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Archive November 2020 XXI, No. 11

Thinking of Buying... Automated Endoscope Reprocessors

Delicate procedures demand dynamic patient positioning options.

Weston "Hank" Balch

Weston "Hank" Balch, CRCST, CIS, CHL

BIO

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

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