Sophia Antipolis, FRANCE and St. Charles, MO USA - GE Healthcare - a worldwide leader in TEE Ultrasound Imaging systems and BC Group International, Inc., a leading manufacturer of test equipment for the medical industry, announced after months of testing by the GE Healthcare’s Global Ultrasound Division, a new procedure for testing the safety of their TEE Ultrasound probes has been established.
Ken O’Day, Vice President Sales and Marketing for BC Group said, “testing TEE probes for electrical leakage has always been a recommended procedure and effective December 2015 the Intersocietal Accreditation Commission (IAC) Standards and Guidelines for Adult Echocardiography Accreditation went into effect.“
Section 2.2.3B of the standard states:
“The manufacturer’s guidelines must be followed for the appropriate care and cleansing of the TEE transducer and adhere to the appropriate infectious disease standards to prevent the transmission of disease. Effective December 31, 2015, the structural and electrical integrity of the transducer must be checked between each use, using an ultrasound transducer leakage tester. “Passed” or “Failed” must be documented in the routine TEE probe cleaning / maintenance log along with action taken if “failed.”
GE Healthcare’s Cardiac Segment Leader, Global Ultrasound Probes, Daniel Vignet, headed up a team of Engineers who performed the testing and established the leakage limits as well as the additional procedure for testing the GE TEE probes.
“Historically the Electrical leakage testing for Ultrasound probes was performed by the Biomedical or Clinical Engineering Department on a scheduled bases,” stated O’Day. “With the IAC regulations, the responsibility for testing the probes has shifted to the Ultrasound or Cardiology Departments, since the test now needs to be performed after every usage. Although the testing requirement is designed for patient safety, a side benefit is the detection of small problems with the TEE probes before major damage occurs,” O’Day went on to say.
The new recommended guideline just established by the GE Engineering group will now take the testing one step further to include the deflection controls as well as testing for leakage caused by bite holes, damage or other breaks in the sheath of the TEE probes. All TEE Probes need to be tested for electrical leakage, however the GE Ultrasound Probe Models 6VT-D, 6Tc and the 6Tc-RS will require the new additional testing. For more information on what is needed and how to perform this new test procedure, go to our BC Group Store and download the Quick Start Guide. If you're using CS Medical's TD 100®, you can download the TD 100 Quick Start Guide.
The ULT-2020 Ultrasound Leakage system is designed, manufactured and serviced by BC Group International, Inc. under the BC Biomedical product label, at their corporate headquarters in St. Charles, MO. BC Group is ISO-9001:2015 Certified, ISO-13485:2016 Certified, ISO-17025:2005 Accredited, FDA Registered & Inspected, and FDA CGMP Compliant.
The ULT-AC-10 and ULT-SP-20 are available in the GE ULT Testing Kit (BC20-42350) or you can purchase the items separately below.
View the ULT-2020 Ultrasound Leakage Tester. View the BC20-42350 GE ULT Testing Kit. View the ULT-AC-10 Adapter. View the ULT-SP-20 Splitter.
For further information visit the BC Group online store to learn more about their product portfolio, how to purchase, for valuable information and tips on testing TEE probes.
Watch the demonstrational video on how to perform an ultrasound leakage test on GE Probes 6VT-D, 6Tc and 6Tc-RS:
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