GE Healthcare, a provider of TEE ultrasound imaging systems, and St. Charles, Mo.-based BC Group International, Inc., a manufacturer of test equipment for the medical industry, announced that after months of testing by 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 of sales and marketing for BC Group, says: “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 Dec. 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 basis,” says 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.”
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, the Quick Start Guide is available for download.