GE CT - User Manual

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GE Healthcare

IMPORTANT PRODUCT INFORMATION

3000 N. Grandview Blvd. - W440

Waukesha, WI 53188, USA

<Date of Letter Deployment> GEHC Ref# 26861

To: Hospital Administrators / Risk Managers

Managers of Radiology / Cardiology

Radiologists/Cardiologists

RE: Recommendations on the use of “One More” functionality in CT, PET-CT, and SPECT-CT Scanners

Please ensure that all potential users in your facility are made aware of this notification and the recommended actions.

Issue

GE Healthcare has been made aware of an event caused by the errant use of the “One More”

functionality during a CT examination in France. This function is available on all GE Healthcare CT,

PET-CT, and SPECT-CT equipment, except Revolution CT.

This event does not relate to a malfunction of the device and there is no product defect.

However, we are sending this notice to provide additional recommendations on the use of the

“One More” function.

Instructions

Following the installation of a CT, PET-CT, or SPECT-CT system, the users designated by the

site are trained by GE application engineers to use the equipment, including the “One More“

functionality. It is recommended that only duly trained and qualified personnel be allowed

to use the system.

To provide you additional guidance on use of the “One More” function we have included an

operator manual addendum along with this letter.

Additionally, an online training tutorial on the "One More” function is available via the

following links:

Quick Reference Guide - CT One More function (English, Danish, Finnish, Swedish)

Link: https://www.gecares.com/GEHealthCare/GEHCArticle?id=aBU0c00000004kuGAA

Our application engineers are also available to provide additional training on this tool should

users at your site need it.

Please also note that most of the affected GE Healthcare CT, PET-CT, and SPECT-CT systems

are equipped with “Dose Check”, a dosimetry control tool that allows physicists and

radiologists to establish dose thresholds based on their practice. The feature informs

operators of CT devices when scan settings would likely exceed pre-assigned dose

thresholds based on their practice.

Dose Check provides the following:

• Checking against a Notification Value if the estimated dose for the scan is above your

site typical dose value

• Checking against an Alert Value where the user needs specific authority to continue

the scan at the current estimated dose without changing the scan parameters.

• Defining Alert Values for Adult and Pediatric with age threshold

• Audit logging and review

• Protocol Change Control

It is strongly recommended that all users enable the “Dose Check” control feature. GE

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Summary

Recommendations on the Use of One More Functionality

Issue

Details an event caused by errant use of the "One More" function during a CT examination in France.

Instructions for One More Function

Provides guidance on training and resources for the "One More" function, including manuals and tutorials.

Dose Check Feature

Explains the "Dose Check" dosimetry control tool and its recommended enablement for safety.

Summary

Recommendations on the Use of One More Functionality

Issue

Details an event caused by errant use of the "One More" function during a CT examination in France.

Instructions for One More Function

Provides guidance on training and resources for the "One More" function, including manuals and tutorials.

Dose Check Feature

Explains the "Dose Check" dosimetry control tool and its recommended enablement for safety.

Overview

Function Description
Important Technical Specifications (Implied)
Usage Features
Maintenance Features

This document, "IMPORTANT PRODUCT INFORMATION," from GE Healthcare, addresses recommendations for the use of the "One More" functionality in their CT, PET-CT, and SPECT-CT Scanners. The notification, GEHC Ref# 26861, was issued due to an event in France involving the "errant use" of this function during a CT examination. It clarifies that the event was not due to a device malfunction or product defect but rather improper usage.

Function Description:

The "One More" functionality is a feature available on most GE Healthcare CT, PET-CT, and SPECT-CT equipment, with the exception of the Revolution CT. While the document does not explicitly detail the function's precise operation, its context suggests it allows for additional scans or imaging sequences beyond an initial protocol. The emphasis on "errant use" implies that it can be activated in a way that might lead to unintended or excessive imaging if not properly managed. The document highlights the importance of proper training for its use, indicating it's a tool that requires careful consideration and adherence to established protocols to ensure patient safety and optimal imaging practices.

Important Technical Specifications (Implied):

The "One More" functionality is integrated into a wide range of GE Healthcare imaging systems. The affected product details list the following systems:

CT Systems:
- CT HiSpeed Series
- CT ProSpeed Series
- CT BrightSpeed Series
- CT LightSpeed Series
- Brivo CT series
- Optima CT Series
- Discovery CT Series
- Revolution ACT, HD, GSI, EVO
PET Systems:
- Discovery ST, STE, VCT
- Discovery 560, 600, 610, 710
- PET Optima 560, 560FX
- Discovery IQ
- Discovery MI, MI-DR
NM Systems:
- NM/CT Discovery 670, 870, 570c
- NM/CT 860, 850

The broad range of systems indicates that the "One More" function is a common software feature across different generations and types of GE Healthcare CT, PET-CT, and SPECT-CT platforms. The exclusion of the Revolution CT suggests that newer or specific high-end systems might have different or more integrated dose management features, or that the "One More" functionality has been redesigned or removed in that particular model.

Usage Features:

The document strongly emphasizes responsible usage of the "One More" functionality. Key usage features and recommendations include:

Training: Only duly trained and qualified personnel should be allowed to use the system, including the "One More" functionality. GE application engineers provide initial training during system installation and are available for additional training if needed.
Operator Manual Addendum: An addendum to the operator manual is provided to offer additional guidance on the use of the "One More" function. This suggests that the function's operation might have specific steps or considerations that warrant detailed instructions.
Online Training Tutorial: An online Quick Reference Guide for the CT One More function is available in multiple languages (English, Danish, Finnish, Swedish) via a provided link. This indicates GE's commitment to providing accessible training resources.
Integration with Dose Check: The document highlights the importance of the "Dose Check" control feature, which is available on most affected GE Healthcare CT, PET-CT, and SPECT-CT systems. Dose Check is a dosimetry control tool that allows physicists and radiologists to establish dose thresholds. It informs operators when scan settings would likely exceed pre-assigned dose thresholds.
- Notification Value: Alerts if the estimated dose is above the site's typical dose value.
- Alert Value: Requires specific authority to continue the scan if the estimated dose exceeds this value without changing scan parameters.
- Age Thresholds: Allows defining Alert Values for Adult and Pediatric patients.
- Audit Logging and Review: Provides a record of dose-related events and decisions.
- Protocol Change Control: Implies a mechanism to manage and approve changes to scanning protocols. The strong recommendation to enable "Dose Check" underscores its role as a critical safety feature, especially when using functionalities like "One More" that could potentially increase patient dose.

Maintenance Features:

While the document primarily focuses on operational safety and training, the mention of "Audit logging and review" within the "Dose Check" feature can be considered a maintenance-related feature. This allows for:

Performance Monitoring: Reviewing audit logs can help monitor adherence to dose protocols and identify patterns of "errant use" or areas where additional training might be needed.
Quality Assurance: The ability to review dose data contributes to ongoing quality assurance programs within a radiology department, ensuring that imaging practices remain within safe and acceptable limits.
Compliance: Audit logs can be crucial for demonstrating compliance with regulatory requirements and internal safety policies.

The document also implies a continuous support structure through GE Healthcare Service and local Service Representatives for any questions or concerns, which is a broader aspect of device maintenance and support. The availability of application engineers for assistance with "Dose Check" implementation further supports ongoing operational maintenance and optimization.