The Results are In! — Insights from APIC’s Instructions for Use (IFU) Survey

In the high-stakes world of infection prevention, adherence to Instructions for Use (IFUs) can be the difference between safety and risk. The Association for Professionals in Infection Control & Epidemiology (APIC) consistently stands at the forefront of transformative change and has been advocating to improve IFUs in healthcare settings. The IFU survey, a pioneering endeavor undertaken by the association, is the first comprehensive research done to assess and enhance adherence to manufacturer-provided instructions for medical devices, equipment, and products. Below are some of the survey’s key results shared at this year’s APIC conference.

The Survey that Shaped Progress

In a much-awaited session that sparked curiosity and anticipation, APIC’s “Update on IFU Survey and Advocacy Efforts” shed light on challenges that Infection Preventionists (IPs) have with medical device IFUs in healthcare settings. With nearly 1,200 IPs from diverse healthcare settings and experience levels participating, this survey is a pivotal milestone in the pursuit of quantifiable data on IP challenges, best practices, and desired outcomes concerning medical device IFUs.

For equipment manufacturers, one essential aspect of U.S. Food and Drug Administration (FDA) compliance is providing clear and comprehensive IFUs. IFUs provide essential information on the correct operation, maintenance, and safety precautions for medical equipment. They ensure that healthcare professionals can use the equipment accurately and safely, reducing the risk of errors and accidents. However, IFUs can often contain technical and scientific language, making them challenging to comprehend for some users.

70% of IPs Struggle with IFUs

Based on the survey results, a resounding 70% of IPs voiced their struggle with IFUs, labeling them as “unnecessarily complex” and “difficult” to understand. In addition to their daunting complexity, the survey revealed that the primary issues with IFUs include their inadequate emphasis on infection prevention and lack of clarity on proper cleaning procedures. Below are five of the most cited reasons IPs experience challenges with IFUs.

Top 5 most common issues with IFUs:

• 71% — IFUs are unnecessarily difficult to read, complex, and time-consuming       
• 70% — IFUs are inadequately written, conveying more concern for product lifespan/warranty than infection prevention
• 68% — IFUs lack specificity/clarity about how to properly clean
• 67% — IFUs are outdated and inconsistent with current practices and technologies
• 56% — Too much variance between IFUs and directions for use (DFUs) on cleaning and disinfection products

42% of IPs cited for IFU non-compliance

With many IPs finding IFUs less than user-friendly, IFU compliance poses significant challenges. The survey revealed that 42% of IPs received citations from accrediting authorities for non-compliance with equipment IFUs. However, perhaps as a testament to their knowledge and commitment to patient safety, about 35% of IPs were able to successfully contest citations by providing evidence to support their current use protocols.

Additionally, one of the most glaring revelations from the survey was that an overwhelming 84% of IPs have had to contact equipment manufacturers to gain clarity on IFUs. In this same vein, the survey reveals a glimmer of optimism where 60% of IPs believe that manufacturers can offer helpful, clarifying documentation. Yet, the lingering question remains – why does the journey to clarity begin with so much ambiguity or barriers in understanding?

Efforts to Improve IFU Adherence

Improving adherence to IFUs requires a multi-faceted approach that involves collaboration among healthcare facilities, equipment manufacturers, cleaning and disinfecting product manufacturers, and regulatory bodies. APIC offers short-, mid- and long-range advocacy efforts that can help establish a new standard of excellence in medical device IFU adherence.

Some strategies may include:

• Enhanced Clarity in IFUs: Manufacturers avoid technical jargon and provide step-by-step instructions and/or incorporate visual aids and graphics in IFUs to aid in comprehension, making it easier for healthcare professionals to follow instructions accurately
• Educational Programs: Healthcare facilities invest in training programs to educate staff on the importance of IFU compliance
• Standardization and Consistency: Encourage standardization and consistency in IFUs and incorporate updates in line with evolving practices that can improve adherence across healthcare settings                  

The APIC IFU survey revealed crucial insights that demand our attention. The survey highlighted challenges that IPs face when navigating the maze of IFUs, including their complexity, lack of clarity, and outdated information. Through this struggle, however, IPs are bravely challenging citations and seeking clarity from equipment manufacturers, showing their dedication to patient well-being, and highlighting the need for clearer documentation.

All in all, IPs already have enough on their plate – decoding the language on an equipment IFU shouldn’t add to their worries. I believe that the path to clarity starts with collaboration between healthcare facilities, equipment manufacturers, regulatory bodies, and cleaning and disinfecting product manufacturers. The Clorox Healthcare® team aims to be a part of the solution and if we all work together to cultivate a culture of clarity, we can help make IFUs a symbol of reliability rather than confusion.