Healthcare Purchasing News - August/September 2026

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Sourcing & Logistics 7Data to Decisions: Building the Intelligent Supply Chain DANIEL BEAIRD

12Q&A: Clarium CEO Steve Liou on Using AI to Improve Supply Documentation and Reduce OR Waste MATT MACKENZIE

14Six Blind Spots That Weaken Healthcare Supply Chain Resilience

12

LARS THORDING

Infection Prevention 17 Building Stronger Collaboration Through Infection Prevention Leadership MATT MACKENZIE

Sterile Processing 22 Proper PPE/Gown Protection in Decontamination ADAM OKADA

24 Beyond the Checklist: Building the Future SPD Workforce

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29 Evaluating Biological Indicator Performance in Saturated Steam Sterilization for Central Sterile Supply Department Monitoring EMERSON APARECIDO MIGUEL 466211344 © UMAIR LONE | DREAMSTIME.COM

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Departments 5 I ntelligence at the Point of Decision 6W hat’s on the Web, Advertiser Index

EDITOR’S NOTE

Intelligence at the Point of Decision

August-September 2026, Vol. 50, No. 5 Group Content Director Healthcare Melinda Taschetta-Millane mtaschetta-millane@endeavorb2b.com Editor-in-Chief Daniel Beaird dbeaird@endeavorb2b.com Associate Editor Matt MacKenzie mmackenzie@endeavorb2b.com Senior Contributing Editor Kara Nadeau knadeau@endeavorb2b.com ADVERTISING SALES Director of Sales Healthcare Jennifer Hazen jhazen@endeavorb2b.com | 330-598-0308 Director of Business Development Healthcare Deborah Baron dbaron@endeavorb2b.com | 917-763-7275 Advertising & Art Production Production Manager | Ed Bartlett Art Director | Kelli Mylchreest Advertising Services Manager

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Michelle Kopier

ea lt hca re orga n i zat ion s have no shortage of data, technology, standards, or specialized expertise. The greater challenge is connecting those resources so professionals can make timely, infor med decisions. Progress will not come from technology, workforce development, or collaboration alone, but from transfor ming passive systems into active organizational capabilities.

A s t he a r t ic les i n t h i s i ssue demonstrate, meaningful improveme nt happe n s whe n k nowledge becomes action, and when people across supply chain, infection prevention, and sterile processing are equipped to act before a risk becomes a disruption or reaches the patient.

An intelligent healthcare organization is not simply one that deploys advanced technology. It connects people, data, and workflows so professionals can identify risks, communicate across departments, and intervene before a potential problem becomes an operational disruption, or reaches the patient.

That means intelligence remains f u nda menta l ly hu ma n. A I, predictive analytics, dashboards, and

tracking systems can reveal emerging risks and opportunities, but they must fit established workflows and guide people toward the appropriate next step. Data creates va lue on ly when skilled professionals can interpret it, apply clinic a l ju d g m e nt , qu e stion u nsafe practices, a nd clea rly expla i n t he rea son i ng be h i nd their decisions.

The con seque nces of d isconnected systems can be seen across healthcare. Gaps between contracting, purchasing, and payment allow negotiated supply chain value to disappear. Infection prevention programs operating in isolation have less influence over purchasing, surveillance, and emergency readiness.

Sepa ration between ster ile processing and the OR contributes to errors, delays, conflict, and unclear accountability. Collaboration, then, is more than a workplace ideal. It directly affects cost, efficiency, preparedness and patient safety.

Across healthcare, the goal is the same. Connect knowledge to action.

The industry becomes more intelligent when its systems support its people, and its people are prepared and empowered to act.

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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

What’s on the Web

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.

Medline Boosts California Footprint with New Warehouses Following Tracy Fire

Study Finds Over Half of U.S. Adults Ages 30-79 Recommended Statins Under New Guidelines

The new facilities will increase Medline’s customer-facing Northern California distribution capacity by 45% from one month ago, strengthening its ability to support healthcare providers across the region.

The Tracy location is expected to begin receiving inventory from Medline’s broader distribution network and shipping products through the company’s MedTrans transportation fleet in the coming months.

The new recommendations “significantly change how doctors assess cardiovascular risk beyond the next 10 years to a person’s risk over several decades.” The new guidelines broaden eligibility, adding an additional 21.5 million American adults into the tier of people recommended for statins, or 56.6% of adults aged 30 to 79. The governing bodies incorporated an “updated risk calculator released in 2023 and broadened eligibility by expanding the age range from 40-75 to 30-79 and extending the risk horizon from 10 years to 30 years.”

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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

New Therapeutic Candidate Against C. auris Identified The research team was funded by NIH, and it “closely studied the yeast in search of any weaknesses that could be exploited in the fight against it.” Certain strains of C. auris are resistant to all three major classes of antifungal drugs. Between 30 and 60 percent of patients who develop an infection die, “usually due to sepsis after the fungus enters the bloodstream after getting inside the body.” Most infections respond to an intravenous medication, but “even that is showing signs of vulnerability.”

Read on: hpnonline.com/55392136

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Read on: hpnonline.com/55384116

Hartford HealthCare Shares Supply Chain Success at Healthcare Supply Chain Tech Summit During the event, HPN Head of Content Daniel Beaird moderated a discussion with Hartford HealthCare leaders. The panel explored the organization’s enterprise-wide approach to supply chain leadership, innovation, and performance improvement.

CS Solutions, Washington, DC

Index of Advertisers

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SOURCING & LOGISTICS

Building the Intelligent Supply Chain Health systems are turning fragmented data into timely action across sourcing, purchasing, inventory, and utilization.

BY DANIEL BEAIRD

H

ealthcare organizations are connecting AI, predictive analytics and automated workflows to capture savings, anticipate disruptions and make faster, more coordinated decisions.

For years, healthcare supply chain modernization centered on gaining greater visibility into spending, inventory, and product availability. Health systems invested in dashboards, enterprise resource planning systems, and analytics platforms designed to reveal where costs and risks were hiding.

But visibility alone is no longer enough.

As non-labor expenses rise and disruptions become a routine part of healthcare operations, supply chain leaders are under pressure to act on information faster, ensure negotiated savings reach the bottom line, and prevent shortages from affecting patient care. That is pushing the industry toward a more intelligent model. One that connects data, people and workflows across contracting,

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purchasing, payment, inventory and product utilization.

“The intelligent supply chain isn’t about seeing more; it’s about capturing what you already negotiated,” said Bill Selles, senior vice president and general manager of Spend Management Services at Vizient.

In this model, intelligence is measured not by the volume of data available but by an organization’s ability to turn that data into action. That could mean correcting a contract price before an invoice is paid, approving a substitute before a backorder reaches the clinical floor, or identifying a utilization pattern while leaders can still influence it.

“The traditional GPO model treated the contract as the finish line,” Selles said. “Today, it is the starting point.”

Closing the gap between contract and execution Health systems negotiate significant savings through contracts, standardization initiatives and strategic sourcing programs. Yet some of that value is lost before it reaches the organization’s profit-and-loss statement.

Pricing discrepancies, off-contract purchases, unmanaged spend, and inconsistent utilization can create gaps between the savings negotiated and the savings realized. Fragmented technology systems make the problem more difficult because contracting, purchasing, clinical, and financial data frequently reside in separate platforms.

Selles said tens of billions of dollars in potential non-labor value are lost between contracting and execution across the healthcare industry.

“The real opportunity sits in the many steps between contract, purchase, payment and utilization, where value is either captured or lost,” he said.

That challenge is changing the role of group purchasing organizations.

Rather than focusing primarily on

negotiating prices, GPOs are becoming more involved in helping health systems manage what happens after contracts are signed.

Vizient, for example, is expanding capabilities such as price assurance and procure-to-pay integration to reduce discrepancies between contracts and invoices. Tail-spend automation can bring smaller, unmanaged purchases under greater control, while clinically integrated supply chain programs connect product decisions with costs and patient outcomes.

“This is not about adding more services around the edges,” Selles said.

“It is about being embedded in the workflows where purchasing and utilization decisions happen, so value is protected at the point of execution.”

The shift reflects the financial pressures confronting health systems. According to Selles, non-labor costs have risen 50% since 2019. As a result, chief financial officers are asking supply chain leaders for more than retrospective reports or additional dashboards.

They want price accuracy across contracts, purchase orders, and invoices; real-time insight into highcost clinical utilization; and stronger contract compliance across hospitals and ambulatory settings. Most importantly, they want tools incorporated into existing workflows rather than added as separate systems employees must remember to use.

“What health systems are asking for now is intervention, not just information,” Selles said.

Moving from reactive to predictive The same distinction is shaping how health systems manage supply disruptions.

Historically, many organizations relied on transaction data, manual processes and disconnected systems to identify shortages. Supply chain teams often learned about a disruption

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only after orders had been delayed or products were placed on back order.

Brian Wells, senior vice president of sales operations at Medline, said the industry is beginning to replace this reactive approach with predictive, intelligence-driven operations.

“We’re seeing a shift toward predictive models that use real-time data, AI, and advanced analytics to identify risks before they disrupt operations,” Wells said.

Instead of notifying a health system that a shortage is already underway, predictive technology can help determine which products are at risk, when a disruption may occur, how long it could last, and which alternatives are available.

Medline has applied that concept through Mpower, an AI-powered digital control tower that brings together the company’s manufacturing, distribution, inventory, and fulfillment data. The platform analyzes supply information to identify at-risk stockkeeping units, estimate potential disruption and recovery timelines, and recommend substitute products.

That end-to-end view can provide information that may not be available through an individual health system’s ERP platform, which typically reflects only part of the product journey.

“Mpower doesn’t simply report what’s happening—it helps drive action by connecting supply chain, value analysis, and clinical teams through automated workflows, substitution recommendations, and coordinated communications,” Wells said.

That coordination is critical because responding to a disruption often requires input from several departments. Supply chain may identify the shortage, but clinicians and value analysis teams must evaluate whether an alternative is appropriate. Purchasing and operational teams must then implement the change and communicate it across affected locations.

Predictive intelligence gives those stakeholders more time to evaluate alternatives and complete approvals before product availability affects care delivery.

and operational consistency. Realtime location systems can reduce the time clinical teams spend searching for equipment, while RFID technology continues to expand within healthcare inventory and asset management.

Measuring the The larger opportunity, operational impact however, lies in connectThe value of intelligent suping these tools. ply chain technology must ultimately be demonstrated That opportunity is also through measurable operadriving larger technology Bill Selles investments across the tional and financial results.

GPO sector. In February, During an initial Mpower Prem ier a n nou nced a pilot, risk-resolution cycle multi-year program to times decreased by more modernize its data infrathan 50%, falling from 5-7 structure and develop an business days to approximately 2.5 days. More AI-powered decision intelthan 300 at-risk products ligence platform intended Brian Wells were addressed through to connect data, analytearly substitution approvics and execution across als during the first 30 days, accordhealthcare supply chain operations. The company is working with ing to Medline. Pilot customers using Palantir Technologies, Databricks, the company’s pre-approved AutoSub and Microsoft to bring operational program also recorded a 1-2% increase in unadjusted fill rates.

AI, unified data capabilities, and cloud Wells said health systems should infrastructure into the platform. assess these tools using a combinaPremier said the initial work will tion of efficiency and resiliency metfocus on real-time visibility into nonrics, including: labor spending, identifying savings at the point of order, detecting sup• Time required to identify and mitiply risks before they affect care, and gate a supply risk. aligning contract prices across ven• Number of disruptions addressed dors. The initiative illustrates how before operations are affected.

• Fill-rate improvement. the intelligent supply chain is evolving • Reductions in urgent escalations. from a collection of individual technologies into a broader intelligence • Consistency of substitution and layer spanning supply chain, finanapproval workflows. cial, and clinical operations.

• Staff time redirected from crisis management to strategic work.

ERP platforms can provide foundaOther technologies are delivering tional operational data. Automation results in different parts of supply can eliminate repetitive work. AI can chain operations. Selles said wareanalyze patterns and identify emerghouse automation currently offers ing risks. When implemented sepasome of the clearest ROI because its rately, each may deliver incremental labor savings are measurable and improvements. When connected established, even though warehousthrough common workflows, they can ing accounts for only part of total supsupport decisions throughout the supply chain spending. ply chain lifecycle.

AI-supported forecasting is improvIn one pilot with a large Midwestern ing inventory management, fill rates health system, Medline combined

inventory review, process standardization, storage redesign, predictive analytics, automated substitution, AI-enabled inventory visibility, electronic shelf labels, PAR optimization, and emergency preparedness planning.

The effort reinforced that technology alone does not create an intelligent supply chain.

“Meaningful transformation can happen when people, processes and technology are aligned around a shared operating model,” Wells said.

Solving the data disconnect The potential of AI and predictive analytics still depends on the quality and connectivity of the underlying data.

Many health systems have large volumes of contracting, purchasing, inventory, clinical, and financial data.

The problem is that those data sets frequently do not communicate with one another or arrive too late to influence a decision.

“The biggest challenge is not access to data; it is that the data is disconnected,” Selles said.

Retrospective data can show leaders where spending exceeded expectations or where a product decision failed to produce the projected savings. But intelligent supply chain systems must surface that information while purchasing and utilization decisions are being made.

Adding more data without addressing integration can also create additional noise. Leaders may receive more reports and alerts without gaining a clear understanding of what action to take.

Premier’s technology roadmap is similarly built around interoperability, data governance, and the responsible use of AI in areas with clear operational impact. Databricks will support a unified environment spanning the company’s supply chain, clinical, and financial data, while Palantir will provide operational AI and analytics

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designed to support real-time decision-making. Microsoft will supply the cloud infrastructure for securely operating those workloads at scale.

The approach reflects a broader recognition that predictive analytics cannot deliver its full value while key information remains isolated. Premier plans to connect data and execution through a single intelligence layer, with the goal of supporting faster decisions, stronger margins, and more resilient operations.

AI can help organize that information, identify relevant patterns, and deliver recommendations at the point of decision. Vizient is working to embed AI into contract lifecycle management, procure-to-pay processes, and utilization workflows so insights appear within the work rather than through separate reporting tools.

Selles stressed that AI should strengthen human expertise, not replace it. Its role is to provide supply chain, clinical, and sourcing professionals with better information when they can still act on it.

That also requires closer alignment among departments that traditionally view performance through different lenses. Finance monitors cost, clinicians focus on outcomes and quality, and supply chain manages spending and availability. A clinically integrated supply chain brings those perspectives together, so product decisions reflect their combined impact.

“The opportunity ahead is not just better integration, but better orchestration,” Selles said.

Building resiliency without stockpiling Supply chain intelligence is also changing the economics of resiliency.

Following the pandemic, many healthcare organizations increased inventory or established additional reserves to protect against shortages.

Although additional stock can provide a buffer, it also ties up capital, requires

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storage space, and increases the possibility of product expiration.

Health systems are now looking for models that improve preparedness without relying exclusively on stockpiling.

“Resiliency is no longer a tradeoff against cost; it has to be designed into the supply chain,” Selles said.

Vizient Reserve, for example, gives participating organizations access to dedicated inventory without requiring each health system to hold all that product locally. Vizient said the program has helped create more than 180 million doses of essential medications and more than 3 million units of critical medical supplies through inventory commitments. More than 400 health systems have accessed over 5.8 million units of essential products through the program.

The model has been used during disruptions ranging from demand spikes of 280% during the COVID19 pandemic to supply shocks affecting 60% of U.S. IV fluid production.

Predictive platforms complement these reserve models by helping organizations recognize threats earlier.

Together, dedicated inventory, realtime visibility, and coordinated mitigation allow health systems to build readiness into their operating models

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rather than reconstructing a response during each shortage.

Designing AI around the people who use it Even the most sophisticated platform will fail if employees cannot incorporate it into their daily work.

Medline collaborated with 10 U.S. health systems during Mpower’s development to understand how supply chain, clinical, and operational teams communicate, organize work, and make product decisions. One recurring challenge was not simply finding information but coordinating the right stakeholders around it.

That led Medline to design the platform as a shared source of information and collaboration, combining recommendations with automated approval, substitution, and communication workflows.

“Successful AI must ref lect how organizations actually operate,” Wells said.

For health systems evaluating AI platforms, adoption should therefore be considered from the beginning.

Leaders should examine whether a technology fits existing workflows, clarifies responsibilities, and reduces manual effort. They should also determine whether the platform helps

teams act or merely produces another alert for employees to investigate.

The most useful systems will make the appropriate next step clear, bring affected stakeholders into the process and document how a decision was reached.

Physical automation will also expand. Robotics and warehouse technologies could reduce operating costs and relieve labor pressures as health

platform, algorithm, or automation project. It will be defined by whether organizations can connect their technologies and expertise to produce

From purchasing power to performance

The most useful systems will make the appropriate next step clear, bring affected stakeholders into the process and document how a decision was reached.

Over the next three to five years, intelligent sourcing and logistics capabilities are expected to become more embedded in daily operations.

Selles anticipates growth in agentic sourcing, which could allow health systems to address the long tail of lower-dollar suppliers and transactions that often remain unmanaged.

Price-assurance capabilities will help verify that the contracted price is the price paid, while supply chain orchestration will connect planning, sourcing, and execution more closely.

systems and distributors contend with ongoing workforce constraints.

Wells expects AI to play a broader role in supply chain analytics, inventory management, product standardization, and operational improvement.

Across those applications, the objective will remain consistent: reduce complexity, coordinate teams, and help healthcare providers devote more time to patient care.

The intelligent supply chain, therefore, will not be defined by one

timely, repeatable action.

For GPOs and health systems, that means shifting the focus from how much value is negotiated to how much is realized. For manufacturers and distributors, it means using endto-end data to identify risks sooner and coordinate responses before care is disrupted.

The industry has spent years building visibility. Its next challenge is making that visibility operational. HPN

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Q&A: Clarium CEO Steve Liou on Using AI to Improve Supply Documentation and Reduce OR Waste

BY MATT MACKENZIE

I

systems continue to face mounting pressure to control costs and reduce waste. According to Clarium, U.S. hospitals waste an estimated $25.7 billion annually on unnecessary supply chain spending, often driven by fragmented data, manual documentation processes, and outdated governance practices.

As part of the partnership, Mount Sinai will deploy Clarium Vision, a computer vision-enabled platform that uses in-room cameras and artificial intelligence to automatically capture surgical supply usage at the point of care. The technology is designed to improve documentation accuracy, reduce administrative burdens on nursing staff, and provide health systems with better visibility into supply utilization without disrupting clinical workflows.

HPNspoke with Clarium CEO Steve Liou about how Clarium Vision supports clinicians, strengthens collaboration between clinical and supply chain teams, and helps health systems identify opportunities to reduce waste and optimize preference cards.

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n June, Clarium announced a strategic partnership with Mount Sinai Health System, one of the nation’s leading academic health systems. Through the collaboration, Mount Sinai will deploy Clarium’s supply capture and preference card optimization capabilities across eight hospitals and ambulatory surgery centers, bringing new technology to one of healthcare’s most complex and costly operational environments: the operating room.

The stakes are high. Mount Sinai performs approximately 100,000 surgical procedures each year, generating enormous volumes of supply utilization data while requiring careful coordination among clinicians, perioperative leaders, and supply chain teams. At the same time, health

12 | August-September 2026 | Healthcare Purchasing News

How does Clarium Vision make life easier for clinicians?

Liou: Currently in most operating rooms, nursing staff have to use a barcode scanner or manually type in all the supplies and devices that are used during a procedure. This process is tedious, time-consuming, and distracts from a nurse’s primary responsibility of ensuring the best possible outcome for a patient during surgery. Our Clarium Vision product uses mobile cameras and trained AI models to capture surgical supply and implant usage at the point of care. All a

nurse needs to do is point a phone camera at the item and it will automatically get documented in the EHR. This leads to more accurate documentation, better patient safety, and lets nurses focus on patient care, not administrative work.

How do Clarium’s systems and technologies foster collaboration between clinicians and supply chain teams?

Liou: Most health systems lack standardization across their surgical preference cards, which are the supply lists, typically maintained within the EHR, that specify which items, instruments, and implants a surgeon prefers for a procedure. In the case of one health system we work with, they had 140 different surgeons using 140 different preference cards for a single procedure. This kind of variation leads to waste and inefficiency.

Clarium gives health systems a trusted source of integrated data on surgical supply utilization, which reduces waste and improves patient safety. We can help them create a gold standard procedure card, based on case utilization, item popularity across individual preference cards, and availability of clinically equivalent, lower-cost item alternatives. Enables supply chain teams and perioperative leaders to have productive conversations with clinicians on potential changes to their supply requests.

For Clarium Vision, we anticipate the AI-enabled cameras to give health systems insight that will further streamline and optimize surgical supply selection. The cameras take tedious, administrative work off the plates of the nursing staff and offer a future that can be seamlessly embedded into the clinical experience.

In what ways do Clarium’s technologies reduce waste / unused items in the OR? Liou: Clarium’s platform offers a single source of data into a health system’s supply chain that can inform them where they are overinvesting in certain items that are not frequently used or are completely unused. We can also generate insights that help these health systems proactively prepare for disruptions of certain items in the OR. The data really helps health systems look at the overall picture around spend and waste. For example, we’ve helped Mount Sinai identify $3 million in annual savings.

For another academic health system, we’ve identified $26 million in savings.

How can clinicians protect against unused items?

Liou: To prevent wasted, unused items ending up in the trash in the OR—two changes go hand-in-hand: one, ensuring accurate supply documentation and utilization data reliability, and two, continually updating and maintaining

preference cards that detail surgical supply “pick lists.” These two efforts build on each other with accurate, reliable utilization data, teams can more accurately maintain, and update preference cards based on what’s really used in surgical procedures. Our Steve Liou Clarium Vision solution significantly helps improve documentation data accuracy, and our Card Optimizer tool helps optimize surgical supply lists based on this real-world utilization data.

How does Clarium streamline and optimize preference card processes?

Liou: Existing EHR tooling for preference card updating is highly manually intensive and a headache for perioperative teams to maintain. One benchmark health system with seven hospitals had over 30,000 preference cards across its surgeons. Maintaining accurate supply requests and accurate quantities is a nearly impossible task to handle manually on already overburdened teams.

Point a phone camera at the item and it will automatically get documented in the EHR. This leads to more accurate documentation, better patient safety, and lets nurses focus on patient care.

Clarium’s preference card capability connects directly with a health system’s EHR to analyze actual case utilization data, then generates evidence-based recommendations to reduce waste, standardize procedures, and streamline operations. It uses historical utilization data to identify which items on a preference card are consistently used, which are rarely used, and which are missing.

Clarium leverages AI-driven automation for the majority of card updates, minimizing clinical resourcing needs to review updates.

Any other context you’d like to provide for our readers?

Liou: While the challenges of optimizing supply purchasing and reducing waste are well-appreciated by healthcare supply chain teams, until now, they’ve been limited by access to clean, reliable data as well as actionable trusted recommendations for what to change, and tools to engage with clinical teams. We believe that Clarium Vision and our platform will be able to provide these actionable insights and help solve some of these long-running challenges. HPN

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Resilience isn’t built solely through inventory and sourcing strategies. It also depends on enterprise decisions that determine how many options remain when the unexpected happens.

BY LARS THORDING, PHD

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A

supply disruption rarely begins when a hospital receives a backorder notice.

It often begins much earlier— in the design of a device, the terms of a contract, the decision to standardize on one vendor, or the retirement of a reusable product. By the time a critical item becomes unavailable, many of the decisions that magnify the shortage have already been made.

That is why the healthcare resilience discussion must extend beyond emergency sourcing and supplier performance. Mapping upstream suppliers, developing business continuity plans, improving disruption alerts, monitoring backorders and recalls, and creating redundant sources are all essential. They help organizations

NUTHAWUT SOMSUK/ ISTOCK / GETTY IMAGES PLUS/ GETTY IMAGES

Six Blind Spots That Weaken Healthcare Supply Chain Resilience

see risk sooner and respond with greater discipline.

But those practices address only part of the problem. A health system can have excellent visibility into a fragile supply chain and still remain fragile. Product design, clinical standardization, portfolio strategy, contracting, sales practices, and lifecycle decisions can all reduce the number of practical alternatives available when a disruption occurs.

Many of those decisions sit outside the traditional authority of the supply chain department.

The efficiency trap Since the pandemic, hospitals have faced repeated shortages and allocations affecting medical devices, pharmaceuticals, and other products needed for patient care. Purchasing teams may find a substitute on paper, only to discover that clinicians are not trained on it, related equipment is incompatible, or the contract makes switching prohibitively difficult. A backorder can quickly become a clinical operations problem.

For decades, healthcare organizations have been rewarded for removing cost from the supply chain.

Inventories were reduced, vendors were consolidated, and contracts were standardized to improve efficiency and lower acquisition costs. While those strategies generated meaningful savings, they also reduced flexibility.

A supply chain optimized primarily for unit price often has fewer options when disruption occurs.

Sole-source agreements and proprietary technology platforms illustrate the tradeoff. Lower prices or enhanced functionality may come in exchange for greater dependence on a single manufacturer, product family, or technology ecosystem. Health systems may offset rising costs through staffing reductions or other efficiency measures, but those savings do little to restore the flexibility lost when

switching products becomes difficult or impractical during a shortage.

The Symplr State of Healthcare Supply Chain Survey reflects this collision of priorities. Respondents identified cost savings as their leading challenge in 2024, supply disruption as the leading challenge in 2025, and both issues at the top in 2026.

The message is not that cost discipline should disappear. It is that savings and resilience must be evaluated together rather than treated as separate objectives.

Lean supply chains perform well under normal conditions. Their weakness appears when normal conditions vanish, whether because of a pandemic, geopolitical conflict, severe weather, transportation problems, or constraints on raw materials. Health systems did not create every vulnerability in the healthcare supply chain, but years of aggressive cost reduction have contributed to an operating model with fewer cushions and fewer choices.

The common thread is that many of these vulnerabilities originate well before a purchasing team receives notice of a disruption.

Resilience is an enterprise-level issue Healthcare supply chain resilience is the ability to maintain patient care when the flow of medical products is interrupted. Traditional resilience programs rightly focus on supplier mapping, continuity planning, communication protocols, inventory strategy, alternative sources, and service-level reporting. These activities strengthen the logistical and contractual connection between a provider and its suppliers.

The larger risk landscape also includes decisions made in product development, clinical practice, capital planning, value analysis, legal review, sustainability programs, and executive strategy. A product

may be readily available today while its design or contract quietly eliminates alternatives for tomorrow. Six commonly overlooked areas deserve a place in every health system’s resilience assessment.

1. Disposable-by-Design Products.

Single-use products are appropriate in many clinical applications, but the category has expanded to include devices that previously were reusable or that can be safely reprocessed.

Cables used in an electrophysiology

Healthcare supply chain resilience is the ability to maintain patient care when the flow of medical products is interrupted. lab are one example. When a disposable product is on backorder, each procedure consumes one of a finite number of remaining units. When reusable or reprocessable products are part of the model, an existing inventory can continue circulating even while new supply is constrained.

This distinction affects more than availability. A greater reliance on disposable products can increase procedure costs and waste while creating a direct link between factory output and the hospital’s daily capacity. Yet sourcing and value-analysis processes do not always credit reusable, reprocessed, and alternative sourcing strategies for the resilience they provide.

2. Obstacles to Reuse and Reprocessing. Manufacturers naturally promote their newest products, but commercial practices can also discourage hospitals from extending the useful life of devices. In some settings, representatives remove products after procedures, condition technical support on the use of new devices, or use volume commitments to steer facilities away from reprocessed alternatives.

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SOURCING & LOGISTICS

Take-back and recycling programs can create a similar issue. Recycling may sound like the environmentally preferable option, but removing a device from circulation can prevent reuse and eliminate the supply continuity benefit that reuse provides. A sustainability program should consider the full hierarchy of options, including whether a product can remain safely in service before it is converted into raw material.

3. Product Lifecycles. Rapid innovation can improve care, but a faster cadence of product introductions also creates risk. Each generation may bring a price increase, while the previous generation is supported less actively or made incompatible with newer equipment. Hospitals that adopt a new technology early may have few equivalent products available if supply falters.

Newness can therefore carry a resilience premium that is rarely included in the purchasing decision. Before standardizing on the latest generation, organizations should ask how many substitutes exist, whether the prior version will remain supported, and what operational changes would be required to switch.

4. Closed Technology Ecosystems. Many medical products function only with other assets from the same manufacturer. An ultrasound catheter may work with only one vendor’s generator, software, connectors, and accessories.

Once a service line is built around that ecosystem, replacing a single unavailable component can become impossible without changing the entire platform.

This type of dependence is designed into the product architecture, not created by a purchasing team’s failure to negotiate. By the time supply chain leaders encounter the issue, clinical workflows and capital investments may already be locked in. Interoperability and open-platform design should therefore be evaluated as resilience attributes during technology selection.

5. Commercial Influence on Clinical Standardization.

Training, technical support, clinician relationships, consulting arrangements, product access, and opaque pricing can all shape utilization within a service line. These relationships may provide legitimate clinical value, but they can also narrow the range of products that clinicians are comfortable using and make a competing option difficult to introduce during a shortage.

Resilience requires more than having a substitute listed in a catalog. The alternative must be clinically acceptable and contractually

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available. Health systems should examine how vendor relationships influence standardization and ensure that clinical preference does not quietly become irreversible supplier dependence.

6. Bundles That Exchange Savings for Flexibility.

Bundling is common in healthcare contracting. A lower price on one product may depend on purchasing another.

Training, technical support, clinician relationships, consulting arrangements, product access, and opaque pricing can all shape utilization within a service line.

Capital equipment may be provided at little or no upfront cost in exchange for a disposable-volume commitment.

Access to certain products or technical support may be conditioned on broader utilization of the supplier’s portfolio.

Some arrangements may raise legal or compliance questions. Even when permissible, they can create operational vulnerability by tying multiple categories to a single vendor. The apparent savings on one line item may be offset by higher costs elsewhere and by the difficulty of changing products when supply is interrupted. Bundles should be evaluated for their total financial effect and for the concentration risk they introduce.

A wider governance model The purpose of resilience is to preserve the hospital’s ability to treat patients when conditions become difficult. That responsibility is too broad to reside with supply chain professionals alone.

Health systems should elevate resilience to the enterprise level and involve supply chain, clinical leadership, value analysis, finance, legal, sustainability, information technology, and executive management. Product selection and contracting decisions should account not only for acquisition price and current performance, but also for substitutability, interoperability, lifecycle stability, reuse potential, and vendor concentration.

A resilient supply chain is not built only by reacting faster to shortages. It is built by preserving choices before a shortage occurs. Until healthcare organizations examine the structural decisions that create dependence, they will continue treating the symptoms of fragility rather than reducing its source. HPN

RUDALL30/ ISTOCK / GETTY IMAGES PLUS/GETTY IMAGES

INFECTION PREVENTION

Building Stronger Collaboration Through Infection Prevention Leadership As infection prevention becomes more strategic, leaders are partnering with supply chain, clinicians, and laboratory teams to improve preparedness, reduce risk, and demonstrate measurable organizational value.

BY MATT MACKENZIE

C

ross-departmental collaboration within hospitals and health systems is essential to ensuring operations run smoothly and patients receive the safest, highest-quality care possible.

When departments operate in silos, communication gaps emerge, purchasing decisions become less efficient, and patient care can become fragmented. The result is often higher costs, operational inefficiencies, and outcomes that fall short of what healthcare organizations strive to deliver.

Few areas demonstrate the value of collaboration more clearly than infection prevention. Once viewed largely as a compliance-oriented function, infection prevention (IP) has evolved into a strategic discipline that touches nearly every corner of the healthcare enterprise. Today’s IP leaders

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INFECTION PREVENTION

work closely with executive leadership, supply chain teams, physicians, nurses, laboratory professionals, environmental services departments, and other stakeholders to reduce risk, improve outcomes, and strengthen organizational resilience.

From compliance function to strategic business partner The role of infection prevention leaders has changed dramatically over the past several years, driven in large part by the lessons learned during the COVID-19 pandemic. The crisis highlighted the importance of preparedness, communication, organizational flexibility, and supply chain resilience while elevating infection prevention’s visibility within healthcare organizations.

According to Dr. Rodney Rohde, PhD, MS, SM(ASCP)CM, SVCM, MBCM, FACSc, Regents’ Professor at Texas State University System, the pandemic “reinforced the importance of preparedness, real-time surveillance, workforce resilience, supply chain security, and effective risk communication.”

As hea lthca re orga nizations struggled to respond to rapidly changing conditions, infection prevention leaders found themselves helping guide decisions far beyond traditional surveillance activities.

They became advisors on workforce protection, PPE utilization, public communication, supply shortages, emergency planning, and operational continuity.

The exper ience per ma nently changed executive expectations.

“IP leaders are now expected to bu i ld susta i nable systems rather than temporary emergency responses,” Rohde said.

Today, healthcare executives increasingly view infection prevention as a strategic business function rather than solely a regulatory requirement. Beyond reporting HAI metrics

and preparing for surveys, infection prevention leaders are expected to help organizations anticipate risk, protect employees, maintain operational continuity, and support financial performance.

“IP leaders are expected to demonstrate measurable impacts on patient safety, operational continuity, workforce protection, regulatory compliance, and financial performance,” Rohde explained.

Preparedness efforts should include routine drills, surveillance activities, supply inventory assessments, workforce cross-training, outbreak response planning, and regular executive reviews of emerging threats and vulnerabilities.

“Like any true preparedness drills, the activities should occasionally be unannounced for a more realistic response followed by debriefing of the team for lessons learned,” he said.

As healthcare organizations struggled to respond to rapidly changing conditions, infection prevention leaders found themselves helping guide decisions far beyond traditional surveillance activities.

That evolution has transformed infection prevention into a discipline that is deeply integrated into organizational decision-making.

“Infection prevention is no longer siloed,” he said. “It is integrated into organizational decision-making. I would like to believe that our partners in all facets of public health and healthcare are also working to make this a two-way street of communication.”

Transparency has become another critical leadership skill. During periods of uncertainty, healthcare leaders must communicate clearly about what they know while remaining honest about what remains uncertain.

“Anyone associated with public health, healthcare, and/or research leadership must be transparent about what they understand ‘in the moment’ and how that truth may change hours, days, weeks, months, or years later,” Rohde said.

Preparedness remains central to that mission. Rather than treating emergency preparedness as an annual exercise designed to satisfy regulatory requirements, Rohde believes readiness should be integrated into everyday operations.

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The same strategic mindset increasingly applies to financial stewardship. As healthcare organizations continue to operate under budget constraints and margin pressures, infection prevention leaders are being asked to demonstrate measurable financial value in addition to clinical outcomes.

Rohde encourages teams to focus on “preventing healthcare-associated infections (HAIs), reducing outbreak-related disruptions, leveraging predictive analytics, and quantifying avoided costs associated with infections, readmissions, staff illness, and regulatory penalties.”

For hospitals facing ongoing financial challenges, cost avoidance can be one of infection prevention’s strongest business cases. Preventing a single HAI can eliminate substantial treatment costs, reduce patient length of stay, minimize readmissions, and lower exposure to reimbursement penalties.

Reducing hospital-acquired conditions requires a coordinated effort across multiple disciplines. Rohde recommends implementing evidence-based prevention bundles, strengthening surveillance programs,

improving hand hygiene and environmental cleaning compliance, and rapidly identifying high-risk patients through multidisciplinary interventions.

Readmissions can likewise be reduced through better discharge planning, antimicrobial stewardship efforts, patient education, vaccination programs, follow-up care coordination, and earlier identification of post-discharge infection complications.

PPE strategy is another area where infection prevention and financial stewardship intersect. Rather than relying on crisis-driven purchasing decisions, Rohde recommends a more strategic and proactive approach.

Organizations should use “data-driven forecasting, standardized products where appropriate, supply diversification, stockpile management, and targeted PPE use based on risk assessments rather than crisis-driven purchasing.”

The pandemic exposed vulnerabilities throughout healthcare supply chains, making contingency planning a priority for many organizations. According to Rohde, strong relationships with suppliers and regional partners remain essential.

“It is essential to plan for backup strategies often and with respect to your state or regional suppliers and contacts,” he said.

As a result, collaboration between infection prevention and supply chain leaders has become increasingly important. Product selection, inventory management, supplier diversification, and preparedness planning all benefit when both groups work together to balance clinical requirements, operational needs, and financial realities.

Building buy-in across the organization Even the strongest infection prevention strategies cannot succeed without support from the people responsible for implementing them.

Whether introducing new protocols, changing workflows, or deploying new technologies, infection prevention leaders must secure buy-in across departments and disciplines. That process requires more than simply telling people what to do. It requires helping employees understand why changes matter and how they contribute to both patient safety and organizational success.

When engaging physicians, Rohde recommends focusing on evidence and outcomes.

“Present clinically relevant data, demonstrate impacts on patient outcomes, engage physician champions, and align prevention efforts with quality and safety goals,” he said.

Physician champions can be valuable allies because they help reinforce best practices among peers and connect infection prevention initiatives directly to patient care. While many of these principles can apply across

healthcare, they are particularly effective when working with physicians whose primary focus is clinical outcomes.

Working with supply chain leaders requires a different conversation. Procurement teams evaluate decisions through the lens of product performance, availability, reliability, and cost effectiveness.

For that reason, Rohde encourages infection prevention teams to “develop collaborative forecasting models, evaluate product performance, monitor shortages, and ensure infection prevention requirements are incorporated into purchasing decisions.”

Physician champions can be valuable allies because they help reinforce best practices among peers and connect infection prevention initiatives directly to patient care.

Strong collaboration helps ensure products meet both clinical and operational needs while reducing the risk of disruption.

Nursing leadership remains another essential partner.

“Nursing leaders are critical implementation partners who drive compliance, reinforce best practices, support education, and identify frontline barriers to success,” Rohde said.

Because nurses interact continuously with patients and interdisciplinary care teams, they frequently identify workflow challenges before they become larger operational problems. Their engagement is often essential to sustaining infection prevention initiatives over time.

Rohde also believes healthcare organizations should place greater emphasis on collaboration with laboratory professionals.

“I would also add the critical importance of alignment with one’s medical laboratory professionals and the department,” he said. “Laboratory professionals are critical to understanding the microbiology and other epidemiological aspects of particular pathogens and outbreaks related to IP and healthcare environments.”

Laboratory teams provide the diagnostic information that powers surveillance programs, outbreak investigations, and evidence-based decision-making. Their expertise can help infection prevention leaders identify emerging threats sooner and develop more informed response strategies.

Of course, resistance to change remains an inevitable challenge.

New initiatives often compete with existing priorities, increase workloads, or require staff to alter familiar

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INFECTION PREVENTION

behaviors. When employees fail to see the purpose behind an initiative or struggle to observe tangible benefits, adoption can become difficult.

“Transparency and shared accountability are essential,” Rohde said.

Organizations are more likely to achieve success when leaders clearly communicate objectives, explain the rationale behind changes, and demonstrate measurable outcomes.

It is equally important to manage initiative fatigue.

Healthcare professionals already face a growing number of responsibilities, making careful prioritization critical.

To avoid overwhelming staff, Rohde recommends focusing on high-impact interventions, aligning projects with broader organizational priorities, eliminating redundant efforts, and maintaining consistent communication.

“Leadership needs to set the example and expectations consistently,” he said.

Data can be particularly effective in sustaining engagement.

According to Rohde, “Dashboards, benchmarking, trend analyses, and unit-specific performance metrics help connect behaviors with patient outcomes and organizational performance.”

When employees can see how individual actions contribute to organizational goals, they are more likely to remain engaged in improvement efforts.

Performance data also creates opportunities to recognize success.

“Celebrate the wins with everyone and reward those involved at all levels,” Rohde said.

Acknowledging successful departments and frontline teams reinforces positive behaviors while helping establish infection prevention as a shared responsibility across the organization rather than the sole responsibility of a single department.

Demonstrating value and preparing for what comes next As infection prevention leaders assume broader responsibilities, their ability to communicate value to executive leadership becomes increasingly important.

According to Rohde, one of the most effective approaches is focusing on risks that were avoided rather than simply reporting activities completed.

Organizations should quantify “prevented HAIs, outbreaks, regulatory citations, workforce exposures, reputational damage, and avoidable patient harm.”

Whenever possible, those figures should be supplemented by predictive modeling and other analyses that estimate cost savings and health outcomes associated with prevention efforts.

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Operational metrics can be equally compelling.

Rohde advises leaders to highlight “reduced bed closures, staffing shortages, procedure cancellations, supply interruptions, and outbreak-related operational slowdowns.”

These types of outcomes often resonate strongly with executive leaders because they connect infection prevention efforts directly to organizational performance. Every avoided disruption helps preserve capacity, support revenue generation, improve access to care, and reduce strain on frontline staff.

Workforce efficiency presents another opportunity to demonstrate value.

According to Rohde, “automation, improved workflows, and prevention efforts reduce manual surveillance activities, outbreak response demands, and staff absenteeism.”

These efficiencies allow infection prevention professionals to devote more time to strategic initiatives, trend analysis, and collaborative planning instead of constantly responding to preventable problems.

Financial reporting should similarly extend beyond avoided treatment costs.

Organizations can demonstrate value through reduced reimbursement penalties, fewer legal liabilities, lower overtime expenses, and avoided revenue losses associated with outbreak-related disruptions and healthcareassociated infections.

Looking ahead, Rohde sees several emerging challenges that healthcare organizations should monitor closely.

These include antimicrobial resistance, emerging pathogens, biofilm-related issues, climate-related infectious disease expansion, workforce shortages, and increasing diagnostic complexity.

To improve communication between laboratory and clinical teams, Rohde suggests some organizations may benefit from adding a Doctor of Clinical Laboratory Science (DCLS).

“It may be helpful to consider bringing on a DCLS to bridge communication between the laboratory testing and physician, IP, nursing, and EVS teams,” he said.

Organizations should also avoid waiting until the next crisis arrives before investing in key capabilities.

“Invest in surveillance technology, workforce development, diagnostic readiness, preparedness planning, and cross-functional resilience strategies before the next crisis emerges,” Rohde advised.

That preparedness extends directly to workforce sustainability.

Like much of healthcare, infection prevention continues to face challenges related to staffing, retention, and burnout. According to Rohde, flexible staffing models can help organizations improve resilience through cross-training, regional resource sharing, hybrid on-site and remote

Ultimately, Rohde believes one of the most surveillance activities, surge staffing plans, and effective ways to strengthen workforce resilcompetency-based workforce development.

Developing future leaders is equally important. ience is to make infection prevention everyone’s Healthcare organizations should invest responsibility. in mentorship programs, succession planHealthcare organizations should develop ning, leadership development opportunities, infection prevention competencies across nurscertification support, and interdisciplinary ing, environmental services, laboratory, respiraDr. Rodney Rohde collaboration. tory therapy, and physician teams so prevention “This will need to include funding for conbecomes embedded throughout the organizatinuing education at conferences and other vehicles to tion rather than concentrated within a small group of specialists. gain more IP and other types of credentials,” Rohde said.

Technology can further reduce administrative burdens At the same time, organizations should provide psychothrough automated surveillance systems, electronic health logical support resources, workload-management straterecord integration, workflow automation, predictive anagies, peer-support programs, recovery time following major lytics, and AI-assisted data review. outbreaks, and leadership recognition of chronic workAI holds promise for identifying infection trends, place stressors. detecting outbreaks earlier, automating portions of chart Preparedness, collaboration, and shared ownership are review, and supporting predictive risk modeling. However, recurring themes throughout Rohde’s recommendations.

By investing in surveillance, workforce resilience, emerRohde cautions that organizations must remain mindful of issues involving data quality, algorithm bias, transgency planning, and routine readiness exercises before the parency, cybersecurity risks, and overreliance on autonext crisis arrives, healthcare organizations can position mated outputs. themselves to protect patients, support staff, and maintain Like many healthcare leaders, he views AI as a tool that operational stability in an increasingly complex healthcare environment. HPN should augment, not replace, clinical expertise.

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7/6/26 10:19 AM

STERILE PROCESSING INSIGHTS

Proper PPE/ Gown Protection in Decontamination

BY ADAM OKADA

Q

: I have an employee who refuses to wear a complete set of PPE or wears it incorrectly (mask under chin). How do I get them to comply with our department rules on PPE? : When I am in sterile processing depar tments, the most com mon non-complia nce issue that I see is that employees do not wear personal protective equipment (PPE) properly.

Whether it’s masks under the chin or face shields pulled down, workers in the decontamination area continually seem to ignore proper safety protocols.

Let’s dive into the reasons behind this non-compliance and see if we can’t help you with this problem.

I worked on the “front line” of sterile processing for over a decade before moving into leadership and educator roles. During that time, I also worked on all three shifts—morning, PMs, and nights. It was my time on the PM shift at a trauma hospital where I worked the longest (over 5 years), and this was also where I logged the majority of my hours at the sink in the decontamination area.

On the PM shift, the carts start coming down around 11 am, and they don’t stop until late into the evening, so the PM shift often receives the brunt of the sink work. I’m sure I caused significant damage to my back hunching over those sinks before we acquired modern-day, ergonomic adjustable-height sinks.

A

These kids today won’t understand the struggle. Now that my “old man shaking his fist at the sky” moment is over, we can return the point of this article.

Why do intelligent, mostly rule-following sterile processing professionals continually shirk rules about PPE? The answer really has to do with how uncomfortable and unnatural it is for a person to put in 8 hours hunched over a sink full of hot water, with machines running hot all around them, while also wearing layers and layers of PPE. I’ve been there. After 2−3 hours of meticulous brushing and cleaning at the sink, you’re drenched in sweat. I used to peel my plastic gown off my sweaty arms. I remember sweat dripping into my eyes while trying to figure out creative ways to wipe it away so that I could see what I was doing. Personal protective equipment was designed for protection, not for comfort.

So I understand the desire to cool off however you can.

In addition to seeing how many times I can work the word “sweat” into this article, I do also want to provide some clarification.

First, personal protective equipment is not optional.

It is an Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard1 requirement. We are potentially being exposed to dangerous pathogens in

22 | August-September 2026 | Healthcare Purchasing News

the decontamination area, and our PPE is the protective layer that stands between us and possible infections.

Employers must provide complete, adequate PPE for their employees, and as employees, it’s our responsibility to wear that PPE when potentially being exposed to blood and other body fluids. The American National Standards Institute (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI) ANSI/AAMI PB702 also recommends, at minimum, to wear an AAMI Level 3 protective gown.

There’s the first dilemma. On one hand, we must wear full PPE. It’s nonoptional, and the last thing we want to do is to expose ourselves (and potentially our coworkers and families) to any pathogens we might bring back from the decontamination area. But I fully acknowledge that most of our PPE was not made with the comfort of the sterile processing professional in mind. Finding solutions to this problem can be tricky, but if you are a leader, or even a technician who is tired of leaving decontamination so drenched in sweat that it looks like you took a Figure 1: AAMI Level 4 Decontam Gown (courtesy Healthmark, A Getinge company)3

shower in your hospital scrubs, it’s imperative that we try.

Let’s look at the largest piece of PPE—the gown—and its role as the most common source of overheating.

Earlier, I mentioned the plastic gowns we wore in the past. I still cringe when I see these gowns in modern departments. They do offer protection but do not breathe very well, making them uncomfortable for extended wear.

The AAMI Level 3 protective gown is a lighter, more breathable alternative. According to the Level 3 gown’s description, it is designed to protect against droplets, such as those a nurse might encounter at a patient’s bedside

Figure 2: Face Shield with Drape (courtesy Healthmark, A Getinge company)4

when the patient sneezes.

For those unfamiliar with the sterile processing department decontamination area, techs at the sink are not getting tiny droplets of water coming their way. They are getting big splashes and sprays. Even if a worker isn’t leaving decontam drenched in sweat, like I used to do, I see them remove the AAMI Level 3 gowns with a stomach wet with dirty sink water that has soaked through those thin gowns.

Here is another dilemma we might be faced with in sterile processing.

Choose a more protective, heavy plastic gown that doesn’t breathe but better protects us. Or opt for a lighter alternative that provides better

cooling but isn’t designed for the unique challenges a sterile processing professional faces at the sink.

Fortunately, there are gow ns on the ma rket attempting to combine the best of both worlds, and they are designed for the specific trials of sterile processing technicians performing decontamination tasks.

AAMI Level 4 gowns (Fig. 1) provide one level over the minimum standard set by AAMI PB70.2 Some of them even have protective zones to prevent soak-through in the critical areas where our stomachs are pressed right against the sink. These lightweight gowns aren’t as heavy as their older “plastic-y” counterparts. They give better cooling and better protection in the critical areas.

Next, let’s look at the mask and face shield issue. As gross as it might seem, this is usually a “hot breath” issue.

When we are breathing into our face masks, hot breath tends to make us feel overheated or claustrophobic. Add in the factors of gown and face shields, and it’s easy to see why so many techs opt to “pull down” their masks below their chins. The major problem with this is that most of the face shields on the market don’t cover the area under the chin. Therefore, when splashing occurs, even droplet splashing, those droplets might go right under the face shield and into our uncovered mouths!

See, I told you it was gross!

There are two potential solutions to this issue.

First, I would highly recommend a higher quality face shield with a foam nose cover. These avoid the issue of hot breath coming up from the mask into the eyes and face shield areas.

If the hot breath can be contained in the mask area, it is easier to tolerate.

Second, I would also recommend a face shield with an attached neck

Figure 3: Cool Aids (courtesy Healthmark, A Getinge company)5

covering (Fig. 2). Those splashes can be nasty, and we won’t always be able to see or tell when they come under the neck area opening of our face shields.

Face shields with neck covers can help mitigate those issues.

And my last piece of advice is to invest in cooling technology. There are refrigerated “cooling devices” that can go under the PPE and really help with the sweating issues. As a manager, I bought cooling caps and vests (Fig. 3) for my staff, and they loved them and raved about how cool they stayed while performing cleaning duties. Sadly, I didn’t get the chance to experience them as they arrived just after my time at the sink had ended.

These kids today have it so easy!

(Author shakes fist at sky.) HPN REFERENCES: 1. Occupational Safety and Health Administration. Code of Federal Regulations: Occupational Exposure to Bloodborne Pathogens. Title 29 [Bloodborne pathogens], Standard No. 1910.1030. United States Dept of Labor/OSHA. https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1030 2. AAMI (2022). PB70:2022 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. Arlington, VA: Association for the Advancement of Medical Instrumentation.

3. Healthmark Industries. [image]. AAMI Level 4 Decontamination Gown - Healthmark, A Getinge company. Healthmark, a Getinge Company. https://www.hmark.com/product/aamilevel-4-decontamination-gown/ 4. Healthmark Industries. [image]. Face Shield with Drape - Healthmark, A Getinge company. Healthmark, a Getinge Company. https://www.hmark.com/product/face-shieldwith-drape/ 5. Healthmark Industries. [image]. Cool Aids - Healthmark, A Getinge company. Healthmark, a Getinge Company. https:// www.hmark.com/product/cool-aids/

hpnonline.com | August-September 2026 | 23

Beyond the Checklist:

Building the Future SPD Workforce

Industry leaders discuss how competencybased training, interdisciplinary collaboration, and critical thinking are reshaping sterile processing education.

BY KARA NADEAU

24 | August-September 2026 | Healthcare Purchasing News

S

terile processing professionals face increasing complexity as surgical instrumentation grows more sophisticated, regulatory expectations continue to evolve, and healthcare organizations place greater emphasis on patient safety and quality outcomes. At the same time, staffing shortages, workforce turnover, and the need for faster onboarding have created new challenges for sterile processing department (SPD) leaders responsible for developing competent, confident technicians.

For many years, SPD education centered on orientation checklists, annual competencies, and learning specific tasks. Today, however, industry experts are calling for a different approach – one that emphasizes critical thinking,

FAHMI RUDDIN HIDAYAT ISTOCK / GETTY IMAGES PLUS / GETTY IMAGES

STERILE PROCESSING

interdisciplinary collaboration, communication skills, and a deeper understanding of how sterile processing impacts patient care.

As healthcare organizations work to strengthen their SPD workforce, educators are increasingly focused on building programs that move beyond task completion to competency validation, continuous learning, and professional development.

HPN spoke with three sterile processing education leaders about how training programs are evolving, what skills future SPD professionals will need, and how organizations can better prepare technicians to serve as patient safety advocates and clinical partners.

Why checklists are not enough All three experts warned that SPD education often focuses too heavily on completing onboarding requirements rather than validating competency.

Carol Malone, A AB, CSPDT, CRCST, CIS, CHL, CER, sterile processing educator at The Cleveland Clinic, noted how many organizations treat orientation as a checklist exercise, verifying that a task was demonstrated without ensuring the technician can consistently perform it independently or understand the underlying rationale - the “why” behind the task or function. According to Malone, new hires are sometimes moved into staffing roles before they are truly ready because departments need immediate staffing coverage.

“We have checklists of certain things we know we need to show them, but do we really stop to see if they’ve comprehended the information, can repeat it back to us, and can demonstrate to us multiple times consistently? Too often, that validation step is missing, and we end up releasing new hires too early - or pulling them into staffing when they are still not ready simply because we

need coverage. Having someone in when conditions aren’t perfect, which the position isn’t the same as havis often the reality in SPD. Long-term ing a competent, confident technisuccess depends on creating technician who can work independently. cians who can make informed decisions, not just follow instructions.”

Orientation should be about building Bil li ngslea noted competency, not just comthat understanding the pleting a checklist.” “why” behind reprocess“SPD education caning requirements helps not remain just a checktechnicia ns recognize list exercise,” said Jhmeid risk before it reaches the Billingslea, CRCST, CIS, patient. He stated: CER, CHL, CMRP, CST, “Modern SPD educaHACP-IC, executive direcAnna R. Castillo tion must be more than tor, Su rgica l Ser v ices just rote memorization.

Strategy & Performance, Understanding the ‘why’ fosters the Advantage Support Services. “It must most important tool SPD profesbecome part of the organization’s sionals have in their arsenal: critical quality and patient safety infrastructhinking. National standards such ture. That means validated compeas AAMI ST79, ST90, ST91, AORN tencies, specialty-specific training, guidance, and CDC reprocessing real-time performance data, and forguidance all point back to the same mal collaboration between SPD, the principle: safe reprocessing requires operating room (OR), infection predefined processes, competent staff, vention, quality, risk, supply chain, and executive leadership.”

From task completion to critical thinking A common theme among all three experts was the importance of teaching technicians not only how to perform a task, but why each step matters.

Anna R. Castillo, BS, CRCST, CSPDT, CHL, CIS, CFER, sterile processing educator, Texas Children’s Hospital, said effective education moves beyond task-based training and helps technicians understand the science that directly ties their work to patient safety. In her role, she has focused on building education that incorporates psychological theories or human factors.

“One of them is scenario-based training, like our competency ‘triathlon,’ where small groups of staff must think through real-world situations together, rather than just repeat a process,” Castillo explained. “This approach builds critical thinking, team building, and helps staff adapt

All three experts warned that SPD education often focuses too heavily on completing onboarding requirements rather than validating competency. documentation, monitoring, and continuous improvement. When technicians understand the ‘why,’ they are more likely to recognize risk and stop unsafe work before it reaches the patient.”

Malone recalled a recent conversation in which a technician questioned the use of reverse osmosis or deionized water during final rinsings of handwashed items. Once the rationale was explained that critical water undergoes additional processing to remove impurities that may still be present after municipal water treatment, the employee immediately understood the

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STERILE PROCESSING

“Without alignment of all of these at the leadership level, education becomes fragmented. To make this effective, standardization must be flexible but accountable; there must be clear core expectations or goals, with room for site-specific workflow differences.”

Building consistency Standardization does not end through standardization after onboarding. Malone described “My two favorite words are organizausing weekly reviews, questiontion and consistency, and consistency naires, audits, and routine checkcomes from standardized practice,” ins to monitor progress and identify said Malone. knowledge gaps. She recommends She believes departments need clear that during onboarding, educators onboarding structures, standardized workflows, and defined expectations. ask technicians what they succeeded When sterile processing professionals at, where they struggled, and what barriers affected their performance. deviate from established processes, Those conversations often reveal variation can quickly lead to errors, areas where additional training is making consistency in both training needed, particularly for equipment and operations critical. or processes that technicians infreCastillo believes organizations quently encounter. must move beyond treating education Malone also emphasized as a one-time onboarding the importance of preparevent and instead embed learning into daily operaing preceptors. At her orgations. She stated: nization, preceptors attend “Consistency comes an 8-hour class where they are shown what new from standardization, vishires are learning in their ibility, and shared ownership. Education needs to cohorts. The approach helps Jhmeid Billingslea be embedded into daily reduce conflicting messages workflows, not limited to between educators and onboarding or annual competencies. frontline trainers while reinforcing Allowing sterile processing staff to consistency across departments. join process improvement commit“We want to avoid a new hire going tees and work on initiatives engages back to their site where a preceptor staff to understand and believe in questions what they learned during the process. Frontline staff particionboarding,” said Malone. “During pate in defining best practices. That these classes, it is not uncommon engagement improves consistency for preceptors to ask, ‘When did this change?’ It gives us the opportunity because staff understand and believe to reinforce the importance of stayin the process.” ing current through CEUs, reading Castillo added that standardizaarticles, and attending conferences.” tion across facilities reduces variation and directly supports patient safety with the caveat that many organiDeveloping the whole zations must overcome challenges professional to achieve it.

Beyond tech n ica l prof icienc y, Billingslea, Castillo and Malone “The bigger barriers are differences believe the next generation of SPD in resources and tools, culture, and professionals will need stronger leadership priorities,” she explained. purpose. The experience reinforced the importance of explaining the science behind each step.

“When they understand why we’re doing it, they’re much less likely to skip steps,” she said.

26 | August-September 2026 | Healthcare Purchasing News

communication, critical thinking, and conflict management skills.

“AAMI says that all supervisory personnel should demonstrate their current knowledge and participate in continuing education programs and courses, not just the educator,” said Billingslea. “SPD leadership, not just the educator, must train and leverage technicians as frontline risk and infection preventionists. They need to know how to explain why a tray is not ready, why a shortcut is not acceptable, or why a process needs escalation without turning the conversation into conflict. Technical knowledge protects the process.”

“Accou ntabi l ity, conf idence, grit, and community are essential when working in any environment,” said Castillo.

She described an SPD program in Houston that goes beyond preparing technicians for the certification exam to embed core skills. Aside from learning and preparing for the certification exam, this free program requires students to attend weekly social gatherings to build community. Students must also have impeccable attendance and are held accountable for deliverables and timelines.

“This organically builds confidence and grit after practicing discipline while they’re in the program,” noted Castillo. “We’ve seen amazing results in these students, and it’s not triggered by age, ethnicity, or background.”

Malone believes education should help technicians see themselves as healthcare professionals whose expertise matters. Too often, she said, technicians view themselves as “just a tech” and hesitate to challenge requests that conflict with standards or policies - for example, when a member of the OR team wants to take trays from the SPD before they are fully cooled. Education, Malone argued, should give them both the knowledge and confidence to explain

why certain practices are unsafe and speak up when patient safety is at stake.

“We really have to empower our technicians with the knowledge and education to be able to stand up and do the right thing,” she said.

Using data and technology to reinforce learning Technology is becoming an increasingly important tool for reinforcing education and accountability. Castillo said tracking software and cleaning verification tools allow departments to “measure compliance instead of assuming it.”

“Technology plays a critical role in making work visible,” she continued.

“Data helps identify trends, whether it’s repeated defects, missing steps, or delays in processing, which allows leaders to address gaps proactively instead of reactively. Ultimately, data shifts the culture from opinion-based to evidence-based practice.”

Billingslea believes future SPD professionals will have the ability to connect standards, manufacturer instructions for use (IFU), workflow reality, and customer service at the touch of a button. He stated: “Priority work and the data that drives compliance, performance, and on time delivery of sterile goods will be constantly available on a live dashboard that is always visible from their workstations. Technical knowledge without communication can create conflict. Communication without technical knowledge can create unsafe compromise. The profession needs both.”

Breaking down silos through shared education Historically, SPD education has focused on preparing technicians to perform their own departmental responsibilities. Our experts believe future education models must help SPD professionals understand how

their work connects to Billingslea explained how the broader perioperative onboarding provides an environment. ideal opportunity to help “It is essential that teams understand each SPD evolves from a siloed other’s responsibilities depar tment str uggling before silos form. He stated: for respect into a center of “The ea rl ie r tea m s Carol Malone understand each other’s customer experience for responsibilities, the less the surgeons, OR teams, likely they are to develop the ‘that’s and clinics that they serve,” said not my department’ mindset. An Billingslea. “SPD and OR teams should be trained together because ideal model would include joint eduthe instrument cycle belongs to both cation for SPD, OR, infection predepartments. The process does not vention, quality, and perioperative leadership. Topics should include start in decontamination, and it does not end in sterile storage. It includes point-of-use care, loaner trays, IUSS point-of-use treatment, transgovernance, sterile field opening port, cleaning, assembly, sterilizapractices, defect reporting, implant tion, storage, case cart preparation, release, and tray accuracy.”

Data helps identify trends, whether it’s repeated defects, missing steps, or delays in processing, which allows leaders to address gaps proactively instead of reactively. opening of the sterile field, and postcase handling.”

Castillo emphasized that patient safety depends on how well SPD and OR understand each other, not just their own roles. She stated: “An ideal model would include learning from the start, shared simulations, and real case debriefs. It’s less about adding education and more about connecting the work so both teams see how every step affects the next. When SPD and OR train together, communication improves, errors decrease, and accountability becomes shared.”

Both experts stressed that crossfunctional education should begin early. Castillo advocates for introducing these concepts during certification programs and reinforced at onboarding once hired.

“If we wait until staff are already in their roles, we’re now trying to undo silos that have already formed,” she noted. “Early exposure is key.”

However, engaging surgeons and perioperative leaders requires a different approach. Rather than focusing on technical details, Billingslea recommends connecting SPD processes to outcomes that matter to surgical teams, such as first case on time starts (FCOTS), delays, tray accuracy, case readiness, patient safety, and cost.

“To engage surgeons and OR leaders, SPD education has to speak their language; surgeons do not need a lecture on every sterilizer cycle, but they do need to understand how late loaner trays, oversized sets, poor point-of-use treatment, and inaccurate preference cards affect the entire surgical day,” Billingslea explained.

“The best way to engage leadership is with real data,” he added. “Show the top trays causing delays, the instruments that are never used, the IUSS rate by service line, the repair trends, and the defects linked to preventable behaviors. Once the data

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STERILE PROCESSING

is visible, the conversation shifts from blame to shared accountability.”

To better engage surgeons and perioperative leaders in understanding SPD processes and constraints, Castillo recommends short, focused sessions that show how SPD impacts case delays, instrument readiness, and patient safety.

“These are far more effective than broad overviews,” she explained. “The key is making it practical and data driven.

Provide real scenarios, real impacts, and clear connections to surgical efficiency and outcomes. When they see how SPD constraints affect their day, engagement becomes natural, not forced.”

The future of SPD education Billingslea, Castillo, and Malone described a future in which SPD education becomes more structured, collaborative, and competency based.

Malone pointed to programs she has helped develop that combine classroom instruction, hands-on learning, competency validation, ongoing assessments, and dedicated preceptor training. Rather than relying on lengthy classroom sessions, the model incorporates short educational modules, structured learning cohorts, routine

28 | August-September 2026 | Healthcare Purchasing News

check-ins, and repeated skills validation throughout the onboarding process.

“It wasn’t meant to be an all-day, sit-at-a-computer experience; it was meant to enhance learning,” she commented.

Castillo envisions a future in which SPD education is fully integrated with OR practice rather than operating as a separate discipline. It would include simulation, realtime feedback, and ongoing validation.

“Most importantly, it would position SPD as a clinical partner, not a task-based role,” said Castillo. “To make that a reality, we need investment in education, strong leadership alignment, and a cultural shift that values SPD’s impact on patient outcomes just as much as what happens in the OR.” Billingslea believes the future of SPD education will be based on standardized education, specialty credentialing, workflow guardrails, interdisciplinary training, and leadership accountability.

“My bottom line is simple: the future of SPD education is not more PowerPoints,” said Billingslea. “It is smarter education, stronger systems, visible data, and empowered technicians who understand their role in protecting the patient.” HPN

CONTINUING EDUCATION

Evaluating Biological Indicator Performance in Saturated Steam Sterilization for Central Sterile Supply Department Monitoring

BY EMERSON APARECIDO MIGUEL

S

aturated steam sterilization is the most widely used method in Sterile Processing Departments/Central Sterile Supply Departments (SPDs/CSSDs).

Its widespread adoption is due to its high level of safety, efficacy, and favorable cost-benefit ratio compared to other technologies.

To ensure process reliability, several critical steps must be rigorously

controlled. These include cycle validation, preventive and corrective maintenance programs, periodic calibration of sterilizer instruments, and the structuring of routine monitoring.

The daily control of this process relies on physical, chemical, and biological indicators, which are essential for the safe operation of the CSSD. Among these, the biological indicator (BI) is widely recognized as the most

sensitive and reliable tool for demonstrating microbial kill on medical devices. This product is internationally standardized and regulated by industrial manufacturing guidelines, such as International Organization for Standardization (ISO) 11138-1 and ISO 11138-3.1,2 Although the use of BIs is indispensable in the monitoring strategy, a crucial question arises: do all

Learning Objectives 1. Discuss how biological indicator (BI) performance can be evaluated during routine steam sterilization cycles.

ID 163807887© SENKUMAR ALFRED| DREAMSTIME.COM

2. Identify practical considerations for assessing BIs based on sterilizer characteristics and monitoring practices.

3. Compare rapid incubation results with pH-based growth detection and their impact on interpreting BI results in daily use.

Sponsored by:

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CONTINUING EDUCATION

CYCLE PROFILE

CYCLE PROFILE

Standard Sterilization Cycle

Resistometer (BIER) Cycle

Viability (%)

100

0

100

Air Removal Pulse

BIER Cycle

Viability (%)

Total Standard Sterilization Cycle (includes modified phases)

Time

Biological Indicator Kill Curve: Standard Cycle

0

LEARNING OBJECTIVE 1:

Discuss how BI performance can be evaluated during routine steam sterilization cycles.

The routine use of BIs or their application in process validation stages does not aim to evaluate the performance of the indicator itself, but rather the performance of the sterilization equipment. During process validation, specifically in the performance qualification (PQ) phase, BIs are used to demonstrate the success of bioburden inactivation from a biological perspective. At this stage, no tests are performed to determine the quality of the BI used as a challenge. Product selection is generally based on documents provided by the manufacturer attesting to compliance with regulatory requirements.

Consequently, if the indicator is out of specification, there is a risk

Evaluating Biological Indicator Performance in Saturated Steam Sterilization for Central Sterile Supply Department Monitoring

August-September 2026 Time

Biological Indicator Kill Curve: Resistometer Cycle

Figure 1. Differences between standard CSSD sterilization cycles and BIER resistometer cycles used by BI manufacturers

products available on the market offer the same quality? Furthermore, is it possible to evaluate the actual performance of the chosen BI within the CSSD itself?

This article examines these questions, aiming to clarify fundamental points to guide end-users in making informed choices among the BI products available for CSSD monitoring.

Lesson:

of hidden failures occurring during the release of falsely sterilized loads.

Given this, how can the quality of the sterilization monitor be evaluated?

Taking into account the technology of current steam sterilizers, it would be feasible to configure dedicated program cycles to simulate an insufficient exposure relative to the kill time of the tested lot population. In this way, the expected result after incubation would be bacterial growth (positive), rather than no growth (death).

One way to perform this test is to rely on the survival time indicated in the lot’s certificate of analysis (CoA).

According to regulatory requirements, this time defines the window preceding the onset of viable population death; by reaching this point precisely, the expected result is growth at the end of the incubation period.

According to ISO 11138-1, the quality testing of a BI is performed in a resistometer (BIER).1,3 This equipment develops an extremely rapid heating curve, preceded by an effective air removal stage, which prevents noncondensable gases from obstructing the contact of saturated steam with microorganisms. Under this controlled condition, the accumulated lethality before the exposure phase is minimal.

Thus, the survival time provided by the manufacturer strictly reflects the

This lesson was developed by Solventum. Lessons are admin­is­tered

by Endeavor Business Media.

Earn CEUs After 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 pre-approved 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 two years, until July 28, 2028.

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

C, 9. B, 10. D, 11. C, 12. B, 13. B, 14. B, 15. B

30 | August-September 2026 | Healthcare Purchasing News

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7/29/26 1:47 PM

exposure during the cycle’s holding phase, which is terminated by rapid depressurization to avoid a residual lethal effect outside the main evaluation phase.

The sterilizers available in CSSDs possess cycle profiles distinct from those observed in a resistometer, particularly regarding the chamber conditioning and depressurization stages.

Consequently, these two phases exert a residual lethal effect that is added to the exposure plateau. To correct this distortion and evaluate the process holistically, it is recommended to measure the lethal action of the entire cycle, accounting for all stages involving saturated steam injection, through the lethality calculation (F0). Figure 1 illustrates this comparison: when challenging a BI in a hospital sterilizer, it becomes imperative to compensate for the F0 accumulated during the gradual rise in temperature, whereas

the resistometer performs this heating almost instantaneously.

To support the development of these calculations, the use of temperature dataloggers that integrate this mathematical tool is essential.

They allow verification of whether the selected exposure time will yield the same dose of lethality indicated in the lot’s CoA. Thus, the F0 values obtained by the physical sensor, which is positioned immediately alongside the tested BIs, must closely approach the survival time established by the manufacturer. Once the attainment of this thermal target is confirmed at the end of the cycle, the vials are sent for incubation.

Currently, thanks to rapid-read fluorescence technology, modern incubators deliver results within a few minutes. In this sublethal test scenario, the expected outcome is the detection of a process failure (positive

result for bacterial growth), since the exposure was intentionally restricted to the spores’ survival limit. In this manner, the user can track analytical discrepancies with precision, enabling the diagnosis of quality deviations in the indicator lot, issues within the transport and storage chain, or even calibration and operational faults in the incubation equipment itself.

LEARNING OBJECTIVE 2:

Identify practical considerations for assessing BIs based on sterilizer characteristics and monitoring practices In practice, applying the actions indicated above requires several points of attention because, in certain situations, the expected objective cannot be achieved. Situations in which a test cycle cannot be developed through the sterilizer’s

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CONTINUING EDUCATION Quality Culture

Criterion

Rapid-Readout (Fluorescence)

Traditional Detection (pH Change)

Detection Mechanism

Detects the active state of the alpha­glucosidase enzyme, which is naturally bound to the spore coat of viable Geobacillus stearothermophilus spores.

Detects active metabolism. The spore must germinate, multiply, and produce acidic metabolic waste that triggers a pH-induced color change in the

Turnaround Time

Minutes to a few hours (typically ranging from 24 minutes to 3 hours, depending on the manufacturer).

24 to 48 hours (may require up to 7 days for extended incubation in sublethal validation assays).

Turnaround Time

Extremely high for initial enzymatic activity detection near baseline levels

High for macro-scale bacterial population growth and proliferation.

Positive Result Signal

Optical sensors in the incubator detect emitted fluorescent light.

Direct visual color change in the gro\.vth medium (typically shifting from purple/blue to yellow).

Table 1. Comparison of rapid-readout and traditional pH-based growth detection methods. Characteristics summarized from ANSI/AAMI ST79 and the CDC Guideline for Disinfection and Sterilization in Healthcare Facilities.4,5

programming, or where a cycle must be manually canceled at a specific stage to simulate a sterilization failure, can contribute to results that lead to misleading conclusions. If not executed correctly, this action is considered a highly unpredictable operation and is prone to diagnostic errors.

If the operator attempts to manually cancel the cycle upon noticing that the sterilizer has reached the survival time on the timer, the result will be inconsistent for two technical reasons: • Thermal Inertia and Exhaust Time: When aborting a cycle, the chamber does not cool down instantly. The pressurized steam takes time to be expelled (exhaust).

During these minutes of forced depressurization, the temperature drops gradually, continuing to inject heat (F₀) into the BI vials.

• Uncontrollable Lethality: This unplanned residual heat frequently exceeds the spore’s resistance. The BI will end up dying (yielding a negative result), leading the user to the mistaken conclusion that the indicator lot is defective, when in fact it was the methodology failure that added extra lethality.

Many professionals believe that if they cannot run a sublethal cycle on the machine, it is sufficient to rely on the BI incubated directly out of the box (unprocessed positive control). However, an unprocessed positive control only proves that the spores are viable and that the culture medium functions correctly. It does not prove whether the spores maintain the proper thermal resistance defined by the D-value. A lot that has undergone thermal degradation during transport may activate normally in a standard positive control yet die prematurely inside the sterilizer during a routine cycle, generating a false-negative (the approval of a contaminated load).

To bypass these issues without causing misleading conclusions, the CSSD should adopt the following strategies:

32 | August-September 2026 | Healthcare Purchasing News

• Exclusive Use of Dataloggers with F₀ Software: Instead of attempting to guess the exact moment to abort the cycle, a physical datalogger should be used to map a short programmable cycle permitted by the machine.

The datalogger software retrospectively calculates the accumulated lethality to verify whether the survival target was homogeneously achieved.

• Test Cycles: Verify whether the sterilizer manufacturer allows the configuration of a test cycle that primarily includes reduced exposure times, which can be modified in accordance with the survival time of the BI lot being challenged.

By implementing these precautions, errors in test results are avoided, and the design characteristics and technological resources of each sterilizer manufacturer are respected, thereby achieving more reliable and precise outcomes.

LEARNING OBJECTIVE 3:

Compare rapid incubation results with pHbased growth detection and their impact on interpreting BI results in daily use When evaluating the results of sublethal assays using rapid-read incubators, uncertainties may arise regarding the precision of fluorescence detection, raising questions about equipment calibration, operational failures, or the capability to identify a marginal population of viable microorganisms. To mitigate these doubts and confirm the microbiological growth interpretation, the extended incubation method is recommended. By extending the conventional incubation period, surviving spores are allowed to multiply and consume the nutrients in the culture medium.

This active bacterial metabolism results in the production of organic acids that alter the pH of the solution, triggering a visual color change of the growth medium, thereby confirming the microbiological result through two independent detection methods (fluorescence and pH).

The comparison between rapid fluorescence technology and conventional detection via pH-induced color change highlights the balance between the operational agility demanded by modern CSSDs and traditional microbiological safety. The application of each technology directly shapes the Dr. Emerson Aparecido Miguel regulatory defensibility and logistical efficiency of the hospital; therefore, utilizing pH growth confirmation during BI quality testing becomes vital. Table 1 compares these two microbiological growth detection techniques, highlighting their basic characteristics and outlining distinct advantages of each method.

Currently, during the daily use of BIs to monitor sterilization processes in a CSSD, there is no room for extended incubation times. However, the ability to confirm rapidreadout results during product quality testing is fundamental to achieving a correct interpretation of outcomes, thus fulfilling the objective of evaluating the product’s true effectiveness.

Conclusion Validating BIs in CSSDs requires a clear differentiation between routine sterilizer monitoring and quality testing of the indicator itself. Simulating sublethal cycles based on survival time provides a robust scientific tool to audit lots but faces practical challenges in hospital sterilizers due to thermal inertia and software constraints. To mitigate

diagnostic errors and misleading conclusions caused by manually aborting cycles, physical dataloggers and the (F0) lethality calculation are indispensable for compensating for heat accumulated during transition phases.

Furthermore, while rapid-read fluorescence technology ensures the logistical agility essential for daily surgical workflows, the traditional pH color-change method through extended incubation serves as an irreplaceable analytical safeguard. Integrating these methodologies strengthens the hospital’s regulatory defensibility and the ultimate efficacy of infection prevention and control practices. HPN REFERENCES: 1. International Organization for Standardization. ISO 11138-1:2017. Sterilization of Health Care Products: Biological Indicators. Part 1, General Requirements. Geneva, Switzerland: International Organization for Standardization; 2017.

2. International Organization for Standardization. ISO 11138-3:2017. Sterilization of Health Care Products: Biological Indicators. Part 3, Biological Indicators for Moist Heat Sterilization Processes.

Geneva, Switzerland: International Organization for Standardization; 2017.

3. International Organization for Standardization. ISO 18472:2006. Sterilization of Health Care Products: Biological and Chemical Indicators, Test Equipment. Geneva, Switzerland: International Organization for Standardization; 2006.

4. Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST79: Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. Arlington, VA: Association for the Advancement of Medical Instrumentation; current edition.

5. Rutala WA, Weber DJ. Guideline for Disinfection and Sterilization in Healthcare Facilities.

Atlanta, GA: Centers for Disease Control and Prevention; updated 2024.

Dr. Emerson Aparecido Miguel is a chemical engineering professional with more than 20 years of experience in process validation, sterilization, and equipment qualification across the pharmaceutical, healthcare, medical device, and related industries. He holds a PhD in Pharmaceutical Sciences from the University of São Paulo (USP) and actively contributes to the development of International Organization for Standardization (ISO) and Brazilian Association of Technical Standards (ABNT) for healthcare product sterilization. He is also a guest lecturer and frequent speaker on validation, sterilization, and regulatory compliance.

Evaluating Biological Indicator Performance in Saturated Steam Sterilization for Central Sterile Supply Department Monitoring - Practice Quiz 1. What is the primary purpose of using BIs during routine monitoring and process validation?

A. To determine the quality of the BI lot B. To evaluate the performance of the sterilization equipment and process C. To measure the calibration accuracy of the incubator D. To verify the chemical composition of the sterilant 2. How are BI products typically selected for use?

A. By comparing growth results from multiple brands during routine monitoring B. Based on the performance of lot-specific testing in the CSSD after use C. Based on documentation provided by the manufacturer demonstrating compliance with regulatory requirements D. By selecting only the BI with the shortest incubation time

3. Why is it inappropriate to assume that a BI’s survival time can be replicated by simply stopping a sterilization cycle when the indicated time is reached?

A. BIs cannot be used in hospital sterilizers B. The chamber immediately loses all lethality when the cycle is aborted C. Residual heat and depressurization continue to contribute additional lethality after cycle cancellation D. Survival time applies only to chemical indicators 4. When conducting a sublethal BI challenge based on the manufacturer’s survival time, what result is expected after incubation?

A. Bacterial growth (positive result) B. A failed incubation test C. No bacterial growth (negative result) D. Variable results that cannot be predicted

hpnonline.com | August-September 2026 | 33

5. According to the article, why is the lethality accumulated during cycle conditioning and depressurization important when evaluating BI performance in a hospital sterilizer?

A. It has no effect on BI results B. It can contribute additional lethality beyond the exposure phase C. It affects only chemical indicators D. It shortens the incubator readout time 6. What is the purpose of using temperature dataloggers with lethality calculation (F₀) capability during a BI performance evaluation?

A. To determine the manufacturer’s spore population count B. To verify incubator calibration before testing C. To replace the need for BI incubation D. To confirm that the delivered lethality closely matches the survival time specified in the lot’s CoA 7. When evaluating a BI lot against the survival time specified in its CoA, why is manually canceling the sterilization cycle at the indicated survival time considered unreliable?

A. Residual heat and depressurization continue to contribute lethality after cycle cancellation.

B. The BI cannot be incubated after an interrupted cycle.

C. The sterilizer immediately enters a validation mode after cycle cancellation.

D. Steam sterilizers automatically restart the cycle after interruption.

8. What information does an unprocessed positive control provide?

A. That the BI maintains its specified thermal resistance B. That the sterilizer is delivering the correct lethality C. That the spores are viable and the culture medium functions properly D. That the D-value of the BI is within specification 9. What is the recommended role of a datalogger with F₀ calculation capability when evaluating whether a BI performs according to its CoA? A. To replace the BI during testing B. To retrospectively calculate accumulated lethality and verify that the survival target was achieved C. To determine the manufacturer’s spore population count D. To eliminate the need for incubation

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10. What is the primary difference between rapid-readout BI technology and traditional pH-based detection?

A. Rapid-readout technology detects bacterial growth, while pH-based detection measures temperature.

B. There is no difference in the detection mechanism.

C. Rapid-readout technology uses a color change, while pH-based detection uses fluorescence.

D. Rapid-readout technology detects enzymatic activity, while pH-based detection detects bacterial metabolism and growth.

11. Which advantage of rapid-readout technology makes it valuable for routine sterilization process monitoring?

A. It requires extended incubation periods. It detects bacterial population growth more effectively than pH-based methods.

B. It provides results within minutes to a few hours.

C. It eliminates the need for BIs. 12. During BI quality testing, why might extended incubation be used in addition to rapid-readout results?

A. To verify the sterilizer’s temperature calibration.

B. To confirm microbial growth through pH-based detection.

C. To determine the BI population count.

D. To replace fluorescence detection.

13. What additional factor must be considered when evaluating a BI in a hospital steam sterilizer?

A. The BI’s incubation temperature B. The lethality accumulated during conditioning and depressurization phases C. The manufacturer’s recommended storage temperature D. The sterilizer chamber volume 14. What is the primary purpose of a BIER resistometer when establishing BI performance characteristics?

A. To evaluate routine sterilizer loads in healthcare facilities B. B. To provide a controlled cycle that minimizes the influence of non-exposure phases on BI results C. C. To replace incubation during BI testing D. D. To calculate the F₀ value of hospital sterilizers 15. What is the primary benefit of evaluating BIs against the performance characteristics listed in the manufacturer’s Certificate of Analysis?

A. It eliminates the need for routine BI monitoring of sterilization cycles.

B. It helps verify that the BI lot performs as specified, reducing the risk of misleading sterilization monitoring results.

C. It determines whether the sterilizer meets installation qualification requirements.

D. It replaces the need for positive controls and incubation.

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