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VA biopsies could have infected men with HIV, HCV, and HBV
  Nashville center alerts 413 on prostate test; 16 hospitals nationally involved
The Tennessean
Staff Writer
More than 300 Tennessee veterans could be at risk of infections, including HIV, after improperly sterilized equipment might have been used on them during their prostate biopsies at the VA hospital in Nashville.
Officials with the Tennessee Department of Health and the Department of Veterans Affairs stressed that the chance of becoming infected is very low. But as a precaution, letters were sent to everyone who had a prostate biopsy performed with a specific device called a B-K Medical transrectal ultrasound transducer.
About 27,000 patients at 16 of the VA's 154 hospitals across the country, including Nashville, are being alerted, according to Jim Benson, spokesman for the Department of Veterans Affairs.
The Tennessee Department of Health is asking the device manufacturer to notify other hospitals and medical practitioners that use it about the proper way to clean and sterilize the device. The federal Food and Drug Administration is also investigating.
"I don't want people who get these letters to panic," said Dr. Marion Kainer, an infectious disease physician with the Tennessee Department of Health. "This is a really small risk. It's not zero, but it's very small."
The VA letter offers to test the patients for hepatitis B and C and HIV at no cost. There were 413 letters sent April 20 from the Nashville VA hospital - 325 of them went to Tennessee residents, according to Bob Davenport, a spokesman for the Department of Veterans Affairs Tennessee Valley Healthcare System.
"We have recently determined that some of our devices used to perform prostate biopsies may not have been satisfactorily sterilized or disinfected," the letter states. "We wanted to let you know that there is a very small chance that you could have been exposed to hepatitis B virus, hepatitis C virus, or the human immunodeficiency virus (HIV)."
The VA provided a toll-free phone number for patients to call, although the agency would not publicly release it. Davenport said 190 patients had called about the letters and 56 people had been tested for viruses as of Friday. He said it would take a week or two for the results to come back.
"We are taking a proactive approach to this. The people who had this procedure are being notified,"
Davenport said. "Even though the risk is very low, we are concerned for the safety of our patients and we want to make sure we provide them with the opportunity to be tested."
The device is used to conduct prostate biopsies, a test to remove small samples of prostate tissue to be examined under a microscope for cancer. The device is inserted in the rectum and guided to the prostate. A hollow needle enters the prostate gland and takes a tissue sample.
Davenport explained that the cleaning instructions that the manufacturer provided "lacked clarity." The inside of the device, where the disposable needle is housed, was to be cleaned with a brush before it was sterilized, but that was not clear in the directions.
Kainer said it's difficult to sterilize something if it's not properly cleaned first.
"If a hospital didn't use a brush, the channel may not be as clean as it should have been," she said.
"There could still be blood or feces, which means the sterilization solution doesn't work as well. And if it doesn't work as well, you can't be as sure it's as clean as it could be."
Officials with the manufacturer, B-K Medical in Wilmington, Mass., did not return calls seeking comment yesterday.
The letters were sent after a device contaminated with feces was found at a hospital in Maine.
Davenport said the VA hospital in Murfreesboro uses a different kind of device to conduct prostate biopsies and that no patients there would be affected.
Davenport said the Nashville VA hospital has been using the B-K Medical devices since 2003.
Dr. William Schaffner, chair of the infection control committee at Vanderbilt University Medical Center, classified the frequency of such situations nationwide as "occasional."
"I know of roughly a half-dozen facilities in the United States where something like this has happened in the past two or three years," he said.
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