cover story
cover story
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 .
12 may 2023 • www . healthcarehygienemagazine . com