Infection preventionists are reaching out to policymakers for help with the regulatory process around the current convoluted medical device cleaning instructions, known as instructions for use or IFUs, with which they must comply and are calling for reform to put patient safety and healthcare efficiency in the forefront.

In a groundbreaking report published today by the Association for Professionals in Infection Control and Epidemiology (APIC), the group identified the myriad of difficulties, inefficiencies, and wasted time and 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 The report states that IFUs, “are often not available, difficult to locate, out-of-date, overly complex, brand specific, and/or provide instructions that seem focused on protecting medical devices and their warranties rather than protecting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, “Modernizing Medical Device Instructions for Use (IFUs): Infection Preventionists Speak Up for Patient Safety,” 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 healthcare facilities and say that this burdensome process takes an inordinate amount of time away from other core patient safety responsibilities. In addition to diverting attention from patient safety, the current system wastes countless hours of labor and financial resources in the U.S. healthcare system. 

To address these issues APIC recommends:

• Developing tools to help IPs and other healthcare personnel navigate the current laborious and inefficient process for cleaning, disinfection, and sterilization of medical instruments.

• Bringing problematic IFUs to the attention of manufacturers and the FDA.

• Educating policymakers and healthcare organizations about flaws in the current regulatory framework that limit IPs’ ability to protect patients from the transmission of HAIs 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.

“APIC urges policymakers, industry, and allied groups to come together on solutions to make confusing device cleaning instructions clear, concise, and rooted in the principles of infection prevention and control to protect patients from deadly pathogens,” says Dr. Bubb. “Instructions that are so unclear that more than 8 in 10 IPs need to call the company for clarity are inefficient and need revision. We stand ready to help improve and standardize this process.”