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TECH Talk: Instructions for Use: Critical to Patient Safety

08.01.2019 • Industry News

You hear it in departments, publications, at local conferences, from vendors: The answer to every question you have… is in the instructions for use (IFU). Seems simple, right? Not necessarily. Consider the following questions you might have:
  • Where is the IFU?
  • What if I can’t find what I am looking for in the IFU?
  • Do I have time to look at the IFU?
You rely on industry guidelines to assist in your day-to-day practice, but there is more to consider. The sterile processing industry is constantly evolving and it’s vital to stay on track with the changes.

An example of a recent industry change is the FDA update to requirements and recommendations for instrument manufacturers to provide validated reprocessing instructions in 510K submissions. Specifics to the update include: point of use cleaning, safe handling, disassembly, thorough cleaning (proper cleaning solutions, ultrasonics, and brushes), disinfection, and sterilization. The FDA states “…all reusable medical devices are to be designed and constructed to allow adequate cleaning, because if a device cannot be adequately cleaned, any subsequent disinfection or sterilization process may not be effective.” (1)

So how do you keep it all straight? Here some ways you can stay in check with IFUs in your Sterile Processing Department:
  • Become an IFU expert: dissect the reprocessing information in an IFU and talk about it with your team
  • Engage with educators: create worksheets or short quizzes to test knowledge on common instruments, recent challenges, and new instrument IFUs
  • Create a contact list: list of vendors and manufacturers (by the instrument sets and products they represent) to contact if the IFU is not accessible or there is a question
  • Ask for more from your vendor and manufacturer reps: when they perform a training, ask them for a copy of the IFU; having them describe in detail the reprocessing instructions for the department
  • Make IFUs easy to find: having a common place for accessibility of the IFUs. We recommend OneSource.com.
TECH Talk Tip: When in doubt, stop! Ask questions and then proceed. What you do next is critical and important not only to instrument care but most importantly to patient safety. If you skip or miss a step, that could be the step that changes the outcome in the OR.

Jamie Zarembinski, CCSVP
Key Surgical

(1) Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling