Instructions for Use: Manufacturers and Healthcare Stakeholders Owe It to Patients to Fix a Broken System

By Kelly M. Pyrek

Non-compliance with manufacturers’ instructions for use (IFUs) can have far-reaching consequences, including adverse events, infections and other suboptimal patient outcomes. It can also represent an occupational hazard to technicians in the sterile processing department (SPD).

As we know, the Association for the Advancement of Medical Instrumentation (AAMI) defines IFUs as written recommendations provided by the manufacturer that define instructions for operation and safe and effective use of its device.

Numerous medical and professional organizations state that IFUs must be followed, including the Centers for Disease Control and Prevention (CDC), the Association for Professionals in Infection Control and Epidemiology (APIC), the Association of periOperative Registered Nurses (AORN), as well as AAMI. In fact, AAMI clearly states that manufacturers have the responsibility to provide up-to-date IFUs, and healthcare personnel have the responsibility to follow them.

But the reality is that IFUs can be confusing, contradictory and incomplete.

The conundrums are constant in the SPD. For example, an IFU may state that an instrument must be cleaned using automated cleaning equipment such as an automated washer-disinfector; however, a healthcare facility may lack this piece of machinery and so technicians must clean and disinfect the device manually, which may take more time, be less effective, and impact the overall productivity of the SPD.

In another example, a manufacturer may have validated its sterilization process using a very specific sterilizer, but the facility has a completely different sterilizer. Or techs who are under pressure to turn around instrument sets quickly may only conduct one ultrasonic cycle when three cycles are required by an IFU. Post-sterilization, the challenges continue. A manufacturer may have validated a device using a specific disposable wrap, yet the facility’s SPD uses rigid sterilization containers to reduce or eliminate wrap tears. Or techs do not use the extended cycles provided in the manufacturer's IFUs because they take too long. Conversely, techs may place instruments sets not validated for extended cycles in an extended cycle, which could reduce the instruments functionality and use life.

“Sterile processing professionals are always reminded to follow instructions for use diligently and consistently—to the letter, with no shortcuts or missed skips ever being acceptable,” emphasizes Damien Berg, CRCST, AAMIF, vice president of strategic initiatives for the Healthcare Sterile Processing Association (HSPA). “Certainly, IFUs are essential and must always be readily available and carefully followed, but many sterile processing professionals can also attest that understanding and following IFUs can be challenging. We know that some IFUs are vague, confusing and, at times, even conflicting with other recommendations and IFUs. Whenever questions about IFU arise, sterile processing professionals should contact the device or equipment manufacturer for clarification and further guidance. It is critical that IFU for every instrument, device, piece of processing equipment, chemical, and all other supplies are followed to ensure safety and processing effectiveness.”

Read further from the May 2023 issue HERE