Instructions for Use (IFU) are critical references used to maintain medical equipment including calibration, preventive maintenance, cleaning/disinfection, and general use. Without a current IFU, you may not be maintaining your equipment to ensure safe operation for your patients and your staff. IFU's sometimes will be updated by the manufacturer due to changes in software, issues discovered in the field during use, or changes in consumable supplies that may be used with the device. We have noticed recently that organizations are not keeping their IFUs current. We surveyed a client who was using a glucometer to check patient blood glucose levels as a part of their waived testing program. However, we noticed the edition of the IFU was dated 2013. When we referenced the manufacturer's webpage, the most current edition was dated 2021, which reflected 9 separate updates in editions compared to the one provided by the organization.
Ensure that your organization has a process in place to monitor IFU changes and, when necessary, reviews updates and provides notification to the appropriate users on these changes. Some manufacturers will provide push notification of IFU changes, but many will require that you periodically check for updates. There are some subscription services that will provide online access to IFUs who will take on the responsibility of maintaining current IFUs. Regardless of the process you select, ensure that IFUs are current and that changes are identified and communicated as needed.
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.
