From Guidance to Accountability: Navigating the Latest Sterile Processing Standards - And the Reality of Deviations

“Over the past years, sterile processing and endoscope reprocessing have seen some of the most significant standards updates,” said Christy Newland, senior director, clinical solutions and delivery, STERIS. “These changes aren’t just technical - they reshape survey expectations, patient safety, and operational risk. As someone who works closely with teams across hospitals and ambulatory surgery centers (ASC), I see both the progress and the pain points these shifts create.” 

Those “pain points” are becoming increasingly visible as updated standards move from guidance documents to operational requirements. They are scrutinized not only in daily workflows, but also during accreditation surveys.

At the center of this evolution are several key standards and guidance documents redefining how SPD professionals approach water quality, sterilization practices, endoscope reprocessing, and documentation. At the same time, a long-standing but often uncomfortable topic is gaining more attention: How to manage unavoidable deviations from those standards.

Water quality moves to the forefront

Among the most impactful developments is ANSI/AAMI ST108:2023 Water for Processing Medical Devices, which elevates water quality from a background consideration to a defined, measurable component of sterile processing performance.

“If you have worked in sterile processing long enough, you already know this - water has always mattered,” said Shawn Flynn, business unit director, SPD, for Skytron. “We just have not always treated it like our responsibility. ANSI/AAMI ST108 changes that.” 

For many sterile processing professionals, ST108 raises a familiar question: Is this truly new, or simply newly enforced?

“The answer is both,” Flynn added. “The science has always been there. What is new is the clarity, accountability, and expectation that water quality is actively managed, not passively assumed.” 

Historically, water quality was often referenced in broader standards such as ANSI/AAMI ST79 Comprehensive guide to steam sterilization and sterility assurance in health care facilities, with ownership typically falling to facilities departments and limited visibility within the SPD. 

ANSI/AAMI ST108 removes that ambiguity, defining water quality as a critical input into cleaning, disinfection, and sterilization processes.

Danielle M. West, Ph.D., lead scientist, diagnostic solutions service, STERIS, and a member of the AAMI WG95, Water Quality for Processing of Medical Devices – contributing to both ANSI/AAMI ST108:2023 and the forthcoming AAMI TIR119, Guidance on Healthcare Implementation and Use of ANSI/AAMI ST108:2023 - noted that implementation remains a key challenge for many organizations.

“As healthcare facilities work toward implementing ANSI/AAMI ST108:2023, many questions arise regarding the practical aspects of execution,” she said. “Once published, AAMI TIR119 will serve as an implementation guide, offering risk-informed, practical guidance – including tools for gap analysis, action planning, and evaluating system modifications – to support application of the standard within existing facility environments.” 

Importantly, the relationship between the two documents is complementary.

“In essence, ST108 defines the requirements and TIR119 provides guidance on implementation,” West added. 

From an operational standpoint, the implications are significant. Water is not a neutral element in reprocessing - it directly influences outcomes.

“Water is the medium for cleaning chemistry, the final contact point before sterilization, and a direct contributor to instrument and equipment outcomes,” said Flynn. “When water quality drifts, we see it immediately - inconsistent cleaning results, staining and residue, corrosion, wet loads, failed indicators.” 

The impact extends beyond instruments to the equipment itself.

“Poor water quality accelerates scale buildup, corrodes components, and increases stress on washers, ultrasonics, steam sterilizers, and associated plumbing,” Flynn continued. 

Despite this, misconceptions remain.

“One misconception I hear frequently is that ST108 is simply about installing a reverse osmosis system. It is not. Infrastructure matters, but governance matters more,” he added.

ST108 requires organizations to define ownership, monitor performance, trend results, and take action when parameters fall outside defined limits, fundamentally shifting water quality from a passive condition to an actively managed process.

Expanding expectations across core standards

While ST108 has captured significant attention, it is not the only standard on the minds of SPD professionals.

ST79: Raising the bar—and under active revision

ANSI/AAMI ST79 continues to serve as the foundational guidance document for steam sterilization and sterility assurance in healthcare facilities, but it is also actively evolving.

“Amendments and ongoing revision work emphasize daily air-removal testing, quarantining implant loads until biological indicator (BI) results are negative, and trending documentation errors,” said Newland. “Surveyors now expect magnified inspection and mechanical cleaning checks as routine - not optional.” 

At the same time, a broader revision effort is underway to improve clarity, usability, and alignment with real-world workflows.

“A central goal of the revision effort is to make ST79 more streamlined and easier to use in real-world healthcare settings,” said Mary Ann Drosnock, DHSc, CIC, CFER, RM (NRCM), FAPIC, AAMIF, co-chair of AAMI working group 40, which oversees ST79. 

The working group is focused on reorganizing the standard to better reflect the actual flow of instrument processing - from point-of-use (POU) treatment through cleaning, sterilization, and storage - while integrating prior amendment content directly into the main body of the document to reduce redundancy and improve clarity. 

“We really decided to break the document down more closely to have the actual flow of a medical device as it’s going through the processing cycle,” Drosnock explained.

The revision process is also being structured to move more efficiently, with task groups assigned to specific sections and a goal of producing an initial draft for broader review later this year.

For sterile processing professionals, this presents an opportunity to engage. Drosnock emphasized that participation in the standards development process - whether through working groups, public review, or professional feedback - helps ensure that ST79 remains practical, evidence-informed, and responsive to the realities of healthcare delivery. 

“Now is the time to get involved in the working group, because you can have an impact on what the document says in the end,” she said. 

ST91: Endoscope reprocessing under intensified scrutiny

Endoscope reprocessing remains a high-risk, high-visibility area, and the 2021 revision of ANSI/AAMI ST91 continues to drive change.

“The 2021 revision tightened requirements for leak testing, cleaning verification, and storage,” said Newland. “Chain-of-custody and quality assurance (QA) audits are now non-negotiable for patient safety.” 

These requirements have translated into increasingly detailed audits, with surveyors expecting documentation for every step of the process.

Beyond AAMI: ISO and additional guidance

In addition to AAMI standards, broader frameworks are influencing expectations within SPDs.

“Validation discipline (DQ/OQ/PQ) and process control expectations are influencing IFUs and surveyor questions, even when ISO isn’t directly cited,” said Newland regarding ISO 17665:2024 Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices, and related frameworks.

Guidance documents such as AAMI TIR17:2024 Compatibility of materials subject to sterilization are also expanding considerations around material compatibility and device longevity, reinforcing the need for evidence-based decision-making.

Education, certification, and advocacy: Supporting the profession

As standards evolve, so too must the education and professional development of sterile processing personnel.

“Education and standards for the sterile processing profession are constantly evolving and improving,” said Damien Berg, vice president of strategic initiatives, Healthcare Sterile Processing Association (HSPA). “There have been many updates to the standards and education over the years.

“Still, one thing remains constant: we must continually review what is being done, what is required, and how we can ensure that standards and education are up to date with the manufacturer's requirements and regulations.” 

“Aligning HSPA’s educational resources with the most current standards and regulations and having HSPA team members participating in the standards development process are essential to the process,” Berg added. 

Certification efforts are also gaining momentum.

“HSPA maintains a unified voice to advocate for the profession and to create legislative and regulatory changes that help ensure every patient has an educated, certified sterile processing technician responsible for reprocessing their instruments,” said Josephine Colacci, Esq., director of government affairs, HSPA. “HSPA’s dedicated and focused advocacy efforts have resulted in state statutes in New York, Connecticut, Delaware, Pennsylvania, Tennessee, and Minnesota. Before HSPA started its legislative efforts, only New Jersey required certification.” 

The reality no one can ignore: Standards deviations

Despite increasing expectations, one reality remains unchanged: Not every facility can meet every standard requirement perfectly, all the time.

“Here’s the truth: deviations happen,” said Newland. “Facility design constraints, IFU conflicts, supply disruptions, staffing shortages - they’re real. The difference between a finding and a defensible plan lies in structure.” 

This reflects an important shift in how compliance is evaluated. Rather than expecting perfection, surveyors are increasingly focused on how organizations assess risk and document decision-making.

“What matters most is having a clear, documented approach and the ability to explain how decisions are made,” said Flynn. “Surveyors are not looking for perfection. They are looking for awareness, oversight, and accountability.” 

For sterile processing professionals, deviation management is no longer a reactive exercise - it is a core component of compliance.

From deviation to discipline

As scrutiny increases, so does the need for structured, proactive approaches to managing deviations.

“Surveyors are increasing their scrutiny and standards are becoming stricter,” Newland commented. “Facilities that combine strict compliance with organized approaches to managing deviations will safeguard both patient safety and their accreditation. The focus is not on flawless performance, but rather on open communication, assessing risks, and ensuring consistent action.” 

This shift - from perfection to transparency - reflects broader trends in healthcare quality and risk management.

Building reliable systems for patient safety

Ultimately, the evolving standards landscape reflects a larger principle: Patient safety depends on reliable, interconnected systems.

“Patient safety is not achieved in a single step. It is built through dependable systems working together,” said Flynn. 

From water quality and sterilization practices to documentation and deviation management, each component plays a role in ensuring consistent, safe outcomes.

For sterile processing professionals, the challenge and the opportunity is clear. Standards will continue to evolve, and expectations will continue to rise. Success will depend not only on understanding those standards, but on integrating them into resilient, well-documented processes that can withstand both operational pressures and regulatory scrutiny.

In that sense, the shift from guidance to accountability is not just a regulatory change - it is a defining moment for the profession.