A comprehensive checklist for auditing infusion pumps and controllers in accordance with IEC 60601-2-24 standards, ensuring accurate medication delivery, enhancing patient safety, and improving the quality of infusion therapy in healthcare settings.
IEC 60601-2-24 Infusion Pumps and Controllers Audit Checklist
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About This Checklist
The IEC 60601-2-24 Infusion Pumps and Controllers Audit Checklist is a crucial tool for healthcare facilities and medical device manufacturers to ensure the safety and accuracy of infusion equipment. This specialized checklist addresses the particular requirements for the basic safety and essential performance of infusion pumps and controllers. By systematically evaluating these devices against IEC 60601-2-24 standards, healthcare providers can significantly reduce medication errors, enhance patient safety, and improve the precision of drug delivery. Implementing this checklist in your audit process helps identify potential risks associated with infusion devices, ensures accurate flow rates and dosage delivery, and promotes a safer medication administration environment in healthcare settings.
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Select the operational status of the emergency stop function.
Enter the estimated battery life remaining in hours.
Please provide details about the usage log.
Enter the date of the last software update.
Select the labeling compliance status.
Select the status of the risk assessment for the infusion pump.
Enter the number of reported incidents in the last year.
Provide a summary of user feedback.
Enter the date of the last safety audit.
Select the status of the incident response plan.
FAQs
IEC 60601-2-24 focuses on the particular requirements for the basic safety and essential performance of infusion pumps and controllers, ensuring accurate and safe medication delivery in healthcare settings.
Precise control of infusion pumps is crucial to ensure accurate medication dosing, prevent over- or under-infusion, and maintain patient safety, especially for critical medications and in sensitive patient populations.
Infusion pumps should be audited at least annually, with more frequent checks for high-risk areas or devices. Additionally, audits should be conducted after repairs, software updates, or any significant changes to the device.
Key elements include flow rate accuracy, occlusion alarm systems, air-in-line detection, battery performance, software integrity, dose error reduction systems, and overall pump reliability and durability.
Audits should be conducted by qualified biomedical engineers or medical equipment technicians, in collaboration with clinical pharmacists and nursing staff who are familiar with the practical use of infusion devices.
Benefits
Ensures compliance with international standards for infusion pump safety and performance
Reduces risks associated with medication errors in infusion therapy
Enhances patient safety through improved accuracy of drug delivery
Facilitates proper maintenance and calibration of infusion devices
Improves overall quality of care by optimizing infusion pump functionality