10 Key Considerations in Instrument Reprocessing Site Selection

“The demand for surgical procedures is on the rise and continues to grow, putting pressure on sterile processing departments that are not equipped to handle the increased volume,” said Matthew Thell, CHL, CRCST, program manager, High-level Disinfection and Sterilization Practice, M Health Fairview. “This is a common challenge faced by many healthcare facilities, especially considering the financial constraints faced within the healthcare industry.”

“The Sterile Processing Department (SPD) is under a lot of pressure,” said Lars Thording, VP of Marketing and Public Affairs at Innovative Health. “This is where the hospital typically performs its reprocessing of reusable devices like cables, accessories, and many OR instruments. The SPD is tasked with ensuring that devices are reprocessed to the device’s specifications and returned to the many different departments of the hospital that utilize reusable devices.”

“As hospitals struggle with limited space and resources, navigating this issue becomes increasingly complex,” Thell added. “Centralized models have been trending over the years and have proven to be effective in other industries to reduce waste.”

Whether it is driven by the need to consolidate reprocessing in response to low staffing levels and/or cost restraints, expand SP department capacity to meet growing surgical volume, improve the effectiveness and efficiency of SP processes, or another factor, some healthcare organizations are centralizing SP to a single hospital, an offsite reprocessing location, or outsourcing this function to a third party. 

HPN reached out to SP professionals and providers of SP department products, equipment, and services to ask, “What factors must a healthcare organization take into consideration when considering a change in their reprocessing strategy/location?”

This article summarizes their responses (in no specific order of criticality).

1. Stakeholders

“When considering a change in your sterile processing operations, it is crucial to engage the appropriate stakeholders to aid in the decision-making process,” said Thell. “Seeking input from vendors or an analysis performed with a sterile processing consultant can provide invaluable expertise in evaluating your current landscape and determining the viability of an offsite processing model.”

According to Thell, physician buy-in is important. He stated:

“The idea of instrument sets having to travel from one location to their destination can make people feel uneasy about their cases. Helping physicians understand that quality monitoring will be the same offsite as it would be onsite is essential to build trust. Nobody wants to have their case canceled or delayed due to instruments not arriving on time or arriving with quality defects.”

While on the surface it seems logical that those individuals performing instrument and device reprocessing – the organization’s SP professionals – would take a leading role in any type of change, Randalyn Harreld, national clinical education manager, Belimed, said this is not always the case, stating:

“Because health systems and hospitals come to us with ideas and lean on us as experts, we hear a broad range of proposed reprocessing strategies. Often the idea for change in the SP department comes from someone who is not operational, such as a VP or surgeon. And it makes sense that these initiatives would originate from physicians because they want to grow, maybe take on a new specialty, which means additional capacity in SP. But they must have an SP expert at the table.”

Harreld recommends proposed changes in reprocessing should involve other stakeholders as well, including representatives from facilities management to provide expertise on infrastructure, along with those from supply chain, infection control, environmental services (EVS), and risk or quality management.

2. Staffing

As a subject matter expert in centralized SP offsite reprocessing concepts, Kimberly Jones, managing partner, KJ Staffing Solutions, which specializes in staffing and workflow optimization, education and project management, stresses the need to put people at the top of the consideration list. 

“Staffing is tricky for administrators to understand, because many incorrectly assume that the offsite reprocessing center (ORC) can be staffed using a ‘lift and shift’ model with existing sterile processing full-time employees (FTE),” said Jones. “Many organizations base FTE allocation for sterile processing departments on number of surgical cases performed. We know in sterile processing that volume does not equal volume. The number of trays allocated for a complex orthopedic case varies greatly to the number of instrument sets needed to perform a basic general surgery case.”

“When the organization grows in surgical volume in a complex instrument heavy service line, this is almost never translated to the need to increase staffing for sterile processing,” she added. “When preparing to open an ORC, these fluctuations in volume as they relate to the long-term growth plan of the organization need to be realized.” 

Throughout her career, Jones has toured as well as assisted in the development of ORCs across the country. Jones shared an example of one healthcare organization that allocated only 8 net new SP FTEs to open a new offsite reprocessing center. 

“While on paper it appeared the surgical set volume would just relocate to the ORC as would the staff, this allocation proved to be inadequate,” Jones explained. “Unfortunately, the assumption in this case is all too common. Many organizations planning to operationalize an ORC assume among administrators that the organization can move 60%-80% of their SP staff to the offsite location, but that rarely happens right out of the gate. Especially in the beginning, the organization will need to maintain SP operations onsite as well to manage fluctuations in the surgery schedule, preference card inaccuracies, and reprocessing of trays that stay in the home locations due to low quantities of inventory.” 

As Harreld noted, not all SP professionals from the current reprocessing site will have the desire or ability to move to an offsite location. 

“Logistically, you might think, ‘we're just going to build this new location and all our people will move there.’ I worked for an organization that believed this would be the case and we lost 16 staff members with the offsite move. Some were reliant on public transit and there was no way for them to get to the offsite location, which was 30 minutes outside the city.”

“Additionally, an offsite location might require a completely different work schedule, perhaps molding two shifts into six shifts to accommodate a new layout and workflows,” she added. “This might not work for your current team members. I don’t think managers always put a lot of thought into staff accommodations during the planning stage.”

3. OR/SPD communication

While there are barriers to successfully launching an offsite reprocessing center, according to Jones, a move to offsite reprocessing forces constant communication between the SP and operating room (OR) teams because there is no longer the convenience of residing in the same building. 

“Increasing the distance between SP and the OR forces accountability of both teams and opens lines of communication, specifically related to physician preference card updates and surgical scheduling,” said Jones. “The OR must inform the ORC of any preference card changes prior to the instrument sets being prepared and shipped proactively. Having a solid cut off time in place for add on cases and room changes on the surgery schedule will enable SP to be successful in meeting their goal of timely delivery of instrumentation. Without a strict cut off time, SP staff are working at a disadvantage that is out of their control.” 

“Standardization of a singular instrument tracking system as well as a standard naming convention for instruments and devices is also crucial when there are multiple surgery locations that the offsite SP team supports,” she added.

4. Inventory

Sufficient instrument and device inventory was cited by many of those interviewed as a key consideration when planning an offsite move, including Hannah Schroeder, BSHA, CRCST, CHL, CIS, CER, clinical education specialist, Pure Processing, who stated:

“Inventory is a substantial component of success when it comes to centralizing reprocessing practices and updating strategies. Take the time to analyze and understand the appropriate inventory pars needed to not only meet usage rates, but also reprocessing and maintenance times, transportation, and available real estate for storage. All are crucial to the success of both the end user and the sterile processing department.”

Speaking to specific inventory issues related to reprocessing for clinics, Amy DeGraw, BSHA, CRCST, CHL, sterile processing education coordinator, Ambulatory, Froedtert Health, commented:

“Often instruments are not well maintained in the clinic setting or there is an abundance of single-use instruments that have been placed into rotation. These issues should be addressed prior to transitioning offsite, and clinics should have a sufficient instrument inventory to facilitate patient care while instruments are reprocessed.”

“Also, understanding how increased volumes will affect your hospital SPD may lead you to decide to open a separate ambulatory reprocessing location to offset the workload,” she added.

5. Budget

“Overall conversations we’re having with customers regarding sterilization processing are how to drive better cost efficiencies,” said Sean O’Hara VP, Distribution & Customer Operations, Zimmer Biomet. “Several pricing factors that must be evaluated are advancements in facility scalability, reprocessing technology requiring additional compliance updates, and increasing equipment costs.”

As Thell points out, centralized sterile processing does not always remove the need for site-based operations, and sometimes a hybrid option is optimal to balance the workload. 

“Many situations arise where having access to a sterile processing department on-site is needed, whether that is immediate use steam sterilization or reprocessing of complex instrumentation,” he stated.

A multi-site reprocessing approach adds costs, which Harreld said sometimes flies under the radar during offsite planning:

“If you plan to maintain some level of reprocessing in your current SPD space -- for example, reprocessing of loaner trays or endoscopes -- there are additional costs associated with maintaining operations in multiple sites. Supply expenses will increase as the locations will require items such as blue wrap and biologics.”

“To budget for what will be needed, compile a list of everything, including consumables,” she added. “Because you might get a big pool of funds to buy capital equipment, but there are so many additional costs to consider.”

6. Equipment

Terry Hahn, field operations manager, Zimmer Biomet, spoke to considerations around integrating new and old equipment:

“When considering whether you should keep sterile processing onsite that services one or multiple facilities, understand the overall compatibility of the current equipment with new sterilizers because it may be necessary to acquire new equipment. Consider if there is enough space to house the sterilizers plus the increased number of instrument trays. Lastly, can the utilities support the expansion?”

“When purchasing all new equipment, consider consolidating your purchase with a single vendor capable of meeting your needs,” said Jones. “This can present substantial contract savings opportunities, such as bulk pricing, and the ability to negotiate more favorable service contract terms.”

When outfitting an old SPD space with new equipment, Jones cautions stakeholders to assess and budget for any potential roadblocks. 

“One challenge in older facilities when installing new equipment is outdated plumbing,” she explained. “It’s like doing home repair. Once you get the equipment in there and try to hook it up, you may find your facility needs $15k worth of plumbing upgrades to accommodate it. At this point, organizations begin to ask the questions around feasibility and sustainability of maintaining several older sites or looking at consolidating to an ORC.”

7. Risk mitigation and quality control

“Initiate your first steps by engaging with key stakeholders for input, determining a budget, and conducting a risk assessment,” said Hahn. “Within the risk assessment, note the current processes/protocols, equipment, staffing, and the overall environment.”

Schroeder emphasized the need for quality control management when planning a reprocessing site, noting the importance of specialized and governed processes for success. She offered the examples of cleaning verification for medical devices and added visual inspection using borescopes.

“Having specialized teams and consolidated work allows patient-facing staff to focus on direct care, while putting reprocessing back into the hands of trained technicians, where we can centralize the time requirements and resources to achieve compliance,” she stated.

“Regardless of where reprocessing is completed, the same standards should be met to ensure patients are receiving the same quality of care,” said DeGraw. “In terms of ambulatory clinics, there is a general lack of education and oversight leading to gaps and failures in the process that drives the decision to change where reprocessing is performed.”

“The decision to centralize ambulatory clinic reprocessing should include a risk assessment similar to those conducted in a hospital-based SPD and should look at items such as workflow, space requirements, adherence to IFUs, and competencies,” DeGraw continued. “There should also be a thorough assessment of the instrument quality and volume.”

8. Location

Tracy B. Raymond, BS, MS, CRCST, CIS, CER, CHL, manager of Training and Education, Vested Medical, spoke to some of the reasons as to why facilities may look to move instrument processing off-site:

“A facility might need to expand surgical suites or revenue producing services and the facility is landlocked; their SPD and equipment is old, and it is too costly to renovate or add space, again the facility and/or department is landlocked with nowhere to expand to; they are expanding and building ASCs and a centralized SPD can support many locations.”

“You'll want to understand the local and national regulatory requirements,” said Melanie Towery Prevost, associate director marketing, ASC Solutions, Zimmer Biomet. “Is the location centrally positioned for reliable logistics? If the SPD is being built within an existing infrastructure, is there enough capacity and capability to handle reprocessing requirements efficiently? Lastly, consider water lines, supplies, staffing, and regular training to maintain the highest integrity and sterility of instruments.”

When the SP department is in the same building as the OR, while last minute requests for surgical instruments can be tricky in terms of turnaround, the transport of trays between floors is manageable. But when the reprocessing takes places miles away from the procedural site, even scheduled tray requests can be complicated by the distance. 

That’s why Harreld stresses the importance of location when it comes to the selection of an offsite reprocessing site, commenting on potential challenges that must be considered and overcome to keep surgical schedules on track.

“Geographically, think about traffic patterns between the site of reprocessing and the facilities served,” she stated. “If you are planning to have trucks on the road transporting trays at 7:30 a.m. and the route to the care sites encompasses five elementary schools, you will have problems delivering on time.”

9. Logistics and transportation

“Another factor to consider when transitioning to offsite reprocessing is how instruments will be transported,” said DeGraw. “Depending on the number of locations and the instrument volume, transportation needs may strain your current services.”

Raymond spoke to the considerations on how trays are transported - rigid containers or blue wrap, case carts, racks, and instrument tracking systems (ITS), stating:

“Best practices in this area include the use of sealed case carts and rigid containers for transportation as sealed case carts do not allow anything to go into or out of the cart. Blue wrap is prone to holes, therefore rigid containers is the preferred method for transportation. Use of temperature and humidity-controlled vehicles for transportation because outside environmental conditions would potentially render the tray unsterile and risk quality patient care.”

Harreld noted how “moving things from point A to point B opens up a new can of worms for problems.” She explained that when she worked for a healthcare organization that moved reprocessing offsite, there was the assumption that the truck drivers transporting dirty instruments to the offsite and clean instruments to the care sites would use mobile scanners to document this movement in the organization’s instrument tracking system (ITS). But Harreld said they missed the mark on education and training, stating:

“Everybody's got some form of ITS, right? But does that really work in the truck? We implemented mobile device scanners and assumed our drivers would do the scanning, but they were couriers, not experts in instrument tracking. If you plan to leverage transport professionals in the tracking process, you must educate and train them.”

Then there are the federal and state requirements related to transporting dirty instrumentation, which Schroeder further commented on:

“Whether within the same building or across town, departments will want to have sound policies and procedures on how biohazardous and sterile medical devices are being transported that will encourage safety, compliance and integrity.” 

Jones commented on staffing challenges with regards to instrument transport:

“Moving reprocessing offsite begs the question, ‘do you need additional FTEs for transport to load trays onto the case carts and onto the trucks, as well as remove the case carts off the trucks at the care site?’ That raises the question, ‘where do you place the responsibility for moving carts? Do you need to increase staff hours at the offsite location or at the delivery sites?’”

In Jones’ experience, some healthcare organizations create and employ new job codes at the care sites to receive trays from the offsite reprocessing center and station them. 

“Throughout the day, if there are any additions or cancellations in the surgery schedule, this individual is accountable to communicate changes to someone from SP, to keep the lines of communication open, and provide efficiency for the clinical teams in having the proactive communication with the ORC,” she explained.

10. Third party reprocessing

Acknowledging how many SP departments are understaffed and under immense pressure to be efficient, Thording said some hospital leaders are turning to third parties for reprocessing assistance. 

“Unfortunately, there is a trade-off between patient safety (proper cleaning and sterilization handling) and efficiency,” he commented. “When the pressure is on to run hundreds of instruments through sterilization, some cleaning procedures may be cut short, sterilization parameters may be slightly altered to allow for more instruments to go in fewer loads, and the counting of prescribed number of uses may be skipped. Despite the commitment and professionalism of SPD staff, in the SPD, unfortunately, efficiency always beats patient safety.”

“This has led some hospital executives to move the reprocessing of particularly delicate and high-risk devices from the SPD to third-party reprocessors with the appropriate standards and procedures to ensure patient safety and operational quality,” he added.

Raymond says facilities may look to private third parties offsite to take some of the burden off their small or short staffed SPDs especially for smaller ASCs.

“More and more surgeries are being moved over to ASCs and they do not have the space, capacity, or the staffing to meet the large number of trays, especially loaner trays for total joints or spine cases,” she explained. 

Thording noted how single-use device reprocessors operate under tight U.S. Food and Drug Administration (FDA) supervision and handle devices that are more complex than those typically reprocessed in the SPD.

Case in point: Necessity drives offsite reprocessing decision

Health systems and hospitals turn to offsite reprocessing for instruments and devices for a variety of reasons. Sterile processing subject matter expert Sharon Greene Golden, BA, CRCST, CER, SME, FCS, president & CEO, Central Service Patient Advocate, shared her story of an offsite move driven by necessity.

As Greene Golden described, the healthcare organization with one large hospital had merged with a smaller hospital, which did not have the needed or correct equipment to care for any instruments above small trays. 

While the sterile processing (SP) department team in the smaller hospital was reprocessing instrument trays for total joint procedures, they had only two small immediate use steam sterilization (IUSS) sterilizers, one sink in a small room, no ultrasonic machine, no washer decontaminator, and a humidifier blowing all day. 

“Needless to say, we had to make drastic immediate changes in the processing of major total joint instruments right away,” Greene Golden explained. “They were able to get a washer decontaminator, but the actual processing of instruments had to be addressed as a patient safety issue.”

According to Greene Golden, the healthcare organization assembled a multi-task team comprised of SP, infection control, and administrators. They decided the larger hospital would become an offsite processing department for the smaller one. 

“We had to set up delivery of the instruments to our department where we processed them as if they were for our patients,” said Greene Golden. “Once cooled, we would package the trays in dust covers and place them in containers. We had to set up a specific truck for delivery of the clean, processed instruments to the smaller hospital for patient use.”

When asked for her advice to healthcare organizations considering a change in reprocessing location, Greene Golden stated:

“It is imperative that any hospital or surgery center contemplating an offsite reprocessing program do their fiduciary duty to their patients. You must study standards, regulations and the actual process while including all players at the table. Know what is needed and why, while all the time knowing your decisions can impact a patient’s life. What we do matters every day and choices have consequences.”

Looking ahead

As Thell pointed out, SP departments designed and built years or decades ago often cannot accommodate the growing demand for reprocessing reusable medical devices. He believes this squeeze for space is one factor that will continue to drive the move to off-site reprocessing. 

“I foresee more healthcare systems exploring this model in the future, but it must have a return on investment,” said Thell. “Offsite is not a one-size-fits-all solution. Deciding what will be processed onsite and offsite will be critical to the success of implementing an offsite reprocessing model.”