Problematic MIFUs for Low-Level Disinfection: ACHC and APIC Drive a Collaborative Solution

Health care organizations rely on manufacturer instructions for use (MIFUs) to support safe and compliant cleaning and disinfection practices. However, infection prevention and health care operations teams can encounter situations in which those instructions define a restrictive process that is impractical to apply or fails to yield a meaningful outcome.

In response to these ongoing challenges, the Association for Professionals in Infection Control and Epidemiology (APIC), in collaboration with the Accreditation Commission for Health Care (ACHC) and other health care stakeholders, developed new guidance and a toolkit focused on problematic MIFUs for noncritical devices requiring low-level disinfection. The toolkit provides a structured, standardized, and evidence-informed approach for evaluating risks, assessing alternatives, and improving consistency in decision-making.

As part of that effort, ACHC contributed expertise in accreditation and operational adherence during the development of the toolkit, helping ensure the guidance reflects both regulatory expectations and organizations' ability to operationalize it in real-world clinical environments.

Why Problematic MIFUs Create Operational Challenges

Hospitals and health care facilities often find that manufacturer guidance does not easily align with available products, operational realities, or legacy equipment in active use. A manufacturer may specify a cleaning or disinfection product by brand name, even when equivalent products with the same chemical composition exist. When an alternative product is already approved and used throughout the facility, it creates adherence issues. In many cases, the required product may not be available under existing purchasing agreements or may no longer be commercially available, particularly for older equipment that continues to operate safely in patient care environments.

These scenarios create operational burdens for infection prevention and environmental services teams and increase the potential for staff confusion and inconsistent processes. Requiring multiple disinfectants that ultimately achieve the same level of disinfection can complicate workflows rather than strengthen patient safety efforts.

Historically, health care organizations addressing problematic MIFUs lacked a universally accepted process for evaluating safe, equivalent alternative approaches. The result? Missing or inadequate risk assessments that lead to inconsistent understanding by health care staff and even varying surveyor interpretations.

The Importance of Standardized Risk Assessments

The APIC toolkit helps address that gap by introducing a structured, multidisciplinary template for evaluating problematic MIFUs and documenting risk mitigation strategies. The guidance encourages collaboration among infection preventionists, nursing leadership, quality teams, regulatory professionals, facilities management, and other stakeholders to jointly evaluate potential risks and operational realities.

Importantly, the toolkit does not encourage organizations to disregard manufacturer guidance. Instead, it provides a practical, evidence-informed framework for evaluating situations in which manufacturer instructions may not align with current procedures for low-level disinfection, the use of comparable, available products, or established infection prevention practices.

The guidance also reinforces the importance of high-quality risk assessments, an area where some healthcare organizations may have limited experience or inconsistent internal processes. By providing evaluation algorithms and structured documentation approaches, the toolkit helps organizations conduct more thorough and defensible assessments while improving consistency across teams, regardless of the service department.

Balancing Adherence and Operational Reality

From ACHC’s perspective, flexibility in disinfection is not appropriate for critical or semi-critical equipment. But for non-critical equipment that requires low-level disinfection, a meaningful risk assessment can identify solutions without compromising quality. The APIC toolkit supports standardized approaches that improve documentation, evaluation rigor, and multidisciplinary decision-making when addressing problematic MIFUs. More consistent methodologies support stronger mitigation strategies and improved alignment between operational realities and adherence expectations.

Organizations increasingly need practical, evidence-informed approaches that balance patient safety, infection prevention, operational feasibility, and regulatory adherence. The APIC toolkit represents an important step toward helping health care organizations approach problematic MIFUs with greater consistency, collaboration, and confidence.

For infection prevention and facilities leaders, the broader takeaway is clear: Addressing problematic MIFUs requires more than simply identifying adherence concerns. It requires multidisciplinary collaboration, critical evaluation of real-world workflows, and structured risk assessment processes that support both patient safety and procedural consistency.