Sterile Processing – Something’s Gotta Give
Unfortunately, there is a trade-off between patient safety (proper cleaning and sterilization handling) and efficiency. 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 tends to beat patient safety.
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 “single-use” are devices that cannot safely be re-used (except by a third-party reprocessor with an FDA clearance to reprocesss the device), because the devices cannot be safely cleaned or because their functionality is compromised after a single use. Devices that are labeled “re-usable” are devices that can be cleaned easily and do not lose functionality after one use. It is important to note that re-usable 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. The categorization is very sound.
Staffing has been a major problem in hospitals since the pandemic, and the SPD is often the place where staffing shortages are most dire. So SPDs, that were already very busy, are under tremendous pressure to conduct the reprocessing of reusable devices in an efficient and economical manner, and such objectives can easily clash with the formal demands for safe and effective reprocessing. 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 us with 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/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 – and 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. SPD departments need to manage 4 or 5 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 5 times, 15 times, 25 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, while some Boston Scientific cables can be used 15 times.
...some EP cables are designated “single-use” by the manufacturer, while reusable cables can be reused 5 times, 15 times, 25 times...
SPD technicians literally 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. Instead, it is tempting to simply reprocess an EP cable as many times as it can before it “breaks”; in fact, this may 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.
It further adds to the SPD cable reprocessing challenge that EO sterilization is increasingly difficult to come by and the alternative – autoclaving – opens up for a lot more failures in terms of melting connectors, moisture, and pin corrosion.
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 re-usable 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 responded to: Devices are used until they fail. And 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.
...hospital operations are typically not designed to have their SPD treat each device per its IFU.
Something has to give in this constant struggle to have operational efficiency while ensuring devices are safe. Neither staff burn-out nor infection risk are sustainable options. Fundamental, system change is necessary, and this may involve increasingly relying on specialized third-party reprocessors with specialized knowledge of cleaning and device reuse.