May 4, 2023

Here’s where to focus your energy when tackling complex IFUs.

Northwell Health
WHERE TO START? Sterile processing techs deal with a high volume and variety of instruments and devices, each with its own cleaning and disinfection instructions and requirements.

Telling your sterile processing technicians to “just follow the manufacturers’ instructions for use (IFUs)” can often be about as helpful as telling someone to “just read a quantum physics textbook” to understand the fundamental properties of matter and energy. IFUs, especially for instruments and devices with internal channels such as endoscopes, can be notoriously complex and difficult to follow, especially for new and inexperienced sterile processing staff.

When educating and training reprocessing staff, Katharine Hoffman, MPH, CIC, NCMA, LSSGB, and Chrystia Johnson, MSHS, MLS(AMT), CIC, LSSYB, the infection prevention community health program manager and director of infection prevention/quality division, respectively, at JPS Health Network in Fort Worth, Texas, recommend arranging the small steps in IFUs into six major chunks, and then focusing on one section at a time:

Point-of-use treatment. Review the IFU to determine its requirements for initial precleaning at the point of use. This step usually includes flushing the channels of complex devices like endoscopes prior to their transport to the reprocessing area.

Manual cleaning. This step in the reprocessing area is taken to remove soil, contamination and potential bioburden from the device. However, this tactic does not kill microorganisms that may be on or inside it.

High-level disinfection (HLD) or sterilization? The IFU will describe if the instrument or device is compatible with HLD and/or sterilization. While sterilization is the preferred method for reprocessing, many IFUs for devices like endoscopes provide guidance only for HLD, which means they cannot undergo sterilization methods.

Device reprocessing. This chunk is particularly important for facilities that reprocess scopes. Automated endoscope reprocessors can be utilized for HLD, but first confirm that the device in question is compatible with them. If only manual reprocessing is supported by the manufacturer, ensure the linear process steps can be performed.

Transport. The IFU will describe how the instrument or device should be transported between the OR and the reprocessing area, and if there are any special requirements involved such as keeping the device moist. If using a rigid container or bin to transport instruments, review its IFU for its own proper cleaning and disinfection methods.

Storage requirements. If the reprocessed instrument or device isn’t immediately being routed to an OR, how should it be stored so that it stays clean, undamaged and safe for patients? The IFU will tell you. Ms. Hoffman and Ms. Johnson urge leaders to carefully check IFU storage requirements to ensure the device is stored in a manner that prevents damage, contamination or water retention. The same IFUs will tell you if a reprocessed instrument or device that is in storage should be reprocessed after a given amount of time.

Each IFU often will have its own deeper requirements that are specific to a certain make or model of a device. The take-home point is quite simple: Your sterile processing staff should follow the IFUs of every instrument or device they reprocess to the letter.

It could be damaging your instruments.

WATER WOES? The quality of the water that reprocessing staff use at your facility could harm your instrumentation over time.

It’s said that the unique secret to a New York bagel is the quality of the water. The same applies at the Big Apple’s Hospital for Special Surgery (HSS), where water quality plays an important role in instrument reprocessing.

The HSS sterile processing department turns around 1,500 instrument trays a day, and it’s vital that every one of them is correctly and properly sterilized. “This includes keeping a close eye on the quality of the water we use,” says Richard Ortiz, CRCST, HSS’ senior director of central sterile processing and durable medical equipment. “Water impurities can stain instruments and even inactivate your disinfectants.”

Mr. Ortiz lists common water impurities that can negatively impact the decontamination process. When calcium and magnesium dissolve in water, it becomes too “hard” and can appear as a white film on the surface of instruments or the inside of washing equipment. Excessive amounts of chloride can corrode pipes, pumps and plumbing fixtures. Sediment can develop from rusty pipes, which in turn can stain instruments and even break down their passive layers of instrumentation, shortening their lifespan. The alkalinity or acidity level (pH) of water can cause pitting or corrosion on instruments.

HSS’ water quality was good but, according to Mr. Ortiz, “trending in the wrong direction.” Now, during the final rinse in all of its instrument washers, HSS uses deionized water, which is recommended for use with all concentrated instrument cleaners and approved disinfectants. Mr. Ortiz notes that PVC piping must be in place to use deionized water, as it eats through copper piping and instrumentation.

When surgeons or OR teams raise a red flag to Mr. Ortiz about instruments they are using, one of the primary things he and his team examine is how clean the instruments look and how they feel when they come out of the washer. If they have spots on them, it could be because of poor water quality, but also could be because the titration is off, or because too much or too little soap is being injected into the washers.

“There are so many critical steps and factors that aid in a sterile processing department’s ability to properly clean, prepare and sterilize surgical instruments that it’s easy to lose sight of the major role water quality plays in the process,” says Mr. Ortiz. “Left unchecked, however, problems in this area could greatly impact your equipment’s ability to effectively clean your instruments, while also increasing the likelihood that your instruments will become brittle and damaged and need to be repaired and replaced on a much more frequent basis.”

As surgery volumes increase in outpatient facilities, the challenges of reprocessing also grow.

ONE TRAY^®
An example of an EZ-TRAX^™ tray, inside of a ONE TRAY^® sterilization container.

Ambulatory facilities serve communities across the nation by offering surgical procedures that are safely and efficiently carried out by OR teams who work seamlessly together to prepare patients for their pre-op, intra-op and post-op journey. A major part of that process is the critical sterilization step needed for instruments of all shapes and sizes to be used in the wide range of surgeries offered in these same-day organizations.

The ultimate goal is to keep patients – as well as staff members – safe. To accomplish this makes the partnership with any size ambulatory facility of paramount importance as the OR leaders look for the most efficient, cost-effective solutions to their reprocessing needs. Workflows have changed dramatically in the pandemic and post-pandemic years as more cases are moving to the outpatient environment. Providing new solutions and educating staff have become even more critical as surgery volumes across a wide range of specialties has grown.

ONE TRAY^® has transformed the approach to sterilization for ambulatory centers by providing a solution that allows facilities to meet demands head on by processing instrumentation in a fraction of the time it takes sterile wrap or other rigid containers. American made and backed by a Lifetime Warranty, ONE TRAY^® is committed to patient safety and providing years of effective and reliable service.

In the orthopedic environment, in particular, ONE TRAY^® partners with EZ-TRAX^™ and maximizes the reprocessing of orthopedic sets with the ability to take 6 to 8 trays down to approximately 2 to 3. This saves around 3 hours in reprocessing per case resulting in approximately a 75% reduction in cost and labor to process surgical instrumentation. An increase in efficiency increases the cases per day as more surgeries can be completed with less trays.

Education is key to the success of any new program, so the team at ONE TRAY^® have worked to develop a network of support. A full staff of educators is available to work directly with facilities that choose to implement ONE TRAY^® and EZ-TRAX^™. According to the company, “We take pride in being one of the only companies that offer a full staff education team that works directly with facilities to educate… providing industry experts to facilitate the transition of new technology.”

This education team and clinical staff supports a variety of staff members ranging from the Sterile Processing Department (SPD), operating room staff, infection control personnel, surgeons and more for an efficient transition and follow up support. ONE TRAY^® even has a past surveyor on staff that can help prepare, and even be on call, during a survey to address any questions regarding the ONE TRAY^® technology. Additionally, free online Continuing Education Credits (CEs) are available at the company’s CE Page.

Note: For more information go to onetray.com.

To see a LIVE case timelapse showing ONE TRAY^®/EZ-TRAX^™ vs sterile wrap, please go to https://www.youtube.com/watch?v=xflI4mDGWyg&t=59s

Please follow the product IFU’s for use.