Sterile processing (SP) is a highly technical and fast paced environment that supports the care of patients through surgical operations and the delivery of sterilized items that are used during these procedures. The medical devices and surgical instruments that are required for surgery can be very complex and require specific processes to prepare them. The set of detailed instructions that accompanies all medical devices are known as the manufacturer’s instructions for use, M-IFU. It is extremely important for sterile processing staff to be provided with these instructions so they can complete their responsibilities of cleaning, sterilizing, inspecting, preparing, and handling. But are all IFU’s readily available and easy to understand?
The truth is, that in some circumstances practices for cleaning and preparing these complex devices came to be through on-the-job training, or habits formed along the way. It is not uncommon to see deviations from the IFU for many reasons, inability to access, too much detailed information, improper reprocessing resources that do not align with the IFU. Not only can the steps be tedious and lengthy, but there are so many different steps to remember, it’s nearly impossible to expect SP professionals to memorize it all. There can be challenges with interpreting the information found in the IFU, from terminology variations to variances in the step-by-step guidance.
All manufacturers must understand that not all sterile processing departments (SPDs) are the same or can achieve the same levels of reprocessing. It is not acceptable for SPDs to create their own cleaning or sterilization practices, and manufacturers must provide all the information necessary for quality reprocessing to take place and be easily explained.
Instructions for use for medical devices are to be provided by the manufacturer of the product or device and the amount of guidance and information is highly regulated. The Food and Drug Administration (FDA) has rules that help manufacturers determine what information is required. This information should include both cleaning and sterilization steps, and the necessary tools required to complete a full reprocessing cycle. Every medical device has its own IFU, in the United States devices and medications cannot be sold until the validation testing that is required by the FDA shows that the device can be effectively cleaned, disinfected, or sterilized while following those instructions. If there are deviations in the IFU and the steps are not able to be followed, or there are conflicts with the information that result in adverse outcomes, every healthcare professional can contact the FDA to report their concerns, barriers, or challenges if indeed they followed the instructions and outcomes were adverse.
It is the responsibility of all industry partners, vendor representatives, quality departments and SPD leaders to ensure the accessibility of these important instructions for their teams to properly do their reprocessing duties. IFU’s that are not accessible to staff members, or never reviewed, shared, or discussed could potentially be ignored, and lead to poor patient outcomes. It’s every SPD professional’s responsibility to follow these instructions and ask questions when confusion arises. IFU compliance is a must because they can impact patients’ lives when the instruments are contaminated or not properly sterilized. It is also critical to educate our reprocessing technicians on how to find, read and understand these detailed “recipes”.
Interpretation And Language
Every IFU is unique, from its structure to the content and the layout of the document itself. Some IFUs are provided with the product itself. For example, when ordering a new power drill for ortho surgery, you may find the IFU in the package, in a pamphlet or booklet or long document. You may also locate the IFU by reaching out to the manufacturer and asking for an updated version. All manufactures are required to provide these anytime they are released, updated, revised, or needed. SPD professionals must be aware of what they are looking for in the IFU, and where to locate that information. Departments should have a structured and universal method to obtaining IFU’s and storing them within reach. Because of the intricacies of detailed information, educators and leaders must prepare their team on how to read and understand the applications of what’s inside the IFU, making it easier for their teams to follow the guidance and keeping all the IFUs readily available. This can be accomplished digitally, manually or a mixture of both.
It is also important to have other forms of IFUs for all necessary things to complete a full reprocessing cycle and provide devices to the patients who are having procedures. That includes more than just the IFU for the surgical instruments, but everything used in that department.
- Operators Manuals
- Technical Manuals
- Safety and warnings
- Proper maintenance and service requirements
Chemistry and Detergent
- Instructions for Use, Dosing, Protocols
- Safety and handling instructions
- Storage and shelf life
- Safety Data Sheets
Inspection Tools and Resources
- Heat Sealers
- Borescope Use and Instructions
- Insulation Testing Protocols, Instructions, Usage
- Biological Testing Incubators
Supplies and Consumables
- Shelf Life for Supplies used to prepare surgical trays.
- Filters, Indicators, tray liners and barrier packaging
- Cleaning brushes, cleaning tools
Safety and Hazards
- Spill kits
- Emergency eyewash, shower stations
- Fire Extinguishers
ANSI/AAMI ST 79:2017. Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities.
Immediate need for healthcare facilities to review procedures for cleaning, disinfecting, and sterilizing reusable medical devices.
Reprocessing medical devices in healthcare settings: validation methods and labeling guidance for industry and Food and Drug Administration staff. Document issued March 17, 2015.