Tucked inside nearly every medical device package is a document that carries serious clinical, legal, and operational weight, and it routinely gets less attention than the device itself. The Instructions for Use (IFU) defines how a device may be safely used, cleaned, reprocessed, stored, and combined with other equipment. For value analysis teams evaluating products before they enter the supply chain, the IFU is not a formality. It is one of the most consequential documents in the entire review.
A manufacturer’s IFU is binding. When clinicians or reprocessing techs deviate from it, the facility, not the manufacturer, generally absorbs the liability. The FDA and The Joint Commission treat IFU adherence as a baseline expectation. When something goes wrong, an infection, a device failure, a sentinel event, investigators compare what happened against what the IFU said should happen. An IFU that cannot realistically be followed in your environment is not an inconvenience. It is a latent risk waiting to surface.
The harder problem is that many IFUs are not well designed. The FDA expects manufacturers to apply human factors and usability engineering under IEC 62366-1, but in practice, IFU quality varies dramatically. Some read like they were translated three times. Others bury critical warnings in dense paragraphs of fine print. Reprocessing instructions are a particularly well-documented weak point. The duodenoscope outbreaks of the last decade made clear that even high-acuity devices have shipped with reprocessing IFUs frontline techs could not consistently execute. Multi-step cleaning protocols requiring specific brushes, channel adapters, or enzymatic agents tend to fail in real-world conditions.
This is where value analysis adds protective value. Before a product gets approved, the IFU should be read end to end, not skimmed, not summarized by the vendor rep, but read by someone trained to look for problems. The questions worth asking are practical ones. Can your sterile processing department perform the reprocessing steps with the equipment, chemistries, and time it has? Are required brushes, trays, or accessories sold separately, and have those costs been included in the total cost evaluation? Does the device assume compatibility with other equipment your facility may not own? Are contraindications and warnings written so a busy clinician would catch them, or buried in paragraph fourteen? And can the manufacturer document that the IFU was validated through usability testing with representative end users?
A few red flags should trigger deeper review or an outright pause. Vague reprocessing language like “clean thoroughly” or “rinse adequately,” rather than specific times, temperatures, and concentrations, is a warning sign. Dependence on proprietary cleaning chemistries or single-source consumables creates supply chain fragility and belongs in the risk discussion. Inconsistencies between the IFU, the quick reference guide, and the in-service training materials suggest the manufacturer has not aligned its own documentation, which makes consistent safe use across staff much harder to achieve. And an IFU that materially differs from how the vendor rep describes the device in person is a serious problem worth getting clarified in writing before approval.
It is also fair to ask the manufacturer directly whether the IFU has been human factors validated, and to request the summary report. For higher-risk devices, that work should have been done. A vendor who cannot produce evidence of usability validation, or who treats the question as unusual, is telling you something about their quality system that belongs in the purchase decision.
Building IFU review into the workflow does not have to slow the process unmanageably. A brief IFU appraisal checklist on the standard product evaluation form takes minutes per submission. Looping in sterile processing, infection prevention, biomedical engineering, and the clinical end users early gives those disciplines a chance to flag feasibility issues before contracts are signed. Documenting the review in the value analysis record creates institutional memory and a defensible audit trail if questions arise later.
The cost of getting this wrong is significant. Device-related infections, recalls, and litigation tied to off-IFU use are expensive and often preventable at the front end. The cost of doing it well is mostly a matter of discipline and a willingness to ask the unglamorous questions before a product enters the building.
Value analysis professionals occupy a unique spot in the system. You see the device before the patient does. Treating the IFU as a first-class part of the review, rather than a downstream concern for clinical educators or sterile processing, is one of the most consequential safety contributions the function can make.
Article by:
J. Hudson Garrett Jr., Ph.D., MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, VA-BC, BC-MSLcert™, MSL-BC, CPHRM, LTC-CIP, CPPS, CAE, CPHQ, CVAHPTM, CMRP, CPXP, CDIPC, FACDONA, FAAPM, eFACHDM, FNAP, FACHE, FAPIC, FSHEA, FIDSA, FAHVAP
Dr. Garrett is the Executive Director and Executive Vice President for the Association of Healthcare Value Analysis Professionals (AHVAP) and an Adjunct Assistant Professor of Medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine.
Anne Marie Orlando, MBA, BS, RN, RCIS, CVAHP, CMRP, PNAP, FACHDM, FAHVAP
Anne Marie is the Vice President of Clinical Services at Yankee Alliance and serves as the President of the Board of Directors for the Association of Healthcare Value Analysis Professionals (AHVAP).
Articles you may like:
Is Your Value Analysis Program Ready for the CMS TEAM Model?
