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So Many IFUs, So Little Time

How is it even possible to keep track of the ever-evolving instructions for use (IFU) on the thousands of surgical devices we have in our operating rooms? It used to be a mystery until three medical device industry veterans put their minds together and developed oneSOURCE. They are geniuses for saving all our sterile processing departments from the shelves of leatherbound IFUs, in offices that smell of rich mahogany. Okay, it’s more like plastic binders with sleeves that house a plethora of pages, in a sterile room that smells of Sani-Cloths (hopefully you can appreciate that Anchorman humor for a moment). If you’re not familiar with this amazing tool, it’s a database that houses the thousands of IFUs for surgical instruments, devices, and equipment, keeping them all easily accessible and synced with your facility’s tracking systems.

What are IFUs?
We need to quickly cover what instructions for use (IFU) are. Typically, an IFU includes basic operational how-to information, as well as pages of warnings, cautions, and other general or device-specific information beyond simply how to operate the device. Operational troubleshooting, contingency instructions, and maintenance information may also be included. This is consistent with the U.S. Food and Drug Administration’s (FDA) requirements for “prescription” devices, which state “…that the device’s labeling (including the IFU) must supply information about indications, effects, routes, methods, and frequency and duration of administration, as well as any relevant hazards, contraindications, side effects, and precautions under which the device can safely be used.”1 Given that definition, it’s pretty safe to say that we all understand how critical IFUs are to patient safety, and why following them can make a life or death difference.

OneSOURCE states, “Without the latest IFUs, you increase the risk of Hospital Acquired Infections.” They elaborate upon how 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….”2

Now that we understand what exactly an IFU is, what the primary database management company has to say about them, and how vital they are from regulatory agencies like CMS, we can dive into what SPD professionals across the country have to say about how their facilities manage and keep up with them.

The survey says…
In an online survey conducted by me in April 2020 of 285 technicians working in our healthcare facilities today, 76% of them use oneSOURCE, 19% use the paper method, and the remaining 5% use Google or ask a co-worker. In further research and questioning of this same group of technicians, and in interviewing management in sterile processing, some common themes were deduced. It can take a full-time employee to maintain this data, comb through new devices coming into the hospital, and update tracking systems with digital PDFs when a new set is added into service. Vendors can do a more thorough job of educating and highlighting the most relevant components within the IFUs themselves.3,4

In regards to electronic IFUs, known as EIFUs, the regulation defines EIFUs as instructions available from a website, supplied in portable electronic media (e.g., CD, DVD, USB drive), or displayed in electronic form on the product screen. EIFUs can also include video and audio files that demonstrate how to install the device, its operation, implantation, and handling. The EIFUs can enhance the safe use of devices and help ensure that they are used as intended. Device manufacturers can quickly update the EIFU content to further enhance safety. Paper and printing costs can be greatly reduced, while enhancing the speed to which products hit the market. The quick and thorough nature of EIFUs can help manufacturers avoid expensive recalls due to inaccurate information provided by some paper IFUs.5 There are many pros and cons as it relates to going all digital, but that is the way of the future and the direction that the industry as a whole has gravitated toward. In your SPD, what are the top three tips for maintaining your IFUs and communicating changes? Let’s look at three tips from professionals based on my interviews to help your sterile processing department keep it all straight.

Tip One
Get vendors in to educate and cover what must be done in decontamination, assembly, and in sterilization. Vendors take note here; most facilities feel like the education is lacking. Sometimes great education is offered, but sterile processing professionals often feel like the rep is simply more interested in making a sale, and schmoozing the surgeon, than in helping them understand how to safely get that device into the physician’s hands. They also feel that education is not thoroughly covering all shifts, and graveyard or evening staff often has to rely on team members to relay the training to them. We all know how well the game telephone goes, right? The details can get lost in translation.

Tip Two
Assign one or two key players to manage the input of new IFUs as they come on board. Most often the database updates IFUs that change and adds new ones to your tracking systems, such as SPM, CensiTrac, etc. As new sets come on board and are loaded into said tracking system, it’s critical to ensure that the information is available to those assembling and cleaning the sets, and that the information is just a click away. For those without tracking systems, laminated posters in decontamination and printed copies kept in the “New Sets” binder are helpful.

Tip Three
Have a whiteboard dedicated strictly to new sets that gives a snapshot of what’s new, what sterilizer settings are necessary, and any of the hidden gems that the vendor may have relayed during the in-service.

The moral of the story is that it’s really hard to keep track of all the moving parts in an SPD on a good day, all IFUs aside. It is imperative that regardless of the process your facility follows, that it follows one systematically and to a “T” every time. Hopefully one or two of the above tips will help give you some ideas on how your SPD can effectively manage your systems. Finally, reps take note that SPD technicians make your job possible, they want to learn, and they want to effectively and safely reprocess your device, but they need your help in providing thorough and pointed education to guide the process. 

References

  1. https://www.psqh.com/news/medical-devices-who-needs-to-read-device-instructions/
  2. https://www.onesourcedocs.com/products-solutions/ifu/
  3. https://www.facebook.com/groups/540936709274849/permalink/2855209167847580/
  4. https://www.facebook.com/groups/540936709274849/permalink/2857631834271980/
  5. https://www.mddionline.com/electronic-labelling-101-how-comply-eu-regulations

Rebecca Kinney has been working to improve patient safety in the medical arena for more than 13 years. She provides educational content on LinkedIn to help sterile processing and medical professionals gain knowledge as it relates to surgical devices, and her articles have appeared in Outpatient Surgery magazine. Her articles focus on the practical, hands-on knowledge operating room professionals can benefit from—never lacking in entertainment as she unfolds the true reality and struggles that are faced every day in the operating room setting. She is also a small business owner of a startup sales and marketing consulting agency.

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