IEC 60601-2-24 Infusion Pumps and Controllers Audit Checklist

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.

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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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Industry

Healthcare

Standard

IEC 60601-2-24 - Medical Infusion Equipment

Workspaces

Oncology Department
Hospitals
Healthcare Centers
Medical Device Manufacturing Facilities

Occupations

Biomedical Engineer
Clinical Pharmacist
Infusion Specialist Nurse
Medical Equipment Technician
Quality Assurance Manager
1
Is the infusion pump compliant with IEC 60601-2-24 standards?
2
What is the medication delivery accuracy percentage?
Min0
Target100
Max100
3
Are there any incident reports related to the infusion pump?
4
Is the infusion pump maintenance up to date?
5
When was the last calibration of the infusion pump performed?
6
Is the emergency stop function of the infusion pump operational?
7
What is the estimated battery life remaining on the infusion pump (in hours)?
Min1
Target8
Max24
8
Is there a log of all usages of the infusion pump?
9
When was the last software update performed on the infusion pump?
10
Are all warning and instruction labels on the infusion pump clear and intact?
11
Has a recent risk assessment for the infusion pump been completed?
12
How many incidents related to the infusion pump have been reported in the past year?
Min0
Target0
Max100
13
Summarize user feedback regarding the infusion pump's performance.
14
When was the last safety audit conducted on the infusion pump?
15
Is there a current incident response plan in place for infusion pump failures?

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 of IEC 60601-2-24 Infusion Pumps and Controllers Audit Checklist

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