned a bachelor’s degree in nursing from Austin Peay State University and a master’s in health informatics from the University of Illinois. Her certifications include a Lean Six Sigma Green Belt (LSSGB) and is a Certified Professional in Healthcare Information and Management Systems (CPHIMS).

“We are honored to have Petrena’s thought leadership on health informatics trends,” said Andrew L. Halasz, CEO of Vizzia Technologies. “Her extensive clinical experience and valuable insights are a welcomed addition to our distinguished board of advisors, which includes the CIO of Piedmont Healthcare, former CEO of GE Healthcare and other senior leaders from respected global organizations.”

GENTHERM, US MED-EQUIP FORGE ALLIANCE

US Med-Equip has partnered with Gentherm to expand distribution of Gentherm’s Blanketrol System in the United States health care market.

The agreement enables hospitals nationwide who rely on US Med-Equip, to purchase Gentherm’s Blanketrol III Hyper-Hypothermia device, Maxi-Therm Lite water blankets, Kool-Kits and an industry-leading four-year total warranty package.

The new partnership also offers field service and preventative maintenance plans to hospital customers, leveraging US Med-Equip’s extensive team of field service technicians. By utilizing US Med-Equip’s Gentherm-certified technicians, hospitals ensure their devices are operating effectively, protecting their investment and minimizing unforeseen downtime.

“The relationship with US Med-Equip is incredibly

exciting and leverages our respective strengths, adding significant value for our customers,” said Gentherm Medical’s Senior Vice President and General Manager Steve Fletcher. “Combining our temperature management expertise with US Med-Equip’s long-standing hospital relationships and superior customer service and field support allows us to deliver a comprehensive solution to hospitals.”

US Med-Equip and Gentherm share in the commitment to support health care professionals improve patient outcomes.

“Our partnership with Gentherm bolsters our unrelenting commitment to health care heroes seeking smarter solutions that uphold the highest standard of care for every patient seeking comfort and healing,” Greg Salario, US Med-Equip CEO, said.

INDUSTRY UPDATES

FDA ISSUES FINAL GUIDANCE TO CLARIFY ‘REMANUFACTURING’

On May 9, the U.S. Food and Drug Administration issued final guidance to provide the medical device industry clarity on the definition of “remanufacturing” for reusable devices needing maintenance or repair. The final guidance seeks to ensure that there is consistency regarding what constitutes remanufacturing activities and to promote a better understanding of applicable federal law and regulations implicated by remanufacturing activities. The final guidance was issued following the agency’s extensive review of postmarket information and consideration of public comments, which highlighted the need for clarity, considering the different regulatory implications between “servicing” and “remanufacturing” of a medical device.

“Today’s action represents an important step forward in our mission to assure continued patient access to high-quality, safe and effective medical devices,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “This guidance provides important clarity on defining remanufacturing and helps to remove perceived barriers to obtaining repair or maintenance of a device if it does not alter the safety, performance or intended use.”

Many medical devices are reused; for instance, infant warmers, ventilators, endoscopes and defibrillators, and proper servicing is critical to the device’s continued performance and overall total product life cycle. Additionally, many devices are complex and use varying technologies to be safe and effective for their intended use. Without access to information and resources to ensure proper servicing, unintentional remanufacturing, which may cause the device to be out of compliance with and in violation of federal law, can occur. Because of this, the FDA is advising in this guidance that devices include instructions necessary for proper device servicing, as well as providing examples of activities that constitute remanufacturing.

Remanufacturing is the processing, conditioning, renovating, repackaging, restoring or any other act done to a finished device that significantly changes the finished device’s performance, safety specifications or intended use. Servicing is the repair and/or preventive or routine maintenance of one or more parts in a finished device, after distribution, for purposes of returning it to the safety and performance specifications established by the original equipment manufacturer

(OEM) and to meet its original intended use.

The FDA determines whether the specific tasks performed on the device constitute “remanufacturing” activities according to the authorities in the Federal Food, Drug, and Cosmetic Act and its implementing regulations, such as the quality system regulation, but not according to an entity’s self-identified designation as a “remanufacturer” or a “servicer.” Simply put, remanufacturing is when a significant alteration is made to a device’s performance, safety specifications or its intended use, changing the device from what was legally marketed as approved, cleared or authorized by the FDA. The final guidance sets forth guiding principles that the FDA recommends applying in the context of remanufacturing, a flowchart to help determine whether activities may be remanufacturing and examples that may be helpful to industry.

Additionally, the guidance recommends certain information be included in the labeling of reusable medical devices regarding their preventive maintenance and repair, including instructions on how to adequately return a device to its performance and safety specifications established by the OEM. The labeling recommendations do not encourage the disclosure of trade secrets or confidential commercial information. The FDA believes including this information should be considered an industry best practice going forward.

Third-party servicers are entities, other than the manufacturer or healthcare delivery organizations using the device, that maintain, restore, refurbish, repair or service a finished device after distribution, for purposes of returning it to the safety and performance specifications established by the OEM and to meet its original intended use. The agency continues to recognize the importance of stakeholders’ perspectives regarding the need for proper servicing that ensures quality, safe and effective devices remain available throughout their use life.

The availability of timely, cost-effective, quality maintenance and repair of medical devices is critical, both to the successful functioning of the U.S. health care system and the public health. The FDA’s regulations and policies should not be considered an impediment to sharing information, tools and access to third-party servicers, as these policies are intended to help facilitate high-quality servicing by all entities engaged in these activities.

TECHNATION TV DELIVERS VALUABLE HTM CONTENT

View all the biomed and HTM content you want and need at TechNation’s YouTube channel TechNation TV!

TechNation TV delivers diverse content that helps biomed, clinical engineering, IT and more health care professionals keep their finger on the pulse of the healthcare technology community. It assists the community members by providing information they can use to advance their careers and further their profession.

Whether it is one of the several podcasts, videos or “shorts” –TechNation TV has something for everyone! Visit TechNation.TV to check out the library of shorts, Tools of the Trade Product Demos, Webinar Wednesday sessions, the LIVE at MD Expo videos and multiple playlists.

TechNation TV also includes curated content from TechNation Digital Advisory Board (DAB) members: Bryant Hawkins Sr., creator of HTM on the Line and Trimedx Site Manager at Children’s of New Orleans; Dr. Brian Bell founder of HTM Workshop and member of the biomedical engineering faculty at St. Petersburg College in St. Petersburg, Florida; Carlos Villafane creator of BMET Latino and a Certified Biomedical Engineering Technician III with Baycare Health Systems; and AAMI & GE Healthcare BMET of the Year Chace Torres, also known as the Bearded Biomed and lead technician with SPBS in the Dallas-Fort Worth Metroplex.

An exciting new contributor is Rodgerick Wiliams, MSHA, national director of corporate accounts for Tenacore. He has already shared a videos on health care procurement and another about HTM’s silent heroes.

Check out all the content now and click “subscribe” at TechNation.TV

U.S. CALIBRATION LAB ACHIEVES ISO 17025

ACCREDITATION

IMT Analytics Inc. recently announced “a remarkable achievement” that marks a new chapter for the company. Its U.S. calibration laboratory in St. Petersburg, Florida, has been awarded the ISO 17025 accreditation.

This milestone enables IMT Analytics to commence offering ISO 17025 accredited calibrations to the North American market effective immediately.

IMT Analytics’ state-of-the-art solutions, including EasyCal and CalBench X, have been instrumental in this success. They streamline and expedite the calibration process, aligning with ISO 17025’s stringent requirements for defined calibration procedures and objective result evaluation.

IMT Analytics also offers calibration services for private labeled versions of IMT Analytics analyzers such as the BC Group PFC-3000 line, the Rigel Medical VenTest 800 series and the Fluke Biomedical VT305.

Medical equipment everywhere, yet nowhere?

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WARWICK JOINS DMS HEALTH TECHNOLOGIES

Scott Warwick has joined DMS Health Technologies as executive vice president of operations and service. Warwick brings more than 20 years of clinical and health care administrative experience leading strategic and day-to-day operations for cancer centers, oncology groups and radiology programs. He started his career as a certified medical dosimetrist, providing hands-on experience developing radiation oncology treatment plans with physicians, and assisting medical physicists in quality assurance for radiation treatment delivery. Most recently, he was chief administrative officer and president at Thompson Cancer Survival and Thompson Oncology Group. He is also a former executive director for the National Association for Proton Therapy.

“As a former radiologic technologist and throughout my career in diagnostic imaging, I know how critical it is to solve problems and remove barriers so people can do their job well,” said Warwick. “I’m really excited about joining DMS Health Technologies and helping carry out our mission to make health care better in the communities we serve.”

“With his deep experience and expertise, it’s clear that Scott has what it takes to manage clinical operations at a very high level,” said Patrick Doyle, CEO for DMS Health Technologies. “But as importantly, he’s mission focused and committed to making things work better from the front lines on up.”

In his new role with DMS, Warwick will oversee all aspects of DMS operations teams across the country, as well as fleet management and service for one of the largest mobile imaging fleets in the U.S.

WELCOME TO THE TECHNATION COMMUNITY!

SURGI-CALL

Q: WHAT PRODUCT, SERVICE, OR SOLUTIONS DOES YOUR COMPANY PROVIDE TO THE INDUSTRY?

Surgi-Call is a new, small but growing business that specializes in the installation, maintenance, repair and refurbishment of Ziehm and OrthoScan products. Exceeding and surpassing our customer’s expectations is our goal. Having a down or impaired device is already stressful enough, so we aim to make the process of resolution stressless and seamless. To top it all off, prompt service and bringing savings to our customers will have us at the top of their list whenever their devices need attention in the future. We provide nationwide service any day, evening, night or weekend. Products that Surgi-Call supports are Ziehm Solo, Ziehm Solo FD, Ziehm Vision2, Ziehm Vision R (9” & 12”), Ziehm Vision RFD, Ziehm Vision HE (Motorized), Ziehm Vision RFD 3D, OrthoScan HD, OrthoScan FD, OrthoScan OrthoTouch, OrthoScan MDI, OrthoScan TAU

Q: TELL US WHAT DIFFERENTIATES YOUR COMPANY FROM THE COMPETITION?

Aside from the OEM, the lack of expertise in the field is what prompted Surgi-Call. We stand out from the competition by offering complimentary technical support on the aforementioned products, friendly staff, and the fact that we charge a flat rate whether we are on site during the business day, evening, night or weekend.

Q: WHY DID YOU CHOOSE TECHNATION FOR ADVERTISING?

TechNation is the leading biomedical, imaging and healthcare technology management publication, which reaches most of my target audience.

For more information, email MNoll@surgi-call.com.

PARTSSOURCE

Q: WHAT PRODUCT, SERVICE, OR SOLUTIONS DOES YOUR COMPANY PROVIDE TO THE INDUSTRY?

With the mission of ensuring healthcare is always on, PartsSource empowers owners and operators of mission-critical equipment to maximize clinical availability and patient throughput, while achieving sustainable savings and efficiencies. PartsSource connects more than 5,000 hospitals and 15,000 clinical sites with more than 10,000 suppliers, enabling access to parts, services and training through the leading technology platform for managing mission-critical healthcare equipment. The PartsSource enterprise software platform, PartsSource PRO®, enables 1,600 leading hospitals across the country to solve a shared set of challenges and maximize asset uptime, reduce costs, and increase procurement efficiency related to equipment maintenance.

Q: TELL US WHAT DIFFERENTIATES YOUR COMPANY FROM THE COMPETITION?

PartsSource was founded on the belief that an evidence-based, digital approach to the healthcare supply chain can unlock better deliver, lower costs, and enhance clinical outcomes. Today, PartsSource is known for pioneering the industry’s first and only clinical resource management platform and establishing the industry’s largest equipment service network. Only PartsSource provides the following combination of benefits and digital tools to help healthcare providers measure and manage quality, improve operational efficiency, and reduce costs:

• A single, enterprise platform with cloud-based integrated workflow

• Evidence-based PRECISION PROCUREMENT® decision support technology

• Formulary management for enterprise preferences

• Peer-based visual analytics benchmarks

• Community-based purchasing power

Q: WHY DID YOU CHOOSE TECHNATION FOR ADVERTISING?

PartsSource chose TechNation for advertising because of its extensive reach and influence within the healthcare technology industry. As a leading resource for medical equipment service professionals, TechNation provides diverse and relevant content for the customers PartsSource serves across the Biomedical, HTM, Imaging, and IT space.

Mark Noll, CBET Founder & Managing Member
Mara Pare Vice President,

HTM EVENTS DELIVER EDUCATION & MORE

MD Publishing continues to provide outstanding educational opportunities for biomeds at events across the country.

M D Publishing recently hosted an HTM Mixer in Indianapolis with support from the Indiana Biomedical Society. Almost 300 healthcare technology professionals descended on the Westin Indianapolis for the HTM Mixer.

The HTM Mixer is a hybrid event that combines the best of a state association annual meeting and an MD Expo. The HTM Mixer was a two-day event with an exhibit hall, educational opportunities and networking.

The educational sessions covered a variety of important topics including contrast injectors, CMMS, Right-to-Repair, Phaco systems, team building, time management and more.

Trimedx’s Jeffrey Ruiz, CHTM, is the senior site manager-West Michigan with the Sparrow & Holland Organizations. He praised the HTM Mixer.

“Networking, education, synergy” Ruiz said when asked to describe the HTM Mixer in three words.

“Events such as the HTM Mixer allow us to see a different perspective on the many similar challenges we are all facing. True that some of the perspectives are obtained in the various training sessions. However, many are also made between sessions and throughout the day,” Ruiz added.

HTM MIXER LEXINGTON

Just Announced! HTM Mixer is joining forces with the Kentucky Association of Medical Instrumentation (KAMI) to host the HTM Mixer Lexington Friday, November 15 and conclude on Saturday, November 16 at the Marriott Resort Griffin Gate (1800 Newtown Pike, Lexington, KY 40511).

MD Publishing President John Krieg is excited to partner with KAMI and add this educational and networking event to the 2024 calendar.

KAMI President Tom Bledsoe agreed.

“Speaking for our board, KAMI is beyond thrilled to partner with MD Publishing, to present this Mixer. After our first symposium (2019), the virus gave us a real issue, and almost stopped our momentum,” Bledsoe continued. “For those who have been asking for another large show – Here ya go! We are back!”

COMING SOON

Make sure to save the date for the 2025 HTM Mixers taking place in Denver (May 15-16) and Milwaukee (July 31-August 1).

HTM MIXER: INDY SCRAPBOOK

1. Networking is one of the benefits of attending an HTM Mixer.

2. Continuing education sessions provide valuable CE credits to biomeds.

Networking is one of the benefits of attending an HTM Mixer. Continuing education sessions provide valuable CE credits to biomeds.

3. Attendees and vendors benefit from a busy exhibit hall

Attendees and vendors benefit from a busy exhibit hall Biomeds learn about the latest solutions available from PM Biomedical.

4. Biomeds learn about the latest solutions available from PM Biomedical. 5. HTM

Kristen register and ProHealth Care’s Rob

HTM Jobs’ Kristen Register and ProHealth Care’s Rob Bundick catch up at the HTM Mixer in Indy.

catch up at the HTM Mixer in Indy.

6. Exhibitors and attendees enjoy a refreshing break at the finale party.

Exhibitors and attendees enjoy a refreshing break at the Welcome Reception.

Jobs’
Bundick

AAMI UPDATE

New Guidance on FDA CGMP’s for Combination Products

As the breadth and scope of combination products around the world continues to ramp up, are U.S. manufacturers equipped with the best design plans possible? A brand-new guidance document, released by the Association for the Advancement of Medical Instrumentation (AAMI), will assist manufacturers in aligning with the latest best practices for manufacturing combination products.

AAMI TIR48:2024; Quality Management Systems (QMS) Recommendations On Application Of The U.S. FDA’s CGMP Final Rule On Combination Products recommendations on application of the U.S. FDA’s CGMP final rule on combination products is designed to assist manufacturers with abiding by the Food and Drug Administration’s regulation on current good manufacturing practices (CGMPs) for combination products.

Combination products are defined as products that incorporate drugs or biologics with medical devices. However, the taxonomy and regulations surrounding these products may vary wildly from country-to-country, leading to confusion for manufacturers looking to stay compliant with U.S. requirements. AAMI TIR48 provides a comprehensive resource for manufacturers navigating FDA requirements for combination products and ensuring they can bring medical devices to market that will benefit patients. AAMI TIR48: • Assesses FDA’s codified ‘Streamlined Approach’ for

compliance with CGMPs and identifies manufacturer considerations.

• Provides a clause-by-clause assessment of the pertinent sections of 21 CFR and identifies compliance pathways.

• Addresses viable alternative and streamlined mechanisms for complying with CGMPs.

• Compiles management responsibilities for manufacturers of combination products, addressing aspects such as executive oversight, quality policy, risk based QMS, auditing and more.

• Applies design controls and risk management to combination products.

• Includes information on purchasing controls, corrective and preventive action (CAPA), and inspection readiness for manufacturing facilities.

AAMI TIR48 was produced by the AAMI Combination Products Committee, which is co-chaired by John Weiner, director of the Office of Global Operations at FDA, and Susan Neadle, an industry veteran and leading expert in the field of combination products. According to Neadle, “Sometimes you’re using the exact same words for the drug world as you use in the device world, but the interpretation is different. That creates all sorts of confusion not just for industry but also for health authorities. So, the inspection readiness piece of TIR48 will help you contend with that both internal to your organization and as you’re interfacing with health authorities.”

In short, AAMI TIR48 provides the most current industry guidance for combination products manufacturers as they deal with an increasingly complex regulatory environment. The standard is available for purchase in the AAMI store.

HTM LEADERS DEMONSTRATE PROMISING STEM CAREER PATHS FOR STUDENTS

While healthcare technology management (HTM) departments around the U.S. and abroad struggle to fill open positions, AAMI’s members and HTM leaders are inspiring the next generation to consider the essential field as a rewarding career path. Most recently, Bryant Hawkins Sr., site manager for TRIMEDX and the Children’s Hospital of New Orleans, hosted a career fair for students, showcasing what they could accomplish as a HTM professional.

The event was co-hosted with STEM NOLA, a 501(c)(3) nonprofit dedicated to sharing valuable perspectives about STEM career opportunities with students across the U.S., and featured five workstations for students to gain hands-on experience with HTM tools and technologies.

With the help of several other HTM leaders from across the U.S., students learned about sign monitors, defibrillators, MRI unit coils, and learned valuable insight into where an HTM career could take them from a college instructor. Some students even had the opportunity to join Hawkins for a recording of his HTM on the Line podcast, sharing the next generation’s perspective on career prospective and their personal goals.

“Their attentiveness, insightful questions, and valuable suggestions on how the HTM industry could evolve were impressive,” Hawkins later noted. “To say I was blown away by their engagement and insight would be an understatement!”

“Interestingly, only two attendees were previously aware of the HTM industry,” he added, highlighting the importance of bringing more attention to the essential field. “By the end of the fair, every student had gained a comprehensive understanding of the field, signaling the event’s overwhelming success in spreading awareness.”

Maria Denson representing the HTM Women in Leadership Society; D’Juan James, director of clinical engineering at St. Elizabeth Healthcare; HTM instructor and professor Jeffrey Smoot, who is also the CEO of Interactive Healthcare Designs; and Allison Woolford, biomedical equipment specialist at Duke University Health System, supported the event.

RIBBON CUTTING

Pinnacle Health Radiology Services

Pinnacle Health Radiology Services was founded in 2006 by Jody Rotenizer and has grown to offer MRI, CT and PET/CT system sales and service across the United States and the Caribbean. TechNation interviewed Vice President of Sales Jim Prout to find out more about the company and how it helps HTM professionals.

Q: WHAT ARE SOME OF THE SERVICES AND PRODUCTS YOU OFFER? IS THERE A SPECIFIC OR NEW ONE YOU ARE EXCITED ABOUT RIGHT NOW?

PROUT: On MRI we are primarily GE, Philips and Siemens but we also support Hitachi MRIs. We support GE, Siemens, Philips and Canon CTs. We support GE and Siemens PET/CT.

PET/CT has been our newest area of focus, but is fast becoming a core piece of our business as we support both fixed site and mobile PET/CT clients. With its growing use in oncology, urology, cardiac and now Alzheimer’s disease; it is a modality with an enormous amount of potential growth. We intend on further investing and expanding in this space and assisting our customers in expanding into it.

Q: HOW DOES YOUR COMPANY STAND OUT IN THE MEDICAL EQUIPMENT FIELD?

PROUT: I believe one of the things that makes Pinnacle unique is our depth of technical knowledge and scope of capabilities. We have OEM specific ramp and shim equipment but also the new universal Echo ramp kit allowing us to ramp and shim GE, Siemens, Philips and Canon MRI systems. Having spent most of my 24 years in this space, there are not as many groups with that capability as you might think. It’s a clear separator.

Q: WHAT IS ON THE HORIZON FOR YOUR COMPANY?

PROUT: I see exciting opportunities for us to take our scope of knowledge and capabilities to the next level with a variety of clients. Whether it’s IDNs looking for partners to train and assist their in-house clinical engineering teams or partnering with companies with specialties in areas of imaging and service we do not. In this era of rapid change and consolidation, having trusted partners you can depend on matters even more than it ever did.

We want to keep our steady, stable growth curve and continue to expand into the spaces we feel fits us best. Organic growth, partnership growth and continued internal growth to meet the demands of the first two. If we continue along with this path, I expect exciting things in our future.

Q: IS THERE ANYTHING ELSE YOU WOULD LIKE OUR READERS TO KNOW?

PROUT: Pinnacle Health is located in Stuart, Florida, and currently utilizes the warehouse previously used by MagnaServ Enterprises. This space has been optimized for the medical imaging that is our specialty. It is a huge asset for our team and our customers as we have the ability to store up to six MRIs inside and eight MRI mobile systems outside. The space has a PET/CT and CT staging bay as well as a soon to be completed MRI staging bay. When not staging imaging systems, we can use these to test parts. Much of our team is made up of former MagnaServ alumni so working at Pinnacle now is like coming full circle for us.

For more information, visit p2health.com.

ECRI UPDATE Healthcare Incident Management and Investigation

Starts with Awareness and Reporting

Delayed awareness and a lack of reporting can have profound effects on the healthcare incident management and investigation process. For example, if no one brings an incident to the attention of the Risk Manager or other appropriate person, it can happen again before the underlying causes are identified and addressed. Creating a culture in your facilities where incidents are immediately reported so that the appropriate early steps can be taken is paramount to patient safety and investigational success.

One of ECRI’s member hospitals asked us to investigate an incident involving an Alaris infusion system after a nurse reported suspected free-flow of medication from a large volume pump (LVP).

The hospital sent ECRI an Alaris Patient Control Unit (PCU) with 3 Large Volume Pumps (LVPs) attached to it for inspection and testing.

Visual inspection immediately identified the problem. The inner platen door on the suspect LVP was missing. The inner platen door is responsible for compressing the pump segment tubing to control flow as the pump cycles, and prevent gravity flow. We also noticed that the lower platen door hinge and its retention rivet were absent, and a piece of the FloStop receptacle was broken off and absent.

ECRI concluded that the platen door was most

likely displaced from the LVP by a forceful impact when the LVP outer door was open. This results in the pump allowing gravity flow through a properly installed Alaris IV set even if the pump is stopped, not yet programmed, or turned off.

We proceeded with testing to see if there was an alarm produced to warn the user that there was something wrong. The PCU was turned on successfully and immediately produced a “Check IV Set” Alarm.

Analysis of the pump’s logs showed that at the time of the reported free-flow the IV set was installed in the incident pump and the user interacted with the pump for almost 10 minutes during which time multiple “Check IV Set” alarms occurred. These alarms were silenced multiple times as the user probably tried to troubleshoot the problem. During that time the patient

INDUSTRY UPDATES

received by gravity delivery ~50 mL/minute of the drug to be infused.

Further log review indicated that the pump had been in service without its platen door for approximately one month prior to the reported incident. Over that time many attempts were made to administer infusions with it. It is likely that multiple incidents of uncontrolled flow occurred before the unresolvable “Check IV Set” Alarms caused users to obtain and use a different LVP.

ECRI sees this problem often – users use workarounds or move on to another pump and do not report problem devices.

AWARENESS

Incident awareness in the health care setting begins with the specific knowledge of an injury or its reasonable likelihood. Incident awareness most often starts with the clinical staff. While providing care they may recognize that something unexpected has occurred. For example, while caring for their patient the staff may recognize that an unexpected complication or injury has occurred; or they realize that there could have been a “near miss” or “close call.”

Medical devices are in many cases integral to the delivery of health care. Ignoring a device that makes an unexpected noise, repeatedly alarms, or is noticeably broken can result in a health care incident – an unexpected injury, complication or death. Staff should be trained and encouraged to be on the look-out for unexpected device performance and report it when it happens.

REPORTING

Reporting medical-device-related problems is crucial for keeping patients and staff safe. Unfortunately, problems aren’t always reported through appropriate channels, if at all. The reasons for this can vary:

• Device users may be focused on patient care and unable to interrupt a time-sensitive task to submit a report.

• They may be unfamiliar with the method for reporting.

• They may see little benefit to reporting, particularly if no harm was observed.

• They may intend to report the problem but fail to, due to busyness.

• They may fear disciplinary action or other personal consequences.

As a result, broken, malfunctioning, poorly manufactured or poorly designed devices may remain in use. Attempting to use faulty or suspect devices can, at the very least, waste clinician time as users try to effect workarounds or to quickly locate replacement equipment. More significantly, continuing to use such equipment can lead to patient harm.

In contrast, when problems are reported as soon as

they are noticed, they can often be remedied before patient care is affected. To achieve this goal, health care organizations need to identify and eliminate barriers to reporting. Measures that can be taken include:

• Make reporting easy!

• The reporting process should be as easy as possible to minimize disruptions to patient care tasks.

• Create a well-defined reporting process that is consistent across departments

• Consider incorporating the ability to report adverse events into the clinical workflow, if possible

• Build a culture of safety (to encourage reporting).

• Every effort should be made to create a culture where incidents are immediately reported because delayed awareness can have profound effects. For example, accessories may be discarded, hindering the subsequent investigation. If equipment that should have been sequestered continues to be used it can result in loss of stored incident information, or the problem can happen again perhaps with a more severe outcome.

• Make reporting safe by establishing an internal reporting mechanism that encourages open and forthright communication without fear of reprisal. Consider allowing reporting to be confidential and optionally anonymous.

• Educate staff about how to identify potential hazards.

• Educate staff on what types of occurrences should be reported internally and to whom, providing examples of situations in which reporting is needed, such as: deaths, injuries, near-misses, repeated device failures, hazardous practices, or staff impairment.

• Training can help staff understand the importance of awareness and reporting as well as regulatory and accreditation reporting requirements.

• Provide feedback to keep staff informed about the status of a report.

• Acknowledge the reporter and assure them that their report will be acted on

• Promote “wins” – that is, instances in which a report prevented significant harm or led to meaningful improvements.

• Provide support while you investigate what happened, recognizing that caregivers may be victims also.

PREVENTING RECURRANCE

“The goal of any healthcare incident investigation is to determine what happened and take the necessary steps to prevent recurrence,” explains Scott Lucas, ECRI’s vice president of device safety.

Following the investigation described above, ECRI investigators visited the reporting hospital and performed a Proactive Assessment related to infusion pump management. They reviewed the health system’s practices and procedures related to the overall infusion pump fleet and infusion pump incident management.

Specifically, ECRI gathered information from relevant staff to identify common technical problem areas and assess cleaning methods, pump distribution, available storage, and pump incident reporting and sequestration practices.

Opportunities for improvement were identified. With regards to incident reporting and sequestration, ECRI recommended the hospital utilize a standardized tagging system to clearly identify those pumps that should not be used, needed to be evaluated, or needed repair. ECRI also recommended that procedures be put in place and staff training on pump incident reporting and proper equipment sequestration to ensure that when a problem is identified that all associated pump modules and incident consumables are sequestered, allowing follow-up assessment and testing of the entire system.

For Bruce Hansel, chief scientist and principal investigator for ECRI, this case emphasizes the need

to have policies and procedures for removing “problem” or suspect devices from service. He advises “When in doubt, tag it out!”

TO LEARN MORE ...

Awareness and reporting are the first two steps in ECRI’s IMI Plan. The IMI Plan includes 7 points to consider in the management and investigation of healthcare incidents with a focus on helping to improve the process and prevent missteps. Technology managers and other healthcare professionals can learn more about the IMI Plan through ECRI’s Healthcare Incident Management and Investigation eLearning course.

To learn more about ECRI’s Proactive Assessments or to inquire about a third-party independent incident investigation, contact ECRI by telephone at (610) 8256000 ext. 5891, or by email at client services@ecri.org.

Barbara G. Malanga, BSEE, is the director, preventive solutions and device safety operations, ECRI.

BIOMED 101

Earning a seat at the table

Ibegan my career in health care as an Army Combat Medic/EMT/Medical Specialist. I used that certification to work in a civilian nonprofit hospital as an anesthesia technician in surgery. I had an interest in biomed and switched to the Air Force for the Department of Defense medical equipment repair course. My career vision upon entering the field that we now refer to as healthcare technology management (HTM) was to become the highest ranking biomed in America or become a healthcare administrator.

After five years, I became a lead technician for a third-party company. My operational objective with this company was to satisfy all stakeholders. I needed to make money for the company I worked for, provide a service to the leaders of the hospital and save them money and make sure the clinicians were able to safely take care of their patients and the communities we served.

I was able to satisfy my company and the hospital by finding cost-effective repair solutions, eliminating waste by incorporating just in time practices, and by extending the life of medical devices. The corporation that owned the hospital decided to bring biomedical services inhouse. Because of the value I brought the hospital, the hospital CEO called his corproate CEO and told him he had to have me or they couldn’t go inhouse. (Previously, I was supposed to be working at this hospital temporarily when I was a contractor and the CEO called the third-party company CEO and told him he had to have me or they were cancelling the contract.)

This led the National Director of Biomedical Engineering to call me and ask me what I did to these people to make them think they couldn’t function without me. My answer was simple. I listened to the clinicians, the managers, the BMETs and administration and did what I could every time according to what was a win-win situation for all and allowed us to perform medical equipment service according to

manufacturer’s recommendations, Joint Commission, CMMS recommendations and FDA guidelines.

The first thing we all need to do is be the CFO’s friend. The CFO never has a friend in the hospital. The sky is always falling. Hospital professionals go to the CFO with a story of future catastrophe that will occur unless money is spent. They say patients will die, the database will be hacked, and the hospital will be sued out of existence unless the money is spent. It is our job as the healthcare technology managers to access the situation and give an honest assessment. One way numerous HTMs and IT professions lose the trust of the CFO is when they use their technical expertise to lead administration to what they want to happen (which is intellectual dishonesty), while in actuality, that should be the opposite. The technical leader should be an agent for the facility allowing the leaders to use the technical expertise to make decisions. Always give leaders honest options. Explain the labor costs, risks to patient care, long-term possibilities of each choice and advise the leader on how to make the decision.

My first big project after I became an inhouse biomed manager was a patient monitoring system upgrade. The clinical leaders told the CFO they had to have $2.3 million for a patient monitoring system upgrade. Previously, when I was with a third-party, I told the CFO, they only needed a $298,000 upgrade. The hospital only needed to upgrade the central stations and some mainboards, but not the entire system including bed side monitors, computer screens, switches, servers, antennas, etc. My voice was lost among all the clinical leaders. They gained the support of the CNO, then the CEO, then corporate.

The corporate biomed director called me and said, “I see you say you have to have a $2.3-million-dollar patient monitoring system.” I said, “No, that’s the clinicians. We only need $298,000.” Then he said ,“Well, your name is on the quote.” I said, “That’s because they asked me to get the quotes, and I gave them three quotes and they submitted the biggest one.” The national director explained to everyone at corporate this $2.3 million was not needed and the facility was asking for too much.

The division leaders for the corporation still had to visit the hospital because of the urgency relayed to them. I reported to the director of facilities at the time, who reported to an assistant administrator, who reported to the COO. I literally was not at the table when the meeting occurred. The facilities director would leave the board room to ask me questions and I would answer them and he would come back and forth until the division CEO called the national director, who told him there was only one person in

that hospital who knew what they needed, and that person was Rodgerick Williams.

A few days later, I was asked by the national biomed director if I would risk my career advancement on my decision of $298,000 being able to have the hospital patient monitoring system operate correctly. I told him I would put my career on the line for my decision. A few days thereafter, the CFO asked me about the $298,000 option and I told him that would address their needs. We went forward with that project and it worked. I remained at that facility for four more years before it was purchased by another group and that system worked until I left. They did a $2.5 million upgrade six months after I left. I was asked if I could perform those types of cost avoidance decisions at 25 hospitals simultaneously. I replied “Easily, if I don’t turn wrenches anymore.” The hospital was sold, which made me free to leave, due to the corporation having a policy of not hiring from a hospital for division or corporate if the hire would leave the facility in a worse position. I completed an associates concentrating in business at Tulsa Community College, while I was majoring in business with a minor in international business at OSU-Tulsa while working. I was then promoted several times at once to hospital director, regional director and division director over 25 hospitals, their associated clinics and surgical centers. My territory grew to 108 hospitals before I became a national director of biomedical engineering for the third-largest for-profit health care organization in America and then a system capital procurement director before settling into my current role of national director of corporate accounts for Tenacore. Along the way, I also got a bachelor’s degree in healthcare management and a Master’s of Science in health administration from UAB where I also taught health care strategy.

This all grew from being a knowledgeable technician. I read manuals and made a PM binder as I learned how equipment operated during PMs so I’d be prepared for failures. I learned clinical operations and worked closely with nursing education to reduce operator error. I partnered with the CNO and the house supervisor, and risk management after patient incidents. I advised the CEO, CFO and procurement. I made myself a resource and earned a seat at the hospital, corporate and GPO tables.

Rodgerick Williams, MSHA, is the national director of corporate accounts with Tenacore.

Do more. With less. Join our live demo to see how. July 24th at 2:00pm ET

TOOLS OF THE TRADE

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With just a glance at the asset tracking platform dashboard – on your smartphone or computer –you’ll see exactly where your equipment is located, how it’s being utilized, where it’s needed most, and how much inventory you really need. Plus, Kontatk.io’s solution is future-proof. With open APIs and easy integrations, the platform can scale to include dozens of use cases to help optimize your operations while saving time and money.

For more information, visit kontakt.io

THE BENCH

WEBINAR DELIVERS FOR JOB HUNTERS

The Tools of the Trade Live Demo presented by HTM Jobs shared basic information about the website along with an in-depth look at the HTM Jobs Virtual Career Fair. The webinar was sponsored by HTM Jobs and is eligible for 1 CE from the ACI.

The HTM Jobs Dynamic Duo of Kristen Register and Sydney Krieg provided information about HTMjobs.com and all that it has to offer, including the upcoming HTM Jobs Virtual Career Fair.

They also shared some key features of the HTM Jobs website and fielded insightful questions from attendees.

HTMjobs.com is a niche job board powered by TechNation that aims to connect qualified biomedical and imaging professionals with hiring managers from the leading health care systems and companies. It offers a variety of job posting packages for employers and provides a free registration and application process for candidates. As the fastest growing HTM talent network in the United States, HTMjobs.com has opportunities for everyone. For more information, visit htmjobs.com

Attendees were asked, “What was your single biggest takeaway from today’s product demo?”

“HTMJobs is a very decent portal to use when looking for an HTM job, or looking for a candidate.”

– Steven Johnson, BMET II, Renovo Solutions

“Another resource for finding qualified applicants for open positions within our organization.”

– Michael Benner, Biomed Manager, Wellspan Chambersburg Hospital

“Loved hearing all options at the job fair.”

– Jeremy Ekalo, BMET II, Renovo Solutions

All webinars, podcast, and product demos are eligible for 1 CE credit from the ACI.

WEBINAR DECODES VENTILATOR SERVICE

The presentation “Fundamentals of Servicing VentilatorsKey PM Tests Combined with the Power of Test Equipment Automation” sponsored by Pronk Technologies was a hit with attendees. Eligible for 1 credit from the ACI, the webinar delivered insightful tips for HTM professionals.

Presenter Julio Castro, regional sales director at Pronk Technologies, discusse the fundamental principles of testing ventilators and important requirements for service, with emphasis on the key tests required when performing preventive maintenance on these critical devices. Attendees could see how to maximize utilization of test equipment with advanced technology to ensure ventilators are tested per the manufacturer requirements.

Castro also fielded questions from attendees during the live presentation. The entire webinar, including the Q&A session, is available for on-demand viewing at WebinarWednesday.live.

It was a popular session with almost 150 attendees for the live webinar. Andrew Warren, QA Manager with Advent Health Orlando, won a $100 Amazon gift card as part of Webinar Wednesday’s ongoing 10th anniversary celebration! Attendees were asked, “How did today’s webinar meet your expectations?”

“I thought it was well presented. I especially liked the way you could see what he was doing on the equipment, test equipment, and the Mobilize app all at the same time in the video feed. The audio was not quite as good on the live feed testing portion, but I could understand what was going on. Impressive job! We have demoed the safety analyzer and seen the pressure tester. All of us at my work have sim cubes and love them. Super easy to use. We also have the infusion pump testers. It would be nice to have more Webinar Wednesdays like this one.”

– David Scott, Senior BMET, UCHealth

“I was able to see a whole PM for the ventilator, which is what I wanted to see.”

– Jonathan Columbia, a student at NWTC

“Interesting content, learned some new things.”

– Elizabeth Lasek, a BMET II at PeaceHealth SW

CLICK. WATCH. EARN.

EXPERT REVEALS RTLS SECRETS

“Demystifying RTLS: Understanding the Pros and Cons of Different Technologies” presented by Adrian Jennings, chief product officer at Cognosos. The webinar, which was sponsored by Cognosos, is eligible for 1 credit from the ACI.

There are multiple different technologies that can be used to provide real-time locations service (RTLS) – from infrared, to ultrasound, to Bluetooth. Each solution has distinct advantages and disadvantages. In this webinar, Jennings discussed how each technology works and pointed out specific trade-offs that exist in terms of accuracy, expense cost, and coverage.

By the end of the webinar, attendees had a solid grasp regarding the different technologies as well as what innovations like AI are bringing to the RTLS space.

Attendees also benefited from a Q&A session. Jennings answered questions providing additional insights on a variety of RTLS topics.

Almost 100 individuals registered for the webinar and Fred Donnelly from North Carolina won a $100 Amazon gift card as part of the Webinar Wednesday 10th anniversary celebration!

Attendees were asked, “What does Webinar Wednesday provide the industry?”

“Webinar Wednesday provides the industry with up-todate and innovative solutions to issues we face every day in the field.”

– Adam Ruppert, biomedical technician, St. Luke’s Hospital

“Very helpful insight into what’s going on in the industry.”

– Santiago Guevara, BMET II, Hi-Desert Medical Center.

“An opportunity to learn about new techniques, technologies and upcoming businesses in HTM.”

– Brian Snyder, BS, CBET, BMET III, Franciscan Health East

“A means of continuing education for certification credits. Topics that are cutting edge are often discussed.”

– Wellspan Chambersburg Hospital Biomed Manager Michael Benner

WEBINAR HIGHLIGHTS SECURING PATIENT CARE

The recent Webinar Wednesday presentation “Securing Patient Care: Insights from the State of CPS Security Report” was sponsored by Medigate by Claroty and is eligible for 1 credit from the ACI. The webinar was presented by Medigate by Claroty Industry Principal-Healthcare Ty Greenhalgh and Ascension Director of Cybersecurity Skip Sorrels.

Attendees for the live presentation discovered new perspectives on healthcare cybersecurity. The session delved into the Medigate by Claroty’s inaugural “State of CPS Security Report: Healthcare 2023.” The webinar highlighted the pervasive cybersecurity challenges of critical medical devices – ranging from imaging systems to infusion pumps – and uncovers vulnerabilities and implementation weaknesses, underscoring their direct correlation with potential adverse patient outcomes.

The session explored the alarming rise of “Unknown” attack vectors, ransomware and extortion schemes targeting health care institutions, which device types hold the most risk posed by unsupported operating systems, and the critical importance of network and endpoint security measures.

The presenters also shared new insights on safeguarding patient safety in an expanding and increasingly interconnected world within health care.

A question-and-answer session resulted in additional knowledge being shared. A recording of the webinar is available for on-demand viewing at WebinarWednesday.live.

Avita Health System Biomedical Engineering Technician John Graham won a $100 Amazon gift card as Webinar Wednesday continues to celebrate its 10th anniversary!

After the session, attendees were asked, “How much new information did you receive from today’s webinar?”

“I have a little bit of familiarity with cybersecurity, but I did not know about its ties to Medicare reimbursement. I also had not seen it broken down into phishing, lack of support issues and internal issues.”

– Graham

“The presentation was spot on with explaining the threats to health care facilities.”

– Lori Clifford, Area Manager, Renovo Solutions

“I learned some of the paths to take to mitigate cyber threats.” – Michael Mappes, Biomedical Engineer, Children’s Nebraska

GUIDE TO ASHE

Here’s What You Need to Know

Wi th more than 12,500 members, ASHE is the largest association devoted to professionals who design, build, maintain, and operate hospitals and other health care facilities. ASHE members include health care facility managers, engineers, architects, designers, constructors, infection control specialists, and others. While its membership is diverse, ASHE members share a dedication to optimizing health care facilities and creating and maintaining safe healing environments.

ASHE, a professional membership group of the American Hospital Association, is a trusted resource that provides education, regulatory guidance, networking, advocacy representation and professional development for its members. ASHE is committed to its members, the facilities they build and maintain, and the patients they serve.

Top member benefits include:

• Education: Members receive discounts on ASHE educational training programs and conferences.

• Certifications: Receive credentials in health care facility management and construction through ASHE’s professional certifications.

• Resource Library: Access monographs and compliance tools, stay up-to-date with publications and alerts, and receive support from the ASHE advocacy team.

• MyASHE: Join 12,000+ others in the members-only networking community. Learn, share, and connect with fellow healthcare professionals nationwide online and via e-mail.

• Career & Networking Resources: Gai n access to the member directory, and become eligible for awards and recognition on the regional and national level.

There are membership options to fit every individual.

• Health Care Facility Management Professional: Receive the latest updates and education regarding health care facility codes and standards, and resources for advocating on behalf of your facility. Connect with 12,000+ professionals to share best practices and exchange innovative ideas.

• Architect or Design Professional: Stay informed on topics related to health care planning and design through exclusive and discounted resources, education and conferences, including the PDC Summit. Join our online network to connect, learn and innovate with others in the field.

• Contractor/Construction Professional: Access exclusive industry updates, trusted resources and discounted education, including certification exam review programs, specifically focused on practicing construction in a health care environment. Connect and network with 12,000+ industry professionals.

• Health Care Service, Manufacturing or Consulting Professional: Foster business relationships within our community of 12,000+ industry professionals, and learn about how you can help solve the challenges they’re faced with. Gain recognition as a trusted provider among health care facility customers by aligning with ASHE.

• Educator/Student: Memberships include full-time educators or college students taking coursework related to any discipline represented by ASHE. Bring your unique perspective to the community and make a positive impact in the field, as well as the health care industry at large. Students and career changers, click here to discover your future in health care facilities management.

• Retiree: This membership is available to Professional Active Members who have fully retired and still desire to belong to the Society. Retired Members may vote,

serve on committees and participate in the Actions for Professional Excellence (APEx) recognition program, but may not hold office unless they are a current CHFM.

EVENTS

ASHE also hosts annual events for its members and industry professionals, including the PDC Summit International Summit & Exhibition on Health Facility Planning, Design, & Construction, ASHE Academy and the Health Care Facilities Innovation Conference.

At the PDC Summit, more than 2,000 senior leaders involved in the health care planning, design, and construction process come together to discuss the future of health care and its impact on the health care built environment. This summit and exhibition is about uniting the converging perspectives of the full health care PDC team, including those working in health care administration, design, construction, facility management, and real estate.

ASHE Academy is a one-stop shop for health care facilities leaders to earn continuing education credits through a personalized learning experience.

The Health Care Facilities Innovation Conference (formerly the ASHE Annual Conference and Technical Exhibition) is the trusted national conference and trade show for health care facility management and engineering professionals. In 2023, more than 3,000 attendees gathered in-person to get vital information on health care compliance, codes and standards updates, emerging trends, and best practices for efficiency, sustainability, emergency preparedness, and other pressing topics in the field. Whether your company is interested in strengthening relationships with current customers or meeting prospective ones, the Health Care Facilities Innovation Conference is the one event you do not want to miss.

For more information, visit ASHE.org.

ASHE’S RENAMED CONFERENCE STARTS JULY 21

ASHE will host the inaugural Health Care Facilities Innovation Conference July 21-24, at the Anaheim Convention Center in Anaheim, California.

The Health Care Facilities Innovation Conference is an evolution of the ASHE Annual Conference & Technical Exhibition, which has been the premier conference for professionals in the health care facilities field for more than 60 years. The conference’s new identity, which was announced in August 2023, reflects the ASHE’s commitment to equipping its members to meet the opportunities and challenges presented by the rapidly changing health care field.

“This conference marks an exciting new chapter for ASHE and the health care physical environment field,” says ASHE Executive Director Lizzie Ortolano. “With the Health Care Facilities Innovation Conference, I believe ASHE has reaffirmed this event’s status as a best-inclass conference and taken significant steps toward delivering the richest, most impactful experience possible for its attendees.”

The conference is geared toward an array of health care physical environment professionals, including health care facilities managers, hospital and system executive leadership, construction managers, infection preventionists, safety professionals and technicians at all career stages.

Keynote sessions will be delivered by sociologist, best-selling author, educator and entertainer Dr. Bertice

Berry, who will explore methods for finding purpose at work, home and in the community; and Emmy Award-winning journalist and author Ryan Avery, who draws upon his experience as a multiple world record holder to inspire audiences to achieve extraordinary results in their endeavors.

Other noteworthy sessions include an introduction to using facility condition assessments to communicate facilities priorities to hospital executive leadership; case studies on hospitals tackling decarbonization, future-proofing capital projects and introducing automation to infection control risk assessments; a roundup of changes to National Fire Protection Association codes and their impact on other aspects of the regulatory environment; and a deep dive on the challenges and risks of lithium-ion batteries in health care settings.

Tailored conference tracks at four knowledge levels align with different career stages, from foundational to strategic, empowering attendees to choose a personalized conference experience while earning continuing education credits toward Certified Health Care Facility Manager and other industry-standard certifications.

The Health Care Facilities Innovation Conference also brings industry-leading solutions providers to demonstrate the impact of technology in advancing innovation in the health care facilities field. The event’s technical exhibition features dynamic, interactive demonstrations from premier vendors and business partners servicing the areas of fire protection; heating, ventilating and air conditioning; power and electrical equipment; health care lighting, furnishings and flooring; building automation; safety and security; and many others.

For more information, visit ashe.org/innovation.

SCHEDULE

SUNDAY, JULY 21, 2024

7:00 a.m. – 2:00 p.m. Pre-Conference: ASHE Chapter Leadership Forum & Award Presentation

8:00 a.m. - 4:00 p.m.

Pre-Conference: Certified Healthcare Facility Manager (CHFM) Exam Review Program

8:00 a.m. - 4:00 p.m. Pre-Conference: ASHE ICRA 2.0™ Training Program

8:00 a.m. - 4:00 p.m.

2:00 – 4:00 p.m.

8:00 a.m. - 4:00 p.m.

Pre-Conference: Health Care Facility Management: Daily Operations

Pre-Conference: FGI Guidelines – Establishing Pathways and Overcoming Hurdles on the Way to Adoption

Pre-Conference: HealQuest + Tour of the Nation’s First All-Electric Central Utility Plant

4:30 – 6:00 p.m. Regional Updates

MONDAY, JULY 22, 2024

7:00 – 8:00 a.m. Sponsored Breakfast Sessions

8:15 – 9:45 a.m. Welcome & Keynote Session

10:00 – 11:00 a.m. Breakout Sessions (1)

9:45 a.m. – 1:45 p.m. Exhibit Hall & Lunch

10:15 – 10:45 a.m. New Voice Spotlight session (Discovery stage)

12:00 – 12:30 p.m. New Voice Spotlight session (Discovery stage)

2:15 – 3:45 p.m. General Session

4:00 – 5:00 p.m. Breakout Sessions (2)

5:30 – 7:00 p.m. Health Care Facilities Innovation Conference Block Party

TUESDAY, JULY 23, 2024

7:00 – 8:00 a.m. Sponsored Breakfast Sessions

8:15 – 9:45 a.m. Keynote Session

10:00 – 11:00 a.m. Breakout Sessions (3)

9:45 a.m. – 1:45 p.m. Exhibit Hall & Lunch

10:15 – 10:45 a.m. New Voice Spotlight session (Discovery stage)

12:00 – 12:30 p.m. New Voice Spotlight session (Discovery stage)

2:15 – 3:45 p.m. General Session

4:00 – 5:00 p.m. Breakout Sessions (4)

5:00 – 6:30 p.m. Young & New to the Field Professionals Reception WEDNESDAY, JULY 24, 2024

7:00 – 8:30 a.m. General Session

8:45 – 10:00 a.m. Breakout Sessions (5)

10:15 – 11:15 a.m. Breakout Session (6)

11:30 a.m. – 12:30 p.m. Closing General Session

1:00 – 3:00 p.m. Post-conference: Lunch & Learn with The Joint Commission

1:00 – 3:00 p.m. Post-conference: ACHC: Four Levels of Control and Use of AEM

1:00 – 5:00 p.m. Post-conference: DNV’s Physical Environment Operations Professional Quality Workshop

SHADES OF GRAY

AAMI Report Offers Guidance for Medical Equipment Service Responsibilities

When a fetal monitoring system goes down in the middle of the night, who do you call? Too often, no one knows for sure. That’s why AAMI’s Technology Management Council (TMC) recently strove to help healthcare technology management (HTM) leaders resolve confusion regarding the “gray areas” of responsibility for hospital devices.

“In the 40 years that I’ve been in the industry, medical equipment gray areas have been a topic of discussion and an area of confusion,” said Mike Busdicker, CHTM, FACHE, system director, clinical engineering at Intermountain Healthcare. “The TMC Committee saw this as an opportunity to shed light on existing practices and provide baseline guidance.”

To help health care facilities define the scope of inspection, testing and maintenance responsibilities for various medical products, the TMC surveyed leadership representing nearly 200 HTM departments across North America to understand where equipment service responsibilities commonly lie. The results of the survey were compiled into a comprehensive report.

“Service responsibility has shifted between HTM, IT and facilities as technology has become more complex,” Busdicker

added. “Devices that used to be considered furniture or non-medical equipment have become clinical devices or equipment.”

Hospital beds, for example, now connect to electronic medical record systems and contain integrated sensors and software to monitor patients’ movement, weight and other data. In years past, few HTM departments would have serviced hospital beds. Today, about 60% of HTM departments take responsibility for this evolving example of medical equipment, according to the survey.

PATIENT SAFETY AND COMPLIANCE CONCERNS

Regardless of the reason for the gray areas, lack of clarity around equipment service can cause confusion, frustration and wasted time among busy clinicians. Depending on the product at issue, “passing the buck” potentially extends downtime, which leads to patient safety, regulatory compliance, incident response and inventory control issues.

“A malfunctioning desk printer may not cause an adverse outcome, but if a patient lift isn’t working properly, and you have a patient in that room, the malfunction could result in clinicians not mobilizing or rotating that patient at the right time,” said AAMI’s Vice President of HTM Danielle McGeary, CHTM.

“That’s one reason responsibility needs to be clearly defined and documented – so we’re not spending precious time figuring this out.”

Because medical equipment falls under mandates of the U.S. federal agency the Centers for Medicare & Medicaid Services (CMS), extended downtime of this equipment could affect accreditation. During an audit on behalf of CMS, the Joint Commission (TJC) review responsibility agreements and other

documentation related to equipment service.

“At the end of the day we’re here for the patient,” said McGeary. “If equipment breaks on Christmas morning, facilities should have a documented plan in place that identifies who should come in and service that equipment.”

WHAT THE RESULTS SHOW

The TMC compiled a list of more than 45 types of medical and non-medical equipment that tend to fall into gray areas. The committee then asked HTM leaders surveyed to select the department responsible for these products. Respondents also had the opportunity to list additional equipment excluded from the list.

Some results came as no surprise. For example, more than 80% of those surveyed reported freezers and fridges for patient food are strictly within the court of the facilities department. Other equipment, however, was more contentious. Both hospital nursery cameras and gaming systems for patient use, for instance, were notably split between HTM, facilities, IT, security or other departments.

With help from the Joint Commission, the TMC also classified each type of equipment into medical equipment, utility and other categories. “It was helpful for TJC to provide standardized nomenclature and terminology to the report, specifically within the medical equipment and utility components chapters, which address direct links to Joint Commission standards and elements of performance,” said Herman McKenzie, director of TJC’s Department of Engineering in the Standards Interpretation Group. “The document will help healthcare technology management (HTM) professionals become better aware of how health care equipment fixtures and devices are managed by health care organizations.”

HOW HTM LEADERS CAN USE THE GUIDANCE DOCUMENT

The TMC committee developed the report as a resource for the HTM industry and not as a recommendation of service responsibilities. It serves as a guide to help HTM, facilities and other health care leaders standardize their own processes. It may also help rsource-strapped HTM departments take the lead in redefining responsibilities if they choose.

“The report may help them justify what they should and shouldn’t be servicing,” said McGeary. “The survey results give them data to back their claim.”

The report makes clear that written documentation of equipment service responsibility is essential to ensure patient safety and compliance. Regardless of how health care facilities allocate responsibility, “it is imperative to have written policy defining departmental roles and responsibilities for these devices and systems,” the report states.

The TMC committee also recommends health care facilities review and update their equipment service responsibility document periodically. To help inform those updates, the TMC committee intends to conduct more gray area surveys in the future.

“We intend to resurvey the field to see how things change over time,” said McGeary. “Depending on the response, it may trigger another project. We’d also like to hear success stories on how HTM leaders have used this information to structure equipment responsibilities. We’ve had a lot of interest from the field so far and anticipate this report will be welcomed by the field.”

Members of AAMI can download Gray Areas of Equipment Service in HTM for free from AAMI ARRAY.

A ROUNDTABLE Asset Management

sset management remains a hot topic in health care and not just in the biomed shop. TechNation reached out to several insiders to quiz them about asset management strategies, cost savings and more. The answers provide knowledge and solutions for biomeds to consider.

The experts participating in the roundtable article on asset management include:

• Kontkat.io Senior Director of Enterprise IoT Accounts Kapil Asher

• Tech Knowledge Associates (TKA) Vice President of Sales and Business Development Bruce Call

• Renovo Solutions Vice President of Business Development Matt Forrest

• Vizzia Technologies Chief Technology Officer Howard Hatcher

• Midmark RTLS Director of Hardware Research and Innovation HT Snowday

Q: WHAT ARE SOME ASSET MANAGEMENT STRATEGIES?

ASHER: The goal of asset tracking is to contribute data

that helps complex operations to function more efficiently. This can mean improving workflows, streamlining processes, reducing the losses associated with downtime or asset search, optimizing asset use and performance, and generally aiding in the pursuit of smart, lean performance. The result? RTLS deployments that are transforming industries and providing unprecedented opportunities for improved performance. For clinical engineers and hospital systems this means never having to go looking for an IV pump ever again: Track the exact location of every asset in real time with clear insights into equipment utilization and AI-powered analytics.

CALL: These responses are specific to mobile equipment asset management in a hospital setting. There are lots of definitions of asset management in health care! Our offering is called READI+, which stands for Reliable Equipment, Available, Disinfected, and Inspected.

• Assess your challenges – Lost equipment? Cleaning/ processing, or cleanliness of equipment? Hidden or hoarded equipment? Finding equipment for clinical engineering to do PMs? Recent findings on a regulatory survey?

• Involve key stakeholders – Nursing leadership, select staff nurses and caregivers in patient care areas, central distribution employees, supply chain, infection prevention, and others as appropriate.

• Find what is broken in your current practices. Manage to better processes to provide equipment to caregivers in

the best condition possible, as quickly as possible.

• Don’t blame … empower! Nurses don’t hide or hoard equipment because they like reading the fine print on the cases, they do it because they want to have access to the devices needed to care for their patients, when they need them. By putting better practices for equipment cleanliness and distribution in place, you will empower nurses to “get out of the equipment management business” and spend more time with their patients.

FORREST: We try to provide flexible options that offer various strategies such as hybrid programs in which we collaborate with an in-house HTM program to assist their team on equipment they do not support. We also provide supplemental technicians or temporary managers for sites that are shorthanded or in need of an interim HTM leader. We also see several health systems willing to take more risk and not have a significant amount of equipment on full-service contract. This provides an opportunity for additional savings but can also be costly when critical parts fail. It is important to understand the risks associated with each device.

HATCHER: Key is the initial discovery of the main pain points in your hospital facility. When implementing an effective asset management solution at your hospital, it takes a village composed of key stakeholders committed to seeing its success and longevity. No matter if you are a biomedical engineer, senior nurse, or the CFO, it’s critical to understand the key pain points of mismanaged assets from these stakeholders’ perspectives. In essence, poor asset management planning can lead to a decrease in patient care, increased operational costs, and time wasted by critical caregiving staff.

SNOWDAY: There have always been debates around the efficiency of centralized versus decentralized asset management approaches, or lease versus own strategies. When thinking about the strategy that works for your facility or health system, we encourage a focus on the people, as much as the process. When starting an asset management project, we bring the front-line teams into the discussion, both biomedical engineering and nursing, to ensure the process and change management fit the need of your people. In terms of RTLS, it’s also important to consider the larger picture of the efficiencies this technology can bring to the health system. We continually see biomedical teams choose one RTLS to manage assets, and then nursing needing another type of RTLS to automate nurse call, impact workplace violence with a staff duress solution, or manage patient flow. Addressing these needs separately, out of separate budgets, is costly to the health system. The best strategy is to address the larger vision: choosing an RTLS that can both be cost-

effectively deployed facility-wide for asset tracking but can also provide the location accuracy nursing needs in patient care areas.

Q: WHAT ARE THE ADVANTAGES AND DISADVANTAGES OF THE DIFFERENT ASSET MANAGEMENT APPROACHES?

ASHER: When it comes to the technology that powers your asset management solution, an RTLS system powered by Bluetooth Low Energy (BLE) is likely your best approach. Passive RFID is not typically used for asset location purposes since devices using it are not equipped to broadcast their location. Wi-Fi was initially developed for data communication, not asset tracking. NB-IoT and UWB lack constant signals, which makes real-time tracking updates on things that are in constant motion nearly impossible. From a larger perspective, what’s important is that your approach is fast, easy and scalable. This means a deployment that is quick and doesn’t disturb operations with a system that staff can easily learn and leverage day-to-day.

CALL: The two primary mobile medical equipment distribution practices involve:

• Delivering to the patient bedside. Most often employed for new admits, and/or in a med/surg patient room setting. The advantages in this setting include that in a less emergent care setting, you can, over time, develop a database and history of demand patterns, and use this data to adjust inventory and processing practices, and the related staffing and work schedules. The disadvantages include that this is often the largest volume of pick-up and delivery work for the staff, and therefore, hiring, orientation, training and retention of staff are critical functions for HR.

• Delivering to a PAR level, usually in a clean utility area. This practice is usually employed in the settings experiencing the most emergent care needs – ER/ED, and ICUs, for instance. The advantages in this setting are that you are delivering “back-up” inventory, which eases nurse/caregiver concerns in settings where needs can ramp up quickly. However, a key disadvantage in this sort of setting can be that in very rapid order, the patients in this setting can “crash” and even more equipment is needed, rapidly.

FORREST: As stated above, most of the advantages or disadvantages are based on the willingness of the health care organization to take on risk. We have historical data on most clinical equipment in use and can help our clients make better decisions when it comes to service coverage options.

HATCHER: Most health care systems are comprised of multiple facilities across a geographic, metropolitan area

(i.e., hospitals and clinics). Thus, a comprehensive, enterprise-wide plan will yield the highest levels of success (i.e., cost savings, staff satisfaction and increased patient care). Due to the nature of moveable medical equipment, deploying an asset tracking service in only one location typically yields incomplete results.

SNOWDAY: In a centralized approach, one team rounds on the soiled utility closets, making sure each unit has the equipment they need. The advantage here is that equipment is (hopefully) always available for patient care when it’s needed. But, without RTLS, rounding is an incredibly inefficient, manual process. A decentralized model, where each nursing unit manages their own inventory, saves the labor on rounding, but places burden on the nursing teams to find the equipment they need; this model often leads to the practice of “hoarding” – stashing equipment away where it can be found for patient care, but often hidden from the biomedical team who needs to preventively maintain the equipment. The good news is, an accurate RTLS can both monitor supply closets to save on rounding in a decentralized model, and accurately locate equipment within a nursing unit to reduce the need for hoarding. The key is choosing the right mix of RTLS technologies that provide both accuracy and cost-effective facility-wide deployment.

Q: WHAT ARE SOME OF THE NEWEST SOLUTIONS/ FEATURES AVAILABLE FOR MANAGING ASSETS?

ASHER: With just a glance at the asset tracking platform dashboard – on your smartphone or computer – you’ll see exactly where your equipment is located, how it’s being utilized, where it’s needed most, and how much inventory you really need. Plus, Kontatk.io’s solution is future-proof. With open APIs and easy integrations, the platform can scale to include dozens of use cases to help optimize your operations while saving time and money. Legacy providers and point solutions often utilize proprietary systems and software, which can be extremely limiting when it comes to updates and

improvements, new solutions, features, etc. And, of course, the hot topic of the day: Implementing AI as part of your asset management solution. At Kontakt.io, we use AI to analyze patterns and predict trends, scan for hidden waste and inefficiencies, protect devices and networks from malicious attacks, and integrate with user applications to get insights within seconds.

CALL: Our company has initiated the use of our RTLS tracking capabilities as the “backbone” of our READI+ equipment management practices. As a result, everyone (our READI+ program staff as well as the affected nurses and support staff such as unit clerks) has visibility to available equipment and is on the same page with regard to better utilizing available equipment resources. Equipment productivity increases (a key output of successful equipment management programs), and patients and nurses receive the needed equipment more quickly, and in better condition.

FORREST: Although managing data is not new, I believe how a health system uses data to make capital planning decisions is becoming more important than ever, as hospitals continue to struggle financially. Medical device cybersecurity is not new, but continues to evolve and be a critical part of any HTM program. It is critical to ensure all medical devices are protected and the tools allow you to properly mitigate risks.

HATCHER: Vizzia continues its emphasis on innovation by collaborating with clinicians and technology leaders to further enhance its InVIEW software platform. The company has recently released several new integrations that power today’s smart hospital, to include Epic, Microsoft and CMMS applications. These integrations provide multiple benefits to med techs and clinicians alike, such as saving significant time by automating patient information data entry. Other features include secure access to applications with single sign-on (SSO) identity and visibility of all devices with a mobile single pane of glass (SPG).

Bruce Call Tech Knowledge Associates (TKA)
Matt Forest Renovo Solutions
Kapil Asher Kontkat.io
HT Snowday Midmark RTLS
Howard Hatcher Vizzia Technologies

SNOWDAY: Though not new, periodic automatic replenishment (PAR) is gaining traction for effective mobile hospital equipment management. To achieve improved inventory distribution, whether in a centralized or decentralized model, an accurate RTLS can monitor inventory levels in each unit of the facility, so staff can ensure they have the equipment they need to operate efficiently. The biggest game-changer for asset management, though, is Bluetooth Low Energy (BLE) technology and the machine learning algorithms that make BLE useful for RTLS. BLE is easier and more cost-effective to deploy than traditional RTLS and can even leverage existing systems as a BLE-receiving network, such as the latest Bluetooth-capable Wi-Fi access points. It’s a fantastic technology for tracking assets (and by the way, for staff duress as well) – the tags have a great balance of size and battery life, the location accuracy is much better than using Wi-Fi signals. However, it’s not quite accurate enough to automate nurse call or drive patient flow optimization, so health systems looking at the bigger vision should be seeking out hybrid deployments of room-accurate technology, paired with the near-room accuracy of Bluetooth.

Q: HOW CAN ASSET MANAGEMENT SYSTEMS HELP A HEALTH CARE FACILITY SAVE MONEY?

ASHER: With Kontakt.io, it’s easy to calculate the ROI on asset management. Firstly, stop paying for equipment you don’t use, which you’ll understand on day one. So right away you can reduce your rental fleet, “right-size” your inventory, and defer future CAPEX purchases. This is in addition to the money saved on loss prevention. Kontakt. io’s solution automates PAR-level inventory management and increases mobile equipment utilization to over 60%. Unlock significant savings with an RTLS asset tracking solution that increases productivity, optimizes workflow and eliminates inefficiencies.

CALL: With effective, productive mobile equipment management practices, a number of areas are positively impacted, leading to increased process efficiency, improved equipment cleanliness and maintenance, and better nurse and patient satisfaction levels. Direct financial impact can result in:

• Less lost equipment

• Reduction or elimination of the need to rent equipment

• More productive patient care (studies estimate more than 1 hour per day may be spent by nurses in managing and cleaning patient care equipment), meaning savings in overtime may result.

• Smaller quantities of mobile equipment to buy, lease or rent.

FORREST: An effective computerized maintenance management system (CMMS) is imperative for any successful HTM program. This allows for accurate inventory management, device tracking, service status, contract management, asset disposition, parts ordering, reporting and much more. These systems provide insight to help the health system better manage the life cycle of their assets, which will reduce total cost of ownership. A successful HTM program by design can significantly reduce a health system’s annual service spend by consolidating contracts, taking risk where risk is advised, effective parts sourcing and utilizing niche service providers that can achieve additional savings.

HATCHER: Advanced, enterprise-grade data analytics are now optimizing multiple workflows across smart hospitals. Real-time data is improving processes within multiple functions such as scheduling, maintenance and supply chain. Executive dashboards and utilization reports are now used in the C-suite to focus on financial and operational impacts. Legacy purchasing decisions to rent or buy expensive medical equipment are now enhanced with human capital planning.

SNOWDAY: Health care organizations face a widespread problem. Despite having more than enough equipment, nurses and biomedical teams spend 10% of their time walking the halls, looking for equipment needed for patient care and preventive maintenance. Whether equipment is MIA, transferred with patients to other hospitals or simply stolen – asset fleets are increasingly difficult to budget for. And mismanaged fleets come at a hefty price tag – $7 million annually for a 300-bed hospital:

• $5.25M for non-value-added nursing wages, like time spent away from the bedside and instead looking for equipment needed for patient care

• $1.5M for missing equipment write-offs

• $125K for capital expenses including over-purchasing assets to ensure availability

• $100K for hidden operational expenses including individual nursing units replacing lost assets on department budgets

• $43K for biomedical technician wages that is time spent searching for equipment

• $3K for equipment rental costs to supplement missing assets

Q: WHAT SHOULD AN BIOMED DEPARTMENT LOOK FOR IN ASSET MANAGEMENT PRODUCTS?

ASHER: Can your solution scale easily with open standards such as Bluetooth Low Energy and Wi-Fi? Can your solution provide room-level location accuracy without the need for physical servers or significant

requests to your IT teams? Do you need additional power or cable pulls when it comes to deployment and installation? At Kontakt.io, we work closely with our partners and customers to help deliver the solution that’s best for them. We are outcome focused, which means we provide an end result and don’t nickel and dime on hardware. For us, and for any health care system, it’s important to know what questions to ask and what mistakes to avoid when considering asset management solutions. Keep the end outcome in mind and find a provider who shares your goals.

CALL: Partnership: If an asset management program is to have real and lasting impact, the affected nurses/ caregivers, distribution staff, supply chain staff, and infection control practitioners should be involved in its development and implementation, with a leader from the mobile equipment asset management program provider. Transparency: We can only manage what we can measure. Set regular meetings during asset management program implementation, to develop milestones and track progress and trending related to KPIs developed by the stakeholders and asset the management program provider. Key KPIs tend to include:

• Delivery times – are they satisfactory?

• Inventory levels – do they meet patient/caregiver needs?

• Nursing satisfaction – with the revised practices. Are they buying in? Where is more education or direction needed?

FORREST: Not all providers are created equal and you get what you pay for. It is important to talk with references and understand their service delivery plan, especially for the more critical assets found in radiology, cardiology and oncology.

HATCHER: The health care industry is very collaborative and referral based, thus references remain a key factor. Conferences like MD Expo and AAMI serve as valuable learning opportunities to share best practices. Technology is always rapidly evolving and it’s important to validate where solutions are deployed “go live” at Vizzia collaborates with academic partners to test and evaluate new solutions, such as Georgia State University’s Lewis College of Nursing (which has a clinical partnership with Grady hospital).

SNOWDAY: It’s important to consider that different locating technologies offer varying levels of precision. If a general asset location suffices, BLE will do the trick. If you’re considering RTLS for additional or future use cases that require room-level accuracy, infrared is the gold standard. When comparing apples to apples, both battery life and tag size are important factors. Battery life can vary from tag to tag, depending on the technology used. But be careful

because even if a battery life says two years, it could mean that the tags are firing signals at a less-than-real-time frequency. If higher accuracy (more frequent) signal is important to you, you should choose a more real-time option and compare battery life accordingly. And consider tag size options, especially for small items like telemetry packs and other types of assets that are easily lost or misplaced.

Q: IS THERE ANYTHING ELSE YOU WOULD LIKE TO SHARE WITH TECHNATION READERS?

ASHER: For a deeper dive into the industry use cases, benefits, and tech reviews of RTLS, Wi-Fi, UWB, BLE, take a look at our 2024 Buyer’s Guide for Asset Tracking or join our TechNation Tools of the Trade LIVE Demo of Kontakt. io’s Asset tracking platform.

CALL: Effectively designed, implemented, and managed, a high-quality asset management program for mobile medical equipment will positively impact areas critical to a health system’s ability to attract patients, and retain their nurses and caregivers:

• Equipment acquisition expenses

• Equipment distribution process efficiencies

• Patient satisfaction

• Nurse/caregiver job satisfaction

FORREST: We are seeing some vendors offer service pricing that in many cases is “too good to be true” and figure these organizations will not be in business for long. We also understand that some of the OEMs are not willing to provide service on aging imaging equipment. This is requiring hospitals to look to alternative service options to keep their systems running optimally.

HATCHER: Staff safety is top of mind for all health care leaders. Incidents of workplace violence are four times more common in health care than in other professions. RTLS enable staff badges to activate a silent alarm, alerting security the exact location of where help is needed (accurately and quickly).

SNOWDAY: Technology in health care is important, but it’s the people that are at the heart of everything we do. At Midmark RTLS, we believe the key to success is just as much about the right partner and process as it is the technology. With Midmark RTLS, you get the commitment, the people and the expertise for sustained success. Our RTLS experts – both in-house and regionally certified system integrators – lend a wealth of clinical knowledge and best-in-class support to optimize your RTLS investment at discovery, launch and beyond. We’re proud to serve as a long-term partner, leading health care organizations across the nation to RTLS success.

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INCIDENTMANAGEMENT AND INVESTIGATION MASTERTHEPROCESS

D

uties of the biomed department include the responsibility that medical devices are functioning to certain specifications. The efforts of well-trained biomeds supports the efforts and procedures of clinicians around the globe on a daily basis. It is well known that mechanical and electronic devices can malfunction, stop working or be influenced by the environment they operate in. The increasing role of technology in most medical devices means that software, firmware, networking or complexity can further impact their operations.

Technology has introduced additional risks, which means that the potential for technology-related incidents has increased. Recently, the failure of insulin pump software, that connects the insulin pump to an iPhone, resulted in the pump’s battery draining sooner than normal.

The technical issue is alleged to have led to 224 injuries. While this type of incident is beyond the purview of the biomed shop, it points to the susceptibilities that technology adds to the complexity of modern health care. It is a two-edged sword.

In this case, the FDA is investigating. Preliminary findings have already been made public.

What caused the incident and how can a recurrence be prevented? The approach to this investigation is usually more comprehensive, and possibly exhaustive, than a cursory assessment would indicate. There are best practices that the “investigators” should adhere to.

Incident management in the health care setting requires an observance of best practices by all involved. What should biomed’s first reaction be when made aware of an incident, such as a device malfunction?

“Similar to whenever we call a vendor for tech support, our first question to end users should be: ‘Was a patient harmed or nearly harmed?’ This is still a learning process for many team members to make second nature. There’s also the issue that the person placing the call is not always the person who was using the device so information and the severity of the issue can be lost,” says Renato Castro, CHTM, CBET, assistant manager of biomedical engineering at Stanford Health Care Tri-Valley in Pleasanton, California.

He says that if a device is involved in an incident, the biomed team member should gather as much information as possible.

“Sequester the device into biomed custody (if possible, any disposable or consumables involved should also be sequestered by the clinical team). Ask staff if an

incident report has already been placed; if not, then request that one be made. Pulse in biomed leadership to the situation. From there, biomed leadership should be reaching out to either the risk management team, compliance officer, or patient safety officer – each organization tends to have a different point person or team for these incidents so make sure you know who the appropriate party is to make sure the incident report was filed,” Castro says.

He says that he generally has his teams dedicate a place in the shop for the sequestered device.

“I would then also have them put a large visible sign saying something along the lines of ‘not for clinical use’ or ‘inspection in progress’ and send a notice to the rest of team about the device and to not touch it until further instructions,” Castro adds.

Nick Inderdahl, manager of biomedical engineering at ProHealth Care Inc. agrees.

“The equipment should be kept somewhere that it won’t likely be put back into service. Attaching some sort of service record usually helps, and if it has good notes, anyone can read and identify why it is there and what is being done with it,” he says.

Inderdahl also says it’s a good idea to reach out to the safety and/or the risk management group to give them a heads up and start conversations.

“Make sure aid is rendered to the patient if needed, verify the safety of the staff, isolate the device for investigation and record any settings used,” says Mike Powers, MBA, AAMIF, CHTM, CDP, director of healthcare technology management at Intermountain Health.

He says investigate the performance of the unit, and see if the issue is reproduceable. Record data needed for completing FDA MedWatch form 3500A. Repair the unit, verify operation with manufacturer. Return it to service or send it to the manufacturer for invasive testing. Complete and send in form 3500A. Report it to ECRI and their event database.

Powers points out that the meaning of “incident” can have vastly different meanings between biomed and IT.

STUDIED GUIDELINES

Health care providers are not alone in their efforts to address an incident, reporting it or responding to it. ECRI, an organization focused on health care technology and safety, has created a best-practices approach to managing these often-serious events.

“Hospital errors are the third-leading cause of death in the United States. After an incident occurs, it becomes imperative that a comprehensive investigation is completed to prevent recurrence and limit risk to the

organization. However, missteps and gaps in the process, or a lack of investigation experience and resources, can leave organizations open to recurrence and costly claims,” says Barbara Malanga, director, preventative solutions and device safety operations-device safety at ECRI.

She says that ECRI has developed a 7-point approach to manage and investigate health care incidents that considers the process from beginning to end. They call it the IMI Plan. It includes (1) awareness, (2) response, (3) fact gathering, (4) analysis, (5) conclusions (6) recommendations, and (7) legal considerations.

Malanga says that when biomed is made aware of a device malfunction, its first course of action should be to remove that equipment from service.

She says that it is important that health care facilities have a pre-established response plan and that all potentially involved personnel (including clinicians, biomedical engineering staff and risk managers) are trained in how to execute the plan.

“Assuming that there is no persistent unsafe condition present, which would require you to first secure the area, the first step after an incident is to attend to the injured. This may include a patient, clinicians, other hospital staff or visitors,” Malanga says.

The second step would be to preserve the equipment and the environment, if applicable. It is important to preserve anything that may have caused or contributed to the incident.

“Step three is to report the incident. Incidents should be reported in a timely manner to the appropriate person within your facility who will follow-up and coordinate the investigation. A health care system can only act on and analyze events that are reported,” Malanga says.

She says that the next steps would be to sequester equipment. Devices or equipment that are suspected to have caused or contributed to an incident should be set aside in a secure area with limited staff access. Then, gather evidence. This may include photos that document what happened, information that was stored by the devices used (e.g., logs), information from the health record, a detailed summary of what happened, exemplar equipment, device documents, relevant policies and procedures, device purchase information and service history.

“Although incident response is typically coordinated by risk management personnel, biomedical engineering often plays a role and can be the source of critical equipment-related information,” Malanga says.

A RESOURCEFUL APPROACH TO NOTIFICATION AND TAGGING

At the Houston Methodist Hospital, which serves the Greater Houston area, the HTM department devised an acronym to outline a process that is known as the “STARR process.” Clinical engineers Zachary Smith, Cristian Delgado, Hani Khalil and Bailyn Piecewicz all provided insights into how the process works at their medical center.

“TAPS (Transparency and Accountability in Patient Safety) is a reporting system for Houston Methodist employees – any employee can submit a TAPS event – for all patient-involved incidents. Within the TAPS system, the reporter will select the appropriate ‘safety event level of harm.’ Clinical engineers in biomed are automatically notified if a report is submitted that involves medical devices. Clinical engineers have access to the TAPS database where notes and findings must be inputted,” Smith says.

The process involves a tag that is completed by the reporter of the incident.

“For the last R (Report as TAPS event via Biomedical Engineering Dispatch) – this dispatch call would come directly to biomed from the end user, and a service report would be created for that specific device. It would be under the category of ‘incident’ (as compared to ‘routine’ or ‘non-urgent’),” Smith explains.

He says that the clinical engineers will then act as the investigator for the TAPS event for the biomedical engineering department. They will do the following as needed: Speak with the involved staff about what occurred, who was involved, settings used. Examine device – pull event logs, check for defects, contact OEM with questions, etcetera.

These steps are usually done with help from experienced biomed technicians.

Once [the] issue is identified, typically biomed will make any necessary repairs to device, set up corrective action plan with the unit and the patient safety department; re-education, OEM discussion for setting changes, etcetera.

“Biomedical engineering tracks work order codes to determine patterns in equipment, problems, education needs and user errors,” Smith says.

They then report the findings to the hospital safety committee.

WHAT TO PRESERVE AFTER AN INCIDENT

Because it is so important to preserve a malfunctioning medical device and anything relevant to that device, Malanga provides an acronym that allows biomeds an easier approach to memorizing what steps to take.

“Staff should be educated and periodically reminded about the importance of evidence preservation. The acrostic S.A.V.E.D can be used to help staff remember what should be saved,” she says.

S

– Settings: Document what the equipment settings were and whether there were any displayed error codes.

A – Accessories: When possible, leave accessories and components assembled as they were at the time of the incident.

V

– Valuable Data: Save paper printouts that may have been generated during the procedure. Print or download data that is stored by the equipment as soon as

ENGINEERS’“BIOMEDICAL AND TECHNICIANS’ASSOCIATEDRESPONSIBILITIESMAIN ARE TO MAINTAIN DEVICES AND EQUIPMENT SO THAT THEY CONTINUE TO WORK PROPERLY AND SAFELY, AND MEET THE PERFORMANCEMANUFACTURER’SSPECIFICATION.”

Y CAREER CENTER

What to Do When Your Boss Takes Credit For Your Idea

ou’ve introduced an idea during a group meeting that was very well received. A few weeks later, you realize your boss has passed the idea up the chain of command in a way that positions it as his idea. What is the appropriate response?

“Discovering that your boss has presented your idea as their own can be disheartening, but it’s essential to handle the situation with professionalism and diplomacy,” says personal empowerment life coach, executive coach and TEDx speaker Smita D. Jain.

Setting up a private meeting to discuss the situation is one way to handle the situation, as long as you express your feelings in a professional, assertive but calm manner, Jain says.

“Share that while you’re thrilled the idea gained traction, you were hoping for acknowledgement of your contribution. Approach the conversation with a collaborative mindset, emphasizing your commitment to the team’s success and suggesting ways to ensure proper recognition moving forward,” she suggests. “By addressing the issue directly and constructively, you can foster a culture of transparency and respect while safeguarding your contributions.”

Two business owners who found themselves in a similar situation early in their careers opted for the private meeting route — and both recommend taking it if a supervisor takes credit (intentionally or inadvertently) for an idea you previously presented.

“I expressed how valuable it was for me to align my contributions visibly with our team’s goals and subtly reminded them of the original meeting where the idea was presented,” recalls Scott Friedson, CEO of the public adjusting firm Insurance Claim Recovery Support (ICRS). “It’s important to keep the tone positive and forward-looking, focusing on future contributions rather than dwelling on the oversight. This often

helps in re-establishing recognition and ensuring clearer attributions in future discussions.”

Jeff Mains, founder of Champion Leadership Group, chose to schedule a strategic discussion about the department’s future projects, then segued into what he really wanted to discuss.

“During this meeting, I subtly reintroduced my idea as part of a larger strategy, providing detailed execution steps and highlighting how it aligns with our long-term goals,” Mains says. “This approach not only placed me back at the center of the idea but also demonstrated my leadership and forward-thinking to both my boss and the wider leadership team. It was a move to cement my role as an innovative thinker, without directly challenging my boss’s integrity.”

The goal, Mains adds, “was to build my reputation as a leader who enhances the team’s output, ensuring that my contributions are visible and valued.”

To make sure you and your ideas are protected moving forward, Oleg Segal, CEO and founder of the coupon code website DealA, says it is important to keep a trail of the ideas you’ve introduced.

“It’s wise to share ideas over documented mediums like emails or collaborative tools, ensuring an audit trail,” Segal explains. “Through my entrepreneurial journey, I’ve tackled both these scenarios effectively and believe these strategies can facilitate smoother transitions and maintain a healthy workplace environment.”

Kathleen Furore is a Chicago-based writer and editor who has covered personal finance and other business-related topics for a variety of trade and consumer publications. You can email her your career questions at kfurore@yahoo.com.

20/20 IMAGING INSIGHTS

Maintaining the Technical Advantage

Significant advancements have occurred in ultrasound transducer technology in the past few years. Despite these high-tech enhancements, the manners in which probes fail, pretty much, have remained the same. Acoustic lenses still wear, and strain reliefs still fail due to repeated flexing. Both still degrade from continued exposure to harsh cleaning agents. Like the strain relief, system cables still fail from repeated flexing. They also become pinched in mechanical assemblies and experience accidental pulls and roll-overs. System connectors, as well as entire probes are still accidentally dropped. The acoustic array, one of a probe’s most fragile components, can still fail from just a single accidental impact. In fact, the arrays in today’s probes are much more fragile than those from prior generations.

Even though the ways that probes fail have remained fairly consistent, the components within, and the materials used to fabricate these newer high-tech devices have become increasingly more complex.

NEW TECHNOLOGY

The arrays used within traditional 2D probes typically contains anywhere from 64 – 256 individual acoustic elements or “crystals”. Solid state live 3D volumetric probes, such as the Philips X5-1c, XL14-3, and X8-2t, and the GE 4Vc-D and 6VT-D utilize an array with 2500 – 14,000 elements. The array is now bonded to an ASIC (Application Specific Integrated Circuit), which performs much of the beamforming. Traditionally, beamforming is a function of the scanner console, not the probe itself. Wiring harnesses, which once contained less than 100 micro-coaxial wires, the

thickness of a hair, now range to 256, and the wires are a much finer gauge – up to 52 if you can imagine the scale.

Healthcare organizations have been struggling to find true repair solutions for these newer, high-tech, highly expensive probes. Unfortunately, many companies promoting probe repair share the same challenge. The solution being replacement versus repair.

REPAIR SOLUTIONS

As with any newer technology, there can be challenges developing robust repair solutions in a timely manner. What many may not know is that OEM’s do not openly share their design specifications, bills of materials or provide access to replacement parts to 3rd-party repair providers. Providers, typically, have 3 paths with which to approach your probe failure.

1. Sell you a replacement.

2. Harvest parts from numerous failed probes to repair a single customer’s probe. Although sometimes a valid solution, there are a few pitfalls with solely relying upon this method. The first is that a huge junkpile is created from all of the unused parts since failures are, typically, consistent across the same probe model. For instance, almost every cardiac probe will experience cable intermittencies. Another important factor is that the replacement cable, installed on your probe, may actually be used. Finally, a repair performed today may not be available next week due to a lack of replacement parts.

3. Engineer their own solutions to the failures presented.

OUR COMMITMENT TO YOU

For Innovatus, repair capabilities are model-specific. There is no “general” repair process, and we don’t attempt repairs. If asked if we can repair a specific problem on a specific probe model, the answer is always a firm yes or no. We either have a verified & validated repair solution within our ISO 13485:2016 Certified Quality Management System, or we don’t. This includes all of the parts, materials, supplies,

fixtures, design history files and testing devices required to restore your probe’s performance and safety.

HOW IS THAT POSSIBLE?

Innovatus Imaging is an FDA registered manufacturer for ultrasound probes supplied to several prominent OEMs. The company has an acoustic laboratory in Denver, CO and has engineers with a very specialized knowledgebase, instrumentation, and focused skillsets. When we develop new repair capabilities, much of the engineering process is handled by the Design & Manufacturing division. Since OEM’s don’t share design specifications, our specialists in Denver characterize a specific probe model based on acoustics and electrical properties, to materials and physical properties. All of the data is captured in a Design History File within our ISO 13485 certified QMS.

Innovatus employs quite a large team of engineers, for both design as well as repair. Teams engineer proven, sustainable repair solutions by careful technical analysis of each probe model on which repair is offered. This includes developing electronic schematics, wiring diagrams, material specifications, acoustic profiles, and more. Having this level of data allows the development of repair procedures and visual work instructions based on the design of a particular model versus a general, all-encompassing approach to repair. The process mimics new product development for our OEM partners. Very few, if any other, repair providers have access to such expertise. This level of detail also offers and ensures quality, consistency, and sustainability, which powers the industry’s longest warranty period.

WHAT DOES IT MEAN FOR YOU AND YOUR PATIENTS

Whether probes or widgets, as consumers, we all want something upon which we can depend. Based upon Innovatus’ unique approach to repair, customers can feel confident that a repair performed on a specific probe model last week can be consistently performed on others tomorrow, next week, and six-months from now. Currently, Innovatus is the only repair provider that publishes a list of over 100 fully repairable transducer models. From cables, strain reliefs, housings, etc., there’s a solid, virtually completely internalized, supply chain that allows us to say, “Yes! Your probe can be repaired”. And repair is always more budget-friendly than replacement.

Due to the technical challenges with newer model probes and the investment needed in R&D, true repair solutions can be hard to find in the 3rd-party industry. When failures arise in today’s newer-technology transducer models, many are exchanged, at costs over $20,000, versus repairs costing a fraction of that. Innovatus Imaging has developed significant, proven, sustainable repair solutions on these complex, cutting-edge devices. On all these models, quality repair solutions are available by addressing failures across ALL repairable components. And, we’re working on expanding capabilities on newer models every day. As technology advances and demand increases for

budget-friendly solutions, Innovatus Imaging will remain focused upon developing capabilities consistent with customer needs.

Ultrasound probe technology has significantly advanced over the last few years. Be sure to partner with a service provider who has advanced along with the technology you support.

For more information on how Innovatus Imaging can help to reduce your service budget with quality, sustainable repairs for MRI coils and US probes, please contact Matt Tomory, VP of Sales and Marketing at MattT@innovatusimaging.com.

Pulse-Echo Analysis System
Single Ultrasound Pulse
Hydrophone Analysis

NETWORKING NOTES

Intro to DICOM – The Radiology Network structure: PACS, EMR and Worklists

In continuation of the previous article, one of the essential concepts that we did not fully explain was that of a Picture Archive and Communications System (PACS). Regardless of the complexity, people using this term refer to the place the local modalities (CT, MRI, or digital X-ray, etc.) store their images. Sometimes PACS is a single computer, sometimes it is a whole network of machines working together to accomplish the task. Regardless of the back-end structure, PACS is where the images are stored.

However, the PACS network has a little more complexity than just a place to store images. What a radiology department really needs is a way to get patient information to the X-ray machine, a way for the machine to understand what the patient needs to have done and therefore how to configure itself for that study, a way to store the images with a station for a doctor to review, and a text result transcribed back to the hospital’s patient record.

This is what a modern system looks like:

To understand this, we must first cover HL7, the communication protocol for the Electronic Medical Record (EMR) system. It is used by the hospital as the main patient record system. HL7 is text based. Although that allows for quick exchanges of text information, it does not store images or video; that is PACS’ job. Therefore, a hospital network is twofold: the machines that use text to communicate with each other (represented in red on the graphic), and those that exchange pictures and videos with each other (represented in green). The EMR is where the patient records are kept, it is also where a doctor enters in their request for a medical study. This request is forwarded, in HL7 format, to the Radiology Information System (RIS). The RIS is a scheduler, plain and simple. Radiology uses its own system to build a list of what studies to do. A RIS keeps the schedule for the radiology department, but it is often still in text format. To send patient and study information to an imaging modality, a worklist is used. A worklist is literally a list of what modalities must do that day, but in DICOM format. Recall that a DICOM image has a header and headers have text in them. Therefore, DICOM can be used to exchange text information in the form of a header without an image. That is what the worklist stores, and it communicates this information to the modalities, so they know who the next patient is and what study is being done. That study is called an accession. It is a DICOM study number and is one of the most critical bits of information for the rad techs to verify before acquiring the images. Just keep in mind that this patient schedule was built using information from the EMR using the RIS, stored in the worklist server.

Once the worklist is constructed, a queue is built for the modalities. The modalities then perform a query to find their next patient. The user clicks the correct accession number for the patient study and

the modality retrieves the partial DICOM file from the worklist. What comes to the modality is a DICOM file with the patient and study data, but without an image. The modality then performs the study, creating a series of images for each task required in the study. All of this is then pushed to the PACS where it is stored until a radiologist requires the image. The radiologists have their own “to do” list, which is stored on the PACS and can be as simple as an unread or read flag on the accession number. The radiologists select a patient, lock the study, read the image, transcribe their findings to HL7 to be stored back in the EMR, and then release the study in PACS with the status as read. The final goal of the transcription is to give the requesting doctor the information from the radiologists in text format, so that the information can guide a diagnosis, therapy or intervention as required.

Understanding the workflow of the overall network will help in advanced troubleshooting of DICOM networks. It helps to see where the image is coming

from, where we are in the chain of the transfer, and what to look for in the breakdown of communication. Keep in mind that DICOM requires both sides of a communication be set up to talk to each other. That means that each modality must be set in each server, and at a minimum, each modality must at least have the settings of the worklist server and the PACS. Since there are often additional servers with specialized functions, and over 100 modalities (or more) in a hospital system, there are hundreds of points of failure for DICOM settings. This is one of the main reasons why network troubleshooting has become a full third of a biomed’s job.

Garrett Seeley, MS, CBET, Biomedical Equipment Support Specialist, VISN 17: VA North Texas Health Care System, Dallas Veterans Affairs Medical Center.

MOBILE EQUIPMENT ASSET MANAGEMENT

Effective ‘MEAM’ Programs can be a Tool for Improved Distribution of Equipment & Increased Satisfaction Among Hospital Staff

In my travels over three decades representing third-party providers of hospital services programs, I have long since quit being surprised when I learn that a prospective client hospital is practicing a decentralized approach to the cleaning, processing, and management of mobile equipment. While I am firm in my thoughts that centralized control of these processes yield the best results, there are reasons that “other” systems of equipment control exist.

The affected health system’s clinicians and administrators may simply be, “doing what they’ve always done.” Other times, there are “dominions” within the health system in question, such as nurses who believe only they can adequately clean, test, and process the equipment they need to care for their patients; simply put, they don’t want to give up the control of “their” equipment. And, if the situation arises in which they feel more mobile equipment was needed, well, isn’t that why equipment rental companies exist?

MOBILE EQUIPMENT ASSET MANAGEMENT – A PRESCRIPTION FOR BETTER, LESS EXPENSIVE HOSPITAL OPERATIONS

In hospital settings, nurses don’t “hide” or hoard the equipment they need out of any motivation other than the desire to have the equipment necessary to care for their patients, when they need it.

However, as I have seen demonstrated over the years, with an effective Mobile Equipment Asset Management (MEAM) plan, nurses will no longer be in the business of finding, cleaning, and managing (or hiding and hoarding) mobile medical equipment, and they WILL have the

equipment they need.

The involvement of key stakeholders such as nursing, finance, operations, and information technology (at the executive and director/manager levels) are critical to developing interest in and establishing effective MEAM programs. These groups and the teamwork among them are integral to the success of the ensuing program.

DECIDING WHETHER TO ENGAGE A THIRD-PARTY CONSULTANT, OR TO DEVELOP A MEAM PROGRAM INTERNALLY.

Our company and a few other independent service organizations (ISOs) have employees with deep experience in the development and operation of Mobile Equipment Asset Management programs. You may choose to engage a company such as ours as a consultant who – although the perception is that we “come at a cost” – can provide great value and focus your teams on the best practices in preparing for, establishing, and operating a Mobile Equipment Asset Management program which can have a very positive, multi-dimensional impact on your health system.

DEFINING MEAM PROGRAM CHALLENGES, GOALS, AND EQUIPMENT LISTS

• The amount of equipment showing as “lost”, or which “cannot locate”, is significant.

• There is no clear definition of who is responsible for cleaning mobile equipment, and to what standard.

• Equipment is being hidden, and/or hoarded, by nurses.

• A finding(s) on a recent regulatory survey spurred the interest in a MEAM program.

Generating consensus on solving these and other problems that the MEAM program will address is a great way to break down the walls between administrative,

clinical, and technical staff, to solve for the impact of challenges they all experience, albeit in different ways.

EQUIPMENT

TYPES MOST OFTEN INCLUDED IN A MEAM PROGRAM

• Infusion pumps and peripherals

• Bedside monitors

• Sequential compression devices or foot pumps

• Telemetry monitors

• Specialty beds and surfaces

• Bladder scanners

• Rental equipment

• … and others.

SETTING AND MANAGING KEY PERFORMANCE INDICATORS (KPI)

Common areas of measuring MEAM performance improvements include the following … (REMEMBER … your staff has to find ways to measure and manage these variables!)

• RESPONSE TIME – How quickly is it reasonable for equipment to be delivered after order?

• CLEANLINESS OF EQUIPMENT – What are best practices and standards for maintaining equipment cleanliness? Which department is responsible for these functions?

• LOCATION AVAILABILITY – How do you track equipment location at your health system? Is an RTLS tracking system available to help locate equipment?

• EQUIPMENT MAINTENANCE – Are PMs up to snuff? What is the recognized standard for completion percentage, and the timeframe to complete PMs?

• CUSTOMER SATISFACTION – Have the staff affected by the MEAM implementation seen improvement in the indices listed above? On a scale of 1 to 5, what has been their experience with each? … at the outset? … in periodic, post-implementation responses?

A KEY OUTPUT OF A MOBILE EQUIPMENT ASSET MANAGEMENT PROGRAM – EQUIPMENT PRODUCTIVITY

Using the management of infusion devices as a basis for gauging the effectiveness of a Mobile Equipment Asset Management program is common, since these devices represent a large and challenging line item in a hospital’s mobile equipment inventory. The best of MEAM programs can, in my experience, result in a 70% productivity rate for infusion pumps – meaning that at any given time, 70% of available infusion devices are in patient rooms, delivering the drugs or nutrition those patients need.

Most often, a hospital survey will find that the infusion devices they employ are only 30-35% productive, at best. It would follow that if a 500-bed hospital – prior to the establishment of a MEAM program – needs 500 infusion devices, on average, to serve their patients, they have roughly 1,500 devices in inventory, meaning that only a

third of their inventory is in use at any given time. If, however, that same hospital was to establish an effective MEAM program, at a 70% productivity rate, it would be able to service the same patient infusion device demand with only about 714 devices, or roughly HALF (or less) of the devices they currently have in inventory. The financial savings of such efficiency gains would likely mean millions of dollars saved in acquisition costs – significantly more than enough to pay for the staff and training needed to establish a market-leading MEAM program.

STAFF SATISFACTION

Various studies have shown that nurses spend between 20 minutes and one hour per shift locating and managing equipment (Infor.com blog, 9.19.23; aafp.org, posted March 1, 2018). Given this fact, one of the key areas of focus in the development and implementation of a Mobile Equipment Asset Management program should be to alleviate these responsibilities for nurses to the greatest extent possible.

Successfully managed, this impact is likely to be felt by the EVS or Housekeeping department, too.

SUMMARY

With successful design, implementation, and operation, a high-quality Mobile Equipment Asset Management program will positively impact nursing, finance, operations, information technology and other hospital departments. Costs will be controlled as the equipment quantities necessary to provide care are significantly lessened, and routine and emergent maintenance tasks for clinical engineering will be easier to accomplish because of the improved ease of location tracking of mobile equipment.

Similarly, an effective MEAM is among the factors that can increase equipment availability, impact nurse job satisfaction and retention, and greatly reduce or eliminate the need for nurses to manage mobile equipment. The equipment-related therapies prescribed for patients would be started in a more proactive, timelier manner, as well.

As part of the capital planning process, data derived from an effective MEAM will be able to focus equipment acquisition expenses into the health system’s most pressing and mission-critical areas.

Here’s wishing those of you who delve into the development of a focused Mobile Equipment Asset Management program the best of experiences – for your patients, your staff, and your health system’s bottom-line financial performance.

EXPERT ADVICE

CYBERSECURITY

Close Call:

Navigating the Aftermath of Proximity to a Cyber-Attack

In 2023, the health care industry experienced over 500 reported breaches, impacting more than 100 million people. Fast forward to 2024, Change Healthcare experienced a ransomware attack, resulting in a ransom payment of approximately $22 million. This was merely one instance illustrating some significant threats facing the health care industry. Attackers now recognize the significance lies not in the number of attacks, but rather in the strategic locations they will target. Consequently, every cybersecurity professional in health care now anticipates the inevitable day when their organization will face a cybersecurity attack. Health care organizations in the United States are investing millions of dollars annually on their cybersecurity programs to protect their facilities and data. But what happens when after all that investment, a neighboring partner with inadequate security measures gets compromised? What are the consequences of being cyber-proximate to a breached entity? How can we guarantee the comprehensive security of our network, including our partners, to prevent such incidents?

In grasping the recovery process from a cyber-attack, we will go through a scenario and review steps that healthcare technology managers should follow. Picture this: You receive a notification from a partner about an ongoing attack and immediately start to terminate any network connections and tunnels established between them. During the initial hours

and days following the attack, the situation is a little chaotic, and little information is available about the incident affecting your partner. You notice you happen to have VPN (Virtual Private Network) tunnels in place with them and realize you must operate under the assumption that your network could also be compromised. At this point, the security operations go into full swing and actively start to search for signs of compromise. From an HTM perspective, we are initiating our response drills and assessing the implications for our systems. Asking the questions, are administrator access available for supporting systems? What level of patching does the vendor permit on potentially affected systems? What data exchanges are established? Do we transmit data to them within patient workflow? What will the impact be to clinical operations? These are among the areas that we need to look at and present our expert assessments to leadership.

The steps and actions we take when we are near a cyber-attack typically mirror those of an actual attack on our systems. Despite the inconvenience, we must undergo these measures to ensure our security and prevent any potential compromise through lateral movement from affected partners. In a recent simulation exercise, cybersecurity experts collaborated with a vendor to update accounts and passwords under the assumption of their compromise, addressing the possibility of lateral movements. This process involved extensive efforts from various teams, including the vendor, HTM and clinical staff. Assessing the hours spent on these

tasks, there was an estimated recurring cost of approximately $15,000 per site for HTM and clinical staff alone, not factoring in the lost productivity of daily operations or the expenses related to IT and security staffing. Had this system had been deployed across all the sites of that organization, the projected cost would exceed $2.5 million for an incident that wasn’t specifically targeted at the organization.

Health care organizations must thoroughly understand all external partnerships to effectively mitigate such events. It’s crucial to comprehend the data exchange, connections, and potential business impact during device loss. Documenting this information at the onset of the connections and validating it annually is essential. HTM staff should convey to vendors the significant impact security incidents can have on business and emphasize the importance of developing and supporting secure systems with robust infrastructure. Vendors should understand that it is no longer an acceptable practice to develop and sell insecure systems and support them with weak infrastructure. The HTM community must prioritize securing medical environments, as simulations can quickly become reality.

Dan Gonci is an Information Systems BESS, Medical Device Cybersecurity, HTM Operations with the VHA Office of Healthcare Technology Management (19HTM).

NAVIGATING THE HIGH COSTS OF INADEQUATE HOSPITAL BED TRANSPORTATION

In hospital settings, the movement of hospital beds and stretchers is a routine yet critical operation that impacts not only the condition of the medical equipment itself but also the broader infrastructure of health care facilities. Despite the availability of policies and procedures designed to safeguard both the equipment and the facility, lapses in adherence and insufficient training of the personnel involved often lead to significant damage and ensuing hidden costs. Emeritus is addressing these challenges head-on with innovative training solutions aimed at mitigating what is commonly referred to as “bed crash damage.”

THE RISKS OF IMPROPER BED MOVEMENT

The improper transportation of hospital beds and stretchers can lead to a variety of costly issues. For instance, when transport policies are not followed, it’s not uncommon for a 125-pound nurse to maneuver a 600-pound bed through hospital corridors. This scenario increases the risk of the bed bumping into walls, damaging elevator doors, or colliding with other infrastructure, leading to costly repairs and maintenance. Additionally, the practice of placing medical equipment on or underneath beds during transport can result in equipment falling off or getting crushed, further

adding to the financial strain on health care facilities. Hospital beds and stretchers are designed to be robust, yet they are not immune to the wear and tear inflicted by frequent and improper handling. Damage to these essential items can compromise their functionality, leading to downtime and the need for repairs or replacements, which are often significant in terms of cost.

HIGH TURNOVER AND TRAINING CHALLENGES

One of the underlying challenges exacerbating this issue is the high turnover rates commonly seen in Environmental Services (EVS) and Transport departments within hospitals. This turnover complicates efforts to maintain a consistently trained staff, as ongoing education and reinforcement of best practices are required to ensure all personnel are equipped to handle hospital equipment correctly.

Moreover, some hospitals choose to move beds offsite for repairs or storage, which can inadvertently cause additional damage during transportation. This decision, while made to ease logistical burdens within the hospital, often leads to further complications and costs, underscoring the need for improved on-site handling and maintenance strategies.

EMERITUS’S PROACTIVE SOLUTIONS

Recognizing these pervasive issues, Emeritus has developed a targeted transporter training program

designed to enhance the skills of those involved in the movement of hospital beds and stretchers. This program focuses on training staff to adhere strictly to transportation policies, emphasizing techniques that prevent equipment and infrastructure damage. By improving the standard of care in equipment handling, Emeritus aims to reduce the incidence of bed crash damage significantly, thereby saving hospitals considerable resources in the long run.

This training initiative is part of a broader strategy to enhance operational efficiency and safety in health care settings. By addressing the root causes of bed and stretcher damage through comprehensive training, Emeritus is not only helping to protect valuable medical equipment but also contributing to the overall integrity of hospital infrastructure.

THE PATH FORWARD

The issues associated with the improper transportation of hospital beds and stretchers highlight a critical need for systemic change within health care facility operations. As hospitals continue to navigate the complexities

of providing high-quality care in dynamic environments, the focus must increasingly shift towards optimizing every component of hospital operations, including the seemingly mundane task of moving equipment.

With the introduction of its new training program, Emeritus is leading the way in transforming how hospitals handle their most used and most necessary equipment. This proactive approach promises not only to safeguard the physical assets of health care facilities but also to ensure that the environment remains safe and functional for both patients and staff, ultimately supporting the broader goal of delivering exceptional health care.

For more information, visit emerituscs.com

Webb Clark is the Senior Sales Manager at Emeritus. Reach him by phone (469) 371-7093 or email webb.clark@ emerituscs.com.

RIGHT TO REPAIR

FDA Punts on Important Questions in

Remanufacturing Guidance

If I am not allowed to read the service instructions, how am I supposed to know that I am servicing the equipment in the way the manufacturer intended?

This was a question asked by many in the medical device servicing field around the Food and Drug Administration’s (FDA) draft remanufacturing guidance. The agency has now issued their revised guidance document to help the medical device field understand what constitutes “remanufacturing” of a medical device – but the answer to this core question remains unclear.

There are different standards in place for regulating and approving a manufactured or remanufactured device versus repair or servicing of an existing device. There have been disputes over whether some repaired devices should trigger the stronger rules for remanufactured devices. I’m among those who are disappointed that the FDA didn’t address the core underlying issue which animates the debate on remanufacturing, and which is connected to Right to Repair.

The remanufacturing conversation has been a lightning rod in the biomedical community for years. Manufacturers’ trade associations have pressed Congress to rein in aftermarket servicing of medical devices. As a result of their concerns, Congress required the Secretary of Health and Human Services, working with the FDA, to “issue a report on the continued quality, safety, and effectiveness of medical devices with respect to servicing.”

In May of 2018, that report came out, and it found that “the continued availability of third-party entities to service and repair medical devices is critical to the functioning of the U.S. healthcare system.” Instead of finding safety issues, the FDA’s report found that

third-party repair carries no additional risk and that both they and manufacturers “provide high-quality, safe and effective servicing of medical devices.”

It should be noted that hospitals’ own in-house repair teams seemed to be invisible to this report … it’s either the manufacturer or a third-party.

The report noted that negative effects, to the extent that they existed, related to remanufacturing equipment, not normal servicing. So, the next request from manufacturers’ associations was to create new rules to prevent unregulated remanufacturing.

The problem with drawing a line between servicing and remanufacturing is that the easiest way to define servicing is to say you are returning the equipment to the manufacturer’s intended specs. So, what if the manufacturer actively hides the documentation so that only the manufacturer has the information needed to know exactly how the device is supposed to operate?

This was the concern raised by many stakeholde rs after the draft guidance came out. Here’s how the FDA addressed it (found on Page 24):

“Consistent with promoting and protecting the public health, FDA encourages OEMs, as an industry best practice, to provide servicing instructions that facilitate routine maintenance and repair of their reusable devices.”

Something tells me this “encouragement” will not cut it. There are way too many financial incentives at play for manufacturers to consistently and voluntarily share this documentation even if, accordi ng to the FDA, “the continued availability of third-party entities to service and repair medical devices is critical to the functioning of the U.S. health care system.”

The rub seems to be that the FDA can’t make up its mind about whether repair documentation is a “trade secret.” The guidance document notes that:

“FDA’s recommendations are not intended to encourage the disclosure of trade secrets or confidential commercial information.”

Firstly, the information you use to fix equipment is not a trade secret, especially if you are training biomeds across the country to do these repairs. Trade secrets are by definition secret, not widely distributed information. The second criticism I have with this approach is that there isn’t anyone besides the manufacturer who will be determining what is a trade secret or not, which just extends the current situation where sometimes you can access what you need, and sometimes you can’t.

It is bad for patients and the whole health care system for medical device manufacturers to monopolize repair services. I think it’s time to step up for clear rules that protect competition in this space, while maintaining a high standard of quality. It’s clear that more work needs to be done to make this case to regulators.

Nathan Proctor is the senior director of the U.S. PIRG Campaign for the Right to Repair.

HEALTH-ISAC

How VEX helps manage vulnerabilities

Du ring procurement of medical devices, organizations often request a Software Bill of Materials or SBOMs. This is not just any tool, but a crucial asset management tool. SBOMs provide a comprehensive view of what is inside a piece of software, which is essential for vulnerability management. The Vulnerability Exploitability eXchange (VEX) is a framework that leverages SBOM data to enhance vulnerability management. It does this by offering more precise and actionable insights into the risks associated with specific vulnerabilities.

VEX, with its precision, leverages the data from SBOMs. It can precisely pinpoint which components within a software package are impacted by a known vulnerability. This level of precision is crucial for vulnerability management. In addition, VEX uses the information from SBOMs to determine the specific context in which a vulnerability exists, such as its location within the software architecture and how it interacts with other components. This precision can help prioritize patching and remediation efforts more effectively.

VEX includes a range of metadata to provide a detailed understanding of vulnerabilities and their exploitability information about the specific vulnerability, including CVE identifiers, severity scores and

descriptions. Details on whether the vulnerability is exploitable in the given context are based on factors such as the configuration of the software and its environment. If the vulnerability is exploited analysis of the potential impact helps determine the urgency of remediation. Recommendations on addressing the vulnerability, including available patches, workarounds or mitigations. Specific versions of affected components leverage SBOM data to provide precise targeting for updates or patches.

Within VEX, the status of a medical device about a vulnerability is crucial and VEX has four statuses to describe what is known about the vulnerability associated with the component within the medical device. “Under Investigation” indicates that the status is still being determined. “Not Affected” confirms that the medical device is not impacted by the vulnerability. “Affected” indicates the medical device is affected by the vulnerability. “Fixed” indicates a fix is available and has been applied.

Medical device owners can use VEX in several ways to proactively manage cybersecurity vulnerabilities across their organization’s endpoints. By providing precise information on which components are affected and their exploitability, VEX empowers medical device owners to assess the real risk of vulnerabilities more accurately. With detailed remediation guidance and component version information, medical device owners can prioritize and apply patches more efficiently, focusing on the most critical vulnerabilities first. In the event of a security incident, VEX provides detailed information that can help quickly identify affected components

and understand the potential impact, enabling faster and more effective incident response. VEX also helps medical device owners maintain compliance with security standards and regulations by providing comprehensive vulnerability data and status updates, which can be used for reporting purposes. Finally, by continuously updating the status of medical devices and vulnerabilities, VEX allows medical device owners to stay ahead of potential threats and address vulnerabilities before they can be exploited.

In summary, the Vulnerability Exploitability eXchange (VEX) is a powerful tool that enhances the management of cybersecurity vulnerabilities by leveraging SBOM data, providing detailed metadata on vulnerabilities, and offering clear medical device status details. SBOMs are a new level of granularity for asset management and are especially important for maintaining the operational resilience of medical devices. The SBOM is static for a particular device version but the VEX will be highly dynamic

as new vulnerabilities are discovered and their impact on the product are evaluated. VEX helps owners improve risk assessment, prioritize patching, enhance incident response, ensure compliance and manage vulnerabilities proactively across their organization. Be sure to understand how your medical device manufacturers provide VEX information and how quickly and frequently you can expect updates. SBOMs and VEX are the one-two punch needed to help you keep medical devices operational in today’s cyber aggressive environment.

THE FUTURE Godspeed, Pat

Sometimes the past determines the future. I truly believe that the late Patrick K. Lynch determined a lot of our futures. He did mine. I remember the day I found out that I passed the CBET examination. I remember the day I received my CBET certification in the mail. It was in December of 1993. If I remember right, the number at the bottom was 2212 and it was signed at the bottom by Patrick K. Lynch. I remember looking at that name and wondering who he was. I found out later, much later, and my impression and admiration of Patrick K. Lynch only grew over the years.

The first time I met Pat was after I had been an instructor at Texas State Technical College for a few years. I can’t remember the exact details, but I do remember that he visited our students several times over the years and talked about what it took to be a successful biomedical equipment technician. The man never failed to impress me, and he certainly made a huge impression on our students. His presence in a room was commanding and undeniably powerful. Pat just demanded your respect when he spoke. He certainly earned and received mine and that of my students. He gave several presentations at our school and always had crowds of students waiting around after his presentation. He always made time for each of them and answered every question. The students always commented to me about how fired up they were about biomed after he spoke. I’ll never forget that and I’m sure they won’t either.

I remember running into Pat several times at AAMI Expos and MD Expos over the years. The most memorable ones were when he was with GMI as the biomedical ambassador. I remember one occasion in Charlotte, N.C., when we had an excellent time

together. I admit, I probably overindulged on at least one of those occasions, but I did make some excellent connections and Pat was directly responsible. Those times resulted in fantastic professional opportunities and donations.

I admired Pat. I looked up to Pat. And, I still do. Pat was one of those guys who I thought represented what biomed was and I enjoyed hanging around him. He always drew a crowd, and everyone knew him. Where Pat went, the crowd went. He was a fountain of knowledge. Pat was fun.

Later in his career, he reached out to me when he was involved with Biomeds Without Borders. I wish I could have helped him more with some of those endeavors. He did serve as a resource to me when we were considering starting a local biomedical equipment technician association in the Central Texas area. He never hesitated to pick up the phone or answer my emails with answers to seemingly dozens of questions about the process.

I was devastated when I learned of Pat’s illness. I regret not reaching out to him and expressing to him what he meant to me and how much he influenced my career. I really thought he would kick the disease in the butt and recover. I was hoping I would catch up with him at the next gathering. I was hoping I would have the chance to tell him what he meant to my career. I hope he knows that now.

This column is called “The Future.” Sometimes the future is directly affected by the past. In the case of Patrick K. Lynch, a lot of futures will be determined by his influence. Thank you, Pat. I’ll miss you.

Roger A. Bowles, MS, EdD, CBET, is a professor of biomedical equipment technology at Texas State Technical College.

WHAT’S ON Y UR BENCH?

Trevor Crews

Corporate Account Coordinator at reLink Medical

• An X-Ray Tube

• Several bobbleheads

• A drinking vessel

• A stapler

• 2 monitors & laptop

Submit your bench to be featured in TechNation at 1technation.com/my-bench/. You could win a $25 Amazon gift card via the “What’s On Your Bench” Contest!

TECHNATI N P LL

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Accidents happen without warning. How do you respond?

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BULLETIN BOARD

An online resource where medical equipment professionals can find all the information needed to help them be more successful! The easy to navigate Bulletin Board gives you access to informative blogs, expos and events, continuing education opportunities, and a job board. Visit MedWrench.com/BulletinBoard to find out more about this resource. Follow MedWrench on facebook.com/medwrench & linkedin.com/company/medwrench

JULY 22-26, 2024 SERVICING THE DIGITALDIAGNOSTPHILIPS & BUCKYDIAGNOST SYSTEMS

UPCOMING EDUCATION

JULY 29 - AUG 2, 2024

SERVICING PRIVATE PRACTICE X-RAY SYSTEMS: CPI CMP200 & QUANTUM ODYSSEY HF

JULY 29 - AUG 2, 2024 CONTRAST INJECTOR SERVICE TRAINING

Save the Date for ASHE 2024 in Anaheim, CA! JULY 21-24, 2024

HTMA-SC SCRAPBOOK

The Health Technology Management Association of South Carolina (HTMA-SC) recently held its 2024 symposium. The event was held in Charleston, South Carolina on May 9-10 at the Marriott in Charleston. The event was a chance to network with HTM professionals and learn about the latest developments and trends in the industry.

5. A nice lunch break between educational sessions and the exhibit hall. 6. Networking to share ideas, experiences, and so much more. 1 5 4 2 6 3

2. Attendees getting hands on experience with the latest technologies in the industry.

3. HTMA-SC attendees networking before their next educational session.

4. Fantastic educational sessions for local HTM professionals to grow their understanding of the ever changing world of medial equipment.

1. Congratulations to Kamarra Davis from MUSC, TechNation’s door prize recipient!

BIOMED BRAINBUSTER

Visit 1technation.com/crossword for an interactive puzzle. DOWN

1 Software downloads to handle security issues

5 Device used with ultrasound

8 Purchase

Determining the nature, value, quality, ability, extent, or significance of

‘’Metric’’ prefix

Record of events

Eye-related

Letters denoting urgency

19 Bursa, for one 22 Hosp. unit, abbr. 24 Formal discussion

26 Prosecutor, abbr.

27 Unagi in Japanese cuisine

28 Cross-reference

30 _____ accelerator, used in the radiation of cancer tumors

32 Establish validity and veracity as in security accesses

The sheltered side at sea 35 They provide illumination

1 Company expert in patient monitoring devices

2 Test, 2 words

3 Field with the responsibility of managing all health technology and medical equipment, abbr.

4 Authentication stamp

5 Outlet connection

6 Leaves out

7 Electrocardiograph, abbr.

9 California University

11 Request for urgent assistance

15 Top grades

16 Competition to be the first in development of new devices and technologies, e.g.

18 Yields

20 Asembles in order, as printed sheets

21 The C in CTS

23 Commanded

25 Discrete quantity of energy proportional in magnitude to the frequency of the radiation it represents

27 Often used spreadsheet

29 Time record

31 Employs

33 180° turn, slangily

Pronk

USOC Medical usocmedical.com •

Diagnostic Solutions

Innovatus Imaging innovatusimaging.com • 844-687-5100

KEI Medical Imaging Services keimedicalimaging.com •

Tri-Imaging Solutions triimaging.com • 855-401-4891

Diagnostic Solutions diagnostic-solutions.com • 330-296-9729

SERVICE INDEX

ALPHABETICAL INDEX

SHOW US YOUR SH P

The Show Us Your Shop feature is where TechNation will share submitted photos of your biomed/HTM shops. Clean? Messy? We want to see them ALL! Simply post your photo on social media and use the hashtag #ShowUsYourShop. A member of the TechNation team will contact you for approval.

“Very proud of the work our Trimedx team is doing in supporting our University of Michigan Health Sparrow customer during their BD Alaris pump rollout.”

“Day one at a site doing some fun demo modules! NVRT Labs is so cool.”

“Not your average biomed #biomedlife”

“Finally, after batteries were on back order I was able to replace the batteries on these wound vacs”

Photo by Jeff Ruiz
Photo by Shelby McCarty
Photo by Christopher Walters
Photo by Alma Zamora

THE TOTAL PACKAGE HAS ARRIVED.

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