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IFUs: What are they and why are they important?

Every three years The Joint Commission (TJC) conducts a survey at each Yale New Haven Health delivery network to measure hospital performance.

During the survey, TJC surveyors select a patient and follow the patient’s path throughout their hospital stay, observing practices, documentation and the environment, and interviewing staff and other patients. Surveyors ask about each patient’s care and the steps taken to ensure it was safe and high quality.

TJC surveyors review a broad range of topics with staff, including national patient safety goals, medication management, environment of care and clinical safety practices such as fire response and fall prevention strategies.

For the upcoming TJC survey, YNHH expects surveyors to increase their focus on manufacturers’ instructions for use (IFUs). Following IFUs is so important, surveyors will ask if they are readily available for all medical devices. Surveyors might also ask to review our processes to ensure staff are following IFUs.

The Food and Drug Administration requires manufacturers to provide specific instructions on properly cleaning and/or disinfecting medical instruments and devices. IFUs include the steps required for cleaning and disinfection, such as the level of disinfection (e.g., sterilization or high-, low- or intermediate-level disinfection). IFUs also cover the frequency of disinfection and products compatible for use on the device. Instructions may also include storage requirements.

Products used during cleaning, disinfection and sterilization have their own IFUs to ensure effectiveness and/or confirmation that cleaning, disinfection or sterilization cycles are successful. It is critical to follow these instructions to ensure quality control of the process. This includes (but may not be limited to) dilution of products, efficacy testing of the solution or process, exposure times and acceptable temperature.

It is important to understand that each patient care item has its own IFU. By following instructions, we ensure we are providing safe, quality care to our patients.

Your department director or manager is responsible for your area’s TJC survey readiness, in coordination with the YNHHS accreditation and regulatory liaisons assigned to each department. Contact your liaison with questions. If your area does not have a liaison, contact the Accreditation and Regulatory Affairs Department (in network only).