Landmark catheter to be investigated
FDA requires special study to be done
The Food and Drug Administration is directing the maker of the Landmark midline catheter on what type of study must be done to establish the cause of the adverse reactions found to be related to the commonly used catheter.
The safety of the catheter was called into question in December 1995 after an epidemiologist from Providence, RI, published a study linking the product with life-threatening adverse reactions. (A special reprint of our FAXBulletin detailing these events appeared in the February issue of Hospital Home Health.)
"We're working with Johnson & Johnson to decide what kind of study they need to do to satisfy the FDA," says Debbie Blum, RNC, CIC, a nurse consultant with the FDA.
Menlo Care, in Menlo Park, CA, the Johnson & Johnson subsidiary that makes the catheter, recently sent letters warning its 2,300 customers to be prepared for adverse events when using the catheter. The letter acknowledges the fact that there is a problem with the catheter, and lists the signs and symptoms of problems that health care professionals should look for when using the Landmark catheter.
Be prepared to intervene
"The frequency of reports is such that you should be prepared to initiate appropriate medical intervention if an adverse event occurs," the letter reads.
The FDA released its own advisory letter, which it sent out to medical groups and organizations, including the National Association for Home Care (NAHC) in Washington DC.
"The FDA's data on the problems with the Landmark catheter are not the same as Johnson & Johnson's, so we're going to send out our letter as a cover to Johnson & Johnson's letter," Blum explains.
FDA receives more reports, not fewer
The FDA and Menlo Care differ on the number of adverse reactions to the catheter that were reported since the device manufacturer began selling the device in 1989. Menlo care report 173 adverse events, and the FDA reports 190 adverse events. In January 1994 Menlo care began recommending that providers insert the Landmark midline catheter more slowly.
While Menlo Care says the numbers of reports of adverse events it received have declined since that time, the FDA says the numbers of adverse events it received increased.
"We recognize that there is something going on with this particular product and don't know what it is. It's in the best interest of public health to let people know that these are the kinds of reports we're seeing," says Cathy Backinger, PhD, an FDA analyst.
Johnson & Johnson has issued an educational grant to a medical research organization, Communicore, in Seattle, to convene a panel of medical professionals to help determine what type of study should be conducted on the catheter. The study will include two other midline catheters in addition to the Landmark catheter, to determine whether the problems reported are unique to the Landmark brand. *
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content