CDC investigates Landmark catheter problems
CDC investigates Landmark catheter problems
New study to compare adverse events
The Centers for Disease Control and Prevention (CDC) in Atlanta will do an independent study of problems associated with the Landmark midline catheter, reports the CDC hospital infections program's epidemic intelligence service fellow Ann Do, MD.
Problems with the Landmark midline catheter were reported in the December 1995 issue of Annals of Internal Medicine, in a study by Dr. Leonard A. Mermel, DO, ScM, a researcher with the division of infectious diseases at Rhode Island Hospital in Providence, RI.
In addition, more than 70 cases of adverse reactions associated with the catheter, including two deaths and one spontaneous miscarriage, have been reported to the U.S. Food and Drug Administration (FDA) in Rockville, MD.
The CDC also published a report of the reactions associated with the catheter in the Feb. 9, 1996, issue of Mortality and Morbidity Weekly Report.
The CDC study will compare groups of patients that have experienced reported adverse events with groups of patients that experienced no reactions or that used another type of midline catheter.
"It is very important for the CDC to do our own study. Our position is that we need to look at this more closely before we really do something one way or the other," Do says.
Retrospective study
The manufacturer of the Landmark midline catheter, Menlo Park, CA-based Menlo Care, which is a subsidiary of Johnson & Johnson, is conducting its own study of the reported problems. The company has already held preliminary investigations of the reported problems and has found that Aquavene, the biomaterial of which the catheter is made, doesn't appear to be the cause of the reported problems. Menlo Care makes several other catheters using Aquavene in addition to the Landmark midline catheter.
"What Menlo wants to do is a prospective cohort study -- and it would take a while to collect enough cases. What we're doing is more retrospective in nature. We'd like to collect all information on any cases or possible cases that have already happened; in other words, people who had the Landmark catheter inserted and had some sort of reaction, Do says.
[Editor's note: CDC epidemic intelligence service fellow Ann Do, MD, encourages providers whose patients experienced reactions that may be linked to use of the Landmark midline catheter to contact the CDC at (404) 639-6413.] *
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