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Do I really need an IFU for that?

by Ryan Weiers

Simple solutions to everyday challenges are not always simple to find. So what do you do if you don't have manufacturer instructions for use to support the way you use an item? Is there a validated alternative, or another process you could use? How do you balance patient and staff safety with an efficient process? What would your surveyor say? What would you want if YOU were the patient?

Chances are, if you have worked in Central Sterile Processing for long, you have encountered a problem with a process that required a work-around, or some fix to make it work better. You've seen them, or maybe even come up with a few on your own. In many industries, this kind of initiative may be applauded. You are using ingenuity and resources on hand to solve a problem.

In SPD, however, this can lead to unintended consequences and potentially even harm to a patient or staff. You know you need IFU's for that, but sometimes you just have to because there is no good solution available at the moment. You're doing your best, so what's wrong with that?

Whenever possible - especially in non emergency situations - you must follow the manufacturer instructions for use to the letter. Any deviation from this could open you and your facility up to liability. But more importantly, it could put someone in harm's way. This can be difficult to remember when something seems so innocuous and simple, but the reality is there are almost always other variables at play outside your view that could cause your work-around to have unintended results. Is it possible that a piece of tape or paper, which is NOT intended or validated to go inside a surgical set could break apart, or leach ink or adhesive onto a surgical instrument that could harm a patient? Could a standard mesh bottom surgical tray - flipped to cover instruments sets during an automatic washer cycle - restrict water and detergent from contacting instruments, resulting in debris that could cause a surgical site infection? The chances may be slim, but are YOU really willing to take that risk to improve a process? That's a lot to take on. Your job is demanding enough.

Whenever possible, pause and ask yourself if there is a solution designed to solve the issue you're encountering. Ask your professional colleagues how they may have solved this problem, because chances are you're not the only one who has encountered this before. And please, don't accept the "this is the way we've always done it and it's never been a problem" justification. Nothing is ever a problem until it is and you don't want to be the one to have to explain why it's "always been done this way."

If you still can't find an acceptable solution you can always talk with us. We may not have the answer, but this is exactly the type of conversation that can lead to better solutions designed for SPD - designed for you.



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