The responsibility to efficiently and effectively clean and disinfect healthcare facilities to support patient safety and reduce healthcare-acquired infections is a top priority. It falls on the shoulders of many healthcare facility professionals. These professionals are required by regulatory agencies to follow IFUs and care and maintenance guidelines created by manufacturers. If they don’t, fines and penalties will be levied.

The Challenge

Think about this for a few minutes, and if you have an opportunity, walk into a room and just look around. How many IFUs could there be? The answer. . . . .  hundreds. Every single manufacturer that sells products to the healthcare market provides IFUs and or care and maintenance guidelines. Therefore, manufacturers must also be held responsible and accountable to provide comprehensive, accurate information that supports healthcare professionals in achieving expected outcomes. This is where a notable gap begins. None of these are the same. There are no guidelines for writing IFUs so all of them are very different. Some recommend the use of soap and water, no harsh chemicals or a specific disinfectant that in some instances the facility may not have. Many of them will also specify a specific manufacturer and, in some instances, a product the manufacturer sells.

There are also IFUs for disinfectants, and regulatory agencies require that the label be followed.

A potential healthcare scenario; 

It is 2:00 a.m., and a nurse needs to disinfect a medical device urgently. The disinfectant needs to be alcohol-based based on the type of pathogen she is trying to kill.  Where do they find out if an alcohol-based disinfectant can be used? The IFU.

Is there a database of IFUs that provides comprehensive guidance and testing data showing that alcohol-based disinfectants can be used without damaging the device?

• Can she access the information through the manufacturer’s website, and is the information easy to locate?
• At 2:00 am, calling someone at the manufacturer or even the FDA is out of the question.
• If the IFU is found, it may only list one or two approved disinfectants, neither of which are alcohol-based.

If the information is not found or if it is found and doesn’t provide the information needed, the next step is to use the alcohol-based disinfectant to destroy the pathogen that needs to be destroyed.

There are also often conflicts between IFUs and infection prevention guidelines within the healthcare facility, CDC guidelines for cleaning and disinfection, and many other guidelines based on the healthcare setting products are in and based on cleaning and disinfection requirements. There may be policies about the use of specific disinfectants within a patient care setting.  As noted in the HSI case study Surface disinfection incompatibility with medical devices creates potential patient risks. In this case study the hospital had a policy against using the manufacturer-specified disinfectant contained in the IFU. No other disinfectants were recommended, leaving the hospital to find an alternative product. This is one of many examples of challenges. There is significant confusion and challenges associated with IFUs, and recently, The Joint Commission announced they will increase the focus on complying with the manufacturer IFUs.  Critical changes are needed

The Association for Professionals in Infection Control and Epidemiology (APIC) published an article, “Modernizing Medical Device Instructions for Use (IFUs): Infection Preventionists Speak Up for Patient Safety,” APIC highlights the inefficiencies, and complexities, that discount the importance of patient safety but protect the manufacturer warranties before addressing the challenges faced when cleaning and disinfecting medical devices in particular.

The article reveals that IFUs are often difficult to locate, out-of-date, overly complex, and primarily focused on protecting medical devices rather than safeguarding patients from healthcare-associated infections (HAIs).

Healthcare professionals must consider the following:

• Healthcare Facility Protocols: Complying with the specific protocols set by the healthcare facility.
• Type of Disinfectant Needed: In the example above, the healthcare professional required an alcohol-based disinfectant is appropriate for the situation
• CDC Recommendations: Following CDC recommendations for disinfection to prevent the spread of pathogens.
• IFU on the Disinfectant Label: Checking the IFU on the disinfectant label for specific usage instructions.
• Manufacturer IFU: Consulting the manufacturer’s IFU
• Adequacy of IFU Information: Assessing whether the IFU provides adequate information to perform the disinfection safely and effectively.

It is important to recognize that the nurse’s primary focus is patient care and the safety of the patient. If he/she is unable to locate the IFU and information quickly, he/she will move forward to disinfect the medical device efficiently.

Findings from the 2023 APIC survey of 1,198 infection preventionists (IPs) across the country showed that 42% of their facilities had been cited for failure to follow an IFU. Additionally, 84% of IPs had to contact a manufacturer for clarity on proper cleaning, disinfection, or sterilization of a product, and 8% of IPs took the additional step of contacting the Food and Drug Administration to clarify an IFU.  This is an unacceptable burden that will be only exacerbated by the new regulatory guidelines that will fine facilities for non-compliance with IFUs.

HSI’s Commitment to Improvement

Building on APIC’s efforts, HSI aims to play a pivotal role in facilitating communication between healthcare facilities and medical device manufacturers. HSI will work to fill gaps such as standardizing compatibility testing and IFU formats. We will study how surfaces are cleaned and identify barriers that exist during the cleaning process. By developing standardized testing methods and IFU formats, we can ensure that instructions are clear, concise, and effective across various healthcare settings.

The recent updates to the Joint Commission guidelines highlight the financial implications for hospitals failing to adhere to IFUs. Hospitals facing fines for non-compliance are less likely to purchase equipment with convoluted IFUs, impacting manufacturers’ market share. Thus, it is in the best financial interest of manufacturers to act now, simplify their IFUs, and align them with infection prevention and control principles.

HSI encourages manufacturers to collaborate with us to create standardized, clear, and concise IFUs. Our recommendations include:

• Standardized IFU Format: Developing a universally accepted format for IFUs to ensure consistency and ease of use across all medical devices.
• Clear and Specific Instructions: Ensuring IFUs are written with the needs of infection prevention and control, sterile processing, and end users in mind.
• Accessible Device Labels: Labels should be easily accessible, indicate the last update, and provide contact information for questions.
• Public Repository: Establishing a public repository for IFUs to ensure continued access to information for devices no longer manufactured or when the manufacturer is out of business.

By addressing these critical points, manufacturers can help prevent the transmission of HAIs and improve overall healthcare efficiency. HSI stands ready to support these initiatives and work alongside APIC, policymakers, and industry stakeholders to create a new regulatory framework that benefits healthcare providers and patients.

HSI IFU Research Survey

HSI is launching an important research survey focused on how manufacturer Instructions For Use (IFUs) present challenges for healthcare infection prevention and cleaning professionals. This survey will collect the data needed to support critical changes to how these documents are developed and written and what guidance is missing from these documents. The survey data will help bridge communication between healthcare professionals and medical device manufacturers. It will also help us present these issues and potential solutions to regulatory agencies.

We urge all healthcare professionals involved in infection prevention and control to participate in this survey. Your insights are invaluable in driving the change needed to enhance patient safety and healthcare efficiency.

Please take a moment to complete the survey towards a safer, more efficient healthcare system.

About the Authors:

Linda Lybert, Founder and Executive Director of the Healthcare Surfaces Institute has focused on surfaces and their role in healthcare-associated infections (HAIs) over the last twenty years. She introduced the Seven Aspects of Surface Selection© to bring insight into the complexity of the surface issue and how they spread pathogens that cause deadly infections.

Dr. Keri Lestage, Healthcare Surfaces Institute Advisory Council Member, has a Ph.D. in Polymer Science & Engineering from the University of Southern Mississippi and a BSc in Biochemical Engineering from the University of Western Ontario. She has worked with companies in the disinfectant industry, including Clorox and ByoPlanet International, on developing protocols to understand the impact of material compatibility and technologies that complement infection control and public health strategies.