By: Jhmeid Billingslea and Angela Lewellyn on July 2021
Sterile Processing professionals are keenly aware of the statement, “Follow the Manufacturer’s Instructions for Use (MIFUs).” But what happens when the IFU’s do not match the product we are using? Do we choose to follow the MIFU for the instrument, the product we use, or the MIFUs for the equipment? Usually, we are so laser-focused on the MIFUs for the instrument, that we may ignore the other MIFUs. If you have found yourself in this predicament, we would like to share some valuable solutions.
A single tray might contain items from as many as seventeen manufacturers; not to mention that each tray is subject to the MIFUs for the instrument spray, the enzymatic cleaner, the ultrasonic, the washer-disinfector, the instrument air, the magnified inspection light, the borescope, the instrument testing tools, the tray liners, the silicone mats, the instrument stringer, the internal chemical indicators, the towels or corner protectors, the rigid container or wrap, the tape or other external indicators, the labeling systems, and the pens used on the count sheet or the label. That is twenty-one additional MIFUs per tray. There is no mystery why this is confusing!
The first step in eating the MIFU conflict elephant is deciding which work to rule out. When reviewing MIFUs, many instructions do not match, or some that have process steps that are completely left out. A piece of advice we offer is that there is no conflict if your equipment cycle time exceeds the minimum cycle time stated by the product manufacturer of the product states or if no minimum time is stated on the product MIFUs.
Start the process of resolving MIFU conflicts by answering these questions:
To devise a plan of which IFU to use, the following references may help us to deduce the information provided or excluded from the manufacturer.
As professionals, we all know that MIFU compliance is the best way to protect our patients. We also know that not all MIFUs are created equal. It is up to us to take the extra step of reaching out to clarify instructions. These instructions should be constantly reviewed by leaders. A multidisciplinary team is an excellent place to discuss product, instrument, and equipment disagreements with stakeholders and take immediate action to resolve these issues. Full knowledge of the MIFUs in our department allows us to advocate for technology and equipment that ensures compliance.
Reprocessing medical devices in healthcare settings: validation methods and labeling guidance for industry and Food and Drug Administration staff. Document issued March 17, 2015.
ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities. Association for the Advancement of Medical Instrumentation. Arlington, VA.
AAMI TIR12:2010, Designing, testing, and labeling reusable medical devices for reprocessing in healthcare facilities: a guide for device manufacturers. Association for the Advancement of Medical Instrumentation. Arlington, VA.
ANSI/AAMI ST81: 2004/(R)2010, Sterilization of medical devices—information to be provided by the manufacturer for the processing of resterilizable medical devices. Association for the Advancement of Medical Instrumentation. Arlington, VA.
Manufacturer’s Instructions for Use – Addressing Conflicts Amongst IFUs for Different Equipment and Products. posted March 17, 2021. https://www.jointcommission.org/standards/standard-faqs/home-care/leadership-ld/000002252/. Accessed 06/25/2021
Cleaning Instructions for Use: A Central Sterile Service Department Perspective. Susan Klacik. posted 2012.https://meridian.allenpress.com/bit/article/46/sp12/80/142436/Cleaning-Instructions-for-Use-A-Central-Sterile. Accessed 06/25/2021
Missing links in manufacturer instructions-for-use can lead to process kinks. Rick Dana Barlow. posted October 20, 2016. https://www.hpnonline.com/sterile-processing/article/13000341/missing-links-in-manufacturer-instructionsforuse-can-lead-to-process-kinks. Accessed 06/25/21
Written by: Angela Llewelyn LPN CRCST CHL
Director of Development & Research
Advantage Support Services, Inc.
Written by: Jhmeid Billingslea CRCST CIS CHL CMRP CST
Managing Director Surgical Services
Advantage Support Services, Inc.
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