Standardized IFUs: Where Do We Stand?

It’s been a year since infection preventionists banded together to call for improvements, but much work remains.

In May 2024, the Association for Professionals in Infection Control and Epidemiology (APIC) published a report, “Modernizing Medical Device Instructions for Use (IFUs)”, which stated that infection preventionists (IPs) “from a broad array of facility types, sizes and locations in the United States struggle with manufacturers’ IFUs that are overly complex, time consuming, unclear, out of date or difficult to locate.”

Unfortunately, not much has changed … yet. Many IFUs remain unacceptably convoluted. Behind the scenes, however, APIC is diligently getting its ducks in a row to affect the massive change its members want.

Kelly Zabriskie, BS, MLS, CIC, FAPIC, enterprise vice president - infection prevention with Jefferson Health in Philadelphia and coauthor of the APIC report, envisions IFUs that are standardized much like the “Nutrition Facts” labels on all food products. “Those labels tell you, ‘These are the calories, this is the fat content and so on,’” she says. “We want something like that, where the IFU is: ‘Here’s the cleaning process; here’s your low-level disinfection; these are the chemicals; this is the process.’” Although the vision is clear, much more work remains to achieve it. “My understanding is that it took years to get every food product to have a standardized nutrition label,” says Ms. Zabriskie. “It’s the same with this.”

That’s why APIC is employing a multipronged approach by engaging not only manufacturers and accreditation bodies about IFUs, but also legislators. Much as with nutrition labels, self-regulation takes even well-meaning manufacturers only so far. Some might need a government mandate and standards to speed up the process.

Interim and long-term goals

One component of the IPs’ effort is to show other stakeholders what a good IFU looks like … and what doesn’t. “We’re looking to collect as many IFUs that are challenging and difficult as we can to create a template of a good/better/best IFU that we can bring to legislators and others to say, ‘This is what we need. Look at the difference. See how easy this one is to follow? But look at this one. It’s convoluted language. It’s really important for us to help the end user,’” says Ms. Zabriskie.

The APIC team is also focused on an immediate problem: facilities getting dinged by surveyors due to IFUs that are too specific or ambiguous. “One of our challenges when we are looking to get accreditation is when the surveyors pull up an IFU and there’s noncompliance,” says Ms. Zabriskie.

The problem often isn’t staff doing an insufficient job, but rather the unreasonable specificity of the IFU. “They may not be using the one chemical that has been approved, but another chemical that is similar,” says Ms. Zabriskie. “IFUs are very particular. If it says you can use Clorox bleach, you can only use Clorox bleach. There are a lot of citations on ‘Well, you’re cleaning it, but the IFU says you need to use this product.’”

APIC, she says, would like to work with the accreditation agencies on introducing the use of a risk assessment tool to expand the number of acceptable cleaning product options beyond those specified in an IFU. Currently, many facilities are forced to have redundant products on hand that do the same thing, simply because a specific product is required by a specific IFU.

“We want to get the accrediting bodies to say, ‘If this product can be used, we are still compliant,’ instead of being cited. Help us figure out how to make this more viable,” says Ms. Zabriskie. “If we utilize this similar chemical that the manufacturer says kills MRSA and C. diff and TB, that should meet the intent of the IFU.”

Ms. Zabriskie notes that IFUs for many products use information from their original premarket 510(k)s about which chemicals are approved for the device to be cleaned, disinfected or sterilized. Like many IPs, she contacts manufacturers directly for clarification. Citing an international vendor, she says, “I reached out to them and said, ‘We want to use your product, but for low-level disinfection I don’t have any of these chemicals, so it’s not really a ready-to-use product here.’” She says the vendor wanted to know more and subsequently met with her to discuss the situation. It told her she could use alternatives to the cleaning products specified in its IFU if she could validate them. The problem was that the vendor was unaware that surveyors adhere strictly to what is specified in the IFU.

“There are manufacturers who want to understand what they need to do,” says Ms. Zabriskie. “Everybody wants to do the right thing. We want to keep our patients safe, but you can’t have 16 different types of wipes. No one is going to know what to use and when. What we hope is that an IFU could say ‘a one to 10 dilution of bleach’ instead of saying you can only use [a specific vendor’s] wipes or bleach.” Another solution, she says, is for the IFU to specify that if any wipe or chemical disinfectant vendor has already validated its product’s effectiveness for killing specific organisms on the substrates at hand, that product can be used.

APIC hopes lawmakers can help expedite improvements. “We’re hoping to have legislative groups say, ‘This is important. We need a standardized process so people know where to find IFUs, that information is always in the same place in the IFU, different topics are identified, and language is consistent,’” says Ms. Zabriskie. “This way, no matter what company, they’ll know the information they need to put in there. I think without that help, it’s going to be very difficult for us to say, ‘We need everybody to do this standard model.’”

Compliance challenges

In the meantime, IPs continue to engage manufacturers about IFUs. “I think the manufacturers are hearing us,” says Ms. Zabriskie. “The main thing for us is some of the verbiage. If you have an issue, you need to go to the technical advisors of the company and reach out to them. Sometimes they don’t understand why we can’t just use another cleaning product or disinfectant. It’s because we’re slated to follow an IFU and we need something in writing from the manufacturer saying it’s okay to use something, not just the technical advisor telling you it’s okay. It’s important for sterile processing and IP to keep raising these concerns with manufacturers so they understand the difficulties we face.”

Another issue with IFUs is keeping track of updates, of which IPs and sterile processing professionals are often unaware. Many manufacturers don’t “push” IFU updates to their customers, although some third-party platforms track some of them. In a highly digitized world where information about almost everything is easily accessible on demand, it can be difficult to find updated IFUs. “I reach out to the companies if I’m not sure to get the most up-to-date version,” says Ms. Zabriskie. “Finding IFUs on some manufacturers’ websites is not easy; you search and search and cannot find it. Sometimes there’s a separate cleaning and disinfection document if it’s a bigger company with multiple products. Sometimes you need to know a lot of information, like a specific serial number. It should be easier.”

Garrett Hollembeak, CRCST, CIS, CHL, CER, CIC, system infection preventionist - medical device reprocessing with Bon Secours Mercy Health in Cincinnati, is a rare combination of an IP and a sterile processing expert. As such, he has a comprehensive view from two key disciplines affected by suboptimal IFUs.

“It’s one of those rabbit holes where IPs know it’s an issue, but I don’t think they know how bad it is until they open it up and say, ‘Pick five instruments in your department, read through the full IFU and see how compliant our sterile processing department is,’” he says. “Even with IFUs that are written well, the foundational work for the sterile processing department (SPD) often wasn’t completed to comply with it. To audit compliance, it really takes a shoulder-to-shoulder approach between IP and SPD to say, ‘Are you understanding this the way I am?’ Because what I don’t want to do as an IP is say, ‘You are not following the IFU by doing this,’ only to have the SPD manager say, ‘Well, that’s not a required step.’ Even if it’s challenging or requires additional staff or resources, IPs need to be able to help SPDs comply with the validated cleaning process.”

These discussions would become less complicated if IFUs were more straightforward and less ambiguous. “As more people look at IFUs, they see just how poorly some of them are written,” says Mr. Hollembeak. “There are six criteria the FDA outlines for what an IFU should look like. The last two are that it should be comprehensive, and it should be understandable. Those are vague terms without concrete definitions. What may be comprehensible to me might be totally different than what’s comprehensible to you.”

Mr. Hollembeak believes manufacturers would benefit from more frontline feedback about IFUs, especially from sterile processing pros. “There’s a large amount of technical complexity to sterile processing, and it takes talented technicians who care about their job to do it well,” he says. “When I go to a mechanic, I can read my Chevy manual and say, ‘This is everything that you need to do,’ but I couldn’t show the mechanic how to do it. I could write instructions based on the manual, but those might not translate to the real application of the skill.

“My understanding is that it took years to get every food product to have a standardized nutrition label. It’s the same with this.”
Kelly Zabriskie, BS, MLS, CIC, FAPIC

“It’s incumbent on the manufacturers to make sure they’re putting what’s essential in the IFU and clarifying if something is just a best practice or a requirement,” says Mr. Hollembeak. “You may have something that’s vague, like ‘Use detergent F.’ Is that a requirement? Is that the only thing we can use? Can we use a similar product? I don’t think it’s realistic to require the manufacturer to test every single detergent out there on the market for their instrument, but I think it would benefit from some categorization, to say you don’t need to specify a specific detergent, but this type. With brushes, it seems to be more common now to say ‘this brush or an equivalent dimension,’ and I think that’s in response to some of the challenges with costs and getting the right equipment and complying.”

In process

Mr. Hollembeak would like to see fewer broken links to IFUs on manufacturer websites, along with responses to requests for clarifications to IFUs in a reasonable time frame.

“Manufacturers are not the enemy in this conversation,” he says. “They want to do right by the patient too. It’s just a matter of the standards they’re held to, and then some misunderstanding of how their IFUs are going to play out for the technician.” OSM