Surprise, regret: Reactions to Menlo Care decision
A search for replacement catheters
The weeks following Johnson & Johnson’s decision to pull its three Menlo Care catheters off the market has seen a diverse range of reactions. Some professionals claim to have seen the decision coming, while others were taken by complete surprise.
A 1995 study questioned the safety of Menlo Care’s Landmark catheter. Use of the Landmark dropped but was reportedly on the rise following an expert panel’s favorable findings. (See Home Infustion Therapy Management, October 1996, p. 113.) However, Menlo discontinued the Landmark and two other catheters made of the same Aquavene material.
"[The decision] doesn’t surprise me," says Randy Stilley, RN, president of IV Consultants in Victoria, TX, an independent firm that places IVs and teaches professionals to place IVs. Stilley notes that, from his conversations with sales reps, the controversy surrounding the catheters were hindering sales efforts. "Almost every sales rep was dealing with that. When you’re in the defensive position most of the time, you’re in a losing game."
However, the negative reports didn’t affect Stilley’s impression of the catheters.
"I’ve been using Landmarks for years, and I love the things," he says. "I’ve got a four year old and a one year old, and if they needed infusion therapy for six weeks, I would insist on a Landmark."
Stilley estimates that he has put in nearly 4,000 Landmarks and has never had a problem. According to a report published by Communicare, a Seattle-based communications and consulting firm, the adverse event rate improved from one in 4,000 units to one in 13,000 after Menlo recommended a new insertion technique.
However, some felt the move in taking the products off the market was the right one.
"I was completely surprised they took all three off the market [as opposed to just the Landmark]," notes Nancy Moureau, BSN, CRNI, PICC Excellence of Orange Park, FL. "I think it was a very positive move by Johnson & Johnson, and that it finally showed a certain amount of responsibility."
Many IV nurses are now left looking for a replacement.
"There are a lot of patients you cannot insert a through-the-introducer catheter because their veins are just too small, so you need an over-the-needle product like the Landmark to be able to access those patients," notes Lynn Hadaway, RNC, CRNI, president of Lynn Hadaway and Associates of Milner, GA. "Patients are going to have to go back to being stuck multiple times with multiple short peripheral catheters, or they’re going to have to endure central lines."
Hadaway, who worked per diem at an Atlanta hospital and was an IV nurse at a regional medical center prior to starting her own consulting and education firm, says she never had any problem with the catheters and isn’t convinced the Landmark is as bad as its recent image portrays.
"The safety less blood contact was far superior to other products," she says.
Darnell Roth, CRNI, D/R Intravenous Therapy Consulting in St. Louis, adds not enough information was disclosed regarding the studies conducted on the Landmark for her to make a fair judgment.
"Clinically, the catheters are not the problem," she says. "We know more about the catheter than we know about the other parts of this situation the environment, the therapies the patient was on. We didn’t have enough information about all those other things to really make a fair determination of what was causing the problems, and we couldn’t overcome that lack of information."
Information Hadaway wishes would have been disclosed includes:
• the diagnosis of the patient who experienced problems;
• the types of medications the patient was on;
• medical history;
• the skill level of the inserters.
Marzie Blackman, RN, an IV/cardiopulmonary nurse with Alacare Home Health in Albertville, AL, agrees that the information provided in the studies made it difficult to form an opinion.
"The studies I read were not conclusive to me," he says. "Also, other studies I have read say that any type of stimulation of the interior of the vein is going to cause an anaphylactic-type response. But I asked a question in an IV class I was taking and was told the complication rate for other catheters was much less [than the Landmark]."
Blackman, for one, looks forward to seeing what Menlo Care comes out with to replace the shelved catheters.
"It was a nice system the way they had it set up," he says. "If they can use that with a different material [other than Aquavene] that doesn’t cause problems, they have themselves onto something."
In the medical field, all it takes is a shadow of a doubt to sink a product.
"I didn’t use any of the catheters because I felt the risk outweighed the benefit," notes Moureau. "I don’t know what was going on with the catheters, but it certainly did cause a reaction. What caused that is unknown."
That’s exactly what prompted Olsten Kimberly Qualitycare in Virginia Beach, VA, to stop using the Landmarks.
It scared me enough’ to stop using them
"Because of the few problems that were reported, it scared me enough to not want to use those particular catheters," says Mary Beth Owen-D’Amico, manager of clinical practice. Her agency switched within six months of the first reports of anaphylactic reactions, even though the agency never had such problems itself.
"We never saw an anaphylactic reaction occur," says Owen-D’Amico. "We did see a lot of phlebitis occur with the catheters but nothing more than that."
After switching to Gesco’s Perqcath, the phlebitis rate in patients decreased.
Johnson & Johnson is currently conducting market research for replacement catheters. However, spokesman Bob Andrews said the company could not speculate on any specifics, such as when new catheters may be introduced, if the new products will be made of the Aquavene material, or if the design will closely follow those of the previous Menlo catheters.
[Editor’s note; HITM will keep readers posted on new developments from Johnson & Johnson.]
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