Changes are needed to the instructions for safely cleaning, disinfecting and sterilizing medical devices, according to the Association for Professionals in Infection Control and Epidemiology (APIC).

A recent nationwide survey of infection preventionists published by APIC found that:

• 84 percent of IPs had to contact a manufacturer to clarify proper cleaning, disinfection or sterilization of a product
• 42 percent of their facilities had been cited for failure to follow instructions for use (IFUs)
• 8 percent of IPs reached out to the U.S. Food and Drug Administration (FDA) for IFU clarification

“APIC believes this is an unacceptable burden that does not support the goal of preventing the transmission of [healthcare-associated infections],” the organization said in a statement.

The group made several recommendations including:

• Better device labeling 
• Educating policymakers on weaknesses in the current system
• Developing tools to help IPs and others navigate the confusing cleaning process
• An IFU repository to make it easier to access information for devices no longer manufactured and which indicates when a manufacturer is no longer in business

The APIC survey included responses from nearly 1,200 infection preventionists around the country, working in a variety of facility types, sizes and locations across the country.

APIC and infection preventionists are not the only ones advocating for change in this area.

In September 2020, the Association for the Advancement of Medical Instrumentation (AAMI) published TIR12:2020, which was a guide to help manufacturers standardize their IFUs. Yet inconsistencies remain.

A recent Healthcare Purchasing News story cited the AAMI work, noting that a lack of standard IFU format and terminology, coupled with confusing or inadequate information can make what already is a challenging job even more difficult.

Single-use endoscopes, like those sold by Ambu, eliminate the worry of deciphering complicated IFUs and the need for any reprocessing or repairs.

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Related Content:  IFU Improvements Sterile Processors Would Like to See

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