Ideas That Work: Examine IFUs Before Purchases

Practical pearls from your colleagues

Thinking of buying a new product for your facility? Of course, you’ll want to trial the product first, but also take a preemptive look at its Instructions for Use (IFU), advises Garrett Hollembeak, CRCST, CIS, CHL, CER, CIC, system infection preventionist (IP) - medical device reprocessing with Bon Secours Mercy Health in Cincinnati.

Mr. Hollembeak says infection prevention, sterile processing, OR leadership and end users such as surgeons, your facilities team and other stakeholders should examine IFUs before purchases to confirm your center can both achieve and maintain compliance with them.

“The value analysis needs to be led by a strong central leader who can say, ‘Infection prevention, what are your concerns? Safety, what are your concerns? Facilities, what are your concerns?’ and keep track of everything,” he says. “Otherwise, if an IP doesn’t know the equipment and detergents and workflow in sterile processing, they may sign off on that product without really deep-diving into the IFU.”

This inclusive IFU preview is especially important for sterile processing departments, which sometimes discover how challenging it is to comply with an IFU after a product is purchased without their consideration. “That way, they know, ‘Hey, we don’t have the model of automated endoscope reprocessor that is required to support this piece of instrumentation,’” says Mr. Hollembeak. “You may know you have one, but do you have the right type, brand, model? Does it have the capabilities you need?”

If you can’t currently comply with an IFU, determine the changes you would need to make to do so. “Would it be the purchase of a new type of detergent or a different size brush?” he says. “Or would this be a hard stop where it’s a capital investment you can’t comply with right now, or you just don’t have the bandwidth or capacity to comply with it at all because of the way the IFU is written?”

This exercise is particularly important at outpatient facilities where instrumentation and equipment are brought in by physicians. “They may not even have the IFUs accessible for those,” says Mr. Hollembeak.

He encourages centers to consider the human factors involved as well. “Make sure you can comply with an IFU in real-world scenarios,” says Mr. Hollembeak. “Say the IFU outlines a 10-minute soak in your reprocessing sink, and even if you have two bays of sinks, you’re not going to accomplish soaking all those instruments for 10 minutes. Then staff begin cutting corners — maybe they defer to the enzymatic detergents’ contact time of two or five minutes — and then you’re out of compliance with the manufacturer’s IFU.” OSM