Make IFUs Work for You

How to spot — and correct — gaps in your infection prevention processes without losing your mind.

Do you usually read instructions? I rarely do unless I’m stuck.

Take cooking, for example. Once I find a recipe I like, I tend to make it from memory, skipping the instructions. My husband often points out that my meals are never the same twice, and he’s not wrong! Depending on the ingredients I have, my available time and my mood, the meals I prepare always end up being quite different from the original recipe.

If you can relate, you know there are benefits to this approach, including making use of items on hand. The only sacrifice is a variation of the final product.

Dinner is (relatively) low stakes stuff, though. Now let’s think about your ASC. Does this type of behavior translate into your infection control practices? Are there slight variations in your reprocessing techs’ practices based on available resources, reliance on memory, or complacency regarding important but minor details? Have they actually read the manufacturer’s instructions for use (IFU) and, if so, how long has it been since they have?

IFUs provide detailed instructions to ensure that medical devices, equipment and surfaces are cleaned, decontaminated and sterilized as appropriate for their intended uses, reducing their risk of transmitting infectious agents. The methods used to clean, decontaminate and sterilize the items are validated based on the exact instructions and conditions detailed in the IFU. Variations in any step in the process can result in items that are not adequately decontaminated or not sterile.

Must-check areas

ASC leaders can identify gaps in IFU compliance by auditing practices in cleaning, decontamination and sterilization of instruments. Here are a few areas of focus in this endeavor, with questions to help you self-evaluate your center’s practices.

Environmental cleaning. Review your list of cleaning chemicals and detergents, ensure their IFUs are current, and audit your staff’s practices for compliance with the instructions.

• Does your center meet IFU parameters for all chemicals, including storage, temperature, humidity and ventilation if indicated?
• Are the chemicals in their original containers, with documentation of open and/or expiration date according to the IFUs?
• Are the products used according to their IFUs, including contact or “kill” time for surfaces, correct dilution if mixed, and replacement as appropriate?
• Is staff using the proper chemicals to clean equipment as indicated in the IFU of both the equipment and the chemical?

Decontamination area. Observe practices in this area with a focus on the manufacturers’ instructions for pre-cleaning, soaking, washing and preparation for assembly and wrapping. Compare the IFUs with actual processes for a variety of instrument sets, both commonly and rarely used.

• Are there any variations from the IFU? Is each step in the process followed correctly?
• Are the instruments prepared correctly? Are they disassembled completely with ports and clamps open? Any other details that should be observed?

Sterilization. Review the IFUs for a variety of instrument sets and compare to your actual process by observing your staff during assembly, wrapping and sterilization processes.

• Are the IFUs current and do you have one for each instrument or set, including vendor trays? Do all staff working in this area have access to the IFUs?
• Are the instruments processed according to all the steps in the IFU, including assembly, configuration, container or wrap, type of cycle, time, temperature, pressure, humidity, dry and quarantine time, if appropriate?

Completing these steps will help you evaluate your compliance with manufacturers’ IFUs, identify gaps and implement changes to your infection control practices. ASC Academy: Infection Prevention Online Course offers guidance and education on infection control best practices, along with a comprehensive mock survey to help you pinpoint and prioritize problem areas to maintain survey readiness. OSM