Neither here nor there

May 24, 2022
It’s the “how,” not the “where,” that determines reprocessing success

In 2022, a growing number of health systems and hospitals seem to be shaking off the dust that has settled from the COVID-19 pandemic and focusing their sights on the future of healthcare delivery.

In the Central Service/Sterile Processing & Distribution (CS/SPD) department, this means forecasting future procedural volumes to determine whether current space, reprocessing equipment, staffing, and device/instrument inventory can support anticipated growth. This has led to an “a ha” moment for many who have determined that they need significant transformation across all areas of sterile processing to support the future of clinical care.

While some health systems are investing in current CS/SPDs to meet future demands, others are taking a different approach and either centralizing reprocessing to one hospital site that services all the others or moving CS/SPD operations completely offsite outside of the hospital setting. With each of these models, health systems must balance the pros and cons of their chosen approach.

“In the past year, I have come across several facilities that have changed their reprocessing strategy,” said Malinda Elammari, CST, CSPM, CSPDT, CFER, CSIS, CRCST, CIS, CHL, CER, CLSSGB, Clinical Education Specialist Healthmark Industries. “Some facilities have moved to onsite centralized processing, while others have moved entirely offsite. Regardless of which system the facility chooses to utilize, each facility is unique in its approach and idea of the centralized concept.”

“There are advantages and disadvantages for each approach,” said Marcia Frieze, CEO, Case Medical. “When you consider efficiency, having a state-of-the-art instrument processing department in each facility allows for quicker turns and certainly less instrument sets, because you do not need as much duplication to account for transport and travel time. Then having one location serving multiple facilities can reduce inventory and duplication of specialty sets and even equipment.”

Factors driving reprocessing location

Health systems and hospitals are shifting from onsite reprocessing at each facility to offsite centralized reprocessing for a variety of reasons, as Elammari explains:

“Space, staff and standards are the three significant factors driving the health system to change to a centralized approach, I refer to this as the 3S effect. Larger systems seem to be shifting their focus to centralized planning. Such as a hospital system close to me that just opened their offsite facility roughly two months ago. Their driving factors are space limitations and volume growth. This offsite facility functions as a hybrid roll in conjunction with its three main facilities and helps support numerous clinical sites.”

Procedure volumes

Healthcare facilities are performing a greater volume of more complex procedures with many CS/SPD departments struggling to keep up.

“As the complexity of health system’s networks and surgeries themselves continue to increase, the demand on each facility’s sterile processing department is being pushed to do more in their existing space,” said Ash Crowe, Senior Project Manager, St. Onge Company. “Many Ambulatory Surgery Centers are now performing Ortho and other tray intensive cases with sterile processing departments designed for less instrument volume. Looking at the health system as a system and evaluating where best to reprocess instruments, either in a new centralized facility or by consolidating makes sense.”

Standards and standardization

A focus on standardization, recommended by industry guidelines and enforced by accreditation bodies, has been driving the move to centralized reprocessing for years, according to Seth Hendee, CRCST, CIS, CHL, CER, CSPDT, CFER, HSPA Approved Instructor, Clinical Education Specialist, SPD, Healthmark Industries.

“When guidelines began stressing the importance of standardization of practice wherever instrument processing is being performed, survey organizations started looking for it,” said Hendee. “At that point, organizations had a choice to make; attempt to enforce compliance across all processing areas or centralize processing in a single location. The later seemed a logical choice for many.”

“Standards are playing a pivotal role in this movement,” Elammari added. “The recent increased focus on SPD means an increased focus on AAMI standards and increased awareness of the correct procedures and operations, causing facilities to reevaluate department layouts, equipment and policies.”

Specialized knowledge and training

“The most prevalent example of the centralized concept that I have come across is for complex specialty items such as flexible scopes and robotics instruments,” said Elammari.

As Frieze points out, the wide range of devices and instruments used in healthcare facilities today necessitate specialized CS/SPD training and talent to properly reprocess.

“There can be human error given all the varieties of devices from robotics to navigation equipment and certainly flexible endoscopes for minimally invasive procedures. Thus, having a specialized reprocessing service with trained personnel can eliminate error,” said Frieze.

Decentralization of surgical services

Tom Redding, Senior Director, St. Onge Company, notes how health systems are under continued pressure to reassess their surgical strategies to determine the appropriate balance between decentralization and regionalization of surgical services.

“As the number of locations expand, the potential for inefficiencies and quality control will become more challenging for the health system,” said Redding. “The need to develop a reprocessing ‘center of excellence’ for the organization can be a critical enabler for growth of surgical services.”

“At St. Onge, we’ve had the opportunity to work with five health systems in the last year to assess and develop the centralization strategy for device and instrument reprocessing,” he added. “The shortage in staffing and the decentralization of surgical services is forcing the health system to not get stuck in the ‘build it again’ mode for reprocessing services. We are seeing significant pressure on existing reprocessing infrastructure and the inability to expand their footprint to meets the needs of the facility and organization.”

Equipment and process duplication

Crowe comments on how a centralized approach to reprocessing enables a health system to optimize resources – from staff training to instrumentation.

“Most health systems initially begin to evaluate a consolidated reprocessing operation as simply a cost and space saving measure. And, while the evaluation of the business case will often prove positive, the true value proposition for the health system is beyond any direct monetary benefits,” said Crowe. “A centralized facility provides the opportunity to centralize training for staff, to more easily share instruments across the health system, engage surgical services in standardization, and improve staff satisfaction and retention.”

Centralized reprocessing for offsite clinics has been the first step for many health systems, says Bryan Stuart, National Director of Consulting, Aesculap, in their efforts to maximize resources.

“Let’s say you had an anchor hospital with 40 clinics, 25 of them offsite, where each clinic was performing its own reprocessing. Processes and quality could be all over the board from one clinic to the next,” said Stuart. “Therefore, the first big wave of standardization that I saw nationally was health systems centralizing reprocessing for clinics within one CS/SPD site. That move began raising challenges with regards to offsite reprocessing, including inadequate device/instrument inventories to support this model.”

While Frieze personally feels each facility needs to control their processes and devices, and ensure that the patient comes first, she notes how offsite reprocessing might be a good option for ambulatory surgery centers (ASC), stating:

“ASCs could send a majority of their devices to the main facility daily to ensure that the full process of cleaning and sterilization occur with the same level of care as the hospital. Given the expense of low temperature sterilization, if each facility was to acquire this type of sterilizer it would be very costly to do so. If moisture and temperature sensitive devices are not used daily or several times a day, there is little need to invest in a low temp sterilizer for example. On the other hand, an endoscopy suite would be justified to make such a purchase.”

Space constraints

“From the central sterile (CS) or sterile processing department (SPD) perspective, there are facilities that are large enough to perform onsite services easily. However, there are also facilities that have outgrown their onsite capabilities due to the addition of more surgical physicians or more surgical procedures,” said Hassan Bilal, CRCST, CST Consultant, Educator, Author at Medline. “This can overwhelm their CS/SPD leading to the need for a change.”

“Some large hospital groups have a different perspective,” he added. “Due to their size and footprint, many have decided that offsite works better for the group and has developed one centralized location offsite to perform all the SPD duties for all the hospitals in the group.”

According to Stuart, many health systems that have begun “right sizing” inventory to match volume suddenly realize they do not have the space to reprocess added items.

“Health systems began realizing that although they might have adequate space to store additional sterile inventory, they lacked the equipment and space to support the workflows required to reprocess this additional instrumentation,” he said. “For most CS/SPDs, it is very challenging to acquire additional space unless it is new construction that takes into account today’s sterile processing demands.”

Disruptions to CS/SPD operations

Sometimes the decision to move reprocessing offsite isn’t a choice but a necessity.

“In some cases, facilities may have internal problems such as steam quality, which will shut down their department and drive the need for portable SPD units which can operate outside of the external department,” said Bilal.

In the province of Ontario and around Canada, Louis Konstant, Clinical Manager, Medical Device Reprocessing Department, Sick Kids, the Hospital for Sick Children, has seen cases where a hospital’s aging CS/SPD infrastructure contributes to accreditation standards not being met that may result in consideration of offsite, third-party reprocessing.

“Most hospitals in the Toronto area are standalone in terms of their medical device reprocessing and while third party reprocessors have served few larger hospitals in the recent past, they currently serve mostly as a contingency,” said Konstant. “Over the past few years, I have seen some healthcare organizations with systemic issues that could not reprocess onsite, so they have turned to a third party in the short run until the problems are resolved.”

Konstant says while CS/SPD departments viewed third party reprocessors with caution in the past, this is changing. He states:

“In general, we are creatures of habit. Moving reprocessing offsite into the hands of a third party is a major change for an organization so many felt it was threatening. They saw risk in individuals outside of the hospital reprocessing items, perhaps not up to their internal quality standards and the devices not being available when needed. As well, the long-term viability of the offsite service and the difficulty of returning back to an onsite model are a concern. They also felt these parties threatened sterile processing jobs inside hospitals.

“Attitudes are shifting as more organizations have shown successful partnerships with third party reprocessors,” Konstant added. “For many they are now seen as a back-up and serving smaller centers that don’t have the resources to set up something onsite or have had some accreditation flags and don’t want to assume the risk of onsite reprocessing.”

Factors that improve offsite success

While offsite reprocessing can have its advantages, including process standardization, there are a variety of factors that a health system must take into consideration for this model to be successful.

Proactive planning

Redding cautions health systems to “look before they leap” into a change in reprocessing strategy and/or location, stating:

“It is imperative for health systems to conduct a detailed assessment of reprocessing operations to identify gaps, blind spots and risks for the organization. Too many times, we see health systems that can financially justify to centralize reprocessing services but lack the ability to operate like a system. Some of the factors to consider are: surgical volumes and geographic footprint, clinical expectations, organizational commitment and risk tolerance, instrument and tray inventory strategy, transportation infrastructure, workforce readiness, systems and work practices.”

Frieze notes the importance of stakeholder engagement: “For facilities considering offsite processing, they should do a thorough risk analysis, and involve facilities management, SPD and infection prevention.”

Stuart sees health systems today “taking a pause” and looking beyond their immediate CS/SPD needs to how they will address reprocessing for the next eight-to-10 years. In his experience, these are the health systems that have successfully centralized their sterile processing onsite or offsite.

“A big struggle in healthcare today is knowing how to forecast,” said Stuart. “I have been in six new CS/SPD constructions and recent renovations that were five-year plans, and they are already struggling year two. I challenge health systems to expand their horizons to the 12–15-year mark and plan accordingly.”

“This isn’t something where you wake up one morning and decide to centralize,” Stuart added. “It requires six-to-12 months of preparation and due diligence about the process to determine if it is the right solution for your facility.”

As Crowe notes, a move to centralization provides the opportunity for the health system to evaluate and improve its CS/SPD processes and practices, including relationships between the CS/SPD department and clinical teams.

“The best piece of advice would be to really evaluate where your health system is before jumping into a centralization decision,” she said. “Centralizing reprocessing can provide great benefits to the organization, but it can also work as an amplifier for any existing problems in your sterile processing department or in the relationship between the sterile processing department and surgical services without a good understanding of the preexisting realties of the departments and considered plans to make improvements as part of implementing the centralization.”

Staffing models

The switch from individual hospital CS/SPD departments to centralized, offsite reprocessing operations will likely require the health system to reconsider traditional staffing models.

“Facilities are forced to do more with less, which can translate to centralizing processes to decrease the number of staff needed,” said Elammari. “However, caution is necessary for these scenarios because this can cause burnout for the staff, which often translates to disengagement and quality issues.”

Stuart says that, in his opinion, the “three-shift model” doesn’t always meet the needs of today’s onsite or offsite, centralized environment:

“I am starting to see more hospitals adopt stagger shift, but I am surprised at how many still have that three-shift model. There are benefits to looking at sterile processing from more of a manufacturing perspective and incorporating some of the tried-and-true technologies from manufacturing into the space. It’s time to do that type of integration.”

“Healthcare organizations are focused on patient care and the delivery of healthcare services, and are typically not experts in manufacturing,” he added. “The shift to offsite is a departure from anything they have been exposed to in the past, and it’s a huge investment from a financial perspective. Changes in the ability and speed to provide OR support should also be considered. Don’t be afraid to seek assistance from people who have knowledge in the space.”

Inventory management and storage

Because instruments and devices are being processed offsite, added time must be factored for transport to and from the facilities. In most cases, the health system must invest in additional inventory to help ensure clinicians have items when they need them.

David Phillips​, Marketing Manager, Hänel Storage Systems, says health systems must also consider the risk for error when an offsite center delivers instruments for scheduled cases, and ways to minimize the risk, stating:

“Without proper inventory management, there is the risk of life-threatening errors, with the wrong surgical supplies potentially delivered to a hospital. If even one small item is incorrect, then the SPD is no longer located elsewhere in the same hospital but possibly across town. This problem can easily be solved by keeping a small supply of commonly used supplies and instruments onsite at all times, in case of mistakes.”

When centralizing sterile processing offsite, Phillips says it becomes even more critical to efficiently retrieve supplies and required instruments trays according to the surgical schedule, so an entire day’s worth of containers is transported to the corresponding hospital. At the end of the day, these materials are then returned for reprocessing. Phillips points to the Hänel Rotomat automated sterile storage carousel as an excellent solution. The Rotomat protects against dust, dirt and potential contamination, and tracks supplies as they are stored and retrieved, with the extra benefit of saving valuable floor space.

Trusted transport

When reprocessing is moved offsite, a major consideration is how to transport instruments and devices efficiently and safely between facilities. Hendee’s CS/SPD department services multiple offsite locations, which has reduced practice variations greatly, but it has also created challenges in the form of transportation and delayed processing.

“We did not think about the transporter,” said Hendee. “We considered the bins for transport, the vehicles, the DOT regulations etc. However, we did not think the transporter themselves would need any special training. That was until they picked up a load of sterile items and badly mishandled them. When the load arrived at the clinic, there were sterile items placed inside the biohazard transport container and a rigid container had been held by one handle, causing the instruments inside to poke holes in the filter. Once we explained the process fully and what was expected these issues went away but the fact that we missed this needed piece of training could have caused serious issues.”

As Stuart points out, health systems that have centralized supply distribution in place typically have an easier time transitioning to offsite reprocessing, stating:

“Among health systems seriously considering a centralized, offsite model, about 70% have self-distribution in place. They already have trucks going to hospitals each day and courier services to serve clinics. That’s an important factor to consider - for these organizations, transportation is not a new cost when they shift to offsite reprocessing.”

When onsite makes sense

While there is a growing trend toward centralized and offsite reprocessing of reusable devices and instruments, there are some cases where onsite reprocessing is best for clinical care effectiveness, efficiency and safety.

“There are numerous factors that can influence where reprocessing is performed. Infection prevention, regulatory guidance, turnaround time, budgets, process efficiency, inventory management, and sustainability initiatives can all play a part,” said Richard Radford, CEO, Cenorin.

Frieze says healthcare facilities should consider maintaining even a small instrument processing department to handle their immediate needs and variations in schedule, adding:

“And always ensure that there is at least a supply of critical instruments and devices onsite, as well as trained, certified personnel to do the specific task. If all sets are processed offsite with limited resources at the individual facility, then there may be more opportunity for operating room (OR) delays for missing sets, those delayed in transport, and even more impetus to use IUSS sterilization instead of terminal processes.”

For some devices today, reprocessing is performed not in CS/SPD departments but in other hospital areas, such as endoscopy labs, sleep labs and respiratory care departments, explains Radford. He adds how many of the reusable semi-critical medical devices processed in these areas are plastic and require a low-temperature high-level disinfection (HLD) process that is validated for such devices, such as a washer-pasteurizer.

“To balance factors, such as meeting current reprocessing recommendations (ST91:2021 updated March 2022, e.g.), managing single-use inventory, managing costs, and maximizing sustainable healthcare practices, healthcare providers need to consider switching to reusable plastics where appropriate and establishing a dedicated HLD protocol for these devices.”

One device category where onsite processing offers significant advantages is ultrasound probes, according to Ken Shaw, President of Americas, Nanosonics. He notes how ultrasound is used in almost every healthcare department today for a range of invasive and noninvasive procedures.

“Given the high volume of ultrasound probes used in a healthcare facility each day, offsite reprocessing is not practical,” said Shaw. “Instead, probes are usually reprocessed onsite, often in a central sterile service department or at point of care (POC). Technology has made HLD of ultrasound probes at POC possible, offering an option that integrates better into existing workflows than centralized processing.”

Shaw says POC reprocessing can have significant time and cost savings for facilities across multiple areas:

  • Inventory: It minimizes the number of probes in circulation and the turnaround time for reprocessing, meaning facilities do not need to expand probe inventories
  • Logistics: Probe transportation is not required, saving time and eliminating the risk of cross-contamination from dirty transportation containers
  • Staffing: Staff members that carry out ultrasound exams are also able to perform reprocessing, which negates the need for separate reprocessing staff
  • Supplies: POC technologies do not require staff to wear extensive personal protective equipment (PPE) apart from gloves located in the examination room

Radford says a HLD reprocessing program for procedural areas should provide documentation down to the individual device, reprocess devices with a validated, sustainable, and materially compatible HLD technology, and facilitate thorough drying to a clinically dry state that helps assure safe reuse.

“Such a dedicated program can be established in any location and can help a system achieve a compliant and sustainable infection prevention protocol while also saving the healthcare system money,” he added.

For those healthcare facilities considering a move toward POC reprocessing, Shaw says they need to ensure they have a method specifically designed for this approach. This means HLD technology that is:

  • A closed system that mitigates risk of exposure to toxic vapors
  • Designed for chemical safety and doesn’t require mixing or dilution of chemicals
  • Able to be integrated with existing point of care workflows 

Original photo courtesy Bayhealth SPD, HPN's 2021 SPD of the Year, with affects added by generative AI.
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