VA biopsies could have infected men

Saturday, 04/29/06

VA biopsies could have infected men
Nashville center alerts 413 on prostate test; 16 hospitals nationally
involved

By CLAUDIA PINTO
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.

http://www.tennessean.com/apps/pbcs.dll/article?AID=2006604290336



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