APIC Calls for Overhaul of Medical Instruments Cleaning Instructions

Infection preventionists are reaching out to policymakers to address regulations around the current medical device cleaning instructions, known as instructions for use (IFUs).

In a Modernizing Medical Device Instructions for Use: Infection Preventionists Speak Up for Patient Safety report published by the Association for Professionals in Infection Control and Epidemiology (APIC), the group identified numerous difficulties, inefficiencies, and wasted money spent on deciphering cleaning instructions for medical instruments. The report states that IFUs, “are often not available, difficult to locate, out-of-date, overly complex, brand specific, and/or provide instructions that seem focused on protecting medical devices and their warranties rather than protecting patients from being exposed to pathogens.”

The report was shared with policymakers and the U.S. Food and Drug Administration (FDA), which regulates medical device labelling.

Infection preventionists (IPs) are charged with monitoring cleaning adherence to IFUs in health care facilities and say that the process takes an inordinate amount of time away from other core patient safety responsibilities.

“The time that IPs must spend obtaining clarity on arcane and confusing cleaning instructions limits the amount of time they are able to spend on other lifesaving infection prevention work,” said Tania Bubb, PhD, RN, CIC, FAPIC, 2024 APIC president. “This is especially true for individual IPs working alone in their facilities, as about half of our survey respondents were.”

Despite trying to comply with complex IFUs, 42% of IPs said that they were cited by surveying bodies for IFU violations, and that 54% of them were unable to successfully challenge the citation even by bringing forward scientific evidence.

To address these issues APIC recommends:

• Developing tools to help IPs and other health care personnel navigate the current inefficient process for cleaning, disinfection, and sterilization of medical instruments.
• Bringing problematic IFUs to the attention of manufacturers and the FDA.
• Educating policymakers and health care organizations about flaws in the current regulatory framework that limit IPs’ ability to protect patients from the transmission of healthcare-associated infections from medical devices.
• Convening stakeholder organizations to work with APIC to propose a new regulatory framework for cleaning, disinfection, and sterilization of medical devices that includes (but is not limited to):

• • A standardized format for IFUs.
  • IFU language that takes into account the needs of infection prevention and control, sterile processing, environmental services, and end users to protect patients.
  • Device labels that are easily accessible to users for the duration of the product’s lifespan, indicate when the IFU was last updated, and provide information on whom users may contact in case of questions.
  • A public repository for IFUs so that users will have access to appropriate information for devices that are no longer manufactured and/or when the manufacturer is no longer in business.