Demonstrated Safety
Providing a breakthrough technology

To obtain U.S. FDA approval in January 2016, Bracco Diagnostics performed extensive testing to demonstrate the safety of the new CT Exprès contrast management system. The goal was to provide users with a high degree of confidence that CT Exprès could be used safely. Testing was performed under rigorous conditions of simulated use/misuse, of CT Exprès with the Isovue® (Iopamidol Injection) Imaging Bulk Package (IBP) and saline. Protocols were reviewed and agreed upon with FDA prior to testing.1


Testing evaluated 5 key areas:
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DEMONSTRATED SAFETY
PURPOSE
Antimicrobial effectiveness
Formulations do not support microbial growth

Testing sought to confirm that formulations did not support microbial growth at a minimum through the period of time that the Isovue® (Iopamidol Injection) Imaging Bulk Package or saline bag may be used after the container closure is pierced (10 hours).1

DEMONSTRATED SAFETY
METHODS
Antimicrobial effectiveness
  • ISOVUE-300 and -370 and saline were tested.1
  • 7 test organisms were introduced separately, each at a final concentration of 105 – 106 CFU/mL (colony forming units per mL).1
  • Microorganisms: S. aureus, P. aeruginosa, E. coli, C. Albicans, A. niger, plus S. epidermidis and K. pneumoniae.1*
  • Samples were evaluated for microbial count at 0 and 16 hours* and 7, 14, and 28 days.1
  • 105 test samples (3 fluids x 7 organisms x 5 time points) were evaluated.1
  • All formulations were tested in accordance with United States Pharmacopeia 37, National Formulary 32, 2014, General Chapters, General Requirements, Microbiological Tests <51> Antimicrobial Effectiveness Testing.1
*Microorganisms and time points were tested in addition to those required by USP <51>.
DEMONSTRATED SAFETY
RESULTS
Antimicrobial effectiveness

All formulations were bacteriostatic for up to 14 days at a minimum, which is well past the labeled usage time of 10 hours for the Isovue® IBP once the container closure is penetrated.1

DEMONSTRATED SAFETY
PURPOSE
Microbial ingress
Keeping bacteria at bay

Testing sought to demonstrate that even under conditions of gross contamination, microorganisms did not enter the fluid path.1

DEMONSTRATED SAFETY
METHODS
Microbial ingress

The study individually evaluated 7 Challenge Sites—contact areas that serve as potential points of contamination during misuse.1

  • Challenge sites were contaminated with >1,000 CFU, simulating gross contamination.
  • Simulated use studies were performed simulating high and low volume use situations.
  • Simulated patient injections were collected and evaluated for sterility in accordance with United States Pharmacopeia 37, National Formulary 32, 2014, General Chapters, General Requirements, Microbiological Tests <71> Sterility Tests.
1.
Center* of the 
bottle septum
2.
Inner side (near the base) of Bottle Spike
3.
Interior edge of 
Bottle Spike
4.
Exterior of the Day Set III HP Spike near the edge
5.
Area immediately surrounding the septum of the Day Set T-Connector
6.
Exterior of the Patient Set
7.
Base of the Saline Spike
*For the bottle cap (CP-1), a 70% IPA wipe was used to disinfect the site, prior to accessing the fluid path, consistent with good aseptic technique for parenteral injection as recommended by the Centers for Disease Control (CDC), http://www.cdc.gov/injectionsafety/PDF/FAQs-Safe-Practices-for-Medical-Injections.pdf.
DEMONSTRATED SAFETY
RESULTS
Microbial ingress

All test samples were confirmed as sterile. The results of this study demonstrate, in 304 test samples, the ability of CT Exprès as used with the Isovue® IBP and saline, to resist ingress of microorganisms into the fluid path, even under conditions of gross contamination, confirming the delivery of a sterile dose to the patient.1

DEMONSTRATED SAFETY
PURPOSE
Cross-contamination
Rigorously tested safety features

CT Exprès engineering specifically addresses the needs of multi-patient use. It incorporates innovative design features specifically designed to prevent cross contamination—helping to maintain safety from the first patient to the last:

  • Uni-directional rotation of the pump motor at all times, producing positive displacement and pressure to the fluid outlet.
  • Two points of fully sealed compression that prevent backwash. Never at any point is there an open path on the injector.
  • Mechanical, software, and labeling protection against inadvertent reuse of the single-use-only Patient Set from patient to patient.
  • No vacuum producing means to cause reverse fluid motion and retrograde contamination from the patient connection.

These features have been subjected to further stringent testing to prove that–even under extreme and highly improbable conditions–patient-to-patient cross contamination will not occur.

DEMONSTRATED SAFETY
METHODS
Cross-contamination
  • Employed a worst-case scenario in which a Patient Set was filled with red dye concentrate (simulating whole blood) when the Patient Set was connected to a saline primed Day Set.1
  • The distal end of the Patient Set was elevated to the maximum height possible above the connection to CT Exprès, and the system was allowed to sit passively for 30 minutes.1
  • At the end of the 30-minute period, the contaminated Patient Set was removed and a new Patient Set installed.1*
  • Samples were taken using the new Patient Set and quantitatively assayed for the presence of red dye by spectrophotometry.1
  • This challenge was performed 60 times1:
    • For each replicate, the saline bottle (surrogate for contrast), the saline bag, Bottle Spike, Day Set III HP, and the Patient Sets were replaced.1
DEMONSTRATED SAFETY
RESULTS
Cross-contamination

All test samples were negative for the presence of dye. This demonstrates, with a high level of confidence, the ability of CT-Exprès, when used with the Isovue IBP and saline bags, to prevent cross-contamination (patient-to-patient contamination) even under extreme and highly improbable worst-case conditions.1

DEMONSTRATED SAFETY
PURPOSE
Chemical compatibility
Preserving integrity and purity

Testing sought to demonstrate that the chemical integrity of Isovue® and saline is maintained during use.1

DEMONSTRATED SAFETY
METHODS
Chemical compatibility

In a worst-case simulated use study,1 Isovue® IBP and saline were evaluated. The study was based on a usage time of 14 hours, which is 4 hours past the 10-hour labeled usage time for the Isovue IBP, saline (when used with Isovue and CT Exprès), and CT Expres Day Set.1

Samples were collected at 0, 4, 10, and 14 hours.1
Samples were evaluated for:

  • Conformance to the FDA-approved chemistry specification for Isovue®, and the USP 37 Monograph for sodium chloride injection.1
  • Conformance to the USP <788> requirement for particulates.1
  • Presence of leachable compounds.1
Isovue® IBP1
Normal Saline1
Isovue® IBP1

Conformed to the FDA-approved chemical specifications for Isovue: appearance, pH, iopamidol, tromethamine, free iodine, free iodide, free aromatic amine, and disodium calcium edetate.1

Normal Saline1

Conformed to the chemical specification in the USP 37 Monograph for sodium 
chloride injection.1


Met particulates specification in USP <788>, Particulate Matter
in Injections1


Assay results showed any leachable compounds of potential concern 
were below the limit of detection.1

DEMONSTRATED SAFETY
RESULTS
Chemical compatibility

All test samples met the stated criteria. The results of this study demonstrated that the chemical integrity of Isovue® and saline is maintained when used with CT Exprès disposables.1

DEMONSTRATED SAFETY
PURPOSE
Human factors

Testing sought to demonstrate that the design of the CT Exprès Injector results in safe and effective use with ARRT certified users.1

DEMONSTRATED SAFETY
METHODS
Human factors
  • Human factors testing (usability validation) was performed
 consistent with the most current FDA guidance and standards.1
  • Two usability studies were performed.
  • Participants:
    • Were ARRT Certified Users currently employed in a hospital or radiology facility, and routinely performing CECT exams.1
    • Underwent 5 hours of training, including 2.5 – 3 hours of hands-on training.1
    • Experienced 2 hours of testing based on use scenarios representing the primary operating functions of the CT Exprès 3D Injector and at least 2 “off-normal” or unusual situations to evaluate the users’ ability to resolve problems and move forward.1
DEMONSTRATED SAFETY
RESULTS
Human factors

The study demonstrates that CT Exprès can be used by representative users under simulated use conditions without producing patterns of failures that could result in a negative clinical impact to patients or harm to CT Exprès users.1

The individuals who appear are for illustrative purposes only.
All persons depicted are models and not real patients.
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IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE FOR ISOVUE®-300 (Iopamidol Injection 61%) Imaging Bulk Package and ISOVUE®-370 (Iopamidol Injection 76%) Imaging Bulk Package*
Isovue® (Iopamidol Injection) Imaging Bulk Package (IBP) is indicated for intravenous contrast enhancement of computed tomographic (CECT) imaging of the head and body in adult and pediatric patients.

IMPORTANT SAFETY INFORMATION

Isovue IS NOT FOR INTRATHECAL USE. Iopamidol Injection is available as Isovue-M® 
for intrathecal administration.

Caution must be exercised in patients with severely impaired renal function, those with combined renal and hepatic disease, or anuria, particularly when larger and repeat doses are administered. Radiopaque diagnostic contrast agents are potentially hazardous in patients with multiple myeloma or other paraproteinemia, particularly in those with therapeutically resistant anuria. Caution should be exercised in hydrating patients with underlying conditions that may be worsened by fluid overload, such as congestive heart failure. Diabetic nephropathy may predispose to acute renal impairment following intravascular contrast media administration. Acute renal impairment following contrast media administration may precipitate lactic acidosis in patients who are taking biguanides. Preparatory dehydration is dangerous and may contribute to acute renal failure in patients with advanced vascular disease, diabetic patients, and in susceptible nondiabetic patients (often elderly with preexisting renal disease). Patients should be well hydrated prior to and following iopamidol administration.

The possibility of a reaction, including serious, life-threatening, fatal, anaphylactoid or cardiovascular reactions, should always be considered. Patients at increased risk include those with a history of a previous reaction to a contrast medium, patients with a known sensitivity to iodine per se, and patients with a known clinical hypersensitivity (bronchial asthma, hay fever, and food allergies).

*The Isovue Imaging Bulk Package is for use with an automated contrast injector or a contrast management system approved or cleared for use with it.

Please download full Prescribing Information by clicking here.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

IMPORTANT SAFETY INFORMATION
CT Exprès 3D Contrast Media Delivery System

INDICATIONS:
The CT Exprès 3D Contrast Media Delivery System is indicated for controlled automatic administration, on the venous side, of contrast media and saline, to human subjects while undergoing examination by means of a computed tomography (CT) scanner.

The CT Exprès 3D Contrast Media Delivery System is specifically indicated for use in CT procedures for the delivery of Isovue® (Iopamidol Injection) contrast media as supplied in an Imaging Bulk Package (IBP), for a maximum of 20 bottles of contrast media or a maximum of ten (10) hours, whichever comes first, per Day Set III HP disposable. The Bottle Spike disposable is for single-bottle use only and must be discarded with the contrast media bottle. The Patient Set must be discarded after each patient procedure.

The CT Exprès 3D is to be used only by and under quasi-continuous supervision of trained health care professionals in an appropriate licensed health care facility, in a room designated for radiological procedures that involve intravascular administration of a 
contrast agent.

CONTRAINDICATIONS
This device is not intended for injection of contrast media for coronary arteriography, or for any other use for which the device is not indicated.


Isovue and Isovue-M are registered trademarks of Bracco Diagnostics Inc.
CT Exprès is a trademark of Bracco Injeneering S.A.

Not all products are available in all countries. Please contact your Bracco representative.

Bracco Injeneering S.A. reserves the right at any time and without notice, to change the specifications and features described herein, or to change the production or adjust the product described.

Isovue and Isovue-M are currently manufactured for Bracco Diagnostics Inc. at two locations:
BIPSO GmbH, Singen (Germany) and Patheon Italia S.p.A., Ferentino (Italy).

CT Exprès is manufactured for Bracco Injeneering S.A., Avenue de Sévelin 46, CH-1004 Lausanne, Switzerland; imaging.bracco.com

CT Expres is distributed by Bracco Diagnostic Inc.
259 Prospect Plains Road, Bldg. H
Monroe Township, NJ 08831 USA

Phone: (800) 631-5245; Fax: (609) 514-2424; Customer Service: 1-877-BRACCO 9 (1-877-272-2269)

©2016 Bracco Diagnostics Inc. All Rights Reserved.


TAKE THE TOUR
CT EXPRÈS
Dual Touch Screen:
Allows you to store and access more than 100 protocols with up to 8 phases per protocol.
Bottle Spikes:
Used to spike a single bottle of Isovue® (Iopamidol Injection) Imaging Bulk Package (IBP), which can remain spiked and installed on the injector for a maximum of 10 hours.
Day Set:
Can be used with a maximum of 20 bottles of Isovue® (Iopamidol Injection) Imaging Bulk Package, up to 4 liters, or for a total of 10 hours – whichever comes first.
Saline Spike:
Spikes a single bag of saline.
Saline Tag:
One tag to affix to each multi-dose saline bag on the injector.
Displays the “discard by” date and time (installation time + 10 hours).
Patient Set:
Single use component that supplies contrast/saline to patient via peristaltic pump technology.
Isovue® (Iopamidol Injection) Imaging Bulk Package (IBP) contrast bottles (200 or 500 mL)
EXPERIENCE THE
EXPRÈS LANE
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Reference:

1.
Data on file with BRACCO Diagnostics.