IFUs: What should providers do to influence format and content?

Oct. 28, 2019

Instructions for Use (IFUs) are an important part of the central sterile processing department (CSPD) in support of infection control, quality and patient safety. An effective starting point is to develop a standard template that can be accessible and useful to all. This is fundamentally necessary to assist staff in knowing where to look for particular information quickly to complete their duties in support of patient care and safety.

Where are we today?

The upside is that thousands of IFUs are available electronically either from the manufacturer or through an electronic subscription service, such as oneSource, which is an online database that collects manufacturer IFUs and provides access for a fee, or Petriss, which ties the IFUs electronically to manufacturers IFUs in decontam and prep. The downside is that these services only collect and store IFUs provided by manufacturers in the format given by the manufacturers. The IFUs are not structured in a standard format and vary in length from 6 pages to more than 100 pages! How are CSPD technicians going to find the information they need in a timely manner, and complete their duties efficiently?

In search of: Templates 

The CSPD community needs to collaborate with the FDA to devise a standardized template to be used as a quick reference. The manufacturers should utilize this template as a cover page to the existing IFU. Sounds simple, right? Not so much. Every manufacturer has their own viewpoint of how information should be disseminated and what information should be included. My point of view is that having a standard format that we can all easily refer to is a benefit to the CSPD technicians and to the manufacturers. 

I do not feel that the work of creating cheat sheets should reside with staffers in thousands of sterile processing departments around the nation. A cheat sheet is equivalent to a standard format. If we are referring to a scope, the step-by-step process should be provided by each manufacturer. Ninety-five percent of the instructions should be the same/standardized. There will always be variations, however, for the tech who is working to process an untold number of scopes, instrument sets, peel packs, loaner instruments, etc., but the processes need to be consistent. This is a benefit not only for the tech, but also for the patient.

Each organization is able to take this standard information/template and update to their specific terminologies or processes, such as department names, detergents, manual and/or mechanical cleaners, drying location, etc. 

The type of manual or mechanical decontamination equipment should also be in a standardized format allowing the facility to add in their specifics. Sterilization equipment is another area where the IFUs are often very confusing. Most newer washer disinfectors and sterilizers are preprogrammed with various settings for time, water temperature, drying, lubrication. Where does a tech find this information quickly? Is it in the facility policy and procedure (P&P) manual? Was the manufacturer IFU used to develop the P&P? Is it up-to-date? Where is the grid that indicates standard time and temperature for each setting, which helps to determine the appropriate cycle to choose? Oh, okay, page 72 in the IFU. The tech may take 15 minutes to find the information needed. Can – or more importantly – should a tech spend 15 minutes searching for this information at the expense of doing what else?

Experience is not everything

After 35 years in sterile processing and supply chain, I should be able to enter a department, understand where and how to access the various instructions for use within the facility, and with guidance and education to the specifics of the department, get started working. The steps should not go like this: I begin to process a scope, where is the IFU? “Oh, sorry, we don’t have internet access at our (technician) level, so we have to wait until tomorrow when the supervisor is here to access the information.”  Really?! What about the patient that needs this for his or her procedure tomorrow? Do we perform our “best” and “hope” for a good outcome? Imagine how that patient would feel! Or how about this excuse, “The OR staff will process these on the weekends.” What? Are they trained? Do they have access to the IFUs?

What can you do?

The use of standard templates will address these concerns and provide information for the end users when needed. It is up to each of us to have this conversation with the manufacturers and ask for the information in a standard format. Let them know the difficulties your staff experiences and the amount of wasted time searching for information. Report any issues to the FDA to enlighten the FDA regarding the difficulties of the use of Instructions for Use. Who else within our organizations should be involved: Risk Management, Infection Control, Operating Room and Safety. Why? When there is an incident and the IFU is reviewed and compared to processes, all of the above functions will be included in the assessment and will determine how to address the process so the offense does not happen again. Remember, this is a patient-, staff- and facility-safety issue. CSPD leaders should educate their colleagues on the importance of standardized IFUs and gain their support in staff access to IFUs and the need for standard templates.

About the Author

Jean Sargent

Jean Sargent, CMRP, FAHRMM, FCS, currently serves as Principal, Sargent Healthcare Strategies, and is a member of Healthcare Purchasing News’ Editorial Advisory Board. She can be reached at [email protected].