The Importance of Following Manufacturers’ IFUs

August 1, 2019

How do we clean an instrument has always been the question of the day in sterile processing departments all over the world; the answer is to come. The sad truth is, in some instances, the cleaning process was derived from someone in leadership making up a rule. The truth of truths is that those of us in the profession had not one clue as to how an instrument should be cleaned. Somebody taught somebody and that somebody passed it all along to others. Somehow instruments got clean enough for the sterilization process to kill the microbes.

The great news is that we, as a profession, have evolved with the help of guidance and research into our processes. We have learned that the Food and Drug Administration (FDA) has rules that guide manufacturers as to the information needed for our professionals to clean and reach the parameters of sterilization of instruments. Those guidelines are called instructions for use (IFUs) and every medical device has one that must be accessible to the end-users of the product.

The professionals of the sterile processing field must note that every medical device has its own IFUs. In the United States, medical devices cannot be sold until the validation testing required by the FDA shows that the medical device can be effectively cleaned, disinfected, or sterilized in healthcare facilities while following the IFU. The IFU allows sterile processing all over the world to do our job, which is to render the medical device/instrument safe for patient use.

With medical devices/instruments becoming more and more complex in design and the products used to make them require that they are processed according to the IFU. Sterile processing departments (SPDs) are not the manufacturer, therefore they must follow the guidelines as written. The importance of following these guidelines have made their way into the surveys being conducted in hospitals and outpatient centers all over the country. It is no longer acceptable to lean upon your own understanding when cleaning, disinfecting, or sterilizing a medical device/instrument. Surveyors are coming in and requesting that the sterile processing department members can demonstrate their knowledge of the instructions. It is also important that we in the profession understand that patient lives are impacted daily by medical devices/instruments being processed wrong only because the instructions are not followed.

IFUs being followed is a must, as medical devices/instruments are prepared for patient use in minor procedures and surgeries. It is most important that policies guide the use of IFUs in their facilities. Infection Control Prevent list must help the sterile processing department professionals by getting the importance of IFUs through all administrators. Everyone must be made aware that these instructions and the throughput are the keys to a successful hospital program.

Let's examine a case study which illustrates why IFUs are critical to follow. The importance of an IFU covers all medical devices/instruments so, your robotic arms used every day in surgeries are part of the medical device family. There was a hospital group that used the robotic arms daily, conducting more than 300 cases a month. The IFU provided specific instructions on the cleaning process that was not being followed by any of the hospitals in the group. One main component to the cleaning process that was missing was the sonic machine. Not one of the hospitals had a sonic machine and the sonic process was the third step in the IFU document. Each department did its best to clean without the sonic machine. It was finally called into the corporate compliance office because the sterile processing team member could no longer go along with doing harm.

All hospital programs have an organizational integrity program where they ask the employees to report things that are wrong. We in the profession of sterile processing must understand that we are to do the patient “no harm.” So, after many reports to the Joint Commission, surveyors made a visit to the hospital group and shut down all the hospital robotic case service. This was closed until they had installed sonic machines in the building and they were functioning properly. At the same time, doctors started complaining that their patients were coming in with infections. It was noted that the departments not following the IFUs had a large part to play in a contaminated product being presented to the doctors who performed surgery on the patients. Many of those robotic arms were still contaminated when used on the next patient.

IFU compliance is a must because we impact patients’ lives when the instruments used are contaminated. Patients come into the surgical suite with a medical problem that can be made better with surgery; the instruments used on that case must be processed following the IFU all in the name of patient safety.

It is also very important that the written IFU be accessible to all members of the sterile processing team. ANSI/AAMI ST79:2017 states that the current written IFU should be accessible, reviewed and followed. It is noted that if no specific written IFU is available, the manufacturer should be contacted and requested to provide a documented method of cleaning. [ANSI/AAMI ST79:2017 (7.3)]

As important as it is to follow the IFUs that come with medical devices/instruments, it is just as important the instructions be easily understood, with clear, concise directions at every step. I note that all IFUs are not created equal. Some IFUs are written for the engineers who design the medical devices. There are some that are not clear at all, with just a sentence that says, “clean meticulously.” Sterile processing professionals must decipher what is the right thing to do. This means SPD personnel must call the manufacturer's technical support department to request the specific IFUs. It means that a medical device/instrument cannot be processed if you have no IFUs. We are called to be conscientious and trustworthy in everything we do, and our integrity should not and cannot be compromised. We can effectively impact a patient’s surgical outcome.

IFUs come in all shapes and sizes; some are well put together, and others are questionable. It is our responsibility to make sure we have these IFUs in hand or on a computer program so that they can be located and read for a clear understanding as to what is required for the medical device /instrument that is being processed. We must also regularly review the IFUs and institutional policies to be sure we are still practicing according to the rules. 

For too long it was an accepted practice in the profession of sterilization that if the item was wrapped, and the tape turned black/brown, our job was complete. We now work under new rules and best practices. The item must be cleaned and processed according to the IFUs. We check the process by looking at the external and internal parameters, knowing that if any one of them is a fail, the medical device/instrument must be reprocessed. If a medical device/instrument is processed outside the realm of the IFUs, it should not be used on any patient. Remember, we are to do the patient no harm,

Sharon Greene-Golden, BA, CRCST, CER, SME, FCS, is a consultant for OneSource.

References: 

ANSI/AAMI ST 79:2017. Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities.
Immediate need for healthcare facilities to review procedures for cleaning, disinfecting, and sterilizing reusable medical devices. Distributed via the CDC Health Alert, Sept. 11, 2015, CDCHAN-00382.
Reprocessing medical devices in healthcare settings: validation methods and labeling guidance for industry and Food and Drug Administration staff. Document issued March 17, 2015.