Hospital Leaders: It’s Time to Give SPD a Seat at the Table
January 2026 marks 13 years since I joined the HPN editorial team and much of that time has been spent covering sterile processing departments (SPD). I have interviewed countless sterile processing professionals and experts in the field. Their passion for patient care and safety never ceases to amaze me.
While I hear more stories of SPD teams who have built strong, collaborative relationships with their hospitals’ executive leadership and other key partners (e.g., perioperative, infection prevention), there are other professionals who report they are still fighting to be heard.
So, as we close out 2025, I reached out to the sterile processing community to ask, “Where should SPD professionals have a seat at the table, but don’t?”
The response was tremendous—both to my post on LinkedIn and the direct emails and one-on-one conversations I had with SPD professionals.
What follows is a summary of these responses, including real-world stories that highlight the importance of hospital leaders and other stakeholders tapping into the knowledge and expertise of their SPD teams—and the risks of overlooking this critical resource.
Industry level decisions
Sterile processing professionals must play a role in the development of standards, policies, and other guidance and recommendations that impact their work.
“We should be involved in strategic discussions within our organizations and industries as subject matter experts in operations management and patient safety,” said Courtney Mace Davis, MBA, CHL, CRCST, AVP, Sterile Processing for Endeavor Health. “The sterile processing solutions of today may not have the same impact in five years. We can learn from other departments, healthcare organizations, and industries as long as we lean in and are willing to learn from others. These same groups can also learn from some of the great things SPD is doing.”
Manufacturer IFUs
Shawn Flynn, business unit director, SPD, for Skytron, who brings comprehensive experience as a surgical technician in the U.S. Army, medical device manufacturing, regulatory/compliance, SPD operations, and as a medical device entrepreneur, commented on regulatory gaps and their impacts on sterile processing teams, stating:
“There are all these gaps in regulatory pathways leading up to a device being cleared by the FDA where sterile processing professionals don’t have a seat at the table—and we definitely don’t have a seat when it comes to IFU validation. When a manufacturer is drafting an IFU, they are typically doing it from their perspective, and not through the lens of sterile processing.”
Garland-Rhea Grisby, BA, CER, CRCST, manager, Sterile Processing, Sutter Health, and host of the Association for the Advancement of Medical Instrumentation’s (AAMI) Below the Hospital podcast, spoke to the real-world challenges sterile processing leaders face with IFUs today.
“We’re not the instrument manufacturer, but we’re the ones who have to handle, care for, store, and process these products,” said Grisby. “If there’s something out of whack with an IFU that we cannot do, then we need to go back to the manufacturer and ask, ‘Have you heard these complaints, and what did you do about it?’”
He pointed to numerous examples of IFU conflicts. Two nearly identical instruments from the same manufacturer—differing only in size—called for vastly different reprocessing requirements: Sterile gloves for one, nitrile for the other; sterile water for one, potable water for the other. “Then we’re left to figure it out, and risk being cited by surveyors.”
There can be broad variabilities across manufacturer IFUs, even for something as seemingly straightforward as steam sterilization. “It should be standard across the board, but it’s not,” said Grisby. “One manufacturer says four minutes, another says six. What do you do when those instruments are in the same tray?”
Compounding the issue, hospitals often face mixed fleets of old and new instruments and sole-source contracts for high-level disinfectants and other chemicals that limit their options. “We get stuck between a rock and a hard place,” Grisby explained. “If an instrument’s IFU calls for a disinfectant outside our contract, we can’t process it—even if it’s best for the patient.”
“Sterile processing definitely needs to be involved when manufacturers develop IFUs,” Grisby added. “At the end of the day, we’re the ones who have to make it work.”
QMS
Sterile processing professionals should also be involved in the development of quality management systems (QMS), said Mace Davis, stating:
“I think about ANSI/AAMI ST90:2017(R2024) – Processing of health care products – Quality management systems for processing in health care facilities. There are so many vital relationships that go into creating a robust QMS. SPD should not only be included but should think about how we can be leaders in collaboration. For example, our managers host and lead monthly ‘Connections’ meetings that bring together leaders and educators from the OR, EVS, CE, facilities, and infection prevention to celebrate wins and identify (and address) opportunities for improvement.”
Supply chain & purchasing
The issue of IFUs crosses over to decisions related to new equipment and instrument purchases. “Any time new medical equipment is being considered for purchase/trial, someone from SPD needs to look over the manufacturer’s IFU to determine if the facility can reprocess it,” said James Carlock, regional director of Sterile Processing for Mercy in Oklahoma City.
Several sterile processing professionals voiced the need for SPD teams to play a central role in procurement decisions, especially those around new surgical instruments and devices.
Assessment Team Project Lead for Advantage Support Services (ASSI) Janene McGlynn, CRCST, CIS, CER, CHL, emphasized the importance of giving SPD teams a seat at the table whenever a facility brings on new surgeons or expands into new or specialized clinics.
“Typically, that’s going to mean looking at inventory, new equipment/instruments, and soft goods,” said McGlynn.
At UCSF Health, SPD is a stakeholder in the new product request process, as Gene Ricupito, CRCST, CIS, CHL, CFER, PMP, MBA(c), system director, Sterile Processing, explained:
“UCSF employs the GHX Lumere platform as part of the structured approach to ensure all aspects of a new product are evaluated prior to approval for introduction. This requires review of the IFU and acknowledgement to the decision-makers that the device can be effectively supported so that there are no 11th hour surprises when it comes time to implement.”
Beyond the hospital walls
Edna Gilliam, DNP, MBA, RN, CNOR, NEA-BC, assistant vice president, Perioperative Services & SPD, DV, Nemours Children’s Hospital, pointed out how SPD teams are often responsible for instrumentation both inside and outside of the operating room (OR). She shared a story of where the SPD team was lacking visibility to clinic instrument purchases, the ramifications, and how her hospital resolved the issue.
At one point, clinic staff were independently ordering instruments—without involving the SPD and in some cases, unknowingly purchased single-use items. “That becomes a serious issue if those single-use instruments make their way back to SPD,” Gilliam noted. “Reprocessing them could pose significant risks to patient safety and regulatory compliance.”
To address it, Nemours changed its process so that all instrumentation purchases now go through SPD. The SPD team verifies the order, ensures the product is appropriate, receives it, trains and educates staff, and then distributes it to the clinic.
Nemours also established a High-Level Disinfection and Sterilization Committee, co-led by the SPD manager, infection control director, and regulatory director. Any new device approved through value analysis must go to this committee for review, where SPD confirms the instrument can be cleaned and identifies any necessary education.
Gilliam said the centralized process has been “largely successful,” enhancing oversight, validating SPD expertise, and giving the department a stronger voice in decision-making.
Redesigns and new construction
Early involvement of the SPD team in facility design can avoid costly gaps later, as Rebecca Alvino, system director, Hospital Epidemiology and Infection Prevention for UC Davis Health, explained:
“Sterile processing professionals must be at the table during the input phase of designs for renovations or new constructions. It’s time to put a stop to the idea of building a space for teams to figure out how to operationalize instead of getting their input from the start.”
Sterile processing’s expertise is critical not only in the design of in-hospital SPDs, but also anywhere reprocessing is performed. Gilliam offered this example:
“When Nemours Children’s Hospital was planning a new ambulatory surgery center in Malvern, PA in 2024, the C-suite brought our sterile processing leaders to the table right away to talk through the design and equipment required for high-level disinfection and sterilization.”
“SPD’s expertise is critical to ensuring patient safety and efficiency, especially in construction projects involving equipment installation and high-level disinfection areas,” she added. “During this new build, the SPD team offered advice as to new innovations that could make reprocessing workflows more seamless in the ASC setting.”
Surgical procedures/case planning
Our experts say SPD teams must also be involved in planning for new specialties, block time scheduling, and determining whether there is realistic instrument availability.
Alvino spoke about including sterile processing professionals in discussions around block times for surgeons or service lines, stating:
“You have an ortho doc who wants two rooms of arthroplasties 1-2 days a week? Have a conversation first with SPD to ensure they have the instrumentation —and if not, bring the vendors into the conversation.”
“But don’t just set up whimsical scenarios of surgeons running 10-15 total knees and hips over two rooms in a day with only two sets of instrumentation each for knees and hips and demand SPD to urgently turn them over,” she added. “Not only is it creating an environment to encourage corner-cutting, but it also jeopardizes the other service lines operating that day and the next day.”
McGlynn recommends SPD teams ask the following questions:
- What are the block times going to look like?
- Does SPD need to be in-serviced on instruments?
- When is the go live date for these cases?
- Are the instruments in the building? Are they on consignment or a loaner?
- Do we need a capital purchase for equipment to properly follow the IFU?
- Are the OR team on the same page on all these questions?
According to Leslie Kronstedt, LPN, BHCA, CRCST, CIS, CHL, CER, CSF, sterile processing’s voice is critical not only in surgical services decisions but anywhere in a hospital where reprocessed devices/instruments are used.
“Decisions in departments such as labor & delivery, the ICU, and even satellite clinics are directly influenced by the quality and consistency of SPD practices,” said Kronstedt. “Yet too often, those with the deepest expertise in these processes are excluded from the discussions where protocols and procedures are set.”
Infection prevention
Sterile processing, when performed in compliance with manufacturers’ IFUs, industry guidance, and hospital protocols, plays a primary role in infection prevention anywhere reprocessed instruments and devices are used in patient care. Therefore, the importance of collaboration among sterile processing and infection prevention teams cannot be overstated.
At UCSF Health, SPD is a critical participant in the organization’s Infection Prevention Sterilization & Disinfection subcommittee. “As SPD system director, I am a co-chair,” Ricupito explained. “This is a multidisciplinary forum that reviews challenges the organization may face with ensuring compliance with IFUs both within the realm of SPD and endoscopy but also at the point-of-use.”
“SPD is viewed as a valued partner in evaluating the entire reprocessing cycle,” he added. “Our clinical partners also provide tremendously valuable feedback to SPD on performance, particularly in the area of service levels and logistics. I am fortunate to work for an organization that not only recognizes the importance of SPD in the support of patient safety, but has also taken steps to establish a constructive, collaborative culture where SPD is an integral partner.”
While the infection prevention team can serve as the SPD team’s greatest ally in some cases, Gilliam warns that in other cases, a contentious relationship can arise between the teams.
“The partnership between sterile processing and infection prevention opens the door to bringing another party into your space who will critique your processes,” she explained. “But when the relationship has mutual respect and you have a shared vision, the dynamic can be very positive and impactful. We have worked very hard to create that partnership here at Nemours.”
Regulatory and patient safety
As with infection prevention, sterile processing has a direct connection with safety in patient care, as Ricupito described:
“Sterile processing plays a critical role in patient safety by ensuring that all instruments and medical devices are properly cleaned, disinfected, sterilized, and maintained. These efforts support the prevention of surgical site infections, as well as reduce the risks of cross-contamination.”
To strengthen the SPD team’s voice in pressing for safe reprocessing practices, Gilliam said sterile processing leaders need partnerships with their perioperative leaders, chief nursing officers, and whoever manages patient safety in their hospital, which might look very different from one organization to the next.
“Titles may vary depending on an organization’s structure,” she explained. “In some cases, responsibilities for regulatory compliance and patient safety may overlap. However, because regulatory bodies—such as The Joint Commission and state Departments of Health—place such a strong emphasis on patient safety, sterile processing is often the first area they inspect.”
“To capture the attention of your C-suite, emphasize that a single issue in the SPD has the potential to halt surgical operations across the hospital,” said Gilliam. “If you come across a story in HPN or another publication where a regulatory agency suspends procedures due to contaminated instruments, share it with your executive leadership. That scenario represents one of the most serious threats a hospital can face.”
The bottom line
While the role of sterile processing professionals in patient care and safety should be enough to secure them seats at the decision-making table, often a department’s level of influence in a hospital comes down to the bottom line.
“Including SPD at both clinical and administrative tables strengthens outcomes for patients, improves staff collaboration, and supports organizational sustainability,” said Kronstedt. “On the administrative side, SPD performance has a direct impact on hospital revenue and reimbursement. Sterile processing efficiency and equipment choices influence surgical workflows, case delays, or cancellations, and the risk of hospital-acquired infections.
“These factors ripple into reimbursement structures—from fee-for-service and global billing for surgical procedures to penalties tied to HAIs,” she continued. “In short, SPD professionals sit at the intersection of patient safety and financial health, and their voice is essential.”
Aligning IFUs with real-world sterile processing
Garland-Rhea Grisby, BA, CER, CRCST, offers these recommendations for closing the gap between IFUs and real-world practice.
- What manufacturers should do
- Involve SPD teams in IFU development: Test instructions in real-world sterile processing environments to ensure they are practical.
- Notify SPDs of updates: Establish a reliable system to quickly alert facilities when IFUs change.
- Collaborate across companies: Work together to standardize requirements—especially for sterilization—rather than competing with conflicting instructions.
- What SPD teams should do
- Read and track IFUs: Never assume requirements are unchanged; even small updates can affect compliance.
- Raise concerns: Engage manufacturers when IFUs are unclear or unworkable, and request clarification or customer letters when needed.
- Use professional standards: Reference guidance documents (e.g., AAMI) to support best practices when IFUs leave room for interpretation.
When sterile processing isn’t at the table: A $20.6M lesson
Shawn Flynn, then an independent consultant and now business unit director, SPD, for Skytron, shared an intriguing legal case where he was asked to serve as an expert. It underscores what can happen when sterile processing professionals are excluded from critical decisions in the operating room (OR).
A professional Major League Soccer player underwent surgery at an ambulatory surgery center (ASC) to repair shin splints. During the procedure, the surgeon realized a six-hole plate needed for the repair was not available. Instead of using alternative plates that had already gone through terminal sterilization, the surgeon ordered a borrowed tray from a nearby hospital and instructed the SPD team to run it through immediate use steam sterilization (IUSS).
“That decision was in direct opposition to the manufacturer’s instructions for use (IFU), ASC policy, and industry standards,” Flynn explained. “The surgeon told the jury, ‘…and with direct respect to the policies and procedures, these are primarily manuals for employees of the surgery center. These are – not directed at the surgeons that are utilizing those.’”
Flynn was tasked with educating the jury on why the shortcut was taken. “The right approach, terminal sterilization, would have taken more time while the patient was still on the table. To save time, the instruments went through an abbreviated process that wasn’t compliant,” he said.
Within 30 days, the patient developed a deep bone infection at the implant site. Multiple follow-up surgeries were required, and the hardware had to be removed, ending the athlete’s career. The jury awarded him $20.6 million.
“The jury was very clear — ‘I wouldn’t want this done to me,’” Flynn said. “When I was asked if I would ever approve flashing implants, my answer was simple: ‘no.’ The IFU specifically says do not IUSS implants.”
Flynn stressed the accountability that comes with sterile processing documentation. “Every record you generate can be subpoenaed. If SPD records show that an implant was flashed, then responsibility essentially falls on them. That’s why, if I were in that situation, I would insist on a release policy signed by infection control, perioperative services, and administration. Once faced with that accountability, most leaders would refuse and instead agree to a compliant alternative.”
He also posed a provocative question: “Should patients be asked to consent to IUSS in emergencies—to educate them on what constitutes an emergency, the risks, and to get their approval? That’s the level of transparency this case raises.”
Flynn’s takeaway: “This case is the perfect example of why hospital leaders must support sterile processing professionals. Nobody wants to be in that situation.”
Additional areas where sterile processing must have a seat at the table
This article is not meant to be a complete list of decision-making areas, functions, and processes where sterile processing input is vital but rather a summary of what experts have shared with HPN.
Here are additional areas that surfaced in response to the LinkedIn post and in direct correspondence/conversations with sterile processing professionals.
- Accreditation
- Apprenticeship program development
- Capital purchases
- Career growth structure
- Emergency preparedness teams
- Environmental Services (EVS)
- Facilities
- Finance (opportunities for revenue preservation)
- Hazardous duty pay
- Industry organizations
- Learning and development (not only front-line staff but also leaders)
- OR point of use (POU) compliance
- Pay and compensation structures
- Tracking system planning meetings
- Vendor selection and feedback
About the Author
Kara Nadeau
Senior Contributing Editor
Kara Nadeau is Sterile Processing Editor for Healthcare Purchasing News.