Manufacturers Instructions for Use - Expectations Regarding Access To IFUs for Medical Instruments and Devices

What are The Joint Commissions expectations regarding access to manufacturer’s instructions for use (IFU) for cleaning, disinfection, and/or sterilization of instruments, devices and products used in the delivery of patient care?

Any examples are for illustrative purposes only.

IFUs for Medical Instruments and Devices:
The Joint Commission requires organizations to provide access to information needed to support the Infection Prevention and Control program. The FDA requires manufacturers of medical instruments and devices to provide specific instructions on how to properly clean and/or disinfect these items.  These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device. IFUs may include information about maximum number of times the item may be reprocessed as well as storage requirements.  It is important to understand that each patient care item has its own IFUs for cleaning and disinfection and the expectation is that the organization will follow those instructions. Failure to follow such instructions or misuse creates significant risk to safe, quality care.

IFUs for Cleaning, Disinfection and Sterilization Products:
Products used during cleaning, disinfection and sterilization include specific IFUs to ensure efficacy and/or confirmation that cleaning, disinfection or sterilization cycles are successful.  Accredited organizations must follow instructions for quality control of the process, including dilution of products, efficacy testing of the solution or process, exposure times, and acceptable temperature and pressure ranges.  
Last updated on April 15, 2020
Manual: Home Care
Chapter: Leadership LD

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