Infection preventionists Advocates for improved instructions for use (IFU) for medical devices

Recently, the Association of Professionals in Infection Control and Epidemiology (APIC) published the Medical Device Modernization (IFU): Infection Prevention Professionals Advocate for Patient Safety,” which sheds light on the complexities, inefficiencies, and frustrations of IFU. Business owners expressed concerns about the need for greater transparency, outdated information, brand-specific instructions, and contradictions between device specifications and user manuals. These challenges consume valuable time and pose a risk to patient safety.

After speaking with Kelly Zabriskie, MLS, BS, CIC, FAPIC, vice chair of APIC’s Public Policy Committee, to learn more about the IP challenges facing IFU, Infection control today^® (ICT^®) hosted a panel of 3 experienced IP addressees.

• Marie H. Wilson, MSN, RN, CIC, FAPIC, is an infection preventionist in the quality department at Fred Hutchinson Cancer Center in Seattle, Washington, and chair of the 2024 APIC Communications Committee.
• Heather Ridge, BS, BSN, RN, CCHW, CIC, manager of outpatient systemic infection prevention at Novant Health, Inc, in North Carolina. She is also vice-chair of the 2024 APIC Communications Committee.
• Michelle W. King, MT(ASCP), MPH, CIC, is the Corporate Director of Infection Prevention and Control in the Department of Epidemiology at McLeod Health System in Florence, South Carolina, and a member of the APIC Communications Committee.

Each IP included a history example of difficult problems they had encountered with the instructions for use.

“For me, this white paper is the culmination of IPs’ many years of experience as an intermediary between manufacturers and regulators on the appropriate use of devices in healthcare settings, and cleaning and disinfecting them is important to us,” Wilson said. “So the white paper raises a number of issues that will be of interest to infection preventionists who read it based on our experiences in healthcare, perhaps even before we became IPs in the field, so I appreciate APIC is taking this step to recognize that we are only messengers in this process. We need support from manufacturers and regulators to make real, lasting change to improve the health care safety environment.”

King agreed: “One of the most important parts of the white paper was their recommendations. This standardized format of the user manual and ensuring the durability of the user manual throughout the life of the product indicates when the user manual was last updated, as this is also important. One of my biggest pet peeves was making sure you didn’t pay too much attention to the supplier of the products you recommended for cleaning.”

All 3 IBs agreed that the APIC document on IFU was comprehensive and well developed. Ridge said: “The action plan is absolutely in line with where we need to go, particularly as an infection prevention organization…. The one thing I would like to hear a little more focus on is that we have great partnerships with our suppliers and we are very active with our sponsors and our national committee. However, we emphasize this relationship that suppliers should have and know about infection prevention because sometimes it goes beyond just the product that can be sold. This is something that is doable for the end user. They don’t always have the same understanding as us. So to make sure that suppliers understand what’s out there, what’s normal, how we can work together, we’re going to be asking questions, and it’s going to take time to build that collaboration.”