Infection Prevention: Making Sense of Complex IFUs


Here’s how to navigate the intricacies of endoscope reprocessing rules.

Virtually every article, webinar or how-to guide on flexible endoscope reprocessing includes some version of this advice: Be sure to follow the manufacturer’s Instructions For Use (IFU).

Sometimes, however, manufacturers’ IFUs are so complex and convoluted that they need their own instructions for use. After all, these technical documents are often written by engineers and filled with technical jargon and confusing verbiage that may be unclear to the average staff member. Still, IFUs are the gold standard in compliance, offering evidence-based guidelines that align with industry standards — when they are followed properly.

Here are some proven ways to ensure your sterile processing staff is following IFUs to the letter.

Start by standardizing

The role of standardization cannot be understated. It simplifies and solidifies the expectations of your team, which reduces variation in their methods, which in turn reduces the risk of errors both small and large. Fewer errors in the endoscope reprocessing chain ultimately improves patient outcomes by reducing the risk of harm or infection.

Start by identifying your key stakeholders — infection prevention, clinical engineering, endoscopy, SPD, physician champions, facilities engineering, surgical services, etc. — and looking at all the data and relevant information on standardization through their unique perspectives.

For instance, we identified a need for standardization and began reaching out to key stakeholders to form a small committee. This group created an inventory of all endoscopes, reviewed the IFUs and implemented evidence-based guidelines. During the standardization process, we reviewed and identified compatible products, developed policies and procedures, created competencies and made audit tools to collect data and track compliance. In the end, 100% of our off-site clinics changed to single-use disposable endoscopes, resulting in a significant increase in compliance due to standardized processes across multiple departments. We’ve also maintained a 98% or higher compliance during our audits and tracers.

Take stock of inventory

Your team of key stakeholders will want to validate your inventory to identify what types of endoscopes are in the facility — including the different manufacturers and the model numbers.

After auditing your inventory, review all the corresponding scopes’ IFUs to make sure you have the most up-to-date version. Look at the most stringent steps and processes within those instructions and identify any steps that can be standardized and applied to your own inventory and processes.

Break it down

While endoscope reprocessing includes an array of tiny steps, the overall task can be broken down into major areas that apply directly to the IFUs, including:

• Point-of-use treatment. Review the IFU to determine what the requirement is for the initial precleaning at the point of use. Endoscopes have channels that need to be flushed prior to transport to the reprocessing area.

Cleaning. This step removes soil, contamination and potential bioburden but does not kill microorganisms that may be on or in the device.

High-level disinfection (HLD) or sterilization. Check the IFU to see if the endoscope is compatible with HLD and/or sterilization. Sterilization of flexible and rigid endoscopes is the preferred method for reprocessing, however, some IFUs provide only guidance for HLD as the device cannot undergo sterilization methods.

Device reprocessing. Automated endoscope reprocessors can be utilized for HLD, but you must confirm the device is compatible with these devices and supports HLD solutions. If only manual reprocessing is supported by the manufacturer, ensure the linear process steps can be supported. For endoscopes that require or can undergo, sterilization be sure to review the IFU to determine the compatible sterilization method.

Transport requirements. Use the IFU of the endoscope to determine specific transportation requirements. It is also important to review the IFU of the transport bin or container for proper cleaning and disinfection methods.

Storage requirements. Finally, you’ll need to carefully check the storage requirements on the IFU to ensure the device is stored in a manner that prevents damage, contamination and water retention.

Some IFUs require the endoscope to be reprocessed within a certain timeframe, with additional cleaning and disinfection requirements in place if that timeframe is missed. IFUs will also help you determine which types of products are compatible with the device — such as the wipes or sponges, required chemicals and equipment (e.g., leak tester, endoscope flushing aids, borescope). It is also up to your SPD staff to confirm whether specific water is required for any stages of the process (i.e., sterile water vs. utility water).

Lean on expert resources

Endoscope reprocessing is a critical area of care that has a real regulatory impact on facilities. That means you want to utilize clinical risk and accreditation partners for help. You’ll also want to go to your subject matter experts for guidance and recommendations. Your vendors can — and should — play a huge role in ensuring your SPD follows IFUs as intended, so reach out to them and capitalize on the education, training and competency they can often provide.

Anything you can do to standardize SPD’s efforts and ensure they are sticking to IFUs will ensure fewer missed steps, better care of the endoscopes (i.e., less damage and biofilm build-up) and, best of all, safer care for patients. OSM

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