Instructions for Use (IFUs) are an important part of the central sterile processing department (CSPD) in support of infection control, quality and patient safety. Several years ago, the IFU issue became more prominent and important as manufacturers began releasing their detailed testing parameters and results. What enlightened many of us is that we had no idea that medical devices received FDA approval for washer and sterilizer parameters that were outside of the standard parameters. Many provider facilities did not have the ability nor the resources to complete the processing as the parameters stated.
Many questions arose. Among them:
- How do I acquire the lumens to flush fluids in the washer, and where do I hook them up?
- What is about all the new detergents? How do I get those and are they approved for use in my washers?
- Are the sterilizers capable of extended cycles?
- Are the biological and chemical indicators approved for extended cycles? If not, how do we know we are not getting false positives/negatives?
- I don’t have capacity to run one tray per cycle and now it needs to be extended?
- What information do I need to gather to have a conversation with senior leadership?
Issue 1: Access
The line staff must have the ability to access IFUs in a quick and concise basis. There is an online subscription database known as oneSOURCE that collects the IFUs and provides access for a fee. Otherwise, staff members need to have internet access to go to the manufacturer’s website and search for the IFU. Many facilities do not allow internet access, or only allow restricted internet access. SPD staff do not have time to search through a manufacturer’s website, which tends to be designed for clinicians providing product use/sales information, to locate the IFU for the device in question, then read through pages of information before they get to what they need.
It is up to management to have processes, policies and procedures in place for which staff can refer when completing their functions. To build this from the start will take inordinate amounts of time. The use of available programs will cut down on the time the manager will need to ensure that details for anything outside of the standard paraments are displayed in the appropriate area. A new program being released at IAHCSMM in Anaheim, CA, this month, Petriss BLUEfin, contains an automated device IFU database whereby each surgical tray can be programmed into the system, the IFUs for each device are included, and when scanning the tray the staff can get the cleaning instructions for each device in that tray. This is the type of access staff need to perform their duties effectively and completely, in addition to being compliant with The Joint Commission IC.02.02.01, reducing the risk of infections associated with medical equipment and supplies.
Issue 2: Education
Providing education about each discrepancy to the norm is another area of consideration. It is overwhelming to think of all the devices for which review and development of processes, policies and procedures, and education must be completed. I recently reviewed a variety of IFUs and found them to be different in style, formatting, amount of information and length. I have been in this business for more than 28 years in leadership roles. I look at this information and think — where would I begin? Do I assign a task force to develop the information that provides guidance? That would be great education for the staff involved in the project. However, who will cover for the staff involved during this lengthy but important project? What type of templates should be used to ensure standardization of information?
Issue 3: Quick guide/FAQ
In order for me to be successful in this endeavor I would ask for changes from the manufacturers. Develop a quick guide or frequently asked questions (FAQ) document to be displayed in the first two pages of the IFU. Place important information, such as the cleaning and disinfection detergents, times and temperatures, the grid with sterilization parameters, load limits, do’s and don’ts, in this area. Don’t bury them on page 73 where the staff will give up looking before they get to the answer.
Issue 4: Simple structure/template
I say this often: There are 5,000 hospitals and numerous outpatient surgery centers across the United States and more around the world. Instead of having thousands of facilities develop the education, why don’t the manufacturers utilize their clinical educators to develop the tools as a template that each facility then can update per the institution’s make and model of washers, sterilizers, low-temperature sterilizers and other relevant equipment. The manufacturers spend a lot of money on research to develop new products, submit details to the FDA, and marketing. Add a step to that process when developing the IFUs to provide education, quick tips and FAQs as a baseline.
Looking forward
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. As technology evolves, it is also important that facilities budget for the technology to provide the information to support the staff. Remember, this is a patient-, staff- and facility-safety issue. Include risk management, quality, safety and senior leadership in discussing this topic and why it is important that access to the necessary tools is for the good of all.
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].
