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Insufficient for Understanding: Are IFUs Failing Us or Are We Failing Them?

You cannot walk five feet in a sterile processing department without hearing the words “instructions for use” from a team member, certification manual, or accreditation surveyor. Abbreviated as IFU, these manufacturer instructions give insight and directions on everything from chemical soak times to cleaning brush diameters, from validated cycles to preventive maintenance schedules. With the emphasis on the importance of IFUs, there still remains a very real disconnect on the front lines of cleaning and sterilization for how these little instructional devils are to be tackled and tamed.

Let’s take a look at a couple of ways our current cultural and technological focus on IFUs is failing us, what you can do to cultivate a spirit of patient-centered compliance among your team, and how you can help stem the tide of instructional ignorance in our industry.

The worldwide what-does-it-say: Online and out of sight
This first point might take the breath away from a few Millennials: the Internet is not the end-all, be-all solution for every sterile processing problem. Even though I’m one of the biggest advocates out there for the power of social media to change an industry like ours, I’m also willing to admit that psychological danger is lurking beneath the surface of that touchscreen (not to mention all the microbes on the surface). Beside the fact that many studies are now arguing the Internet itself is making us dumber, an unhealthy reliance on the worldwide web can also mean our technicians are never actually learning anything. Few examples of this are more striking than how some of our departments manage their IFUs.

How many times have you heard, “We have a subscription to ______, so all of our IFUs are on the Internet”? But have you ever asked a follow-up question, such as, “What do those IFUs say?” If you ask that question, many times you’ll get a half-guilty, half-surprised, deer-in-the-proverbial headlights look that betrays the truth of the matter. Many of us are trusting more in the accessible nature of our IFUs than actually doing the hard work of accessing them to learn what it is they are really telling us to do. In the broader world, this is known as digital amnesia or the Google effect. In our context, we can call it the subscription effect, where our teams are lulled into a false sense of compliance security because we know that if we ever need to find our device IFUs in a crunch, we can do so in a few clicks. For practical and psychological reasons, this is no way to ensure safe processing among your team.

Throw the microbes from the train
Few of us have the luxury of starting a compliant IFU journey from scratch. The vast majority of the folks reading this article are in the middle of a work day with surgeries going on this very moment or scheduled for first thing tomorrow morning. Most likely the majority of your surgical inventory is already neatly packaged and waiting on a shelf in some sterile storage area, ready to be pulled to put a patient back together after a serious car accident, or complete a minute heart surgery on a three-day-old infant clinging to life. The surgical train has left the station, and now some guy in the caboose is raising his hand to ask a question.

“Have you reviewed all of your IFUs?” It’s an apt question. How can you be sure, with any level of certainty, that you are cleaning, inspecting, and sterilizing your inventory correctly if there are still large swaths of instruments or equipment, the instructions for which no one in recent memory has reviewed? The answer is that you can’t be sure. And that’s the problem.

Practical tips for patient-centered compliance
First, make a list, then make progress. The only way to ensure you are capturing every corner of your department in the name of compliance is to get it all down on paper or a spreadsheet, then to methodically plod through line by line until you have conquered every square inch of your inventory in the name of patient safety. From Adson forceps to Zenker clamps, and every product number in between, that is what it is going to take to move your team from elementary IFUers to experts in their field.  

Getting the list is the (relatively) easy part. Next, ask for resources. This is where you will need a little professional nerve to admit a few things to your hospital administration, infection control, quality, and anyone else who will listen. As hard as it may be to say, you need these teams to know that as of today, there are instruments being used on your patients that you cannot confirm are being processed according to their manufacturer’s IFUs. I know, it sounds like I’m asking you to commit professional suicide. I mean, isn’t it your job to make sure these things are already taken care of? Yes, it is, but the truth is that you are not alone. I’d wager that nearly 95% (if not more) of CS/SPD teams in the U.S. have some number of instruments they are processing without reviewing their IFUs.

The reason for this high percentage of noncompliance is the level of IFU review I’m referring to is a monumental task for departments who very rarely have even a microinventory of their instruments, much less the work force or technological tools to review each item for compliance. Hence the encouragement to leverage this reality to ask your administration for the resources necessary to ensure 100% compliance among your team. While being honest with the current state is a difficult conversation to have, it is the only way you will be able to get the tools (tracking systems, big data partners, etc.) and staff (instrument coordinators, database specialists) you will need to make this compliance magic happen.

Now it’s time to incentivize compliance among your technicians. Compliance with IFUs is not the sole purview of the department manager or instrument coordinator. Patient-centered compliance is a team sport, and it takes the effort of every frontline technician in the department to ensure the mission is a success. Because the task is so behemoth, and our inventories so complex, one of the smartest things you can do as a department is to incentivize your technicians to find deviations from IFUs before you do. They are the ones interacting with these instruments on a daily basis, so they often have a better idea of the items that could pose the greatest threat to compliance than anyone else.

Create incentive programs like a “Pick Your Own Assignment” or a $5 gift card giveaway to Starbucks for team members who identify a current deviation from the manufacturers IFUs in your workflow, and recognize them during your weekly staff meetings. What these types of incentives do for your team is cultivate excitement and confidence regarding IFUs that will engage and encourage your front line technicians to question the status quo of instrument processing, multiplying the eyes and ears of compliance tenfold.  

Make no mistake, tackling the complexity of manufacturer instructions for use is no small task. If you proactively identify the dangers of the IFU subscription effect and develop an instrument-by-instrument game plan for cultivating a culture of compliance in your department, success in this area is possible. If you leverage the importance of this task to garner the administrative resources you need to take your CS/SPD team to the next level of patient safety, and incentivize your front line technicians to carry the torch, IFU compliance can become a reality for every department in the country.

Patients everywhere are counting on you.

Feature articles exclusively for Ultra Clean Systems by Weston “Hank” Balch, BS, MDiv, CRCST, CER, CIS, CHL

Weapon of Mass Microbial Destruction * Professional Clean Freak * Podcast Host * Safety Addict * CS/SPD Consultant

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