The Association for Professionals in Infection Control and Epidemiology (APIC) has released a new practice guidance resource, Guidance for Addressing Problems with the Manufacturer’s Instructions for Use: A Toolkit for Non‑Critical Devices, to help healthcare facilities manage unclear, conflicting, or impractical manufacturer instructions for use (MIFUs).

While manufacturer instructions are essential for device safety and compliance, infection preventionists frequently encounter MIFUs that are difficult to access, overly complex, outdated, or misaligned with evidence‑based infection prevention practices. This toolkit provides a structured, evidence‑based approach to identifying problematic MIFUs and outlines practical steps for resolution.

“Infection preventionists are often placed in the position of having to operationalize instructions that don’t reflect real‑world workflows or current evidence,” said Kathy Ward, APIC’s 2026 president. “This toolkit gives healthcare teams a defensible, systematic way to address problematic instructions while prioritizing patient safety, staff safety, and regulatory alignment.”

The toolkit includes:

Criteria for identifying problematic MIFUs
A step‑by‑step algorithm for addressing issues
Guidance on engaging manufacturers and multidisciplinary teams
Risk assessment frameworks, templates, and real‑world examples
Tools to support documentation and regulatory alignment

The toolkit was developed by the APIC Practice Guidance Committee, with support from APIC’s Center for Research, Practice, and Innovation.

The toolkit is intended for infection preventionists, quality and safety leaders, healthcare administrators, and multidisciplinary healthcare teams and is available through APIC.

The toolkit is available at here: A Resource for Addressing Discrepancies in the Manufacturer’s Instructions for Use of Non-Critical Devices (MIFUs) – APIC