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?

Select the compliance status of the infusion pump.

To ensure the infusion pump meets safety and performance standards.
2
What is the medication delivery accuracy percentage?

Enter the accuracy percentage (0-100).

To assess the accuracy of medication delivery by the infusion pump.
Min0
Target100
Max100
3
Are there any incident reports related to the infusion pump?

Please provide details of any incidents.

To identify any safety issues or incidents that have occurred.
4
Is the infusion pump maintenance up to date?

Select the maintenance status of the infusion pump.

To ensure regular maintenance is performed for patient safety.
5
When was the last calibration of the infusion pump performed?

Enter the date of the last calibration.

To ensure the pump is calibrated correctly for accurate medication delivery.

6
Is the emergency stop function of the infusion pump operational?

Select the operational status of the emergency stop function.

To ensure the safety feature can be activated in case of an emergency.
7
What is the estimated battery life remaining on the infusion pump (in hours)?

Enter the estimated battery life remaining in hours.

To evaluate the battery status for uninterrupted operation.
Min1
Target8
Max24
8
Is there a log of all usages of the infusion pump?

Please provide details about the usage log.

To maintain a record of pump usage for accountability and monitoring.
9
When was the last software update performed on the infusion pump?

Enter the date of the last software update.

To verify that the device has the latest software for optimal performance.
10
Are all warning and instruction labels on the infusion pump clear and intact?

Select the labeling compliance status.

To ensure that all necessary information is visible for safe operation.

11
Has a recent risk assessment for the infusion pump been completed?

Select the status of the risk assessment for the infusion pump.

To ensure potential risks associated with the infusion pump are identified and managed.
12
How many incidents related to the infusion pump have been reported in the past year?

Enter the number of reported incidents in the last year.

To track the safety record and identify trends in device-related incidents.
Min0
Target0
Max100
13
Summarize user feedback regarding the infusion pump's performance.

Provide a summary of user feedback.

To gather insights on user experiences that may impact safety and effectiveness.
14
When was the last safety audit conducted on the infusion pump?

Enter the date of the last safety audit.

To verify that safety audits are performed regularly for compliance.
15
Is there a current incident response plan in place for infusion pump failures?

Select the status of the incident response plan.

To ensure preparedness for handling device malfunctions effectively.

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