There’s no underestimating the importance of Instructions For Use (IFU) documents. In a life-or-death situation, the most current instructions are critical for patient safety.
There’s no underestimating the importance of Instructions For Use (IFU) documents. In a life-or-death situation, the most current instructions are critical for patient safety.
Healthcare product manufacturers are required to produce and provide Instructions for Use (IFU) documents for their reusable surgical instruments, medical devices and equipment and implantable biologics, materials and devices.
To minimize healthcare-associated infections (HAIs) and adhere to accreditation standards, your Sterile Processing and Operating Room technicians continually refer to these documents as they maintain and prepare equipment.
The first step in this process is to ensure validated IFUs are easily accessible to everyone throughout your facility who needs them. oneSOURCE offers IFU-related libraries for two primary categories of products:
CMS is very clear about the purpose and value of manufacturer IFUs in maintaining device sterility. The agency has stated, “If manufacturers’ instructions are not followed, then the outcome of the sterilization process is guesswork, and the practices should be cited as a violation…”
The oneSOURCE Surgical Instruments & Equipment Library contains validated manufacturer IFUs for reusable surgical instruments, devices and equipment. Your technicians in Sterile Processing, Infection Prevention, Decontamination and Operating Room departments throughout your facility can be confident they have the most recent cleaning, decontamination and sterilization guidelines.
More than 80% of U.S. hospitals, including HCA, Ascension Health, Mayo Clinic and Community Health Systems, subscribe to oneSOURCE’s Surgical Instruments & Equipment Library with IFUs from dozens of manufacturers.
The regulatory and accreditation agencies are just as adamant that IFUs are readily available to your Sterile Processing and Operating Room technicians who handle materials implanted into patients – including biological and non-biological tissues and devices.
Biologic tissue Instructions For Use (IFUs) include critical information regarding the storage, handling and preparation of sterilized human-, bovine-, and porcine-derived materials. IFUs for nonbiological implants include similar preparation instructions for prostheses and devices as well as re-sterilization instructions for certain materials (e.g., screws or rods) unused in given procedure that can be used in a future case.
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