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Mark Rupp, M.D. |
The device — a needleless intravascular catheter connector valve — is used for hospital patients with a vascular catheter in place. Vascular catheters are widely used in many types of patients for the infusion of medications, blood products, or fluids, and the connector valve is the small piece of equipment that connects the catheter to the IV tubing.
The first generation of needleless devices was introduced into medical care more than a decade ago in order to prevent needlestick injuries and bloodborne pathogen exposure in health care workers. More recently, mechanical valves have been incorporated into the devices in an attempt to minimize the risk of catheter occlusion. Unfortunately, some of these devices may be putting patients in harm’s way, said Mark Rupp, M.D., an infectious diseases specialist at UNMC and The Nebraska Medical Center and the principal investigator on the study.
The particular needleless connector valve in this study was introduced into clinical use in February 2005 at The Nebraska Medical Center and later completely removed from clinical use when evidence associated the valve with an increased rate of bloodstream infection. Bloodstream infections are quite serious and can result in mortality or prolonged hospital stay. The UNMC research team is one of the first groups in the country to note this trend. They initially presented their findings to the scientific medical community in the spring of 2006.
In performing blood cultures on patients hospitalized during the study period, it was determined that ICU patients with the needleless connector valve experienced bloodstream infections at nearly three times the rate as compared to the time period before the valves were used. In regular inpatient nursing units, the bloodstream infection rate more than doubled when the needleless connector valves were in use.
With the needleless connector valves, bloodstream infections in ICU patients increased from 3.87 infections per 1,000 catheter days to 10.64 infections per 1,000 catheter days. In inpatient nursing units, bloodstream infections increased from 3.47 infections per 1,000 catheter days to 7.3 infections per 1,000 catheter days with the needleless connector valves.
Since discontinuing the use of needleless connector valves, Dr. Rupp noted that the bloodstream infection rate at The Nebraska Medical Center has returned to the accepted national benchmark level.
“Every hospital in the country is using similar types of devices,” Dr Rupp said. “We felt it incumbent upon ourselves to report our study results in a scientific journal. In addition, we notified the Food and Drug Administration (FDA) and the manufacturer.”
Dr. Rupp said similar needleless connector valves are produced by at least six different manufacturers.
“Many of these devices are being introduced into the health care arena without undergoing rigorous testing in clinical settings,” Dr. Rupp said. “Hospitals and doctors need to be aware of the increased risks potentially involved with using some of these devices.”
Dr. Rupp said the valves have a shallow depression and rim.
“It’s possible that microbes and debris could collect in this depression, making them relatively resistant to cleansing or disinfectants,” he said. “They also are opaque, making it more difficult for health care workers to observe if blood or infusion products are collecting within the valve.”
Once the higher rate of bloodstream infections was determined, Dr. Rupp said the hospital immediately stopped using the mechanical needleless connector valves and went back to using the older version connector valve.
Dr. Rupp said, “It really points out that even seemingly small changes in vascular access devices can have devastating unintended consequences and how careful we need to be when people’s lives are at stake.”