APIC Seeks IFU Overhaul

Infection preventionists band together not only to press for better-written reprocessing instructions, but also for update alerts from vendors.

Many surgical equipment and instrumentation manufacturers’ instructions for use (IFUs) for cleaning, disinfecting and sterilizing their products are not as clear, well-written or easy to follow as they should be for sterile processing staff as well as the infection preventionists (IPs) who monitor their work. Perhaps nowhere is that more true than in the world of complex, delicate GI endoscopes, which require an array of specific reprocessing steps.

In May, the Association for Professionals in Infection Control and Epidemiology (APIC) launched an effort to fix this widespread and longstanding problem. APIC shares the belief held by many in outpatient surgery that IFUs in general are a convoluted mess, and that they need a significant overhaul in the interest of efficiency, patient safety, infection prevention and return on investment. “The time that IPs must spend obtaining clarity on arcane and confusing cleaning instructions limits the amount of time they are able to spend on other lifesaving infection prevention work,” states APIC President Tania Bubb, PhD, RN, CIC, FAPIC. “This is especially true for individual IPs working alone in their facilities, as about half of our survey respondents were. Instructions that are so unclear that more than eight in 10 IPs need to call the company for clarity are inefficient and need revision.”

APIC says a “flawed regulatory framework” that forces IPs to interpret out-of-date and overly complex IFUs limits their ability to protect patients from deadly pathogens. Now APIC and its more than 15,000 members are calling on policymakers for help with improving the regulatory process.

Deep dive

APIC published a report, “Modernizing Medical Device Instructions for Use (IFUs): Infection Preventionists Speak Up for Patient Safety,” that it says it shared with policymakers and the Food and Drug Administration (FDA), which regulates medical device labelling. (Download the full report at osmag.net/IFUs.)

The report dives into the difficulties, inefficiencies, patient safety concerns and wasted resources spent on deciphering confusing cleaning instructions for instruments. IFUs, writes APIC, “are often not available, difficult to locate, out-of-date, overly complex, brand-specific and/or provide instructions that seem focused on protecting medical devices and their warranties rather than protecting patients from being exposed to pathogens.”

In 2023, APIC surveyed 1,198 IPs about IFUs, with approximately 70% of respondents finding them unnecessarily complex, difficult or time-consuming; that they seemed designed to address product lifespan more than infection prevention; and that they lacked specificity and clarity about how to appropriately clean products. The survey also found that 84% of IPs surveyed were forced to reach out to manufacturers for clarity on confusing IFUs, with 36% reporting that manufacturers did not offer helpful information. Eight percent of respondents had taken the additional step of contacting the FDA to confirm they were properly complying with cleaning, disinfection and/or sterilization protocols. That last point is important because surveyors who act as agents for the Centers for Medicare & Medicaid Services (CMS) don’t care that IFUs are poorly designed and that facilities are doing the best they can with them. Surveyors simply cite violations that they find. According to the APIC survey, 42% of respondents said they were cited by surveying bodies for IFU violations, and more than half of those respondents were unable to successfully challenge those citations, even when offering scientific evidence.

“The challenge is that IFUs get updated or revised, and you have no idea that has happened,” says Prinu Gabriel, MS, SM(ASCP)CM, CIC, director of infection prevention at Texas Health Harris Methodist Hospital Fort Worth. “Then you have a survey or audit, and somebody asks for the IFU. When you try to retrieve it, it’s something different — either they added an extra step or they changed something. For example, the IFU had bleach listed as ‘sodium hypochlorite,’ and they changed it to a brand name you’re not using.”

Ms. Gabriel says surveyors don’t show much sympathy in these situations. “They cite you, because that’s not a reason,” she says. All the surveyor sees is that your facility is putting patients at risk by not following the manufacturer’s recommendation. The onus, Ms. Gabriel says, is on the facility to put a process in place to keep all IFUs updated.

That’s a lot easier said than done, as IFU updates frequently occur without any heads-up from the manufacturer. “The vendors never let you know when they’re revising the IFU, and there is no way you can keep checking because you have so many products,” says Ms. Gabriel. “Updates are done without customers being notified, and then it’s a surprise for you. It puts you in a predicament.”

Ms. Gabriel says infection preventionists usually need to look IFUs up online proactively to see if they’ve changed, but that they’re not always very easy to find. Even worse, vendors don’t send digital or physical alerts or notifications about IFU changes.

“I would really like some kind of notification like an email sent to our quality department saying, ‘You have purchased our product, and there is a change to the IFU. Please check our website,’” says Ms. Gabriel. “When you are in this situation, you’re reaching out to vendors and it’s hard to get them because the people you remember don’t work there any longer. So you go through the 800 number, where you need to put in your information and have somebody contact you. And then they are as surprised as you are: ‘Oh, we’re so sorry you guys didn’t know. Yeah, this was updated this particular year or month.’”

The IFU update issue is not as acute for certain products, particularly for products that are capital purchases, says Ms. Gabriel, citing automated endoscope reprocessors as an example. She says that vendor is available, and there’s a relationship with the rep who visits her site and will provide notice if the product’s IFUs change.

It’s the smaller, less-costly items that are often a problem. Ms. Gabriel returns to her bleach example. “You already have a bleach wipe, but it’s not the particular brand name that the IFU now suggests,” she says. “So how many products do you need to buy?” Another example she cites is glucometers. “These little point-of-care testing devices always get you in trouble because those vendors aren’t coming in and checking on you,” she says.

Ultimately, a centralized and frequently updated database that contains IFUs from all vendors is what Ms. Gabriel and others would like to see.

Industry response

The problem with IFUs isn’t just about updates, however. “When you look at IFUs, they’re not very clear,” says Ms. Gabriel. “They’re all over the place. The more you read it, you get familiar at it, but it does take some time. Make the IFU less cumbersome and more straightforward, a cleaner process for people to understand.”

APIC made several recommendations in its paper in the interest of improving these conditions. Beyond developing tools to help IPs and other staff better navigate the current IFU situation, it is encouraging its members to alert manufacturers and the FDA about problematic IFUs. APIC also is seeking to educate policymakers and healthcare organizations about the flaws of the current regulatory framework, and wants to convene with stakeholder organizations to propose a new regulatory framework that includes:

• a standardized format for IFUs;
• “IFU language that takes into account the needs of infection prevention and control, sterile processing, environmental services and end users to protect patients”;
• more easily accessible and more durable device labels that indicate when the IFU was last updated and provide information on whom to contact with questions; and
• the creation of a public IFU repository that users can access to acquire appropriate IFUs for devices no longer manufactured or made by companies no longer in business.

“APIC urges policymakers, industry and allied groups to come together on solutions to make confusing device cleaning instructions clear, concise and rooted in the principles of infection prevention and control to protect patients from deadly pathogens,” states Dr. Bubb. “We stand ready to help improve and standardize this process.”

Start of a conversation

Ms. Gabriel is encouraged by APIC’s effort. “I like that they actually have surfaced the problem,” she says. “I like that APIC is asking all the policymakers and all the vendors to come together for a solution to make this less confusing. So many products are being used in healthcare facilities; it’s going to take some time, but now that we’re starting to talk about it, I feel like we’re heading in the right direction.”

When asked if the Healthcare Sterile Processing Association (HSPA), which would also seem to have significant skin in the IFU overhaul effort, is involved, APIC issued this statement to Outpatient Surgery Magazine: “We are working with HSPA and AAMI. We kept them apprised of the study, gave them advance notice of the report and met at our annual conference and after about how we are aligned on this issue. Both HSPA and APIC members are interested in IFUs which are clear and straightforward.”

HSPA did not respond to a request for comment. OSM