Organizations often struggle in complying with manufacturer’s Instructions for Use (IFU) for cleaning and disinfecting non-critical devices. Non-critical devices require low-and intermediate-level disinfection based on their exposure risk to blood, body fluids or mucosal membranes. The guidance, from the Association for Professionals in Infection Control and Epidemiology (APIC), was just released to aid organizations in complying with regulatory requirements when the IFU’s are contradictory to evidenced based guidelines, confusing, or so complex that disinfection procedures do not support evidenced based guidelines. The link to the release notice and directions for access can be found here: https://apic.org/news/apic-releases-new-toolkit-to-address-problematic-manufacturer-instructions-for-use-for-non-critical-devices/ or you can download a PDF copy here.
Organizations are encouraged to review the guidelines and determine how they may be applicable to challenges they are facing with cleaning and disinfecting medical equipment. Any risk assessment conducted to determine disinfection procedures should be documented and periodically reviewed as recommended in the APIC guidance. Furthermore, organizations should be prepared to share risk assessment documentation with survey teams if questions arise regarding compliance with IFU for cleaning and disinfection.
Please contact us for questions or more information at 704-573-4535 or info@courtemanche-assocs.com.
Courtemanche & Associates specializes in Healthcare Accreditation and Regulatory Compliance Consulting Services. With over 30 years of being in business and 100+ years of healthcare experience amongst our consulting team, we are ready to assist with your accreditation and regulatory compliance needs.
