An Infection Preventionist Considers Why Manufacturers Need to Update IFUs

An Infection preventionist reading an IFU.

(Adobe Stock 864527400 by Prostock-studio)

When I first considered “Why is it important to update manufacturer’s instructions for use (IFUs or MIFUs)?” I immediately thought about the major heartburn I experienced while reviewing many MIFUs. Ideally, as infection preventionists (IPs), in our roles as facilitators, educators, and subject matter experts (SME), we are brought to the collaborative table concerned about how a device is rendered safe for reuse. However, we are often late to the MIFU party, where an opportunity or risk is identified during environmental rounding and observation when a device is already implemented and in use. Alternatively, and consequently, this can also occur after a near miss, a serious safety event, or even an outbreak.

I speak from my personal experience, beyond counting my metacarpals and metatarsals, the number of times I reviewed a MIFU and noted that something just isn’t quite right in supporting the safe and successful processing of a medical device or instrument. At times, I felt alone, spending what felt like countless hours intentionally initiating correspondence with manufacturers to strike up a thoughtful conversation on providing clarity into their IFU.

I found one of the most difficult tasks to be gaining understanding from the manufacturer or their representative to specify their intent and alignment with law and regulation driving reusable medical device point-of-use treatment (formally precleaning), cleaning, disinfection, and storage. Additionally, I was often found scratching my head or reading a point of direction out loud to garner some sense of how to follow the instructions. Through experience and knowledge, I could postulate an idea of the direction in which the manufacturer was leading the user. However, I can understand how a step can be misunderstood, executed incorrectly, or skipped for many staff members who do not have the support or direction of an SME and even some experts in health care sterile processing.

Over time, I have gained what I would consider a knack for garnering collaboration with manufacturers. Through my pursuit of IFU clarity, I have found that there isn’t this ill intent to misdirect the user. Still, there are limited expectations for a standardized process to provide a MIFU that we, the users are provided with such variation. For those who are also process improvement focused, we know all too well that a major goal in reducing harm in the health care space is to recognize waste and inefficiencies, such as reducing variation. Here, we come back to the importance of manufacturers updating previous versions of their IFUs. The key takeaways of this critical task include but are not limited to:

1. Updates to alignment with correct processing requirements

2. Updates to language or verbiage within the MIFU directing product intended use, handling, cleaning, and disinfection

3. Updates to products for meeting cleaning and disinfection requirements (consider Environmental Protective Agency [EPA]-registered and Food and Drug Administration [FDA]-cleared products)

4. Update validity effective product usage, such that MIFU noted compatible cleaners/disinfectants are demonstrating compatibility through use and time without noted or visible damage to the device

This is not the first time I have shared my concerns with poorly written or incomplete MIFUs.

At the Association for Professionals in Infection Control and Epidemiology (APIC) 2022 Annual Conference, held June 13-15, 2022, in Indianapolis, Indiana, my colleague Lisa Waldowski, DNP, RN, CIC, and I emphasized the considerable gaps in ophthalmic and optometric MIFU device processing. See our concerns shared with ICT and supporting interview with ICT here: Seeing Eye to Eye: Reprocessing of Eye Devices (infectioncontroltoday.com). Additionally, we recently published what my co-authors and I (Hoffman, Katharine J. et al.) consider a roadmap to success in eye device processing in the American Journal of Infection Control, Volume 52, Issue 3, 324 – 330, Optical Illusions: The vital importance of instructions for use and intentionally approaching eye device processing.

I share my frustration in highlighting these concerns with manufacturers providing clear, appropriate, and up-to-date instruction for use in hopes of improving the expectations for a standardized and safe means of MIFU practice. Thankfully, as an IP, others are pursuing this goal.

While attending the APIC 2023 Annual Conference and Exhibition, held in Orlando, Florida, from June 26 to 28, 2023, I felt elated to learn about the presentation of data and analysis from my fellow APIC members collected so diligently. Like many other IPs I spoke to, we all felt gratified to hear that we were not alone. I appreciate that this information was derived from a survey of almost 1,200 IPs, myself being just one, who eagerly responded to the many necessary questions reading IFUs on behalf of my fellow IPs at our institution. However, it validated many of our IP concerns that so many users struggle to successfully process all reusable medical devices considering lack of direction, misinformation, inappropriate product specificity, misalignment with Spaulding Classification, and misuse of EPA-registered and FDA-cleared cleaner/disinfectant or even hospital-grade cleaner/disinfectant products.

With the recently released manuscript and tip sheet on “Modernizing Medical Device Instructions for Use (IFUs): Infection Preventionists (IPs) Speak Up for Patient Safety” by APIC, I feel hopeful for future expectations of published IFUs to lay to rest the significant concerns raised by many IPs alike. However, I understand it will take some time to garner support for and intentionally address the significant need to standardize IFUs and drive successful publication best to support the safe handling and use of these devices.

Lastly, from a process improvement perspective, I willingly anticipate the future success of standardizing how such MIFUs are written and approved so that we will further reduce the waste and ineffectiveness of the necessity to review poorly written MIFUs. Therefore, further reducing the time of the IP to review such challenging processes will improve not only patient outcomes but also safe environments for staff and patients alike.