Va Biopsy Device Defective Products
The Veterans Administration Discovers Inadequately Sterilized Biopsy Device
In an April 3, 2006 alert, the Veterans Administration (VA) announced that a medical device that has been used in VA facilities since 1992 had not been cleaned adequately at many VA facilities. This possibly contaminated device was used on an estimated 23,000 to 27,000 patients between 1992 and the discovery of the problem.
The medical device, called a transrectal ultrasound transducer, is manufactured by B-K Medical. It is used to take tissue samples from the prostate gland to test for cancer. The hollow needle that is used to take a tissue sample is disposable, but the needle holder and guide that the needle moves through is cleaned and reused. Many VA facilities have cleaned this part of the device by soaking and/or syringing it with disinfectant before sterilizing the instrument. In a routine inspection at a VA facility at Augusta, Maine, a needle holder was found to contain some “bioburden” (blood or fecal material) even though the device had been sterilized and was ready for reuse. Bioburden can carry serious and sometimes deadly viruses, including hepatitits C, hepatitis B, and HIV/AIDS, which can be injected into the prostate gland when the tissue sample is taken.
On discovering the inadequate sterilization of this device, the VA prepared cleaning guidelines to be followed in all VA facilities. The VA’s National Center for Patient Safety, the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention, and the manufacturer, B-K Medical, were all consulted in creating the revised procedure. The new guidelines require that a small brush, about the size of a pipe cleaner, be used to clean the needle holder before the device is sterilized. Cleaning with a brush, as well as a disinfectant, will prevent the buildup of bioburden in the needle holder and other parts of the device.
There is a dispute about who is responsible for the inadequate sterilization of this medical device. According to Bob Davenport, a spokesperson for the Department of Veterans Affairs for the Tennessee Valley Healthcare System, the cleaning instructions provided by the manufacturer were unclear. The Tennessee Department of Health has asked B-K Medical to notify other facilities and health care providers about the possibility of inadequately disinfected devices. In its April 3, 2006 alert about the problem, the VA claimed that transducer assembly kits have not always included the brushes needed to clean the device properly.
Michael Brock, the Managing Director of B-K Medical in Copenhagen, Denmark has claimed that all the necessary procedures for cleaning the device are clearly described in the device manual, which is always delivered with the machine. Dennis Maki, an infectious disease expert at the University of Wisconsin at Madison, argues that anyone should know that a brush was needed to clean the channel holding the disposable needle. Brushing to clean such a device is routine.
The VA has set up a procedure for notifying all the patients who might have been exposed to viruses by the use of the B-K Medical transrectal ultrasound transducers. Each of the facilities that used inadequate cleaning procedures is notifying the patients from the facility by letter, offering them free blood testing for hepatitis C, hepatitis B, and HIV/AIDS, and giving them a toll-free number to call for information. Tests conducted by June 2006 have showed that none of the patients tested were infected.
The letters to patients say 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).” Dennis Maki agrees that the likelihood of an infection from a device that has been soaked or rinsed in disinfectant is very low, though it isn’t zero. The likelihood is particularly low for HIV, which is easily killed by chemical sterilization.
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