Image by Ri Butov from PixabayInstrument sterilization inside any health care facility is crucial for patient safety.
Failing to sterilize properly can lead to serious consequences.
In May, Parkwest Surgery Center, an ambulatory surgery center (ASC) based in Knoxville, Tennessee, was sued by four patients claiming they contracted an unusual bacteria during knee procedures in 2023. This resulted in multiple emergency room visits and repeat surgeries after their initial surgeries failed to heal, according to Knoxville news station WBIR.
As of Nov. 12, the number of affected patients has grown, with four more filing suit.
In Spring 2024, the ASC came under the management of the Tennessee Orthopaedic Alliance, and the infections reportedly ceased.
However, this highlights the importance of sterile processing in an ASC.
“Your operating room is your revenue generator, and you can’t operate without a well-functioning sterile processing department,” Tina Piotrowski, CEO of Copper Ridge Surgery Center in Traverse City, Michigan, told Ambulatory Surgery Center News. “The sterile processing department (SPD) is really the engine that makes all procedures happen.”
Piotrowski is also a member of the Ambulatory Surgery Center Association’s (ASCA) Quality Committee.
The process of sterilizing instruments is essential and involves multiple steps that clean, disinfect and sterilize reusable surgical tools to keep them safe for patient use.
This involves decontamination, inspection and sterilization (using methods like steam or hydrogen peroxide), followed by sterile storage. These tasks are performed by sterile processing technicians who play a critical role in preventing infections and safeguarding patient safety.
As more procedures are done in ASCs, some centers are using off-site sterile instrument processing to manage growth, improve efficiency and ensure compliance, while allowing on-site staff to focus on patient care.
Off-site centers often handle higher volumes more efficiently than in-house SPDs and bring specialized expertise to maintain strict sterilization standards.
This approach also helps ASCs avoid the high costs and space constraints associated with expanding their own SPD, supporting their growth into new service lines and specialties.
Key benefits
As ASCs expand, they might outgrow their on-site processing capacity.
An off-site facility offers a flexible solution to manage such increased volumes, according to experts.
Developing and staffing an in-house SPD can be costly, too; off-site services often prove more affordable, especially for centers lacking space or demand for a full in-house operation.
“If you’re expanding service lines and bringing on more physicians who are doing more procedures, your SPD might not have been designed for the workload and capacity you’re at today,” Piotrowski said. “It’s costly to expand an SPD while you are operational. There are many infection control standards you must follow during construction in a health care facility, which would impact day-to-day operations. Your ability to keep your facility running while you are trying to expand is always an issue.”
Expertise is another key factor when choosing between in-house or off-site sterilization services.
Off-site sterilization providers specialize in sterile processing, staying compliant with regulations, and are equipped with the tools and personnel to manage complex instruments and high volumes.
Seeking alignment, understanding risks
However, convincing others to switch to off-site sterilization can be challenging.
“You need to align with key stakeholders and ASC leadership to outsource like this,” Piotrowski noted. “I believe it ultimately depends on the problem you’re trying to solve and whether off-site sterilization is a suitable solution for that issue.”
Piotrowski mentioned that from a growth perspective, it may be a trade-off between expansion and cost savings.
“I don’t know if there is that much of a cost savings going off site,” she said. “If it lets you take advantage of growing and expanding service lines, it can be a great opportunity to add more procedures.”
She also pointed out that several factors must be considered before making the switch.
Piotrowski emphasized logistics and transportation, noting that inefficiencies could lead to high costs from canceled or delayed cases, which should be carefully evaluated.
Lisa Austin, a senior consultant at Avanza Strategies, echoed her concerns, mentioning delays caused by weather or contamination risks during transport.
“There could be a risk of contamination during transport,” Austin told ASC News. “These risks could include temperature, environment and sterilization compromise. Any delay can disrupt schedules, possibly causing delays or cancellations.”
Avanza Strategies is a Chicago-based educational consulting firm providing strategic guidance to hospitals, ASCs and federally qualified health centers.
Austin is also a member of ASCA’s Government Affairs Committee.
Although current data on off-site providers is limited, the market is substantial and projected to grow from $2.29 billion in 2025 to $3 billion by 2032, according to Fortune Business Insights. North America led the off-site sterilization services market, accounting for 39.63% of the market in 2024.
CMS does not require ASCs to have on-site sterilization equipment for routine procedures. They can arrange off-site sterilization through contractual agreements, Piotrowski stated.
But CMS mandates that ASCs must be equipped for emergency sterilization.
“You need to have sterile processing available on site for emergency sterilization,” she explained. “But I see this as a growth opportunity, as the market for off-site sterilization services expands and becomes more widely accepted.”
Before shifting to off-site sterilization, facilities should verify their goals and consider how it affects overall quality.
“You have no control over the sterilization process when completed off site,” Austin said. “You have to trust that the process is always done correctly. It is impossible to monitor parameters like cycle times, biological indicators, temperature, humidity, or infections. It could also be hard to provide full documentation for compliance.”
Leaders need to evaluate current and future procedure volumes and consider the logistics of moving instruments off site.
Transferring sterilization processes, whether temporarily or permanently, will be a significant change for the ASC and requires proper training and communication.
