Sterile Processing: The Dangerous Trade-Off Hospitals Can’t Afford to Ignore 

The typical U.S. hospital’s sterile processing department (SPD) is under a lot of pressure. 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 use a growing number of reusable devices.

Unfortunately, due to internal pressure, there is often a trade-off between patient safety (proper cleaning and sterilization handling) and efficiency. When there is a need 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 the prescribed number of uses might be skipped. 

These shortcuts can harm patient and are ultimately unsustainable for hospitals. 

Why SPDs Are Forced to Take Shortcuts 

Despite the commitment and professionalism of SPD staff, efficiency tends to trump patient safety when the demand for quick turnarounds becomes too high. The problem is even greater in the rapidly growing ambulatory surgery setting, where facilities don’t have the space, capacity, or staff to meet the large and growing demand for cleaning and sterilization.

Reusable devices are equipped with a set of instructions that directs the facility how to clean and sterilize them for another use; disposable devices do not come with such instructions and are supposed to be discarded after a single use. This distinction is useful and important: 

·       Devices that are labeled “reusable” are devices that can be cleaned easily and do not lose functionality after one use. It is important to note that reusable devices also come with instructions for use (IFUs) that limit reusability to a certain number of uses, after which the manufacturer cannot determine that reuse is safe or effective. 

·       Devices that are labeled “single-use” are devices that cannot safely be reused, except with the help of a third-party reprocessor with an FDA clearance to reprocesss the device. That’s because the devices cannot be safely cleaned or because their functionality is compromised after a single use. 

Staffing has been a major problem in hospitals since the pandemic, and the SPD is often the place where staffing shortages are most dire. As a result, SPDs—which were already very busy—are under tremendous pressure to conduct the reprocessing of reusable devices in an efficient and economical manner; such objectives can easily clash with the formal demands for safe and effective reprocessing. 

EP Cables as a Case in Point 

When processes are standardized to increase efficiency, it is easy to skip steps or fail to accurately identify devices and treat them according to device specific instructions. Electrophysiology (EP) cables provide a great example: There are literally hundreds of different cables connecting EP devices to capital equipment—and they all pretty much look alike. In fact, in some cases, the brand and model is not even clearly displayed on the cable. 

Some IFUs even differ between cables in the same “family.” For example, Carto ablation cables have varied sterilization requirements for autoclaving. There are Carto cables where the IFU calls for resistance testing, while others don’t. Different cable IFUs call for the use of different cleaning agents. Thus, SPD departments need to manage four or five different cleaning processes, conduct testing (without testing, there is no way to know if the connector is dry and the cable is functional), have different sterilization processes, and accurately identify literally hundreds of different cables to follow IFU instructions. 

Additionally, EP cables are very delicate. Even wrapping a cable too tight can cause the cable to malfunction. Further, some EP cables are designated “single-use” by the manufacturer, while reusable cables can be reused anywhere from five times to 50 times; it varies from cable to cable. For example, the Boston Scientific PSA cables can be used 50 times, Carto diagnostic cables can be used 20 times, and some Boston Scientific cables can be used 15 times.

SPD technicians have to know all the different cables, accurately identify them, clean them according to their specific instructions, and count how many times they have been used. This is incredibly challenging. As a result, it is tempting to simply reprocess an EP cable as many times as it can take before it “breaks.” In fact, this might be the only practical way of handling the cables in a busy SPD. However, this can create disruption to routines before or during procedures and cause significant delays while another cable is located.

Adding to the SPD cable reprocessing challenge is the fact that EO sterilization is increasingly rare. The alternative—autoclaving—opens the process to a lot more failures due to melting connectors, moisture, and pin corrosion.

Something Has to Give

The reality is that hospital operations are typically not designed to have their SPD treat each device per its IFU. SPD departments typically treat all reusable devices the same way: They get wiped down, and they get cooked in the sterilization unit. Consequently, how many times the device has been reused is neither recorded nor respected. Devices are used until they fail. Likewise, devices are not tested prior to reuse to determine if they will fail with the patient on the table, raising patient safety concerns as well as operational flags. Additionally, hospitals are increasingly recognizing that SPD’s limitations can mean Joint Commission requirements are compromised if reusable devices are reprocessed on-site.

Something has to give. Today’s SPDs are, by virtue of the expectations being put on them, being asked to choose between device safety and operational efficiency. In many cases, it’s not possible for the two to co-exist within the current system. 

Neither staff burn-out nor heightened infection risks are acceptable or sustainable options. Fundamental systemic change is necessary. Internally, it might mean fundamental changes in terms of resources, budgets, and expectations for SPDs. Beyond that, it also might involve increasingly relying on specialized third-party reprocessors with specialized knowledge of cleaning and device reuse. 

Such change is not easy. But failing to change will be far harder—for everyone.