fontman
06-02-06, 06:38 AM
By RAQUEL RUTLEDGE
rrutledge@journalsentinel.com
Posted: June 1, 2006
More than 2,000 veterans who underwent prostate biopsies at Milwaukee's Zablocki Veterans Affairs Medical Center may have been exposed to deadly viruses such as HIV, the U.S. Department of Veterans Affairs warned in a recent letter to those at risk.
The department sent letters dated May 8 to 2,075 men who had prostate biopsies at the center between 1989 and 2003 cautioning them that the equipment used to perform the procedure may not have been properly sterilized. The letter encourages the veterans to return to the center for a free blood screening.
Department officials called the risk "very small" and said they have "no evidence that any patient who had a prostate biopsy . . . has acquired an infection."
"We want to do the right thing here," said spokesman Chris Houterman. "We want to allay concerns."
So far, 304 men have gotten blood tests in response to the letter and none has turned up positive for hepatitis C, hepatitis B or HIV, the three viruses being screened, Houterman said.
Zablocki is one of 21 VA medical centers nationwide where the Department of Veterans Affairs found potential sterilization problems with prostate biopsy equipment.
In a scenario medical experts call extremely rare, about 23,000 men in the country have or will soon receive letters alerting them to their potential risk.
The problem stems from a piece of equipment, manufactured by B-K Medical Systems, called a biopsy transrectal transducer. A needle is inserted through the transducer into the rectum and further into the prostate. The needle used in the transducer is disposable, but the channel it passes through is not, and if not cleaned properly can host a buildup of fecal matter and blood materials, according to the patient safety alert issued by the VA's central office in April.
The channel needs to be scrubbed with a brush, a step not clearly outlined in the manufacturer's instructions, Houterman said.
"The manufacturer's directions were not very clear," Houterman said.
Aside from washing the equipment with soap and water and soaking it in disinfectant for 20 minutes, the workers at Zablocki took extra steps and exceeded the cleaning requirements by blasting the channel with a syringe full of disinfectant, he said.
"Now they're saying we should have used a brush," he said.
Zablocki Medical Center upgraded its equipment in 2003 and no longer uses the B-K device.
The president of Denmark-based B-K Medical Systems - the only one at the firm authorized to speak to the press on this issue - did not return calls Wednesday or Thursday. B-K Medical Systems is a subsidiary of Massachusetts-based Analogic Corp.
The issue came to light when technicians at a VA medical center in Maine found that the channel of one of the transducers was soiled. An investigation revealed the channel had not been scrubbed.
Lawrence Deyton, chief public health and environmental hazards officer for the Department of Veterans Affairs, said all the medical centers cleaned and sterilized the devices but that each followed a different process.
"I don't want our veterans thinking they had a procedure with a device that was not (cleaned) because it was. It just may not have been done 100 percent perfectly," Deyton said.
Deyton, too, blamed B-K Medical Systems for not adequately defining in writing or in face-to-face training seminars the proper method of cleaning the device.
Dennis Maki, an infectious disease expert at UW-Madison, said he was surprised that any medical facility would clean equipment that comes in contact with blood or fecal matter without using a brush.
"I find it hard to believe they didn't know," Maki said. "You have to be brain dead in 2006 not to run a brush down the channels. . . . You can soak the whole scope in disinfectant, but if you don't clean the channel out vigorously you can have microorganisms survive the disinfectant process. Brushing is routine."
Maki called the problem "a little more serious" than some other similar cases that happened in the 1980s and 1990s with endoscopes because in this case the needle goes into prostate tissue.
"You could inject a virus into the prostate," he said.
Even so, Maki and Deyton said the likelihood of contracting a virus, especially HIV, from chemically sterilized equipment is low.
"It's not zero, but it's very low," Maki said, noting that the HIV virus is not a hardy virus and would likely be killed by chemical sterilization.
More likely would be the transmission of hepatitis B, Maki and Deyton said.
Hepatitis B is a serious disease caused by a virus that attacks the liver. It can cause lifelong infection, cirrhosis of the liver, liver cancer, liver failure, and death.
Roughly 60,000 Americans contract the disease every year, and as many as 30% don't know it.
Nationwide results from the blood tests are not yet available, Deyton said. If any positives are found, it will be difficult to prove how the veteran contracted the virus, Deyton said.
"It will open the door to a lot of legal questions, of course, if it's potentially linked to the biopsy," he said. "But that will be for the lawyers to sort out. . . . I don't care how he got it. I'm just glad we found it so he can get treatment."
One Milwaukee-area veteran said he was traumatized when he got the letter alerting him to his potential risk.
"It kind of shook me up, to say the least," said the 75-year-old man, who didn't want his name published because of the private nature of the subject and for fear that his comments might affect his relationship with the center where he still receives medical care. "That's a pretty serious matter. HIV can be fatal."
The man, who lives on the east side and served in the Army in the 1950s, called it "outrageous" that it took 14 years to discover the problem.
He was notified May 26 that his blood tests for HIV and other infections came back negative, he said.
"I'm going to get a second opinion, an independent opinion," he said.
William See, chairman of the urology department at the Medical College of Wisconsin and an employee of the Department of Veterans Affairs, said patients currently scheduled for prostate biopsies should not be concerned.
"The current systems are designed to ensure patients are at no risk," he said. "Prostate cancer screening is important, and we want to encourage men to be screened for prostate cancer."
Milwaukee-area veterans concerned about potential exposure from previous prostate biopsies should contact the VA at (888) 469-6614, Ext. 45265.
rrutledge@journalsentinel.com
Posted: June 1, 2006
More than 2,000 veterans who underwent prostate biopsies at Milwaukee's Zablocki Veterans Affairs Medical Center may have been exposed to deadly viruses such as HIV, the U.S. Department of Veterans Affairs warned in a recent letter to those at risk.
The department sent letters dated May 8 to 2,075 men who had prostate biopsies at the center between 1989 and 2003 cautioning them that the equipment used to perform the procedure may not have been properly sterilized. The letter encourages the veterans to return to the center for a free blood screening.
Department officials called the risk "very small" and said they have "no evidence that any patient who had a prostate biopsy . . . has acquired an infection."
"We want to do the right thing here," said spokesman Chris Houterman. "We want to allay concerns."
So far, 304 men have gotten blood tests in response to the letter and none has turned up positive for hepatitis C, hepatitis B or HIV, the three viruses being screened, Houterman said.
Zablocki is one of 21 VA medical centers nationwide where the Department of Veterans Affairs found potential sterilization problems with prostate biopsy equipment.
In a scenario medical experts call extremely rare, about 23,000 men in the country have or will soon receive letters alerting them to their potential risk.
The problem stems from a piece of equipment, manufactured by B-K Medical Systems, called a biopsy transrectal transducer. A needle is inserted through the transducer into the rectum and further into the prostate. The needle used in the transducer is disposable, but the channel it passes through is not, and if not cleaned properly can host a buildup of fecal matter and blood materials, according to the patient safety alert issued by the VA's central office in April.
The channel needs to be scrubbed with a brush, a step not clearly outlined in the manufacturer's instructions, Houterman said.
"The manufacturer's directions were not very clear," Houterman said.
Aside from washing the equipment with soap and water and soaking it in disinfectant for 20 minutes, the workers at Zablocki took extra steps and exceeded the cleaning requirements by blasting the channel with a syringe full of disinfectant, he said.
"Now they're saying we should have used a brush," he said.
Zablocki Medical Center upgraded its equipment in 2003 and no longer uses the B-K device.
The president of Denmark-based B-K Medical Systems - the only one at the firm authorized to speak to the press on this issue - did not return calls Wednesday or Thursday. B-K Medical Systems is a subsidiary of Massachusetts-based Analogic Corp.
The issue came to light when technicians at a VA medical center in Maine found that the channel of one of the transducers was soiled. An investigation revealed the channel had not been scrubbed.
Lawrence Deyton, chief public health and environmental hazards officer for the Department of Veterans Affairs, said all the medical centers cleaned and sterilized the devices but that each followed a different process.
"I don't want our veterans thinking they had a procedure with a device that was not (cleaned) because it was. It just may not have been done 100 percent perfectly," Deyton said.
Deyton, too, blamed B-K Medical Systems for not adequately defining in writing or in face-to-face training seminars the proper method of cleaning the device.
Dennis Maki, an infectious disease expert at UW-Madison, said he was surprised that any medical facility would clean equipment that comes in contact with blood or fecal matter without using a brush.
"I find it hard to believe they didn't know," Maki said. "You have to be brain dead in 2006 not to run a brush down the channels. . . . You can soak the whole scope in disinfectant, but if you don't clean the channel out vigorously you can have microorganisms survive the disinfectant process. Brushing is routine."
Maki called the problem "a little more serious" than some other similar cases that happened in the 1980s and 1990s with endoscopes because in this case the needle goes into prostate tissue.
"You could inject a virus into the prostate," he said.
Even so, Maki and Deyton said the likelihood of contracting a virus, especially HIV, from chemically sterilized equipment is low.
"It's not zero, but it's very low," Maki said, noting that the HIV virus is not a hardy virus and would likely be killed by chemical sterilization.
More likely would be the transmission of hepatitis B, Maki and Deyton said.
Hepatitis B is a serious disease caused by a virus that attacks the liver. It can cause lifelong infection, cirrhosis of the liver, liver cancer, liver failure, and death.
Roughly 60,000 Americans contract the disease every year, and as many as 30% don't know it.
Nationwide results from the blood tests are not yet available, Deyton said. If any positives are found, it will be difficult to prove how the veteran contracted the virus, Deyton said.
"It will open the door to a lot of legal questions, of course, if it's potentially linked to the biopsy," he said. "But that will be for the lawyers to sort out. . . . I don't care how he got it. I'm just glad we found it so he can get treatment."
One Milwaukee-area veteran said he was traumatized when he got the letter alerting him to his potential risk.
"It kind of shook me up, to say the least," said the 75-year-old man, who didn't want his name published because of the private nature of the subject and for fear that his comments might affect his relationship with the center where he still receives medical care. "That's a pretty serious matter. HIV can be fatal."
The man, who lives on the east side and served in the Army in the 1950s, called it "outrageous" that it took 14 years to discover the problem.
He was notified May 26 that his blood tests for HIV and other infections came back negative, he said.
"I'm going to get a second opinion, an independent opinion," he said.
William See, chairman of the urology department at the Medical College of Wisconsin and an employee of the Department of Veterans Affairs, said patients currently scheduled for prostate biopsies should not be concerned.
"The current systems are designed to ensure patients are at no risk," he said. "Prostate cancer screening is important, and we want to encourage men to be screened for prostate cancer."
Milwaukee-area veterans concerned about potential exposure from previous prostate biopsies should contact the VA at (888) 469-6614, Ext. 45265.