Think research is dry or academic and rarely relevant in clinical settings? Then you should check out the findings of nationally acclaimed researcher, oncology nurse and author Cynthia Chernecky.
Her research on the connection between needleless intravenous connector technology and catheter-related bloodstream infections has caused quite a stir among manufacturers, the Food and Drug Administration and the medical community.
Needleless IV connectors were invented in the 1990s to prevent accidental needlestick injuries and the spread of hepatitis and HIV, Chernecky explained. The connectors worked well, but hospitals noticed a rise in catheter-related bloodstream infections, which are difficult to treat and can be fatal.
“Catheter-induced bloodstream infections cost hospitals $225 million a year, and patients 200,000 days in ICUs,” said Chernecky, Ph.D., RN, AOCN, FAAN, professor of physiological and technological nursing at Georgia Health Sciences University in Augusta. “In studying bloodstream infections, researchers had looked at the difference in patients [their co-morbidities and immune resistance], and they looked at nursing practice. We’ve been blaming nurses for years, saying that they didn’t scrub well enough.”
She acknowledges that patients and practice are significant variables, but she founds one that’s equally significant — the difference in the technology used. Technology changes all the time and some changes are more effective than others, she says.
“IV connectors are used on almost every line in patient care. They’re the No. 1 disposable product in hospitals, and a $4.5 billion business,” she said. “There are about 20 different models on the market and they are vastly different in their designs.”
Chernecky knew studies had shown that higher bloodstream infection rates can be caused by occlusions in connectors, which appear unable to control bacterial growth in blood that pools in the dead space within the fluid pathways of the devices.
She performed comparison tests on different devices, expecting that fewer harmful bacteria would grow in three silver-treated devices. Manufacturers had added the silver coating for antibacterial properties.
“Instead, the silver-coated devices grew more bacteria than the devices with no coating when they came into contact with blood,” Chernecky said. “We think that the blood has some sort of coating effect that makes the silver ineffective in killing significant amounts of bacteria. Once the silver comes in contact with blood, it doesn’t work.”
She believes the silver-coated devices received FDA clearance because of evidence that the devices killed bugs. The FDA has since sent a letter requiring manufacturers of positive displacement IV connectors to prove within three years that their needleless IV connector devices don’t increase catheter-related bloodstream infections.
Chernecky understands that the implications of her research could open up liability issues for manufacturers.
“The FDA should require a blood-component test protocol when evaluating these devices,” she said. “The devices are not inside the body, but they are connected to something inside the body: the bloodstream.
“It doesn’t make a lot of sense that you wouldn’t test it without using blood. After all, when you buy a coffee pot, you assume it was tested with coffee, right?”
Further testing of devices in in-vitro and oncology settings revealed that a device made by RyMed Technologies — InVision-Plus CS with chlorhexidine/silver ion engineering — was effective in killing eight common microorganisms associated with catheter-related bloodstream infections, including methicillin-resistant Staphylococcus aureus, or MRSA.
“It grew almost no bacteria,” she said. The synergy of silver and chlorhexidine could be the key to improving performance of the devices, she believes.
Chernecky didn’t set out to be the Consumer Reports of IV needleless connectors, but she has no intention of quitting her research.
“I’m a cancer nurse and I’m out to save lives,” she said. “I see my cancer patients working so hard to overcome their disease, then they get an infection that makes things worse.”
In February, Chernecky presented her findings at the National Conference on Cancer Nursing Research and warned against the use of silver-treated IV connectors. She also was to present her findings at a Society for Healthcare Epidemiology of America Conference in Dallas earlier this month.
“I’ve had e-mails from clinicians who want to change what device they use in order to lower infections. The technology definitely matters, especially in health care,” Chernecky said.
How something is made and what it can and can’t do matters, especially in medical technology.
“It’s important that we continue to do research on technology,” she said. “If we can prevent something by using better technology, why wouldn’t we? Our patients deserve the best.”
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