Skipping An IFU Step?

The importance of following a manufacturer’s validated cleaning and sterilization Instructions for Use (IFU) cannot be over emphasized. As readers of this blog know, the issue of adhering to all of the steps in a manufacturer’s validated IFU is a frequently discussed topic.

In a recent Association for the Advancement of Medical Instrumentation (AAMI) Member Discussion Group, a member raised a question about instruments that need to be turned around quickly for a case and whether it was acceptable to manually wash, ultrasonic and alcohol the instruments before sending them off to the clean side. This member was told by an infection control nurse that both doing sonic and washer disinfection was not necessary, even though the manufacturer’s IFUs stated that the instruments must be run through the ultrasonic and washed in the washer disinfector.1

This raised a more general question: is it ever acceptable to skip a step in a manufacturer’s IFUs? Several members posted wonderful responses defending the decision to always follow the manufacturer IFUs. Among the rationales provided were that manufacturer IFUs had validated cleaning processes that should not be altered and that legal exposure could result from not following them.

Other members reasoned that there were situations in operating rooms that warranted deviations from manufacturer IFUs on rare occasions due to patient safety considerations. These include life-threatening situations where instruments were needed quickly. In such cases, it was suggested that surgeons be involved in the decision and that such cases of non-adherence to manufacturer IFUs be reported to infection control as anomalous instances where strict adherence to normal protocol would have put a patient at risk.

You and your staff must never forget that just because an instrument is sterilized after cleaning is no guarantee that it can't harm a patient. The old adage that "If it isn't clean, it can't be sterile" is still true. Skipping one or more steps in a manufacturer’s validated IFU can result in inadequate, incomplete or improper cleaning. This has the potential to allow for residual bioburden and debris to remain on the instrument.

By following all of the steps in the manufacturers’ validated cleaning IFUs on every reprocessing cycle, your patients’ risk of contracting a dangerous, costly and painful surgical infection from a contaminated instrument drops significantly.

  1. AAMI Member Discussion Group, January 16, 17, 20 and 21, 2020