Understanding Hurdles To Successful Cleaning and Disinfection Following IFUs

Instruction for use (IFUs) and care and maintenance documents provide manufacturer recommendations for cleaning, disinfecting, and reprocessing. The challenge to cross all the hurdles begins here. There is not just one IFU. Something that is not considered is how many IFUs there actually are.

The Multitudes of IFUs

There are raw material IFUs – every manufacturer of raw materials creates an IFU for care and maintenance. Assemblies of multiple materials on one product have individual IFUs. This information must be included in the one IFU written by the product manufacturer.

Now, consider the multitude of medical devices and environmental surface materials in a single room or area. It is rare for any of these IFUs to align, adding to the task’s complexity.

Recommended Disinfectants

IFUs also identify the disinfectant they recommend for use. It’s important to note that disinfectant recommendations are often influenced by disinfectant companies rather than the needs of healthcare facilities. Disinfectant companies actively seek to build relationships with medical device manufacturers, who ultimately specify the use of their particular disinfectant.

Regulatory Requirements

The EPA sets requirements on the label for all EPA-approved disinfectants. Problems arise if a product’s IFU gives instructions that conflict with the EPA product label, such as diluting the disinfectant.

To make matters more complex, regulatory agencies require healthcare professionals to follow the manufacturer IFUs or suffer sanctions and penalties.

There Is No Room For Confusion With IFUs

Understanding and following IFUs is a complex task, with multiple documents and recommendations to consider. The importance of reviewing IFUs prior to cleaning and disinfection cannot be overstated. Healthcare professionals, especially those directly involved in these processes, play a crucial role in ensuring compliance with manufacturer recommendations. There is no room for confusion when it comes to referencing these documents.

HSI Is Taking Action

For years, healthcare professionals have expressed frustration and confusion. Recently, regulatory agencies announced that they will renew their focus on the requirement to follow IFUs beginning in July 2024.

The Healthcare Surfaces Institute (HSI), in collaboration with Caroline Etland, former President of HSI and a faculty member in the Hahn School of Nursing and Health Science at the University of San Diego, just launched a research survey to gather data about challenges healthcare professionals face when following IFUs. The survey will take about five minutes to complete, and the data we collect will help us work toward critical changes that must be made.

Who Should Take This Survey?

We are looking for input from professionals who work in:

• Infection prevention
• Environmental services
• Sterile processing
• Facilities management
• Biomedical
• Nursing

This data will be instrumental in supporting necessary changes in the way manufacturer instructions for use (IFUs) are written and enforced. Your participation will contribute to our advocacy for critical changes that enhance clarity and effectiveness in healthcare practices. View a PDF regarding informed consent for participating in this survey.

Seize the opportunity to influence the future of healthcare safety. By taking this survey, you can play a crucial role in this important initiative. Click here to begin!