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FDA, CDC cite contaminated biopsy equipment.

Two reports of contamination of prostate biopsy needle guides caused by improper reprocessing serve as a reminder that such cases, while uncommon, do occur and can result in transmission of bacterial infections.

This summer, a public health notification issued by the Food and Drug Administration's Center for Devices and Radiological Health (CDRH) warned that if reusable ultrasound biopsy transducer assemblies were not correctly reprocessed between patients, "residual material from a previous patient may contaminate the biopsy needle and needle guide" when reused, and could result in infections.

The alert was prompted by the discovery of a contaminated lumen of a needle guide in an ultrasound transducer assembly. Inspectors at the U.S. Veterans Health Administration discovered the contaminated equipment during patient safety rounds and announced the discovery in a press release in April. The inspectors found that some of the equipment was not being scrubbed by a brush after every use, "resulting in the remote possibility of infection."

Although no infections resulting from these cases have been identified yet, the VA is following up with patients who received prostate biopsies with the improperly scrubbed equipment in 11 states, Washington, and Puerto Rico.

The FDA issued its alert on the basis of its belief that "inadequate reprocessing procedures may be a problem for all invasive ultrasound transducer assemblies." The FDA also provided recommendations on cleaning this device before sterilization, including using brushes to clean the transducer assemblies, particularly the lumens.

In July, a report from the Centers for Disease Control and Prevention (CDC) described Pseudomonas aeruginosa infections in four patients who had undergone transrectal ultrasound-guided prostate biopsies "in which contamination of the equipment was the likely source."

The patients were hospitalized with P. aeruginosa infections within 6 days of having a biopsy at a clinic in Georgia in July 2005. P. aeruginosa was recovered in a blood culture in one patient, in the urine in two patients, and in the blood and urine in the fourth; all patients were treated successfully with intravenous and oral antibiotics while hospitalized for 2-12 days.

The P. aeruginosa strain on the lumen of the reprocessed needle guide matched the strain isolated from the three available isolates from patients.

The infections were "likely related" to contamination of the prostate biopsy equipment "that had not been adequately cleaned (i.e., by brushing) or properly sterilized and had been rinsed improperly with tap water after reprocessing," according to the report.

The results of this investigation "underscore the need to adhere to recommendations for the cleaning and disinfection" of transrectal ultrasound-guided prostate biopsy equipment, the report concluded (MMWR 2006;5:776-7).

The MMWR report suggests that "pathogens can be transmitted from improperly reprocessed equipment of this type," said Dr. Arjun Srinivasan, a medical epidemiologist in the CDC's division of health care quality promotion and an author of the report.

Such reports are "very important to raise awareness to let people know that these are issues," he added.

Dr. Srinivasan said that the CDC is contacted periodically by hospitals, outpatient surgical centers, and other facilities when something like this happens. While these cases are not common, considering how many facilities clean and disinfect surgical devices, this is certainly something the CDC hears about "fairly consistently," he said in an interview.

There are no formal estimates on the number of infections that may result from poorly sterilized surgical equipment. "We think the risk is low, but it is very hard to quantify this type of risk," said Dr. Srinivasan. He added that the CDC is consulting closely with the VA on the improperly scrubbed equipment issue.

The FDA encourages the reporting of adverse events to its MedWatch voluntary reporting program: 800-332-1088 or www.fda.gov/med watch/report.htm.

BY ELIZABETH MECHCATIE

Senior Writer
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Title Annotation:Federal Drug Administration; Centers for Disease Control and Prevention
Author:Mechcatie, Elizabeth
Publication:Family Practice News
Geographic Code:1USA
Date:Sep 1, 2006
Words:623
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