Healthcare Purchasing News - April 2025

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Staffing Challenges Persist Across Departments ... 12 Supply Chain + Sustainability... 8 C L I N I C A L I N T E L L I G E N C E F O R T H E H E A LT H C A R E E C O S YS T E M

2025 SPD OF THE YEAR:

UF Health Shands ... 16

APRIL 2025

APRIL 2025

16

Sourcing & Logistics 8 > Environmental Sustainability: The Urgent Rush to Keep Emissions Down in Healthcare MATT MACKENZIE

34 > Reducing Avoidable Hospital Days: Supply Chain’s Role KAREN CONWAY

Surgical/Critical Care 12 > Breaking Down the Healthcare Staffing Shortage

8

JANETTE WIDER

Sterile Processing 16 > A Multi-Faceted, Data-Driven Approach to Sterile Processing Transformation and Optimization KARA NADEAU

24 > Lost in Translation: Ethical Dilemmas in Medical Manufacturing Instructions ANNA CASTILLO-GUTIERREZ

30 > Power of Active HSPA Chapter Involvement

12

JULIE E. WILLIAMSON

32 > Extended Cycle Times ADAM OKADA

COVER PHOTO CREDIT: NATHANIEL GUIDRY

4 | April 2025 | Healthcare Purchasing News

Departments 6 > Your Outie Reads HPN 7 > What’s on the Web, Advertiser Index

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EDITOR’S NOTE

April 2025, Vol. 49, No. 4

Your Outie Reads HPN

VP & Market Leader Healthcare and Dental Chris Driscoll cdriscoll@endeavorb2b.com | 978-880-8345 Editor-in-Chief Janette Wider jwider@hpnonline.com Associate Editor Matt MacKenzie mmackenzie@endeavorb2b.com

BY JANETTE WIDER

Senior Contributing Editor Kara Nadeau knadeau@hpnonline.com

B

y the time this edition publishes, the second season of AppleTV+’s hit TV show Severance will have aired. For those not familiar with the show, here’s a brief description of the premise from Wikipedia: “Employees at the biotechnology corporation Lumon Industries, assigned to highly classified projects, must undergo ‘severance’—a medical procedure that implants a device in their brain ensuring they retain no memories of the outside world while at work and no recollection of their job once they leave. This results in two distinct personalities for each employee: the ‘innie,’ who exists solely within Lumon, and the ‘outie,’ who lives their personal life outside of work.”

I’m not sure if my feature this month on staffing was subconscious or not (I’ve been pretty obsessed with Severance since the second season began in January), but the industry experts included in my piece said a lot of eye-opening things regarding staffing and healthcare careers. Of course, I imagined what it would be like if healthcare professionals were “severed”—only their “innie” would know what is going on at the hospital and their “outie” would be none the wiser to the supply chain decisions they made that day or the patients they visited bedside.

One par ticular comment that really stuck out to me in my piece

this month was from John R. Mehall, MD, MBA, president, Innovative ECMO Concepts. He told me, “The constant need to be available for many years takes a toll. For example, when my family and I went out to dinner, we took two cars because I might have to leave at any moment to go to the hospital. People don’t often think about that side of the job.”

So, obviously, a healthcare facility filled with severed employees would probably be extremely dangerous, not to mention a logistical nightmare (no spoilers, but for those who watch, can you say, “overtime contingency?”), as physicians and other workers often take calls outside of work. What’s more, healthcare staff truly care about their patients and facilities. Healthcare workers are truly some of the most compassionate and caring individuals on the planet.

And finally, this brings me to my la st poi nt. Th is mont h we a lso featu red ou r 2025 Ster i le Processing Department of the Year.

Cong ratu lat ions to U F Hea lt h Shands! As we celebrate the incredible work of UF Health Shands, let’s not forget: the “innies” of healthcare—those who often work behind the scenes or in the quiet moments of night shifts—need support too.

Let’s ensure they don’t have to live with the burdens of a severed worklife balance.

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6 | April 2025 | Healthcare Purchasing News

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Healthcare Purchasing News USPS Permit 362710, ISSN 1098-3716 print, ISSN 2771-6716 online is published 11 times annually - Jan, Feb, Mar, Apr, Jun, Jul, Aug, Sep, Oct, Nov/Dec, Nov/Dec IBG, by Endeavor Business Media, LLC. 201 N Main St 5th Floor, Fort Atkinson, WI 53538. Periodicals postage paid at Fort Atkinson, WI, and additional mailing offices.

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New Studies Detail Efforts to Reduce Antibiotic Use in NICUs

U.S. Cyber Command Instructed to Stop Offensive Operations Against Russia

Two studies published in Pediatrics describe efforts to “reduce antibiotic use in neonatal intensive care units (NICUs).” NICUs have “become a focus for stewardship advocates in recent years because antibiotics are among the most frequently prescribed drugs in these units, and prolonged antibiotic use is common.” Excessive antibiotic use in NICUs has been associated with “a range of harms, including development of resistant organisms and increased risk of childhood allergies.”

According to an article from CNN, Pete Hegseth, defense secretary, instructed the U.S. Cyber Command to stop offensive operations against Russia in the middle of last month. The concern, according to an offical quoted in the article, is that “the pause on offensive cyber operations against Russia will make the U.S. more vulnerable to potential cybera acks from Moscow, which has a formidable cadre of hackers capable of disrupting U.S. critical infrastructure and collecting sensitive intelligence.”

Read on: hpnonline.com/55272512

Read on: hpnonline.com/55263739

2025 Healthcare Supply Chain Viewpoint with Tom Redding Tom Redding is back for another episode! Tom leads the healthcare supply chain practice at St. Onge Company.

On this episode he shares his perspectives on the year to come in healthcare supply chain with Editor-in-Chief Jane e Wider. Topics discussed include biggest challenges in 2025, technologies supporting supply chain leaders, artificial intelligence, supply chain leaders’ seat at the table, and supply chain resiliency.

Listen at: hpnonline.com/55268891

Index of Advertisers

679764821 © MARIA_LH | STOCK.ADOBE.COM

What’s on the Web

Editorial Advisory Board Jimmy Chung, MD, MBA, FACS, FABQAURP, CMRP, Chief Medical Officer, Advantus Health Partners and Bon Secours Mercy Health, Cincinnati, OH Joe Colonna, Chief Supply Chain and Project Management Officer, Piedmont Healthcare, Atlanta, GA; Karen Conway, Vice President, Healthcare Value, GHX, Louisville, CO Dee Donatelli, RN, BSN, MBA, Senior Director Spend symplr and Principal Dee Donatelli Consulting LLC, Austin, TX J. Hudson Garrett Jr., PhD, FNAP, FSHEA, FIDSA, Adjunct Assistant Professor of Medicine, Infectious Diseases, University of Louisville School of Medicine Melanie Miller, RN, CVAHP, CNOR, CSPDM, Value Analysis Consultant, Healthcare Value Management Experts Inc. (HVME) Los Angeles, CA Dennis Orthman, Consulting, Braintree, MA Janet Pate, Nurse Consultant and Educator, Ruhof Corp.

Richard Perrin, CEO, Active Innovations LLC, Annapolis, MD Jean Sargent, CMRP, FAHRMM, FCS, Principal, Sargent Healthcare Strategies, Port Charlotte, FL Richard W. Schule, MBA, BS, FAST, CST, FCS, CRCST, CHMMC, CIS, CHL, AGTS, Senior Director Enterprise Reprocessing, Cleveland Clinic, Cleveland, OH Barbara Strain, MA, CVAHP, Principal, Barbara Strain Consulting LLC, Charlottesville, VA Deborah Petretich Templeton, RPh, MHA,Chief Administrative Officer (Ret.), System Support Services, Geisinger Health, Danville, PA Ray Taurasi, Principal, Healthcare CS Solutions, Washington, DC

This index is provided as a service. The publisher does not assume liability for errors or omissions.

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hpnonline.com | April 2025 | 7

SOURCING & LOGISTICS

Environmental Sustainability: The Urgent Rush to Keep Emissions Down in Healthcare

BY MATT MACKENZIE

C

limate change is continuing unabated, and its effects are being felt with greater urgency with each passing year.

According to a new study that the Associated Press reported on recently, glaciers are shrinking at a rate nearly twice as fast as they were in the early 2000s. A record 604 billion tons of ice were lost from glaciers in 2023. A scientist who wasn’t part of the study stated that “glaciers are apolitical and unbiased sentinels of climate

change, and their decline paints a clear picture of accelerated warming.” The melting of glaciers plays a massive role in sea level rise, and the trends are currently moving in the wrong direction.

The threat climate change poses is not merely theoretical, either. Analysis from World Weather Attribution and Climate Central researchers in 2024 found that people suffered an average of 41 extra days of dangerous heat that year, leading to the deaths of at least 3,700 people.

358541697 © MEDIAWIZARD | DREAMSTIME.COM

8 | April 2025 | Healthcare Purchasing News

Globally, the summer of 2024 was the hottest one on record, endangering people around the world, including (and especially) those people in the poorest and least developed countries. Scientists expect Earth to soon go past the threshold the Kumbia Lewis Paris Agreement set of 1.5 degrees Celsius of warming.

Now, in 2025, President Donald Trump’s administration is attempting to rewrite a key finding that planetwarming greenhouse gases endanger the public. New Environmental Protection Agency chief Lee Zeldin is Jesse Stanton pushing against a 2009 decision by the agency that justifies and applies regulations on heat-trapping emissions of greenhouse gases from the burning of coal, oil, and natural gas. More studies and research have only proven the decision correct, as more evidence of harm continues to pile up.

The healthcare industry plays a significant role in greenhouse gas emissions worldwide. The Lancet reviewed hundreds of publications that included a definition or description of environmentally sustainable healthcare in an attempt to “encourage standardization across sustainability efforts.” Several impact categories cropped up as particular points of emphasis for health systems describing sustainability efforts – among them include “greenhouse gases,” “solid waste,” “energy use,” “water use,” and “air pollution.” Overall, however, there was a great amount of diversity in how health systems defined environmentally sustainable healthcare. Plus, general definitions of sustainability, which many use as benchmarks in their definitions, are not particularly specific.

The review also found a specific emphasis on greenhouse gas emissions, which may lead to some organizations narrowing in on one specific element of sustainability and neglecting other areas. Some consensus did emerge around greenhouse gas, waste, and energy use categories, which is promising. The authors of the study suggest that certain measures be taken to harmonize sustainability efforts, like meetings of expert panels and empirical analyses. Heterogeneity in measurements of environmental sustainability can make things more complicated.

Important work is being done to enhance sustainability efforts in health systems around the U.S. Healthcare Purchasing News spoke with Kumbia Lewis, MBA, CMRP, CVAHP, LSSBB, PMP, FACHE, director of Hospital Distribution, Supply Chain Management at Texas Children’s Hospital in Houston, Texas; and Jesse Stanton,

MBA-HM, CMRP, vice president of Supply Chain at Parkview Health, headquartered in Fort Wayne, Indiana; about measures their organizations are taking to become yet more environmentally sustainable.

What sustainability measures have your organization adopted that have been particularly successful?

Stanton: Over the years, Parkview has made sustainability a focus. A team was established to gather current state sustainability efforts and data. We have partnered with Practice Greenhealth [an organization that delivers environmental solutions to hospitals] for benchmarking and resources across a number of sustainability categories. Our sustainability efforts stretch across multiple areas throughout our health system, from the collection of one-time surgical instruments for repurposing and landfill avoidance to employing energy efficiency strategies throughout our facilities, reducing food waste, and utilizing local and sustainable vendors. We even include language in our contracts outlining our sustainability stance and track vendors based on sustainable ratings.

Lewis: Our organiza— JESSE STANTON tion has an executive-level committee that is focused on decreasing our carbon emissions and creating a sustainable work environment. The committee is working through 7 pillars —Chemical & Waste; Greening the OR; Food; Sustainable Procurement; Climate, Water, & Energy; Green Building; and Transportation—that will lead to a 50% reduction by 2023.

Mike Brown, VP of Supply Chain, heads the Sustainable Procurement initiatives. Some of the sustainability initiatives include reprocessing of eligible medical supplies, conservation of energy, and food waste composition.

“The biggest challenge in creating an environmentally friendly workplace is economies of scale.”

What is the biggest challenge when it comes to creating an environmentally friendly workplace?

Stanton: The biggest challenge in creating an environmentally friendly workplace is economies of scale. It is easier to deploy these efforts in smaller provider offices that were environmentally consciously constructed. However, applying those principles across a dozen hospitals of varying ages is challenging. That is why we tackle each workspace individually, recognizing these challenges and applying unique strategies to ensure that we meet the needs of

hpnonline.com | April 2025 | 9

SOURCING & LOGISTICS

patients, guests, and co-workers while striving to be environmentally friendly.

Lewis: Creating an environmentally friendly workplace comes with many challenges that can impact the organization’s finances, operations, employee engagement, and strategic plans. Years ago, I would have quickly said that employee engagement was the biggest challenge to creating an environmentally friendly workplace due to deployment strategy, lack of communication, and employee buy-in.

Today, the challenge that we are facing is contractual agreements. Some of our contracts make adhering to or participating in supply sustainability efforts more difficult.

Our Strategic Sourcing team is aggressively focusing on ensuring that our future agreements do not reduce our ability to drive more sustainable supplies in our organization.

Lewis: Learning from the past is necessary; the first lesson we take away is that there will be another pandemic, a health, financial, or natural crisis. When we think about pandemic response and environmental sustainability, we have to move quicker and plan ahead as an organization.

How will we respond when vendors restrict our orders, gouge prices, or lack essential supplies? Are we looking for reusable supplies? Are we considering increasing our stockpile? Ask yourself: are we ready?

Did COVID present any unique challenges with sustainability? Did it lead to any new innovations?

“More discussion should occur around the needs and benefits of hospitals adopting environmentally friendly policies.”

Stanton: One unique challenge that COVID presented for sustainability was the large increase in the use of disposable isolation gowns. This led to an increased need for space to store these bulky items and an increase in waste because they are single-use. Early on, we pivoted to using reusable gowns that were initially produced by a local recreational vehicle plant, repurposing materials that were meant for this industry but were not being used during COVID to manufacture isolation gowns. This innovative approach served not only our health system but also supported local business.

Lewis: We were all faced with determining and understanding how to keep serving our communities. There was a huge disruption in the supply flow of medical supplies. We had to be innovative and focus on conservation of supplies.

We examined our caseload, reducing it to only necessary cases, eliminating elective cases. Stricter control around PPE and Appropriate Use Guidelines were created and implemented, and these guidelines are still in use today.

Now that COVID is on the downswing compared to the first couple of years of the pandemic, what lessons can be learned about pandemic response and environmental sustainability?

Stanton: Lessons learned from COVID regarding environmental sustainability focused on diversifying our procurement practices. This has led to purchasing more from local and onshore sustainable vendors than ever before.

With ongoing supply chain disruptions, we have also pivoted to evaluating and using more reprocessed products.

This way, we not only reduce waste but also control our pipeline of products.

10 | April 2025 | Healthcare Purchasing News

Do you have any particular concerns for the future?

Stanton: Even though we have changed some of our practices, resiliency, inflation, and unknown regulatory challenges threaten ongoing sustainability efforts.

— KUMBIA LEWIS

Additionally, the need to balance cost-effectiveness with sustainable choices and the evolving landscape of environmental regulations requires continuous adaptation and innovation. Despite these challenges, our commitment to sustainability remains steadfast as we seek new solutions and partnerships to overcome these obstacles.

Lewis: There are efforts around environmental sustainability in healthcare. More discussion should occur around the needs and benefits of hospitals adopting environmentally friendly policies. We must examine our equipment, processes, transportation, waste, greenhouse gas emissions, and investments.

Another concern is supply variabilities. Our VP of Supply Chain is committed to creating longer term agreements with vendors and suppliers, accelerating the move to more 5–7-year contracts. The belief is that this will aid in the reduction of supply variabilities.

One final concern is the stability of the recycling industry. Do we understand the long-term environmental plan and capability from a State and Federal level? Will our initiatives be supported from a state perspective? There are no guarantees.

Are there any advancements in the space you are working on or aware of that you’d like to spotlight?

Lewis: Our sustainability team has been in place since 2023, and Texas Children’s Hospital has signed the HHS pledge to reduce organizational emissions by 50% by 2030. HPN

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SURGICAL/CRITICAL CARE

Breaking Down the Healthcare Staffing Shortage From rising turnover rates to the shortage of skilled workers, healthcare leaders provide valuable insights into the challenges and potential solutions in staffing.

BY JANETTE WIDER

T

Healthcare Staffing Report by Everee and StaffUpApp, clinicians are facing financial strain, with 62% living paycheck to paycheck and 74% feeling underpaid. As a result, many are turning to temporary work for its

ID 81971885 | CARE © DMITRY KALINOVSKY | DREAMSTIME.COM

he healthcare staffing industry is undergoing significant transformation, driven by clinicians’ increasing preference for flexibility, faster pay, and better support. According to the 2025

higher pay, flexible schedules, and the opportunity to travel. Among clinicians considering a job change, 67% would opt for temporary roles over permanent ones. Staffing agencies must prioritize educating candidates on these benefits.

Clinicians also value faster pay, with 61% indicating they would choose an agency offering sameday pay. This preference is a competitive advantage for agencies, as 67% of recruiters agree that sameday pay enhances their ability to attract and retain talent. Additionally, transparency and support are key to retaining clinicians, with issues like delays in assignment placement, poor

12 | April 2025 | Healthcare Purchasing News

communication, and scheduling challenges being major frustrations.

The adoption of technology, including mobile apps and AI, is becoming crucial for staffing agencies.

Clinicians prefer managing schedules and timesheets through digital platforms, and agencies using mobile-first solutions and same-day pay report higher satisfaction and retention. Recruiters also see AI as a tool to improve hiring speed, candidate screening, and reduce bias. To stay competitive, agencies should focus on offering competitive pay, leveraging technology, and addressing pain points like communication and scheduling.

Accord i ng to t he A mer ica n Association of Colleges of Nursing’s report, “The Nursing Shortage and Efforts to Address It,” the United States is experiencing a significant shortage of Registered Nurses (RNs), a trend that is expected to worsen as the aging Baby Boomer population increases the demand for healthcare services. The Bureau of Labor Statistics projects a 6% growth in the RN workforce between 2022 and 2032, but this is not enough to meet the growing healthcare needs.

Additionally, many nurses are nearing retirement, with studies showing that more than 1 million RNs are expected to retire by 2030. The shortage is further exacerbated by high burnout rates and insufficient capacity in nursing schools, which are unable to admit all qualified applicants due to a lack of faculty and clinical resources.

Research indicates that nurse staffing levels have a direct impact on patient outcomes. Hospitals with higher nurse staffing and more educated nurses, particularly those with a baccalaureate degree, have better patient survival rates and fewer complications. However, addressing the nursing shortage remains a challenge, as nursing schools struggle to

expand enrollment to meet demand. the reason is that healthcare staffing Efforts to combat the shortage include is hands-on work. There’s no remote nursing or remote caregiving—profederal advocacy for increased fundviders must go to a facility, whether ing for nursing education, as well as it’s a hospital, physician’s state initiatives aimed at office, or elsewhere. Many expanding capacity and forms of care also require enhancing workforce divernight and weekend work. sity. Some universities are Patients don’t go home at also forming partnerships 5:00 PM; they’re still in with healthcare providers the hospital overnight, on to develop sustainable pathweekends, and during holways into nursing.

Pam Damsky idays. As a result, healthHealthcare Purchasing News had the opportunity to care providers often have to speak with several industry experts take calls at night, work night shifts, about the current state of staffing in weekends, and holidays.

“This hands-on, on-location work hospitals. Here’s what they had to say. isn’t something everyone is interested Post-COVID update in, and it limits the pool of potential Pam Damsky, managing partner and workers. A large segment of the workco-lead, Clinical Transformation line force isn’t drawn to this type of work of business at Chartis, said “I would or off-hour shifts. Over time, the say it’s different, not necessarily betdemands of nights and weekends also ter, although statistics might sugtake a toll. Many people in their 20s gest otherwise. For instance, overall and 30s may be willing to work these nurse turnover has decreased. The hours, but by the time they reach their latest data from 2023 shows that 40s, 50s, and beyond, they’re much nursing turnover is around 18%, less interested in it. This shortens the which is lower than during COVID longevity of careers in many areas of and approaching pre-COVID levhealthcare.” els. However, first-year turnover is still around 30%.

A look at departments “What’s happening is that there’s around the hospital an experience drain. While the numSteve Downey, VP, chief supply chain bers may suggest improvement, it’s & support services officer, Cleveland actually becoming harder for nurses Clinic, commented on several different areas. Regarding sourcing, on the floor because many of them are Downey commented, “It’s tough to inexperienced. Once they’re trained, they leave, so teams are constantly in find the right people because they need training mode. both specialized skills—like knowl“Additionally, other supporting edge in orthopedics, cardiology, IT, or roles, like allied health and clinical pharmacy—and the ability to negotiservices, are also experiencing high ate, source, and contract. They often turnover. One statistic I recently saw need to collaborate with end-users and noted a 30% increase in open allied gain credibility in that area. Clinical health jobs compared to last year. roles are highly competitive within When teams lack support staff, it health systems, and even indirect makes the work more difficult.” spending is competitive across the John R. Mehall, MD, MBA, presbroader market.” ident, Innovative ECMO Concepts, As for operations, Downey noted, “Traditional supply chain roles, noted “I think staffing is still a major such as buyers, material handlers, challenge in healthcare. A big part of

hpnonline.com | April 2025 | 13

SURGICAL/CRITICAL CARE

and warehouse management, are highly competitive. This is because these positions are also sought after in other industries like retail and e-commerce.”

Further, “Positions requiring both healthcare knowledge and systems

really likes, which only exacerbates the problem.

“Hospitals may also reach a point where they have to close beds or reduce the number of open units due to staffing shortages. For example, on an inpatient unit, they may not

“Compensation is definitely a factor, especially for some support and entry-level roles.”

— PAM DAMSKY

have enough staff to safely support a full unit. Similarly, in areas like imaging, they may not have enough staff to run machines for as long as needed, or it takes longer to process patients through the system, leading to reduced access.”

“I think the main issues are cost and access—longer wait times, longer turnaround times, and delays in getting things done.”

Mehall commented on why individuals may not be so excited about the medical field. He said, “If you’re not in a healthcare position, when you go to bed, you’re not at risk of your phone ringing, making you have to rush to the hospital within 30 minutes and perform a six- or eight-hour operation, where the patient’s survival is uncertain. There’s an acuity Consequences to that kind of work that’s probably underappreciated When asked about the unless you’re living it. consequences of not hav“Additionally, the coning enough staff, Chartis’ John R. Mehall stant need to be available Damsky noted, “The biggest consequence is cost. Hospitals for many years takes a toll. For examwill ensure they have enough staff ple, when my family and I went out to deliver care safely, and I would to dinner, we took two cars because I also add access to that. To meet the might have to leave at any moment to needs of the population, they’ll pay go to the hospital. People don’t often think about that side of the job.” overtime, hire agency staff, or bring in He added, “So, there are just some travelers, although the use of travelpeople who say, ‘I’m not signing up ers has decreased. They’re also asking staff to stay late or even mandating for that.’ They’d rather work in a field overtime, creating situations no one that offers regular hours, no weekend expertise are in high demand today.

These roles are highly valued across the market.”

“Services such as SPD, Food, and Linen each have unique challenges.

SPD in particular is the most competitive. Finding skilled SPD workers who are well-trained in procedures, cleanliness, and attention to detail is rare,” Downey stated.

Damsky also commented on SPD; she said, “Sterile processing is an example of an entry-level job where staffing shortages have a significant impact. Without enough sterile processors, you can’t run your ORs, and that’s a big issue. It becomes very difficult to have the necessary equipment ready, or things run slower, which creates a problem.”

14 | April 2025 | Healthcare Purchasing News

shifts, and holidays off. And there’s nothing wrong with that. But you have to recognize that the demands and rigors of working in healthcare significantly reduce the number of people willing to take on those responsibilities.”

New faces When asked about how to retain and recruit staff, Damsky said, “Compensation is definitely a factor, especially for some support and entry-level roles. For example, a firstline worker in supplies can often get a job at Amazon, which pays more and is easier to obtain. It’s hard to turn that down.

“There is a strong value proposition in healthcare, like a commitment to the community and doing good, which brings a lot of people into the field. However, the challenge is when we don’t reinforce that commitment across the staffing continuum. Everyone, from top to bottom, needs to see their role as part of that service to the community.

“This commitment to culture and mission is reinforced to varying degrees depending on the organization.”

Damsky laid out four main areas that are crucial for creating a stable workforce: • Understanding the drivers of turnover: It’s important to gain detailed, actionable insights into why people want to leave, beyond just the typical engagement survey. These factors vary by role, so role-specific surveys are necessary to identify what’s truly driving turnover.

• Creating a cultural connection: Reinforce the organization’s loyalty to the individual. Whether it’s th rough ca reer progression or a sense of community, these connections have, in some places, been lost.

• Focusing on the daily experience: Working in healthcare can

be challenging, even though it’s ultimately rewarding. We need to understand the specific issues that make the daily experience harder, which can vary by role, and work on addressing them.

• Leadership accountability: Finally, leadership must be committed to addressing these issues. They need to measure and monitor progress, ensuring that the changes needed to create a stable workforce are being made and that they’re held accountable for it.”

“I actually think the biggest imperative is to focus on retaining the staff you already have,” Damsky added.

Mehall largely agreed. He said, “I do encounter young people who are interested in healthcare, and I encourage anyone who feels that calling to absolutely pursue it. If your heart is in it and you’re doing what you love, you’ll enjoy it. Yes, there might be higher-paying jobs elsewhere, but the compensation in healthcare is sufficient, and anyone doing full-time caregiving can make a reasonable living.

“As for making healthcare more appealing, I hadn’t really thought about it, but I do think that, at least on the physician side, there has been a loss of stature and prestige compared to 20 or 30 years ago. This likely mirrors the loss of autonomy and governance physicians have experienced. Most physicians today are employed, whereas in the past, many owned and managed their own independent practices. They had a lot of control over which hospitals they worked with and the care their patients received. In an employed model, that’s not the case. If you’re employed by a hospital, your patients are brought to that hospital, and if you’re dissatisfied with the care there, you don’t have the option to send your patients elsewhere.

“Hospitals no longer compete for doctors in the same way—they don’t

have to. Physicians have lost some pricing can cause transaction errors. of the control over how they manWaste increases, and if temporary age their professional lives, which staffing is needed to cover the shortI think has contributed to fall, costs rise even more.” the diminishing prestige of As for associations and being a physician.” awareness, Downey articMe ha l l we nt on to ulated, “I’m a big supporter explain that another issue of AHRMM, the supply that impacts healthcare is chain division of the AHA, that, when you’re on call, which works hard to eduyou can’t control the volcate and raise awareness Steve Downey ume of patients coming in about the field. Supply during your shift. If the chain is a great career patient load exceeds the staffing with many opportunities across available, there’s often no good way various areas.” to bring in more help, yet the work Damsky shared her outlook for still has to be done. The nature of the future, as well. She commented, the people who go into healthcare is “I haven’t found a magic bullet, but that they’re altruistic. They’ll give in my experience, there are some up their lunch break, work extra key areas to focus on. EHR optimihours, or take work home to finish zation is a big one. People are conit. Over time, though, this sense stantly working on that, but you can use reports to track ‘pajama time’ and focus on streamlining documentation. For example, how can we reduce the need to write everything down? How can we create standardized processes so that for patients with certain conditions, specific — STEVE DOWNEY orders automatically appear, so we don’t have to request them? of altruism can start to feel like “There are many ways to streamit’s being exploited, which is one line the work, but it’s not a onesource of burnout. size-fits-all solution. It requires a He commented, “Another source specialty-by-specialty, componentby-component approach. is the loss of governance and auton“Another promising area is techomy, and then, with staffing shortages, there’s simply more work than nology, like ambient listening, which there are people to do it. This crehas shown significant reductions in ates physical burnout from trying provider time. While not everyone to handle too much or working too has access to these technologies yet, many hours.” they’re starting to be more widely adopted, and I think we’ll see even more of these tools in the future.”

Final thoughts Cleveland Clinic’s Downey noted She concluded, “For me, addressing supply chain specifically. He said, the workforce gap comes down to four “Supply chain is essential for patient key things: You need to identify where the problems are, reinforce the cultural care—it has to run smoothly. When staffing is too low, costs go up. Poor connection people have to the orgasourcing leads to higher expenses, nization, improve the daily experience existing staff has to work overtime to for employees, and ensure accountabilfill gaps, and mistakes like incorrect ity for delivering results.” HPN

“Supply chain is essential for patient care—it has to run smoothly.”

hpnonline.com | April 2025 | 15

STERILE PROCESSING

UF Health Shands is HPN’s 2025 SPD of the Year.

BY KARA NADEAU

W

hile some sterile processing depar tments (SPD) have demonstrated impressive improvements in specific areas of their operations, such as quality, productivity, or education, the UF Health Shands SPD team impacted all these areas in the past year.

They embarked on the transformational change of centralizing instrument reprocessing to a 57,000 square foot Offsite Reprocessing Center (ORC), going live with all surgical services locations in just five months.

Guided by a strategic vision and robust plan; enabled by digital technology solutions, optimized processes, and strong relationships; and informed by advanced data and analytics, the UF Health Shands SPD team didn’t just survive the transition – they shined with exceptional performance.

In 2024, the team of 137.8 full-time employees (FTEs) supported 79 operating rooms (OR), which performed

16 | April 2025 | Healthcare Purchasing News

47,258 surgical cases. The ORC handled 70% of total instrument reprocessing, with 219,145 surgical trays and 7,010,227 surgical instruments sterilized.

Key performance metrics include: • 6.5% increase in total instruments reprocessed from 2023 to 2024 • 5.5% increase in total sets • 7.8% increase in loaner sets • 30% increase in commonly used instrument assets • 18% reduction in sets requiring rapid 24-hour turnover • 66% reduction in sets overdue for repair • 85% increase in scope processing electronic records • 71% increase in OR staff accessing quality events module • 1.3% average defect rate per set • 0.05% ave rage defec t rate per instrument In September 2024, the team successfully completed a survey performed by The Joint Commission (TJC) with zero findings at the ORC.

In her nomination for HPN’s 2025 SPD of the Year, UF Health Shands Sterile Processing Director Sara Vinson, MBA, CRCST, commented on the critical importance of the team’s data-driven and continuous improvement mindset, stating: “What truly sets us apart is our dedication to innovation and investments in advanced analytics. With such a wealth of data at our fingertips we can focus on what truly will impact our operations in a positive and meaningful way. Establishing internal benchmarks and tracking ongoing performance ensures we are delivering our desired results. These robust analytical tools are essential to our successful performance.”

When asked to describe the success of the ORC, Vinson stressed the importance of a multi-faceted approach.

“Our success did not hinge on a single factor; rather, it was reliant on a multitude of elements. Our chosen areas of focus happened to align with the HPN SPD of the Year nomination criteria. This included a strategic plan, customer coordination, collaborative teamwork, productivity aimed at maintaining high quality, and education and training for a talented and sustainable workforce.”

In telling the story of UF Health Shands as the 2025 HPN SPD of the Year, HPN delves into each of these key components that together made for a winning team.

About UF Health Shands University of Florida (UF) Health Shands is a private, not-for-profit hea lt hca re system located i n Gainesville, Florida. The health system includes the UF Health Shands teaching hospital, five specialty

PHOTO CREDIT: NATHANIEL GUIDRY

A Multi-Faceted, Data-Driven Approach to Sterile Processing Transformation and Optimization

The UF Health Shands SPD Team: Elliot Hughston, Espedito Ciego, Sanchiro Balanay, Daryl Jones, Ernesto De Los Reyes, Michelle Robson, Kenneth Schendel, Nasir Lamb, Charles Seymore Jr, Kimberly Jordan, Frankie Jackson Jr, A.J. Jackson, Tara Merricks, Sangria Robinson, Michael Daniels Jamel Graham, Renee Clayton, Charmaine Rice

hpnonline.com | April 2025 | 17

STERILE PROCESSING

hospitals - UF Health Shands Cancer Hospital, UF Health Shands Children’s Hospital, UF Health Psychiatric Hospital, UF Health Heart & Vascular Hospital, and UF Health Neuromedicine Hospital - a network of surgical centers, outpatient rehabilitation centers, and a home health agency. UF Health Shands has been consistently recognized as the top hospital in Florida and among the best hospitals in the country.

About the UF Health Shands SPD The UF Health Shands Sterile Processing Department (SPD) is responsible for the reprocessing of all reusable medical devices used in surgical, inpatient, and outpatient procedures. The team provides care for patients of all ages and for all specialties. Ancillary units supported include intensive care units (ICU), radiology, respiratory, endoscopy, the emergency department, labor and delivery, and many more.

The UF Health Shands SPD team’s reprocessing methods include steam sterilization, low temperature sterilization, and high-level disinfection (HLD). Their process begins when point of use ends. The team performs decontamination, inspection and assembly, and sterilization procedures. Their scope of work ends at the point of return to storage. From there, their surgical services and supply chain partners take over inventory management, case cart building, and delivery of surgical items to the required destinations.

Long-term strategy reflects projected surgical services growth “Having a strategic plan to respond to rapid growth and the ability to adapt quickly is a must for surgical services,” Vinson explained.

UF Health Shands designed and built its ORC to support projected

18 | April 2025 | Healthcare Purchasing News

Case cart staging

Low temp loading

Steam loading

surgical services growth for the next 20-25 years. During the planning and opening of the ORC, UF Health expanded by adding 14 additional ORs with plans to open eight more in 2025.

Designed with continued growth in mind, the ORC features a unique one-piece flow layout to increase efficiency and create shelled space for expansion as needed. Innovative features, including real-time location systems (RTLS) software and automated inventory management systems, streamline workflows to enhance efficiency and productivity. Furthermore, investments in advanced analytics refined the UF Health Shands SPD team’s ability to guide strategic initiatives and key performance metrics.

In-housing instrument maintenance and repairs Recognizing the importance and challenges of timely surgical instrument preventative maintenance and refurbishment, UF Health Shands strategically positioned an in-house instrument repair lab within the ORC. Vinson described their use of technology to streamline these processes: “Our instrument tracking system flags how often a set is due for refurbishment, which will signal to the assemblers when they need to deliver a set to our onsite repair technicians.

Once the technician completes their inspection and refurbishment, the set returns to the decontamination room.

Now these repairs can occur during the reprocessing cycle versus the traditional model of running reports and

Overdue for Repair Rate Trays Overdue for Repair/ Trays with Repair Cycles Set 30.00% UCL 22.46% 20.00%

10.00%

Avg 9.74%

0.00% LCL 2.99% -10.00% 2024-Jan 2024-Feb 2024-Mar 2024-Apr 2024-May 2024-Jun 2024-Jul 2024-Aug 2024-Sep 2024-Oct 024-Nov 2024-Dec

Overdue for Repair Rate

total requests compared to our actual spend and our current budget,” Vinson explained. “We also use these tools to monitor the response time and performance of our instrument coordinators.”

Since implementing and using these tools, the team ended Q2 2024 only 9% over budget fiscal year to date (FYTD). “We have set ourselves up for successful completion of meeting our budget by the end of the fiscal year,” Vinson added.

Trays Overdue for Repair/ Trays with Repair Cycles Set

Integrating technologies to replace missing instruments

25.00%

20.00% UF Shands UF Shands FSC UF Shands HVN UF Shands North Tower UF Shands ONH UF Shands OSC UF Shands Offsite UF Shands South Tower

15.00% 10.00%

5.00%

0.00%

2024-Jan 2024-Feb 2024-Mar 2024-Apr 2024-May 2024-Jun

2024-Jul 2024-Aug 2024-Sep 2024-Oct 2024-Nov 2024-Dec

locating sets each day that a repair technician comes to your facility.”

With this new proactive model and enhanced tracking of repair cycles, UF Health Shands has significantly reduced the number of sets overdue for repair by 66%. According to Vinson, this has had a direct impact on the SPD team’s customers, “as their instruments are maintained at the highest quality standards to ensure proper function and sharpness is available consistently.”

Inventory optimization supports exceptional customer service One challenge that comes from transitioning to off-site reprocessing is the additional time it takes to turn around trays due to increased logistics and transport. To ensure each department has the instruments they need when they need them, UF Health Shands increased its inventory of most used instrument assets

by 30%. The result: an 18% reduction in sets requiring rapid, 24-hour reprocessing turnaround.

The team renovated and converted former hospital-based SPDs into sterile storage to accommodate the additional inventory.

Managing inventory investments As part of its strategic plan, the UF Health Shands SPD team continuously monitors instrument usage and adjusts inventory as case mix and volumes change. Vinson noted how this was and continues to be a significant financial investment for the health system. For Q1 of the 2024 fiscal year (July – September 2024), they were 53% over budget in their instrument spend. Vinson described the steps they took to serve as “good financial stewards of the organization.”

“We developed a standardized instrument request form and tracking tools that help us monitor our

Another challenge that arose from moving to the ORC was an increase in missing instruments.

“Those most familiar with the OR and SPD know it’s not an uncommon occurrence that instruments can become mixed within other sets used from the same case and then subsequently misplaced or lost,” said Vinson. “With the logistics of transporting multiple OR locations to a central reprocessing location, you need to be well organized and

“Having a strategic plan to respond to rapid growth and the ability to adapt quickly is a must for surgical services.”

—SARA VINSON

maintain a robust backup instrument inventory.”

In November 2024, the UF Health Shands SPD team began piloting the Summit E-Procurement Platform, which works in conjunction with the health system’s Sonar instrument tracking system. This allows the team to run missing instrument reports and

hpnonline.com | April 2025 | 19

STERILE PROCESSING

Sterilizer unload with sets

ORC Ribbon cutting

submit requisitions for replacements more efficiently and effectively.

During the first two months of using the integrated solutions, they noted a decrease in tray assemblies with missing instruments.

Addressing missing instruments continues to be the team’s top key performance indicator (KPI) for 2025. They have created a project charter and will be collaborating with the UF Health operational effectiveness and surgical services teams in a multidisciplinary missing instrument task force.

20 | April 2025 | Healthcare Purchasing News

Asmath Mawani, Bricola Johnson, Carmen Neves, Darren Mills, Dennis Hughes, Devon Fleming, Dunier Fuentes, Jamila Jefferson, Jarvis Navarro, Kiara Carrasquillo, Kierra Carver, Luis Gutierrez, Luis Vargas, Maria Rosales, Mary Sowich, Michael Valerio, Monika Bior, Natalie Tussinger, Noah Wolf, Patrick Thisse, Phillip McDonald, Rita Abel, Steven Garcia, Veronica Baez, William Borell, Ainsley Chaseteen, Al Motaz Shambour, Alaijah Bennett, Alex Brown, Almaz Haile, Ariell Long, Beverly Fountain, Cherry Pierson, Christian Diaz, Christopher Wagner, Corey Thomas, David Persons, Emmanuel Rodriguez, Jonlerry Pantaleon, Jose Bisagas, Joynal Abedeen, Kevin Philipsberg, Kia Neave, Kieanna Rembert, Latoya Portee, Mary Danzy, Matthew Lynch, Naomi Baez, Omar Barakat, Omar Naqawa, Patricia Bolen, Pelmar Limpo, Rich Nutt, Roderick Donato, Salvador Ninofranco Jr, Sara Vinson, Sarina Alexis, Sheila McCray, Stanley Lukas, Timothy Davis, Troy Stone, Wesley Amora, Carol Beltran, Sonia Wilson, Briyia Hagley, Roel Acogido, Tyler Thompson

Teamwork ensures a smooth transition “The phrase ‘It takes a village’ takes on a whole new meaning when you are developing and planning for a major change and transition,” said Vinson.

Vinson and her team worked extensively with all key stakeholders to ensure their concerns were heard and

addressed, including the UF Health Shands OR teams. They held several pre-planning meetings to help ease anxiety among surgical services team members.

To ensure a strong collaborative relationship between the SPD and OR teams was maintained, they created a team structure and supporting

Assemblies With Missing Rate Assemblies with Missing Inst / Assemblies Complete 20.00% UCL 17.43% 15.00% Avg 13.33% 10.00%

LCL 9.23%

5.00%

0.00% 2024-Jan 2024-Feb 2024-Mar 2024-Apr 2024-May 2024-Jun 2024-Jul 2024-Aug 2024-Sep 024-Oct 024-Nov 2024-Dec 2025-Jan

Sterilizer unload

processes. This includes having a dedicated OR liaison who is present and performs rounds in each of UF Health Shands’ main OR locations. This individual helps communicate issues and troubleshoot them in real-time.

U F Hea lt h Sha nds Cl i n ica l Coordinator Rebecca Qualmann, MSN, RN, CNOR, CST commented on this work: “I am extremely proud of the UF Health sterile processing department who, on a daily basis, promotes teamwork, quality, and collaboration. This

team has worked incredibly hard to navigate a great deal of change all while promoting UF Health’s mission and focusing on patient outcomes.

The staff care and it shows through their dedication and hard work!”

Gaining support from industry partners The UF Health Shands SPD team acknowledged not only the role of internal teamwork in achieving strategic goals but also the support of external partners in driving their success.

“From consultants to equipment and instrument manufacturers, storage solutions and software platforms, we would not be as successful as we are today without

these partnerships,” said Vinson.

“A special thank you goes out to the teams at Aesculap, Ascendco, DSI, and STERIS.” Vinson reached out to these partners to provide commentary for her team’s HPN SPD of the Year nomination. Here is what they said: “At DSI, we are proud to partner with UF Health Shands in their pursuit of excellence in sterile processing,” said Ian Loper, VP of Sales and Marketing, DSI. “With multiple oncampus SPD locations and the new offsite SPD, UF Health Shands has demonstrated remarkable foresight in standardizing storage practices as part of their ongoing efforts to upgrade storage solutions. These initiatives, including the optimization

Items High Level Disinfected

9,377

UF Shands FSC UF Shands HVN UF Shands North Tower Group total

2024-Jan 2024-Feb 2024-Mar 2024-Apr 2024-May 2024-Jun 2024-Jul 2024-Aug 2024-Sep 2024-Oct 2024-Nov 2024-Dec 42 7 776 565 883 810 744 888 754 802 521 779 738 787 46 115 120 776 565 883 810 744 888 754 964 521 825 860 787

hpnonline.com | April 2025 | 21

STERILE PROCESSING

Quality measures aligned with productivity improvements A driving force behind the establishment of the ORC was the UF Health Shands SPD team’s desire to ensure standard best practices are easily implemented and monitored. To support continuous quality improvement, Vinson and team provided OR staff access to the SPD’s quality events module. In doing so, they ensured the OR had a means of communicating challenges to the offsite SPD team.

As a result, the number of OR staff members who have access to and are utilizing the module jumped from 87 to 149, a 71% increase.

22 | April 2025 | Healthcare Purchasing News

Assembly Speed Inst per Hour Facility

Trays per Hour Facility

109

3.6 5.0

150

4.0 100

3.0

UF Shands HVN UF Shands Offsite

UF Shands HVN UF Shands Offsite

2.0

50 1.0

2024

Oc t No v De c

Jan Feb Ma r Ap r Ma y J un

Oc t No v De c

J ul Au g Sep

Ma r Ap r Ma y J un

Jan Feb

0

J ul Au g Sep

0.0

2024

Defect Rate per Instrument Processed

As Vinson noted, one would expect that an increase in quality event reporters of this magnitude combined with a transformational shift in SPD workflows would significantly impact overall quality metrics, but this wasn’t the case. She stated: “Maintaining the highest quality standards during this incredible change is another noteworthy accomplishment of the SPD team. We have maintained an average defect rate per set at 1.3% and an average defect rate per instrument at 0.05%.”

“In addition to quality, we did not see a significant impact on our overall productivity rates during this change and transition,” Vinson added. “Our case volume and total output grew substantially year-over-year, but we maintained our production rates.

Meeting the increased demand was achieved through an increase in nearly 30% more FTEs. During the calendar year 2024, we added 13.7 FTEs.”

Prioritizing scope processing documentation For those SPD team members who remained on-site in UF Health Shands’ hospitals and surgical centers, a key

ly

us t Se pt em be r Oc to be r No ve m be r De ce m be r

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of storage locations during backfill construction, reflect the team’s unwavering commitment to efficiency and patient safety.”

“What truly sets UF Health Shands apart is their exceptional staff, who work seamlessly together to achieve their goals,” Loper added. “Under Sara’s dedicated leadership, the team has cultivated a culture of collaboration and innovation that drives continuous improvement. Their dedication to excellence sets a benchmark in the industry, and we are honored to help support their efforts in creating a more streamlined and effective SPD environment.”

“UF Health Shands represents where all healthcare facilities will need to be in the next 3-5 years,” said Brian Reed, CEO and co-founder of Ascendco Health. “Their leadership in digital innovation and commitment to raising the bar for patient safety are setting a new standard for the industry. The best partnerships drive mutual growth, and when one organization advances patient care and safety, it strengthens the entire healthcare ecosystem. This is more than progress; it’s the future of healthcare, shaped by their dedication to collaboration and innovation.”

quality improvement priority in 2024 was electronic documentation and tracking of scopes undergoing highlevel disinfection (HLD). By improving utilization of software for scope processing documentation, the team aimed to boost compliance with best practices and ensure higher levels of patient safety.

Through this effort, they increased scope processing records by 85%, from 521 in January 2024 to 964 in December 2024.

Educational partnerships establish a sustainable and talented workforce Given the widespread and ongoing staffing shortages in SPDs across the U.S., the UF Health Shands SPD team has partnered with local colleges and academic centers to recruit and train the next generation of SP professionals. As a result, the department’s overall educational effectiveness, recruitment, and retention have improved.

One partnership is with Santa Fe College, which offers a 30-credithour sterile processing technology certificate program. Students learn

the fundamentals of SP in the class2023 2024 % Increase room then receive hands-on experience at UF Health Shands. Upon Total Scheduled Cases 46369 47258 2% completion of the program, a student Total Sets 207687 219145 5.5% takes the certification exam and if Loaners 28546 30786 7.8% they pass, they are ready to apply for a career opportunity within the Total Instruments 6582647 7010227 6.5% SPD profession.

Julia Wagner, MS, CHES, CSFA, 2023-2024 year over year CRCST, program director, assisat UF Health Shands where they tant professor & clinical coordinator on excellence, our students gradurotate through various departments for Sterile Processing Technology ate from the sterile processing proto observe and learn about healthat Santa Fe College, comgram with the knowledge care careers. mented on the collaboand skills needed to excel ration with UF Health in their roles and succeed “The space at the ORC has allowed Shands, stating: on the CRCST certificaus to expand the number of stu“Our partnership with dents we can host,” said Vinson. tion exam. The partnership UF Health Shands has “Each semester, we train eight to with UF Health Shands is been essential in providing 12 students.” a cornerstone of our proexceptional education and gram’s success.”

Sara Vinson training for our students at The second partnership Looking ahead Santa Fe College. Through is with one of UF Health “The year 2024 was a busy and Shands’ local high schools, which the guidance of UF Health’s educators exciting year for UF Health’s Sterile offers a “Pathway to Healthcare and staff, students gain invaluable Processi ng Depa r tment,” sa id Careers with a Medical Skills hands-on experience that prepares Vinson. “There are almost too many Program.” When a student in the them to enter the workplace confiaccomplishments to recognize in a program enters their senior year, dently. By practicing industry best single nomination submission.” they participate in an internship standards and maintaining a focus With a dedicated space for SPD operations in the ORC, effective and efficient workflows in place, and the Employees not pictured: integration of advanced technologies for process automation, data capBri any Allen Heather Carbaugh Cherry Smith ture, and analytics, the UF Health Donavan Hepburn Kathleen Kelley Clayton Dennis Shands SPD team is positioned for Flor Cruz Eduardo Ablazo Lavondrick Howard continuous optimization and qualGlen Jackson Ronnice Quarterman Ezequiel Flamenco ity improvements.

Seth Lane Heaven Williams Fabiawari Briggs Alongside their technology soluJacqueline Filer Syeda Nahar Irving Rivera tion investments, they onboarded Julia Waring Takita Lee Joemarie Mesias a dedicated platform specialist who Kevin Spencer Tomeka Mister Kendra Range oversees their tracking platform and Lexi Tigg Mario Limbaga Ala Mahmoud serves as a crucial liaison between Brian Herron Li Chang Mark Magbayao departments, which Vinson said “is Evangelina Deleon Lucious Hines Michael Agacid essential in driving process compliGabrille DeBose Marvin Accede Michael Woods ance and improvement.”

Mary Ward Jaime Green Nadege Café “Our strategic plan to support Melva Sheppard Terry Blood Roberto Rivera future growth and streamline our Shaqueria Williams Raina Brown Alice Karuzas processes has completely redefined Reginald Griffin Shayla Gay Amaya Monroe how we operate as an organization,” RichMan Griffin Antone e Drayton Angel Ba les she added. “With a data-driven and Antonia Davis Shaneal Gray Deborah Bright continuous improvement mindset, Shawntae Brown Brianne Bohley Diana Martinez there are endless opportunities for our future success.” HPN

hpnonline.com | April 2025 | 23

CONTINUING EDUCATION

Lost in Translation: Ethical Dilemmas in Medical Manufacturing Instructions

BY ANNA CASTILLO-GUTIERREZ

Learning Objectives 1. Analyze the operational and ethical challenges posed by ambiguous, impractical, or inaccessible Instructions for Use (IFUs) in medical device reprocessing.

2. Discuss how unclear IFUs increase the burden on healthcare facilities, leading to non-compliance, errors, and potential harm to patients.

3. Recommend strategies for manufacturers to improve IFU clarity, accountability, and collaboration with healthcare providers to enhance patient safety and operational efficiency.

4. Promote partnerships between manufacturers, healthcare facilities, and regulatory bodies to ensure that IFUs are practical, accessible, and tested for real-world conditions.

Sponsored by:

24 | April 2025 | Healthcare Purchasing News

I

nstructions for Use (IFUs) are essential for guiding healthcare providers in reprocessing medical devices. However, many IFUs remain vague, impractical, or inaccessible, presenting challenges that facilities must navigate without adequate support. Many specify chemistries or products that are not manufacturerneutral, forcing facilities to adapt to instructions that may not align with their resources. Some IFUs also fail to account for real-world conditions, leaving sterile processing departments (SPDs) and healthcare teams to navigate unclear guidance that was never tested in collaboration with end-users.

Currently, hospitals and manufacturers have regulatory options to ensure some level of postmarket oversight and compliance. In the United States, the FDA mandates programs such as Medical Device Reporting (MDR) to monitor device-related adverse events and product issues, such as those regarding IFUs (FDA, 2024). Facilities are also subject to postmarket surveillance orders under Section 522 of the Federal Food, Drug, and Cosmetic Act, which allows the FDA to require studies addressing specific safety or effectiveness concerns for certain devices (FDA, 2024).

While these mechanisms are important for ensuring safety, they often fall short in addressing the practical challenges posed by IFUs in realworld scenarios. The industry needs actionable change and real-time support from manufacturers, who have a moral obligation to prioritize patient

well-being. In healthcare, ethical principles such as beneficence, non-maleficence, and justice should guide the evaluation and improvement of processes affecting patient care. These ethical dilemmas, their impact on healthcare providers and patients, and actionable steps to improve IFU usability, reduce compliance burdens, and prioritize patient safety are examined here.

The Ethical Dilemma of IFUs and Real-World Challenges IFUs are intended to ensure the safe and effective use of medical devices, yet their inadequacies often create ethical dilemmas. These dilemmas arise when manufacturers produce IFUs that: • Use complex or ambiguous language, leaving healthcare providers to interpret critical instructions.

• Require specific resources or chemistries that may be unavailable in many healthcare environments.

• Present unrealistic or impractical instructions that fail to account for real-world constraints.

Such shortcomings lead to confusion, non-compliance, and increased risks for both patients and healthcare facilities. At the heart of this issue lies the ethical principle of non-maleficence, which obligates manufacturers and healthcare providers to avoid causing harm. When unclear or impractical IFUs result in improper device usage, patient safety is directly compromised, violating this principle. Furthermore, justice, which

demands fairness and equitable access to safe and effective healthcare, is often neglected when facilities with limited resources are unable to comply with IFU requirements.

IFUs are crucial documents that guide healthcare providers in the safe and effective reprocessing of medical devices. However, many IFUs fall short in terms of practicality and accessibility. Their complexity often forces healthcare facilities to adapt processes that may not align with available resources. In some cases, IFUs do not account for real-world conditions or fail to involve end-users in their creation, leaving sterile processing departments (SPDs) and healthcare teams to navigate IFU’s on their own.

Take, for example, the reprocessing of tracheostomy tubes. Some IFUs specify the exclusive use of a detergent that may not be available in home health settings or even in many healthcare facilities. In addition, these IFUs may require tracking reprocessing cycles without providing practical methods for doing so, as critical serial numbers are often printed on disposable packaging. As a result, caregivers and healthcare providers are left to rely on guesswork or improvisation, such as marking the devices themselves, which can raise additional concerns about accuracy and safety. These gaps in guidance create significant risks, leaving SPDs uncertain about how many times trachs have been reprocessed across different settings, and whether their sterilization efforts are truly doing more harm than good.

Another example is IFUs that specify differing limits for device usage and sterilization cycles but fail to offer practical solutions for tracking each of these. Facilities are often unable to attach labels, RFID codes, or other tracking mechanisms because IFUs either omit that these options are possible or explicitly prohibit them.

This forces SPDs and caregivers to improvise, increasing the likelihood

of errors, device degradation, and noncompliance during audits.

Unfortunately, many facilities are forced to invest in costly tracking systems or additional equipment to manage these devices. Yet even with these measures, critical gaps remain because such systems cannot account for the differing requirements of tracking device usage and sterilization cycles. For example, end-users in clinical settings might open a device five times for patient care but only use it three times. Both usage and sterilization cycles must be tracked at different intervals to ensure compliance and safety. Endusers must know both the total number of uses and the number of sterilization cycles, as devices should be discarded based on whichever limit is reached first. However, SPDs can only monitor sterilization cycles, as they are not involved in direct patient care or device use. This disconnect leaves end-users, such as nurses or physicians, without a reliable mechanism to track usage accurately or determine when a device has reached its disposal threshold. Without alignment between end-users and SPDs, even the most advanced tracking systems fall short, creating ongoing risks to compliance, usability, and patient safety.

Manufacturers must prioritize patient safety by creating IFUs that are clear, universally applicable, and tested in diverse environments.

Furthermore, manufacturers have an ethical obligation to offer ongoing updates and support as challenges emerge. By bridging the gap between theoretical guidelines and real-world implementation, they can safeguard patient outcomes while reducing the burden on healthcare providers.

Patient Safety and Compliance Risks When IFUs are poorly written or impractical, the burden shifts to healthcare facilities. For example,

Lesson: Lost in Translation: Ethical Dilemmas in Medical Manufacturing Instructions March 2025 This lesson was developed by Solventum. Lessons are administered by Endeavor Business Media.

Earn CEUs A er careful study of the lesson, complete the examination online at educationhub.hpnonline.com. You must have a passing score of 80% or higher to receive a certificate of completion.

Certification The Certification Board for Sterile Processing and Distribution has preapproved this in-service unit for one (1) contact hour for a period of five (5) years from the date of original publication.

Successful completion of the lesson and post-test must be documented by facility management and those records maintained by the individual until recertification is required. DO NOT SEND LESSON OR TEST TO CBSPD. www.cbspd.net.

Healthcare Sterile Processing Association, myhspa.org, has pre-approved this in-service for 1.0 Continuing Education Credits for a period of three years, until February 23, 2027.

For more information, direct any questions to Healthcare Purchasing News editor@hpnonline.com.

Quiz Answers: 1. A, 2. B, 3. C, 4. B, 5. B, 6. C, 7. C, 8. D, 9. C, 10. D, 11. C, 12. B

hpnonline.com | April 2025 | 25

CONTINUING EDUCATION

facilities may need to invest time and resources in reaching out to manufacturers and prompting them to invest in third-party sterilization testing to verify compatibility with sterilization methods not found on current IFUs. While necessary, this adds costs and administrative work on both the manufacturer and the healthcare facility that could be avoided if manufacturers partnered with facilities and SME’s during the design and testing phases.

Additionally, healthcare facilities face tough decisions when patients arrive with custom or degraded devices that require sterilization. Should they reprocess a patient’s only tracheostomy tube when an emergency arises away from their homes, not knowing if it may have been over-reprocessed in other facilities already? These challenges highlight the need for manufacturers to collaborate with facilities to provide actionable solutions that reduce ambiguity and prioritize patient safety.

Ambiguous or impractical IFUs can have significant implications for both patient safety and facility compliance. One common example involves sterilization chemistries, such as the use of vaporized hydrogen peroxide versus hydrogen peroxide gas plasma. Some IFUs authorize the use of only one of these sterilization methods while neglecting to include guidance for the alternate method frequently employed in healthcare settings.

This lack of clarity often leads to confusion, with healthcare providers mistakenly assuming that similar sterilization methods, such as the two types of hydrogen peroxide, are interchangeable. However, using an unapproved sterilization process could compromise the device’s integrity and safety, ultimately putting patients and hospitals at risk. This leaves facilities who do not have the appropriate equipment unable to process or follow IFUs for specific devices. Furthermore, those life-saving devices that could potentially be used on patients, cannot be obtained due to these IFU limitations.

When auditors visit healthcare facilities, they frequently review sterilization processes and request the corresponding IFUs to verify compliance. If a facility has used a sterilization method not explicitly outlined in the IFU, auditors may question the validity of the process, prompting facilities to conduct detailed risk assessments to justify their decisions. This process often involves obtaining written addendums, testing updates, or verification from manufacturers that alternative sterilization methods are safe and effective. Many facilities go even further, gathering consensus documents, white papers, and published research to substantiate their practices and ensure compliance with safety standards. While these efforts are critical for safeguarding patient outcomes, they fall outside the scope of the original IFUs and require sterile processing leaders to create extensive documentation to address auditor concerns.

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Proving compliance under such circumstances is both labor-intensive and resource-draining. Teams must conduct thorough risk assessments, coordinate with manufacturers, and maintain meticulous records to demonstrate validation of their processes. Even with these exhaustive efforts, facilities may face scrutiny if auditors find the documentation insufficient, putting compliance and accreditation at risk. For instance, transitioning from High-Level Disinfection to an alternative sterilization method necessitates manufacturer-supplied verification, including testing or written guidance, all of which must be diligently maintained to prove that the process was validated, patient safety was prioritized, and the standard of care was upheld.

This reactive approach highlights the pressing need for manufacturers to proactively update and include comprehensive, flexible sterilization guidelines in their IFUs, alleviating the burden on healthcare providers and ensuring a more efficient pathway to compliance.

Collaboration and Accountability Effective collaboration between healthcare facilities and manufacturers is essential to addressing the challenges posed by inadequate IFUs. Facility leaders must work closely with manufacturers to request updated IFUs, obtain addendums, and develop practical solutions tailored to their specific operational needs. This effort includes ensuring that sterilization compatibility matrices provided by sterilization equipment manufacturers align with the unique requirements of medical device manufacturers, fostering seamless integration between processes and devices.

Proactive communication between both parties not only helps healthcare facilities enhance patient safety but also ensures compliance with industry standards, reducing the risk of errors and inefficiencies.

Manufacturers have a moral obligation to provide this guidance and distribute it broadly across the healthcare industry. If one facility identifies a gap or requires clarification, it is likely that others face similar challenges. By sharing solutions and updates proactively, manufacturers can reduce knowledge gaps, foster transparency, and prevent errors or adverse events caused by unclear or impractical IFUs. This collaborative effort can build trust between manufacturers and healthcare providers while creating a safer, more effective system for all stakeholders.

Building Partnerships for Testing and Compatibility Collaboration must extend beyond documentation to include comprehensive testing and compatibility efforts.

Manufacturers and healthcare facilities should work together to ensure that devices are compatible with various sterilization methods used in diverse healthcare settings,

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CONTINUING EDUCATION

from steam to low-temperature processes. By partnering with third-party testing companies, manufacturers can validate their devices’ compatibility and provide healthcare facilities with clear, actionable guidelines.

While facilities have a responsibility to select devices that align with their reprocessing capabilities, manufacturers play a pivotal role in ensuring the usability of their devices aligns with the diverse and practical needs of healthcare facilities and patients. Innovation and market competition drive advancements, but it is equally essential to prioritize the accessibility and clarity of IFUs. Comprehensive testing and collaboration ultimately serve the shared goal of safeguarding patient outcomes and streamlining healthcare operations while driving innovation.

By fostering these partnerships, the healthcare and manufacturing industries can close critical gaps, ensuring that devices and reprocessing methods align seamlessly with real-world needs. This cooperative approach not only enhances compliance but also strengthens the foundation of trust and reliability needed for optimal patient care.

companies, manufacturers can verify device compatibility with a range of sterilization methods, from steam to low-temperature processes.

Expand Access to Resources and Support Manufacturers must prioritize the development of IFUs that recommend manufacturer-neutral chemistries and processes to increase accessibility. Additionally, they should offer training materials, online resources, and live support to guide facilities in implementing IFUs effectively.

Leverage Technology for Tracking and Compliance To address the challenge of tracking reprocessing and usage cycles for certain devices, manufacturers should implement innovative solutions, such as embedding serial numbers directly on the devices and offering online tracking solutions for these items. These technologies should be included in the Instructions for Use (IFUs) with clear guidance on proper usage and compatibility, enabling healthcare facilities and families to meet compliance and safety requirements.

Proposed Solutions and Recommendations

Proactive Risk Assessment and Adaptation

Addressing the challenges associated with vague, impractical, or inaccessible IFUs requires a multi-faceted approach involving manufacturers, healthcare facilities, and regulatory bodies. The following solutions aim to bridge the gap between theoretical guidelines and real-world application, ensuring patient safety while reducing compliance burdens.

When IFUs are inadequate or incomplete, healthcare facilities must conduct risk assessments in collaboration with manufacturers to validate alternative processes. Facilities should maintain thorough documentation of any deviations, including manufacturer-supplied addendums or third-party testing results, to safeguard compliance during audits.

Standardize IFU Language

Develop a Shared Accountability Framework

Instructions for Use (IFUs) should feature clear, concise language to eliminate ambiguity and ensure comprehension across diverse healthcare environments. Engaging subject matter experts (SMEs) and sterile processing professionals in the design and testing phases is crucial to achieving this clarity. This collaboration can identify potential challenges early, ensuring the IFUs are practical, universally applicable, and easy to interpret.

Regulatory bodies, manufacturers, and healthcare providers must work together to establish benchmarks for IFU clarity, accessibility, and flexibility. These benchmarks should be enforced through audits and certification programs to ensure widespread adoption.

Enhance Manufacturer Accountability and Transparency Manufacturers must take proactive steps to address gaps in IFUs by providing regular updates, addendums, and supplementary materials to all stakeholders—not just those who request clarification. Solutions such as sterilization compatibility matrices, tailored to diverse methods and settings, should be made readily available.

Foster Industry Collaboration Manufacturers and sterilization equipment companies should establish partnerships to address compatibility issues. By collaborating with third-party testing

28 | April 2025 | Healthcare Purchasing News

Conclusion IFUs are more than instructional documents; they are the foundation of patient safety and compliance in healthcare. The responsibility for navigating unclear or inadequate IFUs cannot rest solely on healthcare facilities.

Manufacturers have both an ethical and practical obligation to uphold non-maleficence by producing IFUs that are clear, comprehensive, and adaptable to the complexities of modern healthcare environments, minimizing potential harm to patients. Simultaneously, we must all advocate for the resources, training, and systems that support the ethical principle of justice, ensuring equitable access to safe and effective processes across all healthcare settings without compromising the highest standards of care.

The path forward demands shared accountability and immediate action. By fostering collaboration among

manufacturers, healthcare facilities, and regulatory bodies, we can transform IFUs into reliable, user-friendly resources that protect patient safety, enhance compliance, and empower healthcare providers to deliver optimal care. These changes are not merely necessary, they are essential to uphold the ethical principles of our industry and advance patient care standards. HPN

Lost in Translation: Ethical Dilemmas in Medical Manufacturing Instructions - Practice Quiz 1. What is the primary ethical issue discussed in the article regarding IFUs? A. Ambiguity and impracticality of IFUs B. Misuse of medical devices C. Excessive regulatory requirements D. Lack of technological innovation 2. How do unclear IFUs affect healthcare providers?

A. They increase the efficiency of operations B. They lead to non-compliance and errors C. They reduce the cost of medical equipment D. They improve patient outcomes 3. Which of the following is NOT a consequence of inadequate IFUs? A. Delayed procedures B. Increased burden on healthcare staff C. Improved understanding of medical devices D. Potential harm to patients 4. What is one key recommendation for manufacturers regarding IFUs? A. To make IFUs as long as possible B. To ensure IFUs are clear, practical, and accessible C. To reduce the number of IFUs per device D. To require patients to read IFUs 5. Why is collaboration between manufacturers and healthcare providers essential?

A. To increase profits B. To ensure IFUs are tested under real-world conditions C. To avoid regulatory oversight D. To reduce the number of devices used 6. What role does regulatory oversight play in IFU clarity?

A. It is not relevant to IFUs B. It ensures IFUs are not tested in real-world settings C. It helps maintain the clarity and effectiveness of IFUs D. It focuses on the marketing of medical devices

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REFERENCES 1. FDA. (n.d.). Postmarket surveillance under Section 522 of the Federal Food, Drug, and Cosmetic Act. U.S. Food and Drug Administration. Retrieved from https://www.fda.gov/ regulatory-information/search-fda-guidance-documents/postmarket-surveillance-undersection-522-federal-food-drug-and-cosmetic-act 2. FDA. (n.d.). Medical Device Reporting (MDR): How to report medical device problems.

U.S. Food and Drug Administration. Retrieved from https://www.fda.gov/medical-devices/ medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems

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7. What is one solution to the problem of ambiguous IFUs? A. Simplifying all medical procedures B. Limiting the use of medical devices C. Improving the design and usability of IFUs D. Relying solely on staff experience 8. What does the article suggest about the relationship between healthcare providers and medical device manufacturers?

A. It should be one-sided, with manufacturers solely responsible B. It should focus only on cost reduction C. It is irrelevant to patient safety D. It should involve ongoing communication and collaboration 9. How does the ambiguity in IFUs affect patient safety?

A. It does not affect patient safety B. It reduces the chances of medical errors C. It increases the risk of errors and harm to patients D. It helps improve patient care 10. Which of the following is a proposed benefit of clear, practical IFUs? A. Higher healthcare costs B. Decreased efficiency in device reprocessing C. More complex procedures D. Enhanced operational efficiency and compliance 11. What is the main goal of addressing the issues with IFUs according to the article?

A. To reduce the cost of medical devices B. To promote medical device innovation C. To ensure better patient safety and operational efficiency D. To increase the number of medical devices used 12. How can industry-wide collaboration improve IFUs? A. By reducing the number of medical devices available B. By creating standard practices that prioritize clarity and usability C. By focusing only on regulatory compliance D. By increasing the complexity of instructions

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hpnonline.com | April 2025 | 29

HSPA

Power of Active HSPA Chapter Involvement

BY JULIE E. WILLIAMSON

A

c t ive pa r t ic ipat ion i n local Healthcare Sterile Processing Association (HSPA) chapters has the power to positively influence Sterile Processing professionals through targeted educational and networking opportunities. Among the greatest benefits is the ability to obtain quality continuing education and engage in meaningful networking. While virtual meetings allowed professionals to convene during the COVID-19 pandemic and can also be beneficial when inclement weather hampers participants’ ability to travel, many individuals note they gain more from in-person meetings and events. Such opportunities elevate one’s ability to directly network with professional peers to share best practices, answer questions, identify solutions to departmental challenges, converse with speakers and exhibiting vendors, and even develop critical skills to advance at a leadership level.

Whether a sterile processing professional is new or experienced, they can benefit significantly by building a stronger professional community. It is not uncommon for chapter members to glean valuable insight from those working in other facilities in the region—feedback that would otherwise be difficult to attain without the common ground provided by the chapter. One seasoned leader shared with HSPA how they were able to acquire new and much-needed capital equipment after speaking with a fellow chapter member who secured grants at his own facility and was willing to

30 | April 2025 | Healthcare Purchasing News

share more details about his successful approach. Another technician, who had attained certification and was exploring new employment opportunities in the region, landed an elevated technician position (Tech II) after meeting an SP manager from a neighboring town who was also attending the chapter’s membership event. Yet another member, a relatively new SPD manager, learned during a chapter meeting that a longstanding practice at her facility was inappropriate and went against the latest industry standards and guidelines. She was able to take her new-found knowledge back to her facility and make immediate changes to improve quality and safety.

Develop and share talents Many chapter members can attest that the key to their personal success—as well as their chapter’s—is sharing existing talents to promote and advance the organization and its membership and learning from others to develop and sharpen new skills. Some members might possess strong organizational and planning skills, for example, which could be applied adeptly to event planning, and others may be creative and artistic or have exceptional computer skills that could lend themselves to effective marketing of the chapter and its events. What’s more, some members might be confident speakers on certain topics that would make them well suited for providing targeted education or mentorship.

Additionally, members can learn from existing chapter board members and consider running for a position themselves. Attaining this type of position can promote further professional growth and opportunities, giving individuals essential leadership skills that can be applied in their healthcare roles and even lead some to pursue positions on the national HSPA Board of Directors.

Beyond that, chapters with strong membership commitment and involvement have a unique opportunity to support their communities while promoting the profession. In recent years, HSPA chapters have completed charity runs and walks for various awareness campaigns and causes within their communities, allowing chapter members to serve their local population while also promoting the chapter and educating the public about sterile processing’s critical role in patient safety and quality care. Whichever level a member wishes to become involved, taking the first step toward chapter membership and active participation can lead to a sizable leap for their career development, confidence, and professionalism. HPN To learn more about HSPA chapters and identify your nearest chapter, visit myhspa.org/about/hspa-chapters.

Whether a sterile processing professional is new or experienced, they can benefit significantly by building a stronger professional community.

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STERILE PROCESSING INSIGHTS

Extended Cycle Times Extended cycle times are important in hightemperature sterilizers to achieve sterility assurance.

However, not all items are capable of extended cycles based on the material that they are made of.

BY ADAM OKADA

Q A

of reusable devices are required to submit reprocessing instructions to the U.S. Food and Drug Administration (FDA) that show their instrument/set/device can be safely reprocessed. This validation includes reprocessing steps that must be followed to ensure safe devices, and there is a tremendous amount of testing and lab results required to prove the effectiveness of the process (i.e., there is a reasonable assurance that effective cleaning and sterilization will result in the appropriate levels of microbial kill, typically 10–6, using methods currently available to users in the field). This is known as the Sterility Assurance Level (SAL).1

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: “Our facility has a set of loaner trays that require 10 minutes exposure at 270 ℉. We are currently running a full load of our general sets and pouches with these loaners at that extended cycle time. Is this acceptable?” : My official answer is that you’ll need to check the Manufacturer’s (Mfr.’s) Instructions for Use (IFU) on each instrument, device, and set on that load to see if you are following them.

Extended cycle times in an autoclave are tricky, and there are numerous misconceptions about them. First, keep in mind why these extended cycle times exist. Mfrs.

32 | April 2025 | Healthcare Purchasing News

• Steam sterilization at: • 132 °C (270 °F) for four (4) minutes.

• 135 °C (275 °F) for three (3) minutes.

Figure 2: Example of a validated cycle of temperature and time from a Healthmark IFU. 3. Healthmark, A Getinge company. (2025, February). Support Document Library. https:// www.hmark.com/support-module/

Figure 1: Screenshot visual example of how pressure works inside a sterilizer. [Video].

2. Healthmark. (2022, January 18). Presenter: Stephen M. Kovach. What Happens Inside A Sterilizer? [Video]. YouTube. https://www.youtube.com/watch?v=q4Dn8z3-qok

We need to ask ourselves, “Why would a manufacturer require 10 minutes of exposure time?” The answer is possibly because 4 minutes of exposure at 270 ℉ was not effective at sterilizing all parts/sections of that tray/device to achieve the required SAL of 10–6. If the Mfr.’s IFU states 10 minutes of exposure time, then make sure you are following that.

Now that we understand why extended cycle times exist, let’s dive into the meat of your question on running a full load of mixed instruments on that extended cycle.

A typical or standard device can usually achieve an effective SAL of 10–6 at 4 minutes of exposure at 270 ℉—assuming a) the device is tested for functionality; b) effective cleaning and packaging steps are followed; c) the sterilizer is functioning properly; d) any other considerations. (Note: Standard devices [devices that require 4 minutes of steam exposure at 270 ℉] may not be able to withstand contact at this high temperature of 270 ℉ for more than that prescribed time.)

Consider the pressure of the exposure phase of a steam cycle. In the sterilizer chamber, steam is forced inside the sterile packaging to make contact with all surfaces of instruments or devices (Fig. 1). The high pressure (combined with high temperature) may cause damage to instruments or devices (e.g., melting, cracking seals, etc.) or cause loss of functionality.

The Mfr. validates the exposure time provided in their IFU. For example, if their device is validated for 4 minutes, extended cycle exposure times (5, 6, 8, or 10+ minutes) were likely not tested, so there will be no instructions for safely reprocessing the device. Therefore, if you decide to do something different from the IFU, you may damage the device, and your facility will be held responsible for the results.

To go deeper, you’ll need to get the IFU for everything that you plan on putting in that extended cycle to see if it

can be sterilized that way. When reviewing those IFUs, pay particular attention to the sterilization instructions (Fig. 2) and how they are worded. Unless the IFU says “. . . for a minimum of . . .” exposure time, then it’s very likely that they validated their instrument/device at a very specific time/temperature/exposure.

Consider the materials that make up each instrument/ device. For example, single-piece, stainless-steel instruments are less likely to be damaged in an extended exposure period than a digital camera. Anything with complex parts, rubber seals, or electronic components is at a higher risk for damage. The sterilization container itself may have specific limits for exposure (i.e., time, temperature, pressure). Some containers are made of aluminum, plastic, polymers, etc., and they may not hold up or may break down faster under extended cycle conditions.

Ultimately, checking the IFU for every device and container on each extended cycle load that you run seems like a tremendous amount of work. My recommendation would be to separate out the loaner trays with the extended cycle instructions and run them by themselves. The inconvenience of running a smaller load (or with a half-full rack) is a small sacrifice when compared to the potential dangers and fallout from not following the Mfr.’s IFU. HPN REFERENCES (APA Style 7th Edition): 1. U.S. Food and Drug Administration. (2019, July 15; last update 2024, December 23). Recognized Consensus Standards: Medical Devices. ISO/TS 19930:2017 [Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6], Recognition No. 14-533. United States Dept of Health and Human Services (HHS)/FDA. https://www.accessdata. fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=39534

Adam Okada has 18+ years of experience in Sterile Processing and is passionate about helping improve the quality of patient care by giving SPD professionals and their partners greater access to education and information. He has worked in just about every position in the Sterile Processing Department, including Case Cart Builder, SPD Tech I, II, and III, Lead Tech, Tracking System Analyst, Supervisor of both SPD and HLD, Manager, and now as an Educator. Adam is the owner of Sterile Education, the world’s first mobile application dedicated to sterile processing education, and a former Clinical Manager at Beyond Clean. He has published articles for HSPA’s Process magazine, is a co-chair on AAMI WG45 as well as co-project manager for the KiiP “Last 100 Yards” group, and is the former President for the Central California Chapter of HSPA. Adam is currently a Clinical Education Specialist at Healthmark, A Getinge company, where he works on Healthmark webinars, hybrid events, and educational videos, as well as the “Ask the Educator” Podcast with Kevin Anderson.

hpnonline.com | April 2025 | 33

VALUE. DELIVERED.

Reducing Avoidable Hospital Days: Supply Chain’s Role

BY KAREN CONWAY

S

tructural shifts in the healthcare landscape since the pandemic are creating a new challenge for U.S. hospitals: a potential shortage of staffed beds.

This challenge also comes with an opportunity to achieve operational savings by reducing the number of avoidable days in the hospital. And, as with many things, there is a supply chain connection.

First, the problem.

Compared to before the pandemic, there are now 16 percent fewer staffed hospital beds in the U.S. The current mean hospital occupancy rate in the U.S. is just under 64 percent. With an aging and increasingly sicker population, we could see that rate jump to 85 percent as early as 2032. At that rate, the U.S. would officially have a national hospital bed shortage.

On the other hand, according to research by The Advisory Board, the majority of U.S. hospitals (71%) are keeping patients on average one half day too long.

This translates annually to more than 9 million so called “avoidable hospital days,” which are defined as the time spent by patients beyond national length of stay (LOS) averages due to clinical or discharge related delays.

Any unnecessary LOS extension translates to higher labor and facility costs for hospitals. It also increases the risk of patients developing hospital acquired conditions, which increase costs for patient care but without commensurate reimbursement.

Now the opportunity.

Reducing the number of avoidable hospital days has great upside potential for U.S. hospitals and the healthcare industry as a whole, not to mention patients who would prefer to be out of the hospital sooner rather than later. As an example, The Advisory Board calculated that a 400bed hospital that is able to reduce length of stay by one day could realize savings equivalent to adding 65 staffed beds.

Extrapolate these figures out to the entire U.S. hospital universe, and it would cover the annual costs of staffing, beds, and other resources for 86 regional sized hospitals.

Nothing to sneeze at, in or out of the hospital.

34 | April 2025 | Healthcare Purchasing News

How can supply chain help?

Considering how products selected for patient care can reduce LOS is nothing new for value analysis professionals, but in light of this data, supply chain leaders may want to consider giving it some added weight.

Plenty of manufacturers claim their products can reduce LOS, say by lowering infection rates. Perhaps this is an opportunity to explore where you can control variables enough to tie product pricing to the actual achievement of supplier claims.

The challenge of avoidable hospital days is sometimes related to reduced bed availability in post-acute facilities. For example, since the pandemic, nearly 700 nursing homes have closed. A possible solution is to discharge more patients to home-based care. As supply chain leaders, consider how you can support your own institution’s home care strategy. For example: • Do you have the logistical capabilities – in house or through partnerships - to deliver needed supplies to the home?

• Are you able to protect patient data given that shipping information now includes patient home addresses?

• Can patients and/or their caregivers requisition products as needed?

Medical error rates often increase during times of transition from one care setting to another. Supply chain can support these transitions by making sure the right products are available to patients and their new caregivers during the transition. Supply chain can help prepare discharge packages that include the basic supplies and medications that patients will need during and immediately after the transition. Whenever possible, standardizing the products used in the hospital and the next care setting can also increase patient and family member familiarity with the products and how they are used.

These are just a few ideas for reducing LOS and helping make sure the right resources for patient care are available when and where needed. What are you doing in your hospital? Email me at karen@valuedelivered.org. HPN

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