APIC Releases New Toolkit to Address Problematic Manufacturer Instructions for Use for Non‑Critical Devices

Arlington, VA - May 8, 2026 - 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and compliance, infection preventionists frequently encounter MIFUs that are difficult to access, overly complex, outdated, or misaligned with evidence-based infection prevention practices.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

Built Through Collaboration

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

We extend our heartfelt appreciation to the accreditation organizations that participated in this initiative and demonstrated true leadership by recognizing the importance of addressing challenges related to manufacturer instructions for use. Their decision to be at the table, contribute thoughtfully, and engage on this complex issue underscores their commitment to excellence, patient safety, and continuous improvement across the field. We are grateful for their leadership and partnership:

• Accreditation Association for Ambulatory Health Care (AAAHC)
• Accreditation Commission for Health Care (ACHC)
• The Center for Improvement in Healthcare Quality (CIHQ)
  DNV Healthcare

Availability

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

About APIC

The Association for Professionals in Infection Control and Epidemiology (APIC) is the leading professional association for infection preventionists, with 15,000 members. APIC's mission is to advance the science and practice of infection prevention and control to protect patients, healthcare workers, and the public.

For media inquiries or further information, please contact [email protected].