Medical Device Daily National Editor

About 250 Americans die every day in a plane crash ... or a train wreck ... or a terrorist attack.

Choose one of these as a metaphor, but whichever one you pick, the 250 figure represents the number of people, on average, who die in U.S. hospitals every day as the result of catheter-related bloodstream infections, or CRBSIs.

In total, this type of infection, besides causing this estimated number of fatalities, impacts up to 250,000 Americans a year, according to data released by Society of Critical Care Medicine (Mount Prospect, Illinois) at its recent 38th Critical Care Congress in Nashville.

And CRBSIs have been identified as one of the six hospital-acquired infections that the U.S. Department of Health & Human Services aims to eradicate, in a recently unveiled five-year plan.

At the Critical Care Congress earlier this month, Issam Raad, MD, professor and chairman of infectious diseases at the University of Texas M.D. Anderson Cancer Center (Houston), presented data on more than 100 cancer patients that had developed CRBSIs.

The results: that exchanging an infected central venous catheter (CVC) for a CVC impregnated with both minocycline and rifampin was significantly more effective than other measures at resolving the potentially fatal symptoms associated with CRBSIs, such as acute fever and bacteremia, within 72 hours of insertion.

But the timeline for the uptake of this catheter, the Spectrum from Cook Medical (Bloomington, Indiana), has been incredibly slow, since the doubly-impregnated antibiotic catheter was FDA-cleared about 10 years ago.

The reasons? They are multiple, Thomas Cherry told Medical Device Daily.

Cherry, clinical manager of infection solutions and in charge of product development at Cook, said that in the 1990s hospitals weren't even tracking rates of infections. "If you're not looking," he said, "you don't know you have a problem."

He noted the recent concern by HHS, the determination by the Centers for Medicare & Medicaid Services to withhold payment for treatment of unnecessary infections and new regulations by several states to mandate the reporting of hospital infection rates so that awareness of these infections "has improved 100-fold" since the 1990s.

But Cherry said that it is still difficult for nurses and doctors to take "ownership" of the problem.

CRBSIs occur when micro-organisms travel from the contaminated environment of the skin to the sterile environment of the blood along the surface of the catheter. But Cherry said that it is often too easy for one hospital worker to point fingers elsewhere for this happening.

The double use of antibiotics – impregnated into the catheter "inside and outside," said Cherry – was developed by Raad and Rabih Darouiche, MD, of Baylor College of Medicine (Houston), the technology then licensed by Cook.

When an organism migrates onto the catheter, the antibiotics are released and the organism is killed before it can enter the bloodstream and cause a serious infection, the antibiotics then biodegrading out of the body.

Specifically, Cook said that the data presented by Raad demonstrated that an over-the-wire exchange of an infected CVC for a CVC impregnated with the two antibiotics that act together, can more quickly help eliminate an existing infection in cancer patients than currently recommended procedures.

Raad said that the study's findings "suggest that there is a more effective way to manage CRBSIs in cancer patients than current guidelines, which recommend the removal of the infected CVC or replacing it with another CVC inserted at a new access site.

"Although removing a CVC that has led to a CRBSI can help manage the infection, this is not always practical for cancer patients because there is additional cost and risk to the patient associated with replacement of the catheter at a new access site," he said. "Exchanging a CVC for an minocycline and rifampin-impregnated CVC not only reduces cost and risk associated with a new access site, but demonstrates superior clinical outcomes for this high risk group of patients."

Another study of the catheter was presented at the critical care gathering by Craig Coopersmith, MD, associate professor of surgery and anesthesiology and co-director of the Surgical Intensive Care Unit at the Washington University School of Medicine (St. Louis).

He reported that this study showed that CVCs impregnated with the combination of antibiotics were significantly more likely to prevent CRBSIs than second-generation CVCs coated with a solution of chlorhexidine and silver sulfadiazine.

The 46-month study — which Cook called the first-ever, head-to-head comparison — revealed that only 1.4 CRBSIs per 1,000 catheter days developed in patients who had received CVCs impregnated with minocycline and rifampin, vs. 2.7 infections per 1,000 catheter days in patients who had received the second generation chlorhexidine/silver sulfadiazine-coated CVCs.
Cherry noted that while there are two other catheters on the market with the purpose of combating hospital infections, they are primarily preventive.

He said the Spectrum is the only one using the double antibiotic approach, with the impregnation of these materials being key to its effectiveness. And the company says that the doubly-antibiotic impregnated catheters have been proven to be 12 times less likely to result in a CRBSI than catheters coated with antiseptic or invasive agents.

Cherry reported about an 80% to 95% use of the bacteria-fighting catheters in pediatric populations, but that the same use "doesn't correlate to the adult side as well," to as little as 12% in adult populations.

He acknowledged that a primary barrier is price, the Spectrum increasing the cost from 75% to 100%, but very much saving downstream costs by preventing infections and extended hospital stays. And he said that Cook continues to work with insurers for the additional reimbursement coverage.

As a private company, Cook does not report specific sector sales, but Cherry said that with increasing awareness of the infection problem, the growth in the sales of the Spectrum is growing "8% to 15% on a given year" but should be growing up to 300% yearly.

"Now," he said, "administrators finally are starting to recognize that infections cost hospitals a tremendous amount of money."

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