Thinking of Buying... Automated Endoscope Reprocessors

One of the many secondary results of the coronavirus pandemic has been a reemphasis on the importance of cleaning and disinfection at all levels of health care. For the medical device reprocessing industry in particular, the increase in attention and understanding around this critical process has been welcomed. There are few clearer examples of the challenges of taking contaminated devices and effectively reprocessing them to be safe again for patient use than that of a dirty endoscope. Thankfully, automated endoscope reprocessors (AERs) make that dirty job a lot easier.

AERs take the extremely complex manual cleaning and disinfection process for flexible endoscopes — a process with potentially more than 100 steps — and standardize it into a repeatable process that can be measured, documented and implemented in facilities of all sizes. While there's growing discussion within the industry around single-use flexible endoscopes and movement toward terminal sterilization of these scopes via ethylene oxide and hydrogen peroxide, AERs remain the predominant market leader in scope reprocessing.

Here are a few factors to keep in mind when evaluating the features and capabilities of the latest AER options:

• Usability. No matter how high-tech the AER may be, if the frontline users of the device can't easily figure out how the unit should properly function, the manufacturer's design engineers have missed the mark. The concept of user experience definitely comes into play here. A well-designed AER should visually cue users on how it's loaded, unloaded, started, tested and maintained. Yes, one of the primary values of an AER is the automation of manual processes, but there are still manual steps involved in using the devices. Manufacturers should consider the possibility of human error when designing safety functions into their devices.
• Well-written IFUs. Are the AER's instructions for use (IFUs) written in a way that frontline personnel can easily understand and follow? To protect your process from adverse events related to the misuse of AERs, make sure you consider how clearly the device's IFUs are presented in their materials. This may seem like a peripheral recommendation, but AER manufacturers understand the potential implications of IFUs that are incomplete, incoherent or are otherwise unconnected with normal clinical workflows, and have been working closely with the FDA to address these challenges (osmag.net/8NJnoT). Remember, even if your staff receives new product training from technical specialists, they'll still likely need to reference an AER's IFU regularly.
• Reprocessing speed. This factor is crucial due to the expense of holding large inventories of flexible endoscopes and the lack of endoscope storage space available in many facilities, especially in the outpatient sector. Important considerations here include an AER's number of reprocessing basins, the number of scopes that can be processed in each basin, whether the basins can operate independently of one another and what additional cleaning/drying functions the AER has been validated to perform. Don't simply look for the fastest cycle time because that doesn't give you all the information you need. Remember that other factors contribute to the overall reprocessing timeline.
• Quality testing and documentation. One of the most common accreditation citations for endoscope reprocessing areas comes back to improper testing and documentation of the AER's minimum recommended concentration (MRC) of disinfectant. This is one of the few manual steps still common in utilizing an AER for endoscope reprocessing workflows. AERs that cue reprocessing techs to complete this testing step or enable automatic testing of the MRC prior to initiating a load provide a critical defense against user errors. Even if the MRC is tested and passes, these results still must be documented, so AERs that provide an automated or digital means to record these tests further protect against potential citations and patient safety risks.
• Chemical utilization. While not part of the AER unit itself, the disinfectants used in the device will play a major role in your total cost per cycle, impacting your return on investment in ways that may be less apparent than reprocessing speed or cycle time. Gain a thorough understanding of the type of disinfectant recommended by the AER manufacturer, find out whether alternative brands carry it and examine price trends associated with the chemical itself. All of this information can save you a lot of money in the long run. If you don't keep this factor in mind, an unanticipated impact to your budget could result.

AERs are amazing devices that have revolutionized and improved the manual cleaning and disinfection of flexible endoscopes. However, you must understand the substantive differences between the various models currently on the market. There's likely not a one-size-fits-all answer for your facility. When making a purchasing decision, be sure to assess the usability of the device and determine how much it automates the manual steps of scope reprocessing in order to maximize benefits of the investment. OSM

Advanced Sterilization Products (ASP)

Aeroflex

asp.com
888-783-7723

FYI: At 22 minutes, Aeroflex claims the fastest complete cycle time of any AER. An innovative function of this unit is its ability to automatically detect the presence of notoriously difficult-to-clean duodenoscopes and take extra precautions for them by running a special cycle to ensure proper high-level disinfection (HLD). Another interesting feature is its minimum recommended concentration (MRC) monitor, which automatically tests HLD MRC levels during every cycle, eliminating the need for staff to manually dip and subjectively evaluate color test strips — a time-consuming and error-prone process. ASP says this automation streamlines workflow, ensures MRC testing is never skipped, reduces staff exposure to chemicals and turns scope inventory around more quickly, allowing you to perform more procedures. A touchscreen user interface and an electronic records management system is included with the system. MRC status is automatically documented during every cycle; cycles are also monitored automatically and the system prints a report at completion of each cycle.

Cantel

Advantage Plus Pass-Thru

medivators.com
800-328-3340

FYI: This AER's pass-thru design physically separates clean and dirty reprocessing areas with a hard wall in the interest of reducing risk of human error and cross-contamination. The company touts the AER's ability to standardize a unidirectional workflow and improve reprocessing efficiency by supporting a consistent and repeatable high-level disinfecting procedure for endoscopes. Featuring hands-free operation and automatic cycle start for easier operation, the device provides computerized cycle documentation and reporting, and performs continuous leak testing during the cycle. Its large visual display conveys real-time cycle information, while its barcode scanner enables fast and accurate data entry to facilitate cycle management and endoscope traceability.

Custom Ultrasonics

System 83 Plus 2

customultrasonics.com
215-364-1477

FYI: Custom Ultrasonics positions this AER as a cost-effective alternative to the competition for a couple reasons. For one, users are free to source the brand of Ortho-Phthalaldehyde disinfectant validated for use in the AER and, in a nod to cost and time savings for high-volume facilities, the chemicals can be reused — according to the labeling — for up to 14 days. Another differentiator is its ability to simultaneously high-level disinfect (HLD) two endoscopes in its 19-inch chamber as opposed to just one. Custom Ultrasonics claims this both increases throughput and makes for a more efficient footprint for space-challenged facilities. To ensure all scope channels and internal surfaces are contacted during cleaning and HLD, the device adapts to each channel individually. This feature makes it easier for techs to verify fluid and air flows throughout all internal areas of a scope's tubing.

Olympus

OER-Elite

medical.olympusamerica.com
800-848-9024

FYI: Unveiled just last month, Olympus’ new single-basin AER simultaneously cleans and disinfects up to two endoscopes in 28 minutes using Acecide-C, a peracetic acid-based disinfectant. The basin is wider and deeper than that of its predecessor, the OER-Pro. Connecting endoscopes to the AER is simplified with color-coding, automatic monitoring and step-by-step illustrated instructions displayed on a smart LCD touchscreen. To better manage scope leaks, a dedicated decontamination cycle limits fluid invasion, with the goal of reducing service costs and eliminating the need for manual soaking. Olympus says it’s now easier to check disinfectant levels through more convenient access to the minimum recommended concentration port. A Log Data Management feature enables input of endoscope reprocessing information to manage records. Olympus has also modified its manual cleaning flow; by using ultrasonic cleaning combined with an alkaline detergent, seven of the 11 manual cleaning steps for non-elevator endoscopes have been eliminated.

Steris

SYSTEM 1 ?endo Liquid Chemical Sterilant Processing System

steris.com
800-548-4873

FYI: The System 1 endo Processor sterilizes rather than high-level disinfects (HLD) endoscopes. It provides liquid chemical sterilization (LCS) for manually cleaned, immersible, reusable semi-critical heat sensitive medical devices, including endoscopes and their accessories. ?Steris claims LCS goes beyond HLD to eliminate all viable microorganisms, including bacterial spores, in an 18-minute cycle. Steris claims its S40 ?Sterilant Concentrate reaches all parts of devices, including port surfaces, which it claims are commonly shielded from germicide contact in AERs with tight-fitting adapters. Its scanner captures and tracks both scopes and the techs who reprocessed them, and historical digital data is available on demand for compliance reporting.