When evaluating medical devices and products, Healthcare Value Analysis Professionals often focus on evidence, outcomes, and costs. Yet one critical factor that directly influences all three is sometimes overlooked: the quality of a device’s Instructions for Use (IFU). Robust IFUs that are easy to comprehend, validated through human factors testing, and designed to guide safe and reliable use are not just a regulatory requirement — they are essential for protecting patients, supporting clinicians, and ensuring that value analysis decisions translate into real-world success.
From a safety perspective, IFUs serve as the frontline defense against misuse and error. Complex or poorly written instructions can lead to incorrect assembly, improper cleaning, or unsafe application of a product, directly increasing the risk of preventable harm. Human factors validation ensures that instructions have been tested with real end-users — nurses, technicians, and physicians — to confirm they can be followed accurately under real-world conditions. For value analysis leaders, this validation provides confidence that the device can be used as intended, consistently and safely, across all care settings.
IFUs also impact financial and operational outcomes. Devices that require excessive training due to confusing instructions can increase staff burden, lengthen onboarding times, and lead to costly errors or rework. By contrast, clear, standardized, and user-friendly instructions reduce variation, improve staff compliance, and help organizations maintain regulatory readiness. When VA professionals factor the strength of IFUs into their evaluations, they are not only assessing the product itself but also the broader system of safe and efficient implementation.
The Association of Healthcare Value Analysis Professionals (AHVAP) has developed comprehensive guidance and a call for action to improve Instructions for Use associated with medical devices and products. Increased human factors validation of these critical instructions and documents is necessary to improve safe usage of these products. Industry Partners must partner with healthcare clinicians and facilities to innovate IFUs and create simplicity in both device design and IFU documents and associated training materials. One of the major current challenges faced by the industry is regarding cleaning and disinfecting instructions for reusable medical equipment. Many manufacturer recommendations specify a disinfectant brand rather than a formulation type which allows wider flexibility for the healthcare facility to utilize their preferred EPA-registered, hospital-grade disinfectant product. All Healthcare Value Analysis Professionals and Infection Preventionists should pursue the new AHVAP Certification Center Mastering Instructions for Use (IFU) for Medical Products micro-credential to enhance their knowledge about Instructions for Use.
Ultimately, robust IFUs are a cornerstone of evidence-based value analysis. They bridge the gap between product design and patient care, ensuring that the safest and most effective use of a device is accessible to every clinician. By prioritizing IFU quality in their evaluations, VA professionals advance the goals of their organizations — safer care, better outcomes, reduced preventable harm, and long-term financial stewardship.
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. Dr. Garrett is the lead faculty member of the AHVAP Certification Center Micro-Credential Program on Instructions for Use.
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