Instructions for Use (IFU) is not merely a supplementary document, but a legally binding, consequential framework for clinical safety and operational feasibility. Because facilities absorb the liability when deviating from an IFU, value analysis teams must rigorously scrutinize these documents prior to product approval. Poorly designed IFUs—especially those with vague reprocessing protocols, complex multi-step cleaning requirements, or hidden warnings—pose significant latent risks, including device-related infections and sentinel events. By systematically reviewing the IFU in collaboration with sterile processing, infection prevention, and end-users, value analysis professionals can proactively identify operational barriers, demand human factors validation from manufacturers, and ensure that the facility can realistically execute the required protocols, thereby safeguarding both patients and the institution.

Key Highlights for Supply Chain Professionals

• Hidden Costs in the IFU: Thoroughly review the IFU to identify required proprietary accessories (e.g., specific brushes, trays, channel adapters, or cleaning chemistries) that are sold separately, ensuring these are factored into the Total Cost of Ownership (TCO).
• Supply Chain Fragility: Be wary of IFUs that dictate the use of single-source consumables, as this dependence can create supply chain vulnerabilities and bottlenecks.
• Vendor Accountability and Documentation: Do not rely on verbal summaries from vendor representatives. If the IFU contradicts the vendor’s claims or in-service materials, demand written clarification. Additionally, require manufacturers to provide summary reports of usability validation (human factors testing) for higher-risk devices.
• Cross-Departmental Feasibility: Engage Sterile Processing (SPD), Infection Prevention, and Biomedical Engineering early in the review process to verify that the facility possesses the specific equipment, chemistries, and time required to execute the IFU safely.
• Liability and Risk Mitigation: Understand that non-compliance with the IFU shifts liability from the manufacturer to the healthcare facility.

Reference:
Garrett, J. H., Jr., & Orlando, A. M. (2026, May 29). Beyond the box: Why value analysis must take instructions for use (IFU) seriously. Value Analysis.