from the editor
from the editor
IPs Advocate for an Overhaul of Medical Device IFUs
Last May , our cover story addressed problematic instructions for use ( IFUs ) and the challenges they pose for ensuring that requisite sterile processing steps are followed as well as complying with infection prevention imperatives . ( Read Healthcare Hygiene magazine ’ s May 2023 cover story on IFUs HERE .
In a report published last month by the Association for
Professionals in Infection Control and Epidemiology ( APIC ), the group identified the myriad 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 The report states that IFUs , “ are often not available , difficult to locate , out-of-date , overly complex , brand specific , and / or provide instructions that seem focused on protecting medical devices and their warranties rather than protecting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 Food and Drug Administration ( FDA ), which regulates medical device labeling .
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 .
The new APIC report outlines a long list of concerns about IFUs . In a 2023 APIC survey of 1,198 IPs , respondents found IFUs unnecessarily complex , difficult , or time-consuming ( 70.6 percent ); said instructions seemed designed to address product lifespan more than prevention of healthcare-associated infections ( HAIs ) ( 70.2 percent ); and said the IFUs lacked specificity / clarity about how to appropriately clean the product ( 68.3 percent ).
IFUs are so confounding and time-consuming to comply with , according to the report , that 84 percent of IPs surveyed were forced to reach out to manufacturers for clarity ; 36 percent reported that manufacturers did not have helpful information . Eight percent contacted the FDA to make sure they were properly complying with cleaning , disinfection , and / or sterilization protocols .
Despite trying diligently to comply with complex IFUs , 42 percent of IPs said that they were cited by surveying bodies for IFU violations , and that 54 percent of them were unable to successfully challenge the citation even by bringing forward scientific evidence . Surveying bodies operate as agents for the Centers for Medicare & Medicaid Services , surveying hospitals on the agency ’ s behalf .
Sixty-five percent of IPs reported that they have the biggest CDS difficulties with non-critical devices , such as blood pressure cuffs . 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 ; and 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 .
Until next month , bust those bugs !
Kelly M . Pyrek Editor & Publisher Kelly @ healthcarehygienemagazine . com healthcarehygienemagazine
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6 • www . healthcarehygienemagazine . com • june 2024