Landmark midline catheter study complete
Landmark midline catheter study complete
An expert panel that met in January 1996 to review the data surrounding problems with the Landmark midline catheter concluded that no clear pattern exists regarding the problems exhibited in about one of every 4,000 units sold.
The panel noted that available data did not link reported adverse reactions, ranging from transient local edema to two cases of cardiac arrest, to Aquavene, the biomaterial of which the catheter is made.
The panel met under an educational grant from Menlo Care, a division of Johnson & Johnson , which is the company that introduced the catheter to market. The panel reviewed data surrounding reports of adverse events connected with the Landmark catheter.
The panel noted that insertion method, rather than the catheter itself, was a possible cause of the adverse events. When a new insertion technique was recommended in 1995, the rate of adverse event reports fell to one in 13,000. The panel recommended a prospective clinical trial comparing Landmark with other midline catheters.
Leonard A. Mermel, DO, SCM, of the Infectious Disease Division at Brown University School of Medicine in Providence, RI, criticized the panel's findings. Mermel first brought to light problems with the Landmark catheter in an article published in Annals of Internal Medicine.1
"I think that the reader has to be aware of the legitimacy of what the individuals think -- that the reader has to be aware of the legitimacy of what the individuals and the so-called experts have to say," Mermel says. "They are, to the best of my knowledge, being paid directly by the manufacturer of this device, and one can't help but think there is a potential conflict of interest or bias."
Some panelists had past work relationships
While none of the panelists reportedly were paid for participating in the meeting, several previously worked for Johnson & Johnson or Menlo care as consultants in biocompatibility and toxicology issues, says Susan Meister, spokesperson for Seattle-based Communicore, a communications firm.
Mermel questions the panel's findings that insertion technique was an issue and that allergy could be ruled out as a cause to adverse events, noting that evidence exists on both issues to the contrary. *
References
1. Mermel LA, Pareneau S, Tow SM, et al. The risk of midline catheterization in hospitalized patients. Ann Inter Med 1995; 123:841-844.
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