Instructions for medical devices are unnecessarily complex, and the federal process for these labels needs an overhaul, according to the Association for Professionals in Infection Control and Epidemiology.
In a 27-page report shared with lawmakers and the FDA, the organization said most medical supply manuals are obsolete for current infection prevention and control practices.
Medical device cleaning instructions, known as instructions for use or IFUs, are "often not available, difficult to locate, out-of-date, overly complex, brand specific, and/or provide instructions that seem focused on protecting medical devices and their warranties rather than protecting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," APIC said May 16.
Attempting to correct these issues is convoluted, the organization said, because manufacturers update IFUs without telling customers and infection preventionists are frequently phoning devicemakers and the FDA for clearer information. Complicated IFUs then lead to surveyors citing facilities, activating more complexities that obstruct patient care.
In recent months, sterilization issues have prompted multiple hospitals across the U.S. to pause surgery operations.
In a 2023 APIC survey of 1,198 infection preventionists, 70% of respondents found IFUs unnecessarily complex, difficult or time consuming; 70% said instructions seemed to address product lifespan more than prevention of healthcare-associated infections; and 68% said the IFUs lacked specificity or clarity on how to clean the product.
Critical devices, such as surgical forceps, are sterilized; semicritical products, like endoscopes, need high-level disinfection; and noncritical equipment, including stethoscopes, are disinfected. Sixty-five percent of the surveyed infection preventionists said key issues with IFUs are for devices with low and intermediate levels of disinfection.
APIC is calling for stakeholders to collaborate on a new regulatory framework for the cleaning, disinfection and sterilization of medical devices. The organization proposed a standardized IFU format that is easily accessible and has information relevant to infection prevention work.
Read the report here.