Value Analysis Professionals have a daunting task as they must manage so many areas in the healthcare supply chain like new product request evaluations, resilience product alternatives, solving product problems such as increasing infection rates, recalls, contract conversions, and so much more. One area that can fit into just about every Value Analysis Professional’s role is that of the IFU or Instructions for Use which are provided by the manufacturers of the products for the end practitioners to follow.
That is what we are going to discuss in this interview. Yes, IFUs are set in stone by the manufacturers – but what about everything else before, during, and after the IFU that needs to be considered?
Today, I am speaking with a clinical expert from PDI who will share their valuable insights into how Value Analysis Professionals should be addressing IFUs in their day-to-day duties.
HVAUMM: Tell us a little about your background and expertise in IFUs and specifically how you got involved in the healthcare supply chain (and/or value analysis teams) throughout the country.
AB: My background is in infectious disease epidemiology, and I previously served as the System Director of Infection Prevention and Employee Health for a large midwestern health system. In this role I had responsibility for reviewing and evaluating IFUs for both products and devices specific to infection prevention activities but also as a part of ensuring that we were ready for regulatory surveys. I also had the opportunity to serve on value analysis committees for various product categories across infection prevention and employee safety. This experience has been enormously helpful in my current role at PDI as I work with our customers to navigate complex IFU issues and also as I work with my PDI colleagues on how we can best support our customers with product IFUs and communications.
HVAUMM: Why are IFUs often treated as the overlooked element — or the “stepchild” — of the value analysis process? Despite being commonly included as requirements for things like new product requests, and although I’ve reviewed hundreds of IFUs over the years, I’ve never once seen or heard an IFU discussed during a value analysis meeting in my 33-year career.
AB: In the value analysis process, a lot of emphasis is placed on product characteristics and price, however, sometimes the practicalities of implementing a product become an afterthought. But we know that if a product is not easily integrated into existing practice and workflow, then compliance, and ultimately patient care, will be compromised. A critical piece of that integration is how a product will either clean other products or be cleaned itself, and that is where the IFU comes in. It is important to consider the IFU for any new device or product being evaluated and whether the organization can easily clean or care for that product without needing to bring in additional products. Alternatively, when evaluating cleaning or disinfecting products, the IFU should be reviewed to ensure that the product is compatible with a majority of the surfaces and devices it will be used to clean or disinfect. This compatibility question has been an issue of increasing focus for regulators such as The Joint Commission and we are hearing that there have been more citations issued to organizations who are not adhering to IFUs.
HVAUMM: Explain to us how PDI works with health system Value Analysis Professionals to ensure that the IFUs are brought to the forefront of VA evaluations and other VA projects.
AB: PDI works closely with health systems to interpret IFUs and provide additional information from device manufacturers to make IFU compliance and survey participation easier. Health systems typically engage value analysis teams in two scenarios: (1) when considering adoption of a new PDI disinfectant wipe, and (2) when introducing new medical equipment into their facility.
When a health system evaluates a new disinfectant wipe, we conduct a detailed assessment. The system provides a list of approximately 25–50 high-priority medical devices that are likely to be reviewed during surveys. For each device, we verify whether the device’s Instructions for Use (IFU) specify compatibility or permitted disinfectants. We then recommend a disinfectant portfolio that maintains alignment with IFUs while minimizing the total number of disinfectant products to support policy standardization across the enterprise. If medical device prioritization support is needed, we apply criteria such as fleet size, level of patient contact, cost, and active warranties, supplemented by insights from prior Joint Commission findings. Using this framework, commonly prioritized categories include glucose monitoring systems, infusion pumps, beds and mattresses, ultrasound equipment, patient monitors, and neonatal incubators and warmers.
For current PDI customers introducing a new medical device, we are often asked to confirm whether an existing PDI wipe is compatible. Most requests are resolved when the device IFU lists a PDI product. Where the IFU is silent or non-specific, we collaborate with the manufacturer to obtain written confirmation based on existing (sometimes unpublished) data or to generate new evidence. Depending on manufacturer requirements, this may involve a formulation comparison to an already-listed product or formal material-compatibility testing. These engagements typically require close, cross-functional coordination among the health system, the device manufacturer, and our technical team.
HVAUMM: How can Value Analysis Professionals reset their new product evaluations to bring the IFUs front and center instead of forgetting about them?
AB: It’s important to consider that IFU compliance can be just as important to the value of a product as clinical characteristics or price. If the IFU is difficult to comply with, then the organization could face financial penalties because of poor patient outcomes or citations from agencies like The Joint Commission, both of which can severely impact the ability to provide quality care. IFU non-compliance can be considered an indirect cost of using a particular product in contrast to the direct cost of the purchase price. By including implementation considerations and IFU compatibility as a critical assessment point alongside characteristic and price, Value Analysis Professionals can ensure that the organization is not bringing in a product that is going to cause unexpected financial impacts or increase the risk of poor patient outcomes.
HVAUMM: What do you recommend for Value Analysis Professionals who want more education on IFUs so that they don’t get caught up in an IFU related issue in the future?
AB: I am a huge advocate for education to better understand complex issues like IFU compliance. PDI has an excellent team of Infection Prevention Professionals who are available to provide training and education on the latest guidance around IFU compliance as well as provide the perspective of the healthcare providers who are often responsible for IFU compliance. The Association for Professionals in Infection Control (APIC) recently released a report on IFU compliance that could help Value Analysis Professionals understand the issue from the perspective of the end user.
PDI’s Compatibility landing page provides resources to support clinicians in selecting Sani-Cloth® disinfectant wipes aligned with their equipment IFUs. The page includes two sections: One for healthcare professionals focused on product selection and implementation, and one for equipment manufacturers to facilitate collaboration on additional information or testing that may be needed during manufacturers’ IFU evaluations.
PDI customers may also order complimentary Point-of-Care Accessories designed to support adherence to both wipe and equipment IFUs. Commonly used items include canister brackets, the Sani-Canister Caddy, and Sani-Tag labeling stickers. Brackets and caddies help ensure wipes are available at the point of use and display key product details (e.g., contact time and formulation type). Sani-Tag labels are color-coded and available in two sizes — 1″×1″ and 4″×4″ — to indicate, per facility policy and/or device documentation, which Sani-Cloth products are appropriate for a given device or surface. We encourage Value Analysis Professionals to leverage these resources in partnership with Infection Prevention and Clinical Engineering.
Interview with:
Alice Brewer, MPH, CIC, CPHQ, FAPIC, PDI Senior Director of Clinical Affairs
Alice has over 15 years of experience as an epidemiologist in both the pharmaceutical and healthcare industry. She has a record of publications and presentations in the fields of infectious disease and epidemiological research methodology. She has led programs and teams in the areas of regulatory affairs, surveillance, data analysis, and clinical research. Alice earned a Bachelor’s degree in Molecular Biology, a Master’s degree in Public Health Epidemiology, and is pursuing a Doctorate in Health Sciences. She is certified in Infection Control and Epidemiology and as a Healthcare Quality Professional. She is also a Fellow of APIC and an active member of SHEA, ACE, and APHA.
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