Modernizing Medical Device Instructions for Use (IFUs)

IPs from a broad array of facility types, sizes, and locations in the United States struggle with manufacturers’ instructions for use (IFU) that are overly complex, time consuming, unclear, out of date, or difficult to locate.

To avoid citations and potential patient harm, IPs must follow a burdensome process which may include seeking input from manufacturers and/or the FDA in real-time to determine how to safely clean, disinfect, and/or sterilize medical instruments.

Our survey of 1,198 infection preventionists across the country showed that:

• 42% of their facilities had been cited for failure to follow an IFU. 
• 84% of IPs had to reach out to a manufacturer for clarity on proper cleaning, disinfection or sterilization of a product. 
• 8% of IPs took the additional step of reaching out to the Food and Drug Administration for clarification of an IFU.  

APIC believes this is an unacceptable burden that does not support the goal of preventing the transmission of HAIs.

APIC calls for the following:

• A public repository for IFUs so that users will have access to appropriate information for devices that are no longer manufactured and/or when the manufacturer is no longer in business.
• Developing tools to help IPs and other healthcare personnel navigate the current less-than-optimum process, for cleaning, disinfection, and sterilization of medical instruments.
• Bringing problematic IFUs to the attention of manufacturers and the FDA.
• Educating policymakers and healthcare organizations about flaws in the current regulatory framework that limit IPs’ ability to protect patients from transmission of HAIs via medical devices.
• Convening stakeholder organizations to work with APIC to propose a new regulatory framework for cleaning, disinfection, and sterilization of medical devices that includes (but is not limited to):
  • A standardized format for IFUs;
  • IFU language which takes into account the needs of infection prevention and control, sterile processing, environmental services, and end users to protect patients;
  • Device labels which are easily accessible to users for the duration of the product’s lifespan, indicate when the IFU was last updated, and provide information on who users may contact in case of questions;